Direct aortic access system for transcatheter aortic valve procedures

Abstract

Disclosed are a system and method for performing a medical procedure using direct percutaneous access of an aorta. A main sheath is introduced through an incision formed in proximity to the sternum, and positioned along (and preferable against) a posterior portion of the sternum. Instruments passed through the main sheath are used to form a purse-string suture in an exterior wall of the aorta. An opening is formed in the wall of the aorta in a region encircled by the purse-string suture, and a distal end of an introducer sheath is advanced through the opening into the aorta. A medical procedure, which may be a transcatheter aortic valve replacement, is performed using instruments passed through the introducer sheath into the aorta. After the medical procedure, the introducer sheath is withdrawn from the aorta and, as the introducer sheath is withdrawn, the purse-string suture is tightened to close the opening.

We claim: 
     
         1 . A system for direct percutaneous access into an aorta, the system comprising:
 a main sheath insertable through a percutaneous incisionormed at the suprasternal notch and positionable along a posterior of the sternum, the main sheath having a face positionable in stable contact with a posterior surface of the sternum, and a lumen;   a purse-string suture applier extendable through a lumen of the main sheath and positionable in proximity to the aorta, the purse-string suture applier having a needle and suture thereon, the purse-string suture applier manipulatable to form a purse-string suture in a wall of the aorta;   an introducer sheath extendable through a lumen of the main sheath and through an opening formed in a portion of the wall encircled by the purse-string.   
     
     
         2 . The system of  claim 1 , wherein the main sheath has a generally triangular cross section. 
     
     
         3 . The system of  claim 1 , wherein the main sheath has a generally elliptical cross-section. 
     
     
         4 . The system of  claim 1 , further including a channel insert, the channel insert including a proximal end engagable with the proximal end of the main sheath, an elongate section extendable through the lumen of the main sheath, and a lumen through the elongate section. 
     
     
         5 . The system of  claim 1 , further including an embolic protection device including a barrier positionable covering at least the ostia of the brachiocephalic and left common carotic arteries, the barrier having a surface permeable to passage of blood therethrough but impermeable to passage of embolic material. 
     
     
         6 . The system of  claim 5 , wherein the embolic protection device includes a support extendable through the left subclavian artery. 
     
     
         7 . The system of  claim 1 , wherein the introducer sheath includes a passage and a valve positioned to seal the passage against blood loss therethrough. 
     
     
         8 . The system of  claim 7 , wherein the valve has a sealed, position in which the passage is sealed, and an unsealed position, and wherein the valve is biased in the sealed position. 
     
     
         9 . The system of  claim 8 , wherein the valve in the sealed position seals against instruments extending through the passage. 
     
     
         10 . The system of  claim 8 , wherein the introducer sheath includes a member manually moveable to move the valve from the sealed to the unsealed position, the member biased to return the valve to the sealed position upon release of manual force against the member. 
     
     
         11 . The system of  claim 1 , further including a needle extendable through the wall of the aorta encircled by the purse string suture to form an opening in the aorta, and an introducer sheath advanceable through the opening. 
     
     
         12 . The system of  claim 1 , wherein the purse string suture applier comprises a needle holder and an end effector comprising suture needle carried by the needle holder. 
     
     
         13 . The system of  claim 12  wherein the suture applier includes a shaft having a distal portion supporting the end effector, the shaft articulatable at the distal portion. 
     
     
         14 . The system of  claim 13 , wherein the end effector is axially rotatable about the distal portion of the shaft.