JPH0547225B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to a device for the delivery of drugs, more particularly a disposable device for the delivery of drug solutions to a patient by means of a roller-type infusion pump. The present invention relates to a reusable reservoir cassette and reservoir tube assembly for retaining a drug solution as it passes from the reservoir cassette toward a patient.

BACKGROUND OF THE INVENTION Many diseases of humans and animals are treated by subcutaneous, intramuscular or intravenous injection of medicinal solutions into the body of the patient. For example, a common treatment for vacuum diabetes is by subcutaneous injection of insulin with a daily regimen. This treatment method does not fully normalize glucose metabolism and thus affects other metabolic and biochemical properties. Nowadays,
Administering relatively large amounts of insulin every few hours induces capillary, neurotic, and other complications that can be minimized or eliminated by more frequent, relatively small doses of insulin administered subcutaneously. It is recognized that there is a risk.
However, as the frequency of administration increases, a large number of syringes must be kept at all times, and one must also remember the exact time for insulin injections and find a private place to administer the injections. This raises questions regarding benefits for patients. Furthermore, the pain and tissue damage that results from frequent injections of small amounts of insulin make such an attempt impractical. It is more desirable to deliver insulin intermittently into the patient's body by placing an implanted needle within the patient's body via subcutaneous procedures, or to deliver insulin continuously through an implanted intramuscular or intravenous catheter. However, continuous or intermittent injections over a period of time, e.g. 24 hours, are impractical without lightweight and compact administration devices that can be attached to the patient's body or clothing without interfering with the patient's daily life. It's practical.

Muller (U.S. Patent No. 3,384,080) and
Both patents to Maxwell (Id. No. 3,198,385) teach devices capable of continuous injection of medical fluids into the human body. Moreover, these instruments are large and expensive, and cannot be easily installed inside a patient's body without any problems. The Muller patent requires a separate reservoir which would add to the appeal of the pumping device. Also, large separate reservoirs create potentially life-threatening problems if the safety device fails and the pump injects the entire reservoir into the patient. The Maxwell patent teaches a highly complex device for high pressure injection in which the ampoule is removed via a pair of rollers, one of which is driven to squeeze the drug solution from the ampoule.

The Xanthopoulos patent (No. 4,187,057) teaches a disposable cassette for use in a peristaltic infusion pump, and the Brown patent (No. 4,256,437) also relates to a peristaltic infusion pump. be. The Xanthopoulos pump mentioned above is large and sublime and is not suitable for attachment to the patient's body. This is also intended to pump the intravenous drug solution from a separate reservoir. The Xanthopoulos patent moves the cassette into and out of an operating position in which the rollers of the pump engage and compress the tubular portion of the cassette by moving the entire cassette in a plane parallel to the plane of rotation of the rollers. teach things. This type of construction is undesirable in that relative movement between the tube of the cassette and the rollers results in movement of the cassette in the plane of the rollers causing the drug solution to be injected into the patient's body.

Albisser et al. U.S. Patent Application No. 267364, filed May 22, 1981, assigned to the applicant.
teach a compact device for controlled subcutaneous injection of dispersed amounts of a drug, such as insulin, at selected time intervals. The Albisser et al. patent application describes a compact roller-type pump configured to deliver drug fluid through a flexible tube coupled to an injection needle in a subcutaneous location. Users of the Albisser et al. invention place the tube needle assembly on the roller pump and then insert the needle into the insulin container. The pump is then used to draw insulin from the container into the tube. The needle is then removed from the container and placed on the patient. This method requires removing the needle from the patient each time the drug volume is exhausted.

Another problem is that the U.S. patent of Whitney et al.
No. 4,235,234, this patent teaches a hypodermic injection device with a locating pad supporting a needle having a right-angled tube. The portion of the needle in front of the right tube lies in the plane of the locating pad, and the rear portion of the right tube, including the tip, projects a predetermined distance in a generally perpendicular direction from the locating pad. Since the locating pad is in direct contact with the patient's skin, the needle penetration depth is reliably controlled.

Adams US Pat. No. 2,847,995 shows a known spring resilient valve sheath used for sealing the end of a needle cannula. This construction is commonly used with evacuated blood collection tubes that have rubber stoppers. Pressing the tube stopper toward the end of the cannula causes the cannula to pierce the sheath and pass through the stopper, thereby creating a flow condition between the inside of the evacuated blood collection tube and the cannula. secure. When the cannula passes through the rubber stop, the sheath is compressed into an accordion shape. When the needle is withdrawn from this stop, the sheath returns to its original position and seals the cannula.

With the above-mentioned problems of the prior art in mind, the delivery needle can be inserted into and removed from the pump mechanism without removing it from the injection site;
It would also be desirable to provide a disposable reservoir cassette that allows the same catheter tube and delivery needle to be used with successive reservoirs. It would also be desirable to provide a disposable storage cassette that can be purchased prefilled by the user or filled by the user using simple and inexpensive filling equipment. Furthermore, it is easy to install and can be removed from the pump, does not force excess medication into the patient during installation and removal operations, and can be used with a spare storage cassette. It would be desirable to provide a disposable storage cassette that allows the user to defecate.

(Structure of the Invention) The disposable storage cassette of the present invention includes a compressible reservoir, a gas-permeable but liquid-impermeable member at one end of the reservoir, and a member at the other end of the reservoir. and connecting means for coupling with an infusion catheter for injecting a medicinal solution into a user. Further, the connecting means holds the reservoir such that the liquid medicine can be discharged from the reservoir, and presses the reservoir to move the medical liquid held inside the liquid reservoir in a direction toward the connecting means. A cassette housing is provided which can come into contact with the reservoir when an externally applied force is applied.

In one preferred embodiment of this aspect of the invention, a disposable reservoir cassette for use with a roller pump mechanism in dispensing medical fluids to a patient includes a highly flexible reservoir tube;
An air permeable but liquid impermeable member at a first end of the reservoir tube and a discharge chamber coupled to a second end of the reservoir tube. The discharge chamber includes a cylinder, a pierceable septum at one end of the cylinder, and a sealing member at the other end of the cylinder. The septum, cylinder and sealing member define a cavity for receiving and storing a portion of the medicinal solution initially held within the reservoir tube. The sealing member has a centrally located orifice in communication with the second end of the reservoir tube. Ventilation means are provided between the inside of said discharge chamber and the outside of said discharge chamber in order to allow gas to escape from said discharge chamber when the chemical solution enters. Also provided is a rigid cassette housing containing a reservoir tube. The cassette housing includes an opening for receiving a pump roller located on the outside of the roller pump mechanism and a rigid, generally circular rear stop portion supporting the reservoir tube over its entire length. The cassette housing has an outlet therein, and a holding part that fixes and holds the reservoir tube adjacent to the rear stopper part such that a second end of the reservoir tube is adjacent to the outlet. . The rear stopper portion is disposed substantially adjacent to the path of the pump roller of the roller pump, thereby driving the chemical solution held within the storage tube in a direction toward the second end of the storage tube. a locking device for cooperating with the roller pump to position and removably hold the cassette housing such that the pump roller can rotate and press the reservoir tube with sufficient force; It is provided.

In another aspect of the invention, a reusable injection catheter includes a flexible conduit for engaging a first end of the conduit for delivering a drug solution to a patient. an injection device and a cannula extending outwardly from a second end of the conduit along the axis of the conduit and having a free end furthest away from the conduit. A sealing device typically engages the cannula to prevent fluid flow of the medicinal solution. The sealing device responds to an externally applied force or fluid pressure to cause the drug solution to flow into the cannula.

In a preferred embodiment of another aspect of the invention, a reusable injection catheter for use with an externally applied source of pressurized medical fluid comprises:
a highly flexible tube; a first cannula extending outwardly along the axis of the tube from one end of the tube for insertion into a patient; and the other end of the tube. Connector in
It consists of a housing. The connector housing has an end facing the reservoir cassette, an end adjacent the tube, and a passage therethrough. This passage communicates with the tube. A second cannula extends outwardly from the reservoir cassette end of the connector housing and is in communication with the passageway of the connector housing. The free end of this second cannula is
It is located at the furthest position from the connector housing. A highly elastic sleeve is also provided to cover the free end of the second cannula to prevent the flow of the medical solution. This sleeve is
a closed end, the closed end being compressed by the free end of the second cannula when a force is applied to the sleeve in a direction along the second cannula toward the connector housing. punctured,
A medical solution flows into the second cannula. The sleeve is further adapted to return to its original position upon removal of external forces. an attachment device engaged with the connector housing;
The housing cooperates with an externally supplied source of pressurized medical fluid to removably hold the housing in place relative to the source. In this way, the second cannula and the sleeve are held in place and when the closed end of the sleeve is punctured by the second cannula, the second cannula frees the drug solution from its free end. can be accepted.

Many advantages and objectives are achieved in accordance with the principles of the invention. First, the present invention combines a disposable reservoir cassette and a reusable injection catheter for use in a compact drug delivery device for injecting continuous or escalating doses into a patient. supply. The present invention is particularly for use with programmable body-mountable roller pumps. The present invention provides a disposable storage cassette that can be purchased by the user prefilled or filled by the user using simple and inexpensive filling equipment. The reservoir cassette is easy to install, easy to remove from the roller pump, and allows for convenient carrying and use by the user of a spare reservoir cassette. Additionally, this reservoir cassette can be inserted and removed from the roller pump without removing the delivery needle from the site of injection, and because of the evacuation chamber, the same catheter can be inserted into the same catheter for consecutively used reservoirs. Allows for use of tubes and feeding needles. In such cases, reusable injection catheters are advantageous because they include a resilient sleeve or sealing device that prevents liquid medication from escaping from the catheter during reservoir exchange.
Additionally, the entire volume of the drug is contained within the cassette, thereby avoiding the problems that would otherwise occur if the drug was supplied from a large adjacent reservoir.

(Embodiment) In FIG. 1, a drug solution supply device 29 operable to supply a drug solution such as insulin to a user includes a disposable storage cassette 30;
Programmable electrically controlled roller pump 200 and reusable infusion catheter 10
0. This roller pump 20
0 is preferably a small reusable electromechanical rope pump similar to the pump described in the Albisser et al. patent application cited above, which is attached to the human body. The working principle of the feeding device is based on a modified peristaltic motion to feed the entire contents of the re-disposable storage cassette 30 in one pass over the rollers. As described below, the contents of the reservoir cassette are delivered into the patient's body via an infusion catheter.

Roller pump 20 of the embodiment described in the text
4 includes a rugged, dust-tight, water-resistant roller pump housing 201 containing a drive mechanism, electronics package, and power supply (not shown). Projecting outwardly from the roller pump housing 201 are a roller drive arm 202 and a pump roller 204. The drive mechanism driving roller 204 through arm 202 is an internal spring (not shown) that is unwound each time the pump is loaded with a new reservoir cassette. This winding operation is performed by manually moving the roller drive arm 202 to the empty position 20.
5 to load position 206 in the opposite direction. The internal indexing mechanism (not shown)
It constrains the clockwise movement of the rollers and advances in 1.5 degree increments and is actuated by an electronics package. This electronics package times and operates the indexing mechanism and can adjust the automated movement of the pump rollers from advancing one unit every 88.2 minutes to advancing one unit every 15 minutes. The advancing motion speed of the pump roller 204 is
It is proportional to the underlying flow rate, which is the rate at which insulin is delivered from the delivery device. For example, adjustments in the underlying flow rate can be made such that 100 units of insulin are delivered from 0.34 units per hour to 2.00 units per hour. This basic flow rate is determined by the operation button 207 provided on the roller pump housing 201.
Or, it can be adjusted up or down by pressing 209 or by observing the flow rate on the liquid crystal display 210. Allows manual control of the advance angle movement of the rollers,
In addition, an operation button 211 is provided to enable supply of insulin in an amount larger than the basal flow rate. This feature allows the user to receive an extra dose of insulin on demand, for example before a meal. An on-off switch 214 is provided which serves as a control for starting and stopping advance movement of pump roller 204 by controlling the appropriate portions of the electronics package that power the internal indexing mechanism.

2-4, a disposable storage cassette 30 includes a highly flexible storage tube 34 and an air permeable liquid permeable tube located at a first end 68 of the storage tube 34. Part 3 that does not work
5 and a discharge chamber 36 located at the second end 58 of the reservoir tube. Storage tube 34
can be molded along its entire length into a circular ring configuration. A rigid cassette housing 37 encloses the reservoir tube 34, the evacuation chamber 36, and the member 35. Cassette housing 37
includes a solid, substantially circular rear stopper portion 41 that supports the storage tube 34 along the entire length, and a roller.
an opening 42 for receiving the rollers of the pump and a discharge chamber 3;
6 and a discharge port 72 adjacent to the discharge port 72 . The cassette housing 37 has an upper housing portion 39
and a lower housing portion 40.

As shown in FIGS. 5-7, the lower housing portion 40 includes a circular discharge chamber recess 44, a circular reservoir tube recess 45, a shoulder 46 between recesses 44 and 45, and a shoulder 46. and a discharge chamber shoulder 47 at the end of the discharge chamber recess 44 on the opposite side of the discharge chamber recess 44 . The lower housing portion 40 also includes a circular outlet recess 69, one or two connector housing locking grooves 70, a sleeve locking wall 75, and a circular cannula conduit recess 74. When the evacuation chamber 36 and the reservoir tube with attached member 35 are placed in the lower housing portion 40 as shown in FIG. fixed and held. Similarly, member 35 at the opposite end of reservoir tube 34 is received within recess 49 in lower housing portion 40. Upper housing portion 39 has similar recesses, grooves and shoulders so that evacuation chamber 36 and member 35 are sealed therein when upper and lower housing portions 39, 40 are joined. With this structure,
longitudinal movement of the reservoir tube 34 is restricted;
This reduces the possibility of dosage inaccuracies due to movement of the reservoir tube 34 along the back stop 41 as the rollers move. By using adhesive to attach the reservoir tube 34 along the entire length of the back stop 41 or by attaching the reservoir tube 34 to the back stop 41.
A similar result is achieved by providing cooperating structure along the reservoir tube 34 and rear stop 41 to maintain the relative positions of the reservoir tubes 34 and rear stops 41. It will be apparent to those skilled in the art that many configurations can be used to incorporate reservoir tube 34 within cassette housing 37, and that the configurations described above are illustrative of many such possibilities. The joining of the upper and lower housing parts 39, 40 also
It forms a circular cannula conduit including an outlet 72 and a recess 74 in the cannula conduit and a similar recess in the upper housing portion 39 . This cannula conduit connects the recess of the discharge chamber 36 and the discharge port 7.
It combines 2.

In a preferred embodiment of the invention, the housing portions 39, 40 are made of thermoplastic material that can be joined together using cooperating structures, fasteners, adhesives or compatible welding techniques on the housing portions. Made. A preferred disposable storage cassette is approximately 50.8 mm (2.0 inches) wide, approximately 50.8 mm (2.0 inches) high, and approximately 7.6 inches thick.
It has a compact structure with dimensions of mm (0.3 inch). It is also appreciated that while each portion of the cassette housing 37 is reusable, the evacuation chamber 36 and the reservoir tube 34 to which the member 35 is attached include housing portions that are removably attached to each other so that they can be disposable after a single use. Within the scope of the invention. The housing parts 39, 40 are adapted to be releasably attached to each other by the use of threaded fasteners, snap fasteners or other suitable reusable coupling means to hold the housing parts together. There is.

1 and 8, a disposable reservoir cassette 30 must be held in a removably fixed relationship with respect to a roller pump 200, particularly pump roller 204. In FIGS. As the pump rollers 204 move along a circular path while compressing the flexible reservoir tube 34, the action of the pump rollers 204 delivers medication to the patient, so that the reservoir cassette 30 is It is important that roller pump 200 be restrained from rotational movement. If the storage cassette 30 rotates in the direction of movement of the pump roller 204, less than the required amount of drug solution will be delivered, but if the storage cassette 30 rotates in the direction opposite to the movement of the pump roller 204, less than the required amount will be delivered. This means that a large amount of chemical solution will be supplied. It will also be appreciated that the reservoir cassette 30 is installed and removed without any rotational movement relative to the roller pump 200 so that no medicinal fluid is supplied and no air enters the apparatus during the removal and installation operations. This is very important.

To prevent rotational movement of disposable reservoir cassette 30 relative to roller pump 200, locating surface 77 is provided on cassette housing 37. These locating surfaces 77 are adjacent to locating blocks 215 which are attached to roller pump housing 201 of roller pump 200 by set screws 216. The positioning block 215 is connected to the cassette housing 3.
7 and then fixed in this position by tightening the screw 216. It will be appreciated that rotational movement of disposable storage cassette 30 relative to roller pump 200 can be substantially restrained by such a structure. By strictly controlling the dimensional tolerances of various positioning surfaces, positioning block 2
It should be noted that it must be possible to form 15 as an integral part of the roller pump housing 201 without adjustment screws. The cooperating surfaces described above also indicate that the pump roller 204
During installation and removal regarding pump 200,
Movement of the disposable reservoir cassette 30 relative to the roller pump 200 is constrained such that the disposable reservoir cassette 30 must move in a direction substantially perpendicular to the path of the pump rollers 204, thereby displacing the drug solution. This minimizes the chance of air being accidentally introduced into the equipment or drawn into the equipment.

The retaining spring 217 is attached to the cassette housing 37
Pressure is applied to the outwardly extending longitudinal ribs 79 to hold the reservoir cassette 30 against the roller pump housing 201. Holding spring 21
7 can be deflected out of the path by forced movement of the reservoir cassette 30 in a direction perpendicular to the motion of the roller pump 200, thereby placing the reservoir cassette 30 in a removably fixed relationship to the roller pump 200. Provides a snap-fitting device for holding the device in place. Retaining spring 217 is held in place by set screw 216.

9 and 10 illustrate a member 35, preferably air permeable but liquid impermeable, including a plug 51 having a passageway 52 therethrough. Plug 51 has a flange portion 54 having a diameter larger than the outer diameter of reservoir tube 34 and a body portion 55 that is inserted into reservoir tube 34 . Plug 51 is retained within reservoir tube 34 by an interference fit in which the outside diameter of body 55 is slightly larger than the inside diameter of reservoir tube 34, or by the use of an adhesive or the like. A diaphragm 56 that allows air to pass through but not liquid so as to cover the passage 52 is connected to the plug 5.
It is attached to 1. With this structure,
Gas in and out of the plug end of the reservoir tube 34 must pass through this diaphragm, but the drug solution held within the reservoir tube 34 cannot pass through it. In some cases, as shown below, it may be desirable to use a porous diaphragm having a maximum pore size of about 0.5 microns to filter microorganism-containing particles from gases entering the reservoir tube 34. The diaphragm can be attached to the plug 51 using adhesive or heat sealing.
It is also within the scope of the invention to include plugs made of completely air permeable but liquid impermeable materials, thereby eliminating the need for passageways and separate septa.

11 and 12, a preferred evacuation chamber 36 is shown including a cylinder 57, a pierceable septum 59 disposed at one end of the cylinder 57, and a sealing member 60 disposed at the other end of the cylinder 57. has been done. Cylinder 57 and sealing member 60 can be made from a rigid material or a highly elastic elastomeric material, the latter being preferred.
The puncturable septum 59 has a slit 6 that is always closed.
3 is preferably made of a highly elastic elastomeric material with a central portion. slit 63
is forced open when medical fluid is inserted or withdrawn with respect to reservoir tube 34 by components described in more detail below. In addition to the slit 63, it is within the scope of the present invention to include other self-sealing structures, such as a duckbill or reed valve, etc., as part of the solid resilient septum, the pierceable septum, and the slit structure can be used in many ways. This is an example of a possible change. A pierceable septum 59 is attached to the cylinder 57 using adhesive. Sealing member 60 includes a centrally located orifice 61 in communication with second end 58 of reservoir tube 34 . The small diameter portion 62 of the sealing member 60 is connected to the storage tube 3.
4 into the second end 58 of 4. An interference fit is used to connect such portions, with the outer diameter of the small diameter portion 62 being greater than the inner diameter of the reservoir tube 34. Discharge chamber 3
Adhesives or other suitable means may also be used to join 6 and reservoir tube 34. The holes 37 of the discharge chamber 36 allow air to communicate between the inside of the discharge chamber 36 and its outside so that when the chemical liquid enters the discharge chamber 36, any gas that may be held within the discharge chamber 36 can be discharged. It has a ventilation means consisting of a filter 64 that is permeable but not permeable to liquid. Filter 6
4 is in the form of a part or a sheet material installed within the hole 73 in the cylinder 57 so as to cover the port 73 in the cylinder 57.

13-17, a preferred reusable infusion catheter 100 includes a flexible conduit 101 having a lumen 102 therethrough.
and a first cannula 104 at the distal end portion 103 of the highly flexible conduit in communication with the conduit 101.
and has. The first cannula 104 has a pointed bevel point 106 to facilitate insertion into the patient.
has. First cannula 10 using glue
4 is preferably held in a highly flexible conduit. It is desirable that the first cannula 104 has a bent portion 117 in a region adjacent to the distal end portion 103 of the highly flexible conduit 101. Bent part 11
7 causes the free end of the first cannula 104 to project outwardly from the flexible conduit 101 at an obtuse angle with respect to the longitudinal axis of the conduit 101 . This obtuse angle is preferably within the range of approximately 120 to 160 degrees, but
It is not a necessary condition. The length of flexible conduit 101 depends on the distance between roller pump 200 and the injection site. The inner diameter of the flexible conduit 101 is approximately 0.43
Preferably mm (0.017 inch).

A connector having a passage 109 passing through the interior.
The housing 107 includes a rear end 113 of the conduit 101.
It is set in. As shown in FIGS. 13-15, the connector housing 107 is connected to the conduit 100 by means of threadedly engaged attachment means on its outer periphery.
is removably held in a fixed position relative to the Connector housing 107 is preferably made from a thermoplastic material and attached to flexible conduit 101 using adhesive or other suitable means. Protrusion 108 of connector housing 107 extends radially outwardly from connector housing 107 and is sized and positioned to engage connector housing locking groove 70 in cassette housing 37. . A second cannula 105 extends outwardly from the connector housing 107 and extends through the passageway 10.
9 is in fluid communication with. Second canyule 105
can be an integral part of connector housing 107 or can be a separate cannula attached to connector housing 107. As will become clear below, the second cannula 105 need not have a tip. A resilient sleeve 110 covers the free end 111 of the second cannula 105 to prevent the flow of internal drug fluid. Sleeve 110 is made of an elastic material with a normally closed slit 112 at its closed end. As will be explained in more detail below, when an external force F (FIG. 17) is applied to the resilient sleeve 110 in the direction of the connector housing 107, the sleeve 11
The second cannula 105 passes through the slit 112 , thereby allowing the medical solution to flow into the second cannula 105 . Removal of this external force causes the resilient sleeve 110 to return to its original position, in which it prevents the flow of the medicinal fluid within the second cannula 105 and thus prevents the fluid present within the flexible conduit 101. This prevents any possible chemical solution from exiting the second cannula 105.

Further, when an acting force, that is, pressure of the chemical liquid is applied to the flexible conduit 101 in the direction toward the inside of the second cannula 105, it opens to allow the flow of the chemical liquid. It is also within the scope of the present invention to provide a one-way valve arrangement within the connector housing 107 that prevents exit from the resilient conduit 101 via the connector housing 107.

As best shown in FIGS. 18 and 19, another embodiment of a reusable infusion catheter includes a connector housing 119 sized and positioned to engage connector housing locking groove 70. Protrusion 1 of the connector housing with
20. A second cannula 121 extends outwardly from connector housing 119. The shielding member 122 removably engages the connector housing 119 by an interference fit between the inner diameter 124 of the shielding member 122 and the engagement surface 125 of the shielding member 122 on the connector housing 119. Shielding member 122 is provided to protect second cannula 121 from damage and contamination when connector housing 119 is not engaged with disposable reservoir cassette 30. A vent member 126 is also provided to vent air trapped within the shield member 122 while the shield member 122 is engaged with the connector housing 119. If there is no ventilation member 126, the shielding member 1
22 and connector housing 119 may force air into flexible conduit 101 through second cannula 121.
This is undesirable because air within flexible conduit 101 may be injected into the patient. If initially sterile, the second cannula 121 is configured with a filtering material 126 to prevent bacterial flow so as not to become contaminated during subsequent handling before the shielding member 122 is removed. It is desirable to do so. Those skilled in the art will appreciate that there are many ways to design a cover member to engage a connector housing,
It will be appreciated that there are many ways of effecting ventilation within the cover member, such as screw and snap fittings, and that the configurations described above are examples of many of these possible configurations.

Next, in FIGS. 20 to 24, after the first cannula 104 is inserted into the subcutaneous fat layer Q below the patient's skin S, a holding member 114 is used to fix the cannula 104 to the patient P. is provided. The retaining member 114 may be a circular flexible pad having a first side 115 covered with a contact adhesive. After the first cannula 104 is positioned through the central opening 116, the retaining member 114 is folded on its axis intersecting the flexible conduit 101. The contact adhesive maintains the retaining member 114 in this folded state, as best shown in FIG. At this time, the holding member 114
It can be folded again along an axis substantially parallel to the flexible conduit 101. In this position, the patient retention member 114 can be grasped and used as a handle to assist in subcutaneously placing the first cannula 104, as shown in FIG. 23. After the first cannula 104 is properly installed, the patient releases the retaining member 114, returning the suspension member 114 to the configuration shown in FIG. 22 so that it can be taped to the patient's body. The bent portion in the first cannula 104 is
Facilitates subcutaneous placement of first cannula 104. As best shown in FIG. 24, the bends also allow the needle to be lifted from the skin upon removal and to be restrained from movement by the retention member 114 while it is attached to the patient. request. It is desirable to coat the patient-facing surface 118 with an adhesive that removably adheres to the skin, and to cover the adhesive with a paper backing (not shown). Once the needle is properly positioned, the patient can remove this paper backing and press surface 118 against skin S, keeping retention member 114 removably attached to the skin. It also includes a retaining member without an opening for receiving the first cannula 104, and in this case the distal end of the flexible conduit 101 is attached to the retaining member instead of being held between the layers. This is within the scope of the present invention.

In FIG. 25, the programmable roller pump 200 can be secured to the patient's body by a flexible waistband 212. The illustrated waist attachment is an example of a wide range of possible roller pump positions, as there is a wide range of possible roller pump positions within each region of the patient or adjacent clothing. Once the location for the programmable roller pump is selected, the injection site can be any convenient location on the patient's body proximate to the pump and the retention member 114 is used to properly position the first cannula 104 of the infusion catheter. Any site with sufficient fat to warrant subcutaneous placement may be used.

In FIG. 26, to fill the desired disposable reservoir cassette (if it is not pre-filled), the user must first open a standard medication container with a needle-pierceable lid (not shown). The drug solution is transferred to a hypodermic syringe 65 equipped with a needle cannula 66. The needle cannula 66 is then pushed through the pierceable septum 59 and into the sealing member 60 of the discharge chamber 36 . At this time, the drug solution is forced out of the syringe into the reservoir tube 34. The gas in the storage tube 34 discharged by the chemical liquid exits through the member 35, but the chemical liquid cannot pass through this. If air bubbles are trapped in the drug solution in the storage tube 34, the drug solution can be transferred to the storage tube 34 without containing air bubbles.
A quantity of drug solution can be removed by sucking it back into the syringe along with air bubbles so that it can be returned to the syringe. It can be seen that air entrained within the reservoir tube 34 can harbor bacteria. This is not a problem if the drug solution contains a bacteriostatic agent. However, if member 35 is constructed of a material having a maximum pore size of approximately 0.5 microns, bacteria may permeate member 35 so that member 35 can filter microorganisms from gases entering reservoir tube 34. can be prevented from doing so. Note that cannula 66 prevents medical fluid from entering interior portion 67 of discharge chamber 36 . Figures 27 and 2 together with Figures 1 and 8.
As best shown in Figures 8 and 29,
In use, a patient with a programmable roller pump attached to his or her body must
02 toward the load position and rotate it counterclockwise.
The reservoir cassette 30 is placed between the positioning blocks 215 of the roller pump housing 201 and pressed directly towards the roller pump to release the retaining spring 217 in the roller pump housing 201.
A disposable reservoir cassette 30 filled with a drug solution is inserted into the roller pump 200 by engaging external ribs on the cassette housing 37.
Insert against. Reusable infusion catheter 100 now has connector housing 107
The connector housing 107 is coupled to the reservoir cassette 30 by inserting the connector housing 107 into the outlet 72 in the cassette housing 37 so that the protrusion 108 is aligned with the connector housing locking groove 70 in the cassette housing 37. . This connector housing locking groove 70 is
It only allows connector housing 107 to enter outlet 72 to a depth that places second cannula 105 in liquid communication with reservoir tube 34 filled with medical fluid. At this time, the connector
By twisting the housing 107, it can be fixed to the storage cassette 30 in a bayonet-like manner. During insertion, sleeve shoulder 71 on cassette housing 37
The elastic sleeve 110 is pressed against the connector housing 107 to pierce the slit 112 of the sleeve 110, thereby opening the storage cassette 3.
a second cannula 105 for receiving the drug solution from 0;
It will be seen that it opens the . Also, during insertion, the second cannula 105 is in communication with the highly flexible reservoir tube 34 at this time.
Exposed free end 11 of second cannula 105
1 pierces the slit of the pierceable partition wall 59 and enters the orifice 61 of the sealing member 60.

At this time, the pump roller 204 presses operation button 2.
11 is advanced to the starting position as best shown in FIG. pump·
By advancing roller 204 to the starting position, pump roller 204 simultaneously compresses flexible reservoir tube 34 and forces a portion of the drug contained therein into infusion catheter 100. is filled with a chemical solution and all air is expelled from the fluid path 101. The first cannula 104 can then be inserted into the patient's body at a subcutaneous location and attached to the body using the retaining member 114, as described above. At this time, the timing mechanism of roller pump 200 is set by switching on-off switch 214 to the on position. Pump roller 204 is then advanced intermittently to deliver medication to the patient over a period of time ranging from approximately several hours to 48 hours, depending on the type of insulin used by the patient and the dosage required by the patient. inject a controlled dose of drug solution. As the roller pump 200 moves forward, the chemical liquid in front of the pump roller 204 is transferred from the highly flexible reservoir tube 34 to the flexible conduit 10 via the second cannula 105.
1 into the patient through the first cannula 104. Note that the second cannula 105 prevents medical fluid from entering the interior 67 of the discharge chamber 36 . Pump roller 204
The interior of the highly flexible storage tube 34 behind the tube 34, which is no longer devoid of chemical liquid, is filled with air that has entered through the member 35 that is permeable to air but not permeable to liquid. If the first end 68 of the flexible reservoir tube 34 were sealed instead of having the element 35, the portion of the flexible reservoir tube 34 that no longer had drug solution would be advanced by the pump.・Roller 2
04 tends to create an expanded vacuum in the reservoir tube 34, which requires more force to advance the pump roller 204. This tendency is eliminated by the presence of member 35. At the end of the drug supply period,
The timing mechanism of roller pump 200 is released by switching on-off switch 214 to the off position. Next, the infusion catheter 100 is inserted into the storage cassette 30 while the first cannula 104 remains attached to the patient in a subcutaneous position.
be separated from Roller drive arm 202 is now rotated counterclockwise to load position 206 and reservoir cassette 30 is removed from roller pump 200 and discarded. A new disposable storage cassette 30 filled with drug solution is installed in the roller pump 20.
Attached to 0. 1st canyule 10
The infusion catheter, which can be reused while attached to the patient, is filled with a medicinal solution, so the catheter 10
There is no need to supply an initial amount of chemical solution to 0. It will be appreciated that when the infusion catheter 100 is not attached to the reservoir cassette 30, the resilient sleeve 110 prevents the liquid drug contained within the catheter 100 from exiting the second cannula 105. The injection catheter 100 is stored in the storage cassette 30
Before installation, the pump roller 204 is again advanced to the starting position. Empty injection catheter 10
The chemical liquid that is not needed to fill the 29th
It flows into the interior 67 of the discharge chamber 36 as shown. Gas that may be present in the interior 67 is removed from the exhaust chamber 36
The liquid is forcibly extruded from the filter 64 through the filter 64.
At this time, the injection catheter 100 is inserted into the storage cassette 3.
0, and the timing mechanism of roller pump 200 is set to begin another drug delivery period. At the end of this second drug supply period,
Although it is desirable to discard the original catheter and begin the delivery period with a new infusion catheter and new injection site, this step is not required.

Preferably, cassette housing 37 is made from plastics such as polystyrene, polypropylene and polyethylene. Additionally, the upper housing portion is constructed from a transparent plastic, such as polystyrene, so that the patient can easily observe the condition and position of the disposable reservoir cassette 30 and roller pump 200 components within the upper housing portion 39. It is desirable to make 39. It is also desirable to make the entire roller pump housing 201 from a transparent material so that the internal components can be easily observed.

The highly flexible reservoir tube 34 is compatible with the drug fluid contained therein and is sufficiently flexible so as not to require large amounts of energy from the roller pump 200 to compress the reservoir tube 34. must be constructed from a material with Thermoplastic materials such as polyvinyl chloride, thermoplastic elastomers and natural rubber can be used. However, while the material comprising the inner portion of the reservoir tube 34 is selected to have a low water vapor transmission rate and compatibility with the chemical, the material comprising the outer portion is flexible and has low energy consumption when subjected to pressure. Coextruded materials are preferred because they are selected to have a low If insulin, such as U-100 Regular, is the chemical used, a composite material using a polyolefin, such as polyvinyl chloride and polyvinylidene chloride, is preferred, but the polyolefin is placed in the inner portion of the reservoir tube 34 as a liner in contact with the insulin. It acts as.

Plug 51 within air permeable but liquid impermeable member 35 may be made from a plastic such as polyethylene or polypropylene.
The diaphragm 56 allows air to pass through but not liquid to pass through.
polytetrafluoroethylene, polyester polyvinyl chloride, preferably having a thickness within the range of about 0.08 to 0.25 mm (0.003 to 0.010 inch);
It can be made from nonwoven fabrics of polymers selected from polypropylene, polyethylene, etc. Materials such as those just described are available from WLGore & Associates, Elkton, Maryland, USA;
It is commercially available as a GORE-TEX diaphragm product.
A preferred member is polytetofluoroethylene having a thickness of about 0.2 mm (0.008 inch). Diaphragm 56 is attached to plug 51 using adhesive or heat sealing.
Can be installed against. Plug 51 is also located in Verburn, Georgia, USA.
They can be made solely from air-permeable but liquid-impermeable materials, such as microporous polypropylene manufactured by Glasroch Products' Prex Division. Air permeable but liquid impermeable filter 64 and vent member 126 of evacuation chamber 36 of another embodiment of reusable infusion catheter 100
can be made from the same material as diaphragm 56 described above.

Cylinder 57 and sealing member 60 can be constructed from a variety of rigid or flexible materials using elastic materials such as rubber and preferably thermoplastic elastomer. The cylinder 57 and the sealing member 60 can be made, for example, as one piece or as separate components joined together by adhesive. The pierceable septum 59 can be constructed from a variety of resilient materials, with rubber and thermoplastic elastomers being preferred.

The flexible conduit 101 of the reusable infusion catheter 100 is preferably made from extruded polymer tubing, preferably polyolefin or polyvinyl chloride. A preferred material for first cannula 104 is stainless steel. The connector housing 107 is
It can be made from a variety of rigid materials, preferably using thermoplastic materials such as polypropylene and polyethylene. The second cannula 105 is
Can be made from stainless steel or thermoplastic materials such as polypropylene and polyethylene;
Alternatively, it can be molded as an integral part of connector housing 107. Elastic sleeve 11
0 is preferably made from a self-sealing, elastic material such as rubber and thermoplastic elastomers. Preferably, the retaining member 114 is made from a water and bacteria barrier material that is permeable to water vapor. A variety of medical grade adhesive coatings are available to achieve the adhesive properties of the retaining member 114. A preferred material for the adhesive-applied retaining member 114 is sold under the trade name "Tegaderm".
There is a skin patch system manufactured by Minnesota Mining & Manufacturing.

All components of the disposable reservoir cassette 30 and reusable infusion catheter 100 that come into contact with medication or the patient during subcutaneous placement must be sterile. Therefore, the materials should also be selected to be compatible with the aseptic process used.

Thus, the present invention allows for insertion and removal with respect to a roller pump without removing the infusion cannula from the injection site, thus allowing the use of the same infusion catheter for successive use of the reservoir tube. A disposable storage cassette is provided. The disposable storage cassette can be purchased by the user prefilled or can be easily filled by the user using inexpensive filling equipment. Since the reservoir cassette holds all the drug solution to be supplied to the user, a separately mounted reservoir is unnecessary. The present invention also includes an elastic sleeve or sealing member at one end of the reservoir cassette to prevent loss of drug solution during exchange, and a retaining member at the other end to secure a hypodermic needle placed in a subcutaneous position. A reusable infusion catheter is provided.

[Brief explanation of the drawing]

FIG. 1 is a plan view showing a preferred reusable injection catheter attached to a reservoir cassette and a preferred disposable reservoir cassette attached to a programmable roller pump;
Figures are perspective views showing a preferred disposable reservoir cassette and a preferred reusable injection catheter;
FIG. 3 is an exploded perspective view of a preferred disposable storage cassette; FIG. 4 is an enlarged view showing a storage tube with an evacuation chamber and an air permeable but liquid impermeable member as part of the storage cassette; 5 is an enlarged plan view showing the lower housing part of the storage cassette; FIG. 6 shows the storage tube in the lower housing part of the storage cassette with an evacuation chamber and an air permeable but not liquid permeable member. 7 shows an enlarged cross-sectional view of the disposable reservoir cassette taken along line 7-7 of FIG. 1; FIG. 8 shows the preferred reservoir cassette and roller pump taken along line 8-8 of FIG. 9 is an enlarged side view showing air permeable but liquid impermeable elements of a preferred disposable storage cassette; FIG. 10 is a cross sectional view showing elements taken along line 10--10 of FIG. 9; , FIG. 11 is an enlarged side view showing the discharge chamber of the preferred disposable storage cassette, FIG.
2 is a cross-sectional view of the evacuation chamber taken along line 12-12 of FIG. 11; FIG. 13 is a perspective view of the preferred reusable infusion catheter; and FIG.
15 is an enlarged side view of the connector housing with the resilient sleeve of the preferred reusable infusion catheter; FIG. 16 is a cross-sectional view of the connector housing taken along line 16-16 of FIG. 15; FIG.
Figure 16 further shows a second cannula projecting through the slit in the resilient sleeve.
18 is an enlarged side view of the connector housing and cover member of another embodiment of a reusable infusion catheter; FIG. 19 is a cross-sectional view of the connector housing shown in FIG. FIG. 20 is a perspective view showing the retention member opening for attachment to the first cannula end of the preferred infusion catheter; FIG. FIG. 22 is a perspective view of the first cannula end of the preferred infusion catheter with one cannula inserted; FIG. FIG. 23 is an assembled perspective view of FIG. 21 showing the folded state; FIG. 23 is an assembled perspective view of FIG. Figure 24 is an enlarged side view of the distal end of the preferred infusion catheter in use; Figure 25 is a perspective view of the drug delivery device attached to the desired location on the patient's body; and Figure 26 is the preferred disposable catheter. FIG. 27 is an enlarged cross-sectional view showing the syringe in use for filling the reservoir cassette; FIG. FIG. 28 is an enlarged cross-sectional view showing a preferred reusable infusion catheter coupled in fluid communication with a preferred disposable reservoir cassette; FIG. 29 is an enlarged plan view showing a preferred disposable reservoir cassette; FIG. 2 is an enlarged partial cross-sectional view of the preferred disposable storage cassette shown. 29... Chemical solution supply device, 30... Disposable storage cassette, 34... Storage tube, 35...
Air permeable liquid impermeable member, 36...Discharge chamber, 37
...Cassette housing, 39... Upper housing part, 40... Lower housing part, 41...
... Back stopper part, 42 ... Opening, 44 ... Discharge chamber recess, 45 ... Storage tube recess, 46 ... Shoulder, 47 ... Discharge chamber shoulder, 49 ... Recess, 51 ...
... Plug, 52 ... Passage, 54 ... Flange portion, 55 ... Body, 56 ... Air permeable liquid impermeable diaphragm, 57 ... Cylinder, 59 ... Punctureable partition, 60 ... Sealing member, 61 ...orifice, 6
2... Small diameter part, 63... Slit, 64... Air permeable liquid impermeable filter, 65... Hypodermic syringe,
66...needle cannula, 69...discharge port recess, 7
0...Retaining groove, 71...Sleeve shoulder, 72...
Discharge port, 74... recess, 77... positioning surface, 7
9...Rib, 100...Injection catheter, 10
1... Conduit, 102... Lumen, 104... First cannula, 105... Second cannula, 10
6...Sharp bevel point, 107...Connector housing, 108...Protrusion, 109...Passway, 1
10...Sleeve, 111...Free end, 112
...Slit, 114...Holding member, 116...
Opening, 117... bending part, 126... ventilation member,
200...Roller pump, 201...Roller pump housing, 202...Roller drive arm,
204...Pump roller, 205...Empty position,
206...Load position, 207-209...Operation button, 210...Liquid crystal display, 211...
Operation button, 212...Waist band, 21
4...On/off switch, 215...Positioning block, 216...Positioning screw, 217...Retaining spring.

Claims (1)

[Scope of Claims] 1. A disposable storage cassette used for supplying a medical solution to a user using a roller pump, which is long and flexible, and includes a reservoir for storing a medical solution. , an air-permeable but liquid-impermeable member provided at a first end of the reservoir; and an injection catheter provided at a second end of the reservoir for injecting a medicinal solution into a user. a rigid cassette housing including a substantially circular rear stop portion for accommodating and supporting the reservoir along the length of the reservoir; The cassette housing has an opening into which a pump roller is inserted for pressing the reservoir against the back stopper portion and sending the drug solution held inside the reservoir toward the connecting device, and an opening into which a pump roller is inserted to push the reservoir against the back stopper portion and send the drug solution held inside the reservoir toward the connection device. an outlet for discharging the medicinal solution to the patient; and a retaining portion for retaining the reservoir such that the connecting device is positioned adjacent to the outlet; a discharge chamber that receives and stores a portion of the drug solution originally held in the reservoir that remains in the cassette after the drug has been removed; the discharge chamber has two ends and a side wall surface; a cylinder, a sealing member having an orifice through which liquid passes and disposed at one end of the two ends of the cylinder, and a partition wall disposed at the other end of the cylinder; the sealing member engages the second end of the reservoir, and the septum is a normally closed septum that is puncturable by a cannula and is adapted to close when the cannula is removed. . A storage cassette, characterized in that the discharge chamber has ventilation means for ventilating the inside of the discharge chamber and outside air. 2. The reservoir cassette according to claim 1, wherein the reservoir is a flexible tube. 3. The member that allows air to pass through but does not allow liquid to pass through,
Claim 1, characterized in that the plug comprises a plug having a passage passing through the inside thereof, and a membrane permeable to air but not permeable to liquid, attached at one end of the plug over the passage. Storage cassette. 4 the membrane has a maximum porosity of about 0.5μ;
Claim 3, characterized in that it acts as a substantial barrier to the passage of particles of
Storage cassette as described in section. 5. The reservoir according to claim 1, wherein the cassette housing comprises an upper housing portion and a lower housing portion joined in a plane substantially parallel to a plane including the rear stopper portion. Cassette. 6. The storage cassette of claim 5, wherein one of said upper and lower housing portions is made from a transparent material. 7. The venting means comprises a membrane permeable to air passing through the venting means and impermeable to fluids, the membrane having a maximum porosity of about 0.5μ and acting as a substantial barrier to particles larger than about 0.5μ. A storage cassette according to claim 6, characterized in that: 8. The storage cassette of claim 2, wherein said tube has a circular cross section. 9. The cassette housing includes a rib extending outwardly on an outer surface of the cassette housing and adapted to removably engage a roller pump, the cassette housing being in engagement with the roller pump. and a surface for aligning the cassette housing with a roller pump, the ribs being substantially perpendicular to the direction of an externally applied force applied by the roller pump during the engaged state. characterized in that it includes a rib for securing the cassette housing adapted to limit relative movement between the cassette housing and the roller pump during a disengaged state of the cassette housing. A storage cassette according to claim 1. 10. The reservoir cassette of claim 1, wherein said reservoir is made from a material selected from the group consisting of thermoplastic materials, thermoplastic elastomers, and natural rubber. 11. The storage cassette of claim 10, wherein the thermoplastic material is polyvinyl chloride. 12. said thermoplastic material is a composite of polyvinyl chloride and polyolefin material, said polyolefin material being positioned in an inner portion within said reservoir to act as a liner for contacting fluid present within said reservoir; A storage cassette according to claim 10, characterized in that: 13. The storage cassette of claim 2, wherein said tube is removable from said cassette housing. 14. The storage cassette according to claim 2, wherein the tube holds a medicinal solution to be supplied to a user. 15. The storage cassette according to claim 14, wherein the drug solution is insulin. 16 A storage tube assembly used in a disposable storage cassette used to supply a medical solution to a user using a roller pump, which is elongated and flexible for storing a medical solution. a storage tube; a member provided at a first end of the storage tube that is permeable to air but not permeable to liquid; and a member provided at a second end of the storage tube for injecting a medicinal solution into a user. a connecting device for coupling with an infusion catheter of the patient, said connecting device configured to remove a portion of the drug solution originally held in said reservoir that remains in said cassette after the drug solution has been delivered to the patient; The discharge chamber comprises a cylinder having two ends and a side wall surface, and an orifice through which the liquid passes, one of the two ends of the cylinder having an orifice through which the liquid passes. a sealing member disposed at an end; and a septum disposed at the other end of the cylinder, the sealing member engaging the second end of the reservoir, and the septum , a normally closed septum punctuable by a cannula and adapted to close when the cannula is removed, the evacuation chamber having a reservoir having ventilation means for venting the interior of the evacuation chamber with outside air; tube assembly. 17. The storage tube assembly according to claim 16, wherein the tube holds a medicinal solution to be supplied to a user. 18. The storage tube assembly according to claim 17, wherein the drug solution is insulin.