System and method of establishing a protocol for providing electrical stimulation with a stimulation system to treat a patient

• US 9,072,903 B2
• Filed: 05/31/2011
• Issued: 07/07/2015
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kaula, Norbert, Iyassu, Yohannes, Polefko, Richard J., Wilder, Steven E., Leyh, Scott G.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US13/118,775
• Publication Number:
  US 20120310300A1
• Time in Patent Office: 1,498 Days
• Field of Search: 607/46, 607/59, 607/60
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

A stimulation system, such as a spinal cord stimulation (SCS) system, having a programmer and a patient feedback device for establishing a protocol to treat a patient. The programmer uses a computer assisted stimulation programming procedure for establishing the protocol. Also described are methods of treating a patient with a spinal cord stimulation system including the programmer and the patient feedback device.

Claims

1. A method of establishing a protocol for providing therapeutic electrical stimulation with a stimulation system for treating a patient, the stimulation system comprising an electrical stimulation generator, one or more implanted medical leads coupled to the electrical stimulation generator, the one or more implanted medical leads including a plurality of electrodes, a programmer configured to communicate with the electrical stimulation generator, and a patient feedback device configured to communicate with the programmer, the method comprising:

initiating automated and systematic sweeping through the plurality of electrodes with electrical stimuli provided by the electrical stimulation generator in response to communication from the programmer, wherein the initiating step includes

performing a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode, the first automated and systematic sweep including

providing a first electrical stimulus having a first amplitude to a first electrode,

waiting a time period for detecting patient feedback after providing the first electrical stimulus,

then providing a second electrical stimulus having the first amplitude to a second electrode,

waiting the time period for detecting patient feedback after providing the second electrical stimulus,

then providing a third electrical stimulus having the first amplitude to a third electrode,

waiting the time period for detecting patient feedback after providing the third electrical stimulus, and

repeating the providing and waiting steps with the first, second, and third electrical stimuli having a second amplitude greater than the first amplitude, and

performing a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area of the patient, the second automated and systematic sweep including

providing a fourth electrical stimulus having a third amplitude to the first electrode,

waiting the time period for detecting patient feedback after providing the fourth electrical stimulus,

then providing a fifth electrical stimulus having a fourth amplitude to the second electrode,

waiting the time period for detecting patient feedback after providing the fifth electrical stimulus,

then providing a sixth electrical stimulus having a fifth amplitude to the third electrode,

waiting the time period for detecting patient feedback after providing the sixth electrical stimulus, and

wherein the fourth, fifth, and sixth electrical stimuli are based on the respective perception thresholds from the first automated and systematic sweep;

determining whether the patient provided feedback with the patient feedback device while performing the automated and systematic sweeping, wherein the determining step includes

detecting patient feedback with the patient feedback device while performing the first automated and systematic sweep, and

detecting patient feedback with the patient feedback device while performing the second automated and systematic sweep; and

creating the protocol for providing therapeutic electrical stimulation to treat the patient based on the automated and systematic sweeping through the plurality of electrodes and the patient provided feedback, wherein the creating step includes developing the protocol for providing therapeutic electrical stimulation to treat the patient based on the second automated and systematic sweep and the detected patient feedback.

2. The method of claim 1, wherein the automated and systematic sweeping includes automatically generating at least one electrical stimulus over a time period corresponding to each electrode in a systematic sequence.

3. The method of claim 2, wherein the respective electrical stimulus includes a pulse having a constant voltage.

4. The method of claim 2, wherein the respective electrical stimulus includes a pulse having a constant current.

5. The method of claim 2, wherein the creating the protocol includes adjusting at least one of amplitude, frequency, pulse width, pulse shape, and stimulation type of an electrical stimulus to refine the protocol.

6. The method of claim 2, wherein the creating the protocol further includes modifying the enablement or disablement of one of the plurality of electrodes to refine the protocol.

7. The method of claim 1, wherein the stimulation system includes a spinal cord stimulation system and the stimulation generator includes a pulse generator, and wherein the therapeutic electrical stimulation includes providing paresthesia for the patient.

8. The method of claim 1, and further comprising performing a third automated and systematic sweep through the plurality of electrodes to determine a respective impedance associated with each electrode.

9. The method of claim 1, wherein the second automated and systematic sweep includes automatically generating a respective electrical stimulus having a relation to the perception threshold of the electrodes, respectively, for a time period in a systematic sequence.

10. The method of claim 1, wherein the detecting patient feedback while performing the first automated and systematic sequence results in the method further comprising

pausing the first automated and systematic sweep;

performing a third automated and systematic sweep through the plurality of electrodes in a reverse systematic sequence from the systematic sequence;

detecting patient feedback with the patient feedback device while performing the third automated and systematic sweep; and

reinitiating the first automated and systematic sweep.

11. The method of claim 1, further comprising:

storing a location of the patient for implanting the one or more leads to receive stimulation; and

image capturing an aspect of the one or more leads.

12. The method of claim 11, and further comprising image capturing an aspect of the pulse generator.

13. The method of claim 11, wherein the initiating the automated and systematic sweep includes automatically generating a respective electrical stimulus for a time period with each electrode in a systematic sequence.

14. The method of claim 11, wherein the initiating the automated and systematic sweep includes performing an automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode.

15. The method of claim 11, wherein the initiating the automated and systematic sweep includes performing an automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.

16. The method of claim 11, wherein the initiating the automated and systematic sweep includes performing a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode, and performing a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.

17. A method of establishing a protocol for providing therapeutic electrical stimulation with a stimulation system for treating a patient, the stimulation system comprising an electrical stimulation generator, one or more implanted medical leads coupled to the electrical stimulation generator, the one or more implanted medical leads including a plurality of electrodes, a programmer configured to communicate with the electrical stimulation generator, and a patient feedback device configured to communicate with the programmer, the method comprising:

initiating automated and systematic sweeping through the plurality of electrodes with electrical stimuli provided by the electrical stimulation generator in response to communication from the programmer, wherein the automated and systematic sweeping includes automatically generating at least one electrical stimulus over a time period corresponding to each electrode in a systematic sequence, including

providing a first electrical stimulus with a first amplitude to a first electrode,

then providing a second electrical stimulus with the first amplitude to a second electrode, and

then providing a third electrical stimulus with the first amplitude to a third electrode;

determining whether the patient provided feedback with the patient feedback device while performing the automated and systematic sweeping, wherein the determining step includes receiving a feedback signal from the feedback device;

pausing the automatically generating the at least one electrical stimulus in the systematic sequence;

automatically generating a second at least one electrical stimulus over a second time period with the plurality of electrodes in a reverse systematic sequence from the systematic sequence, including

providing the second electrical stimulus with the first amplitude to the second electrode,

then providing the first electrical stimulus with the first amplitude to the first electrode;

determining whether the patient provided feedback with the patient feedback device while automatically generating the second at least one electrical stimulus; and

creating the protocol for providing therapeutic electrical stimulation to treat the patient based on the automated and systematic sweeping through the plurality of electrodes, and the patient provided feedback.

18. The method of claim 17, wherein the initiating the automated and systematic sweeping includes performing an automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode.

19. The method of claim 17, wherein the initiating the automated and systematic sweeping includes performing an automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.

20. The method of claim 17, wherein the initiating the automated and systematic sweeping includes performing a first automated and systematic sweep through the plurality of electrodes to determine a respective perception threshold associated with each electrode, and performing a second automated and systematic sweep through the plurality of electrodes to determine an electrode that is associated with a pain area.

21. The method of claim 20, wherein the first automated and systematic sweep and the second automated and systematic sweeps are performed in less than thirty minutes.