Abstract: A device, a kit and a method are presented for permanently augmenting the pump function of the left heart. The basis for the presented innovation is an augmentation of the physiologically up and down movement of the mitral valve during each heart cycle. By means of catheter technique, minimal surgery, or open heart surgery implants are inserted into the left ventricle, the mitral valve annulus, the left atrium and adjacent tissue in order to augment the natural up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling and the piston effect of the closed mitral valve when moving towards the apex of said heart in systole and/or away from said apex in diastole.

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.

Abstract: Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Abstract: In an embodiment, a device for loading a prosthesis onto a delivery system comprises a cap and a reducing member. The cap has a piston member that seats a prosthesis. The piston member has at least one side wall configured to contact a portion of the side of the prosthesis seated therein. The reducing member has a conical wall, a first open end, and a second open end. The first open end is configured to receive the piston member. The reducing member reduces an external dimension of at least a portion of the prosthesis seated in the piston member as the prosthesis is moved along an inner surface of the conical wall.

Abstract: The invention relates to scaffolds for artificial heart valves and vascular structures comprising a biocompatible block copolymer. A method and means for producing said scaffold are also provided.

Abstract: Methods and devices for treating defective heart valves are disclosed herein. In one exemplary embodiment, a transcatheter heart valve includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.

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

Abstract: Described here are methods, devices, and kits for treating a prolapsed valve leaflet. The devices generally comprise a flexible cord, a first anchor attached to the cord at its distal end, and a second anchor slidably attached to the cord. The first anchor may be configured to secure the cord to cardiac tissue located below a prolapsed valve leaflet and the second anchor may be configured to secure into the prolapsed valve leaflet. Also described are methods for treating a prolapsed valve including the steps of securing a first anchor to cardiac tissue located below the prolapsed mitral valve leaflet, securing a second anchor to the prolapsed mitral valve leaflet, tensioning a cord connecting the two anchors and securing the cord. Kits including the described devices are also provided.

Abstract: Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

Abstract: A cardiac valve prosthesis includes a frame and a set of prosthetic valve leaflets supported by the frame. The frame defines a principal axis of the cardiac valve prosthesis and includes first and second annular elements expandable from a radially contracted state to a radially expanded state, a plurality of valve supports supporting the leaflets, and a plurality of connecting members. The valve supports are angularly spaced from one another about the principal axis of the cardiac valve prosthesis, and the connecting members extend between and connect the first and second annular elements. When the annular elements are in the radially expanded state each of the connecting members arches radially outward with respect to the annular elements and is configured to project into one of the Valsalva sinuses when implanted. The connecting members are angularly spaced from the valve supports about the principal axis.

Abstract: Apparatus and methods are described including a trocar (40) that defines a lumen therethrough, configured to provide a passage through skin of a subject into a body of the subject. A cannula (60) is configured to be placed into the subject's body via the passage provided by the trocar, the cannula being configured to be slidable with respect to the trocar. The cannula includes an outer tube (64) having a first expandable element (77) disposed at a distal end thereof, and an inner tube (62) having a second expandable element (72) disposed at a distal end thereof, the inner tube being configured to be slidable with respect to the outer tube. A vacuum port (61) applies vacuum pressure to the first expandable element via a space (65) between the inner and outer tubes of the cannula. Other applications are also described.

Abstract: The disclosure pertains to valvuloplasty devices which include a first outer shaft, a second inner shaft, a plurality of elongate members disposed therebetween and adapted to be expanded radially by relative motion between the first outer shaft and second inner shaft and a circumferential member disposed about the central portions of the plurality of elongate members, wherein the circumferential member is urged by radial expansion of the plurality of elongate members to contact the valve to be treated thereby effecting a valvuloplasty and methods of use therefor.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: Systems and methods using a heart valve and an implantable medical device, such as for event detection and optimization of cardiac output. The cardiac management system includes a heart valve, having a physiological sensor. The physiological sensor is adapted to measure at least one of an intrinsic electrical cardiac parameter, a hemodynamic parameter or the like. The system further includes an implantable electronics unit, such as a cardiac rhythm management unit, coupled to the physiological sensor of the heart valve to receive physiological information. The electronics unit is adapted to use the received physiological information to control delivery of an electrical output to the subject.

Abstract: A heart valve implant may include a shaft and an anchor configured to be coupled to an end of the shaft. A spacer may be coupled to a portion of the shaft and comprise a plurality of individual segments including a first and at least a second individual segment. The first segment may be coupled to the shaft. The second segment may be coupled to at least a portion of an exterior surface of the first segment and may have at least one cross-section dimension which is greater than an internal cross-sectional dimension of a delivery lumen. Additional segments may be coupled to an inner, adjacent segment. The segments may include a collapsible body portion to facilitate percutaneously delivery through a lumen. The segments may define an outer surface of the spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position.

Abstract: The invention relates to catheter system for introducing an expandable heart valve stent (150) into the body of a patient, the catheter system comprising: a catheter tip (10) having a seat portion for accommodating the stent (150) in its collapsed state and a stent holder (15) for releasably fixing the stent (150), wherein the seat portion is constituted by a first sleeve-shaped member (11) and a second sleeve-shaped member (21), said sleeve-shaped members (11, 21) being moveable relative to each other and relative to the stent holder (15), and a catheter shaft (30) for connecting the catheter tip (10) to a handle (70).

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: The present invention relates to a stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis fastened to a stent will occur relative the stent in the implanted state of the stent, even given the peristaltic motion of the heart, the stent according to the invention comprises at least one fastening portion via which the valvular prosthesis is connectable to the stent. The stent further comprises positioning arches and retaining arches, whereby at least one positioning arch is connected to at least one retaining arch.

Abstract: The present disclosure relates to devices and methods for implanting a prosthesis into a heart of a mammal, such as a person. The disclosure includes a prosthesis that acts as a pressure vent between the left and right atria of the heart. The intracardiac pressure vents disclosed allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. The devices also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombi or other embolic material from entering arterial circulation.

Abstract: A valve with a frame and valve leaflets that provide a sinus pocket. The valve provides for unidirectional flow of a liquid through the valve.

Abstract: In one embodiment, the present invention provides a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets so that an open end of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.

Abstract: A replacement heart valve has an expandable frame configured to engage a native valve annulus and a valve body mounted to the expandable frame. The valve body can have a plurality of valve leaflets configured to open to allow flow in a first direction and engage one another so as to close and prevent flow in a second direction, the second direction being opposite the first direction.

Abstract: In some embodiments, a cardiac monitoring system includes multiple sensors configured for implantation in a cardiovascular system of a user. Each sensor includes a sensing unit configured to be disposed in sensory communication with the location for measuring a biological parameter in the at least one heart chamber. The sensing unit is also configured to generate a sensory signal associated with the biological parameter. Each sensor also includes a wireless transceiver configured to receive the sensory signal from the sensing unit. The wireless transceiver is further configured to wirelessly transmit the sensory signal to an external processing device disposed outside a body of the user. The external processing device monitors, based on the sensory signal received from at least two sensors from the plurality of sensors, cardiac health associated with at least one of an implanted device or a surgery.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described.

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

Abstract: An artificial mitral valve is anchored in the left atrium by placing the valve between the annulus of the natural mitral valve and an artificial annulus. The artificial annulus is formed by inserting a tool into the coronary sinus, and adjusting the tool to force the wall of the left atrium to form an annulus above the artificial valve, this locking it in place and forming a hemostatic seal.

Abstract: Configurations are described for assisting in the execution of a percutaneous procedure while protecting the vascular pathway to the operational theater, which may comprise diseased tissue. A railed sheath may be utilized which is controllably expandable and collapsible, and may comprise two or more elongate rail structures configured to assist in the distribution of loads to associated diseased tissue structures, while also contributing to the deployment of percutaneous tools by maintaining alignment of such tools with the railed catheter and associated anatomy.

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

Abstract: The device and method for reducing heart wall stress. The device can be one which reduces wall stress throughout the cardiac cycle or only a portion of the cardiac cycle. The device can be configured to begin to engage, to reduce wall stress during diastolic filling, or begin to engage to reduce wall stress during systolic contraction. Furthermore, the device can be configured to include at least two elements, one of which engages full cycle and the other which engages only during a portion of the cardiac cycle.

Abstract: A method for repairing an aortic valve of a heart of a patient is provided, the method comprising (1) placing around a portion of an aorta of the patient in a vicinity of the aortic valve, an adjustable implant structure comprising an adjusting mechanism coupled to a first portion of a flexible contraction member; and (2) adjusting a dimension of the aortic valve by adjusting a dimension of the implant structure by rotating a rotatable structure of the adjusting mechanism. Other embodiments are also described.

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

Abstract: 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: An intra-annular mounting frame for an aortic valve having native aortic cusps is provided which includes a frame body with native leaflet reorienting curvatures and interconnecting points; the curvatures shaped to be received inside the valve below the native aortic cusps and to reorient the native aortic cusps within the aortic valve, where each of the curvatures extends concavely upward from a reference latitudinal plane tangential to each curvature's base.

Abstract: A method for treating glutardialdehyde-stabilized biological tissue of animal or human origin, such as porcine, bovine pericardium or human cadaver heart valves, provides a physical plasma treatment of the, in particular, collagen tissue for increasing the biocompatibility, cell colonization and durability thereof.

Abstract: A prosthesis is provided for implantation at a native semilunar valve of a native valve complex, the native valve complex having three semilunar sinuses and three native commissures. The prosthesis includes a valve prosthesis support, which comprises a support structure comprising exactly three engagement arms that meet one another at three respective junctures. The engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes. Upon implantation of the prosthesis, each of the engagement arms is at least partially disposed within a respective one of the semilunar sinuses, such that each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.

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

Abstract: In some embodiments, an apparatus 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, and a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

Abstract: The present invention relates to a stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis fastened to a stent will occur relative the stent in the implanted state of the stent, even given the peristaltic motion of the heart, the stent according to the invention comprises at least one fastening portion via which the valvular prosthesis is connectable to the stent. The stent further comprises positioning arches and retaining arches, whereby at least one positioning arch is connected to at least one retaining arch.

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

Abstract: A method of implanting a prosthetic valve within the heart comprises translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart. A first chamber of the inflatable structure is inflated and then, independently, a second chamber of the inflatable structure is inflated.

Abstract: An implant delivery system comprising a catheter including at least one lumen, an implant configured for receipt in the lumen, and a latching mechanism configured for receipt in the implant. The latching mechanism may be configured to releasably couple the implant to a delivery wire and to transmit torque through the delivery wire to cause at least a portion of the implant to rotate. The an implant may comprise a shaft, a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position, a garage configured to couple the spacer to a first end region of the shaft, and at least one anchor mechanism. The garage may define a cavity to receive the latching mechanism and to increase rotational and translational stability of the latching mechanism.

Abstract: An apparatus for treating a heart valve apparatus includes at least two anchoring elements designed to be anchored at the annulus and/or heart wall of the valve to be treated. Each anchoring element has a support surface. At least one linking element includes a central branch and two curved side branches, one of which is designed to be engaged on the support surface of an anchoring element, while the other is designed to be engaged on the support surface of another anchoring element, the linking element then being designed to be pivoted to a position such that the anchoring elements interconnect and in which the ends of the central branch are located in the vicinity of the support surfaces.

Abstract: A method of repairing a heart valve provides intravascular access for repair of a heart valve through a ventricular trans-septal approach. An external guide catheter can be inserted through a vein of a patient into the right ventricle via the right atrium. An internal guide catheter can be inserted through the external guide and can provide access to the septum for a puncture tool to create an opening through the septum to the left ventricle. The internal guide can then be advanced into the left ventricle and used to guide a deployment catheter that deploys a repair device onto the heart valve.

Abstract: A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.

Abstract: Prosthetic implant of the type comprising: a tubular support (12) of axis X, which can be deformed between a compressed state with a small diameter and a dilated state with a larger diameter, the tubular support comprising a lattice comprising rhombus-shaped meshes (26), each mesh having a first diagonal (28) parallel to the axis X and a second diagonal (32) perpendicular to the axis X; and at least one resilient membrane (14A, 14B) arranged inside the tubular support. The membrane comprises a fixing portion (48, 52), the fixing portion being fixed to a fixing section (65, 66) delimited by a strand (20A, 20B) of the tubular support, the fixing section being oriented substantially parallel to the axis X.

Abstract: A method is provided, including providing a semilunar valve prosthesis, and implanting the prosthesis without using any imaging techniques. Another method is provided, including providing a semilunar valve prosthesis, placing the prosthesis in a body of a subject, and determining a correct rotational disposition of the prosthesis with respect to a semilunar valve site based on tactile feedback. Other embodiments are also described.

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 prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and to apply a first axial force directed toward a ventricle. The prosthesis further includes a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side. A ratio of the first axial force to a radial force applied outwardly by the prosthesis against the native semilunar valve is greater than 1.5:1. Other embodiments are also described.

Abstract: A medical device, for example a stent, has a surface which in use contacts body tissue, wherein said surface has on it a biocompatible coating layer comprising a polymer having covalently bound allyl-terminated pendent groups, said pendent groups comprising a moiety selected from -0-CH2—CH?CH2—S—CH2—CH?CH2—S(=0)-CH2—CH?CH2—Se—CH2—CH?CH2 and —Se (=0 J-CH2—CH?CH2. This surface has good biocompatibility and can bind strongly to a metallic surface. The polymer may be made from an electropolymerisable monomer, e.g. a pyrrole.

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