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.
1. An elongate lead, comprising:
a lead body including a proximal portion configured to be connected to an implantable medical device, and a distal portion having a spiral shape or generally spiral shape with at least a first loop and a second loop configured to be implanted in a lumen, the first loop and the second loop being joined together by a stabilizing feature pre-formed between the first loop and the second loop so as to impart shape to the lead body;
a guide wire or stylet configured to be removably installed within the lead body, the guide wire or stylet configured to be removed from the lead body after the lead is deployed in a desired location in the lumen, wherein the desired location is at least one of a subclavian vein or a brachiocephalic vein; and
a plurality of electrodes disposed on the lead body, at least one of the electrodes arranged on the distal portion and configured to be positioned proximate a vessel wall of the lumen.
2. The lead of claim 1 , wherein the plurality of electrodes includes a first electrode positioned on the first loop, a second electrode positioned on the second loop, and a third electrode at a distal end of the distal portion of the lead body.
3. The lead of claim 1 , wherein the lead is configured to be deployed such that the at least one of the electrodes is positioned proximate a phrenic nerve.
4. The lead of claim 1 , further comprising an implantable signal generator configured to provide a stimulation signal to at least one electrode of the plurality of electrodes.
5. The lead of claim 1 , wherein the stabilizing feature includes a third loop between the first loop and the second loop.
6. The lead of claim 5 , wherein the third loop is configured to act as a fixation element to fix the lead body at the desired location in the lumen.
7. The lead of claim 1 , wherein the stabilizing feature is configured to act as a fixation element to fix the lead body at the desired location in the lumen.
8. The lead of claim 1 , wherein the stabilizing feature includes a pre-formed bend between the first loop and the second loop.
9. The lead of claim 8 , wherein the bend is configured to act as a fixation element to fix the lead body at the desired location in the lumen.
10. The lead of claim 1 , wherein the stabilizing feature imparting the shape to the lead body assists with orienting the distal end of the lead body during implantation of the lead body in the lumen.
11. The lead of claim 1 , wherein the plurality of electrodes includes a first electrode positioned on the first loop and a second electrode positioned on the second loop.
12. A method of implanting an elongate lead in a lumen, the method comprising:
deploying a combination of a lead body and a removable guide wire or stylet in the lumen, the lead body including a proximal portion and a distal portion, the distal portion having a spiral shape or generally spiral shape with at least a first loop and a second loop and a plurality of electrodes disposed on the distal portion of the lead body, the first loop and the second loop being joined together by a stabilizing feature pre-formed between the first loop and the second loop so as to impart shape to the lead body;
arranging at least one electrode of the plurality of electrodes proximate to a vessel wall of the lumen; and
removing the guide wire or stylet from the lead body after the lead is deployed in a desired location in the lumen,
wherein deploying the combination of the lead body and the removable guide wire or stylet in the lumen includes deploying the combination in at least one of a subclavian vein or a brachiocephalic vein.
13. The method of claim 12 , wherein the at least one electrode is positioned proximate a phrenic nerve.
14. The method of claim 12 , wherein the plurality of electrodes includes a first electrode positioned on the first loop, a second electrode positioned on the second loop, and a third electrode at a distal end of the distal portion of the lead body, and wherein arranging the at least one electrode of the plurality of electrodes proximate to the vessel wall of the lumen includes arranging at least one of the first electrode, the second electrode, or the third electrode proximate to the vessel wall of the lumen.
15. The method of claim 12 , wherein the elongate lead includes an implantable signal generator, the method further comprising providing, by the implantable signal generator, at least one stimulation signal to the at least one electrode.
16. The method of claim 12 , wherein the stabilizing feature includes a third loop between the first loop and the second loop, and wherein deploying the combination of the lead body and the removable guide wire or stylet in the lumen includes fixing, by the third loop, the combination at the desired location in the lumen.
17. The method of claim 12 , wherein the stabilizing feature, and wherein deploying the combination of the lead body and the removable guide wire or stylet in the lumen includes fixing, by the stabilizing feature, the combination at the desired location in the lumen.
18. The method of claim 12 , wherein the stabilizing feature includes a pre-formed bend between the first loop and the second loop, and wherein deploying the combination of the lead body and the removable guide wire or stylet in the lumen includes fixing, by the pre-formed bend, the combination at the desired location in the lumen.
19. The method of claim 12 , wherein the plurality of electrodes includes a first electrode positioned on the first loop and a second electrode positioned on the second loop, and wherein arranging the at least one electrode of the plurality of electrodes proximate to the vessel wall of the lumen includes arranging at least one of the first electrode or the second electrode proximate to the vessel wall of the lumen.
20. An elongate lead, comprising:
a lead body including a proximal portion configured to be connected to an implantable medical device, and a distal portion having a spiral shape or generally spiral shape with at least a first loop configured to be implanted in a first lumen and a second loop configured to be implanted in a second lumen branching off of the first lumen at a lumen junction, the first loop and the second loop being joined together by a stabilizing feature pre-formed between the first loop and the second loop so as to impart shape to the lead body;
a guide wire or stylet configured to be removably installed within the lead body, the guide wire or stylet configured to be removed from the lead body after the lead is deployed in a desired location in at least one of the first lumen and the second lumen; and
a plurality of electrodes disposed on the lead body, at least one of the electrodes arranged on the distal portion and configured to be positioned proximate a vessel wall of one or more of the first lumen and the second lumen.
21. The lead of claim 20 , wherein the stabilizing feature is configured to be implanted in the lumen junction and is configured conform to a shape of the lumen junction.