Medical lead and method of making and using

• US 5,755,762 A
• Filed: 06/14/1996
• Issued: 05/26/1998
• Est. Priority Date: 06/14/1996
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bush, M. Elizabeth
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/663,850
• Time in Patent Office: 711 Days
• Field of Search: 607/116, 607/121, 607/122, 607/123, 607/125, 607/126, 607/127, 607/128, 128/642, 128/639, 600/372, 600/373, 600/374, 600/388
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

A continuous sheath of open-celled porous plastic, preferably ePTFE, is used on the outside of an implantable lead, extending along the lead body and the electrodes, in such a way that the lead is isodiametric along its length, and is very strong in tension as is required for lead removal. Because the plastic is open-celled, when the pores are filled with saline, the lead can deliver defibrillation energy through the pores in the plastic. Pore size is chosen to discourage tissue ingrowth while allowing for defibrillation energy delivery through it.

Claims

1. An implantable medical lead comprising:

a lead subassembly comprising an electrode, a conductor electrically coupled to said electrode, and a connector electrically coupled to a proximal end of said conductor; and

a porous tubular covering extending over at least a portion of said electrode and at least a portion of said conductor, wherein said porous tubular covering has an outer surface pore size such that said porous tubular covering substantially isolates said portion of said electrode and said portion of said conductor from ingrowth of tissue.

2. The lead of claim 1, wherein said tubular covering is substantially isodiametric.

3. The lead of claim 1, wherein said tubular covering is chosen from the group consisting of:

fluoropolymer, polyester, polyurethane, cellulose acetate, mixed esters of cellulose, acrylic copolymer on nylon support, polyvinyl difluoride, polysulfone, polypropylene, cellulose nitrate, polycarbonate, nylon, and polyethylene.

4. The lead of claim 3, wherein said tubular covering comprises a fluoropolymer chosen from the group consisting of:

FEP, PTFE, and PFA.

5. The lead of claim 1, wherein said tubular covering comprises a composite or laminate of at least two materials.

6. The lead of claim 1, wherein said porous tubular covering has a structure chosen from the group consisting of:

expanded, woven, felt, and fused mesh.

7. The lead of claim 1, wherein said tubular covering has an inner surface pore size larger than said outer surface pore size.

8. The lead of claim 1, wherein said porous tubular covering has pores that are at least partially filled by a wet-out agent.

9. The lead of claim 1, wherein said lead is packaged in a sealed package, wherein said package contains saline.

10. The lead of claim 1, wherein said electrode is a defibrillation electrode.,

11. The lead of claim 10, wherein said defibrillation electrode has a length greater than 7.5 centimeters.

12. The lead of claim 1, wherein said electrode is a sensing electrode.

13. The lead of claim 1, wherein said electrode is a defibrillation electrode and said lead further comprises a second electrode and a second conductor at least partially covered by said porous tubular covering.

14. The lead of claim 13, wherein said second electrode is a sensing electrode.

15. The lead of claim 1, wherein said porous tubular covering has an inner diameter greater than an outer diameter of said electrode thereby forming a gap between said porous tubular covering and said electrode.

16. The lead of claim 1, and further comprising an electrically insulating layer between said conductor and said porous tubular covering.

17. The lead of claim 16, wherein said porous tubular covering has an inner diameter greater than an outer dimension of said electrically insulating layer thereby creating a gap between said porous tubular covering and said electrically insulating layer.

18. The lead of claim 1, said lead body further including a second conductor coupled between a second connector at said lead body proximal end and a second electrode on said lead body.

19. The lead of claim 1 wherein said lead subassembly is of a construction that, without said porous tubular covering, a 10 day, 37°

C., 9 g/l saline soak and subsequent one minute, 5N tensile load application results in permanent elongation greater than 5%.

20. The lead of claim 1 wherein at least a portion of said electrode has a fragile high-surface area coating.

21. The lead of claim 1 wherein said lead subassembly has a low abrasion resistance.

22. The lead of claim 1 wherein said lead subassembly is nonbiocompatible.

23. The lead of claim 22 wherein at least a portion of said lead subassembly has rough edges that would irritate body tissue if implanted without said porous tubular covering.

24. The lead of claim 22 wherein said electrode has crevices that would encourage tissue ingrowth if implanted without said porous tubular covering.

25. An implantable medical lead comprising:

a lead body having a proximal end and a distal end and including at least one conductor;

an electrode positioned on said lead body and electrically coupled to said conductor;

a connector positioned at said proximal end of said lead body and electrically coupled to said conductor; and

a porous tubular covering having proximal and distal ends and extending over at least a portion of said electrode and at least a portion of said lead body.

26. The lead of claim 25 wherein said distal end of said tubular covering is mechanically coupled to said lead body near said distal end of said lead body, and said proximal end of said tubular covering, is mechanically coupled to said lead body near said proximal end of said lead body whereby said tubular covering completely covers said electrode.

27. A method of making an implantable medical lead comprising the steps of:

(a) electrically connecting a conductor to a connector;

(b) electrically connecting said conductor to an electrode; and

(c) inserting said electrode and conductor into a porous tube having proximal and distal ends.

28. The method of claim 27 and further comprising the step of:

(d) mechanically attaching said porous tube proximal end to said connector.

29. The method of claim 27 and further comprising the step of:

(e) mechanically attaching said porous tube distal end near a distal end of said lead.

30. The method of claim 29 wherein said step (e) comprises applying an adhesive to said porous tube and to a distal pacing electrode shank.

31. The method of claim 29 wherein said step (e) comprises tying a ligature around said porous tube and a distal pacing electrode shank.

32. The method of claim 27 and further comprising the steps of:

(f) forming holes or slots in said distal end of said porous tube; and

(g) inserting tines positioned on said lead distal end through said holes or slots.

33. A method for implanting a lead having a porous tubular covering extending over at least a portion of an electrode and at least a portion of a lead body comprising the steps of:

(a) applying a wet-out agent to said lead; and

(b) positioning said lead within a patient.

34. The method of claim 33, and further including after said step (a) and before step (b), the step of:

(c) soaking said lead with said wet-out agent in saline.