Implantable stimulation lead and method of manufacture

• US 6,477,427 B1
• Filed: 03/31/2000
• Issued: 11/05/2002
• Est. Priority Date: 03/31/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stolz, Brian T., Baudino, Michael D.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/539,833
• Time in Patent Office: 949 Days
• Field of Search: 600/372-375, 600/393, 600/377-378, 600/380-381, 607/115-117, 607/119, 607/122, 607/123
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An implantable lead and an improved method of manufacture is disclosed that is highly automated and simplified over prior art techniques. An implantable lead is disclosed having a flexible tubing member, a central coil member having a first portion having differing pitches, and a least one contact sleeve having a through radial hole for receipt of the wire member. A method for manufacture of the lead is disclosed by providing a coil member having a fixed pitch portion and a variable pitch portion, extending at least one filar member radially from the coil member, placing a lead body over the coil member, providing a contact sleeve over a portion of the lead body, the contact sleeve having a slot for receipt of the filar member, and welding the filar member to the contact sleeve.

Claims

1. An implantable lead having a distal end, a proximal end and a body, comprising in combination:

(A) a flexible tubing member along an outside portion of the lead;

(B) a coil member running along a central lumen portion of the lead, the coil having at least a first portion having a first pitch and at least a second portion having a second pitch;

(C) at least two wire members forming the coil member, each wire member having a filar at a distal end that extends from the coil member, wherein the first pitch and second pitch are predetermined to allow the filars to be substantially collinear at a predetermined distance therebetween independent of wire member width and number; and

(D) at least one contact sleeve positioned over an impression of the flexible tubing member and having an opening for receipt of the filar, the opening having a weld point coupling the filar to the contact sleeve.

2. A lead, as claimed in claim 1, wherein the flexible tubing is a polyurethane material.

3. A lead, as claimed in claim 1, wherein the first portion of the coil member is along the body of the lead and the second portion of the coil member is along the distal end of the lead.

4. A lead, as claimed in claim 1, further comprising:

(E) a distal tip adjacent a distal end of the flexible tubing member.

5. A lead, as claimed in claim 1, further comprising:

(E) a lumen extending through the coil for delivering a drug.

6. An implantable lead of claim 1, wherein the flexible tubing member has at least one impression.

7. An implantable lead having a distal end, a proximal end and a body, comprising in combination:

(A) a coil member running along a central lumen portion of the lead, the coil having a first portion having a first pitch and a second portion having a second pitch;

(B) at least two wire members forming the coil member, each wire member having a filar at a distal end that extends from the coil member, wherein the first pitch and second pitch are predetermined to allow the filars to be substantially collinear at a predetermined distance therebetween independent of wire member width and number;

(C) a flexible tubing member formed over the coil member; and

(D) at least one contact sleeve having a through radial hole for receipt of the filar, the filar being welded to the contact sleeve along the radial hole.

8. A lead, as claimed in claim 7, wherein the flexible tubing member is a polyurethane material.

9. A lead, as claimed in claim 7, wherein the flexible tubing member has at least one impression for receipt of the contact sleeve.

10. A lead, as claimed in claim 7, wherein the first portion of the coil member is along the body of the lead and the second portion of the coil member is along the distal end of the lead.

11. A lead, as claimed in claim 7, further comprising:

(E) a distal tip that is heat formed at a distal end of the flexible tubing member.

12. A lead, as claimed in claim 7, further comprising:

(E) a lumen extending through the coil for delivering a drug.

13. An implantable lead having a distal end, a proximal end and a body, comprising in combination:

(A) a flexible tubing member along an outside portion of the lead;

(B) a coil member running along a central lumen portion of the lead, the coil having at least a first portion having a first pitch and at least a second portion having a second pitch;

(C) at least two wire members forming the coil member, each wire member having a filar at a distal end that extends from the coil member, wherein the filars are collinear at a predetermined distance therebetween being determined by the pitches of the coil member and being independent of wire member width and number; and

(D) at least one contact sleeve positioned over an impression of the flexible tubing member and having an opening for receipt of the filar, the opening having a weld point coupling the filar to the contact sleeve.

14. A lead, as claimed in claim 13, wherein the flexible tubing member is made of a polyurethane material.

15. A lead, as claimed in claim 13, wherein the first portion of the coil member is along the body of the lead and the second portion of the coil member is along the distal end of the lead.

16. A lead, as claimed in claim 13, further comprising:

(E) a distal tip adjacent a distal end of the flexible tubing member.

17. A lead, as claimed in claim 13, further comprising:

(E) a lumen extending through the coil for delivering a drug.

18. A method of manufacturing an implantable lead comprising the steps of:

(A) forming a coil member comprising at least two wire members, the coil member having a fixed pitch portion and a variable pitch portion, each wire member having a filar member at a distal end, wherein the variable pitch portion is predetermined to allow the filars to be substantially collinear at a predetermined distance therebetween independent of wire member width and number;

(B) forming a flexible lead body over the coil member;

(C) extending the filar members of each of the wire members radially from the coil member at a predetermined portions along the variable pitch portion of the coil member;

(D) providing a contact sleeve over a portion of the lead body, the contact sleeve having a opening for receipt of the filar member; and

(E) welding the filar member to the contact sleeve.

19. A method, as claimed in claim 18, wherein the step of forming a flexible lead body further includes the step of forming impressions for placement of the contact sleeve.

20. A method, as claimed in claim 18, further comprising the step of:

(F) heat forming a tip at a distal end of the lead.

21. A method, as claimed in claim 19, wherein the step of forming impressions is performed by a technique selected from the group consisting of grinding and laser etching.

22. A method, as claimed in claim 21, further comprising the step of heat sealing the lead body to provide a final dimension for the impressions.