Method and apparatus for transapical access and closure

Abstract

Methods and apparatus for providing transapical access to a heart chamber for performing an intra cardiac procedure are described. The apparatus include a helical needle driver, a dilator, a straight access needle, and optionally a guidewire. After entering the heart chamber with the straight access needle, the helical needle driver is used to place a helical suture within the myocardium. After removing the needle driver, the dilator is advanced through the pre-placed helical suture, dilating both a passage and the circumscribing suture. After performing procedure, the pre-placed suture may be closed by proximally retracting an external end of the suture.

What is claimed is: 
     
         1 . A system for establishing transapical access through myocardial tissue to a heart chamber, said system comprising:
 a cylindrical shaft having a distal end, a proximal end, and a central passage extending between said ends;   a helical needle coupled to the distal end of the shaft;   suture releasably carried by the helical needle; and   a dilator having a width greater than that of the shaft, said dilator being adapted to be advanced over or in exchange for the shaft to enlarge a passage through the suture which is left in place through the myocardium.   
     
     
         2 . A system as in  claim 1 , further comprising a sheath for accessing the pericardium over an apical region of the heart through an intercostal access site, wherein the cylindrical shaft is adapted to be advanced through the sheath. 
     
     
         3 . A system as in  claim 1 , further comprising a sheath for accessing the pericardium over an apical region of the heart through a subxiphoid approach, wherein the cylindrical shaft is adapted to be advanced through the sheath. 
     
     
         4 . A system as in  claim 1 , wherein the helical needle is fixedly attached to the distal end of the cylindrical shaft so that the needle is advanced through tissue by rotating the shaft. 
     
     
         5 . A system as in  claim 1 , further comprising a driver for rotating the helical needle relative to the cylindrical shaft to advance the helical needle through tissue. 
     
     
         6 . A system as in  claim 1 , wherein the helical needle is hollow and the suture is received in the needle. 
     
     
         7 . A system as in  claim 1 , wherein the suture carries barbs along a distal region, wherein the barbs are adapted to self-deploy to anchor in myocardial tissue as the helical needle is withdrawn. 
     
     
         8 . A system as in  claim 1 , wherein the suture carries a T-bar to anchor in a heart chamber as the helical needle is withdrawn. 
     
     
         9 . A system as in  claim 1 , further comprising a straight needle for initially accessing the heart chamber through the myocardium. 
     
     
         10 . A system as in  claim 9 , wherein the cylindrical shaft and helical needle are adapted to be advanced over the straight needle. 
     
     
         11 . A system as in  claim 9 , wherein the needle is adapted to position a guidewire through the myocardium and the cylindrical shaft and helical needle are adapted to be advanced over the guidewire. 
     
     
         12 . A system as in  claim 1 , wherein the dilator has a threaded exterior to facilitate advancement through tissue. 
     
     
         13 . A system as in  claim 1 , wherein the dilator comprises an outer sleeve and an inner obturator, wherein the obturator can be removed to leave the sleeve in place in a dilated tissue tract. 
     
     
         14 . A system as in  claim 13 , wherein the sleeve includes a hemostatic valve.