Leads with electrode carrier for segmented electrodes and methods of making and using

• US 9,427,567 B2
• Filed: 10/23/2015
• Issued: 08/30/2016
• Est. Priority Date: 08/03/2012
• 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
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US14/922,011
• Publication Number:
  US 20160038732A1
• Time in Patent Office: 312 Days
• US Class Current: 1/1
• 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 1/0556 Cuff electrodes
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A stimulation lead includes a lead body having a longitudinal length, a distal portion, and a proximal portion; terminals disposed along the proximal portion of the lead body; an electrode carrier coupled to, or disposed along, the distal portion of the lead body; segmented electrodes disposed along the electrode carrier; and conductors extending along the lead body and coupling the segmented electrodes to the terminals. The electrode carrier includes a lattice region defining segmented electrode receiving openings. Each of the segmented electrodes extends around no more than 75% of a circumference of the lead and is disposed in a different one of the segmented electrode receiving openings of the electrode carrier.

Claims

1. A stimulation lead, comprising:

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

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

a single electrode carrier coupled to, or disposed along, the distal portion of the lead body, the electrode carrier comprising a lattice region defining a plurality of segmented electrode receiving openings, wherein the lattice region is formed of a non-conductive material, wherein the segmented electrode receiving openings are arranged in a plurality of sets with each of the sets being disposed at a different longitudinal position along the lead and comprising two or more of the segmented electrode receiving openings, wherein the plurality of sets comprises a first set and a second set adjacent to the first set, wherein the lead body and the electrode carrier are formed of different materials;

a plurality of electrodes comprising a plurality of segmented electrodes, each of the segmented electrodes disposed in a different one of the segmented electrode receiving openings of the electrode carrier; and

a plurality of conductors extending along the lead body and coupling the plurality of electrodes to the plurality of terminals.

2. The stimulation lead of claim 1, wherein the plurality of electrodes further comprises a first ring electrode, wherein the electrode carrier comprises a proximal portion disposed proximal to all of the segmented electrodes, wherein the first ring electrode is disposed on the proximal portion of the electrode carrier and separated from each of the segmented electrodes by the electrode carrier, wherein the proximal portion of the electrode carrier is radially beneath the first ring electrode.

3. The stimulation lead of claim 2, wherein the plurality of electrodes comprises a second ring electrode and the electrode carrier comprises a distal portion disposed distal to all of the segmented electrodes, wherein the second ring electrode is disposed on the distal portion of the electrode carrier and separated from each of the segmented electrodes by the electrode carrier.

4. The stimulation lead of claim 1, wherein the plurality of electrodes further comprises a first ring electrode, wherein the electrode carrier comprises a distal portion disposed distal to all of the segmented electrodes, wherein the first ring electrode is disposed on the distal portion of the electrode carrier and separated from each of the segmented electrodes by the electrode carrier, wherein the distal portion of the electrode carrier is radially beneath the first ring electrode.

5. The stimulation lead of claim 1, wherein the electrode carrier further comprises at least one breakage position configured and arranged to be weakened relative to adjacent portions of the electrode carrier to permit breakage of the electrode carrier after manufacture of the stimulation lead.

6. The stimulation lead of claim 5, wherein the at least one breakage position comprises a first breakage position disposed between two of the sets of the segmented electrode receiving openings.

7. The stimulation lead of claim 6, wherein the plurality of electrodes further comprises a first ring electrode disposed on the carrier and the at least one breakage position comprises a second breakage position disposed between one of the sets of the segmented electrode receiving openings and the first ring electrode.

8. The stimulation lead of claim 1, wherein the electrode carrier defines a central lumen through which at least a portion of the plurality of conductors passes.

16. A electrical stimulation system, comprising:

the electrical stimulation lead of claim 1; and

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing and configured and arranged to generate and direct electrical stimulation to the electrodes of the electrical stimulation lead.

18. The stimulation lead of claim 1, wherein the segmented electrode receiving openings of the first set are staggered with respect to the segmented electrode receiving openings of the second set.

19. The stimulation lead of claim 1, wherein the lead body and the carrier are made using polyurethane, but the polyurethane of the carrier has a higher durometer than the polyurethane of the lead body.

9. A stimulation lead, comprising:

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

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

a single electrode carrier coupled to, or disposed along, the distal portion of the lead body, the electrode carrier comprising a lattice region defining a plurality of segmented electrode receiving openings, wherein the lattice region is formed of a non-conductive material, wherein the lead body and the electrode carrier are formed of different materials;

a plurality of electrodes comprising a plurality of segmented electrodes, each of the segmented electrodes disposed in a different one of the segmented electrode receiving openings of the electrode carrier; and

a plurality of conductors extending along the lead body and coupling the plurality of electrodes to the plurality of terminals.

10. The stimulation lead of claim 9, wherein the plurality of electrodes further comprises a first ring electrode, wherein the electrode carrier comprises a proximal portion disposed proximal to all of the segmented electrodes, wherein the first ring electrode is disposed on the proximal portion of the electrode carrier and separated from each of the segmented electrodes by the electrode carrier, wherein the proximal portion of the electrode carrier is radially beneath the first ring electrode.

11. The stimulation lead of claim 10, wherein the plurality of electrodes comprises a second ring electrode and the electrode carrier comprises a distal portion disposed distal to all of the segmented electrodes, wherein the second ring electrode is disposed on the distal portion of the electrode carrier and separated from each of the segmented electrodes by the electrode carrier.

12. The stimulation lead of claim 9, wherein the electrode carrier further comprises at least one breakage position configured and arranged to be weakened relative to adjacent portions of the electrode carrier to permit breakage of the electrode carrier after manufacture of the stimulation lead.

13. The stimulation lead of claim 12, wherein the at least one breakage position comprises a first breakage position disposed between two of the segmented electrode receiving openings.

14. The stimulation lead of claim 13, wherein the plurality of electrodes further comprises a first ring electrode disposed on the carrier and the at least one breakage position comprises a second breakage position disposed between one of the segmented electrode receiving openings and the first ring electrode.

15. The stimulation lead of claim 9, wherein the electrode carrier defines a central lumen through which at least a portion of the plurality of conductors passes.

17. A electrical stimulation system, comprising:

the electrical stimulation lead of claim 9; and

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing and configured and arranged to generate and direct electrical stimulation to the electrodes of the electrical stimulation lead.

20. The stimulation lead of claim 9, wherein the segmented electrode receiving openings are arranged in a double helix.