Passive hemostatic sheath valve

A bifurcated medical introducer sheath comprising:

• a bifurcated tubular shaft having a first proximal end, a second proximal end, and one distal end;
• a first hemostasis valve positioned within the first proximal end of the tubular shaft;
• a second hemostasis valve positioned within the second proximal end of the tubular shaft;
• a first valve cartridge positioned within the first proximal end of the tubular shaft;
• and
• a second valve cartridge positioned with the second proximal end of the tubular shaft.

A method for creating a hemostatic seal around a medical instrument, the method comprising:

• providing a passive valve housed within an introducer sheath, the valve including:
• a valve body having an upstream end and a downstream end, the valve body defining a lumen having an inner and outer surface therethrough;
• wherein the lumen comprises an hourglass configuration having a funnel-shaped upstream lumen that converges inwardly and a funnel-shaped downstream lumen that diverges outwardly, the upstream and downstream lumens intersecting at a sealing aperture configured nominally to remain open;
• wherein the upstream end includes an upstream annulus region having at least one slit or slot;
• wherein the downstream end includes a downstream annulus region;
• wherein each annulus region and lumen outer surface define at least one chamber;
• and
• traversing the instrument through the valve, the at least one slit or slot transmitting pressure from the upstream end through the upstream annulus region so as to allow a fluid to enter the at least one chamber to equalize pressure on the upstream and downstream ends of the valve body and to enhance the hemostatic seal around the instrument.

A method for assembling a medical device, the method comprising:

• providing an introducer sheath;
• housing a passive valve within the introducer sheath, the valve including:
• a valve body having an upstream end and a downstream end, the valve body defining a lumen having an inner and outer surface therethrough;
• wherein the lumen comprises an hourglass configuration having a funnel-shaped upstream lumen that converges inwardly and a funnel-shaped downstream lumen that diverges outwardly, the upstream and downstream lumens intersecting at a sealing aperture configured nominally to remain open;
• wherein the upstream end includes an upstream annulus region having at least one slit or slot;
• wherein the downstream end includes a downstream annulus region;
• wherein each annulus region and lumen outer surface define at least one chamber;
• providing a medical instrument;
• and
• positioning the instrument through the valve, the at least one slit or slot transmitting pressure from the upstream end through the upstream annulus region so as to allow a fluid to enter the at least one chamber to equalize pressure on the upstream and downstream ends of the valve body and to enhance the hemostatic seal around the instrument.