Method and System For Cardiac Valve Delivery

Abstract

The invention provides methods and systems for introducing a delivery device in the heart at or near the apex of the heart, wherein the delivery device includes a prosthesis, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery device at the target site for implantation. Specifically, the present invention provides valve replacement systems for delivering a replacement heart valve to a target site in or near a heart. The valve replacement system comprises a trocar or other suitable device to penetrate the heart at or near the apex of the heart, a delivery member that is movably disposed within the trocar, and a replacement cardiac valve disposed on the delivery member. The delivery member may further comprise mechanical or inflatable expanding members to facilitate implantation of the prosthetic valve at the target site.

1 . A valve replacement system for delivering a replacement valve to a target site in a heart, the system comprising:
 a delivery device comprising an elongate member, wherein the diameter of the delivery device is significantly greater than the diameter of a human adult femoral artery; and   a radially collapsible and expandable heart valve prosthesis mounted to the delivery device in a collapsed state, wherein the heart valve prosthesis comprises a support frame and a tissue valve secured to the support frame,   wherein the delivery device is sized and shaped to deliver the heart valve prosthesis through an apical area of a heart to a native annulus in a heart, and wherein the heart valve prosthesis is configured to be expanded to an expanded state when the heart valve prosthesis is delivered to a native annulus.   
     
     
         2 . The system of  claim 1 , wherein the heart valve prosthesis is a replacement cardiac valve. 
     
     
         3 . The system of  claim 2 , wherein the heart valve prosthesis is a replacement aortic valve. 
     
     
         4 . The system of  claim 2 , wherein the heart valve prosthesis is a replacement mitral valve. 
     
     
         5 . The system of  claim 1 , wherein the delivery device is configured to be introduced into the left ventricle of the heart. 
     
     
         6 . The system of  claim 1 , wherein the delivery device is configured to be introduced into the right ventricle of the heart. 
     
     
         7 . The system of  claim 1 , wherein the support frame is constructed from a self-expanding material. 
     
     
         8 . The system of  claim 7 , wherein the support frame comprises nitinol. 
     
     
         9 . The system of  claim 1 , wherein the delivery device includes a balloon, wherein the heart valve prosthesis is mounted on the balloon for delivery to a native annulus, and wherein the delivery device is configured to expand the heart valve prosthesis in a native annulus by inflating the balloon. 
     
     
         10 . The system of  claim 1  further comprising a trocar, wherein the trocar includes a tissue-piercing head configured to pierce a heart at an apical area of the heart. 
     
     
         11 . The system of  claim 10 , wherein the trocar includes a lumen extending therethrough, and wherein the delivery device is configured to be inserted into the lumen and thereby through an apical area of a heart. 
     
     
         12 . The system of  claim 1 , wherein the delivery device includes a sheath having a lumen, wherein the heart valve prosthesis is mounted on the elongate member, and wherein the diameter of the sheath is greater than the diameter of the heart valve prosthesis when the heart valve prosthesis is in the collapsed state, and wherein the delivery device is configured such that the valve prosthesis can be positioned within the sheath lumen during delivery of the heart valve prosthesis to a native annulus. 
     
     
         13 . The system of  claim 12 , wherein the delivery device is configured such that the heart valve prosthesis can be removed from the sheath when the heart valve prosthesis has been delivered to a native annulus. 
     
     
         14 . The system of  claim 1 , wherein the diameter of the delivery device is significantly larger than approximately 8 mm and less than approximately 25 mm. 
     
     
         15 . A valve replacement system for delivering a replacement valve to a target site in a heart, the system comprising:
 a penetration device configured to penetrate an apical area of a heart, wherein the penetration device comprises a central lumen;   a delivery device comprising an elongate member, wherein the diameter of the delivery device is significantly greater than the diameter of a human adult femoral artery; and   a radially collapsible and expandable heart valve prosthesis mounted to the delivery device in a collapsed state, wherein the heart valve prosthesis comprises a support frame and a tissue valve secured to the support frame, and wherein the support frame comprises a self-expanding material;   wherein the delivery device is sized and shaped to deliver the heart valve prosthesis through an apical area of a heart to a native annulus in a heart, and wherein the heart valve prosthesis is configured to be expanded to an expanded state when the heart valve prosthesis is delivered to a native annulus.   
     
     
         16 . The system of  claim 15 , wherein the delivery device includes a sheath having a lumen, wherein the heart valve prosthesis is mounted to the elongate member, and wherein the sheath is sized and shaped such that the heart valve prosthesis can be positioned within the sheath lumen during delivery of the heart valve prosthesis to a native annulus. 
     
     
         17 . The system of  claim 16 , wherein the heart valve prosthesis is configured to self-expand to the expanded state in a native annulus when the heart valve prosthesis is removed from the sheath. 
     
     
         18 . The system of  claim 15 , wherein the heart valve prosthesis is a replacement cardiac valve. 
     
     
         19 . The system of  claim 18 , wherein the heart valve prosthesis is a replacement aortic valve. 
     
     
         20 . The system of  claim 19 , wherein the heart valve prosthesis is a replacement mitral valve. 
     
     
         21 . The system of  claim 15 , wherein the delivery device is configured to be introduced into the left ventricle of the heart. 
     
     
         22 . The system of  claim 15 , wherein the delivery device is configured to be introduced into the right ventricle of the heart. 
     
     
         23 . The system of  claim 15 , wherein the diameter of the delivery device is significantly larger than approximately 8 mm and less than approximately 25 mm. 
     
     
         24 . A valve replacement system for delivering a replacement valve to a target site in a heart, the system comprising:
 a delivery device comprising an inner member and an outer member, wherein the outer member has a central lumen, wherein the diameter of the outer member is significantly greater than the diameter of a human adult femoral artery; and   a radially collapsible and expandable heart valve prosthesis mounted to the delivery device in a collapsed state, wherein the heart valve prosthesis comprises a support frame and a tissue valve secured to the support frame, and wherein the support frame comprises a self-expanding material;   wherein the delivery device is sized and shaped to deliver the heart valve prosthesis through an apical area of a heart to a native annulus in a heart, and wherein the heart valve prosthesis is configured to be expanded to an expanded state when the heart valve prosthesis is delivered to a native annulus.   
     
     
         25 . The system of  claim 24 , wherein the outer member is sized and shaped such that the heart valve prosthesis can be positioned within the central lumen during delivery of the heart valve prosthesis to a native annulus. 
     
     
         26 . The system of  claim 24 , wherein the diameter of the outer member is significantly larger than approximately 8 mm and less than approximately 25 mm. 
     
     
         27 . A system for delivering a replacement heart valve prosthesis to the aortic region of the heart comprising:
 a self expandable heart valve prosthesis comprising a stent and a tissue valve associated with the stent, the self expandable heart valve prosthesis being capable of assuming a contracted state and an expanded state;   an elongate tubular member having a distal end portion adapted to be introduced into the heart through its apex, a proximal portion, and a hollow lumen;   a delivery member having a portion adapted to receive the heart valve in its contracted state; the delivery member and heart valve prosthesis being movably disposed within the lumen of the elongate tubular member while the heart valve prosthesis is in the contracted state, the delivery member being sized and shaped to extend through an apical area of the heart to the native aortic annulus of the heart; and   wherein the heart valve prosthesis is adapted to be expanded to an expanded state when the heart valve prosthesis is delivered to a native aortic annulus.   
     
     
         28 . The system of  claim 27 , wherein the stent comprises a nitinol material. 
     
     
         29 . The system of  claim 27 , wherein the stent is a mesh. 
     
     
         30 . The system of  claim 27 , wherein the elongate tubular member further includes a trocar. 
     
     
         31 . The system of  claim 27 , wherein the delivery member includes a tip and further includes a wire for controlling tip deflection. 
     
     
         32 . The system of  claim 27 , wherein the diameter of the elongate tubular member is significantly greater than the diameter of a human adult femoral artery.