Sterilizable medication infusion device with dose recharge restriction

• US 5,085,644 A
• Filed: 05/20/1991
• Issued: 02/04/1992
• Est. Priority Date: 04/02/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Pudenz-Schulte Medical Research Corporation
• Inventors: Licata, Mark J., Watson, David A.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Lynch, Michael
• Application Number:
  US07/703,247
• Time in Patent Office: 260 Days
• Field of Search: 604/93, 604/140, 604/153, 604/891.1, 604/890.1, 604/181, 604/183, 604/185, 604/186, 604/9, 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 a one-way valve positioned within a primary fluid conduit between the pump and the normally closed valve. 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 capillary-like fluid pathway through which the recharge fluid must pass before entering the pump, is provided to limit the rate the pump is recharged with medication, and to restrict the total amount of medication which can be pumped into the catheter over a given period of time. An alternate fluid conduit extends between the pump and the normally closed valve, and a Porex-type plug situated within the alternate fluid conduit prevents the flow of liquid medication therethrough under normal use conditions, but permits the passage of gasses through the alternate fluid conduit to facilitate steam autoclave sterilization of the pumping chamber.

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 for controlling the flow of discharge fluid from the pumping chamber, the valve means forming a portion of the discharge fluid conducting means;

an alternate fluid conduit extending between the pumping chamber and a portion of the discharge fluid conducting means within the valve means; and

means for preventing the passage of liquid fluid through the alternate fluid conduit, and yet permitting the passage of gaseous fluid therethrough.

2. 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.

3. A fluid control assembly as set forth in claim 1, including 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.

4. A fluid control assembly as set forth in claim 3, wherein the restricting means includes at least one capillary-like fluid pathway through which the recharge fluid must pass before entering the pumping chamber.

5. A fluid control assembly as set forth in claim 1, wherein the valve means includes a normally closed valve actuable by manual percutaneous manipulation, and wherein fluid is directed from the pumping chamber to the normally closed valve through a primary fluid conduct.

6. A fluid control assembly as set forth in claim 5, wherein the normally closed valve 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 primary fluid conduit, 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.

7. A fluid control assembly as set forth in claim 6, wherein the normally closed valve includes a displacement finger which is situated and configured to displace the valve member and open the normally closed valve to fluid flow therethrough when the normally closed valve is actuated by manual percutaneous manipulation.

8. A fluid control assembly as set forth in claim 5, wherein the valve means further includes a one-way valve controlling passage of fluid through the primary fluid conduit.

9. A fluid control assembly as set forth in claim 5, wherein the alternate fluid conduit extends between the pumping chamber and the normally closed valve.

10. A fluid control assembly as set forth in claim 1, wherein the means for preventing the passage of liquid fluid through the alternate fluid conduit, and yet permitting the passage of gaseous fluid therethrough, comprises a Porex-type plug.

11. 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 a pump for flushing a measured quantity of medication from a pumping chamber, and valve means for controlling the flow of medication from the pumping chamber to the catheter;

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; and

means for bypassing a portion of the conducting means within the controlling means, the bypassing means permitting steam autoclave sterilization of the pumping chamber through the valve means, and yet disallowing the flow of liquid fluid through the bypassing means.

12. A system as set forth in claim 11, wherein the means for receiving medication into the system by injection comprises 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 peripheral flange of the septum, a second base member situated within the first base member and the outer housing, the second base member contiguously engaging the peripheral flange of the septum opposite the first base member such that the septum is compressed between the first and second base members, wherein the second base member and the septum define an internal chamber, and an outlet extending from the lower portion of the internal chamber exteriorly through the outer housing.

13. A system as set forth in claim 12, wherein the injection port includes a filter barrier supported by the second base member and separating the internal chamber into an upper portion adjacent to the septum and a lower portion, and means for sealing an outer peripheral flange of the filter barrier adjacent to the second base member, to require any fluid injected into the upper portion of the internal chamber to pass through the filter barrier before passing through the outlet to exit the injection port, wherein the sealing means includes a needle guard for preventing contact between a needle inserted through the septum into the internal chamber, and the filter barrier.

14. A system as set forth in claim 12, wherein the elastomeric outer housing 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, the first base member comprising 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 peripheral flange of the septum to provide a rigid barrier between the peripheral flange of the septum and the adjacent side wall portions, wherein the upper flange circumscribes the septum and engages the peripheral flange of the septum.

15. A system as set forth in claim 14, 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, the wall including an upper septum-engaging section which underlies the peripheral flange of the septum and compresses the peripheral flange of the septum against the upper flange of the first base member.

16. A system as set forth in claim 11, wherein the reservoir includes a flexible outer body capable of expanding to accommodate varying amounts of medication.

17. A system as set forth in claim 11, 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 the pumping chamber therebetween.

18. A system as set forth in claim 11, wherein the valve means includes a normally closed valve actuable by manual percutaneous manipulation, and wherein fluid is directed from the pumping chamber to the normally closed valve through a primary fluid conduit.

19. A system as set forth in claim 18, wherein the normally closed valve includes a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the normally closed valve, a valve inlet in fluid communication with the pump through the primary fluid conduit, a valve outlet in fluid communication with the catheter inlet, and a valve passageway situated directly between the valve inlet and the valve outlet, wherein the valve member is resiliently biased to occlude the valve passageway.

20. A system as set forth in claim 19, wherein the normally closed valve includes a displacement finger which is situated and configured to displace the valve member and open the normally closed valve to fluid flow therethrough when the normally closed valve is actuated by manual percutaneous manipulation.

21. A system as set forth in claim 18, wherein the valve means further includes a one-way valve controlling controlling passage of fluid through the primary fluid conduit.

22. A system as set forth in claim 18, wherein the bypassing means includes an alternate fluid conduit extending between the pumping chamber and the normally closed valve, and means for preventing the passage of liquid fluid through the alternate fluid conduit, and yet permitting the passage of gaseous fluid therethrough.

23. A system as set forth in claim 22, wherein the means for preventing the passage of liquid fluid through the alternate fluid conduit and yet permitting the passage of gaseous fluid therethrough, comprises a Porex-type plug.

24. A system as set forth in claim 11, wherein the restricting means includes a capillary-like fluid pathway through which the medication must pass before entering the pump.

25. A system as set forth in claim 24, wherein the capillary-like fluid pathway comprises a length of capillary tubing having an inlet end in fluid communication with the reservoir and the medication receiving means, and an outlet end in fluid communication with the pumping chamber.

26. A system as set forth in claim 25, wherein the capillary tubing is wound about a spool and situated within a rigid housing.

27. A system as set forth in claim 25, wherein the capillary tubing inlet is positioned within a Bifurcation Valve which permits medication to flow freely between the reservoir, the medication receiving means, and the capillary tubing inlet.

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

an injection port for receiving medication into the assembly by injection, including;

an elastomeric outer housing including an integral elastomeric septum;

a first base member situated within the outer housing and contiguously engaging a peripheral flange of the septum;

a second base member situated within the first base member and the outer housing, the second base member contiguously engaging the peripheral flange of the septum opposite the first base member such that the septum is compressed between the first and second base members, wherein the second base member and the septum define an internal chamber;

a filter barrier supported by the second base member, the filter barrier separating the internal chamber into an upper portion adjacent to the septum and a lower portion; and

an outlet extending from the lower portion of the internal chamber exteriorly through the outer housing;

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

a capillary-like fluid pathway for conducting pump recharge medication into the pumping chamber, the capillary-like fluid pathway including a length of capillary tubing having an inlet end in fluid communication with recharge medication injected into the assembly, and an outlet end in fluid communication with the pumping chamber, the capillary tubing effectively limiting the amount of recharge medication permitted to enter into the pumping chamber over a given period of time;

a primary fluid conduit for conducting discharge medication from the pumping chamber; and

valve means for controlling the flow of discharge medication through the primary fluid conduit, the valve means including a normally closed valve actuable by manual percutaneous manipulation, and a one-way valve situated within the primary fluid conduit between the pumping chamber and the normally closed valve, wherein the normally closed valve includes a resiliently flexible body which defines a fluid flow passageway therethrough, a valve member positioned within the fluid flow passageway to occlude the normally closed valve, a valve inlet in fluid communication with the primary fluid conduit, a valve outlet, 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 normally closed valve to fluid flow therethrough when the normally closed valve is actuated by manual percutaneous manipulation.

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

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

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

a capillary-like fluid pathway for conducting pump recharge medication into the pumping chamber, the capillary-like fluid pathway including a length of capillary tubing having an inlet end in fluid communication with recharge medication injected into the assembly, and an outlet end in fluid communication with the pumping chamber, the capillary tubing effectively limiting the amount of recharge medication permitted to enter into the pumping chamber over a given period of time, wherein the capillary tubing is wound about a spool and situated within a rigid housing, and wherein the capillary tubing inlet is positioned within a bifurcation valve;

a primary fluid conduit for conducting discharge medication from the pumping chamber; and

valve means for controlling the flow of discharge medication through the primary fluid conduit, the valve means including a normally closed valve actuable by manual percutaneous manipulation, and a one-way valve situated within the primary fluid conduit between the pumping chamber and the normally closed valve.

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

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

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

a capillary-like fluid pathway for conducting pump recharge medication into the pumping chamber, the capillary-like fluid pathway including a length of capillary tubing having an inlet end in fluid communication with recharged medication injected into the assembly, and an outlet end in fluid communication with the pumping chamber, the capillary tubing effectively limiting the amount of recharge medication permitted to enter into the pumping chamber over a given period of time;

a primary fluid conduit for conducting discharge medication from the pumping chamber;

valve means for controlling the flow of discharge medication through the primary fluid conduit, the valve means including a normally closed valve actuable by manual percutaneous manipulation, and a one-way valve situated within the primary fluid conduit between the pumping chamber and the normally closed valve; and

means for bypassing the primary fluid conduit, the bypassing means permitting steam autoclave sterilization of the pumping chamber through the normally closed valve, and yet disallowing the flow of liquid fluid through the bypassing means.

31. A control assembly as set forth in claim 30, wherein the bypassing means includes an alternate fluid conduit extending between the pumping chamber and the normally closed valve, and means for preventing the passage of liquid fluid through the alternate fluid conduit, and yet permitting the passage of gaseous fluid therethrough.

32. A control assembly as set forth in claim 31, wherein the means for preventing passage of liquid fluid through the alternate fluid conduit, and yet permitting the passage of gaseous fluid therethrough, comprises a Porex-type plug.