Abstract: Improvements to intracardiac devices such as intracardiac blood pump assemblies, and associated methods. In one example, the present technology includes systems and methods for pacing the heart, and/or performing cardiac ablation using electrodes mounted on a portion of the intracardiac device. In another example, the present technology includes systems and methods for detecting mural thrombi in a patient's heart using electrical sensors or ultrasonic phased arrays mounted on the intracardiac device. In another example, the present technology includes systems and methods for detecting tissue changes and reactions in heart tissue during treatment using one or more temperature sensors. In another example, the present technology includes an improved distal tip for use with an intracardiac device.

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: Disclosed is a blood pump rotor, and an intravascular blood pump that utilizes the rotor. The blood pump rotor is configured to rotate around an axis of rotation, and comprises a distal portion and a proximal portion. The distal portion includes a rotor hub, which tapers in a distal direction. The rotor hub has at least one blade extending outward from the rotor hub. Further, a distal end of said rotor hub extends distally beyond a most distal portion of the at least one blade. The proximal portion, which is connected to the distal portion, has permanent magnets arranged so as to form a modified Halbach array generating a magnetic field having a magnetic flux in a proximal direction that is greater than a magnetic flux in a distal direction, said first magnetic flux being greater than said second magnetic flux.

Abstract: Systems and methods for packaging an optical sensor assembly. An optical sensor assembly for use in a blood pump assembly comprises a visor affixed to a pump housing of the blood pump assembly. A support jacket is in contact with an inner surface of the visor, and defines a cavity in which an optical sensor is disposed. Silicone gel is introduced into the cavity, where it cures. Silicone gel within the cavity protects the optical sensor, and the support jacket prevents the overflowing of the gel and contamination of the visor.

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: 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: 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: 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: Devices and methods for providing an internal balloon sheath are disclosed. One device includes a sheath for insertion through an arteriotomy of a patient. The sheath comprises a tubular sheath body having a longitudinal axis, an open proximal end, an open distal end, an outer surface and an inner surface, the inner surface defining a lumen between the proximal and distal ends for passage of a catheter device. The sheath also comprises an inflatable balloon disposed within the lumen. The inflatable balloon is configured to occupy a longitudinal space in the lumen between the inner surface of the sheath body and the catheter device when the catheter device is disposed within the sheath and the balloon is inflated, and fluidically seal the lumen.

Abstract: A method for providing a treatment recommendation to a physician for treating a patient is disclosed. The method comprises determining, from a processor in communication with a patient data repository, a first treatment recommendation based on a combination of selected patient demographics from the patient data repository applicable to the patient, and operational parameters of a plurality of ventricular assist devices (VADs) suitable for treating the patient, the first treatment recommendation having a first survival rate and comprising the use of a first VAD. The method then obtains a first signal from using the first VAD on the patient. The method then determines a second treatment recommendation based on the first signal and the first treatment recommendation, the second treatment recommendation having a second survival rate. The method then provides the second treatment recommendation to the physician if the second survival rate is higher than the first survival rate.

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: 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: 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: A crimp tool facilitates crimping a resiliently radially compressible human-implantable catheter pump, and transferring the crimped pump into a tubular transfer sheath, by pulling the heart pump through an elongated tube that defines a tapered longitudinal bore. The bore has an inside dimension that tapers gradually along the length of the bore. A large end of the bore is sufficient to accept an uncrimped heart pump. A small end of the bore has a dimension similar to an inside dimension of the transfer sheath. A proximal end of the tube has a hub. A proximal end of a bore through the hub is configured to receive a distal end portion of the transfer sheath coaxially with the tube bore. Optionally, a latch is configured to releasably restrain the distal end portion of the transfer sheath within the hub.

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: An introducer assembly includes an elongate sheath sized for insertion into a blood vessel of a patient and a hub. The hub can be coupled to a proximal portion of the sheath and can include a first hub portion and a second hub portion. The hub can include various features to facilitate breaking apart or separating the introducer assembly from a patient. For example, the first hub portion can have a first notch which can facilitate breaking, splitting, or fracturing the hub. The second hub portion can partially surround the first hub portion and can include two wings and an opening disposed above the first notch. The first hub portion can be formed from a first material and second hub portion can be formed from a second material. In some embodiments, the second material can be stiffer than the first material to facilitate fracturing the hub.

Abstract: A method for manufacturing a medical introducer includes placing an introducer sheath onto a mandrel, and overmolding an introducer hub onto a proximal end of the introducer sheath. The introducer sheath has one or more score lines formed on an inner surface and the mandrel has a number of surface protrusions so that when the introducer sheath is positioned on the mandrel, each of the surface protrusions contacts one of the score lines formed on the introducer sheath. The surface protrusions on the mandrel prevent plastic material from the introducer hub from contacting the score lines thereby maintaining the score lines during the overmolding.

Abstract: Blood pump assemblies and methods of manufacturing and operating blood pump assemblies are provided. The blood pump assembly includes a pump and an impeller blade rotatably coupled to the pump. The blood pump assembly also includes a pump housing component sized for passage through a body lumen and coupled to the pump. The pump housing component includes a peripheral wall extending about a rotation axis of the impeller blade. The peripheral wall includes an inner peripheral wall surface and an outer peripheral wall surface. The peripheral wall also includes one or more blood exhaust apertures. Each blood exhaust aperture in the one or more blood exhaust apertures is defined by an inner aperture edge and an outer aperture edge. Each inner aperture edge is chamfered between the inner peripheral wall surface and the outer peripheral wall surface.

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: Systems and methods for determining the positioning of intracardiac devices, such as intracardiac blood pump assemblies, using electrical sensors configured to sense electrical potential as it propagates through the heart. In one example, the present technology provides an intracardiac device with one or more electrical sensors mounted thereon, and a controller configured to determine the absolute or relative location of the intracardiac device based on the timing, shape, and/or amplitude of the electrical signals received from the one or more sensors.