Abstract: An ablation apparatus for creating a lesion in target tissue, the ablation apparatus including a handle, an elongate shaft extending from the handle to a distal tip, where the shaft includes a first portion, an ablation portion distal to the first portion and having an outer sheath, and at least one ablation energy element disposed within the outer sheath, where a space is formed between the at least one ablation energy element and the outer sheath. The ablation apparatus further includes a thermally conductive liner disposed within the space.

Abstract: A docking device includes a hollow cylindrical body portion having an internal surface and an outer surface. The hollow cylindrical body portion is formed of a three-dimensional (3D) woven fabric comprising a plurality of different types of fibers.

Abstract: A docking device for a bioprosthesis is disclosed that can change shape and recover after a deforming stress is removed, that adjusts to surrounding conditions to accommodate different complex anatomic geometries, and that mitigates leakage around the bioprosthesis. The docking device can include a 3D woven fabric forming an internal surface, an outer surface, and a thickness therebetween. A filler can be coupled to the outer surface. A method for making a docking device is also provided. The method includes weaving a 3D woven fabric by interlacing a shape memory material, a low-melt thermoplastic polymer or resin having a melting point, and a high-tenacity biocompatible material; and pressing and heating the 3D woven fabric over a shape-setting mold at temperatures greater than the melting point of the low-melt thermoplastic polymer or resin.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

Abstract: A prosthetic heart valve includes an annular frame that has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. The prosthetic heart valve further includes a leaflet structure positioned within the frame and secured thereto, and an outer sealing member mounted outside of the frame and adapted to seal against surrounding tissue when the prosthetic heart valve is implanted within a native heart valve annulus of a patient. The sealing member can include a mesh layer and pile layer comprising a plurality of pile yarns extending outwardly from the mesh layer.

Abstract: An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. The prosthetic valve can comprise an annular frame, leaflets, an inner skirt, and an outer skirt. The outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack that buckles outward radially when the valve is in the expanded configuration and which lies flat when the valve is in the collapsed configuration. In some embodiments, the outer skirt is stiffer in the axial direction of the valve than in the circumferential direction of the valve. In additional embodiments, the outer skirt comprises a self-expandable fabric comprising fibers made of a shape memory material having a shape memory set to enhance the radially outward buckling of the outer skirt. Methods of crimping such valves to a collapsed or partially collapsed configuration are also disclosed.

Abstract: The present disclosure relates to laminated sealing members for prosthetic valves and methods of making the same. In a representative embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. The prosthetic valve can comprise an annular frame, leaflets, an inner skirt, and an outer skirt. The outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack that buckles outward radially when the valve is in the expanded configuration and which lies flat when the valve is in the collapsed configuration. In some embodiments, the outer skirt is stiffer in the axial direction of the valve than in the circumferential direction of the valve. In additional embodiments, the outer skirt comprises a self-expandable fabric comprising fibers made of a shape memory material having a shape memory set to enhance the radially outward buckling of the outer skirt. Methods of crimping such valves to a collapsed or partially collapsed configuration are also disclosed.

Abstract: A docking device for a bioprosthesis is disclosed that can change shape and recover after a deforming stress is removed, that adjusts to surrounding conditions to accommodate different complex anatomic geometries, and that mitigates leakage around the bioprosthesis. The docking device can include a 3D woven fabric forming an internal surface, an outer surface, and a thickness therebetween. A filler can be coupled to the outer surface. A method for making a docking device is also provided. The method includes weaving a 3D woven fabric by interlacing a shape memory material, a low-melt thermoplastic polymer or resin having a melting point, and a high-tenacity biocompatible material; and pressing and heating the 3D woven fabric over a shape-setting mold at temperatures greater than the melting point of the low-melt thermoplastic polymer or resin.

Abstract: A textured fabric for an implantable bioprosthesis is provided. The textured fabric can include a woven base layer and a plurality of loops projecting from the woven base layer. The plurality of loops are formed from a composite core-sheath yarn. The core can be made of a material that is different from the sheath. The core material can be selected to impart strength and resiliency to bending and the sheath material can be selected to impart a larger surface area or texture that facilitates cellular or tissue in-growth.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

Abstract: The present disclosure relates to laminated sealing members for prosthetic valves and methods of making the same. In a representative embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

Abstract: Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. The prosthetic valve can comprise an annular frame, leaflets, an inner skirt, and an outer skirt. The outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack that buckles outward radially when the valve is in the expanded configuration and which lies flat when the valve is in the collapsed configuration. In some embodiments, the outer skirt is stiffer in the axial direction of the valve than in the circumferential direction of the valve. In additional embodiments, the outer skirt comprises a self-expandable fabric comprising fibers made of a shape memory material having a shape memory set to enhance the radially outward buckling of the outer skirt. Methods of crimping such valves to a collapsed or partially collapsed configuration are also disclosed.