Apparatus, kit and methods for puncture site closure

A kit for forming and thereafter closing an opening in anatomical tissue in a minimally invasive procedure comprising

• a penetrating instrument including a portal sleeve having a lumen therethrough and an obturator disposed in said lumen, said portal sleeve having a central longitudinal axis, a distal end for disposition internally of the anatomical tissue and a proximal end for disposition externally of the tissue, said obturator having a distal end for penetrating the tissue, said distal end of said obturator protruding distally beyond said distal end of said portal sleeve whereby an opening is formed in the tissue by penetration of said obturator therethrough and said portal sleeve extends through the opening, said obturator being withdrawable from said portal sleeve, upon disposition of said distal end of said portal sleeve internally of the tissue, such that said portal sleeve remains in the opening with said lumen of said portal sleeve establishing communication through the tissue from externally to internally thereof;
• and
• a puncture site closure apparatus for being removably, slidably disposed on said portal sleeve and including a collar having a cavity for receiving said portal sleeve such that said portal sleeve extends longitudinally through said collar, and a pair of guide members disposed at opposing locations on said collar at a predetermined angle to said central longitudinal axis of said portal sleeve, said guide members being angled in opposite directions, each of said guide members having upper and lower open ends and a passage extending longitudinally therethrough, said passages being adapted to receive a hollow penetrating member for penetrating the anatomical tissue, said guide members guiding the penetrating member into and through the anatomical tissue such that lengths of suture material can be passed through the tissue via the penetrating member and said guide members, respectively, for use in forming a suture stitch to close the opening upon removal of said portal sleeve therefrom.

A method of closing an opening in anatomical tissue through which a portal sleeve extends comprising the steps of

• moving a collar of a puncture site closure apparatus along the portal sleeve, while the portal sleeve is disposed in the opening, to position open lower ends of guide members, carried by the collar, adjacent the anatomical tissue at selected locations spaced outwardly from the opening;
• inserting a hollow penetrating member into a lumen of one of the guide members;
• advancing the penetrating member within the lumen of the one guide member to penetrate the anatomical tissue, at an entry point on the anatomical tissue, with an open distal end of the penetrating member;
• moving the penetrating member through the tissue, as guided by the one guide member, to cause the open distal end of the penetrating member to exit the tissue internally at an exit point on the tissue;
• passing a length of filamentous suture material through the penetrating member so that a first end of the length of suture material protrudes internally of the tissue through the open distal end of the penetrating member and a second end of the length of suture material is disposed externally of the tissue;
• introducing a grasping instrument through a lumen of the portal sleeve to position a distal end of the grasping instrument internally of the tissue;
• grasping the length of suture material internally of the tissue with the distal end of the grasping instrument;
• removing the penetrating member from the tissue leaving the length of suture material extending through the tissue;
• withdrawing the grasping instrument from the portal sleeve so that the first end of the length of suture material is drawn externally of the tissue;
• repeating said inserting, said advancing, said moving the penetrating member, said passing, said introducing, said grasping, said removing and said withdrawing steps on the other guide member to place another length of suture material in the anatomical tissue;
• tying the first ends of the lengths of suture material together, externally of the tissue, to form a knot;
• passing the knot through the portal sleeve to dispose the knot internally of the tissue;
• withdrawing the portal sleeve from the opening;
• pulling the second ends of the length of suture material to approximate the anatomical tissue at the opening;
• and
• tying the second ends of the lengths of suture material together to form a knot externally of the entry points whereby a suture stitch of desired tension is formed in the tissue with the lengths of suture material.