Methods of making and using coiled sheet graft for single and bifurcated lumens

• US 6,048,360 A
• Filed: 03/25/1998
• Issued: 04/11/2000
• Est. Priority Date: 03/18/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Spiridigliozzi, John, Khosravi, Farhad, Patel, Himanshu, Hogendijk, Michael, Ross, Michael R.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/047,805
• Time in Patent Office: 748 Days
• Field of Search: 623/1, 623/12, 600/36
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthesis is provided for treating aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, occurring in single and bifurcated lumens. The prosthesis comprises an expandable coiled sheet portion having a biocompatible graft, either a sheet or tube, affixed thereto along part or all of the circumference of the coiled sheet portion. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis in single and bifurcated lumens are also provided.

Claims

1. A method of making a graft stent for treating a section of a body lumen, the method comprising:

providing a coiled sheet of a resilient material, the coiled sheet having a surface, a contracted state of reduced diameter and an expanded state of enlarged diameter, the coiled sheet forming a series of overlapping turns in the contracted state; and

affixing a biocompatible graft material to a portion of the surface of the coiled sheet, the graft material being wound within the overlapping turns of the coiled sheet when the coiled sheet is wound to its contracted state.

2. The method as defined in claim 1 wherein affixing a biocompatible graft material to the surface of the coiled sheet comprises:

coating the surface of the coiled sheet with a biocompatible adhesive having a cured state, the biocompatible adhesive being flexible in the cured state; and

adhering the coiled sheet to the biocompatible graft material.

3. The method as defined in claim 1 wherein providing a coiled sheet further comprises providing a coiled sheet having a plurality of teeth on one edge and mating openings that interengage the teeth on an opposing edge.

4. The method as defined in claim 1 further comprising:

trimming excess graft material from the coiled sheet to complete assembly of the graft stent; and

sterilizing the graft stent.

5. The method as defined in claim 1 wherein affixing a biocompatible graft material to the surface of the coiled sheet comprises suturing or stitching the biocompatible graft material to the coiled sheet.

6. The method as defined in claim 1 wherein affixing a biocompatible graft material to the surface of the coiled sheet comprises dipping the coiled sheet into a curable biocompatible liquid polymer, the biocompatible liquid polymer forming the biocompatible graft material when cured.

7. A method for making a graft stent for treating a section of a body lumen, the method comprising:

providing a sheet including a lattice and a surface, the sheet having an initial flat shape and being capable of being formed into a coiled shape;

forming the sheet into the coiled shape, the coiled shape having a series of overlapping turns; and

affixing a biocompatible graft material to at least a portion of the surface of the sheet, the biocompatible graft material being wound within the overlapping turns when the sheet is in the coiled shape.

8. The method as defined in claim 7, wherein the affixing step comprises:

coating at least a portion of the surface of the sheet with a biocompatible adhesive; and

bonding the sheet to the biocompatible graft material with the biocompatible adhesive.

9. The method as defined in claim 7, wherein the affixing step comprises suturing the sheet and biocompatible graft material together.

10. The method as defined in claim 7, wherein the affixing step comprises:

dipping the sheet into a liquid polymer; and

bonding the sheet to the biocompatible graft material with the liquid polymer.

11. The method as defined in claim 7, wherein the affixing step comprises:

dipping the sheet into a liquid polymer to form a film along the surface of the sheet; and

curing the liquid polymer, the cured polymer film comprising the biocompatible graft material.

12. The method as defined in claim 11, wherein the lattice comprises a multiplicity of openings therein, and wherein the film extends across the multiplicity of openings when the sheet is dipped therein.

13. The method as defined in claim 7, wherein the winding step comprises spirally winding the sheet into the coiled shape to provide an outer overlapping edge that spirals around an outer surface of the sheet.

14. The method as defined in claim 7, wherein a length of the biocompatible graft material is left extending from an edge of the sheet to form a flap when the biocompatible graft material is affixed to the sheet, and wherein the flap is wound to overlap a longitudinal seam extending along an outer surface of the sheet when the sheet is formed into the coiled shape.

15. The method as defined in claim 7, further comprising affixing a tubular graft to an opening in the surface of the sheet.

16. The method as defined in claim 15, further comprising providing a suture loop through an end of the tubular graft.

17. The method as defined in claim 7, wherein the sheet comprises first and second sheets, and wherein the affixing step comprises sandwiching the biocompatible graft material between the first and second sheets.

18. The method as defined in claim 17, wherein the first and second sheets are glued together with an adhesive, trapping the biocompatible graft material therebetween.

19. The method as defined in claim 17, wherein the first and second sheets comprise mating projections and sockets, and wherein the affixing step comprises inserting the projections into the mating sockets.

20. A method for making a graft stent for treating a section of a body lumen, the method comprising:

providing a sheet including a surface, the sheet having an initial flat shape and being capable of being formed into a coiled shape;

forming the sheet into the coiled shape having a series of overlapping turns;

providing a pair of layers of biocompatible graft material; and

affixing the sheet between the pair of layers of biocompatible graft material, at least a portion of one of the layers of biocompatible graft material being wound within the overlapping turns when the sheet is in the coiled shape.

21. The method as defined in claim 20, wherein the sheet comprises a multiplicity of openings, and wherein the affixing step comprises:

sandwiching the sheet between the two layers of biocompatible graft material; and

heating the biocompatible graft material to a temperature at which the two layers fuse together through the multiplicity of openings.

22. The method as defined in claim 21, wherein the affixing step further comprises applying pressure to the pair of layers of biocompatible graft material during the heating step.

23. The method as defined in claim 21, wherein the affixing step further comprises suturing the pair of layers of biocompatible graft material to the sheet.

24. The method as defined in claim 20, wherein the affixing step comprises:

affixing the pair of layers of biocompatible graft material together;

inserting the sheet between the affixed pair of layers of biocompatible graft material; and

stitching the sheet to the affixed pair of layers of biocompatible graft material.

25. The method as defined in claim 24, wherein the step of affixing the pair of layers of biocompatible graft material together comprises sewing the pair of layers of biocompatible graft material together to form a pillow case structure into which the sheet is inserted.