A medical valve assembly includes a tube extending between a first and second tube end along an axis, and a plunger plate extends radially from the second tube end. A valve housing surrounds the tube and includes a radially inwardly extending flange. A compression member is biased against the plunger plate and compresses an elastomeric seal from a non-compressed condition to a compressed condition to establish a sealed condition of the medical valve assembly. An inner surface of the elastomeric seal in the non-compressed condition has a plurality of planar portions and a plurality of radiused portions, with adjacent planar portions interconnected with one of the radiused portions to improve a closure of the elastomeric seal during compression. The inner surface preferably includes three planar portions and three radiused portions to define a generally triangular-shaped inner surface as viewed in cross section in the non-compressed condition.

Hemostasis valves and methods for making and using hemostasis valves are disclosed. An example hemostasis valve may include a main body having a proximal end region. A cartridge may be at least partially disposed within the proximal end region. The cartridge may include a seal member. The seal member may be designed to shift between an open configuration and a sealed configuration. A plunger, having an inner tubular region and a distal end, may be coupled to the proximal end region of the main body. The distal end of the inner tubular region may be spaced a clearance distance from a proximal end of the seal member so that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

A catheter assembly includes a flexible catheter (22), a needle (12) having a sharp distal tip, the needle (12) disposed in the flexible catheter (22) and moving from a first position that exposes the needle (12) to a second position, an outer member (26) that is configured to engage and disengage a catheter hub (14), an inner member (28) disposed in the outer member (26), and a needle protection (30) member disposed in the inner member (28), the needle protection member (30) enclosing at least a portion of the needle (12) when the needle (12) is in the second position.

A seal assembly including a septum seal, a lower seal support, an upper seal support and a return spring is disclosed. The septum seal includes an orifice and a plurality of apertures. The lower seal support includes an engagement surface configured to engage a portion of the septum seal. The upper seal support includes a plurality of fingers, wherein each of the plurality of fingers is configured to extend through a corresponding aperture of the septum seal. The return spring includes a collar portion and a plurality of spokes extending radially outward from the collar portion. At least a portion of the return spring may be sandwiched between the lower seal support and the upper seal support. The plurality of spokes is configured to bias the seal assembly toward a radial center of a housing.

A medical valve has a housing with an inlet housing and an outlet housing. The interior of the inlet housing and/or the outlet housing has a contact surface. A resilient element sits within the housing and is configured to control fluid flow through the inlet. The resilient element has a proximal portion with a normally closed aperture configured to open when actuated by a medical device. The resilient element also has a distal portion adjacent to the outlet, and a central portion between the proximal portion and the distal portion. The central portion has a wall that defines a fluid chamber in the open mode and in the closed mode. The wall has at least one projection extending radially outward. The projection is configured to maintain compressive contact with the contact surface of the housing and to apply an inwardly compressive force on the resilient element, increasing the wall stiffness.

Disclosed are a system and method for performing a medical procedure using direct percutaneous access of an aorta. A main sheath is introduced through an incision formed in proximity to the sternum, and positioned along (and preferable against) a posterior portion of the sternum. Instruments passed through the main sheath are used to form a purse-string suture in an exterior wall of the aorta. An opening is formed in the wall of the aorta in a region encircled by the purse-string suture, and a distal end of an introducer sheath is advanced through the opening into the aorta. A medical procedure, which may be a transcatheter aortic valve replacement, is performed using instruments passed through the introducer sheath into the aorta. After the medical procedure, the introducer sheath is withdrawn from the aorta and, as the introducer sheath is withdrawn, the purse-string suture is tightened to close the opening.

Introducer sheath systems including a pressure regulator operably coupled to a hemostatic valve, wherein the pressure regulator includes a chamber filled with a gas that is fluidly isolated from the hemostatic valve. The introducer sheath systems may include a tubular sheath, a hub assembly, and a dilator disposed therein connected to a proximal end of the sheath; the hub assembly including a housing and a hemostatic valve disposed therein; a pressure regulator connected to the hub and in fluid communication with the hemostatic valve; and a sealed chamber defined by the pressure regulator, the chamber having an interior, wherein the interior of the chamber is filled with a gas that is fluidly isolated from the hemostatic valve.

A medical valve assembly includes a tube extending between proximal and distal tube ends. A plunger plate extends radially from the distal tube end, and a valve housing surrounds the tube and extends between proximal and distal valve housing ends. The valve housing includes a flange extending radially inwardly from the distal valve housing end and disposed in spaced relationship with the plunger plate to define a distance dimension D extending therebetween. An elastomeric seal is compressed between the plunger plate and the flange to establish a closed condition of the medical valve assembly. The elastomeric seal axially moves one of the valve housing and the tube relative to the other when a medical device is inserted into the medical valve assembly to automatically increase the distance dimension and establish an open and sealed condition of the medical valve assembly with the inserted medical valve.

An introducer sheath including a valve hub and an elongate shaft extending from the valve hub. The valve hub defines a main port and a side port. The main port includes a hub body, a compressible seal disposed within the hub body, a pusher at least partially positioned within the hub body and slidably movable relative thereto, and a lock nut surrounding the pusher. The lock nut is threadably engaged with the hub body such that rotation of the lock nut moves the pusher axially toward and/or away from the compressible seal.

A valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator including a shaft portion at a distal end of the valve actuator that is configured to pierce the valve, a mating portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region that connects the shaft portion and the mating portion, and a plurality of windows that extend through the valve actuator for flushing fluid, the plurality of windows being disposed in the diameter reduction region, wherein each of the plurality of windows does not extend a full length of the diameter reduction region.