Intraluminal graft/stent and balloon catheter for insertion thereof

• US 5,156,620 A
• Filed: 02/04/1991
• Issued: 10/20/1992
• Est. Priority Date: 02/04/1991
• Status: Expired due to Fees

• Current Assignee: John P. Pigott
• Original Assignee: John P. Pigott
• Inventors: Pigott, John P.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Gualtieri, Gina
• Application Number:
  US07/649,974
• Time in Patent Office: 624 Days
• Field of Search: 623/1, 623/11, 623/12, 623/14, 128/DIG. 25, 604/9, 606/194
• US Class Current: 623/1.25
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An intraluminal graft includes an inner layer, an intermediate layer and an outer layer defining a passageway for transmisson of blood and a method and apparatus for implantation in a blood vessel.

Claims

1. An intraluminal graft member for positioning in a blood vessel having an inner wall surface comprising inner and outer layers of resilient material suitable for implantation in said blood vessel, each of said inner and outer layers defining an annular cross-sectional configuration and which, when in a fully expanded position, the outer layer encircles the inner layer in spaced relationship forming a chamber therebetween, said chamber extending longitudinally from a proximal end to a distal end, means in the vicinity of each of said proximal and distal ends for joining said inner layer to said outer layer, valve means for introducing fluid into said chamber, said inner and outer layer being collapsible in the absence of fluid in said chamber to a size permitting introduction thereof, including said valve means, into said blood vessel wherein said outer layer engages said inner wall surface of said blood vessel, and means for sealing said valve means following introduction of fluid into said chamber, said inner layer forming a passageway for the flow of blood therethrough following introduction of fluid into said chamber.

2. An intraluminal graft member according to claim 1 further including an outflow aperture for venting said chamber and means for sealing said outflow aperture.

3. An intraluminal graft member according to claim 1, wherein at least one of the proximal end and the distal end of said outer layer has a larger cross-sectional size that other portions of said outer layer.

4. An intraluminal graft member according to claim 1, wherein said means for sealing said inflow aperture comprises a one-way valve having a pair of lip members defining an outlet end extending into said chamber and having an inlet end outside of said chamber, the outlet end of said lip members, in normal position, being resiliently urged into sealing engagement with each other and being moveable to a spaced apart position by the application of pressure only from said inlet end.

6. An intraluminal graft member according to claim 1 further including means intermediate said proximal and distal ends connecting said inner and outer layers.

7. An intraluminal graft member according to claim 6, wherein said intermediate connecting means comprises a plurality of tabs extending between said inner and outer layers.

8. An intraluminal graft member according to claim 6, wherein said intermediate connecting means comprises a continuous web extending along a substantially helical path.

5. An intraluminal graft member comprising inner and outer layers of resilient material suitable for implantation in a blood vessel, each of said inner and outer layers defining an annular cross-sectional configuration and which when in a fully expanded position, the outer layer encircles the inner layer in spaced relationship forming a chamber therebetween, said chamber extending longitudinally from a proximal end to a distal end, means in the vicinity of each of said proximal and distal ends joining together said inner and outer layers, an inflow aperture for introducing fluid into said chamber, and means for sealing said inflow aperture, said means for sealing said inflow aperture comprising a one-way valve having a pair of lip members defining an outlet end extending into said chamber and having an inlet end outside of said chamber, the outlet end of said lip members, in normal position, being resiliently urged into sealing engagement with each other and being moveable to a spaced apart position by the application of pressure only from said inlet end and means for mounting on a catheter, said mounting means comprising a housing having (a) a side wall, (b) an interior wall and (c) an end wall defining a chamber, said side wall extending beyond said interior wall to an open end engaged to said outer layer, means for engaging said valve to said interior wall and the portion of said side wall extending beyond said interior wall, each of said interior wall and said end wall having an aperture, a catheter extending through said valve to a position between said lip members, said catheter having an inflatable bladder positioned in said housing having a first end sealingly engaged to said catheter in the vicinity of said end wall and a second end sealingly engaged to said catheter in the vicinity of said interior wall, said bladder, when inflated, firmly engaging said housing.

9. An intraluminal graft for implantation in a blood vessel comprising inner and outer layers of resilient material, each of said inner and outer layers defining a tubular segment having an annular cross-sectional configuration, said outer layer encircling the inner layer in spaced relationship forming a chamber therebetween, said chamber extending longitudinally from a proximal end to a distal end, said chamber having a material therein for (a) maintaining said outer layer spaced from said inner layer and (b) maintaining said inner layer open to define a passageway for transmission of blood, said outer layer being of a size suitable for engaging the interior wall of a blood vessel and valve means communicating with said chamber for introducing said material into said chamber.

10. An intraluminal graft member according to claim 9 further including inflow means for introducing said intermediate layer into the space between said inner and outer layers after said inner and outer layers are positioned in a blood vessel.

11. An intraluminal graft according to claim 10 further including outflow means for monitoring the inflow of said intermediate layer.

12. An intraluminal graft member according to claim 9, wherein said outer layer includes a proximal end portion and a distal end portion, at least one of which has a larger cross-sectional size than other portions of said outer layer.

13. An intraluminal graft member according to claim 9 further including means extending through said intermediate layer connecting said inner and outer layers.

14. An intraluminal graft member according to claim 13, wherein said connecting means comprises a plurality of tabs extending between said inner and outer layers.

15. An intraluminal graft member according to claim 13, wherein said connecting means comprises a continuous web extending along a substantially helical path.

16. An intraluminal graft suitable for implantation in a blood vessel comprising inner, intermediate and outer layers of resilient material joined together, defining a tubular segment having an annular cross-sectional configuration, said inner layer defining a passageway for transmission of blood, and cooperating with said outer layer to define a chamber containing said intermediate layer, said graft extending longitudinally from a proximal end to a distal end and having means on said outer layer at each of said proximal and distal ends engageable with said blood vessel, and valve means communicating with said chamber for introducing said intermediate layer therein.

17. An intraluminal graft member according to claim 16, wherein said valve means is located in the vicinity of one of said proximal end and said distal end.

18. An intraluminal graft member according to claim 16, wherein said outer layer has a larger cross-sectional size at one said proximal end and said distal end than other portions of said outer layer.

19. An intraluminal graft member according to claim 16 further including reinforcing means extending through said intermediate layer and joined to said inner and outer layers.

20. An intraluminal graft member according to claim 19, wherein said reinforcing means comprises a plurality of tabs.

21. An intraluminal graft member according to claim 19, wherein said reinforcing means comprises a continuous web extending along a substantially helical path.