Systems and methods for making and using improved leads for electrical stimulation systems

• US 9,474,895 B2
• Filed: 01/26/2015
• Issued: 10/25/2016
• Est. Priority Date: 06/07/2011
• Status: Expired

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: DiGiore, Andrew, Lopez, Thomas
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/605,781
• Publication Number:
  US 20150142091A1
• Time in Patent Office: 638 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: H01B 13/0016 for heat treatment
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A method for manufacturing a lead includes forming an elongated multi-lumen conductor guide defining a central stylet lumen and a plurality of conductor lumens arranged around the stylet lumen. The multi-lumen conductor guide is twisted to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the stylet lumen. Each of the helical pathways of the at least one helical section has a pitch that is no less than 0.04 turns per centimeter.

Claims

1. A lead for providing deep brain stimulation the lead comprising:

a lead body having a distal end, a proximal end, and a longitudinal length, the lead body comprising a multi-lumen conductor guide having an outer surface and defining a central stylet lumen configured and arranged for receiving a stylet and a plurality of conductor lumens disposed around the central stylet lumen in a ring, each conductor lumen configured and arranged to receive at least one conductor, wherein the plurality of conductor lumens are completely inset from the outer surface of the multi-lumen conductor guide, wherein at least a portion of the multi-lumen conductor guide is twisted such that the multi-lumen conductor guide forms at least a first helical section and a second helical section where each of the plurality of conductor lumens forms a helical pathway around the stylet lumen, wherein each of the helical pathways of the first and second helical sections has a pitch that is no less than 0.04 turns per centimeter, wherein the multi-lumen conductor guide further forms a first straight section disposed between the first helical section and the second helical section;

a plurality of electrodes disposed on the distal end of the lead body;

a plurality of lead terminals disposed on the proximal end of the lead body; and

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of lead terminals, wherein the plurality of conductors extend along the longitudinal length of the leady body within the plurality of conductor lumens, wherein the multi-lumen conductor guide extends the entire longitudinal length of the lead body from the electrodes to the terminals.

2. The lead of claim 1, wherein each of the plurality of conductor lumens is configured and arranged to receive a different single conductor of the plurality of conductors.

3. The lead of claim 1, wherein each of the plurality of conductor lumens is configured and arranged to receive a plurality of conductors of the plurality of conductors.

4. The lead of claim 1, wherein the first helical section and the second helical section are twisted in opposite directions from one another along the longitudinal length of the lead body.

5. The lead of claim 1, wherein the first helical section has a constant pitch.

6. The lead of claim 1, wherein the first helical section has a variable pitch.

7. An electrical stimulation system comprising:

the lead of claim 1; and

a control unit coupleable to lead, the control unit configured and arranged for providing stimulation to the plurality of electrodes of the lead.

8. A method for manufacturing the lead of claim 1, the method comprising:

forming the multi-lumen conductor guide defining the central stylet lumen and the plurality of conductor lumens arranged around the stylet lumen; and

twisting the multi-lumen conductor guide to form the first helical section wherein the first helical section has the pitch that is no less than 0.04 turns per centimeter.

9. The method of claim 8, further comprising applying heat to the multi-lumen conductor guide to set the first helical section.

10. The method of claim 9, further comprising inserting at least one of the plurality of conductors into at least one of the plurality of conductor lumens.

11. The method of claim 10, further comprising inserting at least one mandrel into each of the plurality of conductor lumens prior to applying heat to the multi-lumen conductor guide.

12. The method of claim 11, further comprising removing the at least one mandrel from each of the plurality of conductor lumens prior to inserting the at least one conductor into each of the plurality of conductor lumens.

13. The method of claim 8, wherein twisting the multi-lumen conductor guide comprises twisting the multi-lumen conductor guide to form helical pathways each having a pitch that is no greater than 0.8 turns per centimeter.

14. The method of claim 8, wherein forming an elongated multi-lumen conductor guide comprising extruding the multi-lumen conductor guide and wherein twisting the multi-lumen conductor guide comprises twisting the multi-lumen conductor guide while extruding the multi-lumen conductor guide.

15. A lead for providing deep brain stimulation, the lead comprising:

a lead body having a distal end, a proximal end, and a longitudinal length, the lead body comprising a multi-lumen conductor guide having an outer surface and defining a central stylet lumen configured and arranged for receiving a stylet and a plurality of conductor lumens disposed around the central stylet lumen in a ring, each conductor lumen configured and arranged to receive at least one conductor, wherein the plurality of conductor lumens are completely inset from the outer surface of the multi-lumen conductor guide, wherein at least a portion of the multi-lumen conductor guide is twisted such that the multi-lumen conductor guide forms at least a first helical section and a second helical section where each of the plurality of conductor lumens forms a helical pathway around the stylet lumen, wherein each of the helical pathways of the first and second helical sections has a pitch that is no less than 0.04 turns per centimeter, wherein the first and second helical sections are axially separate from each other and the first helical section and the second helical section are twisted in opposite directions from one another along the longitudinal length of the lead body;

a plurality of electrodes disposed on the distal end of the lead body;

a plurality of lead terminals disposed on the proximal end of the lead body; and

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of lead terminals, wherein the plurality of conductors extend along the longitudinal length of the leady body within the plurality of conductor lumens, wherein the multi-lumen conductor guide extends the entire longitudinal length of the lead body from the electrodes to the terminals.

16. The lead of claim 15, wherein each of the plurality of conductor lumens is configured and arranged to receive a different single conductor of the plurality of conductors.

17. The lead of claim 15, wherein each of the plurality of conductor lumens is configured and arranged to receive a plurality of conductors of the plurality of conductors.

18. The lead of claim 15, wherein the first helical section has a constant pitch.

19. The lead of claim 15, wherein the first helical section has a variable pitch.

20. An electrical stimulation system comprising:

the lead of claim 15; and

a control unit coupleable to lead, the control unit configured and arranged for providing stimulation to the plurality of electrodes of the lead.