Obstructive sleep apnea treatment devices, systems and methods

• US 20080103407A1
• Filed: 10/12/2007
• Published: 05/01/2008
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Atkinson, Robert, Persson, Bruce, Hoegh, Thomas, Mazar, Scott, Bolea, Stephen
• Granted Patent: US 7,809,442 B2
• Time in Patent Office: Days
• US Class Current: 600/529
• 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, systems and methods for nerve stimulation for OSA therapy.

Claims

1. A method of treating obstructive sleep apnea, comprising:

chronically implanting an electrode on a hypoglossal nerve at a site to stimulate a tongue protruder muscle and a tongue retruder muscle; and

periodically delivering a stimulus to the nerve via the electrode to mitigate obstruction of the upper airway,

wherein the stimulus is configured to selectively activate the tongue protruder muscle more than or before the tongue retruder muscle.

2. A method as in claim 1, wherein the stimulus is triggered based on a sensed parameter indicative of respiration.

3. A method as in claim 1, wherein electrical field steering is used for selective activation.

4. The method of claim 1, wherein chronically implanting an electrode includes

chronically implanting a first electrode cuff on the hypoglossal nerve at a first site to stimulate a tongue protruder muscle and

chronically implanting a second electrode on the hypoglossal nerve at a second site, proximal of the first site, to stimulate a tongue retruder muscles, and wherein periodically delivering a stimulus to the nerve via the electrode includes

periodically delivering a stimulus to the first and second nerve sites via the electrodes.

5-7. -7. (canceled)

8. A method of treating obstructive sleep apnea, comprising:

chronically implanting a first electrode on a first nerve;

chronically implanting a second electrode on a second nerve, different from the first nerve; and

periodically delivering a stimulus to the nerves via the electrodes to mitigate obstruction of the upper airway.

9. A method as in claim 8, wherein the first nerve is a hypoglossal nerve and the second nerve is an ansa cervicalis nerve.

10-16. -16. (canceled)

17. A method of treating obstructive sleep apnea, comprising:

providing an electrode comprising a cuff having a relatively long side and a relatively short side; and

chronically implanting the electrode on a portion of a hypoglossal nerve such that the relatively short side of the cuff extends around a deep side of the nerve; and

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

18. A method as in claim 17 wherein a cathode is disposed on the short side of the cuff.

19. A method as in claim 18 wherein two anodes are disposed on the long side of the cuff and positioned diametrically opposite and longitudinally spaced relative to the cathode.

20. A method as in claim 17 wherein a cathode and two anodes are disposed on the long side of the cuff.

21. A method as in claim 17 wherein the short side of the cuff includes a removable strap extending therefrom to facilitate placement around the deep side of the nerve.

22. A method as in claim 17, wherein three or more electrode contacts are disposed on an inside surface of the cuff, and wherein delivering a stimulus includes selectively delivering a stimulus to two or more of the electrodes to steer an electrical field in the cuff and selectively activate fascicles in the nerve.

23. A method as in claim 17, wherein the cuff includes a compliant wrap configured to be secured to the hypoglossal nerve, the wrap including an extension and an opening for receiving the extension to secure the cuff to the hypoglossal nerve.

24. A method as in claim 17, wherein the cuff is secured to the hypoglossal nerve by disposing the relatively short side within a fenestration on the relatively long side.

25. A method as in claim 24, wherein the relatively short side includes a tow strap to facilitate inserting the relatively short side into the fenestration on the relatively long side.

26. A method as in claim 24, wherein the relatively long side includes a cathode disposed between two anodes, and the relatively short side includes an anode.

27. A method as in claim 17, wherein the cuff includes a split cuff having a plurality of electrodes radially spaced around an inside surface of the cuff.

28. A method as in claim 17, wherein the cuff includes a split cuff body having a plurality of extensions extending from opposite ends of the cuff body, the extensions being configured to be connected together to secure the cuff to the hypoglossal nerve.

29. A method as in claim 17, wherein the cuff includes a split cuff body having a proximal end and a distal end, wherein at least one of the proximal and distal ends of the cuff body includes an extension having a tapered thickness.

30-46. -46. (canceled)

47. A method of treating obstructive sleep apnea, comprising:

chronically implanting one or more electrodes on a hypoglossal nerve innervating a tongue protruder muscle;

determining respiration based on a bio-impedance parameter using an implanted bio-impedance sensor;

periodically delivering a stimulus, based on the sensed parameter, to the nerve via the electrode to mitigate obstruction of the upper airway;

detecting one or more types of events using the implanted bio-impedance sensor; and

adjusting a parameter of the stimulus to increase efficacy as a function of detected events.

48. A method as in claim 47, wherein the one or more types of events include a respiratory event.

49-50. -50. (canceled)

51. A method of treating obstructive sleep apnea, comprising:

chronically implanting one or more electrodes on a hypoglossal nerve innervating a tongue protruder muscle;

determining respiration using an implanted sensor;

periodically delivering a stimulus, based on sensed respiration, to the nerve via the electrode to mitigate obstruction of the upper airway;

detecting one or more types of events using the implanted sensor; and

adjusting a parameter of the stimulus to increase efficacy as a function of detected events.

52. A method as in claim 51, wherein the event comprises an episode of obstructive sleep apnea.

53. A method as in claim 51, wherein the event comprises an episode of central sleep apnea.

54. A method as in claim 51, wherein the event comprises an episode of hypopnea.

63. A method as in claim 51, wherein the one or more types of events includes a respiratory event.

55. A method of treating obstructive sleep apnea, comprising:

chronically implanting one or more electrodes on a hypoglossal nerve innervating a tongue protruder muscle;

determining respiration based on a bio-impedance parameter using an implanted bio-impedance sensor, wherein the bio-impedance sensor includes an electrode array having an electrode positioned proximate an apex of a lung and a second electrode positioned proximate a diaphragm; and

periodically delivering a stimulus, based on the sensed parameter, to the nerve via the electrode to mitigate obstruction of the upper airway.

56. A method of treating obstructive sleep apnea, comprising:

chronically implanting one or more electrodes on a hypoglossal nerve innervating a tongue protruder muscle;

determining respiration using an implanted sensor;

periodically delivering a stimulus, based on sensed respiration, to the nerve via the electrode to mitigate obstruction of the upper airway;

detecting one or more types of events using the implanted sensor; and

logging the respiratory events for subsequent download by an external device.

57. A method as in claim 56, wherein the implanted sensor comprises a bio-impedance sensor.

58. A method as in claim 56, wherein the event comprises an episode of obstructive sleep apnea.

59. A method as in claim 56, wherein the event comprises an episode of central sleep apnea.

60. A method as in claim 56, wherein the event comprises an episode of hypopnea.

61. A method as in claim 56, wherein the one or more types of events include a respiratory event.

62. A method of treating obstructive sleep apnea by delivering a stimulus to activate an upper airway dilator muscle, wherein the stimulus is delivered according to an algorithm that triggers stimulation to occur during inspiration predicted as a function of expiration onset.

64. A method of treating obstructive sleep apnea, the method comprising:

chronically implanting an electrode on a nerve innervating an upper airway dilator muscle; and

stimulating the nerve based on predicted expiratory onset.

65-66. -66. (canceled)

67. A method of treating a patient with obstructive sleep apnea, comprising:

a. chronically implanting a respiration sensor on a right lateral side of the patient to reduce cardiac noise in a sensed respiratory signal; and

b. chronically implanting an electrode on a hypoglossal nerve to deliver a stimulus to the nerve via the electrode to mitigate obstruction of the upper airway.

68. A method as in claim 67, wherein the respiration sensor comprises a bio-impedance sensor including a plurality of electrodes disposed on the right lateral side of the patient.

69-74. -74. (canceled)

75. A method of treating obstructive sleep apnea in a patient, the method comprising:

chronically implanting an electrode on a nerve innervating an upper airway dilator muscle of the patient;

chronically implanting a lead substantially within a neck of the patient, wherein the lead is connected to the electrode and includes a lead body having a sigmoid shape and a coiled conductor disposed within the lead body; and

selectively delivering a stimulus to the electrode via the lead.

76. A method as in claim 75, wherein the lead body includes a plurality of flexible undulations disposed in a plane.

77. A method as in claim 75, wherein the coiled conductor includes a plurality of coiled conductors.