Abstract:
A tamper evident protective cap for a container having a pharmaceutical or biological fluid. The barrel of the container is equipped with two protuberances. The protective cap consisting of top and bottom portions are connected by a frangible portion. The bottom portion contains two notches to engage the protuberances. Without engaging the protuberances with the notches the protector cap cannot be removed. Upon engaging the protuberances with the notches, the top portion of the protective cap is twistably removed at the frangible area and the content of the container is removed by attaching a luer connector or a syringe equipped with a luer connector.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to a tamper evident protector overcap for a pre-filled syringe barrel. More particularly, the invention relates to a cap for a syringe barrel containing a liquid medication therein for securely holding a closure in the tapered tip of the syringe barrel and serving as a tamper evident indicator.  
         BACKGROUND OF THE INVENTION  
         [0002]    Pre-filled syringe barrels or cartridges containing injectable solutions therein are stoppered by elastomeric closures, such as soft rubber stoppers at the distal, tapered end thereof, while the proximal end of the barrels are closed by slidable plungers. The pre-filled syringe barrels or cartridges are sterilized, such as by autoclaving, and packaged ready for use.  
           [0003]    It has been observed that during in-line processing, handling, and sterilizing of the pre-filled barrels, some polymeric or elastomeric closures were missing from the tips of the barrels resulting in rejects. Also, during shipment of the finished product and handling by healthcare professionals some untipped barrels were observed which necessitated discarding of batches containing failed samples. For product integrity a corrective measure was indicated to prevent the polymeric or elastomeric closure from becoming dislodged from the tip of the barrel.  
           [0004]    More importantly, it has also been recognized that untipped barrels, whether the damage occurred during shipment or handling, attracts the suspicion that the product was tampered with. Such possible tampering is a concern for both the National Regulating Authorities and the manufacturers who are required to insure safety, efficacy and the product integrity.  
           [0005]    The prior art has provided various tamper evident closures for syringes.  
           [0006]    For example, tamper evident syringes may be characterized in that the syringe barrel, the cap, and the plunger rod are covered with a tubular sealing device that is made from a heat-shrinkable film and which has been shrunk under heat so that it adheres closely to the surfaces of those members. The sealing device comprises a tube and a tear tape. The tube is formed of a transparent heat-shrinkable film. The tear tape is attached by bonding to the inner surface of the tube from one end to the other in the longitudinal direction.  
           [0007]    Another example is a hypodermic syringe used with a needle for lyophilized medicament comprising: a syringe body having a piston therein equipped with a tip cap at its distal end; an elastomeric plug having a passage channel closing the neck of the syringe; and a protector cap which encloses the tip cap and the neck portion of the syringe body. The protector cap and tip cap are integral with each other and can be moved axially to open and close the syringe. The protector cap consists of a top portion and a bottom portion, the two parts being held together by a weakened portion. The center of the protector cap is provided with a small hole through which the tip cap can be viewed. In use, the top portion of the protector cap is snapped off at the weakened portion, and the tip cap is taken off and discarded. A needle is then fitted in the passage channel of the elastomeric plug to access the content of the syringe.  
           [0008]    Still another example is discloses a syringe cap assembly placed on the distal end of a syringe. The assembly includes: an elastomeric insert having a passage therein; a retaining collar which fits over the elastomeric insert to hold the insert in place; a plug or tip cap is engaged in the insert to block the passage in the insert; and a retaining safety cap fitted over the tip cap. The end wall of the retaining safety cap is formed with a hole in its center and is slightly smaller in diameter than the plug so that the user can ascertain that the plug is properly in its place without opening the assembly.  
           [0009]    In use the safety cap is pulled, twisted, and lifted off the assembly. The plug is then lifted off to expose the collar, and a needle assembly is fitted to the collar.  
           [0010]    A further example is a pre-filled syringe with break-away tip seal which closes the passageway to the content of the syringe. A score means is provided adjacent to the tip for accommodating removal of the sealed tip.  
           [0011]    An object of the present invention is to provide a pre-filled tamper evident syringe or cartridge barrel which makes apparent the unauthorized use of the medical fluid contained in the barrel of the syringe or cartridge or at least warns healthcare professionals that such unauthorized use may have occurred.  
           [0012]    Another object of the present invention is to provide tamper evident syringe or cartridge barrels the content of which is easily accessed by the healthcare professionals while their unauthorized use is readily apparent.  
           [0013]    A further object of the present invention is to provide a tamper evident syringe or cartridge barrel the content of which can be accessed by luer connections or a tubing conduit so as to avoid the use of “sharps” and thereby preventing needle stick injuries.  
         SUMMARY OF THE INVENTION  
         [0014]    In accordance with the present invention, an overcap is provided for a syringe or cartridge barrel containing a pharmaceutical or biological liquid. The overcap is designed to indicate unauthorized use of the content of the syringe or cartridge barrel.  
           [0015]    The pre-filled syringe or cartridge barrel terminates in a tapered tip having a bore therethrough. The tapered tip is equipped with a female luer connector to which a male luer connector or an injection needle may be attached. The bore in the tapered tip is stoppered by an elastomeric stopper, such as a soft rubber plug. At the base of the tapered tip above the shoulder of the syringe or cartridge barrel two protuberances or knobs are provided for engagement with cut-outs or notches in the overcap. A ring above the protuberances or knobs on the tapered tip serves to allow the overcap to turn in clockwise or counter-clockwise directions prior to disengaging the overcap from the syringe or cartridge barrel. The overcap covering the tapered tip comprises: a cylindrical top portion; and a cylindrical bottom portion. The cylindrical top and bottom portion may have the same diameter, or the bottom portion may have a slightly larger diameter than the top portion.  
           [0016]    The top and bottom portions of the overcap are connected by a frangible area allowing the top portion to be removed from the bottom portion. The bottom portion in both embodiments is provided with cut-outs or notches designed to engage the protuberance or knobs on the distal end of the syringe or cartridge barrel.  
           [0017]    In use, the healthcare practitioner depresses the overcap toward the barrel so that cut-outs or notches in the first embodiment, or cut-outs or notches in the second embodiment engage protuberances or knobs on the distal end of the barrel. Holding on to the top portion the overcap is twisted in clockwise or counter-clockwise direction so that the top portion is separated from the bottom portion at the frangible area between the top and bottom portions. The top portion is discarded while the bottom portion of the overcap remains on the distal end of the barrel. Next, the resilient closure is removed exposing the female luer connector to which a male luer connector or a syringe is attached for removal of the content of the barrel.  
           [0018]    Separation of the top portion of the overcap from the bottom portion thereof prior to use indicates evidence to the healthcare professional that the product may have been tampered with and should not be used.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]    [0019]FIG. 1 is a perspective view of a syringe or cartridge barrel equipped with an overcap and containing a pharmaceutical or a biological liquid therein;  
         [0020]    [0020]FIG. 2 is a perspective view of a syringe or cartridge barrel without an overcap and containing a pharmaceutical or a biological liquid therein;  
         [0021]    [0021]FIG. 3 is a perspective view of an overcap constituting one embodiment of the present invention;  
         [0022]    [0022]FIG. 4 is a top plan view of the overcap shown in FIG. 3;  
         [0023]    [0023]FIG. 5 is a bottom plan view of the overcap shown in FIG. 3;  
         [0024]    [0024]FIG. 6 is a side-elevational view of the overcap shown in FIG. 3;  
         [0025]    [0025]FIG. 7 is a perspective view of an overwrap constituting another embodiment of the present invention;  
         [0026]    [0026]FIG. 8 is a top plan view of the overcap shown in FIG. 7;  
         [0027]    [0027]FIG. 9 is a bottom plan view of the overcap shown in FIG. 7; and  
         [0028]    [0028]FIG. 10 is a side-elevational view of the overcap shown in FIG. 7.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0029]    [0029]FIGS. 1 and 2 show a syringe or cartridge barrel (hereinafter referred to as a barrel) in perspective views generally designated by the numeral  10  and an overcap generally designated by the numeral  24 . FIG. 1 shows the barrel with the overcap, while FIG. 2 shows the barrel without the overcap.  
         [0030]    The syringe or cartridge barrel, made of glass or a polymeric material, has an inner surface  12  defining a cylindrical chamber  13  for retaining a pharmaceutical or biological liquid  17  therein, such as a liquid x-ray contrast medium. The barrel has a distal end  14  terminating in a tapered tip  15  having a bore therethrough to which an injection needle or a luer connector with a tubing conduit can be attached, and a proximal end  16  for receiving a plunger  18  which retain the pharmaceutical or biological liquid in the barrel and which, upon use, expels the pharmaceutical or biological liquid from the barrel when an external pressure is exerted on the plunger. The tapered tip  15  having a bore therein is stoppered by a resilient closure  20 , such as an elastomeric closure or a soft rubber stopper, for hermetically sealing the distal end of the barrel. At its proximal end  16  the barrel is equipped with an integral flange  22  to facilitate the handling of the barrel. When the pharmaceutical or biological liquid is an injectable solution, the barrel along with its content is sterilized, preferably by autoclave. After sterilization the barrel is packaged and stored ready for use when needed. Delivery of the injectable solution is accomplished by removing the overcap from the distal end of the barrel, and from the tapered tip of the barrel and attaching an injection needle or a luer connector onto the tapered tip of the barrel.  
         [0031]    The barrel is equipped with two opposing protuberances or knobs  26  and  26 ′ jutting out form the distal end  14  of the barrel adjacent to the tapered tip  15 . The function of these protuberances or knobs will be pointed out as the description of the invention proceeds.  
         [0032]    The tapered tip  15  of the barrel terminates in a typical female luer connector  28 , generally designated, for attachment of a male luer connector or an injection needle thereto. The luer connector is integral with the tapered tip of the barrel and comprises an open distal end  30 , and a closed proximal end  32 . At the proximal end of the female luer connector and spaced from protuberance or knobs  26  and  26 ′, there is provided a ring  35  surrounding the female luer connector  28 . The outside diameter of the ring is slightly smaller than the inside diameter of the overcap thereby allowing turning of the overcap either in clockwise or counter-clockwise direction.  
         [0033]    [0033]FIGS. 3, 4,  5  and  6  shows the overcap, generally designated at  24 , in various views.  
         [0034]    [0034]FIG. 3 is a perspective view of the overcap comprising: a top portion  34 , and a bottom portion  36  separated by a frangible portion  38 . The bottom portion has a slightly larger diameter than the top portion. The proximal end  37  of the bottom portion is provided with two cut-outs or notches  40  and  40 ′ on opposite sides of the bottom portion. The notches are designed to engage protuberances or knobs  26  and  26 ′ at the distal end of the barrel.  
         [0035]    [0035]FIG. 4 shows a top plan view of the overcap  24  having top portion  34  and bottom portion  36 .  
         [0036]    [0036]FIG. 5 shows a bottom plan view of the overcap  24  having cut-outs or notches  40  and  40 ′ on opposite sides of the bottom portion  36 . The bottom portion further comprises a rim or flange  41  extending inward from the proximal end  37 , except it lacks continuity at cut-outs or notches  40  and  40 ′, The height of rim  41  is larger than the height of the ring  35  on the barrel so that the overcap  24  cannot be removed from the barrel without other manipulations described later in the process of using the overcap in preventing unauthorized use of the content of the barrel.  
         [0037]    [0037]FIG. 6 shows a side-elevational view of the overcap  24  comprising: top portion  34 , bottom portion  36  which are separated by a frangible portion  38 . The proximal end  37  is provided with two cut-outs or notches  40  and  40 ′ on opposite sides of the bottom portion. The notches are designed to engage protuberances or knobs  26  and  26 ′ at the distal end of the barrel.  
         [0038]    [0038]FIGS. 7, 8,  9  and  10  show another embodiment of the overcap, generally designated at  42 , in various views. Unlike the previously described overcap wherein the bottom portion has a slightly larger diameter as compared to the diameter of the top portion, in this embodiment the diameters of the bottom and top portions of the overcap are the same.  
         [0039]    [0039]FIG. 7 is a perspective view of the overcap comprising: a top portion  44 , and a bottom portion  46  separated by a frangible portion  48 . The proximal end  50  of the bottom portion is provided with two cut-outs or notches  52  and  52 ′ on the opposite sides of the bottom portion. The notches are designed to engage protuberances or knobs  26  and  26 ′ at the distal end of the barrel.  
         [0040]    [0040]FIG. 8 shows a top plan view of the overcap  42  in which top portion  44  and bottom portion  46  have the same diameter.  
         [0041]    [0041]FIG. 9 shows a bottom plan view of the overcap  42  having cut-outs or notches  52  and  52 ′ on opposite sides of the bottom portion  46 . The bottom portion further comprises a rim or flange  54  extending inward from the proximal end  50 , except it lacks continuity at cut-outs or notches  52  and  52 ′. The height of rim or flange  54  is larger than the height of the ring  35  on the barrel so that the overcap  42  cannot be removed from the barrel without other manipulations described later in the process of using the overcap in preventing unauthorized use of the content of the barrel.  
         [0042]    [0042]FIG. 10 shows a side-elevational view of the overcap  42  comprising: top portion  44  and bottom portion  46  which are separated by a frangible portion  46 . The diameters of the top and bottom portions are equal. The proximal end  50  is provided with two cut-outs or notches  52  and  52 ′ on opposite sides of the bottom portion. The notches are designed to engage protuberances or knobs  26  and  26 ′ at the distal end of the barrel.  
         [0043]    The overcaps  24  and  42 , respectively in the two embodiments of the present invention, may be made of a polymeric material including but not limited to: polyolefins such as polyethylene and polypropylene; polystyrene, polycarbonate, polymethylpentene, cyclic olefin co-polymers, acrylic polymers and methacrylic polymers.  
         [0044]    Both embodiments of the present invention are used with pre-filled barrels containing, for example, a biological liquid or a pharmaceutical such as contrast media. Subsequent to the pre-fill the overcap is positioned on the distal end of the barrel, such as by crimping the overcap onto the distal end of the barrel. The rim or flange  41  or  54  respectively are pressed and forced to slide over the ring  35  to be placed in position over the distal end of the barrel. The content of the barrel is sterilized with traditional means, such as autoclaving.  
         [0045]    When the overcap is positioned over the distal end of the barrel, it may be turned clockwise or counter-clockwise without resulting in the removal of the overcap. Personnel not familiar with the proper removal procedure will not be able to remove the overcap. The proper removal of the overcap is as follows: the overcap is pressed down towards the barrel until the cut-outs or notches  40  and  40 ′ or  52  and  52 ′, respectively, engage protuberances or knobs  26  and  26 ′ on the distal end of the barrel. Upon such engagement the overcap will not turn either clockwise or counter-clockwise direction. The top portion of the overcap  34  and  44  respectively, is then turned clockwise or counter-clockwise to separate the top portions from the bottom portions  36  and  46 , respectively. The frangible portions  38  and  48 , respectively, allow such separation of the top and bottom portions. While the bottom portions remain on the distal end of the barrel, the top portions are removed to expose the resilient closures  20  upon the removal of which the female luer connector  28  is exposed. To the female luer connector a male luer connector, having an injection needle or IV tubing, is attached for withdrawal of the content of the barrel.  
         [0046]    It is to be noted that upon separation of the top portion of the overcap from the bottom portion thereof along the frangible portion therebetween, the two portions cannot be reconnected without notice by the healthcare practitioner. If the overcap is tampered with, the healthcare professional will readily observe the separated top and bottom portions of the overcap along the frangible portion therebetween. As a result of this tamper evidence the content of the barrel will not be used.  
         [0047]    While the present invention has been described in combination with a pre-filled syringe or cartridge barrel, it may be used in combination with other pre-filled containers such as tubes and bottles.  
       PARTS LIST  
       [0048]    Syringe or cartridge barrel, generally designated 10  
         [0049]    Overcap, generally designated 24  
         [0050]    Inner surface of syringe or cartridge barrel 12  
         [0051]    Cylindrical chamber of syringe or cartridge barrel 13  
         [0052]    Pharmaceutical or biological liquid 17  
         [0053]    Distal end of barrel 14  
         [0054]    Tapered tip of barrel 15  
         [0055]    Proximal end of barrel 16  
         [0056]    Plunger 18  
         [0057]    Resilient closure 20  
         [0058]    Integral flange of barrel 22  
         [0059]    Protuberances or knobs at distal end of barrel 26, 26′ 
         [0060]    Female luer connector, generally designated 28  
         [0061]    Open distal end of female luer connector 30  
         [0062]    Closed proximal end of female luer connector 32  
         [0063]    Top portion of overcap 34  
         [0064]    Ring on distal end of the barrel 35  
         [0065]    Bottom portion of overcap 36  
         [0066]    Proximal end of bottom portion 37  
         [0067]    Frangible area between top and bottom portions of overcap 38  
         [0068]    Cut-outs or notches in the proximal end of the bottom portion 40, 40′ 
         [0069]    Rim or flange in bottom portion 41  
         [0070]    Overcap, generally designated 42  
         [0071]    Top portion of overcap 44  
         [0072]    Bottom portion of overcap 46  
         [0073]    Frangible area between top and bottom portions of overcap 48  
         [0074]    Proximal end of bottom portion 50  
         [0075]    Cut-outs or notches in the proximal end of bottom portion 52, 52′ 
         [0076]    Rim or flange in bottom portion 54  
         [0077]    Various modifications of the present invention disclosed will become apparent. This invention is intended to include such modifications to be limited only by the scope of the claims.