Obstructive sleep apnea treatment devices, systems and methods

Patent metadata

Field	Value
Publication number	US-10105538-B2
Application number	US-98084010-A
Country	US
Kind code	B2
Filing date	Dec 29, 2010
Priority date	Dec 31, 2008
Publication date	Oct 23, 2018
Grant date	Oct 23, 2018

Abstract

Devices, systems and methods of neurostimulation for treating obstructive sleep apnea.

First claim

What is claimed is:

1. A method of positioning an electrode cuff on a hypoglossal nerve of a patient, the method comprising:
positioning the electrode cuff at a first location on the hypoglossal nerve, wherein the electrode cuff includes a plurality of electrode contacts;
delivering a first electrical stimulation to the hypoglossal nerve via the electrode cuff at the first location on the hypoglossal nerve;
monitoring an upper airway of the patient at a first time to evaluate a positioning of the electrode cuff at the first location on the hypoglossal nerve, wherein monitoring the upper airway includes visualizing the upper airway, and wherein the monitoring at the first time indicates that a predetermined response is not fully achieved; and
repositioning the electrode cuff at a second location on the hypoglossal nerve, wherein the second location on the hypoglossal nerve is different from the first location on the hypoglossal nerve;
delivering a second electrical stimulation to the hypoglossal nerve via the electrode cuff at the second location on the hypoglossal nerve; and
monitoring the upper airway of the patient at a second time for the predetermined response to evaluate a positioning of the electrode cuff at the second location on the hypoglossal nerve.

2. The method of claim 1 , wherein visualizing the upper airway includes visualizing at least one of a hyoid bone, an anterior wall in the upper airway, a lateral wall in the upper airway, and a palate.

3. The method of claim 2 , wherein visualizing the upper airway includes visualization with one of an endoscope and a fluoroscope.

4. The method of claim 1 , wherein the predetermined response includes at least one of an increase in a dimension of a retro-glossal airway, an increase in a dimension of a retro-palatal airway, and an increase in stiffness of one of an anterior and a lateral wall of a retro-glossal airway.

5. The method of claim 4 , wherein the predetermined response further includes protrusion of a tongue of a patient.

6. The method of claim 1 , wherein visualizing the upper airway includes observing movement of anatomy in the upper airway.

7. The method of claim 1 , wherein delivering at least one of the first electrical stimulation and the second electrical stimulation to the hypoglossal nerve includes steering an electrical field to stimulate fascicles of the nerve.

8. The method of claim 1 , wherein the predetermined response includes anterior movement of the hyoid bone.

9. The method of claim 1 , wherein monitoring the upper airway at the first and/or second times includes observing a position of a tongue of the patient.

10. The method of claim 1 , wherein the monitoring at the first and/or second times indicates that the predetermined response is fully achieved when the second electrical stimulation is delivered to the hypoglossal nerve via the electrode cuff at the second location.

11. A method of positioning an electrode on a hypoglossal nerve of a patient, the method comprising:
positioning the electrode at a first location on the hypoglossal nerve;
delivering an electrical stimulation to the hypoglossal nerve;
confirming desired positioning of the electrode by monitoring an upper airway of the patient for a desired response, wherein monitoring the upper airway includes visualizing the upper airway with an imaging device; and
repeating the steps of positioning the electrode and delivering an electrical stimulation until the desired response is observed.

12. The method of claim 11 , wherein the desired response is a predetermined response.

13. The method of claim 12 , wherein repeating the step of positioning the electrode includes repositioning the electrode at a second location on the hypoglossal nerve, the second location on the hypoglossal nerve being different from the first location on the hypoglossal nerve.

14. The method of claim 13 , wherein the predetermined response is observed when the electrical stimulation is delivered to the hypoglossal nerve via the electrode at the second location.

15. The method of claim 12 , wherein confirming desired positioning of the electrode includes determining that the predetermined response is not observed when the electrical stimulation is delivered to the hypoglossal nerve via the electrode at the first location.

16. The method of claim 12 , wherein the predetermined response includes anterior movement of an anterior wall of the upper airway.

17. The method of claim 11 , wherein repeating the step of positioning the electrode includes repositioning the electrode at a second location on the hypoglossal nerve, the second location on the hypoglossal nerve being different from the first location on the hypoglossal nerve.

18. A method of positioning an electrode cuff on a hypoglossal nerve of a patient, the method comprising:
evaluating a first response of an upper airway of the patient to a first stimulation signal delivered to a first location on the hypoglossal nerve via the electrode cuff, the first response comprising a first magnitude of movement of upper airway tissue;
repositioning the electrode cuff from the first location on the hypoglossal nerve to a different second location on the hypoglossal nerve; and
evaluating a second response of the upper airway of the patient to a second stimulation signal delivered to the second location on the hypoglossal nerve via the electrode cuff, the second response comprising a second magnitude of movement of upper airway tissue, the second magnitude being greater than the first magnitude.

19. The method of claim 18 , wherein the first magnitude is less than a predetermined magnitude of movement of upper airway tissue, and wherein the second magnitude is greater than or equal to the predetermined magnitude.

20. The method of claim 18 , wherein the second magnitude of movement is a desired response to the second stimulation signal.

21. The method of claim 18 , wherein at least one of the evaluating of the first response and the evaluating of the second response includes a visualizing of the upper airway with at least one of an endoscope and a fluoroscope.

Assignees

• Bolea Stephen L
• Hoegh Thomas B
• Kuhnley Brian D
• Suilmann Dale G
• Persson Bruce J
• Beck John P
• Hauschild Sidney F
• Kaplan Paula M
• Hoyhtya Adam K
• Tesfayesus Wondimeneh
• Atkinson Robert E
• Cyberonics Inc

Inventors

• Bolea Stephen L
• Hoegh Thomas B
• Kuhnley Brian D
• Suilmann Dale G
• Persson Bruce J
• Beck John P
• Hauschild Sidney F
• Kaplan Paula M
• Hoyhtya Adam K
• Tesfayesus Wondimeneh
• Atkinson Robert E

Classifications

• A61B5/4818

  Sleep apnoea · CPC title

• A61N1/0556

  Cuff electrodes · CPC title

• A61N1/3611

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61B5/0538

  invasively, e.g. using a catheter · CPC title