Systems and methods for determining a sleep disorder based on positioning of the tongue

• US 8,577,472 B2
• Filed: 09/28/2012
• Issued: 11/05/2013
• Est. Priority Date: 10/20/2009
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi, Mueller, Carsten
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US13/629,694
• Publication Number:
  US 20130072999A1
• Time in Patent Office: 403 Days
• Field of Search: None
• US Class Current: 607/48
• 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 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• 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 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0548 Oral electrodes
• 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 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• 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 1/36125 : Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/37211 : Means for communicating with stimulators
• 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 1/37235 : Aspects of the external programmer
• CPC Class Codes: A61N 1/37264 : Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3727 : characterised by the modulation technique
• 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
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated

Abstract

Devices and methods are disclosed that include an external unit comprising at least one processor. The processor may be configured to receive a signal indicative of tongue movement in a subject from an implant unit implanted in the subject, determine whether the tongue movement is representative of sleep disordered breathing, generate a modulation control signal to correct the sleep disordered breathing when the at least one processor determines an occurrence of sleep disordered breathing.

Claims

1. A device, comprising:

an external unit comprising a primary antenna and at least one processor having an interface, the at least one processor being configured to;

receive, via the interface, a signal indicative of movement of a secondary antenna relative to the primary antenna, wherein the secondary antenna is located on an implant unit implanted in a subject, and movement of the secondary antenna relative to the primary antenna is indicative of tongue movement in the subject;

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

cause generation of a modulation control signal to correct the sleep disordered breathing when the at least one processor determines, based on the signal, an occurrence of the sleep disordered breathing.

2. The device of claim 1, wherein the at least one processor is further configured to determine whether the sleep disordered breathing includes an apnea precursor.

3. The device of claim 1, wherein the at least one processor is further configured to determine whether the sleep disordered breathing includes hypopnea.

4. The device of claim 1, wherein the at least one processor is further configured to determine whether the sleep disordered breathing includes an hypopnea precursor.

5. The device of claim 1, wherein the implant unit is implanted in a location in contact with the subject'"'"'s tongue muscle.

6. The device of claim 1, wherein the primary antenna is in electrical communication with the at least one processor, and the primary antenna is configured to transmit the modulation control signal to the secondary antenna associated with the implant unit;

and

wherein the modulation control signal includes a stimulation control signal configured to interact with the implant unit to cause a contraction in a muscle.

7. The device of claim 1, wherein the at least one processor is further configured to:

generate a sub-modulation control signal for transmission to the implant unit via the primary antenna; and

detect the movement of the secondary antenna relative to the primary antenna based on a degree of coupling between the primary antenna and the secondary antenna;

wherein the degree of coupling includes at least one of a measure of capacitive coupling, radiofrequency coupling, or inductive coupling.

8. The device of claim 1, wherein the at least one processor is further configured to adjust at least one characteristic of the modulation control signal based on a severity of the sleep disordered breathing, the at least one characteristic of the modulation control signal including voltage amplitude, current amplitude, pulse frequency, or pulse duration.

9. A device, comprising:

an external unit comprising a primary antenna and at least one processor having an interface, the at least one processor configured to;

receive, via the interface, a signal indicative of movement of a secondary antenna relative to the primary antenna, wherein the secondary antenna is located on an implant unit implanted in a subject, and movement of the secondary antenna relative to the primary antenna is indicative of movement of a subject'"'"'s tongue;

cause generation of a modulation control signal based on the received signal indicative of movement of the secondary antenna; and

cause transmission of the modulation control signal via the primary antenna to the secondary antenna.

10. The device of claim 9, wherein the modulation control signal includes a stimulation control signal configured to interact with the implant unit to cause a contraction in a muscle.

11. The device of claim 9, wherein the at least one processor is further configured to:

generate a sub-modulation control signal for transmission to the implant unit via the primary antenna; and

detect the movement of the secondary antenna relative to the primary antenna based on a determination of a degree of coupling between the primary antenna and the secondary antenna.

12. The device of claim 11, wherein the determination of the degree of coupling includes at least one of a measure of capacitive coupling, radiofrequency coupling, or inductive coupling.

13. The device of claim 9, wherein the at least one processor is further configured to adjust at least one characteristic of the modulation control signal based on the movement of the secondary antenna relative to the primary antenna, the at least one characteristic of the modulation control signal including voltage amplitude, current amplitude, pulse frequency, or pulse duration.

14. A method for detecting tongue movement in a subject, comprising:

receiving from an implant unit implanted in the subject a signal indicative of movement of a secondary antenna relative to a primary antenna, wherein the secondary antenna is associated with the implant unit, the primary antenna is associated with an external unit located external to the subject, and movement of the secondary antenna relative to the primary antenna is indicative of tongue movement in the subject;

generating a modulation control signal based on the signal indicative of movement of the secondary antenna relative to the primary antenna; and

transmitting the modulation control signal from the primary antenna associated with the external unit to the secondary antenna associated with the implant unit.

15. The method of claim 14, further comprising determining whether the tongue movement is representative of sleep disordered breathing.

16. The method of claim 15, further comprising determining whether the sleep disordered breathing includes an apnea precursor.

17. The method of claim 15, further comprising determining whether the sleep disordered breathing includes hypopnea.

18. The method of claim 15, further comprising determining whether the sleep disordered breathing includes an hypopnea precursor.

19. The method of claim 14, wherein the modulation control signal includes a stimulation control signal configured to interact with the implant unit to cause a contraction in a muscle.

20. The method of claim 14, further comprising:

generating a sub-modulation control signal for transmission to the implant unit via the primary antenna; and

detecting the movement of the secondary antenna relative to the primary antenna based on determination of a degree of coupling between the primary antenna and the secondary antenna.

21. The method of claim 20, wherein the determination of the degree of coupling includes at least one of a measure of capacitive coupling, radiofrequency coupling, or inductive coupling.

22. The method of claim 14, further comprising adjusting at least one characteristic of the modulation control signal based on the signal indicative of movement of the secondary antenna relative to the primary antenna, the at least one characteristic of the modulation control signal including voltage amplitude, current amplitude, pulse frequency, or pulse duration.