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

• US 20130105071A1
• Filed: 11/02/2012
• Published: 05/02/2013
• 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
• Granted Patent: US 9,079,013 B2
• Time in Patent Office: Days
• US Class Current: 156/256
• 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 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.

2. The method of claim 1, wherein pre-forming at least one relief section along a length of an elongated conductor 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 inserting the pre-formed conductor into the conductor lumen comprises pulling the pre-formed conductor along the conductor lumen via a substantially-straight region of the pre-formed conductor.

4. The method of claim 1, wherein inserting the pre-formed conductor into the conductor lumen comprises pulling the pre-formed conductor along the conductor lumen using a pull mandrel.

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

forming an access aperture in an elongated lead body having a first end and an opposing second end to expose a conductor lumen extending along a length of the lead body;

inserting a first end of an elongated conductor into the first end of the lumen and advancing the conductor along the conductor lumen until the first end of the conductor is visible through the access aperture from a location external to the lead body;

accessing the first end of the conductor through the access aperture and forming at least one relief section along a portion of the conductor; and

sealing the access aperture.

6. The method of claim 5, further comprising advancing the first end of the conductor to the second end of the lead body after the relief section in formed along a portion of the conductor.

7. The method of claim 5, wherein forming at least one relief section along a portion of the conductor comprises forming at least one of a plurality of axially-spaced-apart coils, crimps, zigzags, waves, or undulations.

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

inserting an elongated conductor into a conductor lumen of an elongated first lead body portion having opposing first and second ends, wherein a portion of the conductor that includes a first end of the conductor extends outwardly from the second end of the first lead body portion;

forming a relief section in the portion of the conductor extending outwardly from the second end of the first lead body portion;

inserting the first end of the conductor into a first end of a spacer section having opposing first and second ends until the first end of the spacer section abuts the second end of the first lead body portion and the relief section of the conductor is disposed in a strain relief cavity defined in the spacer section, wherein when the first end of the spacer section abuts the second end of the first lead body portion, a portion of the conductor that includes the first end of the conductor extends outwardly from the second end of the spacer section;

inserting the first end of the conductor extending from the second end of the spacer section into a conductor lumen disposed at a first end of an elongated second lead body portion having opposing first and second ends until the first end of the second lead body portion abuts the second end of the spacer section; and

reflowing the first lead body portion, the second lead body portion, and the spacer section to couple the spacer section to the first lead body portion and the second lead body portion.

9. The method of claim 8, wherein the strain relief cavity has a diameter that is larger than both a diameter of the conductor lumen of the first lead body portion and a diameter of the conductor lumen of the second lead body portion.

10. The method of claim 8, wherein the conductor has a nominal clearance within the conductor lumens of both the first and the second lead body portions of at least 0.005 cm.

11. The method of claim 8, wherein inserting a conductor into the conductor lumen of the first lead portion comprises inserting a conductor with insulation disposed over the conductor, and wherein the insulation is coated with at least one of perfluoroalkoxy or polytetrafluoroethylene.

12. The method of claim 8, wherein forming a relief section in the portion of the conductor extending from the severed end comprises forming at least one of a plurality of axially-spaced-apart coils, crimps, zigzags, waves, or undulations.

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

inserting an elongated conductor into a conductor lumen of an elongated first lead body portion having opposing first and second ends, wherein a portion of the conductor that includes a first end of the conductor extends outwardly from the second end of the first lead body portion;

forming a relief section in the portion of the conductor extending outwardly from the second end of the first lead body portion;

boring a strain relief cavity into a first end of an elongated second lead body portion having opposing first and second ends, the strain relief cavity in communication with a conductor lumen extending along at least a portion of a longitudinal length of the second lead body portion;

inserting the first end of the conductor extending from the second end of the first lead body portion into the conductor lumen of the second lead body portion until the first end of the second lead body portion abuts the second end of the first lead body portion and the relief section of the conductor is disposed in the strain relief cavity defined in the second lead body portion; and

reflowing the first lead body portion and the second lead body portion to couple the first lead body portion to the second lead body portion.

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

inserting a conductor 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;

fixedly attaching the conductor to the conductor lumen at a fixation attachment disposed along the length of the lead body;

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.

15. The method of claim 14, wherein fixedly attaching the conductor to the conductor lumen at a fixation attachment disposed along the length of the lead body comprises forming an access aperture in the lead body in proximity to the fixation attachment.

16. The method of claim 15, wherein fixedly attaching the conductor to the conductor lumen at a fixation attachment disposed along the length of the lead body comprises reflowing the lead body at the fixation attachment.

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

inserting a conductor 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 a first conductive contact at the first end of the lead body with a first gap formed between the first conductive contact and the first end of the lead body;

electrically coupling the first end of the conductor to the first conductive contact;

disposing a second conductive contact at the second end of the lead body;

electrically coupling the second end of the conductor to the second conductive contact; and

reducing the first gap between the first conductive contact and the first end of the lead body, wherein reducing the first gap causes the conductor to form at least one first relief section.

18. The method of claim 17, wherein disposing a second conductive contact at the second end of the lead body comprises disposing the second conductive contact at the second end of the lead body with a second gap formed between the second conductive contact and the second end of the lead body.

19. The method of claim 18, further comprising reducing the second gap between the second conductive contact and the second end of the lead body, wherein reducing the second gap causes the conductor to form at least one second relief section.

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

inserting a conductor 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;

stretching the lead body;

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; and

allowing the lead body to relax, the relaxation of the lead body causing the conductor to form at least one relief section.