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: 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 method of treating a native heart valve includes delivering a replacement valve to the native heart valve. The native heart valve can be any one of aortic, pulmonary, mitral and tricuspid valves. The replacement valve comprising an expandable frame and a valve body attached to the expandable frame. The method can also include expanding the frame at a patient's valve annulus, wherein expansion of the frame causes respective ends of both proximal anchors and distal anchors connected to the frame to draw closer together to grasp native tissue between the respective ends of the proximal anchors and distal anchors.

Abstract: A prosthetic atrioventricular tissue valve comprising a continuous tubular member formed from a first biocompatible material, the tubular member having proximal and distal ends, and at least one valve leaflet formed therein, the distal end of the tubular member including cardiovascular structure engagement means for connecting the tubular member to a cardiovascular structure, the cardiovascular structure engagement means comprising a plurality of elongated members that extend distally from the distal end of the tubular member.

Abstract: A valve mounting apparatus having an elongated tubular mesh structure with proximal and distal ends, a cardiovascular structure engagement region disposed between the proximal and distal ends, and a lumen therethrough, the distal end of the structure including a valve engagement region that is configured to engage a first end of a prosthetic valve, the mesh structure being configured to transition from a pre-deployment configuration, wherein the structure is capable of being disposed at a cardiovascular valve region, such as a valve annulus region, to a post-deployment expanded configuration, wherein the cardiovascular structure engagement region is anchored to the cardiovascular valve region.

Abstract: Apparatus is provided including a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses, the prosthesis including a valve prosthesis support, which includes a support structure including at least two engagement arms. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses. A shape of at least one of the engagement arms is generally characterized by a function z?(r)>=0, where z is a height of any given point on the at least one engagement arm measured along a longitudinal axis of the prosthesis, and r is a distance from the longitudinal axis to the given point. Other embodiments are also described.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and to apply a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof. The prosthesis is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve. Other embodiments are also described.

Abstract: In accordance with one embodiment of the present disclosure, a prosthetic valve is provided. The prosthetic valve includes an annulus, a pair of leaflets, and a pair of support elements. The annulus has a generally saddle-shape formed by a movable pair of first portions separated from each other by a movable pair of second portions. The pair of leaflets extend from the annulus and are separated from each other by the pair of support elements. The first portions of the annulus and the second portions of the annulus are configured to move back and forth from being generally concave to being generally convex such that any movement of the first portions of the annulus occurs at generally the same time as any movement of the second portions of the annulus.

Abstract: A heart valve prosthesis has a supported valve including a biological valve portion mounted within a support structure. The supported valve has inflow and outflow ends spaced axially apart from each other. A fixation support member includes an inflow portion that extends from a radially inner contact surface of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. An outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve.

Abstract: A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

Abstract: The present invention relates to methods for inhibiting stenosis, obstruction, or calcification of a valve following implantation of a valve prosthesis which may involve disposing a coating composition on an elastical stent or valve leaflet. The valve prosthesis is mounted on the elastical stent such that the elastical stent is in contact with the valve.

Abstract: The present invention discloses devices and methods for performing intravascular procedures without cardiac bypass. The devices include various embodiments of temporary filter devices, temporary valves, and prosthetic valves. The temporary filter devices have one or more cannulae which provide access for surgical tools for effecting repair of the cardiac valves. A cannula may have filters of various configurations encircling the distal region of the cannula, which prevent embolitic material from entering the coronary arteries and aorta. The temporary valve devices may also have one or more cannulae which guide the insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel. In one embodiment, the temporary valve is a disc of flexible, porous, material that acts to filter blood passing therethrough. A set of valve leaflets extend peripherally from the disc.

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: 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: Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve.

Abstract: The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing devices configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. In one embodiment, a prosthetic heart valve includes an annular sealing member that can be placed in a delivery orientation extending axially away from one end of the valve when the valve is in a radially compressed state. When the valve is expanded, the expansion of the frame causes the sealing member to be pulled to an operative orientation covering a portion of the frame. The present disclosure also discloses new mechanisms and techniques for mounting valve leaflets to a frame of a prosthetic heart valve.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A prosthetic heart valve includes an annular frame having annularly spaced commissure portions and an annulus portion disposed near an inflow edge, a fabric covering at least a portion of the frame and a valve assembly connected to the frame at the commissure portions, the valve assembly including a plurality of leaflets. A stiffening member is disposed about the frame to limit ovalization of the frame when a radial force is applied to the frame.

Abstract: A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures.

Abstract: A device and method for controlling commissural tip deflection of a prosthetic valve, thereby both preventing failure due to repeated movement and/or uneven loading of the commissural points and also improving coaptation of the valve leaflets, including connecting reinforcing material between the commissural points so a spring-like span is created across the points. The spanning material may be in the form of a ring that is lashed, sewn or otherwise connected to the commissural points. The reinforcing material may form curved segments between the commissural points that extend outwardly to form sinuses behind the leaflets of the prosthetic valve. The reinforcing material may also extend in an upstream direction to avoid interfering with blood flowing out of the prosthetic valve.

Abstract: A prosthetic heart valve comprises a collapsible and expandable support frame comprising a longitudinal axis. The frame comprises a first circumferential undulating structure defining an outflow end of the frame, and a second circumferential undulating structure spaced apart from the first circumferential undulating structure. The frame also comprises a plurality of struts longitudinally aligned with the longitudinal axis of the frame, and connecting: the first circumferential undulating structure to the second circumferential undulating structure. Each strut of the plurality of struts comprises a first end terminating at a trough of the first circumferential undulating structure, and a second end terminating at a peak of the second circumferential undulating structure. The prosthetic heat valve also comprises a biological tissue valve coupled to the frame.

Abstract: A prosthetic heart valve comprises a biological tissue valve and a collapsible and expandable support frame comprising longitudinal axis. The frame comprises an outflow circumferential structure defining an outflow end of the frame and defining a single row of expandable cells, and a circumferential undulating strut structure spaced apart from the outflow circumferential structure. The frame also comprises three struts longitudinally aligned with the longitudinal axis, configured to facilitate mounting the biological tissue valve to the frame, and interconnecting the outflow circumferential structure to the circumferential undulating structure. Each strut comprises a first end terminating at a respective junction between two adjacent expandable cells of the outflow circumferential structure, and a second end terminating at the circumferential undulating strut structure.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.

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: Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve.

Abstract: A device and method for controlling commissural tip deflection of a prosthetic valve, thereby both preventing failure due to repeated movement and/or uneven loading of the commissural points and also improving coaptation of the valve leaflets, including connecting reinforcing material between the commissural points so a spring-like span is created across the points. The spanning material may be in the form of a ring that is lashed, sewn or otherwise connected to the commissural points. The reinforcing material may form curved segments between the commissural points that extend outwardly to form sinuses behind the leaflets of the prosthetic valve. The reinforcing material may also extend in an upstream direction to avoid interfering with blood flowing out of the prosthetic valve.

Abstract: A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient's body and expanded to secure a heart valve prosthesis in the patient's aorta. In an embodiment, the endoprosthesis has at plurality of positioning arches configured to be positioned with respect to a patient's aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a first collapsed mode during the process of introducing it into the patient's body and a second expanded mode when it is implanted.

Abstract: An apparatus for replacing a diseased cardiac valve is movable from a radially collapsed configuration to a radially expanded configuration. The apparatus comprises an expandable support member and a prosthetic valve secured therein. The main body portion extends between first and second end portions and includes an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region. Each of the wing members includes first and second end portions and a flexible middle portion extending between the end portions. The second end portion is integrally formed with the main body portion. The first end portion is adjacent the circumferential axis and substantially flush with the outer circumferential surface in the radially collapsed configuration. The first end portion extends substantially radial to the outer circumferential surface in the radially expanded configuration.

Abstract: A prosthetic valve including an annulus, a pair of leaflets, and a pair of support elements is described. The annulus has a generally saddle-type shape and is connected to the support elements. The pair of leaflets extends from the annulus and are separated from each other by the support elements. In use, the valve is open when the support elements are angled or separated outward, and sealed or closed when the support elements are angled or moved inward.

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: 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: 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 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 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: 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: 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. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Abstract: A device for replacement of a bioprosthetic valve having an annulus (104) and one or more leaflets (105), the device having an outer housing (106) and an inner shaft (108) with a distal end (110). The outer housing (106) is slideable relative to the inner shaft (108) such that a portion of the inner shaft (108) may be revealed. A cap (112) is associated with the distal end (110) of the inner shaft (108), the cap (112) movable between a first position adjacent the inner shaft (108) and a second position displaced from the inner shaft (108). The cap (112) is adapted to trap a skirted valve frame (102) between said cap (112) and the inner shaft (108) when in the first position. The skirted valve frame (102) may be released by the cap (112) upon sliding of the outer housing (106) relative to the inner shaft (108) to reveal the inner shaft (108) and upon movement of the cap (112) to the second position. Also disclosed are associated methods.

Abstract: Described are implantable prosthetic valve devices comprising isolated granulation tissue. Also described are methods of treatment that include implanting at least one of these valves within a body passageway of a patient, for example, within a vein to treat venous insufficiency.

Abstract: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

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

Abstract: In one embodiment, the present invention provides a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets so that an open end of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.

Abstract: A transcatheter valve having an expandable frame and a collapsible multi-portion skirt within the frame are provided with seams between the portions of the skirt that are located to cooperate with features of the frame and thereby reduce the exposure of the seams.

Abstract: Described are preferred prosthetic valve devices including a first extracellular matrix material having a second extracellular matrix material deposited thereon. The preferred materials are made by culturing cells in contact with an extracellular matrix graft material in a fashion to cause the cells to biosynthesize and deposit extracellular matrix components on the material. The cells are then removed to provide the extracellular matrix composite material. In preferred embodiments, the prosthetic valve devices are configured for use in vascular applications.

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 using heat or pressure welding crimping, adhesive, or other techniques 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 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: Apparatus, methods and kits which, when installed or used, occlude or partially occlude a cervical canal, the internal opening of a cervical canal (cervical os), or a uterine side wall rupture location, such as to inhibit or prevent bacterial access and retard leakage of amniotic fluid resulting from PROM. The present apparatus can include an expandable support member of a biocompatible and non-toxic material. In some examples, the support member can include a top portion having a first diameter and a bottom portion having a second diameter less than the first diameter. In some examples, the support member can include an expandable stent of a suitable length and uniform diameter to be inserted in a non-dilated cervical canal or transabdominal access route. In various examples, the apparatus further includes a fluid-resistant fabric, polymer, substance or other material placed over at least the top portion of the support member.

Abstract: A replacement heart valve can comprise a valve body and an elongate frame. The valve body can define a plurality of leaflets adapted to move between an open state and a coapted state. The elongate frame can be configured to move between a radially compacted state and a radially expanded state, the frame comprising a plurality of struts. Stitches attach the valve body to the plurality of struts. At least one of the stitches can be a loose stitch configured to freely slide over the corresponding strut when the frame is moved between the radially compacted and radially expanded states.

Abstract: A prosthetic heart valve includes a radially expandable stent and a plurality of leaflets. Each leaflet includes a coaptation portion, an arcuate edge, and a belly. The coaptation portion is movable relative to respective coaptation portions of the other leaflets. The acuate edge has a first end and a second end and is coupled to the stent. The belly extends from the arcuate edge to an axis defined by the first and second ends of the arcuate edge, wherein the ratio of the surface area of the belly to the outer cross-sectional area of the expanded stent is about 0.09 to about 0.16.