Transvascular medical lead
A medical electrical lead and methods of implanting medical electrical leads in lumens. Leads in accordance with the invention employ preformed biases to stabilize the lead within a lumen or lumen and to provide feedback to lead implanters. In some embodiments, a preformed bend in the lead may assist an implanter with orienting the lead within a lumen.
1. An elongate medical lead comprising:
a. a lead body having a proximal portion and a distal portion, the proximal portion configured to be connected to an electrical signal generator; and
b. a stabilizing section proximate the distal portion comprising;
i. a first two-dimensional loop comprising a first single coil, wherein the first single coil is configured to turn in a first direction;
ii. a second two-dimensional loop comprising a second single coil, where the second single coil is configured to turn in the first direction; and
iii. a bend between the first and second loops wherein the first loop, the second loop and the bend together comprise a two-dimensional structure.
2. The lead of claim 1 , wherein the proximal portion is more flexible than the distal portion.
3. The lead of claim 1 , further comprising at least one electrode located on the distal portion of the lead.
4. The lead of claim 3 , comprising an electrode on the first loop and at least two electrodes on the second loop.
5. The lead of claim 4 , which provides an extended bipole configuration between an electrode on the first loop and an electrode on the second loop when implanted.
6. The lead of claim 1 , wherein the bend is configured to assist in orienting the lead at the junction of two lumens.
7. The lead of claim 1 , wherein the bend is configured to assist in orienting the lead at the junction of a subclavian vein and a brachiocephalic vein.
8. The lead of claim 1 , the lead body forming a lumen through which a guide wire or stylet may pass.
9. The lead of claim 1 , further comprising a fixation assistance element on an exterior surface of the distal portion.
10. The lead of claim 9 , wherein the fixation assistance element is selected from the group consisting of a barb, a hook, a material promoting cellular formation, a depression, a ridge, and a bump.
11. An elongate medical lead comprising:
a. a lead body having a proximal end configured to be connected to an implantable medical device, the lead body forming a lumen through which a guide wire or stylet may pass; and
b. a distal end having at least two electrodes, the distal end of the lead body comprising a plurality of loops, wherein each loop is constructed as a two-dimensional single coil and each loop is configured to form a three-dimensional spiral when deployed in an appropriately sized lumen.
12. The lead of claim 11 , wherein the distal end comprises three loops.
13. An elongate medical lead comprising:
a. a lead body having a proximal portion, a first distal portion comprising a first single two-dimensional loop, and a second distal portion comprising a second single two-dimensional loop;
b. a bend formed in the lead body between the first distal portion and the second distal portion wherein the first loop, the second loop, and the bend together comprise a two-dimensional structure; and
c. at least one electrode on each of the first and second distal portions.
14. The lead of claim 13 , wherein the bend is configured to help stabilize the lead at the junction of two blood vessels such that the first distal portion is disposed in a first vessel and the second distal portion is disposed in a second vessel.
15. The lead of claim 13 , wherein the first distal portion comprises the first loop turning in one direction and the second distal portion comprises the second loop turning in a direction opposite the one direction.
16. The lead of claim 15 , wherein the bend serves to displace the first loop from the second loop.
17. The lead of claim 13 , wherein the first distal portion comprises the first loop turning in one direction and the second distal portion comprises the second loop turning in the one direction.
18. A method of implanting a lead in a lumen comprising;
a. feeding a combination of a lead with a removable guide wire/stylet therein into a lumen to a desired location so that the distal region of the combination is located where the lumen is non-straight or branched, the combination having a nonstraight shape proximate a distal end of the combination;
b. rotating the combination to a point where resistance to rotation caused by the combination contacting but not penetrating the non-straight or branched lumen increases; and
c. removing the guide wire/stylet from the lead while the combination is in a position of increased rotational resistance.
19. The method of claim 18 , wherein the shape is imparted to the combination by a bent or shaped stylet or guide wire.
20. The method of claim 18 , wherein the lead has a preformed bias proximate a distal end of the lead and the shape is imparted to the combination by the preformed bias.
21. The method of claim 20 , wherein the bias is located at a distal end of the lead between a first lead fixation structure and a second lead fixation structure.
22. The method of claim 21 , wherein the first lead fixation structure is a first loop and the second lead fixation structure is a second loop.
23. The method of claim 22 , wherein the first loop turns in one direction and the second loop turns in a direction opposite the one direction.
24. The method of claim 22 , wherein the first loop turns in one direction and the second loop turns in the one direction.
25. The method of claim 18 , wherein the feeding step comprises feeding a lead into a second lumen from a first lumen.