Abstract: An intravascular blood pump has an intake filter that reduces risk of heart tissue being sucked into an intake port of the pump. The filter defines a plurality of apertures, through which blood flows through the filter. The apertures are sized to prevent ingestion, by the input port, of the heart tissue. The filter includes a plurality of generally helical first struts wound about a longitudinal axis of the filter, and a plurality of second struts. The first and second struts collectively define the plurality of apertures therebetween. The struts may be woven filaments, or the apertures may be defined in a thin film (foil) tube, where remaining material between the apertures form the struts.

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, methods, and devices that provide an expandable sheath assembly for insertion of an interventional medical device (e.g., an intracardiac heart pump) into a blood vessel through a vessel aperture. The assembly may have an elongate sheath body having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The sheath body may have a first layer, wherein the first layer is a liner defining the lumen. The sheath body may have a second layer disposed over the first layer, wherein the second layer is a patterned structure. The sheath body may have a third layer disposed over the second layer. The elongate sheath body may include a slit through the second layer and the third layer, wherein the slit extends along at least a portion of the elongate sheath body. A first portion of the elongate sheath body may overlap a second portion of the elongate sheath body along the slit to form a fold.

Abstract: A web-based interface enables medical personnel to remotely monitor medical devices. A monitoring system records operational data and alarms from the medical devices in a file. However, since network connections between the medical devices and the monitoring system are intermittent, the file does not contain a contiguous stream of data for each medical device. The file pauses recording during gaps in network connectivity. The system displays current data, as well as a list of alarms. If medical personnel wish to view more detail about an earlier time or one of the alarms, the system calculates where in the file the medical device data was recorded. This calculation accounts for the discontiguous nature of the data. The system uses times the network connection is made and broken to calculate an index into the file that corresponds to the time of the user-selected alarm.

Abstract: An adapter for securing a catheter may include a housing composed of a first and second housing part and a locking mechanism, as well as a first flexible seal coupled to the first and second housing parts. The adapter has an “open” configuration where the first flexible seal is capable of being repositioned axially along a first catheter, cannula, or sheath having a first outer diameter. The adapter also has a “closed” configuration where the first flexible seal is incapable of being repositioned axially along the first catheter, cannula, or sheath without substantially deforming the first catheter, cannula, or sheath. The first flexible seal is configured to circumferentially surround an axial portion of only the first catheter, cannula, or sheath. The adapter can be coupled to a sheath hub to prevent at least axial motion of the adapter relative to the sheath hub.

Abstract: A device and method are provided for minimizing and/or preventing limb ischemia, such as when a medical device is inserted into a patient’s vasculature that may occlude the vessel. The device may include a tubular member and one or more radially expandable features, such as balloons and/or hydrostatic skeletons, configured to be expanded at a target site, allowing blood to flow around and/or through the radially expandable features.

Abstract: A device and method are provided for minimizing and/or preventing limb ischemia, such as when a medical device inserted into a patient's vasculature occludes the vessel. The device may include a tubular member and a first anchor configured to hold a position of the tubular member relative to a vessel. The first anchor is configured to appose an internal wall of the vessel. A second anchor may cooperate with the first anchor to hold the position of the tubular member relative to the vessel.

Abstract: A device and method are provided for minimizing and/or preventing limb ischemia, such as when a medical device inserted into a patient’s vasculature occludes the vessel. The device may include a tubular member and one or more expandable features having metal wires disposed around the tubular member, the one or more wires disposed around the tubular member configured to be expanded at a target site, allowing blood to flow around and past any potentially occluding medical device.

Abstract: An expandable sheath body for a sheath assembly. The sheath body has a tubular frame having a lumen therein. The frame has interstices therein. The frame is expandable to a larger diameter and contractable to a smaller diameter, and also flexible. The sheath body has an inner liner formed over a surface of the lumen defined by the tubular frame and an outer liner formed over an exterior surface of the frame. The inner liner and an inner layer of a multilayer outer liner may be made of expanded polytetrafluoroethylene. The expanded polytetrafluoroethylene may be infused with silicone oil for increased lubricity.

Abstract: Methods and apparatus for determining whether a circulatory support device is correctly positioned in a heart of a patient are provided. The method comprises receiving a motor current signal from a motor of the circulatory support device, receiving a pressure signal from a pressure sensor arranged on the circulatory support device, generating a normalized motor current signal based, at least in part, on the pressure signal, determining a pulsatility of the normalized motor current signal, determining whether the circulatory support device is correctly positioned in the heart of the patient based, at least in part, on the pulsatility of the normalized motor current signal, and outputting an alarm when it is determined that the circulatory support device is not correctly positioned in the heart of the patient.

Abstract: A perfusion sheath with covered perfusion apertures. The covers each have a pull affixed thereto. The pull is used to remove a perfusion aperture cover from a perfusion aperture when the perfusion sheath is deployed in a patient. The perfusion sheath is deployed in the patient through an arteriotomy. When deployed the pull or pulls extend out of the arteriotomy. Exerting a tension on the pulls causes the pull to tear away the perfusion aperture cover from the perfusion aperture. The perfusion sheath has a plurality of perfusion apertures, each positioned to provide limb perfusion, when the cover is removed for different depths of arteriotomy. Once the perfusion sheath is deployed, the pull is tensioned to remove the cover from a selected perfusion aperture that will provide limb perfusion for the depth of the arteriotomy.

Abstract: We provide herein a method of preventing or limiting the effects of heart failure in a human patient that has sustained myocardial infarction by reducing maladaptive cardiac remodeling in the patient. The method comprises percutaneously inserting a transvalvular blood pump, comprising a rotor and a cannula, into the patient's vasculature and positioning the cannula across the aortic valve of the patient's heart, with a distal end of the cannula located in the left ventricle of the heart and a proximal end of the pump located in the aorta. The method then comprises, prior to reperfusing the heart, operating the positioned pump to unload the left ventricle at a pumping rate of at least 2.5 L/min of blood flow for a support period between at least 30 minutes and less than 60 minutes. Then, after the support period, the method comprises applying coronary reperfusion therapy to the heart.

Abstract: An integrated sheath assembly for inserting a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.

Abstract: An expandable introducer sheath with an interlock dilator. The present technology provides an expandable sheath with a step feature inside its distal opening, and a dilator with an interlock that includes a catch surface configured to engage with the step feature and resist further relative movement so that the body of the dilator is prevented from exiting the distal end of the expandable sheath. This interlocking engagement may allow the dilator to be used to extend and maintain tension on the expandable sheath during insertion into a patient, and then to be retracted from the expandable sheath by pulling the dilator in the opposite direction. The present technology also provides a dilator hub with a spring mechanism configured to achieve and maintain a desired tension on the expandable sheath and to prevent overextension of the expandable sheath when the dilator is being inserted into the expandable sheath.

Abstract: Devices, system, and methods are provided based on a technique for purging a blood pump. The technique may include providing a blood pump having an impeller and providing a fluid comprising a bicarbonate. The technique may include flowing the fluid through a first gap between a bearing and an outer surface of a rotatable shaft coupled to the impeller, the bearing and gap being disposed within a lumen of a tubular member and depending on the flow rate of the fluid and the speed of the impeller, the fluid may flow through the first gap and into a second gap between the bearing and a surface of the impeller facing the bearing. The bicarbonate reduces denaturation and adsorption of any blood proteins in the gap(s).

Abstract: Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump, the peel-away sheath assembly including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly. The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. A first layer material and a third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner notches, outer notches, or both inner notches and outer notches. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: Support devices and/or support blocks are provided that support medical devices, such as access devices, at an desired orientation relative to a patient's body. Support blocks may include a bottom surface and a top surface, where the top surface may be configured to be substantially at an angle (such as 5-30 degrees) relative to the bottom surface. The top and/or bottom surface may have a connection mechanism configured to allow the support block to connect with at least one additional support block. The connection mechanism may be, e.g.