Implantable lead with improved stylet lumen

• US 7,206,642 B2
• Filed: 04/22/2002
• Issued: 04/17/2007
• Est. Priority Date: 04/22/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stolz, Brian T., Pardo, Xavier E.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/131,559
• Publication Number:
  US 20030199954A1
• Time in Patent Office: 1,821 Days
• Field of Search: 607/122, 607116-128, 607/101, 606/41, 606/47, 600373-375, 604/103, 604/164.11
• US Class Current: 607/116
• 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: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• 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 for a medical device with an improved stylet lumen reduces the potential for damage to a stylet and seals the lead proximal end. The implantable lead comprises a lead body having a distal end and a proximal end, a stylet lumen, at least two conductor lumens, at least two conductors, at least two contacts carried on the proximal end, at least two contacts carried on the distal end, and a proximal flare formed on the lead proximal end. The two conductors are contained in the conductor lumens and extend from the lead proximal end to the distal end. The two contacts carried on the lead distal end are electrically connected to the conductors. The proximal flare has tapering walls that narrow toward a stylet opening to guide insertion of a stylet into the stylet lumen, and the proximal flare seals the conductor lumens proximal end to isolate the conductor lumens.

Claims

1. An implantable lead with improved stylet lumen, comprising:

a lead body having a proximal end, a distal end, a stylet lumen, and at least two conductor lumens each having a proximal end;

at least two conductors contained in the conductor lumens extending from the lead proximal end to the distal end;

at least two contacts carried on the proximal end and electrically connected to the conductors;

at least two contacts carried on the lead distal end and electrically connected to the conductors; and

,

a proximal flare formed on the lead body proximal end, the proximal flare having tapering walls that narrow toward a stylet opening to guide insertion of a stylet wire into the stylet lumen, and the proximal flare being formed to seal the proximal ends of the conductor lumens to electrically isolate the conductor lumens.

2. The implantable lead as in claim 1 wherein the proximal flare is flexible to reduce stylet wire deformation during use of the stylet.

3. The implantable lead as in claim 1 wherein the proximal flare is manufactured from the same material as the lead body.

4. The implantable lead as in claim 1 wherein the proximal flare substantially prevents the stylet from entering the conductor lumens upon insertion of the stylet in the lead body proximal end.

5. A method of manufacturing an implantable lead, comprising:

extruding a lead body having a proximal end, a distal end, a stylet lumen, and at least two conductor lumens;

extending at least two conductors within the conductor lumens from the lead proximal end to the distal end;

coupling at least two contacts on the proximal end;

connecting the at least two contacts on the proximal end to the conductors;

coupling at least two contacts on the lead distal end;

connecting the at least two contacts on the distal end to the conductors; and

,

forming a proximal flare on the lead body proximal end, the proximal flare having tapering walls that narrow toward a stylet opening to guide insertion of a stylet wire into the stylet lumen, and the proximal flare being formed to seal the proximal ends of the conductor lumens to electrically isolate the conductor lumens.

6. The method of claim 5, wherein the proximal flare seals the conductor lumens proximal end to isolate the conductor lumens.

7. The method of claim 6, further comprising the step of routing material into the conductor lumens no farther than the beginning of the conductors located within the conductor lumens during the forming of the flare.

8. The method of claim 7, wherein the material routed into the conductor lumens seals the conductor lumens to minimize electrical conductance between the conductors, fluid migration into the lumens, and unwanted stylet introduction into the conductor lumens.

9. The method of claim 8, wherein the proximal flare is manufactured from a non-rigid material similar to the lead body.

10. The method of claim 5, wherein the flare can be formed by inserting the proximal end of the lead body into a conical shape mold.

11. The method of claim 10, wherein the conical shape is inserted axially into the center stylet lumen.

12. The method of claim 11, wherein heat is transferred from the conical mold to an interior portion of the lead to seal the outer lumens and create the flare.

13. A method of manufacturing an implantable lead, comprising:

providing a lead body having a proximal end, a stylet lumen, and a conductor lumen having a proximal end;

sealing the proximal end of the conductor lumen to electrically isolate the conductor lumen, the step of sealing the proximal end of the conductor lumen to isolate the conductor lumen comprising forming a proximal flare on the proximal end of the lead body to seal the proximal end of the conductor lumen, the proximal flare having tapering walls that narrow toward a stylet opening to guide insertion of a stylet wire into the stylet lumen.

14. The method of claim 13 wherein the step of forming a proximal flare on the proximal end of the lead body includes placing material in the conductor lumen.

15. The method of claim 14 further comprising locating a conductor within the conductor lumen, the conductor having a proximal end, the step of forming a proximal flare on the proximal end of the lead body includes placing material in the conductor lumen no farther than the proximal end of conductor.

16. The method of claim 13 wherein the step of forming a proximal flare on the proximal end of the lead body includes molding the proximal end with a conically shaped mold.

17. The method of claim 16 wherein the step of forming a proximal flare on the proximal end of the lead body further includes inserting a conical shape axially into the stylet lumen.

18. The method of claim 17 wherein the step of molding the proximal end with a conically shaped mold includes transferring heat from the conically shaped mold to proximal end of the lead body.

19. The method of claim 18 wherein the lead body is formed of polyurethane, the step of molding the proximal end with a conically shaped mold includes molding the polyurethane.

20. The method of claim 19 wherein the lead body further has a distal end, the step of providing a lead body including extruding the lead body, the method further comprising:

extending a conductor within the conductor lumen, the conductor having a proximal end and a distal end;

coupling a proximal contact on the lead body;

connecting the proximal contact to the proximal end of the conductor;

coupling a distal contact on the lead body;

connecting distal a contact to distal end of the conductor.

21. The method of claim 20 wherein the conductor lumens comprise at least two conductor lumens, and the conductor comprises at least two conductors.

22. An implantable lead, comprising:

a lead body having a proximal end, a distal end, a stylet lumen, and at least two conductor lumens each having a proximal end;

at least two conductors contained in the conductor lumens extending from the lead proximal end to the distal end;

at least two contacts carried on the proximal end and electrically connected to the conductors;

at least two contacts carried on the lead distal end and electrically connected to the conductors; and

,

a proximal flare formed on the lead body proximal end, the proximal flare having tapering walls that narrow toward a stylet opening to guide insertion of a stylet wire into the stylet lumen, and the proximal flare being formed to seal the proximal ends of the conductor lumens to electrically isolate the conductor lumens;

the proximal flare formed by inserting the proximal end of the lead body into a conical shaped mold that is inserted axially into the stylet lumen and heated to seal the conductor lumens and create the flare.

23. The implantable lead of claim 22, wherein the proximal flare is manufactured from a non-rigid material similar to a lead body material.

24. The implantable lead of claim 22, wherein the tapering walls have a slope in the range from about 0.25 cm/cm to about 0.50 cm/cm.

25. The implantable lead of claim 22, wherein the proximal flare axial length is no greater than 0.064 cm.

26. The implantable lead of claim 22, wherein the proximal flare wall thickness ranges from 0.01 cm at the most proximal end to 0.05 cm at the distal end of the flare.

27. An implantable lead comprising:

a lead body having a proximal end, a stylet lumen having a stylet opening, and a conductor lumen having a proximal end;

a proximal flare formed on the proximal end of the lead body, the proximal flare having tapering walls that narrow toward the stylet opening to guide insertion of a stylet wire into the stylet lumen;

the proximal flare formed by thermally molding the proximal end of the lead body such that the conductor lumen is sealed as the proximal flare is molded.

28. The implantable lead of claim 27 wherein the conductor lumen comprises at least two conductor lumens.

29. The implantable lead of claim 28 further comprising:

at least two conductors contained in the conductor lumens extending from the lead proximal end to the distal end;

at least two contacts carried on the proximal end and electrically connected to the conductors;

at least two contacts carried on the lead distal end and electrically connected to the conductors.

30. The implantable lead of claim 29 wherein the thermally molding the proximal end of the lead body places material in the conductor lumens.

31. The implantable lead of claim 30 wherein thermally molding the proximal end of the lead body places material in the conductor lumen no farther than the proximal end of conductor.

32. The implantable lead of claim 27 wherein the proximal end of the lead body is thermally molded with a conically shaped mold.

33. The implantable lead of claim 27 wherein the lead body is formed of polyurethane.