Lead and methods for brain monitoring and modulation

• US 8,321,025 B2
• Filed: 07/26/2007
• Issued: 11/27/2012
• 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
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US11/828,547
• Publication Number:
  US 20080027504A1
• Time in Patent Office: 1,951 Days
• Field of Search: 600/373, 600/378, 600/393, 607/45, 607/46, 607/116
• 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 longitudinal axis, a circumference, a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end of the elongate member, the central lumen sized to receive a stylet for advancement of the elongate member slidably thereover;

a plurality of stimulating regions fixedly coupled with the elongate member, the stimulating regions arranged along the elongate member and axially spaced apart along the longitudinal axis, the stimulating regions disposed near the distal end, the stimulating regions being adapted to pass current into tissue, and wherein at least one stimulating region consists of three independent stimulation electrodes equally spaced apart from one another and separated from one another by an insulator so that each stimulation electrode may be stimulated independently of the other stimulation electrodes, the at least one stimulating region completely surrounding the circumference of the elongate member;

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

a plurality of conductors coupled with the stimulating regions 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 the stimulating regions.

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

6. An apparatus as in claim 1, 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.

7. An apparatus as in claim 6, wherein the therapeutic agent comprises levodopa.

8. An apparatus as in claim 6, wherein the ports are disposed between the stimulating regions.

9. An apparatus as in claim 6, wherein at least one of the ports is disposed at the distal end of the elongate member.

10. An apparatus as in claim 6, wherein the ports comprise a gating member adapted to permit selective enablement of the ports.

11. An apparatus as in claim 10, wherein the gating member is a semi-permeable membrane.

12. An apparatus as in claim 10, wherein the gating member is chemically controlled.

13. An apparatus as in claim 12, wherein the gating mechanism is a chemically reactive hydrogel.

14. An apparatus as in claim 1, further comprising a stimulating electrode disposed in the lumen.

15. An apparatus as in claim 14, wherein the stimulating electrode disposed in the lumen comprises a wire.

16. 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.

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

18. 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.

19. An apparatus as in claim 18, wherein the first pitch is different than the second pitch.

20. 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.

21. An apparatus as in claim 1, wherein the plurality of stimulating regions are compatible with magnetic resonance imaging.

22. 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.

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

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

25. A method of treating tissue comprising:

advancing a probe having a central lumen over a stylet, wherein the stylet slidably passes through the central lumen;

implanting the probe in tissue, the probe having an elongate member with a circumference and at least one stimulating region fixedly coupled with the elongate member, wherein the at least one stimulating region consists of three independent stimulation electrodes equally spaced apart from one another and separated from one another by an insulator so that each stimulation electrode may be stimulated independently of the other stimulation electrodes, the at least one stimulating region completely surrounding the circumference of the elongate member;

stimulating the tissue with a therapeutic electrical current from the at least one stimulating region; and

steering the electrical current by directing the current from one of the three independent stimulation electrodes, or by directing the current from two of the three independent stimulation electrodes.

26. A method as in claim 25, wherein the tissue comprises brain tissue.

27. A method as in claim 25, further comprising stimulating the tissue with a therapeutic agent.

28. A method as in claim 25, further comprising releasably coupling the probe to the tissue with an anchor.

29. A method as in claim 25, wherein the probe is compatible with magnetic resonance imaging.

30. A method as in claim 25, further comprising collecting a chemical substance from the tissue to provide feedback on the effectiveness of the stimulation.

31. A method as in claim 25, further comprising controlling a gating member so as to selectively open or close one or more ports disposed on the probe.

32. A method as in claim 25, wherein the ports are adapted to control delivery of a therapeutic agent to and/or receive a chemical substance from the tissue.

33. A method as in claim 25, wherein the steering comprises steering the electrical current from a first location in the tissue to a second location in the tissue, wherein the step of steering the current comprises stimulating the first location with current from a first group of stimulation electrodes and stimulating the second location with current from a second group of stimulation electrodes, the first group different than the second group.

34. A method as in claim 33, wherein steering comprises coordinating activation of the stimulating electrodes.

35. A method as in claim 33, wherein steering the electrical current reduces undesirable side effects.

36. A method as in claim 33, wherein steering the electrical current increases therapeutic effectiveness of the stimulation.

37. A method as in claim 25, further comprising shaping the volume of the stimulated tissue, wherein shaping comprises stimulating the tissue with current from a first group of stimulation electrodes and stimulating the tissue with current from a second group of stimulation electrodes, the first group different than the second group.

38. A method as in claim 25, wherein the probe further comprises one or more recording electrodes disposed adjacent the at least one stimulating region, the method further comprising measuring local tissue potentials with the recording electrodes;

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

adjusting the stimulation in response to the feedback.

39. A method as in claim 25, wherein the probe further comprises a recording electrode disposed on the elongate member adjacent the at least one stimulating region, the method further comprising measuring local tissue potentials with the recording electrode in response to the stimulation.

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

a stimulating and recording probe having an elongate member with a circumference, a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end of the elongate member, the central lumen sized the receive a stylet for advancement of the elongate member slidably thereover, and a plurality of recording electrodes adapted to measure local tissue potentials and a plurality of stimulating regions fixedly coupled with the elongate member, wherein at least one stimulating region consists of three independent stimulation electrodes equally spaced apart from one another and separated from one another by an insulator so that each stimulation electrode may be stimulated independently of the other stimulation electrodes, the at least one stimulating region completely surrounding the circumference of the elongate member, and wherein the stimulating regions 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.

41. A system as in claim 40, wherein the tissue treated comprises brain tissue.

42. A system as in claim 40, further comprising an anchoring device, the anchoring device adapted to removably fix the probe to a patient'"'"'s head.

43. A system as in claim 40, further comprising a patient programmer, the patient programmer being adapted to control the pulse generator.

44. A system as in claim 40, further comprising a multiple contact connector electrically coupled with the recording and stimulating electrodes.

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