Expandable supportive branched endoluminal grafts

• US 5,632,772 A
• Filed: 11/13/1995
• Issued: 05/27/1997
• 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: Kato, Yasushi, Alcime, Rysler, Pinchuk, Leonard
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/558,028
• Time in Patent Office: 561 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• 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 indent defining leg portions within which the other components fit in a telescoping manner.

Claims

1. A multiple-component branching 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 being generally tubular and having a first portion with a given diameter and a second portion including a longitudinally disposed indent generally defining at least two leg portions, each with a diameter less than said given diameter, and each said leg portion has a leg opening;

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 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 component has a trunk liner which includes a compliant wall of essentially inert biocompatible material, said trunk liner being attached to the internal surface of the trunk component, said compliant wall having a diameter size that expands with said trunk component.

7. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the generally cylindrical supportive leg component is a compliant wall of essentially inert biocompatible material, said compliant 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 trunk component includes a third portion having a diameter approximating said given diameter of the first portion, and said second portion is positioned between said first portion and said third portion.

9. The supportive endoluminal graft in accordance with claim 8, wherein said first portion and said third portion are each generally cylindrical.

10. 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.

11. The supportive endoluminal graft in accordance with claim 5, wherein said liner of the leg component is a compliant wall made from a porous material that provides a structure which allows normal cellular invasion thereinto from the body vessel when implanted therewithin.

12. The supportive endoluminal graft in accordance with claim 6, wherein said porous material of said compliant wall is an elastomeric polymer.

13. The supportive endoluminal graft in accordance with claim 6, wherein said porous material of said compliant wall is a polycarbonate urethane.

14. The supportive endoluminal graft in accordance with claim 6, wherein said porous material is coated with a thin layer of silicone rubber.

15. The supportive endoluminal graft in accordance with claim 6, wherein said trunk liner includes an interior liner and an intermediate liner between said interior liner and said tubular supporting member.

16. The supportive endoluminal graft in accordance with claim 1, wherein said trunk component includes a plurality of wire strands with open areas therebetween to form a braided mesh.

17. The supportive endoluminal graft in accordance with claim 16, wherein said wire strands of the tubular supporting component include a plurality of individual strands which are longitudinally adjacent to and in contact with each other in a braided, crossing configuration.

18. The supportive endoluminal graft in accordance with claim 1, wherein said generally cylindrical tubular supportive components include wire strands shaped as intersecting elongated lengths integral with each other and defining openings therebetween to form a braided mesh-shaped tubular supporting member.

19. The supportive endoluminal graft in accordance with claim 1, wherein the endoluminal graft is subjected to surface treatment with a compliant adhesive-like polymer.

20. The supportive endoluminal graft in accordance with claim 19, wherein compliant adhesive-like polymer is a polycarbonate urethane.

21. The supportive endoluminal graft in accordance with claim 21, wherein said trunk component has a plurality of said indents, each indent having a longitudinal internal surface, and said longitudinal internal surfaces engage each other to thereby define said leg portion to be generally cylindrical.

22. The supportive branching expandable endoluminal graft in accordance with claim 21, wherein said longitudinal internal surfaces are longitudinal edges that are secured together.

23. A branching expandable supportive endoluminal graft comprising:

an expandable supportive endoluminal graft component which is deployed individually at a selected location within a body vessel, said supportive endoluminal graft component being radially compressible and radially expansible; and

said expandable supportive endoluminal graft component is a trunk component which is generally tubular and has a first portion with a given diameter and a second portion including a longitudinally disposed indent generally defining at least two leg portions, each with a diameter less than said given diameter, and each said leg portion has a leg opening.

24. The branching expandable supportive graft in accordance with claim 23, wherein said trunk component has a plurality of said indents, each indent having a longitudinal internal surface, and said longitudinal internal surfaces engage each other to thereby define said leg portion to be generally cylindrical.

25. The branching expandable supportive graft in accordance with claim 24, wherein said longitudinal internal surfaces are longitudinal edges that are secured together.

26. The branching expandable supportive graft in accordance with claim 23, wherein said trunk component has a polymeric porous wall of essentially inert biocompatible material, said compliant porous wall being applied onto at least said internal surface of the tubular supporting component, and said polymeric wall has a longitudinally disposed crease which lies along said indent of the trunk component.

27. The branching expandable supportive graft in accordance with claim 23, wherein said trunk component includes a third portion having a diameter approximating said given diameter of the first portion, and said second portion is positioned between said first portion and said third portion.

28. The branching expandable supportive graft in accordance with claim 27, wherein said first portion and said third portion are each generally cylindrical.

29. The branching expandable supportive graft in accordance with claim 26, wherein said porous material of said compliant wall is an elastomeric polymer.

30. The branching expandable supportive graft in accordance with claim 26, wherein said porous material of said compliant wall is a polycarbonate urethane.

31. The branching expandable supportive graft in accordance with claim 26, wherein said trunk liner includes in interior liner and an intermediate liner between said interior liner and said tubular supporting member.

32. The branching expandable supportive graft in accordance with claim 23, wherein said trunk component includes a plurality of wire strands with open areas therebetween to form a braided mesh.

33. The branching expandable supportive graft in accordance with claim 23, wherein the endoluminal graft is subjected to surface treatment with a compliant adhesive-like polymer.

34. A method for implanting a multi-component branching expandable supportive endoluminal graft, comprising the steps of:

providing a generally tubular supporting trunk component having a first portion with a given diameter and a second portion including a longitudinally disposed indent generally defining at least two leg portions, each leg portion defining a leg opening having a diameter less than the given diameter of the first portion;

inserting the trunk component generally at a branching site within a body vessel, and expanding the trunk component to engage a main vessel path of the vessel body;

providing a generally cylindrical supportive leg component which includes a tubular supporting member;

inserting the generally cylindrical supportive leg component into the body vessel at a location between a leg portion of the trunk component and a branched pathway associated with a main pathway of the body vessel, and expanding the leg component so as to be deployed at said location;

providing another generally cylindrical supporting leg component having a tubular supporting member; and

inserting the another generally cylindrical supportive leg component into the body vessel at a location between the other leg portion of the trunk component and another branched pathway associated with the main pathway of the body vessel, and expanding the component so as to be deployed at said location in order to form a bifurcated supportive endoluminal graft at a bifurcation site within the body vessel.

35. The method in accordance with claim 34, wherein said step of providing the trunk component includes lining the trunk supporting component, each step of providing the leg component provides a leg component which includes a liner and a tubular supporting member, and each such leg component is deployed inside of a respective one of the leg portions of the trunk component, each of which is generally coextensive with the tubular supporting member of the trunk component.

36. A method for manufacturing a branched expandable supportive endoluminal graft, comprising the steps of:

forming a cylindrical braided mesh tube by braiding metal strands into a cylindrical member;

crimping longitudinal portions of the cylindrical braided mesh tube to form at least one longitudinally disposed indent therein to provide a crimped braided mesh tube;

attaching an adhesive layer to the inside surface of the crimped braided mesh tube;

inserting a cylindrical polymeric compliant tube within the crimped braided mesh tube into engagement with the adhesive layer; and

applying pressure to secure the polymeric compliant tube onto the inside surface of the crimped braided mesh tube and simultaneously form a crease in the polymeric compliant tube that generally conforms in shape and size to the indent of the crimped braided mesh tube.