Apparatus and methods for administration of reconstituted medicament

Apparatus for reconstituting a medicament in a vial with a liquid from a syringe, the apparatus comprising:

• a body portion defining an interior cavity and having first, second, and third fluid ports communicating with the interior cavity, the body portion further defining a body lumen extending through the body portion so as to be fluidly isolated from the interior cavity, and fourth and fifth fluid ports communicating with each other bidirectionally through the body lumen;
• a fitting on the first fluid port configured to receive a syringe;
• a fluid regulating element located within the interior cavity and configured to be selectively movable among (a) a first position in which fluid communication through the interior cavity is blocked, (b) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (c) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports;
• an adapter assembly fixed to the body portion and configured for removable attachment of a medicament vial so that the vial is in fluid communication with the second fluid port and the fourth fluid port;
• and
• an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and the fourth fluid port.

A method for reconstituting a medicament contained in a vial with a liquid from a syringe, the method comprising:

• (a) providing a medicament reconstituting apparatus, comprising:
• a device body defining an interior cavity;
• first, second, and third fluid ports communicating with the interior cavity;
• a body lumen extending through the body so as to be isolated from the interior cavity;
• and fourth and fifth fluid ports communicating with each other through the body lumen;
• a fluid regulating element located within the interior cavity and configured to be selectively movable among (i) a first position in which fluid communication through the interior cavity is blocked, (ii) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (iii) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports;
• and
• an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and fourth fluid port;
• (b) with the fluid regulating element in the first position, engaging the syringe containing the liquid with the device body so as to be in fluid communication with the first fluid port, and engaging the vial with the device body so as to be in fluid communication with the second and fourth fluid ports;
• (c) moving the fluid regulating element to the second position;
• (d) injecting the liquid from the syringe into the vial through the first fluid port, the interior cavity, and the second fluid port to create a reconstituted medicament;
• (e) withdrawing the reconstituted medicament from the vial into the syringe through the second fluid port, the interior cavity, and the first fluid port;
• (f) moving the fluid regulating element to the third position;
• and
• (g) expelling the reconstituted medicament from the syringe out of the device body through the first fluid port, the interior cavity, and the third fluid port.