Treatment of sleep apnea via bilateral stimulation

• US 9,463,318 B2
• Filed: 06/17/2014
• Issued: 10/11/2016
• Est. Priority Date: 10/20/2009
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi, Mashiach, Itzik
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/307,040
• Publication Number:
  US 20140379049A1
• Time in Patent Office: 847 Days
• Field of Search: 607/48, 607/60, 607/134, 607/152, 607/118
• US Class Current: 1/1
• 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 5/11 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 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• 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 1/36057 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 1/3614 : based on impedance measurement
• 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

A neuromodulation device is provided. The neuromodulation device may include a carrier configured for implantation in a subject, the carrier including a first elongated arm and a second elongated arm, each extending from a central portion of the carrier. The device may further include a first pair of modulation electrodes arranged on the first elongated arm, a second pair of modulation electrodes arranged on the second elongated arm. The carrier may be sized and shaped for implantation in a vicinity of a hypoglossal nerve to be modulated such that the first pair of modulation electrodes is located to modulate a first hypoglossal nerve on a first side of the subject and the second pair of modulation electrodes is located to modulate a second hypoglossal nerve on a second side of the subject.

Claims

1. A device, comprising:

a carrier configured for implantation in a subject in a vicinity of a hypoglossal nerve to be modulated, the carrier including a first elongated arm and a second elongated arm, each extending from a central portion of the carrier;

a first pair of modulation electrodes on the first elongated arm; and

a second pair of modulation electrodes on the second elongated arm;

wherein

the first pair of modulation electrodes is located to modulate a first hypoglossal nerve on a first side of the subject, the first pair of modulation electrodes being spaced apart from one another and configured to facilitate a first electric field in response to the electric signal,

the second pair of modulation electrodes is located to modulate a second hypoglossal nerve on a second side of the subject, the second pair of modulation electrodes being spaced apart from one another and configured to facilitate a second electric field in response to the electric signal, and

in response to a transmitted electrical signal, the first and second pairs of modulation electrodes alternate a sequence of the first and second neuromuscular modulating electric fields by alternating a polarity of the first neuromuscular modulating electric field and the second neuromuscular modulating electric field.

2. The device of claim 1, wherein the carrier is configured for location on a genioglossus muscle of the subject.

3. The device of claim 1, wherein the first pair of modulation electrodes and the second pair of modulation electrodes modulate the first hypoglossal nerve and the second hypoglossal nerve through intervening tissue.

4. The device of claim 1, further comprising:

an antenna; and

at least one circuit electrically coupled to the first pair of modulation electrodes and the second pair of modulation electrodes,

wherein the antenna is configured to receive the transmitted electrical signal and the circuit is configured to transfer the electrical signal to the first pair of modulation electrodes and the second pair of modulation electrodes.

5. The device of claim 1, wherein the carrier is substantially flexible.

6. The device of claim 4, wherein the first electric field includes field lines extending in a longitudinal direction of the first hypoglossal nerve, and

the second electric field includes field lines extending in a longitudinal direction of the second hypoglossal nerve.

7. The device of claim 1, wherein the carrier is sized and shaped to permit the first pair of modulation electrodes and the second pair of modulation 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.

8. A control unit for controlling an implant unit configured for placement in a body of a subject, the implant unit having at least a first pair and a second pair of modulation electrodes and being configured for bilateral stimulation of a first and second hypoglossal nerves, the control unit comprising:

a primary antenna associated with a unit external to the subject'"'"'s body; and

at least one processing device associated with the unit configured to;

cause generation of the hypoglossal nerve modulation control signal for application to the primary antenna; and

cause application of the hypoglossal nerve modulation control signal to the primary antenna in order to wirelessly transmit the hypoglossal nerve modulation control signal to a secondary antenna included on the implant unit located in the subject'"'"'s body,

wherein the hypoglossal nerve modulation control signal is configured to;

cause generation of a first neuromuscular modulating electric field at the first pair of electrodes and cause generation of a second neuromuscular modulating electric field at the second pair of electrodes, and

alternate a sequence of the first and second neuromuscular modulating electric fields by alternately reversing a polarity of the first neuromuscular modulating electric field and the second neuromuscular modulating electric field.