The present invention relates to devices and methods for measuring physiological parameters, such as flow, pressure, temperature, electric conductivity and/or visual indication of thrombus formation or deposits accumulations, prior to, during and/or after prosthetic heart valve implantation procedures.

An orifice-expanding device for measuring an expanded heart valve. The device includes a proximal handle having a shaft and an orifice-expanding device with a hub mounted to a distal end of the shaft and a plurality of arms evenly spaced around the axis and connected to the hub and extending therefrom in a distal direction to distal ends of the arms. The distal end of each arm has an expanding portion with an outer surface, the expanding portions being configured to move radially outward with respect to each other, wherein expansion of the expanding portions causes the distal ends of the arms to flex outward. A pressure-measuring device measures a pressure applied to the aortic valve annulus, and a size-measuring device measures a dimension of the aortic valve annulus after the annulus has been expanded.

Embodiments described herein address the need for improved catheter devices for delivery, repositioning and/or percutaneous retrieval of the percutaneously implanted heart valves. One embodiment employs a plurality of spring-loaded arms releasably engaged with a stent frame for controlling expansion for valve deployment. Another embodiment employs a plurality of filaments passing through a distal end of a pusher sleeve and apertures in a self-expandable stent frame to control its state of deployment. With additional features, lateral positioning of the stent frame may also be controlled. Yet another embodiment includes plurality of outwardly biased arms held to complimentary stent frame features by overlying sheath segments. Still another embodiment integrates a visualization system in the subject delivery system. Variations on hardware and methods associated with the use of these embodiments are contemplated in addition to those shown and described

A delivery system for a transcatheter heart valve (THV) to a subject is provided, the delivery system includes a delivery catheter housing the THV therein; an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of components for alignment with commissures of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or valve leaflet at a desired angle.

A heart valve sizer and sizer cover are provided for determining the size of a heart valve annulus. The valve sizer can include a handle, a shaft extending distally from the handle, a sizing element coupled to the distal end of the shaft, the sizing element being movable between a first retracted position and a second expanded position, and a sizer cover. The sizer cover can be formed from a continuous sheet of material configured to surround at least a portion of the sizing element of the heart valve sizer so as to guard against entanglement of the sizing element with structures of a human heart.

Systems and methods for planning delivery of an object via a catheter, such as transseptal delivery of a prosthetic mitral valve to a patient's heart are disclosed.

An articulating implant holder system for heart valve repair or replacement has an implant configured to be secured to a heart valve annulus, an implant holder secured to the implant, an articulating handle assembly comprising a handle, a swivel pivotably secured to the handle at a first location and a connector pivotably secured to the swivel at a second location, an actuating cable secured between the handle and the connector to cause the swivel to move from a first position to a second position, and a latch removably secured to the implant holder. A plurality of sizer heads are configured to correspond to different sizes of heart valve annuluses and each of the plurality of sizer heads has a latching feature. A latching feature of the swivel is configured to removably snap on to the latching feature of each of the plurality of sizer heads and is configured to permanently snap on to the latch.

In a first aspect, the present invention relates to a method for patient-specific virtual percutaneous implantation, comprising estimating a patient-specific anatomical model of a patient-specific aorta based on cardiovascular 2D or 3D medical image data and virtually deploying an implant model representing an implant into said patient-specific anatomical model. In a second aspect, the present invention provides a method for patient-specific virtual percutaneous implantation. In a third aspect, the present invention provides an implant for virtual percutaneous implantation. In a fourth aspect, the present invention provides a system for virtual percutaneous implantation.

An annuloplasty ring assembly with detachable handle includes an annuloplasty ring configured to be secured to an annulus of a heart valve and an annuloplasty ring. The annuloplasty ring is attached to the ring holder such that the annuloplasty ring is in conformal contact along a lower surface of a peripheral edge portion of the ring holder. The assembly includes a handle adapter extending proximally from an upper proximal face of the ring holder. The handle adapter is also attached or attachable to a distal attachment end of the handle on one side and removably attached to the annuloplasty ring holder on another side.

A personalized naturally designed mitral valve prosthesis and a method for manufacturing the such to precisely fit a specific patient for which the valve prosthesis is made for, is provided. The method includes measuring size and shape of a mitral valve of the specific patient by using imaging means, building a 3D model of the personalized mitral valve prosthesis, optimizing the 3D model using FEM method and fabricating the personalized mitral valve prosthesis by cutting and connecting the annular ring, leaflets and chords to form a personalized prosthesis mitral valve.