Obstructive sleep apnea treatment devices, systems and methods

• US RE48,025 E1
• Filed: 04/22/2015
• Issued: 06/02/2020
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Hauschild, Sidney F., Kaplan, Paula M., Kuhnley, Brian D., Jasperson, Keith E., Tesfayesus, Wondimeneh, Thorp, Christopher K.
• Primary Examiner(s): Williams, Catherine S
• Application Number:
  US14/693,836
• Time in Patent Office: 1,868 Days
• CPC Class Codes: N/A

Abstract

In one embodiment, a method for maintaining patency of an upper airway of a patient to treat obstructive sleep apnea may include delivering an electrical stimulation to a portion of a superior laryngeal nerve via a nerve cuff when the nerve cuff is adjacent an external surface of the superior laryngeal nerve, the nerve cuff having a plurality of electrodes, wherein the nerve cuff is configured to be connected to an electrical stimulator via a stimulation lead.

Claims

1. A method of maintaining patency of an upper airway of a patient to treat obstructive sleep apnea, the method comprising:

sensing a biological parameter indicative of respiration, wherein the biological parameter includes impedance;

analyzing the biological parameter to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting an onset of a future expiratory phase; and

beginning stimulation of a nerve a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

2. The method of claim 1, wherein the nerve is an internal branch of a superior laryngeal nerve.

3. The method of claim 1, further comprising:

implanting an impedance sensor within the patient, wherein the impedance sensor is coupled to an electrical stimulator by a sensing lead.

4. The method of claim 1, wherein beginning stimulation of the nerve includes delivering electrical stimulation to one of a hypoglossal nerve and a glossopharyngeal nerve.

5. The method of claim 4, further comprising delivering stimulation to a portion of a superior laryngeal nerve concurrently with the stimulation delivered to the one of a hypoglossal nerve and a glossopharyngeal nerve.

6. The method of claim 1, further comprising:

steering an electrical field of a nerve cuff to stimulate only afferent fibers of the nerve.

7. The method of claim 1, wherein the step of beginning stimulation of a nerve includes delivering stimulation to only afferent fibers of an internal branch of a superior laryngeal nerve.

8. The method of claim 1, wherein the stimulation is delivered via a nerve cuff connected to an electrical stimulator via a stimulation lead including a portion having a serpentine configuration.

9. The method of claim 8, wherein the stimulation lead includes a portion configured to be secured to a body structure other than a nerve.

10. The method of claim 8, wherein the nerve cuff includes a plurality of electrodes in direct contact with the nerve.

11. The method of claim 1, further comprising:

an electrode sensor for wherein the step of sensing the biological parameter, wherein the electrode sensor is performed via an electrode sensor coupled to sensing circuitry of an electrical stimulator,

wherein stimulation of the nerve includes delivering an electrical stimulation to a glossopharyngeal nerve via a nerve cuff having a plurality of electrodes, wherein the nerve cuff is connected to-the to the electrical stimulator by a stimulation lead, and wherein a portion of the stimulation lead is configured to elongate in response to movement by the patient.

12. The method of claim 11, wherein the stimulation lead further includes a portion configured to be secured to a body structure other than a nerve.

13. The method of claim 1, wherein the stimulation is delivered to the nerve via a nerve cuff connected to an electrical stimulator, the nerve cuff comprising:

a base member extending from a first side wall to a second side wall and having a top wall and a bottom wall;

a first member extending from the first side wall;

a second member extending from the second side wall; and

a third member having a first end fixedly engaged to the first side wall adjacent the first member, wherein the third member extends over the top wall of the base member, the second member extends over the top wall of the base member, and the first member, the second member, and the third member define a lumen.

14. The method of claim 13, wherein the third member is capable of transitioning between a first position, prior to positioning of the electrode cuff about a nerve, and a second position subsequent to the positioning of the electrode cuff about the nerve, wherein the third member is positioned a first distance above the top wall of the base member in the first position, and the third member is positioned a second distance smaller than the first distance above the top wall of the base member in the second position.

15. The method of claim 13, wherein the second member is capable of transitioning between a first position, prior to positioning of the electrode cuff about a nerve, and a second position subsequent to the positioning of the electrode cuff about the nerve, wherein the second member is positioned a first distance above the top wall of the base member in the first position, and the second member is positioned a second distance, greater than the first distance, above the top wall of the base member in the second position.

16. The method of claim 13, wherein the second member has a first thickness at a first end of the second member and a second thickness, less than the first thickness, at a second end.

23. The method of claim 1, further comprising steering an electrical field of a nerve cuff to stimulate fibers of the nerve, wherein a majority of the stimulated fibers of the nerve comprises afferent fibers.

24. The method of claim 1, wherein beginning stimulation of the nerve includes delivering stimulation to fibers of an internal branch of a superior laryngeal nerve, and wherein a majority of the fibers to which stimulation is delivered comprises afferent fibers.

17. A method of treating obstructive sleep apnea by innervating a mechanoreceptor within a patient'"'"'s upper airway via stimulating a superior laryngeal nerve including both afferent and efferent fibers, the method comprising:

chronically implanting a nerve cuff adjacent a portion of a superior laryngeal nerve;

;

sensing a biological parameter indicative of respiration, wherein the biological parameter includes impedance;

analyzing the sensed biological parameter to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting the onset of a future expiratory phase; and

beginning stimulation of the superior laryngeal nerve a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the superior laryngeal nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

18. The method of claim 17, further comprising:

delivering an electrical stimulation to one of a hypoglossal nerve and a glossopharyngeal nerve simultaneously with the stimulation to the superior laryngeal nerve.

19. The method of claim 17, further comprising:

steering an electrical field of the nerve cuff to stimulate only the afferent fibers of an internal branch of the superior laryngeal nerve.

20. The method of claim 17, wherein the nerve cuff includes a plurality of electrodes in direct contact with a surface of the superior laryngeal nerve.

25. The method of claim 17, further comprising steering an electrical field of the nerve cuff to stimulate fibers of an internal branch of the superior laryngeal nerve, wherein a majority of the stimulated fibers of the nerve comprises afferent fibers.

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

chronically implanting a nerve cuff adjacent a portion of a superior laryngeal nerve;

sensing a biological parameter indicative of respiration, wherein the biological parameter includes impedance;

analyzing the biological parameter to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting an onset of a future expiratory phase; and

beginning stimulation of the superior laryngeal nerve a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the superior laryngeal nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.

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

sensing a biological parameter indicative of respiration, wherein the biological parameter includes impedance;

analyzing the biological parameter to identify onsets of expiration;

calculating a respiratory period from the onsets of expiration;

predicting an onset of a future expiratory phase; and

beginning stimulation of a nerve a fraction of the calculated respiratory period before the onset of the future expiratory phase, and continuing stimulation of the nerve during an entire inspiratory phase, wherein the method is performed without identifying an onset of the inspiratory phase.