Implantable electric stimulation system and methods of making and using

• US 8,364,284 B2
• Filed: 09/15/2008
• Issued: 01/29/2013
• Est. Priority Date: 09/15/2008
• Status: Expired due to Fees

• 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): Layno, Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/210,451
• Publication Number:
  US 20100070009A1
• Time in Patent Office: 1,597 Days
• Field of Search: 607115-116, 607/119, 607122-123, 600/585, 604/43, 604/171
• US Class Current: 607/117
• 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 lead assembly comprising:

a lead with a distal end, a proximal end, and a longitudinal length, the lead comprising

a plurality of electrodes disposed at the distal end,

a plurality of terminals disposed at the proximal end,

at least one central lumen defined by the lead and extending along the longitudinal length of the lead from the proximal end to the distal end,

a plurality of outer lumens defined by the lead and extending along the longitudinal length of the lead from the proximal end to the distal end, the plurality of outer lumens extending laterally from the at least one central lumen, wherein the plurality of outer lumens are each oval-shaped with a major axis, and

a plurality of conductive wires extending along the longitudinal length of the lead, each conductive wire coupling at least one of the plurality of electrodes electrically to at least one of the plurality of terminals, wherein exactly two different conductive wires of the plurality of conductive wires are disposed in each of the plurality of outer lumens, the two different conductive wires each having an insulative coating to electrically insulate the two conductive wires from one another, and wherein each of the plurality of conductive wires has a diameter,

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 the diameters of the two conductive wires disposed in that outer lumen.

2. The lead assembly of claim 1, further comprising

a lead splitter configured and arranged to electrically couple with the lead, the lead splitter having a distal end and a plurality of proximal tails, the lead splitter comprising

a connector disposed at the distal end for receiving the proximal end of the lead, the connector comprising a connector housing defining at least one port for receiving the proximal end of the lead, and a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple electrically to at least one terminal on the proximal end of the lead, and

each of the plurality of proximal tails having a distal end and comprising at least one lead-splitter terminal and at least one lead-splitter conductive wire, the lead-splitter terminal disposed at the distal end and the at least one lead-splitter conductive wire electrically coupling at least one of the plurality of connector contacts of the connector to the at least one lead-splitter terminal.

3. The lead assembly of claim 1, 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.

4. The lead assembly of claim 1, 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.

5. The lead assembly of claim 1, wherein the proximal end of the lead further comprises an end plug disposed in the at least one central lumen, the end plug configured and arranged to stiffen the proximal end of the lead to facilitate insertion of the proximal end of the lead into a connector.

6. The lead assembly of claim 1, wherein sixteen electrodes are disposed at the distal end of the lead.

7. The lead assembly of claim 1, wherein the entire longitudinal length of the lead is isodiametric.

8. The lead assembly of claim 1, wherein for each of the plurality of outer lumens the outer lumen is symmetrical about the major axis.

9. The lead assembly of claim 1, wherein the plurality of outer lumens extend the entire longitudinal length of the lead between the plurality of electrodes and the plurality of terminals.

10. The lead assembly of claim 1, wherein the plurality of conductive wires extend the entire longitudinal length of the lead between the plurality of electrodes and the plurality of terminals.

11. An electrical stimulating system comprising:

the lead assembly of claim 1;

a control module configured and arranged to electrically couple to the lead of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector configured and arranged for receiving the lead of the lead assembly, the connector comprising

a connector housing defining at least one port for receiving the proximal end of the lead of the lead assembly, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one terminal of the plurality of terminals disposed at the proximal end of the lead of the lead assembly.

12. The electrical stimulating system of claim 11, further including a lead splitter having a distal end and a plurality of proximal tails, the connector disposed on the distal end of the lead splitter.

13. The electrical stimulating system of claim 12, wherein each of the proximal tails of the lead splitter is configured and arranged for insertion into another connector.

14. A lead assembly comprising:

a lead with a distal end, a proximal end, and a longitudinal length, the lead comprising

a plurality of electrodes disposed at the distal end,

a plurality of terminals disposed at the proximal end,

at least one central lumen defined by the lead and extending along the longitudinal length of the lead from the proximal end to the distal end,

a plurality of outer lumens defined by the lead and extending along the longitudinal length of the lead from the proximal end to the distal end, the plurality of outer lumens extending laterally from the at least one central lumen, wherein the plurality of outer lumens are each oval-shaped with a major axis, and

a plurality of conductive wires extending along the longitudinal length of the lead, each conductive wire coupling at least one of the plurality of electrodes electrically to at least one of the plurality of terminals, wherein exactly two different conductive wires of the plurality of conductive wires are disposed in each of the plurality of outer lumens, the two different conductive wires each having an insulative coating to electrically insulate the two conductive wires from one another, and wherein each of the plurality of conductive wires has a diameter,

wherein each of the plurality of outer lumens has 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 two conductive wires disposed in that outer lumen.

15. The lead assembly of claim 14, wherein for each of the plurality of outer lumens the outer lumen is symmetrical about both the major axis and the transverse axis of that outer lumen.

16. The lead assembly of claim 14, further comprising

a lead splitter configured and arranged to electrically couple with the lead, the lead splitter having a distal end and a plurality of proximal tails, the lead splitter comprising

a connector disposed at the distal end for receiving the proximal end of the lead, the connector comprising a connector housing defining at least one port for receiving the proximal end of the lead, and a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple electrically to at least one terminal on the proximal end of the lead, and

each of the plurality of proximal tails having a distal end and comprising at least one lead-splitter terminal and at least one lead-splitter conductive wire, the lead-splitter terminal disposed at the distal end and the at least one lead-splitter conductive wire electrically coupling at least one of the plurality of connector contacts of the connector to the at least one lead-splitter terminal.

17. The lead assembly of claim 14, 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.

18. The lead assembly of claim 14, 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.

19. The lead assembly of claim 14, wherein sixteen electrodes are disposed at the distal end of the lead.

20. An electrical stimulating system comprising:

the lead assembly of claim 14;

a control module configured and arranged to electrically couple to the lead of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector configured and arranged for receiving the lead of the lead assembly, the connector comprising

a connector housing defining at least one port for receiving the proximal end of the lead of the lead assembly, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one terminal of the plurality of terminals disposed at the proximal end of the lead of the lead assembly.