Abstract: The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

Abstract: A clip for securing suture includes a generally tubular body, with one or more tabs cut from the wall of the generally tubular. The tab in an open configuration has the tabs in general alignment with the tab out wall, and the tab in a closed configuration has the tabs bent or otherwise positioned to extend into and at least partially obstruct the inner lumen. The tab may be formed as a generally horse-shoe shaped cut out, and may include a generally elliptical portion having a width and length. The tab may have a width generally the same size as the diameter of the inner lumen. The clip can be formed from memory material such as nitinol, and the clip may be biased toward its closed configuration.

Abstract: A valve prosthesis for implantation in the body by use of a catheter includes a stent made from an expandable cylinder-shaped thread structure including several spaced apices. The elastically collapsible valve is mounted on the stent as the commissural points of the valve are secured to the projecting apices. The valve prosthesis can be compressed around balloons of the balloon catheter and inserted in a channel, for instance, in the aorta. When the valve prosthesis is placed correctly, the balloons are inflated to expand the stent and wedge it against the wall of the aorta. The balloons are provided with beads to ensure a steady fastening of the valve prosthesis on the balloons during insertion and expansion. The valve prosthesis and the balloon catheter make it possible to insert a cardiac valve prosthesis without a surgical operation involving opening the thoracic cavity.

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 system for delivering and deploying a self-expandable heart valve includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the end portions of the heart valve. Controlled radial movement of the fingers regulates the expansion of the heart valve such that the proximal and distal ends radially expand at the same rate. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means.

Abstract: An improved crimping mechanism well-suited for use with stented prosthetic heart valves. The crimping mechanism includes a plurality of jaws configured for linear non-rotational movement toward a central axis. A rotational plate is formed with a plurality of spiral grooves or tracks for engaging the jaws. Rotational movement of the spiral tracks produces linear movement of the jaws. Nesting of the inner ends of the jaws permits each to be acted on along different radial lines while their inner faces move together evenly to reduce the crimping aperture in a smooth fashion. The crimping mechanism is particularly well-suited for use with stented prosthetic heart valves, such as a prosthetic aortic valve, though it can also be applied to other stented heart valves, venous valves, and even stent grafts which tend to be fairly large.

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a 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, and a 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. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

Abstract: A mitral annuloplasty and left ventricle restriction device is designed to be transvenously advanced and deployed within the coronary sinus and in some embodiments other coronary veins The device places tension on adjacent structures, reducing the diameter and/or limiting expansion of the mitral annulus and/or limiting diastolic expansion of the left ventricle. These effects may be beneficial for patients with dilated cardiomyopathy.

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: Devices and methods for treating mitral regurgitation by reshaping the mitral annulus in a heart. One preferred device for reshaping the mitral annulus is provided as an elongate body having dimensions as to be insertable into a coronary sinus. The elongate body includes a proximal frame having a proximal anchor and a distal frame having a distal anchor. A ratcheting strip is attached to the distal frame and an accepting member is attached to the proximal frame, wherein the accepting member is adapted for engagement with the ratcheting strip. An actuating member is provided for pulling the ratcheting strip relative to the proximal anchor after deployment in the coronary sinus. In one preferred embodiment, the ratcheting strip is pulled through the proximal anchor for pulling the proximal and distal anchors together, thereby reshaping the mitral annulus.

Abstract: A system for percutaneously introducing a prosthetic valve into a patient's vasculature comprises a balloon dilatation catheter, a prosthetic valve mounted coaxial to the dilatation balloon, and a pusher member comprising a longitudinally extending tubular member encompassing the shaft of the catheter. The distal end of the pusher member preferably corresponds to the proximal end of the stent component of the prosthetic valve. The pusher member provides enhanced longitudinal pushability for facilitating advancement of the prosthetic valve to a treatment site. The system is well-suited for advancing a prosthetic valve or other medical device through an introducer sheath having a relatively small inner diameter. The introducer sheath may be formed with a tapered proximal end portion for receiving the prosthetic valve and for reducing a diameter of the prosthetic valve during advancement therethrough.

Abstract: An adjustable support pad for adjustably holding a tensioning line used to apply tension to a body organ. The adjustable support pad can include a locking mechanism for preventing slidable movement of the tensioning element in one or both directions. The locking mechanism may include spring-loaded locks, rotatable cam-like structures, and/or rotatable spool structures. The adjustable support pad may be formed from rigid, semi-rigid, and/or flexible materials, and may be formed to conform to the outer surface of a body organ. The adjustable support pad can be configured to adjustably hold one or more separate tensioning lines, and to provide for independent adjustment of one or more tensioning lines or groups thereof.

Abstract: A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures.

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 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: The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The one-piece stents may include an annulus anchoring section, a sinus section with the membranes attached over sinus apertures, and a rigid outflow section. The two-piece stent may include a primary stent to provide a tubular base at the annulus, and a secondary stent having the membranes that couples within the primary stent. Lockout tabs to secure the stents in their expanded shapes are provided. Also, alignment structure may be provided to ensure concentric unfurling. Anchoring barbs at the stent edges or in the stent body secure the valve within the annulus. Methods of implantation are also provided.

Abstract: An atherectomy device comprising cannula systems having lumens adapted for insertion of a blood filter and an atherectomy catheter useful for performing atherectomy directly on a patient's cardiovascular tissue. Other embodiments include a lumen for arterial perfusion useful in providing oxygenated blood to the aorta during cardiopulmonary bypass. The distal end of the atherectomy catheter includes an assembly that comprises a pincer, a loop with or without a mesh, laser, hydraulics, or other suitable mechanism adapted for removing atheroma from a cardiac or vascular tissue. Methods of using the systems for vascular atherectomy are also disclosed herein.

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: 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.