Implantable lead and method of manufacture

• US 6,216,045 B1
• Filed: 04/26/1999
• Issued: 04/10/2001
• Est. Priority Date: 04/26/1999
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jones, Robert Earl, Lauro, B. Reno, Black, Damon Ray, Erickson, John, Daglow, Terry
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/299,702
• Time in Patent Office: 715 Days
• Field of Search: 607/116, 607/119, 607/122, 600/373-375, 600/381, 600/377
• US Class Current: 607/122
• 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 1/056 Transvascular endocardial electrode systems
• 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 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor
• CPC Class Codes: Y10T 29/49176 with molding of electrically insulating material
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing
• CPC Class Codes: Y10T 29/49208 by assembling plural parts
• CPC Class Codes: Y10T 29/4922 with molding of insulation

Abstract

An implantable, substantially isodiametric, low resistance implantable lead having at least one electrode positioned in a stimulation/sensing portion of the lead. At least the stimulation/sensing portion is unitized through partially surrounding and supporting insulation and conductive element(s) of the stimulation/sensing portion with a fused matrix of material having mechanical properties consistent with a body of the lead.

Claims

1. An implantable lead comprising:

a lead body having a distal end and a proximal end, wherein the lead body is formed of a material having prescribed mechanical properties;

a first region extending distally from the distal end of the lead body, wherein the first region includes a plurality of electrodes, and adjacent electrodes are separated by a first insulative material having mechanical properties consistent with the material of the lead body;

a second region extending proximally from the proximal end of the lead body, wherein the second region includes at least one terminal, and when the implantable lead includes a plurality of terminals, adjacent terminals are separated by a second insulative material having mechanical properties consistent with the material of the lead body; and

at least one conductor electrically coupling each terminal with at least one corresponding electrode of the plurality of electrodes, wherein each conductor extends along an interior passage defined within the lead body, first region, and second region,

wherein in addition to the at least one conductor, the interior passage of the first region is substantially filled with a third insulative material having mechanical properties consistent with the material of the lead body.

2. An implantable lead in accordance with claim 1, wherein the first insulative material, second insulative material, and third insulative material are the same.

3. An implantable lead in accordance with claim 1, wherein the first insulative material, second insulative material, third insulative material, and the material of the lead body are the same.

4. An implantable lead in accordance with claim 1, wherein each conductor is formed of stranded wire and has a resistance equal to or less than 25 ohms for a conductor length equal to or less than 60 cm.

5. An implantable lead in accordance with claim 1, wherein an outer diameter of the lead body is approximately 0.050 inches.

6. An implantable lead in accordance with claim 1, further comprising a stylet guide, positioned within the interior passage defined by the lead body, first region, and second region, wherein an inlet of the stylet guide is at the proximal end of the second region, and the third material substantially surrounds the stylet guide.

7. An implantable lead in accordance with claim 1, wherein the implantable lead is substantially isodiametric.

8. An implantable lead in accordance with claim 1, wherein the third insulative material is a fused matrix.

9. An implantable lead in accordance with claim 1, wherein in addition to the at least one conductor, the interior passage of the second region is substantially filled with a fourth insulative material having mechanical properties consistent with the material of the lead body.

10. An implantable lead in accordance with claim 9, wherein the first insulative material, second insulative material, third insulative material, and fourth insulative material are the same.

11. An implantable lead in accordance with claim 9, wherein the fourth insulative material is a fused matrix.

12. An implantable lead comprising:

a lead body having a distal end and a proximal end, wherein the lead body is formed of a material having prescribed mechanical properties;

a first region extending distally from the distal end of the lead body, wherein the first region includes a plurality of electrodes, and adjacent electrodes are separated by a first insulative material having mechanical properties consistent with the material of the lead body;

a second region extending proximally from the proximal end of the lead body, wherein the second region includes at least one terminal, and when the implantable lead includes a plurality of terminals, adjacent terminals are separated by a second insulative material having mechanical properties consistent with the material of the lead body; and

at least one conductor electrically coupling each terminal with at least one corresponding electrode of the plurality of electrodes, wherein each conductor extends through at least a portion of each of the lead body, the first region, and the second region,

wherein at least the first region has a substantially solid cross-section, and excepting the at least one conductor passing therethrough and the plurality of electrodes thereof, material(s) forming the first region has mechanical properties consistent with the material of the lead body .

13. An implantable lead in accordance with claim 12, wherein the material(s) forming the first region, which supports the plurality of electrodes and carries the at least one conductor, is a fused matrix.

14. An implantable lead comprising:

a lead body having a distal end and a proximal end, wherein the lead body is formed of a material having prescribed mechanical properties;

a stimulation portion extending distally from the distal end of the lead body, wherein the stimulation portion includes a plurality of electrodes, and adjacent electrodes are separated by an insulative material having mechanical properties consistent with the material of the lead body;

a terminal portion extending proximally from the proximal end of the lead body, wherein the terminal portion includes at least one terminal, and when the implantable lead includes a plurality of terminals, adjacent terminals are separated by an insulative material having mechanical properties consistent with the material of the lead body; and

at least one conductor electrically coupling each terminal with at least one corresponding electrode of the plurality of electrodes, wherein each conductor extends through at least a portion of each of the lead body, the stimulation portion, and the terminal portion,

wherein at least the stimulation portion is formed from a substantially solid, fused matrix of materials having consistent mechanical characteristics, and the fused matrix of material(s) supports the plurality of electrodes and the at least one conductor extends at least partially therethrough.