Method for making a self-expanding stent-graft

• US 6,245,100 B1
• Filed: 02/01/2000
• Issued: 06/12/2001
• Est. Priority Date: 02/01/2000
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Davila, Luis A., Wilson, David
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/494,861
• Time in Patent Office: 497 Days
• Field of Search: 606/194, 606/198, 606/200, 606/1, 606/108, 623/1.13, 623/1.18, 623/1.32, 623/1.12
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

In accordance with the present invention, there is provided a method of making a stent-graft for insertion into target site within a vessel of a patient. The graft has a crimped state for delivery to the target site, and an expanded state for implantation therein. The method uses a self-expanding tubular elastic outer stent having a crimped and expanded state, and includes the step of expanding the outer stent to its expanded state. The method also uses a tubular flexible porous graft member and includes the step of inserting the graft member along an interior of the outer stent. The method also uses a self-expanding tubular elastic inner stent, and includes the step of crimping the outer stent to a diameter smaller than a diameter of the expanded outer stent. The method then continues by inserting the inner stent within an interior of the graft member, and expanding the inner stent such that the inner stent, the graft member and the outer stent are all abutting.

Claims

1. A method of making a stent-graft for insertion into target site within a vessel of a patient, said graft having a crimped state for delivery to said target site, and an expanded state for implantation therein, said method comprising the steps of:

a) providing a self-expanding tubular elastic outer stent having a crimped and expanded state, and expanding said outer stent to its expanded state;

b) providing a tubular flexible porous graft member and inserting said graft member along an interior of said outer stent; and

c) providing a self-expanding tubular elastic inner stent and crimping said outer stent to a diameter smaller than a diameter of said expanded outer stent, inserting said inner stent within an interior of said graft member, and expanding said inner stent such that said inner stent, said graft member and said outer stent are all abutting.

2. The method according to claim 1 further including the step of attaching said graft member to said outer stent.

3. The method according to claim 2 wherein said graft member has front and back ends which extend beyond a front and back end of said outer stent, and wherein said step of attaching said graft member to said outer stent comprises folding said front and back ends of said graft member over said front and back ends of said outer stent to form cuffs.

4. The method according to claim 3 further including the step of applying heat and pressure to said cuffs.

5. The stent graft according to claim 1 wherein said inner and outer stents are made from a nickel titanium alloy which exhibits superelastic properties at body temperature.

6. The stent-graft according to claim 2 wherein said alloy comprises from about 50.5 percent to about 60 percent Nickel and the remainder comprising Titanium.

7. The stent-graft according to claim 1, wherein said graft member comprises expanded polytetrafluroethylene which forms nodes interconnected by fibrils.

8. The stent graft according to claim 7, wherein the average said graft member has an average internodal distance greater than 100 microns.

9. A method of making a stent-graft for insertion into target site within a vessel of a patient, said graft having a crimped state for delivery to said target site, and an expanded state for implantation therein, said method comprising the steps of;

a) providing a self-expanding tubular elastic outer stent having a crimped and expanded state and front and back ends, and expanding said outer stent to its expanded state;

b) providing a tubular flexible porous graft member having front and back ends, and inserting said graft member along an interior of said outer stent, wherein afterwhich a length of said graft member which is disposed along said interior of said outer stent between its front and back ends that is greater than a length of said outer stent between its front and back ends, whereby there is slack in said graft member; and

c) providing a self-expanding tubular elastic inner stent and crimping said outer stent to a diameter smaller than a diameter of said expanded outer stent, inserting said inner stent within an interior of said graft member, and expanding said inner stent such that said inner stent, said graft member and said outer stent are all abutting.

10. The method according to claim 9 further including the step of attaching said graft member to said outer stent.

11. The method according to claim 10 wherein the step of attaching said graft member to said outer stent comprises the step of attaching said graft member to said outer stent at said outer stent'"'"'s front and back ends.

12. The method according to claim 11 wherein said step of attaching said graft member to said outer stent comprises folding said front and back ends of said graft member over said front and back ends of said outer stent to form cuffs.

13. The method according to claim 12 further including the step of applying heat and pressure to said cuffs.

14. The stent graft according to claim 9 wherein said inner and outer stents are made from a nickel titanium alloy which exhibits superelastic properties at body temperature.

15. The stent-graft according to claim 14 wherein said alloy comprises from about 50.5 percent to about 60 percent Nickel and the remainder comprising Titanium.

16. The stent-graft according to claim 9, wherein said graft member comprises expanded polytetrafluroethylene which forms nodes interconnected by fibrils.

17. The stent graft according to claim 16, wherein the average said graft member has an average internodal distance greater than 100 microns.

18. A method of making a stent-graft for insertion into target site within a vessel of a patient, said graft having a crimped state for delivery to said target site, and an expanded state for implantation therein, said method comprising the steps of:

a) providing a self-expanding tubular elastic outer stent having a crimped and expanded state and front and back ends, and expanding said outer stent to its expanded state;

b) providing a tubular flexible porous graft member having front and back ends, and inserting said graft member along an interior of said outer stent, folding said front and back ends of said graft member over and onto to said front and back ends of said outer stent to form cuffs, wherein afterwhich a length of said graft member which is disposed along said interior of said outer stent between its front and back ends that is greater than a length of said outer stent between its front and back ends, whereby there is slack in said graft member; and

c) providing a self-expanding tubular elastic inner stent and crimping said outer stent to a diameter smaller than a diameter of said expanded outer stent, inserting said inner stent within an interior of said graft member, and expanding said inner stent such that said inner stent, said graft member and said outer stent are all abutting.

19. The method according to claim 18 further including the step of applying heat and pressure to said cuffs.

20. The stent graft according to claim 18 wherein said inner and outer stents are made from a nickel titanium alloy which exhibits superelastic properties at body temperature.

21. The stent-graft according to claim 20 wherein said alloy comprises from about 50.5 percent to about 60 percent Nickel and the remainder comprising Titanium.

22. The stent-graft according to claim 18, wherein said graft member comprises expanded polytetrafluroethylene which forms nodes interconnected by fibrils.

23. The stent graft according to claim 22, wherein the average said graft member has an average internodal distance greater than 100 microns.

24. The stent-graft of claim 18 wherein the step of attaching said graft member to said outer stent results in said length of said graft member disposed along said interior of said outer stent between its front and back ends which is 3% to 10% greater than said length of said outer stent between its front and back ends.