Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: An assembly includes an expandable prosthetic heart valve, a catheter shaft, and a stabilization device. The expandable prosthetic heart valve has a valve body and a plurality of leaflets coupled to the valve body. The catheter shaft has a proximal end portion and a distal end portion. The prosthetic heart valve is coupled to the distal end portion of the catheter shaft. The stabilization device is coupled to the catheter shaft adjacent the prosthetic heart valve and is movable between a contracted configuration and an expanded configuration. In the expanded configuration, the stabilization device is configured to contact surrounding tissue adjacent a site of implantation to stabilize the catheter shaft relative to the site of implantation while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state at the site of implantation.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: A method of implanting a prosthetic heart valve includes advancing the prosthetic heart valve in a radially-contracted configuration into an annulus of a native aortic valve. The prosthetic heart valve includes a self-expanding body and a plurality of leaflets fastened to the body. The body of the prosthetic heart valve is formed with an annulus anchoring section, a sinus section, and an outflow section. During implantation, the prosthetic heart valve is allowed to self-expand such that the annulus anchoring section contacts the annulus of the native aortic valve and the outflow section contacts a native ascending aorta. The outflow section is less rigid than the annulus anchoring section for conforming to the native ascending aorta. The outflow section flares outwardly from the sinus section. The sinus section preferably includes three sinus apertures.

Abstract: A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: A medical assembly for replacing a native heart valve of a patient. The medical assembly includes a radially expandable and collapsible prosthetic heart valve having a self-expandable stent body and a plurality of leaflet-forming membranes. The medical assembly also includes a deployment mechanism configured to deploy the prosthetic heart valve within the native heart valve of the patient. The deployment mechanism preferably includes a plurality of proximal deployment members coupled to a proximal end of the stent body. The deployment mechanism may also include a plurality of distal deployment members coupled to a distal end of the stent body. The prosthetic heart valve desirably includes a mechanical locking device configured to lock the prosthetic heart valve in a radially expanded configuration.

Abstract: Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism having a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism include a pinion gear that engages a gear track on the prosthetic heart valve.

Abstract: A method for delivering and implanting a prosthetic heart valve in a native aortic valve includes collapsing a prosthetic heart valve to a contracted configuration while the prosthetic heart valve is coupled to a mechanical deployment mechanism. A catheter shaft is advanced over a guidewire and through a femoral artery with the deployment mechanism and prosthetic heart valve disposed along a distal end portion thereof. The prosthetic heart valve is permitted to self-expand to an initial expanded configuration. The deployment mechanism is actuated from an operating handle to expand the prosthetic heart valve from the initial expanded configuration to a final expanded configuration. The prosthetic heart valve is locked in the final expanded configuration via a mechanical locking device located on the prosthetic heart valve.

Abstract: A method for replacing a diseased aortic valve includes selecting a prosthetic heart valve based on a measurement of a patient's aortic annulus, the prosthetic heart valve stored in a storage container while in an expanded configuration. The preservative solution is drained from the storage container and the prosthetic heart valve is removed. The prosthetic heart valve is compressed to a contracted configuration and advanced through a patient's vasculature along a distal end portion of a catheter system. The prosthetic heart valve is positioned within the diseased aortic valve and re-expanded to an initial expanded configuration. A deployment mechanism is actuated via an operating handle to further expand the prosthetic heart valve into secure engagement with surrounding tissue until lockout features on the prosthetic heart valve secure the prosthetic heart valve in a final expanded configuration.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.

Abstract: A medical assembly for replacing a native heart valve of a patient can include a deployment mechanism and a radially expandable and contractable prosthetic heart valve coupled to the deployment mechanism. The prosthetic heart valve can comprise a self-expandable stent body and a plurality of leaflet-forming membranes. The assembly can further include a storage container, wherein the prosthetic heart valve and the deployment mechanism are disposed in the storage container.

Abstract: Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outwardly from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium, for example, porcine pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

Abstract: A method for delivering and implanting a prosthetic heart valve in a native aortic valve is provided. The method comprises advancing the prosthetic heart valve through a patient's vasculature while the prosthetic heart valve is coupled to a mechanical deployment mechanism along a distal end portion of a catheter shaft. The prosthetic heart valve is permitted to self-expand from a contracted configuration to an initial expanded configuration. The mechanical deployment mechanism is then actuated via an operating handle to further expand the prosthetic heart valve to a fully expanded configuration while equilibrating the rate of the expansion of the proximal and distal ends of the prosthetic heart valve. The prosthetic heart valve is locked in the fully expanded configuration via a mechanical locking device disposed on the prosthetic heart valve.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.

Abstract: A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive.

Abstract: Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism comprising a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism comprise a pinion gear that engages a gear track on the prosthetic heart valve.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.