Lead body and method of lead body construction

• US 20060111768A1
• Filed: 01/11/2006
• Published: 05/25/2006
• Est. Priority Date: 09/26/2000
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Micronet Medical, Inc. (Abbott Laboratories Incorporated)
• Inventors: Wessman, Bradley J., Pohndorf, Peter J., Schrom, Mark Gerald
• Granted Patent: US 7,555,349 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

In one embodiment, a neurostimulation lead, comprises: a lead body, the lead body comprising an inner insulator, an outer insulator positioned around the inner insulator, wherein the outer insulator and the inner insulator are fused together; at least one conductor that is wound between the inner insulator and the outer insulator; and at least one electrode that is electrically coupled to the at least one conductor.

Claims

1. A neurostimulation lead, comprising:

a lead body, the lead body comprising an inner insulator, an outer insulator positioned around the inner insulator, wherein the outer insulator and the inner insulator are fused together;

at least one conductor that is wound between the inner insulator and the outer insulator; and

at least one electrode that is electrically coupled to the at least one conductor.

2. A neurostimulation lead, as in claim 1, further comprising:

a lumen.

3. A neurostimulation lead, as in claim 1, comprising:

a plurality of conductors, wherein the inner insulator is fused to the outer insulator to electrically isolate the plurality of conductors.

4. A neurostimulation lead, as in claim 3, further comprising:

at least one insulating spacer spirally wound about the inner insulator between respective wound conductors to electrically isolate the wound conductors from each other.

5. A neurostimulation lead, as in claim 4, wherein the at least one insulating spacer is fused to at least one of the inner insulator and the outer insulator.

6. A neurostimulation lead, as in claim 1, wherein the inner insulator and the outer insulator comprise a material selected from the group consisting of polyurethane and silicone rubber.

7. A method for manufacturing a neurostimulation lead, comprising:

providing a mandrel having an inner insulating material disposed intermediate a first end and a second end of the mandrel, wherein the mandrel extends beyond the inner insulating material at the first end and the second end of the mandrel;

securing a first end of at least one conductor to the first end of the mandrel;

positioning the at least one conductor spirally around the inner insulating material and securing a second end of the at least one conductor to the second end of the mandrel;

disposing an outer insulating material around the wound conductors coextensive with the inner insulating material;

fusing the inner insulating material to the outer insulating material to form a lead assembly;

forming a lead body from the lead assembly; and

forming at least one electrode on a distal end of the lead body.

8. A method, as in claim 7, wherein fusing the inner insulator to the outer insulator further comprises:

disposing shrink-wrap tubing over the outer insulating material; and

heating the shrink-wrap, the outer insulating material and the inner insulating material to shrink the shrink-wrap tubing and fuse the outer insulating material to the inner insulating material.

9. A method, as in claim 7, wherein fusing the inner insulator to the outer insulator further comprises:

disposing tubing over the outer insulating material;

sealing a first end of the tubing;

applying a partial vacuum to a second end of the tubing; and

heating the tubing, wherein the partial vacuum draws the outer insulating material and the inner insulating material into contact and the heating fuses the outer insulating material to the inner insulating material thereby encapsulating the at least one conductor.

10. A method, as in claim 7, further comprising:

removing the mandrel from the inner insulator to form a lumen.

11. A method, as in claim 7, further comprising:

removing the shrink-wrap material.

12. A method, as in claim 7, wherein the winding of the conductors comprises spirally winding the conductors.

13. A method, as in claim 12, further comprising:

providing at least one insulating spacer; and

spirally winding the insulating spacer between a plurality conductors to electrically isolate each one of plurality of conductors from one another.

14. A method, as in claim 7, wherein the inner insulating material and the outer insulating material comprise material selected from the group consisting of polyurethane and silicone rubber.

15. A neurostimulation system, comprising:

a pulse generator for generating electrical pulses; and

a neurostimulation lead for delivering electrical pulses from the pulse generator to tissue of the patient, the neuromodulation lead comprising;

(i) a lead body, the lead body comprising an inner insulator, an outer insulator positioned around the inner insulator, wherein the outer insulator and the inner insulator are fused together;

(ii) at least one conductor that is wound between the inner insulator and the outer insulator; and

(iii) at least one electrode that is electrically coupled to the at least one conductor.

16. A neuromodulation system of claim 15 wherein the neurostimulation lead further comprises a lumen.

17. A neuromodulation system of claim 15 wherein the neurostimulation lead further comprises:

a plurality of conductors, wherein the inner insulator is fused to the outer insulator to electrically isolate the plurality of conductors.

18. A neuromodulation system of claim 17 wherein the neurostimulation lead further comprises:

at least one insulating spacer spirally wound about the inner insulator between respective wound conductors to electrically isolate the wound conductors from each other.

19. A neuromodulation system of claim 18, wherein the at least one insulating spacer is fused to at least one of the inner insulator and the outer insulator.

20. A neuromodulation system of claim 15, wherein the inner insulator and the outer insulator comprise material selected from the group consisting of polyurethane and silicone rubber.