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EP-4735105-A2 - METHODS AND SYSTEMS FOR CONTROL AND MODIFICATION OF STIMULATION

EP4735105A2EP 4735105 A2EP4735105 A2EP 4735105A2EP-4735105-A2

Inventors

  • MOORE, Lisa, Denise
  • YOO, Peter, J.

Assignees

  • Boston Scientific Neuromodulation Corporation

Dates

Publication Date
20260506
Application Date
20240807

Claims (15)

  1. 1. A method for operation of a stimulation system, the method comprising: receiving a request to modify stimulation; displaying a graph for at least one adjustable stimulation parameter; indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting of at least one of the at least one adjustable stimulation parameter which represents at least one of a minor change in the stimulation based on a predefined minor change criteria or a moderate change in the stimulation based on a predefined moderate change criteria; receiving a selection of a new setting for at least one of the at least one adjustable stimulation parameter; and modifying the stimulation according to the selection.
  2. 2. The method of claim 1, wherein the indicating comprises indicating on the graph both the range representing the minor change and the range representing the moderate change.
  3. 3. The method of any one of claims 1 or 2, wherein the indicating comprises indicating on the graph at least one previous setting for at least one of the at least one adjustable stimulation parameter.
  4. 4. The method of claim 3. wherein, for at least one of the at least one previous setting, the indication signifies an assessment of the stimulation provided by the previous setting.
  5. 5. The method of any one of claims 3 or 4, wherein the indicating further comprises indicating on the graph an estimated disliked range based on a one of the at least one previous setting that has been assessed as providing disliked stimulation.
  6. 6. The method of any one of claims 3 to 5, further comprising displaying a medication state for either the current setting or at least one of the at least one previous setting.
  7. 7. The method of any one of claims 1 to 6, further comprising querying whether the modified stimulation is acceptable after providing the modified stimulation for a predefined period of time and continuing the modified stimulation when a response to the query indicates that the modified stimulation is acceptable.
  8. 8. The method of claim 7, further comprising either i) halting the modified stimulation when the response to the query indicates that the modified stimulation is not acceptable or ii) returning to the previous stimulation when the response to the query indicates that the modified stimulation is not acceptable.
  9. 9. A method for operation of a stimulation system, the method comprising: receiving, from a patient or a non-clinician caregiver, at least one priority' for stimulation of the patient, wherein at least one of the at least one priority is selected from an improvement in a symptom or a set of symptoms, a reduction in a side effect or a set of side effects, an improvement in a therapeutic effect or a set of therapeutic effects, avoidance of a side effect or a set of side effects, a reduction in battery use, or any combination thereof; identifying and providing at least one program based on the at least one priority; receiving a selection of a one of the at least one stimulation program; and stimulating the patient using the selected one of the at least one stimulation program.
  10. 10. The method of claim 9, wherein the receiving comprises ranking a plurality of the priorities.
  11. 11. The method of any one of claims 9 or 10, wherein the identifying and providing comprises identifying and providing the at least one stimulation program based on the ranking of the plurality of priorities.
  12. 12. The method of any one of claims 9 to 11, further comprising querying whether the selected one of the at least one stimulation program is acceptable after providing the selected one of the at least one stimulation program for a predefined period of time and continuing the selected one of the at least one stimulation program when a response to the query indicates that the selected one of the at least one stimulation program is acceptable; and optionally, when the response to the query indicates that the selected one of the at least one stimulation program is not acceptable, either halting the selected one of the at least one stimulation program or returning to a previous stimulation program.
  13. 13. A method for operation of a stimulation management system, the method comprising: obtaining, from at least one sensor, data for the patient regarding at least one symptom, at least one therapeutic effect, at least one side effect, or any combination thereof; connecting the at least one sensor to a processing device, wherein the connecting optionally comprises attaching, or coupling with a cable, at least one of the at least one sensor to the processing device; delivering the data to the processing device; processing the data to determine at least one score based on the data; determining an adjustment to stimulation of the patient based on the at least one score; and stimulating the patient according to the adjustment.
  14. 14. The method of claim 13, further comprising displaying the at least one score for the patient or a non-clinician caregiver or providing a stimulation report.
  15. 15. The method of any one of claims 13 or 14, further comprising querying whether the adjustment to the stimulation is acceptable after providing the adjustment for a predefined period of time and continuing the adjustment when a response to the query indicates that the adjustment is acceptable; and optionally, when the response to the query indicates that the adjustment is not acceptable, halting the stimulation or returning to a previous stimulation.

Description

METHODS AND SYSTEMS FOR CONTROL AND MODIFICATION OF STIMULATION CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Serial No. 63/532,296, filed August 11, 2023, which is incorporated herein by reference. FIELD The present disclosure is directed to the area of therapeutic stimulation systems and methods of making and using the systems. The present disclosure is also directed to methods and systems for control and modification of therapeutic stimulation including control and modification by a patient or non-clinician caregiver. BACKGROUND Implantable electrical and optical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Deep brain stimulation can be used to treat a variety of diseases and disorders. Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator) and one or more stimulator electrodes or optical emitter. The one or more stimulator electrodes or optical emitters can be disposed along one or more leads, or along the control module, or both. In electrical stimulation systems, stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. BRIEF SUMMARY One aspect is a method for operation of a stimulation system. The method includes receiving a request to modify stimulation; displaying a graph for at least one adjustable stimulation parameter; indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting of at least one of the at least one adjustable stimulation parameter which represents at least one of a minor change in the stimulation based on a predefined minor change criteria or a moderate change in the stimulation based on a predefined moderate change criteria; receiving a selection of a new setting for at least one of the at least one adjustable stimulation parameter; and modifying the stimulation according to the selection. Another aspect is a stimulation system having an implantable control module and a programmer for programming the implantable control module, the programmer including a memory having instructions stored thereon and a processor coupled to the memory and configured to execute the instructions to perform actions. The actions include receiving a request to modify stimulation; displaying a graph for at least one adjustable stimulation parameter; indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting of at least one of the at least one adjustable stimulation parameter which represents at least one of a minor change in the stimulation based on a predefined minor change criteria or a moderate change in the stimulation based on a predefined moderate change criteria; receiving a selection of a new setting for at least one of the at least one adjustable stimulation parameter; and modifying the stimulation according to the selection. A further aspect is a non-transitory computer readable memory having instructions stored thereon for operation of a stimulation system, wherein the instructions, when executed by a processor, perform actions. The actions include receiving a request to modify stimulation; displaying a graph for at least one adjustable stimulation parameter; indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting of at least one of the at least one adjustable stimulation parameter which represents at least one of a minor change in the stimulation based on a predefined minor change criteria or a moderate change in the stimulation based on a predefined moderate change criteria; receiving a selection of a new setting for at least one of the at least one adjustable stimulation the stimulation according to the selection. In at least some embodiments, the indicating includes indicating on the graph both the range representing the minor change and the range representing the moderate change. In at least some embodiments, the indicating includes indicating on the graph at least one previous setting for at least one of the at least one adjustable stimulation parameter. In at least some embodiments, for at least one of the at least one previous setting, the indication signifies an assessment of the stimulation provided by the previous seting. In at least some embodiments, the indicating fur