SYSTEM AND METHOD OF ESTABLISHING A PROTOCOL FOR PROVIDING ELECTRICAL STIMULATION WITH A STIMULATION SYSTEM TO TREAT A PATIENT

• US 20120310300A1
• Filed: 05/31/2011
• Published: 12/06/2012
• 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.
• Granted Patent: US 9,072,903 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• 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 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;

determining whether the patient provided feedback with the patient feedback device while performing the automated and systematic sweeping; 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.

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 2, wherein the determining step includes receiving a feedback signal from the feedback device, and the method further comprises

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

automatically generating a second respective electrical stimulus for a second time period with the plurality of electrodes in a reverse systematic sequence from the systematic sequence;

determining whether the patient provided feedback with the patient feedback device while performing the automatically generating the second respective electrical stimulus.

8. The method of claim 1, 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.

9. The method of claim 1, 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.

10. The method of claim 1, 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.

11. The method of claim 10, wherein the first automated and systematic sweep and the second automated and systematic sweeps are performed in less than thirty minutes.

12. 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.

13. A method of establishing a protocol for providing therapeutic electrical stimulation with a stimulation system for treating a patient, the stimulation system including 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 in communication with the electrical stimulation generator, and a patient feedback device in communication with the programmer, the method comprising:

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

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

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 using the respective perception thresholds from the first automated and systematic sweep;

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

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.

14. The method of claim 13, and further comprising performing a third automated and systematic sweep through the plurality of electrodes to determine a respective impedance associated with each electrode.

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

16. The method of claim 13, 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.

17. The method of claim 13, 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.

18. The method of claim 13, wherein the developing 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.

19. The method of claim 13, wherein the performing the first automated and systematic sweep includes systematically providing a respective electrical stimulus to each of the plurality of electrodes, and waiting a time period for detecting patient feedback after providing the respective electrical stimulus to each of the plurality of electrodes.

20. The method of claim 19, wherein the systematically providing a respective electrical stimulus includes systematically increasing the amplitude of the respective electrical stimulus.

21. The method of claim 13, wherein the performing the second automated and systematic sweep includes systematically providing a respective electrical stimulus to each of the plurality of electrodes, and waiting a time period for detecting patient feedback after providing the respective electrical stimulus to each of the plurality of electrodes, wherein the respective electrical stimulus has a relation to the respective perception thresholds from the first automated and systematic sweep.

22. The method of claim 13, 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.

23. A method of providing therapeutic treatment to a patient with a spinal cord stimulation system, the stimulation system including a pulse generator, one or more implanted medical leads having a plurality of electrodes coupled to the pulse generator, a programmer in communication with the pulse generator, and a patient feedback device in communication with the programmer, the method comprising:

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

image capturing an aspect of the one or more leads; and

establishing a protocol for the one or more leads with the programmer by performing an automated and systematic sweep through the plurality of electrodes.

24. The method of claim 23, wherein the establishing the protocol for the one or more leads includes receiving patient feedback via a patient feedback device while performing the sweep

25. The method of claim 23, and further comprising image capturing an aspect of the pulse generator.

26. The method of claim 23, wherein the performing the automated and systematic sweep includes automatically generating a respective electrical stimulus for a time period with each electrode in a systematic sequence.

27. The method of claim 23, wherein the performing 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.

28. The method of claim 23, wherein the performing 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.

29. The method of claim 23, wherein the performing 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.