Abstract:
An adapter for mounting on drug vial of various sizes to provide needleless access to the interior of each vial regardless of its size. The adapter includes sharpened cannula surrounded by peripheral sidewall. The peripheral sidewall includes an upper portion and a lower skirt flaring outward from the upper portion and terminates in a peripheral free edge extending beyond the sharpened end of the cannula to protect users from an accidental needle-stick. The sidewall includes plural equidistantly spaced projections extending radially inward to form a ledge also has slits extending upward from the peripheral edge of the skirt to enable portions of the sidewall including the projections to flex outward. By so doing the cap of the vial is enabled to pass between the projections and then return to a position wherein the ledge has inside diameter just slightly less than the outside diameter of the rim of the cap to releasably secure the adapter to the vial with the cannula piercing through the septum of the cap.

Description:
BACKGROUND OF THE INVENTION 
     This invention relates generally to vial access devices, and more particularly to an adaptor device for use with conventional pierceable-septa vials of different sizes to provide needle-less access to the interior thereof. 
     Conventional vials for containing drugs and the like typically comprise a cylindrical glass body closed at the bottom and terminating upwardly at a narrowed neck to an opening. The opening is closed or covered by a cap. The cap is usually formed of metal includes a pierceable septum formed of an elastomeric material, such as latex rubber or the like. The septum is arranged to be pierced by a sharp cannula or needle to either introduce or withdraw a fluid into/out of the vial. Upon withdrawal of the cannula/needle the septum reseals itself to maintain a sterile environment in the vial. 
     Various devices have been disclosed in the patent literature for penetrating the septum of a drug vial. For example, in U.S. Pat. Nos. 5,839,715 (Leinsing) and 6,142,446 (Leinsing) there is disclosed medical adaptors having both a needleless valve and a sharpened cannula for use with pierceable septa containers, e.g., drug vials, or other devices having different sizes. The adaptor includes a needle-less site at one end and a sharpened cannula at the other end protected by spring arms. The arms include claws at their distal ends to grasp the neck of the vial to which the sharpened cannula is to be inserted. The claws include sharpened points for gripping the device. The arms are located on either side of the adaptor body and are connected to the body through springs. Handles are also included on the arms for use by the operator to separate the arms against the spring forces during engagement of the adaptor with the septum. In one case, the handles include finger grips located above the springs for pressing the handles inward to open the arms and claws and in another case, the handles are located closer to the distal ends of the arms for pulling the arms outward. The adaptor in one case comprises only three parts for reduced materials and manufacturing expense. 
     Other adaptors for accessing the interior of a pierceable septum drug vial are found in U.S. Pat. No. 5,393,497 (Haber), U.S. Pat. No. 5,429,614 (Fowles et al.), and U.S. Pat. No. 6,113,583 (Fowles et al.). 
     While the foregoing devices may be suitable for their intended purposes they never the less leave something to be desired from one or more of the standpoints of simplicity of construction, easy of use, ability to be used with various size vials, and protection from accidental sticking of personnel. 
     SUMMARY OF THE INVENTION 
     An adaptor device for respective releasable mounting on first and second vials, e.g., drug vials, to provide needle-less access to the interior of each vial. Each vial is of conventional construction, e.g., a cylindrical glass body having a closed bottom and terminating upwardly at a narrowed neck to an opening that is closed by a cap that includes a pierceable septum formed of an elastomeric material. The cap includes a cylindrical rim of predetermined outside diameter that surrounds the septum. The predetermined outside diameter of the rim of the first vial is smaller than the predetermined outside diameter of the rim of the second vial. 
     The adaptor device comprises a longitudinal central axis along which a piercing member, e.g., sharpened cannula, extends and a peripheral sidewall surrounding the piercing member. The piercing member is hollow and terminates at a sharpened end arranged to pierce through the septum of the vial to which the device is releasably mounted. The peripheral sidewall includes an upper portion having a circular inner surface centered around the piercing member and a lower skirt flaring outward from the upper portion. The skirt terminates in a peripheral free edge extending beyond the sharpened end of the piercing member. 
     The peripheral sidewall of the adaptor includes a plurality, e.g., six, of slits extending upward from the peripheral edge of the skirt to enable portions of the sidewall between those slits to flex outward. The sidewall also includes plural equidistantly spaced projections, e.g., two groups of three projections each, extending radially inward adjacent the inner surface of the upper portion of the sidewall to form a ledge. These projection are resiliently mounted on the sidewall to enable the cap of the first vial to pass between the projections and then return to a position wherein the ledge has inside diameter just slightly less than the outside diameter of the rim of the first vial to form a seat on which the rim of the first vial may sit to releasably secure the adaptor to the cap of the first vial, and with the rim of the first vial being adjacent the inner surface of said sidewall and the sharpened end of the piercing member piercing through the septum of the first vial. The resilient mounting of the projections also enables the cap of the second vial to pass between the projections and then return to a position wherein the ledge has an inside diameter just slightly less than the outside diameter of the rim of the second vial to form a seat on which the rim of the second vial may sit to releasably secure the adaptor to cap of the second vial, with the rim of the second vial being adjacent the inner surface of the sidewall and with the sharpened end of the piercing member piercing through the septum of the second vial. 
     In accordance with one exemplary preferred embodiment of this invention the adaptor includes a top wall having a peripheral edge from which the sidewall projects and a tubular member secured to the top wall and extending along the longitudinal axis. The tubular member has a central passageway in fluid communication with the hollow piercing member to enable needle-less transfer of fluid therethrough. 
    
    
     DESCRIPTION OF THE DRAWING 
     FIG. 1 is an isometric view, looking downward from the top, of one exemplary embodiment of an adapter constructed in accordance with this invention; 
     FIG. 2 is an isometric view, looking upward from the bottom of the adaptor shown in FIG. 1; 
     FIG. 3 is a top plan view of the adaptor shown in FIG. 1; 
     FIG. 4 is a bottom plan view of the adaptor shown in FIG. 1; 
     FIG. 5 is a sectional view taken along line  5 — 5  of FIG. 3; 
     FIG. 6 is a side elevation view, partially in section, showing the adaptor of FIG. 1 mounted on a conventional small diameter pierceable capped vial; and 
     FIG. 7 is a side elevation view, similar to FIG. 6, showing the adaptor of FIG. 1 mounted on a conventional large diameter pierceable capped vial and being used with an injector device to introduce a liquid into the vial or to extract a liquid from the vial. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to FIG. 1, there is shown at  20  one exemplary embodiment of an adaptor device constructed in accordance with this invention for use with either small diameter pierceably capped vials  10 A (FIG. 6) or large diameter pierceably capped vials  10 B (FIG.  7 ). The adaptor  20  is arranged to be releasably mounted on either of those vials to pierce through the vial&#39;s cap (to be described hereinafter) to enable a liquid to be introduced through the adaptor into the vial and/or to be removed from the vial via the adaptor. 
     Before describing the adaptor, a brief description of the vials  10 A and  10 B is in order. To that end both vials are of identical construction except for their size. In particular vials  10 A and  10 B each include a glass bottle or vial  12  that closed at its bottom end (not shown) and terminates in an upwardly directed narrowed cylindrical neck  14  forming the opening or mouth  16  (FIGS. 6 and 7) to the interior of the vial. The mouth  16  is closed or covered by a cap  18 . The cap includes a circular, generally planar top wall  18 A and a cylindrical rim or circular sidewall  18 B. As is conventional, the cap is typically formed of metal, e.g., stainless steel. The top wall of the cap includes a central circular opening  18 C. The central opening  18 C in each cap is closed by a thin, planar, pierceable disk-like septum  18 D located centered under the top wall. The septum  18 D is formed of an elastomeric material, such as latex rubber or the like. When the cap  18  is secured onto the neck  14  of the bottle  12 , the septum  18 D overlies the bottle&#39;s mouth as best seen in FIGS. 6 and 7. 
     As mentioned earlier the device  20  can be used with various conventional pharmaceutical vials. In the exemplary embodiments, the outside diameter of the cap  18  small vial  10 A is approximately 1.75 cm, the outside diameter of the cap of the large vial  10 B is approximately 2.06 cm, the diameter of the central opening  18 C of the small vial  10 A is approximately 0.95 cm, and the diameter of the central opening  18 C of the large vial  10 B is approximately 0.95 cm. All other features of the two vials  10 A and  10 B are the same. 
     The septum  18 D is arranged to be pierced by a sharp cannula portion (to be described later) of the adaptor when the adaptor is mounted on the vial&#39;s cap to either introduce or withdraw a fluid into/out of the vial. The fluid can be introduced and/or withdrawn by any conventional device, such as a syringe or injector  100  shown in FIG. 7, coupled to the adaptor. Upon removal of the adaptor, the cannula is withdrawn back out through the septum, whereupon the septum reseals itself to maintain a sterile environment for anything remaining within the bottle  12 . 
     The details of the adaptor device  20  will now be described. To that end, as best seen in FIGS. 1 and 2, the adaptor device  20  basically comprises a cup-shaped, hollow member formed of any suitable material, e.g., a tough, somewhat flexible plastic such as polycarbonate, having a generally planar, circular top wall  22  from which a peripheral sidewall  24  extends downward centered about a central longitudinal axis  26 . The adaptor is preferably an integral or one-piece member molded of the heretofore identified plastic. 
     As best seen in FIG. 1, the sidewall  24  includes three portions, namely, an upper portion  24 A which flares slightly outward and terminates at its lower end in an intermediate portion in the form of an angularly extending peripheral skirt  24 B. The lower end of the skirt  24 B terminates at the third portion of the sidewall, namely, an annular flange  24 C. Thus, the sidewall  24  is made up of the three portions  24 A,  24 B and  24 C. 
     As best seen in FIGS.  2  and  5 - 7 , an elongated tubular cannula  28  projects downward from the inner surface of the top wall  22  along the central longitudinal axis  26  and terminates at a sharpened or pointed, e.g., conical, free end  30 . The free end forms a piercing tip. The piercing tip  30  terminates slightly above the plane of the bottom of the annular flange  24 C, as best seen in FIG. 5, so that the piercing tip is not exposed. This is of considerable importance to prevent persons using the device from being accidentally stuck by the tip  30 . 
     A conventional tubular connector  32  extends upward from the outer surface of the top wall  22  centered about the central longitudinal axis  26 . The connector  32  includes a central bore  34  extending through it in axial alignment with a central bore  36  extending through the cannula  28 . The two bores  34  and  36  conjoin and taper slightly from the top or free end  38  of the connector  32  to the piercing tip  30  of the cannula  28  to form a central passageway through the adaptor  20 . A pair of ports or outlets  40  are located in the conical tip  30  at diametrically opposed positions (see FIGS. 5-7) and are in fluid communication with the bore  36 . The tubular connector is arranged to accommodate the tip  102  of a conventional syringe  100  or some other device therein, as shown in FIG. 7, whereupon fluid introduced by the syringe into the adaptor&#39;s connector  32  will pass through the bores  34  and  36  and out through the ports  40  in the piercing tip to flow into the vial  10 A or  10 B when the adaptor is connected thereto (as will be described later). 
     As best seen in FIGS. 3 and 4 the adaptor  20  includes a plurality of slits  42 ,  44 ,  46 ,  48 ,  50  and  52  about the periphery of the adaptor  20 . Each of the slits extends upward the full height of the sidewall  24  and slightly radially into the top wall  22 , i.e., from the bottom of the flange  24 C to the top wall  22 . The slits in the adaptor&#39;s sidewall enable portions of the sidewall between them to flex outward to enable the adaptor  20  to readily snap-fit on the cap of the vial  10 A or the vial  10 B, as will be described later. The slits  42 ,  46  and  50  are equidistantly spaced from one another about the periphery of the adaptor&#39;s sidewall. The slits  44 ,  48  and  52  are also equidistantly spaced from one another about the periphery of the adaptor&#39;s sidewall. The spacing between the immediately adjacent slits  44  and  46  is the same as the spacing between the immediately adjacent slits  48  and  50 , and  52  and  42 . In a similar manner, the spacing between the immediately adjacent slits  42  and  44  is the same as the spacing between the immediately adjacent slits  46  and  48 , and  50  and  52 . However, the spacing between the immediately adjacent slits  42  and  44 ,  46  and  48 , and  50  and  52  is greater than that between the immediately adjacent slits  44  and  46 ,  48  and  50 , and  52  and  42 . 
     The sidewall  24  of the adaptor  20  includes plural projections which form expandable discontinuous ledges on which the caps of vials  10 A and  10 B rest when the adaptor is mounted on those vials. In particular, as can be seen in FIGS. 2 and 4 and as will be described hereinafter, the adaptor  20  includes two groups of three projections each, extending radially inward adjacent the inner surface  54  of the upper portion  24 A of the sidewall  24  to form respective ledges. For example, the inner surface of the sidewall between slits  44  and  46  includes a projection extending inward radially to form a ledge  56 , the inner surface of the sidewall between slits  48  and  50  includes a projection extending inward radially to form a ledge  58 , and the inner surface of the sidewall between slits  52  and  42  includes a projection extending inward radially to form a ledge  60 . The ledges  56 ,  58  and  60  form the first group of projections and are equidistantly spaced from one another about the central axis  26 . Moreover, they are located at the same height on the inner surface of the adaptor&#39;s sidewall  24 . Each of the individual ledges of the first group is in the form of an arcuate wall extending across the inner surface  54  of the adaptor&#39;s sidewall between contiguous slits. Together the individual ledges  56 ,  58  and  60  form a first discontinuous circular ledge on which the underside of the rim  18 B of the cap of the large vial  10 B rests when the adaptor is mounted on that vial. In particular, the inside diameter of the first discontinuous circular ledge is just slightly smaller than the outside diameter of the rim  18 B of the large vial&#39;s cap  18 . 
     Since the portions of the sidewall  24  from which the ledges  56 ,  58  and  60  project are separated from one another by the slits  44  and  46 ,  48  and  50 , and  52  and  42 , respectively, those portions of the sidewall  24  are arranged to flex or bend slightly outward when the adaptor is placed on the cap  18  of the large vial  10 B. This action effectively temporarily enlarges or expands the inside diameter of the first discontinuous ledge to enable the cap  18  to pass thereby, whereupon the portions of the adaptor&#39;s sidewall holding the projections  56 ,  58  and  60  snap back into place. Once this has occurred the inside diameter of the first discontinuous ledge is again just slightly less than the outside diameter of the rim of the vial to form a seat on which the rim of the vial sits to releasably secure the adaptor that vial. When so mounted the rim  18 B of the vial  10 B is located adjacent the inner surface  54  of the sidewall  24 , with the sharpened end  30  of the piercing member  28  piercing through the septum  18 D of the vial as shown in FIG.  7 . Thus, the ports  40  in the tip  30  are in fluid communication with the interior of the vial. 
     In order to facilitate the passage of the cap  18  through the first discontinuous circular ledge formed by projections  56 ,  58  and  60  to mount the adaptor on the vial  10 B, the underside of each of those ledges is in the form of a cam surface  62  (FIGS.  2  and  5 ). 
     Mounting of the adaptor  20  on the cap of the vial  10 B so that the cannula pierces the system  18 D of the cap is as follows: The adaptor  20  is positioned over the cap  18  and pressed downward so that the cap enters the hollow interior of the adaptor. This causes the piercing tip to pierce through the cap&#39;s system. Continued downward pressure on the adaptor or upward pressure on the vial (or pressure from both directions) causes the top surface  18 A of the cap  18  of the vial  10 B contiguous with its rim to engage the undersurface  62  of the ledges  56 ,  58  and  60 . Further pressure on the adaptor (or vial or both) causes the engaging portion of the cap to ride along the cam surfaces  62  of the ledges  56 ,  58  and  60  to cause the portions of the sidewall mounting those ledges to flex outward slightly until the rim of the cap clears the inner surface of the ledges, whereupon those portions of the sidewall will immediately snap-back into place to seat the adaptor on the cap of the vial. 
     The top surface of each of the ledges  56 ,  58  and  60  is also in the form of a cam surface  64 . This surface facilitates the passage of the cap through the discontinuous circular ledge to remove the adaptor  20  from the vial  10 B when it is desired to do so. In this regard when it is desired to remove the adaptor  20  from the vial  10 B all that is required is to pull the two apart, whereupon the underside of the rim  18 B of the cap will ride across the cam surface  64  of each of the ledges  56 ,  58  and  60 . This action will cause the portions of the sidewall mounting those ledges to flex outward slightly until the rim of the cap clears the inner surface of the ledges, whereupon the cap is freed from the adaptor and those portions of the sidewall will immediately snap-back into place. 
     In order to mount the adaptor  20  onto the cap  18  of the smaller vial  10 A, the adaptor  20  also includes a second group of projections. This second group is also made up of three resiliently mounted projections  66 ,  68  and  70 . In particular, each of these projections is in the form of a cantilevered finger defined within the bounds of an inverted U-shaped slot  72  in the upper portion  24 A and contiguous skirt portion  24 B of the sidewall  24 . For example, the inner surface of the sidewall between slits  46  and  48  includes an inverted U-shaped slot  72  bounding the projection  66 . The projection  66  extends inward radially to form a ledge. In a similar manner the inner surface of the sidewall between slits  50  and  52  includes an inverted U-shaped slot  72  bounding the projection  68 . The projection  68  extends inward radially to form a ledge. Lastly, the inner surface of the sidewall between slits  42  and  44  includes an inverted U-shaped slot  72  bounding the projection  70 . The projection  70  extends inward radially to form a ledge. The ledges  66 ,  68  and  70  form the second group and are equidistantly spaced from one another about the central axis  26  and are located at the same height with respect to the adaptor&#39;s sidewall  24 . Each of the individual ledges of the second group is in the form of an arcuate wall extending across the inner surface  54  of the adaptor&#39;s sidewall bounded by its associated U-shaped slot  72 . Together the individual ledges  66 ,  68  and  70  form a second discontinuous circular ledge. It is on this second discontinuous ledge that the underside of the rim  18 B of the cap  18  of the small vial  10 A rests when the adaptor is mounted on that vial. In particular, the inside diameter of the second discontinuous circular ledge is just slightly smaller than the outside diameter of the rim  18 B of the cap  18  of the small vial  10 A. 
     Since the portions of the sidewall  24  from which the ledges  66 ,  68  and  70  project are separated from the contiguous portions of the sidewall  24  by the U-shaped slots  72 , those portions of the sidewall are arranged to flex or bend slightly outward when the adaptor is placed on the cap  18  of the small vial  10 A. This action effectively enlarges the inside diameter of the second discontinuous ledge to enable the cap  18  to pass thereby, whereupon the portions of the adaptor holding the projections  66 ,  68  and  70  snap back into place. Once this has occurred the inside diameter of the second discontinuous ledge is again just slightly less than the outside diameter of the rim of the vial to form a seat on which the rim of the vial may sit to releasably secure the adaptor that vial. When so mounted the rim  18 B of the vial  10 A is located adjacent but spaced from the inner surface  54  of the sidewall, with the sharpened end  30  of the piercing member  28  piercing through the septum  18 D of the vial as shown in FIG.  6 . 
     In order to facilitate the passage of the cap  18  of the small vial  10 A through the second discontinuous circular ledge formed by the projections  66 ,  68  and  70  to mount the adaptor on the vial  10 A, the underside of each of those ledges is in the form of a cam surface  74  (FIGS. 5-7) to facilitate the mounting of the adaptor  20  onto that vial. The top surface of each of the projections or ledges  66 ,  68  and  70  is also in the form of a cam surface  76  (for reasons that will be appreciated from the discussion to follow). A radially directed slot  78  is located in the top surface  76  of each of the ledges  66 ,  68  and  70 . 
     When the adaptor  20  is to be mounted on the small vial  10 A, it is disposed over the cap of the vial so that the cap is within the hollow interior of the adaptor. The adaptor is then pressed downward or the vial pressed upward (or both are pressed together). This action causes the top surface  18 A of the cap  18  of the vial  10 A contiguous with its rim to engage the undersurface  74  of the fingers or ledges  66 ,  68  and  70 . Further pressure on the adaptor (or vial or both) will cause the engaging portion of the cap to ride along the cam surfaces  74  of the underside of the ledges  66 ,  68  and  70  to cause the portions of the sidewall bounded by the associated U-shaped slots  72  and which mount those projections to flex outward slightly until the rim of the cap clears the inner surface of the ledges. Once this has occurred the portions of the sidewall mounting the projections  66 ,  68  and  70  will immediately snap-back into place to seat the adaptor on the cap of the vial. In particular, the underside of the rim  18 B of the cap  18  will rest on the cam top surface  76  of each of the projections  66 ,  68  and  70 . As will be appreciated by those skilled in the art, since the top surface  76  is in the form of a cam or slope the adaptor  20  can accommodate other sized vials whose caps are smaller than the cap of vial  10 B but larger than the cap of vial  10 A. Moreover, since the top surface of each of the ledges  66 ,  68  and  70  is in the form of a cam surface  64 , these surfaces facilitate the passage of the cap through the second discontinuous circular ledge formed by those projections to remove the adaptor  20  from the vial  10 A when it is desired to do so. In this regard when it is desired to remove the adaptor  20  from the vial  10 A all that is required is to pull the two apart, whereupon the underside of the rim  18 B of the cap will ride across the cam surface  76  of each of the fingers or ledges  66 ,  68  and  70 . This action will cause the portions of the sidewall mounting those ledges to flex outward slightly until the rim of the cap clears the inner surface of the ledges, whereupon the cap is freed from the adaptor and those portions of the sidewall will immediately snap-back into place. 
     It should be appreciated by those skilled in the art that when the adaptor  20  is mounted to the large cap vial  10 B, the cap of that vial must also pass by the projections or fingers  66 ,  68  and  70  in order to be seated on the first discontinuous ledge (i.e., the ledge formed by the projections  56 ,  58  and  60  as described earlier). Thus, when the adaptor  20  is to be mounted on the large cap vial  10 B by placing the cap of the vial in the interior of the adaptor and pressing downward onto the adaptor or upward on the vial (or in both directions) the cannula will pierce the system and the top surface  18 A of the cap contiguous with the rim  18 B will engage the cam surface  74  on the underside of each of the projections  66 ,  68  and  70 . Further pressure on the adaptor (or vial or both) will cause the engaging portion of the cap to ride along those cam surfaces to cause the portions of the sidewall mounting the ledges to flex outward slightly until the rim of the cap clears the inner surface of the ledges. Continued pressure on the vial, adaptor or both brings the top surface  18 A of the cap contiguous with the rim into engagement with the undersurface  62  of the ledges  56 ,  58  and  60  to cause them to begin to flex outward as described above. Continued pressure will also cause those portions of the sidewall mounting the ledges  56 ,  58  and  60  to flex outwardly by a sufficient distance so that the cap clears them, whereupon those portions of the sidewall will immediately snap-back into place to seat the adaptor on the cap of the vial as described above. 
     As will be appreciated by those skilled in the art during the removal of the adaptor  20  from the vial  10 B, the underside of the cap&#39;s rim  18 B will also ride across and down the cam top surface of each of the ledges  66 ,  68  and  70  in addition to riding down the cam top surface  64  of the ledges  56 ,  58  and  60 . This latter action causes the portions of the sidewall mounting the  66 ,  68  and  70  ledges to flex slightly outward until the cap clears those ledges, whereupon the cap will be freed from the adaptor. 
     Without further elaboration the foregoing will so fully illustrate my invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.