Abstract: Implants or systems of implants apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants also make use of strong fluoroscopic landmarks.

Abstract: A method for direct therapeutic treatment of myocardial tissue in a localized region of a heart having a pathological condition. The method includes identifying a target region of the myocardium and applying material directly and substantially only to at least a portion of the myocardial tissue of the target region. The material applied results in a physically modification the mechanical properties, including stiffness, of said tissue. Various devices and modes of practicing the method are disclosed for stiffening, restraining and constraining myocardial tissue for the treatment of conditions including myocardial infarction or mitral valve regurgitation.

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: Various embodiments of the present invention provide a conduit device including an attaching device configured for defining a helical pathway through a tissue wall and complementary ring in cooperation for securing the device within an aperture defined in the tissue wall. Some embodiments of the present invention further provide a system for implanting a conduit device in a tissue wall. More specifically, some embodiments provide a system including a coring device for defining an aperture in a tissue by removing and retaining a tissue core and securely implanting a conduit device therein so as to provide fluid communication between a first and second surface of the tissue wall via the conduit device.

Abstract: Devices, systems, and methods employ an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation.

Abstract: A method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor in an unexpanded configuration within a catheter to a vicinity of the heart valve; deploying the anchor from the catheter; expanding the anchor to contact tissue at an anchor site; and retrieving the anchor into the catheter. The invention also includes an apparatus for endovascularly replacing a heart valve, including: a catheter; a replacement valve configured to be disposed within the catheter for delivery to a vicinity of the heart valve; and an expandable anchor configured to be disposed within the catheter for delivery to a vicinity of the heart valve, to be deployed from the catheter, to be expanded to contact tissue at an anchor site and to be retrieved back into the catheter after having been expanded.

Abstract: A method for treating a stenotic native aortic valve in a human heart is provided. The method comprises dilating the stenotic native aortic valve using a dilatation catheter and then deploying a prosthetic heart valve within the dilated stenotic native aortic valve. The prosthetic heart valve comprises a collapsible and expandable metallic stent and a valvular structure formed of a synthetic biocompatible material. The valvular structure is positioned substantially between the inlet and outlet ends of the stent for preventing the flow of blood in one direction. The prosthetic heart valve may further comprise an internal sleeve for creating a seal along at least a portion of the stent wall.

Abstract: A method for implanting a heart valve assembly includes a first annular prosthesis for implantation within a tissue annulus, a second valve prosthesis, and a multi-lobed connection adapter to secure the second prosthesis to the first prosthesis. In one embodiment, the adapter is arranged to allow the second prosthesis to be secured to the first prosthesis in a predetermined angular orientation. During use, the first annular prosthesis is implanted into the annulus, and the second valve prosthesis is inserted into the annulus. The adapter secures the second prosthesis relative to the first prosthesis to align the second prosthesis with the first prosthesis in a predetermined angular orientation; and secure the second prosthesis to the first prosthesis in the predetermined angular orientation.

Abstract: A device for measuring an expanded internal orifice of a patient includes an orifice-expanding device, a pressure measuring device, and a size-measuring device. The size-measuring device measures a dimension of the orifice after it has been expanded by the orifice-expanding device.

Abstract: Methods, delivery systems and engaging apparatuses for the placement and treatment of an insufficient or stenotic cardiac valve, such as the mitral valve are disclosed. One such method is based on a two step procedure, where during the first step the engaging apparatus is brought to the valve annulus using a delivery system which permits continued normal blood flow. In some preferred embodiments, this is implemented with a balloon and other preferred embodiments it is implemented using a multi-pronged structure that is collapsible like an umbrella frame. The second step is performed after the engaging apparatus has been integrated into the annular wall by natural processes of tissue healing and remodeling. In the second step the engaging apparatus is tightened leading to tightening of the valve annulus and correction of existing valvular insufficiency.

Abstract: Catheter based systems and methods for securing tissue including the annulus of a mitral valve. The systems and methods employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

Abstract: A percutaneously inserted bistable heart valve prosthesis is folded inside a catheter for transseptal delivery to the patient's heart for implantation. The heart valve has an annular ring, a body member having a plurality of legs, each leg connecting at one end to the annular ring, claws that are adjustable from a first position to a second position by application of external force so as to allow ingress of surrounding heart tissue into the claws in the second position, and leaflet membranes connected to the annular ring, the body member and/or the legs, the leaflet membranes having a first position for blocking blood flow therethrough and a second position for allowing blood flow therethrough. The heart valve is designed such that upon removal of the external force the claws elastically revert to the first position so as to grip the heart tissue positioned within the claws, thereby holding the heart valve in place. The body member and claws may be integrated into a one-piece design.

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent adapted to be initially crimped in a narrow configuration for catheterization through the body duct to a target location and adapted to be deployed to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material providing collapsible slack portions of the conduit at the outlet. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse flow is prevented. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing. The device can be deployed in a native heart valve position using a deployment catheter.

Abstract: Devices for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combination thereof.

Abstract: A method of implanting a prosthetic valve in a stenosed aortic valve via a catheterization technique. A balloon catheter is advanced into a patient's vasculature and a balloon is expanded within the stenosed aortic valve to push aside the calcified leaflets. The prosthetic valve is then introduced into a patient's vasculature through an 18 French arterial introducer. After advancement through the femoral artery and aorta, the prosthetic valve is radially expanded for implantation in the dilated aortic valve. The prosthetic valve includes a compressible and expandable frame and a valvular structure made with pericardial tissue. The prosthetic valve further includes an internal cover fastened to an internal surface of the frame between an inlet end of the frame and the valvular structure.

Abstract: The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Abstract: A method for direct therapeutic treatment of myocardial tissue in a localized region of a heart having a pathological condition. The method includes identifying a target region of the myocardium and applying material directly and substantially only to at least a portion of the myocardial tissue of the target region. The material applied results in a physically modification the mechanical properties, including stiffness, of said tissue. Various devices and modes of practicing the method are disclosed for stiffening, restraining and constraining myocardial tissue for the treatment of conditions including myocardial infarction or mitral valve regurgitation.

Abstract: The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Abstract: A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the stenotic aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface. The valve prosthesis can be delivered percutaneously, surgically, or endoscopically.

Abstract: Described are methods and systems for modifying vascular valves in order to reduce retrograde blood flow through the valves. Preferred methods include connecting vascular valve leaflets with at least one remodelable material, such that the valve leaflets become fused by the ingrowth of the patient's native tissue. Preferred remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Abstract: The present invention provides a valve configured for insertion on the proximal and distal sides of a heart valve annulus to replace the heart valve of a patient. The valve comprises a first substantially annular portion adapted to be positioned on a proximal side of the annulus of a patient and a second substantially annular portion adapted to be positioned on a distal side of the annulus of a patient, wherein at least one of the first and second substantially annular portions is movable towards the other portion to a clamped position to clamp around the annulus. The second portion has a flow restricting portion extending therefrom and is movable between a first position to permit the flow of blood and a second position to restrict the flow of blood. In one embodiment, the valve has a suture joining the first and second portions to draw the first and second portions into closer proximity and a cinch member to secure the suture to maintain the first and second portions in the clamped position.

Abstract: A method of implanting a heart valve prosthesis is disclosed. A valve is mounted within a support apparatus that is deformable between an expanded and a reduced cross-sectional condition. The prosthesis can be implanted into a patient's heart, such as during a direct vision procedure through a generally tubular implantation apparatus that maintains the prosthesis in its reduced cross-sectional condition until discharged from the tubular apparatus at a desired implantation site.

Abstract: An annuloplasty ring holder including a head having an upper surface and an annuloplasty ring receiving surface facing opposite the upper surface. The annuloplasty ring holder also includes means for attaching an annuloplasty ring to the annuloplasty ring receiving surface. The means for attaching an annuloplasty ring to the annuloplasty ring receiving surface may include one or more suture guides operatively associated with the head and configured to position one or more sutures to removably associate an annuloplasty ring with the annuloplasty ring receiving surface. The head may include a central hub and more than one spoke radiating out from the central hub. If the head is thus configured, each spoke will include a portion of the annuloplasty ring receiving surface.

Abstract: Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.

Abstract: The present invention is directed to methods and devices for repairing a cardiac valve. Generally, the methods involve a minimally invasive procedure that includes creating an access in the apex region of the heart through which one or more instruments may be inserted so as to repair a cardiac valve, for instance, a mitral or tricuspid valve. Accordingly, the methods are useful for performing a variety of procedures to effectuate a repair. For instance, in one embodiment, the methods are useful for repairing a cardiac valve by implanting one or more artificial heart valve chordae tendinae into one or more cardiac valve leaflet tissues so as to restore the proper leaflet function and thereby prevent reperfusion. In another embodiment, the methods are useful for repairing a cardiac valve by resecting a portion of one or more cardiac valve leaflets and implanting one or more sutures into the resected valve tissues, which may also include the implantation of an annuloplasty ring.

Abstract: A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

Abstract: Tools can be used to assist with the implantation of heart valve prostheses, especially stentless aortic heart valve prostheses. In some embodiments, a heart valve prosthesis includes a plurality of flexible leaflets, a commissure support and a plurality of fasteners inserted into the inner surface of the commissure support and protruding from the outer surface of the commissure support. The fasteners comprise an elongated portion and a tip at an end of the elongated portion. In other embodiments, a heart valve prosthesis includes a plurality of flexible leaflets and a reinforcement secured to an inner surface of a valve commissure support. The reinforcement has an aperture. The heart valve prosthesis and fastener components can be placed into kits. The fasteners can be used to perform improved implantation procedures.

Abstract: Devices for attaching a first mass and a second mass and methods of making and using the same are disclosed. The devices can be made from an resilient, elastic or deformable materials. The devices can be used to attach a heart valve ring to a biological annulus. The devices can also be used for wound closure or a variety of other procedures such as anchoring a prosthesis to surrounding tissue or another prosthesis, tissue repair, such as in the closure of congenital defects such as septal heart defects, tissue or vessel anastomosis, fixation of tissue with or without a reinforcing mesh for hernia repair, orthopedic anchoring such as in bone fusing or tendon or muscle repair, ophthalmic indications, laparoscopic or endoscopic tissue repair or placement of prostheses, or use by robotic devices for procedures such as those above performed remotely.

Abstract: An implantable prosthetic valve having an in situ formable support structure and methods of deploying such a valve are disclosed. In one arrangement, the valve has a base and at least one flow occluder. A first flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature extends proximally of the base of the valve. A second flexible component which is incapable of retaining the valve at a functional site in the arterial vasculature extends distally of the base of the valve. At least one rigidity component combines with at least one of the first and second flexible components to impart sufficient rigidity to the first or second components to retain the valve at the site.

Abstract: A method and apparatus for replacing both the native mitral valve and the native aortic valve in a heart with a stentless bioprosthetic graft is provided. The bioprosthetic graft comprises a harvested homograft that includes a mitral valve portion and an aortic valve portion, and an extension portion made of a biocompatible material. The extension portion is sutured to the homograft and is for suturing to the left atrial wall of the heart to close an incision in the left atrial wall following implantation of the mitral valve portion and the aortic valve portion of the homograft.

Abstract: Described are methods and systems for modifying vascular valves in order to reduce retrograde blood flow through the valves. Preferred methods include connecting vascular valve leaflets with at least one remodelable material, such that the valve leaflets become fused by the ingrowth of the patient's native tissue. Preferred remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.

Abstract: A method of implanting a prosthetic valve within a heart comprises translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart. A portion of the inflatable structure that is distal to the native valve is inflated. A portion of the inflatable structure that is proximal to the native annular valve is inflated.

Abstract: A sizing apparatus and a method for ascertaining a size for a cardiac prosthesis are disclosed. Specifically, the sizing is implemented by positioning a contact member at a patient's heart valve for engagement by one or more viable leaflets of the patient's valve. The size is determined based on the engagement between the contact member and the leaflet (or leaflets) of the patient's valve.

Abstract: An implantable prosthetic valve that is transformable from a first helical pre-implantation configuration to a second valvular functional configuration, and methods of delivery.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart.

Abstract: A device for modifying the shape of a mitral valve annulus. In one embodiment, the device includes a connector disposed between first and second anchors, the first and second anchors each adapted to be deployed in a coronary sinus adjacent the mitral valve annulus to anchor the device in the coronary sinus; and an actuation element adapted to receive a proximally or distally directed actuation force from an actuator and to transmit the actuation force to the first and second anchors simultaneously.

Abstract: The present invention is a group of medical devices designed to improve heart valve function. The medical devices may be used individually, or in combination to supplement damaged valves, replace damaged valves, or improve damaged valves function. The medical devices include leaflet retainers, a neo-annulus, neo-leaflet, and a framework. In addition, the present invention is novel methods for surgically treating heart valves.

Abstract: A catheter based system for treating mitral valve regurgitation includes a reshaping device having a body and a plurality of movable anchoring barbs attached to the body of the device. The reshaping device can be made from a biocompatible material having suitable shape memory properties. The devices of the current invention can be self expandable, balloon expandable, or a combination self expandable and balloon expandable. One embodiment of the invention includes a method for attaching a reshaping device to the annulus of a mitral valve, moving the body of the device from a fully expanded configuration to a resting configuration, and thereby reshaping the mitral valve annulus.

Abstract: A method and a device for improving cardiac function are provided. The device is packaged in a collapsed state in an end of a catheter. Portions of a frame construction of the device spring outwardly when the catheter is withdrawn from the device. Anchoring formations on the frame construction secure the frame construction to a myocardium of the heart. A membrane secured to the frame construction then forms a division between volumes of an endocardial cavity of the heart on opposing sides of the membrane.

Abstract: An assembly and method for effecting the condition of a mitral valve annulus of a heart includes a guide wire configured to be fed into the coronary sinus of the heart, and a mitral valve annulus therapy device configured to be slidingly received on the guide wire and advanced into the coronary sinus of the heart on the guide wire. A guide tube may further be employed for guiding the device into the coronary sinus. An introducer which may be employed for pushing the device into or pulling device out of the heart has a mechanism for releasably locking to the device. This enables substitution of the device if needed. Also, the crossover point of the circumflex artery and coronary sinus may be determined and avoided when the device is deployed.

Abstract: A device and method for improving flow through a native blood vessel valve, such as the aortic valve, are provided. The present invention allows a miniature valve to be implanted into affected leaflets percutaneously, obviating the need for coronary bypass surgery. The method includes the cutting of small holes, on the order of 4 mm, in the leaflets of a targeted valve, thereby allowing blood to flow through the newly formed holes. The holes are used as attachment sites for the miniature valves of the present invention.

Abstract: A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: A valve repair system, preferably including an annuloplasty prosthesis and a holder for the prosthesis. The holder includes a first component having a central opening, a circumferential surface and an outwardly extending member. The annuloplasty prosthesis is located adjacent to the circumferential surface, above the outwardly extending member. The holder further includes a second component movable upwardly relative to the first holder component and includes a rigid penetrating member extending downward from the second component into the prosthesis, holding it adjacent the circumferential surface. The holder also includes a suturing guide for assisting a physician in valve repair surgery, which may be a cuttable suture extending across the central opening along a path approximating a desired line of leaflet coaption. The cuttable suture may additionally secure the first and second components to one another.

Abstract: A stentless bioprosthetic valve includes at least one piece of biocompatible material comprising a bi-leaflet conduit. The conduit has a distal end and a proximal end that defines a first annulus for suturing to the valve annulus of a heart. The conduit further includes first and second leaflets that mimic the anterior and posterior leaflets of the native mitral valve. The first and second leaflets extend between the proximal and distal ends. The distal end defines a second annulus at which the first and second leaflets terminate. The second annulus is for suturing to free edges of the anterior and posterior leaflets of the native mitral valve that remain intact following resection of the native mitral valve so that the native chordae tendineae continue to provide prolapse prevention and left ventricular muscle support functions in addition to maintaining the continuity between the valve annulus and the papillary muscles.

Abstract: A method for reducing mitral regurgitation includes deploying deforming matter into a selected one of (i) a mitral valve annulus adjacent a posterior leaflet, and (ii) tissue adjacent the mitral valve annulus and proximate the posterior leaflet, to cause conformational change in the mitral valve annulus to increase mitral valve leaflet coaptation.

Abstract: An assembly for effecting the condition of a mitral valve of a heart includes a mitral valve therapy device, a guide wire, and a guide tube. The mitral valve therapy device is configured to reshape the mitral valve annulus of the heart when placed within the coronary sinus adjacent the mitral valve annulus. The guide wire is configured to be fed into the coronary sinus of the heart adjacent the mitral valve annulus. The guide tube has a distal end, a proximal end, and a lumen extending between the distal end and the proximal end. The guide tube further includes a side port, intermediate the distal and proximal ends which communicates with the lumen. This permits the guide tube to be slidingly received on the guide wire with the guide wire extending from the distal end, through the lumen, and out the side port. In use, the guide tube is slid along the guide wire into the coronary sinus.

Abstract: An intravascular balloon occlusion device according to the invention is shown. The device is ideally suited for use in a coronary artery bypass graft procedure. The device includes a body having at least one selectively inflated balloon provided on the distal end thereof. Preferably, the body is a closed end body so that fluid can only flow from the proximal end of the body into the balloon. In use, the distal end of the body and the balloon are inserted into an aperture provided in the aorta. The balloon is inflated and then the device is retracted until the balloon seats against the incision or aperture in the aorta, thereby effectively sealing the aperture from the blood flow through the aorta, but not occluding blood flow through the body of the aorta itself. Next, the graft vessel is telescopically positioned on the occlusion device and mounted to the aorta. Once the vessel is secured thereto, the balloon is deflated and then the occlusion device is retracted from both the aorta and the graft vessel.

Abstract: A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

Abstract: A jacket of biological compatible material has an internal volume dimensioned for an apex of the heart to be inserted into the volume and for the jacket to be slipped over the heart. The jacket has a longitudinal dimension between upper and lower ends sufficient for the jacket to surround a lower portion of the heart with the jacket surrounding a valvular annulus of the heart and further surrounding the lower portion to cover at least the ventricular lower extremities of the heart. The jacket is adapted to be secured to the heart with the jacket surrounding at least the valvular annulus and the ventricular lower extremities. The jacket is adjustable on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole.