Device with penetrable septum, filling needle and penetrable closure, and related method

Abstract

A device has a sealed chamber; a first penetrable septum in fluid communication with the chamber that is formed of an elastic material and is penetrable by a first injection member to fill the first chamber with a substance therethrough; and a second penetrable septum movable between first and second positions. In the first position, at least a portion of the second septum is spaced away from the first septum to allow the injection member to penetrate the first septum and aseptically or sterile fill the chamber with a substance therethrough. In the second position, the portion of the second septum overlies and seals a resulting injection aperture in the first septum after withdrawal of the first injection member therefrom, and is penetrable by a second injection member to penetrate the first and second septums and withdraw a filled substance from the chamber and through the second injection member.

What is claimed is: 
     
         1 . A device comprising:
 a sealed chamber;   a first penetrable septum in fluid communication with the chamber, wherein the first septum is penetrable by a first needle or like injection member to fill the chamber with a substance therethrough; and   a second penetrable septum, movable between (i) a first position, wherein at least a portion of the second penetrable septum is spaced away from the first penetrable septum to allow the first needle or like injection member to penetrate the first penetrable septum, without penetrating the second penetrable septum, and, in turn, fill the chamber with substance, and (ii) a second position, wherein said at least a portion of the second penetrable septum overlies and seals a resulting injection aperture in the first penetrable septum after withdrawal of the first needle or like injection member therefrom;   wherein the second penetrable septum is penetrable in the second position by a second needle or like injection member to, in turn, penetrate the underlying first penetrable septum and withdraw substance from the chamber.   
     
     
         2 . A device as defined in  claim 1 , further comprising a body defining the chamber and a first closure connected to the body and forming a fluid-tight seal therebetween, wherein the first closure includes the first penetrable septum. 
     
     
         3 . A device as defined in  claim 2 , further comprising a second closure connectable to at least one of the first closure and body, wherein the second closure includes the second penetrable septum. 
     
     
         4 . A device as defined in  claim 3 , wherein at least one of the first and second penetrable septums is at least one of (i) co-molded and (ii) over-molded with the first closure and second closure, respectively. 
     
     
         5 . A device as defined in  claim 4 , wherein the first penetrable septum is co-molded or over-molded with the first closure, and the second penetrable septum is co-molded or over-molded with the second penetrable septum. 
     
     
         6 . A device as defined in  claim 3 , wherein the second closure is connected to the first closure, and at least one of the first and second closures is movable relative to the other to position the second closure in the first or second position. 
     
     
         7 . A device as defined in  claim 6 , further comprising a hinge coupled between the first and second closures to allow movement of the second closure from the first position to the second position. 
     
     
         8 . A device as defined in  claim 7 , wherein the hinge is a living hinge. 
     
     
         9 . A device as defined in  claim 7 , wherein the first and second closures are injection molded as one part, and the first and second penetrable septums are over-molded to the first and second closures, respectively. 
     
     
         10 . A device as defined in  claim 1 , wherein the first penetrable septum is sufficiently resilient to close upon itself after withdrawal of a needle or like injection member to thereby maintain the chamber in a sealed condition prior to sealing the resulting injection aperture with the second penetrable septum. 
     
     
         11 . A device as defined in  claim 1 , wherein at least one of the first penetrable septum and the second penetrable septum is approximately dome or convex shaped. 
     
     
         12 . A device as defined in  claim 11 , wherein the at least one of the first penetrable septum and the second penetrable septum is approximately dome or convex shaped on a side thereof substantially opposite the side of the chamber. 
     
     
         13 . A device as defined in  claim 1 , wherein the first penetrable septum comprises a substantially homogeneous material. 
     
     
         14 . A device as defined in  claim 10 , wherein the first penetrable septum comprises silicone. 
     
     
         15 . A device as defined in  claim 1 , wherein the first penetrable septum defines a durometer within the range of about 20 Shore A to about 50 Shore A. 
     
     
         16 . A device as defined in  claim 15 , wherein the first penetrable septum defines a durometer within the range of about 25 Shore A to about 45 Shore A. 
     
     
         17 . A device as defined in  claim 1 , wherein the first penetrable septum defines a thickness within the range of about ½ to about two times a largest diameter of the filling member member. 
     
     
         18 . A device as defined in  claim 1 , wherein the first penetrable septum is configured such that penetration of the first penetrable septum by the first needle or like injection member achieves at least approximately a 3 log reduction in bio-burden on a tip of the first needle or like injection member. 
     
     
         19 . A device as defined in  claim 18 , wherein the first penetrable septum is configured such that penetration of the first penetrable septum by the first needle or like injection member achieves at least approximately a 6 log reduction in bio-burden of the tip of the first needle or like injection member. 
     
     
         20 . A device as defined in  claim 3 , wherein the first closure includes a first connecting member, the second closure includes a second connecting member, at least one of the first and second connecting members is engageable with the other to secure the second penetrable septum in the second position. 
     
     
         21 . A device as defined in  claim 20 , wherein at least one of the first and second connecting members is receivable within the other to secure the second penetrable septum in the second position. 
     
     
         22 . A device as defined in  claim 21 , wherein the first connecting member defines a recess, and the second connector member defines a protrusion receivable within the recess to secure the secure the second penetrable septum in the second position. 
     
     
         23 . A device as defined in  claim 22 , wherein the protrusion defines a chamfer or beveled surface slideable against the recess to insert the second connecting member into the first connector member, and wherein the protrusion is engageable with an underside of the recess to secure the second connecting member to the first connecting member. 
     
     
         24 . A device as defined in  claim 23 , wherein the recess extends annularly about the first connecting member, and the protrusion extends annularly about the second connecting member. 
     
     
         25 . A device as defined in  claim 1 , wherein the sealed chamber is empty and at least one of aseptic and sterile. 
     
     
         26 . A device as defined in  claim 1 , wherein the sealed chamber is at least partially filled with a substance that is at least one of sterile and aseptic. 
     
     
         27 . A device as defined in  claim 2 , wherein the body comprises plastic or glass. 
     
     
         28 . A device as defined in  claim 1 , wherein the entirety of the second penetrable septum is spaced away from the first penetrable septum in the first position. 
     
     
         29 . A device as defined in  claim 1 , further comprising a body defining the chamber and a closure overlying the first penetrable septum and connected to the body and forming a fluid-tight seal therebetween, and wherein the second penetrable septum is slidably received in the closure. 
     
     
         30 . A device as defined in  claim 29 , further comprising a disk including the second penetrable septum, and wherein the closure further defines a lateral slot therein for slidably receiving the disk therein, and wherein the disk creates a dimensional interference fit with the slot, thereby creating a sliding, fluid-tight seal, therebetween. 
     
     
         31 . A device as defined in  claim 29 , further comprising a disk including the second penetrable septum, wherein the second penetrable septum is positioned substantially off-center within the disk. 
     
     
         32 . A device as defined in  claim 1 , wherein the second septum comprises a first portion and a second portion, wherein said second portion defines said at least a portion of the second septum, and in the first position, the first portion of the second septum sealingly overlies the first septum and the second portion of the second septum is spaced away from the first septum, and in the second position, the second portion of the second septum sealingly overlies the first septum and the first portion of the second septum is spaced away from the first septum. 
     
     
         33 . A device comprising:
 a sealed chamber;   first means for filling the first chamber with a substance therethrough, in fluid communication with the chamber, and penetrable by a first needle or like injection member, and   second means for sealing the first means, movable between (i) a first position, wherein at least a portion of the second means is spaced away from the first means for allowing the first needle or like injection member to penetrate the first means without penetrating the second means and fill the chamber therethrough, and (ii) a second position for sealing a resulting injection aperture in the first means after withdrawal of the first needle or like injection member therefrom, and penetrable by a second needle or like injection member for penetrating the first and second means and withdrawing a filled substance from the chamber and through the second needle or like injection member.   
     
     
         34 . A device as defined in  claim 33 , wherein the first means includes a first penetrable septum, and the second means includes a second penetrable septum. 
     
     
         35 . A device comprising:
 a sealed chamber, and   a penetrable septum having a first penetrable portion and a second penetrable portion,   wherein the penetrable septum is movable between (i) a first position where the first penetrable portion is in fluid communication with the chamber to allow a first needle or like injection member to penetrate therethrough, and, in turn, fill the chamber with substance, and (ii) a second position where the first penetrable portion is not in fluid communication with the chamber, and the second penetrable portion seals the chamber from the ambient environment and is in fluid communication with the chamber to allow a second needle or like injection member to penetrate therethrough, and, in turn, withdraw substance from the chamber.   
     
     
         36 . A device as defined in  claim 35 , further comprising a body defining the chamber and a closure connected to the body and forming a fluid-tight seal therebetween, wherein the penetrable septum is slidably received in the closure. 
     
     
         37 . A device as defined in  claim 36 , further comprising a disk including the penetrable septum, and wherein the closure further defines a lateral slot therein for slidably receiving the disk therein, and wherein the disk creates a dimensional interference fit with the slot, thereby creating a sliding, fluid-tight seal, therebetween. 
     
     
         38 . A filling device comprising: a hollow filling member, a penetrating tip formed at one end of the filling member, at least one port in fluid communication between an interior of the hollow filling member and an exterior of the hollow filling member, and a closure, wherein at least one of the closure and filling member is movable between (i) a first position wherein the closure closes the at least one port and forms a fluid-tight seal between the at least one port and ambient atmosphere to maintain sterility of the at least one port and an interior of the filling member, and (ii) a second position opening the at least one port to allow substance to pass between said interior and said exterior. 
     
     
         39 . A filling device as defined in  claim 38 , wherein the closure is biased in a direction from the second position toward the first position to normally close the at least one port. 
     
     
         40 . A filling device as defined in  claim 39 , further including a biasing member biasing the closure in the direction from the second position toward the first position. 
     
     
         41 . A filling device as defined in  claim 38 , wherein the closure is configured such that, upon engagement of the closure with a penetrable septum or a portion of a device including a penetrable septum and penetration thereof by the filling member, the at least one of the closure and filling member moves from the first position toward the second position. 
     
     
         42 . A filling device as defined in  claim 38 , wherein the closure is configured such that, during withdrawal of the filling device from the septum, the at least one of the closure and the filling member moves from the second position toward the first position. 
     
     
         43 . A filling device as defined in  claim 38 , wherein the closure extends annularly about the filling member. 
     
     
         44 . A filling device as defined in  claim 38 , wherein the tip of the filling member defines a stop surface, and an end of the closure adjacent the tip is engageable with said stop surface in the first position, thereby stopping the closure and forming a fluid-tight seal therebetween. 
     
     
         45 . A filling device as defined in  claim 44 , further comprising a sealing member located between the end of the closure and the stop surface forming a substantially fluid-tight seal therebetween when the closure is engaged with the stop surface in the first position. 
     
     
         46 . A filling device as defined in  claim 45 , wherein the sealing member is molded to one of (i) the end of the closure and (ii) the stop surface. 
     
     
         47 . A filling device as defined in  claim 38 , further comprising a flexible shell extending annularly about, and sealingly enclosing, a portion of the filling member. 
     
     
         48 . A filling device as defined in  claim 47 , wherein the flexible shell comprises a bellows. 
     
     
         49 . A filling device as defined in  claim 47 , wherein the flexible shell defines a valve configured to vent air from within the shell to the ambient atmosphere when the at least one of the closure and the filling member is moved from the first position toward the second position. 
     
     
         50 . A filling device comprising: first means for the passage of fluid therethrough;
 second means for penetrating a septum formed at one end of the first means, third means formed on the first means for the passage of fluid between an interior of the first means and an exterior thereof; and fourth means movable between (i) a first position for closing the third means and forming a substantially fluid-tight seal between the third means and ambient atmosphere, and (ii) a second position for opening the third means for permitting the passage of substance between said interior and said exterior of the first means.   
     
     
         51 . A filling device as defined in  claim 50 , wherein the first means comprises a filling member, the second means comprises a penetrating tip of the filling member, the third means comprises at least one port, and the fourth means comprises a closure. 
     
     
         52 . A method comprising the following steps:
 penetrating a first penetrable septum with a first needle or like injection member and placing the first needle or like injection member into fluid communication with a sealed, empty chamber;   introducing a substance through the first needle or like injection member and into the chamber;   withdrawing the first needle or like injection member from the first penetrable septum; and   sealing a resulting penetration aperture in the first penetrable septum with at least a region of a second penetrable septum.   
     
     
         53 . A method as defined in  claim 52 , wherein the sealing step includes moving the second penetrable septum from a first position where a first portion thereof overlies the first penetrable septum, to a second position where the at least a region of the second septum overlies and sealingly engages the first penetrable septum. 
     
     
         54 . A method as defined in  claim 52 , wherein the sealing step includes moving the second penetrable septum from a first position spaced away from the first penetrable septum to a second position overlying and sealingly engaging the first penetrable septum. 
     
     
         55 . A method as defined in  claim 54 , wherein a first closure includes the first penetrable septum and a second closure includes the second penetrable septum, and in the second position, the second closure is fixedly secured to the first closure. 
     
     
         56 . A method as defined in  claim 52 , wherein the sealing step includes overlying the first penetrable septum with said at least a region of the second penetrable septum, and further comprising penetrating the second penetrable septum and the first penetrable septum with a second needle or like injection member and into fluid communication with the substance in the chamber and withdrawing substance from the chamber through the second needle or like injection member. 
     
     
         57 . A method as defined in  claim 52 , further comprising the step of, prior to the sealing step, sterilizing at least an top surface of the first penetrable septum and a bottom surface of the second penetrable septum. 
     
     
         58 . A method as defined in  claim 57 , wherein the sterilizing step includes applying radiation to said surfaces. 
     
     
         59 . A method as defined in  claim 52 , further comprising the step of sterilizing the sealed empty chamber prior to penetrating the first penetrable septum. 
     
     
         60 . A method as defined in  claim 52 , wherein the step of penetrating the first penetrable septum further comprises wiping a tip of the first needle or like injection member with the first penetrable septum. 
     
     
         61 . A method as defined in  claim 60 , wherein the first penetrable septum defines a durometer within the range of about 20 Shore A to about 50 Shore A. 
     
     
         62 . A method as defined in  claim 60 , wherein the first penetrable septum defines a thickness within the range of about ½ to about two times a largest outer diameter of the needle or like injection member. 
     
     
         63 . A method as defined in  claim 60 , wherein the step of penetrating the first penetrable septum comprises penetrating with a needle or like injection member including a tip defining an included angle within the range of about 20 degrees to about 40 degrees. 
     
     
         64 . A method as defined in  claim 60 , wherein the wiping step includes providing at least approximately a 3 log reduction in bio-burden on the needle or like injection member. 
     
     
         65 . A method as defined in  claim 52 , wherein the step of penetrating the first penetrable septum comprises penetrating with a first injection member comprising a hollow filling member, a penetrating tip formed at one end of the filling member, at least one port in fluid communication between an interior of the hollow filling member and an exterior of the hollow filling member, and a closure, wherein at least one of the closure and filling member is movable between (i) a first position wherein the closure closes the at least one port and forms a fluid-tight seal between the at least one port and ambient atmosphere to maintain sterility of the at least one port and an interior of the filling member, and (ii) a second position opening the at least one port to allow substance to pass between said interior and said exterior, and further comprising, prior to or during the step of penetrating the first penetrable septum, moving the at least one of the closure and filling member from the closed position to the open position. 
     
     
         66 . A method as defined in  claim 65 , further comprising the step of, before or during the withdrawing step, moving the at least one of the closure and filling member from the open position to the closed position. 
     
     
         67 . A method as defined in  claim 65 , wherein the introducing step comprises introducing substance from the first injection member and into the chamber after penetrating the first penetrable septum or after part of the at least one filling port has passed through an interior surface of the first penetrable septum and is located within the chamber. 
     
     
         68 . A method as defined in  claim 65 , further comprising, during the penetrating and withdrawing steps, substantially preventing any contact between the at least one filling port and the first penetrable septum. 
     
     
         69 . A method as defined in  claim 68 , wherein the substantially preventing step includes maintaining the closure in the first position, and thus between the at least one filling port and first penetrable septum. 
     
     
         70 . A method as defined in  claim 52 , wherein the first penetrable septum sufficiently resilient to close upon itself after withdrawal of the needle or like injection member to thereby maintain the chamber in a sealed condition prior to sealing the resulting injection aperture with the second penetrable septum.