CN105263542A

CN105263542A - Manifold diaphragms

Info

Publication number: CN105263542A
Application number: CN201480029452.0A
Authority: CN
Inventors: B.N.富尔克森; A.黄; B.T.凯利
Original assignee: Fresenius Medical Care Holdings Inc
Current assignee: Fresenius Medical Care Holdings Inc
Priority date: 2014-04-22
Filing date: 2014-04-22
Publication date: 2016-01-20
Also published as: EP2999497A4; EP2999497A1

Abstract

The specification discloses a portable dialysis machine having a detachable controller unit and base unit. The controller unit includes a door having an interior face, a housing with a panel, where the housing and panel define a recessed region configured to receive the interior face of the door, and a manifold receiver fixedly attached to the panel. The manifold includes diaphragms adapted to minimize the dead space between the dialysis machine pins and improve responsivity. The base unit has a planar surface for receiving a container of fluid, a scale integrated with the planar surface and a heater in thermal communication with the container. Embodiments of the disclosed portable dialysis system have improved structural and functional features, including improved modularity, ease of use, and safety features.

Description

Manifold diaphragm

The cross reference of related application

The part continuation application of the application's to be the title submitted on February 8th, 2011 be No. 13/023490th, U.S. Patent application (hereinafter referred to as " ' 490 apply for ") of the CO-PENDING of " portable dialysis machine ".

' 490 applications are part continuation applications of No. 12/237914th, the U.S. Patent application in JIUYUE in 2008 submission on the 25th, and its priority depends on No. 60/975157th, the United States Patent (USP) provisional application in JIUYUE in 2007 submission on the 25th.

' 490 applications are part continuation applications of No. 12/610032nd, the U.S. Patent application in submission on October 30th, 2009, and its priority depends on No. 6l/109834th, the United States Patent (USP) provisional application submitted on October 30th, 2008.

' 490 applications are part continuation applications of No. 12/324924th, U.S. Patent application, and its priority depends on No. 60/990959th, the U.S. Provisional Patent Application that the name submitted on November 29th, 2007 is called " SystemandMethodofChangingFluidicCircuitBetweenHemodialys isProtocolandHemofiltrationProtocol " and No. 61/021962nd, the U.S. Provisional Patent Application with same names submitted on January 18th, 2008.

' 490 applications are part continuation applications of No. 12/249090th, U.S. Patent application, and its priority depends on No. 60/979113rd, the U.S. Provisional Patent Application that the name submitted on October 11st, 2007 is called " Photo-AcousticFlowMeter ".

' 490 applications are part continuation applications of No. 12/575449th, U.S. Patent application, and its priority depends on No. 6l/10327lth, the United States Patent (USP) provisional application submitted on October 7th, 2008.

' 490 applications are part continuation applications of No. 12/75l930th, U.S. Patent application, and its priority depends on No. 6l/165389th, the United States Patent (USP) provisional application submitted on March 31st, 2009.

' 490 applications are part continuation applications of No. 12/705054th, U.S. Patent application, and its priority depends on No. 61/151912nd, the United States Patent (USP) provisional application submitted on February 12nd, 2009.

' 490 applications are part continuation applications of No. 12/875888th, U.S. Patent application, it is the division of No. 12/238055th, U.S. Patent application, and the priority that No. 12/238055th, U.S. Patent application depends on No. 60/975840th, the United States Patent (USP) provisional application in JIUYUE in 2007 submission on the 28th.

' 490 applications are part continuation applications of No. 12/210080th, U.S. Patent application, and its priority depends on No. 60/971937th, the United States Patent (USP) provisional application in JIUYUE in 2007 submission on the 13rd.

' 490 applications are part continuation applications of No. 12/35l969th, the U.S. Patent application in submission on January 12nd, 2009.

' 490 applications are part continuation applications of No. 12/713447th, U.S. Patent application, and its priority depends on No. 6l/155548th, the United States Patent (USP) provisional application submitted on February 26th, 2009.

' 490 applications are part continuation applications of No. 12/575450th, U.S. Patent application, and its priority depends on No. 6l/103274th, the United States Patent (USP) provisional application submitted on October 7th, 2008.

The full content of all description listed above is incorporated to herein by reference.

Technical field

The present invention relates to and a kind of there is the architectural feature of improvement and the portable dialysis system of functional character.Especially, dialysis system of the present invention relates to a kind of portable dialysis system of modularity, ease for use and the security features with improvement.

Background technology

For carrying out hemodialysis, the blood purification system of hemodiafiltration or the hemofiltration process that relates to blood has the extracorporeal circulation of the exchanger of semipermeable membrane.Such system also comprises the hydraulic system for blood circulation and the hydraulic system for cyclic permutation liquid or dialysis solution, and described displacement liquid or dialysis solution comprise concentration some electrolyte balance close to the concentration of the blood of the experimenter of health.But, most conventional can the size of blood purification system very huge and be difficult to operation.In addition, the design of these systems makes them very heavy and is unfavorable for using and installing of disposable unit.

Use the normal dialysis treatments of the fixing device in hospital, comprise two stages, i.e. (a) dialysis, wherein poisonous material and scum silica frost (being generally micromolecule) from blood through semipermeable membrane to dialysis liquid, and (b) ultrafiltration, the pressure differential wherein between blood circuit and dialysis fluid circuit is that the decompression in the latter loop makes the water content of blood be reduced the amount of pre-determining or rather.

The dialysis procedure of use standard device is often loaded down with trivial details and cost is very high, and requires that patient is bound by dialysis center by long duration.Although have developed portable dialysis system, the portable dialysis system of routine has suffered some shortcoming.First, they are not enough to modularity, prevent from being thus easy to default, movement, transhipment and maintenance.The second, system is not enough to be used in the reliable accurate of patient and uses with being simplified.Use the interface of system of disposable unit and method be subject to patient use in misuse and/or mistake.In order to make portable dialysis system really effective, it easily should be used by the individual not being health care professional, and wherein disposable input and data input are sufficiently constrained to and prevent coarse use.

A conventional design of dialysis system uses once-through system.In once-through system, the blood of dialysis solution in dialyser once and be then abandoned.Once-through system has the multiple shortcomings coming from and use large water gaging.First, suppose 50% elimination factor of R.O. (reverse osmosis) system, then need the water of at least 1000 to 1500ml/min.The second, need the water purification system for the continuous-flow of 100 to 800ml/ minute providing the water purified.3rd, need the circuit of at least 15 amperes, so that the water of pumping 100 to 800ml/minute, and the 4th, need land drainage or any other the used dialysis solution that can hold at least 1500ml/min and RO to get rid of the reservoir of water.

Conventional system is also very unreliable, because must use a large amount of pipes of the fluid circuit comprising cleaning system, thus increases the risk of leaking and rupturing.Except being difficult to except transport because its size is comparatively large, conventional dialysis machine also suffers from the shortage of motility.Such as, the hemodialysis procedure based on adsorbent has a lot of special hardware requirement, these hardware not share by hemofiltration technique.Therefore, will it is advantageous that have shared hardware component such as pumping system, it can be used for making dialysis system can at hemofiltration pattern and hemodialysis MODE of operation.

In addition, need one can with safety, cost effectively and reliably mode effectively provide dialysis system functional portable system.Especially, a kind of liquid delivery that can meet dialysis procedure is needed to require simultaneously the compact dialysis fluid reservoir system of other key functions various that integrated such as fluid heating, fluid measurement and supervision, leak detection and disconnection wherein detect.

Especially, just disconnect detection, the effective detection disconnected return line is difficult, because most known method is the change based on the pressure monitored and in detection vein line of return pipeline.Return line disconnects and usually occurring because situation extracted by pin.Because pin provides the highest fluid resistance in extracorporeal blood circuit usually, so not being very significantly because pin disconnects the pressure change caused and can not being detected easily in return line.Pressure Drop is also low-down catheter disconnects cause return line to disconnect from the health of patient wherein.Therefore, it is insecure for using pressure to detect as indicant or tolerance the disconnection returned in venous blood loop, and can cause serious damage.In addition, the method using the detection of air bubble as the instruction disconnected can not be relied on, because the disconnection in vein return line does not make air be inhaled into return line pipeline.Therefore, a kind of equipment and method for detecting the disconnection in vein return line of improvement is needed.In addition, a kind of equipment and the method that are such as placed on the moistureproof cushion at pin insertion position without any need for additional element is also needed.

In addition, do not have in the prior art gratifying for keeping the mechanism of volume degree of accuracy during the dialysis procedure easily can implemented with rational cost.Great majority for the art methods keeping the volume degree of accuracy of displacement liquid and output fluid are not suitable for and use with disposable apparatus.A kind of for keeping the art methods of volume degree of accuracy to relate to weighing both displacement liquid and output fluid.But this method is difficult to carry out in practice.Another art methods comprises the volumetric balance room used for dialysis system.But, such room not only complicated and cost but also high on structure, and be also unsuitable for disposable apparatus.Volume flow measurement is another known method, but the degree of accuracy of this method is not proved to be.In addition, this method is implemented for being very difficult to the dialysis system of disposable form.Another art methods relates to use two piston pumps to realize volume degree of accuracy.But this method is difficult to implement with disposable form with rational cost terrifically, and for also uneconomical with the operation of required volume pumped (order of magnitude of 200ml/min).Therefore, need a kind of can be used for accurately keeping being infused into patient and from its removing fluid volume and can with low cost implement method and system.

In addition, a kind of multipass dialysis system based on adsorbent reducing total water demand relative to conventional system is needed.Also need a kind ofly to can be used for the dialysis system based on adsorbent of once-through and the manifold of Multiple through then out system of the present invention, it provides the portable structure with molded blood and dialysis solution flow path to avoid the pipeline of complex mesh.

It is also contemplated that, there is a kind of portable dialysis system possessing the structural design of the modularity being configured to optimization system, make it possible to thus easily to default, movement, transhipment and maintenance.Be configured to prevent from use occurring mistake it is further desirable that have and be enough to retrain the system interface preventing inaccuracy from using, patient is by its input data or dispose disposable unit.

Summary of the invention

In one embodiment, subject description discloses a kind of dialysis machine, comprising: controller unit, wherein said controller unit comprises: door, and it has inside face; Have the shell of panel, wherein said shell and panel limit the sunk area being configured to the described inside face receiving described door; And manifold receiver, it is fixedly attached to described panel; And base unit, wherein said base unit comprises: plane surface, and it is for receiving the container of fluid; Scale, itself and described plane surface are integrated; Heater, itself and described plane surface thermal communication; And sodium sensor, itself and described plane surface electromagnetic communication.

Alternatively, described manifold receiver comprises at least one in the guide of shaping, pin or breech lock.Described panel configuration becomes to provide the path leading to multiple pump.Described panel configuration becomes to provide the path of four peristaltic pumps leading to almost parallel aligning.Described inside face comprises four pump boots (pumpshoe).When described door is received in described sunk area, aim at for one in each and described four peristaltic pumps in described four pump boots.At least one in described pump boots is movably attached to described door by component and spring.Described component is bolt.

Alternatively, described controller unit also comprises the sensor of the motion for measuring described component.Described controller unit also comprises the measurement for receiving from the described motion to described component of described sensor and determines the controller of fluid pressure based on described measurement.

Alternatively, described machines configurations becomes to use the water of about six liters to carry out dialysis treatment, and wherein said water is from non-sterile source.Described manifold receiver is configured to receive the molded plastics substrate limiting first flow path of fluidly isolating with the second flow path.Each hydraulic diameter had in the scope of 1.5mm to 7.22mm in described first and second flow paths.Described molded plastics substrate is attached to multiple pipeline, and wherein said multiple pipeline is attached to dialyser.Described controller unit also comprises the component of the outside being connected to described shell, and wherein said component is configured to physically receive described dialyser.

Alternatively, described base unit also comprises the component of the outside being connected to described base unit, and wherein said component is configured to physically receive described dialyser.Described multiple pipeline is suitable for removably being attached to adsorbent box.Described base unit also comprises the component of the outer surface being connected to described base unit, and wherein said component is configured to physically receive described adsorbent box.Described controller unit comprises basal surface, and wherein said basal surface comprises the first physical interface and the first data-interface.

Alternatively, described base unit has top surface, and wherein said top surface comprises and is configured to coordinate the second physical interface of described first physical interface and second data-interface that can be connected with described first data-interface.Described scale comprises multiple deflection division and Hall element, each and described plane surface physical connection in wherein said deflection division, and each being configured in wherein said Hall element senses physical displacement.Described sodium sensor comprises conductivity sensor.

Alternatively, described conductivity sensor comprise there is multiple circle coil, with the capacitor of described coil electric connection and energy source, wherein said coil and capacitor limit circuit, described energy source and described circuit electric connection.Described conductivity sensor exports the value of the na concn in the described fluid of instruction based on the energy input from described energy source protected required for whole capacitor constant voltage.

Alternatively, described base unit comprises at least one humidity sensor.Described base unit comprises the door that can be in open state or be in closed condition, and wherein when the described inside face of door is contained in described sunk area described door by physically stop be in open state.Described base unit comprises the door that can be in open state or be in closed condition, and wherein when the described inside face of door is in described sunk area described door by physically locking be in closed condition.Described controller unit comprises multiple sensor, and it is communicated with molded plastics substrate when the described inside face of door is in described sunk area.At least one in described multiple sensor comprises pressure transducer.Described pressure transducer and the flexible membrane pressure communication be integrated in described molded plastics substrate.

Alternatively, described controller unit comprises at least one valve member be communicated with described molded plastics substrate.Described controller unit comprises the multiple programmed instruction being configured to activate described valve member, and the activation of wherein said valve member makes fluid flow is conducted through in described molded plastics substrate two fluid paths be separated one.The operator scheme of blood purification system is depended in the activation of described valve member.

Alternatively, described valve member has release position and closed position, and wherein said valve member comprises: aperture closure element, and it is adjacent to the aperture that fluid may flow through; Biasing member, it has Part I and Part II, and wherein said Part I is adjacent to described aperture closure element when valve member is in described release position; First magnet and the second magnet, wherein said first and second magnets are sufficiently in close proximity to institute's displacement member, to be applied to by magnetic force on institute's displacement member; And actuator, it moves institute's displacement member towards described first magnet for generation of magnetic field, makes described Part I against described aperture closure element, and makes aperture closure element close described aperture.

Alternatively, described Part I comprises shell, elastomeric material, bar and the gap between described elastomeric material and described bar.It is exist or do not exist that optical pickocff is positioned to the gap sensed in described valve member.Described Part I comprises bar, and the described Part II of institute's displacement member is the metallic object with the diameter larger than described bar.Described bar is incorporated into cylinder.Described first magnet is larger than described second magnet.Described aperture closure element comprises at least one in diaphragm, elastomeric material and compressible material.Described aperture closure element closes described aperture against valve seat.

Alternatively, described valve member comprises: aperture closure element, and it is adjacent to the aperture that fluid may flow through, wherein said aperture closure element when valve is in the closed position against valve seat; Movable link, it is physically movable relative to described aperture closure element, wherein said movable link moves to the second position when described valve is in described closed position from the primary importance when described valve is in release position, and wherein, in the described second position, movable link against aperture closure element to impel described aperture closure element against described valve seat; First magnet and the second magnet, it has separated part, and wherein said first magnet and the second magnet produce magnetic field in described separated part, and wherein said magnetic field has direction; And actuator, it can produce electromagnetic force, the direction in the reverse described magnetic field of wherein said electromagnetic force.

Alternatively, described dialysis machine comprise be positioned to sensing gap be exist or non-existent optical pickocff.Described first magnet and the second magnet are provided for the area supported of the motion of described movable link.First magnet with the first magnetic pole is larger than second magnet with the second magnetic pole.Described first magnetic pole and the second magnetic pole repel each other, and wherein said first magnet and the second configurations of magnets become to make described first magnetic pole and the second magnetic pole strength to each other.

Alternatively, described controller unit also comprises the valve with the first steady statue and the second steady statue, wherein said valve comprises magnet, wherein will produce the magnetic force that biasing member is moved in described controller unit in energy input to described valve, the motion of wherein said biasing member impels and changes between described first state and described second state, and the maintenance of the wherein said first or second state does not need energy input.

Alternatively, described molded plastics substrate has aperture, and wherein said aperture fluid flow when described valve is in described first steady statue is closed, and wherein said aperture fluid flow when described valve is in described second steady statue is open.Described aperture fluid flow when institute's displacement member is pressed into material in described aperture is closed.At least one in described multiple sensor is effusion meter.

Alternatively, described effusion meter comprises at least two probes, each in described probe has main body and is positioned at the contact surface on described molded plastics substrate, first heat wave produced in the fluid flowing through described molded plastics substrate in response to the first thermal signal in wherein said at least two probes, and the described heat wave of second sensing in described fluid in described at least two probes.Described effusion meter also comprises reference generator, wherein said reference generator output reference signal.Described effusion meter also comprises thermal source, wherein said thermal source receives the described reference signal from described reference generator, be configured to and first thermal bonding in described at least two probes, and produce described first thermal signal with the phase place deriving from described reference signal.Described effusion meter also comprises temperature sensor, and wherein said temperature sensor is configured to and described second probe thermal bonding, and produces second thermal signal with the phase place deriving from described heat wave.Described effusion meter also comprises multiplexer, and this multiplexer is for receiving from the input signal of described reference generator, for receiving described second thermal signal and for exporting the 3rd signal.Described effusion meter also comprises for the low pass filter of receipt source in the signal of described 3rd signal and for receiving the described reference signal from described reference generator, and wherein said low pass filter modulates its cut-off frequency based on described reference signal.

Alternatively, the distance being less than two inches separated by described second probe and described first probe.Described dialysis machine also comprises for amplifying described 3rd signal and producing the amplifier deriving from the signal of described 3rd signal.Each main body in described at least two probes has the diameter in the scope of 0.03 inch to 0.15 inch.Each contact surface in described at least two probes has the diameter in the scope of 0.025 inch to 0.2 inch.Described second probe comprises thermal resistor.Described low pass filter produces the signal through filtering, and wherein said reference generator produces described reference signal based on the described signal through filtering at least in part.Described effusion meter dynamically adjusts described reference signal to keep constant frequency.Described effusion meter dynamically adjusts described reference signal to keep constant phase.

Alternatively, described effusion meter is configured to beam projection in the fluid in described molded plastics substrate; Detection first, upstream place in a fluid and the acoustical signal obtained at second point place, downstream; Determine the phase contrast between the described acoustical signal that upstream is in a fluid detected and the described acoustical signal that downstream is detected; And from described by the flow of fluid described in the phase difference calculating determined.Described phase contrast is by determining the signal subtraction representing the described acoustical signal phase place detected at upstream and downstream.

Alternatively, described effusion meter comprise for by beam projection to flow through described molded plastics substrate transparent fragment fluid in optical system; For detecting the first sound wave detector of the acoustical signal at first place in the upstream of described transparent fragment; For detecting the rising tone wave detector of the described acoustical signal at the second point place in the downstream in described transparent fragment; And for determine the described acoustical signal that detects in upstream and detect in downstream described acoustical signal between phase contrast and for the processor of the flow from the fluid in molded plastics substrate described in determined phase difference calculating.

For determining that the processor of described phase contrast comprises subtrator.Described optical system is pulse laser system.Described light beam projects along the direction perpendicular to the flowing of described fluid.Described effusion meter has the operability sensing range between 20ml/min to 600ml/min.Described effusion meter has the operability sensing range between 20ml/min to 600ml/min.Described controller unit also comprises the reader for detecting the identification data be embedded in molded plastics substrate.Described controller unit also comprises and is suitable for when described door is in described sunk area and the temperature sensor of molded plastics substrate thermal communication.

Alternatively, described controller unit comprises the disconnection monitor whether the blood lines connecting portion for being determined to patient has disconnected.Described disconnection monitor comprises: pressure transducer, the blood flow paths pressure communication in itself and described manifold, and wherein said pressure transducer produces the signal of the pulse signal in the described blood flow paths of instruction; Heart reference generator, wherein said heart reference generator detects and produces the signal of the pulse indicating described patient; Pressure transducer data sink, wherein said pressure transducer data sink receives the described signal of the pulse signal in the described blood flow paths of instruction; Heart reference signal receiver, wherein said heart reference signal receiver receives the described signal of the pulse of the described patient of instruction; And processor, wherein said processor makes the described signal of the pulse signal in the described blood flow paths of instruction be correlated with to produce the data indicating the blood lines being disconnected to described patient to be connected with the described signal cross of the pulse of the described patient of instruction.

Alternatively, described disconnection monitor also comprises controller, the described data-triggered siren that wherein said controller connects based on the blood lines being disconnected to described patient.Described disconnection monitor also comprises controller, and the described data that wherein said controller connects based on the blood lines being disconnected to patient close dialysate pump.

Alternatively, described pressure transducer non-invasively produces the signal of the pulse signal in the described blood flow paths of instruction.Described processor is relevant with indicating the described signal cross of patient pulse with the described signal of the pulse signal made in the described blood circuit of instruction by the product of the corresponding pairs point of the described signal of the signal and instruction patient pulse that calculate the pulse signal in the described blood circuit of instruction in the time frame of specifying.

Alternatively, described disconnection monitor also comprises and is used to guide patient and is starting the programmed instruction being first attached described heart signal reference generator before dialysate pump.Described disconnection monitor also comprises and is used to guide described system at the programmed instruction starting the described signal of catching the pulse signal in the described blood flow paths of instruction before dialysate pump.

Alternatively, described controller unit also comprises: display; Scale; Barcode reader; And store the memorizer of multiple programmed instruction, wherein when performing, described instruction produces: the first graphic user interface a) for presenting on the display, and wherein said first graphical user interface displays needs each additive used in dialysis treatment; B) the second graph user interface for presenting on the display, the user of system described in wherein said second graph user interface prompt submits to multiple additive to scan to use described bar code scanner; And the 3rd graphic user interface c) for presenting on the display, the user of system described in wherein said 3rd graphical user interface prompts submits to multiple additive to measure to use described scale.

Alternatively, described scale is digital scale.Described bar code scanner provides the vision successfully read instruction.Described memorizer also comprises the form multiple additive title be associated with multiple bar code.Described memorizer also comprises the form be associated with multiple gravimetric value by multiple additive.The visual representation of described first graphical user interface displays additive packing.Described 3rd graphic user interface only points out the user of described system to submit to additive to measure to use described scale when the bar code of additive is not identified.Described 3rd graphic user interface only points out the user of described system to submit to additive to measure to use described scale when unavailable for the bar code of additive.

Alternatively, described controller unit also comprises: display; Scale, it comprises multiple magnet; Electronic reader; And store the memorizer of multiple programmed instruction, wherein when performing, described instruction produces: the first graphic user interface a) for presenting on the display, and the user of system described in wherein said first graphical user interface prompts submits to multiple additive to scan to use described bar code scanner; And second graph user interface b) for presenting on the display, the user of system described in wherein said second graph user interface prompt submits to multiple additive to measure to use described scale.

Alternatively, when performing, described instruction also produces the 3rd graphic user interface for presenting on the display, and wherein said 3rd graphical user interface displays needs each additive used in described dialysis treatment.Described scale is digital scale, and wherein said digital scale produces the data that representative is placed on the weight of the object on described digital scale.Described digital scale also comprises at least three deflection divisions.Each in described deflection division comprises magnet and corresponding Hall element.

Alternatively, described dialysis system also comprises molded plastics substrate, and wherein said molded plastics substrate comprises the first flow path and the second flow path that are limited to wherein, and wherein said first flow path and described second flow path are fluidly separated by valve.Described controller unit also comprises the memorizer storing multiple programmed instruction, and wherein said programmed instruction is configured to limit the first state of described valve and the second state of described valve according to selected operator scheme.Selected operator scheme or priming mode (primingmode) or Therapeutic mode.Described first flow path is placed in and is communicated with described second flow path fluid by the first state of described valve.Described first flow path is placed in and described second flow path fluid isolation by the second state of described valve.Described dialysis system also comprises molded plastics substrate, the second fluid loop that wherein said substrate comprises the first fluid loop for fluid infusion being entered patient and is used for from patient's removing fluids.

Alternatively, described controller unit also comprises the first pump being configured to blocked operation on described first loop and described second servo loop; Be configured to the second pump of blocked operation on described second servo loop and described first loop; And for making described first pump can selection operation and for making described second pump can the controller of selection operation on described first loop and described second servo loop on described first loop and described second servo loop, each in wherein said first pump and the second pump only operates a loop in the given time.

Alternatively, compared to described second pump, the fluid of described first pump time per unit pumping higher amount.Described first and second pumps blocked operation on described first and second loops reaches regular hour section, and the wherein said time period derives from the admissible difference by the amount of the fluid of described first and second pump time per unit pumpings.Described first and second pumps are peristaltic pumps.The current limiter of the pressure differential between described dialysis system also comprises for described first and second loops of equilibrium.Described current limiter is active, and carrys out balanced described pressure differential based on the first pressure transducer derived from described first loop and the pressure differential measured by the second pressure transducer derived from described second servo loop.

Alternatively, described panel also comprises the funnel limited by two inclined surfaces leading to passage, and wherein said passage comprises at least one humidity sensor.When described door is contained in described sunk area, described funnel to be positioned at below described manifold and to be configured to the fluid from described manifold leaks to guide towards described humidity sensor.

Alternatively, the basal surface of described controller unit is suitable for the top surface being removably attached to described base unit.Described controller unit and described base unit electric connection.Described controller unit is physically separated with described base unit.Described controller unit and described base unit data communication.Described controller unit is communicated with described base unit fluid.

In another embodiment, the present invention relates to a kind of dialysis machine, comprising: first module, wherein said first module comprises: door, and it has first surface; Shell, it is attached to described door, and its housing has second; At least one manifold receiver, it is fixedly attached to described second; And display, it is for display graphics user interface; And second unit, wherein said second unit comprises: plane surface, and it is for the container of support fluid; Weighing device, itself and described plane surface are integrated; Heater, itself and described plane surface thermal communication; And sodium sensor, it is in close proximity to described plane surface.

Alternatively, described manifold receiver is configured to receive molded plastics substrate, and this molded plastics substrate limits first flow path of fluidly isolating with the second flow path.Described molded plastics substrate comprises: ground floor; The second layer; The first flow path limited by the first surface of described ground floor and the first surface of the described second layer; The second flow path limited by the first surface of described ground floor and the first surface of the described second layer; And valve, its with described first flow path with described both second flow paths all fluid be communicated with, wherein said valve has the first state and the second state, and wherein when being in described first state, described first flow path and the second flow path fluid isolation, and when being in described second state, described first flow path is communicated with the second flow path fluid.

Alternatively, described molded plastics substrate comprises and more than second relative more than first port aimed at of port.At least one in described more than first port and more than second port comprises the component with external cylindrical shell, and wherein said component has the inner space limited by central axis.Described central axis has a certain degree relative to the plane residing for described plastic base.Described angle is in the scope of 5 degree to 15 degree.At least one in described more than first port is by having the first diameter and limiting perpendicular to the transverse cross-sectional area of the Second bobbin diameter of described first diameter.At least one in described more than first port is connected to by the port channel having the 3rd diameter and limit perpendicular to the transverse cross-sectional area of the 4th diameter of described 3rd diameter, wherein said 3rd diameter is greater than described first diameter, and wherein said 4th diameter is less than described Second bobbin diameter.Described port channel comprises the protruding member that at least one has the height being less than described 4th diameter.Described port channel is covered by flexible membrane.Described port channel comprises at least one and is configured to prevent flexible membrane to collapse in described port channel and the protuberance blocking described port channel completely.The described transverse cross-sectional area of described port channel is different from the described transverse cross-sectional area of described port, and the described transverse cross-sectional area of described port channel is configured to be maintained across described port and the speed entering the constant of the fluid of described port channel.

Alternatively, described molded plastics is limited by the first sections, the second sections and the 3rd sections; Wherein said first sections is parallel to described second sections; Wherein said 3rd sections perpendicular to and to be attached in described first sections and the second sections each; And wherein said first, second, and third sections limits first flow path of fluidly isolating with the second flow path.

Alternatively, described first sections has more than first port, and described second sections has more than second port, and wherein said more than first and second ports are aimed at.At least one in described more than first and second ports comprises the component with the inner space limited by central axis.Described central axis has a certain degree relative to the plane residing for described first and second sections.Described angle is in the scope of 5 degree to 15 degree.At least one in described more than first port is by having the first diameter of the length being parallel to described first sections and limiting perpendicular to the transverse cross-sectional area of the Second bobbin diameter of described first diameter.At least one in described more than first port is connected to the port channel of the 3rd diameter that has and possess the length being parallel to described first sections and the transverse cross-sectional area perpendicular to the 4th diameter of described 3rd diameter, wherein said 3rd diameter is greater than described first diameter, and wherein said 4th diameter is less than described Second bobbin diameter.Described port channel comprises at least one protruding member with the height being less than described 4th diameter.Described port channel is covered by flexible membrane.Described port channel comprises and is configured to prevent flexible membrane from collapsing at least one protuberance in described port channel.The transverse cross-sectional area of described port channel is different from the described transverse cross-sectional area of described port, and the transverse cross-sectional area of described port channel is configured to be maintained across described port and the Reynolds number entering the constant of the fluid of described port channel.

Alternatively, described 3rd sections is attached to the center of described first sections and described second sections.Described 3rd sections is not attached to the center of described first sections or described second sections.Described first sections has at least one port, and a part for the inside of wherein said port is limited by smooth base portion.Described first sections and described second sections have the length in the scope of 4 to 7 inches and the width in the scope of 0.5 to 1.5 inch.Described 3rd sections has the length in the scope of 2.5 to 4.5 inches.Described first sections has the first length and the first width, described second sections has the second length and the second width, and described 3rd sections has the 3rd length and the 3rd width, and wherein said first length and described second length are greater than described 3rd width, described first width and described second width are less than described 3rd length.Described first sections has the first length and the first width, and described second sections has the second length and the second width, and wherein said first length equals described second length and described first width equals described second width.

Alternatively, described manifold receiver is configured to receive molded plastics substrate, and wherein described molded plastics substrate is connected to dialyser by tubular segment.Described dialysis machine comprises the receptor of the outer surface for described dialyser being removably attached to described dialysis machine.Described tubular segment comprises the disposable conducting probe with internal capacity, and wherein said internal capacity receives the fluid flowing through described tubular segment.Described disposable conducting probe is suitable for being detachably connected to the probe of the coupling on the outer surface being positioned at described dialysis machine.

In another embodiment, the present invention relates to a kind of dialysis machine, comprising: first module, itself and second unit data communication, wherein said first module comprises: door, and it has the pressure plare in the inside face being positioned at described door; Have the shell of panel, wherein said shell and panel limit the sunk area being configured to the described inside face receiving described door; Aligning guide, it is fixedly attached to described panel, and wherein said aligning guide is configured to manifold removably to receive on the panel, and is positioned to against described pressure plare when described door is contained in described sunk area by described manifold; And wherein said second unit comprises: plane surface, it is for receiving the container of fluid; Weighing device, itself and described plane surface are integrated; Heater, itself and described plane surface thermal communication; And sodium sensor, it is in close proximity to described plane surface.

In another embodiment, the present invention relates to many logical hemodiafiltration systems based on adsorbent, advantageously in many wildcards are put, combine hemofiltration and hemodialysis.

In another embodiment, the present invention relates to the manifold support portion for blood purification system, described blood purification system is such as but not limited to hemodiafiltration and ultrafiltration.In one embodiment, manifold of the present invention comprises the composite plastic manifold being wherein molded with blood and dialysis solution flow path.This manifold based on plastics can use jointly with many logical hemodiafiltration systems based on adsorbent of the present invention.

In another embodiment, blood purification system parts, such as sensor, pump and disposable product are integrated in molded manifold.Disposable, such as but not limited to dialyser and adsorbent box, removably can be loaded on manifold or be in fluid communication with it.Disposable, such as but not limited to dialyser and adsorbent box, is fixedly attached to and is fixedly attached to described manifold and the pipeline be in fluid communication with it.

In another embodiment, ultrafiltration system is integrated in manifold by blood and ultrafiltrate flow path being all molded in manifold.In one embodiment, manifold disclosed herein comprises the single compound plastic structure can made by combination two plastic base half portion, is also referred to as substrate or shell.

In another embodiment, the present invention relates to the dialysis system of a kind of support based on the blockade system of electronics.Therefore, in one embodiment, reader is arranged on system shell and/or manifold such as but not limited on hemodiafiltration and ultrafiltration manifold, and reads the identification indicant on the disposable that is loaded on dialysis shell and/or manifold.By network such as public network or private network and database communication, reader checks that whether effectively, accurately or have enough integrity being safe and can use disposable.This is carried out about the information of disposable from remote database lookup by the identification indicant based on article.If disposable has " invalid " or " impaired " state, then (information based on receiving from data base) system " blockade " use of disposable product of being loaded, and therefore do not allow user to continue to use this system to be used for the treatment of.

This description also relates to a kind of diaphragm/barrier film, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises: convex surface, it from described manifold outwardly and be fixedly attached to described manifold at first end with at the second end, distance between wherein said first end and the second end limits length and the height of described diaphragm, wherein, described diaphragm has the height identical with described manifold at described first end and the second end, wherein, the height of described convex surface is increased to the first height relative to described manifold from described first end, and wherein, the height of described convex surface is highly decreased to described the second end from described first.

In one embodiment, described diaphragm/barrier film first height relative to described manifold between 0.03 and 0.04 inch.

In one embodiment, described diaphragm has along the thickness from described first end to the length of described the second end, and wherein, described thickness is constant along described length.In one embodiment, the thickness of described diaphragm is between 0.03 and 0.04 inch.

In one embodiment, the total length of described diaphragm is between 0.625 and 0.675 inch.

This description also relates to and a kind ofly comprises one or more manifold with the diaphragm of convex surface mentioned above.

This description also relates to a kind of diaphragm, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises: the first roughly plane surface, it has first end and the first bending section, wherein, distance between described first end and the first bending section limits length and the height of described first plane surface, wherein, described first end is fixedly attached to described manifold, and wherein, the described height of described first plane surface is substantially equal to the height of described manifold, convex surface, its from described first plane surface described first bending section continue and outwardly, described convex surface proceeds to the second bending section from described first bending section, wherein, distance between described first bending section and the second bending section limits length and the height of described nonreentrant surface, wherein, described nonreentrant surface has the height identical with described first plane surface at described first bending section with described second bending section, wherein, the height of described convex surface is increased to the second height relative to described manifold from described first bending section, and wherein, the height of described convex surface is highly decreased to described second bending section from described second, and the second roughly plane surface, it proceeds to the second end from described second bending section, wherein, distance between described second bending section and the second end limits length and the height of described second plane surface, wherein, described the second end is fixedly attached to described manifold, and wherein, the described height of described second plane surface is substantially equal to the described height of described first plane surface, and the described length of described second plane surface is substantially equal to the described length of described first plane surface.

In one embodiment, described convex surface described second height relative to described first roughly plane surface between 0.03 and 0.04 inch.

In one embodiment, described diaphragm from the described first end of described first plane surface to the total length of the described the second end of described second plane surface between 0.625 and 0.675 inch.In one embodiment, the length of described convex surface is between 0.125 and 0.15 inch, and the length of the length of described first plane surface and described second plane surface is between 0.25 and 0.2625 inch.

This description also relates to and a kind ofly comprises one or more manifold with the diaphragm of the first and second plane surfaces mentioned above and convex surface.

This description also relates to a kind of diaphragm, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises: the first inclined surface, it has first end and the first bending section, wherein, distance between described first end and the first bending section limits the length of described first inclined surface, wherein, described first end is fixedly attached to described manifold, and wherein, described first inclined surface has the first height at described first end and has the second height at described first bending section, described second of wherein said first inclined surface is highly greater than described first height of described first inclined surface relative to described manifold, and wherein, described first of described first inclined surface is highly substantially equal to the height of described manifold, convex surface, its from described first inclined surface described first bending section continue and outwardly, described convex surface proceeds to the second bending section from described first bending section, wherein, distance between described first bending section and the second bending section limits length and the height of described nonreentrant surface, wherein, described nonreentrant surface is highly identical with second of described first inclined surface with the height of described second bending section at described first bending section, wherein, the height of described convex surface is increased to second height of described nonreentrant surface relative to the second height of described first inclined surface from described first bending section, and wherein, the height of described convex surface is highly decreased to described second bending section from described second of described nonreentrant surface, and second inclined surface, it proceeds to the second end from described second bending section, wherein, distance between described second bending section and the second end limits the length of described second inclined surface, wherein, described the second end is fixedly attached to described manifold, and wherein, described second inclined surface has the first height at described second bending section and has the second height at described second bending section, described first of wherein said second inclined surface is highly greater than described second height of described second inclined surface relative to described manifold, and wherein, described second of described second inclined surface is highly substantially equal to described first height of described first inclined surface, described first of described second inclined surface is highly substantially equal to described second height of described first inclined surface, and the described length of described second inclined surface is substantially equal to the described length of described first inclined surface.

In one embodiment, described second height of described convex surface is relative to described second height of described first inclined surface and described first height of described second inclined surface between 0.01 and 0.02 inch, and described first of described second height of described first inclined surface and described second inclined surface is highly about 0.02 inch relative to described manifold.

In one embodiment, described diaphragm has along the thickness from described first end to the length of described the second end, and wherein said thickness is constant along described length.In one embodiment, the thickness of described diaphragm is between 0.03 and 0.04 inch.

In one embodiment, described diaphragm from the described first end of described first inclined surface to the total length of the described the second end of described second inclined surface between 0.625 and 0.675 inch.In one embodiment, the length of described convex surface is between 0.125 and 0.15 inch, and the length of the length of described first inclined surface and described second inclined surface is between 0.25 and 0.2625 inch.

This description also relates to and a kind ofly comprises one or more manifold with the diaphragm of the first and second inclined surfaces mentioned above and convex surface.

These and other embodiment is illustrated in detailed description part, should read detailed description part with reference to accompanying drawing.

Accompanying drawing explanation

These and other feature and advantage of the present invention will be understood, because they are also better understood with reference to detailed description hereafter in conjunction with the drawings, in the accompanying drawings:

Fig. 1 is the front view of an embodiment of dialysis system of the present invention;

Fig. 2 is the view of an embodiment of dialysis system, shows the modularity of system;

Fig. 3 is the view of the front portion of an embodiment of dialysis system, and wherein door is open;

Fig. 4 is the top view of an embodiment of portable dialysis system, illustrated therein is exemplary size;

Fig. 5 is the front view of an embodiment of portable dialysis system, illustrated therein is exemplary size;

Fig. 6 is the front view of another embodiment of dialysis system;

Fig. 7 is the view of another embodiment of dialysis system, shows the modularity of system;

Fig. 8 is the front view of another embodiment of dialysis system;

Fig. 9 is the top view of an embodiment of the reservoir unit of dialysis system;

Figure 10 is the schematic diagram of the example components on the top surface of the reservoir unit being positioned at dialysis system;

Figure 11 is the schematic diagram of the exemplary attachment component on the top surface of the reservoir unit being positioned at dialysis system;

Figure 12 is the schematic diagram of the example components on the top surface of the reservoir unit being positioned at dialysis system;

Figure 13 is the schematic diagram of the example components on the basal surface of the controller unit being positioned at dialysis system:

Figure 14 is the schematic diagram of the exemplary link on the top surface of the reservoir unit being positioned at dialysis system;

Figure 15 is the schematic diagram of an embodiment of the inner frame of the controller unit of dialysis system;

Figure 16 A is the forward sight/side view of an embodiment of dialysis system of the present invention;

Figure 16 B is the forward sight/side view of another embodiment of dialysis system of the present invention;

Figure 16 C is the side view of another embodiment of dialysis system of the present invention;

Figure 17 A is the schematic diagram of the inner structure of an embodiment of the reservoir unit of dialysis system of the present invention;

Figure 17 B is the schematic diagram of the inner structure of an embodiment of the reservoir unit of dialysis system of the present invention;

Figure 17 C is the schematic diagram of the inner structure of an embodiment of the reservoir unit of dialysis system of the present invention;

Figure 17 D is the circuit diagram of exemplary electrical derivative sensor;

Figure 17 E is the diagram of the example coil used in conductivity sensor;

Figure 18 is the schematic diagram of the deflection division used in an embodiment of the reservoir unit of dialysis system of the present invention;

Figure 19 is the schematic diagram of the door locking mechanism implemented in an embodiment of the controller unit of dialysis system of the present invention;

Figure 20 is the schematic diagram of the door locking mechanism implemented in an embodiment of the controller unit of dialysis system of the present invention;

Figure 21 is the view of the front portion of an embodiment of dialysis system, and wherein door is open and is provided with manifold;

Figure 22 is the schematic diagram of an embodiment of the humidity sensor be positioned on the reservoir unit of dialysis system;

Figure 23 is the schematic close up view of an embodiment of the humidity sensor be positioned on the reservoir unit of dialysis system;

Figure 24 is the front view of an embodiment of the reservoir unit of dialysis system, and wherein door is open;

Figure 25 is the schematic diagram of an embodiment for adsorbent box and/or concentrated flow container being attached to the connector mechanism of dialysis system;

Figure 26 is the first exemplary fluid loop diagram;

Figure 27 is the second exemplary fluid loop diagram;

Figure 28 is the 3rd exemplary fluid loop diagram;

Figure 29 is the 4th exemplary fluid loop diagram;

Figure 30 is the schematic diagram of an embodiment of exemplary manifold;

Figure 31 is the schematic diagram of another embodiment of exemplary manifold;

Figure 32 is the schematic diagram of another embodiment of exemplary manifold, illustrated therein is relative size;

Figure 33 is the schematic diagram of another embodiment of exemplary manifold;

Figure 34 depicts the diagram that the first exemplary fluid flows through port;

Figure 35 depicts the diagram that the second exemplary fluid flows through port;

Figure 36 is the diagram of the embodiment depicting angled manifold port structure;

Figure 37 is the diagram of an embodiment in the molding fluid path with general plane base portion;

Figure 38 is the 5th exemplary fluid loop diagram;

Figure 39 is the schematic diagram of another embodiment of exemplary manifold that parts use explicitly of dialysing with other;

Figure 40 is the schematic diagram of another embodiment of exemplary manifold;

Figure 41 is the front view of an embodiment of the controller unit of dialysis system, and wherein door is open and is provided with manifold;

Figure 42 is the front view of an embodiment of the controller unit of dialysis system, and wherein door is open and manifold is mounted by using attachment guide portion;

Figure 43 is the circuit diagram depicting exemplary light sonic flowmeter;

Figure 44 depicts the multiple transmitting signals produced by exemplary light sonic flowmeter;

Figure 45 is the loop diagram depicting exemplary hot effusion meter;

Figure 46 depicts the multiple transmitting signals produced by exemplary hot effusion meter;

Figure 47 depicts multiple variablees of the operation limiting exemplary hot effusion meter;

Figure 48 depicts the multiple transmitting signals produced by exemplary hot effusion meter;

Figure 49 depicts multiple variablees of the operation limiting exemplary hot effusion meter;

Figure 50 A depicts the multiple transmitting signals produced by exemplary hot effusion meter;

Figure 50 B depicts the multiple transmitting signals produced by exemplary hot effusion meter;

Figure 51 depicts multiple variablees of the operation limiting exemplary hot effusion meter;

Figure 52 depicts multiple variablees of the operation limiting exemplary hot effusion meter;

Figure 53 is the schematic diagram depicting exemplary hot effusion meter;

Figure 54 is the schematic diagram depicting exemplary hot effusion meter;

Figure 55 depicts the multiple transmitting signals produced by exemplary hot effusion meter;

Figure 56 is the front view of an embodiment of the controller unit of dialysis system, and wherein door is open and is provided with manifold;

Figure 57 is the diagram of exemplary temperature probe;

Figure 58 is the diagram of exemplary disconnection surveillance;

Figure 59 is the diagram of exemplary disconnection monitor;

Figure 60 is the flow chart limiting exemplary disconnection detection process;

Figure 61 shows the diagram of the exemplary placement of the catheter for measuring CVP;

Figure 62 shows the diagram of the exemplary dialysis system using CVP to measure;

Figure 63 shows the diagram of the exemplary placement of catheter and the measurement of CVP;

Figure 64 is the 6th exemplary fluid loop diagram;

Figure 65 is the 7th exemplary fluid loop diagram;

Figure 66 is the 8th exemplary fluid loop diagram;

Figure 67 is that representative uses pump to exchange the chart realizing an embodiment of volume degree of accuracy;

Figure 68 is the 9th exemplary fluid loop diagram;

Figure 69 A is the tenth exemplary fluid loop diagram;

Figure 69 B is the 11 exemplary fluid loop diagram;

Figure 69 C is the 12 exemplary fluid loop diagram;

Figure 70 is the 13 exemplary fluid loop diagram;

Figure 71 A is the first schematic diagram of exemplary magnetic valve system;

Figure 71 B is the second schematic diagram of exemplary magnetic valve system;

Figure 71 C is the viewgraph of cross-section diagram of an embodiment of the manifold diaphragm of convex surface with projection;

Figure 71 D is with the viewgraph of cross-section diagram being positioned at an embodiment of the manifold diaphragm of the protrusion protuberance of the projection of central authorities in general plane periphery;

Figure 71 E is with the viewgraph of cross-section diagram being positioned at an embodiment of the manifold diaphragm of the protrusion protuberance of the projection of central authorities in the protrusion periphery of projection;

Figure 72 is the schematic diagram of the parts of exemplary magnetic valve system;

Figure 73 is the schematic diagram of another exemplary magnetic valve system;

Figure 74 is the diagram of the operation depicting exemplary magnetic valve system;

Figure 75 is for the diaphragm displacement of the exemplary magnetic valve system chart relevant to power;

Figure 76 is the diagram of the operation depicting exemplary magnetic valve system;

Figure 77 is the flow chart of the operation depicting exemplary magnetic valve system;

Figure 78 is the diagram of the exemplary hardware architecture of an embodiment for dialysis system;

Figure 79 is the chart of the embodiment represented for the multiple additives used in dialysis system;

Figure 80 depicts the flow chart for enabling user accurately add an embodiment of the process of additive;

Figure 81 shows the schematic diagram of the disposal reagent kit packed;

Figure 82 shows the schematic diagram comprising the embodiment being attached to the manifold of multiple pipe and the disposal reagent kit of dialyser;

Figure 83 shows the schematic diagram that the electronics be integrated in disposable product blocks an embodiment of system;

Figure 84 is the 14 exemplary fluid loop diagram;

Figure 85 is the 15 exemplary fluid loop diagram, shows preliminary filling operator scheme; And

Figure 86 is the schematic diagram of another embodiment of exemplary manifold.

Detailed description of the invention

Although the present invention can be implemented in many different forms, in order to promote the object understood principle of the present invention, use concrete syntax to describe them below with reference to embodiment illustrated in the accompanying drawings.But should be understood that and can not attempt to limit the scope of the invention thus.Any further application of any change in described embodiment and further amendment and the as described herein principle of the invention is all envisioned for that the technical staff in field involved in the present invention normally expects.

" persistent period " and its variant refer to the time course of the treatment of regulation, from initial to end, no matter treat because disease is solved or because treat because any reason is terminated by stopping.Within the persistent period for the treatment of, can specify that the stimulation of multiple one or more regulation during it is applied to the treatment cycle of experimenter.

" cycle " refers to that one " dosage " stimulating is applied to the time of experimenter as the part of the treatment plan of regulation within it.

Term "and/or" means two or more the combination any in the one or all or listed key element in listed key element.

Term " comprises " and its variant does not have the restrictive meaning, if these terms occur in the specification and in the claims.

Unless otherwise specified, otherwise " one ", " one ", " refer in particular to that ", " one or more " and " at least one " be used interchangeably and mean one or more.

For any method comprising discrete step disclosed herein, these steps can be carried out with any feasible order.In addition suitably, any combination of two or more steps can be carried out simultaneously.

Equally in this article, the quoting to comprise and all be included in numeral within the scope of this (such as l to 5 comprises l, 1.5,2,2.75,3,3.80,4,5 etc.) of use end points of digital scope.Unless otherwise directed, otherwise the numeral of the amount, molecular weight etc. of all expression ingredients used in the specification and in the claims will be understood to be modified by term " about " in all cases.Therefore, be contrary unless otherwise directed, otherwise the digital parameters proposed in the specification and in the claims is approximation, it can change, depend on sought by the present invention the character of expectation that obtains.At least, and not as the attempt of restriction to the instruction of the equivalent of the scope of claim, each digital parameters should be at least fabricated by the common technology of rounding up of application according to the numeral of reported significant digits.

Although the digital scope and the parameter that propose broad range of the present invention are approximations, the digital value proposed in concrete example is as far as possible accurately reported.But all digital values are inherently containing the scope necessarily deriving from the standard deviation found in they respective thermometricallies.

Apparatus structure

Subject description discloses the embodiment of safety and functional modular portable dialysis system with improvement.With reference to figure l and 2, in one embodiment, dialysis system 100,200 comprises the top unit 101, the 20l that are detachably fixed to base portion 102,202.Base portion 102,202 comprises the reservoir 122,222 for fluid storage, measurement and supervision.Top unit 101,201 (being also referred to as formant or controller unit) comprise graphic user interface 114,214, pumping unit and there is the door 110,210 of power lock and machinery mechanism for subsequent use, as discussed further below.

Button 105 is for being detachably fixed to first side of top unit 10l, 20l by dialyser 103.Adsorbent box locking base portion 104,204 for adsorbent box 107 is detachably fixed to top unit 10l, the second-phase of 20l tosses about.Should be understood that, button 105, hemofilter 103,315, adsorbent box locking base portion 104,318 and adsorbent box 107,317 can be positioned on the same side of top unit 10l, as shown in Figure 3.In any one situation, base unit has the enough larger area relative to top unit, to keep adsorbent box, maintenance infusion flow container, catch any spilling and/or any leakage be directed in leak detector on the either side making bracket be formed in top unit.

With the anticoagulant pump of the form of syringe pump 190 between dialyser 103 and door 110.Alternatively, top unit 101 can comprise bottle keeper, and the slightly pointed base portion of its tool is to be contained in bottle upside down in bottle keeper shell.Infusion line is connected to the outlet (blood side) of the entrance of blood pump, blood delivery side of pump or dialyser.Infusion line can also " pass " air bubble detector with sensing whether/when anticoagulant is drained or stops.

In one embodiment, have the degree of depth identical from base unit 402 with reference to Fig. 4, top unit 40l (it comprises user interface and controller) but different length and height, base unit 402 comprises the reservoir integrated with scale.In this exemplary, top unit 40l and base unit 402 all have in the scope of 10 to 30 inches, the more preferably degree of depth D of about 19 inches.Below simultaneously with reference to Figure 4 and 5, in this exemplary, top unit 40l, 50l have in the scope of 6 to 20 inches, the more preferably length Lt of about 14 inches, and base unit 402,502 has in the scope of 14 to 40 inches, the more preferably length Lb of 27 inches.In this exemplary, top unit 40l, 50l have in the scope of 7 to 2l inch, the more preferably height H t of about 14.5 inches, and base unit 402,502 has in the scope of 3 to 11 inches, the more preferably height H b of 7 inches.

As shown in Figure 5, base unit 402,502 can also be limited by two shoulders 504, and the sidepiece of each top unit 50l from being positioned at center stretches out along the length of base unit 502.Top unit is preferably positioned at the center of base unit 502, as measured by length Lb in the diagram.Therefore, shoulder 504 can be restricted to have in the scope of 4 inches to 10 inches, the more preferably length of about 7 inches.Lip 503 upwards extending on the surface that its shoulder 504 physically contacts top unit 50l from base unit 502, this lip limits the surface that top unit 50l aims at and places thereon.Lip 503 is continuous around the base portion of top unit 50l, and have the length identical with top unit 50l and the degree of depth, the height had is restricted to the difference between Ht2 and Ht.In one embodiment, lip height in the scope of 0.1 to 3.5 inch, more preferably 0.6 inch.The total height H t3 of system in the scope of 10 to 35 inches, more preferably 22 inches.

The outer enclosure structure limiting top unit 50l and base unit 502 can be characterized by rectangular parallelepiped protrusion part, cuboid or box, and each have four sidepieces, a top and a bottom.In an exemplary embodiment, for both top unit 50l and base unit 502, two (each have outside and interior surface) in four sidepieces have identical height, length and the degree of depth, and top and polycrystalline substance (each have outside and interior surface) have identical height, length and the degree of depth.

Should be understood that, the system configuration shown in figure l, 2,3,4 and 5 is exemplary and nonrestrictive.Such as, as shown in Figure 3, top unit 30l can be positioned on the side of base unit 302 and (produce asymmetric base portion), as contrary at center relative to the overall length of base unit 302 with on the top being positioned at base unit 302 (producing symmetrical base portion).Although side top unit 301 being placed into base unit 302 has the advantage all conduit connection and consumable goods are placed on the same side of system, adsorbent box 317 and dialyser 313 there is no need to be crowded together and make machine more be difficult to use.

With reference to Fig. 6, in another embodiment, top unit 60l (comprising user interface and controller) has the degree of depth identical from base unit 602 height still different with length, and base unit 602 comprises the reservoir integrated with scale 604.In this exemplary, top unit 60l and base unit 602 all have in the scope of 16.0 to 20.0 inches, be more preferably less than 24 inches and the degree of depth of about 17.0 inches.In this exemplary, top unit 60l and base unit 602 have in the scope of 10.0 to 15.0 inches, are more preferably less than the length Lt of 18 inches or about 13.0 inches.In this exemplary, top unit 60l has in the scope of 10.0 to 14.0 inches, be more preferably less than 17 inches and the height H t of about 12.0 inches, and base unit 602 has in the scope of 9.0 to 11.0 inches, be more preferably less than 13 inches and the height H b of about 9.5 inches.The total height that two unit are combined is represented by Ht3.But therefore base unit 602 and top unit 60l have identical surface area different height.Should be understood that, base unit 602 and top unit 60l also can have identical surface area and identical height.

What extend out below base unit 602 is planarized flank 610, and it comprises the adapter for being attached adsorbent box and transfusion container 615.The surface of flank 610 can comprise the existence that can sense moisture electronically and/or the film that can tilt any moisture to be guided to the sensor placed on strategy.

With reference to Fig. 7, in another embodiment, top unit 70l physically can be connected with docking station (dockingstation) 705, its be positioned at long-range base unit 702 electronically and be fluidly connected 715.Although the reservoir being arranged in base unit 702 will still must be communicated with controller 70l fluid, but the use of docking station 705 will allow to change by the larger motility of the size of reservoir system used, Controller gain variations is allowed to be implemented under multiple operational version thus or such as, for patient, little patient and the large patient of more wide region.

With reference to Fig. 8, in another embodiment, portable dialysis system 800 merges upper subsystem (pumping and the control unit) 80l with lower assembly 802, as described earlier.The lower part 802 of system 800 comprises the dialyzate bag 805 of independent suspension.That is, the part of dialyzate bag 805 not as lower assembly 802 is combined, as in disclosed embodiment before.In addition, lower assembly 802 is designed such that it is combined with the Weighing mechanism being integrated into and hanging in the structure 810 of independently dialyzate bag 805.This dialysis system that is arranged in is configured to when operating under hemofiltration pattern be suitable, such as, because do not need the various sensors used in based on the dialysis of adsorbent under hemofiltration pattern, ammonia, pH and sodium sensor; Therefore can remove whole reservoir assembly module, and system 800 can be operated simply by using dialyzate bag 805.The modularity of lower subsystem 802 and compact design makes it be easy to remove, and the system by operating under taking unrequired parts away and being reduced at hemofiltration pattern.This is another advantage be integrated into by the critical piece of the dialysis fluid circuit used during hemodialysis pattern in lower base unit 802.

Dialysis system of the present invention realizes representing function and the operating parameter relative to prior art with significant improvement.With reference to the embodiment shown in figure l to 6, top unit is in the scope of about 20-40 pounds and more particularly 30 pounds, and base unit is in the scope of about 15-30 pounds and more particularly 22 pounds, thus lighter than prior art systems.Top unit is in the about scope of l to 4 cubic feet and more particularly 2.3 cubic feet, and base unit is in the about scope of l to 4 cubic feet and more particularly 2.8 cubic feet, thus has the volume less than prior art systems.

In addition, dialysis system uses the water more less than prior art systems.Although conventional system treats use about 120 liters at every turn, in one embodiment, between native system uses 3 to 8 liters, and more particularly between 5 to 6 liters.In addition, system does not need household drain, supplies the outlet of connection or separation to process excessive water.

In addition, system design is compacter, has low power requirements (peak value is only 300W, is 50 to 100W during operation), not in order to the fluid pouch of preliminary filling or required separation of advancing, and has integrated pump.This device uses the blood flow scope of 20-600Qb (ml/min), the dialysate flow operation of 50-500Qd (ml/min).Volume degree of accuracy is accurate to equally and is less than +/-30ml/ hour.

As shown in Figure 2, dialysis system is modular.In one embodiment, top unit 20l physically can be separated with base unit 202.Top unit 20l comprises the primary electronic component of the system be formed integrally as in stand-alone shell, comprises graphic user interface, controller and pump.Not only large but also heavy base unit 202 comprises reservoir 222.System electronics allows portable dialysis system to be separated into multiple unit for installing, safeguard and advancing with being separated of reservoir, and wherein each subelement is easy to be handled, pack and carry.The size designing control assembly is especially transported to a carrier for by UPS or other doors.Its motility also providing product to grow.Such as, if to controller unit or improve (such as reducing the change that fluid volume or volume scale are measured) reservoir individually, then existing client only needs in upgrading two component parts, instead of the two.Equally, if only one break down (such as pump has burnt out) in two parts, then client has only needed submission one for repairing or buy in two parts.

Possibility is become in order to make above-described modularity, embodiment of the present invention adopt bolt lock mechanism, base unit 202 is attached to top unit 20l securely by bolt lock mechanism in the first configuration, and can be manipulated to and base unit 202 dismantled removedly from top unit 20l.Even if two systems can not use breech lock and are stacked on top of each other simply, but the existence of breech lock and use reduce the unexpected probability disconnected.In addition, when being latched in together, device more easily moves.Bolt lock mechanism does not preferably use any instrument, and is connected by convex/recessed coupling that the top surface of the base portion with base unit that are used in top unit exists and is realized simply.Further preferably, bolt lock mechanism is designed to the firm aligning guaranteed between top and base unit, make it possible to thus use the electronic unit (electric power connector be exposed such as on the bottom of top unit and the top of base unit, as described further below), it automatically contacts when unit is properly aligned beneath and completes motor circuit.This allows to use single power supply and be simply connected/disconnect.

With reference to Fig. 9, base unit 902 has four sidepiece 905a, 905b, 905c, 905d, a base portion, a top surface 906 and through the accessibility reservoir 922 of the first sidepiece 905d.Base unit 902 is also included in multiple breech lock matching structure 920a, 920b on its top surface 906.In one embodiment, the present invention includes two breech lock matching structures 920a, 920b, they are centrally located into relative to the length of base unit 902 guarantees uniform distribution of weight.First breech lock matching structure 920a is preferably positioned at the distance equaling 1/3rd of the width of base unit 902 as measured from sidepiece 905d.Second breech lock matching structure 920b is preferably positioned at the distance equaling 1/3rd of the width of base unit 902 as measured from sidepiece 905b.

As shown in Figure 10, bolt lock mechanism comprises metal framework 1001, and it is securely fastened to the top surface of base unit l005 by using such as bolt, screw or other securing member 1002.Framework l001 supports and can insert flexibly in corresponding breech lock and the protuberance can dismantled from it or slender member 1003.

In order to by base unit firmly and be removably attached to top unit, top unit comprises complementary mechanical slip breech lock, and it is securely attached to the base portion of top unit.In one embodiment, the base portion of top unit comprises the first breech lock, and it is preferably positioned at the center of top unit relative to the length of top unit, and is in the distance equaling 1/3rd of the width of top unit as measured from the first side.Base portion also comprises the second breech lock, and it is preferably positioned at the center of top unit relative to the length of top unit, and is in the distance equaling 1/3rd of the width of top unit as measured from the second side contrary and parallel with the first side.

As shown in figure 11, top unit comprises the breech lock 1100 of the metal flat base portion 1120 with slip.Track 1130 engages slidably with the lower surface of top unit, and the lower surface of top unit has coupling component to be held in place by track 1130.Breech lock 1100 has two breech lock boss 1115, and they are suitable for slipping into and skid off the matching structure being physically attached to base unit top surface.

Breech lock matching structure 920a, the 920b be attached on the breech lock 1100 of top unit and the top surface of base unit 906 mates.In operation, when slide latch 1100 is in primary importance, in fact top unit will not coordinate or aim at base unit, because slide latch 1100 can not physically mate with breech lock matching structure 920a, 920b rightly on the top of base unit.Firmly being placed into prepare top unit on the top surface of base unit 906, moving in the member retaining structure of slide latch on the bottom being positioned at top unit and being placed in the second position.In the second position, the handle of breech lock 1111 will be given prominence to, thus mobile boss 1115 allows top unit to be correctly seated in base unit away from breech lock matching structure 920a, 920b.

With reference to Figure 12 and 13, by the little rubber foot of four on the bottom of top unit 130l or base oneself upon pad 1340, the top unit 130l with slide latch 1380 aims at base unit 1202, four little rubber foots or base oneself upon pad 1340 be configured to or be suitable for closely and be assembled to securely be located close to base unit 1202 top on four cavitys of each corner or pit 1230 in.In addition, top unit 130l can be used in alignment pin 1260 on the top surface of base unit 1202 or protuberance and accurately aim at base unit 1202, and alignment pin 1260 or protuberance are configured to or are suitable for firmly and be closely assembled in the respective cavities 1390 in the lower surface of top unit 130l.Base unit also has breech lock matching structure 1263, as described above.

Rubber is based oneself upon portion 1340 to be registered in cavity 1230 and pin 1260 is registered in cavity 1390 breech lock 1380 guaranteed on top unit 130l and can be aimed at and be latched to breech lock matching structure 1263 easily, and there is no excessive test and mistake.Once aim at, breech lock 1380 just by being slided in breech lock matching structure 1263 by breech lock 1380 and mating with breech lock matching structure 1263, thus produces tight fit between these two unit.Referring back to Fig. 9 and 11, be understand breech lock, latch handle 1111 is pulled or otherwise handles, thus by boss 1115 from base unit groove 920a, 920b release, and to allow on top unit from bottom lower unit lifting.

In addition, possibility is become in order to make above-described modularity, embodiment of the present invention also adopt electricity and data communication bindiny mechanism, it in the first configuration, be based upon electric connection between base unit and top unit safely and/or data communication connects, and the electric connection terminated in the second configuration between base unit and top unit and/or data communication connect.

With reference to Figure 14, being connected electrically in when top unit is placed in base unit between top and base unit is produced.These connect by non-contacting infrared COM1 1403 and promote power port 1404 and makes, and they to be integral in plate 1402 and to be securely attached to the top surface of base unit 1405 by using securing member 140l.Should be understood that, the lower surface of top unit is then by the electrical contact pad comprised with promote proper alignment.It is to be further understood that to promote and the position of contact pad can be put upside down, thus contact pad is placed on the top surface of base unit by lower surface distribution being placed on top unit.

In one embodiment, the pin by being spring loaded six is placed in and forms high current power with the electrical contact of the contact pad of the lower surface being integrated into top unit and be connected.Three pins are used for+24 volt DC electric currents and three pins are used for ground connection.In one embodiment, pin or probe have following characteristic: a) the minimum center of 0.175 inch, b) current rating of 15 amperes (continuous print), c) at 0.06 inch of spring force in 6.2oz to 9.0oz scope to 0.067 inch stroke, d) typical resistances of 10m Ω is less than, e) range within the scope of 0.09 to 0.1 inch, f) impulse stroke within the scope of 0.06 to 0.067 inch, g) made and gold-plated cylinder by nickel/silvery, h) stainless steel spring (gold-plated alternatively), i) manufactured and gold-plated plunger by fully hard beryllium copper, and j) rustless steel biases ball alternatively.The spring force of pin is bent by absorption or other are twisted and warped and contribute to preventing fracture.Should be understood that, term electricity pin represent any can the protuberance of transmission electric power, electrical contact pad represents any surface that can receive electric pin.

Non-contacting infrared COM1 1403 adopts two LED emitter and two LED receptors, and they are aimed at the LED emitter of two in the lower surface of top unit with two LED receptors and communicate with them.Distance between transmit port and receiving port is less than 0.3 inch.On the top surface of base unit and both lower surface of top unit, it is two right that four LED unit are divided into, and one controlled (comprising an emitter and a receptor) and a safety (comprising an emitter and a receptor).When top and base unit are fitted when aligned, these ports are placed in data communication.

In one embodiment, LED emitter is the 870nm high speed infrared emitting diode manufactured by the two heterogeneous technology of GaAlAs.LED emitter is the high speed diode with following characteristic: a) radiant power of superelevation, b) low forward voltage, c) high impulse currents operation is suitable for, d) angle of half intensity of about 17 degree, e) peak wavelength of about 870nm, f) backward voltage of about 5V, g) forward current of about 100mA, h) peak forward current of about 200mA, i) the surge forward current of about 0.8A, j) power dissipation of about 190mW, k) junction temperature of about l00 degree Celsius, and the l) operating temperature range of-40 to 85 degrees Celsius.Should be understood that, non-contacting infrared COM1 can be distributed in the top surface of base unit or the lower surface of top unit in the mode of any function.It is to be further understood that any other COM1 well known by persons skilled in the art or structure can be implemented in this article.

In one embodiment, LED receptor is high-speed silicon photodiode, has the response time, the about 0.25mm that are exceedingly fast ²radiation sensitive regions and the angle of half sensitivity of about 15 degree.Receptor has following characteristics: a) backward voltage of about 60V, b) power dissipation of about 75mW, c) junction temperature of about l00 degree Celsius, d) operating temperature range of-40 to 85 degrees Celsius, e) forward voltage of about lV, f) MBV of 60V, and the diode capacitance of g) about 1.8pF.

Referring back to figure l, 2 and 3, at the top of controller unit 20l is handle 211,311 and with the work space of the form of spendable bracket 112,212.The handle be positioned in system top pumping part is directly connected to inner structure or the framework of system, and be not simply that outer plastic is molded, the extension of shell or the epidermis around top unit 10l, 20l.Allow to use handle by system with safety and the form re-locating system of reliable treatments load, particularly when instrument adopts six premium on currency (adding about 40lbs) to operate to directly connecting of internal system framework.

With reference to Figure 15, in one embodiment, top unit 150l comprises interior metal housing, framework or shell 1510, and electronic unit, controller and other top unit parts comprise within it or are mounted to it.Inner shell 1510 comprises the horizontal protruded arm 1507 of the side, back extending to top unit 150l.Approximate horizontal top support frame 1505 comprises at least one and is integrated into handle 1520, base bracket 1530 and vertical arm 1506 in top support frame structure 1505, thus produces single continuous print metal or molded plastic parts.Base bracket 1530 is attached to the inner shell 1510 in top unit 150l front portion securely, and vertical arm 1506 is securely attached to protruded arm 1507 by using screw at point 1508 place.By bracket 1505 and handle 1520 sound construction are attached to the inner shell 1510 of top unit 150l, avoiding usually can by being placed on junction point place between the outside of handle and top unit or outside shell and the Latent destruction occurred or fracture by heavy weight load.

Metallic door 1562 is also attached to inner frame or housing 1510 by hinge 1565, and it forms the inner frame of door 110, as shown in Figure 1.Door 1562 is attached to the plate 1561 as a part for inner frame 1510 securely.Structure 1563 and 1572 is the structures of the protuberance keeping and/or represent internal motor and pulley assembly.The protuberance 1583 extended from framework 1510 back is used for connecting various electronic unit, comprises power input module and is connected l582 with USB.The top of controller unit or bracket l505 are smooth and have sidewall, make it be desirable for the storage supplied or temporary transient working surface.

Another architectural feature of controller unit 160l is shown in Figure 16 A.Preferably, unit 160l has the reader of built-in exposure, such as barcode reader or RFID label tag reader 1605, and it may be used for reading the code on disposable unit or label.Operatively, user will preferably use the whole code/labels on reader run-down parts.Can carry out the prompting to user by initial GUI dialysis setting steps, this initial GUI dialysis arranges indicating user by inswept for each disposable unit reader.

In doing so, reader obtains the identifying information about disposable product, this identifying information is transferred to storage internal table in memory, identifying information is compared with the content of internal table, and verifies that (or not verifying) correct disposable unit (additive particularly used in dialysis solution) exists.The content of internal table or can be described the identity of disposable product and the prescription of amount in detail by remote access and produce by the manual input of the identity of disposable product and amount.This verification step has at least two benefits.First guarantee user have in it occupies all needed for parts, second is guarantee to use correct parts (not being forge or inappropriate disposable product).These parts can be used for making multiple user interfaces become possibility, as described further below.

In another embodiment, the reader 1605 be arranged on the sidepiece of top unit is specialized Multifunction infrared photographing units, and it provides the ability reading bar code and the level change detected in another pattern in transfusion container in a pattern.Photographing unit is transmitted in the infrared signal that fluid level is reflected.Received by the infrared remote receiver of photographing unit by the signal reflected, and the position by making purpose processor obtain processing the meniscus determining liquid level.In one embodiment, photographing unit can be determined and monitor the resolution changing to 0.02mm of liquid level.In one embodiment, photographing unit is 1.3 pixel single-chip camera modules, what have in following characteristic is one or more: a) 1280W × 1024H active pixel, b) 3.0 μm of Pixel Dimensions, c) l/3 inch optical format, d) RGBBayer color filter array, e) integrated 10 ADC, f) integrated digital image processing capacity, comprise defect correction, camera lens shadow correction, image scaling, demosaicing, sharpening, Gamma correction and color space conversion, g) embedded controller of camera, for auto-exposure control, AWB controls and back of the body level compensation, h) frame rate able to programme and output derate function, i) reach 15fpsSXGA to line by line scan, j) low-power 30fpsVGA lines by line scan, k) 8 parallel-by-bit video interfaces, 1) two wire serial control interface, m) PLL on sheet, n) analog power of 2.4 to 3.0V, o) the I/O power supply be separated, p) there is the integrated power management of on and off switch, and q) 24 pin shielding socket options.In one embodiment, photographing unit is 1.3 million pixel camera manufactured by STMicroelectronics, and model is VL6624/VS6624.

Top or the base unit of dialysis system equally preferably have electrical interface, such as Ethernet connecting portion or USB port, to make it possible to be directly connected to network, thus are convenient to the checking of long-range prescription, in accordance with vigilance and the operation of other remote service.USB port allows to be directly connected to accessory product such as blood pressure monitor or haemat/saturated monitor.Interface is isolated electronically, guarantees the safety of patient thus, and the quality of no matter joint connecting device.

The front portion of top unit has the graphic user interface 114 providing simple user interface to system l00.In family is arranged, importantly device should be easy-to-use.Maximum use color and touch screen are suitable for this application ideally.Touch screen allows multiple user's input configuration, provides multiple linguistic competence, and can easily be seen at night (particularly having brilliance control and night vision color).

The feature that GUI also comprises is for automatically closing during operation, opening and lock door.In one embodiment, door is opened to the first position latching by GUI, and then user must press physics door and open button fully to open door.In another embodiment, device have allow user open door manual override control part (such as by press beat door open button twice or use extra power) manually open door.With reference to Figure 16 A, preferably, what be in close proximity to GUI1630 is the single mechanical button 1610 with the instruction of light vision, if it is activated, provides the central stop button with common function (such as halt system), and has nothing to do with the state of operation.

In order to provide further fixing and safety, system 1600 controls opening of reservoir door 1625 in base unit 1615, and does not need the door controller of the accelerator control system independent of top unit 160l, button or mechanical system.In one embodiment, by department 1635 before being physically attached to, being connected to top unit 160l or otherwise by the protuberance 1620 that department before top unit 160l 1635 controls, reservoir door 1625 is physically stoped to be opened.Protuberance 1620 can extend from any direction relative to top unit 160l at reservoir door 1625, and this protuberance is in order to provide the physical barrier to opening reservoir door 1625.Therefore, in the present embodiment, people can not when not first unlock and open reservoir door 1625 when opening controller door 1635, controller door is by user interface control.

In another view of an embodiment of dialysis system, as shown in fig 16b, dialysis system 1600 comprises and has ammoniacal sensor 1670, GUI1630 and the controller unit 160l for the single mechanical button 1610 that opens and closes controller door 1635, and there is the base unit 1615 of reader such as barcode reader or RFID label tag reader 1605 of reservoir door 1625 and built-in exposure, reservoir door 1625 is physically stoped by protuberance 1620 to be opened, protuberance 1620 is physically attached to, be connected to the front department 1635 of top unit 1601 or otherwise controlled by department before top unit 160l 1635.Controller unit 160l and base unit 1615 are positioned at the top of the flat base 1645 of single continuous print general plane base portion or segmentation, and this flat base 1645 has two attachment means 1675,1695.The first attachment means 1675 for being held in place by adsorbent box 1680 is positioned to be adjacent to the second attachment means 1695 for being held in place by concentrated flow container 1695, on the same side of dialysis system 1600.Flat base 1645 preferably includes drain pan or other moisture catches or sensing surface.

With reference to Figure 16 C, controller unit 160l and base unit 1615 illustrate with side.Adsorbent box 1680 is held in place by attachment means 1675 and concentrated flow container 1690 is held in place by attachment means 1695.Both adsorbent box 1680 and concentrated flow container 1690 are placed on the top of plane surface such as drain pan 1668 to guarantee that all moisture is all captured.On the sidepiece that scanning device 1605 is positioned at base unit 1615 and with the directly optical communication of concentrated flow container 1690.Fluid flow to adsorbent box 1680 from system 1600 and flows from it and flow from concentrated flow container 1690 via three tubuloses or fluid sections 164l, 1642,1643.Concentrated flow container 1690 is positioned through concentrated solution manifold port and is communicated with manifold fluid by pipe sections 1642.Adsorbent box 1680 is positioned through adsorbent stream outbound port and is communicated with manifold fluid by pipe sections 164l, thus will the dialysis solution of regeneration be needed to be sent to adsorbent box 1680.Adsorbent box 1680 is positioned through adsorbent stream inbound port and is communicated with manifold fluid by pipe sections 1643, thus receives the dialysis solution regenerated of self-absorbent box 1680.Pipe sections 1643 uses mechanism 167l and is removably attached near ammoniacal sensor 1670, and mechanism 167l is such as that hook, clip, clamper or other permission pipe sections 1643 are easily dismantled and be placed on the sidepiece identical with adsorbent box 1680 and be positioned at ammoniacal sensor 1670 close contact on the sidepiece of controller unit l60l.In one embodiment, ammoniacal sensor 1670 comprises optical pickocff, and this optical pickocff uses colorimetric measurements to determine whether the existence of ammonia and such ammonia exceed predetermined threshold.

With reference to figure l, reservoir system 102 has door 118, reservoir 122 slides out when being pulled and do not stopped by any protuberance or otherwise makes reservoir 122 be that user is accessibility by this door, inserts or change the fluid for dialysing to allow user.Reservoir volume is by scale system monitoring.Fluid balance 604 (in figure 6 and more particularly describe in Figure 17 A and 17B) based on scale forms with reservoir and provides accurate fluid to remove data and make it possible to accurately EQUILIBRIUM CALCULATION FOR PROCESS, prevents the hypotension that caused by fluid imbalance and other diseases thus.By scale and reservoir integrated and encapsulate them more strong system is provided completely.

With reference to Figure 17 A, show the inner structure l700 of reservoir system.The front portion 1723 that metal inside framework 1720 comprises two sidepiece 172l, face, 1722, one, a back opens and a base portion 1724.The inner structure illustrated or framework do not have outer enclosure, as being depicted as the element 102 in figure l.Scale 1718 is integrated in reservoir inner structure l700.The basal surface 1715 of scale 1718 comprises metal surface or dish, and the remainder of metal surface or dish and scale 1718 hangs (scheming to be 102 shown in l) from exterior reservoir shell commonly by four deflection divisions 1705.Preferably, heating cushion is positioned at below the lower surface 1715 of scale, such as can cause temperature increase and using increase temperature as conduction of heat to surface 1715 square, rectangle, circle or other shapings surface.Can applied field and use this change to be integrated in base surface 1715 to the conductance coil 1770 measuring conductance.Therefore, when reservoir bag (not shown) is placed on basal surface 1715, it can be heated by heating cushion, and because it contacts with coil 1770, so can monitor its conductance.

The inner surface of sidepiece 172l comprises multiple track, slender member or protuberance 1719, and it can be attached to its disposable reservoir bag mounting surface for fixing, keeping, encapsulate or be attached to reservoir bag, such as plastic sheet 1710.Especially, the reservoir bag be positioned on surface 1715 can have the outlet being attached to the conduit 177l be integrated in sheet 1710.It is each that deflection division l705 is arranged in four turnings on scale surface 1718, wherein eachly comprises Hall element and magnet.

Therefore, in one embodiment, the parts of reservoir subsystem components include but not limited to dialysis solution reservoir, comprise disposable reservoir pipeline or bag, dialysis solution heater, dialysate temperature monitor, reservoir weighing system, comprise magnetic deflection division and inclination sensor, dialysis solution ammonia density and pH sensor, comprise disposable sensor element and repeatedly used optical pickup, dialysis solution conductivity sensor (non-contact type) and humidity or leak sensor.

It will be understood by those skilled in the art that, except sensor listed above, the miscellaneous part in dialysis fluid circuit such as pump and sensor such as pressure transducer also can be included in reservoir module.In addition, various sensor such as ammonia and pH sensor can be integrated in reservoir module as single-sensor, or as comprising single " the sense signals module " of all the sensors.

To comprise in these parts each is designed with the form making reservoir assembly module be applicable to the operation of the dialysis system based on adsorbent of recirculation especially.In addition, module is designed so that, during other forms such as single-pass hemofiltration of dialysis, any inessential element be only exclusively used in based on the dialysis of adsorbent of module can be removed equally.

Figure 17 B shows an embodiment of reservoir assembly module, and wherein crust or covering are transparent, thus reveal internal is arranged.Opening 174l is arranged on the front portion of reservoir subsystem module 1700.The major function of reservoir sub-component comprises dialysis solution.Opening 174l allows disposable reservoir bag to be inserted into, and disposable reservoir bag can be have the conventional IV bag wherein including dialysis solution.Reservoir module l700 is also provided with the dish 1742 for comprising reservoir bag in front opening inside.In one embodiment, both planar film heater and temperature sensor are all positioned at the bottom part down of reservoir dish 1742, and help the temperature of dialysate fluid to remain on body temperature or close to it.In one embodiment, the temperature of dialysate fluid can be arranged by user.

In one embodiment, reservoir dish 1742 is suspended in weigher structure 1743, as described further below.Weigher structure 1743 may be used for the weight accurately measuring the dialysate fluid in reservoir bag before starting to dialyse, and for keeping the volumetric balance of the dialysate fluid in loop between dialysis period.

At the top of reservoir assembly module 1700, be provided for the feature 1744 being attached to dialysis system pumping unit, as previously discussed.These features help reservoir assembly module be easily connected to pumping unit and remove from it, and this pumping unit can be arranged on the top of reservoir assembly in one embodiment.As discussed further below, the top of reservoir assembly module is also equipped with gutter 1745 on the either side of this module.Single humidity sensor (not shown) is arranged in each ditch.As known in the art, humidity sensor is a kind of Optical devices, and its connection based on the increase that the light caused by the differing from of refractive index between air and fluid is entered in the fluid relative with air senses moisture.Humidity sensor in gutter 1745 keeps when it is arranged on the top of reservoir assembly following the trail of moisture and indicating any leakage in pumping system.By the humidity sensor of separation being arranged in the gutter on either side, leaking and can be located and particular pilot about any correction that may need can be given user.

Figure 17 C shows another view of reservoir assembly module, and wherein the outer covering of module l700 is completely removed and some internal part shows as transparent.With reference to Figure 17 C, reservoir dish 1752 is provided with internal access 1753.Ditch 1753 is also equipped with humidity sensor, and it is positioned at immediately below dialysis solution dish 1752, and deflection division 1755 is attached to humidity sensor, makes it can sense the leakage of reservoir assembly 1700 inside.

Reservoir assembly module 1700 also comprises sensor cabin 1754 or submodule, and it is included in the set of the various sensors on same circuit board.Sensor board comprises ad hoc about the sensor of the dialysis based on adsorbent, such as ammonia and pH sensor.In one embodiment, ammoniacal sensor comprises disposable Color-sensitive tape, by the level in response to the ammonia existed in dialysis solution, it shows that the material of the visible change of color is made.Such as, the color of indicant tape can change over yellow gradually from blueness, and this depends on the ammonia level existed around this tape.Such visual color instruction makes more easily to keep following the trail of ammonia level and identifying whether ammonia critical point occurs.In one embodiment, in order to assess the color change in ammonia indicant tape more accurately, optical pickocff is used.Optical pickocff is arranged in sensor assembly 1754 equally, and may be used for the accurate instruction general perceived color reading being converted to ammonia level.

About dialysis solution na concn, should be understood that, in order to carry out Kidney Dialysis suitably and cause the correct diffusion through dialyser, the concentration of sodium must remain within the scope of certain.Determine that the conventional method of the na concn of fluid measures the electrical conductivity of fluid and the temperature of fluid, then calculate approximate na concn.Measure in a non contact fashion the na concn in dialysis solution improve one's methods and system uses the non-contact electric conductivity sensor be built in bottom reservoir dish 1752.

In one embodiment, non-contact conductance sensor is the inductance device utilizing coil.The change of na concn changes the conductance of dialysate constituents, this so that change the impedance of coil.By conductivity sensor being placed on the bottom of reservoir dish 1752 and being therefore placed in reservoir below dialyzate bag, large surf zone is presented to coil.This guarantees the pinpoint accuracy measured, and does not need sensor and dialysate fluid physical contact in addition.

With reference to Figure 17 D and 17E, show the parts of non-contact conductance sensor, be included in by the coil l788 with n circle of the generation that suitably encourages time limit fixed-field and the coil limited by resistive element Rs1786 and Rp1785 and inductor element L1787 by electricity be coupled in capacitor 178l time produce the diagram of resonance LCR oscillation circuit l780 that obtains.

Coil l788 is the multi-layer circular flatwise coil being jointly used as energy accumulating device with capacitor 178l.Coil l788 has losser, and it comprises the electrical conductivity of fluid in the resistance of winding wire Rsl786 and loss of field element Rpl785, bag.

Coil l788 diameter is the function in the magnetic field penetrated in fluid.Another factor for fluid permeability is operation frequency.Low operation frequency will deeper penetrate in fluid, but have more low-loss cost.Larger coil will have the little effect caused by dimensional tolerance.Definite equation provides as follows:

\begin{matrix} L = \frac{0.31 {(a N)}^{2}}{6 a + 9 h + 10 b} & (μ H) \end{matrix}

Wherein a=coil in centimetre mean radius, the N=number of turn, b=in centimetre winding thickness, h=in centimetre winding height.In one embodiment, the radius of coil in the scope of 2 to 6 inches, and more particularly, 2,3,4,5 and 6 inches and all increments in-between.

With reference to loop l780, physics coil l788 is represented by L1787 and Rsl786, and wherein L is the inductance of coil, and Rs is the resistance of winding wire.The energy loss in the magnetic field produced by L1787 is represented by Rpl785.Energy loss Rp derives from the electroconducting fluid that is in close proximity to coil l788 and directly related with it.Therefore, if coil l788 is placed in reservoir dish, be integrated in the surface of reservoir dish, or be otherwise placed on certain distance, make the magnetic field produced by coil l788 can be subject to the existence of the dialysis solution in bag or be more particularly the electrical conductivity impact of dialysis solution in bag, then the na concn of bag and the change of the therefore conductance corresponding change in magnetic field that can be produced by coil l788 by tracking and obtain monitoring and measuring.

Loop l780 makes it possible to the change of accurately measuring the magnetic field produced by coil l788.When loop l780 is driven with its resonant frequency, energy transmits back and forth between inductance component L 1787 and capacitor 178l.When resonance, energy loss and R _sand R _pi ²r is worn to ratio.In order to remain on the constant AC voltage on whole C178l, energy must be provided to loop l780, and the energy be supplied must equal R _pl785 and R _sthe energy loss of l786.When L1787 and C178l element is placed in the Pierce oscillator with automatic growth control, control voltage is by with just proportional in the electrical conductivity of sensed fluid, because more for needs energy vibrates to accompany by more high resistance field loss by agitator, the change of this dialysis solution conductance mainly caused due to the change because of na concn level.

As before with reference to Figure 17 B mention, reservoir dish is suspended in for accurately measuring weight in weigher structure, and for remaining on the volumetric balance of the dialysate fluid between dialysis period in loop.For the hitch point 1755 of weigher structure shown in Figure 17 C.In one embodiment, provide four hitch points 1755, wherein each comprises Weighing mechanism, as described earlier.Except four hitch points 1755, reservoir component subsystems l700 also comprises horizon sensor.Horizon sensor allows the calculating of accurate weight, even if reservoir bag is not level.Figure 17 C also show the pin 1756 on the top of reservoir assembly module l700, and it can be used for the electrical connection being provided to control and/or pumping unit, and as mentioned above, control and/or pumping unit can be arranged on the top of reservoir assembly.

With reference to Figure 18, deflection division 1805 comprises multiple attachment point 186l, and deflection division is fixed to exterior reservoir shell at this place.Deflection division also comprises magnetic 1862, such as two magnets, and Hall element 1864.The base portion 1867 of deflection division 1805 is attached to the top surface 1715 of scale 1718.When scale 1718 is subjected to displacement due to the applying of mass loading, (such as when reservoir bag is filled with dialysis solution, bag is pressed on surface 1715, thus pull scale 1718 downwards), be connected to scale an end and the deflection division 1805 being connected to outer enclosure in another end will bend, and the change by means of the magnetic field produced by magnetic 1862 is followed the trail of this change by the magnet 1862 be arranged on an end of deflection division 1805.Hall element 1864 detects the change of magnetic field intensity.It will be appreciated by those skilled in the art that and how this magnetic field sensed is changed the tolerance being converted to applied mass loading.

Anterior door roomily (about l00 degree) is opened, to load disposable manifold.There is spacious opening be convenient to manifold and load and the face of easy cleaning machine and the inner side of door.To make to close and the motion parts of cladding system makes its safety and more strong more, this is for particular importance family uses.In addition, Shi Qian department holds display and saves space and strengthen important point again, and namely device will not operated, unless the in place and door of disposable product is closed.Door provides the closing force of necessity on manifold and pump sections thereof.Door also comprises touch screen, audio frequency siren and manual stop button in the face of door.

In one embodiment, door remains in complete closed position by electric stepper motor.This motor, by operating user interface, is pressed the button by user when door has been ready to be fully closed or open especially and operates.Be placed on manifold structure in order to ensure suitable pressure by door and pump boots, preferably there is door and be closed by it and the electronic mechanism producing enough closedown door power.In one embodiment, the closedown door power of 90 to 110lbs is produced.

With reference to Figure 19 and 20, show an embodiment of powered door closing organ 1900.Stepper motor 1906 mechanically engages with driving screw 1916, makes when by controller actuating, and stepper motor 1906 makes driving screw 1916 rotate, and therefore makes bar 1918,2018 that starting power is applied to hook.Be positioned at hook below component 2040 for being latchable to U-shaped latching portion 2030, and when being pulled, rotating or otherwise inwardly moving towards stepper motor 1906, U-shaped latching portion 2030 is pulled as further closedown, thus applies required closedown door power.Hook physically engages with bar 1918,2018, and can be manipulated to and U-shaped latching portion 2030 to be pulled as closely closing or loosely engaging with U-shaped latching portion 2030.Power shutdown system is mounted by mounting bracket 1905 and keeps suitable orientation.

With reference to Figure 21, operatively, door is closed and for being enough to, the U-shaped latching portion 2110 on door is engaged with the hook 2150 inside the internal capacity of controller unit by user.Then user closes the expectation of door to portable dialysis machine instruction, preferably by mechanical button or graphic user interface icon, signal is sent to controller when being pressed by it, controller and then actuating stepper motor.Starting power is applied to hook 2150 by stepper motor, and then hook 2150 pulls the U-shaped latching portion 2110 engaged into tight cut out.In one embodiment, controller monitors the torsion applied by motor, and when it reaches preset limit, stepper motor of stopping using.In another embodiment, be positioned to the extension of the hall device sensing driving screw being close to driving screw and determine the movement degree of driving screw.If driving screw produce larger closedown door power direction on sufficiently move, then Hall element by Signal transmissions to controller with inactive motor.Alternatively, sensor transmits the signal of the extension of instruction driving screw constantly, and then signal is explained to determine whether to apply enough starting powers and stepper motor of whether should stopping using by controller.In these embodiments any, if motor exceedes moment of torsion, the distance pre-seted is exceeded, or door does not reach its complete closed position within the predetermined time, then controller can driven motor with stop and being inverted to the state opened completely.Controller can also make vision and/or audible alarm sound.

When user wishes to open, mechanical button or graphic user interface icon are activated, and signal is sent to controller, controller and then oppositely activate stepper motor.Then hook loosely engages with U-shaped latching portion.Then mechanical release button is pressed and is departed from from U-shaped latching portion by the hook of lax joint.

Except providing required closing forces, this powered door closing organ has multiple important feature.The first, it is designed to avoid barrier to be trapped in door and stands powerful door closing forces.With reference to Figure 21, be recessed in door 2105 for the region that accepts manifold 2130 by four side margins protection departments 2107 around, if the disposable product of the finger of tamper such as people or suitably installation is between door 2105 and the base plate of top unit, then these four side margins protection departments 2107 prevent latch from engaging with the latch receptacles in top unit.Door 2105 comprises the inner surface 2106 that metal shell 2125 is attached to.In one embodiment, the top surface of the inner surface 2106 of door 2105 is securely attached to the outer surface of housing 2125.Housing 2125 is roughly rectangle and limits the cavity with four sidepieces 2107 and base portion 2108, produces internal capacity.Cavity is opened towards the manifold structure 2130 of dialysis system 2100, surrounds and around manifold structure 2130 and protection department 2140, and protection department 2140 is preferably at the top of manifold structure 2130 and the sidepiece nerd pack around this manifold structure.Pump boots 2115 and at least one U-shaped latching portion 2110 are attached to the surface of base portion 2108, and this U-shaped latching portion is given prominence to towards back plate.Hook 2150 to be integrated in protection department and to extend from it, and hook 2150 is configured to engage and depart from U-shaped latching portion 2110 securely.If door is correctly closed and do not had object to be trapped between door and protection department, then U-shaped latching portion mechanically will be hooked by power door locked hook mechanism.If barrier is in gate way, then metal shell 2125 can not extend to (and surrounding protection department) in the internal capacity of top unit, therefore U-shaped latching portion can not engage hook, thus prevent from the machinery of the door when barrier is in place from hooking closing with unexpected power.

The second, mechanical button release is only closed Men Li at power and just can be activated by during dissipation by the adverse movement of stepper motor, thus prevents the accident of door from discharging and opening fast.With reference to Figure 19 and 20, when door is closed and lock, the axle collar 2050 in push button shaft 1907,2007 rotates 90 degree, and mobile distribution locks hook away from powered door.The axle collar 2050 rotates by means of bar 192l, and bar 192l is connected to the axle collar at point 2045 and mechanically engages with driving screw 1916.The axle collar 2050 is spring loaded and is locked by little pin solenoid.If user presses the button when being in latched position, then button will move in machine, but the displacement because being caused by the rotation of the axle collar, so can not hook be departed from, thus prevent from opening door.

If loss of power or be not intended to stop, then pin solenoid will discharge, thus the permission axle collar returns and turn 90 degrees and distribution is placed in suitable aligning.Then when the user depresses the button, distribution will contact powered door hook and released latch.The convenience that this mechanism provides machine door to discharge and carrying out safety backup, and do not pay close attention to machine door release may unexpectedly be activated to make door with huge power rotating opening.Should be understood that, term " hook " or " breech lock " should be broadly defined as any protuberance that physically or mechanically can engage with another protuberance or component or component.It is to be further understood that term " U-shaped latching portion " is not restrictive, and any bolt lock mechanism as limited or hook mechanism can be used above.

As discussed above, to be formed by base unit and carrier space around top unit adopts the drainage path with fluid sensor, to make it possible to subregion leak detection in the multiple positions that device is inside and outside.Particularly, by being building up in the outer body of device by the drainage path with optical leakage sensor, system is by the fluid capture leaked from external component (such as adsorbent canister) potentially and guide to optical leakage sensor.Such as, in one embodiment, manifold 2130 is mounted thereto and housing 2125 is close to the inclined surface 2190 that its surface 2132 stopping and formed the top unit of cavity comprises formation sloping edge, moisture for catching the moisture from the area alignment around manifold 2130 and manifold 2130 or leakage, and is guided to the humidity sensor 2180 at the center of being positioned at by it by gravity.Preferably, inclined surface 2190 is sufficiently inclined to and makes the moisture dropped on sloping edge downwardly be positioned to receive one or more humidity sensors 2180 of moisture to move.In one embodiment, humidity sensor 2180 is equidistant relative to the position of manifold 2130 in centralized positioning and apart from the end of each inclined surface 2190.

In one embodiment, at least three different optical leakage detectors are integrated in the outer enclosure of base unit.With reference to Figure 22, the top surface of base unit 2202 tilts slightly, and center 2280 is promoted relative to sidepiece 228l and 2282.In one embodiment, the angle of preferably 3 degree is spent on surface from middle section 2280 to sidepiece 228l and 2282 downward-sloping l to 10.Passage 2287, around the top surface of base unit, extends around periphery, extends through the center of top surface, and/or extend through any other part of top surface.By means of the angled top surface of base unit 2202, passage 2287 also tilts to sidepiece 2281,2282 from center 2280.In another embodiment, top surface also slightly slopes down to anterior face 2290 from side, back 229l.Ramp way 2287 makes fluid onwards be guided away from the center of system and/or back and the sidepiece of being located to leak detector 2288 and being communicated with passage 2287 fluid.

First optical leakage detector 2288 is positioned on the front right turning of the top surface of base unit 2202.Second optical leakage detector 2288 is positioned on the front left turning of the top surface of base unit 2202.Each leak detector to be positioned in well or cavity and to comprise optical pickocff, and it is positioned at the sidepiece of well.Optical pickocff detection discharged and/or be transported to well fluid and by the Signal transmissions that detects to the controller in top unit.By processor process, the signal detected determines whether leakage occurs.Then the signal detected is stored, and if if required, processor makes alarm or warning be presented on GUI.Well or cavity preferably include rounded base portion to allow user easily that well wiping is dry.Figure 23 shows the more detailed view of the top surface of base unit 2302, the leak detector 2388 having passage 2387 and be positioned in well 2397.

With reference to Figure 24, it is interior and more particularly inner at reservoir 2403 that at least one additional leak detector is positioned at base unit 2402, and scale 2404 is within it integrated.Passage 2405 is integrated in reservoir structure such as inner shell or metal bag keeper, and preferably tilts to either side from lopsidedness to opposite side or from center.In one embodiment, the angle of inclination is in the scope that l to 10 spends and more particularly 3 degree.Hold the well 2410 of leak detector to be integrated in liquid reservoir shell and to be communicated with passage 2405 fluid in the one or both sides of liquid reservoir shell.Occur in disposable bags if leaked, then fluid will drain into the turning of metal dish or liquid reservoir shell by passage 2405, and is directed at least one and has in the well of leak sensor 2410.

Drainage path is used for two functions: a) guarantee that fluid does not enter instrument, and b) guarantees to leak that promptly limited and be directed to can the sensor of alerts triggered or alarm.In addition, device preferably also comprises the fluid drainage passage of the well guiding to the optical pickocff had on the inside of device.Therefore such as, if having leakage in internal reservoir, then fluid is directed away from the optical pickocff alarm of critical component and leakage.Based on the sensor activated, GUI can present to user alarm and can identify the position that fluid leaks especially.By providing the region (multiple fluid sensor and drainage path) of multiple independently leak detection, instrument can guide user promptly to find to leak.Have multiple passage and sensor allow components of system as directed ground automatically identified leakage source and provide figure to assist the problem of correction to user.

Referring to Figure 25, when adsorbent box 2580 is filled with waste materials, it expands, and if suitably do not anchored to base portion, then and may overturning.In one embodiment, adsorbent box 2580 is anchored to base portion 2520 by multiple adapter 2540 and is temporarily physically attached to this.Base portion 2520 is the planar structures with adapter 2510, and adapter 2510 is configured to the adapter of the coupling be removably attached on dialysis system base portion.In one embodiment, base unit 2520 comprises the adapter 2510 of two couplings of the adapter of the complementation coupling had in base unit.Adapter 2540 comprises at least two, preferably three or alternatively more than three L shape components.In three adapter configurations 2540, adapter distributes equably round slightly larger than the periphery of adsorbent box 2580 base portion periphery.When adsorbent box 2580 is placed in adapter, its be closely assemblied in wherein and by box 2580 weight and be held in place.Plane surface 2520 also comprises the adapter 2550 of second group, and it comprises at least two, preferably three or alternatively more than three L shape components.In three adapter configurations 2550, adapter distributes equably round slightly larger than the periphery of concentrated flow container base portion periphery.When concentrated flow container is placed in adapter 2550, its be closely assemblied in wherein and by tank 2550 weight and be held in place.

Exemplary blood and dialysate fluid path

Disclosed embodiment may be used for providing dialysis treatment to patient.Figure 26 is the functional block diagram of an embodiment of many logical dialysis systems based on adsorbent of the present invention.In one embodiment, dialysis system 2600 adopts and comprises high flux membrane so that toxin is passed through diffusion and the dialyser box 2602 removed from blood by convection current.Flow on the side of film along a direction by allowing dialysis solution and allow blood flow on the other side of the membrane along contrary direction and be based upon the Concentraton gradient on whole semipermeable membrane simultaneously, thus realizing removing toxin by diffusion.Use hemodiafiltration to remove toxin to strengthen, displacement liquid is added continually in blood, before dialyser box (front dilution) or after dialyser box (afterwards dilute).Amount equals fluid quilt " ultrafiltration " on whole dialyser box film of the amount of the displacement liquid be added into, and carries with it solute be added into.

Simultaneously with reference to Figure 26 and 27, in one embodiment, the blood containing toxin by blood pump 260l, 270l blood vessel pumping from patient, and is passed to flow through dialyser box 2602,2702.Alternatively, the entrance and exit pressure transducer 2603,2604,2703,2704 in blood circuit measures the pressure of blood before blood enters dialyser box 2602,2702 via blood inlet tube 2605,2705 and after leaving dialyser box 2602,2702 via blood outlet tube 2606,2706.The pressure reading carrying out sensor 2603,2604,2628,2703,2704,2728 is used as the monitoring and controlling parameter of blood flow.Effusion meter 262l, 272l can be placed in being positioned in the part of the next-door neighbour upstream of blood pump 260l, 270l or being otherwise communicated with this partial pressure of blood inlet tube 2605,2705.Effusion meter 262l, 272l are positioned to the predetermined amount of flow monitoring and keep the blood in impure blood supply tube line.Displacement liquid 2690 can be added continually in blood, before dialyser box (front dilution) or after dialyser box (afterwards dilute).

In one embodiment, with reference to Figure 26 and 27, dialyser box 2602,2702 comprises the semipermeable membrane 2608,2708 dialyser 2602,2702 being divided into hematology lab 2609,2709 and dialysis fluid chamber 2611,2711.Along with blood is through hematology lab 2609,2709, uremic toxins is filtered across whole semipermeable membrane 2608,2708 due to convection current power.Other blood toxicity is passed on whole semipermeable membrane 2608,2708 by diffusion, is mainly induced by the difference of the concentration of the fluid respectively through hematology lab and dialysis fluid chamber 2609,2709 and 2611,2711.The dialyser box used can be have anyly to be suitable for hemodialysis, hemodiafiltration, hemofiltration or pachyhematous type, as known in the art.In one embodiment, dialyser 2602,2702 holds high flux membrane.The example of suitable dialyser box includes but not limited to can to obtain from the FreseniusMedicalCare of the Lexington of the Kentucky State f80, the BaxterCTll0 that can obtain from the Baxter of the Deerfield of Illinois, CTl90, or the MinntechHemocor that can obtain from the Minntech of Minnesotan Minneapolis 2000.

In one embodiment of the invention, dialysis liquid pump 2607,2707 extracts the dialysis solution consumed and forces dialysis solution to enter dialysate regeneration system 2610,2710 and return 2613,2713 in dialyser box 2602,2702 in many logical loops from dialyser box 2602,2702, thus produces " regeneration " or fresh dialysis solution.Alternatively, effusion meter 2622,2722 is positioned in from the dialysis solution of the consumption supply pipe 2612,2712 of the upstream of dialysis liquid pump 2607,2707, and effusion meter 2622,2722 monitors and keeps the predetermined amount of flow of dialysis solution.Blood leakage sensor 2623,2723 is also placed in and has consumed in dialysis solution supply pipe 2612,2712.

Many logical dialysate regeneration systems 2610,2710 of the present invention comprise and multiplely comprise box for regenerating the adsorbent consuming dialysis solution and/or filter.By using adsorbent box to carry out regenerated dialysate, dialysis system 2600,2700 of the present invention only needs the sub-fraction of the amount of the dialysis solution of conventional single-pass haemodialysis equipment.

In one embodiment, each adsorbent box in dialysate regeneration system 2610,2710 is the microminiaturized box comprising different adsorbent.Such as, dialysate regeneration system 2610,2710 can adopt five adsorbent boxes, and wherein each box comprises separately active carbon, urease, zirconium phosphate, hydrous zirconium oxide(HZO) and active carbon.In another embodiment, each box can comprise above-described adsorbent with multiple layers, and can have the layering box of the multiple this separation be connected in serial or parallel with each other in dialysate regeneration system.It will be understood by those skilled in the art that, active carbon, urease, zirconium phosphate, hydrous zirconium oxide(HZO) and active carbon are not only chemicals that can be used as adsorbent in the present invention.In fact, when not departing from the scope of the invention, any amount of additionally or alternative adsorbent (comprising the adsorbent based on polymer) can be adopted.

How penetrating analysis system based on adsorbent of the present invention provides the multiple advantages relative to conventional single-pass sytem.These comprise:

● do not need continuous print water source, the Water warfare machine of separation or floor draining, because system of the present invention regenerates the dialysis solution of certain volume continuously.This allows the portability strengthened.

● system of the present invention needs low-current power supply, such as 15 amperes, because system utilizes the dialysis solution of same small size by diafiltration program cycle.Therefore, there is no need for extra dialysis liquid pump, concentrate pump and the large heater of the dialysis solution of the large volume in single-pass dialysis system.

● system of the present invention can use the tap water of low volume, and in the scope of 6 liters, dialysis solution can be prepared by tap water at whole treatments period.

● sorbent system is used as water purifier and the adsorbent box worked as the means for by used dialysate regeneration being fresh dialysis solution.

Although current embodiment has the pump 260l, the 270l that are separated, 2607,2707 for blood and dialysis solution being pumped across dialyser, but the single dual pathways pulsate pump both blood and dialysis solution being advanced past hemodiafiltration system 2600,2700 in an alternate embodiment, can be adopted.In addition, centrifugal pump, gear pump or diaphragm pump can also be used.

In one embodiment, excessive fluid waste removes from the dialysis solution consumed consumed dialysis solution pipe 2612,2712 by using volume refuse micropump 2614,2714 and deposits in waste collection reservoir 2615,2715, and waste collection reservoir can by exporting such as faucet by periodically emptying.The electronic control unit 2616 comprising microprocessor monitors and the function of all parts of control system 2600.

In one embodiment, the blood leaving the diafiltration of dialyser box 2602,2702 is mixed with by the aseptic displacement liquid of adjusted volume be pumped in blood outlet tube 2606,2706 by volume micropump 2618,2718 from displacement liquid container 2617,2717.Displacement liquid can be used as aseptic/non-heating fluid be included in flexible pouch usually.This fluid can also be produced through the filtration of suitable filter cartridge online by non-sterile dialysis solution, makes it be aseptic and non-heating.

Figure 28 shows the functional block diagram of an embodiment of ultrafiltration therapy system 2800 of the present invention.As shown in figure 28, the blood from patient is extracted in blood entry port pipeline 280l by pump such as wriggling blood pump 2802, and this pump forces blood to enter hemofilter box 2804 via blood inlet port 2803.Before and after entrance and exit pressure transducer 2805,2806 is connected to blood pump 2802 just online.Hemofilter 2804 comprises semipermeable membrane, and it allows excessive fluid by convection current from through its blood ultrafiltration.The blood of ultrafiltration is passed through blood exit port mouth 2807 pumping out from hemofilter 2804 further, enters blood outlet tube road 2808, turns back in patient with infusion.Actuator such as clamper 2809,2810 regulates the fluid flowing through it for pipeline 280l and 2808.

Pressure transducer 2811 is connected near blood exit port mouth 2807, is the air bubble detector 2812 in pressure transducer 2811 downstream subsequently.Ultrafiltrate refuse to extract from hemofilter 2804 via UF (ultrafiltrate) outlet port 2814 and enters UF export pipeline 2815 by ultrafiltration liquid pump such as peristaltic pump 2813.Pressure transducer 2816 and blood leakage detector 2817 are displaced in UF export pipeline 2815.Ultrafiltrate refuse is finally pumped in waste collection reservoir 2818 such as flask or soft sack, and waste collection reservoir is attached to the leg of the patient walked about and is equipped with drain port to allow the emptying of interval.The amount of the ultrafiltrate refuse produced can be monitored by using any measuring technique, comprises scale 2819 or effusion meter.Microcontroller 2820 monitors and manages the function of blood pump and UF pump, pressure transducer and air and blood leakage detector.Rule connecting portion such as the Luer slip device and luer lock device of standard are used for pipeline being connected to pump, hemofilter and being connected to patient.

Another blood that can implement in the embodiment of dialysis system or use and dialysis fluid circuit shown in Figure 29.Figure 29 depicts the fluid circuit of the extracorporeal blood treatment system 2900 for carrying out hemodialysis and hemofiltration.In one embodiment of the invention, system 2900 is implemented as and can carries out the portable dialysis system of dialysing for being in by patient.Hemodialysis system comprises two loops, i.e. blood circuit 290l and dialysis fluid circuit 2902.Blood treatment between dialysis period relates to the extracorporeal circulation of the exchanger by having semipermeable membrane-hemodialyzer or dialyser 2903.The blood of patient is in the side cocycle of film (dialyser) 2903 in blood circuit 290l, and dialysis solution (comprising with the main electrolyte of the blood of the concentration specified by doctor) circulates on another side in dialysis fluid circuit 2902.Therefore the circulation of dialysis solution provides adjustment and the adjustment of the electrolyte concentration in blood.

From the pipeline 2904 of patient by unpurified blood transportation to the dialyser 2903 blood circuit 290l, be provided with occlusion detection device 2905, its contact with vision or audible alarm substantially with by the signalisation of any barrier to blood flow.In order to the condensation of anti-Hemostatic Oral Liquid, for anticoagulant such as heparin injections is also provided to the delivery apparatus 2906 in blood such as pump, syringe or any other injection device.Peristaltic pump 2907 is also provided for guarantees that blood is along the flowing of normal (expectation) direction.

Pressure transducer 2908 is arranged on the porch that impure blood enters dialyser 2903.Other pressure transducer 2909,2910,2911 and 2912 each position be arranged in hemodialysis system is followed the trail of and the fluid pressure at the specified point place in corresponding circuit is remained on the level of expectation.

The blood leakage sensor 2913 used dialysate fluid be arranged on from dialyser 2903 enters the some place of dialysis fluid circuit 2902, to sense and alarm hemocyte enters any leakage of dialysis fluid circuit.A pair bypass valve 2914 is also arranged on starting point and the end point of dialysis fluid circuit, make in the start-up conditions, or be considered as the necessary time at other by operator, dialyser can be flowed around by from dialysate fluid, and dialysate fluid flowing can still be kept, namely for rinsing or preliminary filling operation.Before another valve 2915 is arranged on preliminary filling/drain port 2916 just.Port 2916 for initially adopt dialysate constituents fill loop, and with dialysis after and between dialysis period, remove used dialysate fluid in some cases.Between dialysis period, valve 2915 may be used for adopting the fluid replacement with suitable concn to replace the part with the high concentration of such as sodium of used dialysis solution, makes the overall concentration of component of dialysis solution maintain the level of expectation.

Dialysis fluid circuit is provided with two peristaltic pumps 2917 and 2918.Pump 2917 for dialysate fluid is pumped to draining or waste canister, and for the dialysis solution regenerated is pumped in dialyser 2903.Pump 2918 for the dialysis solution that will consume from dialyser 2903 pumping out, is maintained by the fluid pressure of adsorbent 2919, and dialysis fluid is carried out fill system from port 2916 pumping or keeps the concentration of component dialysis solution.

Adsorbent box 2919 is arranged in dialysis fluid circuit 2902.Adsorbent box 2919 comprises multilayer material, each effect with removing impurity such as carbamide and kreatinin.The combination of the material of these layerings allows drinkable water to be loaded in system and is used as dialysate fluid.It also allows closed loop to dialyse.That is, adsorbent box 2919 makes it possible to by the dialysate regeneration consumed from dialyser 2903 is fresh dialysis solution.There is suitable capacity such as 0.5, l, the lining container of 5,8 or 10 liters or reservoir 2920 and be provided for fresh dialysate fluid.

Depend on patient requests and based on the prescription of doctor, the infusion solution 292l of desired amount can be joined in dialysis fluid.Transfusion 292l is the solution containing mineral and/or glucose, its contribute to mineral such as potassium and calcium in dialysate fluid by adsorbent unexpected remove after desired level is added to it.Peristaltic pump 2922 is provided to the infusion solution 292l of desired amount to be pumped to container 2920.Alternately, infusion solution 292l can be pumped in the outflow pipeline from reservoir 2920.Photographing unit 2923 be provided to alternatively monitor infusion solution change liquid level as transfusion flowing fault safety inspection alarm and/or work as the bar code sensor of the bar code be associated for the additive scanned with will be used in dialysis procedure.Alternatively, ammoniacal sensor 2928 can be provided.

Heater 2924 is provided to the temperature of the dialysate fluid in container 2920 to remain on desired level.Dialysate fluid temperature can the temperature sensor 2925 entered before the entrance of dialyser 2903 senses by being just positioned at fluid.Container 2920 be also equipped with for keep the weight of the fluid followed the trail of in container 2920 and therefore volume scale 2926 and determine and monitor the conductivity sensor 2927 of electrical conductivity of dialysate fluid.Conductivity sensor 2927 provides the instruction of the sodium level in dialysis solution.

Before the medical port 2929 blood system of entering be arranged on from patient is dialysed.Before another medical port 2930 blood clean be arranged on from dialyser 2903 is back to patient.Air (or bubble) sensor 293l and alligator clamp 2932 adopt in the loop, to detect and to prevent any air, gas or bubble to be back to patient.

Preliminary filling external member 2933 is attached to dialysis system 2900, and this preliminary filling external member adopted Sterile Saline to help preparation system to its filling before being used for dialysis at blood circuit 290l.Preliminary filling external member can comprise the short segment with the IV bag spine of pre-attached or the pipeline of IV pin or the combination of the two.

Should be understood that, combine although some in embodiment mentioned above discloses and use the injection receiving anticoagulant or the port used, produce air-blood interface thus to connect, but such port can be eliminated, if the minimum risk operation that device can adopt blood to condense in the port of entrance and exit.As hereafter further institute discuss, manifold design particularly reduces the risk of blood clotting as far as possible about the indoor design of manifold port, thus produces the option of the injection eliminated for receiving anticoagulant or the air used-blood interface connection.

Those skilled in the art infer by from discussing above, and the exemplary fluid loop for hemodialysis and/or hemofiltration system is very complicated.If implemented in a conventional manner, then system using as pipeline net operation and will for home dialysis user configuration and too complicated using.Therefore, in order to make system be for patient be in use be simple and easy to use, embodiment of the present invention implement the fluid circuit of compact manifold form, and wherein most of component integrations of fluid circuit are to one piece molded plastic or be configured to be joined together to form in the more than one piece molded plastics of single operation manifold structure.

Exemplary manifold

Should be understood that, the how logical dialysis procedure represented by above-described blood and dialysis fluid circuit can be implemented and be implemented by it in the multiple blood be molded in disposable manifold and dialysis fluid circuit.As shown in figure 21, the embodiment of dialysis system disclosed herein operates with the manifold 2130 of various sensor, quantifier and pump pressure, heat and/or optical communication by using to limit multiple blood and dialysis fluid circuit and be placed in by fluid.

In one embodiment, manifold of the present invention comprises the composite plastic manifold being wherein molded with blood and dialysis solution flow path.Blood purification system parts such as sensor and pump are placed in and the fluid flow pressure be included in mold manifold, heat and/or optical communication.Figure 30 shows the structural detail of the compact manifold according to one embodiment of the invention.Disposable manifold pumping and guide fluid to flow, measures the pressure in key area simultaneously.These fluids comprise blood, dialysis solution, transfusion and anticoagulant.In addition, manifold provides following characteristics, namely for detect from dialyser blood leakage, detection arterial line in obturation and detection venous line in air.

With reference to Figure 30, in one embodiment, compact manifold 3000 comprises multiple plastic layer, and parts are firmly attached wherein.More particularly, manifold 3000 comprises following element:

● back cover 300l

● pressure transducer film 3002

● valve film 3003

● middle part body 3004

● anterior covering 3005

● pump line sections (not shown in fig. 30)

The passage that middle part body layer 3004 is molded at side upper-part.These passages are completed by anterior blanket layer, and anterior blanket layer comprises ultra-sonic welded by any amount of method and is attached to middle part body securely.Anterior covering-middle part the body structure of this combination forms the major part of fluid path in manifold.The opposition side of middle part body 3004 has the feature on the surface formed for valve mediation pressure-sensing, and this feature is communicated to the fluid path on the anterior covering side of manifold.Manifold comprises the elastomer member for valve mediation pressure-sensing.These elastomer members are trapped between back cover layer and middle part body layer by using ultra-sonic welded, and complete the fluid path by manifold.

With reference to Figure 30, in one embodiment, manifold 3000 comprises five pressure transducer films 3002 and three to four films 3003 for two-port valve.In one embodiment, the middle part body 3004 of two covering 300l and 3005 and manifold 3000 is molded by makrolon material or ABS (acronitrile-butadiene-styrene).Pressure transducer film 3002 and valve film 3003 are molded by common material, such as Santoprene or more preferably Sarlink, and it is a kind of medical grade elastomeric polymer.In one embodiment, anterior and back cover 3005 and 300l can be molded by optically transparent material, are at least transparent to some preselected wavelength of light, to allow the spectrum analysis of the fluid comprised within it.

In addition, manifold preferably includes four pumping member.These pumping member are the sections on the pvc pipe road of extrusion molding, composition and size be determined to be have for pump use particularly roller pump use the performance optimized.This pipeline is attached to the integrally moulded barb accessory to body in the middle part of manifold.One of four pumping member for extracting out blood and being pumped across dialyser and pumping is back to the vein of patient from the tremulous pulse of patient.Two pumping member are used for dialysis solution flowing, one for deliver transfusions to dialysate fluid loop.The syringe pump be separated can be used for being pumped into by anticoagulant in arterial blood path, pre-dialyser.

In one embodiment, manifold is also combined with line ports, preferably in the scope of 10-14 and more preferably 12 ports, for all fluid paths in manifold being connected to the miscellaneous part in disposable external member, comprise dialyser, adsorbent box, bag reservoir, transfusion container, blood samples of patients line, anticoagulant, sensor, preliminary filling pipeline and discharge pipe line, as discussed further below.

In one embodiment, the shape of manifold is as capitalization " I ", there is the first sections parallel to each other with the second sections and be connected sections, connect sections a) perpendicular to the first sections with the second sections and b) for being connected the first sections and the second sections.In one embodiment, connect the middle part that the middle part of the first sections is connected to the second sections by sections, thus make connection sections and the distance between the first sections and each end of the second sections be equidistant.Should be understood that, connect the end that sections can be placed on the first and second sections, thus make capitalization " C " or reverse " C ".Manifold can also rotate relative to dialysis system, and does not need to orientate capitalization " I " as, and such as it can be positioned on its side or locate at a certain angle.As shown in figure 32, in an exemplary embodiment, manifold 3200 has following size: Ll and L2 is in the scope of 4 to 7 inches, and preferably about 5.7 inches, L3 and L4 is in the scope of 0.5 to 1.5 inch, and preferably about l inch, L5 is in the scope of 2.5 to 4.5 inches, and preferably about 3.5 inches, and L6 is in the scope of l to 3 inch, and preferably about 1.8 inches.Although size is provided, should be understood that, invention disclosed herein is not limited to the set of any concrete size or size.

In one embodiment, the assembling process of manifold 3000 comprises and back cover 300l is matched to middle part body 3004, simultaneously by making the first side of film physically be attached or contact middle part body and making the second side of film through the hole in back cover 300l, space or hole 3011 by position for film 3002 and 3003.Covering 300l can be divided into two parts, i.e. top section and base section, wherein top section comprises top section and the top water plain film section 3080 of center upright part 3082, and base section comprises base section and the bottom horizontal segment 3085 of center upright part 3084.In the present embodiment, the top of covering 300l and base section can be attached to middle part body 3004 individually, and relative to continuous print covering 300l, material cost can be saved by the material not included in the middle fragment region 3083 of center upright part.Preferably, the second side of film has the structure having level, and it allows the first level through hole 3011, and the second level remains between back cover 300l and middle part body 3004.Film 3002,3003 is fixed in back cover 300l by this.In addition, preferably, the first side that middle part body 3004 comprises film 3002,3003 rests in depressed part wherein, thus they is fixed to middle part body 3004.In selectable configuration, film 3002 and 3003 can be common-mode to back cover 300l in multiple molding process.

It will be understood by those skilled in the art that, all parts of manifold can combine by using any suitable means or be fixed together.In one embodiment, the sealing between middle part body and back cover is realized by ultra-sonic welded or binding agent.Alternatively, laser weld can also be adopted.Anterior covering is attached to the opposite side of middle part body in a similar manner.In one embodiment, pump line road sections is by solvent in conjunction with in place, or in selectable embodiment, sections can be hermetically laser welded by using the additive of absorbing laser in plastics.

In one embodiment, anterior covering is molded by BASFTerlux2802HD, ABS, and it is transparent and will be provided to the visibility of fluid path.The transparency of ABS also will be provided for the means checking ultra-sonic welded surface integrity.For its biocompatibility and concerning the compatibility of ultra-sonic welded, ABS is preferred.In addition, anterior covering can comprise the textured surface that has be molded into and helps the better combination promoted between anterior covering and middle part body.This have textured surface to be chemical etching process well known by persons skilled in the art.A preferred depth of lines is 0.0045 ".Other suitable lines also can by laser-induced thermal etching.The surface be welded on anterior covering is designed to have 0.003 " depressed part, this change on mould by lifting 0.003 " surface.This provides accurate for receiving the surface of lines.Once become lines (texturing) to occur on mould, then this 0.003 " height on surface just declines.Because the 0.0045 " Feng Hegu of depth of lines, so hypothesis meansigma methods will be the half or 0.00225 of this amount ".Result will make mould 0.00075 " very safe condition under.Covering 3005 with the form of only center upright part 3090, and can also not comprise top and bottom horizontal portion 309l, 3092.By center upright part 3090 being placed in the sunk area that limited by the edge of the lifting on the surface contrary with the surface towards covering 300l of middle part body 3004, and part 3090 is combined in sunk area, center upright part 3090 can be attached to middle part body 3004.

In one embodiment, anterior covering is provided in the blood flow guider in both arterial channel and venous access.These features are designed to reduce haemolysis as far as possible.Blood flow guider provides the consistent cross-sectional area of through-out pathway, and reduces the sharp edges that blood will be in contact with it when not having blood flow guider as far as possible.Wall on the opposition side of blood flow guider is alleviated into the more consistent wall thickness be provided in molded plastic part.This will prevent from sinking in this region, sink may affect around face of weld.In one embodiment, anterior covering wall thickness is 0.075 ".

Alternatively, anterior covering has mating holes, and mating holes is provided for assembling object, to guarantee that anterior covering and middle part body are precisely aligned during ultrasonic welding process.Boss around the lifting of mating holes helps to increase the contact with the alignment pin of weld jig as far as possible, and plastics are not easily melted because of friction.These boss do not contact and are not soldered to middle part body, to guarantee that hole is open.

Fig. 3 l provides the perspective view of the middle part body component of compact manifold of the present invention.As shown in figure 31, the complete blood of hemodialysis/hemofiltration system and dialysis solution flow path 3101 are molded in the body of middle part.Accommodation section for each function element such as pump, valve and the sensor of blood purification system is also integrated in the middle part body piece section of compact manifold.

Middle part body can be molded by BASFTerlux2802HD, ABS.Another selectable ABS is Lustran348, White.ABS is selected due to its biocompatibility and to the compatibility of ultra-sonic welded.Middle part body and anterior covering are jointly provided for the fluid path passage of manifold.Middle part body comprises the energy drag device of the ultra-sonic welded for banjo fixing butt jointing pattern.In one embodiment, the size of energy drag device is 0.019 " height and width base portion 0.024 ".This causes the cross-sectional area of 0.00023 square inch.The width of face of weld is 0.075 ", cause about 0.003 " × 0.075 " welding volume.The energy drag device of banjo fixing butt jointing pattern is preferred relative to other patterns such as shear joint, ribbet, step joint, and this is due to its simplicity and the ability controlling molded part geometry.Passage is arranged in weld seam geometry, to prevent the gas retained to be forced through weld seam, causes the poor weld seam that may leak.

The back cover side of middle part body preferably provide be molded into have textured surface, to help to promote the better combination between back cover and middle part body.This have textured surface to be chemical etching process well known by persons skilled in the art.Preferred depth of lines is 0.0045 ".Other suitable lines also can by laser-induced thermal etching.Be welded on middle part body on surface design for having 0.003 " depressed part, this change on mould by lifting 0.003 " surface.Once become lines to occur on mould, then this 0.003 " height on surface just declines.Because the 0.0045 " Feng Hegu of depth of lines, so hypothesis meansigma methods will be the half or 0.00225 of this amount ".Result will make mould 0.00075 " very safe condition under.

The size of just soldered parts may have major effect to the success of ultrasonic welding process.If surface area is larger, so welding process is more difficult.Importantly, face of weld is accurately controlled.The thickness of anterior covering and back cover is more important than flatness, because slightly uneven covering will be driven plain during welding process.Flatness on the body of middle part is very important, and this is due to it will be prevented during welding process to be able to planarized structural design.Due to these problems, it is highly important that, part is properly designed and is not easy to suffer exception, such as warpage, sinking, dimensional discrepancy etc.In addition, mold structure and quality need coupling part by the high standard of demand fulfillment.This will follow molding process and controls and will require highest standard.

Back cover can be molded by BASFTerlux28021HD, ABS.Back cover comprises the energy drag device of the ultra-sonic welded for banjo fixing butt jointing pattern.The size of energy drag device is 0.019 " high, wide base portion is 0.024 ".This causes the cross-sectional area of 0.00023 square inch.The width of face of weld is 0.075 ", cause about 0.003 " × 0.075 " welding volume.This is 0.003 years old " welding volume should be considered when determining the geometry of the parts assembled.Passage is arranged in weld seam geometry and prevents the gas retained to be forced through weld seam, causes the poor weld seam that may leak.Mating holes in back cover is provided for the object of assembling, to guarantee that back cover is precisely aligned to middle part body during ultrasonic welding process.Mating holes in back cover is also provided in by the accurate aligning of fitting manifold and instrument when loaded.Boss around the lifting of mating holes is designed to increase the contact with the alignment pin of weld jig as far as possible, makes plastics not be easy to fusing because of friction.These boss do not contact and not welded fetching guarantees that hole is open.

Ultra-sonic welded is selected as the method in conjunction with manifold three critical pieces, because the cost of this manufacturing process is very low.Relatively low equipment cost and for generation of cycle time of weld seam owing to this lower manufacturing cost.Once part is loaded into fixture, then there is angle and to advance and the weld cycle that removes can realize in several seconds.Actual weld interval is about one second.Other associated methods comprises hot plate, laser and UV binding agent.

With reference to Fig. 3 l, in one embodiment, middle part body piece section 3l00 has integrated three two-port valves within it 3107, five pressure transducers 3106, occlusion detection device, an air bubble detector and a blood leakage detector.What it will be understood by those skilled in the art that is, the quantity and the type that are integrated in the functional part in the body piece section 3l00 of middle part can change according to the requirement of blood purification system and application, therefore l, 2,3,4,6,7,8,9,10 or more pressure transducers can be comprised, l, 2,4,5,6 or more two-port valves, 0,2,3,4 or more occlusion detection devices, 0,2,3,4 or more air bubble detectors, 0,2,3,4 or more a blood leakage detector.In addition, body piece section 3l00 in middle part comprises multiple port 3103,3104.

Port comprises internal port 3104, fluid via pump sections (not shown) from and between first sections and the second sections of manifold 3l00, flow through this internal port.In one embodiment, the first sections has four internal ports 3104, the first sections be connected sections junction point every side on be two.Should be understood that, the first sections can have l, 2,3,5,6,7 or more internal ports.In one embodiment, the second sections has four internal ports 3104, the second sections be connected sections junction point every side on be two.Should be understood that, the second sections can have l, 2,3,5,6,7 or more internal ports.In addition, preferably, the position of the position of the internal port of the first sections and the internal port of place and the second sections and place mirror image.Port also comprises the outside port 3103 of the element to manifold 3l00 outside.In one embodiment, the first sections has two outside ports 3103.In one embodiment, the second sections has ten outside ports 3104.In one embodiment, the first sections has l, 3,4,5,6,7,8,9,10,11,12,13,14,15 or more outside ports 3103.In one embodiment, the second sections has l, 2,3,4,5,6,7,8,9,11,12,13,14,15 or more outside ports 3104.

As described above, fluid contacting components is attached in manifold, make it possible to design such system, namely reusable sensor is arranged in dialysis machine, and manifold mates necessarily disposable fluid contacting components simultaneously and is separated and is placed in manifold with it.In order to ensure making suitable reading and measurement, fluid contacting components and reusable sensor need to be aligned.Coupling between manifold and dialysis machine and aim at for location and institute's applied pressure most important.Usually, such coupling accuracy must be provided in the 0.00l in X, Y and Z-direction " to 0.010 " tolerance, and the installing force be applied in the scope of 10-100PSI to resist with the fluid force of manifold.This key is located through that mate with the reciprocal positioning surface on dialysis machine, on manifold specially designed locating surface and realizes.By the analysis and design of dialysis machine structure to allow to be less than about 0.00l under all fluids developed in manifold during operation and mechanical pressure " to 0.010 " X and Y position and Z-direction deflection send required power.Because manifold comprises many structures on a monolithic substrate, only need to carry out once, for by all feature location of mating of all features of manifold with dialysis machine so this key is aimed at.

Middle part body channel sized is nominally 0.190 " be deeply multiplied by 0.190 " in wide scope, the radius at the channel bottom turning on side, middle part is 0.020 ".Radius at channel bottom turning should be large to prevent sinking from occurring in below conduit wall as much as possible.These conduit walls have valve on the opposition side of middle part body and pressure-sensitive diaphragm geometry, and this sinking that may be subject in these regions adversely affects.In one embodiment, fluid path is square.That the wall thickness of flank (being conduit wall in this case) should the 50-60% of no more than adjacent wall attached by it for preventing the general design rule sunk.Conduit wall is 0.075 " and adjacent wall (primary manifold structure) is 0.130 ", cause being 58%.0.190 " × 0.190 " dialysis solution passage transits to 0.155 through via hole " line ports.This degree of accuracy reduced to anterior covering is aligned to needed for the body of middle part of trying one's best, and reduce by the potential possibility of the sinking produced compared with heavy wall, this sinking may affect the seal feature on body opposition side, middle part. as far as possibleSame procedure is used to anticoagulant and transfusion passage.Soft curve is designed in passage, to increase laminar flow and to reduce turbulent flow as far as possible as far as possible.In one embodiment, as discussed below, the size of anticoagulant and transfusion channel measurement is 0.190 " be deeply multiplied by 0.100 " wide.

In one embodiment, middle part body has the mating holes for assembling object, to guarantee that both anterior covering and back cover are precisely aligned to middle part body during Ultrasonic welding processes.Boss around the lifting of mating holes increases the contact with the alignment pin of weld jig as far as possible, makes plastics not be easy to fusing because of friction.These boss do not contact and not welded fetching guarantees that hole is open.

Figure 33 is the diagram of the fluid circuit for compact manifold described in detail according to an embodiment of the invention.Fluid circuit comprises four pump line sections P1330l, P23302, P33303 and P43304 with the pump boots pressure communication in the pump in top controller unit and top controller cell gate.It also comprises and five pressure membrane of pressure transducer S13305, S23306, S33307, S43308 and S53309 pressure communication and region that is hot with temperature sensor S63310 or optical communication.In the embodiment shown in Figure 33, three couples of film VlA and V1B33311, V2A and V2B33312 and V3A and V3B33313 are integrated in manifold.Film is used as valve when the pin of their origin self-controller unit, component or protuberance are inaccessible.

Paired six check valves 3311A, B, 3312A, B, 3313A, B divide into groups by this way, form three two-port valve assemblies 3311,3312,3313.Two-port valve is provided in the greater flexibility of control loop configuration aspect.When the two-port valve of routine is used for occlusive part shunting body path, they are configured to make two different fluid paths to become possibility usually, one for the first valve state, one for the second valve state.Disclosed in hereafter, some the valve embodiment combinationally used with the valve film be integrated in manifold or pressure spot makes it possible to control more subtly, makes it possible to the fluid flow path that generation four difference are different.

Pump line sections 330l, 3302,3303,3304 is attached in compact manifold.Multiple port is arranged in manifold, and it is connected with the pipe of manifold external, flows into and flow out manifold to allow various fluid.These ports are connected to each pipe in blood purification system to carry following fluid:

Port A3315-to the blood of dialyser 3330;

Port B3316-dialyser exports (used dialysis solution);

Port C3317-from the blood of patient;

The heparin of port D3318-for mixing in blood;

Port E3319-reservoir exports (fresh dialysis solution);

Port F3320-dialyser input (fresh dialysis solution);

Port G3321-dialyser exports (blood);

Port H3322-patient return (blood clean);

Port J3323-be connected to Trunk Line and discharge pipe line;

Port K3324-reservoir transfusion input;

Port M3325-enter from the transfusion of transfusion reservoir;

Port N3326-the flow to dialysis solution in adsorbent.

In one embodiment, the fluid stream of the heparin 3314 entered via port D3318 is connected to the fluid stream of the blood entered via port C3317 by the pipe sections being formed as being molded into the path in manifold structure 3300.Heparin and the blood of combination flow through port 3317a via pump sections 330l, and enter the port 3317b of manifold 3300.Pressure transducer be formed in film 3305 physical connection in manifold structure 3300, film 3305 and then make blood and heparin fluid through port A3315.The dialyser 3330 of manifold 3300 outside is flowed through from manifold 3300 fluid out at port A3315.The blood of dialysing is transmitted by port G332l and turns back in manifold 3300 and enter sections 3307, and this sections is formed as being molded into the path in manifold structure 3300, this path and pressure transducer physical connection.Then fluid passes port H3322 from this sections and enters patient's return line.

In addition, dialysis fluid enters manifold 3300 from reservoir via port E3319.Fluid in reservoir has transfusion wherein, first transfusion enters manifold 3300 via port M3325, through the sections being formed as the path be molded in manifold structure 3300, through another port 3325a, through the sections 3302 be communicated with pump, and turn back in manifold 3300 via port 33251b.Transfusion is through the sections being formed as the path be molded in manifold structure 3300, and at port K3324 from manifold 3300 out, in this port, its transmission enters in reservoir.The dialysis fluid entering manifold via port E3319, through the sections being formed as the path be molded in manifold structure 3300, through another port 3319a, through the sections 3303 be communicated with pump, and turns back in manifold 3300 via port 3319b.

Dialysate fluid transmission enter with a pair valve 3311 physical connection, in the sections that is formed as the path be molded in manifold structure 3300.Dialysate fluid is passed to another to valve 3313 by the sections being formed as the path be molded in manifold structure 3300.This sections and pressure transducer 3308 and optional temperature sensor 3310 physical connection.Dialysate fluid is transmitted out from manifold 3300 by port F3320, and enters in the pipeline be delivered in dialyser 3330.

From dialyser 3330 pipeline out fluid transmitted by port B3316 and turns back to manifold 3300, and enter with first pair of valve, 3311, second pair of valve 3312 and pressure transducer 3306 physical connection, the sections that is formed as the path be molded in manifold structure 3300.Used dialysate fluid is transmitted out from manifold 3300 by port 3326b, by the sections 3304 be communicated with pump, and turns back in manifold via port 3326a.The sections be communicated with port 3326a fluid and pressure transducer 3309 physical connection, and fluid is passed port N3326 and is passed to sorbent regeneration system.

Port is designed to circuit lines 0.268 " × 0.175 " pipeline or anticoagulant and transfusion pipeline 0.16l " × 0.135 ".Preferably, line ports adopts suitable solvent to combine.

Should be understood that, the valve 3311,3312,3313 shown in Figure 33 can be positioned at the diverse location in manifold.With reference to Figure 86, valve 8611 (valve 3311 in Figure 33) can be positioned at and is adjacent to and is parallel to the center upright part 8650 of the manifold 8600 of valve 8612 (valve 3312 in Figure 33).Valve 8613 (valve 3313 in Figure 33) is also in the center upright part 8650 of manifold 8600, and top horizontal component 8630 and bottom horizontal portion 8640 link together by it.Valve 8613 on the base section of center upright part 8650, and is positioned to the central authorities roughly below valve 8611,8612 and between them.

In one embodiment, elastomer diaphragm operates in the upper compression of volcano sealing (volcanoseal) by making the valve actuator be arranged on instrument by two-port valve, to prevent dialysis solution from flowing through its corresponding path, as described in greater detail below.The diameter of volcano sealing opening is about 0.190 ", to mate passage geometry.At least 0.190 is equivalent to when valve is opened by the cross-sectional path of valve inside " diameter.When the valve is in the closed position, valve actuator and elastomer diaphragm consume the major part around the fluid path space of volcano sealing, and reduce the potential of air trapping may as far as possible.Middle part body has the plastic features of lifting, and it reduces the dead space in fluid path as far as possible, and contributes to preventing diaphragm from subsiding around central fluid path under negative pressure condition.Elastomer diaphragm have around its girth be assembled to middle part surface on groove in O type ring feature.O type ring is compressed between middle part body and back cover, to form the sealing of fluid-tight.This design is provided in about 30% on O type ring and compresses.Two-port valve controls the direction that dialysis solution flows through manifold.

Manifold comprises the structure allowing to monitor fluid pressure on whole diaphragm by using the sensor in instrument.Fluid is allowed to from the channel flow the anterior covering side of middle part body by the ingate below the diaphragm on back cover side and outlet opening.At least be equivalent to 0.190 by the cross-sectional path of pressure sensing structure inside ".Inner track is designed to reduce air trapping as far as possible, provides the fluid contact enough with diaphragm simultaneously.Elastomer diaphragm have around its girth be assembled to middle part surface on groove in O type ring feature.O type ring is compressed between middle part body and back cover to form the sealing of fluid-tight.This design is provided in 30% compression on O type ring.

Valve and diaphragm can by multiple different materials and by different manufacture technics.In one embodiment, elastomer member is manufactured by silicones.In another embodiment, elastomer member is by multiple thermoplastic elastomer.Molded may be used for valve and diaphragm to be attached to back cover.The molded of valve and diaphragm will no longer need these parts to be assembled into separately in manifold, therefore reduce cost of labor and improve the quality of manifold component.

Pumping member in manifold design has been restricted to PVC collector pipeline.The combined flowing that blood, dialysis solution and transfusion are provided of rotational creep pumping system of these collectors and instrument.For the circuit lines material preferably antitorque knot of dialysis solution, transfusion and anticoagulant, such as by Natvar and all TEKNIplex companies extruded be called as Colorite, UnichemPTN780, the pipeline of (80A hardness).Pipeline size scope for dialysate lines is from 0.268 " × 0.189 " to 0.268 " × 0.175 ".

In order to make manifold sections by elastica and the effective heat of one or more sensor, optics or pressure communication, importantly produce the fluid flowing of the enough next-door neighbours exposure to sensor device.A kind of method so done has been shown in Figure 34.Manifold sections 3400 receives fluid stream 3410, its stop due to the protuberance in fluid path 3410, component or other structures 3408 and the position and caused moving upward of leading again.Upward fluid and concentrate between film 3405 and structure 3408, makes it possible to improve sensing thus.But, such embodiment have cause blood clotting be formed in bending section 340l, 3415 or the base portion 3406 of film 3405 that brings because of negative pressure adhere to the top 3407 of structure 3408 and the potential of obturation that cause may.

Below simultaneously with reference to Figure 35 A and 35B, in order to reduce the potential possibility of blood clotting or obturation as far as possible, therefore be preferably, be designed to avoid generation can increase the zig zag of the probability of grumeleuse or obturation, bending section or U-shaped path by elastica 3505 and the structure of the manifold sections 3500 (be also referred to as and sense sections) of one or more sensor heat, optics or pressure communication, and be still provided in streaming flow and be positioned on sections or be close to enough contacting between its sensor.With reference to Figure 35 A and 35B, internal fluid pathway 3515 is limited by top surface and lower surface now, top surface comprises film 3505, sensor can be placed in and the heat occurred by path 3515 by this film, optics or pressure communication, lower surface is limited by following: a) highly reduce path 3515 first to be inclined upwardly wall 3525 highly along the length of wall 3525 from the first height to second, b) planar segment 3526 of same paths height 3515 is highly kept second, and in the length of whole wall 3527, c) again highly increase the skew wall 3527 that dips down of path 3515 height down to first from the second height.Wall 3525,3527 angled be inclined upwardly/and the downward-sloping fluid path 3515 that makes narrows.But simultaneously, the width limited by inclined wall 3525,3527 and planar segment 3526 of sections is broadening relative to manifold part before and after this sensing sections.The height reduction relative to the manifold sections before and after sensing sections of sensing sections and width increase provide the speed of the constant of fluid, thus avoid may by the velocity variations of blood haemolysis, eliminate dead space and keep low reynolds number, being still provided for sensor simultaneously and carrying out contact area needed for the flexible membrane 3505 measured by it.In one embodiment, one or more pillar 3535 is attached in fluid path 3515, the top of plane surface 3526 and subsiding completely with the film 3505 preventing from causing because of negative pressure below film 3505.

It being understood that the blood of manifold and dialysis circuit can be limited by one piece molded plastic part from above-mentioned discussion, instead of the multiple plastic components welded together.But, when blood and dialysis circuit are limited by single integral piece of material, some can be brought to challenge.Especially, port 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b in Figure 33 are for challenging cost is effectively and reliably molded, if the protuberance limiting the cylinder form of each port directly vertically extends from manifold surface, or in other words, with the sidepiece of the part apart from the manifold attached by columniform protuberance roughly in zero slope.If port is with completely vertical configuration manufacture, then the pin from molding machine can not be removed easily.Simultaneously with reference to Figure 33 and 36, preferably, port 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b is manufactured by the sides tapered of the manifold 3645 (as limited by surface 3675) making the cylindrical projection of restriction port organization 3655 be attached to relative to protuberance 3655.Therefore, in one embodiment, internal manifold port will tilt relative to manifold surface.This angle reduces the stress in any pump line minor segment be inserted between two inclination ports further.Its further pump line minor segment is orientated as be in slight curving, flexing or otherwise nonlinear shape to comply with pump collector contact surface better.In one embodiment, the angle limited in the line of manifold sidepiece in the line of inclination port center and normal direction by normal direction is less than 20 degree and is preferably less than 10 degree.In one embodiment, this angle is about 10 degree.In one embodiment, internal manifold port 3317b, 3317a, 3319b, 3319a, 3325a, 3325b, 3326a and 3326b manufacture with angle mentioned above, and all the other ports are with the angle manufacture being approximately equal to zero simultaneously.In another embodiment, protuberance 3655 (although being described to be columniform) has interior zone or volume 3753, wherein base portion 3754 is general plane instead of bends, the remainder maintenance of the inner structure of defined volume 3753 is simultaneously bending 3756, as shown in figure 37.In another embodiment, all ports or fluid path have interior zone or volume 3753, and wherein base portion 3754 is general plane instead of bends.

Another embodiment of manifold is shown in Figure 38 to 40, and wherein blood and dialysis solution flow path are molded in single compact plastic unit.In one embodiment, manifold 3800 holds easy-to-assemblely to have built-in molded blood and the compact plastic unit in waste flow path.Alternatively, sensor, pump and hemofilter box also can be integrated with compact plastic unit by being inserted in the spill molding section in unit.In one embodiment, dialysis system of the present invention can at every turn process operation more than 8 hours and continued operation reaches 72 hours.Should be understood that, fluid is flowed into by limited ingress port and outlet port and flows out manifold, such as, to external pump with from external pump, to refuse UF reservoir, or to patient's return line.

Figure 39 shows the modular assembly of the manifold 3900 in one embodiment of the invention.Pumping fragment 3930 comprises blood and waste pump 3903,3913 respectively.Module 3940 comprise for blood and ultrafiltrate refuse molded flow path 3942 and comprise the hemofilter module 3950 of hemofilter box 3908.This modularized design allows modules to be easily assembled into single cramped construction fast.

Figure 40 shows the zoomed-in view of the middle part module 3940 of Figure 39.In one embodiment, middle part module 4040 comprises the built-in molded flow path 4041 for carrying blood and refuse.Connecting portion port 4042 is also molded in the module of middle part, for connecting (via luer connector and pipeline) to the pump in middle part module 4040 ends and the hemofilter box that is connected in another end of middle part module 4040.

Referring back to Figure 38, blood is inhaled in manifold 3800 via blood inlet port 380l and molded flow path 3802 with the volumetric blood pump 3803 of manifold tubes sections pressure communication by using.Blood is pumped in hemofilter box 3808 via molded flow path 3804 by volumetric blood pump 3803.Inlet pressure transducer region 3806,3807 is also integrated in manifold 3800 in molded flow path 3802,3804.

Referring back to Figure 38, refuse from infiltration area 3809 is drawn out of by molded flow path 3814 by refuse displacement pump 3813, in one embodiment, molded flow path 3814 has the integrated pressure sensor area 3815 being positioned at flow path 3814 online.Refuse is pumped through molded flow path 3816, in one embodiment, molded flow path 3816 has the integrated blood leakage detector region 3817 online with the flow path 3816 of being drawn by Waste outlet port 3819 from manifold 3800 and waste stream gauge 3818.

In one embodiment, hemofilter box 3808 is disposable, and is removably integrated in the corresponding molded depressed part in manifold 3800 and has carried out ultrafiltration circuit.The interface that manifold 3800 is also provided to redundancy clip pipe valve connects, with the vascular system preventing air from entering patient.Pinch valve is designed so that it is in closedown (obturation) position when not having electrical power to be applied in.

Molded flow path 3802,3804,3810,3814 and 3816 limits blood and the ultrafiltrate flow circuits of manifold 3800.In one embodiment, these flow paths comprise disposable pipeline and are suitable for blood with multiple and ultrafiltrate contacts the interface connection component reaching at least 3, such as joint.Joint is preferably designed to be has at least 5lbs intensity and the sealing (being namely greater than hemofilter maximum transmembrane pressure) to 600mmHg.In one embodiment, corresponding to the blood external member pipeline of flow path 3802,3804 and 3810, there is appropriate length for supplying 50ml/ minute blood flow and internal diameter.In one embodiment, the main volume of blood external member pipeline (comprising hemofilter) is less than 40ml.Blood external member pipeline is connected with volumetric blood pump 3803 interface.In one embodiment, blood pump 3803 pipeline is Tygon board, model S-50-HL, size l/8 " internal diameter × 3/16 " external diameter × l/32 " wall.

Similarly, in one embodiment, the ultrafiltrate flowing of 500ml/ hour (8.33ml/ minute) can be supplied corresponding to the ultrafiltrate external member pipeline of flow path 3814 and 3816.Ultrafiltrate external member pipeline is also connected with refuse displacement pump 3813 interface.In one embodiment, waste pump 3813 pipeline is Tygon board, and model is S-50-HL, size 3/32 " internal diameter × 5/32 " external diameter × l/32 " wall.

Because manifold of the present invention comprises the molded flow path for blood, dialysis solution, waste fluid and displacement liquid, so whole flow path can be easily manufactured as portable compound manifold.Manifold is also easy to handle, because all being attached on the side of manifold in the flexible conduit of manifold outside.Use the manifold with built-in molded flow path to strengthen trouble-proof process, because of being off, incorrect assembling reduced compared with the prior art systems of the many flexible conduit of use with the probability of leakage as far as possible.Use novel manifold also to strengthen ease for use, cause portability to be enhanced.

In one embodiment, dialysis manifold is independently compact unit, makes them can by independent and individually for the treatment of the blood from patient.In another embodiment, two manifolds can be connected to each other, to be used as two-stage blood processing system.In one example, blood is extracted by from the artery site in patient, and is passed through dialyser, and waste fluid a large amount of in dialyser is by flowing out.Manifold is used for the fluid of equivalent to be back to blood, and then infused blood.Manifold is measured waste fluid and waste fluid is poured in litter bag.

As is known to persons skilled in the art, hemofilter or dialyser, box 3808 comprise hollow tube, and hollow tube also comprises multiple hollow fiber conduits that its wall is used as semipermeable membrane.Hemofilter box 3808 is divided into the blood flow district 3805 in hollow fiber conduit and the filtration outside hollow fiber conduit or infiltration area 3809 by described multiple semi permeable hollow fiber conduit.Along with blood is through blood district 3805, blood plasma water (plasmelwater) transmission strides across the semipermeable membrane of hollow fiber conduit.Hemofilter box 3808 is little hemofilters.More concentrated blood is flowed out from box 3808 by molded flow path 3810 and is flowed out from manifold 3800 by blood exit port mouth 3811.Air detectors region 3812 is also integrated into blood and returns in flow path 3810.

Below the exemplary physical specification of hemofilter according to an embodiment of the invention or dialyser 3808:

During dialysis treatment, one of above-described manifold is arranged in dialysis machine by patient or nursing supplier.With reference to Fig. 4 l, dialysis machine 410l has can broadly be opened to install department 4103 before disposable unit.In order to install, manifold 4104 needs to be inserted in the space of the object be provided in unit with dialysis 4101 simply, as previously discussed.Dialyser 4102 is installed and also relates to the simple insertion in appointment depressed part.Front department 4103 is provided with pump boots 4105, and these pump boots make the loading of disposable unit be very easy to, because without any need for pump line road through roll packer and boots.In addition, this layout allows to guarantee that the mode of relative non-once parts such as pressure readers, sensor and other parts proper alignment installs dialyser 4102 and manifold 4104.This complete simple method makes it possible to disposable loading and cleaning systems easily.It also guarantees that flow circuits is suitably configured and is easy to use.

With reference to Figure 42, in one embodiment, manifold 4202 is arranged on the vertical front panel 4203 of dialysis system 420l.Manifold 4202 is accurately positioned on this panel 4203 by multiple aligning guide.First aligning guide is included in multiple alignment pins of the mating holes in the joint manifold 4202 in panel 4203.Second aligning guide comprises at least one breech lock, and manifold 4203 is remained on specific installation site by it, until door 4206 is closed and obtained final exact position.In one embodiment, the back cover of manifold 4,202 two of having in top and bottom are designed in interior boss.Before door 4206 is closed, manifold 4202 is latched in the first holding position by these boss, and subsequently manifold 4202 is placed on exact position.Boss makes can by manually or be required to use hands to force the bolt lock mechanism of the ball detent release of removing manifold 4202 to become possibility.In another embodiment, bolt lock mechanism is included in spring-loaded insertion and the relieving mechanism at the top of back cover.This mechanism has the connecting rod between top latches and bottom breech lock.When being activated at the relieving mechanism at top, bottom breech lock is also released.

3rd aligning guide comprises the guiding general location of manifold 4202 and the profiling guide 4208 of configuration.Profiling guide 4208 is preferably shaped to coupling or otherwise supplements the physical arrangement of manifold 4202.In one embodiment, guide 4208 is substantially rectangle, and is configured to be assemblied in by the first sections of manifold 4202, the second sections and the interior volume being connected sections constraint, as described above.4th aligning guide comprises door 4206, and this door has at least one spring-loaded pressure plare 4205, and manifold 4202 is captured between door 4206 and front panel 4203 by this pressure plare, thus applies to be in harmonious proportion pressure enough pressure sensing for valve.Door 4206 also comprises four pressure shoe, and enough pressure is applied to the rotational creep that pumping member is used for fluid and sends by these pressure shoe.

Should be understood that, what can use in aligning guide is one or more, or alone or in combination, to realize aiming at needed for manifold and the position of pressurization.It is to be further understood that aligning guide is attached to the surface of the sunk area in dialysis apparatus enclosure.Sunk area comprises front panel 4203, it is relative to dialysis apparatus housing depressions and by four walls (the first wall, the second wall, the 3rd wall and wall) constraint, it upwards extends to contact from front panel 4203 and is attached to dialysis apparatus enclosure securely.Depressed part is enough dark, and is configured to receiving gate 4206.

Sensor-based system

As described above, dialysis system particularly top controller unit comprises sensor-based system, sensor-based system and partial manifold be the transparent part of manifold or the membrane interaction that is embedded in manifold structure particularly, to sense some parameter or state, the blood of the existence of such as flow, temperature, pressure, sodium, the existence of ammonia, pH level, leakage, obturation or air bubble.Such as, be realize by being attached to and being included in dialysis machine around the optical pickocff of manifold presumptive area to the sensing of blood leakage, air bubble and/or obturation.Manifold can comprise multiple pipe-support support, and it is convenient to accurately be placed into by circuit lines when manifold is mounted and door is closed in the separated optical pickocff such as Optek sensor be arranged in instrument.Sensor is provided for the means of obturation, the blood leakage in the blood lines in dialyser downstream and the air detection in venous blood pipeline detected in arterial line.Pipeline is strapped on the side of sensor by support, and line ports carries out the constraint on the opposite side of sensor simultaneously.These optical pickocffs are U-shaped devices, and pipeline is pushed into when manifold is mounted in this U-shaped device.Pipe-support support provides the support to pipeline, three all these sensors is loaded with the motion identical with loading manifold, and does not have extra effort in the part of user.To hereafter further describe for the sensor-based system of flow, temperature, disconnection, central venous pressure and other system.

Flow

In one embodiment, dialysis system comprises the both acoustic flowmeters of Noninvasive or non-contact type, it has the ability directly producing acoustical signal when not having physical contact in fluid to be monitored, thus provides based on the measurement of sound wave delivery time the flow measurement having and improve degree of accuracy.Further imagination, this effusion meter can use jointly with one of above-described manifold, non-invasively to measure the flowing in manifold.

Figure 43 is the circuit diagram depicting exemplary light sonic flowmeter 4300.Flow fluid 4304 to be measured is being carried by arrow 4306 indicated direction by fluid bearings path 4305 (such as pipe, pipeline or manifold sections).Photoacoustic pulse effusion meter 4300 comprises light emission system 4310.In one embodiment, system 4310 also comprises LED or solid-state laser 4307, and it is excited in sinusoidal mode by signal source 4308.In another embodiment, Q-switch ruby laser may be used for replacement system 4310.It will be understood by those skilled in the art that, any other suitable optics as known in the art produces system and can be used for this object.

Optics produces system 4310 by light beam 4309 by being formed in optical aperture in the wall of path 4305 (i.e. manifold sections) or optically transparent fragment projects in fluid 4304.In one embodiment, traversed through fluid 4304 on the direction in the direction of the axis 4312 perpendicular to fluid bearings path 4305 by the light beam 4309 projected.The optically transparent fragment of pipe 4305 should be transparent to the specific wavelength of light source 4310.The wavelength of light source 4310 must be selected such that light is easily absorbed by the fluid 4304 that system is intended to measure its flow.It should be further understood that, when this system 4300 uses jointly with manifold, optics produces system 4310 and to be preferably included in the dialysis machine that disposable manifold is loaded into wherein and to aim at manifold, makes produced light beam 4309 pass the transparent fragment of manifold.

Along with light beam 4309 imports fluid 4304 into, the heat energy relevant to light beam is inhaled in fluid.Absorb the hot direction along light beam 4309 occur and cause the thermal agitation in fluid 4304.These thermal agitations occur as the fluid heating of local and cause the thermal expansion in fluid.As the result of this thermal expansion, acoustical signal 4311 is produced.In pressure change in fluid 4304, the characteristic of this signal replicates at the waveform for producing in the signal source 4308 of optical signalling producing component 4307 energy supply.The change of this pressure is relative to the downstream, position in path 4305 of light beam 4309 and propagate upstream.

As known in the art, will be phase different from each other by sensor 4313 and 4314 respectively in the acoustical signal that upstream and downstream receives.The amount of the phase contrast between the acoustical signal that upstream and downstream receives is directly proportional to flow.It is to be further understood that when jointly using with disposable manifold, sensor 4313 and 4314 is positioned to be in close proximity to manifold line or be embedded in manifold line.

Therefore, in one embodiment, detector of sound T14313 and T24314 is placed on upstream and downstream respectively, equidistant apart from light beam 4309, makes d14313a and d24314a be equal.In another embodiment, the upstream and downstream of 4313 and 4314 is placed and is needed not be equidistant apart from 4309.Detector Tl and T2 can be pressure transducer or sonic transducer such as mike.The model WM that mike box is such as manufactured by Panasonic company-55A103 is suitable for this application.

Detector T14313 and T24314 inquires that fluid flowing is with the acoustical signal 4311 of detection at the some place that detector T14313 and T24314 locates.Pressure along with acoustical signal 4311 changes (sound) and is passed to sensor 4313 and 4314 by the wall of conduit 4305, inquires and is acoustically occurring.

First reception amplifier 4315 is connected to detector T14313, and the second reception amplifier 4316 connects into the output received from detector T24314.The output of the first and second amplifiers 4315 and 4316 is connected respectively to the input of the first and second phase sensitive detection 4317 and 4318 by gain control element 4319 and 4320.An enforcement of phase sensitive detection 4317 and 4318 is called " lock-in amplifier " in the art.Be exaggerated after device 4315,4316 and phase sensitive detection 4317,4318 process at signal, the output of 4317 and 4318 through low pass filter 432l and 4322, to eliminate the high frequency noise components stayed from phase-sensitive detection process 4324 from signal or pulsation.The result output of wave filter 432l and 4322 is stabilization signals of the relative phase of the primary signal relative to generator 4308 representing the acoustical signal detected by 4313 and 4314 respectively.Therefore, optoacoustic effusion meter provides the instruction at the phase angle relative to reference signal to upstream and downstream acoustical signal.

After by the process of phase sensitive detection element and phase detection, upstream and downstream phase angle signal is provided to addition/subtraction unit 4323.Addition/subtraction unit 4323 output representative by acoustic detector T14313 upstream and by acoustic detector T24314 accepted downstream to acoustical signal phase contrast.This phase contrast between these acoustical signals is directly proportional to the flow of fluid, and as it will be understood by those skilled in the art that, can be used as the basis calculating actual flow or flow change.All means for calculated flow rate comprise processor and for being derived the software algorithm that flow or flow change by least phase data.Therefore, the output of addition/subtraction unit 4323 provides the measurement of the flow of convection cell 4304.

Therefore, as described above, in one embodiment, the output voltage signal of the first and second low pass filter 432l and 4322 is sampled, and in unit 4323, stand subtraction to determine the phase signal of the fluid flow indicated in path 4305.It will be understood by those skilled in the art that, any other suitable can being used for the means being calculated phase contrast by the output of acoustic detector.All such means comprise processor and the software algorithm for the hard coded that calculates phase contrast or soft coding.

As mentioned before, the signal produced by source 4308 is used as the reference signal of upstream and downstream sonic transducer T14313 and T24314.Figure 44 depicts the reference signal 4400a produced by the source 4308 of Figure 43.Figure 44 respectively depict and standing acoustic signals 4400b and 4400c after the signal processing of the output of Figure 43 difference gain-controlled amplifier 4315 and 4316.

In one embodiment, photoacoustic pulse effusion meter is utilized non-invasively to monitor the flow of the fluid in dialysis system such as hemodialysis well known by persons skilled in the art, hemofiltration and/or hemodiafiltration system.The blood of the fluid of measuring flow mainly respectively in blood and dialysis fluid circuit and dialysis solution is needed between dialysis period; But it will be understood by those skilled in the art that, the flow of other fluids such as transfusion or concentrated solution also can adopt effusion meter of the present invention to measure.Those skilled in the art it is also to be understood that, when effusion meter of the present invention has immobilising fluid in conduit/path if can also indicating.

Therefore, referring back to Figure 43, if the difference between the signal output of low pass filter 432l and 4322 is zero, then hint does not have fluid to flow by this.In dialysis system application, this very useful to there is no the detection of streaming flow, because it can indicate serious problem to be such as connected to the disconnection of the artery/vein conduit of patient.

In another embodiment, the flowing in manifold can be measured by thermal flow meter.Figure 56 shows the hot fluid flow measurement devices 560l of the present invention be jointly arranged on manifold 5602 in dialysis machine 5610.As previously mentioned, manifold 5602 has embedded fluid flow path within it or conduit 5603.Dialysis machine 5610 has can be opened to install department 5620 before disposable manifold 5602.In addition, front department 5620 is equipped with pin 562l, and its electric point that can contact when door 5620 is closed on manifold 5602 inputs to read information or to provide electric.

Hot fluid flow measurement devices 560l also comprises a series of contact 5611,5612 and 5613.Operatively, along with fluid (such as blood, dialysis solution or other fluids) flows through fluid flow path 5603 between dialysis period, it is through the first contact 5611 be embedded in plastics path.Contact 5611 and electric power source electrical contact, in one embodiment, electric power source is the pin 5621 on machine front door 5620.Electric power source or pin are controlled by the controller in dialysis machine 5610.Electric power source provides electricity irritation to contact 5611, and electricity irritation is used for adding thermal contact based on sinusoidal wave method is next micro-.

In one embodiment, micro-heating process causes the temperature in just measured fluid between 0.1 to 1.0 degree Celsius to increase.This is caused by means of the micro-heater being positioned at the first contact 5611, and micro-heater produces heat when receiving electricity irritation.Micro-heater for hot fluid flow measurement devices of the present invention can by using any design of being suitable for this application and manufactured.Such as in one embodiment, micro-heater is by the 30g copper wire manufacture of 10 circles be wound around around the pin being positioned at the first contact position 5611.

Along with contact 5611 is by micro-heating, the heat energy obtained is used for producing heat wave, and heat wave is from the first contact 5611 propagates down stream.Multiple contact (its in one embodiment quantity be two-5612 and 5613) is positioned at the downstream from the first contact 5611, and for measuring the propagation time of heat wave.Then measured wave phase compares with the primary wave produced by the first contact 5611.Therefore determined phase contrast provides the instruction of flow.

Figure 45 shows an embodiment of the effusion meter 4500a with the probe that can be used for flow measurement.Passage 450la surrounds the volume 4502a that fluid such as water or saline solution (0.9N) 4503a flows through.In one embodiment, passage has the height of in the scope of lmm to 5mm (preferably 3mm), the width of (preferably 8mm) in the scope of 3mm to 13mm, the length of (preferably 50mm) in the scope of 10mm to 100mm, at 3mm ²to 65mm ²scope in (preferably 24mm ²) aisle spare, and/or in the scope of 1.5mm to 7.22mm the hydraulic diameter of (preferably 4.36mm).

The direction of fluid flowing is illustrated by arrow 4504a.Probe 4505a is excited to be positioned to be in close proximity to receptor probe 4506a.The relative distance of probe is the key character of design, because electricity irritation needs depend on the spacing between probe 4505a and 4506a by the stimulating frequency exciting pin or probe 4505a to send.In one embodiment, excite probe to become apart with receptor probe positioning and be less than 2 inches, be preferably less than 0.8 inch, more preferably about 0.6 inch or about 15mm.In the present embodiment, exciting and measuring only needs two contacts, and each contact has contact surface 4507a.It will be understood by those skilled in the art that, under these circumstances, only by needs two contact points, instead of three, as above about shown in disposable manifold and dialysis machine.

Excite pin or probe 4505a to be embedded in passage 450la, and for providing thermostimulation (form with heat wave) to the fluid of flowing, then thermostimulation is sensed and is measured by reception probe 4506a.In one embodiment, the main diameter (preferably 0.08 inch) in the scope of 0.03 inch to 0.15 inch of pin or probe, the diameter (preferably 0.125 inch) in the scope of 0.025 inch to 0.2 inch on top contact surface, and by gold-plated pyrite or any other have about 8500kg/m ³the thermal conductivity of density, about 1.09W/mK and/or the material of the specific heat of about 0.38J/KgK make.

In one embodiment, exciting pin or probe 4505a to be molded in manifold with the main body receiving both pin or probe 4506a (pin or probe are not contacted with fluid physics, and its top contact zones is exposed to a surface of manifold).The main body of pin or probe is in unit center of a lattice and fluid passes through it.The top of pin is exposed, so can carry out thermo-contact from the spring-loaded contact of board, thus enables the transmission of heat energy between spring-loaded contact and the contact surface of pin.

Such as, with reference to Figure 45, show the side view of an embodiment of thermal flow meter 4500b of the present invention, wherein contact surface 4507b is exposed, make the spring-loaded contact (shown in Figure 56) from the board of dialysis machine to carry out thermo-contact, and heat energy can exchange in spring-loaded contact and exciting between pin or probe 4505b.Passage 4501b surrounds the volume 4502b that fluid 4503b flows through.The direction of fluid flowing is illustrated by arrow 4504b.Excite probe 4505b to be positioned to be in close proximity to receptor probe 4506b, each probe has contact surface 4507b.

Figure 45 also show the thermal flow meter 4500c from flow channel 450lc end, and this flow channel comprises the volume 4502c that fluid 4503c flows through.In this article, only receptor probe 4506c and contact surface 4507c thereof is illustrated.In one embodiment, receive the similar of contact or pin 4506c in the structure exciting pin 4505b, and its top 4507c is also exposed.In one embodiment, receptor pin surface 4507c is also designed to the spring-loaded contact of low thermal mass.Excite 4505a and receptor 4506a probe or pin to be made up of the suitable material with Gao Re and conductivity, it is gold-plated pyrite in one embodiment.

In one embodiment, the spring-loaded contact of low thermal mass in instrument such as dialysis machine is controlled by temperature by using heater and thermal resistor.Then temp. control function produces cosine temperature waveform within the probe, and it is reflected in the temperature wave produced in spring-loaded contact.Obtained as exciting the excitation signal of the feature of pin to be defined as:

E _s=E _scos (ω t), wherein ω t is stimulating frequency.

The thermal response of receptor pin can be characterized by following formula:

R _r=R _rsin (ω t+ θ), wherein ω t is stimulating frequency and is phase place.

One of heat wave propagation represents shown in Figure 46.With reference to the direction (and therefore hot direction of wave travel) of the fluid flowing in the fluid path 4602 that Figure 46, arrow 460l represent in passage.Metering contact represents by 4611,4612 and 4613.Because micro-heater is positioned to be in close proximity to the first contact 4611, so heat wave is initial in the first contact, and then respectively towards be positioned at from second of the first downstream, contact 4611 and the 3rd contact 4612 and 4613 propagate.Distance between second contact 4612 and the 3rd contact 4613 is 4615.

Figure 46 also show the exemplary fluctuation measurement 4620 in three contacts 4611,4612 and 4613.The heat wave produced in the first contact 4611 is represented by the first curve 462l.Consider that flowing is from left to right, this heat wave will slightly arrive in the contact 4612 of the second position before the time of the contact 4613 of the 3rd position in its arrival.Second and the 3rd the output of contact 4612 and 4613 represented by curve 4622 and 4623 respectively.

Phase shift between secondary signal 4622 and the 3rd signal 4623 can by comparing point for each zero crossing and measured.Distance 4615 between second contact 4612 and the 3rd contact 4613 equals the flowing velocity of fluid divided by the time (being also referred to as the transition time) between corresponding zero crossing.In addition, the diameter flowing velocity calculated being multiplied by fluid path obtains volume flow.

Heat wave can be monitored by serviceability temperature sensor, in one embodiment, temperature sensor is built by thermal resistor such as Cantherm dash number CWF4B153F3470, and is placed as and is positioned at second and the 3rd contact physical contact of position.In one embodiment, contact be monitored/is measured by the measurement device (it contacts with two hard contacts) be used in dialysis machine itself.This does not need the temperature measuring equipment of separation to be integrated in manifold.Should be understood that, in preferred embodiments, dialysis machine or non-once instrument comprise processor and memorizer, this memorizer record: a) being communicated at the disposable manifold of installation is the stimulating frequency with the spring-loaded contact of the contact surface physical connection exciting probe, and b) be communicated to the temperature wave frequency of the spring-loaded contact in dialysis machine or non-once instrument by the contact surface of receptor probe by receptor probe sensing.Derivation described herein implemented by processor, to determine temperature levels and change based on the data be stored listed above.It is to be further understood that then this temperature information is communicated to display driver, it impels information to be passed on by visual display or audition via user interface.

In one embodiment, detection circuit by mixed activation signal and receptor signal, compare and result be committed to low pass filter and check phase shift to obtain phase shift information.More particularly, in one embodiment, phase detection is by being multiplied by receptor signal to realize by stimulating frequency.Result obtains the signal with two components, and one with two of frequency times and a DC signal being and exciting the phase shift between reference signal and receptor signal proportional.This is represented by following formula:

Phase detection:

e_{s} r_{r} = \frac{E_{s} R_{r}}{2} [\sin (2 ω t + θ) + \sin θ]

Wherein, e _sexcitation signal, r _rbe receptor signal, ω t is stimulating frequency and is phase place.

As described above, the present invention depends on the ripple for transition time measurement and does not rely on thermal pulse.This method provides significant advantage, because thermal pulse diffusion, causes the uncertainty starting part at the edge of a pulse, and greatly increases measurement noises.Ripple also spreads, but even if after diffusion, sinusoidal wave phase shift still remains obvious.Therefore, depend on sine wave to carry out to measure and introduce less noise.

Another advantage of the present invention is heat-flow sensor to be integrated in disposable manifold.The plastics used in manifold are used as heat insulator, and this realizes measuring valuably.As mentioned before, in one embodiment, spring-loaded probe is used for heat flow measuring device, and this makes its cost very low and is disposable.

Design consideration three parameters of apparatus of the present invention are optimized: a) thermal excitation (frequency of hot input signal), the flow of b) expecting (needs the frequency different from high flow compared with low discharge, because the comparatively more diffusion of low discharge experience), and c) amount of thermal diffusion and degree.In one embodiment, in order to noise decrease and improvement detect degree of accuracy as far as possible, the optimum configurations of key can be constant by people, such as constant phase shift, constant frequency or constant flow area.

In one embodiment, constant phase shift method is implemented by using phase sensitive detection and numerically controlled frequency generator.As described above, the transition time causes exciting the physical delay between probe and receptor probe.At high flow capacity, physical delay is very little, and at low discharge, physical delay is very large.Therefore, in order to keep constant phase shift, stimulating frequency is controlled by the feedback from phase sensitive detection.Feedback control loop comprises in systems in which, and important parameter such as stimulating frequency can be dynamically adjusted, and makes phase shift keep constant.

With reference to Figure 53, show the schematic diagram of the one embodiment of the invention adopting constant phase shift operator scheme.Flow through the liquid 5303 of passage 530l through exciting probe 5305 and receptor probe 5307, they are by separation distance 5309, as described above.In one embodiment, passage 530l to be designed to be inserted in dialysis machine and a part for the manifold within it used.Once be arranged in dialysis machine, then excite the contact surface of probe 5305 with regard to thermo-contact heater driver 5325 and the contact surface thermo-contact temperature sensor 5330 of receptor probe 5307.Heater driver 5325 and temperature sensor 5330 with implement in dialysis machine and/or integrated loop electrical contact within it.

Exciting in probe side, loop comprises reference signal source 5310, and it will have the Signal transmissions of phase theta r to summing unit 5315, and this device also receives the signal input θ m from low pass filter, as mentioned below.Two signals are summed, process or otherwise compare to obtain output, and this output is transferred to voltage-controlled oscillator 5320.Voltage-controlled oscillator 5320 outputs signal Rp, and wherein Rp=Kpsin (ω t), signal Rp are received by heater driver 5325 and for driving heater driver 5325 to obtain the excitation wave being communicated to probe 5305 by heat.

Heat wave is propagated through passage 530l as the function of fluid 5303 flow.The heat wave heat sensed is communicated to temperature sensor 5330 by receptor probe 5307.The heat wave sensed can be expressed as function, represents as follows: Es=Kssin (ω t+ θ c).

As described above, temperature sensor 5330 with implement in dialysis machine or the loop electrical contact that is integrated into wherein.The heat wave (Es) sensed is communicated to the synchronous phase sensitive detection adopting multiplier component 5335, it is by the heat wave (Es) that senses and the input signal (Rn from voltage-controlled oscillator 5320, wherein Rn=Kncos (ω t)) be multiplied, obtain output signal EsRn.Output signal EsRn (it can be expressed as EsRn=(KnKs/2) [sin (2 ω t+ θ c)+sin (θ c)]) to be imported in amplifier 5340 and to be exaggerated constant Kl.Then amplifying signal is imported in low pass filter 5345, and it receives the input signal from voltage-controlled oscillator 5320.From the input signal of voltage-controlled oscillator 5320 for changing filtering threshold or the cut-off frequency of low pass filter 5345.From output (the θ m of low pass filter 5345, it can be expressed as function KnKsKl θ c/2) be the signal indicating fluid flow (it can be exported by any means well known by persons skilled in the art), and be back to described summing unit 5315 by communication, produce reference signal for from voltage-controlled oscillator 5320.

Figure 47 is the form that diagram is dynamically adjusted to keep the scope of the stimulating frequency of constant phase shift.With reference to Figure 47, the value of various parameter is taken into account by deterministic process, such as flow 470l, and it changes between 25 to 600ml/min, and flow velocity 4702, and its scope is from 17.36mm/s to 416.67mm/s.Use and be used for the 15mm value of probe separates 4703, stimulating frequency 4705 will from ~ 1.16Hz25ml/min flow to 27.78Hz600ml/min changes in flow rate.The analog value of journey time and receptor amplitude is expert at respectively in 4704 and 4706 and is described in detail.It is to be noted, receptor amplitude maintains zero for constant phase shift.

Figure 48 shows the curve chart of output relative to time shaft 4810 of phase sensitive detection.Various curve 4820 represents a series of outputs of the phase sensitive detection for various flows value.Figure in Figure 48 has drawn out the value for providing in the form of Figure 47; Therefore, range of flow from 25 to 600ml/min and corresponding stimulating frequency change from ~ 1.16Hz to 27.78Hz.

In another embodiment, phase shift can be allowed to change, and frequency excites and keeps constant simultaneously.Constant frequency excites and is jointly adopted with phase sensitive detection, and does not use feedback mechanism.Figure 49 shows the form of the value of the various parameters be described in detail in when stimulating frequency 4906 maintains 1.157Hz.This value is the flow velocity 4902 from 17.36mm/s to 416.67mm/s for the flow 490l changed between 25 to 600ml/min and scope.When probe separates 4903 is arranged on 15mm, the analog value scope of journey time 4904 is from 0.0360 second (harmonic wave 4905 for 1.000 is worth) to 0.864 second.Change phase shift reflection is expert in the corresponding receiver amplitude described in detail in 4907.Receptor amplitude 4907 is shown in last row.Figure 50 A and 50B shows two groups of curve charts relative to time shaft of the output (scope for the flow of specifying in Figure 49) of phase sensitive detection.

With reference to Figure 54, show the schematic diagram of the one embodiment of the invention adopting constant frequency operator scheme.Flow through the liquid 5403 of passage 540l through exciting probe 5405 and receptor probe 5407, they are by separation distance 5409, as described above.In one embodiment, passage 540l to be designed to be inserted in dialysis machine and a part for the manifold within it used.Once be arranged in dialysis machine, then excite the contact surface of probe 5405 with regard to thermo-contact heater driver 5425, and the contact surface thermo-contact temperature sensor 5430 of receptor probe 5407.Heater driver 5425 and temperature sensor 5430 with implement in dialysis machine and/or integrated loop electrical contact within it.

Exciting in probe side, loop comprises reference signal source 5410, such as forcing function generator, and its Signal transmissions will with frequency (such as or about 1.17Hz) is to heater driver 5425.Forcing function generator 5410 outputs signal Rp, wherein Rp=Kpsin (ω t), and this signal is received by heater driver 5425 and for driving heater driver 5425 to obtain the excitation wave being communicated to probe 5405 by heat.Preferably, stimulating frequency is enough low, so be less than 80 degree in low discharge phase shift.Forcing function generator 5410 also outputs signal Rn, wherein Rn=Kncos (ω t), and this signal is received by multiplexer 5435 and low pass filter 5445, as described further below.

Heat wave is propagated through passage 540l as the function of fluid 5403 flow.The heat wave heat sensed is communicated to temperature sensor 5430 by receptor probe 5407.The heat wave sensed can be expressed as follows function: Es=Kssin (ω t+ θ c).Temperature sensor 5430 with implement in dialysis machine or the loop electrical contact that is integrated into wherein.The heat wave (Es) sensed is communicated to the synchronous phase sensitive detection adopting multiplier component 5435, it is by the heat wave (Es) that senses and the input signal (Rn from forcing function generator 5410, wherein Rn=Kncos (ω t)) be multiplied, obtain output signal EsRn.Output signal EsRn (it can be expressed as EsRn=(KnKs/2) [sin (2 ω t+ θ c)+sin (θ c)]) to be imported in amplifier 5440 and to be exaggerated constant Kl.Then amplifying signal is imported in low pass filter 5445, and it receives the input signal from forcing function generator 5410.From the input signal of forcing function generator 5410 for changing filtering threshold or the cut-off frequency of low pass filter 5445.Output (θ m, it can be expressed as the function of KnKsKl θ c/2) from low pass filter 5445 is the signal of the flow (it can be exported by any means well known by persons skilled in the art) of instruction fluid.Should be understood that, the frequency cutoff of low pass filter is the about l/20 of stimulating frequency.Low pass filter should by 2 ω t signal attenuation at least 80db.

Figure 55 shows the relative phase shift of the signal adopting low discharge and high flow capacity to produce in constant frequency pattern.Excitation signal 5530 was produced in the time 0.Under low flow condition, the signal 5520 sensed offsets θ from excitation signal 5530 _lFphase shift 5540, and under high traffic condition, the signal 5510 sensed offsets θ from excitation signal 5530 _hFphase shift 5550.

Phase shifting method that is constant or that change is irrelevant for measuring with adopting, phase shift is used to be favourable as the basis of flow measurement compared with use amplitude, because amplitude can be subject to the impact of external factor such as extraneous thermal effect, external factor should not affect phase shift.

In one embodiment, the hot fluid flowmeter of Noninvasive of the present invention provides the measuring range of 20ml/min to 600ml/min.Except factor listed above, flow performance such as fluidised form, maximum Reynolds number and flowing velocity are comprised for important other factors in order to optimal performance target heat flux gauge; And the physical features of flow unit lattice, such as channel height, width and length.

Fig. 5 l comprises listing to be optimized to and makes fluidised form remain on laminar flow and Reynolds number 5109 maintains the form of exemplary group of design parameter of the maximum stream flow 510l for 600ml/min lower than 2000.In order to fluidised form is remained laminar flow, channel sized (comprising channel height 5102, width 5103, length 5104, area 5105 and hydraulic diameter 5106) is optimised.Reynolds number 5109 is being calculated the character of the value of flowing velocity 5107, hydraulic diameter 5106 and water 5108 such as density, dynamic viscosity and kinematic viscosity after taking into account.

In one embodiment, flow unit lattice designed to be used turbulent fluidised form, instead of laminar flow.This design of flow unit lattice causes constant flow area, this so that will relate to around the broadening flow area (it is reduced around probe for laminar flow) of probe.When the area of probe is broadening, fluid to increase and the speed increased makes fluidised form move into turbulent flow fluidised form around probe in speed.

Figure 52 shows for exciting the form with another group of the exemplary design parameters of receptor probe, in one embodiment, excites the thermal time constant 5205 lower than l millisecond being determined to be with the size of receptor probe and having in order to optimal performance.The factor be taken into account for this purpose is material (it is pyrite in this case) and character 520l thereof, such as density, thermal conductivity and specific heat and convection coefficient 5204.Therefore, the size 5202 of probe and the surface area 5203 of exposure are determined.

Temperature sensing

As mentioned above, the compact manifold for dialysis system also comprises temperature sensor.In one embodiment, temperature sensor is positioned in reservoir assembly.But temperature sensor can also be positioned at reservoir component external, and in such embodiments, it can be integrated in manifold.

There are three main method by using the temperature sensing that can be integrated in manifold.Those skilled in the art will be appreciated that, the version of each method is possible, and does not cause any significant change of manifold master-plan.These methods are discussed below:

High conductance fluid contact

In high conductance direct flow contact method, metal dish is built in the wall of manifold, wherein thermal resistor or any other suitable temperature sensor as known in the art be placed in dialysis pusher side contacts with metal dish and on patient side with fluid contact.Therefore fluid temperature (F.T.) can be monitored by metal dish.

Usually, temperature is monitored by being directly placed on by thermal resistor in fluid stream.Use metal dish to monitor that temperature provides the advantage reducing pollution risk in the present invention, and therefore avoid needing clean thermal resistor.

It will be understood by those skilled in the art that, any suitable metal such as stainless metal dish of 316 type may be used to this object.In addition, any thermal resistor being applicable to application at present can be adopted.Exemplary hot sensitive resistor is the dash number 10K3AlA manufactured by BetaTherm.

In one embodiment, metal dish is for single patient's purposes and is disposable, and thermal resistor is a part for dialysis machine and is used repeatedly.

Medium conductive fluid contact

The pressure transducer film of compact manifold is relatively very thin, and is built by moderate fever conductivity material.Usual use 0.040 " thickness and can from 0.005 " be changed to 0.050 ".If material is thinner and thermal conductivity is higher, then the temperature of dialysis fluid more accurately will be transferred to the pressure transducer be arranged in dialysis machine by pressure transducer film.By design, they directly contact with the fluid on patient side with the pressure transducer in machine side.Suitable temperature sensor is placed in pressure transducer the supervision allowing fluid temperature (F.T.).Some pressure transducer as known in the art comprises the temperature sensor for correcting transducer according to temperature drift.The pressure transducer with temperature sensing feature like this may be used for the object of the application.Exemplary combination pressure-temperature sensor is the model MPT40 manufactured by MicronInstruments.This combination of sensor is adopted to avoid directly contacting measured fluid and the number of components reduced in manifold.This provide the alternative form of metal dish, as used in the method above.

Indirect optical temperature survey

If the plastic wall in manifold fluid path has limited thickness, such as about 0.020 ", then plastic wall by temperature with the fluid balance in manifold.In such a situa-tion, non-contact optical temperature survey can be carried out from the outside of thinning wall, and can determine the fluid temperature (F.T.) in it.Exemplary non-contact optical temperature sensor is the dash number MLX90614 manufactured by Melexis.The advantage that non-contact method provides is, it does not need the additional parts in manifold.Unique requirement is the thin slice section in fluid path wall.The method provides low cost, and still maintains single patient's use safety feature.

Possible embodiment for the Integrated Conductivity sensor in manifold is the conductivity cell as the electric pin with contact dialysate fluid.The ins and outs of exemplary electrical conductivity cell are shown in Figure 57.With reference to Figure 57, conductivity cell 5700 comprises the bias pin 570l for little constant current being applied to fluid.Sensing pin 5702 detects the voltage in fluid, and the amplitude of the voltage wherein detected depends on conductance and the temperature of fluid.Be placed as by use the thermal resistor 5703 being in close proximity to conductivity cell 5700 and carry out measuring tempeature.Alternatively, temperature can be determined by one of means disclosed above.Since it is known the temperature measured by sensing pin 5702 and the value of voltage, so can determine the conductance of fluid.

The electric current applied by bias pin 570l can be DC or AC signal, and usually in 50-l00kHz frequency range.In one embodiment, the amplitude of the electric current applied is at the order of magnitude of 10mA.Sensing pin 5702 presses depth localization usually during the manufacture of conductivity cell, and usually to the degree of depth of +/-0.00l inch, calibration solution in the battery.Thermal resistor 5703 has the typical accuracy of 0.5 degree Celsius.Conductivity cell can pass through to be driven by conductivity pin (bias pin and sensing pin) or make in molded in place to manifold bodies them contact with dialysis solution but do not allow dialysis solution to be out built into the dialysate fluid path of compact manifold from manifold leaks.

Disconnect detection

The embodiment of disclosed dialysis system also combines equipment for detecting the disconnection in the extracorporeal blood circuit being just used to any blood treatment treatment procedure and method.The example of blood treatment treatment procedure comprises hemodialysis, hemofiltration, ultrafiltration or blood plasma and is separated displacement.Vascular access for setting up extracorporeal blood circuit is obtained by the catheter using transdermal pin or Rule to connect usually.Off device uses with method the indicant be connected as complete pin or the catheter to vascular system by the pressure pulse that patient's pulsatile heart is dirty produced.The pressure pulse produced by patient's heart is very little; All the more so in the venous return line of blood circuit in vitro.In order to detect little pressure pulse, the present invention uses crosscorrelation methods, wherein benchmark heart signal and pressure pulse signal crosscorrelation.

Figure 58 is according to embodiments of the present invention for detecting the block diagram of the system 5800 that patient and extracorporeal blood circuit disconnect.System 5800 comprise enter arterial blood loop 5802, dialyser 5804, dialysis fluid circuit 5806, patient pulse's pressure transducer 5808, for benchmark patient's heart signal generator 5815, disconnect monitor 5820, controller 5825 and return to venous blood loop 5810.In the various embodiments of the present invention, pass dialyser 5804 from the blood of patient's suction via arterial blood loop 5802, and be back to patient from the cleaned blood of dialyser 5804 via venous blood loop 5810.The contaminated dialysis solution of discharging from dialyser 5804 is purified or regenerates in dialysis fluid circuit 5806, and is pumped and turns back in dialyser 5804.In the various embodiments of the present invention, the catheter that cleaned blood connects via transdermal pin or Rule is back to patient body.Return blood flow in venous blood loop 5810 usually in the scope of 300-400ml/min.Should be understood that, any suitable dialysis circuit can be adopted.

The pressure pulse standing the patient of blood treatment treatment procedure measured by pressure transducer 5808, and pulse pressure is communicated to roughly continuously disconnection monitor 5820.In one embodiment, transducer 5808 is venous pressure sensor of the invasive or Noninvasive of any position be positioned in dialysis blood lines (the arterial blood loop 5802 entered or return to venous blood loop 5810).In another embodiment, transducer 5808 is the venous pressure sensor being positioned in the dialysis blood lines between dialyser 5804 and patient the invasive or Noninvasive (namely returned in venous blood loop 5810) especially.The air bubble detector of Noninvasive and/or pinch valve (not shown) be positioned at alternatively transducer 5808 and to patient Rule connecting portion between.In one embodiment of the invention, pressure transducer 5808 be positioned to be in close proximity to insert in patient body for providing pin corresponding to the vascular access returning to venous blood loop 5810 or catheter.Pressure transducer 5808 is positioned to be in close proximity to pin or catheter, to maintain Shape fidelity.In other embodiments, pressure transducer 5808 can be connected to any position returned in venous blood loop 5810.In one embodiment of the invention, the pressure signal produced by pressure transducer 5808 exchanges (AC) signal, and it is not the accurate measurement of vascular pressure.Therefore, pressure transducer 5808 is not pinpoint accuracy transducer.

The heart signal of patient is communicated to disconnection monitor 5820 and is used for reference by reference generator 5815 roughly continuously.In one embodiment of the invention, benchmark heart signal obtains from the plethysmograph being connected to the identical body part (such as arm) be connected to by the blood supply processed to pin or the catheter of patient.In another embodiment of the invention, benchmark heart signal obtains from finger pulse transducer/oximeter.In other embodiments various of the present invention, benchmark heart signal can pass through electrocardiogram (ECG) signal, real-time blood pressure signal, stethoscope, the arterial pressure signal carrying out autoblood extraction pipeline, oximeter pulse signal, variable site volume tracer signal, transmittance and/or reflexive plethysmograph signal, acoustics heart signal, the acquisition of wrist pulse or obtain from any other heart signal source well known by persons skilled in the art.

Disconnect monitor 5820 detection return in venous blood loop 5810 by pin or catheter and stand the patient body that blood treatment is treated disconnection the interruption that causes.In order to detect disconnection, monitor 5820 processes patient pulse's pressure transducer signal and heart reference signal.It will be understood by those skilled in the art that, such disconnection can by pin or catheter because of the unexpected motion of any reason such as patient pulled out from patient body cause.With reference to Figure 59, disconnection monitor 5808 is described in detail.Controller 5825 is any microprocessors well known by persons skilled in the art.The function of controller 5825 is inputs of receiving from the process of monitor 5820 and therefore triggers suitable action when needed.

One skilled in the art will appreciate that pressure transducer and reference signal are communicated to by the emitter be attached in reference generator and pressure transducer and disconnect monitor 5820.Emitter can make it possible to wire or wirelessly be communicated to corresponding receptor.Similarly, controller 5825 is communicated to from the data disconnecting monitor 5820 by wired or wireless connecting portion.In one embodiment, by using suitable wired or wireless public and/or private network such as LAN, WAN, MAN, blueteeth network and/or Internet can obtain this signal communication.In addition, in one embodiment, disconnection monitor 5820 and controller 5825 are positioned to be closely adjacent to each other and are in close proximity to pressure transducer 5808 and heart reference generator 5815.In a selectable embodiment, disconnect in monitor 5820 and controller 5825 one or two be positioned at apart from each other and/or apart from the remaining part distant location of system 5800.

Figure 59 is the block diagram diagram of the equipment 5900 for detecting the disconnection returned in venous blood loop according to an embodiment of the invention.Disconnect monitor 5900 and comprise pressure transducer receptor 5902, reference signal receiver 5904 and crosscorrelation processor 5906.Transducer transceiver 5902 and reference signal receiver 5904 receive respectively from the pressure transducer 5808 of Figure 58 and the input signal of heart reference generator 5815.

The pressure pulse signal obtained by pressure transducer receptor 5902 and the benchmark heart signal obtained by reference signal receiver 5904 are stored in local storage and are supplied to crosscorrelation processor 5906, this crosscorrelation processor and then the dependency calculated between two signals.The output of processor 5906 is fed in the controller 5825 of Figure 58.If the output produced by crosscorrelation processor 5906 indicates the dependency between two input signals, then infer that it is complete for returning to venous blood loop.If the output produced by crosscorrelation processor 5906 does not indicate the dependency between two input signals, then infer that returning to venous blood loop is interrupted due to pin or catheter pull-out, and the controller 5825 of Figure 58 triggers suitable action of working as, such as, send tell-tale alarm and/or completely or partially close dialysis system.

Those skilled in the art it should be noted that the present invention imagines and use contact, corresponding or otherwise produce any crosscorrelation processor of measurable, the quantifiable and/or predictable relation between pressure transducer signal and reference signal.In one embodiment of the invention, crosscorrelation is undertaken by using lock-in amplifier, the SR810 lock-in amplifier such as manufactured by the StanfordResearchSystems of California.Various known technologies for the very crosscorrelation detection of low signal-to-noise ratio system and heart signal can be combined in crosscorrelation processor 5906.

In the various embodiments of the present invention, the cross correlation function calculated by crosscorrelation processor 5906 is for measuring two input signals and the similarity between benchmark heart signal and pressure pulse signal.The calculating of cross correlation function be included in the product of the corresponding pairs point of two input signals in fixed time framework or window and calculating.Calculate also by comprising first term or consequent any potential phase contrast between two input signals being taken into account.Mathematical formulae corresponding to cross correlation function is expressed as:

r_{(12)} (j) = \frac{1}{N} Σ_{n = 0}^{N - 1} x_{1} (n) x_{2} (n + j)

The wherein quantity of N representative sample, j represents lag coefficient, xl and x2 represents two input signals respectively.

Figure 60 shows the flow chart of the illustrative steps of the method that determination patient according to an embodiment of the invention and extracorporeal blood circuit disconnect.In operation, multiple instruction is comprised and first the dialysis system software prompt patient performed on a processor is attached heart signal generator (such as finger pulseoximeter) obtains 6005 reference signals.At this point, patient maybe can be free of attachment to dialysis system.Catch heart reference signal after or simultaneously, comprise multiple instruction and the dialysis system software prompt patient performed on a processor is connected to the system 5800 of Figure 58, thus patient pulse's pressure transducer signal also obtained 6010.Then, crosscorrelation processor attempts relevant 6015 reference signals and transducer signal.If do not have dependency can be implemented when starting, so in one embodiment, prompting patient closes 6020 all or some parts, or in another embodiment, the controller 5825 of the system 5800 of Figure 58 automatically carries out these operations and reduces noise level.Such as, the pump of cutting out dialysis system can reduce noise, and makes these two signals of more easily catching and be correlated with.In another embodiment, before the system unit such as pump producing noise is unlocked, crosscorrelation is attempted.Therefore, before system start-up completely can be done, locking dependency is attempted.In one embodiment, if do not have dependency to be locked, then alarm is triggered, and instruction patients with hemodialysis system may have exception.

But if obtain dependency, then this dependency is monitored 6025 roughly constantly.Depart from if to have in this dependency any, then alarm is triggered 6030, indicates possible leakage, or optionally system is closed (completely or partially) and is again attempted to attempt setting up relevant signal again.In one embodiment, if the essence of dependency changes or departs from exceed predetermined threshold or in predefined threshold value, then some system unit such as pump is closed and crosscorrelation processor is attempted setting up dependency again.If dependency can not be set up again, then alarm is triggered.In another embodiment, if the essence of dependency changes or departs from the scope that exceeds predetermined threshold or outside the scope of predetermined threshold, then some system unit such as pump is closed, and before any other trial of setting up dependency again, alarm is triggered immediately.

Thisly significantly to improve for some monitoring the method for disconnection and provide relative to prior art.First, be different from prior art, what the present invention responded is that pin is only slightly pulled out or it is removed from insertion section displacement and pulls very many distances.The second, the present invention is placed on without any need for extra equipment and inserts position, such as moistureproof cushion.3rd, by the heart signal of crosscorrelation patient oneself, false negative is eliminated greatly.4th, the combination of pressure pulse sensing and crosscorrelation makes the present invention be unique and can detect Low SNR signal.5th, monitor that crosscorrelation state enables system detect and the small-signal of disconnection may be indicated potentially to depart from continuously.Therefore, for detecting the equipment of the disconnection in the extracorporeal blood circuit being just used to any blood treatment treatment procedure and method by the invention provides.

Central venous pressure monitors

The embodiment of dialysis system disclosed herein also makes the volume of the fluid stood in the patient of dialysis/ultrafiltration remain on method and system in expected range in conjunction with for monitoring and controlling ultrafiltration (UF) speed.Central venous pressure (CVP) monitors and to be integrated in dialysis system and to use the speed of CVP Survey control ultrafiltration (UF) by the present invention.CVP feedback data contributes to excessively removing as the anti-fluid of security measurement, and is provided for the means of the titration UF speed in order to improve therapy.

CVP measurement requirement measures the average pressure existed in the central venous catheter for dialysing, thus measures with dialysis integrated by CVP.In order to measure CVP, suitable catheter needs to insert in patient body, and the termination of catheter is placed in thorax.Fig. 6 l depicts the exemplary position of the central venous catheter measured for hemofiltration and CVP.With reference to Fig. 6 l, central venous catheter (CVC) 6110 is for being provided for the vascular access of UF.In this special embodiment, the entry site 6120 being selected for CVC6110 below clavicle (clavicle) 6130, at subclavian vein 6140 place.It will be understood by those skilled in the art that, any other large vein in patient body can be selected as the optional position for inserting CVC, keeps its termination in thorax simultaneously.CVC6110 through subcutaneous 6150, and is fixed by means of clamper 6160 and standard Luer lock 6170.Outlet position 6180 equal central venous pressure at the pressure of CVC end.

In one embodiment of the invention, CVC6110 is used for arriving blood during hemofiltration, and central venous pressure can by being used in sensor in hemofiltration machine and measured.In this case, other equipment is not needed to measure for CVP.In another embodiment, two tube chamber CVC are used for hemofiltration.In this case, near-end tube chamber may be used for blood and extracts out, and far-end tube chamber (in end) may be used for returning blood.Tube chamber or port can provide CVP to measure.In both cases, when CVC is used for blood arrival, before system of the present invention is provided in and carries out CVP measurement, blood flow is temporarily stopped, to make it possible to accurately measure pressure.Therefore, in one embodiment, the present invention is integrated in conventional dialysis machine programme-control, for stopping blood flowing through this device based on predetermined CVP measuring rate.

Figure 62 shows the block diagram of dialysis control system of the present invention.With reference to Figure 62, provide the user interface 6210 of the input receiving the optimized frequency of instruction CVP measurement and the preferable range of CVP value from user (clinicist).These inputs are provided to central dialysis control unit 6220.Central authorities' dialysis control unit 6220 may be used for regulating CVP to monitor and regulating the programmable system of the speed of hemodialysis/ultrafiltration based on monitored CVP.Depend on the frequency that the CVP that determined by user measures, signal is communicated to blood pump in dialysis system 6230 to stop blood flow by central dialysis control unit 6220 when CVP measures to be recorded.Then, the CVP sensor in dialysis system 6230 carries out measuring and is communicated to central dialysis control unit 6220, and this controller can transmit it to user interface 6210 for display.After CVP measurement completes, another signal is communicated to dialysis system 6230 by central dialysis control unit 6220, and blood flow is recovered.Central authorities' dialysis control unit 6220 also keeps the CVP value that measures of tracking to determine them whether in user-defined scope.The scope that CVP is reduced to lower than limiting will indicate hypovolemia.Under these circumstances, central dialysis control unit 6220 stops the process of ultrafiltration, and making does not have other fluid to be removed, until CVP returns to the scope of expectation.In one embodiment, ultrafiltrate is removed the scope being titrated to 2-6mmHg by central dialysis control unit 6220, and CVP remains in the scope of expectation by this.

The wide region CVP measuring system that CVP monitors and UF regulating system imagination is integrated with conventional dialysis machine.Measure CVP can realize in many ways.In one embodiment, CVP can adopt the sensor being positioned at suitable catheter end to measure.In another embodiment, CVP can adopt the special pressure transducer be positioned at apart from catheter distant location to measure, and wherein transducer remains on the level place identical with heart.Figure 63 is the graphical representation of exemplary of a rear embodiment.With reference to Figure 63, show the catheter 6310 for arriving blood.Catheter 6310 is placed in central chamber vein 6320.Pressure transducer 6330 measures central venous pressure in heart level.In this case, CVP measures the speed being used for controlling hemofiltration in the mode identical with when using CVC.

In another embodiment, adopt the distance sensor in hemofiltration machine to measure CVP.With reference to Figure 64, show the exemplary blood loop 6400 having and provide CVP to measure.Along with blood enters loop 6400 from patient, anticoagulant is injected in blood by using syringe 640l to prevent condensation.Provide the pressure transducer PBIP6410 for measuring central venous pressure.Blood from patient pushes in dialyser 6430 by blood pump 6420.Two other pressure transducer PBI6411 and PBO6412 are separately positioned on the entrance and exit of dialyser 6430.Pressure transducer PBI6411 and PBO6412 contributes to the fluid pressure keeping following the trail of and remain on the advantageous point place in hemodialysis system.Paired bypass valve B6413 and A6414 is also arranged with dialyser, and this guarantees that fluid is flowing in closed loop dialysis circuit along desired direction.User can remove air at port 6417, if air bubble is detected by sensor 6418.Before blood heat sensor 6416 is arranged on eliminating atmosphere port 6417.AIL/PAD sensor 6418 and pinch valve 6419 with in the loop, to guarantee that blood clean is steadily and unhinderedly flow to patient.To help in system for the preliminary filling external member 642l of preparation system before dialysing by pre-attached to hemodialysis system.

In order to carry out CVP measurement, carried out the blood flow in stop loop 6400 by stopping blood pump 6420.At this point, will balance for the pressure arrived in the conduit (not shown) of blood, and the pressure that the pressure measured by pressure transducer PBIP6410 in hemofiltration machine will equal at catheter end head place.The pressure (CVP) of this measurement is then for the volume of the fluid that regulates the speed of ultrafiltration and remove from patient.

Therefore operationally, system of the present invention have modified conventional dialysis system, and ultrafiltration is undertaken by with the speed preset by doctor.Periodically, blood flow is stopped and by using one of above-described various measuring method to measure average CVP.In one embodiment, provide safe mode, if wherein CVP drops to lower than predetermined limit, then hemofiltration is just interrupted and alarm is sounded.

In Another application, Hypervolemia patient, the patient such as suffering from congestive heart failure (CHF) can be given ultrafiltration and carry out removing fluids.As known in the art, although ultra-filtration process is from blood removing fluids, wish that the fluid be removed is positioned in interstice.In addition, fluid is unknown from the speed that interstice flows to blood.If do not have system of the present invention, then doctor only can guess and removes speed by the fluid from blood flow is removed with the tissue fluid of the fluid balance flow back in blood from interstice, and arranges dialysis machine for this speed.Under these circumstances, require that persistent surveillance doctor one side is to guarantee that fluid removes speed not excessively or insufficiently aquation patient.If adopt system of the present invention, then doctor just can preset the total amount (usually being calculated by patient weight) of the fluid that he wants to remove, and the minimum average B configuration CVP be allowed to.System is then automatically to keep the maximum rate removing fluids expecting CVP.That is, system of the present invention automatically fluid is removed speed with from interstice to blood in fluid flow balance.

Should be understood that, normal CVP level is between 2 to 6mmHg.The CVP raised indicates excess moisture, and the CVP reduced indicates hypovolemia.The application of the invention, patient can to start ultra-filtration process higher than normal CVP such as 7-8mmHg, and through such as 6 hours treatment processes with the final CVP target terminal procedure of 3mmtHg.But, if in the midway of therapeutic process, CVP has declined more than expect to decline 50%, and the fluid be removed only reached for the final goal removed 50%, then the system speed that can be removed with the target reducing fluid and remove or minimizing fluid by reprogramming.Other actions can also be carried out based on more complicated algorithm.Final result is, avoids hypovolemia by the speed and actual value monitoring CVP.Should be understood that, the method can also be used for controlling fluid and remove speed, is not only during hemofiltration, and for all types of renal replacement therapy.

Monitor and keep volume degree of accuracy

The embodiment of dialysis system disclosed herein also combines the method and system of the volume degree of accuracy for keeping displacement liquid in hemodialysis system and output fluid.In one embodiment, the method relates to exchange at displacement liquid side and the pump in outlet side use, and the fluid of equivalent is pumped in each side.Pump exchange system of the present invention is provided for the accurate means keeping fluid volume during dialysis procedure, and can be implemented at low cost, for repeatedly used and disposable device.

The example pump that Figure 65 shows as adopted in one embodiment exchanges loop.Pump for hemofiltration exchanges loop 6500 and comprises two pumps, pump A6545 and pump B6555.These two pumps are communicated with output fluid loop O6570 fluid with displacement liquid loop R6560.Promote that fluid is communicated with by two pairs of two-port valves 6505 with 6507.For displacement liquid loop R6560, displacement liquid source 6510 provides fluid to this to two-port valve 6505 by current limiter 6517.Then, depend on that this is open to which in two valves in 6505, displacement liquid is pumped to second group of two-port valve 6507 by pump A6545 or pump B6555.Displacement liquid is guided to displacement loop R6560 by this group two-port valve 6507, and it is communicated with output 6542 fluid of dialyser 6540.In the present embodiment, being communicated with the output 6542 of dialyser 6540 is that rear dialyser infusion configures.In another configuration be known in the art, be instead be communicated with the input 6544 of dialyser.It will be understood by those skilled in the art that, any one can be used to configure, and scope of the present invention can not be affected.

This can be configured to open alternatively to two-port valve 6505, makes to set up any following fluid communication path:

● between output fluid loop O6570 and pump A6545;

● between displacement liquid loop R6560 and pump B6555;

● between displacement liquid loop R6560 and pump A6545; And,

● between output fluid loop O6570 and pump B6555.

System 6500 also comprises two pressure transducers 6515 and 6516.Sensor 6516 is positioned on output loop O6570, and sensor 6515 is positioned to be in close proximity to displacement liquid source 6510.Pressure transducer 6515 and 6516 is for monitoring pressure.Pressure data from these sensors is provided to active restrictors 65l7 via difference amplifier 6525.Depend on pressure measxurement, current limiter 6517 limits the flowing of displacement liquid as required changeably.

Between dialysis period, other fluid can remove from patient with the form of ultrafiltrate (UF), if necessary.In order to this object, provide UF pump 6535, UF is pumped to bag or discharge portion 6530 by it.Because be removed before the tonometric point of UF fluid in output fluid sub-loop O6570, so volume degree of accuracy is maintained, how many volumes be removed with UF has nothing to do.

Operatively, by exchanging on displacement liquid side and the pump 6545 and 6555 used on the output side, making fluid mutually commensurability in each some place's pumping after even-times exchanges, thus realizing the volume degree of accuracy in hemodialysis system of the present invention.Two pairs of two-port valves 6505 and 6507 help each pump jointly to use with displacement liquid loop R6560 and output fluid loop O6570 alternatively.

In one embodiment, the pump used is peristaltic pump.It will be understood by those skilled in the art that, the pump of other types can also be used, because the volumetric balance in Kidney Dialysis realizes by using pump switching technology, and not depending on the type of pump.In one embodiment, pump A6545 sends the more fluid of time per unit than pump B6555.Therefore, this is pumped causing the more displacement liquid of specific output fluid in any given time period.

It will be understood by those skilled in the art that, the pump comprising disposable elements can have pump speed rate variance, because the volume of whole disposable elements unequal, even if they have identical size and type.Such as, two of inserting in two syringe-pump assemblies have the disposable syringe of nominal same size volume will and incomplete same.Those skilled in the art it is also to be understood that, two pumps without disposable elements can be conditioned usually, so the difference will do not had on pump rate between.Include but not limited to by using the example of the pump that can adopt the present invention and effective disposable elements rotate or linear peristaltic pump, syringe pump, rotary vane pump, centrifugal pump and diaphragm pump.

In order to realize the volumetric balance between displacement liquid and output fluid, pump 6545 and 6555 every T minute just exchanged.At the end of first ' T ' minute interval, due to the special characteristic of pump, pump A6545 will send volume more more than pump B6555.Be called as ' Q ' by the fluid volume that pump A6545 sends.Therefore, if in the first pumping interval ' T ' period, displacement liquid is conducted through pump A6545 and output fluid is conducted through pump B6555, so at the end of interval T, displacement liquid loop R6560 is compared to the output fluid in the O6570 of loop, and more ' Q ' displacement liquid will be pumped.

Then, pump A6545 and B6555 is exchanged in next interval, and the output fluid in the O6570 of loop by the displacement liquid in pump A6545 pumping and loop R6560 by pump B6555 pumping.In that interval, compared to the output fluid in O6570, less ' Q ' displacement liquid in R6560 will be pumped.Therefore, at the end of the second interval (and even-times exchange at the end of), the difference of the volume be pumped in each interim will be: Q-Q=0.Therefore, after even-times exchanges, net volume difference is zero, thus realizes by the volumetric balance between the displacement liquid of infusion and the output fluid returned by dialyser from patient.It will be understood by those skilled in the art that, can have the flow by pump passed in time and the therefore change slightly of volume that is delivered of time per unit.In this case, net volume difference can be inaccurately zero, but is in close proximity to zero.

Pressure head is depended on by the volume of peristaltic pump pumping.Be the function of sub-loop instead of the function of pump for pump head, and be different in system relative to output loop O6570 in the R6560 of displacement liquid loop.Therefore the pressure head that equalization is experienced by pump A6545 and pump B6555 is necessary.

In one embodiment, equalization pressure head is carried out by being modulated at from the current limiter 6517 input circuit in displacement liquid source 6510.Output based on difference amplifier 6525 realizes current limiter modulation, the pressure differential between the force value that the calculating of this difference amplifier is measured by the pressure head sensor 6515 and 6516 between pump 6545 and 6555.Required compensation dosage will depend on how pump is subject to the pressure head impact in displacement liquid loop R6560 and output fluid loop O6570.Pressure head in the O6570 of loop is by normally negative.If displacement liquid bag (source) 6510 is raised to the level higher than pump, then the pressure head in the R6560 of loop will be positive, if bag is positioned to the level lower than pump vertically, then the pressure head in the R6560 of loop will be negative.For the pump utilizing heavily loaded pump line sections, difference may be relatively little.

As mentioned, by measuring the pressure in sub-loop R6560 and O6570, these pressure are provided to difference amplifier 6525 as input, and are carried out equalization pressure head by the influx that the variable restrictor 6517 of the Drazin inverse of difference amplifier 6525 is modulated from displacement liquid bag 6510 in use sub-loop R6560.Because pressure head is the function of sub-loop instead of the function of pump, be therefore necessary the mean deviation regulated between the pressure head of two sub-loops in non-regulated state.Can initially and during operation at the interval expected by closing the pressure regulating and measure under non-regulated state simply.Thisly to calibrate again without the need to stopping pumping.

In one embodiment, pump head can be changed to from zero and exceed hundreds of mmHg, depends on that combined dialyser, displacement liquid are arranged relative to the height of dialysis machine and dialysate flow.Such as, the dialysis solution for 200ml/min flows and is suspended on the displacement liquid bag of 5-10 inch above dialysis machine, and pressure differential is in the scope of 10mmHg.Usually, when replacing the pressure in the pressure ratio loop O6570 in the R6560 of loop and being higher, current limiter 6517 by restriction from the flowing in displacement liquid source 6510 to compensate this pressure differential.

For using wherein, dialysate fluid is just by recirculation is through the dialysis system of the closed loop dialysis fluid circuit of adsorbent box constantly, and Figure 66 shows selectable pump and exchanges loop.Pump for hemofiltration exchanges loop 6600 and comprises two pumps, pump A6645 and pump B6655.These two pumps are communicated with adsorbent stream body loop S6670 fluid with Returning fluid loop R6660.Fluid connection is promoted by means of two pairs of two-port valves 6605 and 6607.For Returning fluid loop R6660, reservoir fluid source 6610 provide fluid by current limiter 6617 to this to two-port valve 6605.Then, depend on that this is open to which in two valves in 6605, displacement liquid is pumped to second group of two-port valve 6607 by pump A6645 or pump g6655.This group two-port valve 6607 by fluid by adsorbent box 6608 and guided to the return loop R6660 be communicated with input port 6642 fluid of dialyser 6640 by reservoir 6610.

This can be configured to open alternatively to two-port valve 6605, makes it possible to set up any following fluid communication path:

● between adsorbent stream body loop S6670 and pump A6645;

● between Returning fluid loop R6660 and pump B6655;

● between Returning fluid loop R6660 and pump A6645; And,

● between adsorbent stream body loop S6670 and pump B6655.

System 6600 also comprises two pressure transducers 6615 and 6616.Sensor 6616 is positioned on the S6670 of adsorbent loop, and sensor 6615 is positioned to be in close proximity to reservoir fluid source 6610.Pressure transducer 6615 and 6616 is for monitoring pressure.Pressure data from these sensors is provided to active restrictors 6617 via difference amplifier 6625.Depend on pressure measxurement, current limiter 6617 limits the flowing of reservoir fluid as required changeably.

As described in embodiment above, the present embodiment has the setting for UF (ultrafiltrate) pump 6635, makes to be removed by from patient between dialysis period with the other fluid of (UF) form, if necessary.Ultrafiltrate is pumped to bag or discharge portion 6630 by UF pump 6635.Because be removed before the tonometric point of UF fluid in sorbent fluid sub-loop S6670, so volume degree of accuracy is maintained, how many volumes be removed with UF has nothing to do.

Operatively, by exchanging the pump 6645 and 6655 used on Returning fluid side and on adsorbent side, mutually commensurability fluid being pumped at each some place after even-times exchanges, thus realizing the volume degree of accuracy in hemodialysis system of the present invention.Two pairs of two-port valves 6605 and 6607 promote that each pump uses jointly with Returning fluid loop R6660 and adsorbent stream body loop S6670 alternatively.

In one embodiment, the pump used is peristaltic pump.It will be understood by those skilled in the art that, the pump of other types can also be used, because the volumetric balance in Kidney Dialysis realizes by using pump switching technology, and not depending on the type of pump.In one embodiment, pump A6645 sends the more fluid of time per unit than pump B6655.Therefore, this is pumped causing than the more Returning fluid of sorbent fluid in any given time period.

It will be understood by those skilled in the art that, the pump comprising disposable elements can have pump speed rate variance, because the volume of whole disposable elements unequal, even if they have identical size and type.Those skilled in the art it is also to be understood that, two pumps without disposable elements can be conditioned usually, so the difference will do not had on pump rate between.

In order to realize the volumetric balance between Returning fluid and sorbent fluid, pump 6645 and 6655 every T minute exchanged.At the end of first ' T ' minute interval, due to the special characteristic of pump, pump A6645 will send volume more more than pump B6655.Be called as ' Q ' by the fluid volume that pump A6645 sends.If therefore in the first pumping interval ' T ' period, reservoir fluid is conducted through pump A6645 and sorbent fluid is conducted through pump B6655, then at the end of interval T, compared to the sorbent fluid in the S6670 of loop, in the R6660 of Returning fluid loop, more ' Q ' reservoir fluid will be pumped.Then, exchanged and sorbent fluid in the S6670 of loop is by pump A6645 pumping in next interval for pump A6645 and B6655, and the Returning fluid in the R6660 of loop is by pump B6655 pumping.In that interval, compared to the sorbent fluid in S6670, ' Q ' reservoir fluid less in R6660 will be pumped.Therefore, at the end of the second interval (and even-times exchange at the end of), the difference of the volume be pumped in each interim will be: Q-Q=0.Therefore, after even-times exchanges, net volume difference is zero, thus realizes by the volumetric balance between the Returning fluid of infusion and the sorbent fluid returned by dialyser from patient.In addition, because pass some common little change that can have by the flow of pump in time, make the stereomutation that time per unit is delivered, so net volume difference can be inaccurately zero sometimes, but be generally proximate to zero.

As embodiment shown in Figure 65 is set up, depend on pressure head by the volume of the peristaltic pump pumping in the embodiment shown in Figure 66.In addition, because be the function of sub-loop instead of the function of pump for pump head, and be different in system relative to adsorbent loop S6670 in the R6660 of Returning fluid loop, so be necessary the pressure head that equalization is experienced by pump A6645 and pump B6655.

In one embodiment, equalization pressure head is carried out by being modulated at from the current limiter 6617 input circuit in reservoir fluid source 6610.Current limiter modulation is implemented in the mode similar to the embodiment of Figure 65, and it is based on the output of difference amplifier 6625.Difference amplifier 6625 calculates the pressure differential between the force value measured by pressure head sensor 6615 and 6616 between pump 6645 and 6655.Required compensation dosage will depend on how pump is subject to the pressure head impact in Returning fluid loop R6660 and adsorbent stream body loop S6670.Pressure head in the S6670 of loop is normally born.If reservoir 6610 is raised to the level higher than pump, then the pressure head in the R6660 of loop will be positive, and if reservoir is positioned to lower than pump vertically level, then the pressure head in the R6660 of loop will be negative.For the pump utilizing heavily loaded pump line sections, this difference can be relatively little.

As mentioned, by measuring the pressure in sub-loop R6660 and S6670, these pressure are supplied to difference amplifier 6625 as input, and the influx using the variable restrictor 6617 regulated by the output of difference amplifier 6625 in sub-loop R6660 to modulate from reservoir 6610 carrys out equalization pressure head.Because pressure head is the function of sub-loop instead of the function of pump, therefore want the mean deviation between the necessary pressure head regulating two sub-loops in non-regulated state.Pressure in non-regulated state can initially be measured and during operation expect interval by simply close regulate and measured.Thisly to calibrate again without the need to stopping pumping.

In one embodiment, pump head can be changed to from zero and exceed hundreds of mmHg, depends on that combined dialyser, reservoir are arranged relative to the height of dialysis machine and dialysate flow.Such as, for 200ml/min dialysate flow and wherein reservoir be positioned at dialysis machine pump above the situation of 5-10 inch, pressure differential is in the scope of 10mmHg.When the pressure pressure ratio loop S6670 (from dialyser) in loop R (returning) 6660 is higher, current limiter 6617 limits and compensates from the flowing of reservoir 6610.

In configuration in Figure 65 or the configuration in Figure 66, sometimes can have the discharge to the increase in dialysis fluid circuit sections (being O6570 or S6670 respectively) that the dialyser transmembrane pressure (TMP) because increasing causes.Such as this may occur because of the outflow obstacle of dialyser (being 6540 or 6640 respectively).In this case, the probability that current limiter (being 6517 or 6617 respectively) can not sufficiently be opened to carry out regulating may be had, if such as displacement liquid source 6510 or reservoir 6610 are positioned to the level lower than pump.In order to tackle this situation, booster pump can insert in the loop after displacement liquid source 6510 or reservoir 6610.Booster pump can be configured to can not be automatically switched on when regulating system at difference amplifier (being 6525 or 6625 respectively) and/or current limiter (being 6517 or 6617 respectively).

Because generation time gap between pump commutation period, so be necessary to calculate the interval between exchanging.This calculating is that the maximum of the Fluid Volume be pumped in any given time can the function of tolerance, as determined by two functions.But, calculate and must compensate to the pump for the fluid from displacement liquid container and the difference of pressure head that presents for the pump of the fluid returned by dialyser from patient.

The exchanged frequency of pump depends on maximum acceptable increase for the fluid volume of any given interval T during dialysis procedure in patient or reduction.Such as, if admissible net gain or loss are 200ml and displacement liquid inputs with the speed of 200ml/min, then the pump exchange frequency for the various levels of the difference of the pump rate of two pumps is described in detail in the form 6700 of Figure 67.

The parts related in embodiment shown in Figure 65 are below described, but with same with the same way of embodiment shown in Figure 66 applicable.With reference to Figure 67, the first row 670l of form shows when the percentage difference of the pump rate of two pumps (pump A6545 and pump B6555) is l% (this is equivalent to the fluid volume difference (allowed net gain or loss for 200ml) of 2ml), so will realize zero volume difference with the interval exchanging pump of 200ml/2ml=l00 minute.Similarly, for the pump rate difference of 2%, volumetric balance etc. will be realized with the interval exchanging pump of 200ml/4ml=50 minute.This is shown in the subsequent rows of form 6700.

Even if stricter restriction will be placed in the maximum volume of the fluid that can be infused into patient or remove from patient, such as from embodiments hereinbefore ± 200ml is different ± 30ml, will be 30ml/10ml=3 minute for being the exchange interval of the situation of 5% when pumping difference.Because exchanging pump only needs to switch two-port valve (showing to be 6505 at Figure 65), and does not need start and stop pump, so even 3 minutes (or shorter) short is interposed between practice is also enforceable.

Frequently exchanging pump can also relax any difference in the sub-performance of pump line.Because in the system of the present invention, the pipe of two pumps stands the impact of equal number, so pump performance tends to not deviation.

When using pump switching method, if this process does not stop in the exchange of even-times, then it can cause the difference mistake of the volumetric balance of displacement liquid and output fluid.Therefore, in one embodiment, system configuration becomes only to stop when the exchange of even-times completes, except nonsystematic is written.The potential impact of the problem caused in clean difference mistake can also be reduced by frequently exchanging pump.Under any circumstance, can ensure, any clean poor will not for maximum admissible net flow bulk diffusion or gain such as ± border of the initial setting of 200ml outside.Therefore, in one embodiment, the present invention includes the controller communicated with all operations Pump data.Controller comprises having follows the trail of by increasing progressively the software that pump exchanges the enumerator of quantity.If the quantity that pump exchanges is not even number, so the pent block signal of anti-locking system implemented by controller.Controller discharges block signal when enumerator is even number, thus allows system closing.Controller is also responsible for transmission and is exchanged signal, exchanges signal and suitable valve is opened and closed, thus cause pump to exchange.

During the process that pump exchanges, move to another sub-loop by having a small amount of residual fluid from a sub-loop.Such as, if peristaltic pump pipeline is 0.8ml/ inch and pump-pipe segmental length is 3 inches, then residue will be per time period 2.4ml (3 inches × 0.8ml/ inch=2.4m1).The pump rate of 200ml/min is adopted, by the fluid (50min × 200ml/min=10000m1) of pumping 10 liters in the exemplary time periods of 50 minutes.Therefore, be only 0.024% (2.4ml/10000ml=0.024%) in the residue risen and the percent of total fluid be pumped.Even the impact of this little percent of residue will be eliminated, because the movement between sub-loop occurs because pump exchanges, this offsets clean effect.

To enter the problem another sub-loop about residual fluid from a sub-loop, from dialyser fluid out only from patient, therefore, this fluid and aseptic displacement liquid are pushed back in patient very safe jointly.

As mentioned above, between dialysis period, if necessary, other fluid can remove from patient with the form of ultrafiltrate (UF), and in order to this object, provides UF pump in the system of the present invention.In addition, volume degree of accuracy is maintained, and the volume be removed with UF number irrelevant.

When pumping out ultrafiltrate to remove excessive fluid from patient, if system has lower pump rate, the order of magnitude of such as different from two-forty such as 200ml/min 10ml/min, the cumulative volume degree of accuracy so realizing limiting is more prone to.If such as required degree of accuracy is ± 30ml, so on the time period of 60 minutes, 600ml will press the pump rate pumping of 10ml/min.This implies that the percent degree of accuracy realized is 30ml/600ml=.05 or 5%, and this rationally obtains.But it will be understood by those skilled in the art that, system of the present invention can realize the volume degree of accuracy expected, and has nothing to do with the pump rate of the UF pump in dialysis apparatus.

Disposable conductivity sensor

In addition to other components, Figure 86 shows disposable conductivity sensor 8690, and it comprises the first end that has for receiving the first disposable pipeline sections and the tubulose fragment for the second end that receives the second disposable pipeline sections.Tubulose fragment comprises more than first probe, and they to extend in the internal volume limited by tubulose fragment and form fluid flow path.In one embodiment, three seekers be separated at least are adopted.In another embodiment, four seekers be separated at least are adopted.

Disposable conductivity sensor 8690 is adapted to be attached to more than second probe by the complementation coupling be attached to regularly and/or for good and all outside control unit.Preferably, the position of attachment comprise control unit outer surface be in close proximity to dialyser or with the part on its homonymy, as described in above with reference to figure l.Operatively, disposable conductivity sensor 8690 is fastened into the temporary transient of the multiple probe of the non-once mated with complementation but the relation be attached.Therefore, more than second probe to be received in more than first probe and to be positioned to be communicated with them.Probe is then by following and operate: launch and the signal of detection in the fluid flow path that tubulose fragment and the second disposable pipeline sections by the first disposable pipeline sections, conductivity sensor limits, as discussed in this article before, and then the Signal transmissions detected is carried out for monitoring and controlling dialysis system to the memorizer in control unit and processor.

Valve system

In order to allow to control to flow through blood and dialysis fluid circuit and in order to select the operator scheme (hemodialysis or hemofiltration) expected, in one embodiment, Operation system setting has two-port valve, as described above.These valves can be activated guide dialysis solution to flow through dialyser in one operating mode or be directly delivered to patient to be flowed by transfusion level dialysis solution in the second mode of operation by user.These two-port valves also can be integrated with the compact manifold of dialysis circuit.This is shown in Figure 68.Should also be noted that in Figure 68 to 70, for purposes of clarity, corresponding element has identical label.

With reference to Figure 68, extracorporeal blood treatment system 6800 comprises the molded compact manifold 6810 of plastics, its multiple molded blood of encapsulating and dialysate fluid path and multiple sensor region, valve and fluid pump sections.The blood circuit of dialyser 6805 completion system 6800 when being connected to arterial blood pipe 680l and the venous blood pipe 6802 of manifold 6810.In one embodiment, dialyser 6805 is disposable.The dialysis solution that two pipelines 6803 and 6804 have consumed for circulating respectively and fresh dialysis solution.In order to the lower operating system 6800 of any one in two patterns (hemodialysis and hemofiltration), two-port valve 6845 and two-port valve for subsequent use 6846 are provided.

Have employed service valve 6846, because the dialysis solution used in hemodialysis is not aseptic and is not infusion level, and the fluid used in hemofiltration is.If if operation or have leakage or other faults of valve 6845 in hemodialysis pattern, so valve 6846 provides opposing fluid to be pumped into duplicate protection in blood stream of patients.Service valve 6846 is adopted to allow safe handling manifold to come for hemodialysis and hemofiltration.As noted above, two-port valve such as service valve 6846 is made up of two single valves.In this case, two check valves are series connection, like this by closing two ports of two-port valve 6846, giving duplicate protection, preventing dialysis solution from entering blood flow.In a selectable embodiment, manifold can be manufactured to and only be intended for hemodialysis, does not connect between dialysis fluid loop and blood circuit, thus allows valve 6846 to be eliminated safely.

Figure 69 A illustrates in greater detail the loop for hemodialysis/hemofiltration system according to an embodiment of the invention.The dialysis solution pipe consumed and fresh dialysis solution pipe 6903 and 6904 are connected respectively to dialysate regeneration system 6906, thus the dialysis fluid circuit of completion system 6900.Dialysate regeneration system 6906 also comprises disposable adsorbent box 6915 and for keeping the reservoir 6934 of the dialysis solution cleaned by box 6915.With reference to Figure 69 B, make an explanation to the system miscellaneous part shown in Figure 69 A, Figure 69 B shows the exploded view of the extracorporeal blood treatment system 6900 being configured to operate under hemodialysis pattern.Respective element in Figure 69 A, 69B and 69C has identical label.

Blood circuit 6920 comprises wriggling blood pump 692l, and impure for the tremulous pulse of patient blood extracts along pipe 690l and blood is pumped across dialyser 6905 by it.Injection device 6907 by anticoagulant such as heparin injections to extract impure blood flow in.Pressure transducer 6908 is placed on the porch of blood pump 692l, and pressure transducer 6909 and 6911 is placed on the upstream and downstream of dialyser 6905 to monitor the pressure at these advantageous point places.

Along with the blood purified is back to patient from dialyser 6905 flow further downstream, blood heat sensor 6912 is arranged in pipeline to keep following the trail of the temperature of the blood purified.Air eliminator 6913 is also arranged to the bubble gathered removed from dialyser blood clean.The gas that a pair air (bubble) sensor (or alternatively single-sensor) 6914 and pinch valve 6916 adopt to prevent from gathering in the loop is back to patient.

Dialysis fluid circuit 6925 comprises two dual pathways pulsation dialysis liquid pumps 6926,6927.Dialysis liquid pump 6926,6927 extracts from dialyser 6905 dialysate constituents that consumed respectively and extracts the dialysate constituents regenerated from reservoir 6934.Enter the some place of dialysis fluid circuit 6925 in the used dialysate fluid from dialyser 6905, sensing is arranged to by blood leakage sensor 6928 and anti-Hemostatic Oral Liquid is any leaks in dialysis fluid circuit.The dialysis solution consumed exported from dialyser 6905 so passes bypass valve 6929 to arrive two-port valve 6930.Pressure transducer 693l is placed between valve 6929 and 6930.Ultrafiltration liquid pump 6932 is arranged in dialysis fluid circuit, and ultrafiltration liquid pump is periodically operated extract ultrafiltrate refuse from the dialysis solution consumed and be stored in by periodically emptying ultrafiltrate bag 6933.

As mentioned, regenerate by using adsorbent box the dialysis solution consumed above.The dialysis solution regenerated by adsorbent box 6915 is collected in reservoir 6934.Reservoir 6934 comprises conductivity sensor and ammoniacal sensor 696l and 6962 respectively.From reservoir 6934, the dialysis solution regenerated through current limiter 6935 and pressure transducer 6936 to arrive two-port valve 6937.Depend on patient requests, by the infusion solution from reservoir 6950 of desired amount and/or can join in dialysis fluid from the concentrated solution of reservoir 695l.Transfusion and concentrated solution are, containing contributing to, the mineral in dialysate fluid such as potassium and calcium are remained on the mineral of the level specified by doctor and/or the sterile solution of glucose.Bypass valve 694l and peristaltic pump 6942 are arranged to select the desired amount of transfusion and/or concentrated solution and guarantee that this solution suitably flow to from the clean dialysis solution that reservoir 6934 sends.

Dialysis fluid circuit comprises two two-port valves 6930 and 6937.Valve 6930 dialysis solution consumed a stream is guided to dialysis liquid pump 6926 first passage and another stream of the dialysis solution consumed is guided to dialysis liquid pump 6927 first passage.Similarly, valve 6937 dialysis solution regenerated a stream is guided to dialysis liquid pump 6926 second channel and another stream of the dialysis solution regenerated is guided to dialysis liquid pump 6927 second channel.

The stream carrying out the dialysis solution consumed of self-pumping 6926 and 6927 is collected by two-port valve 6938, and the stream carrying out the dialysis solution regenerated of self-pumping 6926 and 6927 is collected by two-port valve 6939.Two of the dialysis solution consumed streams are combined as single stream by valve 6938, and this single stream is pumped via pressure transducer 6940 and by adsorbent box 6915, the dialysis solution wherein consumed is cleaned and filter, and is then collected in reservoir 6934.Two of the dialysis solution regenerated streams are combined as single stream by valve 6939, and this single bypass valve 6947 that flows through flows to two-port valve 6945.Pressure transducer 6943 and dialysate temperature sensor 6944 are arranged on on the dialysis solution flowing stream of two-port valve 6945.

By the state of two-port valve 6930,6937,6938 and 6939 of reversing, two pumps 6926 and 6927 extract dialysis fluid out and reversion with regard to another action dialysis fluid being supplied to dialyser 6905 with regard to their one from dialyser 6905.Being reversed in like this is carried out periodically guarantees the Fluid Volume that in the long period section of the whole dialysis procedure dialysate fluid volume be pumped in dialyser equals to be pumped out and the only total fluid volume lost by dialysis circuit 6925 is the volume removed by ultrafiltration liquid pump 6932 through the time period short relative to dialysis procedure, as discussed above.

In hemodialysis pattern, two-port valve 6945 allows the dialysis solution regenerated to enter dialyser 6905 becomes possibility to make the normal hemodialysis of blood samples of patients.The side that valve 6945 leads to blood samples of patients return line is closed.Another two-port valve 6946 is used as subsequent use, keeps dialysis solution away from the blood lines of patient, though make two of valve 6946 ports valve 6945 leak or fault time also close.

With reference to Figure 69 C, under hemofiltration pattern, two-port valve 6945 can activated that the stream of fresh ultra-pure dialysis solution is guided through valve 6946 from reservoir 6952, make now two ports all open directly to enter the blood purified sent from dialyser stream and flowing be back to patient.

Those skilled in the art it should be noted that two-port valve 6946 for subsequent use is redundant safety valves, to guarantee not cause the direct infusion of the dialysis solution regenerated in patient in the fault of the next valve 6945 of hemodialysis pattern.That is, valve 6945 and 6946 can be directed to the venous blood pipeline of patient as security consideration by this system activation to allow fluid.In one embodiment, two-way service valve 6946 is single valves, to allow or to stop fluid flowing.

Those skilled in the art should it is further noted that the valve as described in description be above called as ' bypass ' or ' two-way ', and this depends on their purposes.Therefore, valve is called as ' bypass valve ' when they walk around parts such as dialyser.Otherwise they are called as ' two-port valve ', and flowing are guided at least two directions simply.But bypass valve and two-port valve can be constructively identical.

In one embodiment, be manufactured to elastomer film for two-port valve of the present invention, it against aperture, flows the fluid contact with fluid circuit remainder to stop flowing, as discussed further below by the mechanism be contained in dialysis machine.

Two-port valve 6945 and 6946 may be used for the operator scheme changing blood processing system.With reference to Figure 69 C, depict the fluid flowing in blood and dialysis fluid circuit 6920 and 6925.Because system just operates under hemofiltration pattern, so the dialysis solution pipe 6903 consumed is connected to discharge portion, and fresh dialysis solution pipe 6904 is connected to fresh ultrapure and injectable grade dialysis solution reservoir 6952.The fresh dialysis fluid being dripped room 6953 by ball valve passes heater bag 6954 to flow into fresh dialysis fluid pipe 6904.The element of blood and dialysis fluid circuit 6920,6925 and the remainder of fluid path are similar to Figure 69 B, difference is that dialysis solution fresh in hemofiltration or displacement liquid are introduced in dialysis fluid circuit 6925, because the dialysis solution consumed is discharged and is not used repeatedly.In addition, in transfusion subsystem, parts 6942,6950,6941 and 6951 are not used.

Blood circuit 6920 comprises along the pipe 690l extraction impure blood of patient's tremulous pulse and blood is pumped across the wriggling blood pump 692l of dialyser 6905.Selectable pump 6907 by anticoagulant such as heparin injections in the impure blood flow be extracted.Pressure transducer 6908 is placed on the porch of blood pump 692l, and pressure transducer 6909 and 6911 is placed on the upstream and downstream of dialyser 6905.The blood purified from dialyser 6905 is pumped through pipe 6902 through blood heat sensor 6912, air eliminator 6913 and air (bubble) sensor 6914 and is back to the vein of patient.Pinch valve 6916 is also placed with and stops blood flow completely, if air is sensed at the air bubble sensor 6914 of pinch valve 6916 upstream by pipeline, thus prevents air from arriving patient.

Dialysis fluid circuit 6925 comprises two dual pathways dialysis liquid pumps 6926,6927.Dialysis liquid pump 6926,6927 extracts from dialyser 6905 dialysate constituents that consumed respectively and extracts fresh dialysate constituents from reservoir 6952.The dialysis solution consumed exported from dialyser 6905 is extracted by blood leakage sensor 6928 and bypass valve 6929 to arrive two-port valve 6930.Pressure transducer 693l is placed between valve 6929 and 6930.Ultrafiltration liquid pump 6932 is periodically operated extract ultrafiltrate refuse from the dialysis solution consumed and be stored in ultrafiltrate bag 6933 (it is by periodically emptying).From the fresh dialysis fluid of reservoir 6952 through current limiter 6935 and pressure transducer 6936 to arrive two-port valve 6937.It will be understood by those skilled in the art that, in this programme, not need transfusion and concentrated solution, and can not use the element 694l relevant to these functions, 6942,6950,695l.

Heater bag 6954 sufficiently promotes the temperature of fresh dialysis fluid, make from dialyser 6905 motion be back to the blood of the ultrafiltration of patient temperature or from the ultrafiltration of dialyser 6905 blood and be equivalent to the body temperature of patient to the bulk temperature of the mixture of the fresh dialysis fluid the blood purified by direct infusion by activated valve 6945,6946, thus prevent any thermal shock.

Figure 70 shows the selectable embodiment of fluid circuit, does not wherein use two-port valve 6946 for subsequent use.Blood circuit comprises wriggling blood pump, and it extracts the impure blood of tremulous pulse of patient along pipe 700l and blood is pumped across dialyser 7005.Syringe or pump 7007 by anticoagulant such as heparin injections in the impure blood flow be extracted.Pressure transducer 7008 is placed on the porch of blood pump, and pressure transducer 7009 and 7011 is placed on the upstream and downstream of manifold sections.Be pumped through pipe 7002 through blood heat sensor 7012, air eliminator 7013 and air (bubble) sensor 7014 be back to the vein of patient from purifying the blood of dialyser 7005.Pinch valve 7016 be also placed on to patient loop connect before, to stop blood flow completely when air (bubble) sensor 7014 of pinch valve 7016 upstream senses in air is by pipeline, thus prevent air arrive patient.

Dialysis fluid circuit 7010 comprises two the dialysis liquid pump sections 7026,7027 be communicated with pump pressure.Dialysis liquid pump sections 7026,7027 extracts from dialyser 7005 dialysate constituents that consumed respectively and extracts the dialysate constituents regenerated from reservoir 7034.The dialysis solution consumed exported from dialyser 7005 is extracted by blood leakage sensor 7028 to arrive bypass valve 7029.Flow transducer 7020 is one of two flow transducers of the volume of the dialysis solution determining to flow over loop (another are flow transducers 7046).Valve 7030 is constructively similar with two-port valve and for walking around liquid pump 7026 of dialysing.Valve 7030 cuts out usually on the direction walked around.When liquid pump 7026 of dialysing is stopped, valve 7030 is opened that pump 7026 is walked around in the guiding of fluid stream.Pressure transducer 703l is placed between flow transducer 7020 and valve 7030.Between normal flow periods, the dialysis solution consumed is pumped through pressure transducer 7040, pipe 7003 and adsorbent box 7015, and the dialysis solution wherein consumed is cleaned and filter.Then clean/dialysis solution of having filtered enters reservoir 7034.Ultrafiltration liquid pump 7032 is periodically operated extract ultrafiltrate refuse from the dialysis solution consumed and be stored in by periodically emptying ultrafiltrate bag (not shown).

The dialysis solution regenerated from reservoir 7034 passes pipe 7004, current limiter 7035, dialysate temperature sensor 7044, flow transducer 7046 and pressure transducer 7036 to arrive two-port valve 7045 by bypass valve 704l.When the respective flow path of bypass valve 7029,7045 and 704l is activated, their guide the dialysis solution regenerated to walk around dialyser 7005.Be directed to via pipe 7037 from the clean dialysis solution that reservoir 7034 sends and in the dialysis solution consumed in flow transducer 7020 downstream by infusion liquid pump sections and concentrate pump sections 7042,7043 respectively from the infusion liquid stream of transfusion and concentrated solution reservoir 7050,705l and concentrated solution stream.

Two-port valve 7045 decision systems operates under what pattern.Therefore, in an operator scheme, two-port valve 7045 allows the dialysis solution regenerated to enter dialyser via pipe 7060 becomes possibility to make the normal hemodialysis of blood samples of patients.In another operator scheme, two-port valve 7045 activated and imports in venous blood pipeline to be flowed by the fluid of ultrapure transfusion level dialysis fluid and directly guide to patient.Therefore, this multi-purpose valve makes operator scheme can switch between hemofiltration and hemodialysis.Such as, in the hemofiltration shown in Figure 69 C, three valve direct admission valves 6946 can be conducted through be connected in the blood flow at rear dialyser place by infusion level fluid.In this mode, valve 6945 prevents dialysate fluid from entering the lower port of dialyser.As shown in Figure 69 B, in hemodialysis, valve 6946 cuts out, and dialysate fluid is guided to dialyser by valve 6947 and 6945.It should be noted that the embodiment of Figure 69 B uses pump exchange and multiple valve to control fluid volume, and the embodiment use traffic sensor 7020 and 7046 of Figure 70 controls fluid volume.

As discussed above, valve is implemented in manifold preferably by the elastica at the flowing control point of the protuberance from the extension of manifold machine be used in as required, pin or other component selectivity obturations.In one embodiment, fluid obturation is realized by the low-yield magnetic valve of use safety.

Valve system comprises light weight and consumes the magnetic displacement system of minimum power, and it is also desirable for making it even when portable renal dialysis system uses the disposable manifold for fluid circuit.This system can use jointly in conjunction with the aperture in any structure.Especially, aperture is any hole in any types of material, opening, hole or separating part.This is included in path in pipeline, manifold, disposable manifold, passage and other paths.It will be understood by those skilled in the art that, as discussed further below, by biasing member and magnet being positioned at the valve place place that manifold external is being expected, disposable manifold will be adopted implement disclosed valve system at present.Actuator is also separated with disposable manifold and discrete, and a part for the normally non-once part of renal dialysis system.

Functionally, valve of the present invention has two steady statues: open and close.Its by use operated by magnetic force with by biasing member motion for being close to diaphragm and thus producing enough power and be close to valve seat by pressuring film plate and make diaphragm close aperture.The closedown in aperture will close fluid flowing.Umklapp process, namely use magnetic force by biasing member away from motion of membrane and thus by diaphragm from be close to valve seat compression release, open aperture and allow fluid to flow.

Should be understood that, although discussion in the preferred embodiment that the present invention should describe in Fig. 7 lA and 7lB and the not preferred embodiment described in Figure 73, but the present invention relates generally to valve to be had with any use in properties renal dialysis system: a) two steady statues, open and close, b) change state needs energy input, c) hold mode does not need energy input, d) state changes by using magnetic force to change the position of biasing member, and biasing member makes valve open or close when being modified.

In one embodiment, with reference to Fig. 7 lA and 7lB, valve system 7l00 of the present invention is flowed by the fluid of fluid flowing passage 7102 for controlling, and this fluid flowing passage is retrained by valve seat 7104, thus produces valve annular orifice 7103.Aperture 7103 is any hole in any types of material particularly manifold, disposable manifold, passage and other paths 7110, opening, hole or separating part.Show the valve 7100 being in open state.The parts of valve system comprise aperture closure element, biasing member, the mechanism for moving displacement component, selectable optical pickocff, coil actuator loop and have the actuator of coil.

In one embodiment, aperture closure element comprises diaphragm/barrier film 7106, and as discussed below, this diaphragm is close to valve seat 7104 when being compressed by biasing member, thus valve annular orifice 7103 is closed.In open state, main body and the valve seat 7104 of diaphragm 7106 separate gap 7198.In one embodiment, diaphragm 7106 is by soft material such as silicone rubber manufacture.Diaphragm 7106 must in time, temperature and actuating keep its shape.Valve 7l00 depends on diaphragm material 7106, is back to it not by the shape compressed to be in when open state is removed at biasing member (compression stress).

One skilled in the art will appreciate that aperture closure element can comprise any combination of spring, compressible or incompressible structure, this is combined in when being promoted by biasing member and closes aperture.In one embodiment, valve seat 7104 can be molded in manifold.Merlon, ABS and similar plastics for the material that valve seat is suitable.In preferred embodiments, the diameter range of valve orifice 7103 is from 0.1 to 0.3 inch (and more particularly 0.190 inch).Port size can be increased increase flowing for of the present invention can selective gist, or reduce alternatively to reduce flowing for selectable application.

In one embodiment, biasing member comprises piston cap or shell 7110, and piston cap or shell 7110 are close to diaphragm 7106 and are aimed at when valve is in open state, but does not substantially compress diaphragm 7106.Being positioned in piston cap 7110 is compliance parts, and the head 7199 of such as spring 7112 and plunger, they are separated by space 7114.Piston cap 7110 is fluid-tight portion 7120 and surrounds in outside, in one embodiment, this fluid seal is thin soft silicone rubber pad.In one embodiment, piston cap 7110 be pushed be close to silicone rubber pad and compression gasket to form fluid seal 7120.When in closed position, piston cap 7110 is not pushed is close to pad, and therefore it does not compressed and located by loosely for edge cap 7130.Spring 7112 is materials of any elastic or compliance, and comprises wavy spring in one embodiment.

Piston cap 7110, contained spring 7112, air gap 7198, stopper head 7199, plunger body 7140 and core 7142 are parts of preferred displacement component of the present invention.In one embodiment, plunger body 7140 has the external diameter (more particularly 0.122 inch) in the scope of 0.1 to 0.2 inch and is about 0.5 to 2.5 inch long.Should be understood that, depend on application, plunger body 7140 is any bar structures with any length.Plunger body 7140 is positioned in annular core 7142 (it has a larger end and a less end), and be attached to core by any method known to those skilled in the art, comprise epoxy resin, screw attachment, pin or welding.The external diameter in the scope of 0.3 inch to 0.5 inch (and more particularly 0.395 inch) of the larger end of core 7142, thickness is (and more particularly 0.05 to 0.10 inch) in the scope of 0.03 to 0.15 inch, and length in the scope of 0.50 to 1.75 inch long (and more particularly 1.05 inches).The small end of core 7142 has the diameter of 0.1 to 0.4 inch, and more particularly 0.25 inch.

What surround the small end of core at least in part is bobbin 7195, and coil 7148 is held in place and provides dimensional stability to coil 7148 by it.Gap is preferably present between bobbin 7195 and core 7142.The size in gap is about 0.0l to 0.03 inch (and more particularly 0.02 inch).In one embodiment, bobbin 7195 is nylon structure of glass-filled, and it should be nonmetallic and non-ferromagnetic.Bobbin 7195 is loop configuration, and its external diameter has to be enough to provide and fits closely to size in shell aperture and its internal diameter is enough to encapsulate core, and it is had for moving and standing the space of certain degree thermal expansion.Bobbin 7195 is wedged in place and prevents its motion or slide, particularly when being exposed to electromagnetic force by two end caps 7130,7160.

Plunger body is made up of metal or nonmetallic materials such as pyrite or glass fibre, and core is also by metal particularly steel making.Preferably, plunger body is nonmagnetic and core body is ferromagnetic.As discussed further below, plunger body 7140 and core 7142 are by moving for the mechanism of moving displacement component.

Mechanism for moving displacement component comprises a part of large magnet assembly, small magnet parts and magnet and biasing member and plunger body 7140 and core 7142 and comprises shell within it.More specifically, with reference to Fig. 7 lA and 7lB, the mechanism for moving displacement component comprises the large magnet end cap 7130 for keeping and aim at large magnet, large magnet 7132, elastomeric material 7134, gap 7197, coil 7148, small magnet parts 7162, small magnet installation portion and end cap 7160 and elastomeric material 7164.

Large magnet assembly 7132 and bobbin 7195 keep and aim in place by large magnet end cap 7130 in shell 7170, are called as actuator body, its have parts described herein be placed through hole.Large magnet assembly 7132 needs suitably to aim at core 7142, plunger body 7140 and little magnetic part 7162 appropriate motion guaranteeing biasing member.End cap 7130 and 7160 by bobbin 7195 and coil 7148 in position.

In addition, installing plate can be used for catching and keep end cap 7130.In one embodiment, installing plate is positioned to vertically and the side being close to end cap flushes and between end cap and boring.Installing plate has hole wherein, size identical with the small diameter of end cap approx.Main body remains by clamping device is close to this plate; Alternatively, described plate can be secured permanently by using any combination technology well known by persons skilled in the art.Different from prior art such as No. 683620lth, United States Patent (USP), in a preferred embodiment, magnet is positioned at boring inner side instead of outside, and is provided for the bearing of plunger, as discussed below.

Large magnet assembly 7132 is separated by gap 7197 and elastomeric material 7134 such as silicones pad and core 7142, in one embodiment, this silicones pad has the hardness of the external diameter of 0.3 to 0.5 inch (and more particularly 0.37 inch), the internal diameter of 0.1 to 0.3 inch (and more particularly 0.188 inch), the thickness of 0.005 to 0.015 inch (and more particularly 0.0l inch) and 35 to 45 (and more particularly 40).Small magnet parts 7162 by elastomeric material 7164 such as silicones pad and core segment every, in one embodiment, this silicones pad has the hardness of the external diameter of 0.1 to 0.4 inch (and more particularly 0.24 inch), the internal diameter of 0.1 to 0.3 inch (and more particularly 0.188 inch), the thickness of 0.005 to 0.015 inch (and more particularly 0.0l inch) and 35 to 45 (and more particularly 40).Little magnetic part 7162 is supported by small magnet installation portion and end cap 7160 and remains and suitably aims in shell 7170.Small magnet end cap screw 7172 is also for catching and being held in place by small magnet end cap 7160.

With reference to Fig. 7 lA, valve system of the present invention also comprises coil actuator circuit board 7150, coil actuator adapter 7154 and optical pickocff 7152, this coil actuator circuit board drives the actuator comprising coil 7148, and be preferably mounted to actuator body 7170 via Screw, the position of the large end of this optical pickocff sensing core 7196.Coil 7148, for causing the change in magnetic field, produces motion to make core 7142 and plunger body 7140.In one embodiment, coil is about 0.05 to 1.5 inch long (and more particularly l inch is long), there is the external diameter of 0.35 to 0.55 inch (and more particularly 0.46 inch), and the internal diameter of 0.15 to 0.35 inch (and more particularly 0.26 inch), there is the line 29AWG line of six layers.

The various elastomeric materials used in biasing member and the mechanism for moving displacement component provide stopping " soft " that bar 7140 moves when valve opens or closes.Especially, it is for guaranteeing that the motion of core does not destroy magnet.

Large magnet assembly 7132 can be a single magnet, or in a preferred embodiment, comprises multiple magnet, such as three.Small magnet parts 7162 also can be single magnets or comprise multiple magnet.In one embodiment, magnet is preferably made up of magnet steel, SmCo, neodymium, rare earth or ceramagnet.In one embodiment, large magnet 7132 is neodymium toroidal magnets, has the external diameter of 0.2 to 0.5 inch (and more particularly 0.375 inch), the internal diameter of 0.05 to 0.3 inch (and more particularly 0.125 inch) and the length of 0.2 to 0.5 inch (and more particularly 0.375 inch).In one embodiment, small magnet 7162 is made up of neodymium toroidal magnet, has the external diameter of 0.15 to 0.4 inch (and more particularly 0.25 inch), the internal diameter of 0.05 to 0.3 inch (and more particularly 0.125 inch) and the length of 0.15 to 0.4 inch (and more particularly 0.25 inch).Larger magnet 7132 is for closer to aperture closure element, because this size is that to produce the enough power contrary with valve seat necessary.In addition, the actuation force produced by actuation coil is roughly equal, even if magnet is of different sizes, thus causes simple coil actuator loop.

In one embodiment, bar, plunger or other slender members 7140 use the centre bore of magnet as linear bearings.Therefore, the centre bore of magnet preferably should have area supported, such as chromium or any smooth hard surface with minimized friction.Gap is arranged between bobbin 7195 and core 7142, because there is the thermal expansion of bobbin, time dependent bobbin creep and bobbin, core and magnet tolerance.But in all the operating conditions, gap should be enough, make plunger body 7140 freely can move and not be combined in the opening of magnet and coil.In a preferred embodiment, gap is about 0.01 to 0.06 inch (and more particularly 0.02 inch) in room temperature.

With reference to Fig. 7 lB, when the valves are closed, valve system 7l00 of the present invention is by compressing aperture closure element such as diaphragm 7106 and thus hindering valve annular orifice 7103 to control the fluid flowing of the fluid flowing passage 7102 by being retrained by valve seat 7104.In off position, the main body of diaphragm 7106, against valve seat 7104, therefore eliminates gap 7198 (seen in Fig. 7 lA) substantially.

Once next-door neighbour's diaphragm 7106, then biasing member just compresses diaphragm 7106 now.Especially, piston cap 7110 has moved into compression diaphragm 7106.Piston cap 7110 is moved, because the change in magnetic field makes core body 7142 move towards large magnet assembly 7132.When core head 7196 is through (in Fig. 7 lA) core body 7142 stop motion during gap 7197, and stop at elastomeric material 7134 place being positioned to be adjacent to large magnet assembly 7132.The plunger body 7140 that the motion of core 7142 makes core 7142 combine also moves.The motion of plunger body 7140 makes stopper head 7199 move in piston cap 7110, through gap 7114 (in Fig. 7 lA), and Compress Spring 7112.After a certain amount of compression, piston cap 7110 is moved and is compressed diaphragm 7106.The motion of piston cap 7110 is adjacent between the elastomeric material 7120 of large magnet end cap 7130 at cap main body 7110 and being positioned to and produces new gap 7192.

As shown in Fig. 7 lB, the miscellaneous part of valve keeps identical, comprises actuator body 7170, coil actuator loop 7150, coil connector for dynamoelectric 7154, coil 7148, bobbin 7193, little end cap screw 7172, optical pickocff 7152 and small magnet end cap 7160.But should be understood that, move by means of core 7142, gap 7195 produces between the smaller end and elastomeric material 7164 of core 7194, and this elastomeric material is positioned to be adjacent to little magnetic part 7162.

Should be understood that, in order to shutoff valve, power is applied to aperture closure element by biasing member, such as diaphragm 7106.From biasing member in order to by diaphragm deformation to film contact valve seat point needed for power be substantial linear, and can Hookean spring be modeled as.But along with diaphragm is compressed in valve seat, power demand exponentially increases.Therefore, become nonlinear and more complicated for the force curve of biasing member.Therefore, there is some unique challenges relevant with the tolerance between the hard stop stop of all parts of biasing member, aperture closure element and displacement mechanism to the design of valve.Displacement mechanism must can send non-linear force curve, and is not for good and all out of shape diaphragm.This means that just in time appropriate power must be sent by mechanism.

As discussed above, biasing member comprises the bar, plunger or other slender members that are attached to another structure being called as core, this core there is larger diameter and can be upwards close to another structure example as during magnet face be used as stopper.One skilled in the art will appreciate that biasing member or movable member are not limited to bar and cylinder configuration.On the contrary, it can comprise non-cylindrical configurations, single or multiple parts that are soldered or that combine in any other manner.In a word, biasing member can comprise many different structures, as long as required power can be applied on aperture by the motion of component, with reliable and consistent mode compression element.

For example, referring to Figure 73, show selectable more not preferred embodiment.For Kidney Dialysis application, valve is not reliably remained on closed condition by the present embodiment usually.Biasing member 7300 comprises shell 7305, and it comprises the electromagnet 7310 with substantial cylindrical structure and the boring 7315 extending through it.Electromagnet 7310 is positioned in shell 7305 securely between two parties by nonmagnetic spacer 7320, and in one embodiment, this nonmagnetic spacer is end cap.End cap has two objects-by magnets in place and is clamped by coil in place.In one embodiment, element 733l and 7320 comprises the first integral piece, and 7305 and 7320 comprise the second integral piece.The ferromagnetic core part 7325 with the cylinder form in first surface 7323 and the second face 7324 is positioned to allow the part of core 7325 between first surface 7323 and the second face 7324 to have and assembles with the linear slidable of boring 7315.Second face 7324 is sufficiently larger than boring 7315, thus the linear movement of restriction core 7325.In one embodiment, second is determined differently size relative to first surface, is maintained in its closed position by valve to produce enough magnetic force.Core 7325 can carry out left and right linear sliding motion in boring 7315.

The magnet 7330,7335 of two different sizes to be also fixed in shell 7305 and to be fixed on two end cap 733l, 7332 places of this shell.The first surface 7323 of core 7325 contacts with the first magnet 7330 the first steady statue forming displacement system 7300, and the second face 7324 of core 7325 contacts with larger magnet 7335 the second steady statue forming displacement system 7300.The placement of permanent magnet 7330,7335 is designed in the diameter of shell 7305, because it reduces the size of displacement system 7300.Be connected to the first bar 7340 of the first surface 7323 of core 7325 through the first magnet 7330, thus give prominence to from shell 7305 an end, and be connected to second bar 7345 in the second face 7324 of core 7325 through the second magnet 7335, thus give prominence to from shell 7305 in another end.Bar 7340,7345 can be made up such as but not limited to pyrite of noncorrosive nonmagnetic substance as known in the art.Although an embodiment has two bars in two faces being connected to core, in a selectable embodiment, there is a unique bar in one of the face being connected to shuttle.

It will be understood by those skilled in the art that, the magnetic force be applied on core 7325 by electromagnet 7310 is high to the retentivity being enough to overcome permanent magnet 7330,7335, makes displacement system 7300 can change to the second steady statue from the first steady statue.In addition, it will be understood by those skilled in the art that, bar/plunger 7345 moves along with core 7325, thus produces starting power and compress or decompression aperture closure element.But the present embodiment has been defined as being inferior to the first embodiment, because it can not keep closed condition fully.

Should be understood with some design feature of the aperture closure element of biasing member and mechanism's co-operate.The first, with reference to Figure 74, and as above with reference to Fig. 7 lA and 7lB discuss, gap 7408 is present between piston cap 7404 and aperture closure element 7405 (particularly primary diaphragm face 7405).Gap 7408 is in the scope of 0.040 to 0.070 inch and more particularly about 0.055 inch.Diaphragm comprises silicones, preferably has the thickness of 0.040 inch, and can be modeled as the spring (K of the spring constant with 2701bf/in _v2).Secondary diaphragm face 7406 and valve seat 7407 are separated and are modeled as the spring K of spring constant and about 0.047 inch thickness with about 22.51bf/in _v1magneticaction.

The power that magnetic attraction by core 740l produces transits to by spring K by bar 7404 _pthe magnet 7403 of modeling, this spring in off position in separated by the silicones of such as 0.010 inch, pad and core head 7401, and separate about 0.110 inch with core head 7401 in open state.This silicones pad provides and is modeled as spring K _sLpower.Core 740l is incorporated into bar 7404.When valve activated, bar 7404 moves upward in the side of valve seat 7407, because the core that bar combines moves upward in the side of large magnet 7403.

With reference to Figure 74, K _v2and K _sLsuch as, corresponding to the elastomeric material being modeled as stiffness spring, silicones.Should be understood that when the valve 4 is in a closed state, there are two important positions.First position being bar and being close to diaphragm, second position being core face and being close to large magnet.When the valve is closed, bar is using and enough is defeating on valve film, to resist at least 600mmHg back pressure produced in the fluid passage of renal dialysis system.In the present embodiment, fluid pressure can reach 2600mmHg and this system 7400 be designed to diaphragm to remain be close to securely valve seat with seal orifice high to and comprise 2600mmHg.

In addition, when the valve is closed, the large face of core is pulled close to or is directly close to large magnet.The magnetic attraction to large magnet of core produces the power that bar puts on aperture closure element such as diaphragm.In order to produce consistent and reliable power, the spacing between the face of core face and large magnet must be consistent.Therefore, preferably, elastomeric material 7402 is placed between core face 740l and magnet face 7404.Elastomeric material has nonlinear spring constant, and will compress, until for elastomeric material make a concerted effort equal magnetic force.When power is applied to diaphragm via core by bar, experience should be made a concerted effort by core.For the static conditions that will occur, these power on core and must equal zero.In addition, elastomeric material does not peel off for the protection of magnet face or ruptures between period of energization.

With reference to Figure 76, when valve 7600 is in closed condition, core head 7605,7602 has been moved away from small magnet face 760l (from position 7602a to position 7602).When in position 7602, core head is such as had the silicones pad of about 0.015 inch thickness by elastomeric material 7617 and small magnet 7601 is separated.When position 7605, core head is by about 0.140+/-0.20 inch of moving, comprise the distance of 0.45+/-0.005 inch, bar 7608 does not move in the meantime, and be close to elastomeric material 7616 (such as having the silicones pad of about 0.015 inch thickness) to stop, core head 7605 and large magnet face 7606 are separated by this elastomeric material.Large magnet 7606 and then separate with club head 7607.

When valve is in open state, large magnet 7606 is such as had the silicones pad of about 0.015 inch thickness by elastomeric material 7615 and club head 7607 is separated.When the valve 4 is in a closed state, large magnet 7606 is such as had the silicones pad of about 0.015 inch thickness and club head 7607 by elastomeric material 7615 and separates and the distance separating about 0.055+/-0.10 inch.When the valve is closed, club head 7607 moves to be in close proximity to valve seat 7610 from being in close proximity to large magnet 7606 and elastomeric material 7615.Especially, diaphragm 7608 is compressed in club head 7607 motion, thus against elastomeric material 7609 (such as there is the silicones of about 0.040 inch thickness), and this elastomeric material and then again against valve seat 7610.This impels and adopts the power of about 14N to carry out shutoff valve.

Should be understood that, biasing member and mechanism relative to aperture closure element configuration and describe tolerance herein diaphragm displacement curve 7500 be provided, as shown in Figure 75, this diaphragm displacement curve is suitable for the application needing to resist at least 600mmHg back pressure, such as renal dialysis system.With reference to Figure 75, provide exemplary diaphragm displacement curve 750l, the power 7502 wherein applied by biasing member is arranged in y-axis, and corresponding diaphragm displacement is arranged in x-axis.When flex point instruction diaphragm on this curve 7503 starts to be compressed to be close to valve seat.To the left side of flex point 7503, diaphragm is just being forced to bend towards valve seat, but is not close to the substance compression of valve seat.To the right side of flex point 7503, diaphragm is close to valve seat and is bent, and makes diaphragm material modification and affects the excellent sealing of fluid pressure.

Another vitals of displacement mechanism system is the actuator system 7200 described in Figure 72.During actuation process, coil 7205 is energized and magnetic field builds, and therefore produces the magnetic force contrary with small magnet captivation.When power builds, core setting in motion discussed above is to closed position (large magnet).Once core moves across point of no return, then the captivation on large magnet core has overcome the captivation of small magnet.Do not overcome the captivation of large magnet in order to ensure the opposing force caused by valve film, be provided with gap, as discussed above.

Coil design is made up of coil form and magnet-wire 7210.The size of coil form size is preferably based on the coil form of commercially available acquisition, the pulse current capacity of power supply and actuation force required especially and supply voltage.Ampere-the circle of actuation force and coil is specified proportional.In one embodiment, preferably coil current is restricted to 6 amperes or less.

Key factor in coil design comprises the quantity of layer, packing factor, linear diameter and coil resistance.In one embodiment, the bobbin that the present invention uses has 6 layer lines and is about 0.010 inch at bobbin lip diameter and the space finally between one deck.Adopt the coil resistance of the insulating requirements of reaggregation nylon and 3.5+/-0.5 ohm, linear dimension is about 29AWG.The coil form of any size can be used.

Circuit for drive coil is H bridgt circuit, and it enables electric current be inverted to open and close operation.H bridgt circuit is driven by unique pulse width modulation (PWM) signal.Pwm signal is for generation of the cosine currents pulse by coil.The cycle of cosine impulse is relevant with opposing force with core quality.Preferred embodiment does not use bipolar DC power switch or sensitive switch; On the contrary, the position of core is determined in optical pickocff operation, infers valve state, and produces electric drive cosine waveform and move in a desired direction to make plunger, thus changes the state of valve.

Alternatively, as shown in Fig. 7 lA and 7lB, valve system 7l00 is used as the sensor of element 7152, preferably optical pickocff 7152, to determine the state (opening or closing) of valve.This can realize by the position that optical pickocff 7152 is positioned at the enough difference in the reflexive or other optical properties that have between valve open mode and valve closed condition.Such as, when the valve is closed, in one embodiment, the large end of core 7196 is positioned to be close to elastomeric material 7134 and large magnet assembly 7132.The large end of core 7196 has enough wide width, to be sensed by reflective optical sensor 7152, but too not wide, so optical pickocff 7152 has position resolution.Optical pickocff 7l52 will be placed on the outside of biasing member/mechanism and be observed by its main body, and this main body is preferably made up of transparent Merlon.The wavelength of optical pickocff 7152 will close in infra-red range (NIR), to have the good transmission through polycarbonate body.It will be understood by those skilled in the art that, sensor can be selected to applicable any material structure, as long as it comprises suitable wave filter.In this article, optical pickocff 7152 preferably have be built into wherein for NIR response length lead to light filter.

Functionally, when core is in release position, as shown in Fig. 7 lA, the visual field of optical pickocff 7152 is shifted out in the large end of core 7196, because only almost not reflecting and will be seen by optical pickocff.When the large end of core 7196 is in the visual field, as shown in Fig. 7 lB, by the reflection having sensor 7152 and will see, thus instruction core is in the closed position.What it will be understood by those skilled in the art that is, sensor 7152 can be located so that its sensing is from a large amount of reflections of core when valve 7l00 is in release position, and it senses less reflection (because core has shifted out the visual field) when valve 7l00 is in the closed position.In addition, it will be understood by those skilled in the art that, sensor 7152 can be positioned to be in close proximity to gap to sense gap and when exist and when gap does not exist, thus the state of indicator valve 7l00.

Although the general plane surface of the manifold diaphragm in above-mentioned embodiment causes function system, the response of this system is delayed by.Particularly, the sensor in dialysis machine or the gap between pin and membrane surface or dead space produce the response curve seeing Figure 75.When diaphragm starts against valve seat, until flex point 7503 just sees response.But in certain embodiments, more direct response may be expect.Therefore, in other embodiments, manifold comprises one or more diaphragm, and wherein the part of projection on its outer surface or protuberance are configured to and dialysis machine pin or sensor close contact fully, and the gap be present in above-mentioned embodiment is eliminated.Elimination gap or dead space cause system responses to move to the linearity of the improvement in diaphragm in pin.

Figure 71 C is the sectional view of an embodiment of the manifold diaphragm 7106 of nonreentrant surface 7120 with projection.The surface 7120 of diaphragm 7106 starts from the phase same level of manifold 7107, increases and then reduce height h relative to the height of manifold 7107 on its length l.In one embodiment, the length l measurement of diaphragm is about 0.625 inch to 0.675 inch.In one embodiment, the height h of the outer surface relative to manifold 7107 in centre always increases between 0.03 and 0.04 inch.In one embodiment, thickness t relative constancy on its whole length l of diaphragm, measures between 0.03 and 0.04 inch.Convex film by be hoped into transducer contact diaphragm surperficial time bubble is squeezed out.But, create and maintain convex membrane structure for because of produced heat challenging to manufacture.

Little dome in general planar membrane surface or protuberance more heat-resisting and more easily manufacture.Figure 71 D is the sectional view of an embodiment of the manifold diaphragm 7106 of the convex protuberance 7128 in general plane periphery 7125 with the projection being positioned at center.The height of the apparent height that the periphery 7125 of diaphragm 7106 has and surrounding manifold 7107 outer surface is approximate horizontal.Protruding protuberance 7128 is around the center of diaphragm 7106 or its, and in height having obvious ladder relative to general planar periphery 7125 increases.Protuberance 7128 has the nonreentrant surface 7120 being designed to contact plug or sensor.In one embodiment, the total length l measurement of diaphragm is about 0.625 inch to 0.675 inch.The length l of protuberance ₁measure between 0.125 and 0.15 inch, it is in the sensing diameter of pressure transducer, and in one embodiment, this sensing diameter is 0.185 inch.Periphery l ₂linear measure longimetry on the every side of protuberance is between 0.25 and 0.2625 inch.In one embodiment, the total height h of protuberance is between 0.03 and 0.04 inch.Increase is highly by the curved surface end-blocking of protuberance.In one embodiment, thickness t relative constancy on its whole length l of diaphragm, and measure between 0.03 and 0.04 inch.In one embodiment, protruding protuberance 7128 represents 10% to 40% of total membrane surface, preferably 19% to 23%.

In another embodiment, periphery and the protruding protuberance of diaphragm all have nonreentrant surface, but have the different total heights relative to manifold outer surface.Figure 71 E is the sectional view of an embodiment of the manifold diaphragm 7106 of the convex protuberance 7128 in the convex periphery 7127 of projection with the projection being positioned at center.The apparent height that the periphery 7127 of diaphragm 7106 has increases relative to the approximate horizontal outer surface of around manifold 7107.Periphery 7127 comprises nonreentrant surface 7123.Protruding protuberance 7128 is at the center of diaphragm 7106, and in height having obvious ladder relative to convex periphery 7127 increases.Protuberance 7128 has the nonreentrant surface 7120 being configured to contact plug or sensor.In one embodiment, the total length l measurement of diaphragm is about 0.625 inch to 0.675 inch.The length l of protuberance ₁measure between 0.125 and 0.15 inch, it is in the sensing diameter of pressure transducer, and in one embodiment, this sensing diameter is 0.185 inch.Periphery l ₂linear measure longimetry on the every side of protuberance is between 0.25 and 0.2625 inch.In one embodiment, the total height h of protuberance is between 0.03 and 0.04 inch.In one embodiment, the height h of protuberance ₂every side of periphery is measured between 0.10 and 0.02 inch above the flex point limiting periphery terminal and protuberance initial point.The height h of periphery ₁measure above manifold outer surface and be about 0.02 inch.Increase is highly by the curved surface end-blocking of protuberance.In one embodiment, thickness t relative constancy on its whole length l of diaphragm, and measure between 0.03 and 0.04 inch.It should be understood that in above-mentioned each embodiment, the thickness that diaphragm can have is not constant on its total length l, although this is not preferred.

Have (it can comprise periphery and protuberance) thickness of relative constancy by building whole membrane surface and comprise the central area relative to diaphragm remainder with increase height, the linearity of pressure-responsive improves.Should be understood that, other change of disclosed embodiment is included in this description, comprise diaphragm, wherein there is the periphery of general planar, the first protuberance upwards extended in a curved fashion in the border of periphery and same the second protuberance upwards extended in a curved fashion in the border of the first protuberance placed in the middle in the first protuberance.By this way, protuberance can layering within each other, progressively increases with in height multiple created from periphery towards its center.Because many such protuberances and ladder are possible, and the manufacturability restriction of the quality of the response that is only stressed and design.

Operatively, as reference Figure 77, valve is in one of two states (opening or closing) at first.Suppose that valve is in open state 770l, then first step of shutoff valve is excitation coil actuator loop 7702, thus make the magnetic field produced by coil through core, between core with small magnet, produce contrary magnetic force, and produce weak captivation between large magnet and the large end of core.Along with biasing member setting in motion 7703, small magnet captivation reduces, and increases with large magnet captivation.Biasing member motion is 7703 until point of no return, and then biasing member 7704 is closed gap 7704 and compressed aperture closure element and diaphragm 7705 is close to valve seat 7706.The compression of diaphragm 7706 makes diaphragm close aperture 7707 and shutoff valve 7708.

Suppose that valve is in closed condition 7709, first step then opening valve is excitation coil actuator loop 7710, thus impel the magnetic field produced by coil through core, between core with large magnet, produce contrary magnetic force, and between small magnet and the small end of core, produce weak captivation.Along with biasing member setting in motion 7711, large magnet captivation reduces, and increases with small magnet captivation.Biasing member motion 7711 is until point of no return, and then biasing member decompression diaphragm 7712 is away from valve seat 7713.Aperture is opened by means of no longer being covered by diaphragm 7714.Biasing member is back to its initial position and produces gap 7715 again, thus is back to open mode 7716.

Even if because the first and second steady statues of core are also maintained when being cut off to the power of electromagnet, produce so displacement system can have relative to the low power consumption of prior art actuator and low grade fever, in prior art actuator, need continuous power supply to carry out hold mode, cause high delivery in hot weather raw in addition.

The anti-rinsing of saline

With reference to Figure 86, show and carry out the method and system of the anti-rinsing of saline for safe high rate.Usually, dialysis blood circuit be connected to the tubular segment 8658 of patient at connecting portion 865l place by dismounting and tubular segment 8658 is attached to saline source 8602 via junction point 8652 and 8653 carries out the anti-rinsing of saline, it is for adopting normal saline washing system.But the method for this routine has shortcoming, comprise and destroy aseptic connection.Should be understood that, junction point can be any type of connection, comprises Rule connection, snap fit, needleless insert, the fluid of valve or any other form connects.

Another approach for the anti-rinsing of saline comprises saline source 8602 is connected to junction point 8653 via junction point 8652, remains connected to patient simultaneously.Although it avoids destroying aseptic connection, patient is exposed to and may the brine fluids containing air bubble flows by it.Because in the tubular segment 8658 not having air bubble detector to be usually present between the point of saline connecting portion 8653 and the point being connected to patient 865l, so have following risk: excessive air bubble will be formed, and because inform the mechanism of patient not used for this air bubble of detection and enter the blood flow of patient, cause substantive damage.

Alternately, be keep connecting via the blood circuit between patient and dialysis system of tubular segment 8658 for carrying out the optimization approach of the anti-rinsing of saline, this tubular segment is connected to manifold 8600 at port C8605 place and is connected to patient at junction point 865l; And saline source 8602 is fluidly connected to manifold 8600 at port D8606 place.Because patient is still fluidly connected to dialysis system, so saline is allowed through gravity or impressed pressure flows into manifold 8600 via the port D8606 being adjacent to port C8605.Saline flow, for adopting normal saline washing manifold 8600, especially for flowing out from manifold 8600 via port C8605, enters patient by tubular segment 8658 via connecting portion 865l.Because air bubble detector is present in district 8654, be in close proximity to port C8605, so when manifold 8600 to be arranged in controller unit and to be therefore suitable for detecting the air bubble in the fluid flowing leaving port C8605, leave manifold 8600 and saline towards patient is monitored air bubble by by the air bubble detector in district 8654.If air bubble is detected, so alarm will be sounded, thus send signal to patient: he or she should be disconnected from system or be steeped from inlet point 8610 extracting air by use syringe.Therefore, this method and system for carrying out the anti-rinsing of saline keeps aseptic connection, still monitors and the existence of alarm air bubble simultaneously.

The hardware structure improved

The embodiment of dialysis system disclosed herein can also comprise the hardware structure of the more fast method providing ending system to operate.Usually, if when alarm state dialysis operation during be encountered time or user wish terminates operation, the instruction so sent in higher application layer must advance through multiple lower level, to terminate hardware operation on one's own initiative.This structure makes user stand the unnecessary risk of late release, and late release is unacceptable in key application.

With reference to Figure 78, dialysis system comprises the memorizer of at least one processor and the programmed instruction communicated with software application layer 7805 during for being stored in and being performed.Software application layer 7805 is connected with master controller 7810 interface, this master controller be responsible for controlling various pump, sensor and valve multiple field programmable gate arrays 7815 (control FPGA) data communication and with the operation of the various pump of charge of overseeing, sensor and valve for exceeding multiple field programmable gate arrays 7820 (safe FPGA) data communication of the malfunction of accepted operating parameter.

Control FPGA7815 performs the hardware instruction of the operation for controlling all system units comprising pump, sensor and valve, and by the status information transmission of parts to controller 7810 and safe FPGA7820, controller 7810 and then process information and the data some being used for process and/or display are further passed to application layer 7805, safe FPGA7820 monitors the status information being used for alert consitions, and such as operating parameter exceeds or do not meet one or more predetermined threshold value.

If control FPGA7815 produces the data that instruction alert consitions or instruction termination substantially or hang up need, so controller 7810 or application layer 7805 can send one or more order and carry out terminates operation.But independently, safe FPGA7820 receives data and can directly give an order, or otherwise make the operation of one or more valve, pump or sensor termination, termination or otherwise change state.Safe FPGA7820 can carry out this operation after directly receiving data from control FPGA7815, if or by controller 7810 direct instruction or carry out this independently by application layer 7805 direct instruction and operate.Directly receive data from control FPGA7815 by making safe FPGA and receive instruction from application layer 7805 and controller 7810, and there is no intermediary layer in-between, then system can in response to alert consitions or user instruction more fast and reliably cause closing, stop or other amendments of state.

Graphic user interface

The embodiment of dialysis system also comprises the interface of user by itself and system interaction.As discussed above, controller unit comprises the display for graphic user interface being presented in user.Interface makes user accurately can measure and verify prescription additive, and provide function to check the disposable product adopted in systems in which and the integrity of prescription additive and reliability.

As discussed above, dialysis system comprises scale, and scale can be integrated on the bracket at controller unit top, in the reservoir unit of portable dialysis system, to the side being in close proximity to the keeper for adsorbent box or transfusion of base unit, or in any other position.The survey measurements taked by digital scale is by being integrated into graphic user interface (GUI) display that the display in top controller unit shows.

In one embodiment, controller unit is programmed according to the prescription of user.This can have been come by initial setting up, and in initial setting up, all bags of prescription additive are placed on scale pallet by user one by one.The measurement result of being undertaken by digital scale is recorded and is stored in internal storage.Controller is therefore, it is possible to obtain the data about additive title and prescription weight.Therefore, when before starting dialysis procedure, the bag of any prescription additive is placed on the scale for measuring, the weight of the weight measured with the prescription be stored in internal storage compares by controller.When having any difference between the weight measured and the weight of correct or prescription, controller instructs GUI to show alarm or instructs audio frequency generation unit to produce audible alarm.Therefore, such alarm can be vision, such as flicker error message on the GUI screen, and can be attended by audible alarm.Alternately, user is not allowed to continue dialysis setting up procedure.

Figure 79 shows the example table of data, for can be stored in the prescription additive in the internal storage of portable dialysis system as file, flat file or form.Row 790l describes bag content and row 7902 show corresponding weight.As seen from row 7902, the weight difference between different packagings is several grams, and this can be read by digital scale.In one embodiment, digital scale of the present invention is designed to the weight resolution with 0.1gm magnitude, considers the weight of additive, and this provides and is greater than 5 resolution advantages, more preferably 10 resolution advantages.This resolution is enough to distinguish normally used additive.

Alternatively, the structure of digital scale is designed such that the mode that the bag of prescription additive is placed on scale does not affect by user by weighing process.This is because the structure of scale in the present invention is included in multiple weight sensitive components at multiple hitch point place.Such as, in one embodiment, scale is included in three sensors on trifilar suspension.Gross weight by scale system-computed, as the weight measured by all the sensors and.The advantage of this numerical procedure is used to be that bag weight does not need to be evenly distributed on scale platform.Therefore, even if bag is placed on scale pallet slightly amesiality, smooth or pulverize, will the degree of accuracy of the weight measurement undertaken by scale do not affected.That is, the bag mode be placed on scale does not fetter by it by user.

It is to be further understood that sensor weight can be determined by using any computational methods as known in the art.In one embodiment, data readings is received and according to determining weight as follows with the processor of scale data communication from scale:

Sensor _ weight (i)=Kl (i) * ADC (reading)+K0 (i)

Bag _ weight=(sensor _ weight (0)+sensor _ weight (1)+sensor _ weight (2)+sensor _ weight (3))/4

As above about Figure 16 discuss, portable dialysis system has the reader 1605 of exposure, such as barcode reader or RFID label tag reader, and it can be used for the coding wrapped or the label that read prescription additive.For initial setting up, user is by all coding/labels wrapped preferably by reader 1605 inswept prescription additive.By prompting user, the initial GUI message of the inswept reader of each bag 1605 of prescription additive can be helped user.When carrying out this operation, reader obtains the identifying information about additive and this identifying information is transferred to storage internal table in memory.After this initial setting up, before starting dialysis, no matter when prescription additive will be added in dialysis solution, and the identifying information (being read by reader 1605) of involved bag is compared by with the identifying information for this additive stored during initial setting up in an internal table.This helps to verify that correct additive has been selected for and jointly uses with dialysis solution, and helps the additive getting rid of any forgery.Can manually input about the identity of additive and the data of weight or the content by producing internal table to the remote access describing the identity of additive and the prescription of amount in detail.

In one embodiment, multiple programmed instruction that GUI of the present invention is stored by the processor resided in controller unit and performs produce.Batch processing instruction is designed to be used in the process of family through the identity and amount for verifying additive to be used.Bar code on additive bag is exposed to barcode reader by the one GUI screen prompt user.It will be understood by those skilled in the art that, this identification mechanism can be bar code, RFID label tag or other electronic tags, and reader can be barcode reader, RFID label tag reader or other e-tag reader.Reader reads by the information of encoding, and makes purpose processor to process this information, and by the information transmission that processed to memorizer.Memorizer has the program routine of the identity information translation processed being become additive.In one embodiment, by the form of various identifier and concrete additive name-matches is promoted above-mentioned translation.This form can be entered manually before the procedure, or is downloaded from server by the wired or wireless controller that is connected to.

Once obtain additive identity, GUI just the identity of additive is communicated to user and additive is placed on scale by Dictating user.Digital scale is weighed additive, and the weight measured is communicated to the second form.The weight of additive identity and expection maps by the second form.This second form can be entered manually before the procedure, or is downloaded from server by the wired or wireless controller that is connected to.If additive identity and the weight-matched measured, then content is poured in suitable position by instruction unpack bag by user.This process carries out repetition for all additives.In one embodiment, if if can not being read by the identity of encoding or the unknown of there are differences or wrap between the identity and weight thereof of bag, then do not allow user to continue this process.Therefore, this system provides a step or two step authentication mechanisms: a) use digital scale individually, or b) and bar code or label reader combine to use digital scale, this guarantees that user has all required additives in his or her occupying and correct additive is just being used and be not to forge or inappropriate.

With reference to Figure 80, show the flow chart of another process 8000 represented for initializing dialysis treatment.In one embodiment, controller unit 800l comprises at least one processor and stores the memorizer of multiple programmed instruction.When being executed by a processor, programmed instruction produces the multiple graphic user interfaces be presented on controller display, and it instructs user reliably obtained by a series of being designed to and measure the action for the additive needed for dialysis treatment.First graphic user interface is produced, and user can carry out prompt system by it and initialize additive calculation process 800l.Initial prompt can by for initialization procedure special icon or can as part comparatively Iarge-scale system generation is set.

Then produce 8003 second graph user interfaces, it is with the additive needed for text or graphic form display, the product that the visual pattern preferably including actual additive packing has obtained to allow the visually relatively more required additive of user and user.Then whether user is prompted 8005 and wishes to use bar code scanning or verify additive by weight to indicate him.If user indicates him to wish to use bar code scanning by such as pressing icon, then produce 8007 the 3rd graphic user interfaces, the first additive is passed bar code scanner by prompting user.Then user is by additive through bar code scanner, and preferably with any order, record reads result.Should be understood that, bar code scanner can comprise lamp, such as red light, and it changes color when successfully reading, such as, change over green.

If system successfully reads bar code, then relative to the form stored in memory, it is by checking that code processes 8009 these codes.Bar code is associated with specific additive by the form stored in memory.Once specific additive is identified, then adopts check mark or highlightedly upgrade 8011 second graph user interfaces described above, to be successfully scanned to indicate which additive and this additive is put aside by instruction by user.This process carries out repetition 8019 for all additives.In one embodiment, once all additives are highlighted or final election, then system just automatically advances to the next step in dialysis setting or initialization procedure.In another embodiment, once all additives are highlighted or final election, then system just presents graphic user interface, this graphic user interface informs that all additive of user is recorded, and user manually makes system advance to dialysis to arrange or next step in initialization procedure afterwards.Should be understood that, although use term bar code, any electronic tag or Mk system can also be used.

If be not identified for any scanning step 8009 bar code, additive do not have bar code or user preference uses as verified additive with contrary the weighing of scanning, then graphic user interface is presented to user, and the first additive is placed on scale by prompting 8013 users.Scale is measured additive packing weight 8015 and is compared by the form of gravimetric value same relevant to special additive for the weight measured and identifies additive.Once be identified, then just adopt check mark or highlighted renewal 8017 second graph user interface described above, to indicate which additive to be successfully scanned, and additive is put aside by instruction by user.This process carries out repetition 8019 for all additives.In one embodiment, once all additives are highlighted or final election, then system just automatically advances to the next step in dialysis setting or initialization procedure.In another embodiment, once all additives are highlighted or final election, then system just presents graphic user interface, this graphic user interface informs that all additive of user is recorded, and user manually makes system advance to dialysis to arrange or next step in initialization procedure afterwards.Should be understood that, although use term bar code, any electronic tag or Mk system can also be used.

If additive is not identified, then user is apprised of a part that additive is not therapeutic process and is prompted suitable additive of weighing.In another embodiment, the additive identified if user can not be scanned or weigh, then user is not allowed to continue to initialize or setting up procedure.

What it will be understood by those skilled in the art that is, although proving program mentioned above is described prescription additive, but identical program can also be expanded the disposable unit to jointly using with dialysis system, such as adsorbent box and other disposable products.

It is to be further understood that the process of scanning and additive of weighing can be integrated and automatization.As discussed, user can be pointed out to initialize additive weighing process above, and the display for the project needed for treatment can be shown.Additive is placed on scale by user, and this weighing-appliance has and is in close proximity to or integration barcode reader wherein.In one embodiment, user is prompted to be placed on by additive in specific position or configuration and guarantees that bar code can suitably be read.When additive being placed on the scale with barcode reader that is integrated or combination, barcode reader scanning additive, attempt identifying bar code, and if be identified, then by final election or the highlighted additive be identified carry out processing item over the display.If barcode reader can not identify additive, if system needs other supplementary inspection, if or system wish obtain or otherwise record weight information, then scale measure weight and attempt relative to store value identify additive.If be identified, then system is by final election or the highlighted additive be identified carry out processing item over the display.Scale is measured and therefore barcode reader can occur, and will not move to another place or position from the three unities or position by additive.

To automatically each additive be put down, place or otherwise locate it is to be further understood that additive can be inserted in maintenance container in the appropriate location on scale/barcode reader, chute, cylinder, box, bucket or staging area.Therefore, all additives can be placed in single container by user, activation system, and each additive are in turn positioned on scale and are automatically recognized.Can point out user after each additive is identified, remove each additive or user can be pointed out to allow all additives first to be processed.

It is to be further understood that additive can after recognition automatically, after recognition manually and before or after hemofilter and/or adsorbent box are mounted be added in system.In one embodiment, top unit or the base unit of portable dialysis system also preferably have electrical interface, such as Ethernet connecting portion or USB port, to make it possible to be directly connected to network, thus promote that long-range prescription is verified, compliance is guarded against and the operation of other remote service.USB port also allows to be directly connected to accessory product, such as blood pressure monitor or hematocrit/saturation monitor.Interface is isolated electronically, thus guarantees patient safety, and has nothing to do with the quality of joint connecting device.

In another embodiment, dialysis machine comprises the interface that can be manipulated to the dialysis machine making to be loaded manifold and start with Therapeutic mode or priming mode to operate, and it is to have the form of the graphic user interface of touchscreen button, physical keyboard or mouse.When being instructed to operate with Therapeutic mode, controller produce signal (in response to this Therapeutic mode order) to make manifold valve from opening, precharging state switches to closedown therapeutic state.When being instructed to operate with priming mode, controller produces signal (in response to this priming mode order) and switches to make manifold valve open precharging state from cut out therapeutic state.It will be understood by those skilled in the art that, all control mentioned above and user command functions are by realizing in conjunction with one or more processor performing the programming implementing instruction mentioned above (being stored in local storage).

When being activated suitably, system can at least with priming mode and Therapeutic mode operation, and it can comprise other operator scheme (such as hemodialysis, hemofiltration or be simply non-priming mode).About exemplary Therapeutic mode and with reference to Figure 84, comprise dialyser 8402, sorbent regeneration system (such as box) 8412, manifold 8410 with the dialysis system 8400 of dialysis mode operation, to be entered transfusion source 8416 in manifold 8410 by port and fresh dialysis fluid is transfused to from it reservoir 8415 turned back to manifold 8410 via port.In operation, blood enters blood lines 840l, enter in manifold 8410 by port, is entered in dialyser 8402 by the two-port valve 842l in primary importance.The blood purified leaves dialyser 8402 by outlet 8403, by the two-port valve 8422 in primary importance, and is entered in manifold 8410 by port.Blood through manifold, through multiple valve 8417, as described about manifold 8410 above, and from port out and enter into the blood lines 8423 entering patient.

Simultaneously, the transfusion transmitted from source 8416 enters into manifold 8410 by port, by manifold 8410, by another port out, and enter in reservoir 8415, dialysis solution to be delivered from reservoir 8415 via dialysate lines 8424 and to enter dialyser 8402.After passing dialyser 8402, dialysis solution passes external pipeline 8425 and turns back in manifold 8410 by port, and it is directed to the dialysate regeneration system 8412 based on adsorbent at manifold 8410 via port.The dialysis solution regenerated passes back through manifold 8410 via port, and recirculated through dialyser 8402 together with new dialysis solution (and if when needing).In order to manage dialysate fluid flowing, reservoir 8415 for storing the dialysis solution regenerated, and if when needing.In one embodiment, reservoir keeps the dialysis solution of 5 liters, and have keep reach 10 liters from the dialysis solution of patient and the capacity of effluent.

About exemplary priming mode and with reference to Figure 85, comprise dialyser 8502, sorbent regeneration system (such as box) 8512, manifold 8510, transfusion source 8516 and reservoir 8515 with the dialysis system 8500 of priming mode operation.In operation, be not connected to the blood lines in manifold 8510 from patient (such as Figure 84 8401), and so there is no blood and flowing into and maybe can flow into manifold 8510.On the contrary, the dialysis solution carried from source 8515 to be entered manifold 8510 by multiple port and dialysate lines 8524 by being connected to two-port valve port 8522.

In a preferred embodiment, single two-port valve 8517 is attached in the physical bodies of manifold 8510, and is manipulated to and switches between therapeutic operation mode and preliminary filling operator scheme, as discussed above.In the present embodiment, manifold 8510 comprises two-port valve 8517, if it is activated or is switched to the second position (such as opening) by from primary importance (such as closing), causes the change of the internal flow path of the liquid in manifold.Because this flow path changes, the blood of fluidly isolating each other when the valve is closed and dialysis fluid circuit are placed in and fluid communication with each other now.Preferably, do not have other valve or switch to need to be handled to realize this state and change, namely impel the blood of separation and dialysis fluid circuit to become fluid and connect.

Vavle switching can be realized by any means as known in the art, comprise by physically handling the Mechanical course portion in manifold surface, or operating dialysis machine by the interface between the dialysis machine of controller with the operator scheme control valve state for selecting according to user and the valve interface being integrated in manifold surface electronically, impelling and changing valve state.

In priming mode, valve 8517 will be opened, thus make dialysate fluid flow through pump to pass manifold 8510, enter in dialyser 8502 via pipe 8524,8503 and two-port valve port 8522, from dialyser out, turn back in manifold 8510 via two-port valve port 852l and pipe 8525, and from manifold 8510 out.Therefore, in priming mode, valve 8517 guarantees that dialysis solution cycles through blood circuit, thus blood and dialysis fluid circuit are placed in fluid are communicated with.Functionally, by handling the state of two-port valve 8517, manifold 8510 is placed in priming mode.

To be pumped in blood circuit and by after it, two-port valve is closed at the designated volume of dialysis solution.The pumping of dialysis solution can or can not continue.If continued, then fresh dialysis solution only cycles through dialysis fluid circuit.Residual dialysis solution remains in blood circuit.In order to remove dialysis solution from blood circuit, patient is connected to " from Patient line " 840l, as being commonly called tremulous pulse and entering pipeline shown in Figure 84." to Patient line " 8423 is commonly called vein return line, or remains on waste canister or be connected to patient.

By system is placed in Therapeutic mode, the blood from patient is inhaled in blood circuit, transmits and enters manifold, by pump, from manifold out, by dialyser, turn back in manifold, and return from manifold out.The priming fluid that blood thus make remains by blood circuit by ' expulsion ', is removed remaining air pocket any in this process, and enters waste canister or patient, depend on the connection status of vein return line.After blood fills blood circuit completely, system stops blood pump or user manually to stop pump.If be not yet connected, then then vein return line is connected to patient and treatment continuation.

In another embodiment, filter such as 0.22 μ filter may be used for help and removes any remaining undesirable substance, if adsorbent tank is not enough to produce substantially aseptic dialysis solution.In one embodiment, filter is positioned to and reservoir intake pipeline conllinear, is in close proximity to the port E of manifold, and is all used during preliminary filling and operation.

By using this pre-fill system, avoiding and disposable product external member that is other and that be separated must be used to come the blood side in only preliminary filling loop.Especially, this approach does not need the saline source be separated, and such as l rises the saline of sack, therefore not needing the adapter to the saline source be separated and pipeline yet, comprising the two tube chamber spines for blood lines being connected to saline or single-lumen spine.

Disposal reagent kit

The embodiment of dialysis system disclosed herein is designed to use multiple disposable unit.With reference to Fig. 8 l, in one embodiment, for the disposable product 8106 of system to be pre-assembled in the packed and transported on pallet 8105.Pallet 8105 is placed on the top of controller unit 810l work space, thus allows to be easy to access and the disposable product of administrative institute's need, and this is for particular importance domestic consumer.Controller unit 810l is waterproof, makes when overflow, and it should be non-leakage in top controller unit 810l and damage it.

In one embodiment, test kit 8200 holds all by the manifold 8202 of pre-attached, dialyser 820l and pipeline 8203.With reference to Figure 82, disposal reagent kit 8200 comprises dialyser 820l, manifold 8202, pipeline 8203, valve 8204 (part as manifold), reservoir bag 8205, and they are all disposed for directly being installed in dialysis machine by user by pre-attached.

More particularly, disposable unit, particularly complete disposable blood and dialysis fluid circuit by pre-packaged in test kit (it comprises dialyser, manifold, pipeline, reservoir bag, ammoniacal sensor and miscellaneous part), and then being installed by opening department before top unit (as discussed) above by user, dialyser being installed and to guarantee that the mode of aiming at relative to non-once parts such as pressure transducer and miscellaneous part installs manifold.The multiple pump boots be integrated in the inner surface of front department make to load disposable unit easily.Manifold only needs to be inserted into, and does not have pump line road to need to be threaded between roll packer and boots.The straightforward procedure of this packing makes it possible to load disposable product and cleaning systems easily.It also guarantees that flow circuits is suitably configured and is easy to use.In operation, top unit is attached to the base unit with reservoir.

Alternatively, disposable unit particularly manifold comprise blockade (" e-the blockade ") system based on electronics.Figure 83 shows the functional block diagram that e-of the present invention blocks an embodiment of system.In one embodiment, e-block system 8300 comprise reader 830l, its detection and read be embedded in disposable 8302 such as disposable manifold, for the disposable adsorbent in dialysate regeneration and/or the identification data 8306 in dialyser.Identification data 8306 can will be used to the means of identification of the disposable 8302 of dialysis system 8303 by bar code, RFID label tag, EEPROM, microchip or any other unique identification and be stored on disposable 8302.Reader 8301 is correspondingly barcode readers, RFID reader, microchip reader or any other the reader corresponding to adopted recognition technology, as known in the art.In one embodiment, reader 830l is connected to transceiver, for being wirelessly connected to remote data base 8305 by network 8304, and such as Internet or any other public or private network well known by persons skilled in the art.In another embodiment, reader 830l directly aims at identification data 8306.

Be positioned at and store multiple information of disposable 8302 about can be used for system 8303 apart from the long-range data base 8305 of dialysis system.Information comprises unique identification data 8306 and the information for corresponding disposable, such as reliability, whether may to be in regard to project workability with regard to working condition or project whether due to defect manufactured business recall, its expiration date (if any), and/or any other will advantageously obvious this added value information for those skilled in the art.

In operation, when such as dialyser, manifold or hemofilter box are loaded in system 8303 disposable 8302, reader 830l detects disposable 8302 by the identification data 8306 be embedded in project 8302.This identification data 8306 is read by reader 830l, this reader again with data base 8305 wired or wireless communication, to ask based on identification data 8306 more about the information of project 8302 stored therein, or confirm effectiveness or the integrity of project 8302 based on identification data 8306.

Such as, in one embodiment, the dialyser box 8302 identified by reader 830l may due to certain defect, manufactured business recalls.This call back message to be stored on data base 8305 and as be sent to by network 8304 by reader 830l data base 8305 request signal result and be returned to reader 830l.As the result of the call back message received from data base 8305, the microprocessor controlling the blood purification system supported by system 8303 does not allow user's continual cure.In one embodiment, this is by stopping the function of fluid-propelled by the pump of the fluid circuit of blood purification system 8303 to realize.In addition, audio/visual alarm also can be shown as this effect.

In another example, the dialyser box 8302 identified by reader 830l may not be believable.As its result, microprocessor will not allow the function of the blood purification system of system 8303.Therefore, e-of the present invention blocks system 8300 and prevents use system 8303 when the disposable 8302 being attached to manifold 8303 is in compromise state.

Although illustrated and described the content being considered to the preferred embodiment of the invention at present, but what it will be understood by those skilled in the art that is, when not departing from true scope of the present invention, various change and amendment can be made, and equivalent can replace element wherein.In addition, when not departing from its center range, many amendments can also be made and be adapted to instruction content of the present invention to make concrete conditioned disjunction material.Therefore, desirably the invention is not restricted to as specific embodiments disclosed in the best mode for implementing contemplated by the present invention, and the present invention will comprise all embodiments fallen within the scope of claims.

Claims

1. a diaphragm, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises: convex surface, it from described manifold outwardly and be fixedly attached to described manifold at first end with at the second end, distance between wherein said first end and the second end limits length and the height of described diaphragm, wherein, described diaphragm has the height identical with described manifold at described first end and the second end, wherein, the height of described convex surface is increased to the first height relative to described manifold from described first end, and wherein, the height of described convex surface is highly decreased to described the second end from described first.

2. diaphragm according to claim 1, wherein, described diaphragm first height relative to described manifold between 0.03 and 0.04 inch.

3. diaphragm according to claim 1, wherein, described diaphragm has along the thickness from described first end to the length of described the second end, and wherein, described thickness is constant along described length.

4. diaphragm according to claim 1, wherein, the thickness of described diaphragm is between 0.03 and 0.04 inch.

5. diaphragm according to claim 1, wherein, the total length of described diaphragm is between 0.625 and 0.675 inch.

6. a manifold, comprises one or more diaphragm according to claim 1.

7. a diaphragm, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises:

A. the first roughly plane surface, it has first end and the first bending section, wherein, distance between described first end and the first bending section limits length and the height of described first plane surface, wherein, described first end is fixedly attached to described manifold, and wherein, the described height of described first plane surface is substantially equal to the height of described manifold;

B. convex surface, its from described first plane surface described first bending section continue and outwardly, described convex surface proceeds to the second bending section from described first bending section, wherein, distance between described first bending section and the second bending section limits length and the height of described nonreentrant surface, wherein, described nonreentrant surface has the height identical with described first plane surface at described first bending section with described second bending section, wherein, the height of described convex surface is increased to the second height relative to described manifold from described first bending section, and wherein, the height of described convex surface is highly decreased to described second bending section from described second, and

C. the second roughly plane surface, it proceeds to the second end from described second bending section, wherein, distance between described second bending section and the second end limits length and the height of described second plane surface, wherein, described the second end is fixedly attached to described manifold, and wherein, the described height of described second plane surface is substantially equal to the described height of described first plane surface, and the described length of described second plane surface is substantially equal to the described length of described first plane surface.

8. diaphragm according to claim 7, wherein, described convex surface described second height relative to described first roughly plane surface between 0.03 and 0.04 inch.

9. diaphragm according to claim 7, wherein, described diaphragm has along the thickness from described first end to the length of described the second end, and wherein, described thickness is constant along described length.

10. diaphragm according to claim 7, wherein, the thickness of described diaphragm is between 0.03 and 0.04 inch.

11. diaphragms according to claim 7, wherein, described diaphragm from the described first end of described first plane surface to the total length of the described the second end of described second plane surface between 0.625 and 0.675 inch.

12. diaphragms according to claim 7, wherein, the length of described convex surface is between 0.125 and 0.15 inch, and the length of the length of described first plane surface and described second plane surface is between 0.25 and 0.2625 inch.

13. 1 kinds of manifolds, comprise one or more diaphragm according to claim 6.

14. 1 kinds of diaphragms, to be integrated in the disposable manifold for dialysis machine and to be suitable for by described dialysis machine and at the component compresses of described disposable manifold external, described diaphragm comprises:

A. the first inclined surface, it has first end and the first bending section, wherein, distance between described first end and the first bending section limits the length of described first inclined surface, wherein, described first end is fixedly attached to described manifold, and wherein, described first inclined surface has the first height at described first end and has the second height at described first bending section, described second of wherein said first inclined surface is highly greater than described first height of described first inclined surface relative to described manifold, and wherein, described first of described first inclined surface is highly substantially equal to the height of described manifold,

B. convex surface, its from described first inclined surface described first bending section continue and outwardly, described convex surface proceeds to the second bending section from described first bending section, wherein, distance between described first bending section and the second bending section limits length and the height of described nonreentrant surface, wherein, described nonreentrant surface is highly identical with second of described first inclined surface with the height of described second bending section at described first bending section, wherein, the height of described convex surface is increased to second height of described nonreentrant surface relative to the second height of described first inclined surface from described first bending section, and wherein, the height of described convex surface is highly decreased to described second bending section from described second of described nonreentrant surface, and

C. the second inclined surface, it proceeds to the second end from described second bending section, wherein, distance between described second bending section and the second end limits the length of described second inclined surface, wherein, described the second end is fixedly attached to described manifold, and wherein, described second inclined surface has the first height at described second bending section and has the second height at described second bending section, described first of wherein said second inclined surface is highly greater than described second height of described second inclined surface relative to described manifold, and wherein, described second of described second inclined surface is highly substantially equal to described first height of described first inclined surface, described first of described second inclined surface is highly substantially equal to described second height of described first inclined surface, and the described length of described second inclined surface is substantially equal to the described length of described first inclined surface.

15. diaphragms according to claim 14, wherein, described convex surface described second height relative to described first inclined surface described second height and described second inclined surface described first height between 0.01 and 0.02 inch, and wherein, described second height of described first inclined surface and described first height of described second inclined surface are about 0.02 inch relative to described manifold.

16. diaphragms according to claim 14, wherein, described diaphragm has along the thickness from described first end to the length of described the second end, and wherein, described thickness is constant along described length.

17. diaphragms according to claim 14, wherein, the thickness of described diaphragm is between 0.03 and 0.04 inch.

18. diaphragms according to claim 14, wherein, described diaphragm from the described first end of described first inclined surface to the total length of the described the second end of described second inclined surface between 0.625 and 0.675 inch.

19. diaphragms according to claim 14, wherein, the length of described convex surface is between 0.125 and 0.15 inch, and the length of the length of described first inclined surface and described second inclined surface is between 0.25 and 0.2625 inch.

20. 1 kinds of manifolds, comprise one or more diaphragm according to claim 14.