70 results about "Replacement heart valve" patented technology

A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Apparatuses, systems, and methods for prosthetic valves having sensor systems are disclosed. Examples of prosthetic valves include replacement heart valves for replacing the function of a native heart valve, such as a mitral or tricuspid valve. In various embodiments, replacement heart valves are provided with sensors or markers for assisting with proper placement and / or securement in the body. A replacement heart valve may include anchors for securing the replacement heart valve to native leaflets, wherein sensors and / or markers provide feedback to the physician for confirming proper placement of the anchors during the implantation procedure. Sensors may also be used to assess the function of the prosthetic valve after deployment. Sensors may also be used to monitor blood pressure, temperature, oxygen, insulin, cholesterol, and / or glucose to assess overall patient health.

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 heart valve assembly has a valve frame having a cylindrical body with commissure posts connected to an outflow end, and a leaflet assembly sutured to the plurality of commissure posts and the valve frame. The assembly also has an outflow frame having a plurality of connection posts, with each connection post connected to one of the commissure posts. The valve frame and the annulus frame are made from different materials. A delivery system has a balloon catheter having a shaft, a balloon provided on the shaft adjacent the distal end of the catheter, and a frame seat located on the shaft directly proximal to the balloon. The delivery system includes a sheath assembly having a capsule that slidably covers the balloon and the frame seat such that the outflow frame is seated around the frame seat and the valve frame is seated over the balloon.

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.

Disclosed herein are embodiments of a delivery system which can be used to recapture and / or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the delivery system can involve a torqueing manifold that interacts with multiple tethers that are releasably coupled to eyelets of a replacement heart valve. Engagement pins may be configured to releasably retain one end of the tethers.

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 heart valve assembly has a valve frame having a cylindrical body with commissure posts connected to an outflow end, and a leaflet assembly sutured to the plurality of commissure posts and the valve frame. The assembly also has an outflow frame having a plurality of connection posts, with each connection post connected to one of the commissure posts. The valve frame and the annulus frame are made from different materials. A delivery system has a balloon catheter having a shaft, a balloon provided on the shaft adjacent the distal end of the catheter, and a frame seat located on the shaft directly proximal to the balloon. The delivery system includes a sheath assembly having a capsule that slidably covers the balloon and the frame seat such that the outflow frame is seated around the frame seat and the valve frame is seated over the balloon.

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.