Applicator, assembly, and method for connecting an inlet conduit to a hollow organ

Abstract

The invention provides an applicator for forming a hole in a wall of a hollow organ and for connecting a hemostatic connection assembly to the hollow organ, wherein, when the hole is formed in the wall of the hollow organ, a first fluid seal exists between the hemostatic connection assembly and the wall of the hollow organ and a second fluid seal exists between the hemostatic connection assembly and the applicator, thereby minimizing fluid loss from the hollow organ. The invention further provides a hemostatic connection assembly for connecting an inlet conduit to a hollow organ, the hemostatic connection assembly comprising a organ wall connection portion, a cuff portion, an extension portion, and a seal ring portion, wherein, during the process of connecting the inlet conduit to the hollow organ, a first fluid seal exists between the organ wall connection portion and the wall of the hollow organ, and a second fluid seal exists between the hemostatic connection assembly and the inlet conduit, thereby minimizing fluid loss from the hollow organ. A method is also disclosed in which the applicator and hemostatic connection assemblies of the invention are used to connect an inlet conduit to a hollow organ.

1 . An applicator for forming a hole in a wall of a hollow organ and for connecting a hemostatic connection assembly to the hollow organ, the applicator comprising:
 a hole forming element adapted to form a hole in the wall of the organ, the hole forming element including a cutting element on a distal end thereof;   a retractor element disposed at least partially within the hole forming element, the retractor element comprising a tip at a distal end thereof adapted to penetrate the wall of the hollow organ, and an expansion element positioned near the distal end, the expansion element having a plurality of expansion states;   a sequencing means for coordinating expansion of the expansion element between the expansion states based on the position of the retractor element relative to the hole forming element; and   a mounting element coupled to the hole forming element, the mounting element being configured to support the hemostatic connection assembly,   wherein, when the hole is formed in the wall of the hollow organ, the hemostatic connection assembly is positioned on the mounting element and connected to the hollow organ such that a first fluid seal exists between the hemostatic connection assembly and the wall of the hollow organ and a second fluid seal exists between the hemostatic connection assembly and the applicator, thereby minimizing fluid loss from the hollow organ.   
     
     
         2 . The applicator of  claim 1 , wherein the cutting element is a cutting blade. 
     
     
         3 . The applicator of  claim 1 , wherein the hollow organ is a beating heart. 
     
     
         4 . The applicator of  claim 1 , wherein the plurality of expansion states include an unexpanded state, a fully expanded state, and at least one partially expanded state. 
     
     
         5 . The applicator of  claim 1 , wherein the expansion element is a balloon. 
     
     
         6 . The applicator of  claim 5 , wherein the balloon, when substantially fully expanded, is in the shape of a circular toroid. 
     
     
         7 . The applicator of  claim 1 , wherein the hemostatic connection assembly includes an organ wall connection portion, a cuff portion, and an extension portion. 
     
     
         8 . The applicator of  claim 7 , wherein the mounting element comprises a cuff support portion configured to support the cuff portion of the hemostatic connection assembly, and an extension support portion configured to support the extension portion of the hemostatic connection assembly 
     
     
         9 . The applicator of  claim 8 , wherein the cuff support portion has an outer diameter that is substantially equal to an inner diameter of the cuff portion. 
     
     
         10 . The applicator of  claim 1 , further comprising an occluding means for preventing excessive fluid loss through the applicator such that the hollow organ remains at substantially normal physiological pressures while the hole is being formed in the hollow organ. 
     
     
         11 . The applicator of  claim 10 , wherein the occluding means comprises an outer diameter of at least a portion of the retractor element and an inner diameter of at least a portion of the hole forming element. 
     
     
         12 . The applicator of  claim 1 , wherein the sequencing means comprises a means for expanding the expansion element between the plurality of expansion states. 
     
     
         13 . The applicator of  claim 12 , wherein the means for expanding comprises a syringe in fluid communication with the expansion element 
     
     
         14 . The applicator of  claim 12 , wherein the means for expanding comprises a cylinder having a piston slideable therein and coupled to the expansion element. 
     
     
         15 . The applicator of  claim 1 , wherein the sequencing means comprises means for moving the retractor element relative to the hole forming element whereby the expansion element is moved from a position distally outside of the hole forming element to a position at least partially disposed within the hole forming element. 
     
     
         16 . The applicator of  claim 12 , wherein the retractor element comprises a cylinder portion and a retractor mounting portion extending from a distal end of the cylinder portion, the expansion element being disposed on the retractor mounting portion, and wherein the sequencing means comprises a sequencing bolt coupled to the means for expanding. 
     
     
         17 . The applicator of  claim 1 , wherein the mounting element further comprises a stop portion adapted to restrict the travel distance of the retractor element into the hollow organ. 
     
     
         18 . The applicator of  claim 1 , wherein the sequencing means comprises means for causing the elements to assume the following states in seriatim;
 a) a first state where the retractor element is locked in a fully extended position relative to the hole forming element with the expansion element in the unexpanded state;   b) a second state in which the expansion element is in the fully expanded state and the expansion element moves toward the hole forming element;   c) a third state in which the hole has been formed; and   d) a fourth state in which the expansion element is in the partially expanded state and the expansion element is moved to be at least partially disposed in the hole forming element.   
     
     
         19 . A hemostatic connection assembly for connecting an inlet conduit to a hollow organ, the hemostatic connection assembly comprising:
 a organ wall connection portion adapted to connect to a wall of a hollow organ;   a cuff portion connected to the wall connection portion, the cuff portion being adapted to support the inlet conduit during insertion of the inlet conduit through the wall of the hollow organ;   an extension portion connected to the cuff portion, the extension portion being extendible from a compressed state to an extended state; and   a seal ring portion connected to the extension portion, the seal ring portion being adapted to connect to a portion of the inlet conduit,   wherein, during the process of connecting the inlet conduit to the hollow organ, a first fluid seal exists between the organ wall connection portion and the wall of the hollow organ, and a second fluid seal exists between the hemostatic connection assembly and the inlet conduit, thereby minimizing fluid loss from the hollow organ.   
     
     
         20 .- 32 . (canceled) 
     
     
         33 . A method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly, the method comprising:
 positioning the hemostatic connection assembly on the applicator for forming a hole in a wall of a hollow organ such that a fluid seal is formed between the hemostatic connection assembly and the applicator;   connecting the hemostatic connection assembly to a wall of the hollow organ such that a fluid seal is formed between the hemostatic connection assembly and the wall of the hollow organ;   forming a hole in the wall of the hollow organ using the applicator;   withdrawing the applicator from the hole formed in the wall of the hollow organ while maintaining the fluid seal between the hemostatic connection assembly and the applicator;   occluding the hemostatic connection assembly to form a fluid seal;   detaching the applicator from the hemostatic connection assembly while maintaining the fluid seal formed by the occlusion of the hemostatic connection assembly;   inserting an inlet conduit into the hemostatic connection assembly such that a fluid seal is formed between the hemostatic connection assembly and the inlet conduit;   removing the occlusion of the hemostatic connection assembly; and   inserting the inlet conduit into the hole formed in the wall of the hollow organ.   
     
     
         34 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , further comprising:
 forming a further fluid seal between the inlet conduit and the hemostatic connection assembly such that a predetermined portion of the hemostatic connection assembly can be removed without excessive fluid loss; and   removing the predetermined portion of the hemostatic connection assembly.   
     
     
         35 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the hemostatic connection assembly comprises:
 an organ wall connection portion adapted to connect to the wall of the hollow organ;   a cuff portion connected to the wall connection portion, the cuff portion being adapted to support the inlet conduit during insertion of the inlet conduit through the wall of the hollow organ;   an extension portion connected to the cuff portion, the extension portion being extendible from a compressed state to an extended state; and   a seal ring portion connected to the extension portion, the seal ring portion being adapted to connect to a portion of the inlet conduit,   wherein, during the process of connecting the inlet conduit to the hollow organ, a fluid seal exists between the organ wall connection portion and the wall of the hollow organ, and a fluid seal exists between the hemostatic connection assembly and the inlet conduit, thereby minimizing fluid loss from the hollow organ.   
     
     
         36 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the inlet conduit is an inlet cannula. 
     
     
         37 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the applicator comprises:
 a hole forming element adapted to form the hole in the wall of the organ, the hole forming element including a cutting element on a distal end thereof;   a retractor element disposed at least partially within the hole forming element, the retractor element comprising a tip at a distal end thereof adapted to penetrate the wall of the hollow organ, and an expansion element positioned near the distal end, the expansion element having a plurality of expansion states;   a sequencing means for coordinating expansion of the expansion element between the expansion states based on the position of the retractor element relative to the hole forming element; and   a mounting element coupled to the hole forming element, the mounting element being configured to support the hemostatic connection assembly,   wherein, when the hole is formed in the wall of the hollow organ, a fluid seal exists between the hemostatic connection assembly and the wall of the hollow organ, and a fluid seal exists between the hemostatic connection assembly and the applicator, thereby minimizing fluid loss from the hollow organ.   
     
     
         38 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 37 , wherein the fluid seal between the hemostatic connection assembly and the applicator is formed by the positioning of the hemostatic connection assembly relative to the mounting element. 
     
     
         39 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the fluid seal between the hemostatic connection assembly and the wall of the hollow organ is formed by sutures connecting the hemostatic connection assembly to the wall of the hollow organ. 
     
     
         40 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the hollow organ is a beating heart. 
     
     
         41 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the occlusion of the hemostatic connection assembly is caused by a compression of the hemostatic connection assembly. 
     
     
         42 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 41 , wherein the compression of the hemostatic connection assembly is caused by clamping the hemostatic connection assembly. 
     
     
         43 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the fluid seal between the hemostatic connection assembly and the inlet conduit is formed by positioning a seal ring portion of the hemostatic connection assembly around the inlet conduit. 
     
     
         44 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the fluid seal between the hemostatic connection assembly and the inlet conduit is formed using sutures or umbilical tape. 
     
     
         45 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the inlet conduit is substantially rigid. 
     
     
         46 . The method of connecting an inlet conduit to a hollow organ using a hemostatic connection assembly of  claim 33 , wherein the inlet conduit is flexible.