Implant unit for modulation of small diameter nerves

• US 10,716,940 B2
• Filed: 06/17/2014
• Issued: 07/21/2020
• Est. Priority Date: 10/20/2009
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US14/306,990
• Publication Number:
  US 20140358196A1
• Time in Patent Office: 2,226 Days
• Field of Search: 607 60, 607 62, 607134, 607152
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• 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 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• 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 5/389 Electromyography [EMG]
• 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 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• 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 1/36057 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 1/36135 : 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 1/37223 : Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 : Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3756 : 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

Abstract

An implant unit configured for implantation into a body of a subject is provided. The implant unit may include an antenna configured to receive a signal, and 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 nerve may have a diameter less than about 2 millimeters at a modulation location, and the at least one pair of modulation electrodes may be 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 spaced apart from the at least one nerve.

Claims

1. An implant unit configured for implantation into a body of a subject, comprising:

a carrier comprising a substantially planar central portion, a first elongated arm extending from a first side of the central portion, and a second elongated arm extending from a second side of the central portion, the carrier being configured to be implanted into the body of the subject with at least one of the first elongated arm and the second elongated arm extending in a vicinity of a terminal end of at least one nerve to be modulated, the carrier further being configured to be implanted into the body of the subject such that the at least one of the first elongated arm and the second elongated arm is not in physical contact with the at least one nerve and such that non-nerve tissue is interposed between the at least one nerve and the at least one of the first elongated arm and the second elongated arm, wherein the first elongated arm includes a suture hole;

an antenna configured to receive a signal, the antenna disposed entirely on the substantially planar surface of the central portion of the carrier; and

a first pair of modulation electrodes disposed on the first elongated arm and a second pair of modulation electrodes disposed on the second elongated arm, each of the first pair of modulation electrodes and the second pair of modulation electrodes being configured to receive an applied electric signal in response to the signal received by the antenna and generate an electric field, the electric field being configured for penetrating non-nerve tissue interposed between the at least one nerve and the modulation electrodes and for modulating the at least one nerve at the modulation location.

2. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, the at least one nerve has a diameter of less than about one millimeter.

3. The implant unit of claim 1, wherein the first pair of modulation electrodes are spaced apart in a longitudinal direction of the at least one nerve to be modulated and configured to generate an electric field in the longitudinal direction.

4. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 1 mm.

5. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 500 microns.

6. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 200 microns.

7. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 100 microns.

8. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 50 microns.

9. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the least one nerve is less than 25 microns.

10. The implant unit of claim 1, wherein the electric field includes a plurality of field lines substantially parallel to a longitudinal axis of the at least one nerve.

11. The implant unit of claim 1, wherein the non-nerve tissue includes muscle tissue.

12. The implant unit of claim 1, wherein the non-nerve tissue surrounds the at least one-nerve.

13. The implant unit of claim 1, wherein at the terminal end of the at least one nerve, a diameter of the at least one nerve is less than about two millimeters.