Abstract:
A method of sterile needless vial access, utilized to transfer materials from one unit to another. The method utilizes a swab-able access port and a blunt cannula. The access port receives the blunt cannula to couple and aseptically transfer medical and body fluids. The swab-able access port permits disinfectant treatment before receipt of the blunt cannula to limit and prevent contamination of sterile fluids.

Description:
FIELD OF THE INVENTION 
     This invention relates to coupling systems for one transfer of materials from one unit to another, and, more particularly, to coupling units with a first unit including a 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 cannula to limit the extent to which pathogens can enter the cannula after coupling is effected. 
     BACKGROUND OF THE INVENTION 
     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 aministration to a patient. 
     The need for a needle or 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. 
     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. 
     In additional to medicinal containers, pointed needles or annulae have been widely used in conjuction with other forms of access ports, which take the form of a septum or piercable membrane. An illustrative access port that is used with a piercing cannula is disclosed in Zdeb U.S. Pat. No. 4,412,573 “Injection Site” assigned to Baxter International Inc. of Deerfield, Ill. 
     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. 
     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. 
     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. 
     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. 
     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. 
     One attempted solution has been to eliminate sharp cannulae and use blunt cannulae instead. An example is Garrett et al. U.S. Pat. No. 4,197,848 “Closed Urinary Irrigation Site”, assigned to Baxter International. In Garrett the injection site is a relatively low pressure device with 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. 
     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. 
     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. 
     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. 
     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. 
     One 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 openings that allow 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 permit locking engagement of the adapter with injection site to standard vials, despite dimensional variations in vial closures. The coupling spike can having 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. 
     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 
     In accomplishing the foregoing and related objectives, the invention provides for a swabbable access port formed by a stopper having a bore extending from an entry position to an exit position; and a swabbable plug in the bore at the entry position and movable in the bore. 
     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. 
     In accordance with another aspect of the invention the swabbable plug has a non-planar external surface and is pierceable by a cannula. The stopper can have a collar at the entry position, and the collar can have external Luer threads. 
     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. 
     In accordance with a method of the invention for accessing a port, the steps include (a) swabbing 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. 
     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 take place with respect to frangible connections to the bore. 
     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. 
     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; sretching 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. 
     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. 
     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. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     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: 
     FIG. 1A is a plan view of a stoppered medicinal container in accordance with the invention; 
     FIG. 1B is a top view of the stoppered medicinal container of FIG. 1A; 
     FIG. 1C is a partial sectional view of the stoppered medicinal container of FIG. 1A; 
     FIG. 2A is a full-scale side view of the stopper and plug of the medicinal container of FIG. 1A; 
     FIG. 2B is a full-scale top view of the stopper and plug of the medicinal container of FIG. 1A; 
     FIG. 2C is an enlarged sectional view of the stopper of the medicinal container of FIG. 1A; 
     FIG. 2D is a partial top view of the stopper of FIG. 2C; 
     FIG. 2E is a partial bottom view of the stopper of FIG. 2C; 
     FIG. 2F is an enlarged, partial sectional view of an alternative stopper collar portion of the invention; 
     FIG. 2G is an enlarged sectional view of an alternative stopper for the container of FIG. 1C; 
     FIG. 3A is a full-scale side view of the plug of the stopper of FIG. 2A; 
     FIG. 3B is a full-scale top view of the plug of the stopper of FIG. 2A; 
     FIG. 3C is an enlarged view of the plug of FIG. 3A; 
     FIG. 3D is an enlarged view of the plug of FIG. 3B; 
     FIG. 3E is a sectional view of the plug of FIG. 3C; 
     FIG. 3F is a bottom view of the plug of FIG. 3E; 
     FIG. 4A is an enlarged, partial sectional view of the container of FIG. 1C preparatory to activation by a Luer fitment; 
     FIG. 4B is an enlarged, partial sectional view of the container of FIG. 1C during activation by a Luer fitment; 
     FIG. 5A is a plan view of an alternative, stoppered medicinal container in accordance with the invention; 
     FIG. 5B is a top view of the stoppered medicinal container of FIG. 5A; 
     FIG. 5C is a partial sectional view of the stoppered medicinal container of FIG. 5A; 
     FIG. 6A is a full-scale side view of the stopper and plug of the medicinal container of FIG. 5A; 
     FIG. 6B is a full-scale top view of the stopper and plug of the medicinal container of FIG. 5A; 
     FIG. 6C is an enlarged sectional view of the stopper and plug of the medicinal container of FIG. 5A; 
     FIG. 6D is a partial top view of the stopper and plug of FIG. 6C; 
     FIG. 6E is a partial bottom view of the stopper of FIG. 6C; 
     FIG. 6F is an enlarged, partial sectional view showing the alternative stopper for the container of FIG. 5C; 
     FIG. 7A is an enlarged, partial sectional view of the container of FIG. 5C preparatory to activation by a Luer fitment; 
     FIG. 7B is an enlarged, partial sectional view of the container of FIG. 5C during activation by a Luer fitment; 
     FIG. 8A is a partial sectional view of the container of FIG. 1C during activation by a cannula; 
     FIG. 8B is a partial sectional view of the container of FIG. 1C during activation by a Luer fitment; 
     FIG. 8C is a partial sectional view of the container of FIG. 5C during activation by a cannula; 
     FIG. 8D is a partial sectional view of the container of FIG. 5C during activation by a Luer fitment; 
     FIG. 9A is an enlarged, partial sectional view of another alternative embodiment of the invention preparatory to activation by a Luer fitment; 
     FIG. 9B is an enlarged, partial sectional view of another alternative embodiment of the invention during activation by a Luer fitment; 
     FIG. 9C is a partial sectional view of the bottom of the stopper and plug combination of FIGS. 9A and 9B; 
     FIG. 10A is an enlarged, partial sectional view of still another alternative embodiment of the invention preparatory to activation by a Luer fitment; 
     FIG. 10B is an enlarged, partial sectional view of another alternative embodiment of the invention during activation by a Luer fitment; and 
     FIG. 10C is a partial sectional view of the bottom of the stopper and plug combination of FIG.  10 A. 
    
    
     DETAILED DESCRIPTION 
     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 . 
     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. 
     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. 
     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 . 
     The stopper  20  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as TEFLON M material. The stopper  20  has a throughbore  22  which extends from an entry portion  23  to an exit portion or opening  24 . 
     Aligned with the entry portion  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  25  is surrounded by a recess  26  below the entry position  23 . As indicated in FIG. 2F, the neck  24  can have Leur threads  27  in the recess  26 . 
     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.  2 D. 
     Details of the plug . 30  are shown in FIGS. 3C though  3 F. The plug  30  has an upper surface  31  with protrusions  32 - 1  though  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 from the fitment to the surface  31 . The plug  30  also has longitudinal groove  33  in the side wall  34 . 
     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 . 
     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. 
     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. 
     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  160  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 . 
     The stopper  200  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as TEFLON M material. The stopper  200  has a throughbore  220  which extends form an entry portion  230  to an exit portion or opening  240 . 
     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 . 
     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.  6 E. 
     Details of the plug  300  are shown in FIGS. 6C and 6F. The plug  300  has an upper surface  310  with protrusions  320 - 1  though  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. 
     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 permit a proper dosage of medication to be withdrawn into the barrel  430  of the syringe  400 . 
     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  220 , and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe. 
     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  400  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. 
     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 . 
     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 . 
     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 . 
     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. 
     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 . 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 . 
     The stopper  600  may be of an elastomeric, rubber-like material or a hard, self-lubricating plastic such as TEFLON Material material. The stopper  600  has a throughbore  622  which extends from an entry portion to an exit portion or opening. 
     Aligned with the entry portion of the stopper  600  is the outer surface  731  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 Leur threads (not shown). 
     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.  9 C. 
     The plug  700  has an upper surface  731  with protrusions  732 - 1  though  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 . 
     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. 
     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 . 
     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. 
     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. 
     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.  9 A. 
     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 Id 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 . 
     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. 
     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 . T he 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 . 
     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 Leur threads (not shown). 
     The side wall  1629  is connected from side-to side with outlets  1628 - 1  through  1628 - 4  as shown in FIG.  9 C. 
     The plug  1700  has an upper surface  1731  with protrusions, of which protrusions  1732 - 1  though  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 . 
     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 and fluid can be exchanged between the syringe and the container. The flow is through the channels and the bore of the syringe. 
     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.  11 A. 
     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.