JP2018161510A - Intravascular line and port cleaning methods, methods of administering agent intravascularly, methods of collecting and testing blood, and devices for implementing such methods - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a syringe assembly having a barrier material at least partially encompassing a cap.SOLUTION: A syringe assembly comprises a syringe cylinder 174 extending from an opening configured to receive a plunger 176 to an end 172 configured to couple with a needle and/or medical tubing, a cap 180 configured to couple to the end 172, and a barrier material 178 at least partially encompassing the cap 180 and the end 172. The cap 180 may further comprise one or both of an applicator material and/or a cleansing solution.SELECTED DRAWING: Figure 17

Description

[Cross-reference of related applications]
This application claims priority from US Provisional Patent Application No. 61 / 605,095, filed February 29, 2012, the entirety of which is incorporated herein by reference.

  The present invention relates to an intravascular port access device, an intravascular port cleaning device, an intravascular port cleaning method, a method of administering a drug to an intravascular line port, a method of collecting a blood sample from an individual, and a set of intravascular line port caps. It is about.

  Venous lines, such as the peripheral IV line and the central IV line, are common venous access methods that administer drugs, nutrients, blood products, or other substances to the blood vessels. Arterial lines are used, for example, to monitor physiological parameters by collecting arterial blood during coronary artery, intensive care or critical care. However, microorganisms that have invaded from the patient's own endogenous flora or from contaminated equipment or other sources of environmental contamination can result in microbial intravascular device metastasis, or infection. As a result, local or systemic infections or sepsis can occur and life can be at risk.

  Invasion of microorganisms into an intravascular line occurs during the handling of catheters, hubs, associated piping, equipment or infusion ports, especially during the operation of the line being prepared and during the start of fluid administration to the line or fluid withdrawal from the line. Cheap. Microorganisms present on the surface of the injection port can enter through the port during administration. Microorganisms present in the contaminated device used for administration can enter through the port and cause metastatic growth and infection. Bacterial growth and / or aggregation in a port or catheter can be a focus of clotting, embolization and / or occlusion of the port or catheter. Further manipulation or administration through the ports may diffuse the microorganisms in the ports, catheters and lines and ultimately into the patient's veins / arteries and / or surrounding tissues. Therefore, to reduce the risk of metastatic growth and infection, it is advantageous to develop a method and device that cleans the outer surface and / or inner port area of an intravascular access port.

  Another complication that can occur in connection with intravascular lines, catheters or access ports is thrombosis caused by blood return. Early thrombosis can spread to and / or embolize the superior vena cava and / or the right atrium and / or right ventricle of the heart and subsequently into the pulmonary system that circulates to the lungs. In order to minimize or eliminate coagulation associated with intravascular ports, it would be advantageous to develop procedures and devices that deliver agents that lyse or inhibit clots via the intravascular port.

  Yet another problem that can be associated with intravascular lines is the accumulation and accumulation of fat within the lines or ports. It would be advantageous to develop a procedure and device for delivering a lipolytic agent via an intravascular port to minimize or eliminate fat accumulation associated with the port.

  In one aspect of the invention, the invention relates to an intravascular port access device. The device has a first component that includes a chamber and is configured to reversibly attach to an intravenous line port. A second component is reversibly attached to the first component, and the second component includes polyethylene felt sponge, polyethylene foam sponge, plastic foam sponge, silicone foam sponge, and other sponge-like or absorbent An applicator material and disinfectant selected from the group consisting of sexual materials are contained. The second component is configured to be reversibly received on the outer surface of the intravenous line port.

  In one aspect of the invention, the invention includes an intravascular line port cleaner with a syringe barrel having first and second ends. The slidable piston is received in the cylinder via the second end. The line port cleaner includes a first cap that contains a cleaning agent and a second cap that contains a disinfectant.

  In one aspect of the invention, the invention includes a method of cleaning an intravascular line port. The method includes providing a port cleaning device that includes a first component having a chamber with a first cleaning agent. The second component includes a second cleaning agent. The third component has a disinfectant and is reversibly attached to the first component. The method includes removing the second component from the device, contacting the outer surface of the port with the second cleaning agent, injecting the first cleaning agent from the chamber into the port, and removing the third component. Detaching from the device and covering the port with a third component.

  In one aspect of the invention, the invention includes a method of collecting a blood sample from an individual. The method includes providing a port access device having a first component that includes a chamber, a second component that includes a cleaning agent, and a third component that includes a disinfectant. The third component is reversibly attached to the first component. The method includes removing the second component from the device and contacting the outer surface of the port with a cleaning agent. The method further includes drawing blood from the individual through the port into the chamber of the first component, removing the third component from the device, and covering the port with the third component. Yes.

  In one aspect of the invention, the invention includes a set of intravascular line port caps. The set of intravascular line port caps includes a first port cap that contains a first medicament and a first applicator material. The set of intravascular line port caps further comprises a second port cap that houses the second medicament and the second applicator material.

  The present invention also includes a syringe cylinder extending from an opening configured to receive a plunger at an end configured to couple to a needle and / or medical tube, and a cap configured to couple to the end. And a barrier material that at least partially surrounds the cap and the end. The syringe assembly also includes a syringe cylinder extending from the opening configured to receive the plunger at the end configured to couple with the needle and / or medical tube, and a plunger extending from one end to the seal end. And at least one cap configured to be coupled to one end. A further syringe assembly includes a syringe cylinder extending from an opening configured to receive a plunger at an end configured to couple with a needle and / or a medical tube, and a plunger extending from one end to a seal end. And one end of the plunger defines a recess configured to receive at least one cap.

    Embodiments of the present invention will be described below with reference to the accompanying drawings.

FIG. 1 is a schematic perspective view illustrating a device according to one aspect of the present invention. FIG. 2 is a schematic side view of the device shown in FIG. FIG. 3 is a schematic exploded perspective view of the device shown in FIG. FIG. 4 is a schematic cross-sectional view of the device shown in FIG. FIG. 5 is a schematic cross-sectional view of the device shown in FIG. 1 after repositioning with respect to the position shown in FIG. FIG. 6 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 7 is a schematic side view of the device shown in FIG. FIG. 8 is a schematic exploded perspective view of the device shown in FIG. FIG. 9 is a schematic cross-sectional view of the device shown in FIG. FIG. 10 is a perspective view of a preferred package concept for the device shown in FIG. FIG. 11 shows a multi-pack package concept of the device shown in FIG. FIG. 12 is a schematic exploded perspective view showing a device according to another aspect of the present invention. FIG. 13 is a schematic cross-sectional view of the device shown in FIG. FIG. 14 is a schematic exploded perspective view showing a device according to another aspect of the present invention. FIG. 15 is a schematic exploded perspective view showing a device according to another aspect of the present invention. 16 is a schematic cross-sectional view of the device shown in FIG. FIG. 17 is a perspective view of a device according to another aspect of the present invention. FIG. 18 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 19 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 20 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 21 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 22 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 23 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 24 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 25 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 26 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 27 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 28 is a schematic perspective view showing a device according to another aspect of the present invention. FIG. 29 is a schematic perspective view of a package concept according to one aspect of the present invention. FIG. 30 is a schematic perspective view of the package concept shown in FIG. FIG. 31 is another schematic perspective view of the package concept shown in FIG. FIG. 32 is a schematic perspective view showing a set of components according to one aspect of the present invention. FIG. 33 is an exploded perspective view showing the set of components shown in FIG. FIG. 34 is a schematic exploded perspective view showing a package concept according to one aspect of the present invention.

  In general, the present invention encompasses devices and procedures for cleaning and / or accessing an intravascular line port. In certain applications, the devices of the present invention can be used to clean the outer surface of an intravascular line port, subsequently clean the port itself, and in certain cases to clean the intravascular line.

  In another application, the devices of the present invention can be utilized to administer drugs intravascularly. During these applications, the device according to the present invention can typically be used to clean the outer surface of the port prior to use of the device for administering a drug into a blood vessel. In another application, the device of the present invention can be utilized during the work of taking a blood sample from an individual. The device according to the present invention is typically used to clean the outer surface of the port before the device is used to draw a blood sample from the port. The present invention also includes procedures for such port cleaning and blood sampling techniques.

  In one embodiment of the invention, the device has two components. An example of two component devices will be described with reference to FIGS.

  Referring initially to FIG. 1, the port access device 10 has a first component 12 at the first end 14 of the device and a second component 16 at the second end 18 of the device. ing. The second component 16 can include a tab 20 or other enhanced feature that helps remove the second component from the first component. The first component 12 includes a chamber housing 22 that may be a foldable housing. The first component 12 can also have an extension 24.

  With reference to FIG. 2, the depicted device 10 can include a second portion 16 that can be inserted into the connector portion 24. However, it should be understood that the present invention contemplates other configurations in which the second portion 16 fits over or covers the extension 24. It should also be understood that the shape and dimensions of the foldable housing 22 are examples, and alternative shapes, sizes and configurations are contemplated.

  Referring to FIG. 3, the device shown in FIGS. 1 and 2 is shown in an exploded perspective view. As shown, the chamber housing 22 of the device 10 can accommodate a chamber 23. The connector 24 can have a separator 25, which has an opening 29 therethrough. The connector 24 can further include a receiving port 30 that receives the dispenser 26, which can have a valve portion 28. The second component 16 can have a container 21.

  Referring now to FIG. 4, a dispenser 26 with a valve 28 seated in the receiving port 30 is shown. As shown, such a valve mechanism is in a “closed” position, and the contents of chamber 23 are prevented from flowing to connector 24. Referring now to FIG. 5, the action of a force on the foldable housing 22, such as a down pressure on the top surface of the housing, can be utilized to displace the valve device 28 from the receiving port 30 as illustrated. Such displacement allows the contents of the chamber 23 to pass through the connector portion 24.

  As shown in FIG. 4, the second component 16 can contain an applicator material 32. Such an applicator material may be, for example, a sponge or a sponge-like material. Examples of sponge-like materials can include, but are not limited to, polyethylene felt sponges, polyethylene foam sponges, plastic foam sponges, silicone foam sponges, and other sponge-like materials such as felts and other absorbent materials.

  When the device 10 is to be used for port cleaning applications, the container 21 of the second component 16 typically contains a cleaning agent. The cleaning agent may be a disinfectant that cleans the outer surface of the port. The drug is not limited to a specific cleaning agent or disinfectant, but may contain, for example, an alcohol solution consisting of alcohol, preferably about 5% to about 99% alcohol. In certain applications, the alcohol solution contains 25% to 90% alcohol. Spongy applicator materials can be utilized when containing a cleaning agent and can further aid in applying the drug to the outer surface of the intravascular port. The second component 16 is removably attached to the device 10. To clean the port, the removable component 16 is removed from the first component 12 and utilized to contact the outer surface of the port to clean the exterior of the intravascular line port.

  After cleaning the exterior of the port, the first component of the device that can be utilized for internal cleaning of the intravascular port in cleaning / disinfection applications can be reversibly attached to the port to be cleaned. The chamber volume may be up to, for example, 3.5 ml, but the preferred volume range may be from about 1 to about 3 ml. However, alternative chamber dimensions are possible for smaller or larger volumes. The chamber can be equipped with a calibration mark (calibration scale) appropriate for the total volume of the chamber. For example, in a 3.5 ml fluid volume chamber, volume marks such as every 1 ml, every 0.5 ml, every 0.1 ml, etc. can be provided. In a particular embodiment, the connector portion is a LEUR-LOK® fitting (not shown) for connection to a LEUR-LOK® (Becton, Dickinson and Company Corp., Franklin Lakes NJ) type port. ). The cleaning agent may be provided in the chamber 23 and may be an antibiotic or an alternative suitable disinfectant. A suitable agent may be an alcohol or alcohol solution as described above with respect to the second component container 21. For cleaning applications, the chamber 22 can alternatively or additionally contain chemical agents including ethylenediaminetetraacetic acid (EDTA) and / or sodium citrate, hydrogen peroxide, and other preservative or antimicrobial components.

  When connected to a line port, external pressure is applied to the collapsible housing 22 by displacing the dispenser 26, for example by inward squeezing, pinching or pushing in the housing, thereby opening or displacing the valve 28 from the receiving port 30. Can be applied. Continuous squeezing or external force can be used to push or release the contents of chamber 23 through connector 24 and into the connection port. Depending on the volume of the chamber 23, the infused irrigation solution can extend into the intravascular line itself. After extruding the contents of the chamber 23, the device component 12 is removed from the port (for example) to allow fluid supply into the vessel. If such delivery is not performed immediately upon lavage, the irrigation device component 12 can be held in the port until such time as intravascular delivery is desired.

  In another aspect, the devices and procedures described above can be used to administer anticoagulants that minimize or prevent thrombosis in blood vessels or dissolve existing clots. In this aspect, rather than the antimicrobial agent or in addition to the antimicrobial agent, the chamber 23 can contain a suitable anticoagulant or thrombolytic agent. Examples of anticoagulants that can be used include, but are not limited to, anticoagulants such as EDTA, sodium citrate, heparin and heparin derivatives, and antithrombotic agents such as tissue plasminogen activator. Is not to be done. Where fat accumulation is a problem, a suitable dispersant, ie, a lipolytic agent, can be administered alone or in combination with antibacterial and / or anticoagulant agents. The injection of any such drug can be accomplished in a similar manner as described above for the cleaning agent. These applications can also be made using the embodiments illustrated and described below.

  Alternative embodiments of the device according to the present invention are illustrated and described with reference to FIGS. Referring to FIG. 6, another example port access device 40 is illustrated, which includes a first component 42 and a second component 44, such as a syringe. With reference to FIG. 7, a first component 42, such as a syringe, includes a plunger 46. FIG. 8 is an exploded perspective view of the port access device. The first component 42 includes a syringe-shaped housing 48 having a first end 50 and a second end 52, and the second end 52 has an internal chamber 54. Is provided. Chamber 54 may preferably have a volume of 1 ml to about 3.5 ml. The housing 48 may be provided with suitable calibration marks as described with respect to the above embodiments.

  Plunger 46 may have a stem portion 56 with a seal 57. The plunger 46 can be inserted into the second end 52 of the housing 48. A second seal 59 is provided on the large-diameter body of the plunger. Seal 59 is preferably provided to form a seal between the plunger and the inner surface of the device chamber. The seal 59 is preferably an elastic seal, which is overmolded onto the piston (preferably any molded hard plastic material). However, the present invention contemplates the use of alternative sealing materials and non-overmolding techniques.

  The seal 57 can be a single seal or a set of seals, and for example, a set of two O-rings, a single broad overmolded elastic O-ring or sleeve, or a rigid plastic seal molded integrally with a piston stem. good. By providing the seal 57, undesirable or unintended backflow of fluid into the device chamber can be advantageously suppressed or prevented, thereby reducing the risk of contamination of the device and / or the contents of the device. Instead, with respect to the illustrated configuration, the single seal includes a base portion that forms a seal between the inner wall of the device chamber and the large diameter portion of the piston, and a sleeve portion that covers the wall of the small diameter portion of the piston (not shown). It can be overmolded to form.

  The second component 44 is a removable cap having a housing 60 and an inner container 62. Container 62 can contain applicator material 64. The applicator material may be, for example, any material described with respect to the above embodiments. Further, the applicator material can be formed to facilitate surface contact between the applicator material and the various concave and / or convex shapes of the device to be cleaned. The second component 44 can accommodate additional cleaning agents such as those listed above. The second component 44 can preferably be fitted to an intravascular port so that a cleaning agent can be applied to the outer surface of the port. Such cleaning is preferably performed prior to dispensing the contents of chamber 54 (eg, anticoagulant, antibacterial or other cleaning agent) into the port. However, the present invention contemplates post-administration cleaning of the port using a removable cap.

  Referring now to FIG. 9, an unused form of the implementation device 40 is shown in cross-section. In use, the second component 44 can be removed and used to clean the outer surface of the port. Subsequently, the first end 50 of the second component is attached to the port, and the contents of the chamber 54 can be dispensed into the port by the action of a force on the plunger 46. Alternatively, the chamber 54 can be emptied or adapted to contain, for example, an anticoagulant and the plunger 46 of the device 40 can occupy a forward position. Thus, the device 40 can collect and / or test a blood sample from an individual by attaching the first end 50 of the device to the port and repositioning the plunger 46 to draw fluid through the port and into the chamber 54. It can be used for such purposes.

  Referring to FIG. 10, a package 70 for providing, storing and / or disposing of access device 40 components is illustrated. Such a package includes a lid 72 and a tray portion 74. The tray portion 74 includes a cavity 76 that includes a retainer 78 that positions / holds the device while maintaining the integrity of the device and also helps to properly position the plunger relative to the device chamber. Molded. Such a package can be sealed and used to create a sterile environment for the device 40. As shown in FIG. 11, the continuum 71 of individual packaging units 70 can provide individually sealed units so that the units can be individually removed while maintaining the sterility of successive additional units.

  Another alternative embodiment will be described with reference to FIGS. In this embodiment, the first component 42a is the same as the previous embodiment. However, referring to FIG. 12, the second component 44a comprises a “dual cap” system. The cap housing 60 a includes a container part 62 and a second cap extension part 65, and the cap extension part 65 accommodates the second container 66. Container 62 can contain an applicator material 64, such as the sponge-like material described above. Similarly, the container 66 can contain a sponge or other applicator material 67. The container 62 can further contain a cleaning agent as described above.

The container 66 can preferably contain one or more bactericides having a composition different from that of the cleaning liquid stored in the cleaning cap 62. An exemplary pharmaceutical composition within the cap portion 65 can include about 3% to about 11% H ₂ O ₂ . Additional components of the drug include, for example, ethanol (about 25% to about 60%), sodium citrate (about 1% to about 4%), EDTA, peracetic acid (less than about 1% or about 1%), and / or Or carbamide peroxide (less than about 11% or about 11%). Preferably, the pH is about 5-10 and can be adjusted to about pH 7.4 as required based on physiological pH and biocidal properties using NaOH or other suitable base / acid. The presence of EDTA provides sporicidal activity, for example against Bacillus spores, by the Mn complex and further helps to stabilize H ₂ O ₂ . It is also conceivable to complex or chelate various other metal ions with corresponding effects. A combination of H ₂ O _{2 in} the solution can achieve synergistic effects and / or additive effects. The present invention also contemplates the use of alternative chelating agents and pH stabilizers to those disclosed.

  In some cases, a similar solution with a low peroxide content may be contained in the first container 62 and, in certain cases, provided in the chamber of the first component. It should be noted.

  Referring to FIG. 13, an unused device before use is shown. In port cleaning applications, the second component 44a is removed from the device, and a portion 60a is used to cover the port so that the port contacts the contents of the container 62. Applicator material 64 serves to apply a cleaning agent to the outer surface of the port. When the contents of chamber 54 are dispensed, component 44a is removed from the port and the first component is attached to the port. By pushing the plunger 46, the contents of the chamber 54 are injected into the port. The syringe component is then removed from the port. The removable seal 68 can be removed from the second cap portion 65. The cap portion 65 can be disposed on the port so that the contents of the container 66 are in contact with the port. The second component 44 can then be removed from the port or held in the port until further port access or manipulation is desired. In addition, an adhesive layer can be formed between the two parts of the breakable joint (not shown) or 44a, thereby releasing the solutions from each other while keeping the two solutions separate. Preparation means are provided for use in the cleaning step.

  Referring to FIG. 14, an alternative embodiment is shown in which the port access device 40b is comprised of a first component 42b, a second component 44b, and a third component 45b. 44b and the third component 45b are independently removable caps. As shown, these caps are initially placed at both ends of the device and are of different sizes. However, other relative sizes and positioning of the caps in the device are also conceivable. For example, the first component 44b and the second component 45b can be disposed above or below the wing extensions 51, 53 of the chamber housing 48b.

  In the illustrated form, the large cap (first component 44b) can be removed from the device and used to clean the external port in a manner similar to that described above. The second small cap (third component 45b) can be removed from the device after administration of the chamber contents, and as a port cap to protect the port until subsequent port access is desired as described above. Can continue to be used. The third component 45b is optional but can contain the applicator material 82 and / or a cleaning or disinfecting agent as described above.

  In another two cap configurations, a device with a large outer cap relative to a small inner cap is provided, the first cap being removable from the second cap, one of the first and second caps. Is configured for use as a port cap.

  In the device shown in FIG. 14, the cap housing 60b of the second component 44b and the cap housing 80 of the third component 45b are of different colors. In this way, the cap can be color coded (or otherwise coded) to communicate the status of the port or intravascular line to the user or other individual. For example, a first color, such as green, can be utilized on all or a portion of the cap housing 80 that is retained in the port after device use to signal an appropriate sterilized port. It should also be noted that the absorbent material 64 of FIG. 14 and 82c of FIG. 15 are shown with a central through hole for a more complete attachment and thus for a more complete cleaning. Other shapes that enhance the cleaning power are also conceivable. The cap housing 60b can be a second color (eg, yellow or red) indicating that the cleaning or other procedure to be performed has not yet been completed. Thus, the cap can be used as an additional safety measure to help ensure proper use and to maintain sterility and proper record keeping. For example, the cap allows visual monitoring and can be tracked by hospital pharmacies and / or central examination software.

  Independent inspection / compliance using barcodes, radio frequency identification tags (RFIDs) and / or other pharmacy dispensing rooms or inventory control systems in combination with devices in addition to visual inspection for proper cleaning and sterility maintenance Can provide a system.

  Referring now to FIG. 15, an additional alternative embodiment is shown in which a conventional syringe and plunger structure can be used and a cap according to the present invention can be used. Accordingly, the first component 42 c can include a syringe housing 48 c and can include a LEUR-LOK® fitting that fits over the first end 50. Plunger 46c may include a conventional piston seal 57c that is configured to insert into second end 52 of housing 48c and to form a seal with the wall of chamber 54c. The second component 44c includes a housing 60c, and the housing 60c can include, for example, an internal receiving port, and the internal receiving port is internally fitted with respect to the LEUR-LOK (registered trademark) fitting portion, or Alternatively, it fits over the LEUR-LOK® fitting at the first end 50 of the first component housing 48c to cover the LEUR-LOK® fitting. The third component 45c can also include a housing 80c that fits internally against the LEUR-LOK® fitting or is the port that will be cleaned. An internal receiving port that fits over the LEUR-LOK (R) fitting to fit over a LEUR-LOK (R) fitting (or may include an alternative type of fitting) based on type Configured as follows.

  FIG. 16 is a sectional view of the device shown in FIG. An exemplary cap housing is shown covering a LEUR-LOK® fitting. For example, the third component 45c includes a housing 80c, and a portion of the housing 80c fits into a LEUR-LOK® type fitting, thereby covering such a fitting. On the other hand, the second component 44c includes a housing 60c, and the housing 60c is provided with a screw so as to be screwed onto the LEUR-LOK (registered trademark) type fitting portion. It should be understood that what has been illustrated is for illustrative purposes only and each or both caps may be in a threaded or snap-on configuration. The cap housings 60c, 80c can be further color coded as described above.

  The present invention also contemplates a dual cap system provided at the far end (no administration) of a port cleaning device (not shown). In this dual cap system, the first “green” cap can be reversibly bonded to both devices, and can also be bonded back and forth in a stacked relationship to the second “yellow” cap. Each of the two caps may be, for example, a LEUR-LOK (registered trademark) type fitting cap, a friction fitting cap, or the like. The green cap can accommodate the above bactericidal composition. In this form, the yellow cap does not contact the administration end of the device, so the yellow cap can contain a fungicide composition such as that contained in the previously described cleaning composition or green cap, for example.

  Materials that can be used for the cap include, but are not limited to, polyethylene, polypropylene, and / or copolymer materials. In addition, the cap can be provided with a material or agent that is preferably UV-protective to maintain the integrity of hydrogen peroxide, preferably during storage or transport. The package may also contain UV protection material to inhibit peroxide decomposition.

  As mentioned above, the device of the present invention can be used to collect blood from an individual through an intravascular catheter or intravascular port. In certain applications, the device can be used directly for blood testing purposes. The device chamber can preferably have a chamber size in the range of 1-3 ml with an appropriate calibration scale as described above. If whole blood is desired, depending on the particular purpose to be collected, the blood can be either a device with an empty chamber or an anticoagulant such as EDTA, sodium citrate or an alternative (as described above) It can be collected in a device containing a coagulant. A device containing blood and an anticoagulant can be used directly in a blood test instrument or the blood can be transferred to another device for testing.

  In applications where serum is desired, whole blood can be collected in the device chamber, and after clotting, the device containing the blood sample can be rotated to separate the serum from the red blood cells. If an anticoagulant is present in the device chamber, further separation can be performed to separate the plasma. In addition, after the sample is taken into the device chamber, a filter such as a MILLIPORE (registered trademark) (Millipore Corp., Bedford MA) filter may be attached to the device. With such a technique, red blood cells, white blood cells, and platelets can be filtered, and plasma is allowed to flow from the chamber while retaining blood cells within the filter. Anticoagulants are optional but if desired based on the test or other treatment to be performed (ie, complete blood count, CBC, platelet count, reticulocyte count, T and B lymphocyte counts and chemistry) May be provided in the chamber for moving blood cells or plasma.

  A suitable filter can also be used to filter the particles during collection of a blood sample from the individual into the chamber.

  With reference to FIGS. 17-19, another embodiment is shown that may be used during or for administration. In accordance with a specific embodiment, the assembly can be used to deliver a solution via an access port, such as a LEUR-LOK® port.

  Accordingly, the syringe cylinder 174 may include a LEUR-LOK (registered trademark) fitting portion at the first end 172. Plunger 176 may extend from a conventional piston seal 177 configured to be inserted into the second end of cylinder 174 to form a seal with the cylinder wall to another end 170. Accordingly, the cylinder 174 can extend from an opening configured to receive the plunger 176 to the first end 172, such that the first end 172 is coupled to a needle and / or medical tube. It is configured. The cap 180 can have a housing that can include, for example, an internal receiving port. The internal receiving port is internally fitted to the LEUR-LOK (registered trademark) fitting part or fitted on the LEUR-LOK (figure) fitting part at the first end 172 and is connected to the LEUR- Cover the LOK (registered trademark) fitting part. The cap 160 may be fitted with an LEUR-LOK® fitting (or alternative based on the type of port that will be internally fitted or cleaned against the LEUR-LOK® fitting. It may be configured to include an internal receiving port that fits over and covers the LEUR-LOK® fitting. In some embodiments, the appendage 171 can be part of or extend from the end 170 and is configured as a male LEUR-LOK® fitting, and Cap 160 is configured to couple to it. Accordingly, the cap of the present invention may be configured to couple to an assembly such as end 172 and / or appendage 171, for example. The caps 180, 160 can be colored as described above, with the green cap being 160 and the yellow cap being 180.

  Referring to FIGS. 18 and 19, the assembly of FIG. 17 is shown in another form. For example, the assembly of FIG. 17 can include a barrier member 178 that extends from a portion of the cylinder to the end 172. This barrier material may seal the contents of the cylinder 174 when not in use, for example. With reference to FIGS. 18 and 19, the barrier material 178 may extend to surround at least a portion of the cap 180. The barrier material can include a translucent and crushed material such as a thin polymer sheet material, but is not limited to such a material.

  20-28, the present invention also contemplates a dual cap system located at the distal end of the dispensing device. In this dual cap system, the first “green” cap 160 can also be reversibly joined to the device, with the second “yellow” cap 180 being stacked back and forth. Each of the two caps may be, for example, a LEUR-LOK (registered trademark) type fitting cap, a friction fitting cap, or the like. The green cap can accommodate the above bactericidal composition. In this form, the yellow cap does not contact the administration end of the device, so the yellow cap can contain a fungicide composition such as that contained in the previously described cleaning composition or green cap, for example.

  In another embodiment shown in FIGS. 20 and 21, for example, caps 180, 160 can be removably coupled back to back, cap 180 is releasably sealed, and cap 160 is coupled to plunger 176. Referring to FIG. 21, the sealing of both caps in the barrier material 184 is also contemplated. With reference to both these figures, an additional cap 182 may or may not be provided with or without an applicator and / or solution.

  Referring to FIGS. 22 and 23, according to another embodiment, the caps 160, 180 may be aligned, for example, face-to-face, both caps sharing, for example, a releasable seal or individual release. Provide a possible seal. Piston 176 is configured with a housing 190 that is configured to receive one or both of caps 160 and / or 180 or a portion of each cap. Further, the barrier material 192 may be provided so as to surround any part of both the caps 160 and 180. In the illustrated embodiment, the cap 160 is substantially entirely within the housing 190, while the cap 180 is present within the barrier material 180. In this embodiment, the barrier material 192 may be configured as a rigid cover that is releasably attached to the piston 176, for example. Yet another view of this embodiment is shown in FIG. 24, where the device shown includes a blue cap 182 and a barrier material 178 that surrounds both the end 172 and the blue cap 182, for example.

  In accordance with another embodiment of the present invention, a syringe having a plunger with a housing 250 is shown. The housing 250 can be configured to receive and / or receive at least two caps, such as the illustrated caps 180, 160. According to a specific embodiment, these caps can be yellow and green caps, respectively. These caps can be placed in the housing 250 in a front-to-back configuration as shown, and the releasable seal is independent of the other caps. One or more of these caps can be provided in the housing 250 at the proximal end of the plunger shaft, and the housing is sealed to form a cavity at the base of the plunger or on the side access inlet with respect to the cap chamber. The The housing can be sealed by a cover that can be attached to the plunger, for example via a hinge. The cover can also be releasably mounted, for example as a polymer foil seal or snap fit.

  Referring to FIGS. 25-28, an additional cap as a yellow cap 180a may be provided in the device. In different configurations, a barrier material 178 may be provided that surrounds all of the end 172 and cap 180a, or at least a portion of the cap 180a. Referring to FIG. 28, the device can be configured with a blue cap 182, for example. A cap 182 that can contain a sponge and a cleaning / disinfecting solution can be placed at the tip of the syringe. Barrier materials such as barrier polymers can cover both the cap and the distal end of the syringe or the entire syringe, prevent particulate and microbial contamination, and maintain a sterile environment after final sterilization. According to other configurations, the end 172 may be configured with a barrier material such as a polymer / metal foil seal on the end 172 to prevent mixing with the fluid in the cap, This barrier material can be used to protect male luer or slip-fit connectors from IV lines or syringes.

  It should be understood that all the devices described above can be used for cleaning purposes, administration purposes or blood collection / testing purposes. The method is similar to variations based on the particular device used as described above.

  Examples of device packaging are shown in FIGS. The package 100 can include a lid 102 and a package tray 104 as shown in FIG. Referring to FIG. 30 and FIG. 31, the package tray 104 may be a molded tray having a holding function integrally molded in accordance with the shape of the device 40c according to the present invention. Preferably, the molding function corresponds to the shape of the device in the non-wearing position during transportation, storage or the like. Accordingly, the tray 104 can include one or more integrally formed holding function units 106, 107, 108, and 109. The tray 104 also includes an integrally molded cradle 110 that can be configured to receive the device 40c in an upright position, as shown in FIG. Such a cradle can hold the device 40c inserted during or after the administration procedure. The tray 104 can also be used for device processing purposes.

  The device cap according to the present invention can be utilized separately from the device for irrigation and protection of other access catheters and ports such as intravascular, peritoneal dialysis, urine ports and catheters and the like. Thus, the caps can be independently packaged in pairs (in two different sizes, each color, such as one or more color groups or volumes). FIGS. 32 and 33 show an example of two cap package systems 115, which may be yellow caps, for example, and preferably LEUR-LOK® type caps. A first cap 117 and a second cap 118, which may be a green cap, for example, and may be a LEUR-LOK (registered trademark) type cap, are also provided. The package system 115 can have a package tray 120 and can include suitable receiving ports / receiving rings 122, 124 integrally molded as shown in FIG. If additional or a small number of caps are to be packaged together, the tray 120 can include an appropriate number of receiving ports to receive and reversibly hold the caps. If the caps have different sizes (diameters), the ports preferably have different sizes. The caps can be one green cap and four yellow caps per package, or any other suitable number depending on the specific procedure utilized in the number and size of the package port corresponding to the number and size of the various caps. It should be understood that such a groove may be provided.

  Referring now to FIG. 34, an alternative package system 130 is illustrated. The package system 130 includes a lid 132 and a tray 130 that includes integral receiving ports 136, 138 for receiving caps 117, 118. As noted above, alternate numbers and sizes of receiving ports can be provided based on the number and size of caps to be used.

  Where large caps are provided, such caps may be packaged individually and may be individually provided on a sheet or on a piece. The cap can alternatively be provided on the catheter or line / import device. Such a cap may be included in a generic package that is loosely or attached to a port catheter or line to be used for port cleaning and / or protection after opening the package and / or using the device. In some cases, the cap (s) can be packaged in one or more subpackages contained within a large package surrounding the catheter device.

10 Port Access Device 12 First Component 14 Device First End 16 Second Component 18 Device Second End 20 Tab 21 Container 22 Chamber Housing 23 Chamber 24 Connector Portion 24 Expansion Portion 25 Separator 26 Dispenser 28 Valve portion 29 Opening 30 Receiving port 32 Applicator material 40 Port access device 42 First component 44 Second component 46 Plunger 48 Housing 50 First end 51 Wing extension 52 Second end 53 Wing extension 54 Internal chamber 56 Stem 57 Seal 59 Seal 60 Housing 62 Internal container 64 Applicator material 70 Package (package unit)
72 Lid 74 Tray part 76 Cavity part 78 Holding part 42a First component 44a Second component 60a Cap housing 62 Container part 64 Applicator material 65 Second cap extension part 66 Second container 67 Applicator material 40b Port Access Device 42b First Component 44b Second Component 45b Third Component 48b Chamber Housing 80 Cap Housing 80c Housing 82 Applicator Material 80 Cap Housing 82c Adsorbent Material 60b Cap Housing 100 Package 102 Lid 104 Package Tray 106, 107, 108, 109 Retainer function unit 110 Receiving base 115 Two-cap package system 117 First cap 118 Second cap 120 Package tray 12 4, 124 receiving port / receiving ring 130 package system 132 lid 134 tray 136, 138 cap 160 cap 170 another end 171 appendage 172 first end 174 syringe cylinder 176 plunger 177 conventional piston seal 178 barrier material 180 Cap 182 Blue cap 184 Barrier material 190 Housing 192 Barrier material 250 Housing

Claims (19)

A syringe cylinder extending from an opening configured to receive the plunger to an end configured to couple with a needle and / or medical tube;
A cap configured to couple to the end;
A barrier material at least partially surrounding the cap and end;
A syringe assembly comprising:   The syringe assembly of claim 1, wherein the cap further comprises one or both of an applicator material and / or a cleaning fluid.   The syringe assembly of claim 1, wherein the cap and the end are configured to couple via a LEUR-LOK fitting.   The syringe assembly of claim 1, wherein the end portion defines an internal fitting portion and the cap is configured to couple to the end portion outside the internal fitting portion. A syringe cylinder extending from an opening configured to receive the plunger to an end configured to couple with a needle and / or medical tube;
A plunger extending from one end to the seal end;
At least one cap configured to couple to one end;
A syringe assembly comprising:   6. The syringe assembly according to claim 5, wherein one cap further comprises one or both of an applicator material and / or a cleaning liquid.   6. The syringe assembly according to claim 5, wherein one cap and one end are configured to couple via a LEUR-LOK fitting.   6. The syringe assembly according to claim 5, wherein one end portion defines an internal fitting portion, and one cap is configured to be coupled to the one end portion outside the internal fitting portion. Solid.   6. The syringe assembly according to claim 5, further comprising another cap configured to couple with one cap.   10. A syringe assembly according to claim 9, wherein the other cap comprises one or both of an applicator material and / or a cleaning fluid.   6. The syringe assembly according to claim 5, wherein the other cap further comprises a barrier material surrounding the applicator material and / or cleaning fluid in the other cap.   6. The syringe assembly according to claim 5, further comprising a barrier material surrounding both the one cap and the other cap. A syringe cylinder extending from an opening configured to receive the plunger to an end configured to couple with a needle and / or medical tube;
A plunger extending from one end to the seal end and defining a recess configured to receive at least one cap at one end;
A syringe assembly comprising:   14. A syringe assembly according to claim 13, wherein one cap comprises one or both of applicator material and / or cleaning fluid.   14. The syringe assembly of claim 13, further comprising another cap configured to couple with one or both of the plunger or one cap.   16. A syringe assembly according to claim 15, wherein the other cap comprises one or both of an applicator material and / or a cleaning liquid.   16. The syringe assembly according to claim 15, further comprising a barrier material extending at least partially around the other cap.   The syringe assembly of claim 13, wherein the recess is configured to receive at least two caps.   19. A syringe assembly according to claim 18, wherein the two caps are longitudinally alignable within the recess.