Device for connecting or filling and method

Abstract

A valve comprises a shell, a flexible valve member sealingly mounted within the shell, and a valve body mounted atop the flexible valve member within the shell. The flexible member is moveable between closed and open positions to allow the flow of fluid therethrough. The valve is engageable with a filling device having flow ports and a surrounding closure. The closure and/or the shaft is movable between (i) a first position wherein the closure closes the port(s), and (ii) a second position opening the port(s). Alternatively, the valve may comprise a portion of a female connector and the filling device may comprise a portion of a male connector to form an aseptic fluid connector for the aseptic transfer of fluid therethrough.

1 - 92 . (canceled) 
     
     
         93 . An apparatus, comprising:
 a first portion including a conduit comprising a hollow interior, at least one port in fluid communication with the interior, and a closure; wherein one or more of the closure or the conduit is movable between (i) a first position wherein the closure closes the at least one port, and (ii) a second position opening the at least one port;   a second portion adapted to engage the first portion and including (1) a valve, having a valve member and a valve seat, configured to be moved between (i) a closed position, wherein the valve member and the valve seat sealingly engage each other, thereby preventing the flow of substance through the valve, and (ii) an open position, wherein the valve member and the valve seat are disengaged from each other to allow the flow of substance through the valve, and (2) a septum overlying one or more of the valve member or the valve seat;   wherein one or more of the first portion or the second portion is moveable relative to each other between (i) a disconnected position wherein the one or more of the closure or the conduit is in the first position and the valve is in the closed position and (ii) a connected position wherein the conduit has engaged and moved the valve from the closed position to the open position and the one or more of the closure or the conduit is in the second position opening the at least one port; and   wherein the closure is adapted to one or more of: (a) at least partially penetrate the septum or (b) be interposed between the at least one filling port and the septum, during said movement between the disconnected position and the connected position.   
     
     
         94 . The apparatus as defined in  claim 93 , wherein the closure is normally biased in a direction from the second position toward the first position to normally close the at least one port. 
     
     
         95 . The apparatus as defined in  claim 93 , wherein the valve member is normally biased in a direction from the open position toward the closed position, to normally sealingly close the valve from the passage of substance therethrough. 
     
     
         96 . The apparatus as defined in  claim 93 , wherein the septum defines a septum passageway therein, said septum passageway adapted to wipe the conduit during said movement between the disconnected position and the connected position. 
     
     
         97 . The apparatus as defined in  claim 96 , wherein the valve member defines a recess or socket and the septum passageway substantially aligns therewith, allowing the conduit to pass through the septum and engage with the recess or socket. 
     
     
         98 . The apparatus as defined in  claim 97 , wherein the recess or socket and the septum passageway are of substantially a same width or diameter. 
     
     
         99 . The apparatus as defined in  claim 93 , wherein the septum defines a thickness within the range of a thickness equivalent to ½ the width or diameter of the conduit to a thickness equivalent to double the width or diameter of the conduit. 
     
     
         100 . The apparatus as defined in  claim 93 , wherein at least a portion of the closure is engageable with the septum to prevent further movement of the closure relative to the second portion, whereby subsequent movement of the first portion moves the one or more of the closure or the conduit from the first position to the second position. 
     
     
         101 . The apparatus as defined in  claim 93 , wherein movement from the disconnected position to the connected position achieves at least approximately a 3 log reduction in bio-burden. 
     
     
         102 . The apparatus as defined in  claim 93 , wherein, during or upon movement from the connected to the disconnected position, one or more of the closure or the conduit is movable from the second position to the first position, and the valve is movable from the open position to the closed position. 
     
     
         103 . The apparatus as defined in  claim 93 , wherein the closure extends annularly about the conduit. 
     
     
         104 . An apparatus, comprising:
 first means for transferring substance with a second means for engaging the first means and for transferring substance with the first means;   the first means comprising
 third means for providing a conduit for the passage of substance therethrough and for engaging fourth means of the second means; 
 the third means including fifth means for passage of substance therethrough and in fluid communication with an interior of the third means; and 
 sixth means for closing the third means; 
    wherein one or more of the third means or the sixth means is movable between
 (i) a first position wherein the sixth means closes the fifth means; and 
 (ii) a second position opening the fifth means; 
   the second means comprising
 seventh means overlying the fourth means for engaging the third means prior to the third means engaging the fourth means when the first means and the second means are in a connected position with each other; 
    wherein the fourth means is moveable between
 (i) a closed position, wherein the fourth means prevents the flow of substance therethrough; and 
 (ii) an open position, wherein the fourth means allows the flow of substance therethrough; 
    wherein one or more of the first means or the second means is moveable relative to each other between
 (i) a disconnected position wherein the one or more of the third means or the sixth means is in the first position and the fourth means is in the closed position; and 
 (ii) the connected position wherein the third means has engaged and moved the fourth means from the closed position to the open position and the one or more of the third means or the sixth means is in the second position opening the fifth means; 
    wherein the sixth means is adapted to one or more of: (a) at least partially penetrate the seventh means or (b) be interposed between the fifth means and the seventh means, during movement between the disconnected position and the connected position.   
     
     
         105 . An apparatus as defined in  claim 104 , wherein the first means is a first portion, the second means is a second portion, the third means is a conduit, the fourth means is a valve, the fifth means is a port, the sixth means is a closure, and the seventh means is a septum. 
     
     
         106 . A method comprising the following steps:
 engaging first and second devices adapted to engage each other and transfer substance therebetween, the first device including a conduit, a flow aperture in fluid communication between an interior of the conduit and an exterior of the conduit, and a closure, the second device comprising a valve, an interior in fluid communication with the valve, and a septum overlying the valve;   hermetically sealing the flow aperture and the interior of the conduit with respect to ambient atmosphere with the closure and preventing the flow of substance through the flow aperture;   preventing substance from flowing through the valve and hermetically sealing the interior of the second device with respect to ambient atmosphere;   engaging the conduit and the valve; and   opening the valve from a closed position preventing substance from passing therethrough to an open position allowing substance therethrough with the conduit;   wherein the method further comprises:   before or during the step of engaging the conduit and the valve, one or more of (a) at least partially penetrating the septum with the closure or (b) interposing the closure between the flow aperture and the septum;   during or after the said one or more of (a) at least partially penetrating the septum with the closure or (b) interposing the closure between the flow aperture, opening the flow aperture by moving the closure and the conduit relative to each other; and   after the opening steps, transferring substance between the interior of the conduit and the interior of the second device, the transferring step including flowing substance through the valve and the flow aperture.   
     
     
         107 . The method as defined in  claim 106 , wherein said substance is aseptic or sterile, and the method further comprises maintaining said aseptic or sterile during said transferring step. 
     
     
         108 . The method as defined in  claim 106 , further comprising moving the cannula through the septum. 
     
     
         109 . An apparatus comprising:
 a first device comprising a conduit including a first flow aperture, a second flow aperture in fluid communication with the first flow aperture, and a closure; wherein one or more of the closure or the conduit is movable between (i) a first position where the closure closes the second flow aperture, and (ii) a second position where the second flow aperture is open; and   a second device adapted to engage the first device and transfer substance therebetween, and including a septum defining a passageway therethrough configured to receive at least a portion of the conduit therein during engagement of the first and second devices, wherein the septum is configured to wipe contaminants from the at least a portion of the conduit during passage thereof through the passageway.   
     
     
         110 . An apparatus as defined in  claim 109 , wherein the septum comprises an elastomeric material. 
     
     
         111 . An apparatus as defined in  claim 109 , wherein the septum is configured so that said wiping achieves at least approximately a 3 log reduction in bio-burden on the at least a portion of the conduit. 
     
     
         112 . An apparatus as defined in  claim 109 , wherein the passageway is configured to receive at least a portion of the closure during passage of the at least a portion of the conduit through the passageway. 
     
     
         113 . An apparatus as defined in  claim 112 , wherein the closure is in the first position during at least a portion of passage of the at least a portion of the conduit through the passageway. 
     
     
         114 . An apparatus as defined in  claim 109 , wherein, during at least a portion of passage of the at least a portion of the conduit through the passageway, the second flow aperture is substantially prevented from contacting the septum. 
     
     
         115 . An apparatus as defined in  claim 109 , wherein, during at least a portion of passage of the at least a portion of the conduit through the passageway, the closure is interposed between the second flow aperture and the septum to substantially prevent contact between the second flow aperture and the septum. 
     
     
         116 . An apparatus as defined in  claim 109 , configured so that the movement from the first position to the second position occurs during or after passage of the at least a portion of the conduit through the passageway. 
     
     
         117 . An apparatus as defined in  claim 109 , wherein the septum defines a durometer within the range of about 20 Shore A to about 50 Shore A. 
     
     
         118 . An apparatus as defined in  claim 109 , wherein the septum defines a thickness at least about ½ of a diameter of the conduit. 
     
     
         119 . An apparatus as defined in  claim 109 , wherein, in the first position, the closure hermetically seals the second flow aperture from ambient atmosphere. 
     
     
         120 . An apparatus as defined in  claim 109 , wherein, after passage of the at least a portion of the conduit through the passageway, the one or more of the closure or the conduit is in the second position, the second flow aperture is open, and the septum seals the flow outlet from the ambient atmosphere. 
     
     
         121 . An apparatus as defined in  claim 109 , wherein the septum is configured to exert a radial or compressive force on the at least a portion of the conduit during passage thereof through the passageway. 
     
     
         122 . An apparatus as defined in  claim 109 , wherein the conduit includes an end thereof extending past the closure in the first position, and the septum is configured to wipe contaminants from the end upon passage of the end through the passageway. 
     
     
         123 . A method comprising:
 engaging a first device and a second device, wherein the first device comprises a conduit including a first flow aperture, a second flow aperture in fluid communication with the first flow aperture, and a closure; wherein one or more of the closure or the conduit is movable between (i) a first position where the closure closes the second flow aperture, and (ii) a second position where the second flow aperture is open, and the second device is adapted to engage the first device and transfer substance therebetween, and includes a septum defining a passageway therethrough configured to receive at least a portion of the conduit therein during said engaging of the first and second devices, wherein the septum is configured to wipe contaminants from the at least a portion of the conduit during passage thereof through the passageway;   passing the at least a portion of the conduit through the passageway; and   wiping contaminants from the at least a portion of the conduit during said passing step.   
     
     
         124 . A method as defined in  claim 123 , further including, during the wiping step, achieving at least approximately a 3 log reduction in bio-burden on the at least a portion of the conduit. 
     
     
         125 . A method as defined in  claim 123 , further including receiving at least a portion of the closure within the passageway during said passing step. 
     
     
         126 . A method as defined in  claim 125 , further including maintaining the closure is in the first position during at least a portion of the passing step. 
     
     
         127 . A method as defined in  claim 123 , further including substantially preventing the second flow aperture from contacting the septum during at least a portion of the passing step. 
     
     
         128 . A method as defined in  claim 123 , further including one or more of interposing the closure between the second flow aperture and the septum during at least a portion of the passing step, or substantially preventing contact between the second flow aperture and the septum during said at least a portion of the passing step. 
     
     
         129 . A method as defined in  claim 123 , further including moving the one or more of the closure or the conduit from the first position to the second position during or after said passing step. 
     
     
         130 . A method as defined in  claim 123 , wherein one or more of (a) the septum comprises an elastomeric material, (b) the septum defines a durometer within the range of about 20 Shore A to about 50 Shore A, or (c) the septum defines a thickness at least about ½ of a diameter of the conduit. 
     
     
         131 . A method as defined in  claim 123 , further including hermetically sealing the second flow aperture from ambient atmosphere with the closure in the first position. 
     
     
         132 . A method as defined in  claim 123 , further including sealing the second flow aperture from ambient atmosphere with the septum in the second position. 
     
     
         133 . A method as defined in  claim 123 , further including exerting a radial or compressive force on the at least a portion of the conduit during the passing step. 
     
     
         134 . A method as defined in  claim 123 , wherein the conduit includes an end thereof extending past the closure in the first position, and further including wiping contaminants from the end during the passing step.