Delivery system for deployment and endovascular assembly of a multi-stage stented graft

• US 6,280,467 B1
• Filed: 02/25/1999
• Issued: 08/28/2001
• Est. Priority Date: 02/26/1998
• Status: Expired due to Term

• Current Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Original Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Inventors: Leonhardt, Howard J.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US09/257,757
• Time in Patent Office: 915 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.2, 623/1.21, 606/108, 606/191, 606/194, 606/195
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A multi-stage stent graft for implantation into a blood vessel is disclosed. Each stage or layer may comprise radially compressible spring stents with or without a fabric covering, or may comprise a foamed tube. The various stages or layers may also have an adhesive coated thereon. The multi-stage stented graft and the adhesive coatings provide a surface for the in growth of cells and promote healing. Also disclosed is a coaxial delivery system for the delivery and endovascular assembly of the multi-stage stented graft during one trip into the vasculature.

Claims

1. A stent device, which comprises:

a) a support frame having a first support stent spaced apart from a second support stent, wherein said first support stent is connected to said second support stent by at least one connecting wire;

b) a tubular graft comprising a graft material formed into a tubular shape, wherein said tubular graft is disposed to surround a portion of both said first support stent and said second support stent; and

c) a scaffolding stent separate from and unconnected to said support frame and positioned within said tubular graft intermediate said first support stent and said second support stent.

2. The stent device of claim 1 wherein said graft material is a synthetic material selected from the group consisting of polyester, polytetrafluoroethylene, microporous urethane, nylon, and lycra.

3. The stent device of claim 1 wherein said graft material is characterized as having been subjected to a photopolymerization process.

4. The stent device of claim 1 wherein said graft material is a cryogenically preserved biological material.

5. The stent device of claim 1 wherein said graft material is an umbilical cord vein.

6. The stent device of claim 1 wherein said support frame and said scaffolding stent are of Nitinol.

7. The stent device of claim 1 wherein said first support stent and said second support stent and said connecting wire of said support frame are a unitary member.

8. The stent device of claim 1 wherein said scaffolding stent comprises at least two stents connected together.

9. The stent device of claim 1 wherein said graft material includes a plurality of spaced apart flaps.

10. The stent device of claim 9, wherein said first support stent and said second support stent include peaks and troughs located at ends of said first support stent and said second support stent, wherein said flaps are oriented to cover said peaks.

11. The stent device of claim 1 wherein said scaffolding stent is enclosed in a thin covering.

12. The stent device of claim 1 further comprising:

d) a third stage stent, placed within both said support frame and said scaffolding stent to overlap both said support frame and said scaffolding stent.

13. The stent device of claim 1 wherein said scaffolding stent includes an adhesive applied thereto to facilitate attachment to said graft material.

14. The stent device of claim 1, further comprising a second tubular graft comprising a second graft material formed into a tubular shape, wherein said second tubular graft is disposed to surround a portion of said scaffolding stent.

15. The stent device of claim 14, wherein said second tubular graft material is less permeable than said tubular graft material surrounding a portion of both said first support stent and said second support stent.

16. The stent device of claim 14, wherein said second tubular graft material is a different material than said tubular graft material surrounding a portion of both said first support stent and said second support stent.

17. The stent device of claim 16, wherein said second tubular graft material is stretchable and said tubular graft material surrounding a portion of both said first support stent and said second support stent is non-stretchable.

18. The stent device of claim 1, wherein said graft material is fixed to said first support stent and said second support stent by sewing.

19. The stent device of claim 1, wherein said connecting wire longitudinally connects said first support stent and said second support stent.

20. The stent device of claim 1, wherein said connecting wire and said first support stent and said second support stent are comprised of a single wire having terminal ends, wherein said terminal ends are secured in place by a metal band.

21. A stent comprising:

a) a hollow foamed tube;

b) a support frame having a first support stent spaced apart from a second support stent, said first support stent and said second support stent being connected to each other by at least one connecting wire and disposed within said hollow foamed tube; and

c) a scaffolding stent separate from and unconnected to said support frame, said scaffolding stent being positioned intermediate said first support stent and said second support stent of said support frame in said hollow foamed tube.

22. The stent of claim 21 wherein said scaffolding stent comprises at least two stents connected together.

23. The stent of claim 21 further comprising a third scaffolding stent, disposed within both said support frame and said scaffolding stent to overlap at least a portion of both said support frame and said scaffolding stent.

24. The stent of claim 21 wherein an adhesive is applied to an external surface of said hollow foamed tube to form a tight seal with the wall of a blood vessel.

25. The stent of claim 24 wherein said adhesive is fibrin glue.

26. The stent of claim 21, wherein said first support stent, said second support stent, and said connecting wire of said support frame are of a unitary member.

27. The stent of claim 21, wherein said hollow foamed tube is formed of a closed cell thermoplastic material.

28. The stent of claim 21, wherein said connecting wire longitudinally connects said first support stent and said second support stent.

29. The stent of claim 28, wherein said connecting wire is a Nitinol wire.

30. The stent of claim 21, wherein said connecting wire and said first support stent and said second support stent are comprised of a single wire having terminal ends, wherein said terminal ends are secured in place by a metal band.

31. A stent device comprising:

a) a tubular graft having a first open end and a second open end, said graft being made of a graft material,

b) a support frame having a first support stent disposed at and fixed to an annular wall of said tubular graft at a first end of said tubular graft, said support frame having a second support stent disposed at and fixed to said annular wall of said tubular graft at a second end of said tubular graft, wherein said first support stent is spaced apart from said second support stent and wherein said first support stent is connected to said second support stent by at least one connecting wire; and

c) a scaffolding stent separate from and unconnected to said support frame and positioned within said tubular graft intermediate said first support stent and said second support stent.