Clamp and Applicator

Abstract

The present invention provides a surgical clamp comprising a temperature sensitive shape memory material, the clamp capable of taking up a first form in which the clamp ( 6 ) is shaped to at least partially encircle a tubular structure ( 14 ); a second form shaped to substantially completely encircle the tubular structure ( 14 ) and constrict it, the clamp changing from the first form to the second form above the transition temperature of the shape memory material; and a third form derived from the first form by resilient deformation of the clamp in its first form. The present invention also provides applicators for delivering the clamps and kits comprising the clamps.

1 . A surgical clamp ( 6 ) for clamping a blood vessel comprising a temperature sensitive shape memory material, said clamp capable of assuming:
 a first form in which the clamp is shaped to at least partially encircle a blood vessel ( 14 ), the clamp being in the first form below the transition temperature of the shape memory material,   a second form shaped to substantially completely encircle the blood vessel ( 14 ) and to constrict it and thereby close the vessel, the clamp changing from the first form to the second form above the transition temperature of the shape memory material.   a third form which is linear and derived from the first form by resilient deformation.   
     
     
         2 . A surgical clamp ( 6 ) according to  claim 1  which is in the first form. 
     
     
         3 . A surgical clamp ( 6 ) according to  claim 1  which is in the third form. 
     
     
         4 . A surgical clamp ( 6 ) according to  claim 1  which is held in the third form as part of an assembly. 
     
     
         5 . A surgical clamp ( 6 ) according to  claim 4  wherein the clamp in the second form has a smaller internal diameter than the clamp in the first form. 
     
     
         6 . A surgical clamp according to claim in which the shape memory material is Nitinol. 
     
     
         7 . A surgical clamp according to  claim 1  in which the shape memory material is a shape memory polymer. 
     
     
         8 . A surgical clamp according to  claim 1  in which the transition temperature of the shape memory material is above 37° C. 
     
     
         9 . A surgical clamp according to clam  1  in which the transition temperature of the shape memory material is less than or equal to 37° C. 
     
     
         10 . A surgical clamp according to  claim 1  which comprises a means ( 72 ) or heating the shape memory material. 
     
     
         11 . A surgical clamp according to  claim 1  identified by a code according to its size or the size of the blood vessel for which it is suitable. 
     
     
         12 . An applicator for a surgical clamp ( 1 ) for clamping a blood vessel comprising a housing ( 2 ) with an inner chamber ( 5 ) a surgical clamp ( 6 ) within the inner chamber ( 5 ) and a means ( 9 ) for moving the surgical clamp ( 6 ) out of the inner chamber ( 5 ), the surgical clamp ( 6 ) comprising a temperature sensitive shape memory material and capable of assuming:
 a first form in which the clamp is shaped to at least partially encircle a blood vessel ( 14 );   a second form in which the clamp ( 6 ) is shaped to substantially completely encircle the blood vessel ( 14 ) and to constrict it and thereby close the vessel; and   a third form derived from the first form by resilient deformation of the clamp ( 6 ) in its first form and adoptable within the applicator chamber ( 5 ),   the clamp ( 6 ) induced to change from the first form to the second form on exposure to a temperature above the transition temperature of the shape memory material.   
     
     
         13 . An application ( 1 ) according to  claim 12  wherein the housing ( 2 ) is a tubular member ( 19 ) having a proximal end ( 3 ) and a distal end ( 4 ) and a lumen ( 5 ), the clamp ( 6 ) residing in the lumen ( 5 ) of the tubular member. 
     
     
         14 . An applicator according to  claim 12  wherein the means ( 9 ) for moving the clamp ( 6 ) out of chamber ( 5 ) releasably engages the clamp ( 6 ). 
     
     
         15 . An applicator according to  claim 12  comprising an indication ( 26 ) identifying the direction that the clamp ( 6 ) will curve upon being moved out of the chamber. 
     
     
         16 . An applicator according to  claim 12  in which the third form of the surgical clamp ( 6 ) is a linear form. 
     
     
         17 . An applicator according to  claim 12  comprising a means ( 100 ) for preventing the clamp ( 6 ) from being moved from the chamber ( 5 ). 
     
     
         18 . A method of clamping a blood vessel in the body of a subject comprising:
 (a) providing a surgical clamp ( 6 ) comprising a temperature sensitive shape memory material the clamp capable of assuming:
 a first form in which the clamp is shaped to at least partially encircle said blood vessel ( 14 ); 
 a second form shaped to substantially completely encircle said blood vessel ( 14 ) and constrict it and thereby close the vessel, the clamp ( 6 ) changing from the first form to the second form above the transition temperature of the shape memory material, 
 a third form derived from the first form by resilient deformation of the clamp in its first form, the clamp being provided in the third form, 
   (b) applying the clamp ( 6 ) to the blood vessel ( 14 ) whilst allowing the clamp to return to the first form; and   (c) raising the temperature of the shape memory material to a temperature at which it changes to the second form, thereby clamping said structure ( 14 ).   
     
     
         19 . A method according to  claim 18  wherein the clamp ( 6 ) is applied to the blood vessel as it leaves the applicator ( 1 ). 
     
     
         20 . A method according to  claim 18  wherein a fluid is provided to bathe the blood vessel. 
     
     
         21 . A method according to  claim 20  wherein the fluid is cooled to a temperature below 37° C. 
     
     
         22 . A method according to  claim 20  wherein the fluid is degassed. 
     
     
         23 . A method according to  claim 18  wherein the temperature of the shape memory material is raised to a temperature at which it changes to the second form by exposure to the subject's body. 
     
     
         24 . A method according to  claim 18  wherein the progress is to be followed by ultrasound. 
     
     
         25 .- 30 . (canceled)