Apparatus and methods for feedback-based nerve modulation

• US 8,577,464 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
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US13/629,686
• Publication Number:
  US 20130079843A1
• Time in Patent Office: 403 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 sleep apnea treatment 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 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 circuit in response to the physiological signal, wherein the control signal is predetermined to activate neuromuscular tissue within the tongue.

2. The sleep apnea treatment device 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.

3. The sleep apnea treatment device of claim 1, further comprising an antenna configured to transmit the control signal from a location outside of the subject'"'"'s body to an antenna associated with the circuit.

4. The sleep apnea treatment device of claim 1, wherein the physiological signal includes at least one aspect indicative of a movement of the tongue.

5. The sleep apnea treatment device of claim 4, wherein the movement of the tongue is detected as a relative motion between an antenna associated with the at least one processor and an antenna associated with the circuit implanted in the subject.

6. The sleep apnea treatment device of claim 1, 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.

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

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

send the control signal in response to the sleep disordered breathing event.

8. The sleep apnea treatment device of claim 7, wherein the at least one processor is further configured to determine a severity of the sleep disordered breathing event based on the physiological signal and vary a power level associated with the control signal based on the severity of the sleep disordered breathing event.

9. The sleep apnea treatment device of claim 7, wherein the at least one processor is further configured to determine a severity of the sleep disordered breathing event based on the physiological signal and vary a duration of the control signal based on the severity of the sleep disordered breathing event.

10. The sleep apnea treatment device of claim 7, wherein the sleep disordered breathing event is a precursor of sleep apnea.

11. The device of claim 1, wherein the control signal is configured to cause the subject'"'"'s tongue to move in a direction away from posterior pharyngeal wall of the subject.

12. The device of claim 7, wherein the physiological signal is indicative of an efficiency of energy transfer to the circuit, and the at least one processor is further configured to vary a power level associated with the control signal based on the efficiency of energy transfer and an upper threshold associated with the circuit.

13. The device of claim 7, wherein the physiological signal is indicative of an efficiency of energy transfer to the circuit, and the at least one processor is further configured to vary a power level associated with the control signal based on the efficiency of energy transfer and an efficacy threshold associated with the circuit.