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 heart valve includes annularly spaced commissure portions, each of which includes a tip. The stent is formed from a polymeric material, and is specifically configured to perform similarly to conventional metal stents. A first fabric covers each of the tips, and a second fabric covers the first fabric and remaining exposed portions of the stent. A first layer of tissue covers the second fabric, and a second layer of tissue overlies the second fabric. The second layer of tissue includes leaflet portions that extend inwardly between annularly adjacent ones of the commissure portions.

Abstract: Techniques are described for use with one or more sutures. For some applications, techniques are described for fixedly-coupling two or more sutures to each other. For some applications, such techniques are used for treating a heart valve of a subject. Techniques are also described for treating a heart valve of a subject by coupling leaflets of the heart valve to a support using tissue-piercing elements. Other embodiments are also described.

Abstract: Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane.

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 polymer valve and a ventricular assist device using the polymer valve are provided to allow blood to flow in a first direction but prevents blood from flowing backward in a second direction opposite to the first direction. The polymer valve comprises a base body having a hollow therethrough for passing of blood, comprising a pair of support legs formed by cutting opposing sides of an end portion of the base body along an inclined surface toward the center line of the hollow to extend toward the first direction from the body , and a leaflet formed of polymer and attached to the support legs to cover the hollow, wherein the leaflet includes a pair of opposing sides attached to the cutting surfaces of the support legs and an end portion connecting the sides of the leaflet, wherein the leaflet is formed of an opening between the support legs.

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: A novel support system for bioprosthetic cardiac valves with heart shape commissural posts (18) and intercommissural conjunctions with long openings with oval closures (8), allows the better function of the valve by diminishing the forces applied on the leaflets during the cardiac cycle.

Abstract: Embodiments of prosthetics configured for implanting in at the native mitral valve region of the heart include a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Methods and apparatus for delivering and implanting the prosthetic valve are also described.

Abstract: An implantable prosthetic valve, according to one embodiment, comprises a radially collapsible and expandable frame and a leaflet structure supported within the frame. The leaflet structure can comprise a plurality of leaflets paired together at commissures. In one embodiment, the commissures can comprise leaflet tabs rolled into spirals around non-rigid reinforcing inserts. In another embodiment, the commissures can comprise a reinforcing sheet folded around leaflet tabs.

Abstract: Disclosed is a stentless transluminally implantable heart valve, having a formed in place support. The formed in place support exhibits superior crush resistance when compared to conventional balloon expandable or self expandable stent based valves.

Abstract: Heart valve prostheses are provided having a self-expanding frame that supports a valve body comprising a skirt and a plurality of coapting leaflets. The self-expanding frame includes an inflow section, a valve section, and an outflow section. The outflow section forms attachment loops in a collapsed configuration to attach the frame to a delivery system.

Abstract: A resizable valve base for a cardiovascular valve assembly that is comprised of the resizable valve base and a valve member that is detachably coupled thereto. The resizable valve base has adjustable dimensions to allow use with both small and large size valve members. The valve base comprises a frame comprised of a plurality of frame sections, and each frame section includes a mounting portion and a pair of arcuate portions extending from opposite sides of the mounting portion. The valve base also includes a plurality of joining elements for joining together the frame sections to define a generally cylindrical opening having a diameter, wherein said plurality of joining elements allow adjacent frame sections to move towards or away from each other in order to modify the diameter of the opening, thereby moving the valve base between a collapsed position and an expanded position.

Abstract: Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures.

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

Abstract: Described herein is a unique sutureless heart valve that includes a deployment mechanism having a plurality of fasteners. The plurality of fasteners may be actuated at least two states: a disengaged state wherein said plurality of fasteners are retracted, and an engaged state wherein said plurality of fasteners are extended; and further comprising a deployed state wherein said plurality of fasteners, when extended, are irreversibly locked such that said heart valve is securely deployed at the target surgical site. The valve deployment mechanism comprises a ring assembly comprising a first annular member onto which said plurality of fasteners are associated and a second annular member peripheral to said first annular member and comprising a series of windows through which individual fasteners of said plurality of fasteners project.

Abstract: A replacement heart valve, including a securing device and a non-return valve, the securing device including a resiliently deformable material adapted to adopt collapsed and non-collapsed configurations, the resiliently deformable material having a memory such that it returns to the non-collapsed configuration when not held under tension, whereby the valve is adapted to be secured within the valve annulus. Also featured is a method for replacing a heart valve and a kit, which use this replacement heart valve.

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 cardiac-valve prosthesis is adapted for percutaneous implantation. The prosthesis includes an armature adapted for deployment in a radially expanded implantation position, the armature including a support portion and an anchor portion, which are substantially axially coextensive with respect to one another. A set of leaflets is coupled to the support portion. The leaflets can be deployed with the armature in the implantation position. The leaflets define, in the implantation position, a flow duct that is selectably obstructable. The anchor portion can be deployed to enable anchorage of the cardiac-valve prosthesis at an implantation site.

Abstract: A valve prosthesis, such as an artificial venous valve, is described. The valve prosthesis has a support frame formed from a cannula and an attached covering that defines an opening adapted to move between a first position in which the opening is open to fluid flow and a second position in which the opening is closed to fluid flow. The support frame includes a leaflet support portion and a circumferential centering support element disposed adjacent the leaflet support portion with respect to a lengthwise axis of the support frame and mirroring the leaflet support portion with respect to a transverse axis of the support frame.

Abstract: A cardiac valve with a first anchor frame and a cover on the first anchor frame for unidirectional flow of a liquid through the valve.

Abstract: A sequentially deployed prosthetic cardiac valve includes a self-expanding frame having an atrial skirt, a ventricular skirt, and an annular region disposed therebetween. A first anterior tab is disposed on an anterior portion of the frame. A posterior tab is on a posterior portion of the self-expanding frame. The frame may be designed so that any portion may expand sequentially in any desired order. For example, a portion of the first anterior tab and a portion of the posterior tab may partially self-expand first. Next, the first anterior tab may fully self-expand before the posterior tab fully self-expands. The posterior tab may fully self-expand next followed by the ventricular skirt, or the ventricular skirt may self-expand next followed by full expansion of the posterior tab.

Abstract: A prosthetic valve device, including a valve component, frame and methods of manufacturing the same. The present invention, in some embodiments, is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention, is a frame formed from a unique cutting pattern.

Abstract: A two-stage or component-based 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 a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: The replacement device according to the invention makes it possible to replace at least one natural chord (19) making up the mitral valve, said natural chord normally being connected by one end to a pillar (20) formed by a muscular relief on the cardiac wall and, by another end, to a component leaflet (14) of the valve. The replacement device comprises a base (31) that can be fastened on a pillar (20) and on which at least one pair (P3) of chords (34) with predefined lengths are mounted that are suitable for being fastened on the leaflet (14) of the valve. Each pair (P3) of chords is configured in a loop provided with an end reinforcement for fastening on the leaflet (14) of the valve (12) opposite the base (31). The invention also relates to a kit comprising at least two replacement devices.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.

Abstract: This document provides methods and materials related to providing a mammal with a replacement valve (e.g., a synthetic or artificial heart valve). For example, synthetic or artificial heart valve that can be delivered in a minimally invasive manner are provided.

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

Abstract: A prosthetic heart valve includes a stent and a valve assembly attached to the stent. The stent has a longitudinal axis, a distal end and a proximal end adapted to reside adjacent the aortic annulus of a patient. The proximal end of the stent is oriented at an oblique angle to the longitudinal axis.

Abstract: A device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

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 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: An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame.

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 implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element.

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 valve prosthesis, implantation device, and methods for use are provided. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis. Alternative designs of the devices allow different methods for minimally invasive implantation of a sutureless valve prosthesis, including transapical and transcatheter approaches. Also provided is a delivery device for delivery of a medical prosthesis though minimally invasive means.

Abstract: A surgically implantable multiple orifice heart valve having a valve frame with at least two orifices, each of which can accommodate a tissue valve. The multiple orifice heart valve includes a stent frame having a first side, an opposite second side, and multiple orifices or openings, each of which extends from the first side to the second side of the stent frame and is adjacent to at least one of the other multiple orifices or openings.

Abstract: Prosthetic heart valves, which are collapsible to a relatively small circumferential size for less invasive delivery into a patient and which then re-expand to operating size at an implant site in the patient, include a collapsible/expandable stent-like supporting structure and various components of flexible, sheet-like material that are attached to the supporting structure. For example, these sheet-like other components may include prosthetic valve leaflets, layers of buffering material, cuff material, etc. Improved structures and techniques are provided for securing such other components to the stent-like supporting structure of the valve.

Abstract: A valve for use in a body lumen, where the valve includes a valve leaflet with delayed leaflet deployment relative an in vivo implant time. The valve includes a valve frame, a valve leaflet coupled to the valve frame. The valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve, and a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time once implanted in vivo.

Abstract: A method for implanting a prosthetic valve apparatus in a novel location which replaces the function of a native diseased valve. The prosthetic valve apparatus includes a one way valve and an expandable valve seating. anchoring and securing apparatus in a newly created orifice near or at the center of the anterior valve leaflet. The prosthetic valve apparatus also causes the sealing of the native valve and thus results in a solution for paravalvular leakage and regurgitation.

Abstract: A prosthetic heart valve has an annular valve-perimeter-shape-defining structure having a radially outer surface. A clip structure is provided on the outer surface. This clip structure is used to attach flexible valve leaflets to the shape-defining structure. One or more retainer members may be used to help hold the leaflets in the clip structure.

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 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 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 partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion which is suitable for treating patients with heart disease, particularly congestive heart failure. The partitioning device has a reinforced membrane with outwardly biased members to help seal the periphery of the membrane against the wall of the patient's heart chamber. In one embodiment, the outwardly biased member is an expansive strand that extends between adjacent ribs of an expandable frame which reinforces the membrane. In another embodiment, the outwardly biased member is a hydrophilic body such as foam which swells upon contact with body fluid such as blood in the heart chamber. The reinforced membrane has a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane.

Abstract: A valve prosthesis for percutaneous placement within a vein is disclosed that includes a valve scaffold and a backflow barrier. The valve scaffold is of a shape memory or resilient material and the backflow barrier is a flap of flexible material attached to the valve scaffold. The valve prosthesis is operable to alternate between open and closed configurations in response to changes in retrograde blood flow pressure. In the open configuration, the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween and the backflow barrier allows antegrade blood flow through the open spaces. In the closed configuration, the consecutive windings of the valve scaffold are collapsed such that the valve scaffold has a substantially flat profile and the backflow barrier covers the opens spaces of the flattened valve scaffold to prevent retrograde blood flow from leaking there through.

Abstract: An implantable valve prosthesis is provided. The valve prosthesis includes a frame structure having first and second independent frame elements. A graft member is attached to both the first and second frame elements and includes a closure member, such as a valve leaflet. The closure member is movable between a first position that allows fluid flow through the prosthesis in a first, antegrade direction and a second position that restricts flow through the prosthesis in a second, retrograde direction.

Abstract: The subject invention concerns vascular prosthetic devices and methods for ascending aorta and/or valve replacement in humans and animals. In one embodiment, a device of the invention includes a vessel-like structure having a first end adapted for surgical attachment to a left ventricle, a second end adapted for surgical attachment to an aorta, and, interposed between the first and second ends, a sinus portion configured in the shape of the sinuses of Valsalva in a human aortic valve.