Abstract: Systems and methods for producing velocity data associated with three-dimensional (3D) flow field images. In some embodiments, the method includes receiving data associated with a plurality of frames of a flow field relating to image data acquired by a medical imaging device, in which the data includes information corresponding to measurements of the flow field over time within a chamber; performing, for each of the plurality of frames, the following operations including: generating, for a respective frame, a data correction based on an interaction of the flow field with the chamber, applying the data correction to a velocity field corresponding to the respective frame, and imposing an incompressibility constraint for the flow field on one or more data points of the respective frame; and generating, subsequent to imposing the incompressibility constraint, a plurality of corrected velocity fields each of which corresponds to one of the plurality of frames.

Abstract: A growth-accommodating prosthetic valve system that can accommodate a patient's growth over time. The system features an expandable stent that can expand from a contracted configuration to an expanded configuration and leaflets attached to the scaffold that is sewn along a path such that the length of the path stays generally the same as the scaffold moves from the contracted configuration to the expanded configuration.

Abstract: A percutaneous heart valve delivery system including a valve delivery catheter coupled with a first inflatable balloon positioned at a distal end of the valve delivery catheter, wherein the first inflatable balloon is configured to fracture a previously implanted prosthetic heart valve; and a replacement transcatheter heart valve positioned proximal to the first inflatable balloon, wherein the replacement transcatheter heart valve is configured to be implanted subsequently within the previously implanted, fractured prosthetic heart valve, following fracture of the previously implanted heart valve without withdrawal of the percutaneous heart valve delivery system. Also disclosed are methods of implantation of a new heart valve within a previously implanted prosthetic heart valve and methods of valvuloplasty of a native heart valve.

Abstract: Heart failure (HF) is a global pandemic affecting at least 26 million people worldwide. Thus, methods and devices that reduce the clinical and economic burden of HF are critical. The present invention features an adjustable cardiac sleeve comprising a basal ring structure and an apical hub couple together, wherein the basal ring structure comprises a plurality of interconnected loops made from a distensible wire.

Abstract: A gimbal handle assembly including: an inner gimbal and an outer gimbal that are concentrically linked and have pivot axes that are orthogonal relative to each other, a spool coupled to and rotatable around the outer gimbal, and a plurality of draw lines attached to the spool in a circumferential configuration, wherein rotation of the spool and/or rotation of the spool and the outer and inner gimbals increases or reduces tension in the draw lines. Also disclosed are a transcatheter valve delivery assembly that includes the gimbal handle assembly, a multi-lumen catheter, a sleeve attached to a distal end of the multi-lumen catheter, and a transcatheter heart valve including an expandable valve frame. Methods of delivering the transcatheter valve to a subject are described, wherein pitch and yaw orientations of the transcatheter valve can be precisely controlled with enhanced degrees of freedom.

Abstract: Described is a collapsible atrial cage for percutaneous delivery and implantation of an atrioventricular valve within an atrium of the heart. The atrial cage includes an atrial portion and a ventricular portion. The ventricular portion is attached with and separated from the atrial portion by a valve juncture portion. Notably, the cage includes at least one interlock shaped to lock with and secure an atrioventricular valve proximate the valve juncture portion. Thus, when deployed and expanded, the atrioventricular valve is secured at the atrioventricular juncture.

Abstract: Devices, systems and methods related to techniques for performing four-chamber segmentation of echocardiograms are disclosed. In one example aspect, a method for generating segmented image data based on an input echocardiogram includes receiving an input echocardiogram that includes information associated with four chambers of a heart, performing segmentation on the information associated with the four chambers using an adversarial model that comprises a first artificial neural network with multiple layers, and combining data from selected layers of the first artificial neural network to generate an output image that includes the segmented four chambers of the heart.

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.

Abstract: A medical device delivery system including a delivery sheath that includes an internal lumen, and a plurality of delivery arms contained within the internal lumen of the delivery sheath and extending along a longitudinal axis of the internal lumen of the delivery sheath, wherein distal ends of the delivery arms include fasteners configured to engage with a basal structure of a medical device and a apical structure of the medical device, wherein the delivery arms are attached to delivery arm controls that are configured to advance the delivery arms and the medical device attached thereto out from a distal end of the delivery sheath, and removable release wires or release lines configured to engage with the fasteners to hold the basal structure and the apical structure in place at the fasteners.

Abstract: The present invention is directed to a device for first grabbing, and then securing the native atrioventricular valve's leaflet to a prosthesis via transcatheter means. The present invention features a grasping device for securing a leaflet component of a native mitral valve. The leaflet component comprises a leaflet and chordae tendineae associated with the. In some embodiments, the device may comprise a first grasping component configured to grab chordae tendineae of said native mitral leaflet component, and a second grasping component configured to anchor the native mitral leaflet component to a prosthetic component. In some embodiments, the first grasping component may comprise at least one grasping arm configured to transition from a non-extended state to an extended state to a grasping state. In some embodiments, the second grasping component may comprise a hook disposed at a distal end of the device capable of anchoring to the prosthetic component.

Abstract: A cardiac assist device including a sleeve configured to externally wrap around a native, intact heart; a motor, and a drive shaft that connects the motor to the sleeve, wherein, actuation of the motor and the drive shaft provides a synchronized assisting force to a pumping force of the native, intact whole heart, thereby helping contraction and expansion of the heart located within an internal volume defined by the sleeve. Some embodiments relate to a system for synchronizing the cardiac assist device with a heart including the cardiac assist device; a power supply connected to the motor; and an electrical connector-relay configured to receive electrical signals from the pacemaker and to generate actuating signals that are relayed to the motor and the drive shaft, wherein, during operation of the system in a subject, the heart is assisted in contracting synchronously with the pacemaker signal rhythm.

Abstract: Methods for synchronizing the actions of a pulsatile cardiac assist device with a dysfunctional heart using a cardiac pacemaker. Aspects include receiving a signal from the pacemaker and actuating the pulsatile cardiac assist device in response to the signal from the pacemaker to either help push blood out of the heart during systole or to help suck blood from the atria during diastole.

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 of identifying and quantifying calcified regions of a tissue including obtaining an image of a cross-section of the tissue, wherein the image distinguishes between calcified regions and non-calcified regions of the cross-section of the tissue. Also disclosed are methods of detecting a change in size of a calcified region of a tissue over time including identifying and quantifying a first size of the calcified region of the tissue at a first time, identifying and quantifying a second size of the corresponding calcified region of the tissue at a second time, and detecting a change in size between the first and second size of the calcified region of the tissue in the image of a cross-section of the tissue. Some aspects relate to computer software program configured to construct a panoramic image from partial images, quantify RGB values for each pixel in the panoramic image, and calculate the total pixels of calcified and uncalcified regions and a calcification ratio.

Abstract: An oral irrigator system having an ergonomic casing with a pliable nozzle assembly, and coupled to a detachable and refillable fluid reservoir. The ergonomic casing contains a power source and a pump mechanism. The detachable nozzle head delivers a pulsating jet of fluid with adjustable speed into the oropharyngeal cavity. When the system is turned on, the rechargeable battery activates the diaphragm pump to draw fluid from the reservoir using a fluid pipe and delivers the fluid to the tip of the nozzle head.

Abstract: A method of detecting whether or not a body chamber has an abnormal structure or function including: (a) providing a stack of images as input to a system comprising one or more hardware processors configured to obtain a stack of medical images comprising at least a representation of the body chamber inside the patient; to obtain a region of interest using a convolutional network trained to locate the body chamber, wherein the region of interest corresponds to the body chamber from each of the medical images; and to infer a shape of the body chamber using a stacked auto-encoder (AE) network trained to delineate the body chamber, wherein the AE network segments the body chamber; (b) operating the system to detect the body chamber in the images using deep convolutional networks trained to locate the body chamber, to infer a shape of the body chamber using a stacked auto-encoder trained to delineate the body chamber, and to incorporate the inferred shape into a deformable model for segmentation; and (c) detecting

Abstract: Methods, devices, and systems that are related to facilitating an automated, fast and accurate model for cardiac image segmentation, particularly for image data of children with complex congenital heart disease are disclosed. In one example aspect, a generative adversarial network is disclosed. The generative adversarial network includes a generator configured to generate synthetic imaging samples associated with a cardiovascular system, and a discriminator configured to receive the synthetic imaging samples from the generator and determine probabilities indicating likelihood of the synthetic imaging samples corresponding to real cardiovascular imaging sample. The discriminator is further configured to provide the probabilities determined by the discriminator to the generator and the discriminator to allow the parameters of the generator and the parameters of the discriminator to be adjusted iteratively until an equilibrium between the generator and the discriminator is established.

Abstract: A method of altering energy metabolism in a recipient cell including: identifying the recipient cell as being in need of altering its oxidative phosphorylation status, obtaining exogenous mitochondria, and introducing into the recipient cell the exogenously obtained mitochondria, wherein the exogenously obtained mitochondria functions in the recipient cell to increase or decrease oxidative phosphorylation and/or glycolysis. Also disclosed are isolated cells that include an exogenous mitochondria, wherein the cell demonstrates increased energy metabolism compared to a control cell of the same type but wherein the control cell lacks exogenously added mitochondria.

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: Disclosed herein is a valve system with an original deployed diameter that is suitable for a child and/or young adult and that can accommodate the patient's growth by a one-time balloon expansion to attain an expanded diameter in that patient. This novel valve addresses an unmet need for children with valve dysfunction and to stop valve-related progressive ventricular dysfunction, and ultimately avoid heart failure in children and young adults.