Cardiac lead with retractible fixators

• US 5,179,962 A
• Filed: 06/20/1991
• Issued: 01/19/1993
• Est. Priority Date: 06/20/1991
• Status: Expired due to Term

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Dutcher, Robert G., Scott, Robert J., Packard, Brian M.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/718,377
• Time in Patent Office: 579 Days
• Field of Search: 128/784-786, 128/419 P, 128/642
• US Class Current: 607/128
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A cardiac lead has an electrode and fixation assembly including a plurality of fixation members movable to extended positions into heart tissue to retain the electrode in intimate engagement with heart tissue. An elongated stylet is used to move the fixation members to their extended positions into the heart tissue and retract the fixation members into the fixation assembly to allow the lead to be removed from the heart and body of a person.

Claims

1. An implantable lead comprising:

an electrical conductor having a first end adapted to be connected to a cardiac arrhythmia management device and a second end, a sheath of insulative material covering said conductor, and an electrode and fixation assembly connected to the second end of the conductor and the sheath, said electrode and fixation assembly including a body having a chamber, said body being an electrical conductor member connected to the electrical conductor, said body having a distal end including and outer surface for directly containing the endocardium of the heart, a jacket of electrical insulation material covering the body except for said outer surface, carrier means located within the chamber for movement between first and second positions;

at least one fixation means moveable from a first position within the assembly to a second position extended away from the assembly for engagement with the endocardium of the human heart, means mounting said fixation means on the carrier means whereby the fixation means moves with the carrier means, said body and jacket having hole means open to the chamber accommodating the fixation means to allow the fixation means to be moved from the chamber outwardly of the body into the endocardium of the heart and moved inwardly into the body out of engagement with the endocardium of the heart, said carrier means cooperating with means operable to selectively move the carrier means to the first and second positions to extend and retract the fixation means relative to the body.

2. The lead of claim 1 including:

platinum black particles covering the outer surface of the body.

3. The lead of claim 1 wherein:

the outer surface of the body is a surface having a plurality of holes.

4. The lead of claim 3 including:

platinum black particles covering the surface.

5. The lead of claim 1 wherein:

the fixation means comprise a plurality of elongated members.

6. The lead of claim 1 wherein:

the fixation means comprise two pairs of elongated members circumferentially spaced around the electrode and fixation assembly.

7. The lead of claim 1 wherein:

the fixation means comprises a plurality of flexible wire members covered with non-electrical conductive material.

8. The lead of claim 1 wherein:

said carrier means has ring means having grooves accommodating portions of the fixation means, said means mounting the fixation means on the carrier means comprises a sleeve located around the ring means to retain the portions of the fixation means in said grooves.

9. The lead of claim 8 wherein:

the fixation means are U-shaped flexible wire members covered with non-electrical conductive material having first portions located in said grooves and second end portions moveable from the chamber outwardly of the body into the endocardium of the heart and inwardly into the body out of engagement with the endocardium of the heart.

10. The lead of claim 1 wherein:

the fixation means comprises a plurality of elongated fixation members mounted on the carrier means, said hole means comprising a plurality of holes open to the chamber, each of the holes accommodating a fixation member whereby the fixation members move through said holes to their extended positions into the endocardium of the heart.

11. The lead of claim 10 wherein:

four fixation means are mounted on the carrier means, said body and jacket having four of said holes for accommodating said four fixation members.

12. The lead of claim 1 wherein:

the carrier means has a central hole, said means operable to move the fixation means comprises an elongated stylet having a head larger than the hole whereby when the head is forced through the hole, the stylet can be moved relative to the body to move said carrier means between said first and second position thereby moving the fixation means to said extended and retracted positions.

13. The lead of claim 1 wherein:

said carrier means includes ring means for supporting the fixation means, and the means mounted said fixation means on the carrier means comprises a sleeve located around the ring means to retain the fixation means on the ring means.

14. The lead of claim 1 wherein:

said means for selectively moving the fixation means comprising a stylet extended through said sheath and into the chamber of the body, said stylet and carrier means having cooperating means releasably connecting the stylet to the carrier means whereby the stylet is moved to move the carrier means between its first and second positions to extend and retract the fixation means relative to the body.

15. The lead of claim 1 wherein:

the body has a cylindrical side wall surrounding said chamber and a distal end having said outer surface, said jacket surrounding said side wall, said side wall and jacket having said hole means accommodating the fixation means whereby the fixation means project laterally from the body when the fixation means are in the second position.

16. The lead of claim 15 wherein:

the hole means are inclined rearwardly to guide the fixation means outwardly and rearwardly from the body to the second position thereof.

17. The lead of claim 15 wherein:

the fixation means has a plurality of flexible elongated wire members covered with non-electrical conductive material.

18. An implantable lead comprising:

an electrical conductor having a first end adapted to be connected to a cardiac arrhythmia management device and a second end, a sheath of insulative material covering said conductor, and an electrode and fixation assembly connected to the second end of the conductor and the sheath, said electrode and fixation assembly including an electrical conductive body means connected to the electrical conductor having an outer surface for directly contacting the endocardium of the heart, fixation means mounted on the body means for movement from a retracted position within the body means to an extended position away from the body means to retain the outer surface of the body means in contact with the endocardium of the heart, said body means having an internal chamber, and hole means in said body means open to the chamber to accommodate the fixation means, a member located within said chamber moveable between first and second positions, said fixation means being located within said chamber and having elongated portions located in said hole means, means mounting the fixation means on the member for movement with the member into said retracted position in the chamber and said extended position away form said body means into engagement with the endocardium of the heart, said means mounting the fixation means on the member comprises a sleeve located around the member, said member cooperating with the means operable to move the member between said first and second positions thereby selectively moving the fixation means to its extended position and retracted position.

19. The lead of claim 18 including:

platinum black particles covering the outer surface of the body means.

20. The lead of claim 18 wherein:

the fixation means comprise a plurality of elongated members covered with non-electrical conductive material.

21. The lead of claim 18 wherein:

the fixation means comprise a plurality of elongated members circumferentially spaced around the body means, each elongated member having a portion located in said hole means in the body means and moveable between a retracted position within the body means to an extended position into the endocardium of the heart.

22. The lead of claim 19 wherein:

the member has a central hole, said means operable to move the member comprises an elongated stylet having a head larger than the hole whereby when the head is forced through the hole the stylet can be moved relative to the body means to move the member between said first and second positions thereby moving the fixation means to its extended position and retracted position.

25. The lead of claim 18 wherein:

the outer surface of the body means has a plurality of holes.

26. The lead of claim 25 including:

platinum black particles covering said outer surface of the body means.

27. The lead of claim 18 wherein:

the member has groove means accommodating portions of the fixation means, and a sleeve located around the member retaining the portions of the fixation means in said groove means.

28. The lead of claim 27 wherein:

the fixation means are U-shaped flexible wire members covered with non-electrical conductive material having first portions located in said groove means and second end portions moveable from the chamber outwardly through said hole means into engagement with the endocardium of the heart.

29. The lead of claim 18 wherein:

the body means have a cylindrical side wall surrounding the chamber, and non-electrical conductor means surrounding said side wall and mounted thereon, said side wall and non-electrical conductor means having said hole means whereby the elongated portions of the fixation means project laterally from the body means when the fixation means are in the extended position.

30. The lead of claim 29 wherein:

the hole means are inclined rearwardly to guide the elongated portion of the fixation means outwardly and rearwardly from the body means to the extended position thereof.

23. The lead of claim 23 wherein:

the outer surface of the body means is an annular surface.

24. The lead of claim 23 wherein:

platinum black particles covering the annular surface.

31. An implantable lead comprising:

an electrical conductor having a first end adapted to be connected to a cardiac arrhythmia management device and a second end, a sheath of insulative material covering said conductor, and an electrode and fixation assembly connected to the second end of the conductor and the sheath, said electrode and fixation assembly including an electrical conductive body means connected to the electrical conductor having an outer surface for directly contacting the endocardium of the heart, fixation means mounted on the body means for movement from a retracted position in the body means and to an extended position away from the body means to retain the outer surface of the body means in contact with the endocardium of the heart, said body means having a cylindrical side wall surrounding an internal chamber, electrical insulation means surrounding the side wall, hole means in the side wall and electrical insulation means open to the chamber to accommodate the fixation means, a member located within said chamber moveable between first and second positions, said fixation means being located within said chamber and having elongated portions located in said hole means, means mounting the fixation means on the member for movement with the member into retracted position in the chamber and an extended position laterally away form said side wall of the body means into engagement with the endocardium of the heart, said member cooperating with means operable to move the member between said first and second position thereby moving the fixation means to its extended position and retracted position.

32. The lead of claim 31 wherein:

the fixation means comprise a plurality of elongated members covered with non-electrical conductive material.

33. The lead of claim 31 wherein:

the fixation means comprises two pairs of elongated members circumferentially spaced around the body means, each elongated member having a portion located in said hole means in the body means and moveable between a retracted position within the body means to an extended position into the endocardium of the heart.

34. The lead of claim 31 wherein:

the means mounting the fixation means on the member comprise a sleeve located around the member.

35. The lead of claim 31 wherein:

the member has groove means accommodating portions of the fixation means, said means mounting the fixation means on the member retaining the portions of the fixation means in said groove means.

36. The lead of claim 35 wherein:

the fixation means are U-shaped flexible wire members covered with non-electrical conductive material having first portions located in said groove means and second end portions moveable from the chamber outwardly through said hole means into engagement with the endocardium of the heart.

37. The lead of claim 31 wherein:

the hole means are inclined rearwardly to guide the elongated portions of the fixation members outwardly and rearwardly from the body means to the extended position thereof.