Abstract: The present invention relates to a catheter that minimizes or eliminates the recirculation of oxygenated blood. The catheter of the present invention can be used to drain blood from multiple points in the patient, namely the superior vena cava, right atrium, and the right ventricle, while returning blood to the patient's pulmonary artery. Further, the catheter of the present invention is less likely to be moved or dislodged than catheters currently available in the art, thus making the catheter particularly useful for portable lung assist devices. The present invention also relates to methods for inserting the catheter into the patient and using the catheter with a lung assist device.

Abstract: The disclosure relates to devices and methods for the treatment of edema using a purge-free system. The invention provides devices and methods useful for treating edema by means of an indwelling catheter that is placed in a blood vessel of a patient and used to pump blood to cause a decrease in pressure at an outlet of a lymphatic duct. The catheter pumps blood by means of an impeller but is purge-free in that the catheter does not include a system for purging or flushing catheter components with a purge fluid. The purge-free catheter avoids blood-related mechanical complications such as clotting or thrombosis by means of an impermeable sleeve or shroud that protects moving parts of the impeller drive system.

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: Embodiments of the present disclosure relate to imaging a body part using sounds. In embodiments, a system comprises a motion sensor and a processing device communicatively coupled to the motion sensor. The motion sensor is configured to sense an acceleration wave produced by a sound emitted by a source and generate acceleration measurements in response to sensing the acceleration wave, wherein the source is associated with the body part of a subject. The processing device is configured to receive the acceleration measurements and determine a location of the source using a location of the motion sensor and the acceleration measurements. In addition, the processing device is configured to image the body part of the subject using the determined location of the source and the acceleration measurements.

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: A sump pump system detects backflow from an outlet pipe in a sump pump system and implements control of the sump pump in light of the detected backflow (or lack thereof). The sump pump system may detect the backflow (or lack thereof) by detecting and comparing water rise rates in a sump basin before activation or engagement of the sump pump (e.g., immediately before the pump starts pumping) and after the pump has disengaged or deactivated (e.g., immediately after the pump stops pumping). The rises rates may be detected via sensors configured to detect motion or acceleration (e.g., accelerometers, inertial measurement units, or force acceleration sensors) placed in the sump basin such that detect motion of water in the basin corresponding to changing water levels.

Abstract: A flexible catheter with a drive shaft, and associated devices and systems. In some examples, the disclosure describes a flexible catheter with a drive shaft, with a sleeve surrounding the drive shaft and with a sheath surrounding the drive shaft and the sleeve, wherein the drive shaft, the sleeve and the sheath are pliable, wherein the drive shaft at a proximal end of the drive shaft comprises a coupling element for connecting the drive shaft to a drive motor, wherein the drive shaft at least regionally consist of a alloy which contains at least 10% by weight of chromium, nickel and cobalt in each case.

Abstract: The approach presented here relates to an analysis device (100) for analyzing a viscosity of a fluid (217). The analysis device (100) comprises a detection device (110) and a provisioning device (115). The detection device (110) is formed to determine the viscosity of the fluid (217) using at least one Doppler parameter of a Doppler spectrum of the fluid (217). The provisioning device (115) is formed to provide or transmit a viscosity signal that represents the viscosity determined by the detection device (110).

Abstract: Intravascular blood pumps and methods of use. The blood pump include a pump portion that includes a collapsible blood conduit defining a blood flow lumen between an inflow and an outflow. The pump portion includes a distal collapsible impeller axially spaced from a proximal collapsible impeller, at least a portion of each of the distal and proximal collapsible impellers disposed between the inflow and the outflow.

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: The invention concerns a control device for controlling a blood flow of an intravascular blood pump for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit with a drive unit for driving the pump unit and configured to convey blood from a blood flow inlet towards a blood flow outlet, wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode, wherein a blood flow command signal is selected, and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow by adjusting a speed command signal for the drive unit, and the second controller is configured to control a drive speed of the drive unit.

Abstract: A system for assisting a circulation of blood inside a body of a patient includes a pump including: a housing having an upstream portion and a downstream portion; an inducer positioned in the upstream portion of the housing, the inducer including one or more helically-wound inducer blades to rotate around a longitudinal axis of the pump; an impeller positioned downstream of the inducer in the housing, the impeller including one or more impeller blades to rotate around the longitudinal axis of the pump; and a diffuser positioned in the downstream portion of the housing, to direct blood through at least one aperture in a circumference of the housing.

Abstract: A medical device system includes a cardiac electrical stimulation device and a ventricular assist device (VAD). The cardiac stimulation device and the VAD are capable of communication with each other to confirm detection of cardiac events.

Abstract: The invention relates to a line device (105) for conducting a blood flow for a heart support system. The heart support system has a head unit and an outlet unit. The line device (105) has a main part (205). The main part (205) has, at a first end, a first attachment section (210) for attaching the line device (105) to the head unit and, at a second end, a second attachment section (215) for attaching the line device (105) to the outlet unit. Furthermore, the main part (205) has a mesh section (220) between the attachment sections (210, 215), wherein the mesh section (220) has a mesh structure (230) formed from at least one mesh wire (225). In addition, the main part (205) has an inlet section (235), arranged in the first attachment section (210), for introducing the blood flow into the main part (205).

Abstract: A method for determining a state of an electric motor having a stator (2) and a rotor (3) rotatably mounted relative to the stator (2) is disclosed. Due to a rotary motion of the rotor (3), a pressure difference (p) relative to an environment (15) of the electric motor (1, 1?, 1?, 1??) is caused in an air space (16) inside the electric motor (1, 1?, 1?, 1??). Here, in a normal state of the electric motor (1, 1?, 1?, 1??), the pressure difference depends on an actual rotational speed (n) of the rotor (3). A corresponding electric motor suitable for carrying out this method is disclosed, wherein the electric motor may be part of a fan.

Abstract: The present invention relates to a method for early detection of artificial pump dysfunction based on a time-frequency analysis of the pump motor power consumption (PRC). The method allows to prevent low output syndrome, cardiogenic shock, pump thrombus and/or cardiac arrest or death as well as to monitor the efficacy of a thrombolytic therapy and/or to optimize intensity and duration of a thrombolytic therapy.

Abstract: A method of manufacturing electrical tracks in a region of an intravascular blood pump is provided. The method can include providing an intravascular blood pump with a flow cannula including a spiral structure, a sensor and an electrical connection region, applying a conductor structure to a coatable material of the flow cannula, electrically connecting a first portion of the conductor track structure to the sensor and a second portion of the conductor track structure to the electrical connection region and closing the spiral structure using a flexible material where the flexible material can be silicone or polyurethane.

Abstract: Various systems and methods are provided for reducing pressure at an outflow of a duct such as the thoracic duct or the lymphatic duct. A catheter system can include a catheter shaft configured to be at least partially implantable within a patient's vein, a flexible membrane attached to the catheter shaft, the flexible membrane being a collapsible, tube-like member having a lumen extending therethrough, and a single selectively deployable restriction member formed over a portion of the flexible membrane at substantially a midpoint between a proximal end of the flexible membrane and a distal end of the flexible membrane, the restriction member being configured to control a size of the lumen so as to direct a controlled volume of fluid from an upstream side of the restriction member to a downstream side the restriction member.

Abstract: A blood flow assist system can include an impeller assembly including an impeller shaft and an impeller on the impeller shaft, a primary flow pathway disposed along an exterior surface of the impeller. The system can include a rotor assembly at a proximal portion of the impeller shaft. A secondary flow pathway can be disposed along a lumen of the impeller shaft. During operation of the blood flow assist system, blood can be pumped proximally along the primary flow pathway and the secondary flow pathway. The system can include a sleeve bearing distal the impeller. The system can include a drive unit having a distal end disposed distal a proximal end of the second impeller. The drive unit comprising a drive magnet and a drive bearing between the drive magnet and the impeller assembly.

Abstract: Devices for moving blood within a patient, and methods of doing so. The devices can include a pump portion that includes an impeller and a housing around the impeller, as well as a fluid lumen. The impeller can be activated to cause rotation of the impeller and thereby move fluid within the fluid lumen.

Abstract: An implantable medical device includes a functional unit, an introducer unit for introducing and/or navigating the functional unit in a lumen of body conduit(s) of a subject, and an elongated operable element connectable to a controller for operating the functional unit though the elongated operable element in a lumen of body conduit(s) of the subject. The functional unit, introducer unit, and elongated operable element may be in a slidable relationship for assembling and unassembling the implantable medical device in vivo. The implantable medical device is implantable, explantable, and operable in a lumen of body conduit(s) of a subject according to related methods.

Abstract: A method of detecting hypertension in a patient having an implantable blood pump, the method includes operating the implantable blood pump at a first pump set speed during a first period of time. A first flow rate minimum during a cardiac cycle of the patient is measured during the first period of time. The first pump set speed is reduced by at least 200 rpm during a second period of time after the first period of time to a second pump set speed, the second period of time being less than the first period of time. A second flow rate minimum is measured during a cardiac cycle during the second period of time. If the second flow rate minimum decreases during the second period of time at the second pump set speed by more than a predetermined amount, an alert is generated indicating a presence of hypertension.

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: The disclosure provides an intravascular catheter with a purge system that excludes biological fluids and may also include devices such as impellers that can be delivered over, and operated over, a guidewire. Catheters may include treatment devices suited to the treatment of edema and in which the guidewire aids in positioning the device while the purge system facilitates reliable operation.

Abstract: Catheter blood pumps that include an expandable pump portion, which include an expandable impeller housing. The housings include an expandable blood conduit that defines a blood lumen, and one or more pluralities of expandable struts extending axially from an end region of the expandable blood conduit. At least one of the pluralities of struts are non-unitary with a blood conduit at the end region.

Abstract: A method of managing a speed of implantable blood pump. The implantable blood pump is in communication with an internal battery and a transcutaneous energy transfer system (TETS). The method includes starting the pump at a programmed set speed. The speed of the pump is decreased from the programmed set speed to a minimum set speed if either a capacity of the internal battery is less than a predetermined reserve level and TETS power is unavailable, or there is insufficient TETS power to maintain the programmed set speed. The speed of the pump is progressively decreased from the programmed set speed if there is insufficient power to maintain the programmed set speed.

Abstract: A temporary, removable mechanical circulatory support heart-assist device has at least two propellers or impellers. Each propeller or impeller has a number of blades arranged around an axis of rotation. The blades are configured to pump blood. The two propellers or impellers rotate in opposite directions from each other. The device can be configured to be implanted and removed with minimally invasive surgery.

Abstract: A surgical device configured to surround an implantable medical device that includes a collagen membrane and a coating embedded in the membrane, the coating including at least one active pharmaceutical ingredient.

Abstract: Apparatus and methods are described including a catheter, and first and second impellers configured to be inserted into a subject's body via the catheter, the first and second impellers being disposed in series with each other. A first impeller cage is disposed around the first impeller, and a second impeller cage is disposed around the second impeller. A sleeve extends longitudinally along more than 50 percent of a distance between the first and second impellers. Other applications are also described.

Abstract: Apparatus and methods are described for use with a venous system of a subject that includes one or more tributary vessels that flow into a vein at junctions. A blood-pump-catheter (70) includes a material (36) configured to be placed at a downstream location that is downstream of the junctions and to at least partially occlude blood flow through the vein. The material defines a blood-outlet opening (31). A blood pump (24) pumps blood from a region of the vein that is adjacent to the junctions, and through the blood-outlet opening (31). A blood-flow pathway (60) directs upstream venous blood flow from an upstream location that is upstream of the junctions, to downstream of the material (36), without the upstream venous blood flow being pumped by the pump (24). Other applications are also described.

Abstract: A ventricular shunt assembly, used in conjunction with a hyperbaric environment (e.g., having a pressure of about 250 to about 350 mm H2O above atmospheric pressure) can be used to correct a patient's intraparenchymal venous pressure from a sub-normally low value to a normal value. The shunt may comprise a valve, e.g., and adjustable valve, disposed between the ventricular catheter and the distal catheter. Optionally, the shunt comprises a reservoir on the ventricular side of the valve.

Abstract: Catheter blood pumps that include an expandable pump portion. The pump portions include a collapsible blood conduit that defines a blood lumen. The collapsible blood conduits include a collapsible scaffold adapted to provide radial support to the blood conduit. The pump portion also includes one or more impellers.

Abstract: Embodiments include implantable valves with attached polymeric components. In an embodiment, an implantable valve is included having a frame comprising a plurality of frame struts. The frame defines a central lumen and at least one of the frame struts defines a connection aperture. The implantable valve can include at least one valve leaflet including a coaptation edge and two connection portions, with one connection portion disposed on either end of the coaptation edge. The connection portion can be disposed within the connection aperture thereby coupling the valve leaflet to the frame. Other embodiments are also included herein.

Abstract: A system and method for evaluating, altering and/or creating an opening around the heart to receive a construct. Using a minimally invasive techniques, a first guide is advanced into an area adjacent to the heart. The first guide is used to probe the area and determine if an opening can be safely formed in that area. The guide is then used to direct a larger guide catheter into the targeted area. The larger guide catheter is used to direct a more robust guide into the targeted area. The robust guide is then used to direct a delivery guide catheter into the targeted area. The delivery guide catheter can be used to stall a device deployment guide. Either the delivery guide catheter or the device deployment guide can be used to advance the construct into the targeted area.

Abstract: A device to assist the performance of a heart with at least one pump that is formed as a rotary pump and driven via a magneto coupling.

Abstract: To provide a simple embodiment of a rotor for a fluid pump which is nevertheless very flexible in handling and compressible, in accordance with the invention a conveying blade is provided having at least two struts and a membrane spanned between them in the expanded state, wherein the struts each have at least one joint, in particular more than one joint, which enables an angling in a first direction in a first movement plane and bounds an overelongation beyond an elongation angle of in particular 180° in the opposite second direction. In particular when a plurality of joints are provided at the struts, they, and with them the conveying blades, are particularly flexible for simple compressibility.

Abstract: A catheter pump includes a cannula having an inlet, an outlet, and a blood flow channel extending between the inlet and the outlet along a longitudinal axis. At least one impeller blade is operable to convey blood through the blood flow channel between the inlet to the outlet, wherein the at least one impeller blade is axially movable relative the cannula in a first direction toward the inlet and in a second direction away from the inlet.

Abstract: The present invention relates to an implantable device for improving the pump function of the heart of a human patient by applying an external force on a first position of the heart muscle following the heart's contractions. The implantable device comprising a first pump device adapted to assist the pump function of the heart. The pump device comprises a first reservoir, a second reservoir, a fluid connection adapted to fluidly connect said first reservoir with said second reservoir, such that fluid can flow between said first reservoir and said second reservoir.

Abstract: A device to assist the performance of a heart with at least one pump that is formed as a rotary pump and driven via a magneto coupling.

Abstract: A bearing assembly may be provided for mounting a rotor which can be rotated about a rotational axis. In particular, for a rotary fluid pump or rotary blood pump comprising: a main body, a bearing element which can be displaced relative to the main body in the direction of the rotational axis for receiving the rotor, and an adjusting device which is connected to the bearing element for displacing the bearing element in the direction of the rotational axis by a predefined distance, wherein the predefined distance is <=500 micrometres.

Abstract: An implantable device for improving the pump function of the heart of a human patient by applying an external force on the heart muscle. The device comprises at least one pump device comprising a heart contacting organ, an operating device for operating the heart contacting organ, and an implantable pressurized fluid system. The fluid system comprises a first implantable chamber adapted to hold a pressurized fluid, wherein said first chamber is adapted to hold a fluid having a high pressure and a second implantable chamber adapted to hold a pressurized fluid, wherein said second chamber is adapted to hold a fluid having a lower pressure. The movement of the heart contacting organ assists the pump function of the heart.

Abstract: A catheter pump includes a cannula and an impeller system. The cannula has an inlet zone with a first maximum outer diameter, an outlet zone with a second maximum outer diameter and a blood flow channel extending between the inlet zone and the outlet zone. The first maximum outer diameter is greater than the second maximum outer diameter, and the impeller system has a rotatable impeller body operable to convey blood from the inlet zone to the outlet zone. The impeller body may be axially spaced from the cannula in a separated position.

Abstract: A cardiac assist system includes a pneumatic effector which is implanted beneath a pericardial sac and over a myocardial surface overlying the patient's left ventricle. A port is implanted and receives a percutaneously introduced cannula. The port is connected to supply a driving gas received from the cannula to the pneumatic effector. An external drive unit includes a pump assembly and control circuitry which operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm. A connecting tube has a pump end connected to the pump and a percutaneous port-connecting end attached to the implantable port.

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: A system for treating a patient with a heart condition includes an atrial assist device (AAD) configured to be positioned in the patients heart to pump blood from an atrium of the patients heart into a ventricle associated with the atrium. The system also includes a controller operatively connected to the AAD and being configured to control the AAD to pump blood from the atrium of the patients heart into the ventricle associated with the atrium.

Abstract: Methods and systems are provided for the circulation of blood using a purge-free miniature pump. In one embodiment, a pump is provided that may comprise a housing including a rotor and a stator within a drive unit. In this embodiment, the pump may establish a primary blood flow through the space between the drive unit and the housing and a secondary blood flow between the rotor and stator. In another embodiment, a pump establishes a primary blood flow outside the housing and a secondary blood flow between the rotor and stator. In yet another embodiment, a method is provided for introducing the pump into the body and circulating blood using the pump.

Abstract: Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

Abstract: A controller for an implantable blood pump, the implantable blood pump having an impeller. The controller includes processing circuitry configured to reduce a speed of the impeller from a set speed to a first reduced speed if a first predetermined amount of time of detected suction events occurs during a first time interval and increase the speed of the impeller from the first reduced speed if a second predetermined amount of time or less of detected suction events occur during a second time interval and a third predetermined amount of time or less of detected suction events.

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: A non-occluding intravascular pump comprises a shroud providing an inlet for incoming blood flow and an outlet for outgoing blood flow, wherein the shroud is a cylindrical housing; an impeller positioned within shroud, wherein a central axis of the shroud and impeller are shared; a motor coupled to the impeller, wherein the motor rotates the impeller to causes blood to be drawn through the inlet and output to the outlet, and the motor is centrally disposed and shares the central axis with the shroud and the impeller; and a plurality of pillars coupling the motor to the shroud, wherein the pillars secure the shroud in close proximity to the impeller. Various design features of the pump may be optimized to reduce hemolysis, such as, but not limited to, inlet length, impeller design, pillar angle, and outlet design.