Disposable refill unit for implanted medication infusion device

• US 4,684,365 A
• Filed: 10/10/1985
• Issued: 08/04/1987
• Est. Priority Date: 01/24/1985
• Status: Expired due to Fees

• Current Assignee: Eaton Corp. (Wisconsin) (Eaton Corporation PLC.)
• Original Assignee: Eaton Corp. (Wisconsin) (Eaton Corporation PLC.)
• Inventors: Reinicke, Robert H.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/786,213
• Time in Patent Office: 663 Days
• Field of Search: 604/126, 604/45, 604/118, 604/122, 604/129, 604/190, 604/233-235, 604/240-243, 604/268, 604/272, 604/405, 604/406, 604/411-415, 604/891, 604/896
• US Class Current: 604/126
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A refill unit for a negative pressure type implanted infusion device includes a hollow cylindrical housing member which is adapted to receive at one end a bottle of vacuum conditioned medication. As the bottle is inserted first and second needles or tubes penetrate the closure member of the bottle, the shorter one of these needles being positioned to receive medication inside the bottle and the longer one extends into the ullage space of the bottle when it is inserted and held vertically. The shorter needle communicates with a refill needle, which extends downwardly from the other end of the cylindrical member, through a membrane type filter which is hydrophilic to the medication and has a micron rating such that the filter once it is wetted can pass air bubbles but only at a differential pressure substantially greater than the negative pressure differential of the implanted device. The longer needle communicates with ambient air through a membrane type filter which is hydrophobic to the medication and permits the unobstructed flow of air into the ullage space of the bottle while preventing air-borne bacteria from entering this air space.

Claims

1. A medication refill arrangement for an implanted medication infusion device of the type having a medication reservoir and means for maintaining said reservoir at a pressure substantially less than the pressure of the body in which the device is implanted, comprising a hollow tubular member, a manifold member secured in one end of said tubular member carrying first and second tubes extending into the interior of said tubular member, said first and second tubes being adapted to be inserted through the closure member of a medication bottle which is placed in the other end of said tubular member and moved into engagement with said tubes with sufficient force to cause said tubes to penetrate said closure member, said first tube communicating with the medication in said bottle after penetration of said closure member, said first tube communicating with the medication in said bottle after penetration of said closure member and said second tube communicating with the ullage space within said bottle, a hollow needle positioned in said manifold member opposite said tubes and extending outwardly from said one end of said tubular member, means defining a first passageway in said manifold extending between said first tube and said hollow needle, an opening in a sidewall of said tubular member, and means defining a second passageway in said manifold extending between said second tube and said sidewall opening.

2. The refill arrangement of claim 1, which includes first and second filter means positioned respectively in said first and second passageways.

3. The refill arrangement of claim 2, wherein said first and second filter means comprise membrane type medication filters.

4. The refill arrangement of claim 3, wherein said first and second membrane filters each have a rating of approximately 0.22 microns.

5. The refill arrangement of claim 2, wherein said second filter means is effective to prevent air-borne bacteria from entering the ullage space of said bottle through said second passageway and said second tube.

6. The refill arrangement of claim 5, wherein said second filter means is hydrophobic to the medication in said bottle, thereby to permit the unobstructed flow of air through said second filter means and into the ullage space of said bottle.

7. The refill arrangement of claim 2, wherein said first filter means is hydrophilic to the medication in said bottle and permits the free flow of medication to said hollow needle while preventing air bubbles from entering said needle even if the bottle is emptied of medication during the refilling operation.

8. The refill arrangement of claim 2, wherein said first filter means is a membrane type filter having a micron rating such that air bubbles will not pass therethrough at the differential pressure which exists between said reservoir and said bottle during the refilling operation.

9. The refill arrangement of claim 8, wherein said first filter means has a rating of approximately 0.22 microns.

10. The refill arrangement of claim 1, wherein said manifold has a bottom opening recess therein, means defining an annular seat in said recess, a filter disk positioned on said annular seat, and a retainer member positioned within said recess to hold said filter disk against said annular seat, said first passageway including a first portion extending from said first tube to the upper side of said filter disk and a second portion in said retainer and extending from the lower side of said filter disk to said needle.

11. The refill arrangment of claim 10, wherein said retainer is provided with an annular portion outside said filter disk to facilitate the positioning of said filter disk on said annular seat.

12. The refill arrangement of claim 1, wherein said manifold has a side opening recess therein, means defining an annular seat in said recess, a filter disk positioned on said annular seat, and a retainer positioned within said recess to hold said filter disk against said annular seat, said second passageway including a first portion extending from said second tube to one side of said filter disk and a second portion in said retainer extending from the other side of said disk to said sidewall opening.

13. The refill arrangement of claim 12, wherein said retainer is provided with an annular portion outside said filter disk to facilitate the positioning of said filter disk on said annular seat.

14. A medication refill arrangement for an implanted medication infusion device of the type having a medication reservoir and means for maintaining said reservoir at a pressure substantially less than the pressure of the body in which the device is implanted, comprising a tubular member carrying a tube positioned in one end thereof extending into the interior of the tubular member which is adapted to be inserted through the closure member of a medication bottle which is positioned within said tubular member and moved into engagement with said tube with sufficient force to cause said tube to penetrate the closure member, a hollow needle extending outwardly from said one end of said tubular member and adapted to be inserted into the implanted medication infusion device for percutaneously refilling the reservoir thereof, means defining a passageway between said tube and said needle;

and a sleeve positioned on said one end of said tubular member and enclosing said needle, said sleeve being removable from said one end of said tubular member while maintaining a sealed connection thereto so that removal of said sleeve is effective to pull medication through said tube, said passageway and said needle and remove air therefrom.

15. The arrangement of claim 14, wherein said one end of said tubular member includes a cylindrical projection through which said needle extends, said sleeve enclosing said needle and at least a portion of said cylindrical projection, and an O ring positioned between said projection and said sleeve to maintain a sealed relationship therebetween as said sleeve is removed from said projection.

16. The arrangement of claim 15 which includes thread means interconnecting said projection and said sleeve so that said sleeve must be rotated to be removed from said projection, thereby to prevent too rapid a removal of said sleeve from said projection.

17. The arrangement of claim 15, wherein said sleeve is made of a transparent material so that the flow of medication out of the end of said needle as said sleeve is removed from said projection can be visually checked.

18. The arrangement of claim 16, wherein said thread means are positioned so that said O ring maintains said sealed relationship between said sleeve and said projection as said sleeve is rotated.

19. The arrangement of claim 16, wherein said thread means is spaced a substantial distance away from said O ring along the length of said cylindrical projection so that said sleeve can be rotated several revolutions while said O ring maintains said sealed relationship between said sleeve and said projection.

31. The arrangement of claim 14, which includes a membrane type medication filter position in said passageway, said filter having a micron rating such that air bubbles will not pass therethrough at the differential pressure which exists between said reservoir and said bottle during the refilling operation.

32. The arrangement of claim 31, wherein said membrane type filter has a rating of approximatley 0.22 microns.

33. The arrangement of claim 14 which includes a hydrofilic membrane type filter positioned in said passageway which allows medication to pass freely through said passageway to said needle during the refilling process while preventing air bubbles from entering said implanted device.

20. A medication refill arrangement for an implanted medication infusion device of the type having a medication reservoir and means for maintaining said reservoir at a pressure substantially less than the pressure of the body in which the device is implanted, comprising a tubular member carrying a tube positioned in one end thereof extending into the interior of the tubular member which is adapted to be inserted through the closure member of a medication bottle which is positioned within said tubular member and moved into engagement with said tube with sufficient force to cause said tube to penetrate the closure member, a hollow needle extending outwardly from said one end of said tubular member and adapted to be inserted into the implanted medication infustion device for percutaneously refilling the reservoir thereof, means defining a passageway between said tube and said needle;

a needle guard positioned on said one end of said tubular member and having a cavity therein within which said needle is positioned, and means for sealing said cavity while permitting said needle guard to be moved in the direction to increase the volume of said cavity, whereby upon movement of said needle guard in said direction medication is sucked out of the bottle through said tube, said passageway and said needle to remove air therefrom.

21. The arrangement of claim 20, which includes a membrane type medication filter positioned in said passageway, said filter having a micron rating such that air bubbles will not pass therethrough at the differential pressure which exists between said reservoir and said bottle during the refilling operation.

22. The arrangement of claim 21, wherein said membrane type filter has a rating of approximately 0.22 microns.

23. The arrangement of claim 20, which includes a hydrofilic membrane type filter positioned in said passageway which allows medication to pass freely through said passageway to said needle during the refilling process while preventing air bubbles from entering said implanted device.

24. A medication refill arrangement for an implanted medication infusion device of the type having a medication reservoir and means for maintaining said reservoir at a pressure substantially less than the pressure of the body in which the device is implanted, comprising a housing having a recess for receiving a bottle of medication, a tube mounted in said housing and adapted to penetrate the closure member of the medication bottle when it is inserted into said recess, a hollow needle extending from said housing and adapted to be inserted into the implanted medication infusion device for percutaneously refilling the reservoir thereof, means defining a passageway between said tube and said needle, a needle guard having a cavity which is adapted to receive said needle, and means for maintaining said cavity sealed from the atmosphere while permitting movement of said needle guard in the direction to increase the volume of said cavity, whereby upon movement of said needle guard in said direction medication is sucked out of the bottle and through said tube said passageway and said needle to remove air therefrom.

25. The arrangement of claim 24 including means for allowing said needle guard to be completely removed from said needle after the air has been removed from said needle by movement of said needle guard in said direction.

26. The arrangement of claim 24, including means for allowing said needle to be visible as said needle guard is moved in said direction so that the flow of medication out of said needle after air is remvoed therefrom can be verified.

27. The arrangement of claim 24, which includes a cylindrical member connected to said housing and having said needle secured therein and extending therefrom along the axis thereof, said needle guard including a sleeve portion adapted to fit over said cylindrical member, and means for sealing said sleeve to said cylindrical member while permitting said needle guard to be moved along said axis to increase the volume of said cavity.

28. The arrangement of claim 27, wherein said sealing means comprises an O ring mounted on said cylindrical member and in engagement with the inside surface of said sleeve.

29. The arrangement of claim 28, which includes thread means interconnecting said cylindrical member and said sleeve so that said needle guard must be rotated to be removed from said needle.

30. The arrangement of claim 29, wherein said thread means has a coarse pitch so that only a few revolutions of said needle guard produce a substantial movement of said needle guard in said direction.