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US-20260124458-A1 - NEUROMODULATION PROGRAMMING USING STIMULATION FIELD SHAPES

US20260124458A1US 20260124458 A1US20260124458 A1US 20260124458A1US-20260124458-A1

Abstract

A system may include a neurostimulator including electrodes and a processing system, including a programming tool, configured to program the neurostimulator. The programming tool may be configured to receive both a selection of a location for a stimulation field and a selection of a shape from a plurality of shapes where the selected location and the selected shape are used to provide a stimulation field, determine a fractionalization, using the selected shape and the selected location, and program the neurostimulator with the fractionalization. The neurostimulator may be configured to stimulate at least one neural target according to the fractionalization.

Inventors

  • Lisa Denise Moore
  • Mahsa Malekmohammadi
  • Richard MUSTAKOS
  • G. Karl Steinke

Assignees

  • BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Dates

Publication Date
20260507
Application Date
20251105

Claims (20)

  1. 1 . A method, comprising: receiving, using a programming tool that is configured to program a neurostimulator, both a selection of a location for a stimulation field and a selection of a shape from a plurality of shapes, wherein the selected location and the selected shape are used to provide a stimulation field; determining a fractionalization, using the selected shape and the selected location; and stimulating at least one neural target according to the fractionalization.
  2. 2 . The method of claim 1 , wherein each of the plurality of shapes is associated with at least one location, and the selection of the location is based on the selection of the shape from the at least one location and is selected from the at least one location corresponding to the selected shape.
  3. 3 . The method of claim 1 , wherein the plurality of stimulation field shapes corresponds to a plurality of stimulation field models for the selection of the location for the stimulation field.
  4. 4 . The method of claim 3 , wherein determining the fractionalization includes identifying a stimulation field model that produces a stimulation field shape similar to the selection of the stimulation field shape.
  5. 5 . The method of claim 3 , wherein the neurostimulator includes a directional lead, and each of the plurality of stimulation field models is for the directional lead.
  6. 6 . The method of claim 3 , wherein the at least one neural target is stimulated according to a pulse width and a frequency, and the stimulation field models are based on the fractionalization and at least one of the pulse width and the frequency.
  7. 7 . The method of claim 6 , further comprising programming the neurostimulator with the fractionalization, an amplitude and the pulse width, and using the neurostimulator to stimulate the at least one neural target according to the fractionalization, the amplitude and the pulse width.
  8. 8 . The method of claim 5 , further comprising determining a size for the corresponding stimulation field shape for the selected stimulation field model, and determining an amplitude for the stimulating at least one neural target according to the fractionalization to provide the corresponding stimulation field shape with the determined size.
  9. 9 . The method of claim 3 , wherein at least one of the plurality of stimulation field models includes a first fractionalization that corresponds to a first solution for a first region and a second fractionalization that corresponds to a second solution for a second region.
  10. 10 . The method of claim 9 , wherein the programming tool is used to determine the first solution and the second solution, and at least one of the plurality of stimulation field models is based on the first fractionalization and the second fractionalization.
  11. 11 . The method of claim 9 , wherein the first fractionalization and the second fractionalization correspond to different orientations and different longitudinal distances from a tip of a directional lead.
  12. 12 . The method of claim 9 , wherein an amplitude according to which the at least one neural target is stimulated includes a first weighted amplitude contribution for the first fractionalization and a second weighted amplitude contribution for the second fractionalization.
  13. 13 . The method of claim 9 , wherein the at least one of the plurality of stimulation field models further includes a third fractionalization that corresponds to a third solution for a third region.
  14. 14 . The method of claim 1 , further comprising displaying the selected shape on a display that includes an image of a lead, using directional controls to change a position of the selected shape along a longitudinal direction of the lead and/or a rotational position about the lead, and using the programming tool to automatically change the fractionalization corresponding to the changed position of the selected shape.
  15. 15 . The method of claim 1 , further comprising displaying the selected shape on a display that includes an image of a lead, using directional controls to change a relative orientation of the selected shape with respect to the image of the lead, and using the programming tool to automatically change the fractionalization.
  16. 16 . The method of claim 1 , further comprising displaying the selected stimulation field on a display that includes an image of a lead and changing a size of the selected field using user interface controls, the programming tool being used to automatically change an amplitude according to the size of the selected field.
  17. 17 . The method of claim 1 , further comprising: receiving at least one neuromodulation target region; receiving at least one avoidance region; and using the programming tool to select the stimulation field or to determine the fractionalization based on the at least one neuromodulation target region and the at least one avoidance region.
  18. 18 . The method of claim 1 , further comprising using the programming tool to select the stimulation field or to determine an amplitude or the fractionalization based on: an anatomical structure; electrophysical data; or neuromodulation response information, wherein the neuromodulation response information includes at least one of a heat map indicative of a desired response and/or undesired response to neuromodulation sites, sensor feedback when neuromodulation is delivered at neuromodulation sites, or user feedback indicative of symptom relief and/or experienced side effects when the neuromodulation is delivered at the neuromodulation sites.
  19. 19 . A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method, comprising: receiving, using a programming tool that is configured to program a neurostimulator, both a selection of a location for a stimulation field and a selection of a shape from a plurality of shapes, wherein the selected location and the selected shape are used to provide a stimulation field; determining a fractionalization, using the selected shape and the selected location; and stimulating at least one neural target according to the fractionalization.
  20. 20 . A system, comprising: a neurostimulator including a plurality of electrodes; a processing system including a programming tool configured to program the neurostimulator, wherein the programming tool is configured to: receive both a selection of a location for a stimulation field and a selection of a shape to provide a selected shape for the stimulation field from a plurality of shapes; determine a fractionalization, using the selected shape and the selected location; and program the neurostimulator with the fractionalization, wherein the neurostimulator is configured to stimulate at least one neural target according to the fractionalization.

Description

CLAIM OF PRIORITY This application claims the benefit of U.S. Provisional Application No. 63/717,592, filed on Nov. 7, 2024, which is hereby incorporated by reference in its entirety. TECHNICAL FIELD This document relates generally to medical devices, and more particularly, to systems, devices and methods programming a neuromodulation system. BACKGROUND 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). Examples include wearable devices such as but not limited to, transcutaneous electrical neural stimulators (TENS), external or implantable stimulation devices such as but not limited to 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, and the like. A therapy device may be configured or programmed to treat a condition. Thus, by way of example and not limitation, a DBS system may be configured to treat motor disorders such as, but not limited to, tremor, bradykinesia, and dyskinesia associated with Parkinson's Disease (PD). In another nonlimiting example, a stimulation device, such as neurostimulation device (e.g., DBS, SCS, PNS or TENS), may be configured to treat pain. Settings of the therapy device, including stimulation parameters, may be programmed based on observed clinical effects so that the therapy provides desirable intended effects (e.g., reduced tremor, bradykinesia, and dyskinesia for a PD therapy, desirable pain relief or paresthesia coverage for a pain therapy) while avoiding undesirable side effects. Current clinical support tools use algorithms that target stimulation to a single region on each lead. Even though stimulation of different regions along the same lead could improve symptoms or counteract side effects, searching for a secondary target on the same lead may be difficult using those algorithms. It is desirable to provide improved systems for finding and creating combinations of programs for two or more distinct stimulation targets. It is desirable to provide improved systems to provide additional field shapes to stimulate stimulation target(s). SUMMARY An example (e.g., “Example 1”) of a system may include a neurostimulator including electrodes and a processing system, including a programming tool, configured to program the neurostimulator. The programming tool may be configured to receive both a selection of a location for a stimulation field and a selection of a shape from a plurality of shapes where the selected location and the selected shape are used to provide a stimulation field, determine a fractionalization, using the selected shape and the selected location, and program the neurostimulator with the fractionalization. The neurostimulator may be configured to stimulate at least one neural target according to the fractionalization. The shapes available for selection may include images of a selected virtual electrode shape or images of an approximation of the resulting stimulation field. In Example 2, the subject matter of Example 1 may optionally be configured such that each of the plurality of shapes is associated with at least one location where the corresponding shape is capable of being produced, and the selection of the location is based on the selection of the shape from the at least one location and is selected from the at least one location corresponding to the selected shape. In Example 3, the subject matter of any one or more of Examples 1-2 may optionally be configured such that the plurality of stimulation field shapes corresponds to a plurality of stimulation field models for the selection of the location for the stimulation field. In Example 4, the subject matter of Example 3 may optionally be configured such that the programming tool is configured to determine the fractionalization by identifying a stimulation field model that produces a stimulation field shape similar to the selection of the stimulation field shape. In Example 5, the subject matter of any one or more of Examples 3-4 may optionally be configured such that the neurostimulator includes a directional lead, and each of the plurality of stimulation field models is for the directional lead. In Example 6, the subject matter of any one or more of Examples 3-5 may optionally be configured such that the neurostimulator is configured to stimulate the at least one neural target according to a pulse width and a frequency, and the stimulation field models are based on the fractionalization and at least one of the pulse width and the frequency. In Example 7, the subject matter of Example 6 may optionally be configured such that the programming tool is further configured to program the neurostimulator with the fractiona