Self closing connector

Abstract

An apparatus for aseptic transfer of fluid therethrough. A first portion includes a closure and a piercing member comprising a hollow shaft for flowing fluid therethrough, and at least one port in fluid communication with the interior of the hollow shaft for passage of the fluid therethrough. 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). A second portion includes a pierceable septum. The first and second portions are engageable such that the piercing member pierces the pierceable septum. When the pierceable member has at least partially penetrated the pierceable septum, the closure and/or the shaft moves from the first position to the second position for aseptical transfer of fluid.

What is claimed is: 
     
         1 . An apparatus comprising:
 a first portion including a piercing member comprising a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein one or more of the closure or the shaft 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 a pierceable septum configured to be pierced by the piercing member when the first portion and the second portion are in an engaged position with each other;   wherein one or more of the first portion or the second portion is moveable relative to each other between (i) a closed position wherein the one or more of the closure or the shaft is in the first position and closes the at least one port and (ii) an open position wherein the at least one port has at least partially penetrated into or through the septum and the one or more of the closure or the shaft is in the second position opening the at least one port,   wherein the septum is configured to wipe contaminants from the piercing member during movement of one of the first portion and the second portion relative to the other in the engaged position.   
     
     
         2 . An apparatus as in  claim 1 , wherein said wiping achieves at least approximately a 3 log reduction in bio-burden on the piercing member. 
     
     
         3 . An apparatus as defined in  claim 1 , wherein the pierceable septum defines a durometer within a range of about 20 Shore A to about 50 Shore A. 
     
     
         4 . An apparatus as defined in  claim 1 , wherein the pierceable septum defines a thickness within a range of about ½ the diameter of the piercing member to about double the diameter of the piercing member. 
     
     
         5 . An apparatus as defined in  claim 1 , wherein the tip defines an included angle within a range of about 20 degrees to about 40 degrees. 
     
     
         6 . A method comprising:
 engaging a first portion with a second portion,
 the first portion comprising a piercing member including a hollow shaft, a tip formed at one end of the shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein one or more of the closure or the shaft 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; 
 the second portion is adapted to engage the first portion and includes a pierceable septum configured to be pierced by the piercing member when the first portion and the second portion are in an engaged position with each other; and 
 one or more of the first portion or the second portion is moveable relative to each other between (i) a closed position wherein the one or more of the closure or the shaft is in the first position and closes the at least one port and (ii) an open position wherein the at least one port has at least partially penetrated into or through the septum and the one or more of the closure or the shaft is in the second position opening the at least one port; 
   moving one or more of the first portion or the second portion relative to each other from the closed position toward the open position;   piercing the septum with the piercing member, at least partially penetrating into or through the septum with the at least one port, and, during said piercing, wiping contaminants from the piercing member with the septum;   moving one or more of the closure or the shaft from the first position to the second position, opening the at least one port; and   flowing fluid through the at least one port.   
     
     
         7 . A method as defined in  claim 6 , wherein the wiping step comprises wiping the tip of the piercing member with the septum. 
     
     
         8 . A method as defined  claim 7 , wherein the tip defines an included angle within a range of about 20 degrees to about 40 degrees. 
     
     
         9 . A method as defined in  claim 6 , wherein the septum defines a durometer within a range of about 20 Shore A to about 50 Shore A. 
     
     
         10 . A method as defined in  claim 9 , wherein the wiping step comprises wiping the piercing member with the septum defining a thickness with the range of about ½ the diameter of the piercing member to about double the largest diameter of the piercing member. 
     
     
         11 . A method as defined in  claim 6 , wherein the wiping step achieves at least approximately a 3 log reduction in bio-burden on the piercing member. 
     
     
         12 . An apparatus comprising:
 a first portion including a piercing member comprising a hollow shaft, a tip formed at one end of the shaft, and at least one port in fluid communication with an interior of the hollow shaft; wherein one or more of the closure or the shaft 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 a pierceable septum configured to be pierced by the piercing member when the first portion and the second portion are in an engaged position with each other;   wherein one or more of the first portion or the second portion is moveable relative to each other between (i) a closed position, wherein one or more of (a) the closure has at least partially penetrated into or through the septum or (b) the at least one port has at least partially penetrated into or through the septum, and the one or more of the closure or the shaft is in the first position and closes the at least one port and (ii) an open position wherein the at least one port has at least partially penetrated into or through the septum and the one or more of the closure or the shaft is in the second position opening the at least one port.   
     
     
         13 . An apparatus as defined in  claim 12 , wherein the closure is normally biased in the direction from the second position toward the first position to normally close the at least one port. 
     
     
         14 . An apparatus as defined in  claim 12 , wherein the pierceable septum defines a durometer within a range of about 20 Shore A to about 50 Shore A. 
     
     
         15 . An apparatus as defined in  claim 12 , wherein the pierceable septum defines a thickness within a range of about ½ the diameter of the piercing member to about double the diameter of the piercing member. 
     
     
         16 . An apparatus as defined in  claim 12 , wherein the tip defines an included angle within a range of about 20 degrees to about 40 degrees. 
     
     
         17 . An apparatus as defined in  claim 12 , wherein movement of one of the first portion and the second portion relative to the other of the first portion and the second portion from the closed position to the open position achieves at least approximately a 3 log reduction in bio-burden. 
     
     
         18 . An apparatus as defined in  claim 12 , wherein the septum is configured to wipe contaminants from the piercing member during movement of one of the first portion and the second portion relative to the other in the engaged position. 
     
     
         19 . An apparatus as defined in  claim 12 , wherein the closure of the first portion is engageable with a portion of the second portion to prevent further movement of the closure relative thereto, whereby subsequent movement of the first portion moves the shaft and the closure relative to each other from the first position to the second position. 
     
     
         20 . A method comprising:
 engaging a first portion with a second portion,
 the first portion comprising a piercing member including a hollow shaft, a tip formed at one end of the hollow shaft, at least one port in fluid communication with an interior of the hollow shaft, and a closure; wherein one or more of the closure or the shaft 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; 
 the second portion is adapted to engage the first portion and includes a pierceable septum configured to be pierced by the piercing member when the first portion and the second portion are in an engaged position with each other; and 
 one or more of the first portion or the second portion is moveable relative to each other between
 (i) a closed position wherein one or more of
 (a) the closure has at least partially penetrated into or through the septum, or 
 (b) the at least one port has at least partially penetrated into or through the septum; 
 
 and the one or more of the closure or the hollow shaft is in the first position and closes the at least one port; and 
 (ii) an open position wherein the at least one port has at least partially penetrated into or through the pierceable septum, and the one or more of the closure or the hollow shaft is in the second position opening the at least one port; 
 
   moving one or more of the first portion or the second portion relative to each other from the closed position toward the open position;   piercing the septum with the piercing member and at least partially penetrating into or through the septum with the at least one port;   moving one or more of the closure or the shaft from the first position to the second position, opening the at least one port; and   flowing fluid through the at least one port.   
     
     
         21 . A method as defined in  claim 20 , wherein the step of moving one or more of the closure or the shaft from the first position to the second position occurs after the piercing step. 
     
     
         22 . A method as defined in  claim 20 , wherein the flowing step is performed only after at least a portion of the at least one port has passed through an interior surface of the septum and is located within a hollow portion of the second portion. 
     
     
         23 . A method as defined in  claim 20 , wherein the piercing step further comprises wiping contaminants from the piercing member with the septum. 
     
     
         24 . A method as defined in  claim 20 , wherein the wiping step includes reducing bio-burden on the piercing member by at least approximately 3 log. 
     
     
         25 . A method as defined in  claim 20 , further comprising the following steps:
 withdrawing the piercing member from the septum;   before or during the withdrawing step, moving one or more of the closure or the shaft from the second position to the first position, such that the at least one port is in the closed position;   moving the one or more of the first portion or the second portion relative to each other from the open position to the closed position; and   disengaging the first portion from the second portion.   
     
     
         26 . A method as defined in  claim 20 , further including, during the piercing step, substantially preventing any contact between the at least one port and the septum. 
     
     
         27 . A method as defined in  claim 26 , wherein the substantially preventing step includes interposing the closure between the at least one port and the septum to substantially prevent any contact between the at least one port and the septum.