Method of making a lead for an implantable stimulation system

• US 8,966,745 B2
• Filed: 12/27/2012
• Issued: 03/03/2015
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Primary Examiner(s): ARBES, CARL J
• Application Number:
  US13/727,996
• Publication Number:
  US 20130123868A1
• Time in Patent Office: 796 Days
• Field of Search: 298/25, 298/57, 298/68, 298/69, 298/74, 298/76, 298/83
• US Class Current: 29/825
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement
• CPC Class Codes: H01R 25/003 the coupling part being secured only to wires or cables
• CPC Class Codes: H01R 31/02 Intermediate parts for distributing energy to two or more circuits in parallel, e.g. splitter with a holder adapted for supporting apparatus to which its counterpart is attached H01R33/92
• 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 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49172 by molding of insulating material
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor
• CPC Class Codes: Y10T 29/49194 Assembling elongated conductors, e.g., splicing, etc.
• CPC Class Codes: Y10T 29/49195 with end-to-end orienting
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing
• CPC Class Codes: Y10T 29/49206 by powder metallurgy

Abstract

A lead assembly includes a lead with a distal end and a proximal end. The lead includes a plurality of electrodes disposed at the distal end and a plurality of terminals disposed at the proximal end. The lead also defines at least one central lumen and a plurality of outer lumens. The central and outer lumens extend from the proximal end to the distal end such that the plurality of outer lumens extend laterally from the at least one central lumen. The lead further includes a plurality of conductive wires. Each conductive wire couples at least one of the plurality of electrodes electrically to at least one of the plurality of terminals. At least two conductive wires are disposed in each of the plurality of outer lumens.

Claims

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

disposing a plurality of conductive wires into a plurality of outer lumens extending along a longitudinal length of an elongated lead body with at least two different conductive wires of the plurality of conductive wires disposed into each outer lumen of the plurality of outer lumens, wherein the lead body further defines a central lumen extending along a longitudinal length of an elongated lead body;

electrically coupling a different contact of a plurality of contacts to each conductive wire of the plurality of conductive wires at a first end of the lead body with the plurality of contacts being longitudinally-spaced-apart from one another along the first end of the lead body;

placing the first end of the lead body into a mold, the mold comprising a cavity defining a plurality of spaced-apart cylindrical pockets, wherein the first end of the lead body is placed into the mold with each contact of the plurality of contacts aligning with a different pocket of the plurality of pockets; and

injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill the spaces between the spaced-apart cylindrical pockets.

2. The method of claim 1, wherein electrically coupling a different contact of a plurality of contacts to each conductive wire of the plurality of conductive wires comprises for each of the plurality of outer lumens, electrically coupling the at least two conductive wires disposed in that outer lumen to adjacent contacts of the plurality of contacts.

3. The method of claim 1, wherein injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill open spaces between the spaced-apart cylindrical pockets comprises filling open spaces between adjacent contacts of the plurality of contacts.

4. The method of claim 1, wherein injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill open spaces between the spaced-apart cylindrical pockets comprises filling open spaces between an interior surface of each outer lumen of the plurality of outer lumens and an exterior surface of at least one conductive wire of the plurality of conductive wires disposed within the plurality of outer lumens.

5. The method of claim 1, wherein electrically coupling a different contact of a plurality of contacts to each conductive wire of the plurality of conductive wires at a first end of the lead body comprises electrically coupling a different terminal of a plurality of terminals to each conductive wire of the plurality of conductive wires at a proximal end of the lead body.

6. The method of claim 5, further comprising disposing an end plug comprising an end cap and a rod over the proximal end of the lead body with the rod extending into the central lumen and the end cap covering the proximal end of the lead body prior to injecting the resin into the mold cavity between the spaced-apart cylindrical pockets.

7. The method of claim 6, wherein injecting a resin into the mold cavity between the spaced-apart cylindrical pockets further comprises injecting the resin between a proximal-most terminal of the plurality of terminals and the end cap of the end plug.

8. The method of claim 5, further comprising

electrically coupling a different electrode of a plurality of electrodes to each conductive wire of the plurality of conductive wires at a distal end of the lead body with the plurality of electrodes being longitudinally-spaced-apart from one another along the distal end of the lead body;

placing the distal end of the lead body into the mold with each electrode of the plurality of electrodes aligning with a different pocket of the plurality of pockets of the mold; and

injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill the spaces between the spaced-apart cylindrical pockets.

9. The method of claim 1, further comprising grinding down outer surfaces of the lead body and contacts.

10. The method of claim 1, wherein disposing a plurality of conductive wires into a plurality of outer lumens comprises disposing a plurality of conductive wires into a plurality of outer lumens each having a major axis, and wherein for each of the plurality of outer lumens the major axis is disposed approximately perpendicular to a diameter of the lead which passes through a center of that outer lumen.

11. The method of claim 1, wherein disposing a plurality of conductive wires into a plurality of outer lumens comprises disposing a plurality of conductive wires into a plurality of outer lumens each having a major axis, and wherein for each of the plurality of outer lumens the major axis is disposed at an angle in the range of 15 to 60 degrees relative to a diameter of the lead which passes through a center of that outer lumen.

12. The method of claim 1, wherein disposing a plurality of conductive wires into a plurality of outer lumens comprises disposing a plurality of conductive wires into a plurality of outer lumens each having a major axis, and wherein for each of the plurality of outer lumens the outer lumen has a width along the major axis that is equal to the sum of diameters of the at least two different conductive wires disposed in that outer lumen.

13. The method of claim 1, wherein disposing a plurality of conductive wires into a plurality of outer lumens comprises disposing a plurality of conductive wires into a plurality of outer lumens each having a major axis and an axis that is transverse to the major axis, and wherein for each of the plurality of outer lumens the outer lumen has a width along the transverse axis that is equal to the diameter of at least one of the at least two different conductive wires disposed in that outer lumen.

14. The method of claim 8, wherein electrically coupling a different electrode of a plurality of electrodes to each conductive wire of the plurality of conductive wires comprises electrically coupling each of sixteen electrodes to a different conductive wire of the plurality of conductive wires.

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

disposing a plurality of conductive wires into a plurality of outer lumens extending along a longitudinal length of an elongated lead body, wherein the lead body further defines a central lumen extending along a longitudinal length of an elongated lead body;

electrically coupling a different contact of a plurality of contacts to each conductive wire of the plurality of conductive wires at a first end of the lead body with the plurality of contacts being longitudinally-spaced-apart from one another along the first end of the lead body;

placing the first end of the lead body into a mold, the mold comprising a cavity defining a plurality of spaced-apart cylindrical pockets, wherein the first end of the lead body is laced into the mold with each contact of the plurality of contacts aligning with a different pocket of the plurality of pockets;

injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill the spaces between the spaced-apart cylindrical pockets; and

grinding down outer surfaces of the lead body and contacts.

16. The method of claim 15, wherein electrically coupling a different contact of a plurality of contacts to each conductive wire of the plurality of conductive wires at a first end of the lead body comprises electrically coupling a different terminal of a plurality of terminals to each conductive wire of the plurality of conductive wires at a proximal end of the lead body.

17. The method of claim 16, further comprising disposing an end plug comprising an end cap and a rod over the proximal end of the lead body with the rod extending into the central lumen and the end cap covering the proximal end of the lead body prior to injecting the resin into the mold cavity between the spaced-apart cylindrical pockets.

18. The method of claim 17, wherein injecting a resin into the mold cavity between the spaced-apart cylindrical pockets further comprises injecting the resin between a proximal-most terminal of the plurality of terminals and the end cap of the end plug.

19. The method of claim 16, further comprising

electrically coupling a different electrode of a plurality of electrodes to each conductive wire of the plurality of conductive wires at a distal end of the lead body with the plurality of electrodes being longitudinally-spaced-apart from one another along the distal end of the lead body;

placing the distal end of the lead body into the mold with each electrode of the plurality of electrodes aligning with a different pocket of the plurality of pockets of the mold; and

injecting a resin into the mold cavity between the spaced-apart cylindrical pockets to fill the spaces between the spaced-apart cylindrical pockets.