Methods and systems for selecting stimulation parameters for electrical stimulation devices

Patent metadata

Field	Value
Publication number	US-10905883-B2
Application number	US-201715829769-A
Country	US
Kind code	B2
Filing date	Dec 1, 2017
Priority date	Dec 2, 2016
Publication date	Feb 2, 2021
Grant date	Feb 2, 2021

Abstract

Methods and systems for selecting electrical stimulation parameters for an electrical stimulation device implanted in a patient can use an iterative process for identifying electrodes for stimulation, as well as suitable stimulation parameters. The process begins with an initial set of electrode combinations to identify regions of the nerve or other tissue for stimulation. This leads to selection of other electrode combinations to test, followed by the selection of multiple electrode groups (which can include three or more electrodes) for stimulation.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

1. A method of selecting electrical stimulation parameters for an electrical stimulation device implanted in a patient, the electrical stimulation device comprising an electrical stimulation lead comprising a plurality of electrodes, the method comprising:
for each of a plurality of first electrode combinations, receiving at least one value indicative of electrical stimulation using the first electrode combination, wherein each of the first electrode combinations comprises at least two electrodes of the electrical stimulation lead;
based on the received values indicative of electrode stimulation using the first electrode combinations, selecting one or more of the first electrode combinations;
selecting a plurality of second electrode combinations including the selected one or more of the first electrode combinations and one or more additional electrode combinations, wherein at least one of the additional electrode combinations includes at least one electrode from the selected one or more of the first electrode combinations, wherein each of the second electrode combinations comprises at least two electrodes of the electrical stimulation lead;
for each of the plurality of second electrode combinations, receiving at least one value indicative of electrical stimulation using the second electrode combination;
based on the received values indicative of electrode stimulation using the second electrode combinations, selecting one or more of the second electrode combinations;
for each of the selected one or more of the second electrode combinations, receiving values indicative of electrical stimulation using different sets of stimulation parameters with the selected one or more of the second electrode combinations;
based on the values indicative of the electrical stimulation using the different sets of stimulation parameters, selecting at least one third electrode combination that includes two or more electrodes of the electrical stimulation lead;
for each of the selected at least one third electrode combination, receiving values indicative of electrical stimulation using different sets of stimulation parameters with the selected at least one third electrode combination;
based on the values indicative of the electrical stimulation using the different sets of stimulation parameters, selecting one of the at least one third electrode combination as a final electrode group and selecting one of the different sets of stimulation parameters for the final electrode group; and
initiating a signal to the electrical stimulation device implanted in the patient, the signal indicating the final electrode group and the selected set of stimulation parameters to be used with the final electrode group for electrical stimulation of the patient through the electrical stimulation lead using the final electrode group and the selected set of stimulation parameters.

2. The method of claim 1 , further comprising stimulating the patient using the final electrode group and the selected set of stimulation parameters.

3. The method of claim 1 , further comprising
based on the values indicative of the electrical stimulation using the different sets of stimulation parameters, selecting one of the at least one third electrode combination as a second final electrode group and selecting one of the sets of stimulation parameters for the second final electrode group; and
initiating a signal to the electrical stimulation device implanted in the patient, the signal indicating the second final electrode group and the selected set of stimulation parameters to be used with the second final electrode group for electrical stimulation of the patient through the electrical stimulation lead using the second final electrode group and the selected set of stimulation parameters.

4. The method of claim 3 , further comprising
stimulating the patient using the final electrode group and the selected set of stimulation parameters for the final electrode group; and
switching to stimulating the patient using the second final electrode group and the selected set of stimulation parameters for the second final electrode group.

5. The method of claim 3 , further comprising alternating between stimulating the patient using the final electrode group and the selected set of stimulation parameters for the final electrode group and stimulating the patient using the second final electrode group and the selected set of stimulation parameters for the second final electrode group.

6. The method of claim 1 , wherein receiving at least one value indicative of electrical stimulation using the first electrode combination comprises receiving from the patient an indication of a threshold stimulation amplitude, wherein stimulation at tested stimulation amplitudes below the threshold stimulation amplitude is tolerable to the patient, but stimulation at the threshold stimulation amplitude is not tolerable to the patient.

7. The method of claim 1 , wherein receiving at least one value indicative of electrical stimulation using the first electrode combination comprises receiving from the patient an indication of a threshold stimulation amplitude, wherein stimulation at tested stimulation amplitudes above the threshold stimulation amplitude is not tolerable to the patient, but stimulation at the threshold stimulation amplitude is tolerable to the patient.

8. The method of claim 1 , wherein the set of stimulation parameters comprises at least one of stimulation amplitude, pulse frequency, pulse duration, duty cycle, pulse waveform, electrode polarity, or burst frequency.

9. The method of claim 1 , wherein at least one of the at least one third electrode combination comprises at least three electrodes, wherein either a) at least two electrodes are anodes or b) at least two electrodes are cathodes or c) both a) and b).

10. The method of claim 1 , wherein at least one of the at least one third electrode combination comprises an electrode comprising a case of a control unit of the electrical stimulation device.

11. The method of claim 1 , wherein each of the at least one third electrode combination comprises at least two electrodes of a one of the selected one or more of the second electrode combinations.

12. The method of claim 1 , wherein no electrode of the electrical stimulation lead is part of more than two of the first electrode combinations.

13. A system for selecting stimulation parameters for electrical stimulation, the system comprising:
a processor configured and arranged to perform actions, the actions comprising:
for each of a plurality of first electrode combinations, receiving at least one value indicative of electrical stimulation using the first electrode combination, wherein each of the first electrode combinations comprises at least two electrodes of the electrical stimulation lead;
based on the received values indicative of electrode stimulation using the first electrode combinations, selecting one or more of the first electrode combinations;
selecting a plurality of second electrode combinations including the selected one or more of the first electrode combinations and one or more additional electrode combinations, wherein at least one of the additional electrode combinations includes at least one electrode from the selected one or more of the first electrode combinations, wherein each of the second electrode combinations comprises at least two electrodes of the electrical stimulation lead;
for each of the plurality of second electrode combinations, receiving at least one value indicative of electrical stimulation using the second

Assignees

• Boston Scient Neuromodulation Corp

Inventors

• Clark Bryan Allen
• Stoffregen William Conrad
• Govea Michael X
• Stolen Craig M
• Ternes David J
• Blum David
• Thakur Pramodsingh Hirasingh
• Ruble Stephen B

Classifications

• A61N1/3686 Primary

  configured for selecting the electrode configuration on a lead (A61N1/3688 takes precedence) · CPC title

• A61N1/3706

  Pacemaker parameters (stimulation threshold A61N1/371) · CPC title

• A61N1/36171

  Frequency · CPC title

• A61N1/36178

  Burst or pulse train parameters · CPC title

• A61N1/086

  Magnetic resonance imaging [MRI] compatible leads · CPC title