Screening devices and methods for obstructive sleep apnea therapy

• US 8,386,046 B2
• Filed: 10/03/2011
• Issued: 02/26/2013
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Tesfayesus, Wondimeneh, Bolea, Stephen L., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US13/251,856
• Publication Number:
  US 20120197340A1
• Time in Patent Office: 512 Days
• Field of Search: 607/48, 607/42, 607/2, 607/1, 607/62
• US Class Current: 607/48
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/0556 Cuff 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 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

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 providing therapy to a patient, comprising:

performing an assessment of the patient, wherein the assessment comprises protruding the patient'"'"'s tongue without electrical stimulation of a nerve of the patient, wherein the tongue protrusion is volitional, and observing a response of the patient'"'"'s upper airway; and

implanting a hypoglossal nerve stimulation device in the patient only if the response comprises an increase in airway size.

2. A method as in claim 1, wherein the upper airway is observed while the patient is awake and supine.

3. A method as in claim 1, wherein the upper airway is observed by endoscopy.

4. A method as in claim 3, wherein the increase in airway size is at least one of retro-glossal and retro-palatal.

5. A method as in claim 3, wherein the increase in airway size comprises increase in one of an anterior-posterior dimension and a lateral dimension.

6. A method as in claim 1, wherein the assessment further comprises determining a level of collapse in the patient'"'"'s upper airway.

7. A method as in claim 1, wherein the patient is treated with the therapy only if the response of the upper airway is an increase in size, and only if another response is observed during tongue protrusion.

8. A method of providing therapy to a patient, comprising:

performing a tongue protrusion maneuver without electrical stimulation of a nerve of the patient, wherein the tongue protrusion is volitional, and observing a response of the patient'"'"'s upper airway; and

treating the patient'"'"'s upper airway with a therapy as a function of the observed response.

9. A method as in claim 8, wherein the therapy comprises a treatment for obstructive sleep apnea.

10. A method as in claim 9, wherein the therapy comprises a surgical procedure modifying tissue of the upper airway.

11. A method as in claim 9, wherein the therapy comprises implanting a device in the upper airway.

12. A method as in claim 9, wherein the upper airway is observed while the patient is awake and supine.

13. A method as in claim 12, wherein the upper airway is observed by endoscopy.

14. A method as in claim 13, wherein the increase in airway size is at least one of retro-glossal and retro-palatal.

15. A method as in claim 13, wherein the increase in airway size comprises an increase in one of an anterior-posterior dimension and a lateral dimension.

16. A method as in claim 8, wherein the assessment further comprises determining the level of collapse in the patient'"'"'s upper airway.

17. A method of providing therapy to a patient, comprising:

performing a palatoglossal arch maneuver and observing a response of the patient'"'"'s upper airway, wherein the palatoglossal arch maneuver includes volitional tongue protrusion in the absence of electrical stimulation; and

treating the patient'"'"'s upper airway with a therapy as a function of the observed response.

18. A method as in claim 17, wherein the upper airway is observed while the patient is awake and supine.

19. A method as in claim 18, wherein the upper airway is observed by endoscopy.

20. A method as in claim 19, wherein the increase in airway size is at least one of retro-glossal and retro-palatal.

21. A method as in claim 19, wherein the increase in airway size comprises an increase in one of an anterior-posterior dimension and a lateral.