Abstract: Expandable prosthetic heart valves for minimally invasive valve replacement are disclosed. In one preferred embodiment, an expandable prosthetic heart valve includes a support stent comprising an expandable tubular base along an inflow end and three upstanding commissure posts along an outflow end. The three commissure posts are spaced at 120 degree intervals with gaps therebetween. The prosthetic heart valve further includes a tubular flexible member having a prosthetic section and a fabric section. The prosthetic section is connected to the three commissure posts and defines three leaflets, preferably formed of pericardial tissue. The fabric section is sutured to the expandable tubular base. The tubular base may be formed with a shape memory material and is sized for deployment with an annulus of a native aortic valve. After deployment, the three commissure posts support the leaflets above the tubular base for replacing the function of the native aortic valve.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve.

Abstract: A method of implanting a prosthetic mitral valve assembly is disclosed. The prosthetic mitral valve assembly includes a stent and valve combination. The prosthetic mitral valve assembly is provided with an anchoring portion adapted to be positioned in the left atrium. In one embodiment, the anchoring portion includes at least one anchoring arm sized for placement in a pulmonary vein. The stent is radially expandable so that it can expand into position against the walls of the left atrium and accommodate a wide range of anatomies. Contact between the stent and the native tissue in the left atrium reduces paravalvular leakage and prevents migration of the stent once in place.

Abstract: A heart valve delivery system is provided wherein a prosthetic valve is carried on a valve catheter inside a delivery sleeve. A step balloon protrudes from the delivery sleeve and provides a tapered surface for facilitating advancement through a body vessel. The step balloon also aids in crossing the leaflets of a native valve. After the prosthetic valve is positioned within the native valve, the delivery sleeve is retracted to expose the prosthetic valve. In one embodiment, the delivery sleeve is retracted by the use of a lead screw, which effectuates relative movement between the valve catheter and delivery sleeve. The prosthetic valve is preferably self-expandable. If necessary, the step balloon may be expanded to securely seat the prosthetic valve at the site of the native valve.

Abstract: A device and method for reducing ventricular dilation by placing one or more cardiac bridges into vessels extending along a length of the ventricle. Each cardiac bridge preferably includes a pair of anchors and a bridge member secured therebetween. The tension in the bridge member is increased to compress the ventricle and thereby reduce the dilation. In another embodiment, the bridge member is tensioned to reshape the left ventricle for reducing tension on the chordae tendinae in the heart to improve valve function.

Abstract: A method of implanting a prosthetic valve in a stenosed aortic valve via a catheterization technique. A balloon catheter is advanced into a patient's vasculature and a balloon is expanded within the stenosed aortic valve to push aside the calcified leaflets. The prosthetic valve is then introduced into a patient's vasculature through an 18 French arterial introducer. After advancement through the femoral artery and aorta, the prosthetic valve is radially expanded for implantation in the dilated aortic valve. The prosthetic valve includes a compressible and expandable frame and a valvular structure made with pericardial tissue. The prosthetic valve further includes an internal cover fastened to an internal surface of the frame between an inlet end of the frame and the valvular structure.

Abstract: The present disclosure concerns embodiments of a reshaping apparatus and methods for restoring the conical shape of a dilated heart ventricle, or at least reshaping the ventricle to a more conical shape to counter the effects of dilation, thereby improving pumping efficiency. In an exemplary embodiment, a reshaping apparatus comprises an implantable body that can be delivered to a dilated left ventricle via the patient's vasculature in a minimally-invasive procedure. When deployed inside the left ventricle, the body is adapted to apply a longitudinal (downward) force against the inner surface of the left ventricle that causes the ventricle to distend or elongate downwardly relative to the base of the heart so as to at least partially restore the conical shape of the heart. In other embodiments, one or more tension members can be secured to heart tissue inside a heart chamber or on the outside of the heart and placed in tension to reshape the geometry of the heart.

Abstract: A prosthetic valve for implantation in a stenosed aortic valve. The prosthetic valve includes a compressible and expandable frame formed with intersecting metallic bars and a valvular structure made with pericardial tissue. The frame is compressible for delivery into a patient's vasculature through an 18 F (5.7 mm) arterial introducer using a catheterization technique. The bars of the frame preferably have a diameter in the range of 0.1 to 0.6 mm for providing the frame with sufficient radial strength to resist the recoil force exerted by the stenosed aortic valve after implantation. The prosthetic valve includes an internal cover made with pericardial tissue. The internal cover is fastened to an internal surface of the frame between an inlet end of the frame and the valvular structure for preventing regurgitation.

Abstract: An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame.

Abstract: Various embodiments of methods and apparatus for treating defective heart valve are disclosed herein. In one exemplary embodiment, a transcatheter heart valve is disclosed that 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: 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 improved crimping mechanism and method 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 prosthetic valve assembly for implantation within a native aortic valve using a catheterization technique. The prosthetic valve assembly includes a collapsible and expandable metallic frame. The frame is constructed to resist the recoil forces of the native aortic valve. The frame may be formed with a concave profile. A valvular structure made with pericardial tissue is sewn to the frame for permitting blood flow in one direction. An internal cover is provided along an internal surface of the frame and provides a sleeve which prevents blood from passing through gaps in the frame.

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 stenotic 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. The valve prosthesis can be delivered percutaneously, surgically, or endoscopically.

Abstract: Devices and methods for reshaping a mitral valve annulus are provided. One preferred device is configured for deployment in the right atrium and is shaped to apply a force along the atrial septum. The device causes the atrial septum to deform and push the anterior leaflet of the mitral valve in a posterior direction for reducing mitral valve regurgitation. Another preferred device is deployed in the left ventricular outflow tract at a location adjacent the aortic valve. The device is expandable for urging the anterior leaflet toward the posterior leaflet. Another preferred device comprises a tether configured to be attached to opposing regions of the mitral valve annulus.

Abstract: A system for implanting a valve prosthesis comprises a compressible and expandable stent with a collapsible and expandable valve structure mounted within the stent. An insertion catheter is provided for advancing the valve prosthesis through a small inlet opening into a body channel The valve structure is preferably formed of biological tissue. The stent may be self-expandable or may be expanded by a balloon on the distal end portion of the catheter. The stent is configured to expand in the body channel such that the outer surface of the stent engages surrounding tissue. After expansion, the valve structure within the stent becomes functional, thereby allowing blood to flow in only one direction. The valve prosthesis is detachable from the catheter for permanent implantation in the body channel. The valve prosthesis is preferably used for replacing the function of a natural heart valve without requiring open heart surgery.

Abstract: A delivery system for delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly and handle. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes openings in a slotted tube of the delivery sleeve assembly to close, thus causing the delivery sleeve assembly to bend. A stretchable cover is placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the native valve site, the prosthetic valve is deployed by inflating the balloon.

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: An apparatus for treating a mitral valve, comprising an elongate member having a spiral shape, the elongate member having a proximal end portion and a distal end portion, an expandable proximal anchor joined to the proximal end portion of the elongate body, and an expandable distal anchor joined to the distal end portion of the elongate body. The elongate member is configured to adjust from an elongated state to a shortened state after delivery at least partially into a coronary sinus for reshaping a mitral 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.