Devices and methods for low current neural modulation

• US 9,895,540 B2
• Filed: 02/21/2014
• Issued: 02/20/2018
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Man & Science S.A.
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/186,236
• Publication Number:
  US 20140172061A1
• Time in Patent Office: 1,460 Days
• Field of Search: 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 may include an implantable circuit and at least one pair of implantable electrodes, in electrical communication with the implantable circuit. The circuit and the electrodes may configured for implantation in a subject in the vicinity of a nerve. The circuit may be configured to deliver to the electrodes an electrical signal having a current less than about 1.6 milliamps, and the electrodes may be configured to emit an electric field such that a portion of the field lines extend along a length of the nerve such that the delivery of the electrical signal of less than about 1.6 milliamps causes modulation of the nerve.

Claims

1. A device, comprising:

an implantable circuit;

at least one pair of implantable electrodes, electrically connected with the implantable circuit, wherein the circuit and the electrodes are configured for implantation in a subject in the vicinity of a nerve; and

wherein the circuit is configured to deliver to the electrodes an electrical signal having a current less than about 1.6 milliamps,

wherein the circuit includes a harmonics modifier circuit configured to alter a harmonic signal generated in the circuit,

an implantable antenna configured to transmit the altered harmonic signal generated in the circuit to a processor for determining a coupling between the implantable antenna and an external antenna based on non-linear behavior reflected by the altered harmonic signal,

wherein the implantable antenna is configured to generate a signal having a magnitude greater than a predetermined threshold to activate the harmonics modifier circuit;

wherein the circuit and the electrodes are configured for implantation in an implantation location in the subject on a surface of non-nerve tissue interposed between the electrodes and the nerve; and

wherein the electrodes are further configured to emit an electric field such that a portion of the field lines extend along a length of the nerve such that the delivery of the electrical signal of less than about 1.6 milliamps causes modulation of the nerve through the interposed non-nerve tissue from the implantation location spaced apart from the nerve and external to a blood vessel.

2. The device of claim 1, wherein the tissue interposed between the electrodes and the nerve includes muscle tissue.

3. The device of claim 1, wherein the implantable circuit is configured to deliver a plurality of electrical signals to the electrodes, and wherein each of the plurality of electrical signals has a current less than about 1.6 milliamps.

4. The device of claim 3, wherein the plurality of electrical signals include various voltage levels, current levels, or durations.

5. The device of claim 1, wherein the implantable circuit is configured to receive energy from a source external to a subject.

6. The device of claim 5, wherein the implantable circuit is configured to deliver to the electrodes, via the electrical signal having a current less than about 1.6 milliamps, a substantial portion of the energy received from the source external to the subject within about 1 second or less of receiving the energy.

7. The device of claim 1, wherein the implantable circuit is in electrical communication with the implantable antenna for transmitting or receiving electrical signals.

8. The device of claim 1, wherein the coupling between the two antennas enables the processor to determine the implantation location of the circuit under a skin of the subject.

9. The device of claim 1, wherein the tissue interposed between the electrodes and the nerve includes genioglossus muscle tissue.

10. The device of claim 1, wherein the electrical signal having a current less than about 1.6 milliamps has a current less than about 1 milliamp.

11. The device of claim 1, wherein the electrical signal having a current less than about 1.6 milliamp has a current less than about 0.8 milliamps.

12. The device of claim 1, wherein the electrical signal having a current less than about 1.6 milliamp has a current less than about 0.6 milliamps.

13. The device of claim 1, wherein the electrical signal having a current less than about 1.6 milliamp has a current less than about 0.4 milliamps.

14. The device of claim 1, wherein the electrical signal having a current less than about 1.6 milliamp has a current less than about 0.2 milliamps.

15. The device of claim 1, wherein the tissue interposed between the electrodes and the nerve includes connective tissue.

16. The device of claim 1, wherein the tissue interposed between the electrodes and the nerve includes fat.

17. The device of claim 1, wherein the tissue interposed between the electrodes and the nerve includes blood vessel tissue.

18. The device of claim 1, wherein the harmonics modifier circuit is configured to cause a decrease in magnitude of the harmonic signal at a predetermined frequency as an amplitude of an excitation signal increases beyond a predetermined level.

19. The device of claim 1, wherein the circuit includes a power limiting component configured to limit a level of power the circuit outputs to the electrodes.

20. The device of claim 1, wherein the implantable antenna is mounted onto or integrated with a flexible carrier.