Composite Staple for Completing an Anastomosis

Abstract

An anastomosis staple comprising of a plurality of vessel engaging members and a binding structure holding the vessel engaging members together is described. The binding structure has at least one bioabsorbable element. The binding structure is rigid enough to allow for deployment and quickly resorbs to avoid problems associated with intimal hyperplasia and physical hindrance of secondary interventional procedures. The vessel engaging members may be comprised of superelastic or shape memory metal and are independent from one another. The members may be equidistant from one another and embedded within the binding structure. The composite staple can preferably serve as a drug delivery vehicle.

1 . A method of performing a procedure on a vessel having a previously made opening, the method comprising: 
 providing a composite staple having a plurality of vessel engaging members and a binding structure holding each of the plurality of vessel engaging members in a predefined spatial relationship with respect to each of the other vessel engaging members, the binding structure including at least one bioabsorbable element configured such that at least one vessel engaging member is free to move with respect to at least one other vessel engaging member after the bioabsorbable element has resorbed, and wherein each vessel engaging member has two diametrically opposed arms extending out of the binding structure;    positioning at least one vessel engaging member at a location proximate the opening;    holding a distal portion of the at least one vessel engaging member in a first configuration;    penetrating the distal portion of the at least one vessel engaging member into tissue adjacent the opening; and    permitting the distal portion of the at least one vessel engaging member to move to a second configuration to close the opening.    
   
   
       2 . The method of  claim 1 , wherein the procedure is an anatomosis selected from the group consisting of an end-to-side connection, a side-to-side connection, and end-to-end connection.  
   
   
       3 . The method of  claim 1 , wherein the distal portion of the at least one vessel engaging member includes a tissue penetrating point.  
   
   
       4 . The method of  claim 3 , further comprising piercing the sharpened points through tissue adjacent to the opening.  
   
   
       5 . The method of  claim 1 , wherein the distal portion of the at least one vessel engaging member are substantially parallel to a longitudinal axis of the composite staple when the distal portions are in the first configuration.  
   
   
       6 . The method of  claim 1 , wherein the distal portion of the at least one vessel engaging member are substantially orthogonal to a longitudinal axis of the composite staple when the distal portions are in the second configuration.  
   
   
       7 . The method of  claim 1 , wherein the binding structure is a bioabsorbable scaffold.  
   
   
       8 . The method of  claim 7 , wherein the bioabsorbable scaffold is radially expandable.  
   
   
       9 . The method of  claim 7 , wherein the bioabsorbable scaffold is annular in shape.  
   
   
       10 . The method of  claim 7 , wherein the bioabsorbable scaffold is elliptical in shape.  
   
   
       11 . The method of  claim 9 , wherein the annular member has a proximal portion and at least the proximal portion is proximal to the tissue adjacent to the opening when the distal portions are in the second configuration.  
   
   
       12 . The method of  claim 1 , wherein the binding structure forms a C-ring after the bioabsorbable element has resorbed.  
   
   
       13 . The method of  claim 1 , wherein the bioabsorbable element is formed from a mixture of polylactic acid and polyglycolic acid.  
   
   
       14 . The method of  claim 1 , wherein the binding structure contains pharmaceutical or radioactive substances.  
   
   
       15 . The method of  claim 14 , wherein the pharmaceutical or radioactive substances are selected from the group consisting of antibiotics, anticoagulants, procoagulants, and radioisotopes with a β-component.  
   
   
       16 . The method of  claim 15 , wherein the radioisotopes are  32 P and  131 I.  
   
   
       17 . The method of  claim 1 , wherein the vessel engaging members are coated with a radioactive substance.  
   
   
       18 . The method of  claim 17 , wherein the radioactive substance is  32 P or  131 I.