Device and method for staged implantation of a graft for vascular repair

Abstract

A graft for repairing defects in arteries is formed from a flexible graft and at least one attachment system. A device and method is disclosed for implanting a graft within the vasculature of a patient, in which the graft is inserted into the patient at a different stage than the attachment systems, and which allows for direct percutaneous insertion of the graft and attachment systems. The method permits control over the position of the graft in the vasculature during the course of deployment of the graft and attachment systems by providing for traction forces to be applied to opposing ends of the graft.

1 . A method for the percutaneous insertion of a graft supported by at least one attachment system within the vascular system of a patient, the graft capable of assuming a compressed condition and an uncompressed condition, and the at least one attachment system being compressible radially between a compressed and an expanded condition, the method comprising: 
 percutaneously inserting the graft into the vascular system;    positioning the graft adjacent a diseased portion of the vascular system;    subsequently inserting at least one attachment system into the graft; and    implanting the attachment system in the graft to form a seal between the graft and the vascular wall.    
     
     
         2 . The method of  claim 1 , wherein the feeding step includes: 
 feeding the graft into the vascular system by direct percutaneous insertion; and    thereafter, feeding the at least one attachment system into the vascular system by direct percutaneous insertion.    
     
     
         3 . The method of  claim 2 , wherein the graft feeding step includes: 
 inserting the graft in compressed condition by direct percutaneous insertion into a point of access to the vascular system over a prepositioned guidewire;    applying a traction force to opposing ends of the graft to control the position of the graft within the vasculature; and    activating the graft from its compressed condition to its uncompressed condition.    
     
     
         4 . The method of  claim 2 , wherein the attachment system feeding step includes: 
 applying a traction force to opposing ends of the graft to control the position of the graft within the vasculature;    inserting the at least one attachment system in compressed condition by direct percutaneous insertion into a point of access to the vascular system over a prepositioned guidewire;    positioning the at least one attachment system within the bore of the graft;    activating the at least one attachment system from its compressed condition to its expanded condition.    
     
     
         5 . The method of  claim 4 , wherein the traction force applying step is carried out using a plurality of catheters, each catheter configured to exert a force on the graft from a different point outside the vasculature.  
     
     
         6 . The method of  claim 5 , wherein the graft is configured to have a substantially cylindrical profile having an superior end and a inferior end, and wherein a first catheter having a first end and a second end is releasably connected by the first end to the superior end of the graft and configured so that the second end thereof extends through a point of access to the vasculature located in the left axillary artery, and wherein a second catheter having a first end and a second end is releasably connected by the first end to the inferior end of the graft and configured so that the second end thereof extends through a point of access to the vasculature located in an iliac artery.  
     
     
         7 . The method of  claim 5 , wherein the graft is configured to have a bifurcated profile having an superior trunk with an superior end and first and second inferior legs each with an inferior end, and wherein a first catheter having a first end and a second end is releasably connected by the first end to the superior end of the graft and configured so that the second end thereof extends through a point of access to the vasculature in the left axillary artery, a second catheter having a first end and a second end is releasably connected by the first end to the inferior end pf the first leg and configured so that the second end thereof extends through a point of access to the vasculature in a first iliac artery, and a third catheter having a first and second end is releasably connected by the first end to the second leg's inferior end and configured so that the second end thereof extends through a point of access to the vasculature in a second iliac artery.  
     
     
         8 . A system for delivering a graft within the vasculature of a patient, comprising: 
 a graft capable of assuming a compressed condition and an uncompressed condition, wherein the graft does not include an expandable frame attached thereto; and    a plurality of catheters having first ends and second ends, each the first end being releasably connected to the graft, and each the second end configured to extend through a separate point of access to the vasculature.    
     
     
         9 . The system of  claim 8 , wherein the graft is configured to have a substantially cylindrical profile having an superior end and a inferior end, and wherein the plurality of catheters comprises: 
 a first catheter having a first end and a second end releasably connected by the first end to the graft's superior end and configured for the second end thereof to extend through a point of access to the vasculature located in the left axillary artery; and    a second catheter having a first end and a second end releasably connected by the first end to the graft's inferior end and configured for the second end thereof to extend through a point of access to the vasculature located in an iliac artery.    
     
     
         10 . The system of  claim 8 , wherein the graft is configured to have a bifurcated profile having an superior trunk with an superior end and first and second inferior legs each with an inferior end, and wherein the plurality of catheters comprises: 
 a first catheter having a first end and a second end, wherein the first catheter is releasably connected by the first end to the graft's superior end and is configured for the second end thereof to extend through a point of access to the vasculature in the left axillary artery;    a second catheter having a first end and a second end, wherein the second catheter is releasably connected by the first end to the first leg's inferior end and is configured for the second end thereof to extend through a point of access to the vasculature in a first iliac artery; and    a third catheter having a first and second end, wherein the third catheter is releasably connected by the first end to the second leg's inferior end and is configured for the second end thereof to extend through a point of access to the vasculature in a second iliac artery.