SYSTEMS AND METHODS FOR TRANSVENOUS LEAD IMPLANTATION

• US 20080234792A1
• Filed: 03/20/2007
• Published: 09/25/2008
• Est. Priority Date: 03/20/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Reddy, G. Shantanu, Desai, Shrojalkumar M.
• Granted Patent: US 8,000,810 B2
• Time in Patent Office: Days
• US Class Current: 607/120
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

Some embodiments relate to a method of implanting a cardiac lead. An expansion module is implanted in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein. The expansion module is transitioned from a collapsed state to an expanded state within the target region to contact the vasculature. A cardiac lead is implanted through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region. The intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

Claims

1. A cardiac lead system for implantation in a venous pathway from an IMD to a patient'"'"'s heart, the pathway including a target region defined by a portion of a brachiocephalic adjacent to an external jugular vein and a portion of a corresponding subclavian vein adjacent to the external jugular vein, the cardiac lead system comprising:

a cardiac lead extending between a terminal end for connection to an implantable medical device and a working end adapted for at least one of sensing and stimulating, the cardiac lead defining a proximal section, a distal section, and an intermediate section between the proximal and distal sections, the cardiac lead being adapted such that the intermediate section extends through the target region upon implantation of the cardiac lead, wherein the intermediate section of the cardiac lead includes a surface treatment for reducing venous occlusion at the target region; and

an expansion module comprising a first expansion member adapted to expand in diameter from a collapsed state to an expanded state to contact and mechanically support a vessel wall in the target region and to slidably receive the intermediate section in the expanded state.

2. The cardiac system of claim 1, wherein the first expansion member comprises an internal guide structure for supporting the cardiac lead at a desired radial position within the first expansion member.

3. The cardiac lead system of claim 1, wherein the surface treatment of the intermediate section is a non-eluting surface modification for reducing at least one of thrombosis, cell proliferation, fibrosis and inflammation.

4. The cardiac lead system of claim 1, wherein the surface treatment of the intermediate section includes a non-eluting surface modification selected from the group consisting of:

a polyethylene-glycol surface modification, an ethylene-glycol surface modification, a fluorinated hydrocarbon surface modification, a phosphorylcholine surface modification, a taurine surface modification, a sulfobetaine surface modification, a zwitterion-type surface modification, and combinations thereof.

5. The cardiac lead system of claim 1, wherein the surface treatment of the intermediate section includes an eluting coating of a therapeutic agent for reducing at least one of thrombosis, cell proliferation, fibrosis and inflammation.

6. The cardiac lead system of claim 1, wherein the surface treatment of the intermediate section includes a coating of a therapeutic agent selected from the group consisting of:

paclitaxel-SIBS, salicylic acid based polyanhydrides, sirolimus, everolimus, doxorubicin, mitomycin, fluorodeoxyuridine, heparin, heparin derivatives, salicylic acid, salicylic acid polyahydrides, and combinations thereof.

7. The cardiac lead system of claim 1, wherein the expansion module includes an internal sleeve adapted to reduce cellular adhesion between the intermediate section of the cardiac lead and the vessel wall upon implantation of the cardiac lead system.

8. The cardiac lead system of claim 7, wherein the internal sleeve includes polytetrafluoroethylene material.

9. The cardiac lead system of claim 1, wherein the expansion module includes an eluting coating of a therapeutic agent for reducing at least one of thrombosis, cell proliferation, fibrosis and inflammation.

10. The cardiac lead system of claim 1, wherein the expansion module includes an eluting coating of a therapeutic agent selected from the group consisting of:

paclitaxel-SIBS, salicylic acid based polyanhydrides, sirolimus, everolimus, doxorubicin, mitomycin, fluorodeoxyuridine, heparin, heparin derivatives, salicylic acid, salicylic polyahydrides, and combinations thereof.

11. The system of claim 1, wherein the expansion module further comprises:

a second expansion member adapted to expand in diameter from a collapsed state to an expanded state to contact and mechanically support a vessel wall in the target region and to slidably receive the intermediate section in the expanded state; and

a deployment assembly for concurrently positioning the first and second expansion members within the target region, such that the first expansion member is deployed in the brachiocephalic vein adjacent to the external jugular vein and the second expansion member is deployed in the subclavian vein adjacent to the external jugular vein.

12. The system of claim 11, wherein the deployment assembly includes a retractable outer sheath maintaining the first and second expansion members in the collapsed state about the intermediate section.

13. The system of claim 1, wherein the first expansion member includes a bioresorbable body.

14. A method of implanting a cardiac lead, the method comprising:

implanting an expansion module in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein;

transitioning the expansion module from a collapsed state to an expanded state within the target region to contact the vasculature; and

implanting a cardiac lead through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region;

wherein the intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

15. The method of claim 14, wherein the surface treatment of the intermediate section includes a non-eluting surface modification selected from the group consisting of:

a polyethylene-glycol surface modification, ethylene-glycol surface modification, a fluorinated hydrocarbon surface modification, a phosphorylcholine surface modification, a taurine surface modification, a sulfobetaine surface modification, a zwitterion-type surface modification, and combinations thereof.

16. The method of claim 14, wherein the surface treatment of the intermediate section includes an eluting coating of a therapeutic agent selected from the group consisting of:

paclitaxel-SIBS, salicylic acid based polyanhydrides, sirolimus, everolimus, doxorubicin, mitomycin, fluorodoxyuridine, heparin, heparin derivatives, salicylic acid, salicylic acid polyahydrides, and combinations thereof.

17. The method of claim 14, wherein the expansion module includes at least one of an internal sleeve adapted to reduce cellular adhesion between the intermediate section of the cardiac lead and the vasculature and a surface modification adapted to reduce venous occlusion at the target region.

18. The method of claim 14, wherein the brachiocephalic, external jugular, and subclavian veins correspond to the left side of the body.

19. A method of implanting a cardiac lead prior to venous occlusion at a target region defined by a junction of the brachiocephalic vein and the external jugular vein, the method comprising:

implanting a first expansion member in a vascular pathway including the target region;

expanding the first expansion member to an expanded state in the target region; and

implanting a cardiac lead within the vascular pathway such that the cardiac lead extends through the target region and is received within the first expansion member, the cardiac lead including an insulator defining an outer surface of the cardiac lead;

wherein at least a portion of the outer surface of the cardiac lead extending through the target region includes a non-eluting surface modification including at least one of a polyethylene-glycol surface modification, an ethylene-glycol surface modification, a fluorinated hydrocarbon surface modification, a phosphorylcholine surface modification, a taurine surface modification, a sulfobetaine surface modification, and a zwitterion-type surface modification.

20. The method of claim 19, wherein at least one of the first and second expansion members includes an internal sleeve having a non-eluting surface modification.

21. The method of claim 20, wherein the internal sleeve is formed of ePTFE.

22. The method of claim 19, wherein the first expansion member further comprises an internal guide structure supporting the cardiac lead at a desired radial position within the first expansion member.