Method and system for attaching a graft to a blood vessel

Abstract

Anastomotic stents for connecting a graft vessel to a target vessel, and methods of use thereof. The anastomotic stents of the invention are suitable for use in a variety of anastomosis procedures, including coronary artery bypass grafting. One embodiment of the invention comprises a large vessel anastomotic stent for use with large diameter target vessels such as the aorta or its major side branches. Another embodiment of the invention comprises a small vessel anastomotic stent for use on a target vessel which has a small diameter such as a coronary artery. Another aspect of the invention involves applicators for use with the stents of the invention.

What is claimed is:  
     
         1 . An anastomotic stent for connecting one end of a graft vessel to a target vessel, comprising 
 a) a substantially cylindrical body having a longitudinal axis, an open proximal end, an open distal end, and a lumen extending therein configured to receive the graft vessel; and    b) at least one deformable section on the cylindrical body having a first configuration, and a radially expanded second configuration which forms a flange configured to apply an expanding force radial to the cylindrical body longitudinal axis against the wall of the target vessel.    
     
     
         2 . The stent of  claim 1  wherein the deformable section is on a distal section of the cylindrical body.  
     
     
         3 . The stent of  claim 2  wherein the deformable section is on a proximal section of the cylindrical body.  
     
     
         4 . The stent of  claim 2  further including a deformable section on the proximal end of the cylindrical body having a first configuration, and a radially expanded second configuration which forms a proximal end flange.  
     
     
         5 . The stent of  claim 1  wherein the deformable section comprises a plurality of helical members having proximal and distal ends, the helical members being circumferentially spaced around the cylindrical body, so that the cylindrical body longitudinally collapses and the helical members radially expand from the first to the second configuration by circumferential rotation of the proximal end of the cylindrical body relative to the distal end of the cylindrical body.  
     
     
         6 . The stent of  claim 1  wherein the stent is configured to secure one end of the graft vessel to a target vessel having a wall thickness of about 0.5 mm to about 5 mm.  
     
     
         7 . The stent of  claim 6  wherein the stent has a length substantially equal to the thickness of the target vessel wall when the deformable section is in the second configuration.  
     
     
         8 . The stent of  claim 1  wherein the flange is from about 4 mm to about 10 mm in diameter.  
     
     
         9 . The stent of  claim 1  wherein the cylindrical body has a substantially uniform diameter when the deformable section is in said first configuration.  
     
     
         10 . An anastomotic stent for connecting one end of a graft vessel to a target vessel, comprising 
 a) a substantially cylindrical body having a longitudinal axis, an open proximal end, an open distal end, and a lumen extending therein configured to receive the graft vessel;    b) a deformable section located on the distal end of the cylindrical body, having a first configuration, and a radially expanded and longitudinally collapsed second configuration which forms a flange; and    c) a deformable section located on the proximal end of the cylindrical body, having a first configuration, and a radially expanded and longitudinally collapsed second configuration which forms a flange.    
     
     
         11 . The stent of  claim 10  wherein deformable sections comprises a plurality of helical members having proximal and distal ends.  
     
     
         12 . The stent of  claim 11  including at least one deflecting section on each helical member, and wherein the deflecting sections on the distal helical members deflect at lower torque than the deflecting sections on the proximal helical members, so that the distal flange forms before the proximal flange by circumferential rotation of the proximal end of the cylindrical body relative to the distal end of the cylindrical body.  
     
     
         13 . The stent of  claim 12  wherein the deflecting section comprises at least one notch in the helical member, and wherein the size of the notches on the distal helical members is greater than the size of the notches on the proximal helical members.  
     
     
         14 . The stent of  claim 13  wherein the notch is located substantially centrally along the length of the helical member between the proximal and distal ends of the helical member.  
     
     
         15 . The stent of  claim 13  wherein the notch is located distally or proximally of a central point along the length of the helical member, so that the flange has an angled configuration relative to the longitudinal axis of the stent.  
     
     
         16 . An anastomosis assembly for connecting a graft vessel to a target vessel comprising, 
 a) an elongated stent delivery member comprising an outer tubular member having proximal and distal ends and a lumen therein, and an inner tubular member having proximal and distal ends and a lumen therein, rotatably disposed within the outer tubular member lumen; and    b) an anastomotic stent on a distal extremity of the elongated stent delivery member, comprising a substantially cylindrical body having an open proximal end, and open distal end, a lumen extending therein configured to receive the graft vessel, and at least one deformable section having a first configuration for introduction into the target vessel and a second configuration which forms a flange.    
     
     
         17 . The assembly of  claim 16  including an elongated vessel penetrating member which is configured to extend through the lumens of the inner tubular member, cylindrical body disposed thereon, and graft vessel disposed therein, and extend out the distal end of the cylindrical body, having a distal tip configured to penetrate through the wall of the target vessel, and an expandable distal member for positioning at least the distal end of the anastomotic stent within the target vessel.  
     
     
         18 . An implanted anastomotic stent for connecting one end of a graft vessel to a target vessel, comprising 
 a) a substantially cylindrical body having a longitudinal axis, an open proximal end, an open distal end, and a lumen extending therein configured to receive the graft vessel;    b) at least one deformable section on the cylindrical body having a flange applying an expanding force radial to the cylindrical body longitudinal axis against the wall of the target vessel; and    c) a graft vessel secured to the stent and extending within the lumen of the cylindrical body.    
     
     
         19 . A method of forming a vascular anastomosis between a graft vessel and a target vessel, comprising 
 a) connecting an end of the graft vessel to an anastomotic stent comprising 
 a substantially cylindrical body having a longitudinal axis, an open proximal end, an open distal end, and a lumen extending therein configured to receive the graft vessel; and  
 at least one deformable section on the cylindrical body having a first configuration, and a radially expanded second configuration which forms a flange;  
   b) introducing the stent into an incision in the target vessel; and    c) circumferentially rotating the distal end of the stent relative to the proximal end of the stent so that the stent body longitudinally collapses and the deformable section expands from the first to the second configuration to form the flange.    
     
     
         20 . The method of  claim 19  wherein the deformable section is on a distal section of the cylindrical body and the step of connecting the first end of the graft vessel to the stent comprises positioning the graft in the lumen of the stent and everting the end of the graft out the distal end of the stent and at least about at least the deformable section on the distal section of the stent body.  
     
     
         21 . The method of  claim 20  wherein the graft vessel is everted about a section of the stent proximal to the deformable section on the distal section of the stent body.  
     
     
         22 . The method of  claim 19  wherein the stent further includes a deformable section on a proximal section of the stent, and including, after the step of radially expanding the distal deformable section, the step of rotating the distal end of the stent relative to the proximal end of the stent, so that the stent body longitudinally collapses and the proximal deformable section expands from the first to the second configuration to form a proximal end flange.  
     
     
         23 . The method of  claim 22  wherein the distal end of the stent is rotated relative to the proximal end of the stent so that the proximal end flange is in contact with the target vessel.  
     
     
         24 . The method of  claim 19  wherein the step of circumferentially rotating the distal end of the stent relative to the proximal end of the stent comprises 
 a) positioning the stent on a distal extremity of an elongated stent delivery member comprising an outer tubular member having proximal and distal ends and a lumen therein, and an inner tubular member having proximal and distal ends and a lumen therein rotatably disposed within the outer tubular member lumen, so that the distal end of the stent is releasably connected to the inner tubular member and the proximal end of the stent is releasably connected to the outer tubular member; and  
 b) rotating the inner tubular member relative to the outer tubular member to thereby circumferentially rotate the distal end of the stent relative to the proximal end of the stent.  
 
     
     
         25 . The method of  claim 19  wherein the step of introducing the stent into the target vessel comprises 
 a) disposing within the lumen of the anastomotic stent and graft vessel disposed therein an elongated vessel penetrating member having a shaft, a distal tip, and at least one expandable member on a distal section;  
 b) advancing the distal tip through the wall of the target vessel and into the target vessel lumen, to form an incision therein; and  
 c) expanding the expandable member to increase the width of the incision in the target vessel.  
 
     
     
         26 . The method of  claim 25  wherein the elongated vessel penetrating member further includes a second expandable member, and including the step of expanding a second expandable member to draw the penetrating member and stent thereon into the incision in the target vessel.  
     
     
         27 . The method of  claim 25  including before step (a) the steps of 
 a) positioning the stent on a distal extremity of an elongated stent delivery member comprising an outer tubular member having proximal and distal ends and a lumen therein, and an inner tubular member having proximal and distal ends and a lumen therein rotatably disposed within the outer tubular member lumen, so that the distal end of the stent is releasably connected to the inner tubular member and the proximal end of the stent is releasably connected to the outer tubular member; and  
 b) positioning the elongated vessel penetrating member within the lumen of the elongated stent delivery member.  
 
     
     
         28 . The method of  claim 27  wherein the step of circumferentially rotating the distal end of the stent relative to the proximal end of the stent comprises rotating the elongated stent delivery member inner tubular member relative to the outer tubular member.  
     
     
         29 . An anastomosis assembly for connecting a graft vessel between a first target vessel and a second target vessel, comprising 
 a) a first anastomotic stent for securing a first end of the graft vessel to the first target vessel, comprising 
 i) a substantially cylindrical body having a longitudinal axis, an open proximal end, an open distal end, and a lumen extending therein configured to receive the graft vessel; and  
 ii) at least one deformable section on the cylindrical body having a first configuration, and a radially expanded second configuration which forms a flange configured to apply an expanding force radial to the cylindrical body longitudinal axis against the wall of the target vessel; and  
   b) a second anastomotic stent for securing a second end of the graft vessel to the second target vessel, comprising 
 i) an outer flange configured to be positioned adjacent an outer surface of the second target vessel, having a body defining an opening configured to receive the second end of the graft vessel; and  
 ii) an inner flange connectable to the outer flange, having a body defining an opening, and being configured to be positioned adjacent an inner surface of the second target vessel, to provide fluid communication between a lumen of the graft vessel and a lumen of the second target vessel.