# US 2019/0105496 A1 · System and Method to Managing Stimulation of Select A-Beta Fiber Components

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- Number: US 2019/0105496 A1
- Document ID: US20190105496A1
- Status: Published application
- Kind: A1
- Application number: 15/937,427
- Filed: 2018-03-27
- Published: 2019-04-11
- Earliest claimed: 2015-12-22
- Assignees: Pacesetter, Inc.
- Inventors: Xiaoyi Min; Alexander Kent; Richard Williamson
- Web page: https://patentgrep.com/patent/US20190105496A1

## CPC

- A61N 1/36071: {Pain}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36132: {using patient feedback}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36171: {Frequency}
- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/37241: {providing test stimulations}
- A61B 5/7257: {using Fourier transforms}
- 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

A computer implemented method and system is provided for managing neural stimulation therapy. The method comprises under control of one or more processors configured with program instructions. The method delivers a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest. A parameter defines the candidate stimulation waveforms is changed to vary the stimulation intensity. The method identifies a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect. The method further identifies a second candidate stimulation waveform that does not induce the select analgesic effect. The method sets a stimulation therapy based on the first and second candidate stimulation waveforms.

## Claims

### Claim 1

A computer implemented method for managing neural stimulation therapy, comprising: under control of one or more processors configured with program instructions, delivering a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest, wherein a parameter defining the candidate stimulation waveforms is changed to vary the stimulation intensity; identifying a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect; identifying a second candidate stimulation waveform that does not induce the select analgesic effect; and setting a stimulation therapy based on the first and second candidate stimulation waveforms.

### Claim 2 (depends on 1)

The method of claim 1, wherein the second candidate stimulation waveform exhibits a stimulation intensity that blocks large and medium A-beta fibers that would otherwise induce paresthesia and analgesic effects, respectively.

### Claim 3 (depends on 1)

The method of claim 1, wherein the stimulation therapy blocks the large A-beta fibers having diameters of approximately 11.0-13.0 μm and activates medium A-beta fibers having diameters of approximately 6.0-11.0 μm.

### Claim 4 (depends on 1)

The method of claim 1, wherein the candidate stimulation waveform corresponds to a high frequency stimulation waveform or a burst stimulation waveform for spinal cord stimulation (SCS).

### Claim 5 (depends on 4)

The method of claim 4, further comprising delivering tonic SCS pulses during the stimulation therapy in combination with the high frequency stimulation waveform or burst stimulation waveform.

### Claim 6 (depends on 5)

The method of claim 5, further comprising utilizing current steering to direct the tonic SCS pulses to dermatomes of interest.

### Claim 7 (depends on 1)

The method of claim 1, wherein the stimulation therapy includes first and second stimulation modalities, the method further comprising delivering the first and second stimulation modalities from different first and second electrode combinations.

### Claim 8 (depends on 1)

The method of claim 1, further comprising: sensing evoked compound action potential (ECAP) signals; applying a narrow band-pass filter to the ECAP signals to filter out stimulation artifacts from KHFSCS or burst SCS candidate waveforms; performing a fast Fourier transform to the ECAP signals after the filtering operation; and the identifying operations including analyzing the ECAP signals in a frequency domain.

### Claim 9 (depends on 8)

The method of claim 8, wherein the analyzing includes determining a parameter setting associated with the stimulation therapy that yields ECAP signals that fit select profiles.

### Claim 10 (depends on 1)

The method of claim 1, wherein the setting operation sets the stimulation therapy to have an intensity I based on the following equation: I=THPF+k*(THU−RHPF), where k represents a constant, where THPF represents a first intensity level corresponding to a paresthesia-abatement threshold and THU represents a second intensity level corresponding to an analgesic upper threshold.

### Claim 11

A system for managing neural stimulation therapy comprising: a lead having at least one stimulation electrode, the lead configured to be implanted at a target position proximate to nervous tissue of interest; and an implantable pulse generator (IPG) coupled to the lead, the IPG configured to: deliver a series of candidate stimulation waveforms having varied stimulation intensities to at least one electrode located proximate to nervous tissue of interest, wherein a parameter defining the candidate stimulation waveforms is changed to vary the stimulation intensity; identify a first candidate stimulation waveform that induces a paresthesia-abatement effect, while continuing to induce a select analgesic effect; identify a second candidate stimulation waveform that does not induce the select analgesic effect; and set a stimulation therapy based on the first and second candidate stimulation waveforms.

### Claim 12 (depends on 11)

The system of claim 11, wherein the first candidate stimulation waveform exhibits a stimulation intensity that blocks large diameter A-beta fibers that would otherwise induce a paresthesia effect.

### Claim 13 (depends on 11)

The system of claim 11, wherein the second candidate stimulation waveform exhibits a stimulation intensity that blocks large and medium diameter A-beta fibers that would otherwise induce paresthesia and analgesic effects, respectively.

### Claim 14 (depends on 11)

The system of claim 11, wherein the stimulation therapy blocks the large A-beta fibers having diameters of approximately 11.0-13.0 um and activates medium A-beta fibers having diameters of approximately 6.0-11.0 um.

### Claim 15 (depends on 11)

The system of claim 11, wherein the candidate stimulation waveform corresponds to a high frequency stimulation waveform or a burst stimulation waveform for spinal cord stimulation (SCS).

### Claim 16 (depends on 15)

The system of claim 15, wherein the IPG further delivers, as the stimulation therapy, tonic SCS pulses in combination with burst SCS waveforms or kilohertz frequency SCS from the at least one stimulation electrode or from a different stimulation electrode.

### Claim 17 (depends on 16)

The system of claim 16, wherein the stimulation therapy represents a series of pulse bursts separated by quiescent periods, and the tonic SCS pulses are delivered during the quiescent periods.

### Claim 18 (depends on 11)

The system of claim 11, wherein the IPG further senses sensory evoked compound action potential (ECAP) signals from the nervous tissue of interest, and analyzing the ECAP signals for ECAP activity data to identify first and second components, the first component indicative of ECAP activity of large diameter A-beta fibers, the second component indicative of ECAP activity of medium diameter A-beta fibers, the setting operation based on the first and second components of the activity data.

### Claim 19 (depends on 18)

The system of claim 18, wherein the IPG determines a parameter setting associated with the stimulation therapy that yields ECAP activity data for which the first and second components fit within a select profile.

### Claim 20 (depends on 11)

The system of claim 11, wherein the IPG sets the stimulation therapy to have an intensity I based on the following equation: I=THPF+k*(THU−RHPF), where k represents a constant, THPF represents a first intensity level corresponding to a paresthesia-abatement threshold and THU represents a second intensity level corresponding to an analgesic upper threshold.
