Method of Stimulating A Hypoglossal Nerve For Controlling The Position of A Patient's Tongue

• US 20160184583A1
• Filed: 03/07/2016
• Published: 06/30/2016
• Est. Priority Date: 10/09/2008
• Status: Active Grant

• Current Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Original Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Inventors: Meadows, Paul M., Lima, Marcelo G., Zaidi, Faisal N.
• Granted Patent: US 9,579,505 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• 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 1/3615 Intensity
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A method for controlling a position of a patient'"'"'s tongue includes attaching at least one electrode to the patient'"'"'s Hypoglossal nerve and applying an electric signal through the electrode to at least one targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue. Methods may also include the use of more than one contact to target more than one motor efferent and stimulating more than one muscle. The stimulation load to maintain the position of the tongue may be shared by each muscle. The position of the patient'"'"'s tongue may be controlled in order to prevent obstructive sleep apnea.

Claims

1. A method for controlling a position of a patient'"'"'s tongue comprising:

attaching at least one electrode to the patient'"'"'s Hypoglossal nerve; and

applying an electric signal through the electrode to at least one targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue.

2. The method of claim 1, wherein the at least one electrode is programmable.

3. The method of claim 2, further comprising:

programming a threshold amplitude and pulse duration of the electric signal by attaching the at least one programmable electrode to the patient'"'"'s Hypoglossal nerve while the patient is awake and applying the electric signal to the Hypoglossal nerve at a first frequency through the at least one programmable electrode; and

increasing at least one of the amplitude and pulse duration of the electric signal until one of the tongue moves and at least one of the patient reports a sensation and a motion is observed.

4. The method of claim 3, further comprising:

programming a target amplitude and pulse duration of the electric signal by applying the threshold amplitude and pulse duration to the patient'"'"'s Hypoglossal nerve at a second frequency through the at least one programmable electrode, the second frequency being faster than the first frequency; and

increasing at least one of the amplitude and pulse duration of the electric signal to a target level until the tongue moves sufficiently to open the patient'"'"'s airway.

5. The method of claim 4, further comprising:

decreasing the second frequency to a target frequency.

6. The method of claim 1, wherein the at least one electrode includes at least first and second contacts and the electric signal comprises at least first and second electric signals, the method further comprising:

applying the first electric signal through the first contact to a first targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue; and

applying the second electric signal through the second contact to a second targeted motor efferent located within the Hypoglossal nerve to stimulate at least one muscle of the tongue.

7. The method of claim 6, wherein the at least first and second contacts include a plurality of contacts forming a plurality of functional groups.

8. The method of claim 7, wherein each functional group stimulates a different muscle.

9. The method of claim 7, wherein each functional group includes at least one of the plurality of contacts.

10. The method of claim 6, wherein the first and second electric signals are applied at predetermined intervals.

11. The method of claim 6, wherein the predetermined intervals of the at least one first and second electric signals are out of phase with each other.

12. The method of claim 6, wherein the first and second electric signals are generally equal in level and frequency.

13. The method of claim 6, wherein applying the first electric signal to the first targeted motor efferent stimulates a first muscle and applying the second electric signal to the second targeted motor efferent stimulates a second muscle.

14. The method of claim 6, wherein the first and second electric signals are applied at predetermined cycles for alternatively resting and stimulating first and second muscles.

15. The method of claim 6, wherein the cessation of the first electric signal is coincident with the initiation of the second electric signal.

16. The method of claim 1, wherein the at least one targeted motor efferent is a protrusor motor efferent.

17. The method of claim 1, wherein the at least one targeted motor efferent is a muscle that moves to improve airway patency.

18. The method of claim 1, wherein the electric signal is applied for a predetermined duration.

19. The method of claim 1, wherein the electric signal is automatically applied after the patient activates the electrode and following a time delay sufficient to allow the patient to fall asleep.

20. The method of claim 1, wherein the muscle is stimulated such that one of apnea and hypopnea is prevented.

21. The method of claim 1, wherein the electric signal is applied via an open loop system.

22. The method of claim 1, wherein the electric signal is applied continuously for an entire sleep period.