Stent assembly

• US 20060293743A1
• Filed: 10/14/2003
• Published: 12/28/2006
• Est. Priority Date: 10/14/2002
• Status: Abandoned Application

• Current Assignee: Cube Medical A/S
• Original Assignee: Cube Medical A/S
• Inventors: Andersen, Erik, Wen, Ning
• Application Number:
  US10/531,327
• Publication Number:
  US 20060293743A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other

Abstract

A stent assembly comprises an expandable tubular stent (21), an external surface of which is provided with a fabric (5) which may constitute a reservoir to hold drugs to be released in the intravascular system of a living. The fabric (5) may be made from a filamentary material, such as multifilament yarn (6). Electrospinning of nanofibers of, e.g., polymer may be employed for manufacturing the fabric. The stent may comprise an assembly of radially expandable, tubular elements (1) aligned along a common longitudinal axis and successively joined together in pairs by respective sets of linking members (4), e.g. forming a zigzag corrugation. The stent may be crimped onto a balloon.

Claims

1. A stent assembly comprising a tubular stent, an external surface of which is provided with a fabric, characterized in that the fabric has been pre-formed into the shape of a tube, into which the stent has been placed in the unexpanded state of the stent, the fabric tube having an inner diameter which is smaller than the outer diameter of the stent when the tube is placed on the stent to achieve an inward gripping action of the fabric tube on the unexpanded stent.

2. A stent assembly according to claim 1, wherein the fabric tube has been manufactured with an inner diameter which is smaller than the outer diameter of the unexpanded stent.

3. A stent assembly according to claim 1, wherien the fabric tube has been longitudinally folded to a smaller diameter than the outer diameter of the stent when fitted over the unexpanded stent.

4. A stent assembly according claim 1, wherein the fabric constitutes a reservoir to hold drugs.

5. A stent assembly according to claim 1, wherein the fabric is made from a filamentary material.

6. A stent assembly according to claim 5, wherein the filamentary material includes at least one polymer.

7. A stent assembly according to claim 6, wherein the at least one polymer is selected from the group consisting of:

polyurethane, polyamide, gelatine, silicone and agar.

8. A stent according to claim 5 wherein the fabric is made from a multifilament yarn.

9. A stent assembly according to claim 5, wherein at least a portion of the fabric is produced by spinning of nanofibers.

10. A stent assembly according to claim 9, wherein said portion is produced by electrospinning.

11. A stent assembly according to claim 9, wherein the diameter of the nanofibers is in the range of 2 to 4000 nanometers, such as in the range of 2 to 3000 nanometers.

12. A stent assembly according to claim 9, wherein the nanofibers are made from a polymer.

13. A stent assembly according to claim 12, wherein the nanofibers are made from a material selected from the group consisting of:

nylon, fluoropolymers, polyolefins, polyimides, and polyesters.

14. A stent assembly according to claim 1, wherein the fabric has an openness which allows the fabric to serve as a reservoir for liquid-based drugs.

15. A stent assembly according to claim 1, wherein the tubular stent comprises an assembly of radially expandable, tubular elements aligned along a common longitudinal axis and successively joined together in pairs by respective sets of linking members.

16. A stent assembly according to claim 15, wherein each tubular element exists essentially of a strip forming a zigzag corrugation.

17. A stent assembly according to claim 1, wherein the fabric completely covers the cylindrical external surface of the stent.

18. A stent assembly according to claim 1, wherein the stent is crimped onto a balloon for expanding the stent.

19. A stent assembly according to claim 1, wherein the stent is auto-expandable.

20. A stent assembly according to claim 19, wherein the stent is made essentially from a material selected from the group consisting of:

stainless steel, Phynox®

, and nitinol.

21. A stent assembly according to claim 1, wherein the stent is expandable by forced expansion, the stent being made essentially from a metallic material.

22. A stent assembly according to claim 21, wherein the metallic material is selected from the group consisting of:

tungsten, platinum, tantalum, gold, and stainless steel.

23. A method of manufacturing a stent assembly according to claim 1, comprising the steps of:

manufacturing the stent;

applying the fabric to the stent, characterized in that the fabric is preformed into the shape of a tube before the fabric is applied to the stent, the step of applying the fabric to the stent comprising placing the unexpanded stent into the fabric tube, the fabric tube having an inner diameter which is smaller than the outer diameter of the stent when the tube is placed on the stent to achieve an inward gripping action of the fabric tube on the unexpanded stent.

24. A method according to claim 23, wherein the fabric tube is preformed with an inner diameter which is smaller than the outer diameter of the unexpanded stent.

25. A method according to claim 23, wherein the step of applying the fabric tube to the stent comprising longitudinally folding the fabric tube to a smaller diameter than the outer diameter of the unexpanded stent.

26. A method according to claim 23, wherein the fabric is manufactured by spinning of nanofibers.

27. A method according to claim 26, wherein the step of spinning comprises electrospinning.

28. A method according to claim 26, wherein the diameter of the nanofibers is in the range of 2 to 4000 nanometers.

29. A method according to claim 26, wherein the step of spinning comprises feeding a first fiber-forming material into a nozzle for forming nanofibers by using a pressurized gas stream, and ejecting the first fiber-forming material from an exit orifice of the nozzle in the form of a plurality of strands of said first fiber-forming material that solidify and form said nanofibers.

30. A method according to claim 26, wherein the nanofibers are made from a polymer.

31. A method according to claim 30, wherein the nanofibers are made from a material selected from the group consisting of:

nylon, fluoropolymers, polyolefins, polyimides, and polyesters.

32. A method according to claim 23, wherein the stent is manufactured from a hollow tube, in which a pattern of tubular elements and linking elements is formed.

33. A method according to claim 23, wherein the step of manufacturing the stent comprises rolling up of a sheet of material to form the tube, and securing adjoining edge portions of the sheet together.

34. A method of preparing a stent assembly according to claim 1, comprising the step of providing a drug to the fabric.