US-12622588-B2 - Systems and methods for SCS therapy optimization

US12622588B2US 12622588 B2US12622588 B2US 12622588B2US-12622588-B2

Abstract

A system may include a neuromodulator and a processing system. The neuromodulator may be configured to be programmed with a set of more than one program to deliver neuromodulation. The processing system may be configured to: receive sensed data indicative of activity, motion and/or posture of a patient; analyze the activity, motion and/or posture of the patient; and perform a process, based on the analyzed activity, motion and/or posture, for switching from one program in the set of more than one program to another program from the set of more than one program. The process may include automatically implementing the other program from the set of more than one program or suggesting to switch to the other program from the set of more than one program.

Inventors

Luca Antonello Annecchino
Matthew Lee McDonald
Que T. Doan
Changfang Zhu
Rosana Esteller

Assignees

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Dates

Publication Date: 20260512
Application Date: 20221116

Claims (20)

1 . A method performed using a neuromodulator programmed with a set of more than one program to deliver neuromodulation, the method comprising: implementing a program from the set of more than one program to deliver neuromodulation; receiving sensed data indicative of activity, motion and/or posture of a patient; analyzing the activity, motion and/or posture of a patient from the sensed data; and performing a process, based on the analyzed activity, motion and/or posture, for switching to another program from the set of more than one program, wherein performing the process includes automatically implementing the other program to deliver the neuromodulation or suggesting to switch to the other program, wherein: the set of more than one program includes a base program, and the method further comprises automatically generating a plurality of programs around the base program, the plurality of programs is configured to provide modulation field loci at determined distances from a modulation field locus of the base program, and the determined distances are determined using field evidence or determined stochastically through a mathematical deterministic or random process; the method further includes, for the base program and each of the plurality of programs that was automatically generated, executing a threshold mapping for different patient postures and/or different patient activities, the threshold mapping includes determining a perception threshold, a neural threshold or a baseline pain for the different patient postures and/or the different patient activities, and the process for switching to the other program to deliver the neuromodulation includes determining a patient posture and/or a patient activity and selecting the other program based on the threshold mapping.
2 . The method of claim 1 , further comprising using a watch or a phone to determine the activity, motion and/or posture.
3 . The method of claim 1 , wherein the process includes inferring activity and/or posture, the inferred activity and/or posture being indicative of predicted pain, and the process is performed to switch to the other program to alleviate the predicted pain.
4 . The method of claim 1 , wherein the neuromodulator is configured to deliver neuromodulation using electrodes on a lead, and the analyzing activity, motion and/or posture includes detecting activity, motion and/or posture using an accelerometer or gyroscope inside of a tip of the lead.
5 . The method of claim 1 , wherein the analyzing activity, motion and/or posture includes detecting activity, motion and/or posture using a strain or flex sensor in an implanted lead to detect lead curvature, wherein the implanted lead is implanted along a spine such that the lead curvature is indicative of spine curvature.
6 . The method of claim 5 , wherein the strain or flex sensor includes a fiber optic bending sensor.
7 . The method of claim 1 , wherein the analyzing activity, motion and/or posture includes analyzing at least one of posture, gait, sleep, impedances, evoked compound action potentials (ECAPs), heart rate, heart rate variability, respiration, respiration rate, respiration rate variability or oxygen level.
8 . The method of claim 1 , wherein the analyzing activity, motion and/or posture includes detecting when the patient is sleeping, and the performing the process includes switching to a sleep program when the patient is sleeping, wherein the sleep program is configured to be used to deliver neuromodulation during sleep.
9 . The method of claim 1 , wherein the analyzing activity, motion and/or posture includes analyzing impedances and/or ECAPs to determine that a change in variability in the impedances and/or ECAPs is indicative of activity, motion and/or posture by determining that the change is in excess of a variability threshold for longer than a duration tolerance.
10 . The method of claim 1 , wherein the executing the threshold mapping includes: receiving an assessment trigger; and responding to the assessment trigger by delivering the neuromodulation at an amplitude, and increasing the amplitude until a signal is received, the signal being indicative that the amplitude of the neuromodulation reached the threshold, providing calibration data by receiving user input indicative of coverage for the neuromodulation and pain relief, and mapping the analyzed activity, motion and/or posture to at least one of the programs based on the calibration data, wherein the performing the process includes selecting the other program based on the mapping of the analyzed activity, motion and/or posture to the at least one of the programs.
11 . The method of claim 10 , wherein: the executing the threshold mapping includes, before increasing the amplitude, interacting with a user via a user interface for the user to answer questions regarding specific activity, duration and level of pain; and the providing the calibration data includes data indicative of a specific activity, and a duration and level of pain.
12 . The method of claim 1 , wherein the analyzed activity, motion and/or posture corresponds to predicted pain, the method further comprising providing closed loop control to adjust the neuromodulation for the predicted pain.
13 . The method of claim 1 , further comprising providing a bolus of increased neuromodulation therapy based on the analyzed activity, motion and/or posture.
14 . The method of claim 13 , wherein the providing the bolus of increased neuromodulation therapy includes delivering a charge-balanced, active recharge waveform with an actively-driven recharge phase.
15 . The method of claim 1 , further comprising receiving at least one signal from at least one of a transponder or a GPS system indicative of a patient location, wherein the other program is selected based on whether the signal indicative of the patient location is received.
16 . A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method comprising: instructing a neuromodulator to implement a program from a set of more than one program to deliver neuromodulation, wherein the set of more than one program is programmed in the neuromodulator; receiving sensed data indicative of activity, motion and/or posture of a patient; analyzing the activity, motion and/or posture of a patient from the sensed data; and performing a process, based on the analyzed activity, motion and/or posture, for switching to another program from the set of more than one program, wherein performing the process includes automatically implementing the other program to deliver the neuromodulation from the set of more than one program or suggesting to switch to the other program to deliver the neuromodulation, wherein: the set of more than one program includes a base program, and the method further comprises automatically generating a plurality of programs around the base program, the plurality of programs is configured to provide modulation field loci at determined distances from a modulation field locus of the base program, and the determined distances are determined using field evidence or determined stochastically through a mathematical deterministic or random process; the method further includes, for the base program and each of the plurality of programs that was automatically generated, executing a threshold mapping for different patient postures and/or different patient activities, the threshold mapping includes determining a perception threshold, a neural threshold or a baseline pain for the different patient postures and/or the different patient activities, and the process for switching to the other program to deliver the neuromodulation includes determining a patient posture and/or a patient activity and selecting the other program based on the threshold mapping.
17 . The non-transitory machine-readable medium of claim 16 , wherein the neuromodulator is configured to deliver neuromodulation using electrodes on a lead, and the analyzing activity, motion and/or posture includes detecting activity, motion and/or posture using an accelerometer or gyroscope inside of a tip of the lead.
18 . The non-transitory machine-readable medium of claim 16 , wherein the analyzing activity, motion and/or posture includes detecting activity, motion and/or posture using a strain or flex sensor in an implanted lead to detect lead curvature, wherein the implanted lead is implanted along a spine such that the lead curvature is indicative of spine curvature.
19 . The non-transitory machine-readable medium of claim 16 , wherein the analyzing activity, motion and/or posture includes analyzing at least one of posture, gait, sleep, impedances, evoked compound action potentials (ECAPs), heart rate, heart rate variability, respiration, respiration rate, respiration rate variability or oxygen level.
20 . The non-transitory machine-readable medium of claim 16 , wherein the analyzing activity, motion and/or posture includes detecting when the patient is sleeping, and the performing the process includes switching to a sleep program when the patient is sleeping, wherein the sleep program is configured to be used to deliver neuromodulation during sleep.

Description

CLAIM OF PRIORITY This application claims the benefit of U.S. Provisional Application No. 63/280,215, filed on Nov. 17, 2021, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD This document relates generally to medical systems, and more particularly, but not by way of limitation, to systems, devices, and methods for determining or optimizing Spinal Cord Stimulation (SCS) therapy. BACKGROUND Neuromodulation, also referred to as neurostimulation, has been proposed as a therapy for a number of conditions. Examples include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES). Implantable neuromodulation systems have been applied to deliver SCS therapy. An implantable neuromodulation system may include an implantable neuromodulator, which may also referred to as an implantable pulse generator (IPG), and one or more implantable leads each including one or more electrodes. The implantable neuromodulator delivers neuromodulation energy through one or more electrodes placed on or near a target site in the nervous system. An external programming device is commonly used to program the implantable neurostimulator with stimulation parameters controlling the delivery of the neurostimulation energy. Modulation parameters may comprise electrode combinations, which define the electrodes that are activated as anodes (positive), cathodes (negative), and turned off (zero), percentage of modulation energy assigned to each electrode (fractionalized electrode configurations), and electrical pulse parameters, which define the pulse amplitude (measured in milliamps or volts depending on whether the pulse generator supplies constant current or constant voltage to the electrode array), pulse width (measured in microseconds), pulse rate (measured in pulses per second), and burst rate (measured as the modulation on duration X and modulation off duration Y). The values for these parameters may be customized to a patient. The modulation parameters may be configured as a neuromodulation program capable of being implemented by the neuromodulator, and the neurostimulator may be programmed with more than one program. In order to find a program that provides an effectively provides a therapy (e.g., pain relief) with negligible side effects, the patient or clinician may implement different programs within the neuromodulator. However, further optimization of the SCS therapy for the patient is desirable. SUMMARY An example (e.g., “Example 1”) of a system may include a neuromodulator and a processing system. The neuromodulator may be configured to be programmed with a set of more than one program to deliver neuromodulation. The processing system may be configured to: receive sensed data indicative of activity, motion and/or posture of a patient; analyze the activity, motion and/or posture of the patient; and perform a process, based on the analyzed activity, motion and/or posture, for switching from one program in the set of more than one program to another program from the set of more than one program. The process may include automatically implementing the other program from the set of more than one program or suggesting to switch to the other program from the set of more than one program. In Example 2, the subject matter of Example 1 may optionally be configured such that the system includes at least one of a wearable device, a mobile electronic device, or a remote control, and the processing system includes at least one processor in at least one of the wearable device, the mobile electronic device or the remote control. By way of example and not limitation, a wearable device may include a watch, and a mobile electronic device may include a phone, a tablet or pad. The processing system may be located in a single device or distributed over more than one device such that some processing is performed in different local devices. In Example 3, the subject matter of any one or more of Examples 1-2 may optionally be configured to include a watch or a phone configured to determine the activity, motion and/or posture of the patient. In Example 4, the subject matter of any one or more of Examples 1-3 may optionally be configured such that the neuromodulator is configured to deliver neuromodulation using one or more electrodes on a lead, the system further comprising an accelerometer or gyroscope inside of a tip or a body of the lead, wherein the accelerometer or gyroscope is configured for use to provide at least some of the sensed data indicative of the activity, motion and/or posture of the patient. In Example 5, the subject matter of any one or more of Examples 1-4 may optionally be configured to include a strain or flex sensor in an implanted lead, where the strain or flex sensor is configured to detect lead curvature, wherein the implanted lead is implanted along a spine such that the lead curvature is indicative of spine curvature, and t