# US 11,439,823 B2 · Microcurrent-stimulation-therapy apparatus and method

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- Number: US 11,439,823 B2
- Document ID: US11439823B2
- Status: Granted
- Kind: B2
- Application number: 17/416,024
- Filed: 2019-12-19
- Published: 2022-03-03
- Granted: 2022-09-13
- Earliest claimed: 2018-12-20
- Assignees: i-Lumen Scientific, Inc.
- Applicants: i-Lumen Scientific, Inc.
- Inventors: Marshall T. Masko; Blair P. Mowery; John C. Velure; Charles A. Lemaire
- Web page: https://patentgrep.com/patent/US11439823B2

## CPC

- A61N 1/36046: {of the eye}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/3603: {Control systems}
- A61N 5/06: using light
- G06F 21/6245: {Protecting personal data, e.g. for financial or medical purposes}
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 20/30: relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
- G16H 40/67: for remote operation
- A61N 2005/0648: {the light being directed to the eyes}
- G06F 3/012: {Head tracking input arrangements}
- 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)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system and method for applying stimulation therapy to a patient, the system including a first stimulation strip that includes a first elongated portion configured to be placed on the upper eyelid of the first eye of the patient and a second elongated portion configured to be placed on the lower eyelid of the first eye of the patient, wherein the first stimulation strip includes: a first plurality of individually controlled electrodes configured to deliver a microcurrent stimulation therapy to the patient, a first plurality of individually controlled light emitters configured to deliver light stimulation therapy to the patient, and a first plurality of individually controlled heat sources configured to deliver heat therapy to the patient; and a controller operatively coupled to the first stimulation strip and configured to control delivery of the microcurrent stimulation therapy, the light stimulation therapy, and the heat therapy.

## Claims

### Claim 1

A system for applying stimulation therapy to a patient, wherein the patient has a first eye and a second eye, and wherein the first eye and the second eye each include an upper eyelid and a lower eyelid, the system comprising:
a stimulation display configured to display one or more points of light that move across a visual field of the patient such that the patient's eyes orient to different positions during application of the stimulation therapy;
a first stimulation strip that includes a first elongated portion configured to be placed on the upper eyelid of the first eye of the patient and a second elongated portion configured to be placed on the lower eyelid of the first eye of the patient, wherein the first stimulation strip includes:
a first plurality of individually controlled electrodes, wherein the first plurality of individually controlled electrodes is configured to deliver microcurrent stimulation therapy to the patient's first eye, and
a first plurality of individually controlled light emitters, wherein the first plurality of individually controlled light emitters is configured to deliver light-stimulation therapy to the patient's first eye, wherein the light-stimulation therapy includes optical signals that are configured to trigger nerve-action potentials (NAPs) in neural tissue of the patient's first eye, and wherein the optical signals include infrared optical signals; and
a controller operatively coupled to the first stimulation strip and configured to control delivery of the microcurrent stimulation therapy and the light stimulation therapy to the patient's first eye.

### Claim 2 (depends on 1)

The system of claim 1, wherein each respective electrode of the first plurality of electrodes contacts the patient at a respective contact pressure, the system further comprising:
a pressure-control device coupled to the first strip and configured to selectively maintain the respective contact pressure of each respective electrode at a value in a range of two (2) ounces per square inch (0.862 kilopascals) to fifteen (15) pounds per square inch (103.4 kilopascals).

### Claim 3 (depends on 1)

The system of claim 1, wherein the controller is configured to control the first plurality of electrodes and the first plurality of light emitters such that the microcurrent stimulation therapy is delivered simultaneously with the delivery of the light stimulation therapy.

### Claim 4 (depends on 1)

The system of claim 1, wherein the controller is configured to control the first plurality of electrodes and the first plurality of light emitters such that the microcurrent stimulation therapy is delivered during a first time period and the light-stimulation therapy is delivered during a second time period that follows the first time period.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first stimulation strip is coupled to a headset device configured to be placed on a head of the patient, wherein the first plurality of electrodes are part of a disposable electrode-strip housing that includes a respective gelled contact point for each respective one of the first plurality of electrodes, wherein the housing is configured to removably couple to the headset device, and wherein the housing includes a peel-off cover that is removed to expose each respective gelled contact point once the housing is coupled to the headset device.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a stimulator operatively coupled to the first plurality of individually controlled electrodes and configured to generate the microcurrent stimulation therapy delivered by the first plurality of individually controlled electrodes, wherein the stimulator is placed on a temple of the patient.

### Claim 7 (depends on 1)

The system of claim 1, further comprising an audio-output unit configured to provide an indicative sound to indicate a characteristic of the microcurrent stimulation therapy.

### Claim 8 (depends on 1)

The system of claim 1, further comprising:
a second stimulation strip that includes a first elongated portion configured to be placed on the upper eyelid of the second eye of the patient and a second elongated portion configured to be placed on the lower eyelid of the second eye of the patient, wherein the second stimulation strip includes:
a second plurality of individually controlled electrodes, wherein the second plurality of individually controlled electrodes is configured to deliver microcurrent stimulation therapy to the patient's second eye, and
a second plurality of individually controlled light emitters, wherein the second plurality of individually controlled light emitters is configured to deliver light-stimulation therapy to the patient's second eye;
wherein the controller is operatively coupled to the second stimulation strip and the controller is further configured to control delivery of the microcurrent stimulation therapy and the light stimulation therapy to the patient's second eye.

### Claim 9 (depends on 8)

The system of claim 8, wherein at least one selected from the group consisting of the microcurrent stimulation therapy and the light-stimulation therapy is delivered to the patient's first eye and the patient's second eye simultaneously.

### Claim 10 (depends on 8)

The system of claim 8, wherein at least one selected from the group consisting of the microcurrent stimulation therapy and the light-stimulation therapy is delivered to the patient's first eye during a first time period, wherein at least one selected from the group consisting of microcurrent stimulation therapy and light-stimulation therapy is delivered to the patient's second eye during a second time period, and wherein the second time period occurs after the first time period.

### Claim 11 (depends on 1)

The system of claim 1, wherein the light-stimulation therapy is delivered as a continuous wave of light energy.

### Claim 12 (depends on 1)

The system of claim 1, wherein the light-stimulation therapy is delivered as a plurality of light pulses.

### Claim 13

A method for applying stimulation therapy to a patient, wherein the patient has a first eye and a second eye, and wherein the first eye and the second eye each include an upper eyelid and a lower eyelid, the method comprising:
providing a stimulation display;
displaying, using the stimulation display, one or more points of light that move across a visual field of the patient such that the patient's eyes orient to different positions during application of the stimulation therapy;
providing a first stimulation strip that includes a first elongated portion and a second elongated portion, and wherein the first stimulation strip includes a first plurality of individually controlled electrodes and a first plurality of individually controlled light emitters;
placing the first elongated portion of the first stimulation strip on the upper eyelid of the first eye of the patient;
placing the second elongated portion of the first stimulation strip on the lower eyelid of the first eye of the patient;
delivering a microcurrent stimulation therapy to the patient's first eye via the first plurality of individually controlled electrodes; and
delivering a light-stimulation therapy to the patient's first eye via the first plurality of individually controlled light emitters, wherein the delivering of the light-stimulation therapy includes delivering optical signals configured to trigger nerve-action potentials (NAPs) in neural tissue of the patient's first eye, and wherein the optical signals include infrared optical signals.

### Claim 14 (depends on 13)

The method of claim 13, wherein the delivering of the microcurrent stimulation therapy includes ramping up the microcurrent stimulation therapy from a first microcurrent level during a first time period to a second microcurrent level during a second time period that follows the first time period.

### Claim 15 (depends on 13)

The method of claim 13, wherein the delivering of the microcurrent stimulation therapy includes setting a level of the microcurrent stimulation therapy based on a tolerance of the patient, wherein the tolerance is determined by gradually increasing an intensity of the microcurrent stimulation therapy at a rate that allows the patient to respond to discomfort until the patient provides feedback indicating that the microcurrent stimulation therapy has reached a patient-indicated discomfort threshold, and then decreasing the intensity of the microcurrent stimulation therapy until the patient provides feedback indicating that the microcurrent stimulation therapy is below the discomfort threshold, wherein the level of microcurrent stimulation therapy is set at the intensity that brings the patient below the discomfort threshold.

### Claim 16 (depends on 1)

The system of claim 1, wherein the microcurrent stimulation therapy is configured to be delivered with the light-stimulation therapy such that an amount of energy of the optical signals necessary to trigger the NAPs is lower than would be necessary if the microcurrent stimulation therapy was not delivered.

### Claim 17 (depends on 1)

The system of claim 1, further comprising:
a trans-cranial magnetic pulse (TCMP) generator configured to generate a magnetic pulse focused on a selected region of the patient's first eye.

### Claim 18

A system for applying stimulation therapy to a patient, wherein the patient has a first eye and a second eye, and wherein the first eye and the second eye each include an upper eyelid and a lower eyelid, the system comprising:
a stimulation display configured to display red light that includes a wavelength of 600 nanometers (nm) to about 700 nm;
a first stimulation strip that includes a first elongated portion configured to be placed on the upper eyelid of the first eye of the patient and a second elongated portion configured to be placed on the lower eyelid of the first eye of the patient, wherein the first stimulation strip includes:
a first plurality of individually controlled electrodes, wherein the first plurality of individually controlled electrodes is configured to deliver microcurrent stimulation therapy to the patient's first eye, and
a first plurality of individually controlled light emitters, wherein the first plurality of individually controlled light emitters is configured to deliver light-stimulation therapy to the patient's first eye, and wherein the light-stimulation therapy includes optical signals that are configured to trigger nerve-action potentials (NAPs) in neural tissue of the patient's first eye; and
a controller operatively coupled to the first stimulation strip and configured to control delivery of the microcurrent stimulation therapy and the light stimulation therapy to the patient's first eye.

### Claim 19 (depends on 18)

The system of claim 18, wherein the stimulation display is further configured to display one or more points of light that move across a visual field of the patient such that the patient's eyes orient to different positions during application of the stimulation therapy.

### Claim 20

A system for applying stimulation therapy to a patient, wherein the patient has a first eye and a second eye, and wherein the first eye and the second eye each include an upper eyelid and a lower eyelid, the system comprising:
a stimulation display configured to display one or more points of light that move across a visual field of the patient such that the patient's eyes orient to different positions during application of the stimulation therapy;
a first stimulation strip configured to be placed on at least one of the upper eyelid and the lower eyelid of the patient's first eye, wherein the first stimulation strip includes:
a first plurality of individually controlled electrodes, wherein the first plurality of individually controlled electrodes is configured to deliver microcurrent stimulation therapy to the patient's first eye, and
a first plurality of individually controlled light emitters, wherein the first plurality of individually controlled light emitters is configured to deliver light-stimulation therapy to the patient's first eye, wherein the light-stimulation therapy includes optical signals that are configured to trigger nerve-action potentials (NAPs) in neural tissue of the patient's first eye, and wherein the optical signals include infrared optical signals; and
a controller operatively coupled to the first stimulation strip and configured to control delivery of the microcurrent stimulation therapy and the light stimulation therapy to the patient's first eye.

### Claim 21 (depends on 20)

The system of claim 20, wherein the stimulation display is further configured to display colored light.

### Claim 22 (depends on 20)

The system of claim 20, wherein the first stimulation strip further includes:
a first plurality of individually controlled heat sources, wherein the first plurality of individually controlled heat sources is configured to deliver heat therapy to the patient's first eye.

### Claim 23 (depends on 1)

The system of claim 1, wherein the first stimulation strip further includes:
a first plurality of individually controlled heat sources, wherein the first plurality of individually controlled heat sources is configured to deliver heat therapy to the patient's first eye.
