Leads with spiral of helical segmented electrode arrays and methods of making and using the leads

• US 9,248,276 B2
• Filed: 02/25/2014
• Issued: 02/02/2016
• Est. Priority Date: 02/02/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pianca, Anne Margaret, McDonald, Matthew Lee
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US14/189,671
• Publication Number:
  US 20140180375A1
• Time in Patent Office: 707 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: H05K 13/00 Apparatus or processes specially adapted for manufacturing or adjusting assemblages of electric components
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A stimulation lead includes a lead body having a longitudinal surface, a distal end, a proximal end, and a shaft extending along at least a portion of the distal end of the lead body. The stimulation lead also includes multiple segmented electrode members disposed on the shaft along the longitudinal surface of the lead body near the distal end of the lead body. Each segmented electrode member includes a ring structure which forms at least a partial ring and is disposed on the shaft, and a segmented electrode coupled to the ring and having an exposed surface configured and arranged for stimulating tissue when the stimulation lead is implanted.

Claims

1. An assembly for forming a stimulation lead, comprising:

a lead body having a distal end and a proximal end; and

a pre-electrode assembly formed in a tube around a portion of the distal end of the lead body and comprising a plurality of segmented electrodes and a plurality of raised connectors, wherein the segmented electrodes form at least one helix or spiral, wherein each of the segmented electrodes is coupled to at least one other of the segmented electrodes by at least one of the raised connectors and the segmented electrodes and the raised connectors are formed of a same conductive material, the tube defining a longitudinal axis, wherein each of the raised connectors is disposed at a radius with respect to the longitudinal axis that is greater than a radius of any of the segmented electrodes with respect to the longitudinal axis, wherein each of the segmented electrodes is attached to one of the raised connectors at an angle in a range of 10 to 80 degrees with respect to an edge of that segmented electrode.

2. The assembly of claim 1, further comprising at least one ring electrode disposed around a portion of the distal end of the lead body.

3. The assembly of claim 1, wherein the segmented electrodes of the pre-electrode assembly form a single helix.

4. The assembly of claim 1, wherein the segmented electrodes of the pre-electrode assembly form a double helix.

5. The assembly of claim 1, wherein each of the segmented electrodes is directly coupled to at least two other of the segmented electrodes by the raised connectors.

6. The assembly of claim 1, wherein the angle is in a range of 30 to 60 degrees.

7. A method of making a stimulation lead, the method comprising:

forming the assembly of claim 1 by;

providing a pre-electrode assembly comprising the plurality of segmented electrodes and the plurality of raised connectors,

forming the pre-electrode assembly into the tube with the segmented electrodes forming at least one helix or spiral; and

forming at least a portion of the lead body around the segmented electrodes of the pre-electrode assembly; and

grinding the tube comprising the pre-electrode assembly and portion of the lead body to remove the plurality of raised connectors leaving the plurality of segmented electrodes and the portion of the lead body.

8. The method of claim 7, wherein the angle is in a range of 20 to 70 degrees.

9. The method of claim 7, wherein providing a pre-electrode assembly comprises stamping a metal sheet to form the plurality of segmented electrodes and the plurality of raised connectors.

10. The method of claim 9, wherein stamping the metal sheet comprises forming a plurality of gaps between the segmented electrodes and the raised connectors.

11. The method of claim 9, wherein stamping the metal sheet comprises stamping the metal sheet to form the plurality of segmented electrodes and a plurality of connectors and then bending the plurality of connectors to form the plurality of raised connectors.

12. The method of claim 7, wherein forming the pre-electrode assembly into the tube comprises wrapping the pre-electrode assembly around a cylindrical shaft.

13. The method of claim 12, wherein wrapping the pre-electrode assembly comprises wrapping the pre-electrode assembly around a lead tube defining at least one lumen through the lead tube.

14. The method of claim 7, further comprising attaching a conductor wire to at least one of the electrodes prior to forming the pre-electrode assembly into the tube.

15. The method of claim 7, further comprising attaching a conductor wire to at least one of the electrodes after forming the pre-electrode assembly into the tube.

16. The method of claim 7, wherein forming the portion of the lead body comprises molding the portion of the lead body around the segmented electrodes.

17. The method of claim 7, wherein forming the portion of the lead body comprises forming polymeric material beneath the connectors.

18. The method of claim 7, wherein grinding the tube comprises grinding the tube comprising the pre-electrode assembly and the portion of the lead body to form an isodiametric lead.

19. The method of claim 7, wherein the segmented electrodes of the pre-electrode assembly form a single helix.

20. The method of claim 7, wherein the segmented electrodes of the pre-electrode assembly form a double helix.