# US 11,298,539 B2 · Selective high frequency spinal cord modulation for inhibiting pain, including cephalic and/or total body pain with reduced side effects, and associated systems and methods

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- Number: US 11,298,539 B2
- Document ID: US11298539B2
- Status: Granted
- Kind: B2
- Application number: 16/670,978
- Filed: 2019-10-31
- Published: 2020-08-27
- Granted: 2022-04-12
- Earliest claimed: 2011-09-08
- Assignees: Nevro Corporation
- Applicants: Nevro Corp.
- Inventors: James R. Thacker; Konstantinos Alataris; Bradford Evan Gliner
- Web page: https://patentgrep.com/patent/US11298539B2

## CPC

- A61N 1/36071: {Pain}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/06: for high-frequency therapy
- A61N 1/36075: {Headache or migraine}
- A61N 1/36157: {Current (A61N1/3616 takes precedence)}
- A61N 1/36171: {Frequency}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/3616: {Voltage density or current density}
- 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

Selective high-frequency spinal cord modulation for inhibiting pain with reduced side effects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient's spinal cord region from an epidural, cervical location to address at least one of high back pain, mid-back pain, low back pain, and leg pain without creating paresthesia in the patient.

## Claims

### Claim 1

A method for treating pain associated with diabetic truncal neuropathy in a patient, exclusive of pain associated with total body pain, comprising:
configuring a signal generator to generate and deliver a diabetic truncal neuropathy therapy signal to a target vertebral location via at least one implantable signal delivery device coupled to the signal generator,
wherein at least a portion of the therapy signal has a frequency in a frequency range of from 1.5 kHz to 100 kHz, includes pulses with a pulse width in a pulse width range of from 10 microseconds to 333 microseconds, and has an amplitude in an amplitude range of from 0.1 mA to 20 mA, which at least partially alleviates the pain associated with diabetic truncal neuropathy, exclusive of pain associated with total body pain, without generating paresthesia in the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein the frequency range is from 3 kHz to 20 kHz.

### Claim 3 (depends on 1)

The method of claim 1 wherein the frequency range is from 5 kHz to 15 kHz.

### Claim 4 (depends on 1)

The method of claim 1 wherein the therapy signal has a frequency of about 10 kHz.

### Claim 5 (depends on 1)

The method of claim 1 wherein the pulse width range is from 30 microseconds to 35 microseconds.

### Claim 6 (depends on 1)

The method of claim 1 wherein the pulse width range is from 25 microseconds and 166 microseconds.

### Claim 7 (depends on 1)

The method of claim 1 wherein the amplitude range is from 0.5 mA to 10 mA.

### Claim 8 (depends on 1)

The method of claim 1 wherein the frequency range is from 5 kHz to 15 kHz, the pulse width range is from 30 microseconds to 35 microseconds, and the amplitude range is from 0.5 mA to 10 mA.

### Claim 9 (depends on 1)

The method of claim 1 wherein the target vertebral location is at a vertebral level of from T1 to about T12.

### Claim 10 (depends on 1)

The method of claim 1 wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.

### Claim 11 (depends on 1)

The method of claim 1 wherein configuring the signal generator includes programming the signal generator.

### Claim 12

A method for treating pain associated with diabetic truncal neuropathy in a patient, exclusive of pain associated with total body pain, comprising:
applying a diabetic truncal neuropathy therapy signal to a target vertebral location via at least one implanted signal delivery device,
wherein at least a portion of the therapy signal has a frequency in a frequency range of from 1.5 kHz to 100 kHz, includes pulses with a pulse width in a pulse width range of from 10 microseconds to 333 microseconds, and has an amplitude in an amplitude range of from 0.1 mA to 20 mA, and
wherein the therapy signal at least partially alleviates the pain associated with diabetic truncal neuropathy, exclusive of pain associated with total body pain, without generating paresthesia in the patient.

### Claim 13 (depends on 12)

The method of claim 12 wherein the frequency range is from 3 kHz to 20 kHz.

### Claim 14 (depends on 12)

The method of claim 12 wherein the frequency range is from 5 kHz to 15 kHz.

### Claim 15 (depends on 12)

The method of claim 12 wherein the therapy signal has a frequency of about 10 kHz.

### Claim 16 (depends on 12)

The method of claim 12 wherein the pulse width range is from 30 microseconds to 35 microseconds.

### Claim 17 (depends on 12)

The method of claim 12 wherein the pulse width range is from 25 microseconds and 166 microseconds.

### Claim 18 (depends on 12)

The method of claim 12 wherein the amplitude range is from 0.5 mA to 10 mA.

### Claim 19 (depends on 12)

The method of claim 12 wherein the frequency range is from 5 kHz to 15 kHz, the pulse width range is from 30 microseconds to 35 microseconds, and the amplitude range is from 0.5 mA to 10 mA.

### Claim 20 (depends on 12)

The method of claim 12 wherein the target vertebral location is at a vertebral level of from T1 to about T12.

### Claim 21 (depends on 12)

The method of claim 12 wherein the at least one signal delivery device includes a percutaneous lead having one or more electrodes disposed toward a distal end of the percutaneous lead.
