Modulator apparatus configured for implantation

• US 8,577,465 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:
  US13/629,730
• Publication Number:
  US 20130085559A1
• Time in Patent Office: 403 Days
• Field of Search: 607/42, 607/48
• 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 according to some embodiments may include a flexible carrier, at least one pair of modulation electrodes on the flexible carrier, and at least one implantable circuit in electrical communication with the at least one pair of modulation electrodes. The at least one pair of modulation electrodes and the at least one circuit may be configured for implantation through derma on an underside of a subject'"'"'s chin and for location proximate to terminal fibers of the medial branch of the subject'"'"'s hypoglossal nerve, such that an electric field extending from the at least one pair of modulation electrodes can modulate one or more of the terminal fibers of the medial branch of the hypoglossal nerve.

Claims

1. A sleep disordered breathing therapy implant unit, comprising:

a flexible carrier;

at least one pair of modulation electrodes on the flexible carrier; and

at least one implantable circuit in electrical communication with the at least one pair of modulation electrodes, wherein the at least one pair of modulation electrodes and the at least one circuit are configured for implantation through derma on an underside of a subject'"'"'s chin and for location proximate to terminal fibers of the medial branch of the subject'"'"'s hypoglossal nerve, wherein the implantable circuit and the electrodes are configured to cooperate in order to generate an electric field adapted to modulate one or more of the terminal fibers of the medial branch of the hypoglossal nerve, and

wherein the flexible carrier is configured to conform to an exterior surface of the genioglossus muscle such that the at least one pair of electrodes disposed on the flexible carrier reside outside the exterior surface of the genioglossus muscle, and wherein the at least one pair of modulation electrodes is oriented on the flexible carrier to enable selective modulation of terminal fibers of the medial branch of the hypoglossal nerve.

2. The sleep disordered breathing therapy implant unit of claim 1, wherein the electric field is configured to cause substantially no modulation of the lateral branch of the subject'"'"'s hypoglossal nerve.

3. The sleep disordered breathing therapy implant unit of claim 1, wherein the flexible carrier is configured such that at least a portion of the flexible carrier can be located at a position between the subject'"'"'s genioglossus muscle and geniohyoid muscle.

4. The sleep disordered breathing therapy implant unit of claim 1, wherein the flexible carrier is configured such that the at least one pair of electrodes can be located in a space between the subject'"'"'s genioglossus muscle and an adjacent muscle.

5. 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.

6. 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.

7. The sleep disordered breathing therapy implant unit of claim 1, 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.

8. A sleep disordered breathing therapy implant unit, comprising:

a flexible carrier;

at least one pair of modulation electrodes on the flexible carrier; and

at least one implantable circuit in electrical communication with the at least one pair of modulation electrodes, wherein the at least one pair of modulation electrodes and the at least one circuit are configured for implantation through derma on an underside of a subject'"'"'s chin, and wherein the flexible carrier is configured to conform to an exterior surface of the genioglossus muscle such that the at least one pair of electrodes disposed on the flexible carrier reside in a space between the subject'"'"'s geniohyoid muscle and the subject'"'"'s genioglossus muscle, and wherein the at least one pair of modulation electrodes is oriented on the flexible carrier to enable selective modulation of terminal fibers of the medial branch of the subject'"'"'s hypoglossal nerve from a location between the subject'"'"'s geniohyoid muscle and the subject'"'"'s genioglossus muscle.

9. The sleep disordered breathing therapy implant unit of claim 8, wherein the flexible carrier includes a flexible extension portion configured to adapt to a contour of the genioglossus muscle, wherein the at least one pair of modulation electrodes resides on the flexible extension portion.

10. The sleep disordered breathing therapy implant unit of claim 9, wherein the flexible extension portion is configured to extend away from the underside of the subject'"'"'s chin along a contour of the genioglossus muscle.

11. The sleep disordered breathing therapy implant unit of claim 8, wherein the flexible carrier includes a first flexible extension portion configured to adapt to a contour on a first side of the genioglossus muscle and a second flexible extension portion configured to adapt to a contour on a second side of the genioglossus muscle opposite to the first side.

12. The sleep disordered breathing therapy implant unit of claim 11, further comprising an antenna located on the flexible carrier between the first flexible extension portion and the second flexible extension portion, wherein the implant unit is configured to locate the antenna on a plane substantially parallel with a plane defined by an underside of the subject'"'"'s chin.

13. The sleep disordered breathing therapy implant unit of claim 8, wherein a first pair of modulation electrodes resides on the first flexible extension portion and a second pair of modulation electrodes resides on the second flexible extension.

14. The sleep disordered breathing therapy implant unit of claim 8, wherein the flexible carrier is configured such that the at least one pair of modulation electrodes is configured for implantation adjacent a horizontal compartment of the genioglossus muscle.

15. The sleep disordered breathing therapy implant unit of claim 8, 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.

16. The sleep disordered breathing therapy implant unit of claim 8, 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.

17. The sleep disordered breathing therapy implant unit of claim 8, 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.

18. The sleep disordered breathing therapy implant unit of claim 14, wherein the at least one pair of modulation electrodes is configured such that the electric field is substantially parallel to the direction of the muscle fibers in the horizontal compartment.