# US 12,109,413 B2 · Systems and methods for peripheral nerve stimulation to treat tremor

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- Number: US 12,109,413 B2
- Document ID: US12109413B2
- Status: Granted
- Kind: B2
- Application number: 17/216,372
- Filed: 2021-03-29
- Published: 2021-10-07
- Granted: 2024-10-08
- Earliest claimed: 2014-06-02
- Assignees: Cala Health, Inc.
- Applicants: Cala Health, Inc.
- Inventors: Serena HanYing Wong; Kathryn H. Rosenbluth; Samuel Hamner; Paula Chidester; Scott L. Delp; Terence D. Sanger; David Klein
- Web page: https://patentgrep.com/patent/US12109413B2

## CPC

- A61N 1/36031: {using physiological parameters for adjustment}
- A61B 5/1101: {Detecting tremor}
- A61B 5/6824: {Arm or wrist}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/36: for stimulation
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/0496: {characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives}
- A61N 1/36025: {for treating a mental or cerebral condition}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A peripheral nerve stimulator can be used to stimulate a peripheral nerve to treat essential tremor, Parkinsonian tremor, and other forms of tremor. The stimulator can have electrodes that are placed circumferentially around the patient's wrist or arm. Specific nerves in the wrist or arm can be targeted by appropriate spacing of the electrodes. Positioning the electrodes on generally opposing sides of the target nerve can result in improved stimulation of the nerve. The stimulation pattern may alternate between the nerves. Improved stimulation algorithms can incorporate tremor feedback, external data, predictive adaptation, and long-term monitoring data.

## Claims

### Claim 1

A neuromodulation system comprising:
a circumferential band configured to wrap around a user's wrist in a wrapped orientation, said circumferential band comprising:
a first portion comprising a first electrode, the first electrode being configured to be in contact with approximately a midline of a ventral side of the wrist in the wrapped orientation, said first portion being configured to support the first electrode over a median nerve; and
a second portion comprising a second electrode, the second electrode being configured to be in contact with a portion of the wrist that is approximately in between the midline of the ventral side of the wrist and a midline of a dorsal side of the wrist in the wrapped orientation, said second portion being configured to support the second electrode over a radial nerve;
a third electrode positioned on the circumferential band;
a flexible electrode circuit comprising electrical traces;
wherein the first and second electrodes are arranged to lie in a common transverse cross-sectional plane of the user's wrist; and
a pulse generator having electrode connectors configured to interface with the flexible electrode circuit so as to deliver a first electrical stimulus between the second electrode and the third electrode via the electrical traces,
wherein the circumferential band is disposable and replaceable.

### Claim 2 (depends on 1)

The neuromodulation system according to claim 1, wherein the first electrode is configured to stimulate the median nerve.

### Claim 3 (depends on 1)

The neuromodulation system according to claim 1, wherein the first electrode and the second electrode are spaced apart a predetermined distance.

### Claim 4 (depends on 1)

The neuromodulation system according to claim 1, wherein a size of the first portion matches a size of the first electrode.

### Claim 5 (depends on 1)

The neuromodulation system according to claim 1, wherein a size of the second portion matches a size of the second electrode.

### Claim 6 (depends on 1)

The neuromodulation system according to claim 1, wherein a distance between the first portion and the second portion is one quarter of a circumference of the circumferential band in the wrapped orientation.

### Claim 7 (depends on 1)

The neuromodulation system according to claim 1, said pulse generator is further configured to deliver a second electrical stimulus between the first electrode and a fourth electrode positioned on the circumferential band.

### Claim 8 (depends on 1)

The neuromodulation system according to claim 1, wherein the circumferential band comprises a first marker configured to provide a visual indication for alignment of the first portion with the midline of the ventral side of the wrist.

### Claim 9 (depends on 1)

The neuromodulation system according to claim 1, wherein the circumferential band comprise a second marker configured to provide a visual indication for alignment of the second portion with the portion of the wrist that is approximately in between the midline of the ventral side of the wrist and the midline of the dorsal side of the wrist.

### Claim 10 (depends on 1)

The neuromodulation system according to claim 1, further comprising a charging station comprising a groove configured to receive the pulse generator.

### Claim 11

A neuromodulation system comprising:
a band configured to wrap around a user's wrist in a wrapped orientation, said band comprising:
a first electrode configured to be in contact with approximately a midline of a ventral side of the wrist and over a median nerve in the wrapped orientation; and
a second electrode configured to be in contact with a portion of the wrist that is approximately in between the midline of the ventral side of the wrist and a midline of a dorsal side of the wrist and over a radial nerve in the wrapped orientation;
a third electrode positioned on the band;
a flexible electrode circuit comprising electrical traces;
wherein the first and second electrodes are arranged to lie in a common transverse cross-sectional plane of the user's wrist; and
a pulse generator having electrode connectors configured to interface with the flexible electrode circuit so as to deliver a first electrical stimulus between the second electrode and the third electrode positioned on the band via the electrical traces,
wherein the band is disposable and replaceable.

### Claim 12 (depends on 11)

The neuromodulation system according to claim 11, wherein the first electrode is configured to stimulate the median nerve.

### Claim 13 (depends on 11)

The neuromodulation system according to claim 11, wherein the first electrode and the second electrode are spaced apart a predetermined distance.

### Claim 14 (depends on 11)

The neuromodulation system according to claim 11, wherein the band comprises a first marker configured to provide a visual indication for alignment of the first electrode with the midline of the ventral side of the wrist.

### Claim 15 (depends on 11)

The neuromodulation system according to claim 11, wherein the band comprise a second marker configured to provide a visual indication for alignment of the second electrode with the portion of the wrist that is approximately in between the midline of the ventral side of the wrist and the midline of the dorsal side of the wrist.

### Claim 16 (depends on 11)

The neuromodulation system according to claim 11, wherein a distance between the first electrode and the second electrode is one quarter of a circumference of the band in the wrapped orientation.

### Claim 17 (depends on 11)

The neuromodulation system according to claim 11, wherein the third electrode comprises a return electrode.
