Stent valve and stent graft for percutaneous surgery

• US 5,855,597 A
• Filed: 05/07/1997
• Issued: 01/05/1999
• Est. Priority Date: 05/07/1997
• Status: Expired due to Term

• Current Assignee: Vascular Concepts Holdings Limited
• Original Assignee: Iowa-India Investments Company Limited
• Inventors: Jayaraman, Swaminathan
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/852,240
• Time in Patent Office: 608 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A star-shaped stent and replacement valve or replacement graft for use in repairing a damaged cardiac valve includes two to eight star-shaped members interconnected into a "chain". Once this "chain" has been created through interconnection of the star-shaped members, a central opening through all of the interconnected star-shaped members receives a replacement aortic valve tri-cuspid made of any suitable flexible and bio-compatible material. A catheter delivery system is used to deliver the stent with the aortic valve tri-cuspid to the desired site. The star-shaped stents are made by using a laser to cut out a plurality of flat star-shaped members with a plurality of outwardly and inwardly directed points. The outwardly directed points are bent so that they face away from a plane defined by the inwardly directed points and then a series of such stents are fastened together in a chain.

Claims

1. A stent comprising:

a) a plurality of star-shaped members, each including;

i) a plurality of outwardly directed points and an equal plurality of inwardly directed points;

ii) an open center;

iii) said outwardly directed points being bent and facing away from a plane defined by said inwardly directed points;

b) said star-shaped members being connected together.

2. The stent of claim 1, wherein said star-shaped members are connected together by a connection that fastens at least one outwardly directed point of one star-shaped member with a corresponding outwardly directed point of an adjacent star-shaped member.

3. The stent of claim 1, wherein said star-shaped members are connected together by a connection that fastens at least one inwardly directed point of one star-shaped member with a corresponding inwardly directed point of an adjacent star-shaped member.

4. The stent of claim 2, wherein adjacent said star-shaped members form a pair of star-shaped members, and further including two pairs of star-shaped members being fastened together by a connection that fastens at least one inwardly directed point of one star-shaped member of one such pair with a corresponding inwardly directed point of one star-shaped member of an adjacent pair.

5. The stent of claim 3, wherein adjacent said star-shaped members form a pair of star-shaped members, and further including two pairs of star-shaped members being fastened together by a connection that fastens at least one outwardly directed point of one star-shaped member of one such pair with a corresponding outwardly directed point of one star-shaped member of an adjacent pair.

6. The stent of claim 1, wherein each star-shaped member has five outwardly directed points and five inwardly directed points.

7. The stent of claim 1, wherein each star-shaped member has four outwardly directed points and four inwardly directed points.

8. The stent of claim 1, wherein each star-shaped member has three outwardly directed points and three inwardly directed points.

9. The stent of claim 4, further including a replacement aortic valve tri-cuspid fastened within said pairs of star-shaped members.

10. The stent of claim 9, wherein said replacement aortic valve tri-cuspid includes a tubular body.

11. A method of making a stent-valve including the steps of:

a) forming a bio-compatible cylindrical conduit and suturing a patch of a bio-compatible substance to an exterior surface of the conduit;

b) pulling an end of the conduit inside the conduit until the patch is located on an interior surface of the conduit with the former exterior surface of the conduit now the interior surface;

c) suturing a plurality of stents according to claim 1 to the exterior surface of the conduit; and

d) deploying the patch on the inside surface of the conduit to form a mono-cuspid valve.

12. The method according to claim 11 wherein two patches are sutured spaced apart to the exterior surface of the conduit in step a) so that a bicuspid valve is formed.

13. The method according to claim 11 wherein three patches are sutured spaced apart to the exterior surface of the conduit in step a) so that a tricuspid valve is formed.

14. The method according to claim 11 wherein an anti-coagulant is coated on the conduit and patch to prevent clotting around the valve.

15. A method of making a stent including the steps of:

a) forming a plurality of flat star-shaped members each including a plurality of outwardly directed points and an equal plurality of inwardly directed points and an open center;

b) bending said outwardly directed points so that they face away from a plane defined by said inwardly directed points;

c) fastening said star-shaped members together.

16. The method of claim 15, wherein said fastening step includes the step of connecting said star-shaped members together by fastening at least one outwardly directed point of one star-shaped member with a corresponding outwardly directed point of an adjacent star-shaped member.

17. The method of claim 15, wherein said fastening step includes the step of connecting said star-shaped members together by fastening at least one inwardly directed point of one star-shaped member with a corresponding inwardly directed point of an adjacent star-shaped member.

18. The method of claim 16, wherein adjacent said star-shaped members form a pair of star-shaped members, and said method further including the step of fastening two pairs of star-shaped members together by fastening at least one inwardly directed point of one star-shaped member of one such pair with a corresponding inwardly directed point of one star-shaped member of an adjacent pair.

19. The method of claim 17, wherein adjacent said star-shaped members form a pair of star-shaped members, and said method further including the step of fastening two pairs of star-shaped members together by fastening at least one outwardly directed point of one star-shaped member of one such pair with a corresponding outwardly directed point of one star-shaped member of an adjacent pair.

20. The method of claim 15, wherein said forming step includes the step of forming a plurality of flat star-shaped members each having five outwardly directed and five inwardly directed points.

21. The method of claim 18, further including the step of fastening a replacement aortic valve tri-cuspid within said pairs.

22. The method of claim 19, wherein adjacent said star-shaped members form a pair of star-shaped members, and said method further including the step of fastening two pairs of star-shaped members together by fastening at least one inwardly directed point of one star-shaped member of one such pair with a corresponding inwardly directed point of one star-shaped member of an adjacent pair.

23. The method of claim 15 wherein the plurality of flat-star shaped members are derived from cutting a flat metal sheet of a material selected from the group consisting of stainless steel, titanium, elgiloy or NITINOL.

24. A stent comprising:

a) a plurality of star-shaped members, each including;

i) five outwardly directed points and five inwardly directed points;

ii) an open center;

iii) said outwardly directed points being bent and facing away from a plane defined by said inwardly directed points;

b) said star-shaped members being connected together in a plurality of pairs;

c) two pairs of star-shaped members being fastened together by a connection fastening at least one inwardly or outwardly directed point of one star-shaped member of one such pair with a corresponding inwardly or outwardly directed point of one star-shaped member of an adjacent pair;

d) a replacement aortic valve tri-cuspid fastened within said pairs of star-shaped members and including a tubular body.

25. The stent according to claim 24 wherein the star-shaped members are sutured to the tubular body.

26. The stent according to claim 25 wherein the tubular body is bifurcated.

27. The stent according to claim 24 wherein the tubular body is a knitted, woven or extruded polymeric material acceptable to living tissue.