Intraluminal stent

• US 5,951,586 A
• Filed: 05/09/1997
• Issued: 09/14/1999
• Est. Priority Date: 05/15/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wolff, Rodney G., Lindell, Elaine P., Berg, Eric P., Bergan, Matthew A., Schwartz, Robert S., Trescony, Paul V.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US08/853,204
• Time in Patent Office: 858 Days
• Field of Search: 623/1, 623/11, 623/12, 604/96, 606/191, 606/192, 606/193, 606/194, 606/195, 606/198
• US Class Current: 606/198
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29K 2105/04 cellular or porous
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: Y10S 623/921 Blood vessel

Abstract

Intraluminal stents and methods of manufacturing intraluminal stents are disclosed in which the stents have a plurality of recesses in the body of the stent, at least some of the recesses preferably providing a plurality of passageways between the inner and outer surfaces of the stent. The preferred stents are constructed of films on support structures having spaced apart elements, with the films having a thickness of between about 25 micrometers and about 400 micrometers. The stent can also be treated with an antithrombotic or a thrombolytic substance and, in some cases, the stents can incorporate therapeutic agents for delivery. The methods of manufacturing stents include forming the films using a solid particulate material that can be substantially removed after the film is formed, thereby forming the recesses and corresponding passageways described above. In preferred methods, the solid particulate material is soluble in a solvent in which the film is substantially insolvent.

Claims

1. A method of manufacturing an intraluminal stent having a body, the body having an outer surface and an inner surface, the method comprising steps of:

forming the body with a film-forming material;

providing solid particulate material at least partially encapsulated in the body, the particulate material being soluble in a first solvent;

dissolving the particulate material with the first solvent, wherein a plurality of recesses are formed in the inner and outer surfaces of the body, and further wherein at least some of the plurality of recesses in the inner surface open into at least some of the plurality of recesses in the outer surface to form a plurality of passageways between the inner and outer surfaces of the body; and

coating at least the inner surface of the body with an antithrombotic substance, wherein at least some of the plurality of passageways remain open after the antithrombotic substance is coated on the body.

2. A method according to claim 1, wherein the body comprises a substantially cylindrical film formed on a support structure comprising spaced apart elements.

3. A method according to claim 2, wherein the film has a thickness of about 25 micrometers to about 400 micrometers.

4. A method according to claim 3, wherein the plurality of recesses have a nominal size of about 1 micrometer to about 100 micrometers.

5. A method of manufacturing an intraluminal stent having a body, the body having an outer surface and an inner surface, the method comprising steps of:

coating at least a portion of a mandrel with solid particulate material, the particulate material being soluble in a first solvent;

forming the body on the particulate-coated mandrel with a film-forming material that is substantially insoluble in the first solvent, the body at least partially encapsulating the particulate material; and

dissolving the particulate material with the first solvent, wherein a plurality of recesses are formed in the body.

6. A method according to claim 5, wherein the plurality of recesses are formed in the inner surface and outer surface of the body.

7. A method according to claim 6, wherein at least some of the plurality of recesses in the inner surface open into at least some of the plurality of recesses in the outer surface to form a plurality of passageways between the inner and outer surfaces of the body.

8. A method according to claim 7, further comprising a step of coating at least the inner surface of the body with an antithrombotic substance, wherein at least some of the plurality of passageways remain open after the antithrombotic substance is coated on the body.

9. A method according to claim 8, wherein the step of forming the body further comprises wrapping a wire around the mandrel before forming the body on the mandrel with the film-forming material, wherein the wire is at least partially encapsulated within the body, and further wherein the body is a film having a thickness of about 25 micrometers to about 400 micrometers.

10. A method according to claim 9, wherein the plurality of recesses have a nominal size of about 1 micrometer to about 100 micrometers.

11. A method according to claim 10, wherein the film-forming material comprises a polymer.

12. A method according to claim 11, wherein the solid particulate material has a nominal diameter of about 25 micrometers to about 60 micrometers.

13. An intraluminal stent for supporting a portion of a vessel comprising:

a support structure comprising spaced apart elements;

a body having a generally cylindrical shape, the body comprising a film at least partially encapsulating the spaced apart elements, the film having a thickness of about 25 micrometers to about 400 micrometers as measured between an outer surface and an inner surface of the film;

a plurality of recesses in the inner and outer surfaces of the body, at least some of the plurality of recesses in the inner surface opening into at least some of the plurality of recesses in the outer surface to form a plurality of passageways between the inner and outer surfaces of the body;

wherein the plurality of recesses have a nominal size of about 1 micrometer to about 100 micrometers; and

an antithrombotic substance on at least the inner surface of the body, wherein at least some of the plurality of passageways remain open.

14. A stent according to claim 13, further comprising a solid particulate material encapsulated within the film, the solid particulate material being soluble in a first solvent in which the film is substantially insoluble.

15. A stent according to claim 14, wherein the solid particulate material has a nominal diameter of about 25 micrometers to about 60 micrometers.

16. A method of manufacturing an intraluminal stent having a body, the body having an outer surface and an inner surface, the method comprising steps of:

forming the body with a film-forming material;

providing solid particulate material at least partially encapsulated in the body, the particulate material being soluble in a first solvent;

dissolving the particulate material with the first solvent, wherein a plurality of open recesses are formed in the body; and

coating the body with an antithrombotic substance such that at least some of the plurality of recesses remain open.

17. A method according to claim 16, wherein the plurality of recesses are formed in the inner surface and outer surface of the body.

18. A method according to claim 16, wherein at least some of the plurality of recesses in the inner surface open into at least some of the plurality of recesses in the outer surface to form a plurality of passageways between the inner and outer surfaces of the body.

19. A method according to claim 16, wherein the body is a film formed on a support structure comprising spaced apart elements.

20. A method according to claim 19, wherein the film has a thickness of about 25 micrometers to about 400 micrometers.

21. A method according to claim 20, wherein the plurality of recesses have a nominal size of about 1 micrometer to about 100 micrometers.

22. A method of manufacturing an intraluminal stent having a body, the body having an outer surface and an inner surface, the method comprising steps of:

forming a cylindrical body with a plurality of recesses in the inner surface and outer surface of the body wherein at least some of the plurality of recesses in the inner surface open into at least some of the plurality of recesses in the outer surface to form a plurality of passageways between the inner and outer surfaces of the body; and

coating at least the inner surface of the body with an antithrombotic substance, wherein at least some of the plurality of passageways remain open after the antithrombotic substance is coated on the body.

23. A method according to claim 22, wherein the step of forming the body further comprises encapsulating a wire within the film-forming material.

24. A method according to claim 22, wherein the plurality of recesses are formed at a nominal size of about 1 micrometer to about 100 micrometers.