Device with co-molded closure, one-way valve and variable-volume storage chamber, and related method

Abstract

A device includes a first part having a co-molded first support, valve cover and elastic actuator, and a second part having an injection molded second support, valve seat, and variable-volume storage chamber pre-form. The pre-form is blow molded into a flexible pouch defining the variable-volume storage chamber. The one-way valve includes a semi-annular, curvilinear, relatively rigid valve seat defining axially-extending, opposing first marginal portions, and an axially-extending first mid-portion angularly extending between the opposing first marginal portions. A flexible valve member is superimposed on the valve seat and defines axially-extending, opposing second marginal portions fixedly secured on or adjacent to respective first marginal portions of the valve seat, and an axially-extending second mid-portion angularly extending between the opposing first marginal portions and superimposed onto the first mid-portion of the valve seat. The flexible valve cover and valve seat form a normally closed axially and angularly extending valve seam therebetween.

1 - 43 . (canceled). 
     
     
         44 . A closure for a device, comprising:
 a base including a valve seat, and configured to sealingly engage an open end of a device to form a fluid tight seal therebetween and thereby close the device; and   a support configured to sealingly engage the base to form a fluid tight seal therebetween, wherein the support is movable between a first position in which the support does not sealingly engage the base, and a second position in which the support sealingly engages the base;   wherein the support includes a flexible or elastic valve member configured to engage the valve seat when the support is engaged with the base in the second position, and form a one-way valve defining a normally closed valve opening and a hermetic seal between the valve seat and the valve member;   wherein the valve member is movable between the normally closed position and an open position with at least a portion of the valve member spaced away from the normally closed position to allow passage of fluid through the valve opening;   wherein the one-way valve is configured (a) to define an interference fit between the valve member and the valve seat, and/or (b) so that segments of the valve member sequentially move between the normally closed and open positions when fluid moves through the valve opening to maintain the hermetic seal.   
     
     
         45 . A closure as defined in  claim 44 , wherein the valve opening defines an axially-extending valve opening. 
     
     
         46 . A closure as defined in  claim 44 , wherein the valve seat is a rigid valve seat. 
     
     
         47 . A closure as defined in  claim 44 , further comprising (i) a pump configured to pump substance through the one-way valve or (ii) a compression chamber and a manually-engageable actuator coupled to the compression chamber, wherein the actuator is moveable between a rest position and an actuated position for pressurizing substance within the compression chamber and, in turn, dispensing fluid through the one-way valve. 
     
     
         48 . A closure as defined in  claim 44 , further comprising a penetrable portion configured to receive therethrough a filling or injection member for sterile filling therethrough. 
     
     
         49 . A closure as defined in  claim 48 , the penetrable portion containing a penetration aperture therein, and further comprising a liquid sealant overlying the penetration aperture formed in the penetrable portion for hermetically sealing the penetration aperture. 
     
     
         50 . A closure as defined in  claim 49 , wherein the liquid sealant is a silicone. 
     
     
         51 . A closure as defined in  claim 49 , wherein the liquid sealant is at least partially within a recess defined by the closure. 
     
     
         52 . A device, comprising:
 a closure including a first support and a flexible valve cover;   a second support including a valve seat and a storage chamber pre-form that has been blow molded into an expanded shape forming a flexible pouch defining a variable-volume storage chamber; and   wherein the closure and the second support are assembled to one another such that the closure seals the variable-volume storage chamber with respect to ambient atmosphere and the valve cover is superimposed on the valve seat to form a normally closed valve seam therebetween.   
     
     
         53 . A device as defined in  claim 52 , the closure further comprising a flexible actuator at least partially defining a compression chamber disposed between the flexible actuator and the second support and connectible in fluid communication between the variable-volume storage chamber and the valve seam. 
     
     
         54 . A device as defined in  claim 52 , further comprising a penetrable portion in fluid communication with the chamber configured for penetration of a filling or injection member therethrough for filling the chamber. 
     
     
         55 . A device as defined in  claim 54 , further comprising a penetration aperture formed in the penetrable portion and a liquid sealant overlying the penetration aperture for hermetically sealing the penetration aperture. 
     
     
         56 . A device as recited in  claim 55 , wherein the liquid sealant was overlaid at ambient temperature. 
     
     
         57 . A device as recited in  claim 55 , wherein the liquid sealant is a silicone. 
     
     
         58 . A device as recited in  claim 55 , wherein the liquid sealant is overlaid at least partially within a recess defined by the device. 
     
     
         59 . A device as defined in  claim 52 , further comprising a rigid hollow body within which the closure and the flexible pouch are at least partially received. 
     
     
         60 . A device as defined in  claim 52 , wherein the first support includes a second valve cover and the second support includes a second valve seat, and the second valve cover is superimposed on the second valve seat, forming a filling valve defining a normally closed valve seam configured to allow filling of the variable volume storage chamber therethrough. 
     
     
         61 . A device as defined in  claim 52 , wherein the storage chamber is collapsed and/or sterile. 
     
     
         62 . A device as defined in  claim 55 , wherein the storage chamber is collapsed and/or sterile. 
     
     
         63 . A device comprising:
 a first portion defining a relatively rigid outer body;   a second portion defining a relatively flexible or collapsible pouch fixedly secured with the first portion, and a variable-volume storage chamber defined an interior of the pouch, wherein at least part of the variable-volume storage chamber is received within the outer body; and   a closure engaging the first portion and hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere, the closure including a penetrable and resealable portion in fluid communication with the variable-volume storage chamber and penetrable by an injection member, a filling member and/or a needle for introducing substance into the variable-volume storage chamber, and a resulting penetration aperture in the penetrable and resealable portion is hermetically resealable to hermetically seal the variable-volume storage chamber with respect to ambient atmosphere.   
     
     
         64 . A device as defined in  claim 63 , wherein the penetrable and resealable portion is hermetically resealable by applying a liquid sealant thereto and/or laser resealing. 
     
     
         65 . A device as defined in  claim 63 , wherein the wherein the outer body defines an upper support for securing the second portion with the outer body. 
     
     
         66 . A method comprising:
 aseptically filling a device including a first portion defining a relatively rigid outer body, a second portion defining a relatively flexible or collapsible pouch fixedly secured with the first portion, and a variable-volume storage chamber defined an interior of the pouch, wherein at least part of the variable-volume storage chamber is received within the outer body; and a closure engaging the first portion and hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere, the closure including a penetrable and resealable portion in fluid communication with the variable-volume storage chamber and penetrable by an injection member, a filling member and/or a needle for introducing substance into the variable-volume storage chamber, and a resulting penetration aperture in the penetrable and resealable portion is hermetically resealable to hermetically seal the chamber with respect to ambient atmosphere, the filling step including   (a) penetrating the penetrable and resealable portion with an injection member, a filling member or a needle and, in turn, placing said injection member, filling member or needle in fluid communication with the variable-volume storage chamber;   (b) introducing substance into the variable-volume storage chamber through said injection member, filling member or needle;   (c) removing said injection member, filling member or needle from the penetrable and resealable portion; and   (d) hermetically resealing a resulting penetration aperture in the penetrable and resealable portion and, in turn, hermetically sealing the variable-volume storage chamber with respect to ambient atmosphere.   
     
     
         67 . A method as defined in  claim 66 , wherein step (d) includes resealing the penetrable and resealable portion by applying a liquid sealant thereto or laser resealing. 
     
     
         68 . A method as defined in  claim 66 , further including, prior to step (a), collapsing the pouch. 
     
     
         69 . A method as defined in  claim 68 , wherein collapsing the pouch is by applying vacuum on the variable-volume storage chamber. 
     
     
         70 . A method as defined in  claim 68 , wherein collapsing the pouch includes evacuating the pouch. 
     
     
         71 . A method as defined in  claim 68 , wherein after collapsing the pouch the pouch contains little or substantially no air. 
     
     
         72 . A method as defined in  claim 66 , further including substantially preventing formation of foam during step (b).