LEADS WITH SEGMENTED ELECTRODES AND METHODS OF MAKING AND USING THE LEADS

• US 20140358209A1
• Filed: 05/23/2014
• Published: 12/04/2014
• Est. Priority Date: 05/31/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Romero, Daniel James, Howard, Joshua Dale
• Granted Patent: US 9,381,348 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

A stimulation lead includes a lead body. Terminals and electrodes are disposed along opposing end portions of the lead body and are electrically-coupled to one another via conductors. The electrodes include segmented electrodes. Each of the segmented electrodes includes a proximal end, a distal end, an exterior surface, an interior surface opposite the exterior surface, a first side-wall extending radially between the interior surface and the exterior surface from the distal end to the proximal end, and a second side-wall opposite to the first side-wall and extending radially between the interior surface and the exterior surface from the distal end to the proximal end. At least one of the segmented electrodes defines an open cavity that is formed along the first side-wall of the segmented electrode and that facilitates adhesion of the segmented electrode to the lead body.

Claims

1. A stimulation lead, comprising:

a lead body comprising a longitudinal surface, a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of electrodes disposed along the distal end portion of the lead body, the plurality of electrodes comprising a plurality of segmented electrodes, each of the plurality of segmented electrodes comprising a proximal end, a distal end, an exterior surface, an interior surface opposite the exterior surface, a first sidewall extending radially between the interior surface and the exterior surface from the distal end to the proximal end, a second side-wall opposite to the first side-wall and extending radially between interior surface and the exterior surface from the distal end to the proximal end, at least one of the plurality of segmented electrodes defining at least one open cavity formed along the first side-wall of the segmented electrode and extending circumferentially inwardly and extending front the distal end to the proximal end, the at least one open cavity configured and arranged to facilitate adhesion of the segmented electrode to the lead body; and

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes.

2. The stimulation lead of claim 1, wherein the at least one open cavity comprises and internal ridge that extends from the distal end to the proximal end of the at least one segmented electrode.

3. The stimulation lead of claim 1, wherein the at least one open cavity receives a portion of at least one conductor of the plurality of conductors.

4. The stimulation lead of claim 1, wherein the at least one open cavity receives a portion of at least one conductor of the plurality of conductors.

5. The stimulation lead oh claim 1, wherein at least one of the plurality of segmented electrodes receives a portion, of and electrically couples to, at least two conductors of the plurality of conductors.

6. The stimulation lead of claim 1, wherein the first side-wall and the exterior surf ice of at least one of the plurality of segmented electrodes form an angle that is greater than 90°

.

7. The stimulation lead of claim 1, wherein at least one of the plurality of segmented electrodes further defines at least one channel formed along the interior surface of the segmented electrode and extending from the proximal end to the distal end of the segmented electrode, the at least one channel configured and arranged to facilitate adhesion of the segmented electrode to the lead body.

8. The stimulation lead of claim 7, wherein the at least one channel has an arcuate cross-sectional profile.

9. The stimulation lead of claim 7, wherein the at least one channel has a U-shaped cross-sectional profile.

10. The stimulation lead of claim 7, wherein the at least one channel extends along at least 30% of a circumferential length of the ulterior surface of the segmented electrode.

11. A method of making a stimulation lead, the method comprising

disposing at least one pre-electrode along a distal end portion of a lead body, the at least one pre-electrode comprising a substantially-cylindrical body comprising an outer surface, an interior surface opposite the outer surface, a proximal end, and a distal end, the body comprising

a plurality of segmented electrodes disposed along the body in a spaced-apart configuration, each of the plurality of segmented electrodes extending between the proximal end and the distal end of the body, each of the plurality of segmented electrodes also extending between the interior surface of the body and an exterior surface, each of the plurality of segmented electrodes comprising a first side-wall and a second side-wall opposite to the first side-wall, the first side-wall and the second side-wall each extending radially between the interior surface and the exterior surface from the distal end to the proximal end, the plurality of segmented electrodes comprising a first segmented electrode and a second segmented electrode, the first segmented electrode defining a first open cavity extending circumferentially inwardly into the first side-wall from the distal end to the proximal end,

connecting material coupling the first segmented electrode to the second segmented electrode, and

a cutout defined along the body between the first segmented electrode and the second electrode;

and

placing non-conductive material within the first open cavity so facilitate retention of the segmented electrode with the lead body.

12. The method of claim 11, further comprising placing non-conductive material within at least one channel formed along the interior surface of the first segmented electrode, the at least one channel extending from the distal end to the proximal end.

13. The method of claim 11, further comprising removing the connecting material to physically separate the first segmented electrode from the second segmented electrode.

14. The method of claim 11, wherein the at least one pre-electrode comprises a first pre-electrode and a second pre-electrode, and further comprising circumferentially aligning the plurality of segmented electrodes of the first pre-electrode with the plurality of segmented electrodes of the second pre-electrode along a longitudinal length of the lead body.

15. The method of claim 11, further comprising receiving within the at least one open cavity a portion of at least one conductor extending along a longitudinal length of the lead body.

16. A pre-electrode tor a stimulation lead, the pre-electrode comprising:

a substantially-cylindrical body comprising an outer surface, an interior surface opposite the outer surface, a proximal end, and a distal end;

a plurality of segmented electrodes disposed along the body in a spaced-apart configuration, each of the plurality of segmented electrodes having opposing side-walls extending between the proximal end and the distal end of the body;

at least one open cavity defined along at least one side-wall of at least one of the plurality of segmented electrodes, the at least one cavity extending between the proximal end and the distal end of the body;

connecting material disposed along the outer surface of the body, the connecting material coupling each of the plurality of segmented electrodes to one another;

a plurality of cutouts defined between adjacent segmented electrodes of the plurality of segmented electrodes; and

at least one alignment feature formed on or in the outer surface of the body.

17. The pre-electrode of claim 16, wherein the at least one alignment feature forms an opening extending between the outer surface of the body and one of the plurality of cutouts.

18. The pre-electrode of claim 17, wherein the at least one alignment feature comprises an alignment slit extending between the proximal end of the body to the distal end of the body.

19. The pre-electrode of claim 17, wherein the at least one alignment feature comprises at least one of an alignment aperture extending less than an entire dimension between the proximal end of the body to the distal end of the body.

20. The pre-electrode of claim 16, wherein the at least one alignment feature comprises at least one of an alignment tab extending radially outward from the outer surface of the body.