Abstract:
A holding device for holding a protective cap serving as a cover for an injection needle of an injection device, the holding device including a receptacle in a support, the receptacle being recessed from the support and exhibiting a smaller width at its opening than a maximum outer dimension of the protective cap perpendicular to the longitudinal axis of the protective cap, wherein the height of the holding device perpendicular to the support is larger than the length of the protective cap in its longitudinal direction. The invention further encompasses a packaging container for storing and transporting a plurality of cannula supports, wherein the packaging container includes the holding device. In some embodiments, the holding device may include a second receptacle for a packaging container of cannula supports and a holder for securely fastening the holding device.

Description:
PRIORITY CLAIM  
         [0001]    This application claims priority to German Patent Application No.: DE10159628.6, filed on Dec. 5, 2001, which is incorporated herein by reference.  
         BACKGROUND  
         [0002]    The present invention relates to a holding device for holding a protective cap for the injection needle of an injection device which serves to inject a therapeutic or diagnostic fluid. The invention also relates to a packaging container comprising such a holding device for storing and transporting a number of cannula supports with attached protective caps. One application relates to temporarily holding the protective cap of an injection pen for administering an insulin dose, a hormone or another medicine.  
           [0003]    So-called injection pens are increasingly being used to administer fluidic medicines, for example insulin, interferon, growth hormone or the like, in a predetermined dosage. A medicine container and a dosing device for selecting the dosage to be administered are situated in the injection pen. A cannula support comprising the injection needle is attached to the injection pen, such that the distal end of the injection needle pierces a septum or membrane of the medicine container. To avoid unintentional pricking injuries, the injection needle is covered by a needle cover.  
           [0004]    Increasingly, cannula supports are used which, having been used once or a number of times, are removed from the pen and disposed of, in order to ensure sterile injection conditions. Unintentional pricking injuries can easily occur as the cannula support is being attached and/or removed. In order to avoid this, a protective cap can be attached to the cannula support, which is only removed for injecting and can be re-attached to the cannula support after the injection, for securely covering the injection needle or securely disposing of the cannula support.  
           [0005]    Due to the often small outer dimensions of the protective cap (the length of the injection needle often being only 3 to 6 mm), there is the danger that the protective cap is unintentionally lost while injecting, for example, that it rolls away and cannot be found again. Because of the small outer dimensions, there is also a comparatively large danger of a pricking injury when attaching the protective cap to the injection needle after an injection. It is admittedly conceivable in principle to design the protective caps larger, however this would be inconsistent with the need for maximally simple and cost-effective cannula supports with protective caps.  
         SUMMARY  
         [0006]    It is an object of the present invention to take precautions such that the dangers of a protective cap associated with an injection device being unintentionally lost while injecting or of an unintentional pricking injury when attaching the protective cap to the injection needle are effectively reduced. For the same purpose, it is also the intention to provide a packaging container for transporting and storing a number of cannula supports.  
           [0007]    This object is addressed by the present invention which comprises a holding device for holding a protective cap for an injection needle of an injection device which serves to inject a therapeutic or diagnostic fluid, the cap having an outer dimension and a longitudinal axis, the holding device comprising a support for supporting said protective cap, and a first receptacle for accommodating the protective cap, wherein the first receptacle is recessed from a surface of the support and has an opening with a width smaller than the outer dimension of the protective cap, and by providing a packaging container for storing and transporting a number of cannula supports respectively comprising an attached protective cap, said packaging container comprising a holding device comprising a support for supporting the protective cap and a first receptacle for accommodating the protective cap, wherein said first receptacle is recessed from a surface of said support and has an opening with a width smaller than the outer dimension of the protective cap.  
           [0008]    In one embodiment the present invention comprises a holding device for holding a protective cap serving as a cover for an injection needle of an injection device, the holding device including a receptacle in a support, the receptacle being recessed from the support and exhibiting a smaller width at its opening than a maximum outer dimension of the protective cap perpendicular to the longitudinal axis of the protective cap, wherein the height of the holding device perpendicular to the support is larger than the length of the protective cap in its longitudinal direction. The invention further encompasses a packaging container for storing and transporting a plurality of cannula supports, wherein the packaging container includes the holding device. In some embodiments, the holding device may include a second receptacle for a packaging container of cannula supports and a holder for securely fastening the holding device.  
           [0009]    A holding device in accordance with the present invention comprises a support for supporting the protective cap and a first receptacle for accommodating the protective cap in the support, wherein the first receptacle is recessed from a surface of the support and the width of the opening of the first receptacle is smaller than a maximum outer dimension of the protective cap perpendicular to a longitudinal axis of the protective cap. One advantage is that the protective cap can be temporarily and securely stored in the first receptacle in a simple way. Another advantage is that the user can get used to a fixed sequence of steps for injecting, in which he always finds the protective cap again, i.e., without the danger of this being lost. For the user can get used to always placing the protective cap, which is to be removed during the injection, in the first receptacle of the support. The user can then blindly rely on the fact that the protective cap is always situated in the first receptacle, even if temporarily distracted by other processes during injection.  
           [0010]    A further advantage is that the danger of unintentional pricking injuries from an uncovered injection needle is practically ruled out, since the user does not have to grasp the protective cap with his fingers to insert it back onto the injection needle. Rather, by simply attaching the injection device to the support and inserting the injection needle into the protective cap stored in the first receptacle, the protective cap can securely be re-attached to the injection needle. Thus, in accordance with the invention, the sealing cap need not be re-attached to the injection needle by hand.  
           [0011]    In one embodiment, the height of the holding device perpendicular to the surface of the support is preferably larger than the length of the protective cap in its longitudinal direction. This then securely prevents the protective cap from being inserted insufficiently far into the first receptacle and being lost, for instance because of an insufficient distance between the rear side of the support and a surface of the environment.  
           [0012]    Since the protective cap is elongated, it is practically impossible in accordance with the invention for it to unintentionally fall out of the first receptacle. In order to provide an even more secure receptacle in the support for the protective cap, the first receptacle can be provided with a clamping or locking mechanism. An advantage is that, even when the support is shaken heavily, the protective cap remains securely accommodated.  
           [0013]    To this end, the holding force with which the protective cap is held back in the first receptacle can be smaller than the force necessary to remove the protective cap from the injection device or cannula support. An advantage is that this ensures that, after the injection, when the injection device is attached to the support and the injection needle is inserted into the protective cap held in the first receptacle, the protective cap remains attached to the injection device or cannula support even after the injection device has been removed from the support, because the injection device can be removed together with the attached protective cap. This effectively reduces the danger of unintentional pricking injuries.  
           [0014]    In an alternative embodiment, however, the holding force with which the protective cap is held back in the first receptacle can also be selected to be larger than the force with which the protective cap has to be removed from the injection device or cannula support. In this embodiment, the injection device can thus be removed from the support without the protective cap, for injecting again. A corresponding holder is expediently provided on the holding device, for temporarily holding the injection device.  
           [0015]    The clamping or locking mechanism of the first receptacle can be designed such that the clamping or locking force with which the protective cap is held back in the first receptacle can be varied. The clamping or locking force can, for example, be adjusted between the two alternatives cited above, by temporarily pinching the support, by advancing a latch, or the like.  
           [0016]    For reasons of hygiene, cannula supports comprising attached protective caps are usually delivered in sterilely-packaged packaging structures, for example, in cylindrical plastic sleeves with a blistering. In accordance with one preferred embodiment of the present invention, the support comprises a second receptacle, whose inner dimensions are adjusted to the maximum outer dimensions of such a packaging structure, for accommodating the packaging structure in the support. Once the packaging structure is opened, for example, by removing the blistering, then the injection device can be inserted into the packaging structure accommodated in the second receptacle, in order to attach the cannula support to the injection device. Once the injection device has been removed from the packaging structure together with the attached cannula support, and the protective cap has been removed, the injection device is then ready for an injection. In this way, even the packaging structure can be securely stored.  
           [0017]    Expediently, the packaging structure is held back in the second receptacle with a force which is smaller than the removal forces for removing the injection device together with the cannula support from the packaging structure. To this end, a locking or clamping mechanism can also be provided in the second receptacle which cooperates for example with a side wall or with a locking or clamping mechanism of the packaging structure.  
           [0018]    In accordance with one preferred embodiment, the holding device also comprises a holder which is fixedly connected or connectable to the support and which predetermines in a simple way the height of the holder device over its base area. The height of the holder may be larger than the length of the protective cap in its longitudinal direction and/or the maximum length, in its longitudinal direction, of the packaging structure inserted into the second receptacle, such that the cap and/or the packaging structure can be accommodated in such a way that the cap and/or the packaging structure is not lost.  
           [0019]    Expediently, the holder is only arranged on one longitudinal side of the support, such that the holding device can be fastened to a vertical side rim of a conventional packaging container (e.g., a box) for cannula supports. To this end, the holder can be designed as a holding clip. The holding device can then be simply fastened to a fixed position, for example, onto the side wall of the packaging container, and quickly removed again. With the aid of the clip mechanism, the holding device can also be fastened to side pockets of items of clothing, for example to a doctor&#39;s white coat.  
           [0020]    Another suitable holding mechanism can also be provided for holding the support, for example, a stand with side feet into which the support is inserted, the height of the holding device being predetermined by the height of the standing feet.  
           [0021]    Expediently, the holder is connected pivoting to the support, such that the at least one holder can be pivoted back parallel to the face of the support and the holding device then transported as a flat structure, saving space, or can be placed in a packaging structure. Expediently in this respect, the pivoting mechanism can lock in, such that the support extends substantially perpendicular to the holder and offers a sufficient resisting force that the support does not give or only insignificantly when the injection device is attached to the support for inserting the injection needle into the protective cap held in the first receptacle.  
           [0022]    In accordance with one preferred embodiment, the support is produced as a comparatively narrow plate made of a material having sufficient rigidity. The respective receptacle is formed by a simple through-bore of a suitable inner diameter. To hold back the protective cap and/or the packaging structure in the support when the injection device is removed perpendicular to the support, the protective cap and/or the packaging structure can simply be held back laterally by hand.  
           [0023]    Due to the unexpectedly simple design of the holding device, it can easily be added, saving space, to a packaging container which serves to store and transport a plurality of preferably sterilely-packaged cannula supports. Once the packaging container has been opened, the holding device is simply removed and fastened at a suitable location, for example, to a side wall of the packaging container, to which end a locking or clamping mechanism is expediently provided in the side wall of the packaging container, said mechanism cooperating with a locking or clamping mechanism on the holder or with the clip on the holding device, in order to securely fasten the holding device at a firmly predetermined location, i.e., for example, to the packaging container. 
       
    
    
     BREIF DESCRIPTION OF THE DRAWINGS  
       [0024]    The invention will now be described by way of an example and by referring to the enclosed drawings, from which further features and advantages of the invention may be seen and in which:  
         [0025]    [0025]FIG. 1 is a cross-sectional view of a holding device in accordance with the present invention, said device being attached to a side wall of a packaging container;  
         [0026]    [0026]FIG. 2 is a top view of the holding device shown in FIG. 1; and  
         [0027]    [0027]FIG. 3 is a cross-sectional view of another embodiment of a holding device in accordance with the present inventive. 
     
    
       [0028]    In the figures, identical reference numerals indicate identical or functionally identical elements or functional groups.  
       DETAILED DESCRIPTION  
       [0029]    [0029]FIG. 1 shows a cross-sectional view of one embodiment of a holding device  1  attached to a side wall  19  of a packaging container  18 . The holding device comprises a support  2  formed as a flat plate and a holder  3  for fastening the holding device at a suitable location, for example, to the side wall  19 , to a jacket pocket or the like.  
         [0030]    The support  2  comprises a first receptacle  4  for accommodating the protective cap  6  and a second receptacle  5  for accommodating a packaging structure  8  for a cannula support. The protective cap  6  comprises an inner space which is adjusted to the injection needle  12  of the injection device. For injecting, the user removes the protective cap  6  from the injection device (not shown) or the cannula support  11  and inserts the protective cap  6  into the first receptacle  4 . If the user keeps to this sequence of steps, then the user always knows where the protective cap  6  is situated. It can thus no longer be lost.  
         [0031]    After the injection, the user attaches the injection device together with the still exposed injection needle  12  from above, substantially perpendicularly, to the holding device  1 , thus inserting the injection needle into the protective cap  6  without having to grasp the protective cap with his fingers. The protective cap  6  can lie loosely on the rim of the first receptacle  4  via an upper rim  7 . In such a case, there are substantially no frictional forces acting between the protective cap  6  and the first receptacle  4  when the injection device, re-attached to the protective cap  6 , is removed. The injection device, together with the attached protective cap  6 , can thus be reliably removed again from the support  2 .  
         [0032]    As shown in FIG. 1, the support  2  comprises a second receptacle  5 . A packaging structure  8  is inserted into this, said structure comprises an upper rim  9  to lie on the support  2  and a lower cylindrical sleeve  10 . A cannula support  11  is stored in the packaging structure  8 , sterile for transport. To this end, a blistering or other suitable protective film is applied to the upper rim  9  of the packaging structure  8 . Once the blistering or protective film has been removed, the cannula support  11  can be attached to the injection device. To this end, the cannula support shown in FIG. 1 comprises one or more locking elements  14  on the inner face of the side wall  13 , for example locking cams, which cooperate with corresponding locking elements on the casing of the injection device, such that the cannula support  11  can be securely fastened to the injection device. As the cannula support II is attached to the injection device, the distal end of the injection needle  12  pierces a septum or membrane of a medicine container in the injection device.  
         [0033]    To attach the cannula support  11  to the injection device, the blistering or protective film is removed and the injection device is moved toward or lowered from above, generally or substantially perpendicularly, onto the support  2  and the second receptacle  5 , until the locking elements  14  of the cannula support  11  lock in on the injection device. The injection device, together with the cannula support  11  and the attached protective cap  6 , is then raised upwards out of the packaging structure  8 . This releases the cannula support  11  from the packaging structure  8 . To this end, the user can steady the packaging structure laterally. To this end, a locking or clamping mechanism (not shown) can also be provided in the second receptacle  5 , to hold the packaging structure  8  back in the second receptacle  5 . The retaining force for holding the packaging structure  8  back in the second receptacle  5  is smaller than the forces which have to be overcome to remove the cannula support  11  from the packaging structure  8 .  
         [0034]    After the cannula support  11  has been removed from the packaging structure  8 , the protective cap  6  is also still attached to the cannula support  11 . An unintentional pricking injury can thus securely be prevented.  
         [0035]    For injecting, the user removes the protective cap  6  from the cannula support  11  by hand and inserts it into the first receptacle  4 . Alternatively, the user can attach the injection device, together with the cannula support  11  and the attached protective cap  6 , generally perpendicularly, to the support  2 , in order to insert the protective cap  6  into the first receptacle. The user then removes the injection device, together with the cannula support  11 , from the first receptacle  4  again, the protective cap  6  being held back in the first receptacle  4 , such that the injection needle  12  is ready for injecting.  
         [0036]    After the injection, the injection device together with the injection needle is inserted into the protective cap  6  again, and the latter is attached to the cannula support or the injection device. The injection device together with the protective cap is then removed from the first receptacle  4 . Lastly, the cannula support  11  together with the attached protective cap  6  is again separated from the injection device. The cannula support  11  together with the attached protective cap  6  can then be securely disposed of, without the danger of pricking injuries.  
         [0037]    Once the protective cap  6  has been removed, the user can grasp it laterally as he removes the injection device and so hold the protective cap  6  back in the first receptacle  4 . To reduce the danger of pricking injuries even further, a locking or clamping mechanism (not shown) can be provided in the first receptacle  4 , to predetermine the force with which the protective cap  6  is held back in the first receptacle  4 . This locking or clamping mechanism can, for example, cooperate with a recess or a protrusion in the side wall of the protective cap  6 . Other suitable locking or clamping mechanisms will occur to the person skilled in the art when studying this description.  
         [0038]    In accordance with one embodiment of the present invention, said holding force is predetermined to be smaller than a force with which the protective cap  6  is held on the cannula support  11 . Thus, after the injection, when the user attaches the injection device to the support  2  again and so inserts the injection needle  12  into the protective cap  6  again, the protective cap  6  remains on the cannula support  11  or injection device, when the injection device is removed from the support  2  again. In this way, the danger of unintentional pricking injuries can be effectively reduced. In accordance with another embodiment, the holding force with which the protective cap  6  is held back in the first receptacle  4  can also be selected to be larger than the force with which the protective cap is held on the cannula support  11  or injection device. In this embodiment, the protective cap  6  would then remain behind in the first receptacle  4  once the injection device has been removed, such that the injection needle  12  would then be ready for another injection.  
         [0039]    The holding force for the protective cap  6  in the first receptacle  4 , predetermined by the locking or clamping mechanism, can of course also be varied, for example by temporarily pinching the support  2  or by advancing or adjusting the locking or clamping mechanism (not shown) in the first receptacle  4 . Thus, the user can thus easily predetermine whether the protective cap  6  remains on the cannula support  11  or not, once the injection device has been removed.  
         [0040]    As shown in FIG. 2, the support  2  can also comprise two or more first receptacles  4   a ,  4   b  for accommodating protective caps having different outer diameters.  
         [0041]    As shown in FIG. 1, the holding device  1  comprises a holder  3  on one longitudinal side of the support  2  for fastening the holding device at a suitable location, in this example, to a vertical side wall  19  of a packaging container  18  for storing and transporting cannula supports  11 , or packaging structures  8  for sterilely storing a cannula support.  
         [0042]    The holder shown in FIG. 1 is formed as a clip holder comprising two spring-elastic bails  15   a ,  15   b  which cooperate to form a clamping region  16 . The person skilled in the art will, however, know of other suitable holding mechanisms. The height of the holder  3  is dimensioned such that the height of the holding device  1  over its base area, i.e., in FIG. 1, measured from the clamping region  16  to the support  2 , is larger than the height of the protective cap  6  in the longitudinal direction or, if a second receptacle  5  is provided, than the height of the packaging structure  8 . This then ensures that the protective cap  6  and/or the packaging structure  8  is reliably held back in the respective receptacle  4 ,  5  without abutting anywhere.  
         [0043]    [0043]FIG. 3 shows a cross-section of another embodiment of a holding device in accordance with the invention. In this embodiment, the holder  3  comprises two lateral holding feet  17   a ,  17   b  to which the support  2  is fixedly connected or connectable, for example by means of a locking mechanism.  
         [0044]    The lateral standing feet  17   a ,  17   b  or the clip mechanism  15   a ,  15   b  can be connected pivotally or connectably pivotally to the support  2 , such that the holding device  1  in accordance with the invention can be stored and transported as a flat structure in which the lateral standing feet  17  or clip bails  15  extend substantially parallel to the plane of the support  2 . Once the 90° position in accordance with FIG. 1 or  3  has been reached, the lateral standing feet  17  or clip bails  15  can be locked in.  
         [0045]    The packaging container  18  shown in FIG. 1, which is substantially parallelepipedal and comprises a base  20  and vertically protruding side walls  19 , serves to store and transport a suitable quantity of packaging structures  8  comprising cannula supports  11  stored sterilely in them. If the lateral standing feet  17  or clip bails  15  of the holding device  1  are not pivoting, then the height of the side walls  19  of the packaging container  18  is expediently selected such that the holding device  1  can be inserted into the container  18  without the upper side of the support  2  protruding beyond the upper rim of the container  18 . If the lateral standing feet  17  or clip bails  15  are pivoting, then the folded-together holding device  1  can easily be inserted into the container  18 . A cover then seals the container  18 .  
         [0046]    The holding device  1  shown in FIG. 1 is attached to the side wall  19  by means of the clip bails  15 . A locking or clamping mechanism can be provided on the side wall  19 , said mechanism cooperating with a locking or clamping mechanism of the holder  3 . To this end, for example, a recess or a protrusion can be provided at a suitable height on the side wall  19 , cooperating with a corresponding protrusion or recess in the fastening region  16  of the clip bails  15 . Locking or clamping mechanisms suitable for this purpose are known to the person skilled in the art.  
         [0047]    The holding device  1  is preferably manufactured from a suitable plastic material exhibiting a sufficient intrinsic rigidity, for example POM (polyoxymethylene). The low manufacturing costs of the holding device  1  are of little consequence in comparison with the overall costs of the packaged cannula supports. The protective cap  6  and the support plate  2  can exhibit different colors, such that inserting the injection needle  12  into the protective cap  6  can be made even easier due to the greater color contrast. The color of the support can be strongly contrasted with the color of the protective cap and/or the packaging structure, to facilitate injecting the same into the receptacle.  
         [0048]    In accordance with one preferred embodiment, the holding device in accordance with the invention is used with protective caps which serve as needle covers for so-called injection pens, such as described, for example, in DE 199 45 397 by the Applicant. The disclosure of DE 199 45 397, in particular regarding the design of the cannula support, is expressly incorporated into this application by reference. In the same way, however, the holding device in accordance with the invention can also be used for protective caps for disposable syringes, such as are used, for example, for administering insulin doses, or for protective caps for infusion needles in conventional infusion devices.  
         [0049]    Although the support  2  is shown in the figures as a plate comprising through-bores, the support  2  can also be manufactured from a solid material, wherein the receptacles  4 ,  5  are then recessed in the block as blind bores and thin through-bores preferably run from the rear side of the respective bores into the blind hole, such that air can escape through them and protective caps or packaging structures jammed in the blind hole can be pushed out of the blind hole again by inserting a needle or the like from the rear side.  
         [0050]    The protective cap  6  and/or the packaging structure  8  can comprise elastic side walls, such that the holding force with which they are held in the respective receptacle  4 ,  5  is substantially predetermined by the elastic deformation of the side walls, in which case the respective receptacle tightly surrounds the protective cap or packaging structure.  
         [0051]    To augment the respective holding force in the receptacle, suitable locking or clamping mechanisms in this field are known to the person skilled in the art. In some embodiments, the packaging container in accordance with the invention preferably serves to store and transport disposable cannula supports for injection pens for administering insulin, preferably using a 31-gauge injection needle.  
         [0052]    In the foregoing description, embodiments of the invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.