Implantable infusion pump

• US 20020087147A1
• Filed: 01/04/2001
• Published: 07/04/2002
• Est. Priority Date: 01/04/2001
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Inventors: Hooper, Sandra Marie, Wigness, Bruce David, Blischak, Brian Russell
• Granted Patent: US 6,666,845 B2
• Time in Patent Office: Days
• US Class Current: 604/892.1
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1652 Filter with duct, e.g. filtering element incorporated in a flow line, tube, duct
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate

Abstract

An implantable infusion pump to deliver stored infusate to a desired fluid delivery site. The pump includes a collapsible fluid chamber. The pump can include a multi-stage filtration system to filter micro-emboli as well as larger particles that are inadvertently introduced into the pump system. An external member can receive the pump and provide a medium to include additional, interactive components, e.g., a bolus port, as well as provide a versatile suture structure to enable the pump to be properly secured within an implantation site. To improve volumetric efficiency, the pump can further incorporate an outlet flow passage within a movable wall of the fluid chamber.

Claims

1. An infusion pump having a variable-volume fluid chamber for implantation in a living body, the pump comprising:

a housing;

a driving spring;

an inlet conduit, having a self-sealing penetrable member positioned therein, extends between an outer surface of the housing and the fluid chamber; and

an outlet conduit, in communication with the fluid chamber, is adapted to deliver a fluid from the fluid chamber,

wherein the self-sealing penetrable member is adapted to be accessible through a surface of a living body when the pump is implanted therein to facilitate provision of a fluid to the fluid chamber,

wherein the driving spring is adapted to supply a principle force to drive fluid transiently stored in the fluid chamber into the outlet conduit, and

wherein the outlet conduit extends through the driving spring.

2. An infusion pump in accordance with claim 1, further comprising a filter, wherein the filter is positioned within the outlet conduit.

3. An infusion pump in accordance with claim 1, further comprising a flow restrictor, wherein the flow restrictor is positioned within the outlet conduit.

4. An infusion pump in accordance with claim 3, further comprising a filter, wherein the filter is positioned within the outlet conduit.

5. An infusion pump in accordance with claim 1, further comprising a bolus port, wherein the bolus port is in fluid communication with the outlet conduit.

6. An infusion pump in accordance with claim 1, wherein the driving spring is adapted to compensate for changes in internal body pressure when implanted, whereby a pressure differential between the fluid chamber and an internal body pressure remains constant despite changes in body temperature or atmospheric pressure.

7. An infusion pump in accordance with claim 1, further comprising a reinforced-elastomer suture member, fixed relative to the housing, wherein the suture member substantially extends about a perimeter of the housing.

8. An implantable infusion pump having a variable-volume fluid chamber to transiently store a fluid solution, the pump comprising:

a hardened shell structure;

an elastomer spring diaphragm operatively joined to the shell structure, wherein the shell structure and the spring diaphragm cooperate to form the fluid chamber; and

a fluid flow passage, in fluid communication with the fluid chamber, is adapted to deliver a fluid solution from the fluid chamber to an infusion site, such passage being substantially embedded within the spring diaphragm, wherein the spring diaphragm is operatively biased toward the shell structure.

9. An infusion pump in accordance with claim 8, wherein the spring diaphragm is adapted to be responsive to an internal body pressure when implanted so as to provide a substantially uniform pressure differential between the fluid chamber and the internal body pressure.

10. An infusion pump in accordance with claim 8, wherein the spring diaphragm is adapted to provide a principal force for forcing a fluid solution from the fluid chamber into the flow passage.

11. An infusion pump in accordance with claim 8, further comprising a filter, wherein the filter is positioned within the flow passage.

12. An infusion pump in accordance with claim 8, further comprising a filter system having multiple stages, each stage being responsible for filtering an embolus of a prescribed characteristic, and the filter system is positioned within the flow passage.

13. An infusion pump in accordance with claim 12, wherein the filter system comprises a micro-filter stage and a particle-filter stage, the particle-filter stage being positioned downstream of the micro-filter stage.

14. An infusion pump in accordance with claim 8, further comprising a flow restrictor, wherein the flow restrictor is positioned within the flow passage.

15. An infusion pump in accordance with claim 8, further comprising a bolus port, wherein the bolus port is in fluid communication with flow passage.

16. An infusion pump in accordance with claim 8, further comprising a reinforced-elastomer suture member, fixed relative to the shell structure, wherein the suture member substantially extends about a perimeter of the shell structure.

17. An infusion pump in accordance with claim 8, further comprising a boot member adapted to receive and to encompass at least a portion of the shell structure.

18. An infusion pump in accordance with claim 17, further comprising a bolus port, wherein the boot member further includes a bolus port receptacle that receives the bolus port, and the bolus port receptacle is in fluid communication with the bolus port, an output connectable to a delivery catheter, and the outlet passage.

19. An infusion pump in accordance with claim 17, wherein the boot member includes a suture member, and the suture member substantially extends about a perimeter of the shell structure.

20. An infusion pump for implantation in a living body, the pump comprising:

a housing defining a portion of a collapsible fluid-tight chamber;

a moveable spring diaphragm, defining another portion of the chamber, adapted to (i) exert a force on a solution stored in the chamber and (ii) compensate for changes in body pressure by communicating such changes to the chamber;

an inlet conduit, having a self-sealing, penetrable member, extending between an exterior surface of the housing and the chamber;

an outlet conduit in fluid communication with the chamber and an infusion site in the body, wherein at least a portion of the outlet conduit passes through the spring diaphragm; and

a reinforced-elastomer suture structure, extending substantially continuously about a perimeter of the pump, adapted to receive and to retain a suture placed along substantially an entire length of the suture structure.

21. An infusion pump for implantation in a living body, the pump comprising:

a housing defining a portion of a collapsible fluid-tight chamber;

a moveable spring diaphragm, defining another portion of the chamber, adapted to (i) exert a force on a solution stored in the chamber and (ii) compensate for changes in body pressure by communicating such changes to the chamber;

an inlet conduit, having a self-sealing, penetrable member, extending between an exterior surface of the housing and the chamber; and

an outlet conduit in fluid communication with the chamber and an infusion site in the body, wherein at least a portion of the outlet conduit passes through the spring diaphragm.

22. A filter system for an infusion pump implantable in a living body to filter emboli from an infusate, the filter system comprising:

a micro-filter stage to filter sub-micron emboli from an infusate; and

a particulate filter stage to filter particles greater than 1 micron from the infusate,

wherein the particulate filter stage is arranged relative to the micro-filter stage so as to operatively receive infusate filtered by the micro-filter.

23. A filter system in accordance with claim 22, wherein the particulate filter stage is adapted to filter particles having a size of 5 microns and greater.

25. An infusion pump in accordance with claim 24, further comprising a flow restrictor, wherein the flow restrictor is positioned downstream of the filter system.

26. An infusion pump in accordance with claim 24, wherein the filter system includes:

a micro-filter stage to filter sub-micron emboli from the infusate; and

a particulate filter stage to filter particles greater than 1 micron from the infusate,

wherein the particulate filter stage is positioned downstream from the micro-filter stage.

28. An infusion pump in accordance with claim 27, wherein the first filter stage is adapted to filter sub-micron emboli from an infusate.

30. A member in accordance with claim 29, wherein at least the skirt includes a reinforcement material to assist in retaining a received suture.

31. A member in accordance with claim 30, wherein the reinforcement material extends substantially around the perimeter of the member.

32. A member in accordance with claim 29, wherein the second portion includes a fluid inlet and a fluid outlet.

33. A member in accordance with claim 32, wherein the fluid inlet is connectable to an output of an implantable infusion device received within the first portion.

34. A member in accordance with claim 32, wherein the second portion includes a path connecting the fluid inlet and the fluid outlet, and the path enables fluid communication between the fluid inlet and the fluid outlet when the second portion receives a bolus port.

36. A member in accordance with claim 35, further comprising a suture-receiving member, which extends substantially about a perimeter of the member, wherein the suture-receiving member is fabricated from a reinforced elastomer.

37. A member in accordance with claim 35, further comprising an inlet passage, which intersects the second mating surface, and an outlet passage, which also intersects the second mating surface.

38. A member in accordance with claim 37, wherein the second mating surface includes a path connecting the inlet passage and the outlet passage, and the path enables fluid communication between the inlet passage and the outlet passage when the second mating surface supports a bolus port.

24. An infusion pump for implantation in a living body, the pump comprising:

a housing defining a collapsible fluid chamber to transiently store infusate;

an outlet conduit, in communication with the fluid chamber, is adapted to deliver infusate to a delivery site; and

a multi-stage filter system, positioned within the outlet conduit, to filter infusate prior to its delivery to the delivery site.

27. An infusion pump for implantation in a living body, the pump comprising:

a housing defining at least a portion of a variable-volume fluid chamber to receive an infusate;

an inlet conduit, having a self-sealing penetrable member positioned therein, positioned at a surface of the housing and being in communication with the fluid chamber;

an outlet conduit in communication with the fluid chamber and connectable to a delivery catheter;

a flow restrictor, positioned between the fluid chamber and the delivery catheter;

a first filter stage, positioned prior to the flow restrictor; and

a second filter stage, interpositioned between the first filter stage and the flow restrictor.

29. An elastomer member for implantation with a living body, the member comprising:

a first portion to receive an implantable infusion device;

a second portion to receive a bolus port; and

an enlarged skirt, extending substantially around a perimeter of the member, adapted to receive and retain a suture to secure the member at an implantation site.

35. A member to receive an implantable infusion device, which includes a fluid output, for implantation in a living body, the member comprising:

a first mating surface to receive a housing of an implantable infusion device; and

a second mating surface to receive a bolus port.

39. An infusion pump for implantation in a living body, the pump comprising:

a housing having a collapsible fluid chamber to transiently store infusate and an energy source to collapse the fluid chamber;

an inlet conduit, having a self-sealing penetrable member positioned therein, located at a first position relative to the housing and in communication with the fluid chamber;

an outlet conduit, in communication with the fluid chamber, adapted to deliver infusate to a delivery site; and

a member having;

a first mating surface to receive the housing; and

a reinforced-elastomer suture structure, extending substantially about a perimeter of the member, adapted to receive and maintain sutures applied to secure the pump at an implantation site.

40. An infusion pump for implantation in a living body, the pump comprising:

a housing having a collapsible fluid chamber to store infusate and an energy source to collapse the fluid chamber;

an inlet conduit, having a self-sealing penetrable member positioned therein, located at a first position relative to the housing and in communication with the fluid chamber;

an outlet conduit, extending between the fluid chamber and an output aperture;

a bolus port, which includes a self-sealing penetrable member;

a boot structure having;

a first mating surface to receive the housing; and

a bolus port receptacle, having an inlet passage and an outlet passage, to receive the bolus port, wherein the outlet passage is adapted to deliver infusate to a delivery site; and

a connection conduit to extend between the inlet of the bolus port receptacle and the output aperture of the outlet conduit.

41. A pump in accordance with claim 40, wherein the member further comprises a reinforced-elastomer suture structure, extending substantially about a perimeter of the member, to receive and maintain sutures applied to secure the pump at an implantation site.

42. A pump in accordance with claim 40, wherein the bolus port receptacle includes a path connecting the inlet passage and the outlet passage, and the path enables fluid communication between the inlet passage and the outlet passage when the bolus port receptacle receives a bolus port.