Method and device for treating sleep apnea based on tongue movement

• US 9,943,686 B2
• Filed: 08/08/2016
• Issued: 04/17/2018
• Est. Priority Date: 10/20/2009
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US15/231,468
• Publication Number:
  US 20160346537A1
• Time in Patent Office: 617 Days
• Field of Search: 607 61, 607134, 607 62
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• 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 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36075 : Headache or migraine
• CPC Class Codes: A61N 1/3611 : Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/3614 : based on impedance measurement
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/37223 : Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 : Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 : using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

A method for delivering energy as a function of degree coupling may utilize an external unit configured for location external to a body of a subject and at least one processor associated with the implant unit and configured for electrical communication with a power source. The method may determine a degree of coupling between the primary antenna and a secondary antenna associated with the implant unit, and regulate delivery of power to the implant unit based on the degree of coupling between the primary antenna and the secondary antenna.

Claims

1. A method for treating sleep disordered breathing via an implant unit implanted in a location proximate a tongue of the subject, the method comprising:

receiving a signal associated with the implant unit, the signal being indicative of a tongue movement of the subject;

determining, based on the signal, that the tongue movement is representative of sleep disordered breathing; and

communicating a modulation control signal to the implant unit to activate neuromuscular tissue within the tongue via at least one pair of electrodes associated with the implant unit, wherein the modulation control signal causes modulation of a hypoglossal nerve of the subject in response to an electric field generated by the at least one pair of electrodes,

wherein the modulation is confined to a medial branch of the hypoglossal nerve and initiated from a single modulation site along the medial branch to cause modulation of terminal fibers of the medial branch of the hypoglossal nerve.

2. The method of claim 1, wherein the at least one pair of electrodes are configured so as to cause contractions of a genioglossus muscle of the subject via modulation of the medial branch of the subject'"'"'s hypoglossal nerve.

3. The method of claim 2, wherein the at least one pair of electrodes are configured for location adjacent to a horizontal compartment of the genioglossus muscle.

4. The method of claim 1, further comprising receiving the signal associated with the implant unit via an antenna configured for location external to the body of the subject.

5. The method of claim 4, wherein the signal associated with the implant unit is indicative of a degree of coupling between the antenna configured for location external to the body of the subject and an antenna associated with the implant unit.

6. The method of claim 5, further comprising determining the tongue movement based on the degree of coupling, wherein the degree of coupling is based on a relative motion between the antenna configured for location external to the body of the subject and the antenna associated with the implant unit.

8. The method of claim 5, wherein the degree of coupling between the antenna configured for location external to the body of the subject and the antenna associated with the implant unit includes one of a measure selected from capacitive coupling, radiofrequency coupling, and inductive coupling.

7. The method of 5, further comprising determining a characteristic of the modulation control signal based on the degree of coupling between the antenna configured for location external to the body of the subject and the antenna associated with the implant unit.

9. A device for treating sleep disordered breathing via an implant unit implanted in a location proximate a tongue of the subject, the device comprising:

a housing configured for location external to a body of the subject, the housing including a processor further configured to;

receive a signal associated with the implant unit, the signal being indicative of a tongue movement of the subject;

determine, based on the signal, that the tongue movement is representative of sleep disordered breathing; and

communicate a modulation control signal to the implant unit to activate neuromuscular tissue within the tongue via at least one pair of electrodes associated with the implant unit, wherein the modulation control signal causes modulation of a hypoglossal nerve of the subject in response to an electric field generated by the at least one pair of electrodes,

wherein the modulation is confined to a portion of the hypoglossal nerve distal of a terminal bifurcation of the hypoglossal nerve into lateral and medial branches.

10. The device of claim 9, wherein the at least one pair of electrodes are configured so as to cause contractions of a genioglossus muscle of the subject via modulation of the subject'"'"'s hypoglossal nerve.

11. The device of claim 9, wherein the at least one pair of electrodes are configured for location adjacent to a horizontal compartment of the genioglossus muscle.

12. The device of claim 9, wherein the housing is electrically coupled to an antenna and the processor is further configured to receive the signal associated with the implant unit via the antenna.

13. The device of claim 12, wherein the signal associated with the implant unit is indicative of a degree of coupling between the antenna coupled to the housing and an antenna associated with the implant unit.

14. The device of claim 13, wherein the processor is further configured to determine the tongue movement based on the degree of coupling, wherein the degree of coupling is based on a relative motion between the antenna coupled to the housing and the antenna associated with the implant unit.

16. The device of claim 13, wherein the degree of coupling between the antenna of the housing and the antenna associated with the implant unit includes one of a measure selected from capacitive coupling, radiofrequency coupling, and inductive coupling.

15. The device of 13, wherein the processor is further configured to determine a characteristic of the modulation control signal based on the degree of coupling between the antenna coupled to the housing and the antenna associated with the implant unit.