Anastomosis device and method

Abstract

A method for sealingly joining a graft vessel to a target vessel at an anastomosis site, the target vessel having an opening formed therein. The method includes positioning a fastener made from a deformable material radially adjacent to a free end portion of the graft vessel. The material is transformable between a non-fluent state and a fluent state, upon application of energy to the material. The method further includes inserting at least the free end portion of the graft vessel in the target vessel through the opening in the target vessel. Energy is then supplied to the deformable material at an intensity sufficient to transform the material into the fluent state. The free end portion of the graft is radially expanded to expand the graft vessel into intimate contact with an inner wall of the target vessel. The energy supply is discontinued so that the material returns to its non-fluent state to sealingly secure the graft vessel to the target vessel.

What is claimed is:  
     
         1 . A method for sealingly joining a graft vessel to a target vessel at an anastomosis site, the target vessel having an opening formed therein, comprising the steps of: 
 positioning a fastener made from a deformable material radially adjacent a free end portion of said graft vessel, said material being transformable between a non-fluent state and a fluent state, upon application of energy to the material;    inserting at least said free end portion of said graft vessel in said target vessel through the opening in the target vessel;    supplying energy to the deformable material at an intensity sufficient to transform the material into said fluent state;    radially expanding at least said free end portion of said graft vessel to expand the graft vessel into intimate contact with an inner wall of said target vessel; and    discontinuing the energy supply so that the material returns to its non-fluent state to sealingly secure the graft vessel to the target vessel.    
     
     
         2 . The method of  claim 1  wherein said energy is selected from a group consisting of radiant energy, convection heating, conduction heating, light energy, radiofrequency energy, microwave energy, and ultrasonic energy.  
     
     
         3 . The method of  claim 1  wherein said deformable material is selected from a group consisting of polymerics, polymers, and copolymers.  
     
     
         4 . The method of  claim 3  wherein said deformable material is selected from a group consisting of polyglycotic/polylactic acid (PGLA) polymer, polyhydroxybutylate valerate (PHBV) polymer, polycaprolactone (PCL) polymer, polycaprolactone homopolymer, and polycaprolactone copolymers.  
     
     
         5 . The method of  claim 1  wherein said material is bioerodable.  
     
     
         6 . The method of  claim 1  further comprising the step of everting at least a first portion of said free end portion of the graft vessel over a portion of said fastener prior to said step of inserting the graft vessel in the target vessel.  
     
     
         7 . The method of  claim 6  wherein the step of everting comprises attaching the first portion of said free end portion of the graft vessel to the fastener.  
     
     
         8 . The method of  claim 7  wherein the step of attaching the graft vessel to the fastener comprises suturing the graft vessel to the fastener.  
     
     
         9 . The method of  claim 7  wherein the step of attaching the graft vessel to the fastener comprises applying an adhesive material to an external surface of said first portion of said free end portion of the graft vessel.  
     
     
         10 . The method of  claim 7  wherein said deformable material has an adhesive surface and the step of attaching the graft vessel to the fastener comprises adhering the first portion of the free end portion of the graft vessel to the fastener.  
     
     
         11 . The method of  claim 1  wherein said supplying energy step comprises positioning a distal end portion of a light-diffusing balloon catheter in said graft vessel.  
     
     
         12 . The method of  claim 1  wherein said supplying energy step comprises positioning a distal end portion of a thermal balloon catheter in said graft vessel.  
     
     
         13 . The method of  claim 11  wherein said supplying energy step further comprises irradiating said deformable material with light energy from an energy source which is coupled to a light-diffusing end member of said catheter via at least one optical fiber.  
     
     
         14 . The method of  claim 13  wherein said radially expanding step comprises inflating a balloon of said balloon catheter.  
     
     
         15 . The method of  claim 1  wherein said supplying energy step comprises positioning a distal end portion of a light-diffusing catheter in said graft vessel.  
     
     
         16 . The method of  claim 15  wherein said supplying energy step further comprises irradiating said deformable material with light energy from an energy source which is coupled to a light-diffusing end member of said catheter via at least one optical fiber.  
     
     
         17 . The method of  claim 1  wherein said radially expanding step comprises inflating a balloon of a balloon catheter.  
     
     
         18 . The method of  claim 1  wherein said supplying energy step comprises exposing said material to energy having a wavelength of between 100 nm and 15,000 nm.  
     
     
         19 . The method of  claim 1  wherein said supplying energy step comprises exposing said material to energy having a wavelength of between 300 nm and 1100 nm.  
     
     
         20 . The method of  claim 1  wherein said fastener positioning step comprises positioning a tubular sleeve of said deformable material over an external surface of said free end portion of said graft vessel.  
     
     
         21 . The method of  claim 1  wherein said fastener positioning step comprises rolling a thin sheet of said deformable material over an external surface of said free end portion of said graft vessel.  
     
     
         22 . The method of  claim 1  wherein said fastener positioning step comprises longitudinally inserting a tubular sleeve of said deformable material within an opening in said free end portion of said graft vessel.  
     
     
         23 . The method of  claim 1  wherein said radially expanding step is performed prior to said energy supplying step.  
     
     
         24 . The method of  claim 1  wherein the material is impregnated with one or more agents selected from the group consisting of anti-platelet, anti-thrombus, and anti-inflammatory compound.  
     
     
         25 . The method of  claim 1  wherein the material utilized is impregnated with one or more anti-proliferative compounds.  
     
     
         26 . A method for sealingly joining a graft vessel to a target vessel at an anastomosis site, the target vessel having an opening formed therein, comprising the steps of: 
 applying a coating of a curable material to a free end portion of said graft vessel, said material being transformable between a fluent state and a non-fluent state upon application of energy to the material;    inserting at least said free end portion of said graft vessel in said target vessel through the opening in the target vessel;    radially expanding at least said free end portion of said graft vessel to expand the graft vessel into intimate contact with an inner wall of said target vessel; and    supplying energy to the material at an intensity sufficient to transform the material into its non-fluent state to sealingly secure the graft vessel to the target vessel.    
     
     
         27 . The method of  claim 26  wherein said material is bioerodable.  
     
     
         28 . The method of  claim 26  wherein said material is selected from a group consisting of polyethylene-glycol (PEG) based hydrogel, acrylate, and acrylated urethane.  
     
     
         29 . The method of  claim 26  wherein said coating comprises a liquid.  
     
     
         30 . The method of  claim 26  wherein said coating comprises a viscous gel.  
     
     
         31 . The method of  claim 26  wherein the material is impregnated with one or more agents selected from a group consisting of anti-platelet, anti-thrombus, and anti-inflammatory compounds.  
     
     
         32 . The method of  claim 26  wherein the material utilized is impregnated with one or more anti-proliferative compounds.  
     
     
         33 . The method of  claim 26  further comprising the step of everting at least a first portion of said free end portion of the graft vessel over a portion of said coating.  
     
     
         34 . The method of  claim 33  further comprising the step of coupling said first portion of said free end portion to said coating.  
     
     
         35 . The method of  claim 34  wherein said coupling step includes suturing said first portion to said graft vessel.  
     
     
         36 . The method of  claim 34  wherein said curable material has an adhesive surface and wherein said coupling step comprises adhering said first portion to said coating.  
     
     
         37 . The method of  claim 26  wherein said supplying energy step comprises positioning a distal end portion of a light-diffusing balloon catheter in said graft vessel.  
     
     
         38 . The method of  claim 37  wherein said supplying energy step further comprises irradiating said material with light energy from an energy source which is coupled to a light-diffusing end member of said catheter via at least one optical fiber.  
     
     
         39 . The method of  claim 37  wherein said radially expanding step comprises inflating a balloon of said balloon catheter.  
     
     
         40 . The method of  claim 26  wherein said supplying energy step includes the step of positioning a distal end portion of a light-diffusing catheter in said graft vessel.  
     
     
         41 . The method of  claim 40  wherein said supplying energy step further comprises irradiating said material with light energy from an energy source which is coupled to a light-diffusing end member of said catheter via at least one optical fiber.  
     
     
         42 . The method of  claim 26  wherein said radially expanding step comprises inflating a balloon of a balloon catheter.  
     
     
         43 . The method of  claim 26  wherein said supplying energy step comprises exposing said curable material to ultraviolet radiation from an ultraviolet radiation energy source.  
     
     
         44 . The method of  claim 26  wherein said supplying energy step comprises exposing said curable material to visible light from a visible light energy source.  
     
     
         45 . The method of  claim 26  wherein said supplying energy step comprises exposing said curable material to infrared radiation from an infrared radiation energy source.  
     
     
         46 . An anastomosis device for use in coupling an end of a first vessel to a side of a second vessel in an anastomosis, the device comprising a tubular member formed of a deformable material, and a graft vessel connected to the tubular member, the tubular member being transformable upon application of energy to the tubular member between a non-fluent state and a fluent state in which the tubular member is radially expandable to sealingly engage th e graft vessel with the target vessel.  
     
     
         47 . The anastomosis device of  claim 46  wherein the tubular member is pre-shaped and has at least a first bend along a length of the member.  
     
     
         48 . The anastomosis device of  claim 47  wherein the portion of the tubular member extends at an angle of between 30° and 90° relative to the longitudinal centerline.  
     
     
         49 . The anastomosis device of  claim 46  wherein said tubular member is formed from a biocompatible material.  
     
     
         50 . The anastomosis device of  claim 49  wherein said biocompatible material is bioerodable.  
     
     
         51 . The anastomosis device of  claim 46  wherein said biocompatible material comprises a polymeric material.  
     
     
         52 . The anastomosis device of  claim 51  wherein said polymeric material is selected from a group consisting of a polymer, a homopolymer, and a copolymer.  
     
     
         53 . The anastomosis device of  claim 52 , wherein the polymeric material is a polycaprolactone.  
     
     
         54 . The anastomosis device of  claim 46  wherein an end portion of the graft vessel is everted over an end margin of the tubular member.  
     
     
         55 . The anastomosis device of  claim 54  wherein the tubular member has an adhesive surface and the end portion of the graft vessel is adhered to the tubular member.  
     
     
         56 . The anastomosis device of  claim 49  wherein the tubular member includes a chromophore.  
     
     
         57 . The anastomosis device of  claim 56  wherein said chromophore is a dye.  
     
     
         58 . The anastomosis device of  claim 46  wherein said tubular member is impregnated with one or more agents selected from the group consisting of anti-platelet, anti-thrombus, and anti-inflammatory compounds.  
     
     
         59 . The anastomosis device of  claim 46  wherein the tubular member is impregnated with one or more anti-proliferative compounds.  
     
     
         60 . A fastener for sealingly joining a graft vessel to a target vessel in an anastomosis, the target vessel having an opening formed in a side wall thereof, the fastener comprising a tubular member formed of a deformable material and sized and dimensioned for receiving an end portion of said graft vessel, said tubular member being transformable upon application of energy to the tubular member between a non-fluent state in which said tubular member has an outer diameter smaller than the opening in the target vessel, and a fluent state in which said tubular member is radially expandable to permit said graft vessel to be forced into sealing engagement with an inner wall of the target vessel.  
     
     
         61 . An anastomosis device for coupling a graft vessel to a target vessel, the device comprising a graft vessel having a material disposed on an end margin of a free end thereof, the material being transformable upon the application of energy to the material between a fluent state in which the material is radially expandable to permit radial expansion of the graft vessel, and a non-fluent state in which the material retains the end margin of the graft vessel in its expanded state in sealing engagement with the target vessel.  
     
     
         62 . The fastener of  claim 61  wherein said material is bioerodable.  
     
     
         63 . The fastener of  claim 61  wherein said material is selected from a group consisting of polyethylene-glycol (PEG) based hydrogels, acrylates, and acrylated urethanes.  
     
     
         64 . The fastener of  claim 61  wherein the material is impregnated with an agent selected from the group consisting of anti-platelet, anti-thrombus, and anti-inflammatory compounds.  
     
     
         65 . The fastener of  claim 61  wherein the material is impregnated with one or more anti-proliferative compounds.  
     
     
         66 . The fastener of  claim 61  wherein said material is applied to an outer wall of the graft vessel.  
     
     
         67 . The fastener of  claim 61  wherein said material is applied to an inner wall of the graft vessel.