# US 10,864,367 B2 · Methods for using an electrical dermal patch in a manner that reduces adverse patient reactions

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- Number: US 10,864,367 B2
- Document ID: US10864367B2
- Status: Granted
- Kind: B2
- Application number: 15/716,866
- Filed: 2017-09-27
- Published: 2018-03-22
- Granted: 2020-12-15
- Earliest claimed: 2015-02-24
- Assignees: Elira, Inc.
- Applicants: Elira, Inc.
- Inventors: Raul E. Perez; Peter I. Hong; Steven Diianni; Luis Jose Malave; Brad Stengel
- Web page: https://patentgrep.com/patent/US10864367B2

## CPC

- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/1118: {Determining activity level}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/42: {Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems (A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence)}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/6833: {Adhesive patches}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36034: {specified by the stimulation parameters}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0502: {Skin piercing electrodes}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- 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

The disclosed electrical stimulation system generates interventions to assist patients in complying with a diet. The wearable device includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis, through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis, of a T2 dermatome to a T12 dermatome or meridian of the patient, a C5 to a T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and generate interventions. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

## Claims

### Claim 1

A method for using an electrical dermal patch adapted to be continuously worn by a patient, comprising:
providing an electrical dermal patch comprising:
a housing having a controller in electrical communication with a pulse generator; and
at least two electrodes adapted to be adhered to the patient's skin and in electrical communication with the pulse generator, wherein the controller comprises programmatic instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit to the at least two electrodes a first electrical stimulation pulse and a second electrical stimulation pulse, wherein the first electrical pulse is defined by a first phase having a first polarity and a second phase having a second polarity that is opposite the first polarity, wherein the second electrical pulse follows the first electrical pulse and is defined by a third phase having a third polarity and a fourth phase having a fourth polarity that is opposite the third polarity, and wherein the second polarity is equal to the third polarity,
programming the controller such that each of the electrical stimulation pulses comprises a pulse width in a range of 10 μsec to 10 msec, a pulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hz and 10,000 Hz;
determining if the patient experiences a change in appetite as a result of an application of said first set of electrical stimulation pulses or said second set of electrical stimulation pulses to the patient's skin; and
determining if the patient experiences erythema, scaling, pruritus, folliculitis, or zintertrigo at a point where the two electrodes adhere to the patient's skin.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second electrical pulse follows the first electrical pulse after a predetermined time interval.

### Claim 3 (depends on 2)

The method of claim 2 wherein the predefined time interval is in a range of 1 minute to 10 minutes.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first polarity is positive, the second polarity is negative, the third polarity is negative, and the fourth polarity is positive.

### Claim 5 (depends on 1)

The of claim 1, wherein the first polarity is negative, the second polarity is positive, the third polarity is positive, and the fourth polarity is negative.

### Claim 6 (depends on 1)

The method of claim 1, wherein each of the at least two electrodes comprise a hypoallergenic conductive gel with at least one adhesive surface.

### Claim 7 (depends on 1)

The method of claim 1, wherein the electrode does not comprise imidazolidinyl urea or diazolidinyl urea.

### Claim 8 (depends on 1)

The method of claim 1, wherein the electrode comprises carboxymethylcellulose polymer and propylene glycol.

### Claim 9 (depends on 1)

The method of claim 1, wherein the at least one adhesive surface is adapted to adhere to the patient's skin and have a peel strength in a range of 1.0 to 2.1 newtons.

### Claim 10 (depends on 1)

The method of claim 1, wherein the at least one adhesive surface is adapted to adhere to the patient's skin and have a total skin contact surface area in a range of 2 cm2 to 4 cm2.

### Claim 11 (depends on 1)

The method of claim 1, wherein the at least two electrodes are positioned in a same plane parallel to the patient's skin and separated by an area of 0.05 cm2 to 0.4 cm2.

### Claim 12 (depends on 1)

The method of claim 1, wherein an amplitude of the first phase, the second phase, the third phase, and the fourth phase are equal and wherein a pulse width of the first phase, the second phase, the third phase, and the fourth phase are equal.

### Claim 13 (depends on 1)

The electrical dermal patch of claim 1, wherein an amplitude of the first phase and the fourth phase are equal, wherein a pulse width of the first phase and the fourth phase are equal, an amplitude of the second phase and the third phase are equal, wherein a pulse width of the second phase and the third phase are equal, and wherein at least one of the amplitude and the pulse width of the first phase is different from the amplitude and pulse width of the second phase.

### Claim 14 (depends on 1)

The method of claim 1 wherein the first phase is defined by a waveform characterized by a first period and a second period, wherein the first period comprises a first 10 μs of the waveform and the second period comprises a remainder of the waveform and wherein said waveform is defined by a maximum amplitude during the first period and an amplitude less than said maximum amplitude during the second period.

### Claim 15 (depends on 14)

The method of claim 14 wherein the maximum amplitude is in a range of 20 to 40 mA.

### Claim 16 (depends on 14)

The method of claim 14 wherein the maximum amplitude is in a range of 20 to 40 mA and an average amplitude across said first period and second period is in a range of 10 mA to 20 mA.

### Claim 17 (depends on 1)

The method of claim 1 wherein the pulse generator has a maximum compliance voltage in a range of 40 volts to 60 volts.

### Claim 18 (depends on 1)

The method of claim 1 wherein at least one of the first phase, second phase, third phase, and fourth phase is defined by a waveform characterized by a first period, a second period, and a third period, wherein the first period comprises at least a portion of 0 to 10 μs of the waveform, the second period comprises at least a portion of 10 μs to 100 μs of the waveform, and the third period comprises at least a portion of 100 μs to 200 μs of the waveform, wherein the first period is defined by a maximum amplitude and the second and third periods are defined by a remainder amplitude less than said maximum amplitude.

### Claim 19 (depends on 18)

The method of claim 18 wherein the maximum amplitude is in a range of 20 mA to 40 mA.

### Claim 20 (depends on 18)

The method of claim 18 wherein, in the second period, a decay of the remainder amplitude is defined by a first negative slope having a first magnitude and, in the third period, a decay of said remainder amplitude is defined by a second negative slope having a second magnitude, wherein the first magnitude is less than the second magnitude.

### Claim 21 (depends on 18)

The method of claim 18 wherein an average of the maximum amplitude and the remainder amplitude is in a range of 10 mA to 20 mA.