# US 11,439,820 B2 · Devices, systems and methods for treating pain with electrical stimulation

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- Number: US 11,439,820 B2
- Document ID: US11439820B2
- Status: Granted
- Kind: B2
- Application number: 16/571,685
- Filed: 2019-09-16
- Published: 2020-03-12
- Granted: 2022-09-13
- Earliest claimed: 2011-09-22
- Assignees: Djo, LLC
- Applicants: Djo, LLC
- Inventors: Thomas Jerome Bachinski; Dain Silvola; Michael Moore; Jay Dave; Joseph Winn
- Web page: https://patentgrep.com/patent/US11439820B2

## CPC

- A61N 1/36021: {for treatment of pain}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/36034: {specified by the stimulation parameters}
- A61H 23/02: with electric or magnetic drive
- A61H 39/002: {Using electric currents (electrotherapy A61N1/32)}
- A61H 39/04: Devices for pressing such points, e.g. Shiatsu {or Acupressure}(Massage or pressure on general areas A61H9/00 - A61H23/00)
- A61H 39/08: Devices for applying needles to such points, i.e. for acupuncture {; Acupuncture needles or accessories therefor}
- A61H 2201/0153: hand-held
- A61H 2201/0157: portable
- A61H 2201/0184: by raising an alarm
- A61H 2201/0188: Illumination related features
- A61H 2201/10: with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
- A61H 2201/1604: Head
- A61H 2201/1609: Neck
- A61H 2201/1635: Hand or arm, e.g. handle
- A61H 2201/1685: interchangeable
- A61H 2201/5007: computer controlled
- A61H 2201/501: connected to external computer devices or networks
- A61H 2201/5012: using the internet
- A61H 2201/5028: Contact activation, i.e. activated at contact with a surface of the user to be treated
- A61H 2201/5035: Several programs selectable
- A61H 2201/5043: Displays
- A61H 2201/5048: Audio interfaces, e.g. voice or music controlled
- A61H 2201/5082: Temperature sensors
- A61H 2205/02: Head
- A61H 2205/022: Face
- A61H 2205/04: neck
- A61H 2205/062: Shoulders
- A61H 2205/065: Hands
- A61H 2205/081: Back
- A61H 2205/10: Leg
- A61H 2205/12: Feet
- A61H 2230/065: used as a control parameter for the apparatus
- A61H 2230/605: used as a control parameter for the apparatus
- A61H 2230/655: used as a control parameter for the apparatus
- A61N 1/37264: {Changing the program; Upgrading firmware}
- 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)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)

## Abstract

Devices, systems and methods are provided for treating migraine headaches and other conditions by non-invasive electrical stimulation of nerves and other tissue. A hand-held device includes a housing with a controller having a signal generator, an electrode for delivering electrical signals, and a conductive surface configured as a return path for the electrical signals. In certain implementations, the electrode is repositionable with respect to the housing. The patient can self-apply the hand-held device by pressing it against areas in need of pain relief. The device may include a pressure-sensitive gating switch to control delivery of the stimulation therapy. In certain embodiments, the electrode is a rollerball electrode. The device may include a chamber for retaining and dispensing conductive gel to the therapy site. In certain approaches, the device includes an electrode support for coupling an electrical stimulation system to the head for hands-free electrical stimulation therapy.

## Claims

### Claim 1

A non-invasive electrical stimulation device, comprising:
a housing;
a controller comprising a processor and a signal generator disposed within the housing, wherein the processor is configured to receive waveform information and generate a stimulation control signal therefrom, and wherein the signal generator is configured to receive the stimulation control signal from the processor and to generate electrical stimulation waveforms therefrom, wherein the signal generator has a first signal line and a second signal line;
a plurality of delivery electrodes that are repositionable with respect to the housing, each of the delivery electrodes having a surface for contacting a patient's skin and configured to transmit the electrical stimulation waveforms, and the plurality of delivery electrodes electrically discontinuous from the first signal line when in a first position with respect to the housing and in electrical communication with the first signal line when in a second position with respect to the housing, and wherein each of the delivery electrodes are spaced about 1 mm to about 10 mm apart; and
a return electrode coupled to the second signal line.

### Claim 2 (depends on 1)

The device of claim 1, wherein the housing is configured to be shaped like a pen.

### Claim 3 (depends on 1)

The device of claim 1, wherein the return electrode comprises a conductive surface on an exterior of the housing.

### Claim 4 (depends on 1)

The device of claim 1, wherein the return electrode comprises:
an adhesive backing layer configured to be applied to the patient; and
an electrically conductive surface on the adhesive backing layer.

### Claim 5 (depends on 4)

The device of claim 4, further comprising a lead wire connecting the second signal line to the return electrode.

### Claim 6 (depends on 1)

The device of claim 1, further comprising:
a chamber within the housing configured for holding a gel; and
wherein the delivery electrode comprises a rollerball electrode in fluid communication with the chamber.

### Claim 7 (depends on 6)

The device of claim 6, wherein the chamber comprises an aperture configured to promote airflow into the chamber as the gel is delivered.

### Claim 8 (depends on 6)

The device of claim 6, wherein the chamber is removable from the housing.

### Claim 9

A method of delivering electrical stimulation to a patient, the method comprising:
contacting a return electrode of an electrical stimulation device to a patient;
contacting a plurality of delivery electrodes of the electrical stimulation device to the patient, wherein each of the delivery electrodes are spaced about 1 mm to about 10 mm apart;
moving a housing of the electrical stimulation device relative to the patient such that the plurality of delivery electrodes move from a first position wherein the delivery electrodes electrically are discontinuous from a first signal line of the electrical stimulation device to a second position wherein the delivery electrodes are in electrical communication with the first signal line; and
applying an electrical stimulation waveform using a controller comprising a processor and a signal generator disposed within the housing, wherein a signal generator disposed within the housing, wherein the processor is configured to receive waveform information and generate a stimulation control signal therefrom, and wherein the signal generator is configured to receive the stimulation control signal from the processor and to generate electrical stimulation waveforms therefrom with the return electrode and the delivery electrode in the second position.

### Claim 10 (depends on 9)

The method of claim 9, wherein the housing is configured to be shaped like a pen.

### Claim 11 (depends on 9)

The method of claim 9, wherein the return electrode comprises a conductive surface on an exterior of the housing, and contacting the return electrode of the electrical stimulation device to the patient comprises holding the housing such that the conductive surface contacts the patient.

### Claim 12 (depends on 9)

The method of claim 9, wherein the return electrode comprises:
an adhesive backing layer configured to be applied to the patient; and
an electrically conductive surface on the adhesive backing layer.

### Claim 13 (depends on 12)

The method of claim 12, wherein contacting the return electrode of the electrical stimulation device to the patient comprises adhering the return electrode to the patient.

### Claim 14 (depends on 12)

The method of claim 12, wherein the electrical stimulation device further comprises a lead wire connecting the second signal line to the return electrode.

### Claim 15 (depends on 9)

The method of claim 9, wherein the electrical stimulation device further comprises:
a chamber within the housing configured for holding a gel; and
wherein the delivery electrode comprises a rollerball electrode in fluid communication with the chamber.

### Claim 16 (depends on 15)

The method of claim 15, wherein the chamber comprises an aperture configured to promote airflow into the chamber as the gel is delivered.

### Claim 17 (depends on 15)

The method of claim 15, wherein the chamber is removable from the housing.

### Claim 18 (depends on 17)

The method of claim 17, further comprising inserting the chamber into the housing.

### Claim 19 (depends on 15)

The method of claim 15, further comprising filling the chamber with the gel.
