Passive hemostatic sheath valve

A passive valve for creating a hemostatic seal around a medical instrument, the valve configured to be removably housed within an introducer sheath, the valve comprising:

• 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 defining at least one opening;
• wherein the downstream end includes a downstream annulus region;
• and
• wherein each annulus region and lumen outer surface define at least one chamber, the at least one opening transmitting pressure from the upstream end through the upstream annulus region.

A passive valve for creating a hemostatic seal around a medical instrument, the valve being removably housed within an introducer sheath, the valve comprising:

• 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 a conical configuration having a funnel-shaped downstream lumen;
• wherein the upstream end includes an upstream annulus region defining at least one opening, wherein a sealing aperture is positioned between the upstream annulus region and the downstream lumen;
• wherein the downstream end includes a downstream annulus region;
• and
• wherein each annulus region and lumen outer surface define at least one chamber, the at least one opening transmitting pressure from the upstream end through the upstream annulus region.

A medical introducer sheath comprising:

• a tubular shaft having a proximal end and a distal end;
• a passive hemostatic valve removably positioned within the proximal end of the tubular shaft, 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 and a sealing aperture configured nominally to remain open;
• wherein the upstream end includes an upstream annulus region defining at least one opening;
• wherein the downstream end includes a downstream annulus region;
• and
• wherein each annulus region and lumen outer surface define at least one chamber, the at least one opening 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 a hemostatic seal around an instrument;
• and
• a valve cartridge disposed between the upstream annulus region and the downstream annulus region and removably positioned within the proximal end of the tubular shaft.

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

• providing a passive valve removably 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 opening;
• 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 opening 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 opening;
• 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 opening 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.