Medication infusion device with dose recharge restriction

• US 5,152,753 A
• Filed: 04/02/1990
• Issued: 10/06/1992
• Est. Priority Date: 04/02/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation (Medtronic Plc)
• Inventors: Laguette, Stephen W., Carlisle, Thomas J., Watson, David A., East, Gary P.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/503,426
• Time in Patent Office: 918 Days
• Field of Search: 604/93, 604/153, 604/891.1, 604/140, 604/890.1, 604/181, 604/183, 604/185, 604/186, 128/DIG. 12
• US Class Current: 604/153
• CPC Class Codes: A61M 5/1428 with manual pumping action

Abstract

A subcutaneously implantable medication infusion device includes a variable capacity reservoir for receiving and storing fluid medication for delivery to a catheter which directs the medication to a specific infusion location in the body. A control assembly is interposed between the reservoir and the catheter to facilitate and control the transfer of the medication from the reservoir to the catheter in a safe and efficient manner. The control assembly includes a self-recharging pump and a normally closed valve, both of which are manually actuable by percutaneous pressure when subcutaneously implanted, and defines a portion of a fluid flow conduit between the reservoir and the catheter. The control assembly is constructed to permit the infusion of a measured bolus of medication on demand through manual percutaneous manipulation of the control assembly. A restrictor is provided the control assembly to limit the rate the pump is recharged with medication, to restrict the total amount of medication which can be pumped into the catheter over a given period of time. In one preferred form, the pump recharge restriction is created by providing at least one capillary-like fluid pathway through which the recharge fluid must pass before entering the pump. In another preferred form of the invention, the recharge flow rate of medication into the pump is restricted by a wick restrictor.

Claims

1. A fluid control assembly, comprising:

a self-recharging, manually actuable pump for discharging a measured amount of fluid from a pumping chamber,

means for conducting pump recharge fluid into the pumping chamber;

means for conducting discharge fluid from the pumping chamber;

valve means, actuable by manual percutaneous manipulation, for controlling the flow of discharge fluid from the pumping chamber, the valve means forming a portion of the discharge fluid conducting means, the valve means including a normally closed valve having a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pumping chamber, a valve outlet, and a valve passageway situated between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and wherein the recharge fluid conducting means extends at least partially through the valve body; and

means for restricting the rate of fluid flow through the recharge fluid conducting means, wherein the restricting means limits the amount of recharge fluid permitted to enter into the pumping chamber over a given period of time, the restricting means including at least one capillary-like fluid pathway through which the recharge fluid must pass before entering the pumping chamber, wherein the restricting means is positioned relative to the valve means such that actuation of the valve means causes an occlusion of the restricting means to prevent fluid flow through the restricting means.

2. A fluid control assembly as set forth in claim 1, wherein the normally closed valve includes a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation.

3. A fluid control assembly as set forth in claim 2, wherein the restricting means is positioned relative to the displacement finger so that manipulation of the valve means to move the displacement finger, which opens the discharge fluid conducting means, occludes the at least one capillary-like fluid pathway to close the recharge fluid conducting means.

4. A fluid control assembly as set forth in claim 1, wherein the pump includes a pump inlet in fluid communication with the recharge fluid conducting means, a pump outlet in fluid communication with the discharge fluid conducting means, and a resilient crown overlying a floor plate to define the pumping chamber therebetween.

5. An infusion reservoir and pump system, comprising:

means for receiving medication into the system by injection, including an injection port including an elastomeric outer housing having an integral elastomeric septum, a first base member situated within the outer housing and contiguously engaging a first peripheral portion of the septum, a second base member situated within the first base member and within the outer housing, wherein the second base member contiguously engages the first peripheral portion of the septum opposite to the first base member, such that the septum is compressed between the first and second base member, and an outlet extending from an internal chamber between the septum and the second base member, exteriorly through the outer housing;

a reservoir fluidly connected to the receiving means in a manner permitting the subcutaneous transfer of medication from the receiving means to the reservoir;

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

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

means for controlling the flow of medication from the reservoir to the catheter, the controlling means forming a portion of the conducting means and including normally closed valve means and a pump for flushing a measured quantity of medication into the catheter when the normally closed valve means is opened; and

means for restricting the flow of medication from the reservoir to the pump, and this limiting the rate that pump is recharged, to restrict the total amount of medication which can be pumped into the catheter over a given period of time.

6. A system as set forth in claim 5, wherein the elastomeric outer housing of the injection port includes an upper dome attached to a lower reinforced sheet, the upper dome including a lower flange sealed to the reinforced sheet, a frusto-conical side wall extending upwardly from the lower flange, and the septum which is integrally formed with the side wall and supported thereby in spaced relation to the lower reinforced sheet.

7. A system as set forth in claim 6, wherein the first peripheral portion of the septum extends circumferentially outwardly from a body portion of the septum between the side wall and the lower reinforced sheet, and wherein the first base member comprises a generally frusto-conical ring configured to engage and support an interior surface of the side wall, and a rigid upper flange which overlies the first peripheral portion of the septum to provide a rigid barrier between the first peripheral portion of the septum and the adjacent side wall portions, wherein the upper flange circumscribes the septum and engages the first peripheral portion of the septum.

8. A system as set forth in claim 7, wherein the second base member is cup-shaped and includes a floor and a continuous wall which extends upwardly therefrom, wherein the continuous wall projects from the floor to engage an inner surface of the first base member in an interference fit, wherein the second base member, with the septum, defines an internal injection chamber and forms a needle shield adjacent to the lower reinforced sheet, the second base member including an upper septum-engaging section which extends upwardly from the continuous wall to underlie the first peripheral portion of the septum and compress the first peripheral portion of the septum between the upper flange of the first base member and the upper septum-engaging section of the second base member.

9. A system as set forth in claim 5, wherein the reservoir includes a flexible outer body capable of expanding to accommodate varying amounts of medication.

10. A system as set forth in claim 5, wherein the normally closed valve means includes a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pump, a valve outlet in fluid communication with the catheter inlet, and a valve passageway situated directly between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway.

11. A system as set forth in claim 10, wherein the normally closed valve means includes a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation.

12. A system as set forth in claim 11, wherein the restricting means includes at least one capillary-like fluid pathway through which medication must pass before entering the pump, wherein the restricting means is positioned within the valve body relative to the displacement finger so that manipulation of the valve means to move the displacement finger occludes the at least one capillary-like fluid pathway to close that portion of the conducting means defined by the restricting means.

13. A system as set forth in claim 10, wherein the restricting means includes a wick restrictor having a plurality of wicking fibers situated within an impermeable wick housing, wherein the wick restrictor is positioned within a portion of the conducting means such that all fluid drawn into the pump must first pass through the wick restrictor.

14. A system as set forth in claim 13, wherein one end of the wick housing is occluded, and an inlet is provided adjacent to the occluded end through a wall of the wick housing.

15. A system as set forth in claim 5, wherein the pump includes a pump inlet in fluid communication with the reservoir, a pump outlet in fluid communication with the valve means, and a resilient crown overlying a floor plate to define a pumping chamber therebetween.

16. A subcutaneously implantable medication infusion control assembly having a medicament recharge restriction, comprising:

an injection port for receiving medication into the system by injection;

a self-recharging, manually actuable pump for discharging a measured amount of medication from a pumping chamber;

means for conducting pump recharge medication into the pumping chamber;

means for conducting discharge medication from the pumping chamber;

valve means, actuable by manual percutaneous manipulation, for controlling the flow of discharge medication from the pumping chamber, the valve means forming a portion of the discharge medication conducting means, the valve means including a normally closed valve having a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pumping chamber, a valve outlet, and a valve passageway situated between the valve inlet and the valve outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and a displacement finger situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation; and

means for restricting the rate of medication flow through the recharge medication conducting means, wherein the restricting means limits the amount of recharge medication permitted to enter into the pumping chamber over a given period of time;

wherein the recharge medication conducting means extends at least partially through the valve body.

17. A control assembly as set forth in claim 16, wherein the injection port comprises:

an elastomeric outer housing including an upper dome attached to a lower reinforced sheet, the upper dome including a lower flange sealed to the reinforced sheet, a frusto-conical side wall extending outwardly from the lower flange, and a septum integrally formed with the side wall and supported thereby in spaced relation to the lower reinforced sheet;

a rigid outer base member enclosed within the elastomeric outer housing, the outer base member including a rigid upper flange positioned to circumscribe the septum and engage a first peripheral portion of the septum; and

a rigid inner base member enclosed within the elastomeric outer housing, the inner base member being situated within and engaging the outer base member in an interference fit to define, with the septum, an internal injection chamber and form a needle shield adjacent to the lower reinforced sheet, wherein the inner base member includes an upper septum-engaging section which engages the first peripheral portion of the septum opposite to the rigid upper flange to compress it therebetween.

18. A control assembly as set forth in claim 16, wherein the restricting means includes at least one capillary-like fluid pathway through which the recharge medication must pass before entering the pumping chamber, and wherein the restricting means is positioned relative to the displacement finger such that manipulation of the valve means to move the displacement finger, which opens the discharge medication conducting means, occludes the at least one capillary-like fluid pathway to close the recharge medication conducting means.

19. A control assembly as set forth in claim 16, wherein the restricting means includes a wick restrictor having a plurality of wicking fibers situated within an impermeable wick housing, the wick restrictor being positioned within a portion of the recharge medication conducting means so that all fluid drawn into the pumping chamber must first pass through the wick restrictor, wherein one end of the wick housing is occluded and an inlet is provided adjacent to the occluded end through a wall of the wick housing.

20. A process for infusing medication, the steps comprising:

implanting an infusion system constructed of materials suitable for extended subcutaneous emplacement in the body, the infusion system including a self-recharging, manually actuable pump having a pump inlet and a pump outlet, and a normally closed valve actuable by manual percutaneous manipulation for controlling the flow of fluid from the pump;

receiving medication into the system by injection;

storing the injected medication;

opening the normally closed valve by applying percutaneous pressure thereto, to permit medication in the pump to be discharged through the pump outlet;

occluding the pump inlet to prevent medication from entering the pump when the normally closed valve is opened;

discharging medication in the pump through the pump outlet and the normally closed valve, by applying percutaneous pressure to the pump;

closing the normally closed valve by removing the percutaneous pressure applied thereto;

opening the pump inlet to permit fluid flow into the pump when the normally closed valve is closed; and

restricting the rate at which fluid can flow into the pump through the pump inlet by causing fluid stored in the infusion system to pass through a plurality of packed wicking fibers.

21. An infusion process as set forth in claim 20, wherein the steps of opening the normally closed valve and occluding the pump inlet are accomplished simultaneously through the application of percutaneous pressure to the normally closed valve.

22. An infusion process as set forth in claim 21, wherein the step of opening the normally closed valve includes the step of pressing a housing of the normally closed valve downwardly.

23. An infusion process as set forth in claim 21, wherein the step of discharging medication in the pump includes the step of pressing a housing of the pump downwardly to flush fluid from a pumping chamber within the pump.

24. An infusion process as set forth in claim 20, wherein the step of flushing fluid from the pump occurs only after the step of opening the normally closed valve.

25. An infusion process as set forth in claim 23, wherein the steps of closing the normally closed valve and opening the pump inlet are accomplished simultaneously through the withdrawal of percutaneous pressure from the normally closed valve.

26. An infusion process as set forth in claim 20, wherein the step of causing fluid stored in the infusion system to pass through a plurality of packed wicking fibers includes the steps of placing the wicking fibers in a fluid flow conduit between the pump and the stored medication, and introducing the medication perpendicularly to the length of the wicking fibers.

27. A process for percutaneously controlling the flow of fluid through a subcutaneously implanted infusion system including a manually actuable pump having a pump inlet and a pump outlet, and a valve for controlling the flow of fluid from the pump, the process steps comprising:

opening the valve by applying percutaneous pressure thereto, to permit medication in the pump to be discharged through the pump outlet;

occluding the pump inlet to prevent medication from entering the pump when the valve is opened;

discharging medication in the pump through the pump outlet and the valve, by applying percutaneous pressure to the pump;

closing the valve by removing the percutaneous pressure applied thereto;

opening the pump inlet to permit fluid flow into the pump when the valve is closed; and

restricting the rate at which fluid can flow into the pump through the pump inlet by placing packed wicking fibers in or adjacent to the pump inlet such that inlet fluid to the pump is caused to first pass through the packed wicking fibers, and wherein the fluid is introduced perpendicularly to the length of the wicking fibers.

28. A process as set forth in claim 27, wherein the steps of opening the normally closed valve and occluding the pump inlet are accomplished simultaneously through the application of percutaneous pressure to the valve.

29. A process as set forth in claim 28, wherein the step of opening the valve by applying percutaneous pressure thereto includes the step of pressing a housing of the valve downwardly, and wherein the step of discharging medication in the pump includes the step of pressing a housing of the pump downwardly to flush fluid from a pumping chamber within the pump.

30. A process as set forth in claim 29, wherein the step of flushing fluid from the pump occurs only after the step of opening the valve.

31. A process as set forth in claim 27, wherein the steps of closing the valve by removing the percutaneous pressure and opening the pump inlet are accomplished simultaneously through the withdrawal of percutaneous pressure from the valve.

32. A process for percutaneously controlling the flow of fluid through a subcutaneously implanted infusion system including a manually actuable pump having a pump inlet and a pump outlet, and a normally closed valve for controlling the flow of fluid from the pump, the process steps comprising:

opening the normally closed valve by pressing a housing of the normally closed valve downwardly, to permit medication in the pump to be discharged through the pump outlet;

occluding the pump inlet to prevent medication from entering the pump when the normally closed valve is opened, wherein the steps of opening the normally closed valve and occluding the pump inlet are accomplished simultaneously through the application of percutaneous pressure to the normally closed valve;

discharging medication in the pump through the pump outlet and the normally closed valve, by applying percutaneous pressure to the pump, wherein the step of discharging medication in the pump includes the step of pressing a housing of the pump downwardly to flush fluid from a pumping chamber within the pump, wherein the step of flushing the fluid from the pump occurs only after the step of opening the normally closed valve;

closing the normally closed valve by removing the percutaneous pressure applied thereto;

opening the pump inlet to permit fluid flow into the pump when the normally closed valve is closed, wherein the steps of closing the normally closed valve and opening the pump inlet are accomplished simultaneously through the withdrawal of percutaneous pressure from the normally closed valve; and

restricting the rate at which fluid can flow into the pump through the pump inlet by placing a plurality of packed wicking fibers in the pump inlet or in a fluid flow conduit adjacent to the pump inlet, introducing pump inlet fluid perpendicularly to the length of the wicking fibers, and causing the fluid to pass therethrough prior to entering the pump.

33. A fluid control assembly, comprising:

a self-recharging, manually actuable pump for discharging a measured amount of fluid from a pumping chamber;

means for conducting pump recharge fluid into the pumping chamber;

means for conducting discharge fluid from the pumping chamber;

valve means, actuable by manual percutaneous manipulation, for controlling the flow of discharge fluid from the pumping chamber, the valve means forming a portion of the discharge fluid conducting means, the valve means including a normally closed valve having a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pumping chamber, a valve outlet, a valve passageway situated between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation; and

means for restricting the rate of fluid flow through the recharge fluid conducting means, wherein the restricting means limits the amount of recharge fluid permitted to enter into the pumping chamber over a given period of time, the restricting means including at least one capillary-like fluid pathway through which the recharge fluid must pass before entering the pumping chamber, wherein the restricting means is positioned relative to the valve means such that actuation of the valve means causes an occlusion of the restricting means to prevent fluid flow through the restricting means, and wherein the restricting means is positioned relative to the displacement finger so that manipulation of the valve means to move the displacement finger, which opens the discharge fluid conducting means, occludes the at least one capillary-like fluid pathway to close the recharge fluid conducting means.

34. A fluid control assembly, comprising:

a self-recharging, manually actuable pump for discharging a measured amount of fluid from a pumping chamber;

means for conducting pump recharge fluid into the pumping chamber;

means for conducting discharge fluid from the pumping chamber;

valve means, actuable by manual percutaneous manipulation, for controlling the flow of discharge fluid from the pumping chamber, the valve means forming a portion of the discharge fluid conducting means; and

means for restricting the rate of fluid flow through the recharge fluid conducting means, wherein the restricting means limits the amount of recharge fluid permitted to enter into the pumping chamber over a given period of time, the restricting means comprising a wick restrictor, including a plurality of wicking fibers situated within an impermeable wick housing, and wherein the wick restrictor is positioned within a portion of the recharge fluid conducting means so that all fluid drawn into the pumping chamber must first pass through the wick restrictor.

35. A fluid control assembly as set forth in claim 34, wherein one end of the wick housing is occluded, and an inlet is provided adjacent to the occluded end through a wall of the wick housing.

36. An infusion reservoir and pump system, comprising:

means for receiving medication into the system by injection;

a reservoir fluidly connected to the receiving means in a manner permitting the subcutaneous transfer of medication from the receiving means to the reservoir;

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

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

means for controlling the flow of medication from the reservoir to the catheter, the controlling means forming a portion of the conducting means and including normally closed valve means and a pump for flushing a measured quantity of medication into the catheter when the normally closed valve means is opened, the normally closed valve means including a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pump, a valve outlet in fluid communication with the catheter inlet, a valve passageway situated directly between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation; and

means for restricting the flow of medication from the reservoir to the pump, and thus limiting the rate the pump is recharged, to restrict the total amount of medication which can be pumped into the catheter over a given period of time, wherein the restricting means includes at least one capillary-like fluid pathway through which medication must pass before entering the pump, wherein the restricting means is positioned within the valve body relative to the displacement finger so that manipulation of the valve means to move the displacement finger occludes the at least one capillary-like fluid pathway to close that portion of the conducting means defined by the restricting means.

37. A system as set forth in claim 36, wherein the pump includes a pump inlet in fluid communication with the reservoir, a pump outlet in fluid communication with the valve means, and a resilient crown overlying a floor plate to define a pumping chamber therebetween.

38. An infusion reservoir and pump system, comprising:

means for receiving medication into the system by injection;

a reservoir fluidly connected to the receiving means in a manner permitting the subcutaneous transfer of medication from the receiving means to the reservoir;

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

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

means for controlling the flow of medication from the reservoir to the catheter, the controlling means forming a portion of the conducting means and including normally closed valve means and a pump for flushing a measured quantity of medication into the catheter when the normally closed valve means is opened, the normally closed valve means including a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pump, a valve outlet in fluid communication with the catheter inlet, and a valve passageway situated directly between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway; and

means for restricting the flow of medication from the reservoir to the pump, and thus limiting the rate the pump is recharged, to restrict the total amount of medication which can be pumped into the catheter over a given period of time, the restricting means including a wick restrictor having a plurality of wicking fibers situated within an impermeable wick housing, wherein the wick restrictor is positioned within a portion of the conducting means such that all fluid drawn into the pump must first pass through the wick restrictor.

39. A system as set forth in claim 38, wherein one end of the wick housing is occluded, and an inlet is provided adjacent to the occluded end through a wall of the wick housing.

40. A fluid control assembly, comprising:

a self-recharging, manually actuable pump for discharging a measured amount of fluid from a pumping chamber;

means for conducting pump recharge fluid into the pumping chamber;

means for conducting discharge fluid from the pumping chamber;

valve means, actuable by manual manipulation, for controlling the flow of discharge fluid from the pumping chamber, the valve means forming a portion of the discharge fluid conducting means, wherein the valve means includes a normally closed valve having a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pumping chamber, a valve outlet, and a valve passageway situated between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and wherein the normally closed valve includes a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual manipulation; and

means for severely restricting the rate of fluid flow through the recharge fluid conducting means in comparison with the rate at which fluid would otherwise flow therethrough, wherein the restricting means limits the amount of recharge fluid permitted to enter into the pumping chamber over a given period of time to a know flow rate, wherein the restricting means includes a capillary-like fluid pathway defining a portion of the recharge fluid conducting means, and wherein the restricting means is positioned relative to the displacement finger so that manipulation of the valve means to move the displacement finger, which opens the discharge fluid conducting means, occludes the capillary-like fluid pathway to close the recharge fluid conducting means.

41. A process for controlling the flow of fluid through an infusion system including a manually actuable pump having a pump inlet and a pump outlet, and a valve for controlling the flow of fluid from the pump, the process steps comprising:

opening the valve by applying pressure thereto, to permit medication in the pump to be discharged through the pump outlet;

occluding the pump inlet to prevent medication from entering the pump when the valve is opened;

discharging medication in the pump through the pump outlet and the valve, by applying pressure to the pump;

closing the valve by removing the pressure applied thereto;

opening the pump inlet to permit fluid flow into the pump when the valve is closed; and

restricting the rate at which fluid can flow into the pump through the pump inlet, including the steps of causing inlet fluid to pass through a capillary-like fluid pathway as the fluid is drawn into the pump, wherein the capillary-like fluid pathway severely restricts the rate at which fluid would otherwise flow into the pump to a known flow rate that limits the amount of fluid which can be pumped through the system over a given period of time, wherein the step of occluding the pump inlet includes the step of closing the capillary-like fluid pathway by the pressure applied to open the valve.

42. An infusion reservoir and pump system, comprising:

means for receiving medication into the system by injection;

a reservoir fluidly connected to the receiving means in a manner permitting the subcutaneous transfer of medication from the receiving means to the reservoir;

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

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

means for controlling the flow of medication from the reservoir to the catheter, the controlling means forming a portion of the conducting means and including normally closed valve means and a pump for flushing a measured quantity of medication into the catheter when the normally closed valve means is opened, the normally closed valve means including a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the valve means, a valve inlet in fluid communication with the pump, a valve outlet in fluid communication with the catheter inlet, a valve passageway situated directly between the valve inlet and outlet, wherein the valve member is resiliently biased to occlude the valve passageway, and a displacement finger which is situated and configured to displace the valve member and open the valve means to fluid flow therethrough when the valve means is actuated by manual percutaneous manipulation; and

means for restricting the flow of medication from the reservoir to the pump, and thus limiting the rate the pump is recharged, to restrict the total amount of medication which can be pumped into the catheter over a given period of time, wherein the restricting means includes a wick restrictor having a plurality of wicking fibers situated within an impermeable wick housing, wherein the wick restrictor is positioned within a portion of the conducting means such that all fluid drawn into the pump must first pass through the wick restrictor.