# US 11,998,738 B2 · Neuromodulation system

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- Number: US 11,998,738 B2
- Document ID: US11998738B2
- Status: Granted
- Kind: B2
- Application number: 18/067,269
- Filed: 2022-12-16
- Published: 2023-04-20
- Granted: 2024-06-04
- Earliest claimed: 2013-11-27
- Assignees: EBT Medical, Inc.
- Applicants: Ebt Medical, Inc.
- Inventors: Michael Sasha John; Paul B. Yoo
- Web page: https://patentgrep.com/patent/US11998738B2

## CPC

- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0472: {Structure-related aspects}
- A61N 1/0556: {Cuff electrodes}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system}
- A61N 1/37229: {Shape or location of the implanted or external antenna}
- A61N 1/3787: {from an external energy source}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- A61N 2/02: using magnetic fields produced by coils, including single turn loops or electromagnets (A61N2/12 takes precedence)
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/36071: {Pain}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A neuromodulation system includes a conductive element, a magnetic field generator, a power module and a computer processor. The conductive element located internal a patient's body. At least a portion of the conductive element is positioned adjacent to a target tissue. The magnetic field generator is positioned external to the patient's body. The magnetic field generator generates a time varying magnetic field for inducing stimulation of the target tissue in combination with the conductive element to produce stimulation that is larger than that which would occur in the absence of the conductive element. The power module supplies power to the magnetic field generator. The computer processor controls the time varying magnetic field provided by the magnetic field generator according to at least one set of stimulation parameters.

## Claims

### Claim 1

A method of operating a neuromodulation system for stimulating a target nerve of a patient, comprising:
(a) providing at least one combined conductive element and circuitry for rectifying wireless power signals said combined conductive element and circuitry adapted to be positioned internal a patient's body, said at least one conductive element and circuitry being devoid of an implanted secondary coil;
(b) positioning at least a conductive portion of said at least one conductive element adjacent to a target tissue, said at least one conductive element and circuitry having no intervening electrical routing component between said at least one combined conductive element and circuitry and said target tissue;
(c) establishing a magnetic field generator adapted to be positioned external to said patient's body;
(d) configuring said magnetic field generator to generate a time varying magnetic field for inducing stimulation of said target tissue in combination with the at least one combined conductive element and circuitry to produce stimulation of the target tissue that is greater than that which would occur in the absence of the at least one combined conductive element and circuitry;
(e) providing a power module for powering the magnetic field generator; and,
(f) configuring a computer processor in electrical communication with said magnetic field generator for controlling the time varying magnetic field produced by the magnetic field generator according to at least one set of stimulation parameters.

### Claim 2 (depends on 1)

The method of claim 1 including fabricating said at least one conductive element of an electrically conductive material.

### Claim 3 (depends on 2)

The method of claim 2 wherein said at least one conductive element is formed using at least one material selected from the group of: a metal, a metal alloy or a doped composition and combinations thereof.

### Claim 4 (depends on 1)

The method of claim 1 wherein said at least one combined conductive element and circuitry is adapted to operate as a rectenna.

### Claim 5 (depends on 1)

The method of claim 1 wherein said providing at least one combined conductive element and circuitry includes providing at least two conductive elements and circuitry.

### Claim 6 (depends on 1)

The method of claim 1 wherein said circuitry comprises at least one diode that rectifies wireless power signals created by the magnetic field generator.

### Claim 7 (depends on 1)

The method of claim 1 wherein the combined conductive element and circuitry is configured to provide an antenna based circuitry for obtaining wireless power.

### Claim 8 (depends on 1)

The method of claim 1 wherein the establishing of the magnetic field generator and at least one conductive element and circuitry are configured to provide magnetic resonant induction.

### Claim 9 (depends on 1)

The method of claim 1 wherein at least a portion of said at least one conductive element is located within 5 mm. of said target tissue.

### Claim 10 (depends on 1)

The method of claim 1 including forming at least a portion of an outer surface of said at least one conductive element of said combined at least one conductive element and circuitry with a layer of electrically insulating material formed thereupon.

### Claim 11 (depends on 10)

The method of claim 10 including selecting a composition of said electrically insulating material from the group of: phenyltrimethoxysilane, silicone, polymer coating, Parylene C, a polyimide, and combinations thereof.

### Claim 12 (depends on 1)

The method of claim 1 including selecting said target tissue from the group of: a peripheral nerve, a spinal nerve, a vagus nerve, and a median nerve.

### Claim 13 (depends on 1)

The method of claim 1 including selecting said target tissue to be in the head of a patient.

### Claim 14 (depends on 1)

The method of claim 1 wherein said target tissue is a portion of a saphenous nerve and the method further includes configuring the magnetic field generator with stimulation parameters set for treatment of a pelvic floor disorder in order that the external magnetic field generator provides a stimulation waveform sufficient to modulate the saphenous nerve.

### Claim 15 (depends on 14)

The method of claim 14 wherein the pelvic floor disorder is overactive bladder.

### Claim 16 (depends on 1)

The method of claim 1 including forming said at least one conductive element of said combined at least one conductive element and circuitry in a contour selected from the group of: a parallelepiped, an elliptical contour, a cylindrical contour, a mesh contour, and combinations thereof.

### Claim 17 (depends on 16)

The method of claim 16 wherein said at least one conductive element contour is said cylindrical contour having a predetermined diameter and a length wherein said predetermined diameter is less than said length.

### Claim 18 (depends on 16)

The method of claim 16 wherein said at least one conductive element is formed from the group of: a wire segment, a single contact lead electrode, a multi-contact lead electrode, a cuff shaped electrode, or an injectable pellet electrode.

### Claim 19 (depends on 1)

The method of claim 1 wherein said magnetic field generator adapted to be positioned external to said patient's body utilizes at least one magnetic coil.

### Claim 20 (depends on 19)

The method of claim 19 including configuring said magnetic field generator to provide magnetic resonant induction by creating resonance between the at least one magnetic coil and the at least one combined conductive element and circuitry.

### Claim 21 (depends on 1)

The method of claim 1 wherein said at least one conductive element of said combined at least one conductive element and circuitry is fabricated to have a first end and an opposing second end defining a predetermined length that is equal to or less than 12 mm.

### Claim 22 (depends on 1)

The method of claim 1 including configuring said at least one conductive element to have opposing first and second ends defining a predetermined length therebetween that is equal to or less than 10 cm.

### Claim 23 (depends on 1)

The method of claim 1 wherein said combined at least one conductive element and circuitry is devoid of electrical connection to any electrical conduit configured to route energy to the combined conductive element and circuitry.

### Claim 24 (depends on 1)

The method of claim 1 wherein said target tissue is at least one hypoglossal nerve of said patient with said stimulation of said target tissue being provided for the treatment of obstructive sleep apnea.

### Claim 25 (depends on 24)

The method of claim 24 further including establishing a sensing subsystem having at least one sensor for sensing data to obtain said sensed data and processing said sensed data using a closed loop algorithm for adjusting said stimulation of said target tissue provided by said magnetic field generator for providing treatment of said patients sleep apnea.

### Claim 26 (depends on 1)

The method of claim 1 wherein said target tissue is selected to produce modulation of a genioglossus muscle of said patient and said stimulation is provided for the treatment of obstructive sleep apnea.
