Free Edge Supported Mitral Valve Methods

Abstract

A method for placing a transcatheter stent-valve having replacement leaflets that are attached along their free edges. The stent-valve frame has supports that extend distally of the replacement leaflets to fastening sites. The replacement leaflets are attached along a leaflet base forming a linear attachment to the stent-valve frame. The free edges of the leaflets have cords attached; the cords attach the leaflets to the supports. The stent-valve can be a single component stent-valve or it can be a second component that attaches to a first component or dock.

1 . A method of implanting a replacement valve into native cardiac valve tissues of a heart, the method comprising the steps,
 A. providing an expandable stent frame having replacement leaflets with a leaflet base at a leaflet upstream end, said leaflet base being attached to said expandable stent frame via a linear leaflet-frame attachment having a circular attachment, an oval attachment, or saddle-shaped attachment,   B. said replacement leaflets having free edges at a leaflet downstream end, said free edges being attached via cords to one or more fastening sites, said one or more fastening sites being attached to said expandable stent frame and located downstream of said free edges,   C. said expandable stent frame forming a frame-tissue attachment to the native cardiac valve tissues of the heart.   
     
     
         2 . The method of  claim 1  wherein said expandable stent frame has an axial length of 10 mm or less. 
     
     
         3 . The method of  claim 1  wherein said frame-tissue attachment forms a linear frame-tissue path to the native cardiac valve tissues, said linear frame-tissue path being a circular path, oval path, or saddle-shaped path. 
     
     
         4 . The method of  claim 1  wherein said expandable stent frame comprises a support member, said support member extending downstream of said free edges, said support member comprising said one or more fastening sites attached to said cords. 
     
     
         5 . The method of  claim 1  wherein said replacement leaflets are formed from a polymeric film, from tissue-based heart valve leaflet materials, or a composite film, said composite film further comprising fibers or a thin flexible member embedded within said replacement leaflets. 
     
     
         6 . The method of  claim 5  wherein said replacement leaflets have axial components of said fibers or thin flexible member, said axial components being contiguous with or attached to said cords. 
     
     
         7 . The method of  claim 5  wherein said replacement leaflets have a free edge component of said fibers or said thin flexible member, said free edge component being located adjacent to said free edges. 
     
     
         8 . The method of  claim 5  wherein said replacement leaflets have a circumferential component of said fibers or said thin flexible member, said circumferential component providing strength for forming said linear leaflet-frame attachment of said leaflet base to said expandable stent frame. 
     
     
         9 . The method of  claim 5  wherein said replacement leaflets formed from said tissue-based heart valve materials and configured to form said linear leaflet-frame attachment are thinner than said replacement leaflets formed from said tissue-based heart valve materials that that are configured to form a crown-shaped attachment to said expandable stent frame. 
     
     
         10 . The method of  claim 1  wherein said expandable stent frame has a frustum shape, said frustum shape being narrower at an expandable stent frame downstream end. 
     
     
         11 . The method of  claim 1  wherein said frame-tissue attachment includes attachment elements located along a perimeter of said expandable stent frame, said attachment elements being activated by a torus balloon, said torus balloon being located along a perimeter of said stent frame. 
     
     
         12 . The method of  claim 1  wherein said stent frame has a tether member attached thereto near said expandable stent frame downstream end, said tether member being a flexible fiber extending to and being attached to the heart near an apex of the heart, said tether member preventing migration of said stent frame relative to the native cardiac valve tissues. 
     
     
         13 . The method of  claim 12  wherein said tether member is further attached to said cords that are attached to said free edges. 
     
     
         14 . The method of  claim 1  wherein said expandable stent frame has holding arms attached thereto, said holding arms extending from said stent frame on a luminal side of native leaflets to a location behind the native leaflet to a junction of the native leaflet with the native cardiac valve tissues of the heart. 
     
     
         15 . The method of  claim 1  wherein said expandable stent frame forms a frame-dock component attachment to a first component, said first component being an implanted structure adjacent to and attached to the native cardiac valve tissues, said first component having a cylindrical, circular, or D-shaped structure having a central lumen into which said expandable stent frame is placed. 
     
     
         16 . The method of  claim 15  wherein said first component does not contain replacement leaflets. 
     
     
         17 . The method of  claim 15  wherein said first component contains attachment elements located along a perimeter of said cylindrical, circular, or D-shape structure to hold said first component from migrating relative to the native cardiac valve tissues. 
     
     
         18 . The method of  claim 15  wherein said first component has a tether member comprising a flexible fiber to hold said first component to the heart near an apex of the heart and prevent migration of said first component relative to the native cardiac valve tissues. 
     
     
         19 . A method for attaching a leaflet base of replacement leaflets along a linear leaflet-frame attachment to an expandable stent frame for use as a replacement heart valve, said method comprising the steps;
 A. providing replacement leaflets having an upstream end able to form said linear leaflet-frame attachment to said stent frame,   B. each of said replacement leaflets having a cusp with a free edge that is attached to a first end of a cord,   C. a second end of said cord being attached to a fastening site attached to said expandable stent frame at a location downstream of said free edge,   D. said linear leaflet-frame attachment being a circular, oval, or saddle-shaped attachment,   E. wherein said expandable stent frame has an axial length of 10 mm or less.   
     
     
         20 . A method of implanting a replacement valve into native cardiac valve tissues of a heart, the method comprising the steps,
 A. providing an expandable stent frame having replacement leaflets with a leaflet base at an upstream end, said leaflet base being attached to said expandable stent frame via a linear attachment in the shape of a circle, an oval, or saddle shape,   B. said replacement leaflets having free edges at downstream ends, said free edges being attached via cords to one or more fastening sites, said one or more fastening sites being attached to said expandable stent frame and located downstream of said free edges.