Method and apparatus for bilateral intra-aortic bypass

Abstract

A bilateral intra-aortic bypass graft and method and apparatus for repairing an abdominal aortic aneurysm includes two tubular grafts which are intraluminally delivered to the aorta and secured to the aorta by the expansion and deformation of two expandable and deformable tubular members.

We claim:  
     
       1. A bilateral intra-aortic bypass graft for intraluminal delivery to repair an abdominal aortic aneurysm in an aorta having a diameter and two iliac arteries associated therewith, by forming a bilateral passageway through the abdominal aortic aneurysm, comprising: 
       a first tube having a diameter, first and second ends and a wall surface disposed between the two ends, at least a portion of the first tube adapted to be disposed within the abdominal aortic aneurysm;  
       a second tube having a diameter, first and second ends and a wall surface disposed between the two ends, at least a portion of the second tube adapted to be disposed within the abdominal aortic aneurysm; and  
       means for securing the first ends of the first and second tubes in an abutting relationship in the aorta, the securing means including first and second tubular members, each tubular member having first and second ends, the first tube being connected to the first tubular member and the second tube being connected to the second tubular member, the tubular members having a first diameter which permits intraluminal delivery of the tubular members and tubes into the aorta and the tubular members each having a second, expanded and deformed diameter, with at least a portion of the first and second tubular members in an abutting relationship, upon the application from the interior of the tubular members of a radially, outwardly extending force, to expand and deform the tubular members to secure the first ends of the tubular members to the aorta in an abutting relationship and to form a bilateral passageway within the abdominal aortic aneurysm.  
     
     
       2. The bilateral intra-aortic bypass graft of  claim 1 , wherein at least a portion of the first and second tubes are in an abutting relationship with each other when the first and second tubular members have their second, expanded and deformed diameter. 
     
     
       3. The bilateral intra-aortic bypass graft of  claim 1 , wherein each tubular member has a wall having a smooth outer wall surface disposed between its first and second ends, the wall  walls surfaces  having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axes of the tubular members, a first end of a tube being secured to a second end of a tubular member. 
     
     
       4. The bilateral intra-aortic bypass graft of  claim 1 , wherein a biologically inert coating is disposed on the tubes. 
     
     
       5. The bilateral intra-aortic bypass graft of  claim 1 , wherein the tubes are made of a material which is impervious to the flow of fluid. 
     
     
       6. The bilateral intra-aortic bypass graft of  claim 1 , wherein the tubes are made of a material which is bio-erodible. 
     
     
       7. The bilateral intra-aortic bypass graft of  claim 1 , wherein a third expandable and deformable, tubular member is connected to the second end of the first tube; a fourth expandable and deformable, tubular member is connected to the second end of the second tube; and the third and fourth tubular members are expanded and deformed to force the third and fourth tubular members radially outwardly into contact with an iliac artery. 
     
     
       8. The bilateral intra-aortic bypass graft of  claim 1 , wherein each tube is formed of a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       9. The bilateral intra-aortic bypass graft of  claim 8 , wherein the plastic material is silicone. 
     
     
       10. The bilateral intra-aortic bypass graft of  claim 8 , wherein the plastic material is a polytetrafluoroethylene. 
     
     
       11. The bilateral intra-aortic bypass graft of  claim 10 , wherein the plastic material is expanded polytetrafluoroethylene. 
     
     
       12. The bilateral intra-aortic bypass graft of  claim 8 , wherein the plastic material is expanded polyurethane. 
     
     
       13. The bilateral intra-aortic bypass graft of  claim 8 , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected. 
     
     
       14. The bilateral intra-aortic bypass graft of  claim 1 , including a fifth expandable and deformable tubular member, wherein the first and second tubular members are disposed within the fifth expandable tubular member in an abutting relationship with each other and with the fifth expandable tubular member, whereby the first and second tubular members may be secured within the aorta and within the fifth tubular member. 
     
     
       15. The bilateral intra-aortic bypass graft of  claim 1 , wherein each tube is formed of a plurality of expandable and deformable tubular members, each tubular member having a longitudinal axis with the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other; each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       16. The bilateral intra-aortic bypass graft of  claim 15 , wherein the plastic material is silicone. 
     
     
       17. The bilateral intra-aortic bypass graft of  claim 15 , wherein the plastic material is polytetrafluoroethylene. 
     
     
       18. The bilateral intra-aortic bypass graft of  claim 17 , wherein the plastic material is expanded polytetrafluoroethylene. 
     
     
       19. The bilateral intra-aortic bypass graft of  claim 15 , wherein the plastic material is expanded polyurethane. 
     
     
       20. The bilateral intra-aortic bypass graft of  claim 15 , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected. 
     
     
       21. The bilateral intra-aortic bypass graft of  claim 1 , wherein the tubes are made of a synthetic polyester material. 
     
     
       22. The bilateral intra-aortic bypass graft of  claim 1 , wherein the tubes are made of polytetrafluoroethylene. 
     
     
       23. An apparatus for repairing an abdominal aortic aneurysm in an aorta having a diameter and two iliac arteries associated therewith, by forming a bilateral passageway through the abdominal aortic aneurysm, comprising: 
       (a) first and second tubes, each tube having a diameter, first and second ends and a wall surface disposed between the two ends;  
       (b) first and second expandable and deformable tubular members, each expandable and deformable tubular member, having first and second ends and a smooth outer wall surface disposed between the first and second ends, the first end of a tube being secured to a second and  end of a tubular member, the expansion and deformation of the tubular members being controllable; and  
       (c) two catheters, each catheter having an expandable, inflatable portion associated therewith, the tubular members being releasably mounted upon the inflatable portions of each catheter, whereby upon inflation of the expandable, inflatable portion of each catheter, the tubular members are forced radially outwardly into contact in an abutting relationship with the aorta and each other to remain secured thereto, whereby the tubes, secured to the tubular members, provide a bilateral passageway through the abdominal aortic aneurysm.  
     
     
       24. The apparatus of  claim 23 , wherein each tube is formed of  includes a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       25. The apparatus of  claim 24 , wherein the expandable, inflatable portion of each catheter extends along a portion of the length of each catheter for a distance greater than the combined length of each tube and tubular member, whereby upon expansion and inflation of each expandable, inflatable portion of each catheter, each tubular member and its connected tube are simultaneously expanded. 
     
     
       26. The apparatus of  claim 23 , wherein each tube is formed of  includes a plurality of expandable and deformable tubular members, each tubular member having a longitudinal axis with the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other; each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       27. The apparatus of  claim 26 , wherein the expandable, inflatable portion of each catheter extends along a portion of the length of each catheter for a distance greater than the combined length of each tube and tubular member, whereby upon expansion and inflation of each expandable, inflatable portion of each catheter, each tubular member and its connected tube are simultaneously expanded. 
     
     
       28. A bilateral bypass graft for a body passageway, having a diameter, for intraluminal delivery to repair the body passageway by forming a bilateral passageway through the body passageway, comprising: 
       a first tube having a diameter, first and second ends and a wall surface disposed between the two ends, at least a portion of the first tube adapted to be disposed within the body passageway;  
       a second tube having a diameter, first and second ends and a wall surface disposed between the two ends, at least a portion of the second tube adapted to be disposed within the body passageway; and  
       means for securing the first ends of the first and second tubes in an abutting relationship in the body passageway, the securing means including first and second tubular members, each tubular member having first and second ends, the first tube being connected to the first tubular member and the second tube being connected to the second tubular member, the tubular members having a first diameter which permits intraluminal delivery of the tubular members and tubes into the body passageway and the tubular members each having a second, expanded and deformed diameter, with at least a portion of the first and second tubular members in an abutting relationship, upon the application from the interior of the tubular members of a radially, outwardly extending force, to expand and deform the tubular members to secure the first ends of the tubular members to the body passageway in an abutting relationship and to form a bilateral passageway within the body passageway.  
     
     
       29. The bilateral bypass graft of  claim 28 , wherein at least a portion of the first and second tubes are in an abutting relationship with each other when the first and second tubular members have their second, expanded and deformed diameter. 
     
     
       30. The bilateral bypass graft of  claim 28 , wherein each tubular member has a wall surface having a smooth outer wall surface disposed between its first and second ends, the wall surfaces  walls having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axes of the tubular members, a first end of a tube being secured to a second end of a tubular member. 
     
     
       31. The bilateral bypass graft of  claim 28 , wherein a biologically inert coating is disposed on the tubes. 
     
     
       32. The bilateral bypass graft of  claim 28 , wherein the tubes are made of a material which is impervious to the flow of fluid. 
     
     
       33. The bilateral bypass graft of  claim 28 , wherein the tubes are made of a material which is bio-erodible. 
     
     
       34. The bilateral bypass graft of  claim 28 , wherein the tubes are made of a synthetic polyester material. 
     
     
       35. The bilateral bypass graft of  claim 28 , wherein the tubes are made of polytetrafluoroethylene. 
     
     
       36. The bilateral bypass graft of  claim 28 , wherein a third expandable and deformable, tubular member is connected to the second end of the first tube; a fourth expandable and deformable, tubular member is connected to the second end of the second tube; and the third and fourth tubular members are expanded and deformed to force the third and fourth tubular members radially outwardly into contact with the body passageway. 
     
     
       37. The bilateral bypass graft of  claim 28 , wherein each tube is formed of  includes a plurality of expandable and deformable, tubular members, each tubular member having a longitudinal axis, the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       38. The bilateral intra-aortic bypass graft of  claim 37 , wherein the plastic  material is silicone. 
     
     
       39. The bilateral bypass graft of  claim 32 , wherein the plastic  material is polytetrafluoroethylene. 
     
     
       40. The bilateral intra-aortic bypass graft of  claim 39 , wherein the plastic material is expanded polytetrafluoroethylene 
     
     
       41. The bilateral intra-aortic bypass graft of  claim 32 , wherein the plastic  material is expanded polyurethane. 
     
     
       42. The bilateral intra-aortic bypass graft of  claim 32 , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected. 
     
     
       43. The bilateral intra-aortic bypass graft of  claim 28 , including a fifth expandable and deformable tubular member, wherein the first and second tubular members are disposed within the fifth expandable tubular member in an abutting relationship with each other and with the fifth expandable tubular member, whereby the first and second tubular members may be secured within the body passageway and within the fifth tubular member. 
     
     
       44. The bilateral bypass graft of  claim 43 , wherein each tube is formed of  includes a plurality of expandable and deformable tubular members, each tubular member having a longitudinal axis with the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other; each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members; and the plurality of tubular members are embedded within a layer of a deformable and expandable plastic material. 
     
     
       45. The bilateral bypass graft of  claim 44 , wherein the plastic material is silicone. 
     
     
       46. The bilateral intra-aortic bypass graft of  claim 44 , wherein the plastic material is polytetrafluoroethylene. 
     
     
       47. The bilateral intra-aortic bypass graft of  claim 46 , wherein the plastic material is expanded polytetrafluoroethylene. 
     
     
       48. The bilateral intra-aortic bypass graft of  claim 44 , wherein the plastic material is expanded polyurethane. 
     
     
       49. The bilateral intra-aortic bypass graft of  claim 44 , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the deformable and expandable plastic material of the tube to which it is to be connected. 
     
     
       50. A bilateral intra- aortic bypass graft for repairing an abdominal aortic aneurysm in an aorta having a diameter and two iliac arteries associated therewith, by forming a bilateral passageway through the abdominal aortic aneurysm, comprising:    
       
         a first tube having first and second ends and a wall surface disposed between the two ends, said first tube being adapted to be intraluminally delivered through one iliac artery so that the first end of the first tube is adapted to be located in the aorta above the abdominal aortic aneurism, at least a portion of the first tube being adapted to extend through the abdominal aortic aneurysm, with the second end of said first tube being adapted to be located within said one iliac artery, said first end of the first tube having a first delivery diameter and a second expanded diameter;  
       
       
         a second tube having first and second ends and a wall surface disposed between the two ends, said second tube being adapted to be intraluminally delivered through the other iliac artery so that the first end of the second tube is adapted to be located in the aorta above the abdominal aortic aneurism adjacent to the first end of the first tube, at least a portion of the second tube being adapted to extend through the abdominal aortic aneurysm, with the second end of said second tube being adapted to be located within said other iliac artery, said first end of the second tube having a first delivery diameter and a second expanded diameter;  
       
       
         the first ends of said first and second tubes being disposed in a fixed sealed relationship with one another within the aorta once they have been expanded into their second expanded diameters and being adapted to be disposed in a sealed relationship with the inner surface of the aorta above the aneurysm once they have been expanded into their second expanded diameters. 
       
     
     
       51. The bilateral intra- aortic graft of    claim 50   , wherein the first ends of the first and second tubes are disposed in a sealed relationship by first and second tubular members that secure the first ends of the first and second tubes adjacent to one another in the aorta, the first tube being connected to the first tubular member and the second tube being connected to the second tubular member.   
     
     
       52. The bilateral intra- aortic graft of    claim 51    wherein at least a portion of the first and second tubular members are in contact with one another in the aorta.   
     
     
       53. The bilateral intra- aortic bypass graft of    claim 51    wherein at least portions of the first ends of the first and second tubes are in contact with one another in the aorta.   
     
     
       54. The bilateral intra- aortic graft of    claim 51    wherein the first and second tubular members deform as they expand from the first diameter to the second diameter upon the application from the interior of a radially outwardly extending force.   
     
     
       55. The bilateral intra- aortic bypass graft of    claim 51   , wherein each tubular member has first and second ends and a wall having a smooth outer wall surface disposed between its first and second ends, the walls having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axes of the tubular members, a first end of a tube being secured to a second end of a tubular member.   
     
     
       56. The bilateral intra- aortic bypass graft of    claim 51   , wherein a third expandable tubular member is connected to the second end of the first tube; a fourth expandable tubular member is connected to the second end of the second tube; and the third and fourth tubular members are expanded to force the third and fourth tubular members radially outwardly into contact with an iliac artery.   
     
     
       57. The bilateral intra- aortic bypass graft of    claim 51   , wherein each tube is formed of a plurality of expandable tubular members, each tubular member having a longitudinal axis, the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other, each tubular member being detached, and spaced apart, from adjacent tubular members; and the plurality of tubular members are embedded within a layer of an expandable plastic material.   
     
     
       58. The bilateral intra- aortic bypass graft of    claim 57   , wherein the plastic material is silicone.   
     
     
       59. The bilateral intra- aortic bypass graft of    claim 57   , wherein the plastic material is polytetrafluoroethylene.   
     
     
       60. The bilateral intra- aortic bypass graft of    claim 59   , wherein the plastic material is expanded polytetrafluoroethylene.   
     
     
       61. The bilateral intra- aortic bypass graft of    claim 57   , wherein the plastic material is expanded polyurethane.   
     
     
       62. The bilateral intra- aortic bypass graft of    claim 57   , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the second ends of the first and second tubular members in the expandable plastic material of the tube to which it is to be connected.   
     
     
       63. The bilateral intra- aortic bypass graft of    claim 51   , including a fifth expandable tubular member wherein the first and second tubular members are disposed within the fifth expandable tubular member in an adjacent relationship with each other and with the fifth expandable tubular member, whereby the first and second tubular members may be secured within the aorta and within the fifth tubular member.   
     
     
       64. The bilateral intra- aortic bypass graft of    claim 51   , wherein each tube is formed of a plurality of expandable tubular members, each tubular member having a longitudinal axis with the plurality of tubular members being aligned with their longitudinal axes being substantially parallel with each other; each tubular member being spaced apart from adjacent tubular members with a single, flexible connector member being disposed between adjacent tubular members; and the plurality of tubular members are embedded within a layer of expandable plastic material.   
     
     
       65. The bilateral intra- aortic bypass graft of    claim 64   , wherein the plastic material is silicone.   
     
     
       66. The bilateral intra- aortic bypass graft of    claim 64   , wherein the plastic material is polytetrafluoroethylene.   
     
     
       67. The bilateral intra- aortic bypass graft of    claim 66   , wherein the plastic material is expanded polytetrafluoroethylene.   
     
     
       68. The bilateral intra- aortic bypass graft of    claim 64   , wherein the plastic material is expanded polyurethane.   
     
     
       69. The bilateral intra- aortic bypass graft of    claim 64   , wherein the first and second tubular members are connected to the first and second tubes by embedding a portion of the first and second tubular members in the expandable plastic material of the tube to which it is to be connected.   
     
     
       70. The bilateral intra- aortic bypass graft of    claim 50   , wherein the tubes are made of a material which is impervious to the flow of fluid.   
     
     
       71. The bilateral intra- aortic bypass graft of    claim 50   , wherein a biologically compatible coating is disposed on the tubes.   
     
     
       72. The bilateral intra- aortic bypass graft of    claim 50   , wherein the tubes are made of a material which is bio - erodible.   
     
     
       73. The bilateral intra- aortic bypass graft of    claim 50   , wherein the tubes are made of a synthetic polyester material.   
     
     
       74. The bilateral intra- aortic bypass graft of    claim 50   , wherein the tubes are made of polytetrafluoroethylene.