Methods of replacing prosthetic heart valves

Abstract

A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment.

What is claimed is: 
     
         1 . A method of implanting a prosthetic heart valve in a native heart valve annulus of a patient, the method comprising:
 providing a prosthetic heart valve having an outer anchoring member and an inner valve member coupled thereto, the outer anchoring member having a collapsible tubular structure covered with a sleeve of fabric and the inner valve member including an annular frame supporting flexible one-way leaflets adapted to permit blood flow only in an outflow direction, wherein the anchoring member is configured to be constricted to a contracted state and enlarged to an expanded state sized to contact the heart valve annulus;   positioning the anchoring member and the valve member within a delivery tube with the anchoring member in the contracted state;   advancing the delivery tube to a position within the heart valve annulus; and   expelling the anchoring member from within the delivery tube and allowing the anchoring member to expand into contact with the heart valve annulus;   wherein, after deployment, the anchoring member engages the heart valve annulus for securing the prosthetic heart valve in the patient's heart and the valve member is secured within the anchoring member for permitting blood to flow through the frame in the outflow direction.   
     
     
         2 . The method of  claim 1 , wherein the structural frame of the valve member is non-expandable and non-collapsible, and wherein the method includes creating a direct access pathway to the heart valve annulus that permits direct vision of the heart valve annulus. 
     
     
         3 . The method of  claim 1 , wherein the structural frame of the valve member is compressible in diameter, and the method includes reducing the valve member in diameter when positioned within the delivery tube and then allowing the valve member to expand when expelled from within the delivery tube. 
     
     
         4 . The method of  claim 1 , wherein the anchoring member has a plurality of tissue-engaging barbs and the method includes engaging surrounding valve tissue with the barbs when the anchoring member expands into contact with the heart valve annulus. 
     
     
         5 . The method of  claim 4 , wherein the anchoring member has a flared portion and is covered with a sleeve of fabric. 
     
     
         6 . The method of  claim 1 , wherein the valve member is coupled within the anchoring member so that an annular space is formed around the structural frame of the valve member and an inner wall of the tubular expandable body in the expanded state. 
     
     
         7 . The method of  claim 1 , wherein the anchoring member has an outer sealing ring outside the tubular expandable body adjacent an inner fixation ring inside the tubular expandable body, wherein both the outer sealing ring and the inner fixation ring are made of compressible material, and wherein the outer sealing ring contacts and seals against the heart valve annulus in the expanded state of the anchoring member and the inner fixation ring couples to the valve member. 
     
     
         8 . The method of  claim 6 , wherein the inner fixation ring is suture-permeable and the valve member has a suture-permeable sewing ring surrounding an inflow end, and the valve member is coupled to the anchoring member with sutures passed through both the inner fixation ring and the sewing ring. 
     
     
         9 . The method of  claim 1 , wherein the expandable anchoring member is enlarged to the expanded state and into contact with the heart valve annulus prior to coupling the valve member thereto. 
     
     
         10 . The method of  claim 1 , wherein the delivery tube has an outwardly bulged portion, and the method includes dilating the heart valve annulus with the outwardly bulged portion prior to expelling the anchoring member from within the delivery tube. 
     
     
         11 . A method of implanting a prosthetic heart valve in a native heart valve annulus of a patient, the method comprising:
 providing a prosthetic heart valve having an outer anchoring member and an inner valve member, the outer anchoring member having a generally tubular body covered with a sleeve of fabric, the anchoring member being configured to be constricted to a contracted state and enlarged to an expanded state sized to contact the heart valve annulus, the inner valve member having an annular peripheral structural frame surrounding and supporting flexible one-way leaflets configured to permit blood flow in an outflow direction through the frame, wherein the valve member is coupled to the anchoring member so as to be positioned within the anchoring member in the expanded state;   positioning the anchoring member and valve member within a delivery tube with the anchoring member in the contracted state;   advancing the delivery tube to a position within the heart valve annulus; and   expelling the anchoring member from within the delivery tube by relatively pushing the anchoring member or retracting the delivery tube and allowing the anchoring member to expand into contact with the heart valve annulus,   wherein, after deployment, the anchoring member engages the heart valve annulus for securing the prosthetic heart valve in the patient's heart and the valve member is secured within the anchoring member for permitting blood to flow in the outflow direction through the frame.   
     
     
         12 . The method of  claim 11 , wherein the structural frame of the valve member is non-expandable and non-collapsible, and the method is surgical and includes creating a direct access pathway to the heart valve annulus that permits direct naked eye vision of the heart valve annulus. 
     
     
         13 . The method of  claim 11 , wherein the structural frame of the valve member is compressible in diameter, and the method includes reducing the valve member in diameter when positioned within the delivery tube and then allowing the valve member to expand when expelled from within the delivery tube. 
     
     
         14 . The method of  claim 11 , wherein the anchoring member has a plurality of tissue-engaging barbs and the method includes engaging surrounding valve tissue with the barbs when the anchoring member expands into contact with the heart valve annulus. 
     
     
         15 . The method of  claim 14 , wherein the anchoring member has a flared portion and is covered with a sleeve of fabric. 
     
     
         16 . The method of  claim 11 , wherein the valve member is coupled within the anchoring member so that an annular space is formed around the structural frame of the valve member and an inner wall of the tubular expandable body in the expanded state. 
     
     
         17 . The method of  claim 11 , wherein the anchoring member has an outer sealing ring outside the tubular expandable body adjacent an inner fixation ring inside the tubular expandable body, wherein both the outer sealing ring and the inner fixation ring are made of compressible material, and wherein the outer sealing ring contacts and seals against the heart valve annulus in the expanded state of the anchoring member and the inner fixation ring couples to the valve member. 
     
     
         18 . The method of  claim 17 , wherein the inner fixation ring is suture-permeable and the valve member has a suture-permeable sewing ring surrounding an inflow end, and the valve member is coupled to the anchoring member with sutures passed through both the inner fixation ring and the sewing ring. 
     
     
         19 . The method of  claim 11 , wherein the expandable anchoring member is covered with a sleeve of fabric and the anchoring member has a plurality of tissue-engaging barbs projecting outwardly therefrom. 
     
     
         20 . The method of  claim 11 , wherein the expandable anchoring member is enlarged to the expanded state and into contact with the heart valve annulus prior to coupling the valve member thereto.