Obstructive sleep apnea treatment devices, systems and methods

• US 8,498,712 B2
• Filed: 12/29/2010
• Issued: 07/30/2013
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Apnex Medical, Inc.
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Mazar, Scott T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US12/980,774
• Publication Number:
  US 20120010532A1
• Time in Patent Office: 944 Days
• Field of Search: 607/42, 607/48, 607115-116, 607/118, 607 1- 2, 607/62
• US Class Current: 607/48
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

A method of treating an upper airway of a patient. The method may include displacing a tongue of the patient while observing a response of the upper airway. The method may further include treating the upper airway based on the observed response, wherein treating the upper airway includes positioning an electrode adjacent a nerve innervating an upper airway muscle and delivering an electrical stimulation to the nerve to activate the upper airway muscle.

Claims

1. A method of treating obstructive sleep apnea in a patient, the method comprising:

pre-operatively protruding a tongue of the patient while sensing a response of the upper airway, wherein the tongue is protruded without electrical stimulation; and

treating an upper airway of the patient based on the sensed response, wherein treating the upper airway includes positioning an electrode adjacent a nerve innervating an upper airway muscle and delivering an electrical stimulation to the nerve to activate the upper airway muscle, wherein the electrode is connected to an implantable pulse generator via a lead.

2. The method of claim 1, wherein sensing a response includes measuring activity of airway anatomy.

3. The method of claim 2, wherein the airway anatomy includes a muscle.

4. The method of claim 1, wherein the response of the upper airway includes at least one of a change in a dimension of the upper airway, a displacement of the tongue, and a displacement force of the tongue.

5. The method of claim 1, wherein sensing the response of the upper airway includes sensing the response while the patient is asleep.

6. The method of claim 1, wherein sensing the response of the upper airway includes sensing the response while the patient is sedated.

7. The method of claim 1, wherein sensing the response of the upper airway includes sensing the response while the patient is supine.

8. The method of claim 1, wherein the step of pre-operatively protruding the tongue of the patient is performed prior to positioning the electrode adjacent the nerve.

9. A method of treating obstructive sleep apnea, the method comprising:

pre-operatively protruding a tongue of a patient, wherein the tongue is protruded without electrical stimulation;

sensing an upper airway of the patient for a response; and

evaluating the patient for treatment based on the sensed response, the treatment including;

positioning an electrode adjacent a nerve innervating an upper airway muscle;

sensing respiration of the patient; and

delivering an electrical stimulation to the nerve to activate the upper airway muscle, wherein the electrical stimulation is delivered as a function of the sensed respiration, wherein the electrical stimulation is delivered prior to the patient experiencing an apnea event; and

administering the treatment.

10. The method of claim 9, wherein sensing the response includes measuring activity of airway anatomy.

11. The method of claim 9, wherein the response includes at least one of a change in a dimension of the upper airway, a displacement of the tongue, and a displacement force of the tongue.

12. The method of claim 11, wherein evaluating the patient for treatment includes determining if the sensed response meets a minimum threshold for treatment.

13. The method of claim 9, wherein sensing the upper airway of the patient for a response includes sensing the response while the patient is one of asleep and sedated.

14. The method of claim 9, wherein sensing the upper airway of the patient for a response includes sensing the response while the patient is supine.

15. A method of assessing and treating obstructive sleep apnea in a patient, the method comprising:

pre-operatively protruding a tongue of the patient while sensing a response in an upper airway of the patient, wherein the tongue is protruded without electrical stimulation, and wherein the response includes at least one of a change in a dimension of the upper airway, a displacement of the tongue, and a displacement force of the tongue; and

evaluating the response to determine if the patient will respond to a treatment of the upper airway, wherein evaluating the response includes determining if the response meets a minimum threshold for the treatment, and, if the response meets the minimum threshold, implanting an electrode on a nerve innervating an upper airway muscle, wherein the electrode is coupled to an electrical source via a lead.

16. The method of claim 15, wherein sensing a response in an upper airway includes measuring activity of airway anatomy.

17. The method of claim 15, wherein the electrode delivers electrical stimulation to the nerve as a function of sensed bio-impedance.