Abstract: Described embodiments are directed toward prosthetic valves and systems and methods of making prosthetic valves. In accordance with an embodiment, a prosthetic valve comprises and leaflet frame, and outer frame and a film. The leaflet frame has a generally tubular shape defining a plurality of leaflet windows. The outer frame has a generally tubular shape. The leaflet frame is coaxially disposed at least partially within the outer frame. The leaflet frame and outer frame is coupled at least in part by a contiguous portion of the film. At least a portion of the contiguous portion of the film is contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween. The film defines a leaflet extending from each of the leaflet windows.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: A valve device is provided for implantation at the location of a natural heart valve, for replacing the functioning of the natural heart valve. The valve device includes a holding structure and a plurality of leaflets that open and close as the heart beats and pressure changes. The valve device holding structure may comprise a substantially ring-shaped first section, or ventricular ring, and a substantially ring-shaped second section, or atrial ring, connected together by a connector. The valve device holding structure, which may include all parts besides the leaflets themselves, may be formed from a wire or tube made of a suitable flexible material that allows the valve device to be substantially straightened to a low profile in a constrained delivery condition and that allows the valve device to self-expand to its ring-shaped expanded profile when unconstrained during implantation.

Abstract: The present invention provides a leaflet for use in a prosthetic valve that stabilizes the motion of the leaflet as it moves between a closed position and an open position. In accordance with embodiments, a prosthetic valve is provided with a leaflet that contains a stiffening element between layers of film from which the leaflet is made.

Abstract: A method for implanting a valve prosthesis at a native cardiac valve complex of a subject comprises implanting a distal fixation member of the valve prosthesis downstream of a native valve of the native valve complex such that two or more engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first axial force directed upstream. The method also comprises implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second axial force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve complex. The engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.

Abstract: An intravascular cuff acts as a lining between a native vessel and an intravascular prosthetic device. During deployment, the ends of the cuff curl back upon themselves and are capable of trapping native tissue, such as valve leaflet tissue, between the ends. The cuff creates a seal between the vessel and the prosthetic, thereby preventing leakage around the prosthetic. The cuff also traps any embolic material dislodged from the vessel during expansion of the prosthetic.

Abstract: A prosthetic heart valve having a stent, a plurality of leaflets positioned within the stent, and a suspension assembly coupled to the leaflets and the stent. The suspension assembly includes a central support structure that is spaced from the plurality of leaflets in the direction of blood flow. A plurality of elongate suspension members are secured to the central support structure, and at least one elongate suspension member is secured to each leaflet of the valve, thereby providing mechanical reinforcement for the leaflets.

Abstract: A connector for joining first and second hollow structures, comprising a fluid-constraining tube having a fluid-constraining neck extending therefrom, wherein the tube and the neck each comprise a lumen having first and second openings, the neck being joined to the tube such that fluid entering the first opening of the tube can exit the second opening of the tube, and fluid entering the first opening of the neck can exit the second opening of the tube; at least the portions of the tube adjacent to the first and second openings of the tube being biased radially outwardly so that they normally assume a radially-expanded configuration, but being capable of being restrained in a radially-contracted configuration, wherein the tube is sized so that, when it is in its radially-expanded configuration, it has an outer diameter which is larger than the inner diameter of the second hollow structure.

Abstract: A method of treating a diseased cardiac valve can include implanting a valve prosthesis by compressing the valve prosthesis to a compressed state for delivery and expanding the valve prosthesis to an expanded state for deployment. The valve prosthesis can include a valve fixation device having a plurality of struts, a first circumferential row of cells coupled to the struts, and a second circumferential row of cells coupled to the struts. The struts are substantially rigid such that the struts do not change dimensions between the compressed state and the expanded state. The valve prosthesis can also include a plurality of leaflets and a plurality of commissures. The valve is coupled to the valve fixation device such that the commissures are radially aligned with respective struts of the plurality of struts.

Abstract: A prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Abstract: A venous valve with a tubular frame that includes an outer surface and an inner surface opposite the outer surface and defining a lumen, and a cover over at least the outer surface of the tubular frame, where the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen. A system with the venous valve and a catheter including a proximal end and a distal end, the venous valve located between the proximal end and distal end of the catheter. A method including forming the venous valve and reversibly joining the venous valve and a catheter. A method including positioning at least part of the catheter including the venous valve at a predetermined location and deploying the venous valve from the catheter at the predetermined location.

Abstract: An implantable prosthetic valve assembly having a frame comprising a first frame portion and a second frame portion connected end-to-end exhibits enhanced rigidity. Each frame portion includes a plurality of circumferential struts formed with multiple bends, with the bends of the first frame portion having angles that are less than the bends of the second frame portion. Some embodiments of the frame have a semi-collapsed state in which the first frame portion is frustoconical and the second frame portion is generally cylindrical. A valve member is attached to the first frame portion.

Abstract: An apparatus, system, and method for percutaneous valve replacement and/or augmentation. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a thread passing over the valve frame to hold the valve frame in a partially deployed state, where removal of the thread allows the valve frame to expand toward a deployed state. Use of the thread to hold the valve frame allows for staged deployment of the valve.

Abstract: Miniature axial flow pumps are implanted inside the heart or major arteries to provide hemodynamic support. These pumps commonly utilize tubular blood conduit tubes to transport blood across the aortic valve. The valve leaflets themselves are very thin and flexible, and will seal against the conduit if it is centered within the valve orifice. If the conduit is not centered, a leaflet can be pushed to the side of the aorta, preventing the leaflets from sealing and providing a path for backflow. If the blood flow conduit remains pushed against the side of the valve for a long period of time, thrombus may form in the crevice between the conduit and the aorta, causing serious thromboembolic events such as stroke, if the thrombus breaks free. The present invention provides a conduit support device that retains the conduit centered within the annulus of the natural heart valve.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

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 cuff having an inner surface and an outer surface is made sufficiently rough to promote tissue growth. The prosthetic heart valve further includes a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to at least one of the stent and the cuff.

Abstract: A multi-leaflet valve, which includes at least two leaflets, an outer tube, and a seam protector for each seam. Each seam protector is positioned to be in contact with a portion of the outer tube, with tube portions and leaflet ends being positioned between adjacent seam protection pieces. The seam protectors provide a lower stress surface about which the leaflets can bend or flex during their opening and closing. The seam protectors may include an enlarged end portion with an extending straight surface, an inverted U-shaped structure, or a sinusoidal-shaped structure, for example. The valve can further be provided with a seam cover or protector that is stitched onto the seam allowance of the layers of one or more of the seams. The seams can be provided with one or more inserts to fill spaces between adjacent tissue layers and create tension in certain material sheets.

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: An endo luminal support structure (10) includes strut members (11) interconnected by swivel joints (15) to form a series of linked scissor mechanisms. The structure can be remotely actuated to compress or expand its shape by adjusting the scissor joints within a range of motion. In particular, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be employed to introduce and support a prosthetic valve (100) within a body lumen.

Abstract: The invention relates to a valve prosthesis for replacing an atrioventricular valve of the heart, comprising an annular body (12), to which heart valve leaflets are attached and which can be inserted in the valve annulus (18) of the heart (20), and further comprising at least one anchoring part (16, 16?), which protrudes from the annular body (12) on the ventricle side and can be anchored in tissue.

Abstract: A prosthetic valve for replacing an atrioventricular heart valve comprises an annular body (2) on which valvular cusps are fastened and which is adapted to be inserted into a valve annulus (18) of the heart (20). The annular body has a plurality of anchor elements which are connected thereto on the ventricle side and optionally other anchor elements which are connected to the annular body on the atrium side. Said anchor elements extend radially outside the annular body and substantially parallel to its outer wall.

Abstract: One embodiment of the present invention provides an implantable valve prosthesis. The valve prosthesis includes a frame defining a lumen extending between a proximal frame end and a distal frame end along a longitudinal axis, and a first valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame. The first valve leaflet comprises a first and a second slit extend distally from the proximal edge and defining a free portion of the first valve leaflet between the first and second slits. The first valve leaflet is movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction.

Abstract: A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. The valve can have a multi-lobal shape in the unstressed position. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Abstract: An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve's length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

Abstract: A stented valve including a generally tubular stent structure that has a longitudinal axis, first and second opposite ends, a plurality of commissure support structures spaced from the first and second ends and extending generally parallel to the longitudinal axis, at least one structural wire positioned between each two adjacent commissure support structures, and at least one wing portion extending from two adjacent commissure support structures and toward one of the first and second ends of the stent structure. The stented valve further includes a valve structure attached within the generally tubular stent structure to the commissure support structures.

Abstract: A prosthetic mitral valve assembly, comprising a housing in which a plurality of leaflets are pivotally supported, wherein a periphery of the leaflets cooperates with an inner surface of the housing to close the valve and the housing is formed with an external shape which substantially corresponds to that of a mitral valve annulus so as to fit within the annulus.

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: Methods and apparatus are provided for repairing or replacing a defective cardiac valve including an anchor having a double helix configured to engage the cardiac valve leaflets of a diseased or defective cardiac valve, and a replacement valve body disposed in an expandable stent configured to be disposed within the anchor so that the anchor limits expansion of the expandable stent. The expandable stent of the replacement valve body may be self-expanding or mechanically expanded, e.g., using a balloon catheter or catheter-based mandrel and the valve body may be formed of animal tissue or a synthetic fabric.

Abstract: A prosthetic heart valve for functionally replacing a previously implanted prosthetic heart valve is disclosed. The prosthetic heart valve includes a collapsible support structure with leaflets and anchors mounted to the support structure. The support structure also includes an inflow end and an outflow end. The anchors include a radially outwardly extending first anchor proximate to the inflow end and a radially outwardly extending second anchor proximate to the outflow end. The first anchor includes a first configuration and the second anchor includes a second configuration where the first configuration is different than the second configuration. The previously implanted prosthetic heart valve serves as a platform for securement of the prosthetic heart valve to the patient's native tissue.

Abstract: A method is provided for treating a cardiovascular disease, such as pulmonary arterial hypertension, an arrhythmia, or heart failure. One step of the method includes providing an apparatus. The apparatus includes an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. At least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into a blood vessel. The expandable support member is inserted into the pulmonary vasculature and then advanced to a bifurcation in the pulmonary vasculature. The bifurcation includes the intersection of a first pulmonary vessel, a second pulmonary vessel, and a third pulmonary vessel. The expandable support member is secured at the bifurcation to treat pulmonary arterial hypertension, for example.

Abstract: Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.

Abstract: Described is a valve prosthesis comprising: an annular structure, and a plurality of valve leaflets, and a plurality of anchoring members attached around the annular structure, the anchoring members including: a web portion coupled to the annular structure and extending axially thereto, and two end portions at axially opposed sides of the web portion, the end portions having: an insertion condition for insertion of the prosthesis, wherein the end portions are aligned to the web portion and extend axially with respect to the annular structure; and an anchoring condition for anchoring the prosthesis, wherein the end portions extend at an angle to the web portion radially outwardly of the annular structure to provide anchoring of the prosthesis proximally and distally, respectively, of the annulus, and wherein one end portion forms an obtuse angle with the web portion.

Abstract: Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section (102) a second stent section (104) a third stent section (106) and a fourth stent section (108).

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: Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve comprises a collapsed configuration and an expanded configuration. The transcatheter valve can further comprise an everted configuration and a non-everted configuration.

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: A device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.

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: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: A stented valve including a stent structure having a generally tubular body portion, an interior area, a longitudinal axis, an first end, an second end, and an outer surface; at least one outflow barb extending from the outer surface of the stent adjacent to the first end of the stent structure and toward the second end of the stent structure; at least one inflow barb extending from the outer surface of the stent adjacent to the second end of the stent structure and toward the first end of the stent structure; and a valve structure attached within the interior area of the stent structure.

Abstract: A method of using a prosthetic heart valve assembly can include implanting a first prosthesis directly into a native annulus. The first prosthesis can have a central longitudinal axis and a first engagement element. The method can also include engaging the first engagement element of the first prosthesis with a second engagement element of a second prosthesis to securely couple the second prosthesis to the first prosthesis. The second prosthesis can have a prosthetic valve. The first engagement element engages the second engagement element by moving the second prosthesis towards the first prosthesis in a direction generally parallel to the central longitudinal axis until the first engagement element engages the second engagement element.

Abstract: An artificial heart valve comprises a support structure defining an aperture for blood flow and a flexible leaflet connected to the support structure along first and second at least partially straight lines of attachment, wherein the leaflet is movable relative to the support structure between an open configuration in which the leaflet permits blood flow through the aperture and a closed configuration in which the leaflet restricts blood flow through the aperture. A lateral cross-section taken through the leaflet defines an outwardly convex portion, an outwardly concave portion and a junction between the convex and concave portions. The heart valve may be configured for implantation in a human or animal subject. A method of manufacturing a heart valve and a former for use in such a method are also disclosed.

Abstract: A prosthetic heart valve includes a base and a plurality of polymeric leaflets. Each leaflet has a root portion coupled to the base, and each leaflet has an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets. Each leaflet includes) at least two polymers along at least one portion of the leaflet, and each leaflet has a composition gradient of each of the at least two polymers along at least one portion of the leaflet.

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: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: A prosthetic heart valve is provided with a cuff (85, 285, 400) having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion (90) adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements (210, 211, 230, 252, 253) for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness (280) distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part (402) of the cuff may be movable relative to the stent during implantation.

Abstract: A replacement heart valve assembly has a stent frame and a replacement valve. The replacement valve has a plurality of leaflets and a valve frame. The leaflets are attached to the valve frame. Further, the assembly has a plurality of suspension struts attached to the stent frame and the valve frame. The valve frame is suspended within the stent frame via the suspension struts. In some embodiments, the assembly further has a sealing member attached to the stent frame to prevent leakage around the replacement heart valve assembly.