Abstract: A method for manufacturing a cardiac valve prosthesis is disclosed. This method comprises the following steps: a) shaping human or animal body tissue in a shaping process to give the body tissue a shape of a cardiac valve, and b) fixation and stabilization of the body tissue by a cross-linking agent, thereby preserving the shape given to the body tissue by the shaping process and thus obtaining a cardiac valve prosthesis. Furthermore, a method of implanting an autologous or allogenic cardiac valve prosthesis to an individual in need thereof is disclosed.

Abstract: Aspects of the disclosure include a prosthetic heart valve including a stent structure forming a plurality of commissure posts, a valve structure supported by the stent structure, a base supporting the stent structure and at least one radiopaque element positioned around the base. The radiopaque element can include a band extending around the base. In some embodiments the band is coiled. The band can optionally include a badge with an indicator specifying properties of the valve and viewable under fluoroscopy. In some embodiments, the radiopaque element is a badge that can have an indicator. The radiopaque elements of the disclosure increase ease and accuracy in the positioning of a percutaneously delivered replacement valve within a previously implanted valve of the disclosure.

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

Abstract: A prosthetic heart valve leaflet includes a plurality of electrospun fibers at least partially embedded in a polymer matrix. The plurality of fibers includes a first polyisobutylene urethane copolymer having a first predetermined weight average percentage of hard segment portions and the polymer matrix includes a second polyisobutylene urethane copolymer having a second predetermined weight average percentage of the hard segment portions, wherein the first predetermined weight average percentage of the hard segment portions is greater than the second predetermined weight average percentage of the hard segment portions.

Abstract: A method of implanting a prosthetic heart valve within a patient can comprise inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the patient and advancing the prosthetic heart valve to a deployment location within the heart of the patient and inflating one or more of a plurality of differently-sized balloons in a balloon-assembly on the distal end portion of the delivery apparatus. The prosthetic heart valve can be mounted on the balloon assembly in a crimped state and the inflating of the one or more of the plurality of differently-sized balloons can expand the prosthetic heart valve from the crimped state to a radially expanded state having a non-cylindrical shape.

Abstract: According to various aspects and embodiments, a prosthetic valve assembly for controlling fluid flow in an annulus is provided. The prosthetic valve assembly includes a suture ring formed from two or more segments, where each segment is configured to attach to the annulus, and a leaflet subassembly that attaches to an inner portion of at least one segment of the suture ring. The leaflet subassembly includes at least one leaflet configured for controlling a flow of fluid through the prosthetic valve assembly.

Abstract: A valvular sleeve for valvular prostheses including a tubular body extending between an inflow end and an outflow end, the tubular body including a sheet member folded at the outflow end, whereby the tubular body includes an inner tubular portion and an outer tubular portion surrounding the inner tubular portion.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a prosthetic valve. The prosthetic valve may include a jacket configured to cover at least one of gaps, spaces, or interfaces in a frame or between one or more leaflets attached to the frame.

Abstract: The present invention concerns an intraluminal vascular prosthesis for implantation into the heart and/or cardiac vessels of a patient, in particular for anchoring in the region of the cardiac valve leaflets. The vascular prosthesis comprises a stent support and a prosthesis material at least partially covering the stent support, such, that a covered proximal portion and a non-covered distal portion are formed. Furthermore, the vascular prosthesis has at least one elongate wire-shaped anchoring structure at the proximal end, which is substantially loop-shaped and which is fixed at two ends to the stent support and which is positioned with its proximal end in the form of a loop pointing in the proximal direction and projecting beyond the proximal end of the stent support.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The cuff includes a surplus portion capable of forming a sealing structure having a diameter greater than a diameter of the proximal end of the stent when deployed.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a coaption element and a pair of paddles. The coaption element and/or the pair of paddles can be made from a fabric, such as a braided metal fabric. The pair of paddles are connected to the coaption element. The paddles are movable between an open position and a closed position. The valve repair device is configured to attach to the native valve of the patient.

Abstract: Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Abstract: Prosthetic valves and methods of using prosthetic valves may be provided. In one implementation, an expandable annular valve body may include a plurality of atrial anchoring arms and ventricular anchoring legs extending therefrom. The anchoring arms and anchoring legs may be configured to assume a delivery configuration in which they are radially constrained, such as within a delivery device, such that at least one atrial anchoring arm extends in a first upstream direction from the annular valve body, and a deployed configuration, in which they may deflect radially outward. In the deployed configuration, a first arm portion may be configured to deflect radially outward to extend in a downstream direction, and a second arm portion may be configured to deflect radially outward to extend in a second upstream direction, the first upstream direction being angled relative to the second upstream direction.

Abstract: The present disclosure provides an apical connector for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a locking tab configured to engage the port and lock the cannula with respect to the port.

Abstract: A mastopexy implant for maintaining the breast in an elevated and aesthetically pleasing position includes a lower pole support comprising end portions which may be affixed to the chest wall or to a previously installed upper suspension strut. The implant is loaded in an insertion device. The insertion device is inserted through a small incision and into a subcutaneous pocket created in an inferior half of the breast. The lower pole support may have various constructs and in one embodiment includes a unitary conformable mesh having a plurality of arm or band members which are attached across the breast parenchyma and to the chest wall.

Abstract: A tubular seal for a prosthetic heart valve includes an elastomeric polymer matrix and a plurality of non-elastic fibers retained within the matrix. The non-elastic fibers can be arranged in the elastomeric polymer matrix to allow the tubular seal to stretch in axial and radial directions.

Abstract: Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Abstract: Methods and apparatus for heart valve repair utilize a heart valve repair device including a generally annular ring-like structure and a net structure. The ring-like structure is seated in the valve annulus with the net structure extending from the ring-like structure through the coaptation zone between leaflets. The net structure can then be anchored to a heart structure with a suture. Net structure extending between leaflets helps prevent prolapse of leaflets and can aid in coaptation.

Abstract: A prosthetic heart valve provided herein can include at least two leaflets being secured together along aligned edges thereof by a stitch of a single thread. The stitch includes at least one loop extending through a first aperture, around the aligned edges, and back through the first aperture.

Abstract: A polymeric heart valve is disclosed including: a valve body having a central axis having a body fluid pathway extending along the central axis from an inflow end to an outflow end; a flexible stent disposed about an outer circumference of the body and including at least three flexible stent posts each extending in the axial direction to a tip; and at least three flexible leaflets extending from the stent, each of the leaflets having an attached edge defining an attachment curve along the stent extending between a respective pair of stent posts.

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 prosthetic heart valve includes an annularly collapsible and re-expandable supporting structure extending between an inflow end and an outflow end and including a plurality of struts and a plurality of posts, each post having an elongated opening, a plurality of leaflets disposed inside the supporting structure and operative to allow flow in a first direction from the inflow end to the outflow end and to substantially block flow in an opposite direction from the outflow end to the inflow end, each of the plurality of leaflets including flaps, and a first patch covering the opening of a first post, the first patch being attached to a first flap of a first leaflet.

Abstract: A prosthetic heart valve includes a balloon-expandable stent including a plurality of struts and a plurality of commissure posts, each commissure post containing an elongated slot. A plurality of leaflets is made from pericardial tissue and includes flaps. An intermediate polymer sheet is disposed between the stent and the plurality of leaflets. At least one reinforcing polymer core is attached to at least one leaflet and the intermediate polymer sheet using stitches that loop around an end of the at least one leaflet. A plurality of patches covers the elongated slots of the commissure posts, the flaps of the leaflets being attached to the patches. A cuff contacts an exterior of the stent, the cuff and the intermediate polymer sheet sutured to one another so as to cover an axial end of the stent.

Abstract: The present invention regards a valve prosthesis (1; 40; 50; 60) comprising a stent (2) and characterized in that it comprises a valve (3) arranged in said stent (2) and bound thereto in at least one pre-established zone so that it can be deformed between a closed state in which said valve (3) is fully spread out in the stent (2), thus blocking the passage of a body fluid, and an open state in which said valve (3), due to the pressure of said body fluid, is substantially collapsed on an inner wall of said stent (2), thus permitting the flow of said body fluid. The invention also regards a method for making said valve prosthesis.

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. Each leaflet has a planar zone in a central portion, wherein the planar zone is substantially planar. The planar zone defines a shape having an area, wherein the area is larger nearer the base than the free edge.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

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 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 replacement heart valve and method of treating valve insufficiency includes an expandable frame configured to engage a native valve annulus. A valve body is coupled to the frame. The valve body can include a leaflet portion and possibly a skirt portion. A portion of the frame has a foreshortening portion configured to longitudinally expand when urged to a radially compacted state and longitudinally contract when urged to a radially expanded state. In one embodiment the valve skirt is attached to the frame so that it can adapt to changes in the length of the frame. A delivery device in some embodiments can use one or more coverings, such as sheaths, to controllably release the replacement heart valve at a native heart valve.

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 tubular braided mesh scaffold for fabrication of heart valves is described. The tubular braided scaffold can be formed of a shape memory metal, such as Nitinol, and pinched or pressed to form a leaflet shape. When heat treated, the braided mesh scaffold holds and retains its valve-like shape.

Abstract: A polymeric valve which may include a heart valve, and also may include a trileaflet heart valve includes a stent having a base and a plurality of outwardly extending posts from the base and equidistant from each other. A plurality of leaflets each connected to a corresponding one of the posts at one end, and each of the leaflets connected to the base. Each of the leaflets having an operative end opposite the end connected to the post, and the operative ends of the leaflets being biased in a closed position such that the operative ends abut each other. The operative ends are configured to rhythmically open and close in relation to each other, and the leaflets include multiple cross sectional thicknesses at different portions of the leaflets.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

Abstract: The present invention provides an apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient's heart valve, the anchor having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient's heart valve.

Abstract: The present invention concerns a cardiac valve prosthesis system (10; 40) for implantation into the body of a mammal. The prosthesis system (19; 40) comprises a valve (16) mounted on an stent element (18) to form a stented valve element (12), and an anchoring element (14) to be arranged within the aorta of the mammal to be treated with the prosthesis and spaced-apart form the stented valve element (12). Further, the anchoring element (14) comprises a cylindrical tube element composed of fabric (22) supported by a metal mesh, and the stented valve element (12) and the anchoring element (14) represent two constructional distinctive elements being associated by ligament-like connecting means (30; 50), such, that the connecting region (28) between the stented valve element (12) and the anchoring element (14) is generally free from foreign material.

Abstract: A prosthetic heart valve comprises a radially crimpable and radially expandable, net-like, annular support frame and a valve assembly disposed therein, the valve assembly comprising a conduit tapering from an inlet towards an outlet thereof. Some embodiments or the support frame comprise a proximal portion and a distal portion, a diameter of the proximal portion smaller than a diameter of the distal portion. The proximal portion is dimensioned for deployment in an annulus of a native aortic valve and a distal portion for deployment in an ascending aorta. Some embodiments of the conduit comprise a support construction with a three-cusp, crown-shaped cut line, the support construction sutured to the support frame around a bottom portion thereof and around the cut line. A method for using the prosthetic heart valve to replace a defective native aortic valve uses a minimally invasive procedure.

Abstract: A transcatheter valve prosthesis includes a self-expanding tubular stent component and a prosthetic valve disposed within and secured to the stent component. The tubular stent component has a proximal portion, a distal portion, and an intermediate portion between the proximal and distal portions. In a compressed delivery configuration, the tubular stent component has a generally circular cross-section along its length. In an expanded deployed configuration, the proximal and distal portions have a generally circular cross-section while the intermediate portion of the stent component has a generally triangular cross-section with three vertexes that are configured to project into three commissural points of a native valve when the valve prosthesis is implanted in situ.

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: 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 method of replacing a deficient native aortic valve with a self-expandable prosthetic valve is disclosed. The method involves advancing a self-expandable prosthetic valve through a tapered tube for crimping the prosthetic valve into a crimped diameter. The prosthetic valve is then advanced into a restriction tube for maintaining the prosthetic valve in the crimped diameter. The prosthetic valve is then advanced into a body and is positioned within the deficient native aortic valve. The prosthetic valve is then released from the restriction tube such that the prosthetic valve self-expands to an expanded diameter for anchoring within the deficient native aortic valve. The prosthetic valve comprises an expandable tubular support frame and a valve assembly positioned within the support frame. The valve assembly is formed with pericardial tissue and has three leaflets for providing blockage to a reverse flow of blood.

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 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.

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 prosthetic valve assembly configured to be intraluminally implanted into a lumen of a patient to replace a native deficient valve, the valve assembly comprising an outer support for expanding and anchoring against a lumen wall of the patient, a core valve support made of a collapsible and self-expanding material to expand and anchor into the outer support once anchored against the lumen wall, and a plurality of flexible leaflets fixed to the core valve support in a manner that the leaflets are independent from the outer support.

Abstract: Heart valve assembly systems and methods configured for medical interventional procedures. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: A leaflet including fibers oriented at an angle relative to at least one free edge of the leaflet. A leaflet comprising mechanisms for increasing coaptation height, preventing billowing, and reducing stress in critical regions of the leaflet. A prosthetic heart valve, including three leaflets operatively attached together. A method of using a prosthetic heart valve, by applying pressure to the valve, forming a pocket with material of three leaflets operatively attached together and increasing coaptation height, reducing billowing of the leaflets toward a ventricle, and reducing stress in critical regions of the leaflet. A chorded valve including at least one leaflet, wherein bundles of fibers exit said free edges as tethers and can be anchored to tissue. A method of using the chorded valve, by anchoring the tethers to tissue, forming a pocket with the material of leaflets and increasing coaptation height, and reducing billowing of leaflets toward an atrium.

Abstract: A support device for implanting a stentless heart valve prosthesis having three leaflets adapted for coapting and defining three corresponding commissures is disclosed. The support device includes a shaft defining a manipulation axis, the shaft having a proximal portion and a distal portion, and three support formations integrally formed and extending from the proximal end of the shaft, the support formations angularly distributed about the manipulation axis of the shaft, such that each of the support formations correspond to locations of each of the commissures of the stentless heart valve prosthesis. The shaft includes a connection portion flexibly connecting the shaft and the support formations to permit a displacement of the manipulation axis with respect to the support formations. The shaft, the plurality of support formations and the connection portion are integrally formed from a single tubular element.

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 replacement heart valve and stitching method for reducing the unexpanded profile of the replacement heart valve are herein provided. The method includes whip stitching a plurality of leaflets together with a first whip stitch pattern a second whip stitch pattern which overlaps the first whip stitch pattern and is wound in an opposite direction. The method further involves securing the valve leaflets to one another via a running stitch.

Abstract: The technical result of the invention comprises maintaining the physiological structure of the flow of blood, both in the open and in the closed state of a valve on account of the construction and shape of the cusps. The technical result is achieved in that the heart valve prosthesis comprises a body with a flange, and a closing unit in the form of three cusps mounted in the through opening in the body, wherein each of the cusps has a central rib directed from the centre of the through section of the valve to the body, and convex-concave wings are arranged along the sides of the rib, and cusps are mounted in the body by means of a mounting unit, wherein, in the closed position, the geometry of the valve reproduces the geometry of an actual aortal valve.