NERVE CUFF WITH POCKET FOR LEADLESS STIMULATOR

• US 20100312320A1
• Filed: 06/09/2010
• Published: 12/09/2010
• Est. Priority Date: 06/09/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Scott, Steven E., Martin, Roy C., Faltys, Michael A., Loeb, Gerald E.
• Granted Patent: US 8,886,339 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.

Claims

1. A nerve cuff for securing a leadless microstimulator in stable communication with a nerve, the nerve cuff comprising:

a cuff body having a channel extending within the length of the cuff body for passage of a nerve;

a pocket within the cuff body, configured to removably hold the leadless microstimulator; and

an elongate opening slit extending the length of the cuff body configured to be opened to provide access to the pocket.

2. The nerve cuff of claim 1, further comprising an internal electrical contact within the cuff body.

3. The nerve cuff of claim 2, wherein the internal electrical contact is configured to electrically couple the microstimulator and the nerve.

4. The nerve cuff of claim 1, further comprising an external electrical contact on the outer surface of the cuff body configured to couple with the microstimulator.

5. The nerve cuff of claim 1, wherein the cuff body comprises shielding configured to electrically isolate the microstimulator within the nerve cuff.

6. The nerve cuff of claim 1, wherein the cuff body has a uniform thickness.

7. The nerve cuff of claim 1, wherein the cuff body has a non-uniform thickness.

8. The nerve cuff of claim 7, wherein the cuff body has a thickness between about 5 and about 20 mils.

9. The nerve cuff of claim 1, wherein the outer surface of the nerve cuff is substantially smooth and atraumatic.

10. The nerve cuff of claim 1, wherein the outer surface of the nerve cuff is rounded.

11. The nerve cuff of claim 1, wherein the channel comprises a support channel configured to support the nerve within therein, to prevent pinching of the nerve.

12. The nerve cuff of claim 1, wherein the elongate opening slit extends the length of the cuff body in an interlocking pattern.

13. The nerve cuff of claim 1, wherein the slit extends along the side of the cuff body, adjacent to the channel.

14. The nerve cuff of claim 1, further comprising attachment sites in the elongate opening slit configured to help secure the slit closed.

15. The nerve cuff of claim 1, wherein the cuff body is formed of a flexible and biocompatible polymer.

16. A nerve cuff for securing a leadless microstimulator in stable communication with a nerve, the nerve cuff comprising:

an insulating cuff body having a nerve channel extending within the length of the cuff body for passage of a nerve, wherein the cuff body electrically isolates the microstimulator within the cuff body;

a conductive surface within the nerve channel configured to engage one or more electrical contacts on the microstimulator;

a pocket within the cuff body, configured to removably hold the leadless microstimulator; and

an elongate opening slit extending the length of the cuff body configured to be opened to provide access to the pocket.

17. The nerve cuff of claim 16, further comprising an external electrical contact on the outer surface of the cuff body configured to couple with the microstimulator.

18. The nerve cuff of claim 16, wherein the cuff body has a uniform thickness.

19. The nerve cuff of claim 16, wherein the cuff body has a non-uniform thickness.

20. The nerve cuff of claim 19, wherein the cuff body has a thickness between about 5 and about 20 mils.

21. The nerve cuff of claim 16, wherein the outer surface of the nerve cuff is substantially smooth and atraumatic.

22. The nerve cuff of claim 16, wherein the outer surface of the nerve cuff is contoured.

23. The nerve cuff of claim 16, wherein the channel comprises a support channel configured to support the nerve within therein, to prevent pinching of the nerve.

24. The nerve cuff of claim 16, wherein the elongate opening slit extends the length of the cuff body in an interlocking pattern.

25. The nerve cuff of claim 16, further comprising attachment sites in the elongate opening slit configured to help secure the slit closed.

26. The nerve cuff of claim 16, wherein the cuff body is formed of a flexible and biocompatible polymer.

27. A method of implanting a leadless microstimulator in communication with a vagus nerve, the method comprising:

exposing a vagus nerve;

opening a slit of a nerve cuff having a nerve cuff body, wherein the slit opens along the length of the nerve cuff body;

placing the nerve cuff around the vagus nerve so that the nerve is within a channel extending the length of nerve cuff;

inserting a leadless microstimulator within a pocket in the nerve cuff; and

securing the slit of the nerve cuff closed so that the leadless microstimulator is in electrical communication with the nerve and electrically isolated within the nerve cuff body.

28. The method of claim 27, wherein the step of securing the opening slit of the nerve cuff closed comprises securing the slit so that the leadless microstimulator engages an internal electrical contact within the nerve cuff body.

29. The method of claim 27, wherein the leadless microstimulator engages an internal electrical contact configured to provide circumferential stimulation around the nerve within the channel.

30. The method of claim 27, wherein the step of securing comprises suturing the slit closed.

31. The method of claim 27, further comprising the step of testing the microstimulator to confirm electrical communication with the nerve.

32. The method of claim 27, wherein the step of placing the nerve cuff comprises placing an oversized nerve cuff around the vagus nerve.

33. A method of implanting a leadless microstimulator in communication with a vagus nerve, the method comprising:

exposing a vagus nerve;

opening a slit of a nerve cuff having a nerve cuff body, wherein the slit opens along the length of the nerve cuff body;

placing the nerve cuff around the vagus nerve so that the nerve is within a channel extending the length of nerve cuff;

inserting a leadless microstimulator within a pocket in the nerve cuff so that the microstimulator communicates with one or more internal electrical contacts within the nerve cuff; and

closing the slit of the nerve cuff so that the nerve is in electrical communication with the one or more internal electrical contact.

34. The method of claim 33, wherein leadless microstimulator and the internal electrical contact is configured to provide circumferential stimulation around the nerve within the channel.

35. The method of claim 33, wherein the step of closing comprises securing the slit of the nerve cuff closed.

36. The method of claim 33, wherein the step of closing comprises suturing the slit closed.

37. The method of claim 33, wherein the step of placing the nerve cuff comprises placing an oversized nerve cuff around the vagus nerve.