Abstract: A system for insertion into a vasculature of a patient is disclosed. The system utilizes a primary tubular sheath body coupled to a distal portion of an intermediate tubular sheath body, and a hub coupled to a proximal portion of the intermediate tubular sheath. The hub may be couplable to a dilator via an interaction between a dilator cap and the hub, and the hub may contain a hemostatic valve with a foam member having one or more visibly identifiably regions.

Abstract: An improved intravascular blood pump. Intravascular blood pumps using the present technology may be powered by an onboard motor unit configured to be located inside the patient's body, but which is separated from the pump unit by a flexible intermediate section housing a flexible drive shaft.

Abstract: Techniques and systems for using spectroscopy-and/or image-based sensing with an intravascular blood pump may be provided. The techniques generally include capturing a spectral response to light of a measured tissue and/or blood. Based on the specific needs, the method may include, e.g., determining a type of the measured tissue based on the spectral response, determining if the type of the measured tissue matches a target tissue type, determining a health of the measured tissue based on the spectral response, determining a treatment plan based on the health of the measured tissue, determining a type and/or quantity of components and/or characteristics in the blood, and/or determining a degree of heart recovery based on the type and/or quantity of the components and/or characteristics in the blood.

Abstract: Methods and apparatus for securely updating software for a medical device are described. The method comprises receiving, by the medical device from a firewall device, an indication that a software update for the medical device is available, determining whether the medical device is in a patient use state, and sending a request to the firewall device to establish a bidirectional data transfer communication link between the medical device and an Internet-connected device when it is determined that the medical device is not in a patient use state.

Abstract: A method for automatically classifying clinical descriptions of patients by a computer processor using natural language processing is provided. The clinical descriptions relate to the use of a ventricular assist device to treat the patient. The method comprises receiving at least one clinical description comprising text. The method also then comprises determining the position of a target word within the text. Further the method comprises determining the existence of at least one negation word within an active region, the active region comprising a predetermined number of words within the text occurring immediately before and immediately after the target word, including the target word. The method then comprises determining the existence of at least one body-part word within the active region. Lastly, the method comprises determining that the clinical description is to be disregarded if the active region contains either a negation word or a body-part word.

Abstract: Methods and apparatus for determining a torque angle for a synchronous electric motor of a mechanical circulatory support device are provided. The method includes receiving a voltage signal representing a voltage induced in a winding of the synchronous electric motor during operation of the synchronous electric motor, determining a first back electro-motive force (bEMF) value of the voltage signal within at least one time window during which the winding is not energized, determining a torque angle for the synchronous electric motor based, at least in part, on the first bEMF value, and outputting an indication of the torque angle.

Abstract: An electronic interface facilitates automatically transferring data from a heart pump controller database to an EMR system, thereby reducing or eliminating the need for caregivers to manually transcribe heart pump operational data from a heart pump controller screen to the EMR system. Some embodiments reduce or eliminate the need to periodically visit a patient to record the operational data. Instead, once programmed, the interface can automatically periodically send the operational data to the EMR system.

Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal and the distal ends, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: Provided herein is an accessory for use with a catheter of a blood pump system and a method of use. The accessory may include a first end attached to a repositioning unit of a blood pump and a second end. The accessory is configured to move when a force is applied while the catheter of the blood pump system does not move. The method may comprise applying a force to an accessory to a blood pump system and then moving the accessory in a first direction while the blood pump system does not move in the first direction.

Abstract: A puncture-resistant catheter and/or a puncture-resistant sleeve for a catheter may be provided. The puncture-resistant catheter may have a catheter portion and a puncture-resistant portion. The puncture-resistant portion may be made of a material which is resistant to needles and/or sharp objects. The puncture-resistant portion may be a layer on the outside of the catheter or may be a sleeve attachable to a repositioning unit.

Abstract: Resorbable and/or dissolvable atraumatic tips and methods of using atraumatic tips are provided. The atraumatic tip includes a proximal portion and a distal portion. The proximal and/or distal portion may be made of a material configured to be resorbable and/or dissolvable in the blood of a patient. The atraumatic tip may be attachable to a blood pump assembly.

Abstract: Methods and systems for automatically ascertaining physical location information about a plurality of medical device controllers and tracking changes in the physical locations of ones of the respective medical device controllers. One or more machine learning modules infer the physical locations from computer network messages received from the medical device controllers, including information about computer network components that are proximate ones of the medical device controllers.

Abstract: Aspects of the present disclosure describe systems and methods for predicting an intra-aortic pressure of a patient receiving hemodynamic support from a transvalvular micro-axial heart pump. In some implementations, an intra-aortic pressure time series is derived from measurements of a pressure sensor of the transvalvular micro-axial heart pump and a motor speed time series is derived from a measured back electromotive force of a motor of the transvalvular micro-axial heart pump. Furthermore, in some implementations, machine learning algorithms, such as deep learning, are applied to the intra-aortic pressure and motor speed time series to accurately predict an intra-aortic pressure of the patient. In some implementations, the prediction is short-term (e.g., approximately 5 minutes in advance).

Abstract: Devices and techniques for estimating/detecting a location of a mixing cloud in a vessel of a subject may be provided. The techniques may include positioning a first tubular member within the vessel and flowing blood through a first lumen from a proximal end to a distal end of either the first tubular member or a second tubular member in a direction retrograde to a direction blood is natively flowing in the vessel. The techniques may include determining a plurality of blood-related characteristics of blood flowing in the vessel, such as arterial blood oxygen saturation values, each determined from blood acquired at a different axial position along the first tubular member, and/or pressure values, each determined from a pressure sensor at different axial positions along an exterior surface of the first tubular member. The techniques may include estimating a location of the mixing cloud based on the blood-related characteristics.

Abstract: Methods and apparatus for determining whether a circulatory support device is correctly positioned in a heart of a patient are provided. The method comprises receiving a motor current signal from a motor of the circulatory support device, receiving a pressure signal from a pressure sensor arranged on the circulatory support device, generating a normalized motor current signal based, at least in part, on the pressure signal, determining a pulsatility of the normalized motor current signal, determining whether the circulatory support device is correctly positioned in the heart of the patient based, at least in part, on the pulsatility of the normalized motor current signal, and outputting an alarm when it is determined that the circulatory support device is not correctly positioned in the heart of the patient.

Abstract: A device, system, and method of use are provided. The device includes a cannula having a lumen extending therethrough, an inflow cage coupled to one end of the cannula and an outflow cage coupled to the other end of the cage. The inflow cage includes an inflow check valve that is configured to allow blood to flow into the lumen only when a pressure inside the lumen is less than a pressure of blood external to the inflow check valve. The outflow cage includes an outflow check valve that is configured to allow blood to flow out of the lumen through at least one outlet only when a pressure in the lumen is greater than a pressure of blood external to the outflow check valve. A catheter is operably coupled the outflow cage. A pump capable of generating positive and negative pressures is operably coupled to the lumen.

Abstract: A modular blood-gas exchange system is provided. The system may include a first oxygenator manifold, a second oxygenator manifold, and a plurality of blood-gas exchange cartridges removably coupled to the first and second oxygenator manifolds. The first oxygenator manifold may include a plurality of first blood ports. The second oxygenator manifold may include a plurality of second blood ports. Each blood-gas exchange cartridges may be configured to allow blood and a sweep gas to flow through the removably attachable cartridge, and may be configured to allow a gas molecule to transfer between the sweep gas and the blood.