Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: The systems, devices, and methods presented herein use a heart pump to obtain measurements of cardiovascular function. The heart pumps described herein can operate in parallel with and unload the heart. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as pressure or motor current, then calculate and display one or more metrics of cardiovascular function. These metrics, such as left ventricular end diastolic pressure (LVEDP), left ventricular pressure, and contractility, provide valuable information to a user regarding a patient's state of heart function and recovery.

Abstract: Systems and methods are provided herein for treating a patient in cardiogenic shock. An intravascular heart pump system is inserted into vasculature of the patient. The heart pump system has a cannula, pump outlet, pump inlet, and rotor. The heart pump system is positioned within the patient such that the cannula extends across the patient's aortic valve, the pump inlet is located within the patient's left ventricle, and the pump outlet is located within the patient's aorta. Data related to time-varying parameters of the heart pump system is acquired from the heart pump system. A plurality of features are extracted from the data. A probability of survival of the patient is determined based on the plurality of features and using a prediction model. The heart pump system is operated to treat the patient.

Abstract: A heart pump assembly includes an elongate catheter with a proximal portion and a distal portion, a rotor at the distal portion of the elongate catheter, a driveshaft, and a bearing. The rotor can include an impeller blade shaped to induce fluid flow in a first axial direction. The drive shaft may be coupled to or integrally formed with a proximal end of the rotor and can include a pump element formed in a surface of the drive shaft. The bearing can include a bore into which the drive shaft extends. The pump element is shaped so as to induce fluid flow through the bore in a second axial direction which can be the same or opposite to the first axial direction.

Abstract: A data monitoring system comprising a server communicatively coupled to a client device and a data module via a network. The server is configured to store a private key of a public-private key pair associated with the data module, receive a request from the client device for authenticated access to the data module, and generate an authentication key based at least on the private key and a time. The client device is configured to generate the request for authenticated access to the data module and transmit the request to the server. The data module is configured to store the private key of the public-private key pair associated with the data module, generate the authentication key based at least on the private key and the time, and grant access to the data module if the authentication key generated by the data module and the authentication key generated by the server match.

Abstract: Cannula assemblies and methods of manufacturing cannula assemblies are provided. The cannula assembly includes a cannula and a pigtail extension coupled to the cannula. The pigtail extension includes a proximal section having a first stiffness and a distal section having a second stiffness, the first stiffness greater than the second stiffness. The proximal section of the pigtail extension is positioned between the cannula and at least a portion of the distal section.

Abstract: Systems and methods are described herein relating to an intracardiac blood pump system comprising a pump, an elongate multi-lumen catheter, a compartment connected to the catheter, a first lumen, a conduit and a filter disposed within the conduit. At least one electronic element is located within the compartment. The conduit extends through an interface between the compartment and the catheter. The conduit is configured to allow gas to penetrate from a first end of the conduit through the first opening of the compartment to a second end of the conduit. The second end of the conduit is in fluid communication with a central lumen of the elongate multi-lumen catheter. The filter is configured to prevent egress of liquid from the multi-lumen catheter into the compartment after allowing flow of gas from the first end of the conduit through the second end of the conduit and into the multi-lumen catheter.

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: Systems and methods are provided herein for estimating a position of a heart pump system in a patient. The system receives first data indicative of a time-varying motor current during a first time period. The motor current corresponds to an amount of current delivered to a motor, while the heart pump system is operating in the patient. The system receives second data indicative of a time-varying differential pressure during the first time period. The differential pressure is indicative of a position of the heart pump system relative to patient's heart. The system receives third data indicative of time-varying motor current during a second time period, and determines an estimate of differential pressure during the second period of time from the third data and a relationship between the first data and the second data. The estimate is usable to predict the position of the heart pump system in the patient.

Abstract: A polymeric heart valve is disclosed which includes a valve body having a central axis and including a conduit extending along the central axis from an inflow end to an outflow end; and at least three flexible leaflets extending from the body into the conduit, each of the leaflets defining an attachment curve with the body. Respective pairs of leaflets each define a commissure located proximal the body. The at least three leaflets define a partially open position at rest, a fully open position deflecting away from the central axis during forward blood flow along a direction from the inflow end to the outflow end, and a closed position deflecting toward the central axis during reverse blood flow along a direction from the outflow end to the inflow end.

Abstract: An integrated sheath assembly for inserting f a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.

Abstract: A system and method for determining native cardiac output of a heart while maintaining operation of an intracardiac blood pump includes determining a current drawn by the pump motor, a blood pressure within the ascending aorta, and a change in the blood temperature based on a thermodilution technique. An intracardiac blood pump positioned in the aorta includes at least one sensor for determining a motor current and blood pressure and a thermistor for determining the change in blood temperature after a precise fluid bolus has been introduced into the vasculature. A processor receives current, pressure, and temperature measurements, and calculates a pump flow output and a total cardiac output from which the native cardiac output is calculated. The native cardiac output and other clinically relevant variables derived from the measurements inform decisions related to continued therapeutic care, including increasing or decreasing cardiac assistance provided by the intracardiac pump.

Abstract: A method for transferring data from a medical device to a server comprises receiving a video stream from the medical device, capturing an image from the video stream, transmitting the image to the server via a data network, and extracting the data from the image. The image may illustrate and/or represent data over a period of time. The method may also comprise transmitting, from a data module receiving the video stream from the medical device, a signal to a router that indicates that the data module is connected to the network. The method may also comprise transmitting a command to the data module to start capturing the image, transferring the image to the router, broadcasting a signal indicating that the data module has captured the image, receiving the broadcasted signal at the server, and storing the image at the server.

Abstract: A web-based interface enables medical personnel to remotely monitor medical devices. A monitoring system records operational data and alarms from the medical devices in a file. However, since network connections between the medical devices and the monitoring system are intermittent, the file does not contain a contiguous stream of data for each medical device. The file pauses recording during gaps in network connectivity. The system displays current data, as well as a list of alarms. If medical personnel wish to view more detail about an earlier time or one of the alarms, the system calculates where in the file the medical device data was recorded. This calculation accounts for the discontiguous nature of the data. The system uses times the network connection is made and broken to calculate an index into the file that corresponds to the time of the user-selected alarm.

Abstract: A heart pump assembly includes an impeller blade coupled to a rotor or a drive shaft, a cannula, a distal projection coupled to a distal end of the cannula and a blood inlet having a plurality of apertures. The plurality of apertures is radially oriented and disposed about a circumference of the cannula. The plurality of apertures includes at least a first ring of apertures which are proximal to the distal projection and a second ring of apertures which are proximal of the first ring of apertures. The plurality of apertures can allow the heart pump assembly to continue to function if anatomical structures or tissue become suctioned to a portion of the heart pump.

Abstract: Improved securement devices for use with intracardiac blood pump assemblies are provided. The present technology provides securement devices that may be used with a sheath assembly (e.g., an introducer sheath assembly, repositioning sheath assembly), and which are configured to restrict movement of an object (e.g., the catheter of the pump assembly) within the sheath assembly except when a mechanism (e.g., button) of the securement device is actively being actuated (e.g., pressed, held, etc.).

Abstract: A method for transferring data from a medical device to a server comprises receiving a video stream from the medical device, capturing an image from the video stream, transmitting the image to the server via a data network, and extracting the data from the image. The image may illustrate and/or represent data over a period of time. The method may also comprise transmitting, from a data module receiving the video stream from the medical device, a signal to a router that indicates that the data module is connected to the network. The method may also comprise transmitting a command to the data module to start capturing the image, transferring the image to the router, broadcasting a signal indicating that the data module has captured the image, receiving the broadcasted signal at the server, and storing the image at the server.

Abstract: The present disclosure provides medical devices, systems and methods and in particular to devices and methods useful for anchoring graft materials to bodily structures.

Abstract: A heart pump assembly includes an elongate catheter with a proximal portion and a distal portion, a rotor at the distal portion of the elongate catheter, a driveshaft, and a bearing. The rotor can include an impeller blade shaped to induce fluid flow in a first axial direction. The drive shaft may be coupled to or integrally formed with a proximal end of the rotor and can include a pump element formed in a surface of the drive shaft. The bearing can include a bore into which the drive shaft extends. The pump element is shaped so as to induce fluid flow through the bore in a second axial direction which can be the same or opposite to the first axial direction.

Abstract: The systems, devices, and methods presented herein use a heart pump to obtain measurements of cardiovascular function. The heart pumps described herein can operate in parallel with and unload the heart. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as pressure or motor current, then calculate and display one or more metrics of cardiovascular function. These metrics, such as left ventricular end diastolic pressure (LVEDP), left ventricular pressure, and contractility, provide valuable information to a user regarding a patient's state of heart function and recovery.