Methods and systems for establishing neural stimulation parameters and providing neural stimulation

• US 8,090,446 B2
• Filed: 04/08/2008
• Issued: 01/03/2012
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fowler, Brad, Hulvershorn, Justin, Gliner, Bradford E., Sloan, Leif R.
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US12/099,415
• Publication Number:
  US 20090099622A1
• Time in Patent Office: 1,365 Days
• Field of Search: 607/45, 607/46
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Methods for providing electrical stimulation therapy to a cortex of a patient via a plurality of electrodes proximate to the cortex and a pulse generator implanted in the patient. One embodiment of a method in accordance with the invention comprises determining whether the current applied via the plurality of electrodes results in a sufficient current density in the cortex. The current density, for example, may need to be high enough to induce a response in the patient for determining the activation threshold of the specific stimulation site, or the current density may need to be high enough to perform a specific therapy. If the current density is not sufficient, the method continues by selecting a subset of the plurality of electrodes, and applying electrical current to the cortex via the subset of the electrodes. For example, if the current density is not sufficient when the current is applied to the full plurality of electrodes at approximately the maximum output of the pulse generator, then the current level from the pulse generator can be applied to only a subset of the electrodes to effectively increase the current density in the cortex at the active electrodes.

Claims

1. A method for providing electrical stimulation therapy to a cortex of a patient via a plurality of electrodes proximate to the cortex and a pulse generator implanted in the patient, the method comprising:

determining whether a current density of an electrical field in the cortex applied via the plurality of electrodes is sufficient for a desired purpose;

if the current density is not sufficient, then selecting a subset of the plurality of electrodes to produce a higher current density in the cortical area at or beneath the subset of the plurality of electrodes; and

applying electrical current to the cortex through the subset of the plurality of electrodes thereby increasing the current density to achieve the desired therapy.

2. The method of claim 1 further comprising applying electrical current to the cortex via the plurality of electrodes at approximately a maximum output of the pulse generator, and wherein determining whether the current density is sufficient includes making an assessment that the current density is not sufficient when the electrical current via the plurality of electrodes does not induce a motor and/or a sensory response in the patient.

3. The method of claim 2 wherein the electrical current is initially applied to the subset of electrodes at an output less than the maximum output of the pulse generator, and the electrical current is subsequently applied to the subset of electrodes at increasing levels until a motor and/or sensory response is induced in the patient, whereby the current level inducing the response is identified as a suprathreshold current.

4. The method of claim 3, further comprises selecting a subthreshold current less than the suprathreshold current and applying the subthreshold current through the plurality of electrodes.

5. The method of claim 1 wherein the plurality of electrodes are mounted to a flexible substrate and define an electrode array configured to cover an area of the cortex, and wherein a maximum output of the pulse generator is not sufficient to provide the electrical stimulation therapy concurrently through the plurality of electrodes.

6. The method of claim 5 wherein applying the current through a subset of the plurality of the electrodes comprises applying electrical current to the cortex via a first electrode at approximately a maximum output of the pulse generator for a first time period and applying electrical current to the cortex via a second electrode at approximately a maximum output of the pulse generator for a second period of time.

7. The method of claim 5 wherein applying the current through a subset of the plurality of electrodes comprises applying electrical current to different electrodes at different times to provide a current density at individual electrodes greater than when the current was applied concurrently via the plurality of electrodes.

8. The method of claim 5 wherein applying the current through a subset of the plurality of electrodes comprises time multiplexing the current through a first subset of the plurality of electrodes and a second subset of the plurality of electrodes at different time periods.

9. The method of claim 5 wherein applying the current through a subset of the plurality of electrodes comprises frequency multiplexing the current through a first subset of the plurality of electrodes and a second subset of the plurality of electrodes.

10. A method for applying electrical current to a cortex of a patient via a pulse generator implanted in the patient, comprising:

implanting an electrode array at least proximate to the cortex of the patient, the electrode array having a flexible support member and a plurality of electrodes mounted to the support member, and the electrode array being electrically coupled to the implanted pulse generator such that at least one first electrode can be operated independently of at least one second electrode;

determining that an electrical current applied concurrently to the first electrode and the second electrode produces an electrical field in the cortex having a large area current density which is not sufficient to carry out an aspect of a cortical stimulation therapy for the patient;

applying electrical current to the cortex via the first electrode for a first time period without applying electrical stimulation to the second electrode, wherein a first current density at the first electrode is higher than the large area current density; and

applying electrical current to the cortex via the second electrode for a second time period without applying electrical stimulation to the first electrode, wherein a second current density at the second electrode is higher than the large area current density.

11. The method of claim 10 wherein the electrical current applied concurrently to the first and second electrodes is applied at approximately a maximum output of the implanted pulse generator.

12. The method of claim 10 wherein the plurality of electrodes are arranged to cover a large area of the cortex, and wherein a maximum output of the pulse generator is not sufficient to provide the electrical stimulation therapy concurrently through the plurality of electrodes.

13. The method of claim 10 wherein applying the current through the first electrode during the first time period and applying the current through the second electrode for the second time period comprises time multiplexing the current through the first and second electrodes.

14. The method of claim 10 wherein applying the current through the first electrode for the first time period and applying the current through the second electrode for the second time period comprises frequency multiplexing the current through the first and second electrodes.

15. A cortical stimulation system, comprising:

an electrode array configured to be implanted at least proximate to the cortex, wherein the electrode array has a plurality of electrodes; and

a pulse generator configured to be coupled to the electrode array to provide electrical signals to at least one of the electrodes, wherein the pulse generator comprises a controller having instructions that cause the pulse generator to (a) receive a determination of whether a current density of an electrical field in the cortex applied via the electrodes is sufficient for a desired purpose, (b) if the current density is not sufficient, then select a subset of the plurality of the electrodes, and (c) apply electrical current to the cortex through the subset of the plurality of the electrodes to produce a higher current density in the cortical area at or beneath the subset of the plurality of electrodes.

16. The system of claim 15, wherein the instructions of the controller further cause the pulse generator to (a) apply the electrical current to the cortex via the plurality of electrodes at approximately a maximum output of the pulse generator, and (b) receive a determination of whether the current density is sufficient by sensing neural activity and making an assessment that the current density is not sufficient when the electrical current via the plurality of electrodes does not induce a sufficient measurable response associated with neural activity in the patient.

17. The system of claim 16 wherein the instructions of the controller further cause the pulse generator to (a) initially apply the electrical current to the subset of electrodes at an output less than the maximum output of the pulse generator, and (b) subsequently apply the electrical current to the subset of electrodes at increasing levels until a motor and/or sensory response is induced in the patient, whereby the current level inducing the response is identified as a suprathreshold current.

18. The system of claim 17, wherein the instructions of the controller further cause the pulse generator to (a) select a subthreshold current less than the suprathreshold current and (b) apply the subthreshold current through the plurality of electrodes.

19. The method of claim 18 wherein the subthreshold stimulation current is 25%-75% of the suprathreshold current.

20. The method of claim 18 wherein the subthreshold stimulation current is approximately 40%-60% of the suprathreshold current.

21. The system of claim 15 wherein the electrode array further comprises a flexible substrate and the electrodes are surface electrodes carried by the flexible substrate in an arrangement configured to cover an area of the cortex, and wherein a maximum output of the pulse generator is not sufficient to provide the electrical stimulation therapy concurrently through the plurality of electrodes.

22. The system of claim 21 wherein the instructions of the controller cause the pulse generator to apply the current through a subset of the plurality of the electrodes by (a) applying electrical current to the cortex via a first electrode at approximately a maximum output of the pulse generator for a first time period and (b) applying electrical current to the cortex via a second electrode at approximately a maximum output of the pulse generator for a second period of time.

23. The system of claim 21 wherein the instructions of the controller cause the pulse generator to apply the current through a subset of the plurality of electrodes by applying electrical current to different electrodes at different times to provide a current density at individual electrodes greater than when the current was applied concurrently via the plurality of electrodes.

24. The system of claim 21 wherein the instructions of the controller cause the pulse generator to apply the current through a subset of the plurality of electrodes by time multiplexing the current through a first subset of the plurality of electrodes and a second subset of the plurality of electrodes at different time periods.

25. The system of claim 21 wherein the instructions of the controller cause the pulse generator to apply the current through a subset of the plurality of electrodes by frequency multiplexing the current through a first subset of the plurality of electrodes and a second subset of the plurality of electrodes.