Needle with closure and method

Abstract

A needle has a hollow shaft, a tip formed at one end of the shaft, one or more ports in fluid communication with the interior of the hollow shaft, and a 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).

1 . A needle comprising: a hollow shaft; a tip formed at one end of the shaft; at least one port in fluid communication with the interior of the hollow shaft; and a closure; wherein at least one of the closure and 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. 
     
     
         2 . A needle as defined in  claim 1 , wherein in the first position, the closure forms a substantially fluid-tight seal between the at least one at least one port and ambient atmosphere. 
     
     
         3 . A needle as defined in  claim 1 , wherein the closure is biased in the direction from the second position toward the first position to normally close the at least one port. 
     
     
         4 . A needle as defined in  claim 3 , further including a biasing member biasing the closure in the direction from the second position to the first position. 
     
     
         5 . A needle as defined in  claim 3 , wherein the closure is engageable with a penetrable septum to move at least one of the closure and the shaft from the first position wherein the closure closes the at least one port, to the second position opening the at least one port, upon penetrating the septum with the needle. 
     
     
         6 . A needle as defined in  claim 5 , wherein at least one of the closure and the shaft is movable from the second position wherein the at least one port is opened, to the first position wherein the at least one port is closed, during or upon withdrawing the needle from the septum. 
     
     
         7 . A needle as defined in  claim 1 , wherein the closure extends annularly about the shaft. 
     
     
         8 . A needle as defined in  claim 1 , wherein the closure includes a flange on one end thereof engageable with a biasing member for biasing the closure in the direction from the second position to the first position. 
     
     
         9 . A needle as defined in  claim 8 , wherein an end of the closure opposite the flange is engageable with a stop surface of the needle to stop the closure in the first position. 
     
     
         10 . A needle as defined in  claim 1 , wherein a distal end of the closure is substantially flush with an adjacent portion of the needle tip. 
     
     
         11 . A needle as defined in  claim 1 , wherein the tip is defined by a non-coring, conically-pointed tip. 
     
     
         12 . A needle as defined in  claim 1 , further comprising a holder connected to an end of the shaft opposite the tip and engageable in fluid communication with a filling line for introducing fluid from the filling line through the needle. 
     
     
         13 . A needle as defined in  claim 12 , wherein the holder is over-molded to the shaft. 
     
     
         14 . A needle comprising: first means for providing a conduit for the passage of fluid therethrough; second means formed at one end of the first means for penetrating a septum; third means in fluid communication with the conduit for passage of fluid from the conduit therethrough; and fourth means for closing the third means, wherein at least one of the fourth means and the first means is movable between (i) a first position wherein the fourth means closes the third means, and (ii) a second position opening the third means. 
     
     
         15 . A needle as defined in  claim 14 , wherein the first means comprises a needle shaft, the second means comprises a needle tip, the third means comprises at least one port, and the fourth means comprises a closure. 
     
     
         16 . A method comprising the following steps:
 piercing a septum with a needle and placing the needle in fluid communication with a chamber;   prior to or during the piercing step, moving at least one of a closure and at least one filling port of the needle from a closed position closing the at least one filling port to an open position opening the at least one filling port; and   introducing fluid from the needle into the chamber.   
     
     
         17 . A method as defined in  claim 16 , further comprising the following steps:
 withdrawing the needle from the septum; and   before or during the withdrawing step, moving at least one of the closure and the at least one filling port of the needle from the open position to the closed position.   
     
     
         18 . A method as defined in  claim 17 , wherein the fluid is introduced from the needle into the chamber after full perforation of the septum or after part of the at least one filling port has passed through an interior surface of the septum and is located within the chamber. 
     
     
         19 . A method as defined as defined in  claim 18 , wherein the fluid is introduced from the needle into the chamber after the at least one filling port is substantially completely located within the chamber. 
     
     
         20 . A method as defined in  claim 17 , further comprising substantially sealing the at least one filling port from ambient atmosphere in the closed position. 
     
     
         21 . A method as defined in  claim 17 , wherein during the penetrating and withdrawing steps, substantially preventing any contact between the at least one filling port and the septum. 
     
     
         22 . A method as defined in  claim 21 , further comprising interposing the closure between the at least one filling port and septum to substantially prevent any contact between the at least one filling port and septum. 
     
     
         23 . A method as defined in  claim 17 , further comprising the step of sealing a resulting penetration aperture in the septum. 
     
     
         24 . A method as defined in  claim 23 , wherein the sealing step includes applying radiation or energy to the septum, thereby sealing the penetration aperture. 
     
     
         25 . A method as defined in  claim 23 , wherein the sealing step includes at least one of thermal sealing, laser sealing and liquid sealant sealing. 
     
     
         26 . A method as defined in  claim 25 , wherein the liquid sealant is silicone. 
     
     
         27 . A method as defined in  claim 17  further comprising performing the penetrating, filling and withdrawing steps in a non-sterile environment or an environment defining a SAL of about log  3  or less; filling a sterile fluid through the needle and into the chamber; and maintaining the sterility of the filled fluid throughout the penetrating, filling and withdrawing steps. 
     
     
         28 . A method as defined in  claim 27 , further comprising sealing a resulting penetration aperture in the septum and maintaining the sterility of the filled fluid during the sealing step. 
     
     
         29 . A method as defined in  claim 17 , further comprising piercing the septum with a first needle and withdrawing the first needle to create a resulting penetration aperture within the septum, and then performing said piercing step with said needle including the closure through the penetration aperture formed by the first needle. 
     
     
         30 . A method as defined in  claim 29 , wherein the septum is self closing and substantially prevents the ingress of fluid through the resulting penetration aperture.