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: Systems and methods for intermittently occluding a patient's venous vasculature to unload the heart while increasing cardiac output and improving perfusion to the patient's heart is provided. The system may include first and second balloon catheters that may be selectively actuated to intermittently occlude first and second veins for increasing venous vascular resistance in the patient's lower and upper extremities, respectively, to thereby selectively reduce arterial blood flow to the lower and upper extremities, while maintaining arterial vascular resistance of the patient's heart and central organs and increasing perfusion to the patient's heart and central organs.

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 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 system for insertion into a vasculature of a patient is disclosed. The system utilizes a primary tubular sheath body coupled to a distal portion of an intermediate tubular sheath body, and a hub coupled to a proximal portion of the intermediate tubular sheath. The hub may be couplable to a dilator via an interaction between a dilator cap and the hub, and the hub may contain a hemostatic valve with a foam member having one or more visibly identifiably regions.

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.