Methods and apparatus for diluting medicinal substances

Abstract

In certain embodiments, a vial adaptor for removing liquid contents from a vial includes a piercing member and a bag. The bag can be contained within the piercing member such that the bag is introduced to the vial when the vial adaptor is coupled with the vial. In some embodiments, the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial. In other embodiments, a vial includes a bag for regulating pressure within the vial as liquid is removed therefrom. In some embodiments, a vial adaptor is coupled with the vial in order to remove the liquid. In some embodiments, as the liquid is removed from the vial via the adaptor, the bag expands within the vial, and in other embodiments, the bag contracts within the vial.

1 . A method of adding a diluent to a medicinal substance within a sealed vial via a pressure regulating vial adaptor, the method comprising:
 connecting a pressure regulating vial adaptor to the sealed vial, wherein at least a portion of a regulator channel and at least a portion of an extractor channel pass through the pressure regulating vial adaptor;   connecting a syringe containing a diluent to the pressure regulating vial adaptor;   depressing a plunger of the syringe to urge the diluent through the pressure regulating vial adaptor and into the sealed vial; and   after depressing the plunger, permitting the plunger of the syringe to back out of the syringe until pressure within the sealed vial is substantially equal to ambient pressure;   wherein an enclosure is in fluid communication with the regulator channel, and the enclosure is configured to move between a first orientation in which at least a portion of the enclosure is at least partially unexpanded or folded and a second orientation in which at least a portion of the enclosure is at least partially expanded or unfolded when a medicinal fluid is withdrawn from the sealed vial via the extractor channel of the pressure regulating vial adaptor.   
     
     
         2 . The method of  claim 1 , wherein the medicinal substance comprises a powder or a concentrated liquid. 
     
     
         3 . The method of  claim 1 , wherein the diluent that flows from the syringe into the sealed vial passes through the extractor channel. 
     
     
         4 . The method of  claim 1 , wherein the fluid that flows from the sealed vial into the syringe passes through the extractor channel. 
     
     
         5 . The method of  claim 1 , wherein the pressure regulating vial adaptor comprises a piercing member connected to the housing member, and the enclosure is at least partially disposed within the piercing member. 
     
     
         6 . The method of  claim 1 , wherein the pressure within the sealed vial is regulated by allowing the enclosure to expand or unfold in order to substantially equilibrate pressure on opposite sides of the enclosure as the medicinal fluid is withdrawn from the sealed vial. 
     
     
         7 . The method of  claim 1 , wherein the enclosure 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 enclosure. 
     
     
         8 . An apparatus for adding diluent to a medicinal substance within a sealed vial, the apparatus comprising:
 a pressure regulating vial adaptor configured to couple to a sealed vial, the pressure regulating vial adaptor comprising:
 a housing member through which at least a portion of a regulator channel and at least a portion of an extractor channel pass; 
 an enclosure in fluid communication with the regulator channel, wherein the enclosure is configured to move between a first orientation in which at least a portion of the enclosure is at least partially unexpanded or folded and a second orientation in which at least a portion of the enclosure is at least partially expanded or unfolded when a medicinal fluid is withdrawn from the sealed vial via the extractor channel of the pressure regulating vial adaptor; and 
 a medical connector interface in fluid communication with the extractor channel, wherein the medical connector interface is configured to couple to a syringe containing a diluent and having a plunger configured to urge the diluent through the pressure regulating vial adaptor and into sealed vial when the pressure regulating vial adaptor is coupled to the sealed vial; 
   wherein the pressure regulating vial adaptor is configured such that, after the diluent is urged into the sealed vial using the plunger, fluid flows from the sealed vial into the syringe until pressure within the sealed vial is substantially equal to ambient pressure.   
     
     
         9 . The apparatus of  claim 8 , wherein the medicinal substance comprises a powder or a concentrated liquid. 
     
     
         10 . The apparatus of  claim 8 , wherein the diluent that flows from the syringe into the sealed vial passes through the extractor channel. 
     
     
         11 . The apparatus of  claim 8 , wherein the fluid that flows from the sealed vial into the syringe passes through the extractor channel. 
     
     
         12 . The apparatus of  claim 8 , wherein the pressure regulating vial adaptor comprises a piercing member connected to the housing member, and the enclosure is at least partially disposed within the piercing member. 
     
     
         13 . The apparatus of  claim 8 , wherein the pressure within the sealed vial is regulated by allowing the enclosure to expand or unfold in order to substantially equilibrate pressure on opposite sides of the enclosure as the medicinal fluid is withdrawn from the sealed vial. 
     
     
         14 . The apparatus of  claim 8 , wherein the enclosure 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 enclosure. 
     
     
         15 . A method of manufacturing an apparatus for adding diluent to a medicinal substance within a sealed vial, the method comprising:
 providing a pressure regulating vial adaptor configured to couple to the sealed vial, wherein a method of manufacturing the pressure regulating vial adaptor comprises:
 providing a housing member through which at least a portion of a regulator channel and at least a portion of an extractor channel pass; 
 placing an enclosure in fluid communication with the regulator channel, wherein the enclosure is configured to move between a first orientation in which at least a portion of the enclosure is at least partially unexpanded or folded and a second orientation in which at least a portion of the enclosure is at least partially expanded or unfolded when a medicinal fluid is withdrawn from the sealed vial via the extractor channel of the pressure regulating vial adaptor; and 
 placing a medical connector interface in fluid communication with the extractor channel, wherein the medical connector interface is configured to couple to a syringe containing a diluent and having a plunger configured to urge the diluent through the pressure regulating vial adaptor and into sealed vial when the pressure regulating vial adaptor is coupled to the sealed vial; 
   wherein the pressure regulating vial adaptor is configured such that, after the diluent is urged into the sealed vial using the plunger, fluid flows from the sealed vial into the syringe until pressure within the sealed vial is substantially equal to ambient pressure.   
     
     
         16 . The method of  claim 15 , wherein the medicinal substance comprises a powder or a concentrated liquid. 
     
     
         17 . The method of  claim 15 , wherein the diluent that flows from the syringe into the sealed vial passes through the extractor channel. 
     
     
         18 . The method of  claim 15 , wherein the fluid that flows from the sealed vial into the syringe passes through the extractor channel. 
     
     
         19 . The method of  claim 15 , wherein the pressure regulating vial adaptor comprises a piercing member connected to the housing member, and the enclosure is at least partially disposed within the piercing member. 
     
     
         20 . The method of  claim 15 , wherein the pressure within the sealed vial is regulated by allowing the enclosure to expand or unfold in order to substantially equilibrate pressure on opposite sides of the enclosure as the medicinal fluid is withdrawn from the sealed vial. 
     
     
         21 . The method of  claim 15 , wherein the enclosure 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 enclosure.