Aspiration and refill kit for a medication infusion pump

• US 5,217,442 A
• Filed: 09/28/1990
• Issued: 06/08/1993
• Est. Priority Date: 09/28/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Minimed Technologies Inc.
• Inventors: Davis, Mark W.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): CLARKE, ROBERT A
• Application Number:
  US07/590,640
• Time in Patent Office: 984 Days
• Field of Search: 604/220, 604/236, 604/121, 604/248, 604/208, 604/211, 604/218, 604/207, 604/210, 604/191, 604/164, 604/285, 604/890.1, 604/890.2, 604/890.3, 604/187, 604/246 , 604/248, 604/158, 604/161
• US Class Current: 604/285
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A kit is provided for use in refilling a medication infusion pump of the type adapted for implantation into the body of a patient. The kit comprises a syringe having a plunger mounted for reciprocation within a syringe barrel having a manually operable control valve mounted at a nose end thereof. The syringe further includes a lock for retaining the plunger subsequent to retraction motion with the control valve closed to pull and maintain a vacuum within the syringe barrel. With this construction, the syringe can be connected transcutaneously with a medication reservoir within an implanted infusion pump to aspirate residual medication from the pump. Alternately, the syringe can be used to degas medication within the barrel preparatory to transcutaneous delivery to the pump reservoir. In either case, the syringe is designed for facilitated and safe manipulation to permit rapid pump aspiration and refill at periodic intervals according to patient requirements.

Claims

1. A kit for use in refilling an implantable medication infusion pump having an internal reservoir for receiving and storing a selected medication, an inlet port containing a self-sealing septum, an interior portion of the inlet port being in fluid communication with the internal reservoir, said kit comprising:

a syringe having a hollow syringe barrel with a nose end and an open rear end, and further including a reciprocal plunger received slideably within said open rear end of said barrel;

a control valve adapted for mounting onto said nose end of said syringe barrel and including means for selectively opening and closing said control valve;

lock means having a first element mounted on said syringe barrel, said first element of said lock means for releasable engagement with a second element of said lock means disposed on said plunger, said lock means for releasably locking said plunger in a retracted position within said barrel in which longitudinal movement of said plunger is completely inhibited, whereby a significant vacuum may be drawn and maintained within said barrel by retracting said plunger to said retracted position while said control valve is closed; and

needle means adapted for mounting onto said control valve for piercing the pump septum to access the inlet port.

2. A kit as defined in claim 1, further comprising:

a guide needle adapted for insertion at least partially into the inlet port without piercing the self-sealing septum, said needle means for mounting onto said control valve being slideably insertable through said guide needle and the self-sealing septum into fluid communication with the internal reservoir.

3. A kit as defined in claim 1, wherein said means for opening and closing said control valve comprises:

means for allowing said control valve to be opened when said needle means is in fluid communication with the internal reservoir such that the vacuum within the syringe barrel aspirates residual medication from the internal reservoir.

4. A kit as defined in claim 1, wherein said plunger has an inserted position in which said plunger is fully inserted into said syringe barrel and an intermediate position between said inserted position and said retracted position, said syringe being adapted to draw in a first volume of the medication when said plunger is moved from said inserted position to said intermediate position, said plunger thereafter being adapted for movement to said retracted position with said control valve closed to draw a significant vacuum within the syringe barrel to degas the medication, said syringe displacing a second volume therein when said plunger is in said retracted position, said second volume being sufficiently larger than said first volume to allow the medication to be satisfactorily degassed.

5. A kit as defined in claim 4, wherein said syringe barrel and said plunger are arranged and configured to allow said plunger to be drawn into said syringe barrel by the negative pressure of an internal reservoir in a pump having a negative pressure reservoir.

6. A kit as defined in claim 1, wherein said syringe plunger comprises:

a piston adapted for reciprocal motion within said syringe barrel in sealing fashion; and

a plunger stem connected to said piston and extending outwardly from said open rear end of said syringe barrel.

7. A kit as defined in claim 6, wherein said second element of said lock means comprises:

a recess formed in said plunger stem near a forward end thereof at a position for exposure at said rear end of said barrel when said plunger is moved to said retracted position; and

wherein said first element of said lock means comprises;

a lock tab mounted on said barrel for biased movement into said recess when said plunger is moved to said retracted position.

8. A kit as defined in claim 7, wherein said lock tab is formed at one end of a lock lever mounted pivotally onto said barrel.

9. A kit as defined in claim 8, wherein said lock lever is supported on a fulcrum member projecting outwardly from a collar adapted for slidable mounting onto said barrel, said lock lever and said fulcrum member and said collar being integrally formed.

10. A kit as defined in claim 6, additionally comprising:

means for retaining said plunger stem in a coaxial relationship with said syringe barrel.

11. A kit as defined in claim 10, wherein said retaining means comprises:

a pair of spaced-apart, annular rings mounted on and extending radially outwardly from said plunger stem near said forward end thereof.

12. A kit as defined in claim 1, wherein said syringe barrel includes a male luer lock fitting at said nose end thereof, and wherein said control valve includes a female luer lock fitting for mating with said male luer lock fitting on said syringe barrel.

13. A kit as defined in claim 12, wherein said control valve also includes a male luer lock fitting for mating with said needle means.

14. A syringe assembly for use in aspirating and refilling a medication reservoir of an implanted medication infusion pump, said syringe assembly comprising:

a hollow syringe barrel having a first connector fitting at a nose end thereof and defining a barrel port for intake and discharge of fluid from the interior of said barrel, said barrel further defining an open rear end;

a syringe plunger having a piston slideably received into said barrel rear end, and a plunger stem connected to said piston and projecting outwardly from said barrel rear end;

a control valve having a second connector fitting which is removably mounted onto said first connector fitting, said control valve including means for selectively opening and closing said valve;

said plunger being movable within said barrel between an advanced position to a retracted position with said control valve closed to draw a substantial vacuum within said syringe barrel; and

lock means cooperating between said barrel and plunger for retaining said plunger in said retracted position in which longitudinal movement of said plunger is completely inhibited.

15. A syringe assembly as defined in claim 14, wherein said lock means comprises:

a recess formed in said plunger near a forward and thereof at a position for exposure at said rear end of said barrel when said plunger is moved to said retracted position; and

a lock tab on said barrel for movement into said recess when said plunger is moved to said retracted position.

16. A syringe assembly as defined in claim 15, wherein said lock tab comprises:

means for urging said tab toward reception into said recess when said plunger is in said retracted position; and

means for manually withdrawing said tab from said recess.

17. A syringe assembly as defined in claim 15, wherein said lock tab is formed at one end of a lock lever mounted pivotally onto said barrel.

18. A syringe assembly as defined in claim 17, wherein said lock lever is supported on a fulcrum member projecting outwardly from a collar adapted for slidable mounting onto said barrel, said lock lever and said fulcrum member and said collar being integrally formed.

19. A kit for aspirating residual medication from a medication reservoir within an implantable medication infusion pump having an inlet port including a self-sealing septum, said kit comprising:

a syringe including a hollow syringe barrel having a connector fitting at a nose end thereof and defining a barrel port for intake and discharge of fluid from the interior of said barrel, said barrel further defining an open rear end, said syringe further including a syringe younger having a piston slideably received into said barrel rear end, and a plunger stem connected to said piston and projecting outwardly from said barrel rear end;

a control valve removably mounted onto said connector fitting, said control valve including means for selectively opening and closing said valve, said plunger being movable within said barrel between an advanced position to a retracted position with said control valve closed to draw a substantial vacuum within said syringe barrel;

lock means cooperating between said barrel and plunger for retaining said plunger in said retracted position in which longitudinal movement of said plunger is completely inhibited; and

an aspiration needle adapted for mounting onto said control valve and for piercing the pump septum to access the pump reservoir, said means for opening and closing said control valve being movable to open said control valve, thereby communicating the vacuum within said syringe barrel with the pump reservoir to aspirate residual medication within the reservoir into said syringe barrel.

20. A kit for refilling a medication reservoir within an implantable medication infusion pump having an inlet port including a self-sealing septum, said kit comprising:

a syringe including a hollow syringe barrel having a connector fitting at a nose end thereof and defining a barrel port for intake and discharge of fluid from the interior of said barrel, said barrel further defining an open rear end, said syringe further including a syringe plunger having a piston slideably received into said barrel rear end, and a plunger stem connected to said piston and projecting outwardly from said barrel rear end;

a control valve removably mounted onto said connector fitting, said control valve including means for selectively opening and closing said valve, said plunger being movable within said syringe barrel with said control valve open to draw in a quantity of a selected medication to partially fill said barrel, said plunger being further movable within said barrel with said control valve closed and in a direction toward a retracted position to draw a substantial vacuum within said syringe barrel to degree the medication therein;

lock means cooperating between said barrel and plunger for retaining said plunger in said retracted position during degassing of the medication, said lock means completely inhibiting longitudinal movement of said plunger; and

a refill needle adapted for mounting onto said control valve and for piercing the pump septum to access the pump reservoir, said means for opening and closing said control valve being movable to open said control valve thereby communicating the interior of said syringe barrel with the pump reservoir to permit refilling of the pump reservoir with said selected medication.

21. A kit for aspirating and refilling an internal medication reservoir of an implantable medication infusion pump having an inlet port including a self-sealing septum, said kit comprising:

a first syringe assembly comprising;

a hollow syringe barrel having a connector fitting at a nose end thereof and defining a barrel port for intake and discharge of fluid from the interior of said barrel, said barrel further defining an open rear end;

a syringe plunger having a piston slideably received into said barrel rear end, and a plunger stem connected to said piston and projecting outwardly from said barrel rear end;

a control valve removably mounted onto said connector fitting, said control valve including means for selectively opening and closing said valve, said plunger being movable within said barrel between an advanced position to a retracted position with said control valve closed to draw a substantial vacuum within said syringe barrel;

lock means cooperating between said barrel and plunger for retaining said plunger in said retracted position; and

an aspiration needle adapted for mounting onto said control valve and for piercing the pump septum to access the pump reservoir, said means for opening and closing said control valve being movable to open said control valve thereby communicating the vacuum within said syringe barrel with the pump reservoir to aspirate residual medication within the reservoir into said syringe barrel;

a guide needle adapted for insertion at least partially into said pump inlet port without piercing said pump septum, said aspiration needle being sized to fit slideably through said guide needle to pierce said pump septum; and

a second syringe assembly comprising;

a hollow syringe barrel having a connector fitting at a nose end thereof and defining a barrel port for intake and discharge of fluid from the interior of said barrel, said barrel further defining an open rear end;

a syringe plunger having a piston slideably received into said barrel rear end, and a plunger stem connected to said piston and projecting outwardly from said barrel rear end;

a control valve removably mounted onto said connector fitting, said control valve including means for selectively opening and closing said valve, said plunger being movable within said syringe barrel with said control valve open to draw in a quantity of a selected medication to partially fill said barrel, said plunger being further movable within said barrel with said control valve closed and in a direction toward a retracted position to draw a substantial vacuum within said syringe barrel to degas the medication therein;

lock means cooperating between said barrel and plunger for retaining said plunger in said retracted position during degassing of the medication; and

a refill needle adapted for mounting onto said control valve and for piercing the pump septum to access the pump reservoir, said means for opening and closing said control valve being movable to open said control valve, thereby communicating the interior of said syringe barrel with the pump reservoir to permit refilling of the pump reservoir with said selected medication, said refill needle being sized to fit slideably through said guide needle to pierce said pump septum.

22. A kit as defined in claim 21 further comprising:

an auxiliary syringe including needle means for piercing said septum and adapted to withdraw a small quantity of the medication from said pump reservoir after the pump reservoir is filled.