Method of forming a lead

• US 8,316,537 B2
• Filed: 12/04/2009
• Issued: 11/27/2012
• Est. Priority Date: 04/26/1999
• Status: Expired due to Term

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Inventors: Black, Damon Ray, Daglow, Terry, Erickson, John, Jones, Robert Earl, Lauro, B. Reno
• Primary Examiner(s): Nguyen, Donghai D.
• Application Number:
  US12/631,321
• Publication Number:
  US 20100077606A1
• Time in Patent Office: 1,089 Days
• Field of Search: 295/921, 298/25, 298/58, 298/74, 298/76, 298/83, 298/85, 600/373, 600/377, 607/116, 607/122, 607/124
• US Class Current: 29/858
• 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 as well as a method of manufacturing the same. 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. A method of fabricating a stimulation lead for applying electrical pulses to tissue of a patient, the method comprising:

providing a lead body assembly, the lead body assembly comprising;

first insulative material defining at least one interior passageway extending from a proximal portion to a distal portion of the lead body assembly;

a plurality of conductors;

a plurality of electrodes at the distal portion; and

a plurality of terminals at the proximal portion, wherein the plurality of electrodes are electrically coupled to the plurality of terminals through the plurality of conductors;

overmolding at least the distal portion of the lead body assembly with second insulative material to form an intermediate assembly, wherein (i) the first and second insulative materials have consistent mechanical properties such that the overmolding causes the first insulative material to fuse together with the second insulative material and (ii) the overmolding causes filling of the at least one interior passageway at the distal portion with an insulative material; and

removing the insulative material in excess of a prescribed diameter from at least the distal portion of the intermediate assembly.

2. The method of claim 1 wherein:

the plurality of electrodes are separated by spacers in the lead body assembly; and

the second insulative material and the insulative material of the spacers have consistent mechanical properties such that the overmolding causes the insulative material of the spacers to enter a state of flow to fuse with the second insulative material.

3. The method of claim 2 wherein the first insulative material, the second insulative material, and the insulative material of the spacers have a same amount of flexibility.

4. The method of claim 1 wherein the first and second insulative material are both polyurethane materials and have equal durometers.

5. The method of claim 1 wherein the lead body assembly further comprises an inner stylet guide.

6. The method of claim 5 further comprising:

stringing the plurality of conductors from the proximal portion to the distal portion and;

contacting the plurality of conductors against an outer surface of the inner stylet guide.

7. The method of claim 6 wherein, after the contacting, each of the plurality of conductors are disposed in a linear orientation stretching from the proximal portion to the distal portion.

8. The method of claim 1 wherein the removing comprises:

subjecting at least the distal portion to centerless grinding.

9. The method of claim 1 wherein the overmolding comprises placing the lead body assembly into a mold and injecting the second insulative material into the mold.

10. The method of claim 1 wherein the plurality of electrodes in the lead body assembly comprise a greater outer diameter than an outer diameter of the distal portion after the removing is performed.