System and method to control a non-paresthesia stimulation based on sensory action potentials

Patent metadata

Field	Value
Publication number	US-2016129272-A1
Application number	US-201414539802-A
Country	US
Kind code	A1
Filing date	Nov 12, 2014
Priority date	Nov 12, 2014
Publication date	May 12, 2016
Grant date	—

Abstract

A system and method for controlling non-paresthesia stimulation of nervous tissue of a patient. The method delivers a non-paresthesia stimulation waveform, senses sensory action potential (SAP) signals from the nervous tissue of interest, and analyzes the SAP signals to obtain SAP activity data for at least one of an SAP C-fiber component or an SAP A-delta fiber component. The method determines whether the SAP activity data satisfies a criteria of interest and adjusts at least one of the therapy parameters to change the non-paresthesia stimulation waveform when the SAP activity data does not satisfy the criteria of interest.

First claim

What is claimed is:

1 . A method to control non-paresthesia stimulation of nervous tissue of a patient, the method comprising:
delivering a non-paresthesia stimulation waveform to at least one electrode located proximate to nervous tissue of interest, the non-paresthesia stimulation waveform including a series of pulses configured to excite at least one of A-delta fibers or C-fibers of the nervous tissue of interest, the non-paresthesia stimulation waveform defined by therapy parameters; sensing sensory action potential (SAP) signals from the nervous tissue of interest; analyzing the SAP signals to obtain SAP activity data for at least one of an SAP C-fiber component or an SAP A-delta fiber component; determining whether the SAP activity data satisfies a criteria of interest; and adjusting at least one of the therapy parameters to change the non-paresthesia stimulation waveform when the SAP activity data does not satisfy the criteria of interest.

2 . The method of claim 1 , wherein the therapy parameters define at least one of a burst stimulation waveform or a high frequency stimulation waveform.

3 . The method of claim 1 , wherein the determining operation includes determining whether a high frequency content of the SAP signal falls below a threshold or within an acceptable range, thereby indicating that no pain or an acceptable low level of pain is experienced by the patient.

4 . The method of claim 1 , wherein the determining operation includes analyzing a pain-activity data relation to identify a pain score, the pain-activity data relation corresponding to a relation between high frequency content of the SAP signals and pain scores indicative of a level of pain experienced by the patient.

5 . The method of claim 1 , further comprising iteratively repeating the delivering, sensing and adjusting operations to optimize the non-paresthesia stimulation waveform.

6 . The method of claim 1 , wherein the analyzing operation includes analyzing a feature of interest from a morphology of the SAP signal over time, counting a number of occurrences of the feature of interest that occur within the SAP signal over a predetermined duration, and generating the SAP activity data based on the number of occurrences of the feature of interest.

7 . A method to control non-paresthesia stimulation of nervous tissue of a patient, the method comprising:
providing a lead having at least one electrode on the lead configured to be implanted at a target position proximate to nervous tissue of interest; delivering a non-paresthesia stimulation waveform to the at least one electrode based on a therapy parameter set (TPS), the stimulation waveform including a series of pulses configured to excite at least one of A-delta fibers or C-fibers of the nervous tissue of interest; sensing sensory action potential (SAP) signals; iteratively repeating the delivering and sensing operations while changing at least one parameter from the TPS; analyzing the SAP signals to obtain SAP activity data associated with the TPS for at least one of an SAP C-fiber component or an SAP A-delta fiber component, the analyzing operations obtaining a collection of SAP activity data associated with multiple therapy parameter set.

8 . The method of claim 7 , further comprising selecting a candidate TPS from the multiple therapy parameter set, wherein the candidate TPS selected has corresponding SAP activity data that meets a criteria of interest.

9 . The method of claim 8 , wherein the selecting operation includes optimizing the candidate TPS to a stimulation configuration that affords a result of interest without inducing paresthesia.

10 . The method of claim 7 , wherein the analyzing operation identifies a high frequency content of at least one of the SAP C-fiber component or the A-delta fiber component within the SAP signals sensed.

11 . The method of claim 7 , further comprising applying a reference noxious input during an interval between successive burst waveforms, the reference noxious input creating the SAP signals sensed.

12 . The method of claim 7 , further comprising changing at least one of the parameters for the TPS during each iteration through the delivering, sensing and analyzing operation.

13 . The method of claim 7 , wherein the criteria of interest represents a number of peaks that occur in the SAP signal and the candidate TPS selected has a fewest number of peaks with respect to the multiple therapy parameter sets analyzed.

14 . The method of claim 7 , wherein the therapy parameters define at least one of a burst stimulation waveform or a high frequency stimulation waveform.

15 . A system to control non-paresthesia stimulation of nervous tissue of a patient, the system 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 stimulation waveform to the at least one electrode based on a therapy parameter set (TPS), the stimulation waveform including a series of pulses configured to excite at least one of a-Delta fibers or C-fibers of the nervous tissue; sense sensory action potential (SAP) signals; iteratively repeat the delivering and sensing operations while changing at least one parameter from the TPS; analyze the SAP signals to obtain SAP activity data associated with the TPS for at least one of an SAP C-fiber component or an SAP A-delta fiber component, the analyzing operations obtaining a collection of SAP activity data associated with multiple therapy parameter sets (TPSs).

16 . The system of claim 15 , wherein the processor is configured to select a candidate TPS from the multiple therapy parameter sets based on a criteria of interest related to the SAP activity data, and utilize the candidate TPS in connection with delivering non-paresthesia therapy.

17 . The system of claim 15 , further comprising memory configured to store a pain-SAP activity data relation defining a relation between high frequency content of the SAP signals and pain scores indicative of pain experienced by a patient.

18 . The system of claim 15 , wherein the at least one electrode includes a microelectrode configured to be located immediately adjacent C-fibers and configured to sense a C-fiber sensory action potential (SAP) directly at the microelectrode.

19 . The system of claim 15 , wherein the processor is configured to receive a pain score indicative of a level of pain experienced by the patient in connection with each of the therapy parameter sets, the processor configured to define a relation between the SAP activity data and the pain scores and save the relation in memory.

20 . The system of claim 15 , wherein the therapy parameters define at least one of a burst stimulation waveform or a high frequency stimulation waveform.

Assignees

• Pacesetter Inc

Inventors

• Hou Wenbo
• Goodman Keiser Melanie
• Min Xiaoyi
• Morley Bruce A

Classifications

• A61N1/36135

  using physiological parameters · CPC title

• A61N1/36071

  Pain · CPC title

• A61N1/37264

  Changing the program; Upgrading firmware · CPC title

• A61N1/37241 Primary

  providing test stimulations · CPC title

• A61N1/3606

  adapted for a particular treatment · CPC title