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CN-121985979-A - Multi-site deep brain stimulation inducing response guidance

CN121985979ACN 121985979 ACN121985979 ACN 121985979ACN-121985979-A

Abstract

Systems and methods for providing evoked response directed multi-site deep brain stimulation (DSB) at various brain targets are disclosed. An exemplary system includes at least one multi-electrode lead, an electrical stimulator that provides electrical stimulation to a neural target, a sensing circuit that senses an Evoked Response (ER) to the electrical stimulation, and a controller circuit. In response to electrical stimulation of the first neural target in accordance with the first stimulation setting, the controller circuit collects ER from the first sensing location and determines or adjusts a second stimulation setting for stimulating the second neural target based on the sensed ER at the first neural target. The second neural target can be stimulated according to the second stimulation setting to modulate ER for electrical stimulation at the first neural target and produce a desired therapeutic result in the patient.

Inventors

  • G Carle.

Assignees

  • 波士顿科学神经调制公司

Dates

Publication Date
20260505
Application Date
20240925
Priority Date
20231013

Claims (15)

  1. 1. A neuromodulation system, comprising: At least one lead including a plurality of electrodes; an electrostimulator configured to provide electrostimulation to a neural target of a patient via one or more of the plurality of electrodes of the at least one lead; A sensing circuit configured to sense an Evoked Response (ER) to the electrical stimulus, and A controller circuit operatively connected to the electrical stimulator and the sensing circuit, the controller circuit configured to: In response to delivering the electrical stimulus to a first neural target in accordance with a first stimulus setting, collecting ER sensed via the sensing circuit from a first sensing electrode positioned at a first sensing location; Determining or adjusting a second stimulation setting for stimulating a second neural target of the patient different from the first neural target based at least in part on the sensed ER of the electrical stimulation at the first neural target; generating control signals to the electrostimulator to provide electrostimulation at the second neural target in accordance with the second stimulation setting to modulate the sensed ER of the electrostimulation at the first neural target and produce a desired therapeutic result in the patient, and ER sensed via the sensing circuit from a second sensing electrode positioned at a second sensing location is collected for electrical stimulation at the second neural target.
  2. 2. The neuromodulation system of claim 1, wherein the controller circuitry is configured for controlling the electrical stimulator to deliver the respective electrical stimulation to the first and second neural targets substantially simultaneously in accordance with the respective first and second stimulation settings.
  3. 3. The neuromodulation system of any of claims 1-2, wherein the controller circuitry is configured for controlling the electrical stimulator to sequentially deliver the respective electrical stimulation to the first and second neural targets at a particular time offset in accordance with the respective first and second stimulation settings.
  4. 4. The neuromodulation system of any of claims 1-3, wherein the electrically stimulated first and second neural targets are different brain targets in a particular hemisphere of the brain.
  5. 5. The neuromodulation system of claim 4, wherein the first neural target of the electrical stimulation is a subthalamic nucleus (STN) target, and the second neural target of the electrical stimulation is a globus pallidus nucleus (GPi) target.
  6. 6. The neuromodulation system of claim 5, wherein: the first sensing electrode is positioned at a GPi sensing location to sense the ER for electrical stimulation of an STN target, and The second sensing electrode is positioned at an STN sensing location to sense the ER for electrical stimulation of a GPi target.
  7. 7. The neuromodulation system of any of claims 1-6, further comprising an external electrical stimulator operably coupled to the one or more cortical electrodes or the one or more stereotactic electrodes to provide cortical stimulation to modulate one or more of the sensed ER of the electrical stimulation at the first neural target or the sensed ER of the electrical stimulation at the second neural target and produce a desired therapeutic result within the patient.
  8. 8. The neuromodulation system of any of claims 1-7, wherein the electrical stimulator is electrically coupled to a multi-electrode lead, the electrical stimulator configured for providing electrical stimulation to the first neural target via a first electrode on the multi-electrode lead, and providing electrical stimulation to the second neural target via a second electrode on the same multi-electrode lead.
  9. 9. The neuromodulation system of any of claims 1-8, wherein the at least one lead comprises different first and second leads, each lead comprising one or more electrodes, Wherein the electrostimulator is configured to provide electrostimulation to the first neural target via a first electrode on the first lead and to provide electrostimulation to the second neural target via a second electrode on the second lead.
  10. 10. The neuromodulation system of any of claims 1 to 9, wherein at least one of the first or second sensing electrode is selected from the plurality of electrodes of the at least one lead.
  11. 11. The neuromodulation system of any of claims 1-10, wherein at least one of the sensed ER of the electrical stimulation at the first neural target or the sensed ER of the electrical stimulation at the second neural target comprises a cortical electroencephalogram (ECoG) or a stereotactic electroencephalogram (sEEG) sensed via one or more cortical electrodes or one or more stereotactic electrodes.
  12. 12. The neuromodulation system of any of claims 1-11, wherein the controller circuitry is configured for determining or adjusting the second stimulation setting such that the ER for the electrical stimulation at the first neural target is reduced in accordance with the electrical stimulation of the second stimulation setting at the second neural target.
  13. 13. The neuromodulation system of any of claims 1-12, wherein the controller circuitry is configured for determining or adjusting the second stimulation setting such that the ER for the electrical stimulation at the first neural target is enhanced in accordance with the electrical stimulation of the second stimulation setting at the second neural target.
  14. 14. The neuromodulation system of any of claims 1-13, wherein to determine or adjust the second stimulation setting based at least in part on the sensed ER of the electrical stimulation at the first neural target, the controller circuit is configured to: Assessing a therapeutic outcome using the sensed ER of the electrical stimulus at the first neural target, and Based on the evaluation of the treatment results, the second stimulation settings are determined or adjusted, including one or more stimulation parameters for electrical stimulation or one or more electrodes selected from a plurality of electrodes of the at least one lead.
  15. 15. The neuromodulation system of claim 14, wherein the treatment outcome is to be evaluated including comparing the spatial distribution of the sensed ER of the electrical stimulus at the first neural target with an expected ER spatial distribution, Wherein the controller circuit is configured to determine or adjust the second stimulation setting to reduce a difference between a spatial distribution of the sensed ER and a desired spatial distribution of ER for the electrical stimulation at the second neural target.

Description

Multi-site deep brain stimulation inducing response guidance Cross Reference to Related Applications The present application claims the benefit of U.S. provisional application No. 63/590,277, filed on day 13, 10, 2023, which is incorporated herein by reference in its entirety. Technical Field This document relates generally to medical systems and, more particularly, but not exclusively, to multi-site deep brain stimulation (deep brain stimulation, DBS) systems and methods based on evoked responses (evoked response). Background The medical device may include a therapy delivery device capable of delivering therapy to the patient and/or a monitor configured to monitor a condition of the patient via user input and/or sensors. For example, therapy delivery devices for moving patients may include wearable devices and implantable devices, and may also include, but are not limited to, stimulators (such as electrical, thermal, or mechanical stimulators) and drug delivery devices (such as insulin pumps). Examples of wearable devices include, but are not limited to, transcutaneous electrical nerve stimulators (transcutaneous electrical neural stimulator, TENS), such as may be attached to eyeglasses, a piece of clothing, or a patch configured to adhere to skin. Implantable stimulation devices may deliver electrical stimulation to treat various biological disorders, such as pacemakers to treat cardiac arrhythmias, defibrillators to treat cardiac fibrillation, heart failure cardiac resynchronization therapy devices, cochlear stimulators to treat hearing loss, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movements, spinal cord stimulators (spinal cord stimulator, SCS) to treat chronic pain, cerebral cortex and Deep Brain Stimulators (DBS) to treat motor and psychological disorders, peripheral nerve stimulation (PERIPHERAL NERVE Stimulation, PNS), functional electrical stimulation (Functional Electrical Stimulation, FES), and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, and the like. The nerve stimulation device (e.g., DBS, SCS, PNS or TENS) may be configured to treat pain. By way of example and not limitation, DBS systems may be configured to treat tremors, bradykinesia, and dyskinesias, as well as other dyskinesias associated with Parkinson's Disease (PD). Evoked potentials (also known as evoked responses or ER) have been proposed for use in guiding neurostimulation therapy. For example, evoked resonant neural activity (Evoked Resonant Neural Activity, ERNA) has been proposed as a feedback signal for controlling DBS delivery. ERNA may also be referred to by other names such as DBS local evoked potentials (DBS Local Evoked Potential, DLEP), evoked oscillatory neural responses (Evoked oscillatory neural responses, EONR), and other terms. Evoked potentials including ERNA may be present in other indications and anatomical structures or locations. DBS may improve motor symptoms in some patients with advanced Parkinson's Disease (PD) and other motor and non-motor disorders. Stimulation leads/electrodes for PD treatment are typically implanted in subthalamic nuclei (subthalamic nucleus, STN) or pallidum nuclei (globus pallidus internus, GPi), although other neural targets, such as pontic nuclei (pedunculopontine nucleus, PPN) and subthalamic areas (posterior subthalamic area, PSA), have been shown to be effective targets for parkinsonian tremor control and other parkinsonian-like control in patients. However, the best target for DBS to manage PD as well as other motor and non-motor disorders may vary from patient to patient and there is no optimal "universal" DBS target. There is a need for a DBS system that can provide universal and flexible stimulation at multiple neural targets to meet the needs of patients in different conditions. Disclosure of Invention Disclosed herein are systems and methods of multi-site neuromodulation, particularly DBS for multiple brain targets (such as STN and GPi). Multi-site DBS can recruit neural pathways associated with multiple neural targets, achieve a wider stimulation field than a single local target, and maximize therapeutic effects and/or minimize side effects. According to various embodiments, different neural targets may be stimulated substantially simultaneously (within a particular time delay), sequentially with a time offset, or according to a predetermined stimulation pattern. In response to electrical stimulation of the neural target, evoked Response (ER) can be sensed locally, at a location remote from the stimulation site, or both, and used to feedback control the DBS or determine a best solution DBS setting. In one embodiment, ER (hereinafter "ER 1") to stimulus at a first neural target can be used to determine or adjust the stimulus settings at a different second neural target. The electrical stimulation at the second neural target can modulate ER 1 and produce a "compound" ER, which can be a