Stent having adjacent elements connected by flexible webs

• US 9,943,428 B2
• Filed: 01/12/2012
• Issued: 04/17/2018
• Est. Priority Date: 01/11/2008
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Burkart, Dustin C., Cully, Edward H., Duncan, Jeffrey B., Hartman, Cody L., Silverman, James D.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US13/349,346
• Publication Number:
  US 20120109283A1
• Time in Patent Office: 2,287 Days
• Field of Search: 623 111, 623 112, 623 115, 623 116
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2/91 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91558 connected peak to peak

Abstract

A stent incorporating flexible, preferably polymeric, connecting elements into the stent wherein these elements connect adjacent, spaced-apart stent elements. Preferably the spaced-apart adjacent stent elements are the result of forming the stent from a helically wound serpentine wire having space provided between adjacent windings. Other stent forms such as multiple, individual spaced-apart ring-shaped or interconnected stent elements may also be used. The connecting elements are typically web-shaped and result from creating slits or apertures in a covering of graft material applied to the stent and then, for example, applying heat to cause the slits or apertures to enlarge. The remaining graft material forms the interconnecting webs between the adjacent stent elements.

Claims

1. A medical device comprising:

at least two adjacent stent rings comprising an inner surface, an outer surface, a smaller compacted diameter prior to diametrical expansion, a larger diameter following diametrical expansion and a distance between said at least two adjacent stent rings;

wherein said medical device has a length prior to diametrical expansion;

wherein said at least two adjacent stents rings are not attached to each other by stent elements and are attached to each other by at least one polymeric web, wherein said polymeric web is formed from at least one polymeric film layer on said at least two adjacent stent rings and extending over the distance between said at least two adjacent stent rings; and

wherein said at least one polymeric web is bowed with a first portion of an outer surface of the polymeric web free of overlap with a second portion of the outer surface of the polymeric web prior to diametrical expansion of the medical device, thereby providing stored length to the medical device prior to diametrical expansion and limiting foreshortening of the medical device following diametrical expansion for deployment to less than 10% of the length of the medical device prior to diametrical expansion.

2. The medical device of claim 1, wherein said film comprises ePTFE.

3. The medical device of claim 2, wherein said film further comprises fluorinated ethylene propylene (FEP).

4. The medical device of claim 1, wherein said stent rings are covered with said polymeric film only on said inner surface.

5. The medical device of claim 1, wherein said stent rings are covered with said polymeric film only on said outer surface.

6. The medical device of claim 1, wherein said stent rings are covered with said polymeric film on both said inner and outer surfaces.

7. The medical device of claim 1, wherein said at least one polymeric film layer is formed by a polymeric tape helically wrapped over said stent rings and extending over the distance between said stent rings.

8. The medical device of claim 1, wherein said at least one polymeric film layer is formed by a polymeric film cigarette wrapped over said stent rings and extending over the distance between said stent rings.

9. The medical device of claim 1, wherein said stent rings comprise apices.

10. The medical device of claim 9, wherein at least one stent ring apex is linked to an at least one adjacent stent ring apex by said at least one polymeric web.

11. The medical device of claim 10, wherein said ring apices do not touch during flexing, twisting and/or bending of said medical device.

12. The medical device of claim 9, wherein adjacent stent ring apices are offset.

13. The medical device of claim 9, wherein at least one apex on said stent ring is linked to at least two apices of an adjacent stent ring by said polymeric webs.

14. The medical device of claim 13, wherein said ring apices do not touch during flexing, twisting and/or bending of said medical device.

15. The medical device of claim 1, wherein said stent rings comprise stainless steel.

16. The medical device of claim 1, wherein said at least one stent ring comprises at least one metal selected from the group consisting of magnesium based alloys, magnesium, cobalt chromium alloy, titanium and titanium based alloys.

17. The medical device of claim 1, wherein said stent rings comprise shape memory material.

18. The medical device of claim 17, wherein said shape memory material is nitinol.

19. The medical device of claim 1, wherein the web comprises a plurality of openings and wherein the plurality of openings are created by use of a scalpel blade, water jet, laser, or a combination thereof.

20. The medical device of claim 1, wherein said medical device further comprises at least one graft.

21. The medical device of claim 20, wherein said graft is only on said inner surface of said stent rings.

22. The medical device of claim 20, wherein said graft is only on said outer surface of said stent rings.

23. The medical device of claim 20, wherein said graft is on said inner and outer surfaces of said stent rings.

24. The medical device of claim 20, wherein said graft is a polymeric material.

25. The medical device of claim 24, wherein said graft polymeric material comprises ePTFE.

26. The medical device of claim 20, wherein said graft is adhered to said polymeric film on said stent rings.

27. The medical device of claim 1, wherein said polymeric web is melt bonded to said stent rings.

28. The medical device of claim 1, wherein said at least one polymeric web is formed by:

covering at least a portion of one surface of said at least two stent rings and the distance between said stent rings with a polymeric film;

forming openings through said film; and

heating the region around said openings sufficiently to cause the film to shrink back resulting in larger openings.

29. The medical device of claim 28, wherein said heating the region around said openings to sufficiently to cause the film to shrink back resulting in larger openings is produced by an oven or a laser.

30. The medical device of claim 28, wherein said film comprises ePTFE.

31. The medical device of claim 28, wherein said film further comprises fluorinated ethylene propylene.

32. The medical device of claim 28, wherein said stent rings are covered with said polymeric film only on said inner surface.

33. The medical device of claim 28, wherein said stent rings are covered with said polymeric film only on said outer surface.

34. The medical device of claim 28, wherein said stent rings are covered with said polymeric film on both said inner and outer surfaces.

35. The medical device of claim 1, wherein said polymeric web is formed by:

covering at least a portion of one surface of said at least two stent rings and the distance between said stent rings with a polymeric film while said at least two stent rings are in a smaller, compacted diameter;

forming openings through said film; and

expanding said at least two stent rings to a larger diameter, wherein said opening in said films become larger.

36. The medical device of claim 35, wherein said film comprises ePTFE.

37. The medical device of claim 36, wherein said film further comprises fluorinated ethylene propylene.

38. The medical device of claim 35, wherein said stent rings are covered with said polymeric film only on said inner surface.

39. The medical device of claim 35, wherein said stent rings are covered with said polymeric film only on said outer surface.

40. The medical device of claim 35, wherein said stent rings are covered with said polymeric film on both said inner and outer surfaces.