Vascularly stabilized peripheral nerve cuff assembly

• US 7,584,004 B2
• Filed: 06/13/2005
• Issued: 09/01/2009
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Scheiner, Avram, Caparso, Anthony
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US11/151,103
• Publication Number:
  US 20060282145A1
• Time in Patent Office: 1,541 Days
• Field of Search: 607/118, 607/149, 600/381, 600/485
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A vascularly stabilized peripheral nerve cuff assembly is provided. One aspect of this disclosure relates to an electrode assembly used in the delivery of neural stimulation therapy. The electrode assembly includes a body adapted to at least partially encompass a blood vessel and a nerve proximate to the blood vessel. The electrode assembly also includes at least one electrode along at least a portion of the body. The at least one electrode is adapted to be electrically connected to a neural stimulator. According to an embodiment, the electrode assembly includes a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body. Other aspects and embodiments are provided herein.

Claims

1. An electrode assembly, comprising:

an electrode body adapted to chronically and at least partially encompass a blood vessel and a nerve proximate to the blood vessel after implantation of the assembly, wherein the body has a shape to conform to the blood vessel without restricting blood flow through the vessel;

at least one neural stimulation electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator and configured for use to stimulate the nerve; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

2. The electrode assembly of claim 1, wherein the inside surface of the body includes an interior facing wall shaped to conform to the blood vessel and the nerve.

3. The electrode assembly of claim 1, wherein the spacer includes a member having an arc-like shape.

4. The electrode assembly of claim 1, wherein the body has a hollow, cylindrical shape with an opening along a circumference, the opening adapted to enable the body to at least partially encompass the blood vessel and the nerve.

5. The electrode assembly of claim 4, further comprising a fastener adapted to close the opening to prevent separation from the vessel and nerve after implantation.

6. The electrode assembly of claim 5, wherein the fastener is further adapted to secure the second end of the spacer to the inside surface of the body.

7. The electrode assembly of claim 1, wherein the blood vessel includes a carotid artery.

8. The electrode assembly of claim 1, wherein the blood vessel includes an internal jugular vein.

9. The electrode assembly of claim 1, wherein the nerve includes a vagal nerve.

10. The electrode assembly of claim 1, further comprising:

at least one sensor along at least a portion of the body.

11. The electrode assembly of claim 10, wherein the assembly is adapted to provide Functional Electric Stimulation (FES).

12. The electrode assembly of claim 1, wherein the at least one electrode is adapted to be electrically connected to the neural stimulator at least partially via a wireless connection.

13. The electrode assembly of claim 1, wherein the blood vessel has a diameter and the nerve has a diameter, and the diameter of the blood vessel is larger than the diameter of the nerve.

14. The electrode assembly of claim 1, wherein:

the body and the spacer define a first opening in the electrode assembly to receive the blood vessel, wherein the body and the spacer are configured to secure the electrode assembly to the blood vessel when the blood vessel is in the first opening; and

the body and the spacer define a second opening in the electrode assembly to receive the nerve,

wherein, after implantation of the assembly, the nerve is chronically in the second opening and the blood vessel is chronically in the first opening and blood continues to flow through the blood vessel while the blood vessel is in the first opening.

15. The electrode assembly of claim 14, wherein:

the body and the spacer are configured to provide an open position for the first opening to receive the blood vessel in the first opening, and to provide a close position for the first opening to secure the electrode assembly to the blood vessel; and

the body and the spacer are configured to provide an open position for the second opening to receive the nerve in the second opening, and to provide a close position for the second opening to secure the electrode assembly to the nerve.

16. An assembly, comprising:

an electrode body adapted to at least partially encompass a blood vessel and a nerve proximate to the blood vessel after implantation of the assembly, wherein the body has a shape to conform to the blood vessel without restricting blood flow through the vessel;

at least one sensor along at least a portion of the body; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

17. The assembly of claim 16, wherein the at least one sensor is adapted to selectively sense neural activity of an axon or group of axons within the nerve.

18. The assembly of claim 17, wherein the assembly is adapted for recording of selectively sensed neural activity.

19. The assembly of claim 16, wherein the at least one sensor is adapted to sense blood pressure in the blood vessel.

20. The assembly of claim 16, further comprising:

at least one electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator.

21. A system, comprising:

at least one neural stimulation lead;

an electrode assembly connected to the at least one lead, the electrode assembly including;

an electrode body adapted to at least partially encompass a blood vessel and a nerve proximate to the blood vessel after implantation of the assembly, wherein the body has a shape to conform to the blood vessel without restricting blood flow through the vessel;

at least one neural stimulation electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator and configured for use to stimulate the nerve; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body; and

an implantable medical device, coupled to the at least one lead, the implantable device including;

a neural stimulator; and

a controller to communicate with the neural stimulator, the controller being adapted to control the neural stimulator to deliver neural stimulation to at least a portion of the nerve.

22. The system of claim 21, wherein the electrode assembly further includes:

a fastener adapted to close the opening to prevent separation from the vessel and nerve after implantation.

23. The system of claim 22, wherein the fastener is further adapted to secure the second end of the spacer to the inside surface of the body.

24. The system of claim 21, wherein the electrode assembly is adapted to sense blood pressure in the blood vessel.

25. The system of claim 21, wherein the electrode assembly is adapted to include a drug eluding polymer.

26. The system of claim 21, further comprising:

a second electrode assembly electrically connected to the electrode assembly along a stabilizer bar, the second electrode assembly including;

a body adapted to at least partially encompass a blood vessel and a nerve proximate to the blood vessel after implantation of the assembly;

at least one electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

27. The system of claim 26, further comprising:

a third electrode assembly electrically connected to the second electrode assembly along the stabilizer bar, the third electrode assembly including;

a body adapted to at least partially encompass a blood vessel and a nerve proximate to the blood vessel after implantation of the assembly;

at least one electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

28. The system of claim 21, wherein the electrode assembly is adapted to deliver selective neural stimulation to the nerve.

29. A method, comprising:

forming an electrode body adapted to encompass a blood vessel and a nerve proximate to the blood vessel, wherein the body is formed to have shape to conform to the blood vessel without restricting blood flow through the vessel;

embedding at least one neural stimulation electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator and configured for use to stimulate the nerve; and

forming a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

30. The method of claim 29, further comprising:

forming a fastener adapted to prevent separation from the vessel and nerve after implantation.

31. The method of claim 29, wherein forming the body includes forming the inside surface of the body to conform to the blood vessel and the nerve.

32. The method of claim 29, wherein forming the body includes forming the body with a hollow, cylindrical shape.

33. The method of claim 29, wherein forming the spacer includes forming the spacer with an arc-like shape.

34. The method of claim 29, wherein embedding at least one electrode includes embedding multiple stimulating contacts parallel to one another along the body.

35. The method of claim 29, wherein embedding at least one electrode includes embedding multiple stimulating contacts offset from one another along the body.

36. An electrode assembly, comprising:

an electrode body adapted to encompass a blood vessel and a nerve proximate to the blood vessel, wherein the body has a shape to conform to the blood vessel without restricting blood flow through the vessel;

at least one neural stimulation electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator and configured for use to stimulate the nerve; and

a spacer within the body, the spacer having a first and second end, the first end secured to an inside surface of the body and the second end adapted to pass between the vessel and the nerve and to be secured to the inside surface of the body.

37. The electrode assembly of claim 36, wherein the body is adapted to encompass the blood vessel and the nerve proximate to the blood vessel after implantation of the assembly.

38. The electrode assembly of claim 36, wherein the blood vessel has a diameter and the nerve has a diameter, and the diameter of the blood vessel is larger than the diameter of the nerve.

39. A method of using an electrode assembly, comprising:

at least partially encompassing a blood vessel and a nerve proximate to the blood vessel with a body of the assembly, wherein the body includes at least one electrode along at least a portion of the body, the at least one electrode adapted to be electrically connected to a neural stimulator, and wherein the body includes a spacer within the body, the spacer having a first end secured to an inside surface of the body;

passing a second end of the spacer between the vessel and the nerve; and

securing the second end of the spacer to the inside surface of the body.

40. The method of claim 39, further comprising:

delivering selective neural stimulation to the nerve using the neural stimulator and the at least one electrode.