Abstract: A method for replacing a cardiac valve includes an expandable support member having oppositely disposed first and second ends, a main body portion extending between the ends, and a prosthetic valve within the main body portion. The main body portion has an annular shape for expanding into position in the annulus of the valve. The first and second ends include a plurality of upper and lower wing members movable from a collapsed condition into an extended condition for respectively engaging a first section of cardiac tissue surrounding the valve and for: engaging a portion of the native valve leaflets to pin the leaflets back against the annulus. The second end further includes at least two strut members spaced apart from each other. A respective one of the strut members is attached to at least one commissural section of the prosthetic valve to prevent prolapse of the valve leaflets.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable frame, thereby enabling attachment to the annulus without sutures. A small number of guide sutures may be provided for aortic valve orientation. The prosthetic valve may be a commercially available valve with a sewing ring with the frame attached thereto. The frame may expand from a conical deployment shape to a conical expanded shape, and may include web-like struts connected between axially-extending posts. A system and method for deployment includes an integrated handle shaft and balloon catheter. A valve holder is stored with the heart valve and the handle shaft easily attaches thereto to improve valve preparation steps.

Abstract: Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame coaxially disposed within a body frame, as well as methods of making the valve devices.

Abstract: An implant device for a heart having a first chamber and a second chamber and a native valve between the chambers, the device having an elongate body having opposing ends, the body being configured to be implanted within the heart and extend through the native valve with a first end in the first chamber and a second end in the second chamber; a first resiliently compressible part of the body being adapted to be compressively engaged by the heart within the first chamber; and a second resiliently compressible part of the body being adapted to be compressively engaged by the heart within the second chamber; so that the first and second parts hold the elongate body in a desired position within the heart by said compressive engagement. The device can be employed as a prosthetic device replace or supplement a native valve such as the mitral valve.

Abstract: The invention relates to a tubular supporting prosthesis capable of growing, comprising a mesh structure, wherein the mesh structure comprises at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis, wherein the structural rings and/or the connecting members have at least one predetermined breaking point.

Abstract: The systems, devices and methods relate surgical and percutaneous replacement of a valve. The devices may include a frame and artificial leaflets. The devices may include one frame or two frames. The devices may also include a stent device in which the implant valve device may be implanted. The devices may also include a valve retainer device.

Abstract: Apparatus for regulating blood flow of a subject is provided, the apparatus comprising a prosthetic valve that comprises a tubular element, shaped to define a lumen therethrough; and a valve member, configured to be coupled to the tubular element and to be disposed within the lumen. The prosthetic valve has (1) a compressed configuration in which the lumen has a compressed width, the valve member is generally cylindrical, and the prosthetic valve is configured to be percutaneously delivered into the subject, and (2) an expanded configuration in which the lumen has an expanded width that is greater than the compressed width, and the valve member is generally disc-shaped, is coupled to the tubular element, and is disposed within the lumen. Other embodiments are also described.

Abstract: A prosthetic valve assembly can include a radially expandable stent. The stent can include a first expandable annular portion that is configured, in an expanded state, to bear against a wall of a native body lumen, a second expandable annular portion that is configured, in an expanded state, to bear against a wall of a native body lumen. The stent can also include a plurality of rods extending between the first annular portion and the second annular portion. The prosthetic valve assembly can further include an implantable prosthetic valve mounted to the stent such that the valve is between the first annular portion and the second annular portion. The prosthetic valve assembly is configured to be delivered by catheterization.

Abstract: An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly.

Abstract: Embodiments of an apparatus for treating a deficient mitral valve include an expandable spacer configured for placement between the native leaflets of the mitral valve, the spacer anchorable to a wall of the ventricle. Methods and apparatus for delivering and implanting the prosthetic are also described.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. A plurality of commissure features is disposed on the stent and coupled to selected ones of the struts, each commissure feature including a body having a proximal end and a distal end, and at least one eyelet in the body. The heart valve further includes a collapsible and expandable valve assembly including a plurality of leaflets. At least one leaflet is connected to the at least one eyelet and to at least one of the selected ones of the struts via a suture pattern.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent and a plurality of commissure features disposed on the stent. A collapsible and expandable valve assembly includes a plurality of leaflets connected to the plurality of commissure features, each commissure feature including a body having a proximal end and a distal end. A plurality of eyelets is arranged in rows and columns on the body for distributing load from the plurality of leaflets.

Abstract: A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Abstract: Cardiac valve supports and their methods of use.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent has a proximal end, a distal end and a plurality of cells, each cell being formed by a plurality of struts. A valve assembly is secured to the stent and includes a cuff and a plurality of leaflets. The plurality of leaflets are attached to the cuff adjacent an underwire that extends about the perimeter of the cuff.

Abstract: The invention relates to a tubular supporting prosthesis, comprising two terminal regions relative to the longitudinal supporting prosthesis axis and a center region disposed between the two terminal regions, wherein every terminal region is provided with a mesh structure made of at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis. The center region is formed by elongated connecting members, which are connected to the structural rings respectively disposed adjacent to the center of the longitudinal supporting prosthesis axis. An aortic valve, which is produced by means of tissue engineering, is fastened and/or integrated in the center region.

Abstract: A cardiac valve with a first anchor frame and a cover on the first anchor frame for unidirectional flow of a liquid through the valve.

Abstract: A method of repairing a native cardiac valve such as the aortic valve includes positioning a cardiac valve prosthesis at an implantation site proximate the native cardiac valve to be repaired. The cardiac valve prosthesis includes an armature and a plurality of prosthetic valve leaflets, the armature including first and second annular elements, a plurality of anchor members extending between the first and second annular elements, and a plurality of valve support members extending from at least one of the first and second annular elements, the plurality of prosthetic valve leaflets being coupled to and supported by the valve support members.

Abstract: A heart valve that can be expanded following its implantation in a patient, such as to accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted, and to minimize paravalvular leakage. In one aspect, the invention may maximize the orifice size of the surgical valve. The invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

Abstract: An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame.

Abstract: Embodiments of prosthetics configured for implanting in at the native mitral valve region of the heart include a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Methods and apparatus for delivering and implanting the prosthetic valve are also described.

Abstract: An apparatus for endovascularly replacing a patient's heart valve comprises an anchor having an outer surface and an inner surface. The anchor is expandable from a collapsed delivery configuration to a fully deployed configuration. A first locking element and a second locking element are attached to the inner surface of the anchor. The first locking element is engageable with the second locking element. At least one of the first locking element and the second locking element has a curved outer surface. Methods for attaching the second locking element to the anchor are also provided.

Abstract: Devices and methods for implantation at a native mitral valve having a non-circular annulus and leaflets. One embodiment of the device includes a valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets and a second region. The device can further include an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion between the first portion and the second portion. The second portion of the anchoring member is attached to the second region of the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to pass through vasculature of a human. The lateral portion is transverse to the longitudinal dimension.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable contact the anatomical annulus of the native valve when the assembly is properly positioned. Portions of the valve support may expand to a preset diameter to maintain coaptivity of the replacement valve and to prevent occlusion of the coronary ostia.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: Some embodiments of the present disclosure provide a stent-valve for transcatheter implantation to replace a cardiac valve. In some embodiments, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation. In some embodiments, the stent-valve comprises a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprising material that swells in response to contact with blood or components thereof.

Abstract: Methods and devices for treating defective heart valves are disclosed herein. In one exemplary embodiment, a transcatheter heart valve includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

Abstract: A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient's main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient's ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient's aorta relative the heart valve predefinable by the positioning stent (20).

Abstract: A dual valve prosthesis having a self-expanding anchoring frame with first and second prosthetic valve assemblies attached to the anchoring frame is disclosed. Each of the first and second prosthetic valve assemblies includes a balloon-expandable stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve assemblies include prosthetic mitral and aortic valves, respectively, and the dual heart valve prosthesis is configured to replace both the native mitral and aortic valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: A dual valve prosthesis having first and second prosthetic valve components with a linkage that connects the first and second prosthetic valve components together is disclosed. Each of the first and second prosthetic valve components includes a stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve components include prosthetic mitral and aortic valves, respectively, and the dual heart valve prosthesis is configured to replace both the native mitral and aortic valves of the heart in a single transcatheter heart valve implantation procedure. The linkage between the first and second prosthetic valve components is configured to secure the anterior mitral valve leaflet against a wall of the left ventricle when the dual valve prosthesis is implanted within the heart.

Abstract: A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

Abstract: A cardiac valve prosthesis includes a frame and a set of prosthetic valve leaflets supported by the frame. The frame defines a principal axis of the cardiac valve prosthesis and includes first and second annular elements expandable from a radially contracted state to a radially expanded state, a plurality of valve supports supporting the leaflets, and a plurality of connecting members. The valve supports are angularly spaced from one another about the principal axis of the cardiac valve prosthesis, and the connecting members extend between and connect the first and second annular elements. When the annular elements are in the radially expanded state each of the connecting members arches radially outward with respect to the annular elements and is configured to project into one of the Valsalva sinuses when implanted. The connecting members are angularly spaced from the valve supports about the principal axis.

Abstract: Prosthetic heart valve apparatus is adapted for delivery into a patient in a circumferentially collapsed condition, followed by circumferential re-expansion at the implant site in the patient. The apparatus includes an annular anchoring structure that can be implanted in the patient first. The apparatus further includes an annular valve support structure, which supports a flexible leaflet structure of the valve. The support and leaflet structures are initially separate from the anchoring structure, but they can be implanted in the patient by interengagement of the support structure with the already-implanted anchoring structure.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features. Each commissure feature includes a body having a proximal end a distal end, and a plurality of eyelets arranged in at least two rows and at least two columns for attaching the body to the plurality of leaflets.

Abstract: This device (10) includes an implant (20) which has a tubular endoprosthesis (30) with a radially deployable framework (36). The implant (20) includes a flexible interposition member (24) mounted movably on the endoprosthesis (30) so as to be interposed between the outer surface (40) and a blood circulation conduit (14). The device (10) includes a deployment tool (26) which can adopt a configuration for insertion of the implant (20) and a configuration for release of the implant (20). In the configuration for insertion of the implant (20), the flexible member (24) includes at least one free part (68) held axially away from the outer surface (40) in order to minimize the radial dimension of the implant (20). The free part (68) is at least partly displaceable against the outer surface (40) when the tool (26) moves from its configuration for insertion to its configuration for release.

Abstract: A prosthetic valve assembly that includes a stent, a tissue sleeve and an anchoring mechanism. By loading the three components of the valve assembly into a delivery catheter in a series formation, such that no two components are located within each other, the size of the delivery catheter can be reduced.

Abstract: A single piece stent construction having a plurality of commissure posts, each of which extends upwardly from a solid ring along a bend line and generally along a central longitudinal axis of the stent.

Abstract: Described herein are systems and methods for operation of a prosthetic valve support structure (32) having additional reinforcement coupled with panels (36). Multiple support members (620) are distributed across the inner surface of the valve support structure (32) at regular intervals. Each support member (620) can include a looped portion (621) to act as a hinge (52). Each looped portion (621) is in a location coincidental with the interlace between adjacent panels (36).

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described.

Abstract: This document provides methods and materials related to providing a mammal with a replacement valve (e.g., a synthetic or artificial heart valve). For example, synthetic or artificial heart valve that can be delivered in a minimally invasive manner are provided.

Abstract: A quick-connect heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The heart valve includes a substantially non-expandable, non-compressible prosthetic valve and a plastically-expandable stent frame, thereby enabling attachment to the annulus without sutures. The prosthetic valve may be a commercially available valve with a sewing ring and the stent frame attached thereto. The stent frame may expand from a conical deployment shape to a conical expanded shape, and may have a cloth covering its entirety as well as a plush sealing flange around its periphery to prevent paravalvular leaking.

Abstract: A prosthesis can be configured to be deployed within a body cavity. The prosthesis has an expandable frame, a plurality of proximal anchors, and a plurality of distal anchors, where the various anchors are connected to the frame. Radial expansion of the frame can cause the ends of the proximal anchors and the ends of the distal anchors to draw closer together.

Abstract: A prosthetic mitral valve assembly and method of inserting the same is disclosed. In certain disclosed embodiments, the prosthetic mitral valve assembly has a flared upper end and a tapered portion to fit the contours of the native mitral valve. The prosthetic mitral valve assembly can include a stent or outer support frame with a valve mounted therein. The assembly can be adapted to expand radially outwardly and into contact with the native tissue to create a pressure fit. One embodiment of a method includes positioning the mitral valve assembly below the annulus such that the annulus itself can restrict the assembly from moving in an upward direction towards the left atrium. The mitral valve assembly is also positioned so that the leaflets of the mitral valve hold the assembly to prevent downward movement of the assembly towards the left ventricle.

Abstract: A heart valve assembly includes a base including a multi-lobular annular shape within a plane, a valve member or other annular body including a multi-lobular shape complementary to the shape of the base, and cooperating connectors on the base and the annular body for connecting the annular body to the base. The base includes an anchoring ring, and a flexible cuff for attaching the base to a biological annulus. The base and the annular body include guides for aligning their multi-lobular shapes, e.g., visual, tactile, or other markers, or tethers that extend from the base that are slidable through the annular body. During use, the base is attached to a biological annulus, the annular body is directed adjacent the annulus, oriented such that the multi-lobular shape of the annular body valve member is aligned with the base, and the annular body is attached to the base.

Abstract: A valve with a frame and valve leaflets that provide a sinus pocket. The valve provides for unidirectional flow of a liquid through the valve.