Apparatus and Method to Control an Implant

• US 20130085544A1
• Filed: 09/28/2012
• Published: 04/04/2013
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Nyxoah SA
• Original Assignee: Nyxoah SA
• Inventors: Mashiach, Adi
• Granted Patent: US 8,718,776 B2
• Time in Patent Office: Days
• 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

A device according to some embodiments of the present disclosure includes a housing configured to retain a battery, a primary antenna associated with the housing, and at least one processor in electrical communication with the battery and the primary antenna. In some embodiments, the at least one processor may be configured to cause transmission of a primary signal from the primary antenna to an implantable device during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of modulation pulses.

Claims

1. A sleep disordered breathing therapy device, comprising:

a housing configured to retain a battery;

a primary antenna associated with the housing; and

at least one processor in electrical communication with the battery and the primary antenna, the at least one processor configured to;

cause transmission of a primary signal from the primary antenna to an implant unit implanted in at least one of a neck and a head of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.

2. The device of claim 1, wherein at least one of the plurality of stimulation pulses includes an alternating current signal.

3. The device of claim 2, wherein the alternating current signal has a frequency between 6.5 and 13.6 megahertz.

4. The device of claim 1, wherein at least one of the plurality of stimulation pulses includes a plurality of stimulation sub-pulses, each stimulation sub-pulse having a duration of between 50 and 250 microseconds.

5. The device of claim 4, wherein the at least one of the plurality of stimulation pulses includes between 5 and 15 stimulation sub-pulses.

6. The device of claim 1, wherein the at least one processor is configured to cause transmission of the primary signal for at least 90% of the treatment session.

7. The device of claim 1, wherein the battery has a capacity of less than 240 mAh.

8. The device of claim 1, wherein the battery has a capacity of less than 120 mAh.

9. The device of claim 1, wherein the battery has a capacity of less than 60 mAh.

10. The device of claim 1, wherein the pulse train includes more than at least one of 5000, 10,000, and 100,000 stimulation pulses.

11. The device of claim 1, wherein a temporal spacing between a majority of the stimulation pulses is less than 1.3 seconds.

12. The device of claim 1, wherein stimulation pulses occur at a frequency chosen from among four, eight, and sixteen times a breathing frequency.

13. The device of claim 1, wherein a majority of the stimulation pulses have a pulse duration of at least 200 milliseconds.

14. The device of claim 1, wherein the at least one of the housing and the primary antenna is flexible to an extent permitting it to generally conform to the contours of a subject'"'"'s skin.

15. The device of claim 1, wherein the implantable device includes at least one pair of stimulation electrodes, and is configured to cause a muscular contraction inducing current to cause a contraction of a genioglossus muscle of the subject at the at least one pair of stimulation electrodes when the primary signal is received by the implantable device.

16. The device of claim 15, wherein stimulation pulses are temporally spaced so as not to permit a complete relaxation of the genioglossus muscle after muscular contraction.

19. The device of claim 1, wherein a temporal spacing between a majority of the stimulation pulses is less than 500 milliseconds.

20. The device of claim 1, wherein the implantable device includes at least one pair of stimulation electrodes, and is configured to cause a neural stimulation inducing current at the at least one pair of stimulation electrodes sufficient to affect blood pressure of the subject when the primary signal is received by the implantable device.

22. The device of claim 1, wherein a temporal spacing between a majority of the modulation pulses is less than 300 milliseconds.

23. The device of claim 1, wherein the implantable device includes at least one pair of modulation electrodes implanted beneath skin of the substantially haired region in a vicinity of an occipital nerve, and is configured to cause a current sufficient to cause a neural block of an occipital nerve at the at least one pair of modulation electrodes when the primary signal is received by the implantable device.

17. A device, comprising:

a housing configured to retain a battery;

a primary antenna associated with the housing; and

at least one processor in electrical communication with the battery and the primary antenna, the at least one processor configured to;

cause transmission of a primary signal from the primary antenna to an implantable device during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.

18. A hypertension therapy device for affecting blood pressure, the hypertension therapy device comprising:

a housing configured to retain a battery;

a primary antenna associated with the housing; and

at least one processor in electrical communication with the battery and the primary antenna, the at least one processor configured to;

cause transmission of a primary signal from the primary antenna to an implantable device located in a blood vessel of a subject in a vicinity of at least one of a renal nerve, carotid baroreceptor, and glossopharyngeal nerve of a subject during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of stimulation pulses.

21. A head pain management device, comprising:

a patch configured for placement on a one side of a hairline opposite a substantially haired region of a subject;

a primary antenna associated with the patch; and

at least one processor associated with the patch and configured for electrical communication with a battery;

the at least one processor configured to;

cause transmission of a primary signal from the primary antenna to a secondary antenna of an implantable device during a treatment session of at least three hours in duration, wherein the primary signal is generated using power supplied by the battery and includes a pulse train, the pulse train including a plurality of modulation pulses.