Method for Aortic End-to-Side Anastomosis

Abstract

An assembly and method for end-to-side anastomosis to an anatomical conduit is disclosed. The system and method are particularly useful in coupling an LVAD pump to an aorta. The assembly and method include using a tubular graft member having a distal flange section that conforms to and engages an abluminal wall surface of the aorta, an affixation component having a tubular proximal section and a distal flange section that is configured to conform to and engage with a luminal wall surface of the aorta and has a plurality of receiver openings passing through the distal flange section, and a plurality of anchoring components configured to pass through the distal flange section of the graft component, through the wall of the aorta or other major vessel, an engage with the receiver openings of the distal flange section of the affixation component to exert an axially compressive force there between and create a hemostatic seal around an opening formed in the wall of the aorta or major vessel that allows blood or other fluid to pass into and through the assembly and into the aorta or other anatomical conduit.

1 . A method of forming an end-to-side anastomosis between a conduit and an anatomic passageway, comprising the steps of:
 a. Delivering an affixation component into the anatomic passageway such that a portion of the affixation component abuts a luminal wall surface of the anatomic passageway;   b. Placing a graft component having a tubular proximal section and a distal flange section against an abluminal wall surface of an anatomic passageway and approximating the graft component with respect to the affixation component; and   c. Securing the graft component to the affixation component through the abluminal wall of the anatomic passageway.   
     
     
         2 . The method of  claim 1 , wherein the distal flange section of the graft component is configured to conform to the abluminal wall surface of the anatomical passageway. 
     
     
         3 . The method of  claim 1 , wherein the distal flange section of the graft is configured to have a substantially saddle-shape conforming to the abluminal wall surface curvature of the anatomical passageway. 
     
     
         4 . The method of  claim 1 , wherein the affixation component further comprises a diametrically expandable proximal tubular section and a diametrically expandable distal flange section. 
     
     
         5 . The method of  claim 4 , wherein the diametrically expandable distal flange section further comprises a plurality of receiver openings arrayed about a circumference of the diametrically expandable distal flange section. 
     
     
         6 . The method of  claim 5 , wherein the step of securing the graft component to the affixation component further comprises the steps of placing tissue anchors through the distal flange portion of the graft component; passing the tissue anchors through the abluminal wall of the anatomic passageway; engaging the plurality of receiver openings in the diametrically distal flange section of the affixation component; and axially compressing the diametrically expandable distal flange and the distal flange portion of the graft component against the luminal and abluminal walls of the anatomic passageway, respectively. 
     
     
         7 . The method of  claim 1 , wherein the affixation component further comprises a diametrically expandable stent having an annular open region in a wall surface thereof and a plurality of receiver openings arrayed about the annular open region. 
     
     
         8 . The method of  claim 7 , further comprising the step of occluding the anatomical passageway proximal or upstream from the diametrically expandable stent prior to step of placing the graft component. 
     
     
         9 . The method of  claim 8 , further comprising the step of accessing a luminal region of the anatomical passageway through an opening in the abluminal wall of the anatomical passageway after the step of occluding the anatomical passageway. 
     
     
         10 . The method of  claim 9 , wherein the step of accessing a luminal region of the anatomic passageway occurs after the step of securing the graft component to the affixation component. 
     
     
         11 . The method of  claim 1 , further comprises the step of accessing a luminal region of the anatomical passageway through an opening in the abluminal wall of the anatomic passageway. 
     
     
         12 . The method of  claim 11 , further comprising the step of passing a delivery system for the affixation component through the opening in the abluminal wall of the anatomical passageway. 
     
     
         13 . The method of  claim 11 , wherein the step of accessing a luminal region of the anatomic passageway further comprises introducing a guidewire through the abluminal wall of the anatomic passageway; passing at least one dilator over the guidewire; and dilating an opening through the abluminal wall. 
     
     
         14 . The method of  claim 11 , further comprising the step of passing a delivery system for the affixation component through the dilated opening in the abluminal wall of the anatomic passageway. 
     
     
         15 . The method of  claim 1 , further comprising the step of introducing an axial compression plate over the tubular portion of the graft component and the step of securing the graft component to the affixation component further comprises the step of securing the axial compression plate to the distal flange portion of the graft component and the affixation component. 
     
     
         16 . A method of forming an end-to-side anastomosis with a blood vessel, comprising the steps of:
 a. Delivering to the blood vessel a diametrically expandable stent having an annular open region in a wall thereof and a plurality of receiver openings disposed about the annular open region such that the diametrically expandable stent abuts a luminal wall of the blood vessel, and the annular open region is positioned at the site of the end-to-side anastomosis;   b. Placing a graft having a tubular proximal section and a distal flange section against an abluminal wall surface of the blood vessel such that the distal flange section conforms to curvatures of the blood vessel, the distal flange section having a plurality of anchor indicia;   c. Aligning the anchor indicia of the graft with the receiver openings of the stent; and   d. Securing the graft to the stent through the blood vessel wall.   
     
     
         17 . The method of  claim 16 , further comprising the step of occluding the anatomical passageway proximal or upstream from the diametrically expandable stent prior to step of placing the graft. 
     
     
         18 . The method of  claim 17 , further comprising the step of accessing a blood vessel lumen an opening in the blood vessel wall after the step of occluding the anatomical passageway. 
     
     
         19 . The method of  claim 18 , wherein the step of accessing the blood vessel lumen occurs after the step of securing the graft component to the stent. 
     
     
         20 . The method of  claim 16 , wherein the step of securing the graft to the stent further comprises the step of inserting tissue anchors through the anchor indica, passing the tissue anchors through the blood vessel wall, engaging the tissue anchors with the receiver openings in the diametrically expandable stent, and axially compressing the graft, the blood vessel wall, and the stent to each other.