Topical neurological stimulation

• US 10,016,600 B2
• Filed: 05/30/2014
• Issued: 07/10/2018
• Est. Priority Date: 05/30/2013
• Status: Active Grant

• Current Assignee: Neurostim Solutions LLC
• Original Assignee: Neurostim Solutions LLC
• Inventors: Creasey, Graham H., Toong, Hoo-Min
• Primary Examiner(s): Malamud, Deborah
• Application Number:
  US14/893,946
• Publication Number:
  US 20160129248A1
• Time in Patent Office: 1,502 Days
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters

Abstract

A topical nerve stimulator patch and system are provided comprising a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

Claims

1. A topical nerve stimulation system patch comprising:

a flexible substrate;

a malleable dermis conforming bottom surface of the substrate comprising adhesive and adapted to contact the dermis;

a flexible top outer surface of the substrate approximately parallel to the bottom surface;

one or more electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and directly contacting the flexible substrate;

electronic circuitry embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is directly contacting the flexible substrate, the electronic circuitry integrated as the system on the chip and comprising;

an electrical signal generator integral to the malleable dermis conforming bottom surface configured to electrically activate the one or more electrodes;

a signal activator coupled to the electrical signal generator; and

a nerve stimulation sensor that provides feedback in response to a stimulation of one or more nerves;

an antenna configured to communicate with a remote activation device;

a power source in electrical communication with the electrical signal generator, and the signal activator;

the signal activator configured to activate in response to receipt of a communication with the activation device by the antenna;

the electrical signal generator configured to generate one or more electrical stimuli in response to activation by the signal activator; and

the electrical stimuli configured to stimulate one or more nerves of a user wearing the nerve stimulation system patch at least at one location proximate to the patch.

2. The topical nerve stimulation patch of claim 1, the top outer surface configured to maintain an approximately parallel relationship to the bottom surface when the patch is flexibly coupled to a curved portion of a dermis.

3. The topical nerve stimulation patch of claim 1, further comprising a feedback sensor configured to sense muscle activation of a user in response to the nerve stimulation.

4. The topical nerve stimulation patch of claim 1, the antenna configured to communicate muscle activation data to the remote activation device.

5. The topical nerve stimulation patch of claim 1, the electrical signal generator configured to generate a pattern of stimulation, sensing and analyzing, and revising the pattern based on the sensing.

6. The topical nerve stimulation patch of claim 5, the pattern initially begins with sensing and analyzing before stimulation.

7. The topical nerve stimulation patch of claim 1, the electrodes are arranged as a plurality of concentric electrodes, and varying an amount of power from the power source at the electrodes causes a tissue depth of the stimulation to vary.

8. The topical nerve stimulation patch of claim 1, the electrodes are arranged in a plurality of parallel strips, and the electrical stimuli can be generated parallel to or perpendicular to the patch.

9. The topical nerve stimulation patch of claim 1, the electrodes are arranged in a matrix, and the electrical stimuli can be generated between any of two or more electrodes in the matrix.

10. The topical nerve stimulation patch of claim 1, the electrodes are arranged as interlocked pairs of electrodes that provide beam forming in response to an application of time-varying voltages.

11. The topical nerve stimulation patch of claim 1, the nerve stimulation sensor comprises an array of sensors that function as a phased array antenna configured to receive ultrasound signals.

12. The topical nerve stimulation patch of claim 11, the array of sensors comprise piezoelectric sensors or micro-electro-mechanical sensors.

13. The topical nerve stimulation patch of claim 1, the electrodes comprise adhesive conductive pads.

14. A method of using a topical nerve stimulation system patch for electrical stimulation, the method comprising:

applying the patch to a dermis using adhesive, the patch comprising;

a flexible substrate;

a malleable dermis conforming bottom surface of the substrate comprising adhesive and adapted to contact the dermis;

a flexible top outer surface of the substrate approximately parallel to the bottom surface;

one or more electrodes positioned on the patch proximal to the bottom surface and located beneath the top outer surface and coupled to the flexible substrate;

electronic circuitry embedded in the patch and located beneath the top outer surface and integrated as a system on a chip that is in direct contact with the flexible substrate, the electronic circuitry integrated as the system on the chip and comprising;

an electrical signal generator integral to the malleable dermis conforming bottom surface configured to electrically activate the one or more electrodes;

a signal activator coupled to the electrical signal generator;

a nerve stimulation sensor that provides feedback in response to a stimulation of one or more nerves;

an antenna configured to communicate with a remote activation device;

a power source in electrical communication with the electrical signal generator, and the signal activator;

the signal activator configured to activate in response to receipt of a communication with the activation device by the antenna;

the electrical stimuli configured to stimulate one or more nerves of a user wearing the nerve stimulation system patch at least at one location proximate to the patch;

generating one or more electrical stimuli in response to activation by the signal activator; and

receiving feedback from the electrical stimuli.

15. The method of claim 14, the generating one or more electrical stimuli in response to activation by the signal activator comprises a pattern of stimulation, sensing and analyzing, and the pattern is revised based on the sensing.

16. The method of claim 15, the pattern initially begins with sensing and analyzing before stimulation.

17. The method of claim 14, the electrodes are arranged as a plurality of concentric electrodes, further comprising varying an amount of power from the power source at the electrodes causing a tissue depth of the stimulation to vary.

18. The method of claim 14, the electrodes are arranged in a plurality of parallel strips, further comprising generating the electrical stimuli parallel to or perpendicular to the patch.

19. The method of claim 14, the electrodes are arranged in a matrix, further comprising generating the electrical stimuli between any of two or more electrodes in the matrix.

20. The method of claim 14, the electrodes are arranged as interlocked pairs of electrodes, further comprising providing beam forming in response to an application of time-varying voltages.

21. The method of claim 14, the nerve stimulation sensor comprises an array of sensors that function as a phased array antenna configured to receive ultrasound signals.