Stent, stent graft and stent valve

• US 6,245,102 B1
• Filed: 07/21/1999
• Issued: 06/12/2001
• 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:
  US09/358,207
• Time in Patent Office: 692 Days
• Field of Search: 623/1.1, 623/1.15, 623/1.16, 623/1.24
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/90 characterised by a net-like or mesh-like structure
• 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
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-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 damaged vascular organs: Two to eight star-shaped members are 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 graft made of any suitable flexible and bio-compatible material. A catheter delivery system is used to deliver the stent with the graft 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; and

b) said star-shaped members being connected together by identical or dissimilar shaped members to form a continuous stent.

2. The stent of claim 1, wherein said star-shaped members are connected together by a micro-weld 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 micro-weld 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 micro-weld 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 micro-weld 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 placed in a vascular conduit of the human body to relieve a constriction and create an open channel for communication.

7. The stent of claim 1 placed in a non-vascular conduit of the human body to relieve a constriction and create an open channel for communication.

8. The stent of claim 6 mounted on a balloon catheter which expands the stent from a first diameter size to a second diameter size having the same exterior diameter as the inner diameter of the vascular conduit.

9. The stent of claim 7 mounted on a balloon catheter which expands the stent from a first diameter size to a second diameter size having the same exterior diameter as the inner diameter of the non-vascular conduit.

10. A method of making a stent from a flat two-dimensional metal sheet 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 with an octagonal shaped member.

11. The method of claim 10, wherein said fastening step includes the step of micro-welding 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.

12. The method of claim 10, wherein said fastening step includes the step of micro-welding 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.

13. The method of claim 11, 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.

14. The method of claim 12, 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.

15. The method of claim 10 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 nickel-titanium alloy and joining star-shaped members from different material metal sheets together.

16. A stent comprising:

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

i) a plurality of at least three outwardly directed points and a like number 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 micro-welded together; and

c) a graft tubular body fastened to said star-shaped members.

17. The stent according to claim 16 wherein the star-shaped members are sutured to the tubular body.

18. The stent according to claim 17 wherein the tubular body is bifurcated.

19. The stent according to claim 16 wherein the tubular body is a knitted, woven or extruded polymeric material acceptable to living tissue.

20. The stent according to claim 16 wherein a material selected from the group consisting of an anti-coagulant, growth factor, antirestonoic factors and genetic material is incorporated on the graft tubular body.

21. The stent according to claim 16 wherein the plurality of star-shaped members are on an outside surface of the graft tubular body.

22. The stent according to claim 16 wherein the graft tubular body surrounds the plurality of star-shaped members.

23. The stent according to claim 16 wherein the plurality of star-shaped members are on an outside surface of two graft tubular bodies and a middle portion of the star-shaped member is separated from the graft tubular body.

24. A stent formed from the stent joined to the graft tubular body of claim 16 employed as a heart valve.

25. A stent formed from the stent joined to the graft tubular body of claim 16 employed to correct an arterial aneurysm.

26. The stent according to claim 20 wherein the material is incorporated into the graft tubular body through a controlled release agent selected from the group consisting of a synthetic biodegradable compound, a non-biodegradable compound, a biologically derived protein and a liposome.