Methods for making and using improved leads with pre-formed relief sections

• US 9,079,013 B2
• Filed: 11/02/2012
• Issued: 07/14/2015
• Est. Priority Date: 11/02/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: DiGiore, Andrew, Barker, John Michael, Pianca, Anne Margaret, Moffitt, Michael Adam, McDonald, Matthew Lee, Howard, Joshua Dale
• Primary Examiner(s): TRINH, MINH N
• Application Number:
  US13/667,953
• Publication Number:
  US 20130105071A1
• Time in Patent Office: 984 Days
• Field of Search: 298/25, 298/46, 298/50, 298/68, 298/84, 297/29, 297/39, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: H01R 43/00 Apparatus or processes specially adapted for manufacturing, assembling, maintaining, or repairing of line connectors or current collectors or for joining electric conductors of trolley lines B60M1/28
• CPC Class Codes: Y10T 156/1062 Prior to assembly
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor
• CPC Class Codes: Y10T 29/49179 by metal fusion bonding

Abstract

A method for manufacturing a lead includes pre-forming at least one relief section along a length of an elongated conductor having a first end and an opposing second end. The conductor with the pre-formed relief section is inserted into a conductor lumen defined along a length of an elongated lead body. The lead body has a first end and an opposing second end. An electrode is disposed at the first end of the lead body. The first end of the conductor is electrically coupled to the electrode. A terminal is disposed at the second end of the lead body. The second end of the conductor is electrically coupled to the terminal.

Claims

1. A method for manufacturing a lead, the method comprising:

pre-forming at least one portion of an elongated conductor into a relief section, wherein the elongated conductor has a first end and an opposing second end;

inserting the conductor with the relief section into a one of a plurality of conductor lumens of an elongated multi-lumen conductor guide, wherein the conductor lumens are arranged around a central lumen and each of the conductor lumens comprises at least one helical section, wherein the central lumen is configured to receive a stylet, and wherein each of the conductor lumens is defined along a length of an elongated lead body, the lead body having a first end and an opposing second end;

disposing an electrode at the first end of the lead body;

electrically coupling the first end of the conductor to the electrode;

disposing a terminal at the second end of the lead body; and

electrically coupling the second end of the conductor to the terminal.

2. The method of claim 1, wherein the step of pre-forming at least one portion of the elongated conductor into a relief section further comprises pre-forming at least one of a plurality of axially-spaced-apart coils, crimps, zigzags, waves, or undulations.

3. The method of claim 1, wherein the step of inserting the conductor further comprises pulling the conductor with the pre-formed relief section along the conductor lumen via a substantially-straight region of the conductor.

4. The method of claim 1, wherein the conductor is multi-filar.

5. The method of claim 1, wherein at least one of the conductor lumens is oval in cross-section.

6. The method of claim 1, wherein at least one of the conductor lumens is configured and arranged to receive a single conductor.

7. The method of claim 1, wherein at least one of the conductor lumens is configured and arranged to receive a plurality of conductors.

8. The method of claim 1, wherein the lead has coating insulation disposed over the conductor and wherein the coating insulation comprises perfluoroalkoxy polymers (“

PFA”

) or polytetrafluoroethylene (“

PTFE”

).

9. The method of claim 1, wherein each of the conductor lumens defines a plurality of the helical sections separated from one another by straight sections.

10. The method of claim 9, wherein each of the helical sections is arranged in counterrotation to adjacent ones of the plurality of helical sections.

11. The method of claim 9, wherein at least one of the helical sections is arranged in a clockwise configuration and at least one of the helical sections is arranged in a counterclockwise configuration.

12. The method of claim 9, wherein all of the helical sections are arranged in a same rotational configuration.

13. The method of claim 9, wherein the helical sections each have equal lengths.

14. The method of claim 9, wherein each of the helical sections has a length that is different from at least one other of the plurality of helical sections.

15. A method for manufacturing a lead, the method comprising:

pre-forming at least one relief section along a length of an elongated conductor having a first end and an opposing second end;

inserting the conductor with the pre-formed relief section into a conductor lumen defined along a length of an elongated lead body, the lead body having a first end and an opposing second end;

disposing an electrode at the first end of the lead body;

electrically coupling the first end of the conductor to the electrode;

disposing a terminal at the second end of the lead body; and

electrically coupling the second end of the conductor to the terminal,

wherein the step of inserting the pre-formed conductor into the conductor lumen further comprises pulling the pre-formed conductor along the conductor lumen using a pull mandrel.

16. The method of claim 15, wherein a diameter of the pull mandrel is smaller than a diameter of the conductor lumen, yet larger than a diameter of the conductor.

17. The method of claim 15, wherein inserting the conductor comprises inserting the conductor with the pre-formed relief section into a conductor lumen guide that defines a plurality of conductor lumens, including the conductor lumen, disposed around a central lumen.

18. The method of claim 17, wherein the conductor lumens are twisted to form at least one helical section.

19. The method of claim 15, wherein inserting the conductor comprises pulling the conductor via a substantially-straight region of the conductor.