IP Library Granted Patent US 12,485,273
Granted Patent B2
US 12,485,273 · App. 16/460,640 · Granted Dec 2, 2025

Modelling relationships between stimulation parameters and use thereof for automatic customization of sub-perception therapy in a spinal cord stimulation system

Inventors: Ismael Huertas Fernandez (Madrid, ES); Que T. Doan (West Hills, CA)
Assignee: Boston Scientific Neuromodulation Corporation
A61N1/025A61N1/36135A61N1/36171A61N1/36175A61N1/37247A61N1/0551
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Quick Facts
Patent No.
US 12,485,273
App. No.
16/460,640
Granted
Dec 2, 2025
Kind
B2
Abstract

An algorithm for determining optimal sub-perception stimulation parameters for a Spinal Cord Stimulation patient is disclosed. The algorithm uses various modelling information, including a model determined based on empirical testing that relates optimal frequencies and pulse widths with perception thresholds reported by patients at those frequencies and pulse widths. A patient's perception threshold is then measured at different pulse widths, with the result compared to the model to determine a range or volume in the model that best relates frequency pulse width and perception threshold for that patient. Further modeling allows the perception thresholds to be related to an optimal amplitudes, thus resulting in optimal situation parameters (F, PW, and A) for the patient. The optimal stimulation parameters may be provided to a patient's external controller to allow the patient to adjust stimulation within a range of volume of these parameters.

Claims (28)

1 . A method for programming a stimulator device using an external device, the method comprising:

receiving a model at the external device, wherein the model comprises an equation and indicative of a plurality of coordinates, wherein each coordinate comprises a frequency, a pulse width, and an amplitude, wherein the model is specific to a patient having the stimulator device;

providing from the external device a program for the stimulator device, the program specifying an amplitude, a pulse width, and a frequency of stimulation pulses to be provided at one or more of electrodes of the stimulator device, wherein the specified amplitude, pulse width, and frequency of the stimulation pulses comprise one of the coordinates in the model; and

providing on the external device a Graphical User Interface (GUI) comprising a user interface element with a cursor,

allowing a user to move the cursor in the GUI to simultaneously adjust the frequency, the pulse width, and the amplitude of the stimulation pulses in accordance with the equation such that the amplitude, pulse width, and frequency of the stimulation pulses comprise another of the coordinates in the model.

2 . The method of claim 1 , wherein the frequency and the at least one of the pulse width and the amplitude are not adjusted proportionately or in an inversely proportional manner with respect to each other.

3 . The method of claim 1 , further comprising determining the model specific to the patient at the external device during a testing procedure.

4 . The method of claim 1 , wherein the equation comprises a line in a three-dimensional space of frequency, pulse width and amplitude.

5 . The method of claim 1 , wherein the equation comprises a volume in a three-dimensional space of frequency, pulse width and amplitude.

6 . The method of claim 1 , wherein the external device comprises a patient external controller.

7 . The method of claim 6 , further comprising determining the model at a clinician programmer and transmitting the model to the patient external controller.

8 . The method of claim 1 , wherein the external device comprises a clinician programmer.

9 . The method of claim 1 , wherein the stimulation pulses provide sub-perception stimulation.

10 . The method of claim 1 , wherein the user interface element comprises a slider in which the cursor moves.

11 . A system, comprising:

a stimulator device comprising a plurality of electrodes; and

an external device configured to program the stimulator device with at least an amplitude, a pulse width, and a frequency of stimulation pulses to be provided at one or more of the plurality of electrodes,

wherein the external device comprises

a model comprising an equation and indicative of a plurality of coordinates, wherein each coordinate comprises a frequency, a pulse width, and an amplitude, wherein the model is specific to a patient having the stimulator device; and

a non-transitory computer readable medium including instructions that, when executed, are configured to:

provide on the external device a Graphical User Interface (GUI) comprising a user interface element with a cursor,

allow a user to move the cursor in the GUI to simultaneously adjust the frequency, the pulse width, and the amplitude of the stimulation pulses in accordance with the equation such that the amplitude, pulse width, and frequency of the stimulation pulses comprise a coordinate in the model.

12 . The system of claim 11 , wherein the equation comprises a line or volume in a three-dimensional space of frequency, pulse width and amplitude.

13 . The system of claim 11 , wherein the stimulation pulses provide sub-perception stimulation.

14 . A non-transitory computer readable medium configured for operation in an external device configured to program the stimulator device with at least an amplitude, a pulse width, and a frequency of stimulation pulses to be provided at one or more electrodes, the medium including a model, the model comprising an equation and indicative of a plurality of coordinates, wherein each coordinate comprises a frequency, a pulse width, and an amplitude, wherein the model is specific to a patient having the stimulator device, wherein the medium includes instructions that, when executed on the external device, are configured to:

provide on the external device a Graphical User Interface (GUI) comprising a user interface element with a cursor,

allow a user to move the cursor in the GUI to simultaneously adjust the frequency, the pulse width, and the amplitude of the stimulation pulses in accordance with the equation such that the amplitude, pulse width, and frequency of the stimulation pulses comprise a coordinate in the model.

15 . The method of claim 14 , wherein the user interface element comprises a slider in which the cursor moves.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 2, 2019
From: HUERTAS FERNANDEZ, ISMAEL; DOAN, QUE T.
To: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Reel/Frame 049657/0407 →
Continuity (5)
Continuation In Part 16100904 · Aug 10, 2018
Provisional Application 62803330 · Feb 8, 2019
Provisional Application 62693543 · Jul 3, 2018
Provisional Application 62544656 · Aug 11, 2017
Related Publication 20200009367A1 · Jan 9, 2020
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