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EP-4735100-A1 - NEUROMODULATION THERAPY BASED ON SELECTIVE EVOKED RESPONSES

EP4735100A1EP 4735100 A1EP4735100 A1EP 4735100A1EP-4735100-A1

Abstract

Systems and methods for selective sensing of evoked responses (ERs) and using the ERs to guide neuromodulation are disclosed. -An exemplary system comprises at least one multi -electrode lead, an electrostimulator to provide electrostimulation to a. neural target, a. sensing circuit to sense ERs to electrostimulation, and a controller circuit. In response to electrostimulation delivered to the neural target in accordance with a stimulation setting via a. stimulating electrode, the controller circuit can collect ERs from each of a group of sensing electrodes selected from and less than an entirety of the electrodes on the lead. The selected electrodes can be distinct from the stimulating electrode, or within a specific proximity to the stimulating electrode. The controller circuit can use a comparison of the sensed ERs to acceptance criterion to aid in lead placement and stimulation programming.

Inventors

  • STEINKE, G. KARL
  • FRACZEK, Tomasz Mark

Assignees

  • Boston Scientific Neuromodulation Corporation

Dates

Publication Date
20260506
Application Date
20240725

Claims (15)

  1. What is claimed is: 1. A medical-device system, comprising: at least one lead including a plurality of electrodes; an electrostimulator configured to provide electrostimulation to a neural target of a patient; a sensing circuit configured to sense an evoked response (ER) to the electrostimulation; and a controller circuit operably connected to the electrostimulator and the sensing circuit, the controller circuit configured to: deliver the electrostimulation to the neural target in accordance with a stimulation setting via a stimulating electrode selected from the plurality of electrodes on the at least one lead; collect sensed ERs to the electrostimulation from each of a group of sensing electrodes selected from, and less than an entirety of, the plurality of electrodes on the at least one lead, the group of selected sensing electrodes located within a specific proximity to the selected stimulating electrode; compare the ERs sensed from the group of selected sensing electrodes to an acceptance criterion to produce a comparison result; and display the ERs and the comparison result on a user interface.
  2. 2. The medical-device system of claim 1, wherein the selected group of sensing electrodes include two or more electrodes immediate adjacent to the stimulating electrode on the at least one lead.
  3. 3. The medical-device system of any of claims 1-2, wherein the controller circuit is further configured to, based at least in part on the comparison result, provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting to cause the sensed ERs from the group of selected sensing electrodes to compare more favorably to the acceptance criterion.
  4. 4. The medical-device system of any of claims 1-3, wherein the at least one lead includes a deep brain stimulation (DBS) lead, and wherein the electrostimulator is configured to provide DBS to a brain target of the patient.
  5. 5. The medical-device system of any of claims 1-4, wherein the plurality of electrodes include one or more ring electrodes disposed at respective longitudinal positions along a length of the at least one lead, or one or more rows of segmented electrodes where each row comprises segmented electrodes disposed about a circumference of the at least one lead at a specific longitudinal position, wherein the stimulating electrode and the group of selected sensing electrodes are each selected from the one or more ring electrodes or the one or more rows of segmented electrodes.
  6. 6. The medical-device system of any of claims 1-5, wherein the controller circuit is configured to: during each of multiple stimulation sessions, deliver electrostimulation in accordance with respective stimulation settings via respective stimulating electrodes, and collect sensed ERs to the electrostimulation from respective groups of selected sensing electrodes; accumulate the sensed ERs collected from the multiple stimulation sessions; and compare the accumulated ERs to the acceptance criterion to produce the comparison result.
  7. 7. The medical-device system of any of claims 1-6, wherein the acceptance criterion includes acceptance bounds for the ERs sensed from the group of selected sensing electrodes.
  8. 8. The medical-device system of any of claims 1-7, wherein the acceptance criterion includes a target ER template representing a patient-specific ER or a population-based ER to electrostimulation of the neural target.
  9. 9. The medical-device system of claim 8, wherein the target ER template includes a target distribution of ERs across the group of selected sensing electrodes, wherein the controller circuit is configured to: determine a spatial distribution of the sensed ERs across the group of selected sensing electrodes; and provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined spatial distribution of the sensed ERs and the target distribution.
  10. 10. The medical-device system of claim 8, wherein the target ER template includes a target ER feature, wherein the controller circuit is configured to: determine an ER feature from the ERs sensed from the group of selected sensing electrodes; and provide a recommendation on the user interface to reposition the at least one lead or to adjust the stimulation setting based at least in part on a comparison of the determined ER feature to the target ER feature.
  11. 11. The medical-device system of any of claims 1-10, wherein the controller circuit is further configured to filter the ERs sensed from the group of selected sensing electrodes to remove or substantially attenuate an artifact component from each of the ERs, and to compare the filtered ERs to the acceptance criterion to produce the comparison result.
  12. 12. The medical-device system of claim 11, wherein to filter the ERs sensed from the group of selected sensing electrodes, the controller circuit is configured to, for each of the ERs: generate a parametric model to fit the artifact component in the each of the ERs in accordance with a fitting criterion; and subtract the parametric model fitted artifact component from the each of the ERs.
  13. 13. The medical-device system of claim 12, wherein the parametric model is a polynomial-exponential decay model.
  14. 14. The medical-device system of claim 11, wherein to filter the ERs sensed from the group of selected sensing electrodes, the controller circuit is configured to, for each of the ERs: generate a time-reversed signal for each of the ERs; generate a parametric model to fit the artifact component in the time- reversed signal in accordance with a fitting criterion; and subtract the parametric model fitted artifact component from the time- reversed signal.
  15. 15. The medical-device system of any of claims 1-14, wherein the controller circuit is configured to intermittently pause delivery of the electrostimulation, and to collect the ERs sensed from the group of selected sensing electrodes during the intermittent pause.

Description

NEUROMODULATION THERAPY BASED ON SELECTIVE EVOKED RESPONSES CLAIM OF PRIORITY [0001] This application claims the benefit of U.S. Provisional Application No. 63/529,950 filed on July 31, 2023, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD [0002] This document relates generally to medical systems, and more particularly, but not by way of limitation, to systems, devices, and methods for selective sensing of evoked response and using the same to guide neurostimulation therapy. BACKGROUND [0003] Medical devices may include therapy-delivery devices configured to deliver a therapy to a patient and/or monitors configured to monitor a patient condition via user input and/or sensor(s). For example, therapy-delivery devices for ambulatory patients may include wearable devices and implantable devices, and further may include, but are not limited to, stimulators (such as electrical, thermal, or mechanical stimulators) and drug delivery devices (such as an insulin pump). An example of a wearable device includes, but is not limited to, transcutaneous electrical neural stimulators (TENS), such as may be attached to glasses, an article of clothing, or a patch configured to be adhered to skin. Implantable stimulation devices may deliver electrical stimuli to treat various biological disorders, such as pacemakers to treat cardiac arrhythmia, defibrillators to treat cardiac fibrillation, heart failure cardiac resynchronization therapy devices, cochlear stimulators to treat deafness, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movement, spinal cord stimulators (SCS) to treat chronic pain, cortical and Deep Brain Stimulators (DBS) to treat motor and psychological disorders, Peripheral Nerve Stimulation (PNS), Functional Electrical Stimulation (FES), and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, etc. A neurostimulation device (e.g., DBS, SCS, PNS or TENS) may be configured to treat pain. By way of example and not limitation, a DBS system may be configured to treat tremor, bradykinesia, and dyskinesia and other motor disorders associated with Parkinson’s Disease (PD). [0004] It has been proposed to use evoked potentials (also referred to as evoked responses or ERs) to guide neurostimulation therapy. For example, Evoked Resonant Neural Activity (ERNA) has been proposed as a feedback signal for subthalamic nucleus (STN) DBS therapy for Parkinson’s disease. ERNA may also be referred to by other names such as DBS Local Evoked Potentials (DLEP), Evoked oscillatory neural responses (EONR), and other terms. Evoked potentials, including ERNA, may be present in other indications and anatomical structures or locations. [0005] It is desired to improve lead placement and/or programming a neurostimulator based on ERs such as ERNA while reducing the time and effort required for identifying the lead position and/or the programming setting that would produce the desired or target response. SUMMARY [0006] The present inventors have recognized that the desired evoked response target varies. For example, the ERNA target for STN DBS may vary among patients. The present inventors recognize that the ERNA target, or other evoked response target, may vary based on anatomical target and trajectory of the lead placement and can vary with other factors such as the evoking and recording settings, the surgery center, the surgeon, the surgical or programming techniques, preferences, and errors. To accommodate the variations in desired evoked response targets, multiple stimulation-ER tests may be performed, and a large volume of ER recordings may be collected from multiple locations via respective sensing electrodes (also referred to as recording electrodes). The ERs may be analyzed to determine if the measured ERs match a desired or target ER response. Such decision may be used to guide lead placement, such as pushing, pulling, shifting, or rotating the lead to modify lead trajectory or lead depth, thereby facilitating identification of a desired stimulation location that maximally reduces symptoms while inducing minimal side effect. Such stimulation effect can be represented by a desired target evoked response. However, lead placement and/or programming optimization can be time consuming and take a lot of system resources. Embodiments of the present subject matter provide systems, device and methods that implement sensing ERs from a selected group of electrodes to improve the efficiency without compromising the accuracy of identifying ERs that match the desired or target response for different desired evoked response targets. The selected sensing electrodes can be distinct from the stimulating electrode(s) delivering the electrostimulation energy, or within a specific proximity to the stimulating electrode. A model-based artifact characterization and removal technique can improve the quality of ERs sensed from the selected group of elec