Graft connector, an introducer therefor and a method of making a branch connection

Abstract

A graft connector comprises a sleeve ( 10 ) and a collar ( 11 ). The sleeve ( 19 has an opening ( 12 ) in its circumferential surface and comprises a memory material. The collar ( 11 ) consists of a fluid-tight material and is fixed to the sleeve ( 10 ) before use of the graft connector. The collar has a shoulder portion ( 13 ) extending at least around the opening ( 12 ) and a neck portion ( 14 ) integral with the shoulder portion ( 13 ) and projecting radially from the opening ( 12 ). An introducer for the graft connector comprises two L-shaped elements ( 18, 19 ), and first releasable means ( 20, 21, 28 - 30 ) for locking the two L-shaped elements ( 18, 19 ) together so as to form a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24, 25 ). Removable means ( 31; 42; 46 ) are provided for temporarily reducing the diameter of the sleeve ( 10 ) during insertion into a blood vessel ( 2 ) and also for connecting the arms ( 24, 25 ) of the T-shaped element ( 26 ) along the sleeve ( 10 ) of the graft connector. The sleeve ( 10 ) is introduced into the blood vessel ( 2 ) through the longitudinal incision made therein by manipulation of the stem ( 27 ) of the T-shaped element ( 26 ). Then the two L-shaped elements ( 18, 19 ) are released from each other and from the sleeve ( 10 ) and finally they are retracted from the blood vessel ( 2 ).

1 . A graft connector kit, comprising 
 a graft connector comprising 
 a sleeve ( 10 ), which has an opening ( 12 ) in its circumferential surface and comprises a memory material, and  
 a collar ( 11 ) which consists of a fluid-tight material and is fixed to the sleeve ( 10 ) before use of the graft connector and which has, on the one hand, a shoulder portion ( 13 ) extending at least around the opening ( 12 ) in the circumferential surface of the sleeve ( 10 ) and, on the other hand, a neck portion ( 14 ) integral with the shoulder portion ( 13 ) and projecting radially from the opening ( 12 ) in the circumferential surface of the sleeve ( 10 ), and  
 removable means ( 31 ;  42 ;  46 ) for temporarily reducing the diameter of the sleeve ( 10 ) during insertion into a blood vessel ( 2 ).  
   
     
     
         2 . A graft connector kit as claimed in  claim 1 , wherein the removable means ( 31 ;  42 ;  46 ) comprises a suture ( 31 ) encircling at least part of the sleeve ( 10 ) and thereby reducing the diameter of the sleeve ( 10 ).  
     
     
         3 . A graft connector kit as claimed in  claim 2 , further comprising edge means ( 20 ,  34 ,  35 ) for cutting the suture ( 31 ) once the sleeve ( 10 ) is introduced into the blood vessel ( 2 ), whereby the memory material is allowed to expand the sleeve ( 10 ).  
     
     
         4 . A graft connector kit as claimed in  claim 3 , wherein the edge means ( 20 ,  34 ,  35 ) comprises a needle ( 20 ) having an edged hole ( 34 ,  35 ) at a tip thereof, through which hole the suture ( 31 ) is extending.  
     
     
         5 . A graft connector kit as claimed in  claim 4 , further comprising two L-shaped elements ( 18 ,  19 ); 
 first releasable means ( 20 ,  21 ,  28 - 30 ) for locking the two L-shaped elements ( 18 ,  19 ) together so as to form a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24 ,  25 ); and    second releasable means ( 31 ;  42 ;  46 ) for connecting the arms ( 24 ,  25 ) of the T-shaped element ( 26 ) along the sleeve ( 10 ) of the graft connector,    whereby the sleeve ( 10 ) may be introduced into the blood vessel ( 2 ) through the longitudinal incision made therein by manipulation of the stem ( 27 ) of the T-shaped element ( 26 ) and the two L-shaped elements ( 18 ,  19 ) may be released from each other and from the sleeve ( 10 ) and then retracted from the blood vessel ( 2 ).    
     
     
         6 . A graft connector kit as claimed in  claim 5 , wherein the suture ( 31 ) encircles at least part of the sleeve ( 10 ) and the arms ( 24 ,  25 ) of the T-shaped element ( 26 ).  
     
     
         7 . A graft connector kit as claimed in  claim 5 , wherein the T-shaped element ( 26 ) has a longitudinal channel ( 29 ) in which the needle ( 20 ) is positioned.  
     
     
         8 . A graft connector kit as claimed in  claim 7 , wherein the needle ( 20 ) is retractable from the longitudinal channel ( 29 ) of the T-shaped element ( 26 ) and has a cap ( 21 ) enclosing the free ends of the stem ( 27 ) in its non-retracted position.  
     
     
         9 . A graft connector kit as claimed in  claim 8 , wherein the needle ( 20 ) and the cap ( 21 ) is locking the two L-shaped elements ( 18 ,  19 ) to each other.  
     
     
         10 . A graft connector as claimed in  claim 9 , wherein the opening ( 12 ) in the circumferential portion of the sleeve ( 10 ) is unsymmetrically positioned relative to the ends of the sleeve ( 10 ).  
     
     
         11 . A graft connector kit as claimed in  claim 9 , wherein the sleeve ( 10 ) consists of a net-like material.  
     
     
         12 . A graft connector kit as claimed in  claim 1 , wherein the sleeve ( 10 ) consists of a stent material.  
     
     
         13 . A graft connector kit as claimed in  claim 1 , wherein the collar ( 11 ) consists of an elastic material.  
     
     
         14 . A graft connector kit as claimed in  claim 1 , wherein the shoulder portion ( 13 ) of the collar ( 11 ) is attached to the outside of the sleeve ( 10 ).  
     
     
         15 . A graft connector kit as claimed in  claim 14 , wherein the shoulder portion ( 13 ) fully encompasses at least part of the sleeve ( 10 ).  
     
     
         16 . In combination, a T-shaped graft connector comprising 
 a sleeve ( 10 ) that is to be introduced into a blood vessel ( 2 ) through a longitudinal incision made therein, the sleeve ( 10 ) having an opening ( 12 ) in its circumferential surface and a collar ( 11 ) adjoining the opening ( 12 ) and extending radially therefrom and, when the sleeve ( 10 ) is introduced into the blood vessel ( 2 ), extending out from the longitudinal incision made therein;    and an introducer comprising 
 two L-shaped elements ( 18 ,  19 ),  
 first releasable means for ( 20 ,  21 ,  28 - 30 ) locking the two L-shaped elements ( 18 ,  19 ) together so as to form a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24 ,  25 ), and  
 second releasable means ( 31 ;  42 ;  46 ) for connecting the arms ( 24 ,  25 ) of the T-shaped element ( 26 ) along the sleeve ( 10 ) of the graft connector,  
   whereby the sleeve ( 10 ) may be introduced into the blood vessel ( 2 ) through the longitudinal incision made therein by manipulation of the stem ( 27 ) of the T-shaped element ( 26 ) and the two L-shaped elements ( 18 ,  19 ) may be released from each other and from the sleeve ( 10 ) and then retracted from the blood vessel ( 2 ).    
     
     
         17 . A method of connecting a T-shaped graft 
 connector to a blood vessel ( 2 ),    said T-shaped graft connector comprising a sleeve ( 10 ) that is to be introduced into the blood vessel ( 2 ), the sleeve ( 10 ) having an opening ( 12 ) in its circumferential surface and a collar ( 11 ) adjoining the opening ( 12 ) and extending radially therefrom,    said method comprising the steps of 
 locking a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24 ,  25 ) to the sleeve ( 10 ), the sleeve ( 10 ) extending along the arms ( 24 ,  25 ) and the collar ( 11 ) extending substantially along the stem ( 27 ),  
 reducing the diameter of the sleeve ( 10 ),  
 making a longitudinal incision in the blood vessel ( 2 ),  
 inserting the sleeve ( 10 ) through the incision into the blood vessel ( 2 ) using the stem ( 27 ) as a holder, the collar ( 11 ) extending radially out of the incision in the blood vessel ( 2 ),  
 releasing the sleeve ( 10 ) from the T-shaped element ( 26 ) to allow the sleeve ( 10 ) to expand within the vessel ( 2 ), and  
 removing the T-shaped element ( 26 ) from the blood vessel ( 2 ).  
   
     
     
         18 . A method of making a branch connection to a blood vessel, using 
 a T-shaped graft connector ( 10 - 14 ) comprising a sleeve ( 10 ) that is to be introduced into the blood vessel ( 2 ), the sleeve ( 10 ) having an opening ( 12 ) in its circumferential surface and a collar ( 11 ) adjoining the opening ( 12 ) and extending radially therefrom, and    a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24 ,  25 ),    said method comprising the steps of 
 locking the T-shaped element ( 26 ) to the sleeve ( 10 ) such that the sleeve ( 10 ) extends along the arms ( 24 ,  25 ) and the collar ( 11 ) extends substantially along the stem ( 27 ),  
 reducing the diameter of the sleeve ( 10 ),  
 making a longitudinal incision in the blood vessel ( 2 ),  
 inserting the sleeve ( 10 ) through the incision into the blood vessel ( 2 ) using the stem ( 27 ) as a holder, the collar ( 11 ) extending radially out of the incision in the blood vessel ( 2 ),  
 releasing the sleeve ( 10 ) from the T-shaped element ( 26 ) to allow the sleeve ( 10 ) to expand within the vessel ( 2 ), and  
 removing the T-shaped element ( 26 ) from the blood vessel ( 2 ).  
   
     
     
         19 . A method of making a branch connection to a blood vessel, using 
 a T-shaped graft connector ( 10 - 14 ) comprising a sleeve ( 10 ) made from a memory material, which sleeve ( 10 ) is to be introduced into the blood vessel ( 2 ), the sleeve ( 10 ) having an opening ( 12 ) in its circumferential surface and a collar ( 11 ) adjoining the opening ( 12 ) and extending radially therefrom, and    a T-shaped element ( 26 ) having a stem ( 27 ) and two oppositely directed arms ( 24 ,  25 ), the diameter of the sleeve ( 10 ) being reduced by a releasable locking of the sleeve ( 10 ) along the arms ( 24 ,  25 ) of the T-shaped element ( 26 ), the collar ( 11 ) extending substantially along the stem ( 27 ) of the T-shaped element ( 26 ),    said method comprising the steps of 
 making a longitudinal incision in the blood vessel ( 2 ),  
 inserting the sleeve ( 10 ) and the arms ( 24 ,  25 ) of the T-shaped element ( 26 ) through the incision into the blood vessel ( 2 ) using the stem ( 27 ) as a holder, the collar ( 11 ) extending radially out of the incision in the blood vessel ( 2 ),  
 releasing the sleeve ( 10 ) from the T-shaped element ( 26 ) to allow the sleeve ( 10 ) to expand within the vessel ( 2 ), and  
 removing the T-shaped element ( 26 ) from the blood vessel ( 2 ).  
   
     
     
         20 . A method as claimed in any one of claims  17 - 19 , wherein the locking of the T-shaped element ( 26 ) to the sleeve ( 10 ) comprises at least partly encircling the sleeve ( 10 ) and the arms ( 24 ,  25 ) with a suture ( 31 ).  
     
     
         21 . A method as claimed in  claim 20 , wherein the sleeve ( 10 ) is released from the T-shaped element ( 26 ) by cutting the suture ( 31 ).  
     
     
         22 . A method as claimed in any one of claims  17 - 19 , wherein the locking of the T-shaped element ( 26 ) to the sleeve ( 10 ) comprises inserting each one of the arms ( 24 ,  25 ) and an adjoining part of the sleeve ( 10 ) into a tube ( 42 ) made of a plastic film and then shrinking the tube ( 42 ) thereby also reducing the diameter of the sleeve ( 10 ).  
     
     
         23 . A method as claimed in  22 , wherein the sleeve ( 10 ) is released from the T-shaped element ( 26 ) by a longitudinal cut through the tube ( 42 ).  
     
     
         24 . A method as claimed in any one of claims  17 - 19 , wherein the locking of the T-shaped element ( 26 ) to the sleeve ( 10 ) comprises making a tube of each one of the arms ( 24 ,  25 ) and a sheet ( 46 ) of a plastic film, said tube encircling an adjoining part of the sleeve ( 10 ), and reducing the diameter of the sleeve ( 10 ).  
     
     
         25 . A method as claimed in  claim 24 , wherein the diameter of the tube is reduced by shrinking of the plastic film ( 46 ) after the tube is made, whereby the diameter of the sleeve ( 10 ) is reduced.  
     
     
         26 . A method as claimed in  claim 25 , wherein the diameter of the sleeve ( 10 ) is reduced at the same time as the tube is made.