Vascular introducer having hemostatic valve with integral seal

A vascular introducer system, comprising:

• (a) a proximal hub portion which defines an interior bore and an outer engagement surface;
• (b) an elongated sheath extending distally from the hub portion and defining a lumen in communication with the interior bore of the hub portion;
• c) a hemostatic valve operably disposed within the bore of the proximal hub portion and defining a passage extending therethrough, the hemostatic valve including a sealing flap and a distal end wall, the sealing flap having a convex portion movable between an open position relative to the passage and a closed position relative to the passage, the distal end wall defining a concave seat opposite the sealing flap, wherein a majority surface portion of the concave seat and a majority surface portion of the convex portion of the sealing flap are configured to complement and arcuately align with one another to enhance a seal formed therebetween in the closed position;
• d) a dilator having a proximal end and a distal tapered end configured to enter a blood vessel, the dilator longitudinally translatable through the lumen of the elongated sheath and the interior bore of the hub portion;
• and
• e) a locking collar attached to the proximal end of the dilator and configured to engage the outer engagement surface of the proximal hub portion.

A vascular introducer comprising:

• a) a proximal hub portion which defines an interior bore and an outer engagement surface, the interior bore configured to receive a dilator having a proximal end and a distal end, the outer engagement surface configured to engage a locking collar coupled to the proximal end of the dilator;
• b) an elongated sheath extending distally from the hub portion and having a lumen in communication with the interior bore of the hub portion;
• c) a hemostatic valve disposed within the bore of the hub portion and having a passage extending therethrough, the hemostatic valve including a convexly contoured sealing flap and a distal end wall, the sealing flap movable between an open position relative to the passage and a closed position relative to the passage, the distal end wall defining a concave seat opposite the sealing flap, wherein a majority surface portion of the concave seat and a majority surface portion of the sealing flap are configured to complement and arcuately align with one another to enhance a seal formed therebetween in the closed position;
• and
• d) a seal member located proximal to the hemostatic valve.

A method of inserting a vascularly introduced medical device, comprising the steps of:

• (a) providing a vascular introducer comprising:
• i) a proximal hub portion which defines an interior bore and an outer engagement surface, the interior bore configured to receive a dilator having a proximal end and a distal end, the outer engagement surface configured to engage a locking collar coupled to the proximal end of the dilator;
• ii) an elongated sheath configured to receive the dilator and extending distally from the hub portion, the sheath having a lumen in communication with the interior bore of the hub portion;
• and
• iii) a hemostatic valve disposed within the bore of the hub portion and having a passage extending therethrough, the hemostatic valve including a sealing flap and a distal end wall, the sealing flap having a convex portion movable between an open position relative to the passage and a closed position relative to the passage, the distal end wall defining a concave seat opposite the sealing flap, wherein a majority surface portion of the concave seat and a majority surface portion of the convex portion of the sealing flap are configured to complement and arcuately align with one another to enhance a seal formed therebetween in the closed position;
• (b) inserting a needle into a blood vessel of a patient in a desired location;
• (c) inserting a guidewire through the needle cannula to a desired depth;
• (d) withdrawing the needle from the desired location, leaving the guidewire protruding through the blood vessel and skin of the patient;
• (e) threading the vascular introducer and dilator over the guide wire;
• (f) removing the dilator and guidewire, leaving the sheath of the introducer protruding through the skin into the blood vessel;
• (g) introducing the medical device into the sheath;
• (h) advancing the medical device to the desired location;
• and
• (i) removing the sheath, thereby leaving the medical device disposed within the blood vessel of the patient.