Abstract: A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

Abstract: A method for retrieving a previously inserted prosthetic valve is disclosed. In one example, a loader assembly is inserted through a hub of a delivery sheath device. The delivery sheath device includes an expandable sheath that extends into a blood vessel of a patient. The loader assembly is advanced in a distal direction until a distal section of the loader assembly extends into the expandable sheath which is attached to a distal end of the hub. The distal section has a larger inner diameter than a middle tube section of the loader assembly. A delivery catheter is retracted to move a prosthetic valve attached thereto in a proximal direction until the prosthetic valve is received within the distal section. The loader assembly and the delivery catheter are removed from a proximal end of the hub while the prosthetic valve is retained within the distal section.

Abstract: A method of fabricating a docking device involves implementing a three-dimensional (3D) weaving technique to form a 3D textile structure using a plurality of different types of fibers, heating the 3D textile structure on a shape-setting mold at a temperature above a melting point of a first type of fiber of the plurality of different types of fibers to set a cylindrical shape of the 3D textile structure, maintaining the 3D textile structure on the shape-setting mold to cool off for a period of time, and removing the 3D textile structure from the shape-setting mold.

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 a balloon catheter assembly comprising an elongated balloon catheter shaft extending from the handle portion. The balloon catheter shaft includes a proximal end portion coupled to the handle portion and a distal end portion. The balloon catheter assembly further includes a balloon coupled to the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state. A protective cover encapsulates the balloon, the cover defining a cavity shaped to accommodate the balloon.

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 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: Embodiments of a radially collapsible and expandable prosthetic heart valve and method for crimping the prosthetic heart valve are disclosed. A method of radially compressing a prosthetic valve can include partially inserting the valve while in a radially expanded configuration into a crimping device comprising crimper jaws, wherein a portion of the valve comprising an outer skirt extends outside of the crimper jaws. The method can further include crimping the valve to a first partially collapsed configuration, further inserting the valve into the crimping device, such that the outer skirt is between the crimper jaws, and crimping the valve to a second partially collapsed configuration, wherein a diameter of the valve is smaller in the second partially collapsed configuration than in the first partially collapsed configuration.

Abstract: A loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

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 loader and method for loading a transcatheter heart valve into a delivery sheath or catheter is described that is also configured to facilitate retrieval of the heart valve back through the delivery sheath while protecting the delivery sheath from damage. Another loader provides for easier crimping and loading of a THV into a delivery sheath or catheter from a storage jar or container. A method for crimping a THV facilitates easier end user preparation of the valve for implantation and reduces the likelihood of tissue deformation in the valve during storage. These devices and methods for deploying THVs simplify the valve replacement procedure.

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: Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port, arranged on an exterior portion of the catheter configured to receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

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: 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: 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: Embodiments of the invention are directed towards a rapid exchange catheter configured for insertion into a subintimal space and crossing an occlusion in a subintimal space. The catheter includes a proximal end, a distal end, a first lumen configured to receive a first wire, the first lumen extending longitudinally through a least a lateral port of the catheter, and a second lumen having at least a portion distal of the lateral port and extending through at least the distal end of the catheter. The catheter also includes an exchange port, arranged on an exterior portion of the catheter configured to receive a second wire and second rapid exchange port in communication with the second lumen. Moreover, other embodiments of the invention are directed towards methods for using the rapid exchange catheter to cross an obstruction in a vessel, e.g., a total or partial occlusion, in a subintimal space.

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.