Apparatus and methods for implant coupling indication

• US 9,403,009 B2
• Filed: 09/28/2012
• Issued: 08/02/2016
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US13/629,690
• Publication Number:
  US 20130085537A1
• Time in Patent Office: 1,404 Days
• Field of Search: 607/42
• US Class Current: 1/1
• 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 is disclosed that includes an external unit configured to communicate with an implant unit beneath the skin of a subject and an indicator associated with the external unit. The indicator is configured to produce an indicator signal when the external unit is within a predetermined range of the implant unit. In addition, the indicator may be configured to vary the indicator signal according to a distance between the external unit and the implant unit. Furthermore, a method of locating an external unit with respect to an implant unit is disclosed that includes detecting a distance between the external unit and the implanted unit located beneath the skin of a subject, producing an indicator signal when the external unit is within a predetermined range of the implant unit, and varying the indicator signal as a function of a distance between the external unit and the implant unit.

Claims

1. A sleep apnea treatment device, comprising:

an external unit configured for location in a region including a neck and an underside of a chin of a subject, the external unit configured to communicate with an implant unit implanted proximal to a tongue of the subject, the external unit including an antenna including a conductor configured for transferring power in a transmitted power signal from the external unit to the implant unit;

an indicator associated with the external unit, wherein the indicator is configured to produce a variable indicator signal when analysis of a signal component on the conductor induced by a secondary signal on a secondary antenna associated with the implant unit as a result of receiving the transmitted power signal indicates that the external unit is within a predetermined range of the implant unit,

wherein the indicator is configured to produce the variable indicator signal that varies according to a distance between the external unit and the implant unit, based on the analysis of the signal component on the conductor,

wherein the variable indicator signal includes a modulation signal that is transmitted to the implant unit to cause the implant unit to modulate a nerve, and

a skin patch having an adhesive that is configured for adherence to a skin of the subject,

wherein the external unit is removably connected to the skin patch,

wherein connecting the skin patch to the external unit triggers the external unit to begin operating in a placement mode in which the indicator produces the variable indicator signal and in which the external unit transitions from the placement mode to a therapy mode when a correct placement condition is satisfied, and

wherein the external unit comprises at least one processor configured to determine a degree of coupling between the antenna of the external unit and the secondary antenna associated with the implant unit based on an observation of non-linear behavior in a circuit associated with the implant unit.

2. The sleep apnea treatment device of claim 1, wherein the modulation signal causes the implant unit to modulate a hypoglossal nerve and to induce at least one of a proprioceptive or kinesthesic reaction in the tongue of the subject.

3. The sleep apnea treatment device of claim 1, wherein the at least one processor is further configured to:

generate a primary signal on the antenna of the external unit, the primary signal being configured to cause the transmitted power signal, the transmitted power signal being configured to induce the secondary signal on the secondary antenna associated with the implant unit;

cause the indicator to produce the variable indicator signal when the degree of coupling exceeds a predetermined threshold;

operate in the placement mode and the therapy mode;

cause the indicator to produce the variable indicator signal during operation in the placement mode; and

transition from the placement mode to the therapy mode when the correct placement condition is satisfied.

4. The sleep apnea treatment device of claim 3, wherein the correct placement condition includes at least one of a predetermined coupling threshold and a predetermined timing threshold.

5. The sleep apnea treatment device of claim 4, wherein the correct placement condition includes the predetermined timing threshold, and wherein the predetermined timing threshold includes a pre-sleep waiting period.

6. The sleep apnea treatment device of claim 1, wherein the variable indicator signal includes at least one of a visual output, an audible output, and a tactile output.

7. The sleep apnea treatment device of claim 6, wherein the modulation signal causes the implant unit to induce at least one of a proprioceptive or kinesthesic reaction in the subject.

8. The sleep apnea treatment device of claim 3, wherein determination of the degree of coupling between the antenna of the external unit and the secondary antenna associated with the implant unit is based, at least in part, on at least one of a measure of capacitive coupling, a measure of radio frequency coupling, and a measure of inductive coupling.

9. The sleep apnea treatment device of claim 1, wherein the at least one processor is further configured to:

generate a primary signal on the antenna of the external unit, the primary signal being configured to cause the secondary signal on the secondary antenna associated with the implant unit; and

cause the indicator to produce the variable indicator signal when the degree of coupling does not exceed a predetermined threshold.