Segmented electrode leads formed from pre-electrodes with alignment features and methods of making and using the leads

• US 9,149,630 B2
• Filed: 05/23/2014
• Issued: 10/06/2015
• 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: Howard, Joshua Dale, Pianca, Anne Margaret
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/286,829
• Publication Number:
  US 20140358208A1
• Time in Patent Office: 501 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: Y10T 29/49206 by powder metallurgy
• CPC Class Codes: Y10T 29/49208 by assembling plural parts

Abstract

A pre-electrode for a stimulation lead includes a generally cylindrical body having an exterior surface, an interior surface, a proximal end, and a distal end. The body includes multiple segmented electrodes disposed along the body; connecting material disposed along the outer surface of the body and coupling each of the segmented electrodes to one another; and multiple cutouts defined between adjacent segmented electrodes. The body also includes one or more of the following 1) a end wall step section formed in the exterior surface of the body on either the distal end or the proximal end of the body; 2) an alignment feature selected from a slot or a notch extending inwardly from the exterior surface of the body, or 3) a longitudinal step section formed in the exterior surface of the body.

Claims

1. A pre-electrode for a stimulation lead, the pre-electrode comprising:

a generally cylindrical body comprising an exterior surface, an interior surface opposite the exterior 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 having opposing side-walls 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 end wall step section formed in the exterior surface of the body on either the distal end or the proximal end of the body.

2. The pre-electrode of claim 1, wherein the at least one end wall step section has an appearance of a section, bounded by two intersection planes, removed from the generally cylindrical body.

3. The pre-electrode of claim 1, further comprising at least one alignment feature selected from a slot or a notch formed extending inwardly from the exterior surface of the body and aligned with a one of the plurality of cutouts.

4. The pre-electrode of claim 1, further comprising at least one longitudinal step section formed in the exterior surface of the body along a longitudinal side of the body and extending from the distal end to the proximal end of the body.

5. The pre-electrode of claim 4, wherein the at least one longitudinal step section comprises a first longitudinal step section and a second longitudinal step section opposite the first longitudinal step section.

6. The pre-electrode of claim 1, wherein the at least one end wall step section comprises a first end wall step section formed in the exterior surface of the body on the distal end and a second end wall step section formed in the exterior surface of the body on the proximal end of the body.

7. The pre-electrode of claim 1, the body further comprising an annular groove and two annular lips flanking the annular grove.

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

disposing the pre-electrode of claim 1 along a distal end portion of a lead;

forming a lead body around the pre-electrode; and

removing the connecting material from the pre-electrode to release the segmented electrodes.

9. A pre-electrode for a stimulation lead, the pre-electrode comprising:

a generally cylindrical body comprising an exterior surface, an interior surface opposite the exterior 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 having opposing side-walls 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 selected from a slot or a notch extending inwardly from the exterior surface of the body and aligned with a one of the plurality of cutouts.

10. The pre-electrode of claim 9, wherein the at least one alignment feature extends from the exterior surface of the body to the interior surface of the body.

11. The pre-electrode of claim 9, wherein the at least one alignment feature is a slot in the form of a groove extending from the proximal end to the distal end of the body and not extending to the interior surface of the body.

12. The pre-electrode of claim 9, where the at least one alignment feature comprises a first notch formed at the distal end of the body and a second notch formed at the proximal end of the body.

13. The pre-electrode of claim 9, the body further comprising an annular groove and two annular lips flanking the annular grove.

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

disposing the pre-electrode of claim 9 along a distal end portion of a lead;

forming a lead body around the pre-electrode; and

removing the connecting material from the pre-electrode to release the segmented electrodes.

15. A pre-electrode for a stimulation lead, the pre-electrode comprising:

a generally cylindrical body comprising an exterior surface, an interior surface opposite the exterior 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 having opposing side-walls 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 longitudinal step section formed in the exterior surface of the body along a longitudinal side of the body and extending from the distal end to the proximal end of the body.

16. The pre-electrode of claim 15, wherein the at least one longitudinal step section comprises a first longitudinal step section and a second longitudinal step section opposite the first longitudinal step section.

17. The pre-electrode of claim 15, further comprising at least one end wall step section formed in the exterior surface of the body on either the distal end or the proximal end of the body.

18. The pre-electrode of claim 16, further comprising a first longitudinal region and a second longitudinal region, wherein the first and second longitudinal regions flank both the first longitudinal step section and the second longitudinal step section, and the first longitudinal region has an outer radius smaller than an outer radius of the second longitudinal region.

19. The pre-electrode of claim 16, further comprising a first longitudinal region and a second longitudinal region, wherein the first and second longitudinal regions flank both the first longitudinal step section and the second longitudinal step section, and the first longitudinal region and the second longitudinal region have a same outer radius.

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

disposing the pre-electrode of claim 15 along a distal end portion of a lead;

forming a lead body around the pre-electrode; and

removing the connecting material from the pre-electrode to release the segmented electrodes.