Electroactive polymer based artificial sphincters and artificial muscle patches

• US 6,749,556 B2
• Filed: 05/10/2002
• Issued: 06/15/2004
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Banik, Michael S.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/142,861
• Publication Number:
  US 20030212306A1
• Time in Patent Office: 767 Days
• Field of Search: 600/29-32, 600/16-18, 600/37, 128/DIG.25
• US Class Current: 600/30
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2002/0894 Muscles non-implantable A61F2002/5066
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: C08L 65/00 Compositions of macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain C08L7/00 - C08L57/00, C08L61/00 take precedence; Compositions of derivatives of such polymers

Abstract

Provided are artificial muscle patches, which are adapted to be implanted adjacent a patient'"'"'s heart, and artificial sphincter cuffs, which are adapted to be implanted around a body lumen, such as the urethra, the anal canal, or the lower esophagus. The devices of the present invention comprise: (a) one or more electroactive polymer actuators; and (b) a control unit for electrically controlling the one or more electroactive polymer actuators to expand or contract the devices.

Claims

1. An artificial sphincter, comprising:

a cuff that is adapted for placement around a body lumen, said cuff comprising a plurality of electroactive polymer actuators comprising a conductive polymer; and

a control unit electrically controlling said electroactive polymer actuators to expand or contract said cuff.

2. The artificial sphincter of claim 1, wherein said electroactive polymer actuators comprise (a) an active member comprising said conductive polymer, (b) a counter-electrode and (c) an electrolyte disposed between said active member and said counter-electrode.

3. The artificial sphincter of claim 2, wherein a plurality of active members are disposed on at least one substrate layer.

4. The artificial sphincter of claim 3, further comprising at least one barrier layer.

5. The artificial sphincter of claim 4, further comprising an exterior mesh layer.

6. The artificial sphincter of claim 3, wherein said active members are provided in a non-linear configuration.

7. The artificial sphincter of claim 3, wherein at least two of said substrate layers having disposed thereon a plurality of active members are provided.

8. The artificial sphincter of claim 3, wherein said substrate layer is an electrically insulating layer.

9. The artificial sphincter of claim 8, wherein conductive lines are provided on said substrate layer to allow electrical communication between said plurality of active members and said power source.

10. The artificial sphincter of claim 3, wherein said substrate layer is an electrically conductive layer.

11. The artificial sphincter of claim 1, wherein opposing ends of said cuff are provided with fasteners for securing said cuff around said body lumen.

12. The artificial sphincter of claim 1, wherein said control unit comprises a power source and a switch.

13. The artificial sphincter of claim 1, wherein said cuff is adapted for placement around the urethra.

14. The artificial sphincter of claim 1, wherein said cuff is adapted for placement around the anal canal.

15. The artificial sphincter of claim 1, wherein said cuff is adapted for placement around the lower esophagus.

18. The artificial sphincter of claim 1, wherein said electroactive polymer actuators comprise an electroactive polymer selected from the group consisting of polyaniline, polypyrrole, and polyacetylene.

19. The artificial sphincter of claim 18, wherein said electroactive polymer is polypyrrole.

20. The artificial sphincter of claim 1, wherein said cuff is provided with a restoring force to bring it into an expanded or contracted state.

21. The artificial sphincter of claim 20, further comprising at least one elastic structural element, wherein said restoring force is provided by the structural element.

22. The artificial sphincter of claim 21, wherein said at least one elastic structural element is an elastic annular tube structure whose length increases upon a decrease in its cross-sectional diameter.

25. A method of treating fecal incontinence comprising implanting into a patient the artificial sphincter of claim 14.

26. A method of treating urinary incontinence comprising implanting into a patient the artificial sphincter of claim 13.

27. A method of treating gastro-esophageal reflux disease comprising implanting into a patient the artificial sphincter of claim 15.

28. The artificial sphincter of claim 1, wherein said control unit comprises a power source and a computer.

16. An artificial sphincter comprising:

a cuff that is adapted for placement around the esophagus, said cuff comprising one or more electroactive polymer actuators;

a control unit electrically controlling said one or more electroactive polymer actuators to expand or contract said cuff; and

a sensing system in communication with said control unit for detecting when food or beverage enters said esophagus.

17. An artificial sphincter comprising:

a cuff that is adapted for placement around the esophagus, said cuff comprising one or more electroactive polymer actuators; and

a control unit electrically controlling said one or more electroactive polymer actuators to expand or contract said cuff

a sensing system in communication with said control unit for detecting when the stomach is attempting to regurgitate its contents.

23. An artificial sphincter comprising:

a cuff that is adapted for placement around a body lumen, said cuff comprising one or more electro active polymer actuators;

a control unit electrically controlling said one or more electroactive polymer actuators to expand or contract said cuff; and

a sensing system in communication with said control unit for sensing the degree of contraction of said electroactive polymer actuators.

24. The artificial sphincter of claim 23, wherein said sensing system comprises a plurality of strain gauges in communication with said control unit.

29. An artificial muscle patch, comprising:

a plurality of electroactive polymer actuators comprising a conductive polymer; and

a control unit electrically controlling said electroactive polymer actuators to expand or contract said artificial muscle patch, wherein said patch is adapted for placement adjacent a patient'"'"'s heart.

30. The artificial muscle patch of claim 29, wherein said electroactive polymer actuators comprise (a) an active member comprising said conductive polymer, (b) a counter-electrode and (c) an electrolyte disposed between said active member and said counter-electrode.

31. The artificial muscle patch of claim 30, wherein a plurality of active members are disposed on at least one substrate layer.

32. The artificial muscle patch of claim 31, which further comprises at least one barrier layer.

33. The artificial muscle patch of claim 32, further comprising an exterior mesh layer.

34. The artificial muscle patch of claim 31, wherein said active members are provided in a nonlinear configuration.

35. The artificial muscle patch of claim 31, wherein at least two of said substrate layers having disposed thereon a plurality of active members are provided.

36. The artificial muscle patch of claim 31, wherein said substrate layer is an electrically insulating layer.

37. The artificial muscle patch of claim 36, wherein conductive lines are provided on said substrate layer to allow electrical communication between said plurality of active members and said power source.

38. The artificial muscle patch of claim 31, wherein said substrate layer is an electrically conductive layer.

39. The artificial muscle patch of claim 29, wherein said control unit comprises a power source and a switch.

40. The artificial muscle patch of claim 29, wherein said control unit comprises a power source and a computer.

43. The artificial muscle patch of claim 29, wherein said electroactive polymer comprises polypyrrole.

44. A method of treating congestive heart failure, comprising implanting the artificial muscle patch of claim 29 adjacent a patient'"'"'s heart.

41. An artificial muscle patch comprising:

one or more electroactive polymer actuators;

a control unit electrically controlling said one or more electroactive polymer actuators to expand or contract said artificial muscle patch, wherein said patch is adapted for placement adjacent a patient'"'"'s heart; and

a sensing system in communication with said control unit for detecting a patient'"'"'s heartbeat, wherein said control unit paces the contraction and expansion of said electroactive polymer actuators with said heartbeat.

42. An artificial muscle patch comprising:

one or more electroactive polymer actuators; and

a control unit electrically controlling said one or more electroactive polymer actuators to expand or contract said artificial muscle patch, wherein said patch is adapted for placement adjacent a patient'"'"'s heart, and wherein said control unit paces the heart as well as the contraction and expansion of said electroactive polymer actuators.