Abstract: The present invention relates to an attachment device having a sewing ring frame and a locking element mounted on the sewing ring frame. The locking mechanism includes a flange element projecting from the outer surface of the sewing ring frame and a retractable locking pin projecting towards the interior of the sewing ring frame. The flange is coupled to the locking pin and the biasing element. The locking mechanism is transitionable between a locked configuration in which the locking pin is in an engaged position to an unlocked configuration in which the locking pin is in a disengaged position.

Abstract: A method of determining a presence of suction in a patient having an implantable blood pump from down-sampled log files. The method comprising calculating a waveform index for each of a plurality of flow rate data points from the down-sampled log files. The calculated waveform index is compared with a predetermined waveform index threshold. A non-suction trough baseline is calculated from the plurality of flow rate data points. A difference between a measured trough and a calculated non-suction trough baseline is compared with a predetermined threshold. The presence of suction for each of the plurality of flow rate data points is determined if the calculated waveform index is greater than the predetermined waveform index threshold and the difference between the measured trough and a calculated non-suction trough baseline is greater than the predetermined threshold.

Abstract: A kit including a sheath having a tubular body with proximal and distal ends, an axis extending between the ends and a wall defining a bore extending along the axis to the distal end of the body. A delivery tube having proximal and distal ends and a lumen is adapted for disposition within the bore of the sheath in sealing engagement with the sheath, the delivery tube being slideable distally relative to the sheath. An elongated cannula having proximal and distal ends and a lumen is adapted for disposition inside the lumen of the delivery tube and an elongated dilator is adapted to fit within the lumen of the cannula with a proximal portion of the dilator extending proximally beyond the proximal ends of the cannula and delivery tube and in sealing engagement with the delivery tube proximal to the cannula.

Abstract: A control circuit for controlling a pump speed of a blood pump implanted in a patient including a processor in communication with the implanted blood pump, the processor having processing circuitry configured to reduce a pump speed relative to a standard set speed based on a timing of a systole phase of the patient, the systole phase including a first segment during which a ventricular pressure is at its greatest and a second segment occurring after the first segment during which the ventricular pressure is at its lowest, the pump speed being reduced during the second segment.

Abstract: A method of determining a heart rate of a patient having an implanted blood pump including applying a voltage to a plurality of coils of a stator of the blood pump to produce an electromagnetic force to rotate a rotor in communication with the plurality of coils; displaying a waveform associated with a back electromotive force in the plurality of coils of the blood pump, the waveform being proportional to an axial position of the rotor relative to the stator; determining a time interval between a first alteration in the waveform relative to a baseline and a second alteration in the waveform relative to the baseline; and determining the heart rate of the patient based on the time interval.

Abstract: A remote controller updating system for an implantable blood pump including an implantable blood pump, an implantable controller coupled to the implantable blood pump, and a pump driveline including a data network connection in communication with the implantable controller. The system may also include a pump connector coupled to the pump driveline, a remote controller couplable to the implantable blood pump, and a system update assembly including a system update connector couplable to the pump connector and a power source coupled to the system update connector.

Abstract: An apparatus for starting operation of a motor of an implantable blood pump including a memory storing one or more default parameters for at least one of controlling and monitoring the startup operation. A processor operatively coupled to the motor is included, the processor is configured to: commence the startup operation based on the one or more default parameters; detect an error during the startup operation; adjust at least one of the one or more default parameters in response to the detected error; store the at least one adjusted parameter in the memory; and commence subsequent startup operations based at least in part on the at least one adjusted parameter.

Abstract: An implantable blood pump including an impeller, at least a portion of the impeller being composed of a metal alloy that is a solid at normal body temperature and is configured to phase change to a liquid between a predetermined temperature above normal body temperature and about 40 degrees Celsius.

Abstract: A method of operating an implantable blood pump having a first stator, a second stator, and an impeller movably disposed there between. The method includes applying a first voltage waveform at first phase to the first stator to generate a magnetic field to rotate the impeller. A second voltage waveform is applied at a second phase shifted from the first phase to the second stator to rotate the impeller, the second voltage waveform is asymmetric to the first voltage waveform.

Abstract: An attachment device has a sewing ring frame and a locking mechanism movably mounted on the sewing ring frame. The locking mechanism includes a biasing element projecting from the outer surface of the sewing ring frame and a slide substantially co-planar to the sewing ring frame. The slide further includes a first mating member. Additionally, the locking mechanism includes at least one guide member overlapping the slide and a locking pin disposed between the slide and the sewing ring frame. The biasing element is movably coupled to the locking pin and the slide and is transitionable between a first configuration in which the first mating member is in a disengaged position to a second configuration in which the first mating member is in an engaged position.

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 blood pump includes a tube including an inner wall, and wherein during operation of the blood pump, the impeller rotates within the tube and a distance between the inner wall of the tube and the thrust bearing decreases as a speed of the impeller increases.

Abstract: A control circuit for a sensorless implantable blood pump configured to determine mitral valve regurgitation includes processing circuitry configured to generate an estimated blood flow waveform from the sensorless implanted blood pump and generate an alert if between an end period of diastole and a beginning period of systole a measured amplitude of the estimated blood flow waveform does not include an inflection point.

Abstract: A blood pump including a housing having an inflow tube defining a major axis spanning through the inflow tube and a flow path spanning along the major axis, a rotor disposed within the inflow tube, the rotor and the inflow tube defining a gap therebetween, a stator surrounding the inflow tube and the rotor, and the housing defining an access conduit spanning through the inflow tube and the stator transverse to the major axis, the access conduit being in communication with the gap.

Abstract: A controller for an implantable blood pump including processing circuitry in communication with the implantable blood pump and configured to generate at least one preventative alert.

Abstract: A method of determining a mean arterial pressure index of a patient having an implantable blood pump including determining a pump speed and a pump flow value; analyzing the pump speed and the pump flow value to a pump loss constant value; determining a graft hydraulic resistance value during a systolic phase of a cardiac cycle based on the analysis of the pump speed and the pump flow value to the pump loss constant value; determining a mean arterial pressure index during a diastolic phase of the cardiac cycle based on the determined graft hydraulic resistance value; comparing the mean arterial pressure index of the patient to a mean arterial pressure index range; and generating an alert when the mean arterial pressure index varies with respect to a mean arterial pressure index range.

Abstract: An inflow cannula for an implantable blood pump having an impeller defining a plurality of flow channels, the inflow cannula includes a proximal end a distal end proximate the impeller, the distal end including a protuberance extending outward from the inflow cannula.

Abstract: A method of responding to an adverse event associated with an implantable blood pump including detecting the adverse event, reducing a pump speed of the blood pump relative to a set pump speed in response to the detected adverse event, and determining whether at least one of a group consisting of the adverse event and a second adverse event is present following the reducing of the pump speed of the blood pump. If the at least one of the group consisting of the adverse event and a second adverse event is not present, the method includes increasing the pump speed to the set pump speed and if the at least one of the group consisting of the adverse event and a second adverse event is present while increasing the pump speed to the set pump speed, the method includes reducing the pump speed to a maximum safe operating speed.

Abstract: An inflow cannula for an implantable blood pump, the inflow cannula defining an inlet at a proximal end, an opposite distal end, and a lumen therebetween, the inflow cannula being configured to constrict the lumen.

Abstract: A connection system for an implantable blood pump including a pump housing having an impeller disposed therein and a motor housing including a motor disposed therein, the motor housing spaced a distance from the pump housing. A flexible outer sheath couples the pump housing to the motor housing, the outer sheath defining a maximum total length between 7 and 10 centimeters. An inner shaft is coaxial with the outer sheath and couples the motor to the impeller.