Method and apparatus for the surgical repair of aneurysms

• US 5,944,750 A
• Filed: 07/18/1997
• Issued: 08/31/1999
• Est. Priority Date: 06/30/1997
• Status: Expired due to Term

• Current Assignee: EMI (Entegris Incorporated)
• Original Assignee: EMI (Entegris Incorporated)
• Inventors: Tanner, Howard, Trout, Hugh III
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Nguyen, Tram A.
• Application Number:
  US08/896,415
• Time in Patent Office: 774 Days
• Field of Search: 623/1, 623/11, 623/12, 606/108, 606/191, 606/194, 606/195, 606/198, 606/158, 606/157
• US Class Current: 623/1.23
• CPC Class Codes: A61B 1/127 with means for preventing fogging A61B1/253 takes precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

An attachment assembly and repair graft are disclosed for securing a graft to repair a vessel having an aneurysm therein. The attachment assembly comprises an attachment cuff such that the graft is not dimensionally dependent upon the size of the vessel. A visualization apparatus is also disclosed for real time direct viewing of an interior of a vessel. A penetration apparatus is disclosed for use in forming treatment specific holes in a potentially calcified vessel wall which facilitates thereafter the securing of the graft and attachment assembly to the vessel wall. An introducer sheath device is also disclosed that comprises a sealing assembly for preventing the loss of blood from the vessel during the insertion and subsequent removal of surgical components during the surgical procedure.

Claims

1. An attachment assembly for securing a graft to a vessel for repairing the vessel having an aneurysm therein, wherein the vessel has a vessel wall, a proximal end and a distal end and the graft has a proximal end and a distal end, said attachment assembly comprising:

attachment means for securing the distal end of the graft to the distal end of the vessel wall, wherein said attachment means includes a generally radially extending flexible cuff, said flexible cuff includes an inner open portion having an inner diameter and a free outer perimeter portion having an outer diameter, wherein said outer diameter is greater than said inner diameter, wherein said radially extending flexible cuff being adapted to be secured to the vessel wall; and

graft attachment means connected to said attachment means for securing the distal end of the graft to said attachment assembly, wherein said graft attachment means includes at least one graft attachment tube extending from said inner open portion of said flexible cuff, wherein the graft is received within said at least one graft attachment tube, wherein said radially extending flexible cuff accommodates expansion of the vessel without negatively impacting the connection between the distal end of the graft and the vessel, wherein said radially extending flexible cuff laterally projects from said graft attachment means.

2. The attachment assembly according to claim 1, wherein said attachment assembly is formed from a flexible material.

3. A repair graft assembly for repairing a vessel wall having an aneurysm therein, wherein the vessel wall has a proximal end and a distal end, said repair graft assembly comprising:

a proximal graft assembly for creating a passageway within the vessel to reinforce the aneurysm, wherein said graft assembly having a proximal end and a distal end; and

an attachment assembly comprising attachment means for securing said distal end of said proximal graft assembly to said distal end of the vessel wall, wherein said attachment means includes a generally radially extending flexible cuff, said flexible cuff includes an inner open portion having an inner diameter and a free outer perimeter portion having an outer diameter, wherein said outer diameter is greater than said inner diameter, wherein said radially extending flexible cuff being adapted to be secured to the vessel wall, and graft attachment means connected to said attachment means for securing said distal end of said proximal graft assembly to said attachment assembly, wherein said graft attachment means extends from said inner open portion of said flexible cuff, wherein said radially extending flexible cuff accommodates expansion of the vessel without negatively impacting the connection between said distal end of said proximal graft assembly and the vessel, wherein said radially extending flexible cuff laterally projects from said graft attachment means.

4. The repair graft assembly according to claim 3, wherein said attachment assembly is formed from a flexible material.

5. The repair graft assembly according to claim 3, wherein said proximal graft assembly is formed from a flexible material.

6. The repair graft assembly according to claim 3, wherein said proximal graft assembly is a bifurcated graft.

7. The repair graft assembly according to claim 3, wherein said proximal graft assembly comprises proximal attachment means for securing said proximal end of said graft to the proximal end of the vessel.

8. The repair graft assembly according to claim 7, wherein said proximal attachment means comprises a radially extending cuff.

9. The repair graft assembly according to claim 8, wherein said proximal graft assembly is formed from a flexible material.

10. The repair graft assembly according to claim 8, wherein said proximal graft assembly is a bifurcated graft.

11. The repair graft assembly according to claim 3, wherein said attachment means comprises at least one graft attachment leg for receiving said distal end of said proximal graft assembly.

12. A repair graft assembly for repairing an aneurysm in a vessel having a vessel wall, wherein a fluid flows through the vessel, said repair graft assembly comprising:

a graft assembly including at least one tubular assembly, wherein said at least one tubular assembly is located within the vessel to isolate the aneurysm from the circulatory system such that the flow of fluid bypasses the aneurysm through said at least one tubular assembly; and

at least one graft attachment assembly for securing said graft assembly to the vessel wall, said at least one graft attachment assembly including a radially extending flexible attachment cuff, said flexible cuff includes an inner open portion having an inner diameter and a free outer perimeter portion having an outer diameter, wherein said outer diameter is greater than said inner diameter, and at least one graft attachment tube extending from said inner open portion of said flexible attachment cuff, wherein at least a portion of said at least one tubular assembly is received within said at least one graft attachment tube,

wherein said flexible attachment cuff accommodates expansion of the vessel without negatively impacting the connection between the vessel and said at least one graft attachment assembly.

13. The repair graft assembly according to claim 12, wherein said graft assembly includes a first end and a second end, wherein said at least one graft attachment assembly includes a pair of graft attachment assemblies, one of said pair of graft attachment assemblies being secured to said first end and another of said pair of graft attachment assemblies being secured to said second end.

14. The repair graft assembly according to claim 12, wherein the vessel has a first cross-sectional area, the aneurysm has a second cross-sectional that is greater than said first cross-sectional area, said at least one tubular assembly having a third cross-sectional area, wherein said third cross-sectional area is between said first cross-sectional area and second cross-sectional area.

15. A repair system for repairing an aneurysm in a vessel having a vessel wall, wherein a fluid flows through the vessel, said repair system comprising:

a repair graft assembly having a graft assembly including at least one tubular assembly, wherein said at least one tubular assembly is located within the vessel to isolate the aneurysm such that the flow of fluid bypasses the aneurysm through said at least one tubular assembly, said repair graft assembly further having at least one graft attachment assembly for securing said graft assembly to the vessel wall, said at least one graft attachment assembly including a radially extending flexible attachment cuff, and at least one graft attachment tube extending from said flexible attachment cuff, wherein at least a portion of said at least one tubular assembly is received within said at least one graft attachment tube; and

at least one fastener for securing said at least one graft attachment assembly to the vessel wall, wherein said at least one fastener includes a first portion located on one side of said flexible attachment cuff, a second portion located on one side of the vessel wall, and an intermediate portion connecting to said first portion and said second portion, said intermediate portion extending through the vessel wall and said flexible attachment cuff, whereby said first portion, second portion and said intermediate portion act to apply a compressive force to the flexible attachment cuff and the vessel wall to secure said repair graft assembly to the vessel.

16. The repair system according to claim 15, wherein said flexible attachment cuff accommodates expansion of the vessel without negatively impacting the connection between the vessel and said at least one graft attachment assembly.

17. The repair system according to claim 15, wherein said graft assembly includes a first end and a second end, wherein said at least one graft attachment assembly includes a pair of graft attachment assemblies, one of said pair of graft attachment assemblies being secured to said first end and another of said pair of graft attachment assemblies being secured to said second end.

18. The repair system according to claim 15, wherein the vessel has a first cross-sectional area, the aneurysm has a second cross-sectional that is greater than said first cross-sectional area, said at least one tubular assembly having a third cross-sectional area, wherein said third cross-sectional area is between said first cross-sectional area and second cross-sectional area.

19. The repair system according to claim 15, wherein said at least one fastener includes a plurality of fasteners, wherein each of said plurality of fasteners secures said repair graft assembly to the vessel wall under a compressive force.