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 device for repairing a heart valve comprises a medical device (10). The medical device (10) comprises an element in order to downsize the annulus upon insertion and allow the leaflets to open and close properly. The medical device (10) provides a temporary or permanent downsizing of the heart valve. An annuloplasty implant and/or heart valve prosthesis is in embodiments releasably attached to the medical device for insertion to the annulus and permanent fixation of the latter in a desired shape.

Abstract: A mitral valve annuloplasty prosthesis (ring or C) has a generally saddle shape, i.e., portions of the prosthesis that are or will be adjacent the anterior and posterior commissures of the valve are relatively low as compared to at least some other portions of the prosthesis that are or will be between the commissures. However, the saddle shape is asymmetrical, in that the portion that is or will be adjacent the posterior commissure is lower than the portion that is or will be adjacent the anterior commissure.

Abstract: The present invention relates to a minimally invasive method of performing annuloplasty. According to one aspect of the present invention, a method for performing annuloplasty includes accessing a left ventricle of a heart to provide a discrete plication element to the left ventricle, and engaging the plication element to tissue near a mitral valve of the heart. Engaging the plication element includes causing the plication element to gather a portion of the tissue to create a plication. In one embodiment, accessing the left ventricle of the heart to provide the plication element includes accessing the left ventricle of the heart using a catheter arrangement.

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: A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a second loop-shaped support, which is configured to abut a second side of the heart valve opposite to said first side, whereby a portion of the valve tissue is trapped between the first and second supports. An outer boundary of the second support is greater than an outer boundary of the first support.

Abstract: A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve.

Abstract: An apparatus is provided for replacing a native cardiac valve. The native cardiac valve has at least one leaflet and is surrounded by a native cardiac valve annulus having superior and inferior aspects. The apparatus comprises a barbell-shaped, expandable anchoring member including first, second, and main body portions extending between the end portions. The main body portion includes a channel defined by inner and outer surfaces. Each of the first and second end portions has a diameter greater than the diameter of the main body portion. The first and second end portions are sized to respectively contact the superior and inferior aspects of the native cardiac valve annulus when the expandable anchoring member is in an expanded configuration. The apparatus also includes an expandable support member operably disposed within the main body portion of the expandable anchoring member, and a prosthetic cardiac valve secured within the expandable support member.

Abstract: An annuloplasty ring and ring holder combination includes a generally triangular-shaped ring and a generally T-shaped holder. The ring holder has a base portion forming the top of the T shape and engaging against a first segment of the ring, with a radial arm extending from the base portion and forming the post of the T. The radial arm engages against a junction between two segments of the ring. The invention includes placements of suture holes and cutting wells which, in combination with the improved ring holder shape, afford the user improved access and visibility to the surgical site, the ring, and to the suture that is used to retain the annuloplasty ring to the holder.

Abstract: One aspect of the invention is a method of treating mitral valve regurgitation in a patient. The method includes the steps of delivering a tissue shaping device to the patient's coronary sinus in an unexpanded configuration within a catheter having an outer diameter no more than nine or ten french, with the tissue shaping device including a connector disposed between a distal expandable anchor comprising flexible wire and a proximal expandable anchor comprising flexible wire, the device having a length of 60 mm or less; and deploying the device to reduce mitral valve regurgitation, such as by anchoring the distal expandable anchor by placing the distal expandable anchor flexible wire in contact with a wall of the coronary sinus, e.g., by permitting the distal expandable anchor to self-expand or by applying an actuating force to the distal expandable anchor and possibly locking the distal expandable anchor after performing the applying step. The invention also includes a device for performing the method.

Abstract: The invention is a tissue shaping system, including a tissue shaping device with an expandable anchor and a lock; a delivery catheter; a delivery mechanism adapted to deliver the tissue shaping device from outside a patient to a target site within a lumen within the patient via the delivery catheter; and an actuator adapted to deliver an actuation force to the lock to lock the anchor in an expanded configuration. The invention is also a system adapted to percutaneously deliver and deploy a tissue shaping device at a target site within a lumen of a patient. The system includes: a handle; a delivery mechanism supported by the handle and adapted to deliver the tissue shaping device from outside the patient to the treatment site via a delivery catheter; and an actuator supported by the handle and adapted to deliver an actuation force to lock an anchor of the tissue shaping device in an expanded configuration.

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: In one embodiment, the present invention relates to a tissue shaping device adapted to be disposed in a vessel near a patient's heart to reshape the patient's heart. Such tissue shaping device can include an expandable proximal anchor; a proximal anchor lock adapted to lock the proximal anchor in an expanded configuration; an expandable distal anchor; a distal anchor lock adapted to lock the distal anchor in an expanded configuration; and a connector disposed between the proximal anchor and the distal anchor, the connector having a substantially non-circular cross-section.

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: Adjustable annuloplasty rings for repair of a mitral or tricuspid valve which incorporate at least two separate parts that are adjustably interconnectable to create a ring the circumference of which can be changed in dimension. Rings having interconnections at spaced-apart lateral locations, which interconnections allow bidirectional movement to either shorten or lengthen the ring at either such location, afford a surgeon opportunity to make further adjustments to the dimensions of the annuloplasty ring after its initial partial securing to the heart valve tissue and thereby adjust the AP diameter of the valve being repaired. The mating interconnections at two lateral locations on the ring can be constructed so as to allow hinged movement about an axis defined by the interconnections to permit hinged movement between the two separate parts.

Abstract: A tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel. In some embodiments the device includes first and second anchors and a connector disposed between the first and second anchors, with the connector being integral with at least a portion of the first anchor. The invention is also a method of making a tissue shaping device including the steps of removing material from a blank to form a connector and an integral anchor portion; and attaching a non-integral anchor portion to the integral anchor portion.

Abstract: A method and apparatus directed to the repair of regurgitant mitral valves. Mitral valve regurgitation occurs due to miscoaptation of mitral valve leaflets. The mitral valve repair apparatus of the present invention is comprised of a tongue plate which is supported by a suture ring. The apparatus is inserted into the mitral valve orifice with the suture ring sutured to the mitral valve annulus placing the tongue plate between the two mitral valve leaflets. When the mitral valve opens, blood flows through the orifices of the apparatus. When the mitral valve closes, the two miscoaptated mitral valve leaflets cover the orifices on the apparatus and the tongue plate blocks the hole formed by leaflets and seals the leaky flow.

Abstract: A sizing plate for sizing a native valve annulus in a patient's heart for either valve replacement or repair during a minimally invasive surgical procedure is shown and described. The sizing plate is generally shaped such that it corresponds to the shape of the native valve annulus. Additionally, a thickness of the sizing plate is such that it can be inserted through a space between the ribs of the patient during the procedure. The sizing plate includes two keyways extending though the plate separated by a bridge. The keyways are sized and shaped such that they are adapted to be engaged by a minimally invasive surgical tool such as a laparoscopic grasper. The keyways in conjunction with the bridge facilitate manipulation of the sizing plate by the grasper from an external location.

Abstract: A diagnostic device for determining the amount of change required in a coronary sinus to reduce valve regurgitation. The device includes a distal tube having a distal anchor at a distal end portion of the distal tube, a proximal tube having a proximal anchor at a distal end portion of the proximal tube, and an adjustor to move the distal tube relative to the proximal tube. The proximal tube and the distal tube together form a telescoping elongate body adapted to fit within the coronary sinus, and the device includes a scale to measure the movement of the distal anchor relative to the proximal anchor.

Abstract: Devices and methods for reshaping a mitral valve annulus are provided. One preferred device 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 preferred device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device is expandable for urging the anterior leaflet toward the posterior leaflet. Another preferred device comprises a tether configured to be attached to opposing regions of the mitral valve annulus.

Abstract: The present invention provides devices and methods for decalcifying an aortic valve. The methods and devices of the present invention break up or obliterate calcific deposits in and around the aortic valve through application or removal of heat energy from the calcific deposits.

Abstract: A tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel. In some embodiments the device includes first and second anchors and a connector disposed between the first and second anchors, with the connector being integral with at least a portion of the first anchor. The invention is also a method of making a tissue shaping device including the steps of removing material from a blank to form a connector and an integral anchor portion; and attaching a non-integral anchor portion to the integral anchor portion.

Abstract: Artificial valves for use as a venous valve or a heart valve are disclosed. The valve includes a frame including a platform and a valve material coupled to the frame. The valve material is a plurality of filaments or a flap. The valve material is coupled to the frame such that in response to a force in a first direction, e.g. blood flow, the valve material extends in the direct of the force to allow blood to flow past the valve material. In absence of the force in the first direction, the valve material rests against the platform to block blood flow in a direction opposite the first direction.

Abstract: A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

Abstract: This invention relates to devices and methods for the therapeutic changing of the geometry of the left ventricle of the human heart. Specifically, the invention relates to the apical introduction of an anchoring device to align the papillary muscles.

Abstract: The implant has an annularly bent base, whereby the imagined surface enclosed by the base is bent. Preferably the surface enclosed by the base is a symmetrical. It is particularly advantageous if the base is enclosed by a solid material and this is enclosed by a relatively soft material. This offers the possibility of designing fastening clips in the relatively solid material. Such implants are especially suited as heart valve rings.

Abstract: A mitral valve annulus reshaping device includes at least a portion that is formed of a biocompatible shape memory alloy SMA having a characteristic temperature, Af, that is preferably below body temperature. The device is constrained in an unstable martensite (UM) state while being introduced through a catheter that passes through the venous system and into the coronary sinus of the heart. The reshaping device is deployed adjacent to the mitral valve annulus of the heart as it is forced from the catheter. When released from the constraint of the catheter, the SMA of the device at least partially converts from the UM state to an austenitic state and attempts to change to a programmed shape that exerts a force on the adjacent tissue and modifies the shape of the annulus. The strain of the SMA can be varied when the device is within the coronary sinus.

Abstract: A multi-planar annuloplasty ring for implantation adjacent to the tricuspid valve with a gap adjacent to the apex of the triangle of Koch. The anterior part of the ring body extending from the highest point at the anteroseptal commissure down to a lower plane at the anteroposterior commissure. During this course it is curved upwards. The posterior part of the ring body extends downward towards the lowest point at the posteroseptal commissure in a relatively straight course. The septal part of the ring body extending from the lowest point at the posteroseptal commissure upwards towards the highest point at the anteroseptal commissure. During this course it is curved upward.

Abstract: A mitral annuloplasty ring composed of a D-shaped annular structure and made of rigid or semi-rigid material, a coating of the annular structure made of inert tissue and suited to be fixed with sutures to the heart tissues, and a pair of movable and sliding metal or plastic strips positioned in a folded conformation inside the annular structure and having a first end fixed to a rectilinear or circular portion of the annular structure and a second end resting on a curved portion of the annular structure.

Abstract: Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via trans-catheter techniques. The valve prosthesis may include a support ring, a plurality of leaflet membranes mounted with respect to the support ring, and a plurality of retention clip elements. The support structure is advantageously formed from a tubular member or flat stock of shape memory metal. A delivery system for delivery of a valve prosthesis embodying the disclosed support structure is also disclosed.

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: An annuloplasty ring comprising an elongate tube of suturable material formed into a ring. A stiffener configured to prevent axial compression and radial deformation of the ring is received in the tube in a first circumferential segment of the ring. An axial support configured to prevent axial compression of the ring and to permit radial deformation of the ring is received in the tube in a second circumferential segment of the ring. The first circumferential segment of the ring may correspond to a posterior portion of a mitral valve annulus with the first circumferential portion configured to extend between the right and the left fibrous trigones of the mitral valve annulus upon installation. The second circumferential segment of the ring may correspond to an anterior portion of a mitral valve annulus and the second circumferential segment is configured to extend between the right and left fibrous trigones of the mitral valve annulus upon installation.

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: A heart valve sewing prosthesis including an intrinsically conductive polymer. The invention includes annuloplasty rings and bands, and sewing rings or cuffs for prosthetic heart valves. Some annuloplasty rings and sewing rings include fabric that is coated with an intrinsically conductive polymer. The coating can be formed over individual filaments or fibers, or on the fabric surface as a surface layer. One intrinsically conductive polymer is polypyrrole. The intrinsically conductive polymer can be doped to facilitate the intrinsic conductivity. Some devices have a polypyrrole surface layer doped with dialkyl-napthalene sulfonate. The intrinsically conductive polymer can be deposited on a fabric using in-situ polymerization of monomeric or oligomeric species, together with a dopant. Animal studies using implanted annuloplasty rings having an intrinsically conductive polymer coating have demonstrated a substantial reduction in pannus formation and inflammatory response.

Abstract: A prosthetic ring with directional flexibilities and rigidities for use in minimally invasive or standard mitral valve repair includes an anterior segment, a posterior segment, a left lateral segment, and a right lateral segment. The anterior and posterior segments each have an arch, and the arch of the posterior segment is more pronounced than the arch of the anterior segment. The prosthetic ring is formed in a continuous D shape, with an inner body that generally comprises a flexible or semi-flexible material, such as polyethylene or nitinol or other biocompatible material. The inner core, when made of a plastic material, may be reinforced by arched strips of nitinol in the anterior and posterior segments. The lateral segments are thin and fully flexible to allow passive deformation that follows the normal physiological dynamics of the native annulus during the cardiac cycle.

Abstract: This material comprises an annuloplasty member (12) able to be introduced using a catheter (2) through minimally invasive vascular access, then to be delivered by said catheter and fixed to the valve annulus (104).

Abstract: A device for improving the function of a heart valve comprises a first loop-shaped support, which is configured to abut a first side of the heart valve, and a first flange unit being connected to said first loop-shaped support. The flange unit is configured to be arranged against said annulus when said first loop-shaped support is abutting said heart valve.

Abstract: Aortic regurgitation can be treating by implanting in the aortic annulus a transvalvular intraannular band. The band 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 positioned so that it extends transversely across a coaptive edge formed by the closure of the aortic valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

Abstract: Methods and devices are provided for support of a body structure. The devices can be adjusted within the body of a patient in a minimally invasive or non-invasive manner such as by applying energy percutaneously or external to the patient's body. The energy may include, for example, acoustic energy, radio frequency energy, light energy and magnetic energy. Thus, as the body structure changes size and/or shape, the size and/or shape of the annuloplasty rings can be adjusted to provide continued reinforcement. In certain embodiments, the devices include a body member including a shape memory material, and an energy absorption enhancement material configured to absorb energy in response to an activation energy. The energy absorption enhancement material is in thermal communication with said shape memory material.

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: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets, to inhibit prolapse into the left atrium. At least one marginal chordae is severed, to permit leaflet closure against the band.

Abstract: Among other things, a support for living tissue includes gripping elements to attach to the living tissue and to hold the support securely in place. An annular structure is coupled to the gripping elements. The annular structure adjusts the support between a first configuration for installing the support and a second configuration in which the support is held securely in place after installation. The annular structure is self-supporting in the first and second configurations.

Abstract: Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band 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 positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

Abstract: Methods and devices are provided for support of a body structure. The devices can be adjusted within the body of a patient in a minimally invasive or non-invasive manner such as by applying energy percutaneously or external to the patient's body. The energy may include, for example, acoustic energy, radio frequency energy, light energy and magnetic energy. Thus, as the body structure changes size and/or shape, the size and/or shape of the annuloplasty rings can be adjusted to provide continued reinforcement. In certain embodiments, the devices include a shape memory material that is responsive to changes in temperature and/or exposure to a magnetic field. A material having enhanced absorption characteristics with regard to a desired heating energy may be used in order to facilitate heating and adjustment of the support device.

Abstract: Prosthetic valve devices, as well as systems and methods for the delivery thereof, are disclosed. A device includes one or more leaflets disposed within a frameless conduit, wherein the conduit is adapted for attachment to walls of a vascular vessel, and the leaflets are adapted for attachment to walls of the conduit. The leaflets are configured to selectively restrict blood flow through the conduit, and the conduit can include wall-engaging adaptations, for example, barbs or an adhesive. The conduit and the leaflets are formed with a flexible material, which may comprise a remodelable material and/or a synthetic polymer.

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: 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. The sizes of the patch and ring are selected to provide a sufficient advancement of the leaflet to restore the surface of coaptation.

Abstract: A method for modifying a heart valve annulus includes placing a purse string suture at a puncture site adjacent a heart valve, inserting at least one delivery member through the puncture site, positioning a distal end of the at least one delivery member adjacent a portion of a valve annulus, deploying an annuloplasty device carried within the at least one delivery member and implanting the annuloplasty device into the valve annulus. The method also includes reshaping the heart valve annulus after implantation of the at least one annuloplasty device.

Abstract: Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis is configured to assume a compressed delivery state and an uncompressed implantation state. The prosthesis includes a support frame, which is shaped so as to define an upstream inlet having upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state. The prosthesis further includes a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

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 on of the valve. The sizes of the patch and ring are selected to provide a sufficient advancement of the leaflet to restore the surface of coaptation.