Three-dimensional system of electrode leads

• US 8,565,894 B2
• Filed: 10/17/2008
• Issued: 10/22/2013
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Original Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Inventors: Vetter, Rio J., Kipke, Daryl R., Hetke, Jamille F.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US12/253,803
• Publication Number:
  US 20090118806A1
• Time in Patent Office: 1,831 Days
• Field of Search: 607/116
• US Class Current: 607/116
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

The electrode lead system of a preferred embodiment includes a series of first electrical subsystems; a guiding element that positions the series of first electrical subsystems in a three dimensional arrangement within body tissue; a second electrical subsystem; and at least one connector that couples the first electrical subsystems to the second electrical subsystem. The electrode lead system of another preferred embodiment includes a series of electrode arrays; a guide tube that facilitates implantation of electrode arrays within body tissue and temporarily contains the series of electrode arrays; and a guiding element that provides a bias on the series of electrode arrays such that (a) when contained by the guide tube, the first electrical subsystems maintain a substantially singular path within body tissue, and (b) when not contained by the guide tube, the first electrical subsystems diverge along more than one path into a three dimensional arrangement within body tissue.

Claims

1. An electrode lead for implantation into body tissue, the lead comprising:

a) a carrier comprising a rigid three-dimensional shape extending along a carrier length from a carrier proximal end to a carrier distal end;

b) an electrode array comprising a plurality of electrodes supported on the carrier in the rigid three-dimensional shape; and

c) a guiding element extending from a guiding element proximal end to a guiding element distal end, wherein the guiding element distal end is connected to the electrode array, and wherein the guiding element is configured to have a first three-dimensional shape, and

d) wherein the guiding element is maneuverable into a second three-dimensional shape that is different than the first three-dimensional shape while the carrier supporting the plurality of electrodes connected to the distal end of the guiding element maintains its rigid three-dimensional shape, and

e) wherein the plurality of electrodes comprise stimulation electrodes configured for electrical stimulation of biological tissue and recording electrodes configured for recording of biological activity from biological tissue and wherein there are at least a first row and a second row of four stimulation electrodes along the carrier length, the stimulation electrodes being equally spaced around a circumference of the carrier, and two diametrically opposed recording electrodes positioned between the first and second rows of stimulation electrodes.

2. The electrode lead of claim 1, wherein the electrode array is configured to be interfacable with neural tissue.

3. The electrode lead of claim 1 wherein the stimulation electrodes have a surface area of 0.196 mm².

4. The electrode lead of claim 1 wherein the recording electrodes have a surface area of 0.00196 mm².

5. The electrode lead of claim 1 wherein the electrode array is patterned on a thin-film polymer substrate, a silicon substrate, and combinations thereof.

6. The electrode lead of claim 1 further comprising at least one conductive interconnect extending from the electrode array to a bond pad configured for electrical connection to an external instrumentation.

7. The electrode lead of claim 1, wherein the guiding element proximal end is configured to be electrically connectable to an electrical subsystem.

8. The electrode lead system of claim 1 wherein the first and second rows of stimulation electrodes are spaced apart by 750 μ

m along the carrier length.

9. The electrical lead of claim 1 wherein the guiding element supports at least one conductor electrically connected to the proximal end of the electrode array.

10. The electrical lead of claim 1 wherein the guiding element is electrically connected to the proximal end of the electrode array.

11. The electrical lead of claim 1 wherein there are sixty-four stimulation electrodes and thirty-two recording electrodes.

12. The electrical lead of claim 1 wherein individual electrodes of the electrode array are energizable in either a monopolar or a bipolar mode.

13. The electrical lead of claim 1 wherein the guiding element comprises a system of manipulatable cables.

14. The electrical lead of claim 1 wherein the guiding element comprises robotics that are controllable by a user.

15. The electrical lead of claim 1 wherein the guiding element comprises joints that are controllable by a user.

16. The electrical lead of claim 1 wherein the guiding element is of a shape memory material.

17. The electrical lead of claim 16 wherein the shape memory material is adapted to change shape upon either a change in temperature or electrical stimulation.

18. The electrical lead of claim 1 wherein the carrier has a pointed distal end.

19. An electrode lead for implantation into body tissue, the electrode lead comprising:

a) a tubular carrier comprising a rigid three-dimensional shape extending along a carrier length from a carrier proximal end to a carrier distal end;

b) an electrode array supported on the tubular carrier in the rigid three-dimensional shape, wherein the electrode array comprises sixty-four stimulation electrodes and thirty-two recording electrodes; and

c) a guiding element extending from a guiding element proximal end to a guiding element distal end, wherein the guiding element distal end is electrically connected to the electrode array, and wherein the guiding element is configured to have a first three-dimensional shape, and;

d) wherein the guiding element is maneuverable into a second three-dimensional shape that is different than the first three-dimensional shape while the carrier supporting the plurality of electrodes connected to the distal end of the guiding element maintains its rigid three-dimensional shape, and

e) wherein the sixty-four stimulation electrodes are arranged in stimulation groups of four stimulation electrodes equally spaced annularly around a circumference of the carrier at sixteen spaced axial locations along the carrier length and wherein the thirty-two recording electrodes are arranged in recording groups of two recording electrodes positioned on opposites sides of the carrier between immediately adjacent annular stimulation electrode groups.

20. The electrode lead of claim 19, wherein the stimulation electrodes have a surface area of 0.196 mm².

21. The electrode lead of claim 19 wherein the recording electrode have a surface area of 0.00196 mm².

22. The electrode lead of claim 19 wherein the first and second rows of stimulation electrodes are spaced apart by 750 μ

m along the carrier length.

23. The electrode lead of claim 19, wherein the guiding element includes maneuverable joints.

24. The electrode lead of claim 19 including a guide tube that facilitates implantation of a plurality of the electrode leads into body tissue.

25. The electrical lead of claim 19 wherein the guiding element supports at least one conductor electrically connected to the proximal end of the electrode array.

26. The electrical lead of claim 19 wherein the guiding element is electrically connected to the proximal end of the electrode array.

27. An electrode lead system for implantation into body tissue, the lead system comprising:

a) a plurality of leads, each lead comprising;

i) a carrier comprising a rigid three-dimensional shape extending along a carrier length from a carrier proximal end to a carrier distal end;

ii) an electrode array comprising a plurality of electrodes distributed along the carrier in the three-dimensional shape, wherein the plurality of electrodes comprise stimulation electrodes configured for electrical stimulation of biological tissue and recording electrodes configured for recording of biological activity from biological tissue and wherein there are at least a first row and a second row of four stimulation electrodes along the carrier length, the stimulation electrodes being equally spaced around a circumference of the carrier, and two diametrically opposed recording electrodes positioned between the first and second rows of stimulation electrodes; and

iii) a guiding element extending from a guiding element proximal end to a guiding element distal end, wherein the guiding element distal end is connected to the electrode array, and wherein the guiding element is configured to have a first three-dimensional shape, and

iv) wherein the guiding element is maneuverable into a second three-dimensional shape that is different than the first three-dimensional shape while the carrier supporting the plurality of electrodes connected to the distal end of the guiding element maintains its rigid three-dimensional shape;

b) an electrical subsystem; and

c) at least one interconnect that couples the electrode array to the electrical subsystem.

28. The electrode lead system of claim 27 further comprising a guide tube that facilitates implantation of the lead into body tissue.

29. The electrode lead system of claim 28 wherein when housed inside the guide tube, the electrical lead extends substantially along a longitudinal axis of the guide tube.

30. The electrode lead system of claim 27 wherein the connector is a flexible ribbon cable.

31. The electrical lead of claim 27 wherein the stimulation electrodes have a surface area of 0.196 mm².

32. The electrical lead of claim 27 wherein the recording electrodes have a surface area of 0.00196 mm².

33. The electrical lead system of claim 27 wherein the guiding element supports at least one conductor electrically connected to the proximal end of the electrode array.

34. The electrical lead system of claim 27 wherein the guiding element is electrically connected to the proximal end of the electrode array.

35. The electrical lead system of claim 27 wherein the interconnect comprises a flexible ribbon cable.

36. The electrical lead of claim 35 wherein the ribbon cable is encased in silicone.

37. The electrical lead system of claim 27 wherein the interconnect comprises fluidic channels.

38. An electrode lead for implantation into body tissue, the lead comprising:

a) a first electrical subsystem comprising a three-dimensional shape extending from a distal end to a proximal end, wherein the first electrical subsystem includes a plurality of electrodes that are configured for either electrical stimulation of biological tissue or recordation of biological activity;

b) a guiding element configured to have a first three-dimensional shape extending from a guiding element distal end to a guiding element proximal end, wherein the guiding element distal end is connected to the first electrical subsystem proximal end and wherein the guiding element proximal end is configured to be electrically connectable to a second electrical subsystem; and

c) wherein the guiding element is maneuverable into a second three-dimensional shape that is different than the first three-dimensional shape while the first electrical subsystem comprising the plurality of electrodes connected to the distal end of the guiding element maintains its rigid three-dimensional shape, and

d) wherein there are at least a first row and a second row of four stimulation electrodes along the carrier length, the stimulation electrodes being equally spaced around a circumference of the carrier, and two diametrically opposed recording electrodes positioned between the first and second rows of stimulation electrodes.

39. The electrical lead of claim 38 wherein the guiding element supports at least one conductor electrically connected to the proximal end of the electrode array.

40. The electrical lead of claim 38 wherein the guiding element is electrically connected to the proximal end of the electrode array.

41. An electrode lead for implantation into body tissue, the lead comprising:

a) a cylindrical carrier extending along a carrier length from a carrier proximal end to a carrier distal end;

b) an electrode array comprising a plurality of electrodes supported on the carrier in a rigid three-dimensional shape; and

c) a guiding element extending from a guiding element proximal end to a guiding element distal end, wherein the guiding element distal end is connected to the electrode array, and wherein the guiding element is configured to have a first three-dimensional shape, and

d) wherein the guiding element is maneuverable into a second three-dimensional shape that is different than the first three-dimensional shape while the carrier supporting the plurality of electrodes connected to the distal end of the guiding element maintains its cylindrical three-dimensional shape, and

e) wherein the plurality of electrodes comprise stimulation electrodes configured for electrical stimulation of biological tissue and recording electrodes configured for recording of biological activity from biological tissue and wherein there are at least a first row and a second row of four stimulation electrodes along the carrier length, the stimulation electrodes being equally spaced around a circumference of the carrier, and two diametrically opposed recording electrodes positioned between the first and second rows of stimulation electrodes.