Expandable supportive endoluminal grafts

• US 5,723,004 A
• Filed: 01/31/1996
• Issued: 03/03/1998
• Est. Priority Date: 10/21/1993
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Corvita Corporation (Boston Scientific Corporation)
• Inventors: Pinchuk, Leonard, Dereume, Jean-Pierre Georges Emile, MacGregor, David C.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/594,421
• Time in Patent Office: 762 Days
• Field of Search: 623/1, 623/11, 623/12, 606/191, 606/194
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• 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 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An endoluminal graft which is both expandable and supportive is provided either in a longitudinal form or in a bifurcated form. The graft expands between a first diameter and a second, larger diameter. The support component is an expandable stent endoprosthesis. A cover, liner, or a liner, or both a cover and a liner are applied to the endoprosthesis in the form of a stretchable wall material that is porous, elastomeric and biocompatible in order to allow normal cellular invasion upon implantation, without stenosis, when the expandable and supportive graft is at its second diameter. Preferably, the elastomeric wall material is a polycarbonate urethane.

Claims

1. A bifurcated expandable supportive endoluminal graft, comprising:

a tubular supporting component with a trunk tube having a longitudinal axis and at least one branch tube having an axis disposed at an acute angle with respect to said longitudinal axis of the trunk tube, said tubular supporting component having an internal surface disposed toward the longitudinal axis of each of said trunk tube and branch tube and an external surface spaced outwardly from and shaped complementarily with said internal surface, said tubular supporting component having a network of strand areas with interstices therebetween, said tubular supporting component being expandable from a first diameter of each of the trunk tube and branch tube at which the graft can be inserted into a body pathway, each of said trunk tube and branch tube having a second diameter, each said second diameter being greater than each respective first diameter;

a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto both of said internal and external surfaces of the tubular supporting component such that said stretchable wall is both a liner covering said internal surface of the tubular supporting component and also a cover over said external surface of the tubular supporting component, said stretchable wall having a first diameter size when said tubular supporting component is at its said first diameter of each of the trunk tube and branch tube, and said stretchable wall having a second diameter when said tubular supporting component is at its said second diameter size of each of the trunk tube and branch tube;

said liner is bonded to said cover through said interstices of the tubular supporting component so as to encapsulate said tubular supporting component within said stretchable wall; and

said stretchable wall is made from a porous elastomeric material that provides a structure which allows normal cellular invasion thereinto from the body pathway when implanted therewithin.

2. The bifurcated expandable supportive graft in accordance with claim 1, wherein said strand areas of the tubular supporting component include a plurality of rings connected together by a flexible interconnection extending longitudinally of the axis of each of said trunk tube and branch tube.

3. The bifurcated expandable supportive graft in accordance with claim 1, wherein said stretchable wall porous material is selected from the group consisting of grafts constructed by electrostatic spinning of fibers, elution of particulate material from polymeric sheeting, and solvent phase inversion of material from polymeric sheeting.

4. The bifurcated expandable supportive graft in accordance with claim 1, wherein said liner and cover of said stretchable wall comprise elongated fibers wound at an acute angle with respect to the axis of the trunk tube and with respect to the axis of the branch tube, some of said fibers of said liner intersecting with and bonded to some of said fibers of said cover in order to form said liner bonded to said cover through said interstices.

5. The bifurcated expandable supportive graft in accordance with claim 1, wherein said porous elastomeric material of the stretchable wall is a polycarbonate urethane.

6. The bifurcated expandable supportive graft in accordance with claim 1, wherein said porous elastomeric material of the stretchable wall is a silicone rubber material.

7. The bifurcated expandable supportive graft in accordance with claim 1, wherein an exposed longitudinal end of said tubular supporting component extends longitudinally beyond and is not completely covered by said stretchable wall.

8. The bifurcated expandable supportive graft in accordance with claim 1, further including a staple component that passes through one of said open areas of said tubular supporting component.

9. The bifurcated expandable supportive graft in accordance with claim 1, further including a window opening through said stretchable wall.

10. The bifurcated expandable supportive graft in accordance with claim 9, wherein said window opening is through said tubular supporting component.

11. The bifurcated expandable supportive graft in accordance with claim 1, wherein said strand areas of the tubular supporting component are generally sinusoidally configured wire that is helically wound into the tubular supporting component, said wire defining therebetween said interstices.

12. The bifurcated expandable supportive graft in accordance with claim 4, and wherein said strand areas of the tubular supporting component are generally sinusoidally configured wire that is helically wound into the tubular supporting component, said wire defining therebetween said interstices.

13. The bifurcated expandable supportive graft in accordance with claim 1, wherein said strand areas of the tubular supporting component comprise a plurality of braided wires with said interstices therebetween.

14. A bifurcated expandable supportive endoluminal graft, comprising:

a trunk tubular supporting component with a longitudinal axis, an internal surface disposed toward the longitudinal axis, and an external surface spaced outwardly from and shaped complementarily with said internal surface, said trunk tubular supporting component having a network of strand areas with openings therebetween, said trunk tubular supporting component being expandable from a first diameter at which the bifurcated expandable supportive endoluminal graft is insertable into a body pathway to a second diameter, said second diameter being greater than said first diameter;

a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto both of said internal surface and said external surface of the tubular trunk supporting component such that said stretchable wall is both a liner covering said internal surface of the trunk tubular supporting component and also a cover over said external surface of the trunk tubular supporting component, said stretchable wall having an extension portion that extends beyond said trunk tubular supporting component;

said liner is bonded to said cover through and at said openings of the trunk tubular supporting component so as to encapsulate said trunk tubular supporting component within said stretchable wall; and

said extension portion being formed into at least two generally tubular branch sleeves of stretchable wall material, each said sleeve being sized and shaped to receive a branch tubular expandable supporting component.

15. The bifurcated expandable graft in accordance with claim 14, wherein said generally tubular sleeves are defined by longitudinally joining said extension portions into said two adjacent tubular sleeves.

16. The bifurcated expandable graft in accordance with claim 14, further including a plurality of branch tubular expandable supporting components, each of which is independent of said trunk tubular supporting component until joined thereto by insertion of each branch tubular expandable supporting component into respective said generally tubular branch sleeves of said extension portion of the stretchable wall.

17. The bifurcated expandable graft in accordance with claim 14, wherein said strand areas of the trunk tubular supporting component include a plurality of rings connected together by a flexible interconnection extending longitudinally of the axis of each of said trunk tubular supporting component.

18. The bifurcated expandable graft in accordance with claim 14, wherein said stretchable wall material is selected from the group consisting of grafts constructed by electrostatic spinning of fibers, elution of particulate material from polymeric sheeting, and solvent phase inversion of material from polymeric sheeting.

19. The bifurcated expandable graft in accordance with claim 14, wherein said liner and cover of said stretchable wall comprises elongated fibers wound at an acute angle with respect to the axis of the trunk tube and with respect to the axis of the branch tube, some of said fibers of said liner intersecting with some of said fibers of said cover in order to form said liner bonded to said cover through said openings of the trunk tubular supporting component.

20. The bifurcated expandable graft in accordance with claim 14, wherein said stretchable wall is an elastomeric polycarbonate urethane.

21. The bifurcated expandable graft in accordance with claim 14, wherein said stretchable wall is a silicone rubber material.

22. The bifurcated expandable graft in accordance with claim 14, wherein an exposed longitudinal end of said trunk tubular supporting component which is opposite said extension portion of the stretchable wall extends longitudinally beyond and is not completely covered by said stretchable wall.

23. The bifurcated expandable graft in accordance with claim 14, further including a staple component that passes through one of said open areas of said trunk tubular supporting component.

24. The bifurcated expandable graft in accordance with claim 14, further including a window opening through said stretchable wall.

25. The bifurcated expandable graft in accordance with claim 24, wherein said window opening is through said trunk tubular supporting component.

26. The bifurcated expandable graft in accordance with claim 14, wherein said strand areas of the trunk tubular supporting component are generally sinusoidally configured wire that is helically wound into the trunk tubular supporting component, said wire defining therebetween said openings.

27. The bifurcated expandable graft in accordance with claim 19, and wherein said strand areas of the trunk tubular supporting component are generally sinusoidally configured wire that is helically wound into the trunk tubular supporting component, said wire defining therebetween said openings.

28. The bifurcated expandable graft in accordance with claim 14, wherein said strand areas of the trunk tubular supporting component comprise a plurality of braided wires with said openings therebetween.

29. The bifurcated expandable graft in accordance with claim 14, wherein said extension portion of the stretchable wall is an extension of both said liner and said cover.