Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal end and the distal end, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: A blood pump with a stator and rotor wherein the rotor is assembled by bonding the stator components with epoxy. The bonding surfaces of the rotor components are primed with a silane-based primer to improve adhesion between the primer and the rotor components by rendering such surfaces hydrophobic. A bonding surface of one of the stator yoke or the stator sleeve, or both, is treated with a primer that improves wettability of the bonding surface and improves bonding of the epoxy to the binding surface. The device has a bonding surface adhered to epoxy in which a primer was applied on such bonding surface prior to introducing epoxy onto the bonding surface. In addition to improved bond strength, hydrophobic surface would control moister ingress.

Abstract: Systems and methods for providing a blood pump system having a variable stiffness distal extension are disclosed. A variable stiffness distal extension may have at least one section of continuously varying stiffness, resulting in a stiffness profile that decreases in a distal direction along a length of the distal extension. The varying stiffness may be accomplished by varying one or more radial dimensions of the extension. For example, in some implementations, an outer diameter of a distal extension may decrease along at least a portion of a distal extension. The distal extension may include a lumen configured to receive a longitudinally extending element.

Abstract: In one aspect, the invention relates to one or more rotatable elements and one or more stationary element such that the elements are arranged along a common axis of rotation co-linear with or substantially parallel to an optical path. The optical path is a portion of a sample arm of an interferometer. Further, the rotatable and stationary elements are configured to couple electrical signals and optical signals between a data collection probe and an interface unit or other component of an imaging system. In one embodiment, the data collection probe is a combination ultrasound and OCT probe. In one aspect, the invention relates to a rotary joint in which the optical fiber and a fiber optic rotary joint lie in the center of one or more conductive elements of an electrical rotary joint which are annularly disposed around one or both of the optical fiber and optical rotary joint.

Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal and the distal ends, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: A blood pump with a stator and rotor wherein the rotor is assembled by bonding the stator components with epoxy. The bonding surfaces of the rotor components are primed with a silane-based primer to improve adhesion between the primer and the rotor components by rendering such surfaces hydrophobic. A bonding surface of one of the stator yoke or the stator sleeve, or both, is treated with a primer that improves wettability of the bonding surface and improves bonding of the epoxy to the binding surface. The device has a bonding surface adhered to epoxy in which a primer was applied on such bonding surface prior to introducing epoxy onto the bonding surface. In addition to improved bond strength, hydrophobic surface would control moister ingress.

Abstract: Systems and methods for providing a blood pump system having a variable stiffness distal extension are disclosed. A variable stiffness distal extension may have at least one section of continuously varying stiffness, resulting in a stiffness profile that decreases in a distal direction along a length of the distal extension. The varying stiffness may be accomplished by varying one or more radial dimensions of the extension. For example, in some implementations, an outer diameter of a distal extension may decrease along at least a portion of a distal extension. The distal extension may include a lumen configured to receive a longitudinally extending element.

Abstract: Steerable catheter assemblies, such as, steerable intracardiac blood pump assemblies are provided.

Abstract: Catheters for catheter assemblies, such as, intracardiac blood pump assemblies are provided with improved torque transmission capabilities.

Abstract: Disclosed are devices, systems, and techniques for evaluating position support for a medical device. The method includes performing a movement evaluation of one or more extremities of a patient associated with the medical device, determining, using at least one computer processor, passive movement of one or more muscles of the patient during the movement evaluation, and determining a fixation plan for fixing at least a portion of the medical device to one or more anatomical tissues of the patient based, at least in part, on the passive movement of the one or more muscles.

Abstract: A method of operating a blood pump that is purged with a purge solution that contains a pH controlling and buffering agent combined with aqueous dextrose and a reduced amount of heparin or no heparin. The blood pump has a gap between a shaft and housing through which the purge solution flows. In operation, the purge solution exits the housing and is discharged into the patient. The purge solution is therefore required to perform lubricating and heat transfer functions in the pump yet be biocompatible with the patient.

Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: A plug for a blood pump may be provided. The plug may include a housing. A central optical ferrule, coaxial with a central axis of the housing, may extend partially through the housing. A first end of the central optical ferrule may be an axial distance from an outer surface at a first end of the housing. The plug may include a plurality of electrical pins, each pin disposed parallel to the central axis and independently at a radial distance from the central axis. Each electrical pin may have an end extending through the housing and extending beyond the first end of the central optical ferrule. The plug may include additional optical ferrule(s) extending at least partially though the housing. Each additional ferrule being parallel to the central axis and disposed at a radial distance from the central axis.

Abstract: A blood pump with a stator and rotor wherein the rotor is assembled by bonding the stator components with epoxy. The bonding surfaces of the rotor components are primed with a silane-based primer to improve adhesion between the primer and the rotor components by rendering such surfaces hydrophobic. A bonding surface of one of the stator yoke or the stator sleeve, or both, is treated with a primer that improves wettability of the bonding surface and improves bonding of the epoxy to the binding surface. The device has a bonding surface adhered to epoxy in which a primer was applied on such bonding surface prior to introducing epoxy onto the bonding surface. In addition to improved bond strength, hydrophobic surface would control moister ingress.

Abstract: A graft system may be provided. The graft system may include a graft, a hemostasis valve operably coupled to a proximal end of the graft, and a clamp disposed around the proximal end of the graft and configured to hold the hemostasis valve in place relative to the graft. The graft may include a woven or knitted fabric. The clamp may be removably, or permanently, attached to the graft. The hemostasis valve may include a slit membrane disposed within a housing. The hemostasis valve may include an introducer sheath coupled to the housing. The housing may include two portions coupled together along two axial seams, each axial seam extending from a proximal end to a distal end of the hemostasis valve. A grommet may be coupled to an end of the graft.

Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: In one aspect, the invention relates to one or more rotatable elements and one or more stationary element such that the elements are arranged along a common axis of rotation co-linear with or substantially parallel to an optical path. The optical path is a portion of a sample arm of an interferometer. Further, the rotatable and stationary elements are configured to couple electrical signals and optical signals between a data collection probe and an interface unit or other component of an imaging system. In one embodiment, the data collection probe is a combination ultrasound and OCT probe. In one aspect, the invention relates to a rotary joint in which the optical fiber and a fiber optic rotary joint lie in the center of one or more conductive elements of an electrical rotary joint which are annularly disposed around one or both of the optical fiber and optical rotary joint.

Abstract: In one aspect, the invention relates to one or more rotatable elements and one or more stationary element such that the elements are arranged along a common axis of rotation co-linear with or substantially parallel to an optical path. The optical path is a portion of a sample arm of an interferometer. Further, the rotatable and stationary elements are configured to couple electrical signals and optical signals between a data collection probe and an interface unit or other component of an imaging system. In one embodiment, the data collection probe is a combination ultrasound and OCT probe. In one aspect, the invention relates to a rotary joint in which the optical fiber and a fiber optic rotary joint lie in the center of one or more conductive elements of an electrical rotary joint which are annularly disposed around one or both of the optical fiber and optical rotary joint.

Abstract: A system and method for percutaneous ventricular assist devices are provided, where the percutaneous ventricular assist devices include a pump assembly and a cannula assembly. The pump assembly includes one or more connectors at or near a distal end. The cannula assembly includes a cannula and an inflow cage, as well as a mating connector engageable with the connectors of the pump assembly such that the first cannula assembly is attachable to the pump assembly. In various embodiments, the cannula assembly may be fixedly attached or removably attached from the pump assembly.

Abstract: Disclosed is a system and method for supporting and monitoring mechanical blood pumps in use with a subject. The system includes (i) a mechanical blood pump; (ii) sensors configured to detect a movement and a physiological condition of the subject; and (iii) one or more processors. The one or more processors may be configured to enable the adjustment of the support provided by the blood pump, such as via the following steps: (i) receiving input from the one or more sensors; (ii) determining an activity type, an activity intensity, or both an activity type and intensity based on the input; (iii) determining a value representative of cardiac recovery based on the input and the determined activity type, intensity, or both type and intensity; and (iv) generating a response based on the determinations and/or the received input.