Abstract: An in-situ fenestration device. The device includes a sheath, a sonic catheter extending with the sheath and having a cutting tool at a distal section thereof, and a balloon catheter extending within the sonic catheter. The cutting tool of the sonic catheter is configured to cut a fenestration in a graft material at a fenestration site of a stent graft upon being energized with ultrasonic energy at a cutting frequency.

Abstract: A method of manufacturing a heart valve prosthesis includes cutting a flat sheet of a valve material into a single-piece valve pattern having two or more valve leaflet regions and a valve skirt region. The method also includes arranging the two or more valve leaflet regions of the single-piece valve pattern into a mold for forming a leaflet belly for each of the two or more valve leaflet regions. Further, the method includes fixing, while arranged in the mold, a shape of the leaflet belly of each of two or more valve leaflet regions of the single piece-valve pattern. The method additionally includes creating a side seam by attaching two longitudinal edges of the single-piece valve pattern, to thereby form a tubular valve subassembly with two or more valve leaflets. The method includes attaching the tubular valve subassembly within a tubular frame to form a heart valve prosthesis.

Abstract: A prosthetic valve device and a method of forming a frame thereof. The method may include cutting a pattern into a tube having a first inner diameter and an axis, the pattern having a plurality of post pattern sections arranged on the tube in a circumferentially spaced-apart manner and a plurality of lattice pattern sections extending between the post pattern sections. The method may further include diametrically expanding the tube until the tube has a second inner diameter that is greater than the first inner diameter. The expanded tube may have a plurality of axial posts arranged on the expanded tube in a circumferentially spaced-apart manner and a plurality of lattices having open cells extending between the axial posts.

Abstract: Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.

Abstract: A leaflet folding accessory or tool configured for use with a crimper when radially compressing a transcatheter valve prosthesis into a crimped configuration for delivery within a vasculature. The crimping accessory is configured to apply or remove fluid to or from the at least one leaflet of the transcatheter valve prosthesis during the crimping process to prevent protrusion of the leaflets into the frame of the transcatheter valve prosthesis that may cause leaflet pinching and damage.

Abstract: A skirt-reinforcement member for supporting or reinforcing an unsupported portion of a skirt that spans across a side opening of a stent or frame of a valve prosthesis. The skirt-reinforcement member is configured to prevent billowing of the skirt material that spans across the side opening of the inner frame of the valve prosthesis, as such billowing may undesirably result in contact between the skirt and leaflets of the valve prosthesis after the valve prosthesis is deployed in situ.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

Abstract: A prosthesis includes a frame and a skirt coupled to a surface of the frame. The skirt extends over at least one side opening of a plurality of side openings of the frame. The prosthesis also includes a skirt-reinforcement member that spans the at least one side opening from a first crown or strut edge defining the at least one side opening to a second crown or strut edge defining the at least one side opening. The skirt-reinforcement member has a first end, a second end, and a length therebetween. The first end of the skirt-reinforcement member is attached to the first crown or strut edge and the second end of the skirt-reinforcement member is attached to the second crown or strut edge. The skirt-reinforcement member is attached to the skirt along an unsupported portion of the skirt that spans the at least one side opening.

Abstract: Transcatheter aortic valve prostheses for improving the cardiac function of a patient suffering from coronary artery disease. Transcatheter aortic valve prostheses include a valve component and a frame. The valve component includes valve leaflets and a skirt. The frame includes access cells that improve access to a patient's coronary arteries if further intervention is required and/or includes a window or conduction protection cell that is oriented to align with a portion of conduction system of the heart in situ to reduce conduction disturbances of the anatomy. Suture patterns for attaching a commissure to a commissure post of the frame, and for attaching a tissue bumper to the commissure post, are also described.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: An assembly including a transcatheter valve prosthesis and a leaflet folding accessory configured for use when compressing the transcatheter valve prosthesis into the crimped configuration. The transcatheter valve prosthesis includes a stent and a prosthetic valve component including at least one leaflet disposed within and secured to the stent. The transcatheter valve prosthesis has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The leaflet folding accessory includes a plurality of guide fingers. Each guide finger is configured to contact the prosthetic valve component and hold the at least one leaflet in a predetermined configuration when the transcatheter valve prosthesis is compressed into the crimped configuration.

Abstract: The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

Abstract: The devices and methods of this disclosure relate to a heart valve prosthesis that is configured to be implanted within a native heart valve having a smaller perimeter annuli with a generally elliptical shape.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.

Abstract: Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.