Apparatus and methods for feedback based nerve modulation

• US 8,812,113 B2
• Filed: 09/30/2013
• Issued: 08/19/2014
• Est. Priority Date: 10/20/2009
• Status: Active Grant

• Current Assignee: Man & Science S.A.
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/041,520
• Publication Number:
  US 20140107727A1
• Time in Patent Office: 323 Days
• Field of Search: None
• US Class Current: 607/42
• 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

A device according to some embodiments may include a housing configured for location external to a body of a subject. The device may also include at least one processor associated with the housing and configured to communicate with a circuit implanted in the subject within proximity to a tongue of the subject, wherein the circuit is in electrical communication with at least one electrode, receive a physiological signal from the subject via the circuit, and send a control signal to the implanted circuit in response to the physiological signal, wherein the control signal is predetermined to activate neuromuscular tissue within the tongue.

Claims

1. A method of activating neuromuscular tissue with an implanted circuit, comprising:

communicating with the implanted circuit, which is implanted within a proximity of a tongue of a subject, wherein the implanted circuit is in electrical communication with at least one electrode;

receiving a physiological signal from the subject via the implanted circuit;

sending a control signal to the implanted circuit in response to the physiological signal; and

activating neuromuscular tissue within the tongue of the subject via the control signal.

8. The method of claim 1, wherein the control signal is sent within a response time chosen from among the group comprising 1 second, 500 milliseconds, 200 milliseconds, 100 milliseconds, 50 milliseconds, 20 milliseconds, 5 milliseconds, and 1 millisecond.

9. The method of claim 1, wherein the physiological signal is received by a unit located external to the body of the subject, and the control signal is sent from the unit.

10. The method of claim 1, wherein the physiological signal includes at least one aspect indicative of a movement of the tongue.

11. The method of claim 1, wherein movement of the tongue is detected via a relative motion between an antenna located external to the body of the subject and an antenna associated with the implanted circuit.

12. The method of claim 1, further comprising determining, based on the physiologic signal, a quantity of energy to be sent to the implanted circuit via the control signal.

13. The method of claim 1, further comprising:

detecting a sleep disordered breathing event based on the physiological signal; and

generating the control signal to be sent based on the detected sleep disordered breathing event.

14. The method of claim 13, wherein generating the control signal to be sent includes determining a power level for the control signal based on a determined severity of the sleep disordered breathing event.

15. The method of claim 13, wherein generating the control signal to be sent includes determining a time duration for the control signal based on a determined severity of the sleep disordered breathing event.

16. The method of claim 13, wherein the sleep disordered breathing event may be a precursor of sleep apnea.

17. The method of claim 1, wherein activating neuromuscular tissue within the tongue causes the subject'"'"'s tongue to move in a direction away from a posterior pharyngeal wall of the subject.

18. The method of claim 1, wherein the physiological signal is indicative of an efficiency of energy transfer between the housing and the circuit, and generating the control signal to be sent includes determining a power level based on the efficiency of energy transfer and an upper threshold associated with the implant circuit.

19. The method of claim 1, wherein the physiological signal is indicative of an efficiency of energy transfer between the housing and the circuit, and generating the control signal to be sent includes determining a power level based on the efficiency of energy transfer and an efficacy threshold associated with the implant circuit.

2. A device, comprising:

a housing configured for location external to a body of a subject; and

at least one processor associated with the housing and further configured to;

communicate with a circuit implanted in the subject within proximity to at least one nerve to be modulated, wherein the circuit is in electrical communication with at least one electrode;

receive a physiological signal from the subject and

send a control signal to the implanted circuit in response to the physiological signal, wherein the control signal is predetermined to modulate the at least one nerve to be modulated.

3. The device of claim 2, wherein the processor is configured to send the control signal within a response time between 1 millisecond and 10 minutes.

4. The device of claim 2, further comprising an antenna configured to transmit the control signal from the location outside of the subject'"'"'s body to an antenna associated with the implanted circuit.

5. The device of claim 2, wherein the at least one processor is configured to determine, based on the physiological signal, a quantity of energy to be sent via the control signal to the circuit implanted in the subject.

6. The device of claim 2, wherein the at least one processor is further configured to determine a physiological condition based on the physiological signal and vary a power level associated with the control signal based on the determined physiological condition.

7. The device of claim 2, wherein the at least one processor is further configured to determine a physiological condition based on the physiological signal and vary a duration associated with the control signal based on the determined physiological condition.