Abstract: A hybrid tissue engineered heart valve leaflet including a polyurethane core, such as a polycarbonate-based thermoplastic polyurethane like carbothane. The polyurethane core is enclosed within one or more layer of a patient's cells and collagen. Also disclosed are hybrid tissue engineered heart valves, including a frame; and at least two leaflets attached thereto in a configuration of a heart valve, wherein the leaflets are hybrid tissue engineered heart valve leaflets, and methods of making a hybrid tissue engineered heart valve for deployment in a patient.

Abstract: Disclosed is an imprinter device comprising an array of adjacent applicators that are arranged so that longitudinal axes of each of the adjacent applicators are parallel to each other, wherein the applicators are configured to make contact with and conform to a surface of a three dimensional (3D) object. In some embodiments, the applicators move independently of each other with respect to the surface of the object, and wherein the applicators are configured to apply a material over the object while in proximity to the surface of the object. Also disclosed are methods of conformal coating a surface of an object.

Abstract: Some embodiments relate to Some embodiments relate to an integrated ultrasound guided delivery system for positioning or repositioning of a transcatheter heart valve including: a delivery catheter coupled to the transcatheter heart valve, and an intravascular ultrasound (IVUS) catheter operably coupled to the delivery catheter, wherein the IVUS catheter includes an ultrasound transducer tip that is aligned with a base of leaflets of the transcatheter heart valve. Also disclosed is a method for positioning or repositioning a transcatheter heart valve at a target site in a subject including: providing an integrated ultrasound guided delivery system as disclosed herein; advancing the transcatheter heart valve in the vicinity of a native valve, viewing the native valve and the target site in real-time with the IVUS catheter, and deploying the transcatheter heart valve at the target site aiming to maintain a conformal placement within the native valve annulus, thereby avoiding or minimizing paravalvular leak.

Abstract: A method for generating fluid flow images of a region of interest is disclosed. The method includes: scanning the region of interest to acquire a set of 4D-Flow magnetic resonance images, wherein the set comprises an anatomical magnitude image, a first velocity component image, a second velocity component image, and a third velocity component image; isolating the anatomical magnitude image, the first velocity component image, the second velocity component image, and the third velocity component image from the set of 4D-Flow magnetic resonance images; converting the first, second, and third velocity component images into a velocity vector field; modeling a location of an anatomical wall within the region of interest; calculating at least one flow dynamics parameter for the region of interest; and generating a visual representation of the anatomical wall and the at least one flow dynamics parameter.

Abstract: The disclosure relates to method of processing three-dimensional images or volumetric datasets to determine a configuration of a medium or a rate of a change of the medium, wherein the method includes tracking changes of a field related to the medium to obtain a deformation or velocity field in three dimensions. In some cases, the field is a brightness field inherent to the medium or its motion. In other embodiments, the brightness field is from a tracking agent that includes floating particles detectable in the medium during flow of the medium.

Abstract: Described is an apparatus for transcatheter detachment of a stent from a delivery device. A single-ended draw line with loops is inserted through a restraining hole in a glide and a release line is inserted through the loops. The single-ended draw line is thus prevented from pulling through the restraining hole while the release line is through the loops. The single-ended draw line is free to pass through the restraining hole after the release line is pulled out of the loops and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

Abstract: The present invention relates to a heart valve and, more particularly, to a mold and process shaping and securing cells and tissue layers as they are grown in three-dimensions into a heart valve.

Abstract: A tubular braided mesh scaffold for fabrication of heart valves is described. The tubular braided scaffold can be formed of a shape memory metal, such as Nitinol, and pinched or pressed to form a leaflet shape. When heat treated, the braided mesh scaffold holds and retains its valve-like shape.

Abstract: Described is a transcatheter mitral valve. The mitral valve includes a saddle-shaped annulus frame with two prongs extending therefrom. Two leaflets are attached with the frame and prongs to form a bi-leaflet mitral valve. The frame is collapsible to a collapsed configuration that allows for delivery and implantation at a mitral position. When at the mitral position, the mitral valve expands into an open configuration and is secured in place by a fixture, such as clamps that extend from the frame.

Abstract: The disclosure relates to method of processing three-dimensional images or volumetric datasets to determine a configuration of a medium or a rate of a change of the medium, wherein the method includes tracking changes of a field related to the medium to obtain a deformation or velocity field in three dimensions. In some cases, the field is a brightness field inherent to the medium or its motion. In other embodiments, the brightness field is from a tracking agent that includes floating particles detectable in the medium during flow of the medium.

Abstract: Described is a heart valve leaflet manufactured from a mesh material. The mesh material may have an ability to capture circulatory/stationary/migratory cells of the body to become biologically active. In some cases, the mesh material is coated with a bioactive material, such as a molecule that binds to a cell adhesion molecule (CAM), a growth factor, an extracellular matrix molecule, a subendothelial extracellular matrix molecule or a peptide. The mesh has a stiffness that is comparable to a native heart valve leaflet, such that it functionally mimics a native heart valve.

Abstract: A heart valve leaflet including a thermoplastic polyurethane (TPU) mesh material that has a stiffness that is comparable to a native heart valve leaflet, such that it functionally mimics a native heart valve leaflet. The heart valve leaflets optionally include one to three layers of cells cultured on each side of the mesh material. Also disclosed is a heart valve including the heart valve leaflet and a frame.

Abstract: The disclosure relates to a method of automatically producing a three-dimensional (3D) segmentation of a heart chamber, the method comprising: obtaining data sets from cardiac magnetic resonance imaging (MRI) or ultrasound, generating a 3D segmentation of the heart chamber from the data sets using an active contour method, modifying the 3D segmentation by adding a plurality of intra-chamber structures; and identifying an enclosing myocardium using the 3D segmentation generated by the method.

Abstract: Described is a delivery system for percutaneous delivery and implantation of a heart valve. The delivery system includes a handle with a sheath extending therefrom. A splay shaft extends from the handle through the sheath. At least two arms extend from the handle through the splay shaft. The at least two arms are operable for holding a heart valve. A sheath controller is housed within the handle and is operable for selectively advancing or retracting the sheath to constrain or expose a heart valve as attached with the at least two arms. A splay shaft controller is housed within the handle for allowing the user to selectively advance or retract the splay shaft to constrain or expose the at least two arms. Finally, a valve release is attached with the handle to allow a user to selectively release a heart valve as attached with the at least two arms.

Abstract: This disclosure is directed to a collapsible atrioventricular valve prosthesis. The valve includes an annulus wire frame having at least two prongs extending therefrom. At least one catch is formed between each of the prongs and leaflets are attached with the frame, catch, and prongs form the valve. The prongs project a first direction and the catch projects in a direction away from the prongs. The valve is collapsible to provide for easy delivery to an atrioventricular junction or other desired location within a heart. Once deployed, the valve can expand with the catches acting to hold the annulus frame secure on an atrioventricular junction, at a ventricular side or at an atrial side of a heart.

Abstract: Improved catheter devices for delivery, repositioning and/or percutaneous retrieval of percutaneously implanted heart valves are described, including a medical device handle that provides an array of features helpful in conducting a percutaneous heart valve implantation procedure while variously enabling radial expansion or contraction and/or lateral positioning control over the heart valve during the medical procedure.

Abstract: 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.

Abstract: A cardiac assist system using a helical arrangement of contractile bands and a helically-twisting cardiac assist device are disclosed. One embodiment discloses a cardiac assist system comprising at least one contractile elastic band helically arrangement around a periphery of a patient's heart, where upon an actuation the band contracts helically, thereby squeezing the heart and assisting the pumping function of the heart. Another embodiment discloses a helically twisting cardiac-apex assist device comprising an open, inverted, substantially conical chamber with two rotatable ring portions of different diameters located at the base and apex of the chamber, with a plurality of substantially helical connecting elements positioned substantially flush with the chamber wall and connecting the two rotatable ring portions, whereby a relative twisting motion of the two rings causes a change in volume of the chamber thereby assisting the cardiac pumping function.

Abstract: Systems and methods are disclosed for automatically segmenting a heart chamber from medical images of a patient. The system may include one or more hardware processors configured to: obtain image data including at least a representation of the patient's heart; obtain a region of interest from the image data; organize the region of interest into an input vector; apply the input vector through a trained graph; obtain an output vector representing a refined region of interest corresponding to the heart based on the application of the input vector through the trained graph; apply a deformable model on the obtained output vector representing the refined region of interest; and identify a segment of a heart chamber from the application of the deformable model on the obtained output vector.

Abstract: Described is a group of polymeric calcific heart valves with different levels of calcification that can be used for research and development studies related to transcatheter heart valve technologies. Using a heart flow simulator, the valves' function was studied in aortic position in the presence or absence of an implanted transcatheter aortic valve (valve-in-valve). Through multiple experiments based on echocardiography, it was found that these calcific valves can suitably mimic the function of a native calcified stenotic aortic valve and can be used for valve-in-valve studies. Using this novel polymeric calcified valve provides a desired cost-saving solution for testing the performance of new TAVR systems in vitro and in vivo.