Method and apparatus for effecting a minimally invasive distal anastomosis for an aortic valve bypass

Abstract

A connector for joining a first hollow structure to the side wall of a second hollow structure, the connector comprising: a first component comprising: an inner collar for disposition within the interior of the second hollow structure, the inner collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the inner collar being flexible; a hollow body connected to the inner collar and upstanding therefrom, the hollow body of the inner collar being aligned with the inner perimeter of the inner collar; and a graft element mounted to the inner collar and forming a conduit extending through the hollow body and the inner perimeter of the inner collar, the graft being formed out of a fluid-retaining material; and a second component for disposition outside the second hollow structure, the second component comprising an outer collar and a hollow body connected to the outer collar, the outer collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the hollow body of the outer collar being aligned with the inner perimeter of the outer collar; the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft element provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component.

1 . A connector for joining a first hollow structure to the side wall of a second hollow structure, the connector comprising:
 a first component comprising:
 an inner collar for disposition within the interior of the second hollow structure, the inner collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the inner collar being flexible; 
 a hollow body connected to the inner collar and upstanding therefrom, the hollow body of the inner collar being aligned with the inner perimeter of the inner collar; and 
 a graft element mounted to the inner collar and forming a conduit extending through the hollow body and the inner perimeter of the inner collar, the graft being formed out of a fluid-retaining material; and 
   a second component for disposition outside the second hollow structure, the second component comprising an outer collar and a hollow body connected to the outer collar, the outer collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the hollow body of the outer collar being aligned with the inner perimeter of the outer collar;   the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft element provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component.   
     
     
         2 . A connector according to  claim 1  wherein the hollow body of the second component is connected to the hollow body of the first component with a ratchet mechanism. 
     
     
         3 . A connector according to  claim 1  wherein the inner collar is ovoid. 
     
     
         4 . A connector according to  claim 1  wherein the outer collar is ovoid. 
     
     
         5 . A connector according to  claim 1  wherein the hollow body of the first component is ovoid. 
     
     
         6 . A connector according to  claim 1  wherein the hollow body of the second component is ovoid. 
     
     
         7 . A connector according to  claim 1  wherein the various elements of the first component are formed separate from one another, and further wherein the various elements of the first component are assembled during manufacture so as to form a single integral assembly. 
     
     
         8 . A connector according to  claim 1  wherein the inner collar comprises a superelastic material. 
     
     
         9 . A connector according to  claim 1  wherein the inner collar comprises a plurality of elements disposed substantially parallel to one another. 
     
     
         10 . A connector according to  claim 1  wherein the hollow body of the first component comprises a plurality of L-shaped support arms extending therefrom, and further wherein the inner collar is carried by the L-shaped support arms. 
     
     
         11 . A connector according to  claim 1  wherein the hollow body of the first component is molded about the inner collar. 
     
     
         12 . A connector according to  claim 1  wherein the inner collar is enveloped with graft material, and further wherein the graft element is secured to the graft material. 
     
     
         13 . A delivery instrument for delivering a connector for joining a first hollow structure to the side wall of a second hollow structure, the delivery instrument comprising:
 a hollow column;   at least one traction arm pivotally mounted to the hollow column so as to selectively radially project a toe of the traction arm;   a rod movably mounted to the hollow column and having a clamp at the distal end thereof, the rod being adapted to selectively engage the at least one traction arm so as to cause the at least one traction arm to radially project the toe of the at least one traction arm; and   at least one collar actuator slidably mounted to the hollow column.   
     
     
         14 . A delivery instrument according to  claim 13  wherein the rod is movably disposed within the hollow column. 
     
     
         15 . A delivery instrument according to  claim 13  wherein the at least one collar actuator is movably mounted to the exterior of the hollow column. 
     
     
         16 . A delivery instrument according to  claim 13  wherein longitudinal movement of the rod causes the rod to selectively engage the at least one traction arm. 
     
     
         17 . A delivery instrument according to  claim 13  further comprising a spring for yieldably biasing the toe of the at least one traction arm radially inwardly. 
     
     
         18 . A delivery instrument according to  claim 17  wherein there are two traction arms, the two traction arms are diametrically opposed to one another, and the spring comprises a garter spring for inwardly biasing the toes of the two traction arms. 
     
     
         19 . A delivery instrument according to  claim 13  wherein the hollow column is ovoid. 
     
     
         20 . A delivery instrument according to  claim 19  wherein the at least one collar actuator is ovoid. 
     
     
         21 . A delivery instrument according to  claim 13  wherein a plurality of collar actuators are provided. 
     
     
         22 . A delivery instrument according to  claim 21  wherein the plurality of collar actuators can be separately actuated. 
     
     
         23 . A system for joining a first hollow structure to the side wall of a second hollow structure, the system comprising:
 a connector comprising:
 a first component comprising:
 an inner collar for disposition within the interior of the second hollow structure, the inner collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the inner collar being flexible; 
 a hollow body connected to the inner collar and upstanding therefrom, the hollow body of the inner collar being aligned with the inner perimeter of the inner collar; and 
 a graft element mounted to the inner collar and forming a conduit extending through the hollow body and the inner perimeter of the inner collar, the graft being formed out of a fluid-retaining material; 
 
 a second component for disposition outside the second hollow structure, the second component comprising an outer collar and a hollow body connected to the outer collar, the outer collar having a toroidal configuration characterized by an outer perimeter and an inner perimeter, with the hollow body of the outer collar being aligned with the inner perimeter of the outer collar; 
 the hollow body of the second component being sized for coaxial disposition over the hollow body of the first component so that the outer collar of the second component can be adjustably positioned relative to the inner collar of the first component and so that the conduit of the graft element provides fluid communication between (i) the region beyond the inner collar, and (ii) the region beyond the hollow body of the first component; and 
   a delivery instrument for delivering the connector to the second hollow structure, the delivery instrument comprising:
 a hollow column; 
 at least one traction arm pivotally mounted to the distal end of the hollow column so as to selectively radially project a toe of the traction arm; 
 a rod movably mounted to the hollow column and having a clamp at the distal end thereof, the rod being adapted to selectively engage the at least one traction arm so as to cause the at least one traction arm to radially project the toe of the at least one traction arm; and 
 at least one collar actuator slidably mounted to the hollow column; 
   the connector being mounted to the delivery tool such that the hollow body of the first component is mounted coaxially on the hollow column of the delivery instrument, and the at least one collar actuator is aligned with the hollow body of the second component.   
     
     
         24 . A method for joining a first hollow structure to the side wall of a second hollow structure, the method comprising:
 providing a connector having (i) a first component comprising an inner collar and a hollow graft element mounted to the inner collar and extending therefrom, and (ii) a second component comprising an outer collar;   forming an opening in the side wall of the second hollow structure;   positioning the inner collar of the first component within the interior of the second hollow structure, with the graft element extending through the side wall of the second hollow structure; and   advancing the outer collar of the second component toward the inner collar of the first component so as to clamp the side wall of the second hollow structure therebetween.   
     
     
         25 . A method according to  claim 24  further comprising connecting the graft element to the first hollow structure. 
     
     
         26 . A method according to  claim 24  wherein the inner collar of the first component is flexible, and further wherein positioning the inner collar of the first component within the interior of the second hollow structure comprises folding the inner collar along an axis thereof prior to inserting the inner collar into the second hollow structure, and thereafter restoring the inner collar to its initial configuration after insertion of the inner collar into the second hollow structure. 
     
     
         27 . A method according to  claim 26  wherein the first component comprises a resilient structure, and further wherein folding the inner collar along an axis thereof includes restraining the inner collar in a folded configuration with a restraint, and wherein restoring the inner collar to its initial configuration includes releasing the restraint. 
     
     
         28 . A method according to  claim 26  wherein the inner collar comprises an ovoid structure, and further wherein said axis comprises the long axis of the ovoid structure. 
     
     
         29 . A method according to  claim 27  wherein the restraint comprises a clothespin clamp. 
     
     
         30 . A method according to  claim 29  wherein the clothespin clamp is disposed within the interior of the graft element. 
     
     
         31 . A method according to  claim 24  wherein the inner collar comprises a neck upstanding from the remainder of the inner collar. 
     
     
         32 . A method according to  claim 31  wherein the outer collar is configured to be passed over the neck. 
     
     
         33 . A method according to  claim 24  wherein the inner collar and the outer collar are adjustably connected to one another by a ratchet mechanism. 
     
     
         34 . A method according to  claim 24  wherein the inner collar comprises a shape memory alloy. 
     
     
         35 . A method according to  claim 24  wherein the inner collar conforms to the curvature of the inside wall of the second hollow body. 
     
     
         36 . A method according to  claim 24  wherein the outer collar conforms to the curvature of the outer wall of the second hollow body. 
     
     
         37 . A method according to  claim 24  wherein the inner collar is enveloped with graft material. 
     
     
         38 . A method according to  claim 24  wherein fluid flow through the second hollow structure is halted prior to forming an opening in the side wall of the second hollow structure. 
     
     
         39 . A method according to  claim 38  wherein fluid flow is halted by:
 delivering a first balloon within the lumen of the second hollow structure proximal to where the opening is to be formed in the side wall of the second hollow structure; 
 inflating the first balloon within the lumen of the second hollow structure; 
 delivering a second balloon within the lumen of the second hollow structure distal to where the opening is to be formed in the side wall of the second hollow structure; and 
 inflating the second balloon within the lumen of the second hollow structure.