Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: An artificial valve (5; 10; 20; 30; 50) for implantation in a body, in or adjacent to a blood vessel, comprising a casing (12; 37; 61) and an opening and closing mechanism, at least part of said mechanism being a moving part (11; 21, 22; 31, 32, 33; 51) adapted to make an opening and a closing movement to assume an open and a closed position for opening and closing, of the blood through said blood vessel, and positions between said open and closed positions, said closing movement of the moving part (11; 21, 22; 31, 32, 33; 51) being initiated and carried out when a threshold value is reached by a parameter of the mammal or of a device (8) used by the mammal. The opening and closing mechanism is arranged to cause the moving part (51) to its closing movement by means of giving the moving part kinetic energy in a plurality of steps.

Abstract: The invention is a device, system, and method for repairing heart valve function, which may include bisecting native valve leaflets for improved deployment of a prosthetic heart valve in the native valve annulus. The invention may include a catheter having a cutting element shaft with a cutting element configured to puncture a valve leaflet and/or make a controlled cut through the leaflet. The device may have an extendable foot configured to be positioned on an opposite side of the valve leaflet from the cutting element shaft. The device may include magnets to guide the cutting element and/or cutting element shaft in proper alignment with the extendable foot and to hold the elements in place during leaflet bisection.

Abstract: A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Abstract: Described, in certain aspects, are medical devices that can be used to anchor graft materials to bodily structures. These devices comprise an implantable graft structure and tissue ingrowth material. This implantable graft structure is comprised of a body of persistent material having a first face and one or more openings defined therein, wherein the persistent material body first face is configured for opposing a bodily structure wall upon implantation. This tissue ingrowth material is positioned at the one or more persistent material body openings, and is configured for receiving tissue ingrowth from the bodily structure wall effective to anchor the graft structure to the bodily structure wall. The invention also provides methods utilizing these and other inventive medical devices, for example, to anchor graft materials to vascular vessel walls and/or other bodily structures.

Abstract: An annuloplasty prosthesis for a heart valve has a sewing cuff added to the conventional structure. The sewing cuff is preferably an extension of the fabric cover that is provided around the core of the prosthesis. The sewing cuff preferably extends radially outwardly from cross sections of the remainder of the prosthesis. Methods of making such a sewing cuff are also disclosed.

Abstract: A medical device in cardiac surgery for replacement of the diseased native heart valves in humans increases thromboresistance of heart valve prosthesis. A heart valve prosthesis comprising an annular housing with the inner surface defining the blood flow I through the valve prosthesis and leaflets mounted within the annular housing with the possibility to pivot around the reference axis between an open position which allows the passage of the direct blood flow I, and a closed position which restricts the blood backflow II. Each leaflet has an upstream surface facing the direct blood surface I, a downstream surface facing the blood backflow II, a coaptation surface, and a side surface.

Abstract: An artificial heart valve consists of two or more valve members (10, 20) stacked one upon the other in a housing (40) and having blood flow passages (13, 23) that can be aligned with each other in order to open the valve and allow blood flow through the valve and that can be disaligned to close the valve. The valve members are maintained in continuous rotation and the alignment and disalignment of the valve members is achieved by slowing down and reaccelerating one or more of the valve members using a drive (18, 28) appropriately controlled by a control unit (C).

Abstract: A valve that includes an expandable valve body defining a lumen and a longitudinally moveable obstructer retained within the lumen of the valve body between the proximal and distal ends of the valve when the valve is in an expanded configuration. The valve, in the collapsed configuration, is delivered to a native valve site by a catheter where the valve body is expanded to anchor the valve at the valve annulus and the collapsed obstructer is subsequently expanded so that the valve is in the expanded configuration.

Abstract: The invention provides methods and compositions for determining whether a subject containing a stent immobilized in a blood vessel has asymptomatic stent thrombosis or is at risk of developing clinically symptomatic stent thrombosis. In one approach, the method involves imaging a region of the blood vessel that contains the stent using a probe that contains a fluorochrome, for example, a near-infrared fluorochrome, and a targeting moiety that binds a molecular marker indicative of the presence of asymptomatic stent thrombosis or the development of symptomatic stent thrombosis. To the extent that the subject displays one or more such markers, the probe binds to the markers and increases the local concentration of the probe in the vicinity of the stent. The imaging method identifies those patients that display a higher density of such markers in the vicinity of the stent. As a result, those patients can be monitored for, and/or treated to prevent, symptomatic stent thrombosis.

Abstract: A transluminal cardiac valve includes an expandable generally tubular cage including when expanded a generally uniform central region, first and second ends each diametrically constricted relative to the central region, a blood impervious region extending from the first end of the cage to within the generally uniform central region, and an inflatable plunger freely disposed and captured within the cage when inflated.

Abstract: An epicardial clip for reshaping the annulus of the mitral valve of a heart. The epicardial clip includes a curved member having an anterior segment configured to be positioned in the transverse sinus of the heart, a posterior segment configured to be positioned on the posterior side of the heart, such as on or inferior to the atrioventricular groove, and a lateral segment extending between the anterior segment and the posterior segment. The lateral segment includes a curve such that the first end of the member is positioned at or above the plane of the mitral valve and the second end of the member is positioned at or below the plane of the mitral valve.

Abstract: Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Abstract: A biocompatible valve (200) includes a valve mechanism (250, 230a, 230b), which is mounted and is longitudinally displaceable within a valve mount (210) affixed to a recipient patient. A valve annulus (250) defines an orifice (240) in which a closing mechanism (230a, 230b) is received. Upon a transition from an open position to a closed position of the closing mechanism (230a, 230b), hydraulic shock is introduced into the fluid passing through the valve. The present invention provides a dampening mechanism (280) to mitigate the shock and to dissipate its energy. Various embodiments allow for high order frequency response through relationships between dampening mechanism components.

Abstract: A medical device (1210) comprises a generally cylindrical treatment element (1220) for location between a pair of valve leaflets (1212) situated between an atrium (1214) and a ventricle (1216) of a heart. The treatment element (1220) supports the valve leaflets (1212) at the region of co-aptation of the valve leaflets (1212) and occludes the valve opening to resist fluid flow in the retrograde direction through the valve opening. The device (1210) comprises a support (1222) to support the treatment element (1210) at the region of co-aptation of the valve leaflets (1212). The support has an anchor (1224) and a tether (1226), the tether (1226) being provided at the end of a guide wire (1228) which is initially utilised in the percutaneous insertion of the treatment element (1220). The anchor (1224) is secured, in use, to a septal wall (1230), while the guide wire (1228) exits the atrium (1214) through a vein adjacent a rear wall (1224) thereof.

Abstract: An implantable prosthesis can be formed from an improved biocompatible material that provides for cellular colonization of the biocompatible material. Specifically, the biocompatible material is a rigid porous material. In embodiments of particular interest, the implantable prosthesis is a mechanical heart valve prosthesis with a rigid occluder. In some embodiments, the rigid occluder is formed from the biocompatible material. A filler comprising a hydrogel or a structural protein can be located within the pores. In some embodiments, a bioactive agent is within the pores. In some embodiments, the rigid occluder is formed from a polymer material, a carbonaceous solid or a ceramic material. The pores can extend through the rigid material.

Abstract: The present invention relates to the implantation of one or more prosthetic valve(s) in the pulmonary vein(s) of a subject as a means of decreasing or preventing an increase in pulmonary venous pressure. The present invention accordingly provides for novel treatment strategies for the treatment of medical disorders associated with elevated pulmonary venous pressure, including congestive heart failure, as well as for prosthetic pulmonary vein valves and their delivery systems. Expandable as well as fixed-dimension non-expandable pulmonary vein prosthetic valves for implantation by a variety of surgical and percutaneous procedures are also described.

Abstract: A tri-leaflet heart valve includes an annular valve base with an inner surface forming an orifice through which blood flows from the upstream side to the downstream side. Three protruding hinges, each with concave sockets on opposite sides, are formed on the inner surface. Each hinge has a downstream face and an upstream face connected by a ridge. Three leaflets are respectively arranged between adjacent hinges. Each leaflet has round pivots on both sides that rest inside the concave sockets, allowing the leaflets to freely rotate in the annular valve base. When the leaflets are subject to a positive pressure from the blood flow, the leaflets are pushed open and allow a central flow. When the leaflets are subject to a negative pressure, the leaflets are closed to occlude the blood flow.

Abstract: Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Abstract: The present invention provides improved devices and methods for replacing or repairing a malfunctioning heart valve. In particular, improved minimally invasive methods and devices are provided for percutaneous transcatheter implantation of expansible prosthetic heart valves within or adjacent a valved anatomic site within the heart. In one embodiment, an expansible prosthetic heart valve comprises an implantable structure, a flexible membrane, and a membrane support. The implantable structure is expansible from a first reduced diameter to a second enlarged diameter and has a flow path therethrough. The flexible membrane is positionable in the flow path for permitting flow in a first direction and substantially resisting flow in a second direction. The membrane support is positionable in the flow path and affixed to the implantable structure.

Abstract: Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Abstract: A mechanical heart valve prosthesis has a generally rectangular orifice and two leaflets that move between a closed position nearly perpendicular to blood flow and an open position nearly parallel to blood flow. Due to the uniform dimension of a rectangle, the leaflets are hinged at the periphery of the orifice, and present a single large central flow region to the blood when opened. The base provides several means of constraining the leaflet rotation during opening and closing.