Abstract: A system for treating mitral valve regurgitation includes a tensioning device having a flexible annuloplasty ring, a plurality of anchoring members and a tensioning filament attached to the flexible ring. One embodiment of the invention includes a method for attaching a flexible annuloplasty ring to the annulus of a mitral valve, and adjusting the lengths of segments of the tension filament attached to the flexible ring in order to exert force vectors on the annulus, thereby reshaping the mitral valve annulus so that the anterior and posterior leaflets of the mitral valve close completely during ventricular contraction.

Abstract: Implants or systems of implants and methods 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 and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

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: A system and process for correction of regurgitation of heart valves. With mitral valves in particular, the anterior leaflet is advanced through use of a D-plasty patch and a narrow annuloplasty ring which compresses the lateral dimension of the valve. Other specifically configured annuloplasty rings can also be utilized. The sizes of the patch and ring are selected to provide a sufficient advancement of the leaflet to restore the surface of coaptation.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band having an elongate and arcuate body. The elongate and arcuate body has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is displaced from the plane containing the first end and the second end. The transvalvular band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets and the central portion is displaced towards the left ventricle relative to the first anchoring portion and the second anchoring portion. The ventricular direction displacement moves coaption to an earlier point in the cardiac cycle.

Abstract: The invention is an annuloplasty ring, and associated methods therefore, configured to reshape a native heart valve annulus to correct heart valve function, and also configured to be reshaped into a generally circular form in order to receive and/or support a prosthetic heart valve. The annuloplasty ring may be configured to have a generally D-shaped configuration when initially implanted to correct native valve function, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Abstract: A device for treating mitral regurgitation including an anchor which features one or more reinforcing bars, ribbon and suture.

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: An intravascular support device includes a support or reshaper wire, a proximal anchor and a distal anchor. The support wire engages a vessel wall to change the shape of tissue adjacent the vessel in which the intravascular support is placed. The anchors and support wire are designed such that the vessel in which the support is placed remains open and can be accessed by other devices if necessary. The device provides a minimal metal surface area to blood flowing within the vessel to limit the creation of thrombosis. The anchors can be locked in place to secure the support within the vessel.

Abstract: An annular prosthesis for a mitral valve that may include a posterior half-ring and an anterior half-ring coupled to each other on a first transverse plane which defines a maximum width section of the prosthesis. The ratio between the distance between the anterior half-ring and the posterior half-ring, as measured along a second plane, perpendicular to the first plane and equidistant to the couplings, and the maximum width of the prosthesis is lower than 3/4.

Abstract: A protective device or bridge (20) comprising a central arch (24) is suitable to be placed between an annuplasty device placed in the coronary sinus and an underlying coronary artery to inhibit transmission of compressive force on the coronary artery by the annuplasty device.

Abstract: An annuloplasty prosthesis includes a bowed core (10) having an inner edge (10) and an outer edge (12). A plurality of openings (16) are defined by, and spaced apart along, the core so that struts (18) are defined between adjacent openings (16). The openings and struts provide anchoring sites (20) for annuloplasty sutures in use anchoring the prosthesis to a heart annulus. The anchoring sites (20) are not adjacent the outer core edge (14).

Abstract: Devices and methods for reshaping a mitral valve annulus are provided. One device according to the invention is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another embodiment of a device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device may be expandable for urging the anterior leaflet toward the posterior leaflet. Another embodiment of the device includes a first anchor, a second anchor, and a bridge, with the bridge having sufficient length to reach from the coronary sinus to the right atrium and/or superior or inferior vena cava. In a further embodiment a device includes a middle anchor positioned on the bridge between the distal and proximal anchors.

Abstract: A catheter-based, annulus reduction device and system for cardiac valve repair and method of using the same. The system is usable for treating mitral valve regurgitation and comprises a catheter, a reduction ring carried within the catheter, the reduction ring including a plurality of exit ports formed in a side wall of the reduction ring and filament received in the reduction ring. The filament includes a plurality of radially extendible barbs corresponding to the sidewall openings. The reduction ring carrying the filament is deployed adjacent a mitral valve annulus and the filament is translated relative to the reduction ring to deploy the barbs through the exit ports and into the annulus and to further translate the reduction ring with deployed barbs to reshape the annulus.

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. Console projections radially oriented are provided at the inner surface of the housing, and each leaflet has a slot which corresponds to the projection. The inner surface of the housing is mainly cylindrical, and the downstream surface of each leaflet is in the form of the crossing cylindrical and conical surfaces.

Abstract: Papillary muscle position control devices (900) systems and methods are provided. According to an exemplary embodiment, a papillary muscle position control device generally comprises a first anchor (905), a second anchor (920), and a support structure (915). The first anchor can be configured to fixedly connect to an in situ valve of a heart ventricle. The second anchor can be configured to fixedly connect to a muscle wall of the valve. The support structure can be configured to have an adjustable length and be coupled to the first anchor and second anchor such that adjusting the length of the support structure varies a distance between the first anchor and the second anchor. Other embodiments are also claimed and described.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

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: A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

Abstract: A device for treatment of mitral annulus dilatation comprises an elongate body having two states. In a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Abstract: An annuloplasty system including an annuloplasty prosthesis and a holder for the prosthesis.

Abstract: A heart valve assembly includes a prosthesis and a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus. The prosthesis includes an annular member, a flexible core at least partially defining a sewing cuff extending radially outwardly from the annular member, a rail ring disposed between the flexible core and the annular member, and a plurality of guide rails extending from the rail ring through respective openings in the flexible core. A fabric covering covers the prosthesis, and the guide rails extend through respective openings in the fabric covering. The prosthetic valve includes a frame including receptacles for receiving respective guide rails. After implanting the prosthesis within a biological annulus, the prosthetic valve is advanced along the guide rails until retention elements on the guide rails engage the receptacles to secure the prosthetic valve relative to the prosthesis.

Abstract: A holder for an annuloplasty ring having a template defining a proximal face opposite the distal face, and a peripheral edge about which the annuloplasty ring conforms. The annuloplasty ring anchors to the template using one or more flexible filaments. The template includes a single cutting well on its proximal face over which the flexible filament is suspended. Desirably, the single cutting well is located adjacent the peripheral edge so as to be away from any handle connections for ease of access. The flexible filament emerges above the proximal face of the template at only one location at the cutting well, thus presenting a one cut quick-release structure that is highly visible to the surgeon. The annuloplasty ring may have a relatively rigid inner core surrounded by a suture-permeable cover, and the peripheral edge may be formed by a lower axial wall and an upper radial ledge that projects outward from the rigid inner core but not quite as far as a sewing margin of the ring.

Abstract: The cinching apparatus (800) comprising: an anchoring component having a distal end a proximal end; the distal end of the anchoring component having an engaging member (805). A locking component (815) and a tension member (820) wherein the anchoring component is enabled to be positioned on a first target site of a tissue component and the locking component (815) is enabled to be positioned on a second target site of a tissue component of the heart, and the tension member (820) can be coupled to both the anchoring component and the locking component (815) to adjust the distance between the first and second target sites.

Abstract: A prosthetic tricuspid remodeling annuloplasty ring having two free ends that are upturned in the inflow direction to help avoid unnecessary leaflet abrasion. The free ends are desirably separated across a gap that is large enough to reduce the risk of passing sutures through the conductive system of the heart, yet not too large that support of the septal leaflet of the tricuspid annulus is degraded. The tricuspid ring may have four sequential segments looking from the inflow side and extending in a clockwise direction from a free end located adjacent the antero septal commissure after implant. The ring may define an inflow bulge in the first segment and/or an inflow bulge in the fourth segment that help the ring conform to the natural bulges created by the adjacent aorta, thereby reducing stress and the potential for ring dehiscence.

Abstract: A tissue connecting device is provided. The device comprise an elongate delivery device having a lumen, a proximal end, and a distal end. The distal end is configured to engage tissue and advance said device into tissue. At least one anchor deliverable through a lumen of the elongate delivery device. The distal end of the device may be designed to engage tissue upon rotation of the device about its longitudinal axis.

Abstract: A medical device system comprising a guide catheter and a leaflet fastening applicator, the guide catheter having suitable dimensions for deployment and insertion percutaneously into a human heart in a vicinity of a heart valve, the leaflet fastening applicator having a size allowing insertion through the guide catheter and being capable of holding portions of opposing heart valve leaflets, wherein the fastening applicator comprises a pair of grasping-electrodes adapted for holding and engaging the portions of opposing heart valve leaflets together and for applying energy to fasten the portions, in which heart valve leaflets can be captured and securely fastened, thereby improving coaptation of the leaflets and improving competence of the valve.

Abstract: A mitral valve therapy device and method treats dilated cardiomyopathy. The device is configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus. The device includes a force distributor that distributes an applied force along a pericardial wall of the coronary sinus, and a force applier that applies the applied force to one or more discrete portions of a wall of the coronary sinus adjacent to the mitral valve annulus to reshape the mitral valve annulus in a localized manner.

Abstract: A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath formed of a plurality of concentric ring elements or bands. The posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band having an elongate and arcuate body. The elongate and arcuate body has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is displaced from the plane containing the first end and the second end. The transvalvular band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets and the central portion is displaced towards the left ventricle relative to the first anchoring portion and the second anchoring portion. The ventricular direction displacement moves coaption to an earlier point in the cardiac cycle.

Abstract: Described is a set of at least two annuloplasty devices having a particular size that corresponds to an inter-trigonal or inter-commissural distance of a heart valve annulus, wherein the at least two annuloplasty devices have different anterior-posterior ratios. Also, described is a kit for annuloplasty repair of a heart valve annulus including a plurality of annuloplasty devices each comprising one of a plurality of different sizes, wherein the different sizes each correspond to a different inter-trigonal or inter-commissural distance of a heart valve annulus, and for each of the plurality of different sizes there are at least two devices each having the same size but having different anterior-posterior ratios. Additionally, a method of choosing an annuloplasty device for implantation in a valve annulus is described.

Abstract: A system for treating mitral valve regurgitation includes a tensioning device having a plurality of helical anchors and a tensioning filament. One embodiment of the invention includes a method for attaching a tensioning device to the annulus of a mitral valve in a trans-leaflet configuration, and applying a tension force to the tension filament in order to exert force vectors on the annulus, thereby reshaping the mitral valve annulus so that the coaption of the anterior and posterior leaflets of the mitral is improved during ventricular contraction.

Abstract: Apparatus is provided for repairing a valve of a heart of a patient which includes an annulus and at least first and second leaflets. The apparatus includes an annuloplasty structure, a plurality of tissue anchors, and a plurality of flexible longitudinal guide members removably coupled to the structure. Each of the guide members is configured to facilitate anchoring of the annuloplasty structure to the annulus of the patient by a respective one of the anchors. The guide members are configured to be advanced toward the annulus simultaneously with the annuloplasty structure. Other embodiments are also described.

Abstract: A heart valve prosthesis may include a cylindrical support extending between axially spaced apart ends thereof, the cylindrical support including a plurality of support features extend generally axially between the opposed ends of the support, adjacent pairs of the support features being interconnected so as to bias the cylindrical support radially outwardly. A valve is mounted within the support to define a supported valve. The supported valve can include a sidewall portion extending between inflow and outflow ends thereof, the inflow and outflow ends of the valve sidewall portion being mounted within the cylindrical support such that ends of the sidewall portion are spaced axially apart from the spaced apart ends of the cylindrical support.

Abstract: A device, system and method provides mitral valve therapy. The device is implantable in the coronary sinus of the heart to partially encircle the mitral valve annulus. The device is elongated, is resilient, and has a preformed arched configuration. When the device is implanted in the coronary sinus, the device exerts a substantially radially inward force to the mitral valve to restore mitral valve annulus geometry.

Abstract: Methods and devices for modulating heart valve function are provided. In the subject methods, a heart valve is first in structurally modified. Blood flow through the structurally modified heart valve is then monitored, and the heart is paced in response to the monitored blood flow. Also provided are devices, systems and kits that find use in practicing the subject methods. The subject methods find use in a variety of applications.

Abstract: Described herein are devices and methods for improving the hemodynamic function of a patient. In particular, a first device adapted to reshape an atrio-ventricular valve is used in combination with a second device configured to further alter the blood flow through the valve. The first device is typically an implant positioned in the subvalvular space of a ventricle. The second device may be an annuloplasty implant, a non-annulus valve apparatus implant, a ventriculoplasty implant, or a cardiac rhythm management device.

Abstract: A prosthetic valve includes a support frame, a leaflet attached to the support frame, and a bioactive agent associated with the leaflet. A first free edge of the leaflet permits fluid flow through a body vessel in a first direction and substantially prevents fluid flow through the body vessel in a second, opposite direction. A second free edge of the leaflet at least partially defines an opening for permitting a controlled amount of fluid flow through the body vessel.

Abstract: A holder for an annuloplasty ring is disclosed. It comprises a plurality of linked-together suture platforms, wherein said holder comprises an upper face, a lower face, and a closed peripheral edge with means for accommodating and supporting said suture platforms of said annuloplasty ring.

Abstract: An annuloplasty ring holder includes an angled post for improved visibility and access by the surgeon. The post may be configured to be adjusted in angle and rotation. The ring holder can include a relatively open lower template, including relatively narrow extending radial arms with short, generally arcuate ring-retaining distal portions. The invention includes placements of suture holes and cutting wells which, in combination with improved suture routing, afford the user improved access to cutting the suture that is used to retain the annuloplasty ring to the holder.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

Abstract: Described is an adjustable annuloplasty device holder possible of having a plurality of different anterior-posterior ratios, the holder comprising a member having an anterior segment and a posterior segment that are shaped to hold an anterior portion and a posterior portion, respectively, of an annuloplasty device, wherein the anterior segment has a given size and the posterior segment is adjustable in order to change the anterior-posterior ratio of the holder to accommodate annuloplasty devices having a plurality of different anterior-posterior ratios. Also described is a method of using such an adjustable annuloplasty holder device.

Abstract: Described is a device for delivering a valve annulus sizer or annuloplasty device holder to a heart valve annulus, the device comprising: an elongate shaft comprising a proximal end, a distal end and at least a portion of the shaft being malleable, wherein the distal end of the elongate shaft connects to the sizer or holder. Also described are a sizer device for sizing a heart valve annulus, and a delivery device that releasably attaches a sizer device or a holder device for delivery to and/or from a heart valve annulus.

Abstract: The disclosure relates to frames suitable for prosthetic implantable valves, and methods of treatment with such frames, to regulate blood flow and to be compliant in percutaneous delivery and, upon implantation, configured to conform to the changing shape of the body vessel or vein. The frames include at least one anchoring member attached to a support member at one or more attachments, and a valve member, preferably a monocuspid valve leaflet, attached to the support member. Preferred frames include two anchoring members with the support member in between the anchoring members. The support member preferably has a semielliptical shape and extends diagonally to sealingly contact the wall of the body vessel.

Abstract: Among other things, a heart tissue support has gripping elements, each element having a free end that is sharp enough to penetrate heart tissue when pushed against the tissue, and a feature to resist withdrawal from the tissue after the sharp free end has penetrated the tissue. Among other things, the shape of a heart valve annulus is corrected in a catheter laboratory by orienting a tip of a catheter holding a heart tissue support that has gripping elements at the valve annulus, applying a radial force from the catheter against the annulus by opening a structure at the tip of the catheter, and while the structure is opened, forcing the support onto the annulus. Among other things, the shape of a heart valve annulus is corrected during a surgical procedure by pushing a heart tissue support that has gripping elements onto the annulus.

Abstract: A device for treatment of mitral annulus dilation is disclosed, wherein the device comprises two states. In a first of these states the device is insertable into the coronary sinus and has a shape of the coronary sinus. When positioned in the coronary sinus, the device is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.

Abstract: A tissue connecting device is provided. The device comprise an elongate delivery device having a lumen, a proximal end, and a distal end. The distal end is configured to engage tissue and advance said device into tissue. At least one anchor deliverable through a lumen of the elongate delivery device. The distal end of the device may be designed to engage tissue upon rotation of the device about its longitudinal axis.

Abstract: Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient's arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Abstract: Valve repair apparatus and methods for ensuring proper coaptation and operation of the leaflets of a heart valve. Main aspects of the disclosure relate to devices including a support member configured for attachment to the heart valve annulus, a post extending from the support member away from the plane of the annulus and a connector coupled with the post and configured for attachment to at least one of the leaflets. The various embodiments may include a replacement heart valve connected with the support member for facilitating full replacement as opposed to near repair of an existing native heart valve. Various other devices include support structure and one or more posts connected to opposite sides of the support structure and extending from one side of the valve annulus to another to modify the shape of the annulus.

Abstract: Methods for reconfiguring an atrioventricular heart valve may use systems comprising a partial or complete fenestrated annuloplasty ring proportioned to reconfigure a heart valve that has become in some way incompetent, and a plurality of staples which may have pairs of legs that are sized and shaped for association with the ring at spaced locations along its length. These systems permit relative axial movement between the staples and the ring, whereby a patient's heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve components. Shape-memory alloy material staples may have legs with free ends that interlock following implantation. One alternative is to use flexible rings that will bend in the plane of the ring as the heart beats.