# US 12,179,022 B2 · Methods and systems for treating osteoarthritis using an implantable stimulator

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- Number: US 12,179,022 B2
- Document ID: US12179022B2
- Status: Granted
- Kind: B2
- Application number: 17/743,093
- Filed: 2022-05-12
- Published: 2022-08-25
- Granted: 2024-12-31
- Earliest claimed: 2016-08-31
- Assignees: Valencia Bioscience, Inc.
- Applicants: Valencia Bioscience, Inc.
- Inventors: Jeffrey H. Greiner; David K. L. Peterson; Stacy Greiner Chambliss
- Web page: https://patentgrep.com/patent/US12179022B2

## CPC

- A61N 1/36071: {Pain}
- A61H 39/002: {Using electric currents (electrotherapy A61N1/32)}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 1/36192: {Amplitude modulation}
- A61N 1/36196: {Frequency modulation}
- A61N 1/37235: {Aspects of the external programmer}
- A61N 1/0504: {Subcutaneous electrodes}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36125: {Details of circuitry or electric components}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 1/378: Electrical supply
- 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

A method of treating osteoarthritis includes an implantable stimulator generating stimulation sessions at a duty cycle that is less than 0.05 and applying the stimulation sessions by way of the central electrode and the annular electrode to a location within a patient that includes at least one of an acupoint labeled ST35, an acupoint labeled EX-LE-4, or a location on a line that intersects the acupoints labeled ST35 and EX-LE-4.

## Claims

### Claim 1

A method of treating osteoarthritis, comprising:
generating, by an implantable stimulator, stimulation sessions at a duty cycle that is less than 0.05, wherein
the duty cycle is a ratio of T3 to T4,
each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes, and
the implantable stimulator comprises a central electrode of a first polarity centrally located on a first surface of a housing of the implantable stimulator and an annular electrode of a second polarity and that is spaced apart from the central electrode; and
applying, by the implantable stimulator, the stimulation sessions by way of the central electrode and the annular electrode to a location within a patient that includes at least one of an acupoint labeled ST35, an acupoint labeled EX-LE-4, or a location on a line that intersects the acupoints labeled ST35 and EX-LE-4.

### Claim 2 (depends on 1)

The method of claim 1, wherein the implantable stimulator is powered by a rechargeable battery.

### Claim 3 (depends on 2)

The method of claim 2, further comprising receiving, by the implantable stimulator from an external controller, a power signal configured to recharge the rechargeable battery.

### Claim 4 (depends on 1)

The method of claim 1, wherein the implantable stimulator is powered by a primary battery.

### Claim 5 (depends on 4)

The method of claim 4, wherein the primary battery has an internal impedance greater than 5 ohms.

### Claim 6 (depends on 1)

The method of claim 1, wherein the housing of the implantable stimulator is coin-sized and coin-shaped.

### Claim 7 (depends on 1)

The method of claim 1, wherein the annular electrode is located on the first surface of the housing.

### Claim 8 (depends on 1)

The method of claim 1, wherein the annular electrode comprises a ring electrode located around a perimeter edge of the housing.

### Claim 9 (depends on 8)

The method of claim 8, wherein the annular electrode comprises a plurality of electrode segments each having the second polarity and spaced apart from each other in a circumferential pattern around the central electrode.

### Claim 10 (depends on 1)

The method of claim 1, wherein T3 is at least 10 minutes and less than 60 minutes, and wherein T4 is at least 1440 minutes.

### Claim 11 (depends on 1)

The method of claim 1, wherein:
a lead is attached to the implantable stimulator; and
the applying the stimulation sessions further comprises applying one or more of the stimulation sessions by way of a plurality of electrodes located on the lead.

### Claim 12

A method of treating osteoarthritis, comprising:
generating, by an implantable stimulator configured to be implanted beneath a skin surface of a patient, stimulation sessions at a duty cycle that is less than 0.05, wherein
the duty cycle is a ratio of T3 to T4, and
each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes; and
applying, by the implantable stimulator in accordance with the duty cycle, the stimulation sessions to a location that includes at least one of an acupoint labeled ST35, an acupoint labeled EX-LE-4, or a location on a line that intersects the acupoints labeled ST35 and EX-LE-4.

### Claim 13

An implantable stimulator, comprising:
a housing;
a central electrode of a first polarity and centrally located on a first surface of the housing;
an annular electrode of a second polarity and that surrounds the central electrode on the first surface of the housing, the annular electrode being spaced apart from the central electrode; and
pulse generation circuitry located within the housing, the pulse generation circuitry configured to
generate stimulation sessions at a duty cycle that is less than 0.05, and
apply the stimulation sessions to a patient by way of the central electrode and the annular electrode a location that includes at least one of an acupoint labeled ST35, an acupoint labeled EX-LE-4, or a location on a line that intersects the acupoints labeled ST35 and EX-LE-4;
wherein
the duty cycle is a ratio of T3 to T4, and
each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes.

### Claim 14 (depends on 13)

The implantable stimulator of claim 13, further comprising a rechargeable battery within the housing and configured to provide power to the pulse generation circuitry.

### Claim 15 (depends on 14)

The implantable stimulator of claim 14, further comprising a receiver circuit within the housing and configured to receive, from an external controller, a power signal configured to recharge the rechargeable battery.

### Claim 16 (depends on 13)

The implantable stimulator of claim 13, further comprising a primary battery within the housing and configured to provide power to the pulse generation circuitry.

### Claim 17 (depends on 16)

The implantable stimulator of claim 16, wherein the primary battery has an internal impedance greater than 5 ohms.

### Claim 18 (depends on 13)

The implantable stimulator of claim 13, wherein the housing of the implantable stimulator is coin-sized and coin-shaped.

### Claim 19 (depends on 13)

The implantable stimulator of claim 13, wherein the annular electrode is located on the first surface of the housing.

### Claim 20 (depends on 13)

The implantable stimulator of claim 13, wherein the annular electrode comprises a ring electrode located around a perimeter edge of the housing.