Patent ID: 8512307
Filing Date: 2013-08-20
Classification: A61J,A61M,Y10S,Y10T

Abstract:
1. A method of manufacturing a pressure regulating device for use with a vial, the method comprising: providing a connector configured to couple the device with a vial; providing a piercing member having a sheath extending from a base of the piercing member, the piercing member configured to be inserted into the vial when then device is coupled with the vial; forming an extractor comprising a generally rounded aperture and a groove disposed along a sidewall of the sheath, wherein the extractor is positioned within a region spaced from the base of the piercing member, wherein the groove has an elongate dimension extending distally form the aperture, and wherein the aperture has a width that is greater than a width of the groove; attaching a bag to the connector, the bag configured to be expanded or unfolded; and positioning the bag to move from a first orientation substantially unexpanded or folded to a second orientation at least partially expanded or unfolded; wherein the bag comprises a layer that is substantially impermeable to a medicinal fluid disposed within the vial, thereby impeding the passage of said medicinal fluid between an outer surface and an inner surface of the bag; and wherein the device regulates the pressure in the vial such that, as the medicinal fluid is withdrawn from the vial, the bag will expand or unfold in order to substantially equilibrate pressure on opposite sides of the bag.