A delivery device includes an inner shaft, an outer sheath, a nosecone, and a tether component. The outer sheath is slidably disposed over the inner shaft. The nosecone is removably coupled to the inner shaft. The nosecone includes a delivery configuration for delivery to a treatment site, a radially compressed configuration in which a portion of the nosecone is configured to traverse through a heart wall, and a radially expanded configuration in which an outer surface of the nosecone contacts an outer surface of the heart wall. The tether component includes a first end coupled to the nosecone. The nosecone is configured to plug a piercing in the heart wall when in the radially expanded configuration.

Medical delivery system for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter, an inner guide catheter and an interventional catheter. The first deflection portion of the outer guide catheter is steerable to define a first outer-guide-catheter curve and the second deflection portion of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion of the inner guide catheter is steerable to define a first inner-guide-catheter curve.

The expandable sheaths disclosed herein include an elastic outer tubular layer and a multisegmented inner tubular layer that includes at least two coextruded segments having different durometers and different coefficients of friction. The inner tubular layer further includes a thick wall portion integrally connected to a thin wall portion. The thin wall portion has a lower durometer than the thick wall portion. The thick wall portion has a first and second longitudinally extending end, and the thin wall portion extends between the first and second longitudinally extending ends. The elastic outer tubular layer and the inner tubular layer are radially movable between a non-expanded state, where the elastic outer tubular layer urges the first longitudinally extending end under the second longitudinally extending end, and an expanded state, where the first and second longitudinally extending ends of the inner tubular layer expand apart with the thin wall portion extending therebetween.

Devices for assisting with the functioning of a tricuspid valve of a heart include a shaft, a flow optimizer, and an anchoring mechanism. A tilting mechanism can be configured to tilt the shaft relative to a central axis of the anchoring mechanism. Leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and a rim, and the rim can have a higher stiffness than the membrane. A delivery system can be configured to deliver the device and adjust the position of the flow optimizer with respect to the anchoring mechanism.

A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

A method and device for perforating an aortic valve to remove excessive calcium deposits on aortic valve leaflets improves the implantation of TAVI replacement valves in patients. By removing excessive calcium deposits, the radial pressure exerted by implanted TAVI replacement valves is reduced, such that there is less blood leakage around the valve and less stress on the cardiac conductive system. A device with a collapsible punch is inserted into the aortic valve. The punch is separable such that the aortic valve leaflets are positioned between at least two elements of the punch. The two elements then compress together with the leaflets between them, causing the aortic valve to be perforated. A circumferential ring of the remaining aortic valve and calcium deposits are left to provide stability for the TAVI replacement valve.

A tool for use in loading a transcatheter valve prosthesis within a delivery catheter includes a body portion, a pivotable element and a biasing element. The body portion includes a central passageway extending form a proximal end to a distal end of the body portion. The central passageway is configured to receive a distal portion of a delivery catheter therethrough. The pivotable element is attached to the body portion and is configured to secure a tether during loading of a transcatheter valve prosthesis within the delivery catheter. The biasing element compresses the pivotable element against the body portion such that the pivotable element holds a second end against the delivery catheter and secures the tether thereto. The pivotable element may be two or more pivotable elements.

Features for a restraint, such as a cap, are described. The restraint secures a cardiac device in a collapsed, delivery configuration for transcatheter delivery to a heart. The restraint may have a tubular sidewall extending from a proximal end to a distal end, a proximal opening defined by the sidewall at the proximal end and a channel defined by the sidewall and extending distally from the proximal opening. The restraint is configured to receive the implant in the collapsed configuration through the proximal opening to radially restrain the implant within the channel. The restraint eliminates the need for a surrounding sheath, reducing the delivery profile and size of the overall delivery system, among other advantages. The restraint may have an atraumatic leading edge to reduce the risk of injury to the patient.

A prosthetic heart valve comprises an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state. Leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state, and wherein when the frame is in the radially compressed state, the leaflets are stretched in the axial direction.