Granted Patent B2

US 12,403,315 · App. 17/728,493 · Granted Sep 2, 2025

Inventors: Adarsh Jayakumar (Valencia, CA); Thien Tich Doan (West Hills, CA)

Assignee: Boston Scientific Neuromodulation Corporation

A61N1/36139A61N1/37247

Abstract

Claims (55)

1. A method for automating selection of stimulation parameters for a stimulation device implanted in a patient, the method comprising:

setting, by a user, at least one limit on each of at least three stimulation parameters, each of the at least three stimulation parameters being different and selected from an axial position along an electrical stimulation lead, a rotational direction of stimulation, a stimulation amplitude, a pulse duration, a pulse frequency, or a duty cycle, wherein each of the at least one limit comprises an upper limit, a lower limit, a limit on electrode selection, or a limit on stimulation direction; and

performing, automatically using at least one processor, the following actions sequentially and individually for each of the at least three stimulation parameters constrained by the at least one limit, wherein the actions are fully performed with respect to one of the at least three stimulation parameters before performing the actions for another one of the at least three stimulation parameters:

selecting a one of the at least three stimulation parameters,

stimulating tissue of the patient, by the stimulation device, using different first values for the selected one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different first values, sensing one or more first effects arising in response to the corresponding stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more first effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, by the at least one processor and for each of the different first values, a collection of effects and corresponding values of the at least three stimulation parameters with the one or more first effects and the corresponding different first values of the one of the at least three stimulation parameters,

selecting, by the processor, a coarse value from the different first values of the one of the at least three stimulation parameters based on the sensed one or more first effects,

stimulating tissue of the patient, by the stimulation device, using different second values for the selected one of the at least three stimulation parameters that are within a predefined relative range around the selected coarse value of the one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different second values, sensing one or more second effects arising in response to the stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more second effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, by the at least one processor and for each of the different second values, a collection of effects and corresponding values of the at least three stimulation parameters with the one or more second effects and the corresponding different second values of the one of the at least three stimulation parameters, and

selecting, by the processor, a fine-tuned value from the different second values of the one of the at least three stimulation parameters based on the sensed one or more second effects,

wherein, after the fine-tuned value is selected for any one of the at least three stimulation parameters, that fine-tuned value is used in subsequent stimulations when performing the actions for another one of the at least three stimulation parameters.

2. The method of claim 1 , further comprising, after selecting the fine-tuned value of the one of the at least three stimulation parameters, further fine-tuning, manually by the user, to obtain a manual fine-tuned value for one of the at least three stimulation parameters.

3. The method of claim 1 , further comprising programming the stimulation device with the selected fine-tuned values for each of the at least three stimulation parameters.

4. The method of claim 1 , wherein the signal is an evoked compound action potential (ECAP) or an evoked resonant neural activity (ERNA).

5. The method of claim 1 , wherein the at least three stimulation parameters comprises a first stimulation parameter corresponding to an axial location along the electrical stimulation lead.

6. The method of claim 5 , wherein the predefined relative range is one axial electrode spacing on both sides of the selected coarse value of the axial location.

7. The method of claim 5 , wherein the at least three stimulation parameters comprises a second stimulation parameter corresponding to a rotational direction around the electrical stimulation lead.

8. The method of claim 7 , wherein the predefined relative range is 120 degrees on both sides of the selected coarse value of the rotational direction.

9. The method of claim 7 , wherein the at least three stimulation parameters comprises a third stimulation parameter corresponding to a stimulation amplitude.

10. A system for selection of stimulation parameters for a stimulation device implanted in a patient, the system comprising:

at least one processor configured to perform actions, the actions comprising:

receiving, from a user, at least one limit for each of at least three stimulation parameters, each of the at least three stimulation parameters being different and selected from an axial position along an electrical stimulation lead, a rotational direction of stimulation, a stimulation amplitude, a pulse duration, a pulse frequency, or a duty cycle, wherein each of the at least one limit comprises an upper limit, a lower limit, a limit on electrode selection, or a limit on stimulation direction; and

performing the following actions sequentially and individually for each of the at least three stimulation constrained by the at least one limit, wherein the actions are fully performed with respect to one of the at least three stimulation parameters before performing the actions for another one of the at least three stimulation parameters:

selecting a one of the at least three stimulation parameters,

directing the stimulation device to stimulate tissue of the patient using different first values for the selected one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different first values, sensing one or more first effects arising in response to the corresponding stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, for each of the different first values, a collection of the effects and corresponding values of the at least three stimulation parameters with the one or more first effects and the corresponding different first values of the one of the at least three stimulation parameters,

selecting a coarse value from the different first values of the one of the at least three stimulation parameters based on the sensed one or more first effects,

directing stimulation of tissue of the patient, by the stimulation device, using different second values for the selected one of the at least three stimulation parameters that are within a predefined relative range around the selected coarse value of the one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different second values, sensing one or more second effects arising in response to the stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity ERNA), or local field potential (LFP), wherein at least one of the one or more second effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, by the at least one processor and for each of the different second values, a collection of effects and corresponding values of the at least three stimulation parameters with the one or more second effects and the corresponding different second values of the one of the at least three stimulation parameters, and

selecting, by the processor, a fine-tuned value from the different second values of the one of the at least three stimulation parameters based on the sensed one or more second effects,

wherein, after the fine-tuned value is selected for any one of the at least three stimulation parameters, that fine-tuned value is used in subsequent stimulations when performing the actions for another one of the at least three stimulation parameters.

11. The system of claim 10 , further comprising the stimulation device.

12. The system of claim 11 , wherein the stimulation device comprises the electrical stimulation lead having electrodes disposed along a distal portion of the electrical stimulation lead.

13. The system of claim 12 , wherein sensing one or more first effects comprising sensing the one or more first effects arising in response to the stimulation using at least one of the electrodes of the electrical stimulation lead.

14. The system of claim 10 , further comprising a sensor external to the stimulation device, wherein sensing one or more first effects comprising sensing the one or more first effects arising in response to the stimulation using the sensor.

15. The system of claim 10 , wherein the actions further comprise programming the stimulation device with the fine-tuned values selected for the at least three stimulation parameters.

16. A non-transitory computer-readable medium having stored thereon instructions for execution by at least one processor, the instructions comprising:

a) receiving, from a user, at least one limit for each of at least three stimulation parameters, each of the at least three stimulation parameters being different and selected from an axial position along an electrical stimulation lead, a rotational direction of stimulation, a stimulation amplitude, a pulse duration, a pulse frequency, or a duty cycle, wherein each of the at least one limit comprises an upper limit, a lower limit, a limit on electrode selection, or a limit on stimulation direction; and

b) performing the following actions sequentially and individually for each of the at least three stimulation constrained by the at least one limit, wherein the actions are fully performed with respect to one of the at least three stimulation parameters before performing the actions for another one of the at least three stimulation parameters:

selecting a one of the at least three stimulation parameters,

directing the stimulation device to stimulate tissue of the patient using different first values for the selected one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different first values, sensing one or more first effects arising in response to the corresponding stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, for each of the different first values, a collection of the effects and corresponding values of the at least three stimulation parameters with the one or more first effects and the corresponding different first values of the one of the at least three stimulation parameters,

selecting a coarse value from the different first values of the one of the at least three stimulation parameters based on the sensed one or more first effects,

directing stimulation of tissue of the patient, by the stimulation device, using different second values for the selected one of the at least three stimulation parameters that are within a predefined relative range around the selected coarse value of the one of the at least three stimulation parameters constrained by the at least one limit for the one of the at least three stimulation parameters,

for each of the different second values, sensing one or more second effects arising in response to the stimulation including sensing a signal from the stimulated tissue, wherein the signal is an evoked compound action potential (ECAP), evoked resonant neural activity (ERNA), or local field potential (LFP), wherein at least one of the one or more second effects is a feature of the signal over a selected range of time, wherein the feature comprises at least one of a range of amplitude of the signal over the selected range of time, an amount of time between a maximum amplitude of the signal and a minimum amplitude of the signal for the selected range of time, an area under a curve of the signal for the selected range of time, or a length of the curve of the signal for the selected range of time,

updating, by the at least one processor and for each of the different second values, a collection of effects and corresponding values of the at least three stimulation parameters with the one or more second effects and the corresponding different second values of the one of the at least three stimulation parameters, and

selecting, by the processor, a fine-tuned value from the different second values of the one of the at least three stimulation parameters based on the sensed one or more second effects,

wherein, after the fine-tuned value is selected for any one of the at least three stimulation parameters, that fine-tuned value is used in subsequent stimulations when performing the actions for another one of the at least three stimulation parameters.

17. The non-transitory computer-readable medium of claim 16 , wherein the instructions further comprise, after selecting the fine-tuned value of the one of the at least three stimulation parameters, further fine-tuning, manually by the user, to obtain a manual fine-tuned value for one of the at least three stimulation parameters.

18. The non-transitory computer-readable medium of claim 16 , wherein the instructions further comprising repeating the instruction b) periodically to track disease progression over time.

Assignments (1)

Continuity (2)

References Cited (400)