Screening devices and methods for obstructive sleep apnea therapy

• US 9,113,838 B2
• Filed: 09/02/2014
• Issued: 08/25/2015
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Tesfayesus, Wondimeneh, Bolea, Stephen L., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/475,130
• Publication Number:
  US 20150005642A1
• Time in Patent Office: 357 Days
• US Class Current: 1/1
• 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 an upper airway stimulation therapy, the method comprising:

observing with an imaging device whether the patient'"'"'s airway experiences a collapse at the level of the patient'"'"'s soft palate, the collapse comprising at least one of (i) the patient'"'"'s soft palate moving towards the patient'"'"'s posterior pharyngeal wall and (ii) the patient'"'"'s left lateral pharyngeal wall moving towards the patient'"'"'s right lateral pharyngeal wall; and

receiving a criterion, the criterion concerning the patient'"'"'s suitability for the upper airway stimulation therapy.

2. The method of claim 1, further comprising:

instructing the patient to protrude the patient'"'"'s tongue while observing a response of the patient'"'"'s airway with the imaging device.

3. The method of claim 1, further comprising:

protruding the patient'"'"'s tongue without nerve stimulation while observing a response of the patient'"'"'s airway with the imaging device.

4. The method of claim 1, wherein the observing takes place when the patient is subjected to drug-induced sleep endoscopy (DISE).

5. The method of claim 1, wherein the collapse is a complete collapse of the patient'"'"'s airway.

6. The method of claim 5, wherein the observing takes place when the patient is subjected to drug-induced sleep endoscopy (DISE).

7. The method of claim 1, wherein the criterion corresponds to a recommendation that the upper airway stimulation therapy is not suitable for the patient.

8. The method of claim 1, further comprising:

observing an anatomical linkage between at least two of the patient'"'"'s tongue, the patient'"'"'s soft palate, the patient'"'"'s left lateral pharyngeal wall, and the patient'"'"'s right lateral pharyngeal wall.

9. The method of claim 1, wherein the observing of the airway includes observing movement of the patient'"'"'s hyoid bone.

10. The method of claim 1, wherein the patient'"'"'s airway is unpressurized during the observing with the imaging device.

11. A method of assessing a patient'"'"'s suitability for an upper airway stimulation therapy, the method comprising:

recording with an imaging device a collapse of the patient'"'"'s airway, the collapse comprising movements of the patient'"'"'s soft palate towards the patient'"'"'s posterior pharyngeal wall and the patient'"'"'s left lateral pharyngeal wall towards the patient'"'"'s right lateral pharyngeal wall;

recording a position of the patient'"'"'s tongue during the collapse; and

generating a record of said recordings, wherein the record includes a magnitude of said movements,

wherein the record is configured for comparison to a criterion, the criterion concerning the patient'"'"'s suitability for the upper airway stimulation therapy.

12. The method of claim 11, further comprising:

instructing the patient to protrude the patient'"'"'s tongue while generating the record.

13. The method of claim 11, further comprising:

protruding the patient'"'"'s tongue without nerve stimulation while generating the record.

14. The method of claim 11, wherein the record is generated when the patient is subjected to drug-induced sleep endoscopy (DISE).

15. The method of claim 11, wherein the collapse is a complete collapse of the patient'"'"'s airway.

16. The method of claim 15, wherein the record is generated when the patient is subjected to drug-induced sleep endoscopy (DISE).

17. The method of claim 11, wherein the criterion corresponds to a recommendation that the upper airway stimulation therapy is not suitable for the patient.

18. The method of claim 11, further comprising:

documenting an anatomical linkage between at least two of the patient'"'"'s tongue, the patient'"'"'s soft palate, the patient'"'"'s left lateral pharyngeal wall, and the patient'"'"'s right lateral pharyngeal wall.

19. The method of claim 11, further comprising:

documenting a movement of the patient'"'"'s hyoid bone.

20. A method of assessing a patient'"'"'s suitability for an upper airway stimulation therapy, the method comprising:

providing a screening tool including a criterion, the criterion concerning the patient'"'"'s suitability for the upper airway stimulation therapy, wherein the criterion is configured for comparison to observations made with an imaging device of the patient'"'"'s airway during a collapse at the level of the patient'"'"'s soft palate, the collapse comprising movements of the patient'"'"'s soft palate towards the patient'"'"'s posterior pharyngeal wall and the patient'"'"'s left lateral pharyngeal wall towards the patient'"'"'s right lateral pharyngeal wall.