Abstract: There is provided an intravascular blood pump for insertion into a patient's heart. The blood pump comprises a slotless permanent magnet motor contained within a housing, the motor having p magnet pole pairs and n phases, where p is an integer greater than zero, and n is an integer ?3. The motor comprises a stator extending along a longitudinal axis of the housing and having 2np coils wound to form two coils per phase per magnet pole pair. The stator comprises inner and outer windings each comprising np coils electrically connected such that the current flowing through the coils is in the same direction, the coils of the outer winding arranged on an outer surface of the coils of the inner winding.

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: Systems and method are disclosed involving a pump control module configured to control an intravascular blood pump and display information about the intravascular blood pump, and a blood monitoring module configured to derive a value of a blood parameter from information received about a blood sample, such as information received from a blood monitoring sensor, and display the value of the blood parameter on the first display screen and/or on a second display screen. The system and method may also include predicting other parameters based on, e.g., the information received from the blood sample. The predictions may include, e.g., predictions of heart failure or bleeding events.

Abstract: Methods and apparatus for determining flow through a circulatory support device are provided. The method comprises receiving a motor current signal from a motor of the circulatory support device, determining within a time window of the motor current signal, a measured current value at which flow through the circulatory support device is maximum, determining an offset value based, at least in part, on the measured current value, determining based, at least in part, on the received motor current signal, whether an abnormal condition has occurred, adjusting the motor current signal based, at least in part, on the offset value and the determination of whether an abnormal condition has occurred to produce an adjusted motor current signal, and determining the flow through the circulatory support device based, at least in part, on the adjusted motor current signal.

Abstract: A guidewire for backloading and inserting a percutaneous pump affixed to a cannula includes a proximal section made of a first material, with a first diameter, a rounded proximal end, and a distal end. The guidewire also includes a distal section made of a second material, with a second diameter which is greater than the first diameter, a distal end, and a proximal end abutting the distal end of the proximal section. The first material of the proximal section is selected to be softer than a material of the percutaneous pump to reduce damage to the pump during backloading. The distal section of the guidewire is configured to be stiffer than the proximal section to insert the percutaneous pump in a desired location without damaging the guidewire.

Abstract: An introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.

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: An intravascular blood pump has an intake filter that reduces risk of heart tissue being sucked into an intake port of the pump. The filter defines a plurality of apertures, through which blood flows through the filter. The apertures are sized to prevent ingestion, by the input port, of the heart tissue. The filter includes a plurality of generally helical first struts wound about a longitudinal axis of the filter, and a plurality of second struts. The first and second struts collectively define the plurality of apertures therebetween. The struts may be woven filaments, or the apertures may be defined in a thin film (foil) tube, where remaining material between the apertures form the struts.

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: The systems and methods described herein determine metrics of cardiac or vascular performance, such as cardiac output, and can use the metrics to determine appropriate levels of mechanical circulatory support to be provided to the patient. The systems and methods described determine cardiac performance by determining aortic pressure measurements (or other physiologic measurements) within a single heartbeat or across multiple heartbeats and using such measurements in conjunction with flow estimations or flow measurements made during the single heartbeat or multiple heartbeats to determine the cardiac performance, including determining the cardiac output. By utilizing a mechanical circulatory support system placed within the vasculature, the need to place a separate measurement device within a patient is reduced or eliminated. The system and methods described herein may characterize cardiac performance without altering the operation of the heart pump (e.g., without increasing or decreasing pump speed).

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 method of operating a counterpulsation device (CPD) in a human or animal subject is disclosed, the method including: receiving a heart beat signal indicative of the heart beat of the subject; providing counterpulsation therapy by controlling the pressure supplied to a CPD drive line in pneumatic communication with the CPD to cause the CPD to alternately fill with blood and eject blood with a timing that is determined at least in part based on the heart beat signal; while providing counterpulsation therapy, receiving a CPD drive line pressure signal indicative of the pressure in the CPD drive line; and adjusting the pressure supplied to the drive line based at least in part on the drive line pressure signal.

Abstract: An access device may be provided that includes a hub configured to improve the flow of blood within a lumen, in order to prevent, e.g., thrombus formation, while also avoiding hemolysis. The hub may have a removably attachable second arm, protrusions/depressions with the lumens of the hub or system, and/or plugs or plug analogs may be used to prevent flow from entering certain regions of the lumens within the hub. These hubs may be used, e.g., as part of an access device, which may have a modular configuration.

Abstract: A medical device monitoring system and method extract information from screen images from medical device controllers, with a single OCR process invocation per screen image, despite critical information appearing in different screen locations, depending on which medical device controller's screen image is processed. For example, different software versions of the medical device controllers might display the same type of information in different screen locations. Copies of the critical screen information, one copy from each different screen location, are made in a mosaic image, and then the mosaic image is OCR processed to produce text results. Text is selectively extracted from the OCR text results, depending on contents of a selector field on the screen image, such as a software version number or a heart pump model identifier.

Abstract: The present disclosure is drawn to an access device that includes a cannula with a joint lumen therethrough, and a hub coupled to a proximal end of the cannula. The hub includes at least two arms. The first arm may have a first lumen and a first hemostatic valve, the first lumen operably connected to the joint lumen, where the first lumen and the first hemostatic valve are configured for passage of a medical device, and the second arm may be coupled to the first arm and have a second lumen, the second lumen operable connected to the joint lumen, the second arm configured to be operably coupled to an external medical device, such as an extracorporeal membrane oxygenation (ECMO) device.

Abstract: A vascular access system comprising a sheath, a slitted sleeve, and a sealing portion of the slitted sleeve. The slitted sleeve comprises a tubular sleeve body having a longitudinal slit along its length, wherein the slitted sleeve is adapted to receive a first portion of a medical device therein. The longitudinal slit closes, but does not seal, after the first portion of the medical device is inserted therein. The sealing portion of the slitted sleeve is configured to fill a gap and form a seal between an inner surface of the sheath and a portion of the first portion of the medical device disposed in the sheath when the sheath is inserted in the blood vessel and the slitted sleeve is inserted into the sheath lumen. A vascular access device accessory and a method for inserting it into a sheath are also provided.

Abstract: A monitoring patch including a substrate having an adhesive surface and a plurality of sensors disposed in and/or on the substrate. In some embodiments, the plurality of sensors may include one or more sensors arranged to measure oxygen saturation, a lactate sensor, and one or more impedance cardiography electrodes. In some embodiments, the plurality of sensors may include an accelerometer and a strain gauge, and may be free of at least one sensor of a sensor arranged to measure oxygen saturation, a lactate sensor, or an impedance cardiography electrode.