Screening devices and methods for obstructive sleep apnea therapy

• US 8,855,771 B2
• Filed: 08/08/2011
• Issued: 10/07/2014
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Tesfayesus, Wondimeneh, Bolea, Stephen L., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/205,315
• Publication Number:
  US 20140188185A1
• Time in Patent Office: 1,156 Days
• Field of Search: 607/42
• US Class Current: 607/42
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/4552 Evaluating soft tissue within the mouth, e.g. gums or tongue
• CPC Class Codes: A61N 1/0519 Endotracheal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

Devices and methods for treating obstructive sleep apnea by first performing an assessment of the patient that involves observing the patient'"'"'s upper airway during a tongue protrusion maneuver. The assessment may, for example, be done using endoscopy to observe the upper airway while the patient is awake in the supine position. An adequate response of the upper airway during the tongue protrusion maneuver is indicative of likely therapeutic success with hypoglossal nerve stimulation, and may be used for making clinical decisions. The principles of the present invention may be applied to other therapeutic interventions for OSA involving the upper airway.

Claims

1. A method of assessing a patient'"'"'s suitability for a nerve stimulation therapy, comprising:

observing the patient'"'"'s airway with an imaging device;

protruding the patient'"'"'s tongue without nerve stimulation while observing a response of the patient'"'"'s airway; and

scoring the response, wherein the scored response is indicative of the patient'"'"'s suitability for the nerve stimulation therapy.

2. A method as in claim 1, wherein observing the patient'"'"'s airway includes observing the patient'"'"'s soft palate while the patient is awake and supine.

3. A method as in claim 1, wherein the tongue protrusion is volitional.

4. A method as in claim 1, wherein observing the patient'"'"'s airway includes observing the patient'"'"'s soft palate with endoscopy.

5. A method as in claim 4, wherein observing the patient'"'"'s soft palate with endoscopy includes imaging the patient'"'"'s soft palate with a device having a geometric feature of a predetermined dimension within a field of view of the device.

6. A method as in claim 1, wherein the response is scored using a qualitative scale.

7. A method as in claim 1, wherein the response is scored using a quantitative scale.

8. A method as in claim 1, wherein the scored response is a function of anterior-posterior displacement of the soft palate.

9. A method as in claim 1, wherein the scored response is a function of lateral displacement of the lateral pharyngeal walls.

10. A method as in claim 1, wherein the scored response is made with reference to an anatomical feature.

11. A method as in claim 1, wherein the nerve stimulation therapy is a hypoglossal nerve stimulation therapy.

12. A method as in claim 1, wherein the tongue protrusion is non-volitional.

13. A method as in claim 1, wherein observing the response of the patient'"'"'s airway includes observing a response of the patient'"'"'s soft palate.

14. A method as in claim 1, wherein the protruding of the patient'"'"'s tongue includes positioning a tip of the tongue towards a side of the patient.

15. A method as in claim 1, further comprising:

observing a response of the patient'"'"'s hyoid bone.

21. A method as in claim 1, wherein observing a response of the patient'"'"'s airway includes observing the airway at a level of collapse during at least one of sleep and simulated sleep.

22. A method as in claim 1, wherein observing a response of the patient'"'"'s airway includes observing using drug induced sleep endoscopy.

23. A method as in claim 22, wherein the observing a response of the patient'"'"'s airway further includes observing the airway at a level of collapse, the level of collapse located at the level of the tongue base and/or the level of the palate.

16. A method of assessing a patient'"'"'s suitability for a nerve stimulation therapy, the method comprising:

observing a response of the patient'"'"'s soft palate to volitional protrusion of the patient'"'"'s tongue, wherein the volitional tongue protrusion is performed in the absence of electrical stimulation; and

scoring the response, wherein the scored response corresponds to the patient'"'"'s response to an electrical stimulation of a hypoglossal nerve.

17. A method as in claim 16, wherein the scored response is indicative of the patient'"'"'s response to hypoglossal nerve stimulation.

18. A method as in claim 16, wherein the soft palate is observed while the patient is awake and supine.

19. A method as in claim 16, further comprising:

observing a response of the patient'"'"'s soft palate to non-volitional protrusion of the patient'"'"'s tongue.

20. A method as in claim 16, wherein the response is scored using one of a quantitative scale and a qualitative scale.

24. A method of assessing a patient'"'"'s suitability for an implantation of a fully-implanted nerve stimulation device, comprising:

observing a collapse of the patient'"'"'s airway at the level of the soft palate;

observing a response of the patient'"'"'s airway at the collapse while moving the patient'"'"'s tongue during the collapse; and

scoring the response, wherein the scored response is indicative of the patient'"'"'s suitability for the implantation of the nerve stimulation device.

25. A method of claim 24, wherein the observing of the collapse includes using drug induced sleep endoscopy to observe the collapse.

26. A method of claim 25, wherein the moving of the patient'"'"'s tongue is a manual movement of the tongue.

27. A method as in claim 24, wherein the scored response is a function of anterior-posterior displacement of the soft palate.

28. A method as in claim 24, wherein the scored response is a function of lateral displacement of the lateral pharyngeal walls.