Abstract: Catheter device, having a hollow catheter in the catheter cavity of which a moveable shaft is guided, having a proximal coupling device, for detachable coupling of a drive device, the coupling device having a coupling cavity which is open towards the drive device and into which the shaft or an extension of the shaft protrudes with a connection element for mechanical coupling of a motor shaft, the coupling cavity having a germ barrier for reducing the pathogenicity of pathogenic substances or microorganisms.

Abstract: A hemodynamic flow assist device includes a miniature pump, a basket-like cage enclosing and supporting the pump, and a motor to drive the pump. The device is implanted and retrieved in a minimally invasive manner via percutaneous access to a patient's artery. The device has a first, collapsed configuration to assist in implantation and a second, expanded configuration once deployed and active. The device is deployed within a patient's aorta and is secured in place via a self-expanding cage which engages the inner wall of the aorta. The device includes a helical screw pump with self-expanding blades, sensors, and anchoring structures. Also disclosed is a retrieval device to remove the hemodynamic flow assist device once it is no longer needed by the patient and an arterial closure device to close the artery access point after implantation and removal of the hemodynamic flow assist device.

Abstract: A magnetically levitated motor includes a stator, a rotor configured to rotate relative to the stator, and a passive radial magnetic bearing configured to support the rotor relative to the stator in a radial direction. An active longitudinal magnetic bearing is configured to selectively position the rotor relative to the stator in an axial direction.

Abstract: A control device for a ventricular assist device (VAD) with settable speed levels. The control device includes an input configured to receive at least one measuring signal related to a physiological condition of the circulatory system of a patient receiving heart assistance by the VAD, where the control device is configured to derive an actual value of at least one characteristic parameter of the heart from one or more of the at least one measuring signal and to provide a refined actual value of the at least one characteristic parameter in which effects of physiologically caused fluctuations are eliminated or reduced. The control device further includes an output configured to output an updated setting value for the speed level, where the control device is configured to produce the updated setting value based on the refined actual value and a predeterminable set-point value.

Abstract: Devices and methods for providing localized pressure to a region of a patient's heart to improve heart functioning, including: (a) a jacket made of a flexible biocompatible material, the jacket having an open top end that is received around the heart and a bottom portion that is received around the apex of the heart; and (b) at least one inflatable bladder disposed on an interior surface of the jacket, the inflatable bladder having an inelastic outer surface positioned adjacent to the jacket and an elastic inner surface such that inflation of the bladder causes the bladder to deform substantially inwardly to exert localized pressure against a region of the heart.

Abstract: Systems and methods for providing oxygenated blood to a patient, e.g., in a patient with inadequate or failing circulation, including a dual lumen cannula system for drawing blood from the heart and returning oxygenated blood therein. Methods may feature inserting the dual lumen cannula system through the left ventricle such that intake aperture are positioned entirely within the left ventricle and the tip of the cannula is positioned in the aorta of the patients heart. By fluidly connecting the cannula to a cardiac assistance device, deoxygenated blood may be drained from the left ventricle through the intake apertures and oxygenated blood may be pumped into the aorta thorough the tip.

Abstract: An intravascular blood pump having a pumping device including an impeller and an electric motor for driving the impeller. A rotor of the electric motor is disposed inside a cavity in the pumping device and rotatable about an axis of rotation and coupled to the impeller so as to be able to cause rotation of the impeller. The cavity is formed by an inner sleeve made of a ceramic material. At least a portion of the stator of the electric motor, in particular a coil winding, may be arranged on the ceramic inner sleeve.

Abstract: An implantable blood pump system is disclosed herein. The implantable blood pump system includes an implantable blood pump, a controller coupled to the blood pump, a connector receptacle, and a connector insert. The connector receptacle can include a plurality of contacts, and a following surface. The connector insert can be received within the connector receptacle to couple a plurality of insert contacts with the plurality of contacts of the connector receptacle. The connector insert can include walls defining a follower receptacle that can receive a portion of the following surface when the connector insert is in a desired alignment with respect to the connector receptacle, and a cam surface that can engage with the following surface to bias the connector insert to the desired alignment with respect to the connector receptacle when the connector insert is inserted into the connector receptacle.

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: A catheter pump system is disclosed. The catheter pump system can include a shaft assembly and an impeller coupled with a distal portion of the shaft assembly. A motor assembly can impart rotation on the impeller through the shaft assembly, the motor assembly comprising a motor which rotates the shaft assembly. The catheter pump system can include a fluid pathway which conveys fluid proximally during operation of the catheter pump system. A seal can be disposed between the motor assembly and the impeller. The seal can be configured to impede or prevent the fluid from the fluid pathway from entering the motor assembly at least about an outer periphery of the shaft assembly. The seal can comprise an opening through which a portion of the shaft assembly extends.

Abstract: An implantable pump system is provided, suitable for use as a left ventricular assist device (LVAD) system, having an implantable pump, an extracorporeal battery and a controller coupled to the implantable pump, and a programmer selectively periodically coupled to the controller to configure and adjust operating parameters of the implantable pump. The implantable pump includes a flexible membrane coupled to an actuator assembly that is magnetically engagable with electromagnetic coils, so that when the electromagnetic coils are energized, the actuator assembly causes wavelike undulations to propagate along the flexible membrane to propel blood from through the implantable pump. The controller may be programmed by a programmer to operate at frequencies and duty cycles that mimic physiologic flow rates and pulsatility while operating in an efficient manner that avoids thrombus formation, hemolysis and/or platelet activation.

Abstract: A system configured to be at least partially implanted along an aorta includes an inelastic, static member and a pinching member. The pinching member is configured to receive an activation signal at an activation rate and in response to the activation signal, repeatedly compress the aorta at the second location at the activation rate to pump fluid within the aorta in a desired pumping direction. The system is configured to selectively control wave reflections in order to achieve both improved wave dynamics to reduce cardiac load and increased (or at least non-diminished) blood flow to targeted organs within the cardiovascular system.

Abstract: A system for performing extracorporeal blood treatment of recovered blood can include a reservoir to receive a first portion of the recovered blood from a subject, an inline pump coupled the reservoir to regulate a flow rate of at least the first portion of the recovered blood, and an extracorporeal blood conditioner including at least one of an oxygenator to reoxygenate hemoglobin included in the recovered blood for at least intravenous delivery back to the subject or a temperature regulator configured to selectively control a temperature of the recovered blood.

Abstract: Method and systems control a rotational speed of a blood pump during ventricular diastole. A method includes controlling a blood pump in accordance with a first segment operational mode. A controller monitors the blood flow rate through the blood pump. The controller determines, based on the blood flow rate, whether continued controlling of the blood pump per the first segment operational mode would result in the blood flow rate through the blood pump being less than a target minimum blood flow rate. In response to a determination that continued controlling of the blood pump per the first segment operational mode would result in the blood flow rate through the blood pump being less than the target minimum blood flow rate, the controller controls the rotational speed of the blood pump so that the blood flow rate through the blood pump is approximate to the target minimum blood flow rate.

Abstract: A method of fabricating a vascular graft that includes preparing a biodegradable polyester electrospun tubular core; applying an adhesive composition comprising poly(lactide) copolymer to an outer surface of the biodegradable polyester electrospun tubular core; and surrounding the adhesive-applied biodegradable polyester electrospun tubular core with a polyester sheath.

Abstract: The invention relates to a compressible and expandable blade for the rotor of a fluid pump having at least two lamellae which are disposed adjacently, are pivotable respectively relative to an axis of rotation of the rotor and moveable relative to each other, and abut against each other in the expanded state of the blade such that they form together a continuous blade surface.

Abstract: There is provided herein, a method for adjusting a VAD device parameters using a wearable device placed on the patient's hand, the method includes the steps of acquiring a set of signals from sensors in the wearable device, computing at least one quality metric, and adjusting at least one VAD operational parameter so as to optimize at least the one quality metric.

Abstract: An external drive unit for an implantable heart assist pump is provided. The drive unit comprises a motor housing, a transcutaneous drive shaft and a motor for driving the heart assist pump. The motor is connectable to the heart assist pump via the drive shaft, and the motor is arranged inside the motor housing. The drive unit further comprises a catheter surrounding the drive shaft and a purge line for injecting a purge medium into a lumen of the catheter or into a space between the catheter and the drive shaft. The purge line is in thermal contact with an outer surface of the motor housing and/or with an outer surface of a proximal section of the catheter. Due to the thermal contact heat is transferred from the outer surface of the catheter in the proximal section and/or from the outer surface of the motor housing to the purge medium.

Abstract: An implantable device adapted for assisting the flow of blood from a left atrium to a descending aorta of an in-vivo heart is provided. The implantable device includes an inlet cannula adapted to be connected to the left atrium and an outlet cannula adapted to be connected to the descending aorta. In one embodiment, the inlet and outlet cannula is in fluid communication with a blood pressure pump. The implantable device further includes a first accelerometer mounted on a housing of the blood pressure pump, wherein the first accelerometer is adapted for measuring mitral valve motion. The implantable device also includes an implanted controller in electrical communication with at least one implanted ECG sensor adapted for detecting ECG signals, wherein the at least one implanted ECG sensor is positioned between the blood pressure pump and the implanted controller and the implanted controller also includes a processor adapted to analyse detected ECG signals and the mitral valve motion.

Abstract: The invention relates to a stent pump for intravascular, intraventricular or intraatrial placement inside the human heart comprising: —a preferably tubular housing having an inlet and an outlet, —an impeller, and —a stream former, wherein the impeller and optionally the stream former are arranged within the housing, characterized in that the stream former is arranged downstream of the impeller, and the housing, the stream former and/or the impeller are deployable from a first position, in which the housing, the stream former and/or the impeller are folded for being arranged within a delivery device, into a second, expanded position, in which the housing, the stream former and/or the impeller are deployed.

Abstract: A catheter system includes a catheter, an introducer sheath, and a tubular plug. The catheter comprises an elongate body having an expandable medical device coupled with a distal end thereof. The introducer sheath comprises an elongate body defining a lumen therein. The introducer sheath is disposed over the catheter to form a gap therebetween. The tubular plug comprises an elongate body and extends through the lumen of the introducer sheath. The tubular plug is disposed between the catheter and the introducer sheath to occlude the gap. Further, the tubular plug is releasably fixed relative to the introducer sheath such that the tubular plug is removable from the lumen to allow the expandable medical device to pass therethrough.

Abstract: Catheter blood pump that include an expandable pump portion extending distally from an elongate shaft. The pump portions include an expandable impeller housing including an expandable blood conduit that defines a blood lumen between an inflow and an outflow. The pump portions include one or more expandable impellers disposed at least partially within the blood lumen.

Abstract: Devices, systems and methods for altering functioning of a tissue/organ by application of force thereto. In one preferred embodiment, a device for reducing or preventing regurgitation of blood through a valve of a heart is provided. A device may include a main body having a segment adapted to apply force to a surface of tissue/organ and a member that applies counterforce to the force applied by the segment. Kits are provided in which devices having varying lengths and widths can be selected for the best fit for a particular location of treatment. A width sizing instrument may be provided. A length sizing instrument may be provided. A separate sleeve and/or pad may be provided which may be first anchored to the tissue/organ before fixing the device thereto.

Abstract: An intravascular blood pump having a rotatable shaft carrying an impeller and a housing with an opening through which the shaft extends with the impeller positioned outside the housing. The shaft and the housing have surfaces forming a circumferential gap which has a gap width of no more than 2 ?m over at least part of the length of the gap and at least one of the surfaces forming the gap is made of a material having a thermal conductivity of at least 100 W/mK, in particular a ceramic material such as silicon carbide.

Abstract: A catheter pump is disclosed herein. The catheter pump can include a catheter assembly that comprises a drive shaft and an impeller coupled to a distal end of the drive shaft. A driven assembly can be coupled to a proximal end of the drive shaft within a driven assembly housing. The catheter pump can also include a drive system that comprises a motor and a drive magnet coupled to an output shaft of the motor. The drive system can include a drive assembly housing having at least one magnet therein. Further, a securement device can be configured to prevent disengagement of the driven assembly housing from the drive assembly housing during operation of the pump.

Abstract: Mechanical circulatory assist systems and related methods produce a pulsatile blood flow in synchronization with heart activity. A mechanical circulatory assist system includes a continuous-flow pump and a controller. The continuous-flow pump is implantable in fluid communication with a left ventricle of a heart of a patient and an aorta of the patient to assist blood flow from the left ventricle to the aorta. The controller includes a sensor that generates a signal indicative of an activity of the heart. The controller is operatively connected to the continuous-flow pump and configured to operate the continuous-flow pump in an artificial pulse mode in synchronization with the activity of the heart.

Abstract: The approach presented here concerns a pump for delivering a fluid. The pump comprises an impeller, a drive device with a shaft, a shaft housing and a sealing device. The impeller is shaped to deliver the fluid. The drive device with the shaft is designed to drive the impeller. The shaft housing is shaped to receive the shaft and/or the drive device. The sealing device comprises at least one casing sealing element and/or an impeller sealing element which is received between the drive device and the impeller and which is designed to prevent fluid from entering the drive device and/or the shaft casing during operation of the pump.

Abstract: An external controller assembly for a medical device implanted in a patient includes an external controller and an external driveline assembly. The external controller includes an external controller display viewable by the patient. The external driveline assembly includes an external driveline cable and an external driveline distal connector. The external driveline cable is connected to the external driveline distal connector and the external controller. The external driveline cable accommodates positioning of the external driveline distal connector, by the patient, for simultaneous viewing of the external driveline distal connector and the external controller display by the patient. The external driveline distal connector is adapted to be connected to the distal driveline proximal connector by the patient. The external driveline distal connector is adapted to be disconnected from the distal driveline proximal connector by the patient.

Abstract: A controller for an implantable blood pump, includes an accelerometer configured to measure at least one from the group consisting of position and movement of the controller. Processing circuitry is configured to control operation of the implantable blood pump, the processing circuitry being in communication with the accelerometer, the processing circuitry being configured to adjust a speed of the implantable blood pump if the measured at least one from the group consisting of position and movement deviates from a respective predetermined threshold.

Abstract: An apparatus for a heart of a patient having a cardiac assist device adapted to be implanted into the patient to assist the heart with pumping blood. The apparatus has a sensor adapted to be implanted into the patient. The sensor in communication with the cardiac assist device and the heart which measures native volume of the heart. Alternatively, the sensor monitors the heart based on admittance while the cardiac assist device. Alternatively, the sensor monitors the heart based on impedance.

Abstract: A method for synchronously driving more than two or more rotational tissue screws and a method for simultaneously affixing a medical device to tissue employing the synchronous drive system. The method employs a synchronous drive system is particularly configured to affix an apical cuff to cardiac muscle tissue by simultaneously driving a plurality of rotational tissue screws through the apical cuff and into cardiac muscle tissue thereby affixing the apical cuff to the cardiac muscle tissue.

Abstract: An apparatus for a heart of a patient having a cardiac assist device adapted to be implanted into the patient to assist the heart with pumping blood. The apparatus has a sensor adapted to be implanted into the patient. The sensor in communication with the cardiac assist device and the heart which measures native volume of the heart. Alternatively, the sensor monitors the heart based on admittance while the cardiac assist device. Alternatively, the sensor monitors the heart based on impedance.

Abstract: An apparatus for a heart of a patient having a cardiac assist device adapted to be implanted into the patient to assist the heart with pumping blood. The apparatus has a sensor adapted to be implanted into the patient. The sensor in communication with the cardiac assist device and the heart which measures native volume of the heart. Alternatively, the sensor monitors the heart based on admittance while the cardiac assist device. Alternatively, the sensor monitors the heart based on impedance.

Abstract: A human body simulation device includes a heart model simulating a heart, a beat portion for causing the heart model to beat, a blood vessel model simulating a blood vessel, a pulsation portion for sending a pulsated fluid into the blood vessel model, and a control portion for changing a beat rate of the beat portion and a pulsation rate of the pulsation portion depending on a prescribed heart rate.

Abstract: A device for treating an aneurysm of a human or mammal patient, wherein the aneurysm may self-expand, leading to the aneurysm bursting with high risk for death of the human or mammal patient. The device comprising an implantable member adapted to be placed in connection with the outside of a blood vessel having the aneurysm, and to exercise a pressure on the outside of the blood vessel having the aneurysm, a measuring device or sensor for measuring or sensing an expansion of the aneurysm, and a pressure regulator adapted to regulate the exercised pressure on the outside of the blood vessel having the aneurysm.

Abstract: Actuator (1) for a medical device (100), comprising an electromotor, a mechanical transmission, and magnetic coupling means arranged for transmitting a mechanical torque from the electromotor to the mechanical transmission when said electromotor is powered by an energy source, wherein said electromotor and a first part of the magnetic coupling means kinematically linked to the electromotor are arranged and hermetically sealed in a first casing module, and wherein said mechanical transmission and a second part of the coupling means kinematically linked to said mechanical transmission are arranged in a second casing module, said first and second casing modules comprising each complementary fastening means such that said first and second casing modules can be removably connected to each other in such a way that said first and second parts of the magnetic coupling means magnetically couple together upon connection of said first and second casing modules.

Abstract: A system and method for positioning a modular heart pump about the ventricles of the heart. The modular heart pump has at least one active panel and an apical base. Each active panel includes an inflatable membrane. The apical base helps retain the active panels on position about the heart. The components are assembled in vivo to create a pump assembly that encircles all or part of the heart. During installation, the active panels are advanced along the outside of the ventricles. Suction is provided on the leading edge of the active panels to remove any fluids and/or loose tissue that may prevent the active panel from advancing to an operable position.

Abstract: Apparatus and methods are described for improving renal function of a patient, including mechanically occluding the patient's inferior vena cava downstream of the renal vein ostium to form an upstream region and a downstream region of the inferior vena cava, and mechanically pumping blood through the inferior vena cava from the upstream region to a discharge location in the downstream region while the inferior vena cava is occluded, wherein the blood remains in the inferior vena cava while being mechanically pumped. Other applications are also described.

Abstract: An apparatus and a method are described in which a signal is received from a gyroscope sensor mounted on a subject. The gyroscope sensor is configured to measure rotational movement of the subject's heart, the signal being indicative of a left ventricular twist of the subject's heart. A change in the left ventricular twist of the subject's heart caused by occlusion of blood flow by an arterial occlusion device configured to selectively occlude blood flow of the subject is determined.

Abstract: Apparatus and methods are described including a blood pump that includes a catheter, a first impeller disposed on the catheter, and a second impeller disposed on the catheter, proximally to the first impeller. A motor drives the first and second impellers to pump blood of a subject, by driving the first and second impellers to rotate. The blood pumps is configured such that (a) the first and second impellers are shaped differently from each other when the first and second impellers are in non-radially-constrained configurations, (b) the first and second impellers are sized differently from each other when the first and second impellers are in non-radially-constrained configurations, and/or (c) the first and second impellers are driven by the motor to rotate under respective rotation conditions that are different from each other. Other applications are also described.

Abstract: A blood flow environment simulation device is disclosed, including: a liquid reservoir (1) for storing liquid; a vascular simulation tube (4); a pump (2) for pumping liquid; a plurality of circulation tubes (7, 11, 12), which form a liquid circulation path together with the vascular simulation tube; and a valve (6) located in the circulation path, having a valve inlet (17) and a valve outlet (18), wherein the area of the valve inlet (17) is variable to change the dynamic parameters of the fluid in the vascular simulation tube (4) over time. The present disclosure also relates to medical equipment that includes a blood flow environment simulation device as described.

Abstract: Apparatus and methods are described including a ventricular assist device that includes an impeller configured to be placed inside a subject's left ventricle. A frame is disposed around the impeller, the frame defining generally-cylindrical central portion, and a proximal conical portion that widens from a proximal end of the frame to a proximal end of the generally-cylindrical central portion. A motor drives the impeller to pump blood from the left ventricle to the subject's aorta, by rotation of the impeller. The impeller is configured to be disposed at least partially within the proximal conical portion of the frame during at least some of a time during which the impeller rotates. Other applications are also described.

Abstract: Provided is a balloon dilatation system, which includes a signal collecting module, a main controller, a pressurization module, a pressure relief module, a first pressure sensor, a flow rate sensor, a balloon catheter and a balloon. The signal collecting module is electrically connected to the main controller, and is configured to collect a control signal and send the control signal to the main controller; the main controller is electrically connected to the pressurization module and the pressure relief module; the pressurization module is connected to the balloon through the balloon catheter; the pressure relief module is connected to the balloon through the balloon catheter; the first pressure sensor is arranged on the balloon catheter and is configured to monitor a first liquid pressure of the balloon; the flow rate sensor is arranged on the balloon catheter and is configured to monitor a liquid flow rate of the balloon catheter.

Abstract: Some embodiments of percutaneous ventricular assist devices have a two-part design that includes a housing component and a separately deployable rotatable inner catheter component. The housing component can include an expandable pump housing. The inner catheter can include an expandable pump impeller and an associated flexible drive shaft. The drive shaft can be coupled to a motor located external to the patient. The motor can rotate the drive shaft to spin the pump impeller inside of the pump housing, causing blood to be pumped within the patient. In some embodiments, the pump impeller is inflatable or self-expandable. The two-part percutaneous ventricular assist devices with inflatable or self-expandable pump impellers are designed to have very small delivery profiles. Accordingly, various deployment modalities, including radial artery deployment, are practicable using the two-part percutaneous ventricular assist devices described herein.

Abstract: Medical devices, systems, and methods related thereto a glucose monitoring system having a first display unit in data communication with a skin-mounted assembly, the skin-mounted assembly including an in vivo sensor and a transmitter. The first display unit and a second display unit are in data communication with a data management system. The first display unit comprises memory that grants a first user first access level rights and the second display unit comprises memory that grants a second individual second access level rights.

Abstract: A heart pump including: a housing forming a cavity including: at least one inlet aligned with an axis of the cavity; and, at least one outlet provided in a circumferential outer wall of the cavity; an impeller provided within the cavity, the impeller including vanes for urging fluid from the inlet to the outlet; and, a drive for rotating the impeller in the cavity and wherein a flow path through the pump has a minimal cross-sectional area of at least 50 mm2.

Abstract: A blood pump including a housing having an inlet element, the inlet element including a distal portion coupled to the housing and a proximal portion sized to be received within at least a portion of a heart of a patient and a rotor configured to rotate within the housing and impel blood from the heart. At least one pressure sensor is coupled to the proximal portion of the inlet element.

Abstract: An implantable prosthesis for repairing or reinforcing a tissue or muscle wall defect is provided. The implantable prosthesis includes a first biocompatible structure having a tether attached thereto for maintaining stable deployment of the implantable prosthesis through an abdominal wall; a rigid reinforcement member positioned adjacent a bottom side of the first biocompatible structure, the rigid reinforcement member including an inner circumferential ring, a plurality of spoke elements, a plurality of openings, and a plurality of guide members molded thereon; a mesh structure positioned adjacent a bottom surface of the rigid reinforcement member, the mesh structure overlapping the inner circumferential ring of the rigid reinforcement member; a second biocompatible structure and an anti-adhesion barrier having a collagen coating positioned on a bottom surface of the second biocompatible structure.

Abstract: The invention relates to a pump device having a pump (8) and an energy supply device (5, 18), wherein the pump has a conveying element (9, 11) which conveys a fluid by means of supplied energy, wherein the pump has a transport state and an operating state, and wherein at least one first element (9, 9a, 10, 10?, 11) of the pump has a different shape and/or size in the transport state than in the operating state. The operating safety of such a pump device is increased by a detection device (12, 20, 21, 22, 23, 24, 25, 27, 28, 29) which detects whether at least the first element is in the operating state with respect to shape and/or size by means of a sensor.

Abstract: Mechanical circulatory supports configured to operate in series with the native heart are disclosed. In an embodiment, a centrifugal pump is used. In an embodiment, inlet and outlet ports are connected into the aorta and blood flow is diverted through a lumen and a centrifugal pump between the inlet and outlet ports. The supports may create a pressure rise between about 40-80 mmHg, and maintain a flow rate of about 5 L/min. The support may be configured to be inserted in a collinear manner with the descending aorta. The support may be optimized to replicate naturally occurring vortex formation within the aorta. Diffusers of different dimensions and configurations, such as helical configuration, and/or the orientation of installation may be used to optimize vortex formation. The support may use an impeller which is electromagnetically suspended, stabilized, and rotated to pump blood.