# US 11,305,118 B2 · Head worn apparatuses for vision therapy

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- Number: US 11,305,118 B2
- Document ID: US11305118B2
- Status: Granted
- Kind: B2
- Application number: 16/697,689
- Filed: 2019-11-27
- Published: 2020-06-04
- Granted: 2022-04-19
- Earliest claimed: 2018-11-30
- Assignees: Biovisics Medical, Inc.
- Applicants: Biovisics Medical, LLC
- Inventors: Paul Rockley; James R. Chiapetta; Thomas W. Harold; Michael Ashker
- Web page: https://patentgrep.com/patent/US11305118B2

## CPC

- A61N 1/36046: {of the eye}
- A61N 1/0408: {Use-related aspects}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0484: {Garment electrodes worn by the patient}
- G02C 5/001: {specially adapted for particular purposes, not otherwise provided for or not fully classifiable according to technical characteristics, e.g. therapeutic glasses}
- G02C 11/10: {Electronic devices other than hearing aids}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- 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)
- G02C: SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES (trial frames for testing the eyes A61B3/04; goggles or eyeshields not having the same features as spectacles A61F9/00)

## Abstract

Systems, devices, and methods for use in delivering stimulation to the head of a patient, including examples directed to delivering electrical or other stimulation to the eye of the patient. In some examples eyepieces or eyepatches are configured to deliver electrical or other stimulus to the eye of a patient by being worn on the face of the patient.

## Claims

### Claim 1

A system for delivering stimulus to a patient comprising:
a pulse generator having a U-shaped housing adapted and configured to be worn on the neck of a patient, having therein operational circuitry including at least output circuitry configured to generate output electrical pulses;
a frame configured to be worn on the head of a patient, the frame carrying a plurality of stimulus delivery electrodes electrically coupled to the pulse generator and configured such that, when the frame is worn by a patient, the plurality of stimulus delivery electrodes are positioned to deliver stimulus generated using the output circuitry to at least one eye of the patient; and
at least one return electrode adapted for use as a return or indifferent electrode when output electrical pulses are generated, the at least one return electrode being disposed on an interior surface of the U-shaped housing.

### Claim 2 (depends on 1)

The system of claim 1 wherein the stimulus delivery electrodes are disposed on goggles adapted to fit over and about the eye of a user.

### Claim 3 (depends on 1)

The system of claim 1 wherein the pulse generator includes one or more ports for receiving a coupler that electrically couples to the stimulus delivery electrodes, allowing disconnection and reconnection thereof.

### Claim 4 (depends on 1)

The system of claim 1 wherein the pulse generator operational circuitry comprises a microcontroller associated with a memory having thereon instructions for generating therapeutic outputs, the microcontroller configured to control the output circuitry, and a power supply in the form of a replaceable battery.

### Claim 5 (depends on 1)

The system of claim 1 wherein the pulse generator operational circuitry comprises a microcontroller associated with a memory having thereon instructions for generating therapeutic outputs, the microcontroller configured to control the output circuitry, and a power supply in the form of a rechargeable battery.

### Claim 6 (depends on 1)

The system of claim 1, wherein the at least one return electrode comprises a plurality of protruding electrodes extending around the interior surface of the housing.

### Claim 7

A method of treating a patient having an eye disease comprising:
a patient donning a neck-worn pulse generator containing operational circuitry including output circuitry configured to generate output electrical pulses;
a patient donning a frame carrying a plurality of stimulus delivery electrodes electrically coupled to the pulse generator, the frame configured relative to the stimulus delivery electrodes so that, when the frame is worn by a patient, the stimulus delivery electrodes are positioned to deliver stimulus generated using the output circuitry to at least one eye of the patient;
the patient activating the pulse generator to deliver a stimulus to the eye of the patient; and
the pulse generator issuing stimulus to the eye;
wherein the pulse generator comprises a U-shaped housing which includes at least one return electrode on an inner surface thereof, and the step of the pulse generator issuing stimulus to the eye includes using the at least one return electrode on the inner surface of the U-shaped housing to return current.

### Claim 8 (depends on 7)

The method of claim 7, further comprising, in response to the patient activation, the pulse generator testing impedance between one or more pairs of stimulus delivery electrodes to confirm appropriate contact with patient tissue and, in response to confirming appropriate contact with patient tissue, the pulse generator issues the stimulus to the eye.

### Claim 9 (depends on 7)

The method of claim 7 wherein the at least one return electrode comprises a plurality of protruding electrodes extending around the interior surface of the housing.
