Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

Abstract: Disclosed in the present disclosure is a prosthetic heart valve comprising a universal core which can be universally used in different implantation positions and different application scenarios, and an adapter selected from more than one adapters which are respectively suitable for the different application scenarios. The prosthetic heart valve according to the present disclosure has better flexibility and wider application range compared with various existing prosthetic heart valves, and may save time cost and research and development cost.

Abstract: A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

Abstract: A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A filler is annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The filler has a first circumferential layer with a first inner wall, a first outer wall, and a plurality of first ribs connecting the first inner wall to the first outer wall. The filler has an expanded condition in which the first inner wall is spaced a first distance from the first outer wall in a radial direction transverse to the longitudinal direction of the stent, and a collapsed condition in which the first inner wall is spaced a second distance from the first outer wall in the radial direction, the first distance being greater than the second distance.

Abstract: A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

Abstract: A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. A dual-wireform support frame including an upper and a lower wireform permits expansion of the valve by one or two valve sizes, for example, with a 2-mm gap between each valve size. The lower wireform has a relatively shallow undulation so that it may stretch apart by a small amount and then prevent further expansion of the valve.

Abstract: Improved prosthetic heart valves, their methods of manufacture, and systems and devices for manufacturing the valves are described. The prosthetic heart valves can be configured for transcatheter implantation. The prosthetic heart valves can have artificial leaflets. The prosthetic heart valves can be manufactured in numerous ways, such as by polymeric dipping processes.

Abstract: Embodiments include implantable valves with attached polymeric components. In an embodiment, an implantable valve is included having a frame comprising a plurality of frame struts. The frame defines a central lumen and at least one of the frame struts defines a connection aperture. The implantable valve can include at least one valve leaflet including a coaptation edge and two connection portions, with one connection portion disposed on either end of the coaptation edge. The connection portion can be disposed within the connection aperture thereby coupling the valve leaflet to the frame. Other embodiments are also included herein.

Abstract: A shunt for regulating blood pressure between a patient's left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Abstract: The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular a device and method for percutaneous annular plication, as a replacement device for a heart valve, whereby the prosthesis has an atrial annular flange or cuff having one or more integral plication windows connected to a pressure actuated flow control member extending into the ventricle, wherein the is a reciprocating mechanical member that is compressed by pressurized working fluid within the heart during ventricular systole.

Abstract: Methods of preparing calcification-resistant bioprosthetic tissue include providing fresh biological tissue, cross-linking the tissue, treating the cross-linked tissue with an alcohol for a time sufficient to allow the alcohol to be diffused into the tissue, and treating the alcohol-treated fixed tissue with a polyol for a time sufficient to allow fluid in the tissue to be replaced by the polyol. The methods may include sterilizing the cross-linked tissue in a solution including propylene oxide or peracetic acid either before or after the alcohol treatment step; or drying the alcohol/polyol-treated, cross-linked tissue, sterilizing the dried tissue by exposure to ethylene oxide or peracetic acid, and storing the sterilized tissue in a dry, ambient environment. The treated tissue may be a tissue component for a bioprosthetic valve, a valve assembly for a bioprosthetic valve or a fully assembled bioprosthetic valve incorporating the tissue.

Abstract: A heart valve bioprosthesis (100) and a manufacturing method thereof are provided. The heart valve bioprosthesis (100) comprises: a support frame (1), valve leaflets (2) and a valve auxiliary structure. The valve leaflets (2) are connected to the valve auxiliary structure, the valve auxiliary structure is connected to the support frame (1). Both the valve leaflets (2) and the valve auxiliary structure are made of biological tissues. The support frame (1) is formed as a single component with an elastic material, and the valve auxiliary structure is preset with suturing marks. The heart valve bioprosthesis improves the biocompatibility with the human body, reduces the total height of the valve, shortens the suturing time, and decreases the possibility of thrombus or bacterial attachment thereto. In addition, the heart valve bioprosthesis is made by a simple process, exhibit excellent compliance with the cardiac tissue, and has a prolonged service life.

Abstract: The present teachings provide devices to change the pressure in a chamber of a heart and methods of making and using thereof. One aspect of the present teachings provides a device comprising a distal portion, a middle portion, and a proximal portion. The distal portion and proximal portion of the device are configured to be deployed inside the left and right atrium respectively with a minimum contact with the septal tissue. The middle portion of the device is configured to secure the device across an aperture on the atrial septum. The device further includes at least one retrieval portion with a plurality of struts. The distal end of the struts is connected with a proximal end of the proximal portions. The proximal end of the struts come together at a location near the axial center of the device. The radial expansion of the proximal portion will lead to the radially outward movement of the struts. And a radially inward movement of the struts will cause the proximal portion of the device to collapse radially.

Abstract: Stented prosthetic heart valve crimping tools and methods, and transcatheter delivery systems for delivering a crimped prosthetic heart valve. Methods of the present disclosure include crimping or compressing a stented prosthetic heart valve via spherical compression to a spherically compressed shape, and then delivering the so-shaped prosthesis to a target site. Delivery systems carrying a spherically-compressed prosthesis have a reduced length profile as compared to conventional, elongated configurations, providing increased maneuverability and positioning.

Abstract: A prosthetic heart comprising a tube having proximal and distal ends, and a central lumen, a tubular frame having proximal and distal ends, and a central lumen, the tubular frame, comprising a plurality of radially-extending members, being disposed on an outside wall of the tube, the distal end of the tube being everted around the distal end of the tubular frame and extending proximally along the tubular frame and over the radially-extending members, and a valve member attached to the tube.

Abstract: A method of reinforcing or repairing a bioprosthetic tissue for use as a prosthetic valve leaflet. The method includes evaluating a bioprosthetic tissue, identifying a defect in the bioprosthetic tissue, and selectively applying an adhesive to a surface of the bioprosthetic tissue at the defect prior to implantation in a patient.

Abstract: A method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

Abstract: A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. The sewing ring may have a compliant insert having a celled construction defined by outer walls and inner ribs. A method of implantation, and a method of assembly of the heart valve is also provided.

Abstract: Prosthetic heart valves having elastic leaflets and an elastic support structure are described. The support structure can store a load transferred from the leaflets as potential energy and then release it in the form of kinetic energy to exhibit a precursory transition from the closed position to the open position. The support structures can exhibit a sinusoidal movement profile at a base edge during the precursory transition.

Abstract: The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing members configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. The present disclosure also discloses new methods of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient.

Abstract: In a case of repairing an aortic valve by forming a valve cusp with a biomembrane, the shape and the size of a valve cusp can be determined easily. An instrument including a valve cusp sizer for measuring the size of the valve cusp and a template for scribing lines for the shape of a valve cusp conforming to the measured size of the valve cusp, in which the valve cusp sizer has a plurality of differently-sized sizer blocks attached to each of the top ends of grip members respectively and each sizer block has an arcuate surface formed by cutting each of differently-sized circular cylinders at an angle conforming to the central angle for the commissure portions and, the template is formed with a scribing portion including a substantially semi-circular valve cusp base forming portion.

Abstract: The invention relates to a prosthetic heart valve (100) for an endoprosthesis (1) used in the treatment of a stenotic cardiac valve and/or a cardiac valve insufficiency. The prosthetic heart valve (100) comprises of a plurality of leaflets (102), which consist of a natural and/or synthetic material and have a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets (102) being able to switch between their first and second position in response to the blood flow through the heart.

Abstract: A sewing ring for prosthetic heart valves that is connected and configured to pivot outward. A biocompatible fabric covering surrounds at least a portion of the sewing ring, and the ring may be exclusively connected to a stent with the fabric. The sewing ring may be generally planar and of uniform thickness, or may be of varying thickness. The fabric may be used to encompass both the stent and the sewing ring, and may be a single piece. A seam may be provided in the fabric as a discrete pivoting line. The sewing ring may be convertible between bi-stable positions. The ring may extend outward in a frusto-conical shape so as to enable inversion between a position facing the inflow end of the valve and a position facing the outflow end of the valve. A method of implantation, and a method of assembly of the heart valve is also provided.

Abstract: In a case of repairing an aortic valve by forming a valve cusp with a biomembrane, the shape and the size of a valve cusp can be determined easily. An instrument including a valve cusp sizer for measuring the size of the valve cusp and a template for scribing lines for the shape of a valve cusp conforming to the measured size of the valve cusp, in which the valve cusp sizer has a plurality of differently-sized sizer blocks attached to each of the top ends of grip members respectively and each sizer block has an arcuate surface formed by cutting each of differently-sized circular cylinders at an angle conforming to the central angle for the commissure portions and, the template is formed with a scribing portion including a substantially semi-circular valve cusp base forming portion.

Abstract: A prosthetic valve has a support structure that meets with a plurality of leaflets capable of transitioning between open and closed states. The support structure can include a base frame with a polymer coating and the leaflets can be artificial. The interface between the support structure and each leaflet can be at least partially convex when viewed from an exterior of the support structure along a normal to a plane formed by a central axis of the support structure and a central axis of the leaflet.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A prosthetic mitral valve with a compressible and expandable stent that, when expanded, is circumferentially oval, elliptical, or D-shaped, with a major axis and a minor axis ratio of from about 3:4 to about 4:5. Embodiments of the stent comprise three commissure posts disposed towards an outflow end and three curved cusp regions between adjacent commissure posts. Three flexible leaflets are attached to the commissure posts in a tri-foil configuration. Embodiments of the prosthetic mitral valve include an atrial ring disposed at the inflow end of the stent.

Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: A seamless prosthetic valve having an outer abluminal surface, a triple walled intermediate portion, and at least one valve leaflet that is configured to selectively restrict fluid flow through the valve, the valve leaflet being formed by suturing the triple walled intermediate portion at a first commissure connection point.

Abstract: A seamless prosthetic valve having an outer abluminal surface, a triple walled intermediate portion, and at least one valve leaflet that is configured to selectively restrict fluid flow through the valve, the valve leaflet being formed by suturing the triple walled intermediate portion at a first commissure connection point.

Abstract: A prosthetic valve assembly and method of implanting same is disclosed. The prosthetic valve assembly includes a prosthetic valve formed by support frame and valve leaflets, with one or more tethers each having a first end secured to the support frame and the second end attached to, or configured for attachment to, to papillary muscles or other ventricular tissue. The tether is configured and positioned so as to avoid contact or other interference with movement of the valve leaflets, while at the same time providing a tethering action between the support frame and the ventricular tissue. The valve leaflets may be flexible (e.g., so-called tissue or synthetic leaflets) or mechanical.

Abstract: A seamless prosthetic valve comprising a continuous tubular member having an outer abluminal surface, a triple walled intermediate portion, and at least a first valve leaflet that is configured to selectively restrict fluid flow through the valve, the triple walled intermediate portion being formed by everting a first end of member over the member, whereby a double walled end is formed, and reverting the first end over the double walled end of the member, the first valve leaflet being formed by suturing the triple walled intermediate portion at a first commissure connection point.

Abstract: A heart valve prosthesis includes an expandable prosthetic valve including three valve leaflets coupled to an anchoring structure. The anchoring structure includes an annular member and a plurality of arms movably coupled to the annular member at one end. The free ends of the arms extend radially away from the prosthesis toward a valve annulus. The arms are configured to fit in a space defined between an open native valve leaflet and a wall of a valve sinus. The arms are sufficiently resilient such that they resist downward movement in response to pressure exerted on the prosthesis, facilitating anchorage and stabilization of the prosthesis at the implantation site.

Abstract: A prosthesis including a distal fixation member that defines two or more engagement arms that are configured to apply a first axial force to tissue of the subject on a downstream side of the native valve complex. The prosthesis also includes a proximal fixation member configured to apply a second axial force to tissue of the subject on an upstream side of the native valve complex such that application of the first and second axial forces couples the prosthesis to the native valve complex. The proximal fixation member and the distal fixation member are fabricated as one integrated structure. The engagement arms and the proximal fixation member are configured to capture leaflets of the native valve complex therebetween without folding over of leaflets of the native valve complex, upon implantation of the prosthesis.

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 anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase.

Abstract: Methods for forming extracellular matrix valve conduits are disclosed. Extracellular matrix valve conduits produced using the disclosed methods are also disclosed. Methods of sterilizing and decellularizing extracellular matrix materials are also disclosed.

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 heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: An artificial mitral valve has a ring, an anterior cusp-side region, a posterior cusp-side region and a valve leaflet connected along an outer edge of the ring. The valve leaflet includes an anterior cusp forming member connected to the anterior cusp-side region and a posterior cusp forming member connected to the posterior cusp-side region. The anterior cusp forming member is provided with has an upper edge joined to the ring and a lower edge that forms a bifurcated portion. The upper edge is made up of a pair of right and left edges that incline inward and upward from the right and left sides, and a curved edge interposed between the inclined edges that curves along the anterior cusp-side region. The posterior cusp forming member has an upper edge joined to the ring and a lower edge that forms a bifurcated portion.

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 system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

Abstract: Vascular valve systems for treating calcified vascular vessel valves by delivery of one or more calcium chelating agents are described. Methods of making the vascular valve systems are also described.

Abstract: A prosthetic heart valve according to the present disclosure comprises a radially collapsible and expandable annular frame and a leaflet structure comprising a plurality of leaflets mounted within the frame. The frame in particular embodiments can have commissure attachment portions that are configured to support the commissures of the leaflets at locations spaced radially inwardly toward the longitudinal flow axis of the prosthetic valve relative to the frame portions circumscribing the moveable portions of the leaflets. When the leaflets open under pressure of blood flowing through the prosthetic valve, the moveable portions of the leaflets are retained at positions spaced inwardly from the inner surface of the frame to protect against abrasion of the leaflets.

Abstract: A method for treating glutardialdehyde-stabilized biological tissue of animal or human origin, such as porcine, bovine pericardium or human cadaver heart valves, provides a physical plasma treatment of the, in particular, collagen tissue for increasing the biocompatibility, cell colonization and durability thereof.

Abstract: Methods for forming extracellular matrix valve conduits are disclosed. Extracellular matrix valve conduits produced using the disclosed methods are also disclosed. Methods of sterilizing and decellularizing extracellular matrix materials are also disclosed.

Abstract: Extracellular matrix (ECM) material conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM material conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.