Patent Abstract:
The invention provides for a cleansable, i.e., swabbable, access pot, formed by a stopper having a bore extending from an entry position to an exit position; and a plug in the bore at the entry position and movable in the bore; whereby the location of the plug at the entry position of the stopper permits the cleansing or swabbing of the outer surfaces of the plug and the stopper before the plug is depressed into the bore of the stopper for a vial or container in order to reduce the danger of contamination of the bore by pathogens. To convert from single-use vial access, to multiple-use vial access, the plug is replaced by a swabbable, needleless, multiple-use lock connector in which the plug contains a slit that is closed upon initial depression but is thereafter openable to permit flow through the connector into a vial or container.

Full Description:
FIELD OF THE INVENTION  
       [0001]     This is a continuation-in-part of Ser. No. 09/073,022, filed May 4, 1998. The invention relates to coupling systems for the transfer of materials from one unit to another, and, more particularly, to coupling units with a first unit including a swabbable access port and a second unit including a blunt cannula. The access port receives the blunt cannula to effect a coupling of particular medicinal applicability for medications and body fluids. The swabbability of the access port allows disinfectant treatment before receipt of the blunt cunnula to limit the extent to which pathogens can enter the cannula after coupling is effected.  
       BACKGROUND OF THE INVENTION  
       [0002]     In medical practice, containers for medication typically are bottles capped with rubber-like stoppers. A tamper-evident seal surrounds the stopper and at least the upper portion of the container. To administer medication, the seal is removed, a syringe with a needle or cannula is used to puncture the rubber stopper and withdraw a proper dosage for administration to a patient.  
         [0003]     The need for a needle of cannula presents a potential hazard, both to medical personnel and to the patient. There is significant risk of infection by blood-transmitted diseases, AIDS and hepatitis from needle sticks.  
         [0004]     Accordingly, it is an object of the invention to reduce the hazards associated with the administration of medication. A related object is to reduce the hazards associated with removal of medication from sealed containers.  
         [0005]     In addition to medicinal containers, pointed needles or cannulae have been widely used in conjunction with other forms of access ports, which take the form of a septum or pierceable membrane. An illustrative access port that is used with a pierceable cannula is disclosed in Zdeb U.S. Pat. 4,412,573 “Injection Site” assigned to Baxter International Inc. of Deerfield, Ill.  
         [0006]     The pointed cannula can be forced through the septum in order to establish fluid communication between the cannula and the container housing a medicinal substance. Access ports that are pierced by a cannula can be physically damaged by repetitive piercings and produce coring or laceration of the access port, which can result in leakage.  
         [0007]     For standard drug vials, the access ports take the form of rubber stoppers which are routinely entered using conventional hypodermic needles. In order to maintain sterility, the stopper is swabbed with a disinfectant before there is a needle entry. After repeated entries, the stopper can leak because of coring and no longer function as a swabbable sterile barrier.  
         [0008]     In addition to pathogens which may become present in the pierced sites, particulate matter can be generated and injected into a patient, along with pathogens. Alternatively, the pathogens and particulate matter may contaminate the contents of the vial. These conditions are pronounced with vials that are accessed multiple times.  
         [0009]     Moreover, pointed cannulae used with drug vials pose a health risk to their users because of problems associated with infectious agents. Despite the fact that personnel using pointed cannulae do so with great care, from time to time accidents occur, and the users are jabbed or suffer needle sticks. Used needles also present a risk of injury and handling problems for health care facility maintenance and waste removal personnel.  
         [0010]     In an attempt to overcome difficulties associated with the use of pointed cannulae, “dispensing pins” can be used to penetrate the site or stopper of multiple dose vials. A dispensing pin typically takes the shape of a sharp spike and can be used with a check valve to limit fluid leakage. One end of the spike has standard Luer fitment that is typically closed off, when not in use, by a cap. Dispensing pins tend to disengage from the vial stopper with resultant leakage. Further, it is difficult to maintain sterile conditions on this kind of multiple dose system.  
         [0011]     On attempted solution has been to eliminate sharp cannulae and use blunt cannulae instead. An example is Garrett et al. U.S. Pat. 4,197,848 “Closed Urinary Irrigation Site”, assigned to Baxter International. In Garrett the injection site is a relatively thin, molded sealing member that has an opening, which permits a blunt cannula to be forced through the sealing member into fluid communication with the interior of the injection site.  
         [0012]     Injection sites used with a blunt cannula have the advantage that the cannula will not pierce the skin of a user, but the pre-slit injection site has to reseal with enough force that fluids do not ooze outwardly and not allow airborne particulate matter, bacterial or viral, to enter.  
         [0013]     One procedure providing for the use of a needleless syringe is disclosed in Brony, U.S. Pat. No. 5,620,434, which issued Apr. 15, 1997. Unfortunately, the open end of the valve in Brony is below the inlet of the stopper so that germs can collect on the inside wall of the stopper and not be cleansed. As a result, the use of the vial in Brony can be accompanied by dangerous pathogens.  
         [0014]     Hence, there continues to be a need for an injection site, which can be used with a variety of solutions and over a range of fluid pressures. Further, there continues to be a need for such an injection site, which will reliably reseal even after many insertions of a blunt cannula and reduces the danger of contamination by dangerous pathogens.  
         [0015]     If intended to be reusable, the injection site should be able to receive a large number of insertions of the cannula without displaying reseal failure Such an injection site should provide for alignment of the cannula on insertion to result in less chance of damage to the injection site after repeated insertions. In addition, although pointed cannulae desirably are to be avoided, in some situations they may be the only ones available, so that the injection site also should be usable with pointed cannulae.  
         [0016]     Further, the injection site should be usable with a blunt cannula with a reasonable level of insertion force that will permit health care personnel to readily insert the cannula, but yet not have the cannula easily displaced after insertion.  
         [0017]     On attempt to meet these objectives is disclosed in Dudar et al. U.S. Ser. No. 425,790 (Oct. 23, 1989) “Pre-Slit Injection Site” in which one end of a housing carries a pre-slit septum, and a second end has a coupling to adapt the housing to standard vials. The coupling or a vial adapter includes a spike with opening that allows drainage of fluid in the vial through the spike and into the injection site. The vial adapter has a skirt, which protects the adapter spike in both manufacture and use. The skirt also permits locking engagement of the adapter with injection site to standard vials, despite dimensional variations in vial closures The coupling spike can have a barb that can be inserted into a standard vial and resist disengagement. A blunt cannula is used with the combination of the injection site with the coupling. This system is both complex and cumbersome.  
         [0018]     Accordingly, it is a further object of the invention to achieve the foregoing advantages without the need for a pre-slit injection site.  
       SUMMARY OF THE INVENTION  
       [0019]     In accomplishing the foregoing and related objectives, the invention provides for a cleansable, i.e., swabbable, access port, formed by a stopper having a bore extending from an entry position to an exit position; and a plug in the bore at the entry position and movable in the bore; whereby the location of the plug at the entry position of the stopper permits the cleansing or swabbing of the outer surfaces of the plug and the stopper before the plug is depressed into the bore of the stopper in order to reduce the danger of contamination of the bore by pathogens.  
         [0020]     In accordance with one aspect of the invention, the swabbable plug extends integrally across the bore and can be frangibly connected to the bore, or be slidably connected to the bore.  
         [0021]     In accordance with another aspect of the invention the swabbable plug has a non-planar external surface and is pierceable by a cannula or needle. The stopper can have a collar at the entry position, and the collar can have external Luer threads.  
         [0022]     A stretchable and apertured membrane can span the exit position of the bore so that when the plug is depressed into the bore by, for example the end of a fitment, the plug can be restored to its original, swabbable position at the entry position of the stopper when the fitment is removed.  
         [0023]     In accordance with a method of the invention for accessing a port, the steps include (a) swabbing or cleansing a movable plug positioned in the bore of a stopper, for which the bore extends from an entry position, where the plug is swabbed, to an exit position; and (b) moving the plug within the bore away from the entry position; whereby communication can be established along the bore between the entry position and the exit position.  
         [0024]     The method further includes the step of swabbing an integral surface of the movable plug, with the surface extending integrally across the bore. The swabbing can be with respect to frangible connections to the bore.  
         [0025]     In one aspect of the method, further steps include slidably moving the plug along the bore; engaging the plug by a fitment with a transverse gap between a portion of the exterior surface of the plug and the engagement end of the fitment; and piercing the plug by a cannula.  
         [0026]     In another aspect of the method, the steps include engaging a collar of the stopper at the entry position of the bore; engaging external Luer threads of the collar; stretching an apertured membrane that spans the exit position of the bore; and causing fluid to flow in an auxiliary channel of the bore when the plug is depressed in the bore.  
         [0027]     A system of the invention for the transfer of medication from a container includes (a) a needleless syringe having a blunt tubular end; (b) a stopper positioned in a neck portion of the container and having a central throughbore extending from an outer surface of the stopper to the interior of the container; (c) a plug extending into the bore from the outer surface of the stopper; (d) protrusions on the plug for engagement by the end of the syringe permitting fluid flow between the syringe and the plug; and (e) an auxiliary channel in the bore permitting the fluid flow to extend between the container and the syringe.  
         [0028]     The invention enables the needleless and disinfected transfer of medication using a stopper with a movable plug having an integral surface for engagement of the plug by a fitment, such as the Luer end of a syringe. By using the invention, medication can be withdrawn from a container with or without the use of a needle, after disinfectant treatment of the engagement surface of the plug to remove pathogens and possible contaminants.  
         [0029]     In accordance with still another aspect of the invention, single use vial or container access is transformed to multi-use vial or container access by replacing a single-use access plug with a swabbable, needleless, multiple-use lock connector. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0030]     Various other features, advantages and characteristics of the invention will become apparent after considering several illustrative embodiments, taken in conjunction with the drawings, in which:  
         [0031]      FIG. 1A  is a plan view of a stoppered medicinal container in accordance with the invention;  
         [0032]      FIG. 1B  is a top view of the stoppered medicinal container of  FIG. 1A ;  
         [0033]      FIG. 1C  is a partial sectional view of the stoppered medicinal container of  FIG. 1A ;  
         [0034]      FIG. 2A  is a full-scale side view of the stopper and plug of the medicinal container of  FIG. 1A ;  
         [0035]      FIG. 2B  is a full-scale top view of the stopper and plug of the medicinal container of  FIG. 1A ;  
         [0036]      FIG. 2C  is an enlarged sectional view of the stopper of the medicinal container of  FIG. 1A ;  
         [0037]      FIG. 2D  is a partial top view of the stopper of  FIG. 2C ;  
         [0038]      FIG. 2D  is a partial bottom view of the stopper of  FIG. 2C ;  
         [0039]      FIG. 2F  is an enlarged, partial sectional view of an alternative stopper collar portion of the invention;  
         [0040]      FIG. 2G  is an enlarged sectional view of an alternative stopper for the container of  FIG. 1C :  
         [0041]      FIG. 3A  is a full-scale side view of the plug of the stopper of  FIG. 2A ;  
         [0042]      FIG. 3B  is a full-scale top view of the plug of the stopper of  FIG. 2A ;  
         [0043]      FIG. 3C  is an enlarged view of the plug of  FIG. 3A :  
         [0044]      FIG. 3D  is an enlarged view of the plug of  FIG. 3B ;  
         [0045]      FIG. 3E  is a sectional view of the plug of  FIG. 3C :  
         [0046]      FIG. 4A  is an enlarged, partial sectional view of the container of  FIG. 1C  preparatory to activation by a Luer fitment;  
         [0047]      FIG. 4B  is an enlarged, partial sectional view of the container of  FIG. 1C  during activation by a Luer fitment;  
         [0048]      FIG. 5A  is a plan view of an alternative, stoppered medicinal container in accordance with the invention;  
         [0049]      FIG. 5B  is top view of the stoppered medicinal container of  FIG. 5A ;  
         [0050]      FIG. 5C  is a partial sectional view of the stoppered medicinal container of  FIG. 5A ;  
         [0051]      FIG. 6A  is a full-scale side view of the stopper and plug of the medicinal container of  FIG. 5A :  
         [0052]      FIG. 6B  is a full-scale top view of the stopper and plug of the medicinal container of  FIG. 5A ;  
         [0053]      FIG. 6C  is an enlarged sectional view of the stopper and plug of the medicinal container of  FIG. 5A ;  
         [0054]      FIG. 6D  is a partial top view of the stopper and plug of  FIG. 6C ;  
         [0055]      FIG. 6E  is a partial bottom view of the stopper of  FIG. 6C ;  
         [0056]      FIG. 6F  is an enlarged, partial sectional view showing the alternative stopper for the container of  FIG. 5C ;  
         [0057]      FIG. 7A  is an enlarged, partial sectional view of the container of  FIG. 5C  preparatory to activation by a Luer fitment;  
         [0058]      FIG. 7B  is an enlarged, partial sectional view of the container of  FIG. 5C  during activation by a Luer fitment;  
         [0059]      FIG. 8A  is a partial sectional view of the container of  FIG. 1C  during activation by a cannula;  
         [0060]      FIG. 8B  is a partial sectional view of the container of  FIG. 1C  during activation by a Luer fitment;  
         [0061]      FIG. 8C  is a partial sectional view of the container of  FIG. 5C  during activation by a cannula;  
         [0062]      FIG. 8D  is a partial sectional view of the container of  FIG. 5C  during activation by a Luer fitment;  
         [0063]      FIG. 9A  is an enlarged, partial sectional view of another alternative embodiment of the invention preparatory to activation by a Luer fitment;  
         [0064]      FIG. 9B  is an enlarged, partial sectional view of another alternative embodiment of the invention during activation by a Luer fitment;  
         [0065]      FIG. 9C  is a partial sectional view of the bottom of the stopper and plug combination of  FIGS. 9A and 9B ;  
         [0066]      FIG. 10A  is an enlarged, partial sectional view of still another alternative embodiment of the invention preparatory to activation by a Luer fitment;  
         [0067]      FIG. 10B  is an enlarged, partial sectional view of another alternative embodiment of the invention during activation by a Luer fitment;  
         [0068]      FIG. 10C  is a partial sectional view of the bottom of the stopper and plug combination of  FIG. 10A ;  
         [0069]      FIG. 11A  is a partial sectional view of an alternative, single-use vial in accordance with the invention  
         [0070]      FIG. 11B  is a partial sectional view illustrating use of the single-use vial of  FIG. 11A ;  
         [0071]      FIG. 12A  is a partial sectional view of an alternative, multiple-use vial in use in accordance with the invention;  
         [0072]      FIG. 12B  a sectional view of the central adapter for the multiple-use vial of  FIG. 12A ;  
         [0073]      FIG. 13A  is a full scale top view of the central adapter of  FIG. 12B ;  
         [0074]      FIG. 13B  is a full scale side view of the central adapter of  FIG. 13A ;  
         [0075]      FIG. 14A  is an enlarged top view of the central adapter of  FIG. 12B   
         [0076]      FIG. 14B  is a sectional view, taken along the lines  14 B- 14 B of  FIG. 14A , of the central adapter of  FIG. 14A ;  
         [0077]      FIG. 15A  is an alternative view of the central adapter of  FIG. 14A , after rotation through 90 degrees;  
         [0078]      FIG. 15B  is a sectional view, taken along the lines  15 B- 15 B of  FIGS. 14A and 15B , of the central adapter of  FIGS. 14A and 15A ;  
         [0079]      FIG. 16A  is an enlarged sectional view of the moveable plastic plug of  FIGS. 11A, 11B  and  12 A;  
         [0080]      FIG. 16B  is an unsectioned bottom view of the enlarged plastic plug of  FIG. 16A ;  
         [0081]      FIG. 17A  is a side view of the moveable plastic plug of  FIG. 16B ;  
         [0082]      FIG. 17B  is a top view of the enlarged plastic plug of  FIG. 17A ;  
         [0083]      FIG. 18A  is a full scale top view of the resilient seal plug for single and multiple use vials of  FIGS. 11A, 11B  and  12 A;  
         [0084]      FIG. 18B  is a full scale side view of the seal plug of  FIG. 18A ;  
         [0085]      FIG. 19A  is an enlarged top view of the seal plug of  FIG. 18A ;  
         [0086]      FIG. 19B  is an enlarge side view of the seal plug of  FIG. 18B   
         [0087]      FIG. 19C  is a sectional view, taken along the lines  19 C- 19 C of  FIG. 18A ;  
         [0088]      FIG. 20A  is a full scale side view of an alternative seal plug in accordance with the invention;  
         [0089]      FIG. 20B  is a full scale top view of the alternative seal plug of  FIG. 20A   
         [0090]      FIG. 20A  is an enlarged top view of the seal plug of  FIG. 20B ;  
         [0091]      FIG. 20B  is an enlarged side view of the seal plug of  FIG. 20A ;  
         [0092]      FIG. 20C  is a sectional view, taken along the lines  20 C- 20 C of  FIG. 20B ,  
         [0093]      FIG. 20D  is a sectional view, taken along the lines  20 D- 20 D of  FIG. 20A .  
     
    
     DETAILED DESCRIPTION  
       [0094]     As shown in the Figures, there are three basic components for the needleless transfer of medication between a container  10  and a syringe. Besides the syringe, which may be needleless, the invention makes use of a stopper  20  and a plug  30  in the stopper  20 .  
         [0095]     The syringe, such as the syringe  40  of  FIG. 4A , may be of any commercially available type, including the Luer-lock type shown in the Figures.  
         [0096]     It is the combination of the stopper  20  and the plug  30  that permits the needleless transfer of medication with reduced danger of pathogen and other contamination.  
         [0097]     As shown in  FIG. 1A , the medicinal container  10  includes a bottle  12  with a top mouth portion  13  encircled by a flange  14  and sealed by a cover  15  that is instructed in  FIG. 1B  to be “flipped up” at a corner  16  and torn to expose the flange rim  17  of  FIG. 1C , which shows the stopper  20  in snug fit within mouth portion  13  of the bottle  12 . The stopper  20  may include a rib  21 , or the like, to improve the seal. The flange  14  overlies the top edge  18  of bottle  12 .  
         [0098]     The stopper  20  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as Teflon material. The stopper  20  has a throughbore  22 , which extends from an entry portion  23  to an exit portion or opening  24 .  
         [0099]     Aligned with the entry position  23  of the stopper  20  is the outer surface  33  of the plug  30 . Surrounding the plug  30  is a neck  25  of the stopper  20 . In  FIG. 1C  the neck the neck  25  is surrounded by a recess  26  below the entry position  23 . As indicated in  FIG. 2F , the neck  24  can have Luer threads  27  in the recess  26 .  
         [0100]     As more clearly shown in  FIGS. 2C and 2E , the bore  22  of the stopper  20  has side channels  28 - 1  through  28 - 4 , with the channel  26 - 2  having a bottom opening  28 - 0  in the side wall  29 , as shown in  FIG. 2D .  
         [0101]     Details of the plug  30  are shown in  FIGS. 3C through 3F . The plug  30  has an upper surface  31  with protrusions  32 - 1  through  32 - 4  in order to space the tip of an inserted fitment, as discussed below, from the surface  31  in order to allow fluid flow form the fitment to the surface  31 . The plug  30  also has longitudinal groove  33  in the side wall  34 .  
         [0102]     As shown in  FIG. 4A , which is an enlarged, partial sectional view of the container of  FIG. 1C , after removal of the cap  15 , a Luer fitment in the form of a syringe  40  has its tip  41  brought near the surface  31  of the plug  30 , preparatory to activation. The syringe  40  has its blunt tubular leading end tip  41  surrounded by a Luer threaded housing  42 , includes a plunger (not shown) and is calibrated with indicia which permit a proper dosage of medication to be withdrawn into the barrel  43  of the syringe  40 .  
         [0103]     As indicated in  FIG. 4B , when the tip  41  is brought into contact with the protuberances  32 - 1  through  32 - 4 , and the housing  42  is pushed into the groove  26 , the plug  30  is depressed into the bore  22  and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe.  
         [0104]     In actual practice, blunt end  41  is inserted against the plug  30  and into the bore  21  with the plunger extended. For the withdrawal of fluid, air is injected into the container  10  to pressurize contained fluid and facilitate its withdrawal. The plunger can be drawn out of the barrel  43  of the syringe  40  to the position appropriate for a desired dosage. There is an interference fit between blunt nose end  44  and the bore  22  to effectively grip the syringe in the stopper during medication transfer to minimize spillage.  
         [0105]     As shown in  FIG. 5A , the alternative medicinal container  100  includes a bottle  120  with a top mouth portion  130  encircled by a flange  140  and sealed by a cover  150  that is instructed in  FIG. 5B  to be “flipped up” at a corner  16  and torn to expose the flange rim  170  of  FIG. 5C , which shows the stopper  200  in snug fit within mouth portion  130  of the bottle  120 . The stopper  200  may include a rib  210 , or the like, to improve the seal. The flange  140  overlies the top edge  180  of bottle  120 .  
         [0106]     The stopper  200  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as Teflon material The stopper  200  has a throughbore  220 , which extends from an entry portion  230  to an exit portion or opening  240 .  
         [0107]     Aligned with the entry portion  230  of the stopper  200  is the outer surface  330  of the plug  300 . Surrounding the plug  300  is a neck  250  of the stopper  200  to which the stopper  200  is frangibly connected. In  FIG. 5C , the neck  250  is surrounded by a recess  260  below the entry position  230 .  
         [0108]     As more clearly shown in  FIGS. 6C and 6E , the bore  220  of the stopper  200  has side channels  280 - 1  and  280 - 2  in the side wall  290 , as shown in  FIG. 6E .  
         [0109]     Details of the plug  300  are shown in  FIGS. 6C and 6F . The plug  300  has an upper surface  310  with protrusions  320 - 1  through  320 - 4  in order to space the tip of an inserted fitment, as discussed below, from the surface  310  in order to allow fluid flow from the fitment to the surface  310 . The plug  300  is attached to the stopper  200  by a circumferential frangible connection  311 . As shown in  FIG. 7A , which is an enlarged, partial sectional view of the container of  FIG. 5C , after removal of the cap  150 , a Luer fitment in the form of a syringe  400  has its tip  410  brought near the surface  310  of the plug  300 , preparatory to activation.  
         [0110]     The syringe  400  has its blunt tubular leading end tip  410  surrounded by a Luer threaded housing  420 , includes a plunger (not shown) and is calibrated with indicia which permits a proper dosage of medication to be withdrawn into the barrel  430  of the syringe  400 .  
         [0111]     As indicated in  FIG. 7B , when the tip  410  is brought into contact with the protuberances  320 - 1  through  320 - 4 , and the housing  420  is pushed into the groove  260 , the frangible connection  311  is severed and the plug  300  is depressed into the bore  200 , and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe.  
         [0112]     In actual practice, blunt end  410  is inserted against the plug  300  and into the bore  210  with the plunger extended. For the withdrawal of fluid, air is injected into the container  100  to pressurize contained fluid and facilitate its withdrawal. The plunger can be drawn out of the barrel  430  of the syringe to the position appropriate for a desired dosage. There is an interference fit between blunt nose end  440  and the bore  220  to effectively grip the syringe in the stopper during medication transfer to minimize spillage.  
         [0113]      FIG. 8A  is a partial sectional view of the container of  FIG. 1C  during activation by a cannula  40 ′, while  FIG. 8B  is a partial sectional view of the container of  FIG. 1C  during activation by a Luer fitment  40 .  
         [0114]      FIG. 8C  is a partial sectional view of the container of  FIG. 5C  during activation by a cannula  400 ′, while  FIG. 8D  is a partial sectional view of the container of  FIG. 5C  during activation by a Luer fitment  400 .  
         [0115]      FIG. 9A  is an enlarged, partial sectional view of another alternative embodiment of the invention preparatory to activation by a Luer fitment. The three basic components for the needleless transfer of medication between the container  500  and a needleless syringe  40  in  FIG. 9A  include the syringe  40 , a stopper  600  and a plug  700  for the stopper  600 .  
         [0116]     It is the combination of the stopper  600  and the plug  700  that permits the needleless transfer of medication with reduced danger of pathogen and other contamination.  
         [0117]     As shown in  FIG. 9A , the medicinal container  500  includes a bottle  512  with a top mouth portion  513  encircled by a flange  514  and sealed by a cover that has been torn away to expose the flange rim  517 , with the stopper  600  in snug fit within mouth portion  513  of the bottle  512 .  
         [0118]     The plug  700  in the stopper  600  includes a flange  721 , or the like, to fix the position of the plug  700  on the ledge  621  of the stopper  600 .  
         [0119]     The stopper  600  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as Teflon material. The stopper  600  has a throughbore  622 , which extends from an entry portion to an exit portion or opening.  
         [0120]     Aligned with the entry position of the stopper  600  is the outer surface  73  of the plug  700 . Surrounding the plug  700  is a neck  625  of the stopper  600 . The neck  625  is surrounded by a recess  626  below the entry position. The neck  625  can have Luer threads (not shown).  
         [0121]     The bore  622  of the stopper  600  has side channels  627 - 1  and  627 - 2 , and the side wall  629  is connected from side-to-side with outlets  628 - 1  through  628 - 4  as shown in  FIG. 9C .  
         [0122]     The plug  700  has an upper surface  731  with protrusions  732 - 1  through  732 - 4  in order to space the tip of an inserted fitment, as discussed below, from the surface  731  in order to allow fluid flow from the fitment to the surface  731 . The plug  700  also has lateral ledge  721  in the side wall  734 .  
         [0123]     As shown in  FIG. 9B , which is a sectional view of the container  500  after cap removal, a Luer fitment in the form of a syringe  40  has its tip  41  brought near the surface  731  of the plug  700 , preparatory to activation.  
         [0124]     The syringe  40  has its blunt tubular leading end tip  41  surrounded by a Luer threaded housing  42 , includes a plunger (not shown) and is calibrated with indicia which permit a proper dosage of medication to be withdrawn into the barrel  43  of the syringe  40 .  
         [0125]     As indicated in  FIG. 9B , when the tip  41  is brought into contact with the protuberances  732 - 1  through  732 - 4 , and the housing  42  is pushed into the groove  626 , the plug  700  is depressed into the bore  622  and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe.  
         [0126]     In actual practice, blunt end  41  is inserted against the plug  700  and into the bore with the plunger extended. For the withdrawal of fluid, air is injected into the container  500  to pressurize contained fluid and facilitate its withdrawal The plunger can be drawn out of the barrel  43  of the syringe  40  to the position appropriate for a desired dosage. There is an interference fit between blunt nose end  44  and the bore  622  to effectively grip the syringe in the stopper during medication transfer to minimize spillage.  
         [0127]     As the nose end  44  is pushed into the bore  622 , the flange  721  becomes disengaged from the ledge  621 , and the plug is retained by the elastically expanded side wall  629 . When the nose end  44  is withdrawn, the plug  700  returns to the configuration of  FIG. 9A .  
         [0128]      FIG. 10A  is an enlarged, partial sectional view of a further alternative embodiment of the invention preparatory to activation by a Luer fitment. Again, the three basic components for the needleless transfer of medication between the container  1000  and a needleless syringe  40  in  FIG. 9A  include the syringe  40 , a stopper  1600  and a plug  1700  for the stopper  1600   
         [0129]     It is the combination of the stopper  1600  and the plug  1700  that permits the needleless transfer of medication with reduced danger of pathogen and other contamination.  
         [0130]     As shown in  FIG. 10A , the medicinal container  1000  includes a bottle  1512  with a top mouth portion  1513  encircled by a flange  1514  and sealed by a cover that is torn away to expose the flange rim  1517 , with the stopper  1600  in snug fit within mouth portion  1513  of the bottle  1512 . The plug  1700  in the stopper  1600  includes an intermediate rim  1721 , or the like, to fix the position of the plug  1700  against the indent  1621  of the stopper  1600 .  
         [0131]     The stopper  1600  has a throughbore  1622 , which extends from an entry portion to an exit portion or opening. Aligned with the entry portion of the stopper  1600  is the outer surface  1731  of the plug  1700 . Surrounding the plug  1700  is a neck  1625  of the stopper  1600 . The neck  1625  is surrounded by a recess  1626  below the entry position. The neck  1625  can have Luer threads (not shown).  
         [0132]     The side wall  1629  is connected from side-to-side with outlets  1628 - 1  through  1628 - 4  as shown in  FIG. 9C .  
         [0133]     The plug  1700  has an upper surface  1731  with protrusions, of which protrusions  1732 - 1  through  1732 - 3  are visible in  FIGS. 10A and 10B  in order to space the tip of an inserted fitment, as discussed below, from the surface  1731  in order to allow fluid flow from the fitment to the surface  1731 .  
         [0134]     As indicated in  FIG. 10B , when the tip  41  is brought into contact with the protuberances  1732 - 1  through  1732 - 4 , and the housing  42  is pushed into the groove  1626 , the plug  1700  is depressed into the bore  1622 , creating side channels  1627 - 1  and  1627 - 2 , and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe.  
         [0135]     As the nose end  44  is pushed into the bore  1622 , the flange  1721  becomes disengaged from the ledge  1621 , and the plug is retained by the elastically expanded side wall  1629 . When the nose end  44  is withdrawn, the plug  1700  returns to the configuration of  FIG. 10A .  
         [0136]     An alternative, single-use vial  100 ′ in accordance with the invention, in partial sectional view, is shown in  FIG. 11A . The medicinal container  100 ′ includes a bottle  120  with a top mouth portion  130  encircled by a flange  140  The cover seal  15  of  FIGS. 1A-1C  has been omitted in  FIG. 11A , and the flange rim  170  is exposed surrounding a stopper  1200  in snug fit within the mouth portion  130  of the bottle  120  The stopper  1200  may include an external ring  1213 , or the like, that engages the interior wall  122  of the bottle  120  below the rim  121  to improve the seal. The flange  140  overlies the top edge  180  of bottle  120 .  
         [0137]     The stopper  1200  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as Teflon material. The stopper  1200  has a throughbore  1222 , which extends from an entry portion  1223  to an exit portion or opening  1224 .  
         [0138]     Aligned with the entry position  1223  of the stopper  1200  is the outer surface  1333  of a plug  1300  Surrounding the plug  1300  is an engagement neck  1225  of the stopper  1200 . Further engagement of the plug  1300  with the stopper  1200  is by ribs  1301  of the plug  1300 .  
         [0139]     Details of the plug  1300  are shown in  FIGS. 16A through 19C .  
         [0140]     Use of the single-use vial of  FIG. 11A  is illustrated in the partial sectional view of  FIG. 11B . As shown in  FIG. 11B , a Luer fitment in the form of a syringe  40  has its tip  41  brought near the surface  31  of the plug  1300 , preparatory to activation. The syringe  40  has its blunt tubular leading end tip  41  surrounded by a Luer threaded housing  42 , includes a plunger (not shown) and is calibrated with indicia which permit a proper dosage of medication to be withdrawn into the barrel  43  of the syringe  40 .  
         [0141]     When the tip  41  is brought into contact with the plug  1300 , it is depressed into the bore  1222  and fluid can be exchanged between the syringe and the container  100 ′. The flow is from the bore of the syringe through channels between the plug  1300  and the stopper  1200 .  
         [0142]      FIGS. 11   a  and  11 B illustrate single-use vial access. However, the invention also provides multiple vial access as illustrated in the partial sectional view of  FIG. 12A . Multi-use is achieved by employing a multi-use lock connector  1300 ′ in place of the plug  1300 . The multi-lock connector  1300 ′ is discussed in detail below.  
         [0143]     When the vial  120  is provided with a plug  1300 , it is pushed into the vial as illustrated in  FIG. 11C .  
         [0144]     In replacing the plug  1300 , the lock connector  1300 ′ pushes the plug  1300  into the vial  120 . Other techniques can be used for pushing the plug  1300  into the vial  120  before introducing the lock connector  1300 ′.  
         [0145]     The lock connector  1300 ′ is secured in the stopper  1200  by having its detent ring  1310  engage the external ring  1213  of the stopper  1200 .  
         [0146]     In use, the syringe  43  is brought into contact with the corrugated inner plug  1370  and locked on Luer threads  1352  of the housing  1350  of the lock connector  1300 ′.  
         [0147]     With reference to  FIG. 12B , the sectional view of the lock connector  1300 ′ for the multiple-use vial  120  of  FIG. 12A , is formed by the inner plug  1370  which has a head  1371  containing a slot  1373  below a depression  1372  in the head, which extends to side walls  1373  by a corrugated extension  1374  to an end  1375 . The inner plug  1370  is surrounded by an upper housing  1350  which is joined to a lower housing  1360  at a recess  1366 , which accommodate a side wall  1354  of the upper housing  1350 . In order to accommodate a Luer fitment, the upper housing  1350  includes a Luer thread  1352 . The head  1371  engages an internal collar  1353  of the upper housing  1350 . When the inner plug  1370  is depressed, for example, by the tip of a Luer fitment, the inner plug  1370  is depressed into the bore  1365  with the slot  1373  continuing in a closed position until the head  1371  passes from an upper collar  1361 , which has substantially the same inner diameter as the internal collar  1353  of the upper housing  1350 , to a lower collar  1362 , which has a reduced inner diameter so that further depression of the inner plug  1370  opens the slit  1373  and allows fluid passage from a Luer fitment through the inner plug  1370  out of its lower end  1375 .  
         [0148]     A full scale top view of the lock connector  1300 ′ is shown in  FIG. 13A , and a full scale side view is shown in  FIG. 13B .  
         [0149]     An enlarged top view of the lock connector  1300 ′ of  FIG. 13B  is shown in  FIG. 14A  and, a sectional view, taken along the lines  14 B- 14 B of  FIG. 14A , is shown in  FIG. 14B . In  FIG. 14A , the slit  1373  is in a perpendicular position corresponding to the position shown in the full scale presentation of  FIG. 13A .  
         [0150]      FIG. 15A  is an alternative top view of the lock connector  1300 ′ of  FIG. 14A , after rotation through 90 degrees, and  FIG. 15B  is a sectional view, taken along the lines  15 B- 15 B of  FIGS. 14A and 15B , of the lock connector  1300 ′ of  FIGS. 14A and 15A . Consequently, the slit  1373  occupies a horizontal position that is 90° displaced with respect to  FIG. 15A .  
         [0151]      FIG. 16A  shows an enlarged sectional view of the moveable plastic plug  1300  of  FIGS. 11A, 11B  and  12 A. The plug  1300  has an upper surface  1331  with ribs  1301 - 1  through  1301 - 4  in order to provide a suitable seal in relation to the inner wall of the stopper  1200 . The top surface includes a depression  1302  in order to facilitate flow from an engaging Luer tip from the depression  1302  between the ribs  1301  through into the vial  120 .  
         [0152]      FIG. 16B  is an unsectioned bottom view of the enlarged plastic plug  1300  of  FIG. 16A ;  FIG. 17A  is a side view of the moveable plastic plug  1300  of  FIG. 16B ; and  FIG. 17B  is a top view of the enlarged plastic plug  1300  of  FIG. 17A . In a illustrative embodiment of the invention, the plug  1300  was fabricated of medical grade polypropylene.  
         [0153]      FIG. 18A  is a full scale top view of the resilient stopper  1200  for single and multiple use vials of  FIGS. 11A, 11B  and  12 A, and  FIG. 18B  is a full scale side view of the resilient stopper  1200  of  FIG. 18A .  
         [0154]     As shown in  FIG. 19A , which is an enlarged top view of the resilient stopper  1200  of  FIG. 18A , a collar  1215  surrounds a bore  1202  which includes an internal ring  1210  for secure engagement with the plug inserted into the stopper  1200 .  
         [0155]     In  FIG. 19B , which is an enlarged side view of the stopper  1200  of  FIG. 18B , an external ring  1213  is provided to achieve secure engagement with the vial  120  into which the stopper is inserted. Both the external ring  1213  and the internal ring  1210  are further illustrated in  FIG. 19C , which is a sectional view, taken along the lines  19 C- 19 C of  FIG. 18A . In an illustrative embodiment of the invention, the stopper  1200  was fabricated from bromobutyl compound FM257/2 with a durometer (Shore hardness of 50±5).  
         [0156]      FIG. 20A , which is a full scale side view of an alternative stopper  1200 ′ in accordance with the invention, an external ring  1253  is provided for enhanced engagement with the vial and a slot  1254  facilitates insertion of the alternative stopper  1200 ′ for needle access. Other views of the alternative stopper  1200 ′ are provided by  FIG. 20B , which is a full scale top view of  FIG. 20A .  
         [0157]      FIG. 20C  is an enlarged side view of the alternative stopper  1200 ′ of  FIG. 20A  shown in section in  FIG. 20C , taken along the lines  20 C- 20 C of  FIG. 20B , and in  FIG. 20D , taken along the lines  20 D- 20 D of  FIG. 20A .  
         [0158]     Various changes, alternatives and modifications will become apparent to a person of ordinary skill in the art following a reading of the foregoing specification. It is intended that all such changes, alternatives and modifications as fall within the scope of the appended claims be considered part of the present invention.

Technology Classification (CPC): 0