Abstract: Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

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: Methods and systems of maintaining, evaluating, and providing therapy to a lung ex vivo. The methods and systems involve positioning the lung in an ex vivo perfusion circuit; circulating a perfusion fluid through the lung, the fluid entering the lung through a pulmonary artery interface and leaving the lung through a left atrial interface; and ventilating the lung by flowing a ventilation gas through a tracheal interface. Maintaining the lung for extended periods involves causing the lung to rebreath a captive volume of air, and reaching an equilibrium state between the perfusion fluid and the ventilation gas. Evaluating the gas exchange capability of the lung involves deoxygenating the perfusion fluid and measuring a time taken to reoxygenate the perfusion fluid by ventilating the lung with an oxygenation gas.

Abstract: An expandable sheath for use in an intravascular blood pump. The sheath has a sheath frame surrounded by one or more sleeves. The frame may have at least one of a braid, a wound wire, and a laser-cut material. The sheath frame may be a metal that is at least one of Nitinol and stainless steel. The sleeves may be made of one or more plastics. The expandable sheath is manufactured by surrounding the sheath frame with the sleeves and heating the sleeves and the frame around a mandrel. The frame and sleeves are heated in multiple steps, along multiple areas of the sheath, and to different temperatures and for different time periods. The temperatures at which the sheath is heated, and the time periods over which the sheath is heated, are selected such that after heating, the materials of the plastic sleeves penetrate the sheath frame to various depths.

Abstract: A persistent perfusion sheath assembly can be used for the passage of an intravascular medical device while maintain a flow passage in the vessel. The sheath assembly passes through an arteriotomy and can include a first lumen configured for the passage of a medical device, a second lumen configured to allow a flow of fluid from a location in the blood vessel upstream of the arteriotomy to a location downstream of the arteriotomy. The sheath assembly can further include a stylet, a sleeve or an additional sheath configured to selectively open and close the flow of blood between upstream and downstream of the arteriotomy. The sheath assembly can further include a closure device distal of the arteriotomy, the closure device configured to control blood flow through the arteriotomy.

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: Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

Abstract: Various systems and devices, such as sheaths configured for antegrade and retrograde insertion into a patient's vasculature, are provided, to aid in preventing limb ischemia resulting from use of mechanical circulatory support. Such systems and devices may include various combinations of hubs, sheaths, and needle designs to allow, e.g., multiple medical devices to be inserted into a patient's vasculature, while minimizing blockage of the blood vessels.

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: Systems and methods are provided for insertion of a medical device into a blood vessel. The system may include a sheath assembly with an introducer sheath and a variable size repositioning sheath. The variable size repositioning sheath may be configured to be adjustable in size in a radial direction and to be inserted into the blood vessel or an expandable introducer sheath. In some aspects, the system may include an intracardiac device such as a blood pump with an elongate catheter.

Abstract: A positioning device for maintaining positioning of an introducer hub relative to a repositioning sheath or catheter may be provided. The positioning devices may include a first coupler, a second coupler configured to be removably coupled to a portion of a repositioning sheath or catheter that is proximal to the first coupler, and a portion extending between the first coupler and the second coupler, the extension bridge configured to maintain a fixed axial distance between the introducer hub and a proximal end of the repositioning sheath or catheter. A flexible hinge may be incorporated, where a medical device would be configured to pass through the second coupler, the flexible hinge, and the first coupler.

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: 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: 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: 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: A persistent perfusion sheath assembly can be used for the passage of an intravascular medical device while maintain a flow passage in the vessel. The sheath assembly passes through an arteriotomy and can include a first lumen configured for the passage of a medical device, a second lumen configured to allow a flow of fluid from a location in the blood vessel upstream of the arteriotomy to a location downstream of the arteriotomy. The sheath assembly can further include a stylet, a sleeve or an additional sheath configured to selectively open and close the flow of blood between upstream and downstream of the arteriotomy. The sheath assembly can further include a closure device distal of the arteriotomy, the closure device configured to control blood flow through the arteriotomy.

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: A persistent perfusion sheath assembly can be used for the passage of an intravascular medical device while maintain a flow passage in the vessel. The sheath assembly passes through an arteriotomy and can include a first lumen configured for the passage of a medical device, a second lumen configured to allow a flow of fluid from a location in the blood vessel upstream of the arteriotomy to a location downstream of the arteriotomy. The sheath assembly can further include a stylet, a sleeve or an additional sheath configured to selectively open and close the flow of blood between upstream and downstream of the arteriotomy. The sheath assembly can further include a closure device distal of the arteriotomy, the closure device configured to control blood flow through the arteriotomy.