# US 12,048,844 B2 · Modular stimulator for treatment of back pain, implantable RF ablation system and methods of use

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- Number: US 12,048,844 B2
- Document ID: US12048844B2
- Status: Granted
- Kind: B2
- Application number: 17/173,121
- Filed: 2021-02-10
- Published: 2021-06-03
- Granted: 2024-07-30
- Earliest claimed: 2010-03-11
- Assignees: Mainstay Medical Limited
- Applicants: Mainstay Medical Limited
- Inventors: Peter Andrew Crosby; Dan Sachs; Prashant Brijmohansingh Rawat; Jason Alan Shiroff; Johannes Petrus Heemels
- Web page: https://patentgrep.com/patent/US12048844B2

## CPC

- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61N 1/06: for high-frequency therapy
- A61N 1/36071: {Pain}
- A61N 1/37211: {Means for communicating with stimulators}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2018/00339: {Spine, e.g. intervertebral disc}
- A61B 2018/00577: {Ablation}
- A61B 2018/124: {switching the output to different electrodes, e.g. sequentially}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2034/2048: {using an accelerometer or inertia sensor}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36042: {of grafted tissue, e.g. skeletal muscle}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36146: {specified by the stimulation parameters}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Apparatus and methods for treating back pain are provided, in which an implantable stimulator is configured to communicate with an external control system, the implantable stimulator providing a neuromuscular electrical stimulation therapy designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability; the implantable stimulator further including one or more of a number of additional therapeutic modalities, including a module that provides analgesic stimulation; a module that monitors muscle performance and adjusts the muscle stimulation regime; and/or a module that provides longer term pain relief by selectively and repeatedly ablating nerve fibers. In an alternative embodiment, a standalone implantable RF ablation system is described.

## Claims

### Claim 1

A therapeutic electrical stimulation system comprising:
a stimulator housing;
an electrode lead coupled to the stimulator housing and comprising one or more electrodes, the electrode lead configured to be implanted in or adjacent to a tissue associated with a spine of a patient;
a circuitry module disposed within the stimulator housing and operatively coupled to the electrode lead, the circuitry module configured to deliver neuromuscular stimulation and analgesic stimulation to the one or more electrodes to the tissue associated with the spine of the patient; and
a controller disposed within the stimulator housing and operatively coupled to the circuitry module, the controller configured to cause simultaneous delivery of the neuromuscular stimulation and the analgesic stimulation to the one or more electrodes via the circuitry module to effect pain relief or pain reduction in the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the electrode lead is configured to be implanted in or adjacent to a medial branch of a dorsal ramus.

### Claim 3 (depends on 2)

The system of claim 2, wherein the medial branch of the dorsal ramus is located in the lumbar spine of the patient.

### Claim 4 (depends on 1)

The system of claim 1, wherein the circuitry module is configured to deliver RF energy to the one or more electrodes for repeated ablation of the tissue associated with the spine of the patient after a predetermined period of time.

### Claim 5 (depends on 4)

The system of claim 4, further comprising one or more sensors configured to monitor tissue temperature adjacent to the one or more electrodes.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a telemetry system disposed within the stimulator housing and operatively coupled to the controller.

### Claim 7 (depends on 6)

The system of claim 6, further comprising an external control system configured to wirelessly communicate with the telemetry system.

### Claim 8 (depends on 7)

The system of claim 7, wherein the external control system is configured to transmit stimulation operating parameters to the controller via the telemetry system.

### Claim 9 (depends on 7)

The system of claim 7, wherein the external control system is configured to transmit energy to a power source disposed within the stimulator housing via the telemetry system.

### Claim 10 (depends on 7)

The system of claim 7, further comprising a battery within the stimulator housing,
wherein the controller is configured to transmit data indicative of at least one of impedance between electrodes, temperature of the battery, or battery status of the battery to the external control system via the telemetry system.

### Claim 11 (depends on 1)

The system of claim 1, further comprising a power source disposed within the stimulator housing, the power source configured to power the circuitry module.

### Claim 12 (depends on 1)

The system of claim 1, further comprising an electrode switching array disposed within the stimulator housing, the controller operatively coupled to the electrode switching array to select a subset of the one or more electrodes to deliver at least one of the neuromuscular stimulation or the analgesic stimulation.

### Claim 13 (depends on 12)

The system of claim 12, wherein the controller is configured to select the subset of the one or more electrodes to compensate for electrode migration post-implantation.

### Claim 14 (depends on 1)

The system of claim 1, further comprising one or more sensors operatively coupled to the electrode lead and configured to monitor tissue impedance.

### Claim 15 (depends on 1)

The system of claim 1, wherein the circuitry module is configured to deliver the neuromuscular stimulation to a subset of the one or more electrodes to cause contraction of a spinal muscle associated with the tissue associated with the spine of the patient.

### Claim 16 (depends on 1)

The system of claim 1, wherein the circuitry module comprises a first circuitry module configured to cause delivery of the neuromuscular stimulation to efferent nerve fibers associated with the tissue associated with the spine of the patient and a second circuitry module configured to cause delivery of the analgesic stimulation to afferent nerve fibers associated with the tissue associated with the spine of the patient.

### Claim 17

A method for relieving back pain, the method comprising:
implanting an electrode lead comprising one or more electrodes configured to be implanted in or adjacent to a tissue associated with a spine of a patient;
coupling said electrode lead to a circuitry module disposed within a stimulator housing, the stimulator housing comprising a controller configured to cause delivery of neuromuscular stimulation and analgesic stimulation to the one or more electrodes of the electrode lead via the circuitry module to effect pain relief or pain reduction in the patient; and
simultaneously delivering the neuromuscular stimulation and the analgesic stimulation to the one or more electrodes of the electrode lead via the controller to effect the pain relief or the pain reduction in the patient.

### Claim 18 (depends on 17)

The method of claim 17, wherein implanting the electrode lead comprises implanting the electrode lead in or adjacent to a medial branch of a dorsal ramus.

### Claim 19 (depends on 17)

The method of claim 17, further comprising selecting a subset of the one or more electrodes to deliver RF energy, and wherein delivering RF energy to the one or more electrodes comprises delivering RF energy to the selected subset of the one or more electrodes to compensate for electrode migration post-implantation.

### Claim 20 (depends on 17)

The method of claim 17, further comprising repeatedly delivering RF energy to the one or more electrodes to repeatedly ablate the tissue associated with the spine of the patient after a predetermined period of time.