Devices and methods for delivering energy as a function of condition severity

• US 9,302,093 B2
• Filed: 09/28/2012
• Issued: 04/05/2016
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US13/629,757
• Publication Number:
  US 20130085541A1
• Time in Patent Office: 1,285 Days
• Field of Search: 607/42
• US Class Current: 1/1
• 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 for regulating energy delivery to an implanted circuit is disclosed. The device may include at least one implantable circuit and at least one pair of implantable electrodes in electrical communication with the circuit. The at least one pair of implantable electrodes may be configured to modulate at least one nerve. The at least one implantable circuit may be configured deliver a signal to the at least one pair of implantable electrodes. The signal may have at least one of a power level or a duration determined based on a severity of a detected physiologic condition.

Claims

1. A sleep disordered breathing therapy device, comprising:

at least one implantable circuit configured for implantation within a body of a subject; and

at least one pair of implantable electrodes connected for electrical communication with the circuit, the at least one implantable circuit and at least one pair of implantable electrodes being configured for implantation in a vicinity of a genioglossus muscle of the subject, the at least one pair of implantable electrodes being configured to modulate a hypoglossal nerve via contact with tissue of the subject;

wherein the at least one implantable circuit is configured to deliver a power signal to the at least one pair of implantable electrodes, wherein the power signal has at least one of a power level and a duration regulatable based on feedback provided by the at least one implantable circuit to a control unit, from which a severity of a physiological condition is detected, wherein the feedback is related to relative motion between the at least one implantable circuit and the control unit located external to the body.

2. The device of claim 1, wherein the implantable circuit is further configured to regulate the power signal in response to a received signal indicative of the severity of the physiological condition.

3. The device of claim 1, wherein the physiological condition includes tongue movement, and wherein at least one of the power level or duration of the power signal delivered by the circuit to the electrodes is based on an amount of tongue movement.

4. The device of claim 3, wherein the amount of tongue movement relates to at least one of speed of the tongue, vibration of the tongue, and displacement of the tongue.

5. The device of claim 2, wherein the at least one implantable circuit is configured for implantation on a tongue muscle of a subject, and wherein the at least one implantable circuit is configured such that a predetermined movement of the at least one implantable circuit with the tongue triggers delivery of the received signal.

6. The device of claim 3, wherein the tongue movement is indicative of a sleep disordered breathing event and the amount of tongue movement is indicative of a severity of the sleep disordered breathing event.

7. The device of claim 2, further comprising

an antenna, wherein the antenna is adapted to receive a transmitted alternating current signal;

and

a signal modifier configured to convert the alternating current signal into a direct current signal for delivery to the at least one pair of implantable electrodes.

8. The device of claim 1, wherein the at least one implantable circuit is a passive circuit.

9. A method of regulating energy delivery to an implanted circuit for treating a sleep disordered breathing condition, the method comprising:

detecting, based on feedback related to relative motion between the implanted circuit and a control unit located external to the body and provided by the implanted circuit to the control unit located external to the body, a severity of a physiological condition in a body of a subject;

determining, based on the detected severity of the physiological condition, at least one of a power level or a duration of a power signal to be delivered by the implanted circuit to at least one pair of electrodes implanted proximal to a hypoglossal nerve of the subject and in electrical communication with the implanted circuit;

regulating delivery of the power signal to the at least one pair of electrodes according to the determined power level or duration of the power signal;

modulating the hypoglossal nerve of the subject via the power signal with the at least one pair of electrodes contacting tissue of the subject.

10. The method of claim 9, further comprising regulating delivery of the power signal in response to at least one received signal indicative of the severity of the physiological condition.

11. The method of claim 9, wherein the detected physiological condition includes tongue movement, and wherein at least one of the power level or duration of the signal to be delivered to the electrodes is based on an amount of tongue movement.

12. The method of claim 11, wherein the amount of tongue movement relates to at least one of speed of the tongue, vibration of the tongue, and displacement of the tongue.

13. The method of claim 9, wherein the implanted circuit is implanted on a tongue muscle of the subject, and wherein delivery of the power signal is triggered by a predetermined motion of the implanted circuit with the tongue.

14. The method of claim 11, wherein the tongue movement is indicative of a sleep disordered breathing event, and the amount of tongue movement is indicative of a severity of the sleep disordered breathing event.

15. The method of claim 9, further comprising

transmitting an alternating current signal to the implanted circuit;

and

converting the alternating current signal into a direct current signal, wherein the signal delivered to the electrodes is the direct current signal.

16. The device of claim 9, wherein the at least one implanted circuit is a passive circuit.

17. A sleep disordered breathing therapy device, comprising:

at least one implantable circuit configured for implantation in a body of a subject; and

at least one pair of implantable electrodes connected for electrical communication with the circuit, the at least one implantable circuit and at least one pair of implantable electrodes being configured for implantation in a vicinity of a genioglossus muscle of the subject, the at least one pair of implantable electrodes being configured to modulate a hypoglossal nerve via contact with tissue of the subject;

wherein the at least one implantable circuit is configured to deliver power to the at least one pair of implantable electrodes based on a wirelessly transmitted power signal received by at least one component associated with the implantable circuit, wherein the power signal has at least one of a power level and a duration regulatable based on feedback provided by the at least one implantable circuit, from which a severity of a physiological condition is detected, wherein the feedback is related to relative motion between the implantable circuit and a control unit located external to the body.

18. The device of claim 17, wherein the at least one implantable circuit is a passive circuit.