59 results about "Replacement heart valve" patented technology

An expandable framework for use in a replacement heart valve implant includes a plurality of struts defining a lattice structure with an inflow end, an outflow end, and a plurality of stabilization arches extending downstream from the outflow end. The lattice structure includes a first circumferential row of cells defining a plurality of lower crowns at the inflow end and a second circumferential row of cells defining a plurality of upper crowns at the outflow end, where the cells of the first and second circumferential rows each have a lower point and an upper point. The lower point of at least some of the cells in the second circumferential row is a free point devoid of attachment to any other strut and extends radially outward beyond a radially outer surface of any strut immediately below in an axial direction.

A replacement heart valve implant includes an expandable framework including a tubular wall comprising a plurality of interconnected struts and defining a central lumen, wherein the wall includes inflow and outflow ends, and a plurality of commissure posts. A plurality of valve leaflets is secured to the commissure posts. The framework may include a plurality of native leaflet clamps extending upstream from the outflow end, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall. The framework may include a plurality of native commissure clamps extending upstream from the commissure posts, wherein the commissure clamps are configured to pinch native commissures of the native heart valve. The framework may include a plurality of native leaflet clamps extending upstream from the commissure posts, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall.

A replacement heart valve comprises a unibody, folded, double-wall stent, with a stent cover and a leaflet valve attached to the inner lumen of the stent. The heart valve is delivered using a multi-pulley, suture-based stent restraint assembly provided by fixed guide openings or structures along the distal end of the delivery system that independently permits expansion of the distal and proximal ends of the outer wall of the stent, and control of the inner wall expansion simultaneously with or separately from the expansion of the outer wall.

The present invention provides a method for using prostheses, such as replacement heart valves, to be delivered and / or controlled to a desired location within the body. [Solution] A foldable and expandable frame comprising rows of cells may include a plurality of axial connecting portions extending between the top and bottom ends of the cells, each axial connecting portion being shaped to bend to accommodate transient changes in cell height during uneven compression of the replacement heart valve. The frame is advantageous when advancing the replacement heart valve through a funnel-shaped compression tool. The axial connecting portions are sufficiently flexible to accommodate changes in the frame shape during compression, while also being sufficiently resilient to reinforce the structural integrity of the frame in the fully deployed state. The replacement heart valve is preferably a double-frame heart valve, where the axial connecting portions form part of the inner frame, and the outer frame is provided to engage with tissue and form a seal.

A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

A delivery device for a replacement heart valve implant includes a handle having first and second rotatable knobs, and an elongate shaft assembly extending from the handle. A distal portion of the shaft assembly includes an implant holding portion configured to constrain the implant in a radially collapsed configuration. The implant includes a first feature and a second feature. The first knob includes a first tactile element representative of the first feature. The second knob includes a second tactile element representative of the second feature. The first tactile element may be embossed on the first knob. The second tactile element may be embossed on the second knob. The first and second tactile elements are configured to reduce a user's cognitive load during deployment of the implant.

A replacement heart valve prosthesis can be delivered to or within an existing prosthesis through a valve-in-valve delivery procedure. The existing prosthesis can be a prosthetic heart valve or other device that is implanted at a target site, such as an aortic or mitral valve of the heart. The methods provided herein can allow a surgeon to position a replacement prosthesis within or adjacent to an existing prosthesis and permit the replacement prosthesis to expand into engagement against the existing prosthesis. Thereafter, the surgeon can adjust components of the replacement prosthesis, including the position of separate anchor and frame components in order to ensure accurate and secure placement of the replacement prosthesis at the target site.

A replacement heart valve implant includes an expandable framework including a tubular wall comprising a plurality of interconnected struts and defining a central lumen, wherein the wall includes inflow and outflow ends, and a plurality of commissure posts. A plurality of valve leaflets is secured to the commissure posts. The framework may include a plurality of native leaflet clamps extending upstream from the outflow end, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall. The framework may include a plurality of native commissure clamps extending upstream from the commissure posts, wherein the commissure clamps are configured to pinch native commissures of the native heart valve. The framework may include a plurality of native leaflet clamps extending upstream from the commissure posts, wherein the leaflet clamps are configured to pinch native leaflets of the native heart valve against the wall.

A replacement heart valve comprises one or more stent frame features, including inset barbs, ring attachment structures or attachment tabs.

The disclosure relates to heart valve prostheses with the reduced need of pacemaker implantation and / or improved means for positioning the replacement heart valve. A heart valve prosthesis is provided with a stent and at least one locator. The locator has an adapted design for positioning within a cusp of the native aortic valve for implantation at the native heart valve site. Placement of the locators within the cusps preferably prevents movement from the native heart valve site post-implantation, including proximal movement of the prosthesis into the left ventricle.

A guidewire may be adapted for delivering a replacement heart valve implant as well as providing pacing to the heart as part of a process of implanting the replacement heart valve implant. The guidewire includes an elongate shaft including a distal section and a proximal section extending proximally from the distal section. The distal section forms a spiral portion that when unconstrained, includes a proximal spiral portion that curves in a direction and defines a plane and a distal spiral portion that extends out of the plane defined by the proximal spiral. One or more electrodes are disposed within the distal section for pacing.

A replacement heart valve frame assembly includes an expandable framework and an outer skirt coupled to an outer surface of the expandable framework. The outer skirt includes a plurality of pleats.

A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

A replacement heart valve prosthesis for transcatheter repair of a native valve, the replacement heart valve comprises a valve construct mounted to the exterior surface of an expandable frame. The frame comprises an expandable region near the distal end of the frame, and a cusp region near the proximal region comprising a plurality of valve attachment features. The valve construct may be attached to the valve construct at least at the valve attachment features. The replacement heart valve prosthesis of present disclosure may be a more durable and long-lasting valve that has added benefits by placing valve tissue between the expandable frame and native cardiac tissue.

In various embodiments, provided herein are methods, devices and systems to optimize delivery of ring-shaped articles for receiving transcatheter valves or stents. These methods, devices and systems are used to treat patients with valvular diseases. In some embodiments, the device includes at least three cables configured to hold a ring-shaped article having a center hole. The at least three cables are further configured to be anchored to supra-annular tissue at a heart valve peri-annular region. The ring-shaped article is positioned and deployed by means of at least three cables used to embed screws or anchors attached to the ring-shaped article into the supra-annular tissue; this deployed ring-shaped article is configured to receive a replacement heart valve in its inner lumen, thereby acting as a landing zone.

A replacement heart valve implant includes a framework and a plurality of valve leaflets. The framework includes interconnected struts, a plurality of upper crowns, and a plurality of lower crowns. The lower crowns include a bend line extending circumferentially through each lower crown and disposed upstream of upstreammost intersections of the struts and downstream of an upstreammost extent of the lower crowns. A replacement heart valve system includes the implant and an implant delivery system including a handle and an elongate shaft assembly, wherein a distal portion of the shaft assembly includes an implant holding portion. A method of loading the implant includes positioning the implant adjacent the holding portion, positioning the lower crowns surrounding a stent holder of the delivery system, collapsing the framework such that the lower crowns extend into a groove of the stent holder, and shifting the holding portion over the implant.

A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.

The invention relates to a BASILICA system for replacement heart valve implantation. The BASILICA system may include a first catheter (420), an electrically conductive guidewire (430), a second catheter (440), and a snare shaft (450); the first catheter includes a side port (426) disposed proximal to the distal tip and an electrically conductive guidewire slidably disposed within the first catheter and configured to advance away from a side port adjacent a leaflet of a replacement heart valve implant disposed within a patient's native heart valve, and the second catheter includes a lumen extending to a distal end of the second catheter, a snare shaft is slidably disposed within the second catheter, the snare shaft including a wire loop (452) configured to grasp an electrically conductive guidewire. The BASILICA system may include a delivery catheter (410). A first catheter and a second catheter may be disposed within the delivery catheter. The conductive guidewire may be configured to be electrically coupled to a source of radio frequency energy. The conductive guidewire may be configured to pierce the leaflet.

A replacement heart valve implant includes a framework and a plurality of valve leaflets. The framework includes interconnected struts, a plurality of upper crowns, and a plurality of lower crowns. The lower crowns include a bend line extending circumferentially through each lower crown and disposed upstream of upstreammost intersections of the struts and downstream of an upstreammost extent of the lower crowns. A replacement heart valve system includes the implant and an implant delivery system including a handle and an elongate shaft assembly, wherein a distal portion of the shaft assembly includes an implant holding portion. A method of loading the implant includes positioning the implant adjacent the holding portion, positioning the lower crowns surrounding a stent holder of the delivery system, collapsing the framework such that the lower crowns extend into a groove of the stent holder, and shifting the holding portion over the implant.

This application relates to systems and mechanisms for deploying docking devices for replacement heart valves. Systems and methods can be used to deliver a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart, while a distal tip can be positioned at or near the commissure of the native valve. A docking device can be positioned within the delivery catheter. A pusher of a pusher tool, such as a pusher wire or tube, can be advanced distally through the delivery catheter, where the pusher can push the docking device along the delivery catheter. The docking device can be connected to the pusher tool by a wire, such as a suture. A member of the pusher tool can be rotatable to change an amount of suture extending from the pusher tool.

A system for heart valve replacement includes a collapsible and expandable replacement heart valve and a packaging assembly for storing the replacement heart valve. The packaging assembly includes a funnel extending from a first end to a second end. The funnel has a first interior diameter at the first end and a second interior diameter, the second interior diameter smaller than the first interior diameter. The funnel defines an internal lumen extending between the first and second ends. The funnel defines a plurality of longitudinal slots extending along an interior surface of the funnel between the first and second ends.

A replacement heart valve system includes a replacement heart valve implant including an expandable framework and a plurality of leaflets, wherein the framework includes an attachment tab extending upstream from an inflow end, and an implant delivery system including an implant holding portion including a stent holder configured to engage the attachment tab to axially secure the implant relative to the delivery system. The stent holder includes a first radiopaque marker, and the attachment tab includes a second radiopaque marker, the first and second markers may collectively indicate a rotational orientation of the framework relative to a native heart valve under fluoroscopy. The first radiopaque marker may indicate when a middle commissure post of the framework is disposed in a posterior position and an anterior position relative to a native heart valve under fluoroscopy in a 3-cusp view.

A replacement heart valve frame assembly includes an expandable framework and an outer skirt coupled to an outer surface of the expandable framework. The outer skirt includes a plurality of pleats.

Systems and methods usable in delivering a prosthetic implant to a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The prosthetic implant can be located within the delivery catheter. A pusher tool can be advanced distally through the delivery catheter to push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.

An implant delivery system for delivering a replacement heart valve implant to a natural heart valve may include an elongated shaft assembly containing an implant holder configured to restrain the replacement heart valve implant in a radially folded configuration. The elongated shaft assembly may include a plurality of longitudinal marker elements configured to be visible under fluorescence fluoroscopy using an imaging device. The plurality of longitudinal marker elements are configured to rotate the commissure posts of the replacement heart valve implant with the natural valve commissures of the natural heart valve under fluorescence fluoroscopy using an imaging device, once the replacement heart valve implant has transitioned to a radially expanded configuration within the natural heart valve.

The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.