IMPLANTABLE ELECTRIC STIMULATION SYSTEM AND METHODS OF MAKING AND USING

• US 20100070009A1
• Filed: 09/15/2008
• Published: 03/18/2010
• 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
• Granted Patent: US 8,364,284 B2
• Time in Patent Office: Days
• 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 and a proximal end, 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 from the proximal end to the distal end,

a plurality of outer lumens defined by the lead and extending from the proximal end to the distal end, the plurality of outer lumens extending laterally from the at least one central lumen, and

a plurality of conductive wires, each conductive wire coupling at least one of the plurality of electrodes electrically to at least one of the plurality of terminals, at least two conductive wires disposed in each of the plurality of outer lumens.

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 at least two conductive wires disposed in that outer lumen are electrically coupled to adjacent terminals.

4. The lead assembly of claim 1, wherein the plurality of outer lumens are each oval-shaped with a major axis.

5. The lead assembly of claim 4, 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.

6. The lead assembly of claim 4, 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.

7. The lead assembly of claim 1, wherein for each of the plurality of outer lumens each of the at least two conductive wires disposed in that lumen has an insulated coating that is visually distinct with respect to the other conductive wires disposed in that lumen.

8. The lead assembly of claim 1, wherein the proximal end of the lead further comprises an end plug.

9. An electrical stimulating system comprising:

a lead having a distal end and a proximal end, 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 from the proximal end to the distal end,

a plurality of outer lumens defined by the lead and extending from the proximal end to the distal end, the plurality of outer lumens extending laterally from the at least one central lumen, and

a plurality of conductive wires, each conductive wire coupling at least one of the plurality of electrodes electrically to at least one of the plurality of terminals, at least two conductive wires disposed in each of the plurality of outer lumens;

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

a housing, and

an electronic subassembly disposed in the housing; and

a connector configured and arranged for receiving 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 to at least one terminal disposed at the proximal end of the lead.

10. The electrical stimulating system of claim 9, 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.

11. The electrical stimulating system of claim 10, wherein each of the proximal tails of the lead splitter is configured and arranged for insertion into another connector.

12. The electrical stimulating system of claim 9, wherein the connector is disposed on the control module.

13. The electrical stimulating system of claim 9, wherein the plurality of outer lumens are each oval-shaped with a major axis.

14. The electrical stimulating system of claim 9, 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.

15. The electrical stimulating system 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.

16. The electrical stimulating system of claim 9, wherein for each of the plurality of outer lumens each of the at least two conductive wires disposed in that lumen has an insulated coating that is visually distinct with respect to the other conductive wires disposed in that lumen.

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

placing a substantially tubular-shaped lead body with a proximal end and a distal end into a mold with mold cavities between spaced-apart cylindrical pockets, the lead body comprising a plurality of conductive wires in each of a plurality of outer lumens, the outer lumens extending out of both the proximal end and the distal end of the lead body;

disposing a plurality of terminals over the portion of the outer lumens extending out of the proximal end of the lead body so that the each terminal aligns with a different cylindrical pocket;

electrically coupling each terminal to a different conductive wire;

disposing a plurality of electrodes over the portion of the outer lumens extending out of the distal end of the lead body so that the each electrode aligns with a different cylindrical pocket;

electrically coupling each electrode to a different conductive wire; and

injecting a resin into the mold cavities between the spaced-apart cylindrical pockets.

18. The method of claim 17, further comprising disposing an end plug comprising an end cap and a rod over the proximal end of the lead body so that the rod extends into the central lumen and the end cap covers the proximal end of the lead body prior to injecting a resin into the mold cavities between the spaced-apart cylindrical pockets.

19. The method of claim 17, wherein injecting a resin into the mold cavities between the spaced-apart cylindrical pockets further includes injecting the resin between a most proximal terminal and the end cap of the end plug.

20. The method of claim 17, wherein electrically coupling each terminal to a different conductive wire comprises for each of the plurality of outer lumens, electrically coupling the at least two conductive wires disposed in that outer lumen to adjacent terminals.