Encapsulated stent preform

• US 6,475,235 B1
• Filed: 11/16/1999
• Issued: 11/05/2002
• Est. Priority Date: 11/16/1999
• Status: Expired due to Fees

• Current Assignee: Vascular Concepts Holdings Limited
• Original Assignee: Iowa-India Investments Company Limited
• Inventors: Jayaraman, Swaminathan
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/440,926
• Time in Patent Office: 1,085 Days
• Field of Search: 623/1.15, 623/1.18, 623/1.21, 623/1.39, 623/1.42, 623/1.44, 623/1.46, 623/1.53, 623/1.54
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• 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 2210/0076 multilayered, e.g. laminated structures

Abstract

The invention relates to a stent preform for implantation in a body lumen. The stent preform includes an elongated metal core having first and second core ends, a contact surface, and a solid cross-section, and a hollow outer sheath made of a biocompatible polymer and having first and second sheath ends, caps disposed on the sheath ends, and an interior surface. The outer sheath surrounds and contacts the contact surface of the core to prevent the core from directly contacting the body lumen. In another embodiment, the biocompatible polymer of the outer sheath is formed of a heat-shrinkable polymer material, and the elongated core is formed of a shape-memory alloy. In another embodiment, the outer sheath is formed from a polymer tape.

Claims

1. A stent preform for implantation in a body lumen comprising:

an elongated wireform metal core having first and second core ends, a contact surface, and a solid cross-section; and

a hollow outer sheath made of a biocompatible polymer and having first and second sheath ends, caps disposed on the sheath ends, and an interior surface,

wherein the outer sheath surrounds and contacts the contact surface of the core and the caps surround the core ends to prevent the core from directly contacting the body lumen.

2. The stent preform of claim 1, wherein the elongated core is expandable, and the outer sleeve is capable of deforming to compensate for dimensional changes in the cross-section of the expanded core.

3. The stent preform of claim 2, wherein the cross-section of the core is substantially cylindrical.

4. The stent preform of claim 2, wherein the elongated core is formed of a shape-memory alloy.

5. The stent preform of claim 2, wherein the outer sheath is made of a polymer film having a thickness between about 0.1 micron and about 5 millimeters.

6. The stent preform of claim 1, wherein the biocompatible polymer of the outer sheath is formed of a heat-shrinkable polymer material.

7. The stent preform of claim 1, wherein the outer sheath with caps is formed from a polymer tape.

8. The stent preform of claim 1, wherein the sheath caps have a generally rounded contour to minimize stress concentration along the walls of the lumen.

9. The stent preform of claim 1, which further comprises a cover of a biological or synthetic coating to minimize interference of the stent preform with normal blood function.

10. The stent preform of claim 9, wherein the coating is an anticoagulant selected from the group of heparin, hirudin, coumadin, tichlopidiene, and chlopidogrel.

11. The stent preform of claim 9, wherein the coating is disposed in micropores in the outer sheath, allowing controlled release of constituents of the coating.

12. A stent preform for implantation in a body lumen comprising:

an elongated metal core having first and second core ends, a contact surface, and a solid cross-section;

a hollow outer sheath made of a biocompatible polymer and having first and second sheath ends, caps disposed on the sheath ends, and an interior surface; and

at least one intermediate sleeve disposed between the outer sheath and the core,

wherein the outer sheath surrounds the intermediate sleeve and contact surface of the core to prevent the sleeve and core from directly contacting the body lumen.

13. The stent preform of claim 12, wherein the at least one intermediate sleeve comprises a lubricious lining, the core and the lining forming a composite body that is configured and dimensioned to be slidably received by the outer sheath.

14. The stent preform of claim 12, wherein the at least one intermediate sleeve comprises a lubricious lining, the outer sheath and the lining forming a composite body that is configured and dimensioned to be slidably received by the core.

15. The stent preform of claim 12, wherein the at least one intermediate sleeve comprises a lubricious lining.

16. A filamentary member for implantation inside a body lumen comprising:

a rigid, elongated wireform inner filament having first and second filament ends; and

an outer sheath having first and second sheath ends and caps disposed on the sheath ends,

wherein the outer sheath is made of a biocompatible polymer, and wherein the outer sheath completely encapsulates and contacts the inner filament and first and second filament ends to prevent the inner filament from directly contacting a wall inside a body lumen.

17. The filamentary member of claim 16, wherein the inner filament is made of a plurality of woven fibers.

18. The filamentary member of claim 16, wherein the inner filament is made from carbon fiber, kevlar, or glass fiber.

19. A method of making a stent preform comprising the steps of:

providing an elongated wireform core with first and second ends;

completely encapsulating and surrounding the core and ends with a polymer jacket to create a composite so that the polymer jacket forms caps at the ends;

heat treating the composite to promote bonding of the core and jacket; and

bending the composite to a desired shape.

20. The method of claim 19, wherein the elongated core is made of metal.

21. The method of claim 20, wherein the metal is a shape-memory alloy.

22. The method of claim 21, wherein the polymer jacket is formed of a biocompatible polymer.

23. The method of claim 22, wherein the elongated core is expandable, and the polymer jacket is capable of deforming to compensate for dimensional changes in the cross-section of the expanded core.

24. The method of claim 21, further comprising the step of heat treating the elongated core prior to encapsulating the core with a polymer jacket.

25. The method of claim 21, wherein the polymer jacket is formed of a tape of a biocompatible polymer.

26. A method of making a stent preform comprising the steps of:

providing an elongated wireform metal core with first and second ends;

completely encapsulating and surrounding the core and ends with a polymer tape to create a composite so that the polymer tape forms caps at the ends; and

bending the composite to a desired shape.

27. The method of claim 26, wherein the tape is a vascular fabric.

28. A method of making a stent preform for implantation inside a body lumen comprising the steps of:

providing an elongated wireform core with first and second ends, the core being made of a shape-memory material;

completely encapsulating the core and ends with a biocompatible fabric to create a composite so that the biocompatible fabric caps the ends; and

bending the composite to a desired shape.

29. A method of making a stent preform comprising the steps of:

providing an elongated core made of a shape-memory material;

completely encapsulating the core with a biocompatible fabric to create a composite;

bending the composite to a desired shape; and

providing at least one intermediate sleeve disposed between the biocompatible fabric and the core.