Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: A two-component valve prosthesis system includes a docking component and a prosthetic valve component that is configured to be delivered separately from the docking component. The docking component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The docking component includes a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt and a second annular scaffold attached to a second end of the tubular skirt. The first and second annular scaffolds are independent from each other. An intermediate portion of the tubular skirt is unsupported such that neither of the first or second annular scaffolds surrounds the intermediate portion of the tubular skirt. The prosthetic valve component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component.

Abstract: A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Abstract: A two-component valve prosthesis system includes a docking component and a prosthetic valve component that is configured to be delivered separately from the docking component. The docking component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The docking component includes a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt and a second annular scaffold attached to a second end of the tubular skirt. The first and second annular scaffolds are independent from each other. An intermediate portion of the tubular skirt is unsupported such that neither of the first or second annular scaffolds surrounds the intermediate portion of the tubular skirt. The prosthetic valve component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Abstract: An endovascular prosthesis includes a tubular body and a mobile external coupling. The tubular body includes a graft material and stents coupled thereto, a forms a lumen therethrough. The mobile external coupling extends outwardly from the tubular body. The mobile external coupling includes a graft material and is generally frustoconically shaped. The mobile external coupling includes a base coupled to the tubular body, a top spaced from the tubular body, and a coupling lumen disposed between the base and the top, wherein the coupling lumen is in flow communication with the body lumen. The coupling graft material is a woven fabric with warp yarn which run generally parallel to a longitudinal axis of the mobile external coupling including a shape memory material.

Abstract: A minimally invasive surgical instrument having an elongate stem extending between a proximal end which in use is located externally of an operating space and a distal end which in use is located within an operating space. At least a portion of the stem is malleable to facilitate manipulation of the stem in the operating space and then to maintain the stem in the manipulated position and/or orientation within the operating space. The instrument has an end effector at the distal end of the stem, the end effector having a proximal main body and distal operating means, such as graspers or cutters. The instrument has at least one joint for independent movement of the end effector main body in at least one direction relative to the distal end of the stem for enhanced degrees of freedom of the instrument.

Abstract: Apparatus and methods are disclosed for controlling deployment of a self-expanding support structure of a prosthetic valve that flares in a proximal direction upon implantation in vivo. A tubular delivery sheath having a side opening that proximally extends within a side wall thereof is used to deploy the prosthetic valve with the self-expanding support structure in a controlled manner. The prosthetic valve is distally advanced within a lumen of the delivery sheath with the self-expanding support structure held in a compressed delivery configuration within the delivery sheath lumen. The self-expanding support structure of the prosthetic valve is aligned with the side opening of the delivery sheath and the prosthetic valve is rotated relative to the delivery sheath whereby the self-expanding support structure is laterally released from the delivery sheath lumen through the side opening to gradually transition from the compressed delivery configuration to a flared deployed configuration.

Abstract: An endovascular prosthesis includes a tubular body and a mobile external coupling. The tubular body includes a graft material and stents coupled thereto, a forms a lumen therethrough. The mobile external coupling extends outwardly from the tubular body. The mobile external coupling includes a graft material and is generally frustoconically shaped. The mobile external coupling includes a base coupled to the tubular body, a top spaced from the tubular body, and a coupling lumen disposed between the base and the top, wherein the coupling lumen is in flow communication with the body lumen. The coupling graft material is a woven fabric with warp yarn which run generally parallel to a longitudinal axis of the mobile external coupling including a shape memory material.

Abstract: A minimally invasive surgical instrument (1) comprises an elongate stem (2) extending between a proximal end (3) which in use is located externally of an operating space (12) and a distal end (4) which in use is located within an operating space (12). At least portion of the stem (2) is malleable to facilitate manipulation of the stem (2) in the operating space (12) and then to maintain the stem (2) in the manipulated position and/or orientation within the operating space (12). The instrument (1) has an end effector (5) at the distal end (4) of the stem (2), the end effector (5) comprising a proximal main body (6) and distal operating means, such as graspers or cutters. The instrument (1) has at least one joint (8, 9) for independent movement of the end effector main body (6) in at least one direction relative to the distal end (4) of the stem (2) for enhanced degrees of freedom o the instrument.

Abstract: A cannula (1) comprises a shaft (2) extending between a proximal end (3) located externally of an operating space (4) and a distal end (5) inserted into the operating space (4). At least portion of the shaft (2) is malleable to maintain the distal end (5) of the shaft (2) in a desired manipulated position and/or orientation within the operating space (4) for insertion of a surgical instrument (10) through the cannula (1) for carrying out a surgical procedure within the operating space (4).