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 introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.

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 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: 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 introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.

Abstract: Expandable introducer sheaths and associated laser cut frames for the insertion of a medical device into a blood vessel. In some examples, an expandable sheath may have a frame including a plurality of radial expansion bands and a plurality of connecting bridges for connecting adjacent radial expansion bands. The radial expansion bands are configured to accommodate radial expansion and the plurality of connecting bridges are configured to be longitudinally expandable and to impart column strength as a medical device (e.g., an intracardiac heart pump) is passed through the sheath, such as during insertion or removal of the medical device.

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: 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: An integrated sheath assembly for inserting f 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 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: 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 hemostasis valve body provides strong sealing around a medical device during insertion of the medical device into a blood vessel, low forces for tearing, and stability during insertion of the medical devices as well as during peel away. The valve body comprises a first surface, a second surface opposite the first surface, an edge, helical slits, and a pair of longitudinal cuts. The helical slits are positioned at a center of the valve body and traverse the first surface to the second surface. The helical slits provide a seal around the medical device. Each respective longitudinal cut extends from the first surface partially through the valve body to a depth short of the second surface for at least part of a length of the respective longitudinal cut. The longitudinal cuts facilitate a separation of the valve body into two parts during a peel away action.

Abstract: A hemostasis valve body provides strong sealing around a medical device during insertion of the medical device into a blood vessel, low forces for tearing, and stability during insertion of the medical devices as well as during peel away. The valve body comprises a first surface, a second surface opposite the first surface, an edge, helical slits, and a pair of longitudinal cuts. The helical slits are positioned at a center of the valve body and traverse the first surface to the second surface. The helical slits provide a seal around the medical device. Each respective longitudinal cut extends from the first surface partially through the valve body to a depth short of the second surface for at least part of a length of the respective longitudinal cut. The longitudinal cuts facilitate a separation of the valve body into two parts during a peel away action.

Abstract: An introducer sheath assembly for percutaneously delivering a medical device that maintains hemostasis in a patient. The assembly has a hub, a hub cap and a hemostasis valve. The introducer sheath assembly has a longitudinal axis and a lumen formed therein. The hemostasis valve has a frame portion and a valve portion, the valve portion having a plurality of slits that are offset through the thickness of the valve portion therein and an extension of the frame portion formed from an incompressible material. The extension of the frame portion is received by a valve seat feature in the hub, when the valve is received by the hub. The valve seat feature also receives a seating portion of the hub cap as the hub and hub cap are advanced into engagement, the seating portion of the hub cap advanced into the valve seat feature subjecting the incompressible extension of the frame portion to a compressive force.

Abstract: An intravascular system includes an introducer sheath with fixed-diameter lumen, a medical device, and a catheter with a proximal end and a distal end coupled to the first medical device. When the catheter is positioned within the introducer sheath, an annular gap is formed between an exterior circumference of the catheter and an inner circumference of the lumen. The catheter is configured to take different dimensional configurations, such that the sizes of the catheter and the annular gap are variable. The variability of the size of the catheter allows another medical device to pass through the annular gap within the lumen. The catheter may change configurations passively as the second medical device is passed adjacently or by an active mechanism under a physician's control.

Abstract: There is provided an introducer system for percutaneously delivering a first and a second medical device to a patient. The system may comprise an introducer sheath having a longitudinal axis and a lumen formed therein. The system may also comprise a bifurcated hub coupled to a proximal end of the sheath. The hub may comprise a first arm having a first lumen and a first hemostasis valve for the passage of the first medical device. The hub may also comprise a second arm coupled to the first arm and having a second lumen and a second hemostasis valve for the passage of the second medical device. Further, the hub may comprise a connection port such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath for the passage of at least one of the first and second medical devices through the introducer sheath for delivery to the patient.

Abstract: There is provided an introducer system for percutaneously delivering a first and a second medical device to a patient. The system may comprise an introducer sheath having a longitudinal axis and a lumen formed therein. The system may also comprise a hub coupled to a proximal end of the sheath. The hub may comprise a first arm having a first lumen and a first hemostasis valve for the passage of the first medical device. The hub may also comprise a second arm coupled to the first arm and having a second lumen and a second hemostasis valve for the passage of the second medical device. Further, the hub may comprise a connection port such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath for the passage of at least one of the first and second medical devices through the introducer sheath for delivery to the patient.

Abstract: An introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.