Abstract: A percutaneously insertable blood pump assembly comprises a pump section, a catheter attached to a proximal end of the pump section, a first apertured section distal to the pump section and in fluid communication therewith, a cannula affixed to and in fluid communication with the first apertured section, and a second apertured section distal to the cannula and in fluid communication therewith. One of the first and second apertured section is a blood outlet from the cannula. The blood outlet has a body portion, an apertured portion, and a ring portion. The plurality of struts in the apertured portion extend from and join the body portion to the ring portion. The struts are asymmetric along at least a portion of their length from the body portion of the outlet to the ring portion of the outlet.

Abstract: A heart pump assembly includes an impeller blade coupled to a rotor or a drive shaft, a cannula, a distal projection coupled to a distal end of the cannula and a blood inlet having a plurality of apertures. The plurality of apertures is radially oriented and disposed about a circumference of the cannula. The plurality of apertures includes at least a first ring of apertures which are proximal to the distal projection and a second ring of apertures which are proximal of the first ring of apertures. The plurality of apertures can allow the heart pump assembly to continue to function if anatomical structures or tissue become suctioned to a portion of the heart pump.

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 sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: A heart pump assembly, also referred to as catheter assembly, having a desired anatomical shape is provided. The catheter assembly can include a catheter and a cannula having a bend between a proximal portion and a distal portion. A resting shape of the catheter and the cannula can be selected to allow the distal cannula portion to be positioned at a desired angle relative to an anatomical plane (e.g., a plane of an aortic arch). In some embodiments, a packaging tray can be designed to set the catheter assembly in a desired resting shape. For example, the proximal cannula portion can be positioned at a first angle relative to the catheter, and the proximal cannula portion can be positioned at a second angle out of the plane of the packaging tray via one or more inserts.

Abstract: A heart pump assembly includes an impeller blade coupled to a rotor or a drive shaft, a cannula, a distal projection coupled to a distal end of the cannula and a blood inlet having a plurality of apertures. The plurality of apertures is radially oriented and disposed about a circumference of the cannula. The plurality of apertures includes at least a first ring of apertures which are proximal to the distal projection and a second ring of apertures which are proximal of the first ring of apertures. The plurality of apertures can allow the heart pump assembly to continue to function if anatomical structures or tissue become suctioned to a portion of the heart pump.

Abstract: A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: A heart pump assembly, also referred to as catheter assembly, having a desired anatomical shape is provided. The catheter assembly can include a catheter and a cannula having a bend between a proximal portion and a distal portion. A resting shape of the catheter and the cannula can be selected to allow the distal cannula portion to be positioned at a desired angle relative to an anatomical plane (e.g., a plane of an aortic arch). In some embodiments, a packaging tray can be designed to set the catheter assembly in a desired resting shape. For example, the proximal cannula portion can be positioned at a first angle relative to the catheter, and the proximal cannula portion can be positioned at a second angle out of the plane of the packaging tray via one or more inserts.

Abstract: A heart pump assembly includes an impeller blade coupled to a rotor or a drive shaft, a cannula, a distal projection coupled to a distal end of the cannula and a blood inlet having a plurality of apertures. The plurality of apertures is radially oriented and disposed about a circumference of the cannula. The plurality of apertures includes at least a first ring of apertures which are proximal to the distal projection and a second ring of apertures which are proximal of the first ring of apertures. The plurality of apertures can allow the heart pump assembly to continue to function if anatomical structures or tissue become suctioned to a portion of the heart pump.

Abstract: A sheath assembly for the insertion of a percutaneous pump includes a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture. The tubular sheath body includes a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion. The first lumen is dimensioned to allow passage of a portion of the percutaneous pump, and the second lumen is dimensioned for passage of a guidewire. A stylet is removably positioned to substantially occlude the second lumen. The stylet has a proximal end releasably secured to the sheath assembly.

Abstract: The systems, devices, and methods presented herein use a blood pump to obtain measurements of cardiac function. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as aortic pressure or motor current, then calculate and display one or more cardiac parameters and heart function parameters, such as left ventricular pressure, left ventricular end diastolic pressure, or cardiac power output. These parameters provide valuable information to a user regarding current cardiac function, as well as positioning and function of the blood pump. In some embodiments, the system can act as a diagnostic and therapeutic tool.

Abstract: A method for controlled purging of a blood pump and a blood pump assembly for implementing the method are provided. The blood pump is in fluid communication with a purging device. The purging device comprises a purge reservoir and a supplemental reservoir configured to be fluidically connected to the blood pump. The purge reservoir is configured to receive a purge fluid and the supplemental reservoir configured to receive a supplemental purge fluid. At least a portion of the blood pump is inserted into a patient and operated. A flow of the purge fluid is provided from the purge reservoir to the blood pump. A purge flow parameter at the blood pump is measured using a measuring device and when it is determined by a controller that the purge flow parameter meets a predetermined threshold, a remediation protocol is identified.

Abstract: A heart pump assembly having a blood inlet configured to increase blood flow into the heart pump assembly is disclosed herein. The heart pump assembly includes a motor housing, a cannula connected to the motor housing, and a blood inlet connected to the cannula. The blood inlet has a distal body portion, a proximal body portion defining an inlet conduit therewithin, and a plurality of cage openings defined and positioned between the distal and proximal body portions. The inlet conduit has one of a tapered portion, a frustrum-shaped portion, or both a tapered portion and a frustrum-shaped portion and is adapted to reduce flow turbulence at the blood inlet and increase the blood flow into the heart pump.

Abstract: The systems, devices, and methods presented herein use a blood pump to obtain measurements of cardiac function. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as aortic pressure or motor current, then calculate and display one or more cardiac parameters and heart function parameters, such as left ventricular pressure, left ventricular end diastolic pressure, or cardiac power output. These parameters provide valuable information to a user regarding current cardiac function, as well as positioning and function of the blood pump. In some embodiments, the system can act as a diagnostic and therapeutic tool.

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 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: 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: 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: 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 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.