Method for treatment of sleep apnea by electrical stimulation

• US 5,591,216 A
• Filed: 05/19/1995
• Issued: 01/07/1997
• Est. Priority Date: 05/19/1995
• Status: Expired due to Term

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Testerman, Roy L., Erickson, Donald J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Layno, Carl H.
• Application Number:
  US08/446,191
• Time in Patent Office: 599 Days
• Field of Search: 607/42, 128/716, 128/721, 128/725
• US Class Current: 607/42
• CPC Class Codes: A61N 1/3601 of respiratory organs

Abstract

A method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve includes positioning of an electrode into electrical contact with a selected portion of the patient'"'"'s hypoglossal nerve, applying a stimulating electrical current from the electrode to the hypoglossal nerve and intraoperatively verifying the position of the electrode or adjusting the position of the electrode until it can be seen that the correct muscles of the upper airway are being stimulated. In particular, in an intraoperative setting it is possible to determine whether the correct muscles are being stimulated by looking for forward and contralateral extension of the patient'"'"'s tongue or an increase in volume of the patient'"'"'s oropharynx.

Claims

1. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) selecting a portion of the patient'"'"'s hypoglossal nerve;

(b) positioning an electrode into electrical contact with the selected portion of the patient'"'"'s hypoglossal nerve;

(c) applying a stimulating electrical current from the electrode to the hypoglossal nerve;

(d) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx;

(e) repeating steps (c) and (d) while adjusting the position for electrial stimulation on the nerve until the desired response is observed.

2. The method of claim 1 also comprising the step of dissecting the selected portion of the hypoglossal nerve from the fibers of the patient'"'"'s genioglossus muscle, said step to be performed after the selecting step (a) and before positioning step (b).

3. The method of claim 1 also comprising the steps of inserting a balloon into the patient'"'"'s oropharynx and determining the increase in volume of the oropharynx by a decrease in pressure in the balloon occupying the oropharynx.

4. The method of claim 1 wherein the stimulating electrical current is provided in a series of regular pulses interrupted by intervals without a stimulating electrical current.

5. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) selecting a portion of the patient'"'"'s hypoglossal nerve;

(b) dissecting the selected portion of the hypoglossal nerve from the fibers of the patient'"'"'s hyoglossus muscle;

(c) positioning an electrode into electrical contact with the selected portion of the patient'"'"'s hypoglossal nerve;

(d) applying a stimulating electrical current from the electrode to the hypoglossal nerve; and

(e) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx.

6. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) selecting a portion of the patient'"'"'s hypoglossal nerve selected from the group consisting of a proximal main nerve trunk and a first medial nerve trunk;

(b) positioning a multipolar electrode into electrical contact with the selected portion of the patient'"'"'s hypoglossal nerve;

(c) selecting at least one pole of the electrode for applied stimulation;

(d) applying a stimulating electrical current from at least one pole of the electrode to the hypoglossal nerve;

(e) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx

(f) repeating steps (c) to (e) while adjusting the position of electrical stimulation on the nerve until the desired response is achieved.

7. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) selecting a portion of the patient'"'"'s hypoglossal nerve selected from the group consisting of a second medial nerve trunk and a third medial nerve trunk;

(b) positioning an electrode into electrical contact with the selected portion of the patient'"'"'s hypoglossal nerve;

(c) applying a stimulating electrical current from the electrode to the hypoglossal nerve; and

(d) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx.

8. The method of claim 7 wherein the electrode is a multipolar electrode with the stimulation current applied to at least one selected electrode pole on the multipolar electrode.

9. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) dissecting a portion of the hypoglossal nerve from the patient'"'"'s hyoglossus muscle;

(b) positioning an electrode into electrical contact with the dissected portion of the hypoglossal nerve;

(c) applying a stimulating electrical current from the electrode to the hypoglossal nerve; and

(d) observing the patient for an indication of an opened airway.

10. The method of claim 9 wherein the indication of an opened airway is forward and contralateral extension of the patient'"'"'s tongue.

11. The method of claim 9 wherein the indication of an opened airway is an increase in volume of the patient'"'"'s oropharynx.

12. The method of claim 11 also comprising the steps of inserting a balloon into the patient'"'"'s oropharynx and determining the increase in volume of the oropharynx by a decrease in pressure in the balloon occupying the oropharynx.

13. The method of claim 9 wherein the stimulating electrical current is provided in a series of regular pulses interrupted by intervals without a stimulating electrical current.

14. In a method for opening an upper airway of a patient by applying electrical stimulation to the patient'"'"'s hypoglossal nerve, the improvement comprising:

(a) dissecting a portion of the hypoglossal nerve from the patient'"'"'s genioglossus muscle;

(b) selecting a portion of the dissected nerve;

(c) positioning an electrode into electrical contact with the selected portion of the hypoglossal nerve;

(d) applying a stimulating electrical current from the electrode to the hypoglossal nerve; and

(e) observing the patient for an indication of an opened airway;

(e) repeating steps (d) and (e) while adjusting the position of electrical stimulation on the nerve until the opened airway is observed.

15. The method of claim 14 wherein the indication of an opened airway is forward and contralateral extension of the patient'"'"'s tongue.

16. The method of claim 14 wherein the indication of an opened airway is an increase in volume of the patient'"'"'s oropharynx.

17. The method of claim 16 also comprising the steps of inserting a balloon into the patient'"'"'s oropharynx and determining the increase in volume of the oropharynx by a decrease in pressure in the balloon occupying the oropharynx.

18. The method of claim 14 wherein the stimulating electrical current is provided in a series of regular pulses interrupted by intervals without a stimulating electrical current.

19. In a method for opening an upper airway of a patient by applying electrical stimulation to muscles of the patient'"'"'s upper airway, the improvement comprising:

(a) selecting at least one muscle of the upper airway selected from the group consisting of the genioglossus muscle and the geniohyoid muscle;

(b) dissecting a selected portion of the hypoglossal nerve from the fibers of the patient'"'"'s genioglossus muscle;

(c) positioning an electrode on the dissected nerve such that it may provide stimulation of the selected muscle;

(d) applying a stimulating electrical current through the electrode to stimulate the selected muscle;

(e) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx; and

(f) repeating steps (d) and (e) while adjusting the position of electrical stimulation on the nerve until the desired response is observed.

20. The method of claim 19 wherein the stimulating electrical current is provided in a series of regular pulses interrupted by intervals without a stimulating electrical current.

21. In a method for opening an upper airway of a patient by applying electrical stimulation to muscles of the patient'"'"'s upper airway, the improvement comprising:

(a) selecting at least one muscle of the upper airway selected from the group consisting of the genioglossus muscle and the geniohyoid muscle;

(b) selecting a portion of the hypoglossal nerve innervating the selected muscle;

(c) dissecting the selected portion of the hypoglossal nerve from the fibers of the patient'"'"'s hyoglossus muscle;

(d) positioning an electrode on the dissected portion of the hypoglossal nerve such that it may provide stimulation of the selected muscle;

(e) applying a stimulating electrical current through the electrode to stimulate the selected muscle; and

(f) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx.

22. In a method for opening an upper airway of a patient by applying electrical stimulation to muscles of the patient'"'"'s upper airway, the improvement comprising:

(a) selecting at least one muscle of the upper airway selected from the group consisting of the genioglossus muscle and the geniohyoid muscle;

(b) selecting a portion of the hypoglossal nerve innervating the selected muscle, the nerve portion selected from the group consisting of a proximal main nerve trunk and a first medial nerve trunk;

(c) positioning an electrode on the dissected nerve such that it may provide stimulation of the selected muscle;

(d) applying a stimulating electrical current through the electrode to stimulate the selected muscle;

(e) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx; and

(f) repeating steps (d) and (e) while adjusting the position of electrical stimulation on the nerve until the desired response is observed.

23. In a method for opening an upper airway of a patient by applying electrical stimulation to muscles of the patient'"'"'s upper airway, the improvement comprising:

(a) selecting at least one muscle of the upper airway selected from the group consisting of the genioglossus muscle and the geniohyoid muscle;

(b) selecting a portion of the hypoglossal nerve innervating the selected muscle, the portion of the hypoglossal nerve selected from the group consisting of a second medial nerve trunk and a third medial nerve trunk;

(c) positioning an electrode in the patient such that it may provide stimulation of the selected muscle;

(d) applying a stimulating electrical current through the electrode to stimulate the selected muscle; and

(e) monitoring the patient for a desired response, the desired response selected from the group consisting of;

forward and contralateral extension of the patient'"'"'s tongue; and

an increase in volume of the patient'"'"'s oropharynx.

24. An apparatus for testing the opening of an upper airway of a patient when applying electrical stimulation comprising:

(a) electrode means positioned to provide stimulation to an upper airway muscle of the patient;

(b) electrical generating means for supplying current to the electrode; and

(c) means for identifying an increase in volume of the patient'"'"'s oropharynx in response to current supplied to the electrode including means for displaying an indication of the relative volume of the oropharynx as the stimulation is provided.

25. The apparatus of claim 24 wherein the electrode means comprises a nerve electrode positioned to stimulate a selected portion of the hypoglossal nerve.

26. The apparatus of claim 24 wherein the generating means includes means for providing a series of stimulation pulses interrupted by intervals without stimulation.

27. The apparatus of claim 24 wherein the means for identifying an increase in volume of the patient'"'"'s oropharynx includes a balloon positioned in the patient'"'"'s oropharynx.