# US 11,896,827 B2 · Microcurrent device and method for the treatment of visual disease

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- Number: US 11,896,827 B2
- Document ID: US11896827B2
- Status: Granted
- Kind: B2
- Application number: 15/460,702
- Filed: 2017-03-16
- Published: 2017-09-21
- Granted: 2024-02-13
- Earliest claimed: 2016-03-16
- Assignees: MacuMira Medical Devices Inc.
- Applicants: MacuMira Medical Devices Inc.
- Inventors: George D. O'Clock
- Web page: https://patentgrep.com/patent/US11896827B2

## CPC

- A61N 1/36046: {of the eye}
- A61N 1/36014: {External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625)}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/0408: {Use-related aspects}
- 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)

## Abstract

An electrotherapeutic device for treating a visual disease using microcurrent stimulation is provided. The device includes a signal generator in which a waveform controller digitally controls a waveform signal source so as to generate a waveform in which one or more waveform parameters (e.g., pulse width, pulse period, pulse position, pulse coding, peak current amplitude, duty cycle, and/or pulse shape) are varied in accordance with a protocol for treating a visual disease. The device also includes an applicator connected to the signal generator and configured to apply the waveform to at least one stimulation point within an eye region.

## Claims

### Claim 1

A method for treatment of a visual disease, comprising:
providing a signal generator comprising a waveform controller connected to a waveform signal source, wherein the waveform controller is programmed to provide an output comprising a set of waveform parameters for a visual disease treatment protocol, wherein the waveform parameters include a plurality of varying pulse frequencies, wherein the waveform signal source is operable to provide a pulsed current output, and wherein the waveform signal source is configured to receive the output from a microcontroller and generate a waveform in which a plurality of current pulses within the pulsed current output are provided at the varying pulse frequencies included in the set of waveform parameters;
providing a current control and matching circuit to maintain safe current pulse levels;
placing at least one electrode in contact with tissue of an eye region, wherein the electrode is connected to the signal generator;
activating the signal generator to apply the waveform to the tissue via the electrode;
wherein the current pulse levels do not vary by more than plus or minus 10% for load impedance variations; and
wherein the load impedance variations range from 5,000 ohms to 70,000 ohms.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pulse frequencies are varied within a defined frequency range of 0.3 Hz to 300 Hz.

### Claim 3 (depends on 2)

The method of claim 2, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 4 (depends on 2)

The method of claim 2, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pulse frequencies are varied within a defined frequency range of 0.1 Hz to 50 Hz.

### Claim 6 (depends on 5)

The method of claim 5, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 7 (depends on 5)

The method of claim 5, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 8 (depends on 1)

The method of claim 1, wherein the pulse frequencies are varied within a defined frequency range of 0.05 Hz to 10 Hz.

### Claim 9 (depends on 8)

The method of claim 8, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 10 (depends on 8)

The method of claim 8, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 11 (depends on 1)

The method of claim 1, wherein the waveform comprises a first pulse sequence and a second pulse sequence.

### Claim 12 (depends on 11)

The method of claim 11, wherein a polarity of each of the first and second pulse sequences is varied to generate a bipolar waveform.

### Claim 13 (depends on 12)

The method of claim 12, wherein the waveform parameters of the first pulse sequence are the same as the waveform parameters of the second pulse sequence.

### Claim 14 (depends on 12)

The method of claim 12, wherein the waveform parameters of the first pulse sequence are different than the waveform parameters of the second pulse sequence.

### Claim 15 (depends on 1)

The method of claim 1, wherein the visual disease comprises macular degeneration.

### Claim 16

A method for treatment of a visual disease, comprising:
providing a signal generator comprising a waveform controller connected to a waveform signal source, wherein the waveform controller is programmed to provide an output with a set of waveform parameters for a visual disease treatment protocol, wherein the waveform parameters include a pulse width and a pulse frequency that is varied to provide a plurality of levels of frequency content within a sequence of current pulses, wherein the waveform signal source is operable to provide a pulsed current output, and wherein the waveform controller is operable to provide the output so as to digitally control the waveform signal source so that the waveform signal source generates a waveform comprising the sequence of current pulses having the waveform parameters for the visual disease treatment protocol;
providing a current control and matching circuit to maintain safe current pulse levels;
placing at least one electrode in contact with tissue of an eye region, wherein the electrode is connected to the signal generator;
activating the signal generator to apply the waveform to the tissue via the electrode;
wherein the current pulse levels do not vary by more than plus or minus 10% for load impedance variations; and
wherein load impedance variations range from 5,000 ohms to 70,000 ohms.

### Claim 17 (depends on 16)

The method of claim 16, wherein the set of waveform parameters is configured to vary the pulse frequency within a defined frequency range of 0.3 Hz to 300 Hz.

### Claim 18 (depends on 17)

The method of claim 17, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 19 (depends on 17)

The method of claim 17, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 20 (depends on 16)

The method of claim 16, wherein the set of waveform parameters is configured to vary the pulse frequency within a defined frequency range of 0.1 Hz to 50 Hz.

### Claim 21 (depends on 20)

The method of claim 20, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 22 (depends on 20)

The method of claim 20, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 23 (depends on 16)

The method of claim 16, wherein the set of waveform parameters is configured to vary the pulse frequency within a defined frequency range of 0.05 Hz to 10 Hz.

### Claim 24 (depends on 23)

The method of claim 23, wherein the current pulses are provided at 75% or more of the discrete frequencies within the defined frequency range.

### Claim 25 (depends on 23)

The method of claim 23, wherein the current pulses are provided at 90% or more of the discrete frequencies within the defined frequency range.

### Claim 26 (depends on 16)

The method of claim 16, wherein the waveform comprises a first pulse sequence and a second pulse sequence.

### Claim 27 (depends on 26)

The method of claim 26, wherein a polarity of each of the first and second pulse sequences is varied to generate a bipolar waveform.

### Claim 28 (depends on 27)

The method of claim 27, wherein the waveform parameters of the first pulse sequence are the same as the waveform parameters of the second pulse sequence.

### Claim 29 (depends on 27)

The method of claim 27, wherein the waveform parameters of the first pulse sequence are different than the waveform parameters of the second pulse sequence.

### Claim 30 (depends on 16)

The method of claim 16, wherein the visual disease comprises macular degeneration.
