# US 10,765,856 B2 · Systems and methods for peripheral nerve stimulation to treat tremor with detachable therapy and monitoring units

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- Number: US 10,765,856 B2
- Document ID: US10765856B2
- Status: Granted
- Kind: B2
- Application number: 15/580,631
- Filed: 2016-06-10
- Published: 2018-06-21
- Granted: 2020-09-08
- Earliest claimed: 2015-06-10
- Assignees: Cala Health, Inc.
- Applicants: Cala Health, Inc.
- Inventors: Serena HanYing Wong; Kathryn H. Rosenbluth; Samuel Richard Hamner; Paula Jean Chidester; Scott Lee Delp; Terence D. Sanger
- Web page: https://patentgrep.com/patent/US10765856B2

## CPC

- 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 1/0496: {characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives}
- A61N 1/321: {Electromedical belts}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/36067: {Movement disorders, e.g. tremor or Parkinson disease (stimulating motor muscle A61N1/36003)}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36125: {Details of circuitry or electric components}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61N 1/37252: {Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data}
- 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 system and method for providing therapy to a patient can include a monitoring unit and a therapy unit. The monitoring unit can have a user interface and one or more sensors to measure patient data. The therapy unit can have a stimulator for generating electrical stimulation and a microcontroller for controlling the generation of the electrical stimulation based on the measured patient data.

## Claims

### Claim 1

A system for treating tremor of a patient, the system comprising:
a band comprising a first surface configured to contact skin of the patient, and comprising at least two skin electrodes, and a second surface opposite the first surface, the second surface comprising at least two receiving contacts and the band further comprising a first electrical circuit configured to be in electrical communication with both the at least two skin electrodes and the at least two receiving contacts; and
a detachable therapy unit comprising:
a second electrical circuit;
one or more sensors in electrical communication with the second electrical circuit, the one or more sensors configured to measure data from the patient;
a stimulator configured to generate an electrical stimulation, the stimulator in electrical communication with the second electrical circuit;
at least two therapy unit electrodes that are configured to receive the electrical stimulation from the stimulator, the at least two therapy unit electrodes configured to connect to the at least two receiving contacts, thereby forming an electrical pathway between the stimulator and the at least two skin electrodes;
a controller configured to control the generation of the electrical stimulation by the stimulator; and
a power source in electrical communication with the second electrical circuit;
wherein the detachable therapy unit is configured to be reversibly attached to the band.

### Claim 2 (depends on 1)

The system of claim 1, wherein the band further comprises one or more identifiers.

### Claim 3 (depends on 2)

The system of claim 2, wherein the one or more identifiers are associated with stimulation parameters and/or usage life information.

### Claim 4 (depends on 1)

The system of claim 1, further comprising a base station configured to charge the power source.

### Claim 5 (depends on 4)

The system of claim 4, wherein the base station is further configured to receive and transmit data to and from the detachable therapy unit and to and from a cloud computing network.

### Claim 6 (depends on 5)

The system of claim 5, further comprising an online portal configured to access the data stored on the cloud computing network.

### Claim 7 (depends on 1)

The system of claim 1, further comprising an online portal configured to provide information and parameter changes back to the detachable therapy unit.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a portable computing device with a user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the detachable therapy unit and to receive data from the cloud computing network.

### Claim 9 (depends on 1)

The system of claim 1, wherein the detachable therapy unit further comprises a user interface.

### Claim 10 (depends on 1)

The system of claim 1, wherein the controller is configured to control the generation of the electrical stimulation by the stimulator based on data measured by the one or more sensors.

### Claim 11

A system for stimulating at least one nerve of a patient, the system comprising:
a wearable band comprising:
a skin facing surface configured to be in contact with skin of the patient, and a surface opposite the skin facing surface, the surface opposite the skin facing surface comprising at least two receiving contacts;
a first electrical circuit; and
at least two transcutaneous electrodes on the skin facing surface,
wherein the first electrical circuit is configured to electrically connect the at least two transcutaneous electrodes with the at least two receiving contacts; and
a first therapy unit comprising:
a first power source;
a first stimulator powered by the first power source, the first stimulator configured to generate an electrical stimulation that is delivered through the at least two transcutaneous electrodes of the wearable band;
at least two electrical contacts configured to connect to the at least two receiving contacts of the wearable band and form a second electrical circuit between the first stimulator and the at least two transcutaneous electrodes;
one or more sensors configured to measure data from the patient; and
a first controller configured to control the generation of the electrical stimulation by the first stimulator based on data measured by the one or more sensors;
wherein the first therapy unit is reversibly attachable to the wearable band.

### Claim 12 (depends on 11)

The system of claim 11, further comprising a second therapy unit, the second therapy unit comprising:
a second power source, wherein the second power source of the second therapy unit has more electrical capacity than the power source of the first therapy unit;
a second stimulator powered by the second power source, the second stimulator configured to generate an electrical stimulation that is delivered through the at least two electrodes of the wearable band; and
a second controller configured to control the generation of the electrical stimulation by the stimulator based on data measured by the one or more sensors;
wherein the second therapy unit is reversibly attachable to the wearable band.

### Claim 13 (depends on 11)

The system of claim 11, wherein the one or more sensors are configured to measure motion data.

### Claim 14 (depends on 13)

The system of claim 13, wherein the controller is configured to:
determine a tremor frequency, amplitude, and/or phase from the motion data; and
control the generation of the electrical stimulation by the first stimulator based on the determined tremor frequency, amplitude, and/or phase.

### Claim 15

A system for modulating at least one nerve of a patient, the system comprising:
a wearable unit comprising:
a first surface configured to be in contact with skin of the patient and a second surface opposite the first surface, the first surface comprising at least two transcutaneous electrodes and the second surface comprising at least two receiving contacts;
an electrical circuit in electrical communication with the at least two transcutaneous electrodes and the at least two receiving contacts; and
a therapy unit comprising:
a stimulator configured to generate an electrical stimulation;
at least two therapy unit electrodes that are configured to receive the electrical stimulation from the stimulator;
a user interface;
one or more sensors configured to measure data from the patient;
a controller configured to control the generation of the electrical stimulation by the stimulator based on data measured by the one or more sensors; and
a power source disposed within the wearable unit or the therapy unit;
wherein the therapy unit is reversibly attachable to the wearable unit.

### Claim 16 (depends on 15)

The system of claim 15, wherein the wearable unit is a smart watch.
