Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator coupled to the inner shaft.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: In some embodiments, a prosthetic heart valve system, includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and the stent having one or more retention tabs, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

Abstract: According to one aspect of the disclosure, a prosthetic heart valve system includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition and protect portions of the valve assembly during crimping and delivery.

Abstract: A method of implanting a prosthetic heart valve includes delivering the prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped over a deflated balloon of a delivery device. The method may include advancing fluid through the delivery device and into the balloon to inflate the balloon and to expand the prosthetic heart valve into the native valve annulus. The method may include monitoring a pressure within the delivery device while advancing fluid through the delivery device. The method may also include displaying the monitored pressure on a display device in real time during monitoring the pressure.

Abstract: A prosthetic heart valve system may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal end portion of the delivery catheter. In a delivery condition of the system and in an activated condition of the system, the prosthetic heart valve is mounted over the balloon so that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and so that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In the delivery condition of the system, the protective member does not extend radially beyond the outer radial extent of the prosthetic heart valve. In the activated condition of the system, the protective member does extend radially beyond the outer radial extent of the prosthetic heart valve.

Abstract: A grip for inhibiting travel of a prosthetic valve loading tube along an outer shaft of a delivery catheter system has a lumen extending therethrough. A portion of the lumen has a variable internal diameter for selective frictional engagement with the outer shaft. In some arrangements, the variable internal diameter is provided by variable compression of a gasket aligned on the lumen. In other arrangements, the variable internal diameter is provided by a portion of the grip that surrounds the lumen and that has at least one circumferential gap of variable width.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an inner shaft, an outer shaft, and a distal sheath. The distal sheath may be disposed distal to the outer shaft and about a portion of the inner shaft to form a compartment with the inner shaft. The compartment may be sized to receive the prosthetic heart valve. The inner shaft and the distal sheath may be movable relative to one another. A spine may extend along the outer shaft, the spine biasing the outer shaft so that the outer shaft tends to bend in a pre-determined direction.

Abstract: A delivery device for a collapsible prosthetic heart valve may include an operating handle and a catheter assembly. The handle may include a housing, a piston cylinder, a piston longitudinally slidable within the piston cylinder, the piston and the piston cylinder together defining at least one pressure chamber, a deployment actuator coupled to the housing and rotatable relative thereto, and a pneumatic switch adapted to provide a pressurized fluid to the pressure chamber to apply a longitudinal force to the piston. The catheter assembly may include a first shaft around which a valve-receiving compartment is defined, the first shaft being operatively connected to the housing, and a distal sheath operatively connected to the piston, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment. Longitudinal movement of the piston may move the distal sheath between the closed and open conditions.

Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator and a hub, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator coupled to the inner shaft.

Abstract: A delivery device 1010 for a collapsible prosthetic heart valve 200, the delivery device including an inner shaft 1026, a distal sheath 1024 disposed about a portion of the inner shaft and forming a compartment 1023 with the inner shaft, the compartment being adapted to receive the prosthetic heart valve, the inner shaft and the distal sheath being movable relative to one another, and a handle 1020 including a frame 1030 having a longitudinal axis, a proximal end and a distal end, the handle further including a deployment actuator 1021 and a hub 1100, each of the deployment actuator and the hub being independently capable of opening and closing the compartment, the hub further including a hub actuator 1600 coupled to the inner shaft.

Abstract: A guidewire may be configured for insertion into a heart of a patient during a procedure such as a transcatheter aortic valve replacement procedure. The guidewire may include a proximal end and a distal end portion. The distal end portion may include (i) a leading section, (ii) a loop structure at a terminal distal end of the guidewire, and (iii) a transition section extending between the leading section and the loop structure. In the absence of applied forces, the leading section is not tangential to the loop structure. With such a configuration, the guidewire may avoid contact with the ventricular septum of the heart when the loop structure is seated within the left ventricle, which may mitigate potential interference with conduction pathways in the ventricular septum, which may in turn mitigate the need for a pacemaker.

Abstract: A delivery device for an implantable medical device includes an inner shaft with a device-carrying region, an outer shaft surrounding the inner shaft, a sheath at a distal end of the outer shaft, and a sleeve. The outer shaft is movable relative to the inner shaft from an advanced position in which the sheath surrounds the device-carrying region to a retracted position in which the sheath exposes the device-carrying region. The sheath includes a proximal structure having a cylindrical portion between first and second transition zones. The sleeve surrounds the outer shaft and is movable relative to the outer shaft from an advanced position in which a distal end portion of the sleeve surrounds the cylindrical portion to a retracted position in which the distal end portion of the sleeve is spaced proximally from the cylindrical portion.

Abstract: Combined embolic protection devices and prosthetic heart valve delivery devices useful for filtering emboli during a heart valve replacement procedure are described. The delivery devices may include a delivery sheath for housing the prosthetic heart valve in collapsed condition for delivery. The delivery devices may include one or more embolic protection filters received within the delivery device during the delivery of the prosthetic heart valve. The embolic protection filters may be deployed into an expanded or deployed condition prior to deploying the prosthetic heart valve. Any embolic debris entering the bloodstream during the prosthetic heart valve deployment may be trapped within, or deflected by, the deployed embolic filter(s) to reduce the risk of stroke.

Abstract: A delivery device for a collapsible prosthetic heart valve may include an operating handle having a housing and a carriage movable relative to the housing, and a catheter assembly. The catheter assembly may have an inner shaft around which a compartment is defined, an outer shaft surrounding at least a portion of the inner shaft, a distal sheath fixedly connected to the outer shaft, and a spline tube surrounding at least a portion of the inner shaft. The spline tube may have thinner portions having a first maximum thickness in a radial direction of the inner shaft and thicker portions having a second maximum thickness in the radial direction that is greater than the first maximum thickness. The spline tube and the outer shaft may together define one or more channels that provide liquid communication between the operating handle and the compartment.

Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device comprising an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment adapted to receive the valve, the inner shaft and the distal sheath being slidable relative to one another, and a handle including a frame, a deployment actuator, a lever, and a hub, each of the deployment actuator, the lever, and the hub being independently capable of opening and closing the compartment, a resheathing lock configured to alert a user of a position of the distal sheath relative to the inner shaft and to impede movement of the distal sheath relative to the frame, and an indicator disposed on the frame and capable of showing an extent of deployment of the valve.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an outer shaft having a first end and a second end, an inner shaft disposed inside the outer shaft and longitudinally movable relative to the outer shaft, and a distal sheath coupled to the inner shaft and movable with the inner shaft to selectively cover and uncover a compartment for housing the valve. The outer shaft includes a plurality of disks each having at least two hinges to allow articulation of adjacent disks relative to one another, and at least one rib for coupling the adjacent disks to one another.

Abstract: A delivery device for an implantable medical device includes an inner shaft extending in a longitudinal direction and an outer sheath adapted to surround at least a portion of the inner shaft, the outer sheath being slideable relative to the inner shaft in the longitudinal direction. A compartment defined between the inner shaft and the outer sheath is adapted to receive the medical device in an assembled condition. A retaining assembly positioned at one end of the compartment includes a first member rotatable with respect to the inner shaft, and a second member rotationally fixed with respect to the inner shaft. The medical device includes at least one retainer adapted to be received within at least one retainer slot of the first member. This arrangement enables the medical device to rotate within the compartment as the delivery device is advanced to an implantation site.

Abstract: A delivery device for a collapsible prosthetic heart valve, the delivery device including an inner shaft, a distal sheath disposed about a portion of the inner shaft and forming a compartment with the inner shaft, the compartment adapted to receive the valve, the inner shaft and the distal sheath being movable relative to one another, and a handle including a frame having a longitudinal axis, a proximal end and a distal end, the handle including a deployment actuator and a hub, the deployment actuator and the hub being independently capable of opening and closing the compartment, a resheathing lock configured to alert a user of a position of the distal sheath and to impede movement of the distal sheath, and an indicator disposed on the frame and capable of showing an extent of deployment of the valve.

Abstract: A delivery device for a collapsible prosthetic heart valve may include an operating handle and a catheter assembly. The handle may include a housing, a piston cylinder, a piston longitudinally slidable within the piston cylinder, the piston and the piston cylinder together defining at least one pressure chamber, a deployment actuator coupled to the housing and rotatable relative thereto, and a pneumatic switch adapted to provide a pressurized fluid to the pressure chamber to apply a longitudinal force to the piston. The catheter assembly may include a first shaft around which a valve-receiving compartment is defined, the first shaft being operatively connected to the housing, and a distal sheath operatively connected to the piston, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment. Longitudinal movement of the piston may move the distal sheath between the closed and open conditions.