Compressible heart valve annulus sizing templates suitable for minimally-invasive or otherwise reduced accessibility surgeries. The sizing templates may be folded, rolled, or otherwise compressed into a reduced configuration for passage through an access tube or other such access channel. Once expelled from the access tube the sizing templates expand to their original shape for use in sizing the annulus. The templates may be formed of an elastomeric polymer material such as silicone, a highly elastic metal such as NITINOL, or both. Grasping tabs or connectors for handles permit manipulation from outside the body. A NITINOL wireform may be compressed for passage through an access tube and expelled from the distal end thereof into a cloth cover to assume a sizer shape.

Luminal organ sizing devices and methods. In a method of the present disclosure, the method includes performing a valve replacement procedure using a valve device positioned within a valve annulus or opening of a luminal organ while a system including a balloon configured for inflation is at least partially introduced into a luminal organ so that the balloon is adjacent to a valve annulus or opening.

A system is transluminally advanced into a subject. A first portion of the system is positioned adjacent a cardiovascular tissue of the subject, the system including wires disposed at the first portion. The first portion is stabilized at the cardiovascular tissue by positioning a distal portion of the system against a cardiovascular wall of the subject. While the distal portion of the system remains against the cardiovascular wall, the wires are induced to bow laterally such that the wires press against the cardiovascular tissue. While the wires remain pressed against the cardiovascular tissue, the shape of the wires is radiographically imaged. While (i) the first portion remains stabilized, and (ii) the wires remain pressed against the cardiovascular tissue, at least a portion of the system is transluminally implanted at the cardiovascular tissue, facilitated by the imaging. Other embodiments are also described.

The present invention refers to a method for planning a heart valve implantation in a subject. The present invention further relates to a method for determining performance of an implanted heart valve as well as to a method for determining subject-specific blood flow characteristics for at least a portion of the heart and/or aorta. The invention further relates to a system for determining subject-specific blood flow characteristics. The instant means and method of patient-tailored hemodynamics analysis are particularly useful in preoperative planning of an implantation of an artificial heart valve in a human subject.

A system is transluminally advanced into the heart of a subject. A first portion of the system is positioned through a native valve of the heart, the system including wires disposed at the first portion. The first portion is stabilized at the native valve by positioning a distal portion of the system within a blood vessel of the subject. While the distal portion of the system remains within the blood vessel, the wires are induced to bow laterally such that the wires press against the native valve. While the wires remain pressed against the native valve, the shape of the wires is radiographically imaged. An anchor is transluminally anchored to tissue of the native valve, facilitated by the imaging. Other embodiments are also described.

A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

An engineering workflow for prospective design of heart valve leaflet grafts for surgical heart valve reconstruction is disclosed. The engineering workflow includes utilizing a quantitative description of one or more mechanical properties of one or more materials to be used for the heart valve reconstruction to prescribe a size and/or a shape of the materials to achieve a predetermined configuration of a final reconstructed heart valve in its physiological working state for a given patient.

A valve planning tool comprising: (a) a stem having a distal end and a proximal end, (b) an anchor indicator located at the distal end, and (c) a balloon located proximal of the anchor indicator, the balloon including: (i) a retracted state and (ii) a deployed state; wherein the balloon is inflatable from the retracted state to the deployed state and the balloon is substantially non-compliant so that the balloon is only inflatable to one size.

A medical device and method for facilitating selection of a shape and/or size of an annuloplasty implant for a patient comprises a catheter with a proximal end and a distal end, and an extension member at least partly arranged inside the catheter with an operator end and a measurement end. The measurement end is extendable relative from the distal end of the catheter for apposition with at least one commissure of a cardiac valve. The measurement end of the extension member comprises means for guiding the annuloplasty implant at at least one commissure.

A delivery assembly constituted of: a prosthetic valve comprising a plurality of intersecting struts, and a delivery apparatus comprising: a handle; a delivery shaft extending distally from the handle; and a flex sensing assembly, comprising: at least one flex sensor coupled to at least one of the plurality of struts; and a control unit in communication with the at least one flex sensor, wherein the prosthetic valve is movable between a radially compressed configuration and a radially expanded configuration, and wherein, responsive to an output of the at least one flex sensor, the control unit is configured to generate a signal indicative of a diameter of the prosthetic valve.