Screening devices and methods for obstructive sleep apnea therapy

• US 10,231,645 B2
• Filed: 01/27/2017
• Issued: 03/19/2019
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Inventors: Tesfayesus, Wondimeneh, Bolea, Stephen L., Eastwood, Peter R., Hillman, David R.
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/418,467
• Publication Number:
  US 20170202482A1
• Time in Patent Office: 781 Days
• 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 tissue redundancy in pharyngeal walls due to a quantity of adipose tissue;

documenting a degree of tissue redundancy; and

generating an indication of suitability for upper airway stimulation therapy based on the documented degree of tissue redundancy.

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

3. The method of claim 1, further comprising:

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

4. The method of claim 3, wherein the degree of tissue redundancy corresponds to a magnitude of the patient'"'"'s BMI.

5. 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.

6. 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 (DISE).

7. The method of claim 1, further comprising:

evaluating a degree of upper airway collapse, wherein the upper airway comprises a posterior pharyngeal wall, a right lateral pharyngeal wall, a left lateral pharyngeal wall, a soft palate and a tongue.

8. The method of claim 1, further comprising:

responsive to the indication of suitability for upper airway stimulation therapy indicating the patient is suitable for the upper airway stimulation therapy, applying stimulation to the patient'"'"'s upper airway using an implantable neurostimulator.

9. 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 tissue redundancy in pharyngeal walls due to a quantity of adipose tissue;

documenting a tissue redundancy presence due to a quantity of adipose tissue; and

generating an indication of suitability for upper airway stimulation therapy based on the documented degree of tissue redundancy.

10. The method of claim 9, wherein the tissue redundancy presence due to the quantity of adipose tissue is observed in the patient'"'"'s soft palate and/or lateral pharyngeal walls.

11. The method of claim 9, 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 9, 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 9, wherein the documenting of the tissue redundancy presence takes place when the patient is subjected to drug-induced sleep endoscopy (DISE).

15. The method of claim 9, further comprising:

responsive to the indication of suitability for upper airway stimulation therapy indicating the patient is suitable for the upper airway stimulation therapy, applying stimulation to the patient'"'"'s upper airway using an implantable neurostimulator.

16. 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 tissue redundancy in pharyngeal walls due to a quantity of adipose tissue;

recording a tissue redundancy;

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 relating to the tissue redundancy, the criterion concerning the patient'"'"'s suitability for the upper airway stimulation therapy; and

generating an indication of suitability for upper airway stimulation therapy based on the characterization of said tissue redundancy.

17. The method of claim 16, wherein the characterization of said tissue redundancy due to the quantity of adipose tissue is observed in the patient'"'"'s soft palate and/or lateral pharyngeal walls.

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

22. The method of claim 16, further comprising:

evaluating a degree of upper airway collapse, wherein the upper airway comprises a posterior pharyngeal wall, a right lateral pharyngeal wall, a left lateral pharyngeal wall, a soft palate and a tongue.

23. The method of claim 16, further comprising:

responsive to the indication of suitability for upper airway stimulation therapy indicating the patient is suitable for the upper airway stimulation therapy, applying stimulation to the patient'"'"'s upper airway using an implantable neurostimulator.