Device and method for modulating nerves using parallel electric fields

• US 8,588,941 B2
• Filed: 09/28/2012
• Issued: 11/19/2013
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/629,701
• Publication Number:
  US 20130085558A1
• Time in Patent Office: 417 Days
• Field of Search: 607/134, 607/152, 607/156
• US Class Current: 607/134
• 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. A device, comprising:

at least one pair of modulation electrodes configured for implantation in a sub-mandibular region and in a vicinity of a hypoglossal nerve to be modulated such that the electrodes are spaced apart from one another along a longitudinal direction of the hypoglossal nerve, 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 hypoglossal nerve;

a carrier sized and shaped for supporting the at least one pair of modulation electrodes in a manner permitting the at least one pair of electrodes to lie between a surface of a myelohyoid muscle and a surface of a genioglossus muscle, the carrier further including a portion configured to lie between a surface of a geniohyoid muscle and the surface of the genioglossus muscle; and

at least one circuit, on the carrier, 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.

2. The device of claim 1, wherein the electrodes are configured to facilitate generation of the field lines extending in a direction substantially parallel to the longitudinal direction of at least a portion of the hypoglossal nerve.

3. The device of claim 1, wherein the carrier is made of a flexible material.

4. The device of claim 3, wherein the flexible material 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 device of claim 1, wherein the at least one circuit and the at least one pair of modulation electrodes are supported by a common, flexible carrier.

6. The device of claim 1, wherein the at least one pair of modulation electrodes is supported by a flexible carrier configured to adapt to a contour of the surface of the genioglossus muscle 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 hypoglossal nerve.

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

8. The device 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 device 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 device 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 device 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 11, wherein the first pair of electrodes and the second pair of electrodes can be activated to sequentially generate respective electric fields.

13. The device 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 device of claim 13, wherein the AC signal is received via an antenna associated with the at least one circuit.

15. A method of modulating a nerve, comprising:

receiving an alternating current (AC) signal at a device configured to be implanted adjacent a hypoglossal nerve of a subject;

generating a voltage signal in response to the AC signal;

applying the voltage signal to the at least one pair of modulation electrodes configured for implantation in the vicinity of the hypoglossal nerve such that the electrodes are spaced apart from one another along a longitudinal direction of the hypoglossal nerve;

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 hypoglossal nerve; and

modulating the hypoglossal nerve from a position spaced apart from the hypoglossal nerve.

16. The method of claim 15, 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 hypoglossal nerve.

17. The method of claim 15, wherein the AC signal is received via an antenna electrically associated with the electrodes.

18. The method of claim 15, 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.

19. The method of claim 15, 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.