Anastomotic Stapling Reinforcing Buttress and Methods of Deployment

Abstract

The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections so as to improve tissue viability, prevent tissue infection, and to prevent leakage.

I/We claim: 
     
         1 . A circular stapling assembly for anastomotically joining tubular tissue sections comprising:
 a. A circular anvil;   b. A circular staple head assembly having a centrally located passage and a knife located in the passage;   c. A moveable shaft connecting the anvil and staple head;   d. An elongated shaft extending from the staple head assembly and gripping means; and   e. At least one reinforcing buttress comprising
 1) a substantially flat disk of a flexible, bioabsorbable material having a centrally located aperture and 
 2) a plurality of radiating slits directed from said centrally located aperture towards a periphery of said disk that forms a plurality of leaflets, said slits terminating in end apertures at a distance from said periphery. 
   
     
     
         2 . The circular stapling assembly of  claim 1 , wherein said distance from the periphery of the reinforcing buttress disk is substantially equal to a distance between an outside circumference of a stapling head and the circular knife. 
     
     
         3 . The circular stapling assembly of  claim 1 , wherein said slits do not extend into an area of said disk that receives staples from the staple head assembly. 
     
     
         4 . The circular stapling assembly of  claim 1 , wherein the reinforcing buttress disk has from 6 to 12 slits. 
     
     
         5 . The circular stapling assembly of  claim 4 , wherein said radiating slits are spaced equidistance apart as measured along a circumferential axis. 
     
     
         6 . The circular stapling assembly of  claim 1 , wherein the reinforcing buttress disk has 8 leaflets with end apertures at the conclusion of each slit, each end aperture having an internal radius of 0.6 mm. 
     
     
         7 . A circular anastomosis stapler kit comprising:
 a. A reinforcing buttress material comprising a substantially flat disk of a flexible, bioabsorbable material having a centrally located aperture and a plurality of radiating slits directed from said centrally located aperture towards a periphery of said disk that forms a plurality of leaflets, said slits terminating in end apertures at a distance from said periphery;   b. an anastomotic stapler comprising a stapling head and an anvil moveable longitudinally relative to the stapling head and mounted on an axially extending moveable shaft, with the stapling head containing a plurality of deployable staples,   c. a deployment tool comprising a hollow cylindrical body with a slidable plunger partially disposed in said body;   d. a cylindrical radially expandable spring sized to fit within said hollow cylindrical body and within a knife cavity of said stapling head.   
     
     
         8 . The circular anastomosis stapler kit of  claim 7 , wherein said spring comprises a spiral made of a flat metallic or polymeric strip or foil tightly wound into a cylinder shape. 
     
     
         9 . The circular anastomosis stapler kit of  claim 8 , wherein said spring has a height from 1 mm to 5 mm. 
     
     
         10 . A method of establishing an anastomotic joint between tubular tissue lumens with the anastomotic stapler kit of  claim 7 , said method comprising the steps of:
 a) Axially positioning the spring in a compressed state inside the hollow cylindrical body   b) Axially positioning the buttress between the spring inside the hollow cylindrical body and the stapling head;   c) Optionally inserting the hollow cylindrical body into a knife cavity of the stapling head thus bending the leaflets of the buttress into the knife cavity;   d) Moving the spring using the slidable plunger from the hollow cylindrical body into a knife cavity of the stapling head thus bending the leaflets of the buttress into the knife cavity;   e) Allowing the spring to radially expand in the knife cavity thus immobilizing the leaflets inside the knife cavity with said spring;   f) Removing the hollow cylindrical body;   g) Positioning the stapling head inside a first tubular tissue and positioning the anvil inside a second tubular tissue;   h) Connecting the anvil to the stapling head via the shaft   i) Approximating the anvil and the stapling head and compressing said first and second tubular tissues and said buttress between the stapling head and the anvil   j) Firing the anastomotic stapler and establishing the anastomotic joint between said first and second tubular tissues;   k) Severing the leaflets from the buttress.