Dynamic modification of modulation throughout a therapy period

• US 9,061,162 B2
• Filed: 06/17/2014
• Issued: 06/23/2015
• Est. Priority Date: 06/17/2013
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi, Mashiach, Itzik
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/306,968
• Publication Number:
  US 20140371822A1
• Time in Patent Office: 371 Days
• Field of Search: 607/60
• US Class Current: 1/1
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: A61N 1/0404 for external use A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 : Patch electrodes A61N1/0412, A61N1/0428 take precedence
• 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 1/36014 : External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• 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 1/36075 : 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 1/3758 : Packaging of the components within the casing
• 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: A61N 2001/37294 : Means for testing medical devices within the package prior to implantation

Abstract

A device for controlling operation of a nerve-modulating implant unit from a location external to the body of the subject is provided. The device may include a flexible substrate configured for removable attachment to a subject'"'"'s skin, a primary antenna disposed on the flexible substrate, and at least one processing device. The processing device may be configured to cause generation of a modulation control signal and application of the modulation control signal to the primary antenna in order to wirelessly transmit the modulation control signal to a secondary antenna on the implant unit to cause modulation of at least one nerve using energy transmitted wirelessly from the primary antenna to the secondary antenna, and cause a plurality of predetermined alterations of at least one characteristic of the modulation control signal over successive applications of the modulation control signal during a therapy period.

Claims

1. A device for controlling operation of a nerve-modulating implant unit, configured for location in a body of a subject, from a location external to the body of the subject, the device comprising:

a flexible substrate configured for removable attachment to a subject'"'"'s skin;

a primary antenna disposed on the flexible substrate; and

at least one processing device configured to;

cause generation of a modulation control signal and application of the modulation control signal to the primary antenna in order to wirelessly transmit the modulation control signal to a secondary antenna on the implant unit to cause modulation of at least one nerve using energy transmitted wirelessly from the primary antenna to the secondary antenna; and

cause a plurality of predetermined alterations of at least one characteristic of the modulation control signal over successive applications of the modulation control signal during a therapy period.

2. The device of claim 1, wherein the at least one characteristic includes a current level associated with the modulation control signal.

3. The device of claim 1, wherein the at least one characteristic includes an amplitude associated with the modulation control signal.

4. The device of claim 1, wherein the at least one characteristic includes a duty cycle associated with the modulation control signal.

5. The device of claim 1, wherein the at least one characteristic includes a frequency of the modulation control signal.

6. The device of claim 1, wherein the at least one processing device is programmed with the predetermined alterations of the modulation control signal prior to the therapy period.

7. The device of claim 1, wherein the predetermined alterations of the modulation control signal are determined based on a monitored sleep breathing pattern of the subject.

8. The device of claim 2, wherein the predetermined alterations of the current level associated with the modulation control signal include increases over the therapy period according to a determined alteration pattern.

9. The device of claim 3, wherein the predetermined alterations of the amplitude associated with the modulation control signal include increases over the therapy period according to a determined alteration pattern.

10. The device of claim 4, wherein the predetermined alterations of the duty-cycle associated with the modulation control signal include increases over the therapy period according to a determined alteration pattern.