Infusion reservoir and pump system

• US 4,588,394 A
• Filed: 03/16/1984
• Issued: 05/13/1986
• Est. Priority Date: 03/16/1984
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation (Medtronic Plc)
• Inventors: East, Gary P., Schulte, Rudolf R., Heindle, Alfons
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/590,349
• Time in Patent Office: 788 Days
• Field of Search: 604/8-10, 604/175, 604/181, 604/183, 604/185, 604/186, 604/891
• US Class Current: 604/9
• CPC Class Codes: A61M 5/1428 with manual pumping action

Abstract

A totally subcutaneously implantable infusion reservoir and pump system includes a variable capacity reservoir for receiving and storing fluids containing medications for delivery to a catheter which directs the medications to a specific infusion location in the body. A pump and a valving arrangement is interposed between the reservoir and the catheter to facilitate and control the transfer of the medications from the reservoir to the catheter in a safe and efficient manner. In one preferred form, a normally closed first valve is situated between the reservoir and a pump, and a normally closed second valve is situated between the pump and the catheter in a manner such that the pump and valving arrangement defines a portion of a fluid flow conduit between the reservoir and the catheter. The pump and valving arrangement requires at least two deliberate and sequential steps before the medications stored in the reservoir can be transferred to the catheter. As an additional safety feature, an integral flow occluder can be added to the pump and valving arrangement to prevent the emptying of the medications in the reservoir through the catheter into the body when both normally closed valves are opened simultaneously. When the system is used in the treatment of terminally ill patients, the catheter can be placed within the body to direct morphine or other pain killing medications directly into the lateral ventricle of the brain or into the lumbar subarachnoid space.

Claims

1. A normally closed valve for use in an infusion reservoir and pump system, said valve comprising:

a resiliently flexible housing having an inlet and an outlet;

an inlet chamber within said housing, said inlet chamber being in open communication with said inlet;

an outlet chamber within said housing, said outlet chamber generally overlying said inlet chamber and said outlet chamber being in open communication with said outlet;

a valve passageway through said housing between said inlet chamber and said outlet chamber, the portion of said housing generally surrounding said valve passageway forming a valve seat; and

a valve stem attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which sealingly engages said valve seat, the seal being replaceably broken when a housing cover overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

2. A valve as recited in claim 1 wherein said housing is constructed of a silicone elastomer material.

3. A valve as recited in claim 1 wherein said valve stem is constructed of a polypropylene material.

4. A valve as recited in claim 1 wherein said inlet chamber is defined, in part, by a reinforced sheet underlying said housing.

5. A valve as recited in claim 1 including an integral, rigid connector defining said outlet.

6. A valve as recited in claim 1 including a pumping chamber interposed between said outlet chamber and said outlet, said pumping chamber being defined generally by a hollow void created within said housing in a manner providing a resiliently flexible crown over said void which can be depressed to flush fluid from said pumping chamber.

7. A valve as recited in claim 6 including a rigid needle-guard forming a floor for said pumping chamber, said needle-guard preventing a needle which may be inserted through said crown from passing through said floor of said pumping chamber.

8. A valve as recited in claim 1 including means for occluding said outlet when said housing cover is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

40. A valve as recited in claim 1 including means for preventing a reverse flow of fluid through said valve.

41. A valve as recited in claim 40 wherein said preventing means includes a one-way valve situated within said inlet, said one-way valve blocking fluid outflow from said inlet.

9. A subcutaneously implantable infusion reservoir and pump system, comprising:

means for receiving medication into said system by injection when said system in subcutaneously implanted;

a reservoir securely attached to said receiving means in a manner permitting the subcutaneous transfer of medication from said receiving means to said reservoir, said reservoir including a reservoir outlet;

a catheter for directing the medication to a specific location in a body removed from said reservoir, said catheter having a catheter inlet and being positionable within the body independently of the position of said reservoir;

means for subcutaneously conducting the medication from said reservoir outlet to said catheter inlet; and

means for pumping and controlling the flow of medication from said reservoir to said catheter, said pumping and controlling means forming a portion of said conducting means and including normally closed valve means and a pump which is separated from said reservoir outlet and said catheter inlet by other portions of said conducting means.

10. A system as recited in claim 9 wherein said pump includes a pump inlet, a pump outlet, and a resilient crown overlying a floor plate to define a pumping chamber therebetween, said pump being actuated through manual percutaneous pressure applied to said resilient crown, when subcutaneously implated.

11. A system as recited in claim 10 wherein said receiving means includes a self-sealing dome overlying a rigid needle-shield to define an injection chamber therebetween, said needle-shield having a shield outlet passageway to permit the outflow of medication from said injection chamber into said reservoir through a reservoir inlet when the fluid pressure in said injection chamber exceeds the fluid pressure in said reservoir.

12. A system as recited in claim 11 wherein said reservoir inlet is resiliently biased to be normally situated adjacent an undersurface of said needle-shield, said reservoir inlet separating from said undersurface when the fluid pressure within said injection chamber is greater than the fluid pressure within said reservoir to allow fluid flow through said shield outlet passageway to said reservoir inlet.

13. A system as recited in claim 11 wherein said reservoir includes a flexible outer body capable of expanding to accommodate varying amounts of medication.

14. A system as recited in claim 13 further including a flexible tube extending from said reservoir outlet into said reservoir to channel fluids through said reservoir outlet notwithstanding a collapse of said reservoir about said reservoir outlet.

15. A system as recited in claim 10 including a one-way valve situated within said conducting means, said one-way valve causing fluid flow through said conducting means to be unidirectional.

16. A system as recited in claim 15 wherein said one-way valve is situated adjacent said reservoir outlet and includes a rigid encasement which protects a resilient one-way valve membrane situated within said encasement.

17. A system as recited in claim 10 wherein said catheter is constructed of a radiopaque, bariumimpregnated silicone elastomer material.

18. A system as recited in claim 9 wherein said normally closed valve means includes a normally closed first valve positioned between said reservoir and said pump.

19. A system as recited in claim 18 wherein said normally closed valve means further includes a normally closed second valve positioned between said pump and said catheter inlet.

20. A system as recited in claim 19 wherein said first valve includes a rigid first housing and a resilient first cover, said first housing forming a first lower inlet chamber which houses a flexible first valve diaphragm resiliently biased to close a first valve aperture through said first housing, and said first cover including means for displacing said first valve diaphragm away from said first valve aperture to open said first valve.

21. A system as recited in claim 20 wherein said second valve includes a rigid second housing and a resilient second cover, said second housing forming a second lower inlet chamber which houses a flexible second valve diaphragm resiliently biased to close a second valve aperture through said second housing, said second cover including means for displacing said second valve diaphragm away from said second valve aperture to open said second valve.

22. A system as recited in claim 20 wherein said displacing means includes a first knob attached to a lower surface of said first cover, said first knob being positioned to pass through said first valve aperture to displace said first valve diaphragm when said first cover is pressed downwardly, the displacement of said first valve diaphragm allowing the medication to pass from said first lower inlet chamber through said first valve aperture into a first upper outlet chamber, said first upper outlet chamber being in fluid communication with said pump.

23. A system as recited in claim 10 wherein said normally closed valve means comprises:

a resiliently flexible housing having an inlet and an outlet;

an inlet chamber within said housing, said inlet chamber being in fluid communication with said inlet;

an outlet chamber within said housing, said outlet chamber being in fluid communication with said outlet and said outlet chamber generally overlying said inlet chamber;

a valve passageway through said housing between said inlet chamber and said outlet chamber, an intermediate portion of said housing generally surrounding said valve passageway and being tapered to form a valve seat; and

a valve stem attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which cooperates with said valve seat to form a valve seal, said valve seal being replaceably broken when an upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

24. A system as recited in claim 23 wherein said pump is interposed between said outlet chamber and said outlet, said pump being defined generally be a hollow void created within said housing, said void forming said pumping chamber.

25. A system as recited in claim 24 wherein said floor plate forms a rigid needle-guard, said needle-guard preventing a needle which may be inserted through said crown from passing through said floor plate.

26. A system as recited in claim 23 including means for occluding said pump outlet and thereby preventing flow through said pump outlet when said upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

27. A subcutaneously implantable control assembly for use in an infusion reservoir and pump system, said assembly comprising:

a rigid housing and a resiliently flexible cover over said housing, said housing and said cover cooperating to substantially enclose and define a fluid flow passageway through said assembly;

a normally closed first valve formed at least in part by said housing and said cover, said first valve having a first valve inlet and a first valve outlet;

a pump having a pump outlet, a pump inlet in fluid communication with said first valve outlet, and a resilient crown formed at least in part by said cover and defining at least a portion of a pumping chamber; and

a normally closed second valve formed at least in part by said housing and said cover, said second valve having a second valve inlet and a second valve outlet, said second valve inlet being in fluid communication with said pump outlet;

said valves being opened and said pump being actuated by the selective application of percutaneous manual pressure to said cover when said assembly is subcutaneously implanted.

28. An assembly as recited in claim 27 wherein said housing forms a first lower inlet chamber in said first valve, said first lower inlet chamber supporting a first valve diaphragm resiliently biased to close a first valve aperture through said housing.

29. An assembly as recited in claim 28 wherein said housing forms a second lower inlet chamber in said second valve, said second lower inlet chamber supporting a second valve diaphragm resiliently biased to close a second valve aperture through said housing.

30. An assembly as recited in claim 29 wherein said cover includes means for displacing said first valve diaphragm away from said first valve aperture and said second valve diaphragm away from said second valve aperture.

31. An assembly as recited in claim 30 wherein said displacing means includes a first knob attached to a lower surface of said cover, said first knob being positioned to pass through said first valve aperture to displace said first valve diaphragm when said cover is pressed downwardly.

32. An assembly as recited in claim 30 wherein said displacing means includes a second knob attached to a lower surface of said cover, said second knob being positioned to pass through said second valve aperture to displace said second valve diaphragm when said cover is pressed downwardly.

33. A subcutaneously implantable control assembly for use in an infusion reservoir and pump system, said assembly comprising:

a normally closed first valve having a first valve inlet and a first valve outlet, said first valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted;

a pump having a pump outlet, a pump inlet in fluid communication with said first valve outlet, and a resilient crown defining at least a portion of a pumping chamber, said pump being manually actuable by the selective application of percutaneous pressure to depress said crown;

a normally closed second valve having a second valve inlet and a second valve outlet, said second valve inlet being in fluid communication with said pump outlet, and said second valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted;

a generally planar flexible sheet providing a base for said assembly;

a resilient first housing generally attached to and overlying said sheet, said first housing having a first inlet chamber in open communication with said first valve inlet and a first outlet chamber in open communication with a first housing outlet, said first housing being constructed so that a portion of said first outlet chamber generally overlies said first inlet chamber and so that a portion of said first housing outlet generally overlies both said portion of said first outlet chamber and said first inlet chamber, communication between said first inlet chamber and said first outlet chamber being provided by a first valve passageway generally aligned with and positioned below said portion of said first housing outlet; and

a first valve stem being attached to and extending downwardly from a first upper ceiling of said first outlet chamber through said first valve passageway and into said first inlet chamber, said first valve stem including a first lower foot which cooperates with a first valve seat provided by said first housing adjacent said first valve passageway to form a first valve seal, sad first valve seal being replaceably broken when a first housing cover overlying said first outlet chamber is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

34. An assembly as recited in claim 33 wherein said resilient crown forms a portion of said first housing, and said pumping chamber is positioned between said first outlet chamber and said first housing outlet.

35. An assembly as recited in claim 34 further including:

a second housing generally attached to and overlying said sheet, said second housing having a second inlet chamber in open communication with a second housing inlet and a second outlet chamber in open communication with said second valve outlet, said second housing being constructed so that a portion of said second outlet chamber generally overlies said second inlet chamber, communication between said second inlet chamber and said second outlet chamber being provided by a second valve passageway generally aligned with and positioned below said portion of said second outlet chamber; and

a second valve stem being attached to and extending downwardly from a second upper ceiling of said second outlet chamber through said second valve passageway and into said second inlet chamber.

36. An assembly as recited in claim 35 wherein said first and second housings are constructed of a silicone elastomer material.

37. An assembly as recited in claim 36 wherein said first and second valve stems are constructed of a material different then the material of said housings.

38. An assembly as recited in claim 34 including a rigid needle-guard forming a floor for said pumping chamber, said needle-guard preventing a needle which may be inserted through said crown for passing through said floor of said pumping chamber.

39. An assembly as recited in claim 33 including means for occluding said first housing outlet when said first housing cover is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

42. A process for infusing medications, comprising the steps of:

providing an infusion reservoir and pump system suitable for extended subcutaneous emplacement in the body, the system including a reservoir for storing medication, a catheter for directing the medication to a specific location within the body, and means for pumping and controlling the transfer of medication from the reservoir to the catheter, the pumping and controlling means including a pair of normally closed valves and a pump having a resilient crown overlying a floor plate to define a pumping chamber therebetween, the valves and pump being situated to require the medication to pass through a first valve, then the pump and finally through a second valve before being allowed to enter the catheter;

implanting the system subcutaneously within the body; and

transferring the medication from the reservoir to the catheter by applying percutaneous pressure directly to the valves and the resilient crown, the selective application of percutaneous pressure causing the valves to be selectively opened and the pump selectively actuated to effect the flow of medication therethrough.

43. A process as recited in claim 42 wherein percutaneous pressure is selectively applied to the first valve to manipulate and open the first valve for filling a pumping chamber of the pump, and wherein such percutaneous pressure is removed from the first valve to close the same after filling the pumping chamber.

44. A process as recited in claim 43 wherein percutaneous pressure is selectively applied to the second valve after similar percutaneous pressure has been removed from said first valve, to manipulate and open the second valve, and then percutaneous pressure is selectively applied to the pump to flush medication from the pumping chamber through the second valve.

45. A process as recited in claim 44 wherein the percutaneous pressure applied to the second valve is removed prior to removal of the percutaneous pressure on the pump, to avoid the sucking of medication into the pumping chamber through the second valve.

46. A process as recited in claim 42 including a further step of refilling the reservoir by injection subsequent to said step of implanting the system subcutaneously in the body.

47. A process as recited in claim 42 wherein during said implanting step the catheter is situated for delivering medication into the lateral ventricle of the brain.

48. A process as recited in claim 42 wherein during said implanting step the catheter is situated for delivering medication into the lumbar subarachnoid space of the body.

49. A process as recited in claim 42 wherein during said implainting step the reservoir is located adjacent a soft portion of the body so that the reservoir can be percutaneously grasped when subcutaneously implanted.

50. A process as recited in claim 42 wherein during said implanting step the pumping and controlling means is located generally adjacent a bone in the body.

68. A system as recited in claim 50 wherein said pump and said preventing means are constructed to form a single, integral control assembly unit which shares a common base, said control assembly unit having a unit inlet in fluid communication with said reservoir outlet and a unit outlet in fluid communication with said catheter inlet.

51. A subcutaneously implantable infusion reservoir and pump system, comprising:

means for receiving medication into said system by injection when said system is subcutaneously implanted;

a reservoir securely attached to said receiving means in a manner permitting the subcutaneous transfer of medication from said receiving means to said reservoir, said reservoir including a reservoir outlet;

a catheter for directing the medication to a specific location in a body removed from said reservoir, said catheter having a catheter inlet and being positionable within the body independently of the position of said reservoir;

means for subcutaneously conducting the medication from said reservoir outlet to said catheter inlet; and

means for pumping and controlling the flow of medication from said reservoir to said catheter, said pumping and controlling means forming a portion of said conducting means and being independently positionable along the length of said conducting means between said reservoir outlet and said catheter inlet, said pumping and controlline means further being actuated through manual percutaneous pressure when subcutaneously implanted, and being constructed to form a single, integral assembly having an assembly inlet in fluid communication with but separately positionable from said reservoir outlet, and an assembly outlet in fluid communication with but separately positionable from said catheter inlet.

53. A system as recited in claim 51 wherein said pump is interposed between said outlet chamber and said outlet, said pump being defined generally by a hollow void created within said housing, said void forming said pumping chamber.

54. A system as recited in claim 53 wherein said floor plate forms a rigid needle-guard, said needle-guard preventing a needle which may be inserted through said crown from passing through said floor plate.

52. A subcutaneously implantable infusion reservoir and pump system, comprising:

means for receiving medication into said system by injection when said system is subcutaneously implanted;

a reservoir securely attached to said receiving means in a manner permitting the subcutaneous transfer of medication from said receiving means to said reservoir, said reservoir including a reservoir outlet;

a catheter for directing the medication to a specific location in a body removed from said reservoir, said catheter having a catheter inlet and being positionable within the body independently of the position of said reservoir;

means for subcutaneously conducting the medication from said reservoir outlet to said catheter inlet; and

means for pumping and controlling the flow of medication from said reservoir to said catheter, said pumping and controlling means forming a portion of said conducting means and being independently positionable along the length of said conducting means between said reservoir outlet and said catheter inlet and further being actuated through manual percutaneous pressure when subcutaneously implanted, said pumping and controlling means comprising;

a pump having a pump inlet, a pump outlet, and a resilient crown overlying a floor plate to define a pumping chamber therebetween;

a resiliently flexible housing having an inlet and an outlet;

an inlet chamber within said housing, said inlet chamber being in fluid communication with said inlet;

an outlet chamber within said housing, said outlet chamber being in fluid communication with said outlet and said outlet chamber generally overlying said inlet chamber;

a valve passageway through said housing between said inlet chamber and said outlet chamber, an intermediate portion of said housing generally surrounding said valve passageway and being tapered to form a valve seat; and

a valve stem attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which cooperates with said valve seat to form a valve seal, said valve seal being replaceably broken when an upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

55. A system as recited in claim 52 including means for occluding said pump outlet and thereby preventing flow through said pump outlet when said upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

56. A subcutaneously implantable infusion reservoir and pump system, comprising:

means for receiving medication into said system by injection when said system is subcutaneously implanted;

a reservoir for storing medication injected into said receiving means, said reservoir including a reservoir outlet;

a normally closed first valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted, said first valve including;

a resiliently flexible housing having an inlet in fluid communication with said reservoir outlet, and an outlet,

an inlet chamber within said housing, said inlet chamber communicating with said inlet,

an outlet chamber within said housing, said outlet chamer communicating with said outlet and said outlet chamber generally overlying said inlet chamber,

a valve passageway through said housing between said inlet chamber and said outlet chamber, an intermediate portion of said housing generally surrounding said valve passageway and being tapered to form a valve seat, and

a valve stem attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which cooperates with said valve seat to form a valve seal, said valve seal being replaceably broken when an upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway;

a pump having a pump inlet in fluid communication with said first valve outlet, a pump outlet, and a resilient crown defining at least a portion of a pumping chamber, said pump being manually actuable by the selective application of percutaneous pressure;

a normally closed second valve having a second valve inlet in fluid communication with said pump outlet, and a second valve outlet, said second valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted; and

a catheter for directing medication to a specific location removed from said reservoir, said catheter having a catheter inlet in fluid communication with said second valve outlet.

57. A system as recited in claim 56 wherein said pump is interposed between said outlet chamber and said outlet, said pump being defined generally by a hollow void created within said housing, said void forming said pumping chamber.

58. A subcutaneously implantable infusion reservoir and pump system, comprising:

means for receiving medication into said system by injection when said system is subcutaneously implanted;

a reservoir for storing medication injected into said receiving means, said reservoir including a reservoir outlet;

a normally closed first valve having a first valve inlet in fluid communication with said reservoir outlet, and a first valve outlet, said first valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted;

a pump having a pump inlet in fluid communication with said first valve outlet, a pump outlet, and a resilient crown defining at least a portion of a pumping chamber, said pump being manually actuable by the selective application of percutaneous pressure;

a normally closed second valve being opened to fluid flow therethrough by percutaneous manual manipulation when subcutaneously implanted, said second valve including;

a resiliently flexible housing having an inlet in fluid communication with said pump outlet, and an outlet,

an inlet chamber within said housing, said inlet chamber communicating with said inlet,

an outlet chamber within said housing, said outlet chamber communicating with said outlet and said outlet chamber generally overlying said inlet chamber,

a valve passageway through said housing between said inlet chamber and said outlet chamber, an intermediate portion of said housing generally surrounding said valve passageway and being tapered to form a valve seat, and

a valve stem attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which cooperates with said valve seat to form a valve seal, said valve seal being replaceably broken when an upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway; and

a catheter for directing medication to a specific location removed from said reservoir, said catheter having a catheter inlet in fluid communication with said second valve outlet.

59. An infusion reservoir and pump system for the administration of medication to a human body, said system comprising:

means for subcutaneously receiving the medication into said system by injection, said receiving means including a self-sealing dome overlying a rigid needle-shield to define an injection chamber therebetween, said needle-shield having a shield outlet passageway to permit the medication to exit said injection chamber;

a variable capacity reservoir securely attached to said receiving means, said reservoir including a reservoir inlet and a reservoir outlet, said reservoir inlet cooperating with said needle-shield and said shield outlet passageway to permit the transfer of the medication from said receiving means to said reservoir when the fluid pressure of the medication in said injection chamber exceeds the fluid pressure of the medication in said reservoir;

a catheter for directing the medication to a specific location in the body, said catheter having a catheter inlet;

means for conducting the medication of said reservoir outlet to said catheter inlet;

a one-way valve situated within said conducting means, said one-way valve causing the flow of the medication through said conducting means to be unidirectional;

a pump forming a portion of said conducting means, said pump including a resilient crown overlying a floor plate to define a pumping chamber therebetween, said pump having a pump inlet which receives medication from said reservoir and a pump outlet which can be placed in fluid communication with said catheter inlet; and

means for preventing the unintended transfer of medication from said reservoir through said conducting means to said catheter, said preventing means cooperating with said pump to require at least a two-step procedure to transfer a measured quantity of the medication from said reservoir through said pump to said catheter inlet, said preventing means including a normally closed first valve forming a portion of said conducting means between said reservoir and said pump, said first valve including a rigid first housing and a resilient first cover, sad first housing forming a first lower inlet chamber which houses a flexible first valve diaphragm resiliently biased to close a first valve aperture through said first housing, and said first cover including means for displacing said first valve diaphragm away from said first valve aperture to open said first valve.

60. A system as recited in claim 59 wherein said reservoir inlet is resiliently biased to be normally situated adjacent a solid flat undersurface of said needle-shield, said reservoir inlet separating from said undersurface when the fluid pressure within said injection chamber is greater than the fluid pressure within said reservoir to allow the medication in said injection chamber to flow through said shield outlet passageway to said reservoir inlet.

61. A system as recited in claim 59 wherein said reservoir inlet cooperates with said receiving means to prevent the medication stored in said reservoir from flowing into said receiving means.

62. A system as recited in claim 59 wherein said one-way valve is situated within said reservoir outlet.

63. A system as recited in claim 62 wherein said one-way valve includes a rigid encasement which protects a resilient one-way valve membrane situated within said encasement.

64. A system as recited in claim 59 further including a flexible tube extending from said reservoir outlet into said reservoir to channel the medication through said reservoir outlet notwithstanding a collapse of said reservoir about said reservoir outlet.

65. A system as recited in claim 59 wherein said catheter is sized for insertion into the lumbar subarachnoid space of the body.

66. A system as recited in claim 59 wherein said catheter is sized for insertion into the lateral ventricle of a brain.

67. A system as recited in claim 59 wherein said catheter is constructed of a radiopaque, barium-impregnated silicone elastomer material.

69. A system as recited in claim 59 wherein said displacing means includes a first knob attached to a lower surface of said first cover, said first knob being positioned to pass through said first valve aperture to displace said fist valve diaphragm when said first cover is pressed downwardly, the displacement of said first valve diaphragm allowing the medication to pass from said first lower inlet chamber through said first valve aperture into a first upper outlet chamber, said first upper outlet chamber being in open communication with said pump inlet.

70. A system as recited in claim 59 wherein said preventing means further includes a normally closed second valve forming a portion of said conducting means between said pump and said catheter inlet.

71. A system as recited in claim 70 wherein said second valve includes a rigid second housing and a resilient second cover, said second housing forming a second lower inlet chamber which houses a flexible second valve diaphragm resiliently biased to close a second valve aperture through said second housing, said second cover including means for displacing said second valve diaphragm away from said second valve aperture to open said second valve.

72. An infusion reservoir and pump system for the administration of medication to a human body, said system comprising:

means for subcutaneously receiving the medication into said system by injection, said receiving means including a self-sealing dome overlying a rigid needle-shield to define an injection chamber therebetween, said needle-shield having a shield outlet passageway to permit the medication to exit said injection chamber;

a variable capacity reservoir securely attached to said receiving means, said reservoir including a reservoir inlet and a reservoir outlet, said reservoir inlet cooperating with said needle-shield and said shield outlet passageway to permit the transfer of the medication from said receiving means to said reservoir when the fluid pressure of the medication in said injection chamber exceeds the fluid pressure of the medication in said reservoir;

a catheter for directing the medication to a specific location in the body, said catheter having a catheter inlet;

means for conducting the medication from said reservoir outlet to said catheter inlet;

a one-way valve situated within said conducting means, said one-way valve causing the flow of the medication through said conducting means to be unidirectional;

a pump forming a portion of said conducting means, said pump including a resilient crown overlying a floor plae to define a pumping chamber therebetween, said pump having a pump inlet which receives medication from said reservoir and a pump outlet which can be placed in fluid communication with said catheter inlet; and

means for preventing the unintended transfer of medication from said reservoir through said conducting means to said catheter, said preventing means cooperating with said pump to require at least a two-step procedure to transfer a measured quantity of the medication from said reservoir through said pump to said catheter inlet, said preventing means including a normally closed first valve forming a portion of said conducting means between said reservoir and said pump, and a normally closed second valve forming a portion of said conducting means between said pump and said catheter inlet, said second valve including a rigid housing and a resilient cover, said housing forming a lower inlet chamber which houses a flexible valve diaphragm resiliently biased to close a valve aperture through said housing, and said cover including means for displacing said valve diaphragm away from said valve aperture to open said second valve.

73. An infusion reservoir and pump system for the administration of medication to a human body, said system comprising:

means for subcutaneously receiving the medication into said system by injection, said receiving means including a self-sealing dome overlying a rigid needle-shield to define an injection chamber therebetween, said needle-shield having a shield outlet passageway to permit the medication to exit said injection chamber;

a variable capacity reservoir securely attached to said receiving means, said reservoir including a reservoir inlet and a reservoir outlet, said reservoir inlet cooperating with said needle-shield and said shield outlet passageway to permit the transfer of the medication from said receiving means to said reservoir when the fluid pressure of the medication in said injection chamber exceeds the fluid pressure of the medication in said reservoir;

a catheter for directing the medication to a specific location in the body, said catheter having a catheter inlet;

means for conducting the medication from said reservoir outlet to said catheter inlet;

a one-way valve situated within said conducting means, said one-way valve causing the flow of the medication through said conducting means to be unidirectional;

a pump forming a portion of said conducting means, said pump including a resilient crown overlying a floor plate to define a pumping chamber therebetween, said pump having a pump inlet which receives medication from said reservoir and a pump outlet which can be placed in fluid communication with said catheter inlet; and

means for preventing the unintended transfer of medication from said reservoir through said conducting means to said catheter, said preventing means cooperating with said pump to require at least a two-step procedure to transfer a measured quantity of the medication from said reservoir through said pump to said catheter inlet, said preventing means including;

a resiliently flexible housing having an inlet and an outlet,

an inlet chamber within said housing, said inlet chamber being in open communication with said inlet;

an outlet chamber within said housing, said outlet chamber being in open communication with said outlet and said outlet chamber generally overlying said inlet chamber,

a valve passageway through said housing between said inlet chamber and said outlet chamber, an intermediate portion of said housing generally surrounding said valve passageway, said intermediate portion of said housing being tapered to form a valve seat, and

a valve stem constructed of a material different from the material of said housing, said valve stem being attached to and extending downwardly from an upper ceiling of said outlet chamber through said valve passageway and into said inlet chamber, said valve stem including a lower foot which cooperates with said valve seat to form a valve seal, said valve seal being replaceably broken when an upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

74. A system as recited in claim 73 wherein said housing is constructed of a silicone elastomer material.

75. A system as recited in claim 74 wherein said valve stem is constructed of a polypropylene material.

76. A system as recited in claim 73 wherein said inlet chamber is defined, in part, by a reinforced sheet underlying said housing.

77. A system as recited in claim 73 including an integral rigid connector defining said outlet.

78. A system a recited in claim 73 wherein said pump is interposed between said outlet chamber and said outlet, said pump being defined generally by a hollow void created within said housing, said void forming said pumping chamber.

79. A system as recited in claim 78 wherein said floor plate forms a rigid needle-guard, said needle-guard preventing a needle which may be inserted through said crown from passing through said floor plate.

80. A system as recited in claim 73 including means for occluding said pump outlet and thereby preventing flow through said pump outlet when said upper cover portion of said housing overlying said outlet chamber is resiliently deformed to cause the downward movement of said valve stem through said valve passageway.

81. A system as recited in claim 73 wherein said one-way valve is situated within said inlet.

82. An infusion reservoir and pump system for the administration of medications, said system comprising:

means for receiving the medications into said system by injection;

a reservoir securely attached to said receiving means in a manner permitting the transfer of the medications from said receiving means to said reservoir, said reservoir including a reservoir inlet and a reservoir outlet;

a normally closed first valve having a first valve inlet and a first valve outlet, said first valve inlet being in open communication with said reservoir outlet;

a pump having a pump inlet and a pump outlet, said pump inlet being in open communication with said first valve outlet;

a normally closed second valve having a second valve inlet and a second valve outlet, said second valve inlet being in open communication with said pump outlet; and

a catheter having a catheter inlet in open communication with said second valve outlet;

said first valve, said pump and said second valve being combined to form a single, integral control assembly unit, said unit having a unit inlet generally corresponding to said first valve inlet and a unit outlet generally corresponding to said second valve outlet, said unit further comprising a resiliently rigid housing and a resiliently flexible cover over said housing, said housing and said cover cooperating to substantially enclose and define a fluid flow passageway through said unit, said housing forming a first lower inlet chamber in said first valve, said first lower inlet chamber supporting a first valve diaphragm resiliently biased to close a first valve aperture through said housing.

83. A system as recited in claim 82 wherein said housing forms a second lower inlet chamber in said second valve, said second lower inlet chamber supporting a second valve diaphragm resiliently biased to close a second valve aperture through said housing.

84. A system as recited in claim 83 wherein said cover includes means for displacing said first valve diaphragm away from said first valve aperture and said second valve diaphragm away from said second valve aperture.

85. A system as recited in claim 84 wherein said displacing means includes a first knob attached to a lower surface of said cover, said first knob being positioned to pass through said first valve aperture to displace said first valve diaphragm when said cover is pressed downwardly.

86. A system as recited in claim 84 wherein said displacing means includes a second knob attached to a lower surface of said cover, said second knob being positioned to pass through said second valve aperture to displace said second valve diaphragm when said cover is pressed downwardly.

87. An infusion reservoir and pump system for the administration of medications, said system comprising:

means for receiving the medications into said system by injection;

a reservoir securely attached to said receiving means in a manner permitting the transfer of the medications from said receiving means to said reservoir, said reservoir including a reservoir inlet and a reservoir outlet;

a normally closed first valve having a first valve inlet and a first valve outlet, said first valve inlet being in open communication with said reservoir outlet;

a pump having a pump inlet and a pump outlet, said pump inlet being in open communication with said first valve outlet;

a normally closed second valve having a second valve inlet and a second valve outlet, said second valve inlet being in open communication with said pump outlet; and

a catheter having a catheter inlet in open communication with said second valve outlet;

said first valve, said pump and said second valve being combined to form a single, integral control assembly unit, said unit having a unit inlet generally corresponding to said first valve inlet and a unit outlet generally corresponding to said second valve outlet, said unit further comprising;

a generally planar flexible sheet providing a base for said unit,

a resilient first housing generally attached to and overlying said sheet, said first housing having a first inlet chamber in open communication with said unit inlet and a first outlet chamber in open communication with a first housing outlet, said first housing being constructed so that a portion of said first outlet chamber generally overlies said first inlet chamber and so that a portion of said first housing outlet generally overlies both said portion of said first outlet chamber and said first inlet chamber, said first inlet chamber and said first outlet chamber being connected to one another by a first valve passageway generally aligned with and positioned below said portion of said first housing outlet, and

a first valve stem constructed of a material different than the material of said first housing, said first valve stem being attached to and extending downwardly from a first upper ceiling of said first outlet chamber through said first valve passageway and into said inlet chamber, said first valve stem including a first lower foot which cooperates with a first valve seat provided by said first housing adjacent said first valve pasageway to form a first valve seal, said first valve seal being replaceably broken when a first housing cover overlying said first outlet chamber is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

88. A system as recited in claim 87 wherein said unit further includes a pumping chamber forming a void within said first housing, said pumping chamber being positioned between said first outlet chamber and said first housing outlet.

89. A system as recited in claim 88 wherein said unit further includes:

a second housing generally attached to and overlying said sheet, said second housing having a second inlet chamber in open communication with a second housing inlet and a second outlet chamber in open communication with said unit outlet, said second housing being constructed so that a portion of said second outlet chamber generally overlies said second inlet chamber, said second inlet chamber and said second outlet chamber being connected to one another by a second valve passageway generally aligned with and positioned below said portion of said second outlet chamber; and

a second valve stem constructed of a material different than the material of said second housing, said second valve stem being attached to and extending downwardly from a second upper ceiling of said second outlet chamber through said second valve passageway and into said second inlet chamber.

90. A system as recited in claim 89 wherein said first and second housings are constructed of a silicone elastomer material.

91. A system as recited in claim 90 wherein said first and second valve stems are constructed of a polypropylene material.

92. A system as recited in claim 88 including a rigid needle-guard forming a floor for said pumping chamber, said needle-guard preventing a needle which may be inserted through said first housing from passing through said floor of said pumping chamber.

93. A system as recited in claim 87 including means for occluding said first housing outlet when said first housing cover is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

94. A valve and pump device for use in an infusion reservoir and pump system, said device comprising:

an inlet;

an outlet;

a normally closed first valve situated generally adjacent and in fluid communication with said inlet;

a normally closed second valve situated generally adjacent and in fluid communication with said outlet;

a pump interposed between and in fluid communication with said first valve and said second valve, said device being constructed of materials suitable for subcutaneous implantation over extended periods of time;

a resiliently rigid housing and resiliently flexible cover over said housing, said housing and said cover cooperating to substantially enclose and define a fluid flow passageway through said device, said housing forming a first lower inlet chamber for said first valve, said first lower inlet chamber supporting a first valve diaphragm resiliently biased to close a first valve aperture through said housing, and a second lower inlet chamber for said second valve, said second lower inlet chamber supporting a second valve diaphragm resilient biased to close a second valve aperture through said housing, said cover including means for displacing said first valve diaphragm away from said first valve aperture and said second valve diaphragm away from said second valve aperture.

95. A device as recited in claim 94 wherein said displacing means includes a first knob attached to a lower surface of said cover, said first knob being positioned to pass through said first valve aperture to displace said first valve diaphragm when said cover is pressed downwardly.

96. A device as recited in claim 94 wherein said displacing means includes a second knob attached to a lower surface of said cover, said second knob being positioned to pass through said second valve aperture to displace said second valve diaphragm when said cover is pressed downwardly.

97. A valve and pump device for use in an infusion reservoir and pump system, said device comprising:

an inlet;

an outlet;

a normally closed first valve situated generally adjacent and in fluid communication with said inlet;

a normally closed second valve situated generally adjacent and in fluid communication with said outlet;

a pump interposed between and in fluid communication with said first valve and said second valve, said device being constructed of materials suitable for subcutaneous implantation over extended periods of time;

a generally planar flexible sheet providing a base for said device;

a first housing generally attached to and overlying said sheet, said first housing having a first inlet chamber in open communication with said inlet and a first outlet chamber in open communication with a first housing outlet, said first housing being constructed so that a portion of said first outlet chamber generally overlies said first inlet chamber and so that a portion of said first housing outlet generally overlies both said portion of said first outlet chamber and said first inlet chamber, said first inlet chamber and said first outlet chamber being connected to one another by a first valve passageway generally aligned with and positioned below said portion of said first housing outlet; and

a first valve stem constructed of a material different than the material of said first housing, said first valve stem being attached to and extending downwardly from a first upper ceiling of said first outlet chamber through said first valve passageway and into said first inlet chamber, said first valve stem including a first lower foot which cooperates with a first valve seat provided by that portion of said first housing generally surrounding said first valve passageway to form a first valve seal therebetween, said first valve seal being replaceably broken when a first housing cover overlying said first outlet chamber is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

98. A device as recited in claim 97 wherein said pump includes a pumping chamber forming a void within said first housing, said pumping chamber being positioned between said first outlet chamber and said first housing outlet for receiving fluid from said first outlet chamber and exhausting the fluid into said first housing outlet.

99. A device as recited in claim 98 including:

a second housing generally attached to and overlying said sheet, said second housing having a second inlet chamber in open communication with said first housing outlet and a second outlet chamber in open communication with said outlet, said second outlet chamber generally overlying said second inlet chamber, said second inlet chamber and said second outlet chamber being connected to one another by a second valve passageway; and

a second valve stem constructed of a material different from the material of said second housing, said second valve stem being attached to and extending downwardly from a second upper ceiling of said second outlet chamber through said second valve passageway and into said second inlet chamber, said second valve stem including a second lower foot which cooperates with a second valve seat provided by that portion of said second body generally surrounding said second valve passageway to form a second valve seal therebetween, said second valve seal being replaceably broken when a second housing cover overlying said second outlet chamber is resiliently deformed to cause the downward movement of said second valve stem through said second valve passageway.

100. A device as recited in claim 99 wherein said first and second housings are constructed of a silicone elastomer material and said first and second valve stems are constructed of a polypropylene material.

101. A device as recited in claim 97 including an integral, rigid connector defining said outlet.

102. A device as recited in claim 98 including a rigid needle-guard forming a floor for said pumping chamber, said needle-guard preventing a needle which may be inserted through said first housing from passing through said floor of said pumping chamber.

103. A device as recited in claim 98 including means for occluding said first housing outlet when said first housing cover is resiliently deformed to cause the downward movement of said first valve stem through said first valve passageway.

104. A process for infusing medications, comprising the steps of:

providing an infusion reservoir and pump system constructed of materials suitable for extended subcutaneous emplacement in the body, the system including a reservoir for receiving and storing the medications, a catheter for directing the medications to a specific location within the body, a fluid flow conduit connecting the reservoir and the catheter, and a pump and valving arrangement forming a portion of the fluid flow conduit;

implanting the system subcutaneously in the body; and

transferring the medications from the reservoir through the fluid flow conduit to the catheter for delivery of the medications to the body, the flow of the medications through the fluid flow conduit being controlled by the pump and valving arrangement;

wherein said pump and valving arrangement is located so that it can be percutaneously manipulated when subcutaneously implanted to pump measured quantities of the medications through the system during said transferring step, and includes a pair of normally closed valves and a pump, and during said transferring step the valves are manipulated to cause each to open for permitting fluid flow therethrough, and the pump is similarly manipulated to cause a pumping chamber within the pump to be evacuated for propelling the medications through the pump and valving arrangement;

said step of providing the system includes situating the pair of valves within the fluid flow conduit to require the medications to pass through a first valve, then the pump and finally a second valve before being allowed to enter said catheter during said transferring step; and

said transferring step requiring the first valve to be manually manipulated percutaneously to open and permit the medications to flow from the reservoir to fill the pumping chamber.

105. A process as recited in claim 104 including a further step of refilling the reservoir by injection subsequent to said step of implanting the system subcutaneously in the body.

106. A process as recited in claim 104 wherein during said implanting step the catheter is situated for delivering the medications into the lateral ventricle of the brain.

107. A process as recited in claim 104 wherein during said implanting step the catheter is situated for delivering the medications into the lumbar subarachnoid space of the body.

108. A process as recited in claim 104 wherein during said implanting step the reservoir is located adjacent a soft portion of the body so that the reservoir can be percutaneously grasped when subcutaneously implanted.

109. A process as recited in claim 104 wherein during said implanting step the pump and valving arrangement is located generally adjacent a bone in the body.

110. A process as recited in claim 104 wherein said transferring step requires the second valve and the pump to be manually manipulated percutaneously to simultaneously open the second valve and flush the pumping chamber to direct the medications to the catheter.