Screening devices and methods for obstructive sleep apnea therapy

• US 9,555,247 B2
• Filed: 07/20/2015
• Issued: 01/31/2017
• 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:
  US14/803,779
• Publication Number:
  US 20150321008A1
• Time in Patent Office: 561 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:

inserting a visualization device into the patient'"'"'s upper airway to evaluate a tissue linkage between the patient'"'"'s genioglossus and at least one of the patient'"'"'s soft palate and the patient'"'"'s lateral pharyngeal walls;

documenting a degree of tissue redundancy in said tissue linkage; and

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

2. The method of claim 1, wherein the tissue linkage communicates a movement of the patient'"'"'s genioglossus to a corresponding movement of the patient'"'"'s soft palate and/or lateral pharyngeal walls.

3. The method of claim 1, wherein the degree of tissue redundancy corresponds to a quantity of adipose tissue observed in the patient'"'"'s soft palate and/or lateral pharyngeal walls.

4. The method of claim 1, further comprising:

documenting the patient'"'"'s body mass index (BMI).

5. The method of claim 4, wherein the degree of tissue redundancy corresponds to a magnitude of the patient'"'"'s BMI.

6. 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 visualization device.

7. The method of claim 1, wherein the documenting of the degree of tissue redundancy takes place when the patient is subjected to drug-induced sleep endoscopy (OISE).

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

inserting a visualization device into the patient'"'"'s upper airway to evaluate a tissue linkage between the patient'"'"'s genioglossus and at least one of the patient'"'"'s soft palate and the patient'"'"'s lateral pharyngeal walls;

documenting a tissue redundancy presence in said tissue linkage; and

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

9. The method of claim 8, wherein the tissue linkage communicates a movement of the patient'"'"'s genioglossus to a corresponding movement of the patient'"'"'s soft palate and/or lateral pharyngeal walls.

10. The method of claim 8, wherein the tissue redundancy presence corresponds to a quantity of adipose tissue observed in the patient'"'"'s soft palate and/or lateral pharyngeal walls.

11. The method of claim 8, further comprising:

documenting the patient'"'"'s body mass index (BMI).

12. The method of claim 11, wherein the tissue redundancy presence corresponds to a magnitude of the patient'"'"'s BMI.

13. The method of claim 8, further comprising:

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

14. The method of claim 8, wherein the documenting of the tissue redundancy presence takes place when the patient is subjected to drug-induced sleep endoscopy (OISE).

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

recording with an imaging device at least a portion of a tissue linkage between the patient'"'"'s genioglossus and at least one of the patient'"'"'s soft palate and the patient'"'"'s lateral pharyngeal walls;

recording a tissue redundancy exhibited by said tissue linkage; and

generating a record of said recordings, wherein the record includes a characterization of said tissue redundancy,

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

16. The method of claim 15, wherein the tissue linkage communicates a movement of the patient'"'"'s genioglossus to a corresponding movement of the patient'"'"'s soft palate and/or lateral pharyngeal walls.

17. The method of claim 15, wherein the characterization of said tissue redundancy corresponds to a quantity of adipose tissue observed in the patient'"'"'s soft palate and/or lateral pharyngeal walls.

18. The method of claim 15, further comprising:

documenting the patient'"'"'s body mass index (BMI).

19. The method of claim 18, wherein the characterization of said tissue redundancy corresponds to a magnitude of the patient'"'"'s BMI.

20. The method of claim 15, further comprising:

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

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