SYSTEMS AND METHODS FOR MAKING AND USING IMPROVED LEADS FOR ELECTRICAL STIMULATION SYSTEMS

• US 20120316615A1
• Filed: 06/06/2012
• Published: 12/13/2012
• Est. Priority Date: 06/07/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: DiGiore, Andrew, Lopez, Thomas
• Granted Patent: US 8,942,810 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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 method for manufacturing a lead, the method comprising:

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

twisting the multi-lumen conductor guide to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the stylet lumen, wherein 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.

2. The method of claim 1, further comprising applying heat to the multi-lumen conductor guide to set the at least one helical section.

3. The method of claim 2, further comprising inserting at least one conductor into at least one of the plurality of conductor lumens.

4. The method of claim 3, 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.

5. The method of claim 4, 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.

6. The method of claim 4, wherein inserting at least one mandrel into each of the plurality of conductor lumens comprises inserting at least one mandrel into each of the plurality of conductor lumens with each of the at least one mandrels having a diameter that is smaller than a diameter of the conductor lumen into which the at least one mandrel is disposed.

7. The method of claim 4, wherein inserting at least one mandrel into each of the plurality of conductor lumens comprises inserting at least one mandrel into each of the plurality of conductor lumens with each of the at least one mandrels having a diameter that is larger than a diameter of the at least one conductor inserted into the conductor lumen.

8. The method of claim 1, wherein twisting the multi-lumen conductor guide to form helical pathways around the stylet lumen comprises twisting the multi-lumen conductor guide to form helical pathways each having a pitch that is no less than 0.1 turns per centimeter.

9. The method of claim 1, wherein twisting the multi-lumen conductor guide to form helical pathways around the stylet lumen comprises twisting the multi-lumen conductor guide to form helical pathways each having a pitch that is no less than 0.1 turns per centimeter and no greater than 0.8 turns per centimeter.

20. A deep brain stimulation system comprising:

the lead of claim 9;

a lead extension having a first end and an opposing second end, the lead extension comprising

a plurality of lead extension terminals disposed on the second end of the lead extension;

a connector disposed at the first end of the lead extension, the connector comprising a connector housing defining a connector port, the connector port configured and arranged to receive the lead,

a plurality of connector contacts disposed in the connector port, the connector contacts configured and arranged to electrically couple to the lead terminals when the lead is received by the connector housing, and

a plurality of conductors extending along a length of the lead extension, wherein each of the conductors electrically couples at least one of the lead extension terminals to at least one of the plurality of connector contacts; and

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

10. 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 extending from the proximal end of the lead body to the distal end of the lead body, the 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, 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 one helical section where the plurality of conductor lumens form helical pathways around the stylet lumen, and wherein 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;

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 at least one of the plurality of electrodes to at least one of 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.

11. The lead of claim 10, wherein each of the plurality of conductor lumens is configured and arranged to receive a different single conductor of the plurality of conductors.

12. The lead of claim 10, wherein each of the plurality of conductor lumens is configured and arranged to receive a plurality of conductors of the plurality of conductors.

13. The lead of claim 10, wherein the at least one helical section extends the entire longitudinal length of the lead body.

14. The lead of claim 10, wherein the at least one helical section extends less than the entire longitudinal length of the lead body.

15. The lead of claim 10, wherein the at least one helical section comprises a first helical section and a second helical section disposed axially along the multi-lumen conductor guide from the first helical section.

16. The lead of claim 15, wherein the first helical section and the second helical section are wound in opposite directions along the longitudinal length of the lead body from one another.

17. The lead of claim 10, wherein the at least one helical section has a constant pitch.

18. The lead of claim 10, wherein the at least one helical section has a variable pitch.

19. The lead of claim 10, wherein each of the helical pathways of the at least one helical section has a pitch that is no less than 0.1 turns per centimeter.