Abstract: A fixation band for affixing a prosthetic heart valve to tissue having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.

Abstract: A surgical fastener clip for proximating tissue, the clip providing an undeflected state in which the clip comprises a center portion, a first leg, and a second leg. The center portion has a perimeter defining a circle-like shape. The legs project outwardly relative to the perimeter from a point of departure to a tip. Extension of each of the legs relative to the perimeter defines an identical wind direction that is either clockwise or counterclockwise. The clip optionally includes a linear cross-member extending across the perimeter. The surgical clip can be formed by a wire that is partially wound onto itself in a spiral-like fashion, with the center portion and the legs being co-planar in the undeflected state. During use, the clip is rotated, drawing tissue into the center portion. Systems incorporating the clip are also provided.

Abstract: This invention relates to a system used to fashion, size, and implant a tissue annuloplasty band. This system comprises (1) a device to cut tissue; (2) a device to fashion (i.e., roll, fold, bunch, etc.) the tissue into a band (i.e., the tissue annuloplasty band); and (3) a sizer that comprises an mounting ring which allows for determining and maintaining the proper size and shape of the tissue annuloplasty band while it is attached to the annulus of a heart valve. These components can be used alone, together as a system, or in any combination to fashion, size, and/or implant the tissue annuloplasty band.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: A method and device for reducing mitral regurgitation. An elongated body is positioned in a coronary sinus of a patient in a vicinity of a heart mitral valve posterior leaflet. The body is adapted to straighten a natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet to move a posterior annulus anteriorly, which in turn moves the posterior leaflet anteriorly, thereby to improve leaflet coaptation.

Abstract: A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: A method and apparatus for reducing mitral regurgitation. The apparatus is inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the apparatus being adapted to straighten the natural curvature of at least a portion of the coronary sinus in the vicinity of the posterior leaflet of the mitral valve, whereby to move the posterior annulus anteriorly and thereby improve leaflet coaptation and reduce mitral regurgitation.

Abstract: A fixation band for affixing a prosthetic heart valve to tissue, the fixation band comprising: a structure having a proximal end and a distal end in opposition to one another, and a lateral region between the proximal end and the distal end, wherein the prosthetic heart valve is attached to one of the proximal end and the distal end of the structure; a plurality of barbs selectively configurable between a first position and a second position, the barbs being contained within a peripheral boundary of the lateral region of the structure in the first position, and the barbs being extended from the peripheral boundary of the lateral region of the structure in the second position; and an actuator for selectively moving the plurality of barbs between the first position and the second position.

Abstract: A method for reducing mitral regurgitation includes deploying deforming matter into a selected one of (i) a mitral valve annulus adjacent a posterior leaflet, and (ii) tissue adjacent the mitral valve annulus and proximate the posterior leaflet, to cause conformational change in the mitral valve annulus to increase mitral valve leaflet coaptation.

Abstract: This invention relates to a system used to fashion, size, and implant a tissue annuloplasty band. This system comprises (1) a device to cut tissue; (2) a device to fashion (i.e., roll, fold, bunch, etc.) the tissue into a band (i.e., the tissue annuloplasty band); and (3) a sizer that comprises an mounting ring which allows for determining and maintaining the proper size and shape of the tissue annuloplasty band while it is attached to the annulus of a heart valve. These components can be used alone, together as a system, or in any combination to fashion, size, and/or implant the tissue annuloplasty band.

Abstract: A novel system for performing a heart valve annuloplasty. The system involves the use of a plication band. In one embodiment, the annulus of the valve is reduced by constriction of the plication band itself. More particularly, each plication band enters the tissue at two or more points which are spaced from one other by a distance which is dictated by the geometry of the plication band. Subsequent constriction of the plication band causes these points to move toward each other, thereby constricting the tissue trapped between these points and thus reducing the overall circumference of the valve annulus. In a second embodiment, the annulus of the valve is reduced by linking multiple plication bands to one other, using a linkage construct, and then using a shortening of the length of the linkage construct between each plication band so as to gather the tissue between each plication band, whereby to reduce the overall circumference of the valve annulus.

Abstract: Apparatus for reducing mitral regurgitation, by applying a force to the wall of the coronary sinus so as to force the posterior leaflet anteriorly and thereby reduce mitral regurgitation.

Abstract: Apparatus is disclosed for providing access to a functioning vascular system of a patient, the apparatus comprising: a main body having sidewalls defining an interior region and an exterior region, a bottom end and a top end; a base being formed at the bottom end of the main body, securing means being configured on the base so as to allow attachment and formation of a seal between the base and the functioning vascular system of the patient, and the base being configurable to provide a passageway from the interior region of the main body to the functioning vascular system of the patient; and a cover being formed at the top end of the main body, wherein the cover provides a barrier between the interior region and the exterior region at the top end of the main body.

Abstract: A prosthetic heart value assembly comprising a prosthetic heart valve and a fixation band. The fixation band comprises a tubular frame and a tube. The tubular frame comprises longitudinally-extending members having hooks on their distal ends and fixation means on proximal ends, and a stabilizing laterally-extending member. The tube is positioned inside the longitudinally-extending members, a distal end of the tube being everted over the hooks. A sewing cuff is formed in the tube. The prosthetic valve is secured to the fixation band by suturing a prosthetic valve sewing cuff to a fixation band sewing cuff. The prosthetic valve and fixation band are advanced to the valve's seat. The fixation band's hooks are passed through the wall of the everted tube and into surrounding tissue and the fixation band's fixation means are deployed.

Abstract: A novel system for performing a heart valve annuloplasty. The system involves the use of a plication band. In one embodiment, the annulus of the valve is reduced by constriction of the plication band itself. More particularly, each plication band enters the tissue at two or more points which are spaced from one other by a distance which is dictated by the geometry of the plication band. Subsequent constriction of the plication band causes these points to move toward each other, thereby constricting the tissue trapped between these points and thus reducing the overall circumference of the valve annulus. In a second embodiment, the annulus of the valve is reduced by linking multiple plication bands to one other, using a linkage construct, and then using a shortening of the length of the linkage construct between each plication band so as to gather the tissue between each plication band, whereby to reduce the overall circumference of the valve annulus.

Abstract: Apparatus for reconfiguring tissue, the apparatus comprising a shaft having a distal end and a proximal end; at least one effector mechanism movably mounted to the distal end of the shaft, each effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, the at least one effector mechanism being configured to capture the gripped tissue against said shaft, at least one actuating mechanism mounted to the proximal end of the shaft, and at least one connection mechanism connecting the at least one actuating mechanism to the at least one effector mechanism, whereby a user may utilize the at least one actuating mechanism to actuate the at least one effector mechanism so as to reconfigure tissue.

Abstract: Apparatus for reducing mitral regurgitation, including a bendable elongated body adapted to be inserted into the coronary sinus of a patient in the vicinity of the posterior leaflet of the mitral valve, the elongated body being adjustable between a first configuration adapted to be delivered into the coronary sinus and a second configuration adapted to exert a force onto the posterior annulus. The body includes a flexible spine having a proximal end and a distal end, and a flexible wire mounted on the spine and having a distal end fixed to the spine proximate to the distal end of the spine, and having a proximal portion extending from the proximal end of the spine. Axial movement of the wire causes a change in the spine from the first configuration to the second configuration to exert the force on the posterior annulus and thereby reduce mitral regurgitation.

Abstract: A method for deploying an aortic valve prosthesis includes the steps of: making a first opening leading to the left atrium; passing the valve prosthesis through the opening and into a cardiac chamber of the left side of the heart using a first manipulation instrument; making a second opening in the arterial system and advancing one end of a second manipulation instrument through the arterial opening and into the cardiac chamber; securing the second manipulation instrument to the valve prosthesis; and using the second manipulation instrument to retract at least a portion of the valve prosthesis out of the cardiac chamber.