System and method for nerve modulation using noncontacting electrodes

• US 8,577,466 B2
• Filed: 09/28/2012
• Issued: 11/05/2013
• 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:
  US13/629,741
• Publication Number:
  US 20130085560A1
• Time in Patent Office: 403 Days
• Field of Search: 607/42, 607/62
• 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

An implant unit configured for implantation into a body of a subject may include an antenna configured to receive a signal. The implant unit may also include at least one pair of modulation electrodes configured to be implanted into the body of the subject in the vicinity of at least one nerve to be modulated, the at least one pair of modulation electrodes being configured to receive an applied electric signal in response to the signal received by the antenna and generate an electrical field to modulate the at least one nerve from a position where the at least one pair of modulation electrodes does not contact the at least one nerve.

Claims

1. A sleep disordered breathing therapy implant unit configured for implantation proximal to a tongue of a subject, the implant unit comprising:

an antenna configured to receive a signal;

a carrier; and

at least one pair of modulation electrodes disposed on the carrier;

wherein the carrier is configured to conform to an exterior surface of the subject'"'"'s genioglossus muscle in the vicinity of a hypoglossal nerve, such that the at least one pair of modulation electrodes resides outside of the genioglossus muscle, and wherein the at least one pair of modulation electrodes is configured to receive an applied electric signal in response to the signal received by the antenna and generate an electrical field, and the at least one pair of modulation electrodes is oriented on the carrier such that generation of the electrical field enables selective modulation of terminal fibers of the medial branch of the subject'"'"'s hypoglossal nerve from a position where the electrodes of the at least one pair of modulation electrodes are spaced apart from the terminal fibers of the medial branch of the hypoglossal nerve.

2. The sleep disordered breathing therapy implant unit of claim 1, further comprising at least one circuit electrically connected to the at least one pair of modulation electrodes and adapted to cooperate with the electrodes in order to enable the selective modulation of the terminal fibers of the medial branch of the hypoglossal nerve from the position where the electrodes of the at least one pair of electrodes are spaced apart from the terminal fibers of the medial branch of the hypoglossal nerve.

3. The sleep disordered breathing therapy implant unit of claim 1, wherein the electric field generated by the at least one pair of modulation electrodes is configured to penetrate tissue between the at least one pair of modulation electrodes and the terminal fibers of the medial branch of the hypoglossal nerve in order to induce modulation of the terminal fibers of the medial branch of the hypoglossal nerve.

4. The sleep disordered breathing therapy implant unit of claim 3, wherein the tissue includes one or more of a muscle, bone, connective tissue, or adipose tissue.

5. The sleep disordered breathing therapy implant unit of claim 3, wherein the tissue includes a genioglossus muscle.

6. The sleep disordered breathing therapy implant unit of claim 1, wherein the at least one pair of modulation electrodes is configured such that the generated electric field provides an energy density sufficient to modulate the terminal fibers of the medial branch of the hypoglossal nerve without contacting the terminal fibers of the medial branch of the hypoglossal nerve.

7. The sleep disordered breathing therapy implant unit of claim 6, wherein the electric signal received by the at least one pair of modulation electrodes includes a voltage of between about 0.5 volts and about 40 volts.

8. The sleep disordered breathing therapy implant unit of claim 6, wherein the electric signal received by the at least one pair of modulation electrodes includes a current of between about 50 microamps and about 20 milliamps.

9. The sleep disordered breathing therapy implant unit of claim 1, wherein each of the electrodes of the at least one pair of modulation electrodes includes a surface area of about 0.01 mm² to about 80 mm².

10. The sleep disordered breathing therapy implant unit of claim 1, wherein the electrodes of the at least one pair of modulation electrodes are separated from one another by a distance of less than about 25 mm.

11. The sleep disordered breathing therapy implant unit of claim 1, further including wherein the carrier includes a flexible carrier associated with at least one of the antenna and the at least one pair of electrodes, 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.

12. The sleep disordered breathing therapy implant unit of claim 1, wherein the at least one pair of modulation electrodes includes line electrodes, point electrodes, or combinations thereof.

13. The sleep disordered breathing therapy 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 from about 0.2 mm to about 25 mm.

14. The sleep disordered breathing therapy 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 the implant unit and a second pair of electrodes provided on a second side of the implant unit different from the first side.

15. The sleep disordered breathing therapy implant unit of claim 14, wherein the first pair of electrodes and the second pair of electrodes can be activated to simultaneously generate respective electric fields.

16. The sleep disordered breathing therapy implant unit of claim 13, wherein the first pair of electrodes and the second pair of electrodes can be activated to sequentially generate respective electric fields.

17. The sleep disordered breathing therapy implant unit of claim 1, wherein the implant unit is configured to receive an alternating current (AC) signal via the antenna and cause application of at least one of a direct current (DC) signal and an AC signal to the at least one pair of electrodes in response to the AC signal.