Abstract:
A holding device for a container having a closure system to be pierced by a spike includes a base, a shield, and a mounting unit supporting the base. The base includes an elongate body having opposed first and second ends and an elongate body extending therebetween. The base body defines an elongate open spike cavity extending between opposing ends thereof. The channel receives an elongate spike therein so that a free end of the spike extends beyond the base body from the channel. The shield includes first and second opposed open ends and an elongate cylindrical wall extending therebetween. The shield is telescopically mounted over the base so as to be movable between a first position wherein an inserted spike is clear of inserted container cap and a second position wherein the spike pierces through the septum of the container cap at the intended location.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention is directed to the field of container holders. More specifically, the present invention is directed to a combination holder for both a spike and a container. 
       BACKGROUND OF THE INVENTION 
       [0002]    When using a container of a pharmaceutical to be provided intravenously, the art has seen different methods for securing that container while the pharmaceutical is dispensed or removed therefrom. For example, some bag containers include an eyelet or hangar hook by which the container may be suspended. The contents of the container may be withdrawn by a powered injector which draws the contents from the container for injection into a patient. Powered injectors may be used for multi-dosing of a contrast media and may provide both automated saline flushing and purging of the fluid conduits. Efficiency may be increased by the use of powered injectors as set-up can be relatively quick and very little contrast media is wasted between patients. 
         [0003]    Alternatively, when the container is a plastic or glass bottle, a label affixed to the container may include a pre-cut portion not affixed to the container so as to be able to deflect away from the container and provide a loop by which the container may be hung. U.S. Pat. No. 5,135,125 provides an example of a hangar label used to hang the container to which it is attached. The container typically includes a cap supporting a spike-pierceable septum, or closure, which, when the container is hung, faces the floor. The spike is inserted so as to project upward into the container as it hangs. Such containers provide a cheaper alternative to more expensive contrast media cartridges which provide a large syringe-like body with an internal piston for dispensing the contents. 
         [0004]    However, hanging containers also have several drawbacks. The hook on which the container hangs must in some cases be adjusted for each container. The spike which pierces the container&#39;s septum has a fixed height and may be inadvertently extended so far into the container that a large pool of product will collect between the spike tip and the top of the septum, causing that amount of product to go to waste. Improper setting of the hook may render the container unstable or otherwise improperly supported. Additionally, since the bottle and the spike typically tilts during use, and also because of the difficulty to properly center the spike when piercing the septum, there is the potential for leaks. 
         [0005]    There is therefore a need in the art for a bottle holder that can increase efficiency by reducing the time to arrange the bottle while still properly centering the spike through the septum. The holder should reduce the potential for wasted or unused contrast media by optimally positioning the spike at the lowest drain point in the bottle cap just inside the septum. Additionally, the holder should provide a cap opener for allowing easy removal of a protective tab on the container cap so as to expose the septum. Moreover, when the spike is provided with an openable vent, the holder should selectively provide for the opening of that vent. 
       SUMMARY OF THE INVENTION 
       [0006]    In view of the needs of the art, the present invention provides a holding device for a container having a closure system to be pierced by a spike. The holder includes a base, a shield, and a mounting unit supporting the base. The base includes an elongate body having opposed first and second ends and an elongate body extending therebetween. The base body defines an elongate open channel extending between opposing ends thereof. The channel receives an elongate spike therein so that a free end of the spike extends beyond the body from the channel. The shield includes first and second opposed open ends and an elongate cylindrical wall extending therebetween. The container receiving unit is telescopically mounted over the spike receiving unit so as to be movable between a first position wherein an inserted spike is clear of inserted container cap and a second position wherein the spike pierces through the container closure system at the intended location. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  depicts the base and the shield of a bottle holder of the present invention with spike to be received therein. 
           [0008]      FIG. 2  depicts the bottle holder of  FIG. 1  with the Luer-type spike inserted into the spike receptacle thereof. 
           [0009]      FIG. 3  depicts the assembly of  FIG. 2  in which the cap of a container has been mated to the bottle receptacle of the shield so that the septum of the container cap is centered over the Luer-type spike. 
           [0010]      FIG. 4  depicts the assembly of  FIG. 2  in which the shield has been retracted towards the base so that the Luer-type spike has penetrated the septum of the container cap. 
           [0011]      FIG. 5  is a cross-sectional view of the assembly of  FIG. 4 , showing the penetration of the spike through the septum of the container cap. 
           [0012]      FIG. 6  is an oblique view of a base of the present invention. 
           [0013]      FIG. 7  is an oblique view of a shield of the present invention. 
           [0014]      FIG. 8  is an alternate oblique view of a shield of the present invention. 
           [0015]      FIG. 9  is a partial view of a bottle holder of the present invention having a tab for opening the vent of the spike upon spike insertion into the spike receptacle. 
           [0016]      FIG. 10  depicts a bottle opener mounted to a holder arm for the bottle holder of the present invention. 
           [0017]      FIG. 11  depicts a bottle holder of the present invention showing spike approaching the spike receptacle and a bottle approaching the bottle receptacle. 
           [0018]      FIG. 12  depicts an alternate base of the present invention having an integral holder arm for mounting. 
           [0019]      FIG. 13  depicts the inward protruding fin of a shield of the present invention passing over a properly inserted spike. 
           [0020]      FIGS. 14 and 15  are cross-sectional views detailing the engagement between the shield and the base when the shield is in the raised, or extended, position. 
           [0021]      FIG. 16  depicts another embodiment of the present invention incorporating elongate arms for better securing a bottle in the shield. 
           [0022]      FIG. 17  is a cross-sectional view of a spike and bottle attached to the holder of the present invention, showing the shield in the extended position. 
           [0023]      FIG. 18  is a cross-sectional view of a spike and bottle attached to the holder of the present invention, showing the shield in the retracted, or lowered, position, such that the spike pierces the septum of the bottle. 
           [0024]      FIG. 19  depicts a bottle held by a holder of  FIG. 16 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0025]      FIGS. 1-5  and  11  depict a bottle holder  10  of the present invention. Bottle holder  10  includes a base  12  and a shield  14  which can slide thereover between a first extended position and a second retracted position. The base and the shield are desirably formed from suitable polymeric material although any suitable material may be used for their construction. Bottle holder  10  is designed to be mounted to an upright pole  15 , such as an ACIST™ bottle stand, so as to have a vertical orientation as shown in  FIG. 1 . Holder  10  defines a transversely-opening spike-receptacle  50  and an axially-opening bottle receptacle  52  in fluid communication therewith. When shield  14  is in the extended position, as shown in  FIG. 1 , a spike  16  may be inserted into bottle holder  10 . 
         [0026]    With particular reference to  FIGS. 1 and 5 , spike  16  typically includes an elongate dual-lumen spike body  18  with a first lumen  20  in fluid communication with an elongate hollow fluid conduit  22  supporting a luer lock  24  at a free end  26  thereof. Spike  16  also typically includes and a second lumen  28  in fluid communication with a spike vent  30  sealable by an openable vent plug  32  flexibly supported at a hinge  34  affixed to spike body  18 . Vent plug  32  includes a projection  36  extending in opposition to hinge  34 . Spike  16  further includes a planar spike base  38  and tapering rectangular supporting base structure  40 . 
         [0027]    Referring now to  FIGS. 5 ,  11  and  17 - 19 , bottle  200  includes an open end  201  supporting a cap  202  over a pierceable elastomeric septum  204 . Cap  202  defines an aperture  206  through which spike body  18  may extend to pierce septum  204 . Bottle  200  may further include a foil extending across the top surface of septum  204 . Cap  202  further includes an exterior rim  210  which may support an annular flange or protrusion  212 . Bottle  200  is typically formed of plastic or glass and contains a liquid to be dispensed, such as a pharmaceutical compound containing a medical contrast agent. 
         [0028]    While the holder of the present invention may be used for accommodating a +PLUSPAK™ container marketed by Amersham Health AS, it will be appreciated that the teachings of the present invention may be applied to accommodate a wide variety of rigid containers having a cap with a pierceable septum. Additionally, while holder  10  is mountable to an ACIST™ bottle stand it will be appreciated that the present invention contemplates that holder  10  may be adapted for mounting upon a variety of structures. 
         [0029]    Referring again to  FIGS. 1-5 , and with additional reference to  FIGS. 17 and 18 , after spike  16  is properly inserted into spike receptacle  50 , spike body  18  extends out from base  12  towards receptacle  52 . A bottle  200  may be brought down so that cap  202  is inserted into bottle receptacle  52 . Shield  14  engages cap  202  such that as bottle  200  is further brought down, shield  14  slides over base  12  and spike body  18  penetrates through septum  204 . The two lumens  20  and  28  will be in fluid communication with the interior of bottle  200 . Preferably, vent plug  32  is in the open position so as to assist the flow of liquid product through conduit  22 . In operation, a second fluid conduit, not shown, has been connected at luer lock  24  to place the contents of bottle  24  in fluid communication with the vasculature of a patient or animal. 
         [0030]    As shown in  FIG. 6 , base  12  is shown to include a generally cylindrical body  13  and defines an elongate transversely-opening spike cavity  60  which forms a portion of spike receptacle  50 . Spike cavity  60  includes a pair of lateral notches  62  and  64  opening in facing opposition to each other. Notches  62  and  64  receive the lateral extremities of planar spike base  38  therein. Base  12  desirably includes one or more detents or projections, not shown, extending into notches  62  and  64  for base  38  to be inserted over so as to assist in retaining spike  16  within cavity  60 . Base  12  also defines three outwardly-opening elongate grooves  66 ,  68 , and  70  extending from the lower end  12   a  thereof. Each of grooves  66 ,  68 , and  70  support a detent  72  adjacent their upper end (towards shield  14 ). It is further contemplated that base  12  may also define two slots, an elongate outwardly-opening first slot  74  extending in spaced registry with a second slot  76 , as will be described later. Alternatively, as shown in  FIG. 9 , base  12  may be provided with an insert tab  79 . The exposed end of insert tab  79  is positioned in interfering registry with projection  36  on the displaceable cover  32  of spike  16 . If insert tab  79  is present it automatically opens spike vent  32  when spike  16  is inserted into cavity  60 . Desirably, insert tab  79  is removable such that, when removed, spike vent  32  must be manually opened (and can also be closed) by the radiology technologist. As shown in  FIGS. 5 and 6 , base  12  desirably further includes a tapered, i.e. sloping, back wall  75  which is angled to conform to the shape of base structure  40  of spike  16 . 
         [0031]    Referring again to  FIG. 6 , base  12  may further define an aperture  78  for receiving a mounting pin  141 . Mounting pin  141  protrudes from mounting bar  140  which is fixed to pole  15  as shown. e.g., in  FIG. 1 . 
         [0032]      FIGS. 7 and 8  show that shield  14  includes an elongate shield body  80  with first open end  82 , second open end  84  and an elongate cylindrical frustroconical wall  86  extending therebetween. End  82  of shield  14  is slideably receivable over base  12 . Shield body  80  defines an elongate transversely-opening spike cavity  88  which forms a portion of spike receptacle  50 . Cavity  88  is in fluid communication with cavity  60  of base  12 , which together form spike receptacle  50 . End  84  of shield  14  defines bottle receptacle  52  (see  FIG. 1 ) which is also in fluid communication with cavity  88 . End  82  of shield body  80  includes deflectable tabs  92 ,  94  and  96 . Tabs  92  and  94  are defined between spike opening  88  and elongate grooves  98  and  100 , respectively. Tab  96  is formed between two elongate channels  102  and  104  opposite spike cavity  88 . Tabs  92 ,  94 , and  96  each support a tooth  106 ,  108 ,  110 , respectively, adjacent to the free ends thereof. 
         [0033]    End  84  of shield  14  is designed for receiving and retaining the cap  202  of a bottle  200 . Shield  14  includes deflectable bottle detents  112 ,  114 ,  116  defined by a block-U-shaped channels  118 ,  120 ,  122 , respectively. Shield  14  also includes an inwardly-projecting annular rim  124  extending along the interior surface of wall  86 . As seen in  FIG. 5 , rim  124  provides a hard stop for the movement of shield  14  along base  12 . Rim  124  desirably is located so as to ensure the tip of spike  16  just penetrates septum  204  enough so as to render both fluid paths  22  and  30  in fluid communication with the interior of bottle  200 . Such positioning of spike  16  through septum  204  ensures that spike  16  is able to withdraw the maximum amount of fluid from bottle  200  as fluid path  30  is desirably located just above the interior surface of septum  204  in the inverted position. 
         [0034]    Shield body  80  also supports an inwardly-projecting fin  126 . Fin  126  is positioned to slide along slots  74  and  76  of base  12 . Fin  126  projects into spike receptacle  50  such that when spike  16  is properly seated therein, fin  126  will clear past planar base  38 , as shown in  FIG. 13 . However, if spike  16  is not properly inserted into receptacle  50 , fin  126  will catch on planar base  38  of spike  16  and thereby prevent shield  14  from being further retracted. Thus, fin  126  provides an anti-malassembly feature to holder  10 . Slots  74  and  76  are sized to allow fin  126  to move therealong as shield  14  moves between the extended and retracted positions. 
         [0035]    With additional reference to  FIGS. 14 and 15 , deflectable tabs  92 ,  94 , and  96  of shield  14  are positioned in overlying registry with grooves  66 ,  68 , and  70  of base  12 , respectively. With shield  14  in the extended, or raised, position, the teeth  106 ,  108 , and  110  of tabs  92 ,  94 , and  96 , respectively are positioned above the detent  72  in each of grooves  66 ,  68 , and  70 . The grooves and teeth of components  12  and  14  allow shield  14  to be telescopically moved between an extended position, where a cap  202  may be received in end  84  while still spaced from spike  16 , to a retracted position, where septum  204  of cap  202  will be pierced by spike  16 . Cap  202  of container  200 , once inserted and retained by detents  112 ,  114 , and  116 , does not move relative to the shield  14  as it telescopically moves between the extended and retracted position. Detents  112 ,  114 , and  116  are formed to still allow, however, easy removal of the container cap from the shield  14  when desired. Between bottle changes spike  16  is protected from contamination by shield  14  extending perimetrically about it. As seen in  FIGS. 1-4 , the stand provides a second holding arm  148  into which a portion of the conduit extending between the spike and the luer lock may be inserted and retained. 
         [0036]    With reference to  FIG. 10 , a bottle opener  142  with engagement twigs  144  and  146  may be provided on mounting arm  140 . Twigs  144  and  146  are spaced from mounting arm  140  so that the pull tab of the bottle cap may be hung on the twigs of opener  142 . When fully home on the twigs, the bottle is leveraged downwards, and the top is broken off, exposing the septum. 
         [0037]    Referring now to  FIG. 12 , an alternate embodiment for base  12  provides base body  13  and an integrated mounting arm  160  which defines a through passage  162  for mounting pole  15 . A spill channel  180  may be defined by the upper surface of base body  13  for catching any liquid from bottle  200  which may leak during spike insertion or withdrawal through septum  204 . It is further contemplated that spill channel  180  may be provided with an absorbent material for also absorbing any spilled product. Desirably, mounting arms  140  and  160  are able to rotate about pole  15  so as to ease operator positioning of holder  10 . 
         [0038]    As shown in  FIGS. 16 and 19 , bottle holder  10  may also include elongate cantilever arms  128 ,  130 ,  132  extending from open end  84  of shield  14  so as to hold bottle  200  therebetween. Arms  128 ,  130 , and  132  provide additional stability to a bottle inserted into bottle receptacle  52 . Desirably, arms  128 ,  130 ,  132  are supported by, and connected to bottle holder  10 , at deflectable detents  112 ,  114 , and  116 .  FIGS. 17 and 18  depict cross-sectional views of holder  10  in both the extended, or raised, and retracted, or lowered, positions. 
         [0039]    In operation, once spike  16  is inserted into base  12  a bottle  200  may be inserted into the fully-extended shield  14 . As bottle  200  is inserted into receptacle  52 , bottle detents  112 ,  114 , and  118  will first deflect so that bottle is held in place in open end  84  of shield  14 . The septum  204  of container cap  202  is centered over spike  16 . Then as additional downward force is applied, each tooth  106 ,  108 , and  1120  of deflectable tabs  92 ,  94 , and  96  will ride over the detents  72  of base  12  so that shield  14  can slide linearly slide down grooves  92 ,  94 , and  96 , respectively. As bottle  200  is brought down with shield  14 , septum  204  of bottle cap  206  comes down onto spike  16  which thus pierces septum  204 . Contact between base  12  and annular rim  124  of shield  14  halts continued relative movement between base  12  and shield  14 . Spike  16  will have penetrated into bottle  200  to allow fluid flow therefrom. Spike vent  32  may be opened to further assist fluid flow out conduit  22 . Once the contents from bottle  200  are dispensed, shield  14  may be extended back up so as to remove bottle  200  from spike  16 . Continued raising of bottle  200  will lift it from shield  14 , allowing a subsequent bottle to be inserted if so desired. 
         [0040]    While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.