Refillable medication infusion apparatus

• US 4,573,994 A
• Filed: 12/07/1981
• Issued: 03/04/1986
• Est. Priority Date: 04/27/1979
• Status: Expired due to Term

• Current Assignee: Minimed Technologics, Ltd.
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E., Lord, Peter C.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/327,818
• Time in Patent Office: 1,548 Days
• Field of Search: 128/DIG. 12, 128/13, 604/27, 604/30, 604/31, 604/50, 604/65-67, 604/86, 604/131, 604/140, 604/147, 604/148, 604/175, 604/245, 604/411, 604/414
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2039/0241 having means for filtering
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting

Abstract

Apparatus and method for filling, or refilling, the internal reservoir of a medication infusion system, wherein filling or refilling is permitted only when a means for injecting medication is properly positioned relative to the reservoir. Prior to filling or refilling, a pressure integrity check can be made to help assure that injected medication enters the reservoir without leakage. Additionally, flushing of a portion or all of the medication reservoir can be accomplished if desired. Medication is introduced to and is stored in the reservoir at a pressure below ambient body pressure.

Claims

1. A system having a medication infusion apparatus including a medication container and an apparatus for filling the medication container, said system comprising in combination:

a medication container having an input;

a dispensing means adapted to communicate with said input of said medication container; and

,

a valve, operably disposed at said input of said medication container, said valve comprising a reciprocally mounted valve poppet which is urged into an open position when a portion of said dispensing means is disposed in a preselected position in said medication infusion apparatus, removal of said portion of said dispensing means from said preselected position causing said valve poppet to be urged into a closed position, said dispensing means in fluid communication with said medication container only when said valve poppet is urged into said open position.

2. A combination in accordance with claim 1, further comprising flushing means operably coupled to said dispensing means for flushing at least a portion of said medication container.

3. A combination in accordance with claim 2, wherein said flushing means comprises means for supplying and means for evacuating a flushing fluid from said medication container.

4. A combination in accordance with claim 3, wherein said dispensing means comprises a hypodermic needle, said supply means and evacuation means being connectable thereto.

5. A combination in accordance with claim 4, wherein said hypodermic needle comprises two lumens, one of said lumens being connectable to said supply means, the other of said lumens being connectable simultaneously to said evacuation means.

6. A combination in accordance with claim 2, wherein said dispensing means comprising a hypodermic needle having a delivery opening therein, said dispensing means further comprising a stylet for removable selective insertion in said hypodermic needle to block said delivery opening.

7. A combination in accordance with claim 1, further comprising a housing having associated therewith said medication container and means for guiding the position of said dispensing means, said guiding means comprising a control head for accommodating a portion of said dispensing means therethrough, said control head and said housing having complementary structure to aid in alignment when said dispensing means is operably disposed relative to said input of said medication container.

8. A combination in accordance with claim 1, further comprising means for checking at least a portion of said medication container for leaks.

9. A combination in accordance with claim 8, wherein said checking means comprises:

pressurized injection means for injecting a fluid into said portion of said medication container;

means for measuring the pressure within said portion of said medication container over a period of time after said injecting of said fluid, decay of the measured pressure over said period of time being indicative of a leak; and

means for evacuating said fluid from said portion of said medication container.

10. A combination in accordance with claim 9, wherein said medication container comprises an antechamber and a reservoir, said valve being disposed therebetween for permitting the flow of fluid from said antechamber to said reservoir, said at least a portion of said medication container comprising said antechamber, a portion of said pressurized injection means positioned in said antechamber but not disposed in said preselected position, so that said valve poppet remains closed to permit checking said antechamber for leaks.

11. A combination in accordance with claim 9, wherein said medication container comprises an antechamber and a reservoir, said valve being disposed between said antechamber and said reservoir, a portion of said pressurized injection means being insertable into said antechamber, such insertion opening said valve to permit checking of said reservoir and said antechamber for leaks.

12. A combination in accordance with claim 1, wherein said means for dispensing medication into said medication container has associated therewith a supply of medication, said medication container being at a lower pressure than said supply of medication, the pressure differential therebetween thereby causing the movement of said medication from said medication supply to said medication container.

13. A combination in accordance with claim 12, wherein said medication container comprises an antechamber and a reservoir, said valve being disposed between said antechamber and said reservoir, a portion of said dispensing means being insertable into said antechamber, such insertion opening said valve to permit filling of said reservoir.

14. A combination in accordance with claim 12, wherein said medication container is at a pressure lower than ambient pressure.

15. A combination in accordance with claim 1, further comprising means for detecting and indicating if said filling apparatus is in communication with a predetermined type of medication.

16. A combination in accordance with claim 15, wherein said detecting means comprises

means for inputting a patient code,

means for inputting a medication code, and

means for comparing said codes.

17. A combination in accordance with claim 16, further comprising means for identifying the particular medication infusion apparatus to be filled.

18. A combination in accordance with claim 17, wherein said identifying means comprises an electronically identifiable code disposed in said medication infusion apparatus, said comparing means further comparing said electronically identifiable code to said patient code and said medication code.

19. A combination in accordance with claim 17, wherein said means for inputting a medication code comprises an optically readable bar code.

20. A medication infusion apparatus having a medication container and an apparatus for filling the medication container comprising in combination:

a medication container maintained at a pressure below ambient pressure, said medication container having an input;

a dispensing means adapted to communicate with said input of said medication container, and;

a valve means, operably disposed at said input of said medication container, said valve means being opened mechanically through placement of a portion of said dispensing means in a preselected position.

21. A combination in accordance with claim 20, wherein said valve means comprises a reciprocally mounted valve poppet which is urged into an open position when said portion of said dispensing means is disposed in said preselected position, removal of said portion of said dispensing means from said preselected position causing said valve poppet to be urged into a closed position.

22. A combination in accordance with claim 20, wherein said dispensing means has associated therewith a supply of medication, said container being at a lower pressure than said supply of medication, the pressure differential therebetween thereby causing the movement of said medication from said medication supply into said medication container only when said valve means is urged into an open position.

23. A combination in accordance with claim 22, further comprising flushing means operably coupled to said dispensing means for flushing at least a portion of said medication container.

24. A combination in accordance with claim 23, wherein said flushing means comprises means for supplying and means for evacuating a flushing fluid from said medication container.

25. A combination in accordance with claim 24, wherein said dispensing means comprises a hypodermic needle, said supply means and evacuation means being connectable thereto.

26. A combination in accordance with claim 25, wherein said hypodermic needle comprises two lumens, one of said lumens being connectable to said supply means, the other of said lumens being connectable simultaneously to said evacuation means.

27. A combination in accordance with claim 22, wherein said input of said medication container comprises an antechamber, said apparatus comprising a housing having associated therewith said medication container, said housing having a tapered entry port with the wide portion thereof opening through said housing, the narrower portion of said entry port being located adjacent to the entrance of said antechamber, said tapered entry port for guiding the entry of said portion of said dispensing means into said antechamber.

28. A combination in accordance with claim 27, wherein said tapered entry port is substantially conical in shape.

29. A combination in accordance with claim 28, wherein the tapered surface of said entry port is relatively smooth and hard.

30. A combination in accordance with claim 22, further comprising means for checking at least a portion of said medication container for leaks.

31. A combination in accordance with claim 30, wherein said checking means comprises:

pressurized injection means for injecting a fluid into said portion of said medication container;

means for measuring the pressure within said portion of said medication container over a period of time after said injecting of said fluid, decay of the measured pressure over said period of time being indicative of a leak; and

means for evacuating said fluid from said portion of said medication container.

32. A combination in accordance with claim 31, wherein said medication container comprises an antechamber and a reservoir, said valve means being disposed between said antechamber and said reservoir, a portion of said pressurized injection means being insertable into said antechamber, such insertion causing said injection means to be in fluid communication with said reservoir thereby permitting checking of said reservoir and said antechamber for leaks.

33. A combination in accordance with claim 22, wherein said medication container comprises an antechamber and a reservoir, said valve means being disposed between said antechamber and said reservoir, a portion of said dispensing means being insertable into said antechamber, such insertion opening said valve to permit filling of said reservoir.

34. A combination in accordance with claim 22, wherein said medication container comprises an antechamber and a reservoir, said valve being disposed therebetween for selectively isolating said antechamber from said reservoir, the volume of said antechamber when isolated from said reservoir being of a magnitude selected so that said antechamber cannot contain a lethal dose of a given medication selected to be infused by said medication infusion apparatus.

35. A combination in accordance with claim 22, wherein said medication container comprises an antechamber and a reservoir.

36. A combination in accordance with claim 35, wherein said valve means is disposed between said antechamber and said reservoir for selectively isolating said antechamber from said reservoir, and wherein said antechamber further comprises a self-sealing septum for allowing insertion by said dispensing means.

37. A combination in accordance with claim 36, further comprising filter means for filtering fluid communicated between said antechamber and said reservoir.

38. A combination in accordance with claim 37 wherein said filter means comprises a filter having a pore size selected to preclude passage of bacteria there through.

39. A combination in accordance with claim 38, wherein said pore size is less than or equal to 2 microns.

40. The apparatus of claim 22, wherein said dispensing means comprises a hypodermic needle in fluid communication with a supply of medication maintained at a pressure equal to or less than ambient pressure so that medication will not be drawn from said dispensing means when said needle is injected into a patient'"'"'s body, unless said hollow needle is disposed in said preselected position in said medication infusion apparatus.

41. The apparatus of claim 22, wherein said dispensing means comprises a hypodermic needle in fluid communication with a vial containing said supply of medication, and wherein medication is drawn through said hypodermic needle and into medication container only when said hypodermic needle is disposed in said preselected position.

42. A medication infusion apparatus having a medication reservoir, adapted to be filled by means of a hypodermic needle in fluid communication with a medication source, said medication infusion apparatus comprising:

a reservoir for storing selected medication maintained at a pressure lower than both ambient pressure and the pressure of said medication source;

an antechamber with at least a portion of one wall comprising a self-sealing septum, said antechamber being in fluid communication with said reservoir, said hypodermic needle adapted to be inserted through said self-sealing septum into said antechamber;

a valve means being disposed in said antechamber, said valve means adapted to be opened mechanically through placement of a portion of said hypodermic needle in a selected position, wherein said reservoir is in fluid communication with said antechamber only when said valve means is open, thereby causing movement of medication from said medication source into said reservoir due to the pressure differential between said medication source and said reservoir.

43. The apparatus of claim 42, wherein said valve means comprises a reciprocally mounted valve poppet which is adapted to be urged into an open position when said portion of said hypodermic needle is disposed in said preselected position, removal of said portion of said hypodermic needle from said preselected position causing said valve poppet to be urged into a closed position.

44. The apparatus of claim 43, wherein said valve poppet includes a valve seat surrounding a recess and said valve means further comprises a biasing means secured within said antechamber for holding said valve seat in sealing contact with said septum, until such time as said hypodermic needle presses against said recess bottom urging said poppet valve into an open position.

45. The apparatus of claim 42, wherein said antechamber further comprises an annular fluid manifold allowing fluid communication from said antechamber to said reservoir.

46. The apparatus of claim 45, wherein said annular fluid manifold further includes an annular filter means therein for filtering fluid communicated between said antechamber and said reservoir.

47. The apparatus of claim 42, wherein said medication infusion apparatus further comprises a filter means for filtering fluid communicated between said antechamber and said reservoir.

48. The apparatus of claim 42, further comprising a housing, said housing having a tapered entry port with the wide portion thereof opening through said housing, the narrower portion of said entry port being located adjacent to the entrance of said antechamber, said tapered entry port for guiding the entry of said hypodermic needle into said antechamber.

49. The apparatus of claim 48, wherein said tapered entry port is substantially conical in shape.

50. The apparatus of claim 42, wherein said reservoir includes:

a medication chamber for storing said selected medication having an expandable base portion for altering the volume of said medication chamber; and

,

a vapor chamber located adjacent to said medication chamber, wherein said expandable base portion is a common wall to said medication chamber and said vapor chamber, and wherein said vapor chamber has therein a fluid having a vapor pressure less than ambient pressure when said fluid is at the temperature of a living body.

51. A medication infusion apparatus adapted to be filled by a dispensing means, said medication infusion apparatus comprising:

a medication container having an input; and

,

a valve, operably disposed at said input of said medication container, said valve comprising a reciprocally mounted valve poppet adapted to be urged into an open position when a portion of said dispensing means is disposed in a preselected position in said medication infusion apparatus.

52. A combination in accordance with claim 51, wherein said input of said medication container comprises an antechamber, said apparatus comprising a housing having associated therewith said medication container, said housing having a tapered entry port with the wide portion thereof opening through said housing, the narrower portion of said entry port being located adjacent to the entrance of said portion of said dispensing means into said antechamber.

53. A combination in accordance with claim 52 wherein said tapered entry port is substantially conical in shape.

54. A combination in accordance with claim 52, wherein the tapered surface of said entry port is relatively smooth and hard.

55. A combination in accordance with claim 51, further comprising means responsive to the filling of said medication container for indicating when said medication container has disposed therein a preselected quantity of medication.

56. A combination in accordance with claim 55, wherein a portion of said medication container expands in proportion to the quantity of medication disposed therein, said responsive means comprising a switch which is tripped upon said expansion of said portion of said medication container.

57. A combination in accordance with claim 56, wherein said means responsive to the filling of said medication container further comprises signal means, the tripping of said switch activating said signal means.

58. A combination in accordance with claim 57, wherein said means responsive to the filling of said medication container further comprises means for telemetering the signal produced by said signal means;

receiving means for receiving said signal; and

indicating means for indicating when said signal is received by said receiver means, said indicating means being coupled to said receiving means.

59. A combination in accordance with claim 51, wherein said medication container comprises an antechamber and a reservoir, said valve being disposed therebetween for selectively isolating said antechamber from said reservoir, the volume of said antechamber when isolated from said reservoir being of a magnitude selected so that said antechamber cannot contain a lethal dose of a given medication selected to be infused by said medication infusion apparatus.

60. A combination in accordance with claim 51, wherein said medication container comprises an antechamber and a reservoir.

61. A combination in accordance with claim 60, wherein said valve disposed between said antechamber and said reservoir selectively isolates said antechamber from said reservoir.

62. A combination in accordance with claim 60, further comprising filter means for filtering fluid communicated between said antechamber and said reservoir.

63. A combination in accordance with claim 62, wherein said filter means comprises a filter having a pore size selected to preclude passage of bacteria therethrough.

64. A combination in accordance with claim 63, wherein said pore size is less than or equal to 2 microns.