Abstract: Methods and apparatus for mitral valve repair are disclosed herein where the posterior mitral leaflet is supported or buttressed in a frozen or immobile position to facilitate the proper coaptation of the leaflets. An implantable apparatus may be advanced and positioned intravascularly beneath the posterior leaflet of the mitral valve. The apparatus may include one or more individual balloon members, each of which may be optionally configured with supporting integrated structures. A magnet chain catheter may be positioned within the coronary sinus and adjacent to the mitral valve to magnetically secure the apparatus in position beneath the posterior mitral leaflet. Alternatively, a split-ring device may be placed about the chordae tendineae supporting the mitral valve such that the ring slides along the chordae tendineae alternately against the mitral leaflet and towards the papillary muscles during systole and diastole.

Abstract: A percutaneous valve replacement assembly has a catheter and a plurality of discrete elements for tissue attachment. A fastener device is mounted to the catheter. The fastener device includes a working end that is movable to a first configuration to engage one of the discrete elements and a second configuration to crimp the discrete element into target tissue.

Abstract: According to one aspect, heart valve leaflet removal apparatus (100) of the present invention comprises a pair of cooperating cutting elements (112), a holder and members for manipulating the cutting elements (112). The cooperating cutting elements (112) are adapted for cutting and removing leaflets from an aortic valve in a patient's heart, one of the cutting elements (112) is rotatably coupled the other of the pair of cutting elements (112). The holder is coupled to one of the cutting elements and is adapted to receive the cut leaflets and the cutting elements and holder are configured for delivery to the valve leaflets through an aortotomy formed in a patient's aorta. In one variation, the pair of cooperating cutting elements (112) and holder have a radial dimension and are radially collapsible. Replacement valve delivery apparatus also is provided.

Abstract: A valve delivery device and method of use is provided. In one embodiment, a method for attaching a valve prosthesis to a target tissue includes providing a ring having a portion defining a groove and a plurality of fasteners coupled to the ring. A portion of the valve prosthesis is placed in the groove on the ring. The valve prosthesis portion in the groove is then secured to the ring. The ring is mounted on a delivery device and the delivery device is positioned so that the fasteners will engage the target tissue when the fasteners are deployed. A shaped plunger member may then deployed through an interior of the ring to swing said fasteners from a first position to a second tissue engagement position.

Abstract: A valve delivery device and method of use is provided. In one embodiment, the device to deliver a valve prosthesis to a target tissue may include at least one anchor and at least one guide wire coupled to the anchor. The device has a fastener housing. The device may also include a first set of fasteners in said fastener housing, wherein the fasteners are movable from a first position to a second, tissue engagement position. The device may also include a second set of fasteners housed in the anchor to attach the anchor to the tissue, wherein the fasteners are movable from a first position to a second, tissue engagement position. The guide wire may be slidably received in the fastener housing and has a length sufficient to extend from the fastener housing to the target tissue site, wherein the guide wire is used to direct the fastener housing into place.

Abstract: Methods and apparatus are provided for valve repair or replacement. In one embodiment, the apparatus is a valve delivery device comprising a first apparatus and a second apparatus. The first apparatus includes a heart valve support having a proximal portion and a distal portion and a heart valve excisor slidably mounted on said first apparatus. The second apparatus includes a fastener assembly having a plurality of penetrating members mounted to extend outward when the assembly assumes an expanded configuration; and a heart valve prosthesis being releasably coupled to said second apparatus. The first apparatus and second apparatus are sized and configured for delivery to the heart through an opening formed in a femoral blood vessel. The heart valve prosthesis support is movable along a longitudinal axis of the device to engage tissue disposed between the anvil and the valve prosthesis. The system may include a tent and/or an embolic screen to capture debris from valve removal.

Abstract: Methods and apparatus are provided for valve repair or replacement. In one embodiment, the method comprises providing an apparatus having a valve prosthesis, a valve leaflet support and a valve excisor, the apparatus having a first configuration and a second configuration; accessing the aortic root without placing the patient on a heart-lung machine; advancing the apparatus in the first configuration where the valve leaflet support is advanced through a valve, wherein the support is positioned below a valve annulus; expanding the apparatus into a second configuration so that the support will engage the valve; and moving the valve leaflet support and valve excisor together to remove leaflets of the valve. Penetrating members may be advanced into the tissue wherein the penetrating members may act as fasteners to hold the prosthesis in place.

Abstract: A valve delivery device is provided. The device comprises a heart valve prosthesis support having a proximal portion and a distal portion; a plurality of fasteners ejectably mounted on the support; a heart valve prosthesis being releasably coupled to said distal portion of said heart valve prosthesis support; and where the heart valve prosthesis and support are configured for delivery to the heart through an aortotomy formed in the patient's aorta. The device may include an anvil movable along a longitudinal axis of the device to engage tissue disposed between the anvil and the valve prosthesis.

Abstract: Methods and apparatus are provided for valve repair. In one embodiment, the apparatus includes a first bridge portion and a second bridge portion. The apparatus may also include at least one base on each bridge portion. Attachment of the first bridge portion and the second bridge portion brings an anterior leaflet of the valve closer to the posterior leaflet and reduces a gap therebetween.

Abstract: A valve implant or prosthesis includes a skirt or prosthetic valve leaflet configured to cover one of the leaflets of the valve to be repaired in a patient's heart. In one embodiment, a heart valve prosthesis includes a curved member and a skirt. The curved member can have first and second ends and be adapted to form a partial ring along a portion of one of the valve annulae in the patient's heart. Alternatively, the curved member can form a full ring that is adapted to extend along the entire valve annulus. The skirt extends along the curved member and depends therefrom. This prosthesis is especially useful in treating mitral valve insufficiency. In this case, the skirt can be configured so that when the prosthesis is secured to the mitral valve along the mitral valve annulus, the skirt covers the posterior leaflet and the opposed edges of the skirt and the anterior leaflet coapt.

Abstract: According to one aspect, heart valve leaflet removal apparatus of the present invention comprises a pair of cooperating cutting elements, a holder and members for manipulating the cutting elements. The cooperating cutting elements are adapted for cutting and removing leaflets from an aortic valve in a patient's heart, one of the cutting elements is rotatably coupled the other of the pair of cutting elements. The holder is coupled to one of the cutting elements and is adapted to receive the cut leaflets and the cutting elements and holder are configured for delivery to the valve leaflets through an aortotomy formed in a patient's aorta. In one variation, the pair of cooperating cutting elements and holder have a radial dimension and are radially collapsible. Replacement valve delivery apparatus also is provided.

Abstract: An anastomosis device is provided for making connections between various conduits in the body of a patient. The device includes a first assembly that is threaded through the target conduit of the patient to a desired location. The device then pierces the wall of the target conduit and is then attached to an external assembly that is withdrawn through the wall of the target conduit to draw the desired connector and a graft conduit into the desired position along the wall of the target conduit. Thereafter, the first assembly is separated from the connector and graft conduit. In this invention, the connector may be a stent like device, staples or similar components to secure the graft conduit to the desired location along the wall of the target conduit.