Abstract: Systems and methods for assessment and management of adverse event risks in mechanical circulatory support patients are described herein. The method for post-operative risk mitigation in patients with an implanted Ventricular Assist Device (VAD) can include receiving a plurality of features relating to an attribute associated with the patient and ingesting at least some of the features into a multistate model. The multistate model can include a plurality of states, each corresponding to a patient condition. The method can include generating with the multistate model a daily prediction of a likelihood of the patient developing at least one of the conditions corresponding to the plurality of states in a predetermined time period, and controlling a user interface to output an indicator of the likelihood of the patient developing the at least one of the conditions in the predetermined time period.

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: A method of coupling components of a catheter pump assembly includes providing an elongate polymeric tubular body having a proximal end and a distal end, and also providing a metallic tubular body having a proximal portion and a distal portion. The method further includes positioning a mechanical interface having a first interface zone and a second interface zone such that the first interface zone is disposed over a portion of the elongate polymeric tubular body adjacent to the distal end thereof. The method also includes flowing the polymer into the first interface zone, whereby the elongate polymeric tubular body becomes joined with the first interface zone of the mechanical interface, and coupling the metallic tubular body with the second interface zone of the mechanical interface.

Abstract: A catheter pump includes a catheter body having at least one lumen therethrough, and comprising a distal end and a proximal end. An expandable impeller assembly includes an expandable impeller and an expandable cannula coupled to the distal end of the catheter body and housing the expandable impeller, the expandable cannula comprising a substantially straight segment having a distal inlet and a proximal outlet, the substantially straight segment configured to straddle an aortic valve. The catheter body comprises a proximal vessel contact zone and a distal vessel contact zone that are each proximal to the substantially straight segment, the proximal vessel contact zone and distal vessel contact zone configured to provide a force against an aortic arch to stabilize the expandable impeller assembly across the aortic valve.

Abstract: A catheter system includes a catheter, a recovery sheath, and an outer sheath assembly. The catheter includes an elongate body having an expandable medical device coupled with a distal end thereof. The recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein. The recovery sheath is axially movable relative to the catheter body. The outer sheath assembly includes an outer sheath disposed over the catheter body. The outer sheath includes an elongate body that extends from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath. The outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration. The outer sheath is removable from the catheter body.

Abstract: An oxygenator and method for oxygenating blood. The oxygenator includes a housing, an oxygenation chamber, and elongated gas permeable conduits that extend across the oxygenation chamber. The blood flow enters and contacts with exterior surfaces of the conduits and exits the oxygenator to transfer of oxygen from within the conduits to the blood flow and transfer carbon dioxide from the blood flow into the elongated gas permeable conduits. The housing includes a gas inlet and is configured to distribute a gas flow received through the gas inlet to the elongated gas permeable conduits so as to a first portion of the gas flow flows through a first set of the elongated gas permeable conduits in a first direction and a second portion of the gas flow flows through a second set of the elongated gas permeable conduits in a second direction that is opposite to the first direction.

Abstract: Systems and related methods for supplying power to an implantable blood pump are provided. A system includes a base module and a plurality of energy storage devices. A first energy storage device is operatively coupled to the base module. A second energy storage device is operatively coupled to the first modular energy storage device. The energy storage devices are mechanically coupled in series, electrically coupled in parallel, and configured to provide redundant sources of power to drive an implantable blood 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 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: 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: 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: 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: 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: 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. The catheter pump system can include a motor assembly, the motor assembly comprising a chamber and a shaft-driving portion disposed in the chamber. The shaft-driving portion can be configured to impart rotation to the impeller through the shaft assembly. The chamber can be filled with a gas that at least partially surrounds the shaft-driving portion. A fluid pathway can convey fluid proximally during operation of the catheter pump system. A bypass pathway can be in fluid communication with the fluid pathway, the bypass pathway configured to direct at least a portion of the fluid to bypass the chamber.

Abstract: A catheter pump is disclosed. The catheter pump can include an impeller and a catheter body having a lumen in which waste fluid flows proximally therethrough during operation of the catheter pump. The catheter pump can also include a drive shaft disposed inside the catheter body. A motor assembly can include a chamber. The motor assembly can include a rotor disposed in the at least a portion of the chamber, the rotor mechanically coupled with a proximal portion of the drive shaft such that rotation of the rotor causes the drive shaft to rotate, the rotor including a longitudinal rotor lumen therethrough. The motor assembly can also comprise a stator assembly disposed about the rotor. During operation of the catheter pump, the waste fluid flows from the lumen into the chamber such that at least a portion of the waste fluid flows proximally through the longitudinal rotor lumen.

Abstract: A blood pump system includes a pump housing and an impeller for rotating in a pump chamber within the housing. The impeller has a first side and a second side opposite the first side. The system includes a stator having drive coils for applying a torque to the impeller and at least one bearing mechanism for suspending the impeller within the pump chamber. The system includes a position control mechanism for moving the impeller in an axial direction within the pump chamber to adjust a size of a first gap and a size of a second gap, thereby controlling a washout rate at each of the first gap and the second gap. The first gap is defined by a distance between the first side and the housing and the second gap is defined by a distance between the second side and the pump housing.

Abstract: Devices, systems and methods are provided for targeted treatment of a variety of conditions, particularly conditions that are associated with or influenced by the nervous system, such as pain. Targeted treatment of such conditions is provided with minimal deleterious side effects, such as undesired motor responses or undesired stimulation of unaffected body regions. This is achieved by directly neuromodulating a target anatomy associated with the condition while minimizing or excluding undesired neuromodulation of other anatomies.

Abstract: A system and method are provided for determining a pressure associated with a lumen of a body. A wireless sensor is positioned in the lumen of the body. The sensor comprises an LC resonant circuit having a resonant frequency configured to vary in response to changes in pressure in the lumen. One or more sensor calibration parameters are stored at an external base unit. The external based unit generates and transmits an energizing signal. A ring down response is received from the wireless sensor. The system and method determine the resonant frequency of the LC resonant circuit from the ring down response and calculate the pressure in the lumen from the resonant frequency of the LC resonant circuit utilizing the one or more sensor calibration parameters associated with the LC resonant circuit.

Abstract: The invention generally relates to improved medical blood pump devices, systems, and methods. For example, blood pumps may be provided that include a housing defining a blood flow path between an inlet and an outlet. A rotor may be positioned in the blood flow path. A motor stator may be driven to rotate the rotor to provide the blood flow through the pump. Axial and/or tilt stabilization components may be provided to increase an axial and/or tilt stabilization of the rotor within the blood flow path. In some embodiments, biasing forces are provided that urge the rotor toward a bearing component. The biasing force may be provided by adjusting drive signals of the motor stator. Additionally, or alternatively, one or more magnets (e.g., permanent/stator magnets) may be provided to bias the rotor in the upstream and/or downstream direction (e.g., toward a bearing (chamfer, step, conical), or the like).