Abstract: A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

Abstract: A stabilizing unit for a medical device includes a base member, a housing, a stabilizing fork, one or more springs, and a retaining arm. The housing has a lower housing portion and an upper housing portion connected to the lower housing portion. The lower housing portion is disposed in a laterally extending slot of the base member. The stabilizing fork is disposed in the upper housing portion. The one or more springs extend into the stabilizing fork. The retaining arm is slidably coupled to the upper housing portion. The retaining arm retains the stabilizing fork in the upper housing portion.

Abstract: Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

Abstract: A system is provided for anchoring a prosthetic valve to a native valve of a heart. The system includes a steerable catheter, a low friction sleeve, and an anchoring device. The steerable catheter has a first lumen with a distal opening in a distal portion. The low-friction sleeve is configured for delivery through the first lumen. The low-friction sleeve has a second lumen. The anchoring device is configured for delivery through the second lumen such that the low-friction sleeve fits around at least a portion of the anchoring device. The low-friction sleeve is configured to be removed from the anchoring device to expose an exterior surface of the anchoring device when the anchoring device is in position in the native valve.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Abstract: A stabilizing apparatus for a transcatheter delivery system includes a housing having an aperture to receive the transcatheter delivery system. An engagement member is disposed in the housing. A biasing element urges the engagement member against a surface of the transcatheter delivery system when the transcatheter delivery system is placed in the housing.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed steerable catheters can include a handle, a steerable shaft extending from the handle, and a pull wire. The shaft can include a main lumen, an inner polymeric layer surrounding the main lumen, a braided layer surrounding the inner polymeric layer, and an outer polymeric layer surrounding the braided layer, the outer polymeric layer defining a pull wire lumen. The pull wire can extend from the handle and through the pull wire lumen and can have a distal end portion coupled to a distal end portion of the shaft.

Abstract: Tools and methods are provided for delivering a device to a native valve of a patient's heart. A catheter can include a flexible tube, a plurality of links, and a control wire. Applying tension to the control wire pulls on the links, which causes links to bend the flexible tube.

Abstract: An device for treating a native valve includes a sealing element and an anchoring element. The sealing element is made from a braided mesh material. The sealing element is dimensioned to be deployed in an annulus of a native valve of a heart at a position between native valve leaflets to contact the native valve leaflets during ventricular systole to create a seal to prevent regurgitation of blood from the left ventricle to the left atrium. The sealing element is configured to both be radially expanded and radially reduced while at the position between the native valve leaflets. The anchoring element is adapted for deployment in the heart, the anchoring element coupled to the sealing element and configured to support the sealing element at the desired position between native valve leaflets.

Abstract: In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. A stylet having at least a first bent portion extends through a lumen of the nose cone. The at least a first bent portion is disposed within the lumen of the nose cone and restricts axial movement of the elongated shaft relative to the prosthetic valve.

Abstract: Certain aspects of the disclosure concern a device for repairing or replacing a native heart valve. The device can include a frame including a first set of struts intersecting with a second set of struts at a plurality of strut connection points. The frame can be radially expandable from a radially collapsed state to a radially expanded state. The device can include at least one expansion feature including a screw head and a screw shaft connected to the screw head. The screw shaft can extend through a first strut connection point and a second strut connection point. The device can further include a plurality of penetrating members extending from a first end of the frame. Rotating the screw shaft in a first direction can radially expand the frame from the radially collapsed state to the radially expanded state.

Abstract: The present disclosure provides a stabilizing system for a medical device. The stabilizing system includes a table and a stabilizing unit. The table includes a table having a base member and an upper member. The upper member is removably mounted on top of an upper portion of the base member. The upper member includes an inverted T-shaped slot. The stabilizing unit includes a base portion and a support member. The base portion has side rails. The support member is disposed on the base portion. The support member is configured to receive and support a catheter assembly comprising a catheter and a catheter handle. The stabilizing unit is mounted to the upper member of the table by sliding the side rails into the inverted T-shaped slot.

Abstract: A method for deploying an expandable prosthetic heart valve in a patient includes introducing a guidewire into a patient and advancing the guidewire through a vasculature of a patient to a deployment site. A distal end portion of a delivery apparatus and the prosthetic heart valve mounted in a radially compressed configuration along the distal end portion are advanced over the guidewire. The prosthetic heart valve is positioned at the deployment site. A screw mechanism is rotated, which exerts an axially directed onto the prosthetic heart valve, causing the prosthetic heart valve to radially expand from the radially compressed configuration to a radially expanded configuration.

Abstract: An exemplary valve repair device is released from tissue of a valve of a patient by applying tension to a movable arm of a clasp in a retraction direction. A fixed arm of the clasp is attached to an inner paddle portion of a paddle of the valve repair device. The inner paddle portion is connected to an outer paddle portion of the paddle of the valve repair device. Pulling the moveable arm of the clasp flexes the inner paddle portion to allow the moveable arm to move in the retraction direction and thereby release the clasp from the valve tissue.

Abstract: The present disclosure provides a stabilizing unit for a medical device. The stabilizing unit includes a retaining arm having a surface configured to abut a surface of the medical device. The stabilizing unit also includes a stabilizing fork having a slot configured to receive the medical device. A biasing member is in contact with the stabilizing fork and is configured to urge the slot of the stabilizing fork towards the retaining arm. When the medical device is placed in the slot of the stabilizing fork, the basing member urges the stabilizing fork against an adjacent surface of the medical device, and an opposing surface of the medical device against the retaining arm.

Abstract: Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter.

Abstract: An exemplary implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaption element can be connected to leaflets of the native valve by the anchor.

Abstract: Embodiments of the present disclosure provide an introducer device and method for introducing a delivery apparatus into a patient's vasculature. Disclosed methods can include positioning a sleeve of an introducer sheath in a blood vessel of a patient, the sleeve having a lattice layer with a lumen therethrough, inserting a distal end portion of the delivery apparatus and a prosthetic heart valve into the lumen, and advancing the distal end portion of the delivery apparatus through the lumen from the proximal end to the distal end. The method can then include expanding the lumen from a first diameter smaller to a second diameter at least equal to the diameter of the prosthetic heart valve to allow passage of the prosthetic heart valve through the lumen, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic heart valve through the lumen.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a housing, a steerable shaft, a slide nut, and a threaded shaft disposed over the slide nut. The slide nut can have an external threaded surface and an internal surface comprising a slot. The threaded shaft can have an internal threaded surface engaging the external threaded surface of the slide nut. The delivery apparatus can further include an elongated nut guide extending into the slot of the nut to restrain the slide nut against rotation relative to the housing, and a pull wire having a proximal end portion extending into the housing and coupled to the slide nut, and a distal end portion coupled to a distal end portion of the steerable shaft. The threaded shaft can be rotatable relative to the housing to produce axial movement of the slide nut within the threaded shaft.