Composite vascular prosthesis

Abstract

A novel treatment for atherosclerotic vascular disease is described utilizing the implantation of a thin, conformable biocompatible prosthesis constructed from a composite of various structural and therapeutic scaffolds in combination with one or more bioactive agents. This prosthesis can be delivered into position over a lesion in order to passivate atherosclerotic plaques with minimal remodeling of the artery, or alternatively can be applied with a balloon to passivate the remodeled site. The composite prosthesis itself provides mild structural reinforcement of the vessel wall and an evenly distributed platform for the introduction of bioactive therapeutic agents.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates mechanisms of conventional endovascular therapy.

FIG. 2 illustrates a vulnerable plaque atherosclerotic lesion.

FIG. 3 illustrates biological mechanisms of focal vulnerable plaque therapy.

FIG. 4 illustrates an initial phase in the response of a blood vessel to treatment with a prosthesis embodiment of the invention.

FIG. 5 illustrates a next phase in the response of a blood vessel to treatment with a prosthesis embodiment of the invention

FIG. 6 illustrates a next phase in the response of a blood vessel to treatment with a prosthesis embodiment of the invention

FIG. 7 illustrates an embodiment of a composite vascular prosthesis according to the invention.

FIG. 8 illustrates an embodiment of a composite vascular prosthesis according to the invention.

FIG. 9 illustrates an embodiment of a composite vascular prosthesis according to the invention.

FIG. 10 illustrates an embodiment of a composite vascular prosthesis according to the invention.

FIG. 11 illustrates an embodiment of a composite vascular prosthesis according to the invention.

FIG. 12 illustrates the relationship between induced vessel strain, applied vessel force or pressure and lumen diameter.

FIG. 13 illustrates various mechanical stabilization options for treatment of atherosclerotic lesions.

FIG. 14 illustrates a quilting method embodiment for expansion strain-mediated release of drugs or adhesives.

FIG. 15 illustrates various structural surface modification aspects of the prostheses of the invention.

FIG. 16 illustrates a stent design that may serve as a structural component for a composite vascular prosthesis according to the invention.

FIG. 17 illustrates a composite vascular prosthesis embodiment of the invention that consists of three layers, mounted on a low-pressure balloon delivery catheter.

Claims

1. An expandable vascular prosthesis, comprising: an at least substantially tubular, radially expandable structural component comprising an abluminal surface and an adluminal surface; andan adhesive coating comprising at least one molecule selected from the group consisting of a collagen and an elastin, wherein the adhesive coating is disposed on at least part of the abluminal surface of the structural component, andwherein the adluminal surface comprises surface features having depths in the range of 5 nm to 5 μm and lateral dimensions in the range of 50 nm to 5 microns, said surface features being present on the adluminal surface at a density of 1 to 500 surface features per 10 μm2.

2. The prosthesis of claim 1, wherein at least part of the adluminal surface is coated with at least one biomolecule.

3. The prosthesis of claim 2, wherein the at least one biomolecule coated on the adluminal surface comprises a fibronectin.

4. The prosthesis of claim 1, wherein the bioadhesive coating comprises an activatable protein crosslinker.

5. The prosthesis of claim 1, wherein the prosthesis is self-expanding.

6. The prosthesis of claim 1, wherein the structural component is metallic.

7. The prosthesis of claim 1, wherein the structural component is polymeric.

8. The prosthesis of claim 1, wherein the prosthesis exerts a radial expansion force in the range of 30 to 750 mm Hg in a radially expanded state.

9. The prosthesis of claim 8, wherein the prosthesis exerts a radial expansion force in the range of 30 to 250 mm Hg in a radially expanded state.

10. The prosthesis of claim 1, wherein the structural component has a wall thickness in the range of 20-100 microns.

11. The prosthesis of claim 1, wherein the adluminal surface comprises surface features having depths in the range of 5 nm to 200 nm

12. A method for treating an atherosclerotic lesion in a blood vessel of a patient, comprising the steps of: locating a site of an atherosclerotic lesion in a blood vessel of a patient;transporting a prosthesis according to claim 1 in an unexpanded state to the site of the atherosclerotic lesion in the blood vessel; andradially expanding the prosthesis at the site of the atherosclerotic lesion so that the prosthesis contacts the blood vessel at the site.

13. The method of claim 12, wherein the atherosclerotic lesion is a vulnerable plaque.

14. The method of claim 12, wherein the atherosclerotic lesion is an atherosclerotic lesion freshly treated by angioplasty.

15. The method of claim 12, further comprising the step of: crosslinking the bioadhesive coating of the prosthesis to the blood vessel.

16. The method of claim 15, wherein the bioadhesive coating of the prosthesis further comprises an activatable crosslinker and the step of crosslinking the bioadhesive layer of the prosthesis to the blood vessel comprises activating the activatable crosslinker.

17. A radially expandable vascular luminal prosthesis, comprising: a structural component;an adhesive abluminal surface; andan endothelial cell-promoting adluminal surface.

18. The prosthesis of claim 17, wherein the prosthesis exerts a radial expansion force in the range of 30 to 750 mm Hg in a radially expanded state.

19. The prosthesis of claim 18, wherein the prosthesis exerts a radial expansion force in the range of 30 to 250 mm Hg in a radially expanded state.

20. The prosthesis of claim 17, wherein the adhesive abluminal surface is conditionally adhesive.

21. The prosthesis of claim 17, wherein the adhesive abluminal surface comprises at least one protein providing adhesiveness of the prosthesis to a blood vessel wall.

22. The prosthesis of clam 17, wherein the adluminal surface comprises endothelial cell-promoting structural features.

23. The prosthesis of claim 17, wherein the adluminal surface comprises endothelial cell-promoting molecules.

24. The prosthesis of claim 17, wherein the prosthesis comprises an abluminal layer that presents the adhesive abluminal surface.

25. The prosthesis of claim 17, wherein the prosthesis comprises an adluminal layer that presents the endothelial cell-promoting adluminal surface.