Abstract: A medical device and a method for providing a change of shape in a part of the body of an organism. The device is insertable into the body of the organism and comprises a member having a preferred state of shape and having a tendency to transfer its shape towards said preferred state of shape when being in a non-preferred state of shape. The device further comprises a resorbable means which is arranged to hold the member in the non-preferred state of shape and to delay the transfer when the device is inserted into the body of the organism by counteracting said transfer during resorption of the resorbable means by the surrounding body of the organism.

Abstract: A process and system for compressing bioprosthetic tissue for use in medical implants. The process involves placing the tissue between two compressive surfaces and applying a force to reduce any nonuniformity of thickness in the tissue, while at the same time reduce the overall thickness. One particularly useful application is the compression of bioprosthetic sheet during the preparation of heart valve leaflets. Bovine pericardium may be compressed to reduce its thickness by about 50%, and then formed into heart valve leaflets. The thinned leaflets have substantially the same absolute strength as those made from uncompressed tissue, and are particular desirable for use in minimally invasive valves which must be compressed into a small profile. The thin tissue enables a reduction in the overall size of the minimally invasive heart valve for delivery. For instance, rolled MIS valves may be reduced in size to as small as 20 mm in diameter.

Abstract: The present invention is directed to an apparatus and method for the stabilization and fastening of two pieces of tissue. A single device may be used to both stabilize and fasten the two pieces of tissue, or a separate stabilizing device may be used in conjunction with a fastening device. The stabilizing device may comprise a probe with vacuum ports and/or mechanical clamps disposed at the distal end to approximate the two pieces of tissue. After the pieces of tissue are stabilized, they are fastened together using sutures or clips. One exemplary embodiment of a suture-based fastener comprises a toggle and suture arrangement deployed by a needle, wherein the needle enters the front side of the tissue and exits the blind side. In a second exemplary embodiment, the suture-based fastener comprises a needle connected to a suture. The needle enters the blind side of the tissue and exits the front side. The suture is then tied in a knot to secure the pieces of tissue.

Abstract: A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

Abstract: A method for treatment of mitral annulus dilatation comprises reducing the circumference of the mitral valve annulus. The method further comprises inserting an elongate body into the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, fixing the position of the elongate body relative to the coronary sinus, and changing the shape of the elongate body in order to remodel the mitral valve annulus.

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: A medical apparatus and method for remodeling a mitral valve annulus adjacent to the coronary sinus includes an elongate body having a proximal end and a distal end. The elongate body is movable from a first, flexible configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus.

Abstract: A device and method for treatment of atrioventricular regurgitation comprises a suturing device. The suturing device is configured to be introducible, via blood vessels leading to the heart, to two leaflets of the atrioventricular valve between the atrium and a corresponding ventricle of the heart. The suturing device is configured for binding together the two leaflets along the free edges of the leaflets. A method of using the device includes inserting the suturing device into a catheter, introducing the catheter to the heart and positioning a distal end of the catheter close to two leaflets of an atrioventricular valve, capturing the free edges of the two leaflets with the suturing device in its open state, binding together the two leaflets by transition of the suturing device into its closed state, and retracting the catheter from the heart. As a result, the closing of the valve is improved.

Abstract: Disclosed are methods and devices for determining valve leaflet orientation. A catheter is provided with a conformable, radiopaque target. The target is deployed within a valve, such as the mitral valve. The conformable target conforms to the coaptation axis in response to closing of the valve leaflets. That coaptation axis may then be visualized, and utilized to determine information about valve operation, or to assist in placement of devices in the vicinity of the valve.

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 medical apparatus and method suitable for remodeling a mitral valve annulus adjacent to the coronary sinus. The apparatus comprises an elongate body having a proximal region and a distal region. Each of the proximal and distal regions is dimensioned to reside completely within the vascular system. The elongate body may be moved from a first configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus proximate the coronary sinus. A forming element may be attached to the elongate body for manipulating the elongate body from the first transluminal configuration to the second remodeling configuration. Further, the elongate body may comprise a tube having a plurality of transverse slots therein.

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

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet.

Abstract: A surgical knot pushing device is described which has a knot pushing interface mounted on the distal portion of an elongated body and an actuation handle located on the proximal portion of the elongated body. The knot pushing interface has a suture receiving recess formed thereon, and a knot positioning member which traverses the suture receiving interface. At least one extendable knot retaining member is further positioned on the pushing interface, the at least one extendable retaining member capable of engaging suture material. The knot pushing interface also comprises at least one suture cutting member which is in communication with the actuation handle. The present invention is particularly well suited for use in minimally invasive surgical procedures. The present invention also teaches a method of forming a knot in suture material, retaining a knot with a knot pushing device, advancing and applying a knot to an area of interest, and cutting excess suture material.