Obstructive sleep apnea treatment devices, systems and methods

• US 8,311,645 B2
• Filed: 04/26/2011
• Issued: 11/13/2012
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Mazar, Scott T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/094,371
• Publication Number:
  US 20110196445A1
• Time in Patent Office: 567 Days
• Field of Search: 607/118, 607/42, 607115-116
• US Class Current: 607/118
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

A lead system may include a cuff electrode configured to be implanted on a nerve and including a cylindrical cuff body having a plurality of electrode contacts. The cylindrical cuff body may include a first side with a first longitudinal edge and a second side with a second longitudinal edge. The cylindrical cuff body may also have a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end. The lead system may also include first and second lead portions having generally serpentine configurations and a first anchor interposed between the first and second lead portions and configured to be secured relative to a non-nerve body structure. The lead system may also include a connector extending proximally from the second lead portion and configured to electrically connect to an implantable pulse generator.

Claims

1. A lead system comprising:

a cuff electrode configured to be implanted on a nerve and including a cylindrical cuff body having a plurality of electrode contacts disposed therein, the cylindrical cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cylindrical cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end, and wherein, when the cuff electrode is implanted on the nerve, the cuff electrode surrounds substantially an entire circumference of a portion of the nerve, the first and second longitudinal edges are unattached and facing one another, and the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cylindrical cuff body is not associated with the second side of the cylindrical cuff body;

a first lead portion extending from the cuff electrode and having a generally serpentine configuration;

a second lead portion having a generally serpentine configuration and having a length substantially greater than a length of the first lead portion;

a first anchor interposed between the first lead portion and the second lead portion and configured to be secured relative to a non-nerve body structure; and

a connector extending proximally from the second lead portion and configured to electrically connect to an implantable pulse generator.

2. The lead system of claim 1, wherein the generally serpentine configuration of the respective first and second lead portions comprises a generally sinusoidal pattern.

3. The lead system of claim 1, wherein the length of the first lead portion corresponds to an arcuate length that includes a length of a curved portion of the generally serpentine configuration.

4. A lead system, comprising:

a lead body;

a connector disposed at a proximal end of the lead body for connection to a neurostimulator;

a nerve cuff disposed at a distal end of the lead body for connection to and stimulation of a nerve, the nerve cuff including a cylindrical cuff body and a plurality of electrode contacts disposed therein, the cylindrical cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cylindrical cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end, and wherein, when the nerve cuff is implanted on the nerve, the nerve cuff surrounds substantially an entire circumference of a portion of the nerve, the first and second longitudinal edges are unattached and facing one another, and the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cylindrical cuff body is not associated with the second side of the cylindrical cuff body.

5. A lead system as in claim 4, wherein three or more electrode contacts are disposed on an inside surface of the cuff body, and wherein the electrode contacts are configured to create an electrical field in the cuff body.

6. A lead system as in claim 5, wherein the electrical field is configured to activate fascicles across an entire cross-section of the nerve.

7. A lead system as in claim 5, wherein the electrical field is configured to activate only superior fascicles of the nerve.

8. A lead system as in claim 5, wherein the electrical field is configured to avoid stimulating select fascicles of the nerve.

9. A lead system as in claim 5, wherein the electrical field is configured to activate inferior fascicles of the nerve.

10. A lead system as in claim 5, wherein the electrical field is configured to activate lateral fascicles of the nerve.

11. A lead system as in claim 5, wherein the electrical field is configured to activate medial fascicles of the nerve.

12. A lead system as in claim 5, wherein the electrical field is configured to activate fascicles across an entire cross-section of the nerve, with the exception of select fascicles.

13. A lead system as in claim 4, wherein the cuff body includes a compliant wrap configured to be disposed about the nerve.

14. A lead system as in claim 4, wherein the first side further includes a second longitudinal edge, and the second side extends from the second longitudinal edge, and wherein the cuff body includes a plurality of electrode contacts radially spaced around an inside surface of the cuff body.

15. A lead system as in claim 4, wherein the second side is longitudinally shorter than the first side, and wherein the second side is configured to be placed deep to the nerve to minimize dissection around the nerve.

16. A lead system as in claim 15, wherein a cathode is disposed on the second side of the cuff body.

17. A lead system as in claim 16, wherein two anodes are disposed on the first side of the cuff body and positioned diametrically opposite and longitudinally spaced relative to the cathode.

18. A lead system as in claim 15, wherein a cathode and two anodes are disposed on the first side of the cuff body.

19. A lead system as in claim 15, wherein the second side of the cuff body includes a strap extending therefrom to facilitate placement around the deep side of the nerve.

20. A lead system as in claim 15, wherein the second side includes a strap to facilitate inserting the second side into a fenestration on a deep side of the nerve to secure the nerve cuff electrode about the nerve.

21. A lead system as in claim 15, wherein the first side includes a cathode disposed between two anodes, and the second side includes an anode.

22. A lead system as in claim 15, wherein the second side includes a length of less than 6 mm.

23. A lead system as in claim 22, wherein the second side includes a length in the range of approximately 3 mm to 5 mm.

24. A lead system as in claim 15, wherein the first side includes a length of more than 6 mm.

25. A lead system as in claim 24, wherein the first side includes a length in the range of approximately 7 mm to 8 mm.

26. A lead system as in claim 15, wherein the electrode includes a plurality of electrode contacts configured in a transverse guarded tri-polar electrode arrangement.

27. A lead system as in claim 4, wherein the lead body includes a sigmoid shape.

28. A lead system as in claim 27, wherein the lead body includes a plurality of flexible undulations disposed in a plane.

29. A lead system as in claim 27, wherein the lead body includes a coiled conductor disposed within the lead body.

30. A lead system as in claim 29, wherein the coiled conductor includes a plurality of coiled conductors.

31. A lead system as in claim 30, wherein the plurality of conductors are disposed within a lumen of the lead body.

32. A lead system as in claim 4, wherein the cuff body is configured to accommodate one of nerve swelling and over tightening of the cuff.

33. A lead system as in claim 4, wherein the nerve cuff includes an inner surface, wherein an entirety of the inner surface is smooth.

34. A lead system as in claim 4, wherein the first and second sides are semi-cylindrical in shape.

35. A lead system as in claim 4, wherein the nerve cuff electrode completely surrounds the entire circumference of the nerve.

36. A lead system, comprising:

a lead body;

a connector disposed at a proximal end of the lead body for connection to a neurostimulator;

a nerve cuff disposed at a distal end of the lead body for connection to and stimulation of a nerve, the nerve cuff including a cylindrical cuff body having a first side with a first longitudinal edge and a second side with a second longitudinal edge, the cylindrical cuff body having a proximalmost end surface and a distalmost end surface, wherein the first longitudinal edge includes a proximalmost end and a distalmost end, and the second longitudinal edge includes a proximalmost end and a distalmost end and wherein the second side includes a first electrode contact, the first side includes two anode electrode contacts and a cathode electrode contact between the anode electrode contacts, and the cathode electrode contact faces the first electrode contact, and, when implanted on the nerve, the nerve cuff electrode surrounds substantially an entire circumference of a portion of the nerve, with the second side of the cuff body extending around a deep side of the nerve, and the first and second longitudinal edges are unattached and facing one another, and wherein the proximalmost and distalmost ends of the second longitudinal edge are disposed between the proximalmost and distalmost ends of the first longitudinal edge, wherein the distalmost end surface of the cylindrical cuff body is not associated with the second side of the cylindrical cuff body.

37. A lead system as in claim 36, wherein the second side of the cuff body includes a strap extending therefrom.

38. A lead system as in claim 36, wherein a length of the second side is less than 6 mm, and a length of the first side is greater than 6 mm.

39. A lead system as in claim 38, wherein a length of the second side is between about 3 mm and about 5 mm.

40. A lead system as in claim 36, wherein the second side has only a first electrode contact, and the first side has only two anode electrode contacts and a cathode electrode contact between the anode electrode contacts.

41. A lead system as in claim 36, wherein the first and second sides are semi-cylindrical in shape.

42. A lead system as in claim 36, wherein the nerve cuff electrode is configured to completely surround the entire circumference of the portion of the nerve.