Patent Publication Number: US-11026864-B2

Title: Connector section

Description:
FIELD OF THE INVENTION 
     The present invention relates to the field of fluid transfer devices. More particularly, the invention relates to a connector section for use in contamination-free transfer of a hazardous drug from one container to another. 
     BACKGROUND OF THE INVENTION 
     Medical and pharmacological personnel that are involved in the preparation and administration of hazardous drugs suffer the risk of being exposed to drugs and to their vapors, which may escape to the surroundings. As referred to herein, a “hazardous drug” is any injectable material the contact with which, or with the vapors of which, may constitute a health hazard. Illustrative and non-limitative examples of such drugs include, inter alia, cytotoxins, antiviral drugs, chemotherapy drugs, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil, leucovorin, taxol, metatroxat, gemzar, cyclophosphamide, cytoxan, and neosar, or a combination thereof, in a liquid, solid, or gaseous state. 
     Hazardous drugs in liquid or powder form are contained within vials, and are typically prepared in a separate room by pharmacists provided with protective clothing, a mouth mask, and a laminar flow safety cabinet. A syringe provided with a cannula, i.e. a hollow needle, is used for transferring the drug from a vial. After being prepared, the hazardous drug is added to a solution contained in a bag which is intended for parenteral administration, such as a saline solution intended for intravenous administration. 
     Since hazardous drugs are toxic, direct bodily contact thereto, or exposure to even micro-quantities of the drug vapors, considerably increases the risk of developing health fatalities such as skin cancer, leukemia, liver damage, malformation, miscarriage and premature birth. Such exposure can take place when a drug containing receptacle, such as a vial, bottle, syringe, and intravenous bag, is subjected to overpressure, resulting in the leakage of fluid or air contaminated by the hazardous drug to the surroundings. Exposure to a hazardous drug also results from a drug solution remaining on a needle tip, on a vial or intravenous bag seal, or by the accidental puncturing of the skin by the needle tip. Additionally, through the same routes of exposure, microbial contaminants from the environment can be transferred into the drug and fluids; thus eliminating the sterility with possibly fatal consequences. 
     U.S. Pat. No. 8,196,614 to the applicant of the present invention describes closed system liquid transfer systems designed to provide contamination-free transfer of hazardous drugs. The basic innovation in this patent is the provision of two separate channels—one for air and the other for liquid—that allow the differences in pressure within the system to be equalized within the closed system when liquid is transferred from one component, e.g. a syringe, to another component e.g. a drug vial, IV bag, or IV line. 
       FIG. 1  is a vertical cross sectional view of an embodiment of a contamination-free liquid transfer unit  10  described in U.S. Pat. No. 8,196,614. Liquid transfer unit  10  comprises a syringe  27  and a connector section  25 . Syringe  27  comprises a hollow piston rod  30  extending from cap  32  to piston  34 , which sealingly engages the inner wall of, and is displaceable with respect to, barrel  24 . Piston  34  defines two chambers of variable volume: a distal liquid chamber  38  between piston  34  and connector section  25  and a proximal air chamber  40  between piston  34  and stopper  28  that seals the upper part of the barrel  24 . An air conduit  46 , which has the form of a hollow needle, passes through piston  34  and extends inside of hollow piston rod  30 . Air flowing through conduit  46  enters the interior of piston rod  30  and exits to air chamber  40  through an aperture formed at the distal end of piston rod  30 . A second conduit  48 , which is considerably shorter than air conduit  46  and has the same structural features, is present to allow a liquid to flow into or out of liquid chamber  38  from a drug vial, IV bag, or IV line that can be attached to the distal end of the connector section. 
     As shown in  FIG. 2 , connector section  25  comprises a cylindrical, hollow outer body  128  having a distal shoulder portion  129  radially protruding from body  128  and closed proximal cap  113 . The distal shoulder portion  129  terminates with opening  126  through which the proximal end of a fluid transfer component can be inserted for coupling. Connector section  25  also comprises a double membrane seal actuator  130 , which is reciprocably displaceable within the interior of body  128 . Air conduit  46  and liquid conduit  48  described above pass through the proximal cap  113  and are retained by needle holder  115 , which protrudes into interior  119  of connector section  25  from a central portion of closed proximal cap  113 . 
     The double membrane seal actuator  130  comprises a proximal disc shaped membrane  142  having a rectangular cross-section and a distal double disc shaped membrane  143  having a T-shaped cross-section with a rectangular proximal portion  144  and a distal portion  147  disposed radially inwards with respect to proximal portion  144 . Membranes  142  and  143  are seated within casing  137 , while distal portion  147  protrudes distally from casing  137 . Resilient elongated arms  133  and  134  having equal length are substantially longitudinally disposed, being attached at connection points  161 ′ and  162 ′, respectively, to casing  137 . Arms  33  and  34  terminate with distal enlarged elements  161  and  162 , respectively. The resilient arms  133  and  134  are designed such that, if not prevented from doing so, the distance between enlarged elements  161  and  162  is larger than the interior diameter of body  128  of connector section  25 . Enlarged elements  161  and  162  are configured to be received in, and engaged by, shoulder portion  129  when actuator  130  is disposed in a first (distal) position. 
     Conduits  46  and  48  distally extend from needle holder  115 , piercing membrane  142  of actuator  130 . The distal ends of conduits  46  and  48  have sharp pointed ends  46   a  and  48   a , respectively, and are further provided with apertures  111  and  112 , respectively, through which fluid is transferred during a fluid transfer operation. The proximal end of air conduit  46  extends within the interior of hollow piston rod  30  and the proximal end of liquid conduit  48  terminates at or slightly proximally from cap  113  of connector section  25 , so that the liquid conduit will be in fluid communication with the interior of the liquid chamber of syringe  27 . When actuator  130  is in the first (distal) position (as shown in  FIG. 1  and  FIG. 2 ), the pointed ends  46   a  and  48   a  of the conduits are retained between membranes  142  and  143 , preventing a user from being exposed to, and injured by, the pointed ends and also sealing the ends of conduits  46  and  48  from the surroundings, thereby preventing contamination of the interior of fluid transfer unit  10  and leakage of a harmful drug contained within the interior of unit  10  to the surroundings. 
     As said, connector section  25  is adapted to be releasably coupled to another fluid transfer component, which can be any fluid container with a standard connector such as a vial adapter connected to a drug vial, a spike adapter inserted into an intravenous bag, or an intravenous line to produce a “fluid transfer assembly”, through which a fluid is transferred from the fluid transfer component to the syringe or vice versa. When, for example the proximal membrane enclosure of a vial connector is inserted into opening  126  at the distal end of connector  25 , membrane  143  in the connector and a membrane at the proximal end of the vial adapter are pushed together forming a double membrane seal. If the connector and vial adapter continue to be pushed together, double membrane seal actuator  130  moves upwards inside body  128  of the connector and the pointed ends  46   a  and  48   a  of the conduits are pushed through membrane  143  and the membrane in the vial adapter establishing air and liquid channels between the syringe and drug vial via connector section  25  and the vial adapter. With this arrangement two-way transfer of fluids is accomplished by means of a pressure equalization arrangement in which the same volume of the hazardous drug and air are exchanged internally within the fluid transfer assembly. 
     Since filing U.S. Pat. No. 8,196,614, the applicant has filed several patent applications directed to improvements of the original design of most of the components of the apparatus. One such patent application WO 2014/122643 inter alfa describes changes to the apparatus designed to prevent accidental fluid communication between the air and fluid channels by means of the addition of a filter in the air channel and/or a sleeve through which the tips of the needles slide and also a new design for a vial adapter. 
     One component in particular that has been the subject of intensive development is the connector section that connects between two components of a drug transfer system, e.g. a syringe and a vial adapter. In particular emphasis has been placed on improved designs of the actuator that houses the septum or membrane. Actuators having various designs and containing either one or two septa have been described, for example in Israeli Patent Application IL237788. 
       FIG. 3 a   ,  FIG. 3 b   , and  FIG. 3 c    are respectively front, cross-sectional, and exploded views of one embodiment of a septum holder  700  described in IL237788. Septum holder  700  is comprised of a body  702  having a disk shaped annular upper body part  702   a  and a lower body part  702   b . Two equal length resilient elongated arms  704  are attached to the sides of body  700 . The arms terminate with distal enlarged elements  706 . 
     As can be seen in exploded view of  FIG. 3 c   , a septum  708  is fitted into the lower body part  702   b  so that it extends downward between arms  704 . Septum  708  is made of a single piece of cylindrically shaped resilient material. The upper part of septum  708  has a diameter larger than the middle part in order to form a flange that rests on an annular ledge  702   c  created around the inside of the bottom section  702   b  of body  702  when the middle part of septum  708  slides through the open center at the bottom of bottom section  702   b . Upper section  702   a  is then pushed onto the lower section in order to connect septum  708  to body  702 . The upper and lower sections of body  702  can be held permanently together with the septum  708  held between them by any method known in the art, e.g. press fitting, gluing, snap fitting, ultrasonic forming, and laser or ultrasonic welding. 
     In an alternative embodiment the septum, shaped as described above can be forced into the circular opening at the bottom of the bottom section  702   b  from below and, when the flange snaps onto annular ledge  702   c  the upper section  702   a  of the body is pushed into the lower section  702   b  to hold the septum in place. In another embodiment, the upper and middle sections of the septum can have the same diameter that is at least as large as the diameter of annular ledge  702   c . In this embodiment the septum is forced into the lower section  702   b  from the bottom. Because of the flexibility of the material of which the septum is made the upper part of the septum is at first compressed to enter the lower section of the holder and then expands to fill the space on top of ledge  702   c.    
     Two bores  710  that function in the same manner as the seat of a needle valve are created part of the way through the height of the middle part of septum  708 . The lowest part of septum  708  has a diameter that matches that of the septum in the fluid transfer component, e.g. vial adaptor, to which it will be connected. Note that in  FIGS. 3 a  to 3 d    the lower part of the septum is shown as having a diameter less than that of the rest of the septum; however, this is not always necessary and in some cases the lower part of the septum can have the same diameter as the middle part of the septum or the entire septum can have the same diameter. The only condition being that the septum in the septum holder has to be able to contact a septum in a fluid transfer component and form a seal that prevents leakage of air or liquid. 
       FIG. 3 d    schematically shows the holder of  FIG. 3 a   ,  FIG. 3 b   , and  FIG. 3 c    in a syringe connector section of a closed system liquid transfer apparatus. The connector section is essentially the same as that shown in a described in relation to  FIG. 2 . Cylindrical body  718  of the connector section is attached to syringe  712 . Two hollow needles  714 , which function as an air conduit, and  716 , which functions as a liquid conduit, are fixedly attached to the upper end of body  718  of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports  724  that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges  722  near the bottom of cylindrical body  718  serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges  722  are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose. 
     A septum holder  700  is located inside of cylindrical body  718  of the connector section. As shown, the distal ends of needles  716 ,  714  are inserted into bores  710  in septum  708 . The diameters of bores  710  are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the septum is manufactured pushes radially against the shaft of the needle sealing the ports  724 . When not connected to another element of the liquid transfer system the distal enlarged elements  706  of arms  704  are engaged in the shoulder portion  720  at the distal end of body  718 . As shown in  FIG. 3 d   , in this position the tips of the needles are isolated from the outside by septum  708  and the walls of the bores  710  pressing radially on the shafts of the needles prevent fluids from entering or exiting the interior of the needles. 
     Connection of the syringe connector to a fluid transfer component, e.g. a vial adaptor, a spike adaptor for connection to an IV bag, or a connector for connection to an IV line, is accomplished in the same manner as described herein above. When the septum of the fluid transfer component is pushed against the bottom of septum  708 , septum holder  700  begins to move upwards inside body  718  and the tips of the needles begin to exit bores  710  penetrate the solid material of septum  708 . The tips of the needles pass through septum  708  and the septum of the fluid transfer component as holder  700  continues to be pushed upwards, thereby establishing air and liquid channels between the element of the liquid transfer system attached to the fluid transfer component and the proximal air chamber and distal liquid chamber in the syringe. When the fluid transfer component is pulled downward to separate it from the connector section, septum holder  700  moves downwards inside body  718  and the tips of the needles are pulled through the solid material of septum  708  and reenter bores  710 . 
     All embodiments of existing connector sections known to the inventor of the present invention, including those that he has invented and those found in other publications, for example U.S. Pat. No. 8,122,923, comprise either one or two septa. 
     It is a purpose of the present invention to provide a connector section that does not comprise any septa. 
     Further purposes and advantages of this invention will appear as the description proceeds. 
     SUMMARY OF THE INVENTION 
     In a first aspect the invention is a locking element for a connector configured to connect two components of a fluid transfer system. The locking element comprises:
         a. a body comprising an upper part having a hollow interior and a lower part having a channel passing through it;   b. a rigid flat annular disc at the free end of the lower part;   c. elongated flexible arms having distal enlarged elements attached to the sides of the upper part of the body and projecting downwards parallel to the sides of lower part of the body; and   d. an insert configured to be inserted into the channel, wherein the insert is made of flexible material and comprises at least one bore passing through it which forms a sleeve through which the at least one hollow needle is able to pass.       

     Embodiments of the locking element comprise two bores through the inset. 
     In a second aspect the invention is a connector configured to connect two components of a fluid transfer system. The connector comprises:
         a. a hollow cylindrical body that has a closed upper end having a connection arrangement on the exterior side of the closed upper end to connect to a first component of a fluid transfer system and a needle holder on the interior side;   b. a locking element according to claim  1 , wherein the body of the locking element is surrounded by the cylindrical body and is configured to slide up and down inside the hollow interior of the cylindrical body of the connector;   c. an open lower end of the cylindrical body configured to allow an end of a second component to be inserted into the interior of the cylindrical body;   d. shoulder portions at the open lower end of the cylindrical body into which the enlarged elements of the elongated flexible arms of the locking element fit when the connector is not connected to a second component of a fluid transfer system; and   e. at least one hollow needle that passes through the closed end of the cylindrical body of the connector and the hollow interior of the upper part of the body of the locking element and is fixedly attached to the cylindrical body of the connector by the needle holder.       

     Embodiments of the connector of the invention comprise two hollow needles and two bores through the inset. 
     Embodiments of the connector of the invention comprise one hollow needle and one bore through the inset. 
     Embodiments of the connector of the invention comprise one hollow needle and two bores through the inset. 
     In embodiments of the connector of the invention the hollow needles may have openings near their pointed distal tips configured to allow passage of fluid between the interiors and exteriors of the needles. 
     In embodiments of the connector of the invention, when the connector is not connected to a second component of a fluid transfer system, the locking element is at the distal end of the cylindrical body of the connector, the distal enlarged elements of the elongated flexible arms of the locking element are fit into shoulder portions at the open lower end of the cylindrical body of the connector, and the tips of the needles are located in the bores in the insert, whereupon the openings in the sides of the needles are blocked by the interior walls of the bores thereby completely isolating the needles from each other and the outside environment preventing passage of fluid between the interiors and exteriors of the needles and exchange of fluid with the surroundings. 
     In embodiments of the connector of the invention, when the connector is connected to a first component of a fluid transfer system and to a second component of a fluid transfer system that comprises a septum that seals the proximal end of the second component, the septum at the top of the second component is pressed tightly against the annular disc at the distal end of the locking element, the distal enlarged elements of the elongated flexible arms of the locking element are no longer in the shoulder portions at the distal end of the connector but are fit into recesses in the second component locking the locking element and second component together, the locking element is located at or near the proximal end of the interior of the cylindrical body of the connector, and the tips of the needles are pushed out of the bores in the insert of the locking element and through the septum that seals the proximal end of the second component, whereupon the openings in the sides of the needles are no longer blocked by the interior walls of the bores thereby providing continuous fluid channels between the first component and the second component via the interiors of the needles. 
     All the above and other characteristics and advantages of the invention will be further understood through the following illustrative and non-limitative description of embodiments thereof, with reference to the appended drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a vertical cross sectional of an embodiment of the contamination-free drug transfer apparatus of the invention described in U.S. Pat. No. 8,196,614; 
         FIG. 2  is a cross sectional view of the connector section of the embodiment of the contamination-free drug transfer apparatus shown in  FIG. 1 ; 
         FIG. 3 a   ,  FIG. 3 b    and  FIG. 3 c    are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder described in IL237788; 
         FIG. 3 d    schematically shows the septum holder of  FIG. 3 a    in a connector section similar to that shown in  FIG. 2 ; 
         FIG. 4 a    schematically shows an embodiment of a locking element for the connector section of the invention; 
         FIG. 4 b    is a cross-sectional view of the locking element shown in  FIG. 4   a;    
         FIG. 5  schematically shows a connector comprising a locking element according to the present invention; 
         FIG. 6 a    schematically shows a connector of the invention and a vial adapter that will be attached to it; 
         FIG. 6 b    and  FIG. 6 c    respectively show views of the interior of the vial adapter and connector of  FIG. 6   a;    
         FIG. 6 d    is an magnified view of a section of  FIG. 6   c;    
         FIG. 7 a    schematically shows the connector of the invention and the vial adapter shown in  FIG. 6 a    attached to each other; 
         FIG. 7 b    shows a view of the interior of the vial adapter and connector of  FIG. 7   a;    
         FIG. 7 c    is an magnified view of a section of  FIG. 7   b;    
         FIG. 8 a    schematically shows an embodiment of a connector according to the invention and a luer lock adapter that are separated from each other; 
         FIG. 8 c    schematically shows the connector and luer lock adapter of  FIG. 8 a    connected together; and 
         FIG. 8 b    and  FIG. 8 d    are respectively cross-sectional views of  FIG. 8 a    and  FIG. 8   c.    
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION 
     The invention is a locking element for a connector configured to connect two components of a fluid transfer system and a connector that comprises the locking element. The connector works on the same principle as that in connectors previously invented by the inventor examples of which are connector  25  shown in  FIG. 2  and connector  750  shown in  FIG. 3 d   . The locking element of the present invention replaces the double membrane seal actuator  130  in connector  25  and septum holder  700  in connector  750 . 
     The designations “upper” and “lower” used herein are of course relative and are used without reference to the orientation of components in the figures but with reference to how the components would normally be oriented during use. 
       FIG. 4 a    schematically shows an embodiment of a locking element for the connector section of the invention.  FIG. 4 b    is a cross-sectional view of the locking element shown in  FIG. 4 a   . Locking element  200  has a body  202  made of either of a single piece of plastic material or of a few pieces of plastic material connected together, for example by welding or gluing, to form a single item. The upper part  202   a  of body  202  has a hollow interior and the lower part  202   b  has a channel  204  passing through it that, in this embodiment, has a cross section with the shape of the numeral eight that is formed by two overlapping bores. The free end of lower part  202   b  comprises a rigid flat annular disc  208 . Elongated flexible arms  214  having distal enlarged elements  216  are attached to the sides of the upper part  202   a  of body  202  so that they project downwards parallel to the sides of lower part  202   b  of body  202 . 
     An insert  206  made of resilient material, such as, for instance, silicon or soft PVC, is inserted into channel  204 . Insert  206  has two bores  210  and  212  passing through it, which form sleeves through which needles acting as liquid and air channels respectively pass. The insert  206  may, in one embodiment of the invention, be kept in place by friction created by the contact of its outer surface with the inner surface channel  204  or by plastic teeth (not shown) that extend from the channel  204 . The friction can be obtained simply by providing an outer diameter of insert  206  that is greater than the diameter of the inner surface of channel  204 . Thus, the resilient material of which insert  206  is made is compressed and pushes back toward the inner surface of channel  204 . It is also possible to provide a roughening of the outer surface of insert  206 , or to provide anchoring elements on either or both surfaces. 
       FIG. 5  schematically shows a connector comprising a locking element according to the present invention. Except for locking element  200  that replaces septum holder  700 , connector  250  is identical to prior art connector  750  shown in  FIG. 3 d   . Connector  250  comprises a hollow cylindrical body  252  that has a closed upper end having a connection arrangement  254 , e.g. a luer lock or luer slip connector, on its exterior side to connect to a first component, e.g. a syringe of a fluid transfer system, and a needle holder  264  in the interior side. The body  202  of the locking element  200  is surrounded by the cylindrical body  252  of the connector  250  and is able to slide up and down inside the hollow interior of the cylindrical body  252  of the connector  250 . The lower end  256  of cylindrical body  252  is open to allow an end of a second component, e.g. a vial adapter connected to a drug vial, to be inserted into the interior of cylindrical body  252 . This end of body  252  comprises shoulder portions  258  into which the enlarged elements  216  of the elongated flexible arms  214  of locking element  200  fit when connector  250  is not connected to a second component of a fluid transfer system, as shown in  FIG. 5 . 
     Also see in  FIG. 5  are two hollow needles  260  and  262  that respectively function as liquid and air channels through connector  252 . Needles  260  and  262  have openings  266  near their pointed distal tips. Openings  266  allow passage of fluid between the interiors and exteriors of the needles. The needles pass through the closed end of connector body  252  and the hollow interior of the upper part  202   a  of the body  202  of the locking element  200  and are fixedly attached to body  252  by needle holder  264 . 
     When connector  250  is not connected to a second component of a fluid transfer apparatus, as shown in  FIG. 5 , the locking element  200  is at the distal end of connector  250 , the distal enlarged elements of the elongated flexible arms of the locking element are fit into shoulder portions at the open lower end of the cylindrical body of the connector, and the tips of needles  260  and  262  are located in the bores  210  and  212  in the insert  206 . The insert is made of a resilient material and the diameters of bores  210  and  212  are slightly smaller than the outer diameters of needles  260  and  262 . As will be apparent to a skilled person, depending on its intended use, each specific connector may require using a different tolerance in the differences of the diameters in order to balance between the force needed to move the needle so as to maintain user&#39;s convenience, and the pressure resistance desired of the valve to prevent leaks, so as to maintain safety. In the configuration shown in  FIG. 5 , the openings  266  in the sides of the needles are blocked by the interior walls of the bores completely isolating the needles from each other and the outside environment, thereby preventing air from entering the liquid chamber of the syringe or liquid from entering the air chamber even at very high pressures and also preventing exchange of air or liquid with the surroundings. 
       FIG. 6 a    schematically shows a connector  250  of the invention and a vial adapter  300  that will be attached to it. The vial adapter  300  is described in co-pending patent application WO 2014/12264.  FIG. 6 b    and  FIG. 6 c    respectively show views of the interior of the vial adapter and connector of  FIG. 6 a    and  FIG. 6 d    is a magnified view of section A in  FIG. 6   c.    
     Referring to  FIG. 6 a    to  FIG. 6 d   , the part of the vial adapter that is relevant to describing the present invention is the longitudinal extension  302  that is designed to enter connector  250  through its open end  256  and engage the locking element  200 . The top of longitudinal extension  302  is sealed with a septum  304  and on the side of its exterior surface are recesses  306  into which the enlarged elements  216  at the ends of arms  214  of locking element  200  fit when the connector and vial adapter are attached to each other. The interior of longitudinal extension  302  is hollow and acts as an air channel  310 . A closed tube that passes through the interior of longitudinal extension  302  functions as a liquid channel  308 . 
       FIG. 7 a    schematically shows the connector of the invention and the vial adapter shown in  FIG. 6 a    attached to each other.  FIG. 7 b    shows a view of the interior of the vial adapter and connector of  FIG. 7 a    and  FIG. 7 c    is a magnified view of section B in  FIG. 7 b   . Referring to these figures and to  FIG. 5 , when longitudinal extension  302  of vial adapter  300  begins to be pushed into the interior of connector  250 , septum  304  at the top of longitudinal extension  302  presses against annular disc  208  at the bottom of locking element  200  forcing the latter to move upwards. At the same time enlarged elements  216  are forced out of shoulder portions  258  at the end of connector  250  and enter the recesses  306  in the longitudinal extension  302 . As the locking element is pushed upwards, the enlarged elements  216  are held in the recesses  306  by the interior wall of body  252  of the connector, thereby locking the connector and vial adapter together with septum  304  of the vial adapter pressed tightly against annular disc  208  creating, with no septum in the connector section, the equivalent of the double septum seal of the prior art. 
     As the locking element  200  and longitudinal extension  302  are pushed up into the interior of the body  252  the tips of needles  260  and  262  are forced out of the bores  210  and  212  in insert  206  and eventually through septum  304 . When this happens the openings  266  near the tips of needles  260  and  262  are unblocked and the needles enter liquid channel  308  and air channel  310  in the vial adapter, thereby opening continuous separate liquid and air channels between a drug vial connected to vial adapter  300  to a syringe connected to connector  250 . 
     After the fluid transfer process has taken place connector  250  and drug vial  300  can be separated by pulling them apart in an axial direction. As this is done locking element  200  moves downwards inside the body of connector  250  until the enlarged elements  216  are able to spring back into the shoulder portions  258  at the end of connector  250  and exit the recesses  306  in the longitudinal extension  302  thereby unlocking the vial adapter from the connector. As locking element  200  moves downwards inside the body of connector  250 , needles  260  and  262  are pulled upwards through the septum  304  at the top of the vial adapter and into the bores  210  and  212  in insert  206 ; thereby sealing openings  266  near the tips of the needles. As the needles are pulled through self-sealing septum  304  in the vial adapter, the tips of the needles are wiped clean leaving the external surfaces of both connector and vial adapter clean of drug residue. 
     Many different embodiments of the connector of the invention can be produced. For example  FIG. 8 a    schematically shows an embodiment of a connector according to the invention and a luer lock adapter that are separated from each other.  FIG. 8 c    schematically shows the connector and luer lock adapter of  FIG. 8 a    connected together; and  FIG. 8 b    and  FIG. 8 d    are respectively cross-sectional views of  FIG. 8 a    and  FIG. 8   c.    
     Luer lock adapter  450  is a product produced by the applicant of the present application to connect to infusion tubing. The features of luer lock adapter  450  that are relevant to the present invention are self-sealing septum  452 , liquid channel  454 , recesses  456  located near the septum and a trigger-like locking mechanism  458 . 
     In this embodiment connector  400  is very similar in structure to connector  250  but has only one hollow needle  402  that functions as a liquid conduit. Connector  400  comprises a locking element  420  that is very similar in structure to that of locking element  200 , including having an annular disc  404  at its end facing the open end of the connector. When not connected to another component, as shown in  FIGS. 8 a  and 8 b   , the tip of needle  402  is located inside a bore  408  in insert  406  in locking element  420 . The opening  410  near the tip of needle  402  is sealed shut by the resilient material of bore  408  pressing against the exterior of the needle and enlarged elements  412  at the end of the arms of the locking element  420  are located in the shoulder portions  414  at the open end of connector  400 . In the embodiment of the locking element shown in  FIG. 8 b    the insert has two bores, only one of which is used; however embodiments can easily be made in which the insert has only one bore. 
     Referring now to  FIG. 8 d   , when the end of the luer lock adapter  450  is pushed into the open end of connector  400 , the septum  452  in luer lock adapter  450  pushes against the annular disc  404  of the locking mechanism. As locking element  420  moves further inside the body of connector  400 , enlarged elements  412  at the end of the arms of the locking element  420  are released from the shoulder portions  414  and eventually settle into recess  456  on the luer lock adapter  450  and the locking mechanism  458  on the luer lock adapter  450  snaps into the shoulder portion  414  of the connector locking adapter and connector together with septum  452  pressed tightly against annular disc  404  creating the equivalent of the double septum seal of the prior art without a septum in the connector. As in the previously described embodiment, as the locking element  420  and attached luer lock adapter are pushed further into the interior of the body of connector  400  the tip of needle  402  i2 forced out of the bore  408  in insert  406  and eventually through septum  452 . When this happens the opening  410  near the tip of needle  402  is unblocked and the needle enters liquid channel  454  in the luer lock adapter, thereby opening a continuous liquid channel through luer lock adapter  450  and connector  400 . 
     The fact that the locking element of the present connector does not have a septum at its distal end as is present in all prior art septum holders and connectors that contain them provides the locking element with the following important advantages over the prior art:
         1. From the manufacturer&#39;s (and ultimately the customer&#39;s) point of view the locking element is more cost effective because the number of components and assembly steps are reduced; and   2. From the user&#39;s point of view less force is needed to connect the locking element to another component because there is only one septum to pierce as opposed to two with prior art connectors.       

     The applicant has performed tests to compare connectors comprising the locking element of the invention with prior art connectors that form a double septum seal. The results of these comparison tests show no difference in safety and leak prevention performance. 
     Although embodiments of the invention have been described by way of illustration, it will be understood that the invention may be carried out with many variations, modifications, and adaptations, without exceeding the scope of the claims.