Curable fiber composite stent and delivery system

• US 5,766,204 A
• Filed: 09/12/1997
• Issued: 06/16/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Transform Technologies LLC
• Original Assignee: MetaStent Incorporated
• Inventors: Van Tassel, Robert, Porter, Christopher H., Kasinkas, Michael, Amplatz, Curtis
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/928,550
• Time in Patent Office: 277 Days
• Field of Search: 606/198, 606/194, 606/195, 606/191, 606/192, 623/1, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A stent for supporting a selected portion of a body lumen, comprising a fibrous material which is treated with a curable material to form a curable fiber composite. The fiber composite is positioned within a body lumen and, upon curing of the curable material, forms a rigid support structure.

Claims

1. A stent for supporting a selected portion of a body lumen, comprising at least one expandable, flexible fiber composite which is formed to engage the wall of a body lumen, wherein the fiber composite comprises a plurality of fibers and a curable material in contact with the fibers, wherein said stent can be positioned within the body lumen, expanded and, upon curing of the curable material, the fibers are bonded together to form a rigid support structure.

2. The stent of claim 1, wherein the fibers are coated with the curable material.

3. The stent of claim 1, wherein the fiber composite comprises a hollow fiber which encapsulates the curable material.

4. The stent of claim 1, wherein the fiber composite is further contacted with a therapeutic agent.

5. The stent of claim 4, wherein the therapeutic agent is an antithrombogenic agent.

6. The stent of claim 1, wherein the fiber composite has a helical conformation.

7. The stent of claim 1, wherein the fiber composite comprises a plurality of strands which are braided to form a porous mesh.

8. The stent of claim 1, further comprising a layer of a biocompatible material which encapsulates the fiber composite.

9. The stent of claim 8, wherein the biocompatible material is selected from the group consisting of silicones, waxes, polyacrylamides, polyethylenes, polystyrenes, polypropylenes, polyolefins, and polyurethanes.

10. The stent of claim 8, wherein the biocompatible material further comprises a therapeutic agent.

11. The stent of claim 1, wherein the fiber composite is bioresorbable.

12. The stent of claim 1, wherein the fiber composite comprises a multifilament fabric selected from the group consisting of polyester, cotton polyethylene terephthalate, and carbon.

13. The stent of claim 1, wherein the curable material is UV curable.

14. The stent of claim 13, wherein the curable material is selected from the group consisting of epoxies, silicones, urethanes, acrylamides, and polyurethane oligomer mixtures.

15. The stent of claim 1, wherein the curable material is thermally curable.

16. The stent of claim 1, wherein the curable material is chemically curable.

17. An apparatus for forming a stent inside a body lumen comprising:

a flexible elongated tube having a light transmitting expandable balloon attached to its distal end;

at least one expandable, flexible fiber composite desposed about the expandable balloon, the fiber composite comprising a plurality of fibers and a curable material in contact with the fibers;

catheter means connected to said flexible tube and said balloon for inflating the balloon; and

energy conducting means for transmitting radiation from an outside source to the interior of the balloon, the radiation being of a sufficient energy to cause curing of the curable material, thereby bonding together the fibers of the fiber composite in an expanded state, resulting in the formation of a rigid support structure.

18. The apparatus of claim 17, wherein the energy conducting means is an optical fiber.

19. The apparatus of claim 17, wherein the radiation is UV radiation.

20. A method of forming a stent, comprising the steps of:

applying a curable material to a plurality of expandable, flexible fibers, thereby forming a curable, expandable fiber composite;

shaping the fiber composite into a form suitable for insertion inside a body lumen;

mounting the shaped fiber composite over an expandable member;

disposing the expandable member in an unexpanded state inside a body lumen;

locating the expandable member adjacent to a selected region of the body lumen;

inflating the expandable member to expand the fiber composite mounted over the member and to bring the fiber composite into contact with the surrounding lumen wall; and

curing the curable material so as to bond together the fibers of the fiber composite in an expanded state, thereby forming a rigid support structure.

21. The method of claim 20, further comprising the step of coating the fiber composite with a biocompatible material.

22. The method of claim 20, further comprising the step of braiding the fiber composite to form a porous mesh.

23. The method of claim 20, further comprising the step of impregnating a therapeutic agent into the fiber composite.

24. The method of claim 20, wherein the step of curing the curable material comprises cross-linking or polymerizing the curable material by irradiation.

25. The method of claim 24, wherein the irradiation comprises UV radiation.