Expandable supportive branched endoluminal grafts

• US 5,855,598 A
• Filed: 05/27/1997
• Issued: 01/05/1999
• 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
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/863,964
• Time in Patent Office: 588 Days
• Field of Search: 623/1, 623/11, 623/12
• US Class Current: 623/1.13
• 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 2220/0008 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 2220/0025 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

An endoluminal graft which is both expandable and supportive is provided in a form suitable for use in a branched body vessel location. The graft expands between a first diameter and a second, larger diameter. The support component is an expandable stent endoprosthesis. A liner is applied to the endoprosthesis in the form of a compliant wall material that is porous and biocompatible in order to allow normal cellular invasion upon implantation, without stenosis, when the expandable and supportive graft is at its second diameter. The supportive endoluminal graft is preferably provided as a plurality of components that are deployed separately at the branching body vessel location, one of which has a longitudinal seam defining leg portions within which the other components fit in a telescoping manner.

Claims

1. A multiple-component branched expandable supportive endoluminal graft comprising:

a plurality of expandable supportive endoluminal components which are deployed individually at a selected location within a body vessel, each said supportive endoluminal graft component being radially compressible for endoluminal insertion and radially expandable for deployment at a desired location within a body vessel;

one of said expandable supportive endoluminal components is a trunk component, said trunk component including a tubular supporting member and a trunk liner positioned along said tubular supporting member, said trunk liner having a generally cylindrical upper body portion, at least two leg portions, and a generally cylindrical lower body portion, each said leg portion defining a leg opening into said upper body portion and another leg opening into said lower body portion;

at least one other of said expandable supportive endoluminal components is a generally cylindrical supportive leg component; and

said generally cylindrical supportive leg component and one of said leg portions of the trunk component, when said leg component and trunk component are deployed within the body vessel, are telescopically positioned with respect to each other.

2. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive leg component has an end portion which, when deployed, is positioned within one said leg opening of the trunk component.

3. The supportive endoluminal graft in accordance with claim 1, wherein said plurality of expandable supportive endoluminal components are self-expanding.

4. The supportive endoluminal graft in accordance with claim 1, wherein said plurality of expandable supportive endoluminal components are deployed by a radially expandable device.

5. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive component includes a generally cylindrical supporting member and a generally cylindrical liner secured therealong.

6. The supportive endoluminal graft in accordance with claim 1, wherein said trunk liner is a stretchable wall of essentially inert biocompatible material, said stretchable wall being attached to a portion of the internal surface of the trunk component tubular supporting member, said stretchable wall having a diameter size that expands with said trunk component tubular supporting member.

7. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the generally cylindrical supportive leg component is a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto at least the internal surface of the generally cylindrical tubular supporting member of the leg component.

8. The supportive endoluminal graft in accordance with claim 1, wherein said at least two leg portions of the trunk liner are partially defined by a longitudinal seam which extends generally between said generally cylindrical upper and lower body portions of the trunk liner.

9. The supportive endoluminal graft in accordance with claim 8, wherein said leg portions are further defined by portions of the trunk liner which are secured to the tubular supporting member at a location spaced radially from said longitudinal seam.

10. The supportive endoluminal graft in accordance with claim 1, wherein said leg portions of the trunk liner are longitudinally generally coextensive with a central longitudinal portion of said tubular supporting member of the trunk component.

11. The supportive endoluminal graft in accordance with claim 10, wherein an outside section of each of said leg portions of the trunk liner is secured to said tubular supporting member, while inside sections of each of said leg portions are secured to each other along an internal seam.

12. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical supportive leg component, when deployed, is telescopically slidably positioned within one of said leg portions of the trunk component.

13. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the leg component and said trunk liner are each a stretchable wall made from a porous elastomeric material that provides a structure which allows normal cellular invasion thereinto from the body vessel when implanted therewithin.

14. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material of each stretchable wall is an elastomeric polymer.

15. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material of said stretchable wall is a polycarbonate urethane.

16. The supportive endoluminal graft in accordance with claim 13, wherein said porous elastomeric material is coated with a thin layer of silicone rubber.

17. The supportive endoluminal graft in accordance with claim 5, wherein said trunk liner and said liner of the leg component are each a stretchable wall along the internal surface and the external surface of each tubular supporting component.

18. The supportive endoluminal graft in accordance with claim 1, wherein an exposed longitudinal end of said tubular supporting member extends longitudinally beyond and is not completely covered by said liner.

19. The supportive endoluminal graft in accordance with claim 1, wherein said tubular supporting component includes a plurality of wire strands with open areas therebetween.

20. The supportive endoluminal graft in accordance with claim 19, wherein said wire strands of the tubular supporting component are generally sinusoidally configured wire that is helically wound into the tubular supporting component, said wire defining therebetween said open areas of the tubular supporting component.

21. The supportive endoluminal graft in accordance with claim 19, wherein said wire strands of the tubular supporting component are shaped as intersecting elongated lengths integral with each other and defining said openings therebetween to form a mesh-shaped tubular supporting component.

22. The supportive endoluminal graft in accordance with claim 1, wherein said trunk component includes a projecting securement member.

23. A multiple-component branching expandable supportive endoluminal graft comprising:

a plurality of expandable supportive endoluminal graft components which are deployed individually at a selected location within a body vessel, each said supportive endoluminal graft component being radially compressible and radially expansible;

one of said expandable supportive endoluminal graft components being a trunk component having a longitudinal axis, an internal liner including a seam disposed generally along the longitudinal axis, and an external surface which is generally cylindrical and spaced outwardly from said internal liner, said trunk component having a plurality of legs defined in part by said seam, said trunk component further having two generally cylindrical body portions which flank said seam and which extend in opposite directions from said legs;

at least one other of said expandable supportive endoluminal graft components being a generally cylindrical supportive leg component;

said trunk component liner being a stretchable wall of essentially inert biocompatible material, said stretchable wall being applied onto an internal surface of a tubular supporting component; and

each said leg is sized and shaped to receive said generally cylindrical supportive leg component.

24. The branching graft according to claim 23, wherein said trunk component has a network of land areas with open areas defined therebetween.

25. A method for making a multi-component bifurcating expandable supportive endoluminal graft, comprising the steps of:

providing a generally tubular self-supporting member;

providing a generally cylindrical liner made of flexible material, and flattening said liner so opposing surfaces engage each other;

forming a longitudinal seam within the thus flattened liner in order to secure opposing longitudinal portions of the liner to each other;

inserting the thus seamed liner within the generally tubular self-supporting member;

inflating the seamed liner while within the self-supporting member until radially extending surfaces of the liner engage an inner surface of the tubular self-support member; and

securing said liner radially extending surfaces onto the thus engaged inner surface of the tubular self-supporting member in order to thereby assemble a branched trunk component.

26. The method of claim 25 further including providing a further expandable supportive endoluminal graft component by providing a generally cylindrical supportive leg component which is sized to be telescopically assembled with one of the leg portions of the branched trunk component.

27. The method of claim 25, wherein said inflating step includes filling the seamed liner with elutable materials.

28. The method in accordance with claim 25, wherein said inflating step includes inserting an expandable elongated tool into the seamed liner and expanding same so as to dilate the seamed liner into engagement with the self-supporting member.

29. The method in accordance with claim 25, wherein said step of forming a longitudinal seam includes applying heat along the longitudinal seam location.

30. The method in accordance with claim 25, wherein said step of forming a longitudinal seam includes suturing.