Coronary vein leads having an atraumatic TIP and method therefor

• US 20030109914A1
• Filed: 04/23/2002
• Published: 06/12/2003
• Est. Priority Date: 08/30/2000
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Tockman, Bruce, Soltis, Brian D., Westlund, Randy, Bye, Lyle A., Repasky, Christina
• Granted Patent: US 7,628,801 B2
• Time in Patent Office: Days
• 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
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A lead having an atraumatic tip is adapted for implantation on or about the heart within the coronary vasculature and for connection to a signal generator. The lead is constructed and arranged so that when it is implanted, the electrodes are housed in the coronary vasculature and are biased toward a vessel wall by a preformed biased portion. Near the distal end, the lead has an optional tapered portion and a flexible portion, where the flexible portion is more flexible than the biased portion.

Claims

1. A lead assembly comprising:

a lead body adapted to carry signals, the lead body having a proximal end and a distal end, and an intermediate portion therebetween;

a connector located at the proximal end of the lead body;

at least one conductor disposed within the lead body;

the lead body having at least one preformed biased portion at an intermediate portion of the lead body;

an unbiased, flexible tapered portion disposed between the biased portion and the distal end of the lead body, the tapered portion distal to the biased portion is substantially more flexible than the biased portion, the distal portion of the lead having a tapered portion adapted to be implanted within a passage; and

at least one electrode coupled with at least one conductor.

2. The lead assembly as recited in claim 1, wherein the unbiased, flexible tapered portion terminates at a distal tip of the lead body.

3. The lead assembly as recited in claim 1, wherein the conductor forms an inner lumen therein, and the inner lumen is isodiametric from the proximal end to a position near the distal end of the lead body.

4. The lead assembly as recited in claim 1, wherein none of the conductors extend to the distal end of the lead body.

5. The lead assembly as recited in claim 4, wherein the conductor terminates within the unbiased, flexible, tapered portion of the lead body.

6. The lead assembly as recited in claim 1, wherein the biased portion has a helical shape.

7. The lead assembly as recited in claim 6, further comprising electrodes disposed along the helical shape, wherein the electrodes on the helical shape are spaced 120 degrees apart.

8. The lead assembly as recited in claim 1, further comprising radiopaque material molded within material forming the unbiased, flexible, tapered portion.

9. The lead assembly as recited in claim 1, wherein the tapered portion extends from the biased portion to the distal end of the lead body.

10. The lead assembly as recited in claim 1, wherein the tapered portion extends for a predetermined length, where the predetermined length is two or less centimeters.

11. The lead assembly as recited in claim 1, further comprising a drug collar directly adjacent to the tapered, flexible portion.

12. A lead assembly comprising:

a lead body adapted to carry signals, the lead body extending from a proximal end to a distal end, and an intermediate portion therebetween, the lead body terminating at a distal tip;

at least one conductor disposed within the lead body;

the lead body having at least one preformed biased portion at an intermediate portion of the lead body;

a flexible portion and a tapered portion near the distal end of the lead body, the flexible portion is more flexible than the biased portion; and

the distal end of the lead body having a tapered portion adapted to be implanted within a passage.

13. The lead assembly as recited in claim 12, wherein the flexible portion extends from the distal tip.

14. The lead assembly as recited in claim 12, wherein the flexible portion extends from the distal tip to a portion between the biased portion and the distal tip.

15. The lead assembly as recited in claim 12, wherein the flexible portion extends from the distal tip to the preformed biased portion.

16. The lead assembly as recited in claim 12, wherein the tapered portion extends from the distal tip to a portion between the preformed biased portion and the distal tip.

17. The lead assembly as recited in claim 12, wherein the flexible portion has a length greater than the tapered portion.

18. The lead assembly as recited in claim 12, wherein the at least one conductor does not extend to the distal tip.

19. The lead assembly as recited in claim 12, wherein the biased portion has a helical shape.

20. The lead assembly as recited in claim 19, further comprising two or more electrodes disposed along the biased portion, where the two or more electrodes are spaced about 120 degrees apart around the helical shape.

21. The lead assembly as recited in claim 12, wherein the lead assembly includes an open lumen lead.

22. The lead assembly as recited in claim 12, further comprising an electrical stimulation device coupled with the lead body.

23. A lead assembly comprising:

a lead body adapted to carry signals, the lead body extending from a proximal end to a distal end, and an intermediate portion therebetween, the lead body terminating at a distal tip;

at least one conductor disposed within the lead body;

the lead body having at least one preformed biased portion at an intermediate portion of the lead body;

a flexible portion near the distal end of the lead body, the flexible portion is more flexible than the biased portion; and

the distal end of the lead body having a tapered portion adapted to be implanted within a passage.

24. The lead assembly as recited in claim 23, wherein the flexible portion extends from the distal tip.

25. The lead assembly as recited in claim 23, wherein the flexible portion extends from the distal tip to a portion between the biased portion and the distal tip.

26. The lead assembly as recited in claim 23, wherein the flexible portion extends from the distal tip to the biased portion.

27. The lead assembly as recited in claim 23, wherein the lead body has a tapered portion extending from the distal tip, and the tapered portion extends from the distal tip to a portion between the biased portion and the distal tip.

28. The lead assembly as recited in claim 23, wherein the distal end of the lead body includes a premolded tip assembly filled with radiopaque material.

29. The lead assembly as recited in claim 23, where the biased portion includes a preformed helical portion.

30. A method comprising:

placing a guidewire within one or more passageways of a body;

threading a lead assembly over the guidewire, the lead assembly including a lead body adapted to carry signals, the lead body having a proximal end and a distal end, and an intermediate portion therebetween, a connector located at the proximal end of the lead body, at least one conductor disposed within the lead body, the lead body having at least one preformed biased portion at an intermediate portion of the lead body, a flexible portion and a tapered portion are disposed between the biased portion and the distal end of the lead body, the tapered portion is distal to the biased portion and is more flexible than the biased portion, at least one electrode coupled with at least one conductor;

biasing one or more electrodes against a wall of at least one of the passageways; and

placing the distal end in a cardiac vein.

31. The method as recited in claim 30, wherein the lead assembly includes a distal tip assembly including a premolded portion filled with radiopaque material, and further comprising viewing the distal tip assembly under fluoroscopy.

32. The method as recited in claim 30, further comprising flexing the distal end of the lead body.

33. The method as recited in claim 30, wherein biasing the electrodes against the wall of the passageway includes positioning one or more electrodes around a helical portion of the lead body.