Apparatus and methods for modulating nerves using parallel electric fields

• US 9,314,613 B2
• Filed: 09/28/2012
• Issued: 04/19/2016
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Man & Science S.A.
• Original Assignee: Adi Mashiach
• Inventors: Mashiach, Adi
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US13/629,712
• Publication Number:
  US 20130085547A1
• Time in Patent Office: 1,299 Days
• Field of Search: 607/42, 607/134
• 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 may include at least one pair of modulation electrodes configured for implantation in the vicinity of a nerve to be modulated such that the electrodes are spaced apart from one another along a longitudinal direction of the nerve to be modulated. The electrodes may be further configured to facilitate an electric field in response to an applied electric signal, the electric field including field lines extending in the longitudinal direction of the nerve to be modulated. The device may further include at least one circuit in electrical communication with the at least one pair of modulation electrodes and being configured to cause application of the electric signal applied at the at least one pair of modulation electrodes.

Claims

1. An implant unit, comprising:

a carrier;

at least one pair of modulation electrodes configured for implantation external to blood vessels in the vicinity of a nerve to be modulated, and capable of modulating the nerve from a contactless location with respect to the nerve, such that the electrodes are spaced apart from one another along a longitudinal direction of the nerve to be modulated, the electrodes being further configured to facilitate an electric field in response to an applied electric signal, the electric field including field lines extending in the longitudinal direction of the nerve to be modulated;

at least one circuit connected for electrical communication with the at least one pair of modulation electrodes and being configured to generate the electric signal applied at the at least one pair of modulation electrodes; and

at least one antenna configured to receive a transmitted signal from a location outside of a subject'"'"'s body and transfer the received transmitted signal to the at least one circuit such that substantially all energy used by the at least one circuit to generate the applied electric signal originates from energy associated with the received transmitted signal;

wherein the at least one pair of electrodes, the at least one circuit, and the at least one antenna are mounted on the carrier, and

wherein the at least one circuit includes a non-linear circuit component configured to alter characteristics of harmonics generated in the at least one circuit above a transition point that corresponds to a level of excitation current at which an amplitude of at least one even-order harmonic decreases.

2. The implant unit of claim 1, wherein the electric field includes field lines extending in a direction substantially parallel to a longitudinal direction of at least a portion of the nerve to be modulated.

3. The implant unit of claim 1, wherein the carrier is a flexible carrier.

4. The implant unit of claim 3, wherein the flexible carrier includes a biocompatible polymer including at least one of silicone, phenyltrimethoxysilane (PTMS), polymethyl methacrylate (PMMA), parylene C, polyimide, liquid polyimide, laminated polyimide, black epoxy, polyether ether ketone (PEEK), liquid crystal polymer (LCP), Kapton, or combinations thereof.

5. The implant unit of claim 1, wherein the at least one pair of modulation electrodes is supported by a flexible carrier configured to adapt to the contour of tissue in the body of the subject to orient the at least one pair of modulation electrodes such that the electric field generated by the at least one pair of modulation electrodes includes field lines extending in a longitudinal direction of the nerve to be modulated.

6. The implant unit of claim 5, wherein the tissue includes one or more of a muscle, bone, connective tissue, or adipose tissue.

7. The implant unit of claim 1, wherein the at least one pair of modulation electrodes includes line electrodes, point electrodes, or combinations thereof.

8. The implant unit of claim 1, wherein each of the at least one pair of modulation electrodes includes an anode and a cathode spaced apart from one another by a distance of less than about 25 mm.

9. The implant unit of claim 1, wherein each electrode of the at least one pair of modulation electrodes has a surface area of from about 0.01 mm² to about 80 mm².

10. The implant unit of claim 1, wherein the at least one pair of modulation electrodes includes a first pair of electrodes provided on a first side of a flexible carrier and a second pair of electrodes provided on a second side of the flexible carrier different from the first side.

11. The implant unit of claim 10, wherein the first pair of electrodes and the second pair of electrodes can be activated to simultaneously generate respective electric fields.

12. The device of claim 10, wherein the first pair of electrodes and the second pair of electrodes can be activated to sequentially generate respective electric fields.

13. The implant unit of claim 1, wherein the at least one circuit is configured to receive an alternating current (AC) signal and cause application of at least one of a direct current (DC) signal and an AC signal to the at least one pair of modulation electrodes in response to the AC signal.

14. The implant unit of claim 13, wherein the AC signal is received via the at least one antenna.

15. The implant unit of claim 1, wherein the at least one antenna and the at least one circuit are configured to direct substantially all of the energy received by the at least one antenna to generate the applied electric signal at the modulation electrodes.

16. A method of modulating a nerve, comprising:

receiving an alternating current (AC) signal via at least one antenna included in an implant unit configured to be implanted into a body of a subject, the implant unit including a circuit that includes a non-linear circuit component configured to alter characteristics of harmonics generated in the circuit above a transition point, wherein the transition point corresponds to a level of excitation current at which an amplitude of at least one even-order harmonic decreases;

generating a voltage signal in response to the AC signal;

applying the voltage signal to at least one pair of modulation electrodes included in the implant unit and configured for implantation external to blood vessels in the vicinity of the nerve in a contactless location with respect to the nerve such that the electrodes are spaced apart from one another along a longitudinal direction of the nerve, wherein substantially all energy applied as a voltage signal to the at least one pair of modulation electrodes originates from energy associated with the received AC signal;

generating an electrical field in response to the voltage signal applied to the at least one pair of modulation electrodes, the electric field including field lines extending in a longitudinal direction of the nerve; and

modulating the nerve;

while modulating the nerve, monitoring occurrence of the decrease of the amplitude of at least one even-order harmonic above the transition point; and

adjusting a parameter of the AC signal based on the monitoring.

17. The method of claim 16, wherein the electric field generated by the at least one pair of modulation electrodes includes field lines extending in a direction substantially parallel to a longitudinal direction of at least a portion of the nerve.

18. The method of claim 16, wherein the at least one antenna and the electrodes are supported by a flexible carrier.

19. The method of claim 16, wherein each of the at least one pair of modulation electrodes includes an anode and a cathode spaced apart from one another by a distance of less than about 25 mm.

20. The method of claim 16, wherein each electrode of the at least one pair of modulation electrodes has a surface area of from about 0.01 mm² to about 80 mm².

21. The method of claim 16, wherein adjusting the parameter of the AC signal based on the monitoring includes dynamically adjusting the parameter based on the monitoring.