Obstructive sleep apnea treatment devices, systems and methods

• US 7,809,442 B2
• Filed: 10/12/2007
• Issued: 10/05/2010
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Bolea, Stephen L., Atkinson, Robert E., Persson, Bruce J., Mazar, Scott T., Hoegh, Thomas B.
• Primary Examiner(s): Schaetzle; Kennedy J
• Assistant Examiner(s): ANTHONY, JESSICA LYNN
• Application Number:
  US11/907,532
• Publication Number:
  US 20080103407A1
• Time in Patent Office: 1,089 Days
• Field of Search: 607/42, 607/118
• US Class Current: 607/42
• 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

Devices and methods of use are provided for treating a person having a hypoglossal nerve and an upper airway. In one embodiment, a method may include providing a nerve cuff electrode including a cylindrical cuff body. The method may further include chronically implanting the nerve cuff electrode on a portion of the hypoglossal nerve. The method may also include delivering a stimulus to the hypoglossal nerve via the nerve cuff electrode to mitigate obstruction of the upper airway.

Claims

1. A method of treating a person having a hypoglossal nerve and an upper airway, comprising:

chronically implanting a nerve cuff electrode on a portion of the hypoglossal nerve, the nerve cuff electrode comprising 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, when the nerve cuff electrode is implanted on the hypoglossal nerve, the nerve cuff electrode surrounds substantially an entire circumference of a portion of the hypoglossal 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; and

delivering a stimulus to the hypoglossal nerve via the nerve cuff electrode to mitigate obstruction of the upper airway.

2. A method as in claim 1, wherein three or more electrode contacts are disposed on an inside surface of the cuff body, and wherein delivering a stimulus includes selectively delivering a stimulus to two or more of the electrode contacts to steer an electrical field in the cuff body and selectively activate fascicles in the nerve.

3. A method as in claim 2, wherein the electrical field is configured to activate fascicles across an entire cross-section of the hypoglossal nerve.

4. A method as in claim 2, wherein the electrical field is configured to activate only superior fascicles of the hypoglossal nerve.

5. A method as in claim 2, wherein the electrical field is configured to avoid stimulating hypoglossal nerve fascicles that innervate intrinsic muscles of a patient'"'"'s tongue.

6. A method as in claim 2, wherein the electrical field is configured to activate inferior fascicles of the hypoglossal nerve.

7. A method as in claim 2, wherein the electrical field is configured to activate lateral fascicles of the hypoglossal nerve.

8. A method as in claim 2, wherein the electrical field is configured to activate medial fascicles of the hypoglossal nerve.

9. A method as in claim 2, wherein the electrical field is configured to activate fascicles across an entire cross-section of the hypoglossal nerve, with the exception of inferior medial fascicles.

10. A method as in claim 1, wherein the cuff body includes a compliant wrap configured to be disposed about the hypoglossal nerve.

11. A method as in claim 1, 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.

12. The method as in claim 1, 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.

13. A method as in claim 12, wherein a cathode is disposed on the second side of the cuff body.

14. A method as in claim 13, wherein two anodes are disposed on the first side of the cuff body and positioned diametrically opposite and longitudinally spaced relative to the cathode.

15. A method as in claim 12, wherein a cathode and two anodes are disposed on the first side of the cuff body.

16. A method as in claim 12, wherein the second side of the cuff body includes a strap extending therefrom to facilitate placement around the deep side of the nerve.

17. A method as in claim 12, wherein the second side includes a strap to facilitate inserting the second side into a fenestration on a deep side of the hypoglossal nerve to secure the nerve cuff electrode about the hypoglossal nerve.

18. A method as in claim 12, wherein the first side includes a cathode disposed between two anodes, and the second side includes an anode.

19. The method as in claim 12, wherein the second side includes a length of less than 6 mm.

20. The method as in claim 19, wherein the second side includes a length in the range of approximately 3 mm to 5 mm.

21. The method as in claim 12, wherein the first side includes a length of more than 6 mm.

22. The method as in claim 21, wherein the first side includes a length in the range of approximately 7 mm to 8 mm.

23. The method as in claim 12, wherein the electrode includes a plurality of electrode contacts configured in a transverse guarded tri-polar electrode arrangement.

24. The method as in claim 1, further comprising:

providing a lead having a lead body, wherein the lead is operably connected to the nerve cuff electrode; and

chronically implanting the lead within a portion of a neck of a patient.

25. The method as in claim 24, wherein the lead body includes a sigmoid shape.

26. The method as in claim 24, wherein the lead body includes a plurality of flexible undulations disposed in a plane.

27. The method as in claim 24, wherein the lead body includes a coiled conductor disposed within the lead body.

28. The method as in claim 27, wherein the coiled conductor includes a plurality of coiled conductors.

29. The method as in claim 28, wherein the plurality of conductors are disposed within a lumen of the lead body.

30. The method as in claim 24, wherein the step of delivering a stimulus to the hypoglossal nerve via the nerve cuff electrode includes delivering the stimulus via the lead.

31. The method as in claim 24, wherein a proximal portion of the lead is configured to be connected to a pulse generator.

32. The method as in claim 1, wherein the cuff body is configured to accommodate one of nerve swelling and over tightening of the cuff.

33. A method as in claim 1, wherein, when implanted on the hypoglossal nerve, the nerve cuff electrode includes an inner surface, wherein an entirety of the inner surface is smooth.

34. A method as in claim 1, wherein the method further includes observing the upper airway during delivery of the stimulus.

35. A method as in claim 34, wherein observing the upper airway includes endoscopically observing the upper airway.

36. A method as in claim 1, wherein chronically implanting the nerve cuff electrode further includes implanting the nerve cuff electrode on a distal or medial branch of the hypoglossal nerve proximal of a branch innervating a genioglossus muscle and distal of a branch innervating a geniohyoid muscle.

37. A method as in claim 1, wherein chronically implanting the nerve cuff electrode further includes implanting the nerve cuff electrode on a proximal portion of the hypoglossal nerve proximal of the branches innervating a genioglossus muscle and a geniohyoid muscle, and distal of the branches innervating a hyoglossus muscle and a styloglossus muscle.

38. A method as in claim 1, wherein chronically implanting the nerve cuff electrode further includes implanting the nerve cuff electrode on a medial branch of the hypoglossal nerve proximal of a branch innervating a geniohyoid muscle and distal of branches innervating a hyoglossus muscle and a styloglossus muscle.

39. A method as in claim 1, wherein chronically implanting the nerve cuff electrode further includes implanting the nerve cuff electrode on a trunk portion of the hypoglossal nerve proximal branches innervating genioglossus, hyoglossus, and styloglossus muscles.

40. A method as in claim 1, wherein the first and second sides are semi-cylindrical in shape.

41. A method as in claim 1, wherein the nerve cuff electrode completely surrounds the entire circumference of the portion of the hypoglossal nerve.

42. A method of treating a patient with a hypoglossal nerve and an upper airway, comprising:

chronically implanting a nerve cuff electrode on a portion of the hypoglossal nerve, wherein the nerve cuff electrode includes 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 hypoglossal nerve, the nerve cuff electrode surrounds substantially an entire circumference of a portion of the hypoglossal 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; and

delivering a stimulus to the hypoglossal nerve via the nerve cuff electrode to mitigate obstruction of the upper airway.

43. The method as in claim 42, wherein the second side of the cuff body includes a strap extending therefrom.

44. The method as in claim 42, wherein a length of the second side is less than 6 mm, and a length of the first side is greater than 6 mm.

45. The method as in claim 44, wherein a length of the second side is between about 3 mm and about 5 mm.

46. The method as in claim 42, 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.

47. The method as in claim 42, wherein the first and second sides are semi-cylindrical in shape.

48. The method as in claim 42, wherein the nerve cuff electrode completely surrounds the entire circumference of the portion of the hypoglossal nerve.

49. A method of treating a person with a hypoglossal nerve and an upper airway, comprising:

chronically implanting a nerve cuff electrode on a portion of the hypoglossal nerve; and

delivering a stimulus to the hypoglossal nerve via the nerve cuff electrode to mitigate obstruction of the upper airway, wherein the nerve cuff electrode includes a cylindrical cuff body having a first side and a second side, the first side including a first longitudinal edge having proximalmost and distalmost ends, and the second side including a second longitudinal edge having proximalmost and distalmost ends, the cylindrical cuff body having a proximalmost end surface and a distalmost end surface, and, when implanted on the hypoglossal nerve, the nerve cuff electrode surrounds substantially an entire circumference of a portion of the hypoglossal nerve, the first and second longitudinal edges are unattached and face one another, and the second side of the cuff body extends around a deep side of the nerve, wherein the second side includes at least one electrode contact and the first side includes at least one electrode contact, wherein a deep side of the nerve is dissected less than a superficial side of the nerve, 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, and wherein the distalmost end surface of the cylindrical cuff body is not associated with the second side of the cylindrical cuff body.

50. The method as in claim 49, wherein the nerve cuff electrode completely surrounds the entire circumference of the portion of the hypoglossal nerve.