Expandable valve prosthesis with sealing mechanism

Abstract

A prosthetic heart valve includes at least one sealing member. The sealing member is adapted to conform to any surface irregularities found on the inner surface of the valve annulus, including any calcium deposits formed on the valve leaflets. The sealing member can be self-expanding or non-expanding. When deployed, the sealing member is adapted to create a blood tight seal between the prosthetic heart valve and the inner surface of the valve annulus thereby minimizing and/or eliminating perivalvular leakage at the implantation site.

We claim: 
     
         1 . A method of using a heart valve prosthesis at a native heart valve site of a patient, the method comprising:
 delivering a heart valve prosthesis in a radially collapsed configuration to an implantation position at the native heart valve site, the heart valve prosthesis comprising a plurality of prosthetic leaflets coupled to an anchoring structure and at least one non-inflatable, outer sealing skirt coupled to and extending circumferentially about a portion of the anchoring structure such that the anchoring structure does not pass through a side wall of the at least one non-inflatable, outer sealing skirt;   transitioning the heart valve prosthesis from the radially collapsed configuration to an expanded configuration at the implantation position such that the at least one non-inflatable, outer sealing skirt conforms to an inner surface of a native annulus at the native heart valve site to reduce paravalvular leakage; and   permitting blood flow through the heart valve prosthesis upon opening of the plurality of prosthetic leaflets.   
     
     
         2 . The method of  claim 1 , wherein the anchoring structure has a generally cylindrical shape. 
     
     
         3 . The method of  claim 1 , wherein the anchoring structure comprises an inflow portion adapted to engage and secure the anchoring structure to the heart valve site and an outflow portion adapted to be disposed adjacent to a Valsalva sinus of the patient. 
     
     
         4 . The method of  claim 3 , wherein the at least one non-inflatable, outer sealing skirt extends circumferentially about at least a portion of that inflow portion that does not impede blood flow into a coronary ostia of the patient. 
     
     
         5 . The method of  claim 1 , wherein delivering the heart valve prosthesis to the implantation position comprises delivering the heart valve prosthesis to the implantation position at a native aortic valve site. 
     
     
         6 . The method of  claim 1 , further comprising, prior to delivering the heart valve prosthesis, removing native leaflets of the native heart valve. 
     
     
         7 . The method of  claim 1 , further comprising, prior to delivering the heart valve prosthesis, measuring a valve size based on the native annulus and selecting the heart valve prosthesis based on the valve size. 
     
     
         8 . The method of  claim 1 , further comprising expanding a balloon within the heart valve prosthesis in the expanded configuration at the implantation position to apply radial force against an interior of the heart valve prosthesis. 
     
     
         9 . The method of  claim 1 , wherein the at least one non-inflatable, outer sealing skirt comprises at least one of a viscoelastic material or pericardial tissue. 
     
     
         10 . The method of  claim 1 , wherein the at least one non-inflatable, outer sealing skirt comprises at least one of silicone rubber or latex rubber. 
     
     
         11 . A method of using a heart valve prosthesis at a native heart valve site of a patient, the method comprising:
 delivering a heart valve prosthesis in a radially collapsed configuration to an implantation position at the native heart valve site, the heart valve prosthesis comprising an anchoring structure comprising an outflow portion adapted to be disposed adjacent to a Valsalva sinus of the patient and an inflow portion adapted to engage and secure the anchoring structure to the native heart valve site, a plurality of prosthetic leaflets coupled to the anchoring structure, and at least one non-inflatable, outer sealing skirt coupled to and extending circumferentially about at least a portion of that inflow portion of the anchoring structure and adapted to permit blood flow into a coronary ostia of the patient;   transitioning the heart valve prosthesis from the radially collapsed configuration to an expanded configuration at the implantation position such that the at least one non-inflatable, outer sealing skirt conforms to an inner surface of a native annulus at the native heart valve site to reduce paravalvular leakage; and   permitting blood flow through the heart valve prosthesis upon opening of the plurality of prosthetic leaflets.   
     
     
         12 . The method of  claim 11 , wherein the anchoring structure has a generally cylindrical shape. 
     
     
         13 . The method of  claim 11 , wherein the anchoring structure does not pass through a side wall of the at least one non-inflatable, outer sealing skirt. 
     
     
         14 . The method of  claim 11 , wherein delivering the heart valve prosthesis to the implantation position comprises delivering the heart valve prosthesis to the implantation position at a native aortic valve site. 
     
     
         15 . The method of  claim 11 , further comprising, prior to delivering the heart valve prosthesis, removing native leaflets of the native heart valve. 
     
     
         16 . The method of  claim 11 , further comprising, prior to delivering the heart valve prosthesis, measuring a valve size based on the native annulus and selecting the heart valve prosthesis based on the valve size. 
     
     
         17 . The method of  claim 11 , further comprising expanding a balloon within the heart valve prosthesis in the expanded configuration at the implantation position to apply radial force against an interior of the heart valve prosthesis. 
     
     
         18 . The method of  claim 11 , wherein the at least one non-inflatable, outer sealing skirt comprises at least one of a viscoelastic material or pericardial tissue. 
     
     
         19 . The method of  claim 11 , wherein the at least one non-inflatable, outer sealing skirt comprises at least one of silicone rubber or latex rubber. 
     
     
         20 . The method of  claim 11 , wherein the at least one non-inflatable, outer sealing skirt decreases in volume when the heart valve prosthesis transitions from the radially collapsed configuration to the expanded configuration.