SYSTEMS AND METHODS FOR PROVIDING THERAPY USING ELECTRICAL STIMULATION TO DISRUPT NEURONAL ACTIVITY

• US 20170087369A1
• Filed: 09/23/2016
• Published: 03/30/2017
• Est. Priority Date: 09/25/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Manola, Ljubomir, Bokil, Hemant, Carcieri, Stephen
• Granted Patent: US 10,413,737 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

A method for electrical stimulation of a patient includes a) implanting at least a portion of an electrical stimulation lead; b) stimulating the patient using the electrical stimulation lead at multiple test stimulation amplitudes; c) observing a response for each of the test stimulation amplitudes; d) selecting a working stimulation amplitude based on the responses from a group consisting of the test stimulation amplitudes and, optionally, a default stimulation amplitude; e) stimulating the patient using the electrical stimulation lead and the working amplitude at multiple test duty cycles; f) observing a response for each of the test duty cycles; g) selecting a working duty cycle based on the responses from a group consisting of the test duty cycles and, optionally, a default duty cycle; and h) stimulating the patient using the electrical stimulation lead, the working amplitude, and the working duty cycle.

Claims

1. A method for electrical stimulation of a patient, the method comprising:

a) implanting at least a portion of an electrical stimulation lead comprising a plurality of electrodes disposed along a distal end portion of the electrical stimulation lead;

b) stimulating the patient using the electrical stimulation lead at a plurality of test stimulation amplitudes;

c) observing a response for each of the plurality of test stimulation amplitudes;

d) selecting a working stimulation amplitude based on the responses from a group consisting of the plurality of test stimulation amplitudes and, optionally, a default stimulation amplitude;

e) stimulating the patient using the electrical stimulation lead and the working amplitude at a plurality of test duty cycles;

f) observing a response for each of the plurality of test duty cycles;

g) selecting a working duty cycle based on the responses from a group consisting of the plurality of test duty cycles and, optionally, a default duty cycle; and

h) stimulating the patient using the electrical stimulation lead, the working amplitude, and the working duty cycle.

2. The method of claim 1, further comprising

i) stimulating the patient using the electrical stimulation lead and the working amplitude and working duty cycle at a plurality of test burst frequencies;

j) observing a response for each of the plurality of test burst frequencies;

k) selecting a working burst frequency based on the responses from a group consisting of the plurality of test burst frequencies and, optionally, a default burst frequency; and

l) stimulating the patient using the electrical stimulation lead, the working amplitude, and the working burst frequency.

3. The method of claim 1, wherein stimulating the patient using the electrical stimulation lead at a plurality of test stimulation amplitudes comprises randomly selecting an order of the test stimulation amplitudes.

4. The method of claim 1, wherein stimulating the patient using the electrical stimulation lead and the working amplitude at a plurality of test duty cycles comprises randomly selecting an order of the test duty cycles.

5. The method of claim 1, wherein observing a response for each of the plurality of test stimulation amplitudes comprises scoring a response for each of the plurality of test stimulation amplitudes.

6. The method of claim 1, wherein observing a response for each of the plurality of test duty cycles comprises scoring a response for each of the plurality of test duty cycles.

7. The method of claim 1, further comprising i) after stimulating the patient using the electrical stimulation lead, the working amplitude, and the working duty cycle, observing a response for the stimulation;

and j) determining whether the response for the stimulation maintains a threshold level of response.

8. The method of claim 7, wherein determining whether the response for the stimulation maintains a threshold level of response comprises determining whether the response for the stimulation maintains a threshold level of response for each of at least two successive days.

9. The method of claim 7, wherein steps a) to j) are performed at a hospital or patient care facility and then step i) is repeated at a patient home and then step j) is repeated with a clinician.

10. The method of claim 7, wherein steps b) to d) are performed on a first day, steps e) to g) are performed over a course of a plurality of second days following the first day, and steps h) to j) are performed over a course of a plurality of third days following the plurality of second days.

11. The method of claim 1, wherein selecting a working stimulation amplitude comprises selecting the default stimulation amplitude if responses for the test stimulation amplitudes fail to meet a threshold criterion.

12. A system for electrical stimulation of a patient, the system comprises an implantable electrical stimulation lead comprising a plurality of electrodes disposed along a distal end portion of the electrical stimulation lead;

and

a computer processor configured and arranged to perform the following actions;

a) stimulate a patient using the electrical stimulation lead at a plurality of test stimulation amplitudes;

b) receive a response for each of the plurality of test stimulation amplitudes;

c) select a working stimulation amplitude based on the responses from a group consisting of the plurality of test stimulation amplitudes and, optionally, a default stimulation amplitude;

d) stimulate the patient using the electrical stimulation lead and the working amplitude at a plurality of test duty cycles;

e) receive a response for each of the plurality of test duty cycles;

f) select a working duty cycle based on the responses from a group consisting of the plurality of test duty cycles and, optionally, a default duty cycle; and

g) stimulate the patient using the electrical stimulation lead, the working amplitude, and the working duty cycle.

13. The system of claim 12, further comprising a trial stimulator coupleable to the implantable electrical stimulation lead and configured and arranged to provide stimulation through the electrical stimulation lead.

14. The system of claim 12, further comprising an implantable control module coupleable to the implantable electrical stimulation lead and configured and arranged to provide stimulation through the electrical stimulation lead.

15. The system of claim 12, wherein stimulate the patient using the electrical stimulation lead at a plurality of test stimulation amplitudes comprises randomly select an order of the test stimulation amplitudes.

16. The system of claim 12, wherein stimulate the patient using the electrical stimulation lead at a plurality of test duty cycles comprises randomly select an order of the test duty cycles.

17. The system of claim 12, wherein receive a response for each of the plurality of test stimulation amplitudes comprises receive a score of a response for each of the plurality of test stimulation amplitudes.

18. A non-transitory computer-readable medium having processor-executable instructions for identifying a set of stimulation parameters, the processor-executable instructions when installed onto a device enable the device to perform actions, including:

a) stimulate a patient using the electrical stimulation lead at a plurality of test stimulation amplitudes;

b) receive a response for each of the plurality of test stimulation amplitudes;

c) select a working stimulation amplitude based on the responses from a group consisting of the plurality of test stimulation amplitudes and, optionally, a default stimulation amplitude;

d) stimulate the patient using the electrical stimulation lead and the working amplitude at a plurality of test duty cycles;

e) receive a response for each of the plurality of test duty cycles;

f) select a working duty cycle based on the responses from a group consisting of the plurality of test duty cycles and, optionally, a default duty cycle; and

g) stimulate the patient using the electrical stimulation lead, the working amplitude, and the working duty cycle.

19. The non-transitory computer-readable medium of claim 18, wherein receive a response for each of the plurality of test stimulation amplitudes comprises receive a score of a response for each of the plurality of test stimulation amplitudes.

20. The non-transitory computer-readable medium of claim 18, wherein receive a response for each of the plurality of test duty cycles comprises receive a score of a response for each of the plurality of test duty cycles.