Vascular prosthesis and methods of use

• US 20040122504A1
• Filed: 01/13/2003
• Published: 06/24/2004
• Est. Priority Date: 12/24/2002
• Status: Active Grant

• Current Assignee: NovoStent Corp.
• Original Assignee: NovoStent Corp.
• Inventors: Hogendijk, Michael
• Granted Patent: US 7,846,198 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

The present invention is directed to an implantable vascular prosthesis configured for use in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, and allowing for the controlled delivery of therapeutic agents to a vessel wall. The prosthesis comprises a helical proximal section coupled to a distal anchoring section having a generally zig-zag configuration. The prosthesis is configured to comply to a vessel wall without substantially remodeling the vessel, and further is configured to be precisely deployed in a vessel without shifting during deployment. The prosthesis also has a substantially small delivery profile compared to other known stents, while having an increased surface area to enhance delivery of therapeutic agents.

Claims

1. A vascular prosthesis for implantation in a body vessel, the vascular prosthesis comprising:

a helical section comprising a plurality of turns, the helical section having a contracted state suitable for transluminal insertion into a body vessel wherein adjacent turns of the helical section partially overlap and a deployed state wherein the helical section engages the vessel wall; and

an anchoring section coupled to the helical section, the anchoring section having a contracted state suitable for transluminal insertion into a body vessel, and a deployed state wherein the anchoring section engages the vessel wall to retain the vascular prosthesis in position during deployment of the helical portion.

2. The vascular prosthesis of claim 1 wherein the helical section and the anchoring section each comprise a shape memory material.

3. The vascular prosthesis of claim 2 wherein the shape memory material is a nickel titanium alloy.

4. The vascular prosthesis of claim 1 wherein the anchoring section comprises a plurality of interconnected elongated elements having a generally zig-zag configuration.

5. The vascular prosthesis of claim 1 wherein the helical section further comprises a multiplicity of openings disposed between solid regions of the plurality of turns.

6. The vascular prosthesis of claim 5 wherein at least one of the multiplicity of openings comprises one of a circular configuration or a rectangular configuration.

7. The vascular prosthesis of claim 5 further comprising an elastomeric polymer disposed on a portion of an exterior surface of at least one of the plurality of turns.

8. The vascular prosthesis of claim 1 wherein a portion of at least one of the plurality of turns comprises a covered region.

9. The vascular prosthesis of claim 1 further comprising at least one dimple disposed in a solid region of the plurality of turns, the dimple configured to house a therapeutic agent.

10. The vascular prosthesis of claim 1 further comprising at least one through-hole disposed in a solid region of the plurality of turns, the through-hole configured to house a therapeutic agent.

11. The vascular prosthesis of claim 1 wherein the anchoring section has a proximal end and a distal end, the distal end configured to be biased radially outward with respect to the proximal end in the deployed state.

12. The vascular prosthesis of claim 11 wherein the distal end of the anchoring section comprises at least one tooth extending radially outward and in a proximal direction.

13. The vascular prosthesis of claim 1 wherein the helical section is coupled to the anchoring section at a junction, the junction further comprising at least one extension strut disposed between a proximal bend of the anchoring section and a distal turn of the helical section.

14. The vascular prosthesis of claim 13 wherein the junction comprises a radiopaque marker.

15. The vascular prosthesis of claim 1 further comprising a pitch associated with the plurality of turns, wherein the pitch is configured to be varied for different applications.

16. The vascular prosthesis of claim 1 wherein the plurality of turns comprise a plurality of individual helical turns.

17. A method for supporting a body lumen in a patient'"'"'s vessel, the method comprising:

providing a vascular prosthesis having a helical section and an anchoring section in a contracted state disposed within an outer sheath;

positioning the outer sheath within a vessel such that the helical section is situated adjacent a target site in the vessel;

proximally retracting the outer sheath to cause the anchoring section to self-deploy distal of the target site to a generally zig-zag deployed configuration, wherein the anchoring section engages an inner wall of the vessel in the deployed configuration; and

further retracting the outer sheath to cause a plurality of turns of the helical section to self-deploy to a helical configuration in engagement with the target region of the vessel,

wherein deployment of the anchoring section provides controlled deployment of the helical section.

18. The method of claim 17 further comprising delivering a therapeutic agent to the target region.

19. The method of claim 18 wherein the therapeutic agent is delivered for purposes of providing gene therapy to the target region.

20. The method of claim 18 wherein delivering a therapeutic agent to the target region further comprises providing the therapeutic agent on an exterior surface of the plurality of turns.

21. The method of claim 18 wherein delivering a therapeutic agent to the target region further comprises providing the therapeutic agent in at least one dimple formed on a lateral surface of the plurality of turns.

22. The method of claim 18 wherein delivering a therapeutic agent to the target region further comprises providing the therapeutic agent in at least one through hole disposed through a lateral surface of the plurality of turns.

23. The method of claim 17 wherein the target region is an aneurysm, the method further comprising treating the aneurysm by reducing blood flow into the aneurysm.

24. The method of claim 17 wherein the target region is a stenosed region of a vessel, the method further comprising causing the vascular prosthesis to maintain patency in the vessel.

25. The method of claim 17 wherein the vascular prosthesis further comprises a pitch associated with the plurality of turns, the method further comprising varying the pitch to vary the flexibility of the proximal section.