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

Abstract: The subject invention relates to a valve replacement system together with methods of preparation and use, are provided for endovascular replacement of a heart valve in a host. The valve replacement system includes up to five components: a prosthetic valve device, a valve introducer device, an intraluminal procedure device, a procedure device capsule, and a tissue cutter. The system provides for endovascular removal of a malfunctioning valve and subsequent replacement with a permanent prosthetic heart valve.

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

Abstract: A heart valve stent having a section with a heart valve implant and several proximally disposed tissue anchors, also comprising a plurality of anchoring threats, each with a proximate end fastened to the stent or valve and a distal end attached to tissue within a heart chamber to provide tension between the heart chamber tissue and the stent.

Abstract: The disclosure provides valve prostheses and methods of installation. One embodiment of the prosthesis has a generally tubular body adapted for placement proximate a mitral annulus. The tubular body has a generally tubular upper portion adapted to substantially reside in the left atrium above the mitral annulus. The generally tubular upper portion has a first circumferential wall that is outwardly biased to urge against cardiac tissue of the left atrium. The tubular body also includes a lower portion extending downwardly from the generally tubular upper portion, the lower portion being configured to substantially reside in the left ventricle below the mitral annulus. The lower portion of this embodiment can be defined by an generally circumferential wall that extends downwardly from the generally tubular upper portion. The generally circumferential wall has a first circumferential end and a second circumferential end, and defines a circumferential extent therebetween.

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: Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient's body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

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 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 frame structure for a collapsible and re-expandable prosthetic heart valve. The frame structure includes an annular annulus portion that is configured for implanting in or near a patient's native heart valve annulus. This annulus portion of the frame structure may include a plurality of annularly spaced commissure post structures interconnected by connecting structures. The commissure post structures may be more resistant to annular collapse than the connecting structures. In the case of a prosthetic aortic valve, the frame structure may also include an annular aortic portion. The aortic portion may include a plurality of attachment points (for tethers) closest to the annulus portion. Such attachment points and tethers can facilitate re-collapse of a partly deployed valve in the event of a need to reposition or remove the valve.

Abstract: A valve prosthesis includes an expandable frame comprising an outflow portion and an inflow portion connected to the outflow portion. The frame defines a central lumen extending between the outflow portion and the inflow portion. The frame is generally cylindrical in a fully expanded configuration. When the frame is in the fully expanded configuration, an outer surface of the inflow portion is concave. The inflow portion has an upper inflow portion and a lower inflow portion. When the frame is in the fully expanded configuration, the upper inflow portion flares outwardly from the central lumen of the frame to greater extent than the lower inflow portion.

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

Abstract: A prosthetic mitral valve includes a proximal anchor, a distal anchor, and a central portion therebetween. The proximal and distal anchors each include a first outer frame and a second outer frame. The first outer frame includes a plurality of first arcs joined together, and the second outer frame includes a plurality of second arcs joined together. The plurality of first arcs are out of phase relative to the plurality of second arcs.

Abstract: A prosthetic heart valve is circumferentially collapsible for less invasive delivery into a patient. The valve re-expands to operating size at the implant site in the patient. A frame structure of the valve includes restraining structure that can help to push one or more of the patient's native heart valve leaflets radially outwardly so that this native leaflet tissue does not interfere with the operation or service life of the prosthetic valve.

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

Abstract: Artificial heart valve structures and methods of their fabrication are disclosed. The heart valve structures may be fabricated from a biocompatible polymer and include one or more heart valve leaflet structures incorporated within a conduit. The valve structures may incorporate one or more conduit sinuses, as well as a gap between the lower margin of the valve leaflets and the interior of the conduit. In addition, the valve structures may include one or more valve sinuses created in a space between the valve leaflets and the conduit inner surface. Computational fluid dynamics and mechanical modeling may be used to design the valve leaflets with optimal characteristics. A heart valve structure may also incorporate a biodegradable component to which cells may adhere The incorporated cells may arise from patient cells migrating to the biodegradable component, or the component may be pre-seeded with cells prior to implantation in a patient.

Abstract: Apparatus and methods for securing heart valve repair or replacement prostheses in or near the heart. The apparatus and methods are particularly well suited for traditional surgery or minimally invasive surgery. The invention secures a heart valve repair or replacement prosthesis in place while lowering surgical exposure. The invention improves the ease of implantation because it reduces the number of surgical knots a clinician would normally tie in the limited space in and around the heart.

Abstract: A method for percutaneously replacing a heart valve of a patient. In some embodiments the method includes the steps of percutaneously delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site; repositioning the anchor to a second anchor site; and deploying the anchor at the second anchor site.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The stent is formed of a plurality of struts. A cuff is coupled to the stent. The cuff has one or more features configured to reduce abrasion and/or perivalvular leakage.

Abstract: A percutaneous valve device and system are provided, which improve sealing between the anchor and native anatomy. The anchor includes a space-occupying material, such as a hydrogel, on an external surface that swells when exposed to an aqueous environment, filling gaps between the anchor and the native anatomy, and thereby serves as a valve seal.

Abstract: A stented prosthetic heart valve including a stent, a plurality of leaflets, and a coupling apparatus. The stent includes a plurality of struts combining to define a generally tubular body, with the struts forming strut segments. The leaflets are mounted to the stent, and include a leaflet provided as part of a first leaflet layer that further forms a tab region. The coupling apparatus is configured for connecting the first leaflet layer to the stent, and includes a backing layer, a guide plate, and a pin. The guide plate and the pin are formed apart from the stent. In this regard, a portion of the backing layer and the tab region are secured between the guide plate and the pin. Further, another portion of the backing layer is attached to at least one of the strut segments to mount the leaflet of the first leaflet layer to the stent.

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

Abstract: The present embodiments provide a prosthesis comprising first and second segments, and an axially extendable segment coupled to the first and second segments. A valve is coupled to at least one of the axially extendable segment or the second segment. The axially extendable segment comprises a first state in which the valve at least partially overlaps with the first segment, and the axially extendable segment comprises a second state in which the valve lacks an overlap with the first segment.

Abstract: Apparatuses, systems, and methods for use in a vascular system. The apparatus include a circulatory valve having a valve frame in which frame members define frame cells. Frame cells include joints in opposing relationship, where the joints transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state as the joints are drawn towards each other.

Abstract: A method for endovascularly replacing a patient's heart valve including the following steps: endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor having grasping elements adapted to grasp tissue in a vicinity of the heart valve; expanding the anchor, thereby rotating the grasping elements; and grasping the tissue with the rotating grasping elements.

Abstract: Anchored cardiovascular valves having a support member with at least one leaflet formed therein that is sized and configured to selectively restrict regurgitating blood through the valve, and at least one anchoring mechanism. In a preferred embodiment of the invention, the anchored valves have two anchoring mechanisms, i.e.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having an outflow end and an inflow end, a plurality of commissure features attached to the stent, a plurality of anchoring features disposed on legs of the stent, the plurality of anchoring features being coupleable to a delivery device for repositioning, and a valve assembly disposed within the stent. The anchoring features may be configured to attach to heart tissue to help secure the prosthetic heart valve in an operating position.

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

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

Abstract: The present invention relates to a stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis fastened to a stent will occur relative the stent in the implanted state of the stent, even given the peristaltic motion of the heart, the stent according to the invention comprises at least one fastening portion via which the valvular prosthesis is connectable to the stent. The stent further comprises positioning arches and retaining arches, whereby at least one positioning arch is connected to at least one retaining arch.

Abstract: A prosthesis can include a collapsible, reexpandable frame comprising first, second, and third sets of struts that define first and second rows of expandable cells. In some embodiments, the struts of the first, second, and third set of struts can be tapered. In some embodiments, the frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.

Abstract: A valve prosthesis includes one or more anti-paravalvular leakage components coupled to a stent. The anti-paravalvular leakage component may encircle the stent and include a radially expandable control ring coupled to an unattached edge of a flexible skirt which extends the unattached skirt edge outwardly away from the stent and against the native heart valve to form an open-ended annular pocket around the stent. The anti-paravalvular leakage component may encircle the perimeter of the stent and include a flexible skirt having opposing edges coupled to the stent to form one or more enclosed compartments around the stent. Each compartment includes a one-way valve which allows for blood flow into the compartment but prevents blood flow out of the compartment. The anti-paravalvular leakage component may be at least one flap that is coupled to an inner surface of the stent and formed of a flexible material moveable by blood flow.

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 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 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: Disclosed herein is a prosthetic heart valve, and associated methods therefore, 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. The prosthetic heart valve is configured to have an 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: An implantable prosthetic valve assembly includes a radially expandable frame including an inflow portion and a second portion. The inflow portion is configured, in an expanded state, to bear against a native cardiac annulus in a manner so as to resist migration. The second portion extends from the inflow zone in an outflow direction, and is configured, in an expanded state, not to bear against the native cardiac annulus and an ascending aorta. The valve assembly also includes a prosthetic valve coupled to the frame substantially within the second portion.

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 arcuate 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.

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

Abstract: A leaflet for a prosthetic valve formed of at least one layer that includes a composite material containing at least one expanded fluoropolymer membrane having serpentine fibrils and an elastomer is provided. The fluoropolymer may be polytetrafluoroethylene. In at least one embodiment, the elastic properties are present in an axial direction the leaflet. The leaflets may be single layered or multi-layered. The leaflets may be coupled to a support structure and movable between open and closed configurations relative to the support structure to form a heart valve. The elasticity within the leaflets permits, among other things, the leaflets to bend with a reduced occurrence of wrinkles as the valve opens and closes. The elastic properties of the leaflet also, among other things, improve bending properties and reduce closure stresses, thereby extending the life of the leaflet.

Abstract: Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Abstract: A method for reducing regurgitation in a mitral valve using a blood flow controlling apparatus. The blood flow controlling apparatus comprises an anchoring means, preferably arranged to anchor the apparatus to a wall of the left ventricle. The blood flow controlling apparatus further comprises a valve means configured to expand in a direction transverse to blood flow. The valve means is preferably positioned within a native mitral valve and expands for making contact with the mitral valve leaflets during ventricular systole, thereby preventing blood from regurgitating back through the mitral valve into the left atrium. When blood flows from the left atrium to the left ventricle during ventricular diastole, the valve means collapses for allowing blood to pass freely through the mitral valve.

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: Described embodiments are directed toward prosthetic valve leaflets of particular configurations that control bending character. In embodiments provided herein, a valve leaflet is provided with a planar zone that is bounded at a planar zone base by a straight line, wherein the leaflet is operable to bend along a base of the planar zone.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic valve comprises a plurality of leaflets. Each leaflet includes a central region and two side regions on opposite sides of the central region. The central region is defined by a shape substantially that of an isosceles triangle defined by two central region sides, the leaflet base and the leaflet free edge, wherein the two central region sides converge from the leaflet base, and wherein each of the two side regions have a shape substantially that of a triangle and each are defined by one of the central region sides, one of the leaflet sides, and the leaflet free edge.

Abstract: Described embodiments are directed toward prosthetic valve leaflets of a particular shape that allows redundant coaptation height in the leaflets when a planar segment is present in each leaflet.

Abstract: Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.