Percutaneous Transcatheter Heart Valve

Abstract

The present invention provides improved devices and methods for replacing or repairing a malfunctioning heart valve. In particular, improved minimally invasive methods and devices are provided for percutaneous transcatheter implantation of expansible prosthetic heart valves within or adjacent a valved anatomic site within the heart. In one embodiment, an expansible prosthetic heart valve comprises an implantable structure, a flexible membrane, and a membrane support. The implantable structure is expansible from a first reduced diameter to a second enlarged diameter and has a flow path therethrough. The flexible membrane is positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction. The membrane support is positionable in the flow path and affixed to the implantable structure.

1 . An expansible prosthetic heart valve comprising: p 1  an implantable structure which is expansible from a first reduced diameter to a second enlarged diameter and having a flow path therethrough; p 1  a flexible membrane positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction, the flexible membrane comprising a displaceable, expandable valve member; and p 1  a membrane support positionable in the flow path and affixed to the implantable structure.  
   
   
       2 . An expansible valve as in  claim 1 , wherein the membrane support comprises at least one radial rib extending across the flow path.  
   
   
       3 . An expansible valve as in  claim 1 , wherein the membrane support comprises a circular wire frame.  
   
   
       4 . An expansible valve as in  claim 1 , wherein the flexible membrane is attached to a central portion of the membrane support.  
   
   
       5 . An expansible valve as in  claim 1 , wherein the flexible membrane has a substantially circular shape.  
   
   
       6 . An expansible valve as in  claim 1 , wherein the flexible membrane has a substantially conical shape.  
   
   
       7 . An expansible valve as in  claim 1 , wherein the flexible membrane comprises expanded polytetrafluoroethylene or biological materials.  
   
   
       8 . An expansible valve as in  claim 1 , wherein the implantable structure comprises a tubular framework.  
   
   
       9 . An expansible valve as in  claim 8 , wherein the framework comprises a plurality of struts, wherein at least three struts are longer than the remaining struts.  
   
   
       10 . An expansible valve as in  claim 9 , wherein the framework further comprises a plurality of radial protrusions extending beyond the framework when the framework is implanted within or adjacent an intraluminal site.  
   
   
       11 . An expansible valve as in  claim 9 , wherein the radial protrusions extend circumferentially and longitudinally from an outer surface of the framework.  
   
   
       12 . An expansible valve as in  claim 1 , wherein the implantable structure is covered with a layer of expanded polytetrafluoroethylene or biological materials.  
   
   
       13 . An expansible valve as in  claim 1 , wherein at least a portion of the implantable structure, flexible membrane, or membrane support is coated with an anti-thrombogenic substance.  
   
   
       14 . An expansible valve as in  claim 1 , wherein the implantable structure, flexible membrane, and membrane support are expandable from a first reduced profile configuration to a second enlarged profile configuration.  
   
   
       15 . An expansible prosthetic heart valve comprising: p 1  an implantable structure which is expansible from a first reduced diameter to a second enlarged diameter and having a flow path therethrough; p 1  a displaceable, expandable valve member positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; and p 1  a valve member support positionable in the flow path.  
   
   
       16 . An expansible valve as in  claim 15 , wherein the displaceable valve member is affixed to the valve member support.  
   
   
       17 . An expansible valve as in  claim 16 , wherein the displaceable valve member and valve member support comprises an expandable ball valve.  
   
   
       18 . An expansible valve as in  claim 17 , wherein the ball valve is coupled to the implantable structure at a hinge point, and wherein the ball valve is centrally supported.  
   
   
       19 . An expansible valve as in  claim 17 , wherein the ball valve is axially slidable relative to the implantable structure.  
   
   
       20 . An expansible valve as in  claim 16 , wherein the displaceable valve member and valve member support are displaced during opening and closing of the flow path.  
   
   
       21 . A method for implanting an expansible prosthetic heart valve, the method comprising: p 1  providing a prosthetic heart valve having an expansible structure, a flexible membrane, and a membrane support, wherein the flexible membrane comprises an expandable valve member affixed to the membrane support; p 1  implanting the expansible structure within or adjacent to an intraluminal site and expanding the structure from a first reduced diameter to a second enlarged diameter, wherein a flow path extends therethrough; p 1  positioning the flexible membrane in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction; p 1  positioning the membrane support in the flow path, wherein the membrane support does not flex during opening and closing of the flow path by the flexible membrane; and p 1  displacing the expandable valve member and membrane support at a hinge or in an axial direction relative to the structure.  
   
   
       22 . A method as in  claim 21 , wherein the intraluminal site comprises a mitral valve, aortic valve, pulmonary valve, or tricuspid valve annulus of the heart.  
   
   
       23 . A method as in  claim 21 , wherein implanting is carried out by percutaneously passing a catheter endoluminally through an anatomic passageway to a valved anatomic site within the heart.  
   
   
       24 . A method as in  claim 21 , wherein implanting further comprises aligning the structure within the intraluminal site with at least three long struts.  
   
   
       25 . A method as in  claim 21 , further comprising anchoring the structure with a plurality of hooks.  
   
   
       26 . A method as in  claim 21 , wherein positioning further comprises expanding the membrane support from a first reduced profile configuration to a second enlarged profile configuration.