# US 12,213,795 B2 · Devices and methods for remote therapy and patient monitoring

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- Number: US 12,213,795 B2
- Document ID: US12213795B2
- Status: Granted
- Kind: B2
- Application number: 18/389,119
- Filed: 2023-11-13
- Published: 2024-03-21
- Granted: 2025-02-04
- Earliest claimed: 2011-01-12
- Assignees: ElectroCore, Inc.
- Applicants: Electrocore, Inc
- Inventors: Bruce J. Simon; Joseph P. Errico
- Web page: https://patentgrep.com/patent/US12213795B2

## CPC

- A61B 5/394: specially adapted for electroglottography or electropalatography
- A61B 5/4035: {Evaluating the autonomic nervous system}
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/4803: {Speech analysis specially adapted for diagnostic purposes}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6822: {Neck}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7267: {involving training the classification device}
- A61N 1/36021: {for treatment of pain}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- A61B 5/02405: {Determining heart rate variability}
- A61B 5/687: {Oesophagus}
- A61B 2090/3941: {Photoluminescent markers}
- A61B 2560/0456: Apparatus provided with a docking unit
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- 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)
- G16H 40/67: for remote operation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Systems and methods for remote therapy and patient monitoring are provided. A method comprises contacting an outer skin surface of a patient with a contact surface of a stimulator and transmitting an electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient. Data related to parameters of the electrical impulse applied to the nerve is stored and transmitted to a remote source. The data may include duration of treatment, amplitude of the electrical impulse, compliance with a prescribed therapy regimen or other relevant data related to the therapy. The method may further include collecting patient status data, such as symptoms of a medical condition (e.g., severity of a headache) before, during and/or after stimulation. The patient status data is correlated with the treatment data to monitor compliance and/or the effectiveness of the therapy.

## Claims

### Claim 1

A method for treating a patient with a medical condition, the method comprising:
contacting an outer skin surface of a patient with a contact surface of a stimulator;
generating an electrical impulse;
transmitting the electrical impulse from the stimulator transcutaneously through the outer skin surface to a nerve within the patient;
storing data related to parameters of the electrical impulse applied to the nerve, wherein the parameters include a therapy regimen that includes, transmitting the electrical impulses for a time period of about 30 seconds to about 5 minutes as a single dose;
transmitting the data to a remote source; and
collecting user status data from the patient and comparing the user status data with the data related to parameters of the electrical impulse, wherein the user status data comprises severity of a headache.

### Claim 2 (depends on 1)

The method of claim 1, wherein the data is stored within the stimulator.

### Claim 3 (depends on 1)

The method of claim 1, further comprising wirelessly transmitting the data to a mobile device and storing the data within the mobile device.

### Claim 4 (depends on 1)

The method of claim 1, wherein the parameters include a duration of time the electrical impulse is transmitted to the nerve.

### Claim 5 (depends on 1)

The method of claim 1, wherein the parameters include an amplitude of the electrical impulse transmitted to the nerve.

### Claim 6 (depends on 1)

The method of claim 1, wherein the therapy regimen includes one or more single doses applied on a daily basis.

### Claim 7 (depends on 6)

The method of claim 6, wherein the parameters include a number of single doses applied per day.

### Claim 8 (depends on 1)

The method of claim 1, further comprising determining motion data of the stimulator while the electrical impulse is transmitted to the nerve and transmitting the motion data to a remote source.

### Claim 9 (depends on 1)

The method of claim 1, further comprising detecting a physiological parameter of the patient and comparing the physiological parameter with the data related to parameters of the electrical impulse.

### Claim 10 (depends on 9)

The method of claim 9, wherein the physiological parameter is selected from the group consisting of: heart rate, heart rate variability, blood pressure, pupil diameter, electrodermal activity, vagal artery blood flow and cerebral blood flow.

### Claim 11 (depends on 1)

The method of claim 1, wherein the electrical impulse is sufficient to modulate a nerve within the patient to treat the medical condition.

### Claim 12 (depends on 11)

The method of claim 11, wherein the nerve is a vagus nerve.

### Claim 13 (depends on 1)

The method of claim 1, wherein the medical condition comprises headache.

### Claim 14

A system for treating a patient with a medical condition, the system comprising:
a stimulator comprising an electrode for contacting an outer skin surface of a patient;
an energy source coupled to the electrode and configured to generate an electrical impulse and to transmit the electrical impulse transcutaneously through the outer skin surface to a nerve within the patient;
a storage device for storing data related to parameters of the electrical impulse, wherein the parameters include a therapy regimen that includes, transmitting the electrical impulses for a time period of about 30 seconds to about 5 minutes as a single dose;
a transmitter coupled to the storage device for transmitting the data related to parameters of the electrical impulse to a mobile device; and
an application configured to compare the user status data to parameters of the electrical impulse, wherein the user status data comprises severity of a headache.

### Claim 15 (depends on 14)

The system of claim 14, wherein the storage device is disposed within the stimulator.

### Claim 16 (depends on 14)

The system of claim 14, wherein the parameters include a duration of time the electrical impulse is transmitted to the nerve.

### Claim 17 (depends on 14)

The system of claim 14, further comprising a user interface configured to receive user status data of the patient.

### Claim 18 (depends on 14)

The system of claim 14, further comprising a sensor for detecting a physiological parameter of the patient, wherein the processor is configured to compare the physiological parameter with parameters of the electrical impulse.

### Claim 19 (depends on 18)

The system of claim 18, wherein the physiological parameter is selected from the group consisting of: heart rate, heart rate variability, blood pressure, pupil diameter, electrodermal activity, vagal artery blood flow and cerebral blood flow.
