# US 10,864,376 B2 · Systems and methods for improved spinal cord stimulation

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- Number: US 10,864,376 B2
- Document ID: US10864376B2
- Status: Granted
- Kind: B2
- Application number: 16/778,240
- Filed: 2020-01-31
- Published: 2020-05-28
- Granted: 2020-12-15
- Earliest claimed: 2005-01-21
- Applicants: Michael Sasha John
- Inventors: Michael Sasha John
- Web page: https://patentgrep.com/patent/US10864376B2

## CPC

- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/36064: {Epilepsy}
- A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease}
- A61N 1/37235: {Aspects of the external programmer}
- A61M 5/14276: {specially adapted for implantation}
- A61M 5/172: electrical or electronic
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0529: {Electrodes for brain stimulation}
- A61N 1/36071: {Pain}
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Stimulation treatments for various medical disorders, such as neurological disorders, comprise novel systems, strategies, and methods for providing TMS, electrical, magnetic, optical and other stimulation modalities. Some stimulation methods comprise varying the stimulation parameters to improve the therapeutic efficacy of stimulation, and decrease risk of habituation and side-effects such as interference with normal brain, sensory, motor, and cognitive processes. The creation, and subsequent variation, of stimulation parameters can use sensed data in order to match, adjust, or avoid matching characteristics of the stimulation therapy relative to certain endogenous brain activities. Novel methods are described for choosing, creating and subsequently stimulating with partial signals which summate to produce therapeutic vector fields having unique temporal patterns and low- or high-frequency spectral content. Improvements for the treatment of pain are disclosed.

## Claims

### Claim 1

A patient treatment system comprising:
an implantable pulse generator programmed to provide a first pulsed electrical signal having at least one frequency selected within the range of from about 1 kHz to about 100 kHz; and
at least a first implantable electrical lead with a first set of electrical contacts for delivering the first pulsed electrical signal to at least one location along a patient's spinal cord to treat pain in the patient through application of the first pulsed electrical signal; and
wherein the patient system is configured to provide the first pulsed electrical signal without the first pulsed electrical signal producing an unwanted side-effect related to sensory processing.

### Claim 2 (depends on 1)

The system of claim 1 wherein the first pulsed electrical signal is realized as a modulated carrier signal.

### Claim 3 (depends on 1)

The system of claim 1 wherein the first pulsed electrical signal is realized as a modulated carrier signal with a modulation signal selected to avoid producing said unwanted side-effect related to interference of sensory processing.

### Claim 4 (depends on 1)

The system of claim 1 wherein the patient treatment system includes a second implantable electrical lead with a second set of electrical contacts.

### Claim 5 (depends on 4)

The system of claim 4 wherein the implantable electrical leads are configured for placement bilaterally along a patient's spine.

### Claim 6 (depends on 1)

The system of claim 1 wherein the first pulsed electrical signal is configured to provide inhibitory stimulation to nerves.

### Claim 7 (depends on 1)

The system of claim 1 wherein the at least one lead includes at least one electrode configured to operate as stimulating electrode and a sensor.

### Claim 8 (depends on 7)

The system of claim 7 further comprising a sensor subsystem configured to measure impedance sensed at the least one electrode.

### Claim 9 (depends on 1)

The system of claim 1 wherein the first pulsed electrical signal is further realized as a modulated carrier signal selected to avoid producing an unwanted side-effect related to interference of at least one motor process.

### Claim 10 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency being further selected to deter a side-effect related to interference of a motor process.

### Claim 11 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed with a stimulation protocol that creates the first pulsed electrical signal with biphasic pulses.

### Claim 12 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at a frequency of from about 2 kHz to about 6 kHz.

### Claim 13 (depends on 1)

The system of claim 1 wherein electrical contacts of a stimulator used to provide the pulsed electrical signal are spaced apart from each other by a distance and geometry that is selected or adjusted in relation to an intended superposition of signal components of a vector stimulus waveform.

### Claim 14 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency within the range of about 4 kHz to about 100 kHz.

### Claim 15 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency, wherein the frequency is selected to increase transmission of the signal through tissue compared to a lower frequency range than the frequency range between 1 kHz and 100 kHz.

### Claim 16 (depends on 1)

The system of claim 1 wherein the implantable pulse generator is programmed to modulate the first pulsed electrical signal using a selected modulation frequency within the range of approximately 0.1 Hz to 40 Hz.

### Claim 17 (depends on 1)

The system of claim 1 wherein the unwanted side effect includes paresthesia.

### Claim 18 (depends on 1)

The system of claim 1, further including a sensing subsystem having at least one sensor positioned to detect a sensed data including an evoked response to the first pulsed electrical signal, the system configured to adjust a characteristic of the first pulsed electrical signal based upon evaluation of a characteristic of sensed data.

### Claim 19 (depends on 1)

The system of claim 1, further including a sensing subsystem having at least one sensor configured to sense sensed data related to the patient, and an evaluation subsystem configured to evaluate the sensed data and adjust at least one stimulation protocol parameter of the first pulsed electrical signal upon evaluation of the sensed data.