Abstract:
A medicament delivery device is presented having a housing configured to receive a medicament container having a delivery member and a shield, a protective cap, and wherein the protective cap comprises connecting means for connecting to the shield of the medicament container such that removal of the protective cap from the housing causes removal of the shield from the medicament container. The delivery device is characterised in that a protective cap assembly has a first disconnecting means configured to interact with corresponding second disconnecting means of the housing and of the protective cap such that activation of the first disconnecting means of the protective cap assembly causes the displacement of the protective cap relative to the housing.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 14/384,757, filed Sep. 12, 2014, which is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2013/054654 filed Mar. 7, 2013, which claims priority to Swedish Patent Application No. 1250238-1 filed Mar. 14, 2012, which is claims priority to U.S. Provisional Patent Application No. 61/610,567, filed Mar. 14, 2012. The present application also claims priority to Swedish Patent Application No. 1251235-6 filed Nov. 1, 2012 which claims priority to U.S. Provisional Patent Application No. 61/721,049, filed Nov. 1, 2012. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
     
    
     TECHNICAL AREA 
       [0002]    The present invention relates to a medicament delivery device arranged with a protective cap assembly designed for removal of needle shields off medicament containers of the medicament delivery device. 
       BACKGROUND 
       [0003]    There are many medicament delivery devices on the market that have been developed for self administration of medicament, where one large group is medicament injection devices. Many of these injection devices have been provided with removable needle cover assemblies where the core cover may be a so called Rigid Needle Cover or Rigid Needle Shield (RNS) or a so called Flexible Needle Cover or Flexible Needle Shield (FNS). 
         [0004]    These RNS/FNS&#39;s are arranged to protect the injection needle before use in order to keep the needle sterile and also protect from unintentional needle sticks. Many of these RNS/FNS&#39;s are pushed onto the neck portion of a medicament container, such as a syringe, where the RNS/FNS are provided with an inner cap in contact with the surface of the syringe. The inner cap is preferably of a resilient material, normally rubber that ensures a tight grip and a good seal between the cap and the syringe. However this tight grip entail problem in that it is difficult to remove the RNS/FNS from the syringe in order to perform an injection. 
         [0005]    Therefore a number of RNS/FNS removal devices have been developed, which are intended to aid the user in removing the RNS. Documents WO2007/047200, WO 2006/106290 and WO 2005/115508 disclose different solutions to this problem. However, they all include a function where the whole assembly including the RNS and its resilient inner cap, are twisted or rotated manually. This a major drawback since this twisting action if the inner cap very easily causes damage to the injection needles, which usually are thin and easily bendable such that when the RNS is removed, the needle has become so damaged it cannot be used for the injection. 
         [0006]    Also, all these solutions require manual action by gripping the shield remover mechanism and performing a number of manual operations such as twisting and pulling and combinations thereof. This is a drawback for all persons with reduced dexterity in their hands as well as reduced motion control. Further, all these solutions require change of grip of the medicament delivery device after removal of the RNS/FNS. This may also be a drawback in that the injection needle now is exposed when the user is to change grip for the subsequent penetration and injection. Not only may the thin needle be damaged during the process, but the user or other persons in the vicinity may be damaged by the exposed needle. 
         [0007]    Document WO 2009/019440 discloses an injection device comprising a cap that in order to be removed is rotated turns about the longitudinal axis. During rotation, the needle shield retainer does not rotate relative to a discharge nozzle and the rotational movement of the cap relative to the housing is converted into linear movement of the needle shield retainer away from the exit aperture in the axial direction achieved through engagement of the screw threads so the needle shield is pulled away from the discharge nozzle through the exit aperture into the central boss. After rotation, the user finally pulls the cap away from the housing, the needle shield and the discharge nozzle are not engaged with each other and the cap becomes completely detached from the injection device. 
         [0008]    The device according to &#39;440 does not thus twist or rotate the needle shield but a rotational interaction with threaded components causes a linear movement of the needle shield retainer from the exit aperture of the medicament delivery device. However, the solution is complex regarding the number of components required, and still a manual gripping action as described above is required. Again, the user has to change grip after removal of the needle shield with the addressed risks that this may induce. 
         [0009]    There is thus a need for solutions that simplify the removal of needle shields from medicament delivery devices, reducing the risk of damaging the needle as well as reducing the risk of injuring persons. 
       SUMMARY 
       [0010]    In the present application, when the term “distal” is used, this refers to the direction pointing away from the dose delivery site. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal” is used, this refers to the direction pointing to the dose delivery site. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which is/are located closest to the dose delivery site. 
         [0011]    According to a main aspect of the invention, it is characterised by the features of the independent patent claim  1 . Preferable embodiments of the present invention form the subject of the dependent patent claims. 
         [0012]    The present invention relates to a medicament delivery device. Preferably the medicament deliver device may comprise a housing with at least one housing part, which is configured to receive a medicament container. 
         [0013]    The medicament container is provided with a delivery member, either integral with the medicament container, or arranged as an attachable member. The medicament delivery member is further preferably arranged with a shield that covers said delivery member. In this respect it is to be understood that a number of different medicament delivery member shields are incorporated in the present invention, such as Rigid Needle Shields (RNS), Flexible Needle Shields (FNS) and combinations of these are just a few of the feasible shields. 
         [0014]    The housing may comprise first connecting means, wherein the device further may comprise a protective cap assembly comprising a protective cap, which cap may comprise second connecting means. The first and the second connecting means are configured such that a displacement of the protective cap relative to the housing allows the protective cap to be removed from the housing. In this respect it is to be understood that the displacement of the protective cap relative the housing may be a linear displacement, a rotational displacement as well as combinations of these. 
         [0015]    Further, the first and second connecting means may be configured to achieve a positive connection. That is, the two connecting means are designed to lock with each other by the form of the connecting means. For example they may be configured as a bayonet connection or a threaded connection. 
         [0016]    As an alternative, the first and second connecting means may be configured to achieve a non-positive connection. That is, the two connecting means are designed to lock with each other by friction between them. 
         [0017]    Further, according to the present invention, the protective cap further comprises third connecting means for connecting to the shield of the medicament container such that removal of the protective cap from the housing causes removal of the shield from the medicament container. 
         [0018]    According to one major feature of the invention, the protective cap assembly may further comprise first disconnecting means configured to interact with corresponding second disconnecting means of the housing and of the protective cap such that activation of the disconnecting means of the protective cap assembly causes the displacement of the protective cap relative to the housing. Again, it is to be understood that the displacement of the protective cap relative the housing may be a linear displacement, a rotational displacement as well as combinations of these. 
         [0019]    According to one positive alternative of the present invention, the protective cap assembly may comprise an energy accumulating member. This energy accumulating member may be in the form of a mechanical spring member made of a number of materials that display the appropriate features. If a coiled spring is utilized, it may be a compression spring, a torsion spring, a flat clock spring, just to mention a few. Other feasible energy accumulating members may include plate springs, gas springs, resilient materials, and the like. 
         [0020]    In order to handle the energy accumulating member, it is an advantage if the protective cap assembly also comprises an actuating mechanism configured to hold said energy accumulating member in an energized state, and configured, upon activation, to release said energy accumulating member for activation of said disconnecting means. With the actuating mechanism, it is for example possible to assemble the protective cap assembly before it is mounted onto the medicament delivery device. 
         [0021]    The disconnecting means may comprises a number of different designs, where one possible design is to utilize a nut operably connected to said housing and to said protective cap and drivably connected to said energy accumulating member such that activation of said actuating mechanism causes said nut to displace said protective cap. If a nut is included in the protective cap assembly, it is an advantage if the energy accumulating member is capable of providing a rotating displacement as well as a displacement in the proximal direction. In this case, a torsion spring or a flat clock spring may be advantageous. 
         [0022]    The mechanical connection between the nut and the housing said nut may have different designs. For example the nut may be arranged with threads arranged to cooperate with corresponding threads on said housing. According to another design, the nut may be arranged with a bayonet connection member arranged to cooperate with corresponding bayonet connection member on said housing. 
         [0023]    According to another major aspect of the present invention, the protective cap assembly may comprise an actuator operatively connected to said housing and drivably connected to said energy accumulating member, and wherein said actuating mechanism is capable of holding said energy accumulating member by said actuator, such that release of said actuator causes activation of said disconnecting means. 
         [0024]    With this design, the energy accumulating member may preferably comprise a compression spring operably arranged between said protective cap and said activator, thereby providing a linearly directed force in the proximal direction of the device. 
         [0025]    In combination with the energy accumulating member, the actuating mechanism may comprise a button operably arranged on said protective cap. A button is easily managed by a user when positioned on the feature that is to be removed from the medicament delivery device before use. 
         [0026]    The advantage with the above design is that the user does not require a lot of force or power in order to remove the protective cap. Once the energy accumulating member has been activated, the protective cap will automatically be removed from the device, after which the medicament delivery device is ready for medicament delivery. Further, because of the automatic function of removing the protective cap, the medicament delivery device can be designed such that the user does not need to change grip after removal. 
         [0027]    According to a further major aspect of the invention, the disconnecting means my as an alternative or variant comprise a mechanical actuator arranged manually operable, such that a force applied on said actuator causes displacement of the protective cap relative to the housing. With this feature, the force of displacing the protective cap is obtained by other means than an energy accumulating means, whereby the force may be provided by a user holding the device with one grip. 
         [0028]    For example the mechanical actuator is arranged to be operable by a force applied in the distal direction of the device. This means that the medicament delivery device may be pressed against a surface with its proximal end, which will provide a force in the distal direction. Further in this respect, the grip that the user is using for pressing the device against a surface for removing the protective cap, may well be the same grip used for the subsequent medicament delivery steps. 
         [0029]    In order to further facilitate the removal of the protective cap, said disconnecting means may further comprise transmission means capable of transmitting a distally directed displacement of said mechanical actuator to a proximally directed displacement of said protective cap. 
         [0030]    The transmission means may for example comprises a rotator operably connected to said mechanical actuator to rotate said rotator. In this respect it may be advantageous when the rotator is arranged with cam surfaces and protrusions and that said transmission means further comprises a guide member arranged with cam surfaces such that rotation of said rotator by said actuator causes a displacement of said rotator in the proximal direction of the device. The use of a rotator is positive in the sense that it is capable of providing several features and functions in one component. Nevertheless, the transmission means may instead comprise a leverage mechanism or other mechanical functions. 
         [0031]    A further advantage with the use of a transmission means is that it may be designed to provide a protective cap displacement force that is larger than the actuator displacement force. Therefore, a user may not need to use so much force when pressing the device against a surface, which is an advantage for weak users or users with impaired functions of the hands. 
         [0032]    According to a favourable embodiment of the present invention, the connecting means is a FNS/RNS remover, and in this respect the remover is operably arranged to said protective cap such that displacement of said protective cap causes an axial displacement of said remover and shield in relation to said medicament container. 
         [0033]    In all a very versatile, user-friendly as well as safety-increasing device is obtained with the present invention. 
         [0034]    These and other aspects of, and advantages with, the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0035]    In the following detailed description of the invention, reference will be made to the accompanying drawings, of which 
           [0036]      FIG. 1  is a cross-sectional view of a first embodiment of the present invention, 
           [0037]      FIG. 2  is an exploded view of the embodiment of  FIG. 1 , 
           [0038]      FIGS. 3-6  are detailed views of components comprised in the embodiment of  FIG. 1 , 
           [0039]      FIG. 7  is a cross-sectional view of a second embodiment of the present invention, 
           [0040]      FIG. 8  is an exploded view of the embodiment of  FIG. 7 , 
           [0041]      FIGS. 9-11  are detailed views of components comprised in the embodiment of  FIG. 7 , 
           [0042]      FIG. 12  is a perspective view of a third embodiment of the present invention, 
           [0043]      FIG. 13  is an exploded view of the embodiment of  FIG. 12 , 
           [0044]      FIGS. 14-15  are detailed views of components comprised in the embodiment of  FIG. 12 , 
           [0045]      FIGS. 16-17  are detailed views of the function of the embodiment of  FIG. 12 , 
           [0046]      FIG. 18  is a perspective view of a fourth embodiment of the present invention, 
           [0047]      FIG. 19  is an exploded view of the embodiment of  FIG. 18 , 
           [0048]      FIG. 20  is a perspective view of the embodiment of  FIG. 18  with a protective cap removed, 
           [0049]      FIG. 21  is a detailed exploded view of a cap assembly of the embodiment of  FIG. 18 , 
           [0050]      FIGS. 22-23  are cross-sectional views of the function of the embodiment of  FIG. 18 , 
           [0051]      FIG. 24  is a perspective view of a fifth embodiment of the present invention, 
           [0052]      FIG. 25  is an exploded view of the embodiment of  FIG. 24 , 
           [0053]      FIGS. 26-27  are detailed views of components comprised in the embodiment of  FIG. 24 , 
           [0054]      FIG. 28  is a cross-sectional view of the embodiment of  FIG. 24 , 
           [0055]      FIGS. 29-30  are detailed views of components comprised in the embodiment of  FIG. 24 , and 
           [0056]      FIGS. 31-35  are different detailed views of functional states of the embodiment of  FIG. 24 . 
       
    
    
     DETAILED DESCRIPTION 
       [0057]    A first embodiment of the present invention is shown in the drawings  1  to  6 . It comprises a proximal part, in the following named front shell  10 . The front shell  10  is a part of a major housing where the rest of the housing has been removed for clarity. Other components and functions comprised in the device not part of the present invention have also been removed for clarity. 
         [0058]    The front shell  10  is arranged with a proximally directed neck portion  12 ,  FIG. 2 , which neck portion  12  is arranged with threads  14  on its outer surface, which threads  14  form second disconnecting means of the housing. The front shell  10  is further arranged to accommodate a medicament container  16  in the form of an elongated cylindrical body with a collar  18  at its distal end. The inner space of the medicament container is filled with a medicament where its distal opening is closed by a movable stopper (not shown). 
         [0059]    The proximal end of the medicament container  16  is arranged with a medicament delivery member, in the embodiment shown an injection needle  20 . For protection, the injection needle is surrounded by a needle shield  22 ,  FIG. 2 , in the embodiment a so called RNS, rigid needle shield, which comprises an inner tubular sheath of elastic material, such as rubber, enclosing the injection needle. The RNS further comprises an outer shell of rigid material, which is enclosing and is attached to the sheath. The medicament container  16  with its RNS  22  is positioned in the front shell  10  such that the RNS  22  protrudes through the threaded proximal neck  12  of the front shell  10 . 
         [0060]    The device according to the present invention comprises a protective cap assembly  24 ,  FIG. 2 , that in the embodiment disclosed comprises a protective cap  26  having a distally directed opening  27 , which forms second connecting means of the device. The protective cap and the front shell are designed such that the distal end of the protective cap  24  with its opening  27  can fit onto a recessed portion  28  of the front shell  10 , which recessed portion  28  forms first connecting means of the device, with a certain friction between the two in a longitudinal direction  30  of the device, whereby the protective cap  26  and the front shell  10  are designed such that a rotational lock is obtained between the two. 
         [0061]    The protective cap assembly  24  further comprises an actuating mechanism including an activation member  32 , in the embodiment shown in the form of a button  32 ,  FIG. 6 , which is slidably arranged on the outer surface of the protective cap  26 . A portion of the button  32  extends into the protective cap via an opening, which portion of the button  32  is arranged with a plate-shaped actuation member  34 , comprised in the actuating mechanism, and extending in the distal direction. 
         [0062]    Further, the protective cap assembly comprises a nut  36 , hereafter named drive nut, which is arranged with threads  38 ,  FIG. 5 , on its inner cylindrical surface, forming a first disconnecting means. The threads  38  are designed to cooperate with the threads  14  of the neck portion  12  of the front shell  10 . A proximally directed end surface of the drive nut  36  is arranged with a number of proximally directed protrusions  40 ,  FIG. 6 . These protrusions  40  are arranged to fit into a circumferentially extending cut-out  42  on an inner surface of a ring-shaped drive member  44 ,  FIG. 5 , which drive member  44  is comprised in the first disconnecting means. The circumferential cut-out  42  is arranged with a number of distally directed ledges  46 ,  FIG. 5 , such that the protrusions  40  of the drive nut  36  engage the ledges  46 , causing a rotational lock between the drive nut  36  and the drive member  44 . 
         [0063]    The outer surface of the drive member  44  is further arranged with a ledge  48 ,  FIG. 6 , which ledge  48  is designed to cooperate with the actuation member  34  such that a rotational lock is obtained of the drive member  44  when the actuation member  34  is in a position in engagement with the ledge  48  of the drive member  44 . The drive member  44  is further arranged with an attachment point  50 ,  FIG. 6 , for a drive spring  52 , also comprised in the first disconnecting means. In the embodiment shown the drive spring  52  is a torsion spring having a distal end  54 ,  FIG. 5 , which fits in a hole of the attachment point  50  of the drive member  44 . The drive member  44  is arranged with a circumferential ledge  56  on its outer surface, which ledge is arranged to fit into seats  58 ,  FIG. 4 , on the inner surface of the protective cap  26 , providing a relative locking in the longitudinal direction but allowing rotation of the drive member  44  in relation to the protective cap  26 . 
         [0064]    A proximal end  60  of the torsion drive spring is arranged to be engaging a ledge  62 ,  FIG. 4 , on a distally directed end surface  63 ,  FIG. 4 , in the interior of the protective cap  26 , where the end surface  63  forms second disconnecting means of the protective cap  26 . A shield remover  64  is further attached to the protective cap, forming a third connecting means. The shield remover  64  comprises a cylindrical member provided with a circumferential outwardly protruding ledge  66 ,  FIG. 2 , at its proximal end. The proximal end in turn fits into a cylindrical seat  68  on a distally directed end surface of the protective cap  26 , where the cylindrical seat  68  is arranged with a circumferential groove, into which the circumferential ledge  66  of the shield remover  64  fits, such that the shield remover  64  is locked with the protective cap  26 . The shield remover  64  is further arranged with tongues  68  at its distal end, which tongues  68  are directed in the proximal direction and inclined with respect to the longitudinal direction of the device. 
         [0065]    The device according to the present invention is intended to be attached to the front shell  10  such that the drive nut  36  is threaded onto the neck portion  12  of the front shell  10 . A medicament container  16  with an RNS  22  is fitted into the front shell  10 . 
         [0066]    The drive spring  52  is placed into the protective cap with its proximal end  60  in engagement with the ledge  62  and the drive member  44  is attached to the distal end  54  of the drive spring  52 . Then the drive member  44  is pushed into the protective cap and locked into the seats  58  of the protective cap  26 . The push button  32  is pushed in the proximal direction, which allows the drive member  44  to be rotated with a suitable tool (not shown) until the drive spring  52  has been tensioned a certain amount. Then the push button  32  is pushed back in the distal direction whereby the actuation member  34  is moved in engagement with the protrusion  48  of the drive member  44 , thereby rotationally locking the drive member  44  with a tensioned drive spring  52 . 
         [0067]    The protective cap assembly  24  is then pushed onto the front shell  10 , whereby the shield remover  64  encloses the rigid shell of the RNS  22 . During the movement of the shield remover  64  in relation to the RNS  22 , the inclined tongues  68  will come in contact with the rigid shell and flex radially outwards and slide along the outer surface of the rigid shell. When the protective cap  26  has been pushed in position on the front shell  10 , and held there by frictional contact, the proximally directed protrusions  40  of the drive nut  36  fit into the groove  42  of the drive member  44 . The device is now ready to be used. This initial position is shown in  FIG. 1 . 
         [0068]    When a user now intends to administer a dose of medicament, first the protective cap assembly  24  has to be removed. The user then pushes the button  32  of the activation mechanism in the proximal direction. This causes the actuation member  34  to be moved out of contact with the ledge  48  of the drive member  44 . The drive member  44  is now free to rotate and will do so due to the force of the torsion spring  52 . Due to the rotational lock between the drive member  44  and the drive nut  36 , the latter will also rotate along the threads  14  of the front shell  10 , whereby the drive nut  36  is moved in the proximal direction. This movement in the proximal direction forces the whole protective cap assembly  24  in the proximal direction, including the shield remover  64 . The inclined tongues  68  of the shield remover  64  will in turn grip into the rigid shell of the RNS  22 , whereby also the RNS  22  will be moved in the proximal direction. The length of the threaded neck portion  12  and the strength of the drive spring  52  is designed such that the drive nut  36  is rotated until the protective cap  26  is removed from the front shell  10  as well as the RNS  22  is removed from the injection needle  20  of the medicament container  16 , whereby the protective cap  26  falls off or is lifted off. The rotation of the drive nut  36  is thus stopped and it merely rests on the neck portion  12  of the front shell  10 . The device is now ready for penetration and injection of medicament. 
         [0069]    It is of course possible to remove the protective cap assembly  24  from the medicament delivery device purely manually without activating the automatic protective cap remover. The user may merely grip the protective cap and pull it in the proximal direction against the friction force between the protective cap and the front shell and the friction between the injection needle and the sheath. 
         [0070]      FIGS. 7-12  show a second embodiment of the present invention. It comprises a front shell  110  of a medicament delivery device. The front shell  110  is arranged to accommodate a medicament container  112  having an injection needle  114  at its proximal end, which injection needle  114  is protected by a needle shield  116 , in the embodiment shown a RNS. The RNS  116  is protruding through a proximally directed neck portion  118  of the front shell  110 . A generally cylindrical actuator  120 , forming first disconnecting means, is arranged on the neck portion  118  and having a distally directed end surface in contact with a shoulder portion  122  of the front shell  110  surrounding the neck portion  118 , which shoulder portion  122  forms second disconnecting means of the housing. The actuator  120  is further arranged with a radially directed shoulder  124 . 
         [0071]    The actuator  120  is intended to fit into a protective cap  126  comprised in a protective cap assembly  128  of the invention,  FIG. 8 , where the shoulder portion  124  of the actuator  120  has a shape corresponding to the interior shape of the protective cap  126 , thereby providing a rotational lock of the actuator  120  in relation to the protective cap  126 . The protective cap  126  is arranged at the proximal end of the medicament delivery device having a distally directed opening  127  arranged to be pushed onto a recessed portion  129 , forming a first connection means, of the front shell  110  and held there by friction, where the opening  127  forms second connecting means. Further a compression spring  130 , comprised in the first disconnecting means, is arranged between a distally directed interior surface  131  of the protective cap  126  and a proximally directed end surface of the actuator  124 , where the interior surface  131  second disconnecting means of the protective cap. 
         [0072]    The protective cap assembly  128  further comprises an actuating mechanism including an activation member on an outer surface of the protective cap, in the embodiment shown a button  132 ,  FIG. 9 , slidable in a direction transversal to the longitudinal direction  134  of the device. The button  132  extends through an opening of the protective cap  126  and is attached to a plate-shaped actuation member  136 , comprised in the actuating mechanism. The actuation member is in an initial position in contact with a distally directed surface of the shoulder of the actuator,  FIG. 9 . The shoulder portion is further arranged with a cut-out  138 ,  FIG. 10 , adjacent the actuation member  136 . 
         [0073]    A shield remover  140 ,  FIG. 8 , is further attached to the protective cap, which shield remover forms third connecting means. The shield remover  140  comprises a cylindrical member provided with a circumferential outwardly protruding ledge  142  at its proximal end. The proximal end in turn fits into a cylindrical seat  143 ,  FIG. 7 , on a distally directed end surface of the protective cap, where the cylindrical seat is arranged with a circumferential groove (not shown), into which the circumferential ledge  142  fits, such that the shield remover  140  is locked with the protective cap  126 . The shield remover is further arranged with tongues  144  at its distal end, which  144  tongues are directed in the proximal direction and inclined with respect to the longitudinal direction  134  of the device. 
         [0074]    When the protective cap assembly  128  is to be arranged to the device, the compression spring  130  is placed inside the protective cap  126 . The button  132  is then slid from the initial position after which the actuator  124  is pressed into the protective cap against the force of the spring  130 , thereby compressing the latter. The button  132  is then returned to its initial position, whereby the spring  130  is held compressed inside the protective cap  126 . The protective cap assembly  128  is then pushed onto the recessed portion  129  of the front shell  110 , whereby the remover  140  encloses the rigid shell of the RNS  116 . During the movement of the remover in relation to the RNS, the inclined tongues  144  will come in contact with the rigid shell and flex radially outwards and slide along the outer surface of the rigid shell. When the protective cap  126  has been pushed in position on the front shell, and held there by frictional contact, a distally directed surface of the actuator  120  is in contact with the shoulder portion  122  of the front shell, as shown in  FIG. 7 . The device is now ready to be used. 
         [0075]    When a user now intends to administer a dose of medicament, first the protective cap assembly  128  has to be removed. The user then pushes the button  132  of the actuating mechanism in the transversal direction. This causes the actuation member  136  to be moved to the recess  138  of the shoulder  124  of the actuator, and thereby out of contact with the actuator  124 , whereby the force of the compression spring  130  is released such that it presses the actuator  120  in the distal direction against the shoulder  122  of the front shell  110 . The force of the spring  130  causes the protective cap  126  to be moved in the proximal direction against the friction forces between the protective cap  126  and the front shell  110  and the RNS and the injection needle respectively such that the protective cap assembly  128  with the needle shield  116  is removed, thereby exposing the injection needle  114 . The device is now ready for penetration and injection of medicament. 
         [0076]    It is of course possible to remove the protective cap assembly from the medicament delivery device purely manually without activating the automatic protective cap remover. The user may merely grip the protective cap and pull it in the proximal direction against the friction force between the protective cap and the front shell and the friction between the injection needle and the sheath. 
         [0077]      FIGS. 12 to 17  show a third embodiment of the present invention. In this embodiment the medicament container with its needle shield as well as with its shield remover have been omitted, but it may readily be understood by the person skilled in the art that the same components and features described above may be applied to the third embodiment without departing from the inventive idea. 
         [0078]    A proximal end of a housing  210  of a medicament delivery device is arranged with a protective cap assembly  212 ,  FIG. 12 . The protective cap assembly  212  comprises a protective cap  214 ,  FIG. 13 , having a distally directed opening  215 , forming second connecting means, and is designed to fit onto a recessed part  216 , forming a first connecting means, at a proximal end of the housing and held there by certain friction between the protective cap  214  and the housing  210 . The design of the protective cap  214  and the housing part  216  is such that the protective cap  214  is rotationally locked to the housing  210 . 
         [0079]    The protective cap assembly  212  further comprises a guide member  218 ,  FIG. 13 , of a generally tubular shape, forming a first disconnecting means. The guide member  218  is arranged to contact a proximal end surface  220  of the housing with a distal end surface, which proximal end surface  220  forms second disconnecting means. The guide member  218  is arranged with longitudinally extending guides  222 ,  FIG. 14 , which are arranged to fit in corresponding grooves  224  on inner surfaces of the protective cap  214 . With this arrangement, the guide member  218  is rotationally locked to the protective cap  214  and thereby to the housing  210 . A proximally directed end surface of the guide member  218  is arranged with a cut-out  226  having an inclined first surface  228 ,  FIG. 13 . 
         [0080]    The protective cap assembly  212  further comprises a rotator  230  having a generally tubular shape, which rotator  230  is comprised in the first disconnecting means. The rotator  230  has a diameter somewhat smaller than the guide member  218  and arranged extending into the guide member. The rotator  230  is arranged with a radially outwardly extending protrusion  232 ,  FIGS. 14 and 15 , which protrusion  232  is designed to be in contact with the first inclined surface  228 , as will be explained. The rotator  230  is further arranged with a cut-out  234  having an inclined second surface  236 ,  FIG. 13 . 
         [0081]    The protective cap assembly  212  further comprises an actuator  238 ,  FIGS. 13 and 14 , having a general U-shape and arranged extending through an opening  240  in a proximal end surface of the protective cap  214 , where the opening  240  has a shape corresponding to the shape of the actuator  238 . The actuator  238  is further arranged with a radially extending protrusion  242 ,  FIGS. 14 and 15 , on a side surface, which protrusion  242  is designed to be in contact with the second inclined surface  236 , as will be explained. The protective cap  214  is further arranged with a distally directed end surface  246 ,  FIG. 14 , forming second disconnecting means of the protective cap. 
         [0082]    The third embodiment is intended to function as follows. When the protective cap assembly  212  is pushed onto the proximal end of the housing, it is held in place by friction between the protective cap  214  and the housing  210 . Further a needle shield, such as an RNS, is extending through a neck portion  244 ,  FIG. 13  of the housing. The needle shield is surrounded by a remover (not shown), forming a third connection means, which in turn is attached to the interior of the protective cap  214 . 
         [0083]    When a user is to remove the protective cap assembly for administering a dose of medicament, the medicament delivery device is gripped such that the proximal part of the device, including the protective cap assembly  212 , may be pressed against a rigid surface. Thus, when the protective cap assembly  212  is pressed, the actuator  238  is forced in the distal direction into the protective cap  214 . This linear movement causes the protrusion  242  of the actuator  238  to act on the second inclined surface  236  of the rotator  230 ,  FIG. 16 . Due to the inclination of the second surface  242  and the rotational lock of the actuator  238 , the rotator  230  is forced to rotate. 
         [0084]    The rotation of the rotator  230  causes its protrusion  232  to act on the first inclined surface  228  of the guide member  218 . Due to the inclination of the first inclined surface  228  and the rotational lock of the guide member  218 , the rotator  230  is moved in the proximal direction during rotation,  FIG. 17 . The rotator  230  is designed such that a proximal end surface thereof is in contact with the distally directed surface  246  of the protective cap  214  whereby a movement of the rotator  230  in the proximal direction causes also the protective cap  214  to be moved in the proximal direction against the friction force between the protective cap and the housing and the friction force between the needle shield and the injection needle. 
         [0085]    When the actuator  238  has been pressed fully into the protective cap  214 , the protective cap  214  has moved such in the proximal direction that it is out of contact with the housing  210  and may be completely removed. In this respect it is to be understood that the protrusions  232 ,  242  on the rotator  230  and the actuator  238  as well as the inclined surfaces  228 ,  236  of the guide member  218  and the rotator  230  are chosen such that the force requirements are kept moderate and that the stroke of the rotator  230  enables loosening of the protective cap assembly  212 . 
         [0086]    The third embodiment may also be completely manually removed in that a user may grip the protective cap and pull it in the proximal direction against the forces holding it in place, thereby pulling of the protective cap assembly from the medicament delivery device. An advantage with this solution is that the initial grip of the device for removing the protective cap assembly may be continued during the subsequent penetration and injection. Thus, a user does not need to change grips during administration. 
         [0087]      FIGS. 18 to 24  disclose a fourth embodiment of the present invention. It comprises a housing part  310  provided with a proximal area  312  having a reduced size in the general radial direction, providing a proximally directed ledge  314 . Inside the housing part and protruding through the proximal area, a medicament container  316  is arranged to be positioned. A proximal end of the medicament container  316  is arranged with a medicament delivery member  318 ,  FIG. 20 , either attached to or made integral with the medicament container  316 . The medicament delivery member is covered by a protective needle shield  320 , such as e.g. an RNS or an FNS. In the embodiment shown, the shield is a FNS. 
         [0088]    A protective cap assembly  322  is further provided to the device. It comprises a protective cap  324  having a generally tubular shape with a distally directed opening  326 ,  FIG. 21 . The shape and the dimensions of the opening  326  is such that it fits onto the proximal area  312  of the housing with a certain friction, with a distally directed end surface  327  in contact with the ledge  314  of the housing  310 . An inner, distally directed, surface  328  of an end wall  330  of the protective cap is arranged with a generally tubular member  332 , extending in the distal direction. On the inner surface of the tubular member  332 , a number of grip members  334  are arranged,  FIG. 21 , designed as wedge-shaped protrusions, the function of which will be explained below. 
         [0089]    An actuator member  336 ,  FIG. 21 , is arranged to the protective cap  324 , in the form of an elongated member arranged slidable and protruding through a passage  338 ,  FIG. 19 , in the end wall  330  of the protective cap. A distal end of the actuator member  336  is attached to, or made integral with, a ring-shaped activation member  340 ,  FIG. 21 , such that the connection between the actuator member  336  and the activation member  340  provides some hinge action. On an opposite end of the ring-shaped activation member  340  in relation to the hinge connection, a generally radially outwardly directed protrusion  342  is arranged. The protrusion is intended to fit into a recess  344  on an inner side surface of the protective cap  324 , providing a hinge  345 ,  FIG. 22, 23 . Further, the proximally directed end surface of the housing is arranged in two sections  346 ,  348 ,  FIG. 19 , inclined with respect to a longitudinal direction  350  of the device, whereby two pointed projections  352  are obtained. 
         [0090]    The device is intended to function as follows. The safety cap assembly  322  is arranged such that the ring-shaped activation member  340  is placed inside the protective cap  324  with its protrusion  342  in the recess  344  and the actuation member  336  extending through the opening of the protective cap  324 . The protective cap assembly  322  is pushed onto the proximal, recessed, end  312  of the housing  310 , which housing  310  contains a medicament container  316  with its medicament delivery member  318  covered by a shield  320 . When the protective cap  324  is pushed onto the housing, the tubular member  332  of the protective cap surrounds the shield  320 ,  FIG. 20 . The wedge-shaped grip members  334  slide along the surface of the shield  320  until the distal end surface comes in contact with the ledge  314 ,  FIG. 22 . 
         [0091]    When the protective cap  324  is to be removed, the proximal end of the device, and thus the protective cap assembly  322 , is pressed against a firm surface. This causes the actuation member  336  to be pushed in the distal direction,  FIG. 22 , in relation to the protective cap  324 . The movement in the distal direction of the actuation member  336  causes the ring-shaped activation member  340  to be also moved in the distal direction due to the inter-connection between the two. However, due to that the opposite side of the ring-shaped activation member  340  is attached to the protective cap via the hinge  345  and due to the pointed projections  350 , which are placed generally between the hinge  345  and the connection of the actuation member  336 , the ring-shaped activation member  340  will pivot around the pointed projections  350 ,  FIG. 23 . In turn, this pivot action causes the hinge  345  to move in the proximal direction, and thus the protective cap  324  to move in the proximal direction, whereby the protective cap  324  is pushed off the housing part against the friction force between the protective cap and the housing part  312 . Because of the grip members  334  gripping into the shield  320 , the shield  320  will also be pushed off the medicament delivery member  318 . When the protective cap assembly is removed, the device is ready for medicament delivery. 
         [0092]    It is to be understood that the fourth embodiment may also be completely manually removed in that a user may grip the protective cap and pull it in the proximal direction against the forces holding it in place, thereby pulling of the protective cap assembly from the medicament delivery device. An advantage with this solution is also that the initial grip of the device for removing the protective cap assembly may be continued during the subsequent penetration and injection. Thus, a user does not need to change grips during administration. 
         [0093]    A fifth embodiment of a medicament delivery device comprising a protective cap assembly  410  according to the present invention is shown in the drawings  24  to  35 . It comprises a generally tubular sleeve, hereafter named ejector sleeve  412 ,  FIG. 25 . The inner diameter of the ejector sleeve  412  is chosen somewhat larger than a proximal end part of a housing  414  of the medicament delivery device, e.g. a front shell, which proximal end may for example comprise an activation member  416  slidable along a longitudinal axis  415  of the device for activating e.g. penetration and injection of the device. The ejector sleeve  412  is arranged with a circumferential outwardly directed ledge  418  at its distal end,  FIGS. 26 and 27 . A distal surface of the ledge  418  is intended to be in contact with a proximally directed circumferential surface area  420 ,  FIG. 25  of the medicament delivery device, comprised in second disconnecting means of the housing. The ejector sleeve  412  is further arranged with circumferential inwardly directed ledge  422  at its proximal end,  FIG. 27 , forming a circularly shaped passage  424 . The ledge  422  is arranged with a number of slits  426 , the function of which will be described below. 
         [0094]    A generally tubular cap  428 ,  FIGS. 26 and 27 , is arranged radially outside, and coaxial with, the ejector sleeve  412 . The inner diameter of the cap  428  is chosen generally the same as the outwardly directed distal ledge  418  of the ejector sleeve, thereby causing a circumferential gap  430 ,  FIG. 28 , between the ejector sleeve  412  and the cap  428 . The cap  428  is arranged with inwardly directed protrusions  432  comprised in a second connecting means,  FIGS. 29 and 31 , at its distal end, which protrusions fit into a circumferential groove  434  comprised in a first connecting means;  FIGS. 25 and 31 , on a side surface of on the housing  414  adjacent the proximally directed surface  420  such that the cap  428  is releasably attached to the housing  414  of the medicament delivery device. An end wall  436 ,  FIGS. 27 and 29 , is further arranged in the proximal end of the cap  428 , comprised in a second disconnecting means of the cap. 
         [0095]    On an inner surface of the end wall  436 , a generally tubular remover member  438 ,  FIG. 29 , is attached. The remover member  438  is arranged extending into the passage of the ejector sleeve  412 . An inner surface of the tubular remover member  438  is arranged with a circumferential groove  440 . A circumferential protrusion  442  arranged on an outer surface of a tubularly shaped needle shield remover  444  comprised in a third connecting means,  FIG. 29 , fits into the circumferential groove  440 , thereby locking the needle shield remover  444  to the remover member  438 . The needle shield remover  444  is further arranged with an inwardly inclined, proximally directed gripping member  445 , which gripping member is intended to grip into the elastic material of a flexible needle shield  446 , which needle shield  446  surrounds an injection needle  448  as well as a proximal neck portion  450  of a medicament container  452 ,  FIG. 28 . The remover member  438  is further arranged with a circumferential, outwardly extending ledge  439  at a distal end thereof,  FIG. 29 . 
         [0096]    An activation member  454 ,  FIG. 25 , is arranged in the proximal end of the device. It comprises a generally disc-shaped contact member  456 ,  FIG. 27 , having a proximally directed contact surface. From the distal surface of the contact member  456 , two arms  458 ,  FIGS. 26 and 27 , extend distally. The arms  458  have generally rectangular shape as seen in a cross-section. Each arm extends into passages  460 ,  FIG. 26 , formed in the end wall  436  of the cap  428 , where the shape of the passages  460  generally correspond to the rectangular cross-sectional shape of the arms  458 . The arms  458  further extend into the gap  430  between the ejector sleeve  412  and the cap  428 . The activation member  454  is connected to an energy accumulating member  462 , e.g. a spring,  FIG. 25 . Together they form a first disconnecting means. The spring is arranged between the outwardly extending ledge  418  of the ejector sleeve  412  and a distally directed end surface of the arms  458 , urging the activation member  454  in the proximal direction. In an initial position, the activation member  454  is however locked from being moved in the proximal direction by a first set of ledges  464 ,  FIG. 27 , extending from side surfaces of the arms  458  and being in contact with a distal surface of the end wall  436  of the cap  428 ,  FIG. 30 . 
         [0097]    The arms  458  are also arranged with locking members, e.g. a second set of ledges  466 , extending from side surfaces of the arms  458 . The ledges are generally wedge-shaped as seen in the figures, the function of which will be described below. The arms  458  are further arranged with cut-outs  468  positioned between each set of second ledges  466 , as will also be described. 
         [0098]    The device is intended to function as follows. It is intended to be attached to the housing  414  of a medicament delivery device with the inwardly extending protrusions  432  of the cap  428  fitting into the circumferential groove  434  of the housing  414 . A medicament container  452  with an FNS  446  is fitted into the housing  414 ,  FIG. 28 . When the device is attached to the housing  414 , the needle shield of the FNS  446  slides into the needle shield remover  444 . In the initial position, as seen in  FIG. 28 , the activation member  454  extends from the cap  428  in the proximal direction, biased by the spring  462 . The distal surface of the end wall  436  of the cap  428  is in contact with a proximal end surface of the ejector sleeve  412 . 
         [0099]    When the cap assembly is to be removed in order to use the medicament delivery device the user presses the activation member  454  at the proximal end of the device against a surface. The contact member  456  with the arms  458  will then be moved in the distal direction against the force of the spring  462 . The arms  458  will move into the cap  428  and the second set of ledges  466  will pass the passages  460  of the cap. The passing of the second set of ledges  466  is facilitated by the wedge-shape of the ledges and the cut-outs  468  in the arms, where the latter enable a flexing transversal movement of the ledges  466 . When the ledges  466  have passed the passages  460 , the contact member  456  is locked from movement in the proximal direction relative to the cap  428  because the ledges  466  are locked by the distal surface of the end wall  436  of the cap  428 , as seen in  FIG. 32 . The spring  462  has in turn been compressed by the movement of the contact member in the distal direction, building up a force in the spring  462 ,  FIG. 31 . 
         [0100]    This force is now sufficient to overcome the holding forces between the protrusions  432  of the cap  428  and the groove  434  of the housing  414 , whereby the cap  428  is moved in the proximal direction together with the contact member  456 . The movement of the cap  428  also causes the needle shield remover  444 , attached to the cap, to move in the proximal direction relative to the housing  414 . The inclined gripping member  445  of the shield remover  444  will in turn grip into the flexible material of the FNS  446 , whereby also the FNS  446  will be moved in the proximal direction,  FIG. 33 , relative to the injection needle  448 . When the cap  428  has moved in the proximal direction a certain length, at a position where the FNS  446  is out of contact with the injection needle  448  and the proximal end of the medicament container,  FIG. 34 , the circumferential outwardly extending ledge  439  of the remover member  438 , will come in contact with the inwardly directed ledge  422  of the ejector sleeve  412 . Thus, the whole assembly is now removed,  FIG. 35 , and the medicament delivery device is ready for injection. 
         [0101]    It is of course possible to remove the protective cap assembly  410  according to the fifth embodiment from the medicament delivery device purely manually without activating the automatic protective cap remover. The user may merely grip the protective cap and pull it in the proximal direction against the holding force between the protective cap and the housing and the friction between the injection needle and the shield. 
         [0102]    It is to be understood that the embodiment described above and shown in the drawings is to be regarded only as a non-limiting example of the invention and that it may be modified in many ways within the scope of the patent claims.