Lead with lead stiffener for implantable electrical stimulation systems and methods of making and using

• US 8,712,528 B2
• Filed: 02/25/2013
• Issued: 04/29/2014
• Est. Priority Date: 01/31/2008
• 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): Patel, Niketa
• Assistant Examiner(s): Hankins, Lindsey G
• Application Number:
  US13/776,090
• Publication Number:
  US 20130172950A1
• Time in Patent Office: 428 Days
• Field of Search: 607/36, 607/37, 607/115, 607/116, 607/119, 607/122
• US Class Current: 607/37
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• 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 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A lead includes a plurality of electrodes disposed on the distal end of the lead, a plurality of contact terminals disposed on the proximal end of the lead, a plurality of conductor wires extending along the lead to couple the electrodes electrically to the contact terminals, a central lumen defined by the lead and extending from the proximal end of the lead towards the distal end of the lead, and a tubular stiffener disposed in the proximal end of the central lumen. The tubular stiffener is configured and arranged to facilitate insertion of the proximal end of the lead into a connector.

Claims

1. An implantable lead assembly comprising:

a lead configured and arranged for insertion into a patient, the lead comprising

a non-conductive lead body having a proximal end portion, a distal end portion, an outer surface, and a longitudinal length,

a plurality of electrodes disposed along the distal end portion of the lead body,

a plurality of terminals disposed along the outer surface of the proximal end portion of the lead body,

a central lumen defined in the lead body and extending along the longitudinal length of the lead body from the proximal end portion of the lead body towards the distal end portion of the lead body, and

a plurality of conductor wires electrically coupling the plurality of electrodes to the plurality of terminals; and

a tubular stiffener having a first end portion, an opposing second end portion, an intermediate portion disposed between the first end portion and the second end portion, a longitudinal length, an inner diameter, and an outer diameter, the tubular stiffener disposed in the central lumen of the lead body radially beneath at least one of the plurality of terminals with a portion of the non-conductive lead body disposed radially between the tubular stiffener and the plurality of terminals, wherein the tubular stiffener is configured and arranged to facilitate insertion of the proximal end portion of the lead body into a connector, and wherein the tubular stiffener comprises a spiraling cut defined along the longitudinal length of the tubular stiffener, wherein the entire tubular stiffener is disposed proximal to the plurality of electrodes.

2. The lead assembly of claim 1, wherein the spiraling cut forms a plurality of interlocking elements.

3. The lead assembly of claim 1, wherein the spiraling cut is formed along the first end portion of the tubular stiffener.

4. The lead assembly of claim 1, wherein the spiraling cut is formed along the second end portion of the tubular stiffener.

5. The lead assembly of claim 1, wherein the spiraling cut is formed along the intermediate portion of the tubular stiffener.

6. The lead assembly of claim 1, wherein the spiraling cut extends substantially the entire length of the tubular stiffener.

7. The lead assembly of claim 1, wherein the inner diameter of the tubular stiffener is configured and arranged to receive an insertion rod of a stylet.

8. The lead assembly of claim 1, wherein the lead body defines a plurality of conductor lumens that extend along the longitudinal length of the lead body from the plurality of terminals to the plurality of electrodes.

9. The lead assembly of claim 8, wherein the plurality of conductor lumens are disposed peripherally from the central lumen with each of the plurality of conductor lumens being separate from, and distinct from, the central lumen.

10. The lead assembly of claim 8, wherein the plurality of conductor wires extend along the longitudinal length of the lead body within the plurality of conductor lumens.

11. The lead assembly of claim 1, wherein the tubular stiffener forms an interference fit with the central lumen along the proximal end portion of the lead body.

12. The lead assembly of claim 1, wherein the tubular stiffener is bonded to the central lumen along the proximal end portion of the lead body.

13. The lead assembly of claim 1, wherein the tubular stiffener is thermoformed to the central lumen along the proximal end portion of the lead body.

14. An electrical stimulation system comprising:

the lead assembly of claim 1;

a control module configured and arranged to couple to the lead of the lead assembly and to provide electrical stimulation to at least one of the plurality of electrodes, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end portion of the lead body, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals of the lead body;

wherein the tubular stiffener is configured and arranged to facilitate insertion of the proximal end portion of the lead body into the connector.

15. The electrical stimulation system of claim 14, wherein the longitudinal length of the tubular stiffener is greater than the longitudinal length of the connector.

16. The electrical stimulation system of claim 15, wherein at least a portion of the spiraling cut extends outwardly from the connector when the lead body is operationally inserted into the connector.

17. A method for stimulating patient tissue, the method comprising:

implanting the lead assembly of claim 1 into a patient;

disposing the proximal end portion of the lead body of the lead assembly into a control module; and

providing electrical signals from the control module to electrically stimulate patient tissue using at least one of the plurality of electrodes of the lead assembly.

18. The lead assembly of claim 1, wherein the lead body is isodiametric.

19. The lead assembly of claim 1, wherein the tubular stiffener has greater lateral stiffness than the proximal end of the lead body without the tubular stiffener.

20. The lead assembly of claim 1, wherein the tubular stiffener has an outer diameter that is no greater than 0.06 cm.