Stimulator systems and methods for obstructive sleep apnea

Patent metadata

Field	Value
Publication number	US-11638826-B2
Application number	US-202016812947-A
Country	US
Kind code	B2
Filing date	Mar 9, 2020
Priority date	Feb 1, 2017
Publication date	May 2, 2023
Grant date	May 2, 2023

Abstract

An electrode lead comprises an electrically insulative cuff body and at least three axially aligned electrode contacts circumferentially disposed along the inner surface of the cuff body when in the furled state. The electrode contacts may be circumferentially disposed around a nerve, and an electrical pulse train may be delivered to the electrode contacts thereby stimulating the nerve to treat obstructive sleep apnea. The electrical pulse train may be one that pre-conditions peripherally located nerve fascicles to not be stimulated, while stimulating centrally located nerve fascicles. A feedback mechanism can be used to titrate electrode contacts and electrical pulse train to the patient. A sensor that is affixed to the case of a neurostimulator can be used to measure physiological artifacts of respiration, and a motion detector can be used to sense tapping of the neurostimulator to toggle the neurostimulator between an ON position and an OFF position.

First claim

What is claimed is:

1. A method of titrating a neurostimulation system that treats obstructive sleep apnea (OSA), comprising:
circumferentially disposing a plurality of electrode contacts around a trunk of a hypoglossal nerve (HGN);
sequentially delivering an electrical pulse train to each of a plurality of different sets of the electrode contacts;
measuring an electrical potential generated by the muscle cells of a tongue of the patient;
determining an efficacy of each of the sequentially delivered electrical pulse trains in treating the OSA based on the measured electrical potential; and
selecting one of the different sets of electrode contacts based on the determined efficacy of each of the sequentially delivered electrical pulse trains in treating the OSA.

2. The method of claim 1 , wherein the electrical pulse train is delivered from a neurostimulator, the method further comprising programming the neurostimulator with the selected set of electrode contacts.

3. The method of claim 1 , wherein the HGN trunk has a diameter in the range of 2.5 mm to 4.0 mm.

4. The method of claim 1 , wherein the plurality of electrode contacts circumferentially span at least a 180-degree arc around the HGN trunk.

5. The method of claim 1 , wherein the plurality of electrode contacts circumferentially span at least a 270-degree arc around the HGN trunk.

6. The method of claim 1 , wherein a center-to-center spacing of each pair of adjacent ones of electrode contacts is equal to or less than twice the width of each electrode contact of the respective pair of electrode contacts.

7. The method of claim 1 , wherein each set of electrode contacts comprises a pair of adjacent ones of the electrode contacts, and the electrical pulse train is sequentially delivered to each set of electrode contacts in a bipolar mode.

8. The method of claim 1 , wherein each set of electrode contacts comprises a single electrode contact, and the electrical pulse train is sequentially delivered to each set of electrode contacts in a monopolar mode.

9. The method of claim 1 , wherein the nerve comprises a nerve bundle, and wherein the electrical pulse train has an initial, preconditioning current or voltage amplitude and a subsequent higher stimulating current or voltage amplitude, such that one or more peripherally located nerve fascicles in the nerve bundle are pre-conditioned by the initial preconditioning current or voltage amplitude, and one or more centrally located nerve fascicles in the nerve bundle radially deeper within the nerve bundle than the peripherally located nerve fascicles are triggered by the higher stimulating current or voltage amplitude, while the one or more pre-conditioned peripherally located nerve fascicles are not triggered by the higher stimulating current or voltage amplitude.

10. The method of claim 1 , further comprising determining the efficacy of each of the sequentially delivered electrical pulse trains in treating the OSA by computing a score of each of the different sets of electrode contacts based on the respective measured electrical potential.

11. The method of claim 10 , further comprising determining the efficiency of each inspiration phase in the respiratory cycle based on the measured electrical potential, and computing the score based on the determined efficiency of each inspiration phase in the respiratory cycle.

12. The method of claim 10 , further comprising determining the extent to which the tongue of the patient protrudes based on the measured electrical potential, wherein the score is computed based on the determined extent to which the tongue of the patient protrudes.

13. The method of claim 1 , wherein the electrode contacts are located on the HGN trunk proximal to a medial branch of the HGN trunk.

14. The method of claim 1 , wherein the electrical potential generated by the muscle cells of the tongue of the patient is measured while the electrical pulses are sequentially delivered to each of the plurality of different sets of electrode contacts.

15. The method of claim 1 , wherein the electrical potential generated by the muscle cells of the tongue of the patient is measured by one or more electro-myographic (EMG) sensors.

16. The method of claim 15 , wherein the one or more EMG sensors are in surface contact with the tongue of the patient.

17. The method of claim 16 , wherein the one or more EMG sensors are incorporated into an oral appliance worn by the patient.

18. The method of claim 16 , wherein the one or more EMG sensors are one or more needle electrodes placed into the muscles of the tongue of the patient.

Assignees

• The Alfred E Mann Foundation For Scient Research

Inventors

• Suri Harshit
• Calderon Joseph L
• Molnar Gregory Frederick
• Goding Jr George S
• Atyabi Alanie
• Schmidt Siegmar
• Dai William
• Dearden Brian
• Keenan Desmond B

Classifications

• A61N1/3611 Primary

  Respiration control (stimulating respiratory organs A61N1/3601) · CPC title

• A61B5/0836

  Measuring rate of CO2 production · CPC title

• A61B1/267

  for the respiratory tract, e.g. laryngoscopes, bronchoscopes · CPC title

• A61B5/4836

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title

• A61B5/4818

  Sleep apnoea · CPC title