LEAD AND METHODS FOR BRAIN MONITORING AND MODULATION

• US 20080027504A1
• Filed: 07/26/2007
• Published: 01/31/2008
• Est. Priority Date: 07/31/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Cranial Medical Systems, Inc.
• Inventors: Bedenbaugh, Purvis
• Granted Patent: US 8,321,025 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction

Abstract

An apparatus, a system and methods for modulating and monitoring tissue have an elongate member with proximal and distal ends and a plurality of annular stimulating electrodes axially arranged along the elongate member. The stimulating electrodes are disposed near the distal end and are adapted to pass current into tissue. At least one of the annular stimulating electrodes has at least three independent stimulation points on the electrode. The apparatus also includes a plurality of recording electrodes that are adapted to measure local tissue potentials and a plurality of conductors are coupled with the recording and stimulating electrodes. An optional multiple contact connecting terminal may be coupled with the conductors and is disposed near the proximal end of the elongate member.

Claims

1. An apparatus for stimulating and monitoring tissue, the apparatus comprising:

an elongate member having a proximal end and a distal end;

a plurality of annular stimulating electrodes axially arranged along the elongate member and disposed near the distal end, the annular stimulating electrodes being adapted to pass current into tissue, and wherein at least one annular stimulating electrode has at least three independent stimulation points thereon;

a plurality of recording electrodes disposed adjacent to the stimulating electrodes, the recording electrodes being adapted to measure local tissue potentials; and

a plurality of conductors coupled with the annular stimulating electrodes and the recording electrodes.

2. An apparatus as in claim 1, wherein a portion of the elongate member near the proximal end is flexible.

3. An apparatus as in claim 1, wherein a portion of the elongate member near the distal end is rigid.

4. An apparatus as in claim 1, wherein at least some of the plurality of recording electrodes are disposed between annular stimulating electrodes.

5. An apparatus as in claim 1, wherein the tissue is brain tissue.

6. An apparatus as in claim 1, further comprising a lumen axially disposed between the proximal and distal ends of the elongate member.

7. An apparatus as in claim 6, wherein the lumen is adapted to receive a guidewire or stylet.

8. An apparatus as in claim 6, further comprising one or more ports near the distal end of the elongate member, the ports in communication with the lumen and adapted to deliver a therapeutic agent to and/or receive a chemical substance from the tissue.

9. An apparatus as in claim 8, wherein the therapeutic agent comprises levodopa.

10. An apparatus as in claim 8, wherein the ports are disposed between the annular stimulating electrodes.

11. An apparatus as in claim 8, wherein at least one of the ports is disposed at the distal end of the elongate member.

12. An apparatus as in claim 8, wherein the ports comprise a gating member adapted to permit selective enablement of the ports.

13. An apparatus as in claim 12, wherein the gating member is a semi-permeable membrane.

14. An apparatus as in claim 12, wherein the gating member is chemically controlled.

15. An apparatus as in claim 14, wherein the gating mechanism is a chemically reactive hydrogel.

16. An apparatus as in claim 6, further comprising a stimulating electrode disposed in the lumen.

17. An apparatus as in claim 16, wherein the stimulating electrode disposed in the lumen is a wire.

18. An apparatus as in claim 1, further comprising a stimulating electrode at the distal end of the elongate member, the stimulating electrode adapted to pass current into the tissue.

19. An apparatus as in claim 1, wherein the plurality of conductors are helically wound along the elongate member.

20. An apparatus as in claim 1, wherein a first group of the conductors are coupled with stimulating electrodes and a second group of the conductors are coupled with the recording electrodes, and wherein the first group of conductors form a helix having a first pitch wrapped around the second group of conductors which also form a helix having a second pitch.

21. An apparatus as in claim 20, wherein the first pitch is different than the second pitch.

22. An apparatus as in claim 1, wherein the conductors are comprised of a material selected from the group consisting of stainless steel, MP35 and tungsten.

23. An apparatus as in claim 1, wherein the plurality of annular stimulating electrodes are compatible with magnetic resonance imaging.

24. An apparatus as in claim 1, further comprising a multiple contact connecting terminal coupled with at least some of the plurality of conductors and disposed near the proximal end of the elongate member.

25. An apparatus as in claim 1, wherein the recording electrodes are circumferentially disposed about the elongate member.

26. An apparatus as in claim 1, wherein the recording electrodes have a circular shaped surface.

27. A method of treating tissue comprising:

implanting a probe in tissue, the probe having a plurality of recording electrodes and a plurality of annular stimulating electrodes, wherein at least one of the annular stimulating electrodes has at least three independent stimulation points thereon;

stimulating the tissue with a therapeutic electrical current from the annular stimulating electrodes;

measuring local tissue potentials with the recording electrodes in response to the stimulation;

analyzing the measured local tissue potentials to provide feedback on the effectiveness of the stimulation; and

adjusting the stimulation in response to the feedback.

28. A method as in claim 27, wherein the tissue is brain tissue.

29. A method as in claim 27, further comprising stimulating the tissue with a therapeutic agent.

30. A method as in claim 27, further comprising releasably coupling the probe to the tissue with an anchor.

31. A method as in claim 27, wherein the probe is compatible with magnetic resonance imaging.

32. A method as in claim 27, further comprising collecting a chemical substance from the tissue to provide feedback on the effectiveness of the stimulation.

33. A method as in claim 27, further comprising controlling a gating member so as to selectively open or close one or more ports disposed on the probe.

34. A method as in claim 27, wherein the ports are adapted to control delivery of a therapeutic agent to and/or receive a chemical substance from the tissue.

35. A system for treating tissue, the system comprising:

a stimulating and recording probe having a plurality of recording electrodes adapted to measure local tissue potentials and a plurality of annular stimulating electrodes, wherein at least one of the annular stimulating electrodes has at least three independent stimulation points thereon and the stimulating electrodes are adapted to pass current into tissue; and

an implantable and controllable pulse generator, the generator adapted to provide an electrical stimulus to the probe.

36. A system as in claim 35, wherein the tissue treated is brain tissue.

37. A system as in claim 35, further comprising an anchoring device, the anchoring device adapted to removably fix the probe to a patient'"'"'s head.

38. A system as in claim 35, further comprising patient programmer, the patient programmer being adapted to control the pulse generator.

39. A system as in claim 35, further comprising a multiple contact connector electrically coupled with the recording and stimulating electrodes.

40. A system as in claim 35, wherein the tissue probe is compatible with magnetic resonance imaging.