Staples, staplers, anastomosis devices, and methods for their applications

Abstract

A stapling element is provided, operative to pierce and penetrate a tissue by a first end, and close around the tissue. Three factors help prevent local necrosis: 1. The self-closing feature of the staple does not lead to tissue crushing. 2. Edge seams are applied generally perpendicular to the tissue edge, allowing for blood supply to the tissue edge. 3. Excess tissue is cut off at the seam, minimizing the amount of tissue that may undergo local necrosis. A physical feature prevents the staple from rotating, when in an application shaft, to maintain a predetermined closing direction. The stapling element may be formed of an alloy, a pure metal, a polymer, or a composite of at least two materials. Additionally, staplers, anastomosis devices, and methods for their applications are described.

What is claimed is: 
     
         1 . A system for applying staples to a tissue, comprising:
 at least one stapling element for piercing through a tissue and forming a closed loop through said tissue;   a cartridge including a rigid frame defining at least one elongated lumen for fully receiving the at least one stapling element within the lumen; and   a driving unit, in mechanical communication with said cartridge, operative to issue said at least one stapling element from said cartridge;   wherein the at least one stapling element forms:
 a first shape while maintained within the lumen of the cartridge, the first shape being an elongated shaped body with a tapered end; and 
 a second shape when issued from the cartridge; the second shape being a closed loop shape, wherein the stapling element self-deforms from the first shape to the second shape as it issues from the cartridge; and 
   wherein a cross section of the lumen does not match a cross-section of the stapling element.   
     
     
         2 . The system of  claim 1 , further comprises a mechanism configured for changing an orientation of said at least one staple element within said cartridge before issuing. 
     
     
         3 . The system of  claim 1 , adapted for piercing the tissue with minimal tissue crushing. 
     
     
         4 . The system of  claim 1 , wherein said second shape forms a closed loop, with said tapered end fitting into a cavity of formed in an opposite end. 
     
     
         5 . The system of  claim 1 , wherein said elongated body has a physical feature selected from the group consisting of a rim and a notch, located at least along a distal portion of said elongated body. 
     
     
         6 . The system of  claim 1 , wherein said tapered end has a triangular cross section, adapted for piercing hard tissue. 
     
     
         7 . The system of  claim 1 , wherein said tapered end includes a sharp, pointed edge, having a screw thread. 
     
     
         8 . The system of  claim 1 , wherein said second shape is further designed to close around its longitudinal axis, for piercing the tissue, by self-threading into it. 
     
     
         9 . A system according to  claim 1 , wherein said cartridge has an opening which forms an angle different than 90 degrees with said stapling element. 
     
     
         10 . A device for applying staples to a tissue, comprising:
 a cartridge, adapted for receiving at least one stapling element, said stapling element comprising:
 a first shape, while maintained within a lumen of the cartridge, comprising an elongated body, with a tapered end, said elongated body having a cross section which does not match a cross section of said cartridge, for preventing said stapling element from rotating, when in said cartridge, thus maintaining a predetermined closing direction; and 
 a second shape, assumed when said stapling element issues from said cartridge and is inserted into the tissue, said second shape being designed to close into a loop, for forming a staple in the tissue, 
 wherein said cartridge is adapted for maintaining said at least one stapling element at a fixed orientation, with respect to a direction of closing of said stapling element; 
   a mechanism, in mechanical communication with said cartridge, for issuing said at least one stapling element from said cartridge; and   a proximal end, with respect to said tissue, having a rigid, proximal-end frame, which defines an opening from which said at least one stapling elements issues.   
     
     
         11 . The device of  claim 10 , comprising a handle, with a finger lever, for controlling said mechanism, wherein said handle is arranged at an angle to said cartridge, to allow a surgeon maximum maneuverability, with a full range of elbow bending. 
     
     
         12 . The device of  claim 11 , wherein said finger lever is connected to a gripping portion of said handle with a swivel pin, for optimal ease of finger-lever maneuverability. 
     
     
         13 . The device of  claim 10 , wherein said rigid, proximal-end frame, which defines said opening from which said at least one stapling element issues, is at angle, which is smaller than 90° to said at least one stapling element. 
     
     
         14 . The device of  claim 10 , comprising a counter frame, on a side proximal to the tissue, for holding the tissue between said cartridge and said counter frame. 
     
     
         15 . The device of  claim 14 , wherein said counter frame further includes a casing, which defines an inner space, within which said stapling element is designed to close. 
     
     
         16 . The device of  claim 10 , said device having a gripping position, and said device being adapted for changing said predetermined closing direction without changing said gripping position. 
     
     
         17 . A device for applying staples to a tissue, comprising:
 a cartridge, adapted for storing at least one stapling element, in a coiled position, each said stapling element having a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue;   a mechanism, in mechanical communication with said at least one stapling element, for issuing said at least one stapling element from said cartridge;   and   a proximal end, with respect to said tissue, having a rigid, proximal-end frame, which defines an opening from which said at least one stapling element issues.   
     
     
         18 . The device of  claim 17 , wherein said at least one staple comprises a plurality of staples, and said mechanism is adapted to issue said plurality of staples one of in parallel and in series. 
     
     
         19 . A device according to  claim 17 , wherein said stapling element comprises:
 a coiled shape, adapted for coiling in a tissue, so as to form a loop; and   a tapered portion, forming a sharp, pointed edge, at a proximal end, with respect to the tissue, for piercing the tissue,   said staple being formed of a resilient material.   
     
     
         20 . A device according to  claim 19  wherein said mechanism is configured to applying the stapling element into the tissue, while the stapling element remains in a coiled shape.