Multiple Dose Vial and Method

Abstract

A vial for storing multiple doses of a substance to be dispensed into one or more syringes or other delivery devices. The vial has a body, a storage chamber within the body for storing multiple doses of the substance therein, a sterile filter configured to sterilize air or other gas flowing into the storage chamber through the filter, and a one-way valve connectable in fluid communication with a syringe or other delivery device. The one-way valve is moveable relative to the body between first and second positions (i) one of which permits the valve to open so that substance from the storage chamber can flow therethrough and into the syringe or other delivery device connected in fluid communication therewith, and (ii) one of which prevents the valve from opening.

1 . A device comprising:
 a body;   a storage chamber defined within the body for storing substance therein;   a sterile filter coupled in fluid communication between the storage chamber and ambient atmosphere, and configured to allow air or other gas to flow from the ambient atmosphere therethrough into the storage chamber, and to sterilize air or other gas flowing into the storage chamber through the filter; and   a one-way valve connected or connectable in fluid communication with substance in the storage chamber and configured to allow fluid to flow in one direction therethrough but prevent ingress of fluid in an opposite direction, wherein the one-way valve is moveable between first and second positions, and further having a closed position preventing substance from passing therethrough and an open position permitting substance to pass therethrough;   wherein, in the first position, the one-way valve is prevented from opening from the closed position into the open position, so that substance cannot pass through the one-way valve at any time in the first position, and in the second position the one-way valve is permitted to open into the open position, so that substance from the storage chamber may flow through and out of the one-way valve.   
     
     
         2 . A device as defined in  claim 1 , wherein the one-way valve includes an elastic valve member a normally closed, valve seam that substantially prevents the passage of fluid therethrough when a pressure differential across the valve is less than a valve opening pressure, and allows the passage of fluid therethrough when a pressure differential across the valve exceeds the valve opening pressure when the one-way valve is in the second position. 
     
     
         3 . A device as defined in  claim 2 , wherein the one-way valve includes a valve seat, and the elastic valve member engages the valve seat and forms the valve seam therebetween. 
     
     
         4 . A device as defined in  claim 3 , wherein one or more of (i) the elastic valve member defines a progressively decreasing wall thickness in a direction from an inlet toward an outlet of the valve seam, or (ii) the valve seat defines a progressively increasing width or diameter in a direction from an inlet toward an outlet of the valve seam. 
     
     
         5 . A device as defined in  claim 1 , further including a penetrable and resealable portion in fluid communication with the storage chamber that is penetrable by a needle, filling or injection member to form a penetration aperture therein for introducing substance into the storage chamber and is hermetically resealable to hermetically seal the penetration aperture. 
     
     
         6 . A device as defined in  claim 5 , wherein the penetrable and resealable portion is resealable by one or more of a liquid sealant or the application of radiation or energy thereto. 
     
     
         7 . A device as defined in  claim 1 , further comprising a connector located downstream of an outlet of the one-way valve, wherein the connector is adapted for connection thereto by a syringe or other delivery device. 
     
     
         8 . A device as defined in  claim 7 , wherein the connector is a Luer connector. 
     
     
         9 . A device as defined in  claim 1 , wherein the one-way valve is normally biased in a direction from the second position toward the first position. 
     
     
         10 . A device as defined in  claim 9 , further including a spring that normally biases the one-way valve in a direction from the second position toward the first position. 
     
     
         11 . A device as defined in  claim 10 , wherein the spring is formed integral with the valve member. 
     
     
         12 . A device as defined in  claim 1 , wherein (i) in the first position, the one- way valve is engaged with a surface of the device that substantially prevents the one-way valve from opening into the open position, and (ii) in the second position, the one-way valve is sufficiently disengaged from the surface of the device to permit the valve to open into the open position. 
     
     
         13 . A device as defined in  claim 12 , wherein the one-way valve includes a valve seat and a valve member normally engaging the valve seat to define the closed position, the valve member being movable relative to the valve seat when a pressure differential across the one-way valve exceeds a valve opening pressure thereof when the one-way valve is in the second position, and in the first position, the surface of the device substantially prevents movement of the valve member relative to the valve seat, and in the second position, the valve member is sufficiently disengaged from the surface to permit movement of the valve member relative to the valve seat. 
     
     
         14 . A device as defined in  claim 13 , wherein the valve seat and valve member are moveable together relative to the surface of the device between the first and second positions. 
     
     
         15 . A device as defined in  claim 13 , wherein the surface of the device engageable with the valve member extends substantially annularly about the valve member. 
     
     
         16 . A device as defined in  claim 13 , further comprising a connector located downstream of an outlet of the one-way valve, wherein the connector is adapted for connection thereto by a syringe or other delivery device, and connection of the syringe or other delivery device causes the valve to move in a direction from the first position to the second position. 
     
     
         17 . A device as defined in  claim 16 , wherein the connector defines the surface of the device engageable with the valve member in the first position. 
     
     
         18 . A device as defined in  claim 16 , wherein the valve seat is configured so that the syringe or other delivery device engages the valve seat when connected to the device and moves the valve in a direction from the first position toward the second position. 
     
     
         19 . A device as defined in  claim 16 , wherein the connector is a Luer connector. 
     
     
         20 . A device as defined in  claim 19 , wherein the connector a male or female Luer connector adapted to connect to a respectively corresponding female or male Luer connector of the syringe or other delivery device. 
     
     
         21 . A device as defined in  claim 20 , wherein the Luer connector is a threaded or slip fit Luer connector. 
     
     
         22 . A device as defined in  claim 1 , wherein the sterile filter includes a micro-filter. 
     
     
         23 . A device as defined in  claim 1 , wherein the base end comprises a base closure sealingly enclosing the body at the base end thereof, and the base closure includes the penetrable and resealable portion and the sterile filter. 
     
     
         24 . A device as defined in  claim 1 , defining a first end and a second end opposite the first end relative to the storage chamber, wherein the one-way valve is located substantially at the first end and the sterile filter is located substantially at the second end. 
     
     
         25 . A device as defined in  claim 24 , further including a penetrable and resealable portion located substantially at the second end, wherein the penetrable and resealable portion is in fluid communication with the storage chamber, is penetrable by a needle, filling or injection member to form a penetration aperture therein for introducing substance into the storage chamber, and is hermetically resealable to hermetically seal the penetration aperture. 
     
     
         26 . A device comprising:
 first means for storing substance therein;   second means for moving between first and second positions, for allowing substance to flow through the first means in one direction therethrough and preventing ingress of substance in an opposite direction, and for preventing substance from passing through the second means in a closed position and for permitting substance to pass through the second means in an open position;   third means for preventing the second means from opening into the open position in the first position, and for permitting the second means to open into the open position in the second position; and   fourth means for being in fluid communication between the first means and ambient atmosphere, for allowing air or other gas to flow therethrough into the first means, and for sterilizing air or other gas flowing therethrough into the first means.   
     
     
         27 . A device as defined in  claim 26 , further comprising fifth means for penetrating with a needle, filling or injection member, for forming a penetration aperture therein with the needle, filling or injection member, for introducing substance into the first means, and for hermetic resealing to hermetically seal the penetration aperture. 
     
     
         28 . A device as defined in  claim 26 , wherein the first means is a body defining a storage chamber therein, the second means is a one-way valve, the third means is a surface of one or more of a body of the device or the connector that is engageable with the one-way valve in the first position, the fourth means is a sterile filter, and the fifth means is a penetrable and resealable portion. 
     
     
         29 . A method comprising:
 i. storing substance in a storage chamber of a device, the device further comprising:
 a sterile filter coupled in fluid communication between the storage chamber and ambient atmosphere, and configured to allow air or other gas to flow from the ambient atmosphere therethrough into the storage chamber, and to sterilize air or other gas flowing into the storage chamber through the filter; and 
 a one-way valve connected or connectable in fluid communication with substance from the storage chamber and configured to allow fluid to flow in one direction therethrough but prevent ingress of fluid in an opposite direction, wherein the one-way valve is moveable between first and second positions, and further having a closed position preventing substance from passing therethrough and an open position permitting substance to pass therethrough, wherein, in the first position, the one-way valve is prevented from opening from the closed position into the open position, so that substance cannot pass through the one-way valve at any time in the first position, and in the second position the one-way valve is permitted to open into the open position, so that substance from the storage chamber may pass through and out of the one-way valve; 
   ii. moving the one-way valve from the first position to the second position;   iii. in the second position, moving the valve from the closed position to the open position;   vi. passing substance from the storage chamber through the one-way valve;   v. flowing air or other gas from ambient atmosphere into the storage chamber through the sterile filter; and   vi. sterilizing the air or other gas flowing through the sterile filter into the storage chamber.   
     
     
         30 . A method as defined in  claim 29 , wherein step (iii) includes generating a pressure differential across the one-way valve that exceeds a valve opening pressure thereof. 
     
     
         31 . A method as defined in  claim 29 , wherein the one-way valve includes a valve seat and a valve member normally engaging the valve seat to define a closed position, the valve member being movable relative to the valve seat when a pressure differential across the one-way valve exceeds a valve opening pressure thereof to define an open position, and step (ii) includes moving the valve seat and valve member together relative to a surface of the device between the first and second positions. 
     
     
         32 . A method as defined in  claim 29 , further including preventing the one-way valve from opening from the closed position to the open position in the first position by engaging the one-way valve with a surface of the device. 
     
     
         33 . A method as defined in  claim 32 , wherein step (ii) includes sufficiently disengaging the one-way valve from the surface of the device to permit the valve to open into the open position. 
     
     
         34 . A method as defined in  claim 33 , wherein the one-way valve includes a valve seat and a valve member normally engaging the valve seat to define the closed position, the valve member being movable relative to the valve seat when a pressure differential across the one-way valve exceeds a valve opening pressure thereof when the one-way valve is in the second position, the preventing step includes engaging the valve member with the surface of the device and substantially preventing movement of the valve member relative to the valve seat, and step (ii) includes sufficiently disengaging the valve member from the surface of the device to permit movement of the valve member relative to the valve seat. 
     
     
         35 . A method as defined in  claim 29 , wherein the storage chamber and substance are sterile or aseptic, and the method further comprises maintaining the substance in the storage chamber sterile or aseptic at least throughout steps (i) through (vi). 
     
     
         36 . A method as defined in  claim 29 , wherein step (ii) comprises engaging the one-way valve with the syringe or other delivery device. 
     
     
         37 . A method as defined in  claim 29 , wherein the device defines a first end and a second end opposite the first end relative to the storage chamber, wherein the one-way valve is located substantially at the first end and the sterile filter is located substantially at the second end. 
     
     
         38 . A method as defined in  claim 34 , wherein the device further comprises a penetrable and resealable portion located substantially at the second end and in fluid communication with the storage chamber, and the method further comprises: penetrating the penetrable and resealable portion with a needle, filling or injection member; introducing substance through the needle, filling or injection member and into the storage chamber; and hermetically resealing a resulting penetration aperture in the penetrable and resealable portion. 
     
     
         39 . A method as defined in  claim 29 , further comprising preventing germs, contaminants, air, or other gas from entering the device through the one-way valve. 
     
     
         40 . A method as defined in  claim 29 , further comprising biasing the one-way valve in a direction from the second position toward the first position. 
     
     
         41 . A method as defined in  claim 29 , further comprising connecting a syringe or other delivery device in fluid communication with the one-way valve and performing step (ii) with the syringe or other delivery device, and performing step (iii) by creating at least a partial vacuum in the syringe or other delivery device and generating a pressure differential across the one-way valve that exceeds a valve opening pressure thereof.