Two-piece, bifurcated intraluminal graft for repair of aneurysm

A two piece prosthetic graft for repairing an abdominal aortic aneurysm in the arterial wall close to or involving the aortic bifurcation comprising the abdominal aorta and the right and left iliac arteries, said graft comprising:

• a first graft prosthesis having a continuous, fabric side wall extending between a self-expanding right leg opening stent and a self-expanding left leg opening stent and having a self-expanding waist stent in the continuous side wall thereof between the right and left leg opening stents, the continuous side wall and opening stents being collapsible when restrained in a collapsed state and expandable when unrestrained to an expanded state defining a first graft lumen extending between a waist opening, a right leg opening, and a left leg opening, said right and left opening stents adapted to be located and released from restraint in the right and left iliac arteries outside the area affected by the aneurysm to bear against the right and left iliac artery walls to seal the first graft lumen and iliac arteries from the aneurysm, and said waist opening adapted to be oriented to face superiorly from the aortic bifurcation and toward the lumen of the aorta to provide an attachment seat of predetermined size approximating the diameter of the aorta lumen beyond the area of the aneurysm when said waist opening stent is expanded;
• and
• a second graft prosthesis formed of a flexible sheet material rolled to form a tubular member of at least one partially overlapping turn having a length and a continuous side wall between distal and proximal ends and defining a graft lumen within the tubular member extending between distal and proximal end openings, respectively, the turns of the tubular member being collapsible under restraint into a collapsed state and expandable upon removal of the restraint to an expanded state when introduced superior to the aortic bifurcation with the proximal end thereof located within said attachment seat formed by said waist opening stent such that the tubular member expands until the expanded distal end bears against and is restrained by the aortic arterial wall beyond the area of the aneurysm and the proximal end bears against and is restrained by said attachment seat to seal the first and second graft lumens with the aorta lumen and from the aneurysm.

A method of bypassing an aneurysm, defect or injury in a trunk blood vessel wall close to or involving a bifurcation of the trunk blood vessel into first and second branch vessels having first and second branch vessel walls and lumens comprising the steps of:

• percutaneously introducing and advancing a first elongated graft prosthesis in a collapsed state into a position bridging the bifurcation, the first graft prosthesis having a continuous side wall extending between a first leg opening stent and a second leg opening stent and having a waist opening stent in the continuous side wall thereof between the first and second leg opening stents defining a waist opening when expanded, the continuous side wall and leg and waist opening stents being collapsible in the collapsed state during advancement and expandable to an expanded state to define a first graft lumen extending between the waist opening and the first and second leg openings;
• expanding the first leg opening stent, the second leg opening stent and the continuous side wall with the waist opening stent oriented to the trunk vessel lumen so that the first and second leg opening stents bear against first and second branch vessel walls to seal the first graft lumen from the aneurysm, defect or injury;
• expanding the waist opening stent oriented to face the trunk vessel lumen to a fixed waist opening size to provide an attachment seat of predetermined size;
• advancing a second graft prosthesis, having a continuous side wall extending between distal and proximal end openings thereof, the continuous side wall being collapsible in the collapsed state expandable to an expanded state to define an expanded continuous side wall of a second graft lumen, in said collapsed state to align said proximal end opening within said waist opening;
• and
• expanding the second graft prosthesis so that the continuous side wall adjacent the expanded distal end opening bears against the trunk vessel wall beyond the area of the aneurysm, defect or injury and the continuous side wall adjacent to the proximal end opening bears against said attachment seat to seal the second graft lumen and trunk vessel from the aneurysm, defect or injury and to seal the waist opening of the first graft lumen.

A method of repairing an abdominal aortic aneurysm in the arterial wall close to or involving the aortic bifurcation comprising the aorta and the right and left iliac arteries comprising the steps of:

• percutaneously introducing and advancing a guidewire into one of the right and left femoral arteries, into the respective one of the right and left iliac arteries coupled thereto and then across the aortic bifurcation and into the other one of the right and left iliac arteries;
• assembling a first elongated graft prosthesis in a collapsed state about a distal end segment of a first deployment catheter, the first graft prosthesis having a continuous side wall extending between a right leg opening stent and a left leg opening stent and having a waist opening stent in the continuous side wall thereof between the right and left leg openings, the continuous side wall and opening stents being collapsible in the collapsed state against the first deployment catheter distal end segment during introduction and expandable to an expanded state to define an expanded continuous side wall defining a first graft lumen extending between a respective right leg opening, left leg opening and waist opening, the first deployment catheter having a guidewire lumen formed therein adapted to be fitted over the guidewire;
• fitting the guidewire lumen over the guidewire and introducing the assembly of the first deployment catheter and the collapsed first graft prosthesis over the guidewire across the aortic bifurcation to locate the right and left leg opening stents in the right and left iliac arteries with the waist opening and stent oriented to face the lumen of the aorta;
• expanding the right opening stent, the left opening stent and the continuous side wall with the waist opening stent oriented to the lumen of the aorta so that the right and left stents bear against arterial walls of the right and left iliac arteries to seal the first graft lumen and iliac arteries from the aneurysm;
• expanding the waist opening oriented to face the lumen of the aorta to provide an attachment seat of predetermined size approximating the diameter of the aorta lumen beyond the area of the aneurysm;
• withdrawing the first deployment catheter;
• repositioning the guidewire to extend from the one of the right and left iliac arteries into the lumen of the aorta beyond the area of the aneurysm;
• assembling a second graft prosthesis in a collapsed state about a distal end segment of a second deployment catheter, the second graft prosthesis having a continuous side wall extending between distal and proximal end openings thereof, the continuous side wall being collapsible in the collapsed state against the second deployment catheter distal end segment during introduction and expandable to an expanded state to define an expanded continuous side wall of a second graft lumen, the second deployment catheter having a guidewire lumen formed therein adapted to be fitted over said guidewire;
• fitting the second deployment catheter guidewire lumen over the guidewire and introducing the assembly of the second deployment catheter and the collapsed second graft prosthesis over the guidewire past the aortic bifurcation to locate the distal end opening adjacent the aortic arterial wall beyond the area of the aneurysm and the proximal end opening within said attachment seat formed by said waist opening stent;
• expanding the second graft prosthesis so that the continuous side wall adjacent the expanded distal end opening bears against the aortic arterial wall beyond the area of the aneurysm and the continuous side wall adjacent to the proximal end opening bears against said attachment seat to seal the second graft lumen and aorta from the aneurysm and to seal the waist opening of the first graft lumen and to release the second graft prosthesis from the second deployment catheter;
• and
• percutaneously withdrawing the second deployment catheter and guide wire.

A method of repairing an aneurysm, defect or injury in a trunk blood vessel wall close to or involving a bifurcation of the trunk blood vessel into first and second branch blood vessels having branch blood vessel lumens and vessel walls comprising the steps of:

• percutaneously introducing and advancing a guidewire into one of the first and second blood vessel lumens and across the bifurcation and into the other one of the first and second blood vessels;
• assembling a first elongated graft prosthesis in a collapsed state about a distal end segment of a first deployment catheter, the first graft prosthesis having a continuous side wall extending between a first leg opening stent and a second leg opening stent and having a waist opening stent in the continuous side wall thereof between the first and second leg openings, the continuous side wall and opening stents being collapsible in the collapsed state against the first deployment catheter distal end segment during introduction and expandable to an expanded state to define an expanded continuous side wall defining a first graft lumen extending between a respective first leg opening, second leg opening and waist opening, the first deployment catheter having a guidewire lumen formed therein adapted to be fitted over the guidewire;
• fitting the first deployment catheter guidewire lumen over the guidewire and introducing the assembly of the first deployment catheter and the collapsed first graft prosthesis over the guidewire across the trunk vessel bifurcation to locate the first and second leg opening stents in the first and second blood vessel lumens with the waist opening and stent oriented to face the trunk vessel lumen;
• expanding the first leg opening stent, the second leg opening stent and the continuous side wall with the waist opening stent oriented to the lumen of the aorta so that the first and second leg opening stents bear against the first and second branch vessel walls to seal the first graft lumen and branch vessels from the aneurysm, defect or injury;
• expanding the waist opening stent oriented to face the lumen of the aorta to provide an attachment seat of predetermined size approximating the diameter of the trunk vessel lumen beyond the area of the aneurysm, defect or injury;
• withdrawing the first deployment catheter;
• repositioning the guidewire to extend into the trunk vessel lumen extending across the area of the aneurysm, defect or injury;
• assembling a second graft prosthesis in a collapsed state about a distal end segment of a second deployment catheter, the second graft prosthesis having a continuous side wall extending between distal and proximal end openings thereof, the continuous side wall being collapsible in the collapsed state against the second deployment catheter distal end segment during introduction and expandable to an expanded state to define an expanded continuous side wall of a second graft lumen, the second deployment catheter having a guidewire lumen formed therein adapted to be fitted over said guidewire;
• fitting the second deployment catheter lumen over the guidewire and introducing the assembly of the second deployment catheter and the collapsed second graft prosthesis over the guidewire past the bifurcation to locate the distal end opening adjacent the trunk vessel wall beyond the area of the aneurysm, defect or injury and the proximal end opening within said attachment seat formed by said waist opening stent;
• expanding the second graft prosthesis so that the continuous side wall adjacent the expanded distal end opening bears against the trunk vessel wall beyond the area of the aneurysm, defect or injury and the continuous side wall adjacent to the proximal end opening bears against said attachment seat to seal the second graft lumen and trunk vessel from the aneurysm, defect or injury and to seal the waist opening of the first graft lumen and the second graft prosthesis and to release said second graft prosthesis from said second deployment catheter;
• and
• percutaneously withdrawing the second deployment catheter and guide wire.

A two piece prosthetic graft for repairing an aneurysm, defect or injury in a blood vessel wall close to or involving a bifurcation of a trunk blood vessel and first and second branch blood vessels having branch blood vessel lumens and walls and an introduction and deployment system for said two piece prosthetic graft,

• said graft comprising:
• a first graft prosthesis having a continuous, side wall extending between a right leg, expandable opening stent and a left leg, expandable opening stent and having a waist, expandable stent in the continuous side wall thereof between the right and left leg openings, the expandable opening stents being collapsible when restrained in a collapsed state and expandable when unrestrained to an expanded state defining a first graft lumen extending between expanded right leg, left leg, and waist openings;
• and
• a second graft prosthesis formed of a flexible sheet material rolled into a tubular member of at least one partially overlapping turn and defining a graft lumen extending between distal and proximal end openings formed by the tubular member when in an expanded shape, the continuous side wall being collapsible into a collapsed state and expandable to an expanded state;
• and
• said introduction and deployment system comprising:
• first introduction and deployment means for introducing said first graft prosthesis in said collapsed state across the bifurcation to locate the right and left leg opening stents in the first and second branch blood vessels to bridge the area affected by the aneurysm, defect or injury and for deploying the right leg opening stent, the left leg opening stent and the continuous side wall such that the right and left stents bear against the first and second branch blood vessel walls to seal the first graft lumen and the branch blood vessels from the aneurysm, defect or injury, and for deploying the waist opening stent to face the trunk blood vessel lumen to provide an attachment seat of predetermined size approximating the diameter of the trunk blood vessel lumen beyond the area of the aneurysm, defect or injury;
• and
• second introduction and deployment means for introducing said second graft prosthesis in the collapsed state to locate the distal end opening adjacent the trunk blood vessel wall beyond the area of the aneurysm, defect or injury and the proximal end opening within said attachment seat formed by said waist opening stent and for deploying the second graft prosthesis so that the tubular member expands until the expanded distal end bears against and is restrained by the trunk blood vessel wall beyond the area of the aneurysm, defect or injury and the proximal end bears against and is restrained by said attachment seat to seal the first and second graft lumens with the blood vessel lumens and from the aneurysm, defect or injury.