Stimulator systems and methods for obstructive sleep apnea

Patent metadata

Field	Value
Publication number	US-11654284-B2
Application number	US-202017083532-A
Country	US
Kind code	B2
Filing date	Oct 29, 2020
Priority date	Feb 1, 2017
Publication date	May 23, 2023
Grant date	May 23, 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. An implantable neurostimulator for use in a patient having an ailment, comprising:
a case;
stimulation circuitry contained within the case, the stimulation circuitry configured for generating an electrical pulse train;
control circuitry contained within the case, the control circuitry configured for causing the stimulation circuitry to deliver the electrical pulse train to at least one electrode contact; and
a sensor affixed directly to or positioned within the case, the sensor configured for both sensing a plurality of successive taps on or in proximity to the neurostimulator and sensing physiological artifacts that are caused by respiration, wherein the control circuitry is configured for toggling the neurostimulator between an ON state and an OFF state in response to the sensed plurality of successive taps, such that in the OFF state, no stimulation energy is delivered to the at least one electrode contact, and wherein the control circuitry is configured for causing the stimulation circuitry to deliver the electrical pulse train in synchronization with a respiratory cycle based on the sensed physiological artifacts.

2. The neurostimulator of claim 1 , further comprising a receptacle configured for receiving at least one proximal contact of an electrode lead that carries the at least one electrode contact.

3. The neurostimulator of claim 1 , wherein the sensor comprises one of a pressure sensor and an inertial sensor.

4. The neurostimulator of claim 1 , wherein the control circuitry is configured for toggling the neurostimulator between the ON state and the OFF state in response to the same plural number of successive taps.

5. The neurostimulator of claim 4 , wherein the control circuitry is configured for toggling the neurostimulator between the ON state and the OFF state in response to the same plural number of successive taps less than one second apart.

6. The neurostimulator of claim 1 , wherein the control circuitry is configured for:
determining the next projected onset of an inspiratory phase of the respiratory cycle based on the sensed physiological artifacts, and
causing the stimulation circuitry to deliver the electrical pulse train to the at least one electrode contact immediately before, at, or right after the next projected onset of the inspiratory phase of the respiratory cycle.

7. The neurostimulator of claim 1 , further comprising memory configured for storing data representative of the physiological artifacts sensed by the sensor.

8. The neurostimulator of claim 1 , wherein the sensor comprises one of an accelerometer, a gyroscope, a pressure sensor, a bioimpedance sensor, ECG electrodes and a temperature sensor.

9. The neurostimulator of claim 1 , wherein the electrical pulse train has an initial, preconditioning current or voltage amplitude and a subsequent higher stimulating current or voltage amplitude.

10. The neurostimulator of claim 1 , further comprising a reed switch configured for sensing a magnetic field from an external magnet corresponding to a command from the patient to toggle the stimulation circuitry between the ON state and the OFF state.

11. A neurostimulation system, comprising:
an electrode lead; and
the neurostimulator of claim 1 , wherein the receptacle is configured for receiving the electrode lead, and wherein the electrode lead carries the at least one electrode contact.

12. The neurostimulation system of claim 11 , wherein the electrode lead carries a plurality of electrode contacts, the neurostimulation system further comprising a clinician programmer configured for:
selecting the at least one electrode contact from the electrode contacts,
wirelessly communicating with the neurostimulator, and
programming the control circuitry to deliver the electrical pulse train to the selected at least one electrode contact.

13. The neurostimulation system of claim 11 , further comprising a patient programmer configured for:
wirelessly communicating with the neurostimulator, and
toggling the neurostimulator between the ON state and the OFF state.

14. The neurostimulation system of claim 11 , wherein the neurostimulator further comprises a rechargeable battery contained within the case, the neurostimulation system further comprising an external charger configured for wirelessly charging the rechargeable battery of the neurostimulator.

15. The neurostimulation system of claim 11 , further comprising an oral appliance having a sensor configured for measuring a movement of the tongue in response to a delivery of the electrical pulse train from the at least one electrode contact to a hypoglossal nerve (HGN).

16. The neurostimulator system of claim 15 , wherein the sensor is an inertial sensor comprising at least one of an accelerometer and a gyroscope.

17. The neurostimulator system of claim 15 , further comprising a clinician programmer configured for computing a therapy score based on the measured movement of the tongue by the sensor.

18. The neurostimulator system of claim 11 , further comprising at least one electromyographic (EMG) sensor configured for measuring an electrical potential generated by muscle cells of a tongue in response to a delivery of the electrical pulse train from the at least one electrode contact to a hypoglossal nerve (HGN).

19. The neurostimulator system of claim 18 , wherein the electromyographic sensor is configured for being placed on the neck region of the patient.

20. The neurostimulator system of claim 11 , further comprising an oral appliance having at least one electromyographic (EMG) sensor configured for measuring an electrical potential generated by muscle cells of a tongue in response to a delivery of the electrical pulse train from the at least one electrode contact to a hypoglossal nerve (HGN).

21. The neurostimulator system of claim 20 , further comprising a clinician programmer configured for computing a therapy score based on the measured movement of the tongue by the at least one EMG sensor.

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

• A61N1/3601

  of respiratory organs · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61B5/394

  specially adapted for electroglottography or electropalatography · CPC title

• A61N1/0556

  Cuff electrodes · CPC title