Patent Publication Number: US-2022218914-A1

Title: Safety Device for a Medicament Container

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/446,755, filed Jun. 20, 2019, which is a continuation of U.S. patent application Ser. No. 14/914,759, filed Feb. 26, 2016, now U.S. Pat. No. 10,363,379, which is a U.S. national stage application under 35 USC § 371 of International Application No. PCT/EP2014/068130, filed on Aug. 27, 2014, which claims priority to European Patent Application No. 13306179.6, filed on Aug. 29, 2013, the entire contents of which are incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     This disclosure relates to a safety device for a medicament container. 
     BACKGROUND 
     Administering an injection is a process which presents a number of risks and challenges for users and healthcare professionals, both mental and physical. Medicament delivery devices typically fall into two categories—manual devices and auto-injectors. In a conventional manual device, manual force is required to drive a medicament through a needle. This is typically done by some form of button/plunger that has to be continuously pressed during the injection. A conventional auto-injector may provide the force for administering the medicament by a spring, and a trigger button or other mechanism may be used to activate the injection. 
     For use of manual devices and autoinjectors, safety and usability are of the utmost importance. Thus, there remains a need for improved medicament delivery devices which include components or mechanisms for user and patient safety (e.g., to prevent misuse, needlestick, etc.) and enhanced usability (e.g., making the device easier to user before, during and after an injection to improve dose accuracy and compliance). 
     SUMMARY 
     Certain embodiments of the present invention to provide an improved safety device for a medicament container. 
     In an exemplary embodiment, according to the present invention, a safety device for a medicament container comprises a first sheath having a first ledge and a second ledge, a second sheath telescopically arranged with the first sheath and releasably coupled to the first ledge, and a finger flange having at least one res clip adapted to engage the second ledge first sheath. 
     In an exemplary embodiment the resilient clip comprises a transverse beam extending in a radial inward direction, a longitudinal beam extending from the transverse beam in a proximal direction, a hook comprising a slope surface and a block surface extending from the longitudinal beam in the radial inward direction, wherein during insertion of the outer ledge in a distal direction the second ledge engages the slope surface increasingly deflecting the resilient dip in a radial outward direction, wherein, after the second ledge has passed the slope surface the resilient dip relaxes and the second ledge ( 36 ) engages the block surface preventing the second ledge from returning in the proximal direction. 
     In an exemplary embodiment of the transverse beam comprises a hinge in the shape of a a section with a reduced thickness compared to the rest of the transverse beam. 
     In an exemplary embodiment the hinge has a thickness of approximately 30% to 70%, in particular 40°/h to 60% of the thickness of the rest of the transverse beam. 
     In an exemplary embodiment a protrusion is arranged on one of the finger flange and the first sheath, the protrusion arranged to engage a recess in the other one of the finger flange and the first sheath so as to limit relative rotation between the first sheath and the finger flange. 
     In an exemplary embodiment, the finger flange comprises a hole adapted to receive the first sheath. The finger flange comprises a central recess disposed adjacent to the hole adapted to receive the second ledge. 
     In an exemplary embodiment, the finger flange comprises a retaining wall adapted to abut the second ledge. The retaining wall abuts an entire periphery of the second ledge. 
     In an exemplary embodiment, the finger flange comprises at least one lateral recess disposed adjacent the hole. 
     In an exemplary embodiment, the finger flange comprises a central portion and at least one support portion extending radially from the central portion. The at least one support portion includes a support surface and wherein the support surface is made from a first material and the support portion is made from a second material, and wherein the first material has a lower durometer than the second material. The support surface may include one or more frictional features. 
     In an exemplary embodiment the support surface is formed by overmolding or by two-shot injection molding. 
     In an exemplary embodiment, a radial distance between an outer radial surface and an outer diameter of the hole is approximately 20 mm. 
     In an exemplary embodiment, the central portion comprises a substantially flat proximal surface and a concave distal surface, and the at least one support portion comprises a substantially flat proximal surface and a concave distal surface. 
     In an exemplary embodiment, the central portion comprises a substantially flat proximal surface and a substantially flat distal surface, and the at least one support portion comprises a concave proximal surface and a concave distal surface. 
     In an exemplary embodiment, according to the present invention, a medicament delivery device comprises a medicament container and a safety device according to any one of the exemplary embodiments. 
     Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Certain embodiments of the present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus, are not limitive of the present invention, and wherein: 
         FIG. 1  shows a medicament delivery device according certain embodiments of the present invention, 
         FIG. 2  shows a medicament container according to the present invention, 
         FIG. 3  shows a safety device according to the present invention, 
         FIGS. 4A and 4B  show a plunger according to the present invention, 
         FIGS. 5A and 5B  show a cap according to certain embodiments of the present invention, 
         FIG. 6  shows a cap according to certain embodiments of the present invention, 
         FIG. 7  shows an exemplary embodiment of a finger flange according to the present invention, 
         FIG. 8  shows a finger flange according to certain embodiments of the present invention, and 
         FIG. 9  shows a finger flange according to certain embodiments of the present invention, and 
         FIG. 10  shows a finger flange according to certain embodiments of the present invention, 
         FIG. 11  shows a sectional detail view of a finger flange according to certain embodiments of the present invention, and 
         FIG. 12  shows a sectional detail view of a finger flange according to certain embodiments of the present invention. 
     
    
    
     Corresponding parts are marked with the same reference symbols in all figures. 
     DETAILED DESCRIPTION 
       FIG. 1  shows a medicament delivery device  10  according to certain embodiments of the present invention. In an exemplary embodiment, the delivery device  10  comprises a medicament container  20 , a safety device  30  and a plunger  40 . The delivery device  10  may further include a finger flange  50  and/or a cap  60 . 
       FIG. 2  shows a medicament container  20  according to certain embodiments of the present invention. In the exemplary embodiment, the medicament container  20  includes a barrel  22 , a stopper  24  slidably disposed in the barrel  22  and a needle  26  coupled to a distal end of the barrel  22 . In an exemplary embodiment, the stopper  24  may be made from a rubber material. A proximal end of the barrel  22  includes a flange  28  which may be fully or partial circular, elliptical, square, rectangular or any other shape. The barrel  22  may be any size (e.g., 0.5 ml, 1 ml, 2 ml, etc.) and be made of any suitable material (e.g., plastic, glass). In an exemplary embodiment, the barrel  22  may be manufactured from Type I clear glass. In an exemplary embodiment, the stopper  24  is made from a rubber material. In an exemplary embodiment, the needle  26  is made from stainless steel. The needle  26  may be any gauge or length. 
     In an exemplary embodiment, a needle shield  29  may be removably coupled to the distal end of the barrel  22  to cover the needle  26 . In an exemplary embodiment, the needle shield  29  may be a sheath  29 . 1  made of, for example, rubber or elastomer latex. 
     In another exemplary embodiment, the needle shield  29  may further include a casing  29 . 2  made of, for example, polypropylene or any other similar material. The casing  29 . 2  may be disposed partially or entirely on an outer surface of the sheath  29 . 1 . The casing  29 . 2  may provide further support to the sheath  29 . 1  to, for example, prevent the needle  26  from bending or puncturing the sheath  29 . 1 . When the needle shield  29  is removed, the needle  26  is exposed. 
       FIG. 3  shows a safety device  30  according to certain embodiments of the present invention. In the exemplary embodiment, the safety device  30  comprises a first sheath  31  arranged telescopically with a second sheath  32 , and the sheaths  31 ,  32  which are biased relative to each other by a spring  33 . Prior to use, one of the sheaths is in a retracted position relative to the other sheath, and after use, the one of the sheaths is in an extended position relative to the other sheath to cover the needle  26 . In the extended position, the one of the sheaths is locked in the extended position to prevent retraction and uncovering of the needle  26 . 
     In the exemplary embodiment shown in  FIG. 3 , the first sheath  31  is an outer sheath, and the second sheath  32  is an inner sheath, and the second sheath  32  is movable from the retracted position to the extended position relative to the first sheath  31 , The first sheath  31  comprises an open distal end allowing the second sheath  32  to move from the retracted position to the distal position. A proximal end of the first sheath  31  includes an engagement arrangement  34  adapted to engage the flange  28  of the medicament container  20 . In an exemplary embodiment, the engagement arrangement  34  includes a support surface  34 . 1  adapted to abut a distal surface of the flange  28  to prevent distal movement of the medicament container  20  relative to the first sheath  31 , and one or more resilient hooks  34 . 2  adapted to engage the flange  28  to prevent proximal movement of the medicament container  20  relative to the first sheath  31 . When the medicament container  20  is inserted into the first sheath  31 , the flange  28  causes the resilient hooks  34 . 2  to deflect until the flange  28  is distal of the hooks  34 . 2 , at which point the hooks  34 . 2  return to a non-deflected position and can abut a proximal surface of the flange  28 . 
     In an exemplary embodiment, the proximal end of the first sheath  31  includes an inner ledge  35  and an outer ledge  36 . The inner ledge  35  may be formed partially or entirely around a proximal opening of the first sheath  31 . The outer ledge  36  may be formed partially or entirely around an outer surface of the first sheath  31 . As shown in the exemplary embodiment in  FIG. 3 , the first sheath  31  may have a distal portion having a first outer diameter and a proximal portion having a second outer diameter which is larger than the first outer diameter. The outer ledge  36  may be formed partially or entirely around the larger second outer diameter to provide a support surface for a user&#39;s fingers. 
     In an exemplary embodiment, the second sheath  32  comprises an open distal end allowing the needle  26  to pass through when the second sheath  32  is in the retracted position. A proximal end of the second sheath  32  includes one or more resilient arms  37  adapted to releaseably engage the inner ledge  35  to maintain the second sheath  32  in the retracted position against the force of the spring  33  which biases the second sheath  32  towards the extended position. When the second sheath  32  is in the retracted position the resilient arms  37  are radially biased to engage the inner ledge  35 . 
     In an exemplary embodiment, the first sheath  31  is made from polycarbonate, the second sheath is made from copolyesther, and the spring  33  is made from stainless steel. 
       FIGS. 4A and 4B  show a plunger  40  according to certain embodiments of the present invention. In the exemplary embodiment, the plunger  40  includes a distal end  41  adapted to engage the stopper  24 , a proximal end  42  adapted to be pressed by a user, and a stem  43  connecting the distal and proximal ends  41 ,  42 .  FIG. 48  shows a partial cross-section of an exemplary embodiment of the proximal end  42  of the plunger  40 . In the exemplary embodiment, the proximal end  42  includes a bearing surface  42 . 1  adapted to receive a user&#39;s finger. The bearing surface  42 . 1  may be flat (perpendicular relative to a longitudinal axis of the medicament container  20 ) or have a partially or entirely concave or convex surface. In another exemplary embodiment, the bearing surface  42 . 1  may have one or more surface elements (e.g., ridges, bumps, etc.) adapted to frictionally engage the user&#39;s finger to prevent it from slipping off the bearing surface  42 . 1  during use. The proximal end  42  further includes a radial surface  42 . 2  having a distal end that is adapted to engage one or more resilient projections on the first sheath  31  that deflect upon engagement with the radial surface  42 . 2  to engage the one or more resilient arms  37  on the second sheath  32  when the plunger  40  has been pressed a sufficient distance relative to the medicament container  20 . In an exemplary embodiment, the distal end of the radial surface  42 . 2  may comprise one or more ramps  42 . 3  adapted to engage the resilient projections such that the resilient rejections resilient arms  37  deflect and disengage the inner ledge  35 . 
     In an exemplary use, when the plunger  40  is pressed a sufficient distance, the ramps  42 . 3  engage the resilient projections which engage the resilient arms  37  such that the resilient arms  37  deflect and disengage the inner ledge  35 . The force of the spring  33  pushes the second sheath  32  distally relative to the first sheath  31  from the retracted position to the extended position. The second sheath  32  is locked in the extended position, because the resilient arms  37  abut a stop surface  31 . 1  (shown in  FIG. 3 ) on the first sheath  31  preventing the second sheath  32  from moving proximally relative to the first sheath  31  from the extended position. 
     In an exemplary embodiment, the plunger  40  is made from polypropylene. 
     In an exemplary embodiment, the safety device 30 and the plunger 40 may be as described in U.S. Patent Application Publication No. 2002/0193746, the entire disclosure of which is expressly incorporated herein by reference. 
       FIGS. 5A and 5B  show aof a cap  60  according to certain embodiments of the present invention. In the exemplary embodiment, the cap  60  comprises cylindrical portion  61  having a first outer diameter and a disc portion  62  having a second outer diameter larger than the second outer diameter. The cylindrical portion  61  includes a thru hole  61 . 1  adapted to accommodate the needle shield  29 . The disc portion  62  may include a thru hole coaxial with the thru hole  61 . 1  or may include a full or partial cover to fully or partially enclose the thru hole  61 . 1 . When assembled a proximal end of the cylindrical portion  61  may abut a distal end of the first sheath  31 . 
     In an exemplary embodiment, the cap  60  may be made from polypropylene. 
     In an exemplary embodiment, a gripping surface  63  may be coupled to the cap  60 . In the exemplary embodiment, the gripping surface  63  includes a proximal portion  63 . 1  and a distal portion  63 . 2 . The proximal portion  63 . 1  may be coupled to all or part of an outer surface of the cylindrical portion  61  of the cap  60  and/or all or part of a proximal surface of the disc portion  62 . The distal portion  63 . 2  may be coupled to all of part of an inner surface of the cylindrical portion  61  of the cap  60  and/or all or part of a distal surface of the disc portion  62 . In another exemplary embodiment, the proximal portion  63 . 1  or the distal portion  63 . 2  may be disposed partially or entirely around a circumference of the disc portion  62 . 
     In an exemplary embodiment, the gripping surface  63  may be made from a material having a lower durometer than the material comprising the cap  60 . In an exemplary embodiment, the gripping surface  63  may be elastomer thermoplastic. The gripping surface  63  may provide an easily grippable and supportive surface for a user to grip to remove the cap  60  from the medicament delivery device  10 . In an exemplary embodiment, any part of the gripping surface  63  may include one or more frictional features (e.g., ridges, bumps, etc.) to ensure that the user&#39;s fingers do not slip when gripping and removing the cap  60 . 
       FIG. 6  shows an exemplary embodiment of a cap  60  coupled to the medicament delivery device  10 . In the exemplary embodiment, the distal portion  63 . 2  of the gripping surface  63  is partially disposed on the inner surface of the cylindrical portion  61  of the cap  60 . In an exemplary embodiment, a thickness of the distal portion  63 . 2  may decrease along the length of the inner surface in the proximal direction. A proximal end of the distal portion  63 . 2  along the length of the inner surface may include a ramp feature  63 . 2 . 1  adapted to receive and guide the needle shield  29 , e.g., during assembly. The distal portion  63 . 2  of the gripping surface  63  is adapted to frictionally engage the needle shield  29 , such that when the cap  60  is pulled away from the medicament delivery device  10 , the needle shield  29  is removed. In another exemplary embodiment, all or part of the distal portion  63 . 2  may include one or more engagement features (e.g., a barb, a hook, a projection, etc.) adapted to engage the needle shield  29  (or any feature thereof, e.g., a slot, a channel, a recess, etc.) when the needle shield  29  is inserted into the cap  60 . In an exemplary embodiment, the distal portion  63 . 2  may include one or more separate pieces of material. For example, a first piece of material may be disposed on the inner surface of the cylindrical portion  61  and a second piece of material may be disposed on the distal surface of the disc portion  62 . A thru-hole  62 . 1  may be formed in the disc portion  62 , e.g., for molding the gripping surface  63 . 
     In an exemplary embodiment, the cap  60  and/or the gripping surface  63  may include one or more indicia for indicating how to remove the cap  60 . For example, all or part of the cap  60  may be a first color and all or part of the gripping surface  63  may be a second color different from the first color to signify that this is the needle end of the device  10 . In another exemplary embodiment, one or more words or symbols may be disposed on the cap  60  and/or the gripping surface  63 . For example, an arrow point in the distal direction and/or the words “PULL” or “DO NOT TWIST” may be disposed on the cap  60  and/or the gripping surface  63 . 
       FIG. 7  shows a finger flange  50  according to certain embodiments of the present invention.  FIG. 8  shows another a finger flange  500  according to certain embodiments of the present invention.  FIG. 9  shows a proximal view of a finger flange  50 / 500  according to certain embodiments of the present invention. 
     As shown in the exemplary embodiment in  FIG. 9 , a proximal surface of the finger flange  50 / 500  include a hole  70  adapted to receive the first sheath  31 . In an exemplary embodiment, a diameter of the hole  70  is approximately equal to an outer diameter of the first sheath  31 . A central recess  71  may be formed around the hole  70  and be adapted to accommodate a proximal portion of the first sheath  31 . For example, the central recess  71  may include a bearing surface  71 . 1  adapted to abut a distal face of the outer ledge  36 . The central recess  71  may further include a retaining wall  71 . 2  adapted to abut, at least a portion of the outer ledge  36  to prevent rotation of the first sheath  31  relative to the finger flange  50 / 500 . One or more resilient clips  72  are disposed within or adjacent the central recess  71  and adapted to engage the outer ledge  36 . When the finger flange  50 / 500  is coupled to the first sheath  31 , the clips  72  deflect to accommodate the outer ledge  36  and then return to a non-deflected position to engage the outer ledge  36 . 
     In another exemplary embodiment, the bearing surface  71 . 1  may not be recessed but may be in plane with the proximal surface of the finger flange  50 / 500 . In this exemplary embodiment, the retaining wall  71 . 2  and the clips  72  may extend proximally from the flat surface. 
     In an exemplary embodiment, the proximal surface of the finger flange  50 / 500  may include one or more lateral recesses  73  adjacent the central recess  71 . The lateral recesses  73  may be formed to create a hinge effect when supporting the user&#39;s fingers. The lateral recesses  73  may further decrease weight of the finger flange  50 / 500  and reduce constraints on molding. 
       FIG. 7  shows an exemplary embodiment of the finger flange  50  disposed on the outer sheath  31 , In the exemplary embodiment, the finger flange  50  includes one or more support portions  51  extending radially from a central portion  52 . The proximal surface of the finger flange  50  is substantially flat and distal surfaces of the support portions  51  and the central portion  52  are concave relative to the proximal surface (e.g., when the finger flange  50  is placed on a flat surface such that the proximal surface engages the flat surface). The support portion  51  may include a support surface  53 . In an exemplary embodiment, the support surface  53  may be made, e. g. by overmolding or by two-shot injection molding, from a material having a lower durometer than the material comprising the finger flange  50 . In an exemplary embodiment, the support surface  53  may be elastomer thermoplastic. The gripping surface  53  may provide a surface for a user&#39;s finger when administering an injection. In an exemplary embodiment, any part of the support surface  53  may include one or more frictional features (e.g., ridges, bumps, etc.) to ensure that the user&#39;s fingers do not slip when administering the injection. Likewise, the support surface  53  may be formed without such surface structures. While the exemplary embodiment of the invention shows two support portions  51  extending radially in a wing-like fashion from the central portion  52 , those of skill in the art will understand that any number of support portions  51  in any shape, size or dimension may be utilized based on the intended application. For example, a radial distance R between an outer radial surface  54  and an inner radial surface  55  may be approximately 20 mm. However, for use with elderly or arthritic patients, the radial distance may be increased, and the support portions may be larger. 
     In an exemplary embodiment, the finger flange  50  may be made from polypropylene or acrylonitrile butadiene styrene and the support surfaces  53  may be made from elastomer thermoplastic. 
       FIG. 8  shows an exemplary embodiment of the finger flange  500  disposed on the outer sheath  31 . In the exemplary embodiment, the finger flange  500  includes one or more support portions  501  extending radially from a central portion  502 . Proximal and distal surfaces of the support portions  501  are concave, and proximal and distal surfaces of the central portion  502  are substantially flat (e.g., approximately perpendicular to a longitudinal axis of the first sheath  31 ). The support portion  501  may include a support surface  503 . In an exemplary embodiment, the support surface  503  may be made, e. g. by overmolding or by two-shot injection molding, from a material having a lower durometer than the material comprising the finger flange  500 . In an exemplary embodiment, the support surface  503  may be elastomer thermoplastic. The gripping surface  503  may provide a surface for a user&#39;s finger when administering an injection. In an exemplary embodiment, any part of the support surface  503  may include one or more frictional features (e.g., ridges, bumps, etc.) to ensure that the user&#39;s fingers do not slip when administering the injection. Likewise, the support surface  53  may be formed without such surface structures. While the exemplary embodiment of the invention shows two support portions  501  extending radially in a wing-like fashion from the central portion  502 , those of skill in the art will understand that any number of support portions  501  in any shape, size or dimension may be utilized based on the intended application. For example, a radial distance R between an outer radial surface  504  and an inner radial surface  505  may be approximately 20 mm. However, for use with elderly or arthritic patients, the radial distance may be increased, and the support portions may be larger. 
     In an exemplary embodiment, the finger flange  500  may be made from polypropylene or acrylonitrile butadiene styrene and the support surfaces  503  may be made from elastomer thermoplastic. 
       FIG. 10  shows a finger flange  50  according to certain embodiments of the present invention. A proximal surface of the finger flange  50  includes a hole  70  adapted to receive the first sheath  31 . In an exemplary embodiment, a diameter of the hole  70  is approximately equal to an outer diameter of the first sheath  31 . A central recess  71  may be formed around the hole  70  and be adapted to accommodate a proximal portion of the first sheath  31 . For example, the central recess  71  may include a bearing surface  71 . 1  adapted to abut a distal face of the outer ledge  36 . The central recess  71  may further include a retaining wall  71 . 2  adapted to abut at least a portion of the outer ledge  36  to prevent rotation of the first sheath  31  relative to the finger flange  50 . One or more resilient clips  72  are disposed within or adjacent the central recess  71  and adapted to engage the outer ledge  36 . When the finger flange  50  is coupled to the first sheath  31 , the clips  72  deflect to accommodate the outer ledge  36  and then return to a non-deflected position to engage the outer ledge  36 . 
     In another exemplary embodiment, the bearing surface  71 . 1  may not be recessed but may be in plane with the proximal surface of the finger flange  50 . In this exemplary embodiment, the retaining wall  71 . 2  and the clips  72  may extend proximally from the flat surface. 
     In an exemplary embodiment, the proximal surface of the finger flange  50  may include one or more lateral recesses  73  adjacent the central recess  71 . The lateral recesses  73  may be formed to create a hinge effect when supporting the users fingers. The lateral recesses  73  may further decrease weight of the finger flange  50  and reduce constraints on molding. 
     In an exemplary embodiment a protrusion  71 . 3  is arranged in the retaining wall  71 . 2  in a manner to engage a respective recess (not illustrated) in the outer ledge  36  so as to avoid and/or limit relative rotation between the first sheath  31  and the finger flange  50 . In another exemplary embodiment the protrusion  71 . 3  could be arranged in the hole  70  in a manner to engage a respective recess (not illustrated) in the first sheath  31 . In the illustrated embodiment the protrusion  71 . 3  has an arcuate shape, Those skilled in the art will understand that the protrusion  71 . 3  may take any other form. Likewise, it would be possible to arrange the protrusion  71 . 3  on the first sheath  31  or on the outer ledge  36  in a manner to let it engage a corresponding recess in the retaining wall  71 . 2  or in the hole  70 . 
       FIG. 11  shows a sectional detail view of a finger flange  50  according to certain embodiments of the present invention. The resilient clip  72  comprises a transverse beam  72 . 1  originating from the finger flange  50  and extending in a radial inward direction I. The transverse beam  72 . 1  may be arranged substantially in parallel with the finger flange  50 , i.e. substantially at right angles with respect to the first sheath  31  to be received within the hole  70 . The resilient clip  72  furthermore comprises a longitudinal beam  72 . 2  originating from a radial inward end of the transverse beam  72 . 1  and extending in a proximal direction P. A hook comprising a slope surface  72 . 3  and a block surface  72 . 4  is arranged on the proximal end of the longitudinal beam  72 . 2  and extends in the radial inward direction I. The slope surface  72 . 3  allows for inserting the outer ledge  36  of the first sheath  31  in a distal direction D, wherein the outer ledge  36  engages the slope surface  72 . 3  increasingly deflecting it in a radial outward direction θ due to the resilient properties of the transverse beam  72 . 1  and/or the longitudinal beam  72 . 2 . Once the outer ledge  36  has passed the slope surface  72 . 3  during insertion the resilient clip  72  relaxes and returns in the radial inward direction I. The distally facing block surface  72 . 4  thus engages a proximal face of the outer ledge  36  preventing it from returning in the proximal direction P. 
       FIG. 12  shows a sectional detail view of a finger flange  50  according to certain embodiments of the present invention. The embodiment substantially corresponds to the embodiment of  FIG. 11 . However, the embodiment of  FIG. 12  differs from the embodiment of  FIG. 11  in that the transverse beam  72 . 1  comprises a hinge  72 . 1 . 1 , i.e. a section in which a thickness of the transverse beam  72 . 1  is reduced with respect to the rest of the transverse beam  72 . 1 . In an exemplary embodiment the hinge  72 . 1 . 1  has a thickness of approximately 30% to 70%, in particular 40% to 60% of the thickness of the rest of the transverse beam  72 . 1 . In an exemplary embodiment the hinge  72 . 1 . 1  is arranged adjacent the longitudinal beam  72 . 2 . 
     While exemplary embodiments of the components and/or portions of the cap  60  are described as having certain shapes (e.g., cylinders, discs, etc.) with certain properties that connote a shape (e.g., a diameter, circumference, etc.), those of skill in the art will understand that the cap  69  according to present invention is not limited to any shape or size, but may be adapted for any application or use. 
     While exemplary embodiments of the present invention are described as being made from certain materials, those of skill in the art will understand that other materials (and/or combinations of materials) may be utilized based on the intended application or use. 
     The term “drug” or “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, 
     wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-4. 
     Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin. 
     Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N—(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N—(ω-carboxyheptadecanoyl) human insulin. 
     Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. 
     Exendin-4 derivatives are for example selected from the following list of compounds: 
     H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, 
     H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2, 
     des Pro36 Exendin-4(1-39), 
     des Pro36 [Asp28] Exendin-4(1-39), 
     des Pro36 [IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), 
     des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or 
     des Pro36 [Asp28] Exendin-4(1-39), 
     des Pro36 [IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), 
     des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), 
     des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
     wherein the group -Lys6-NH2 may be bound to the G-terminus of the Exendin-4 derivative; 
     or an Exendin-4 derivative of the sequence 
     des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010), 
     H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2, 
     des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NIH, 
     H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2, 
     des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, 
     H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, 
     des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, 
     des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2, 
     H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
     des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, 
     H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-3 NH2, 
     des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
     H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, 
     H-Asn-(Glu)5-des Pro36, Pro37; Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2; 
     or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exendin-4 derivative. 
     Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin. 
     A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof, An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. 
     Antibodies are globular plasma proteins (˜150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM. 
     The Ig monomer is a “Y”-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-110 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two sheets create a “sandwich” shape, held together by interactions between conserved cysteines and other charged amino acids. 
     There are five types of mammalian Ig heavy chain denoted by α,δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively. 
     Distinct heavy chains differ in size and composition; α and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (C H ) and the variable region (V H ). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ,α and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and is composed of a single Ig domain. 
     In mammals, there are two types of immunoglobulin light chain denoted by λ and K. A Tight chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, K or λ, is present per antibody in mammals. 
     Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity. 
     An “antibody fragment” contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab′)2 fragment containing both Fab pieces and the hinge region, including the H—H interchain disulfide bond. F(ab′)2 is divalent for antigen binding. The disulfide bond of F(ab′)2 may be cleaved in order to obtain Fab′. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv). 
     Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts, Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in “Remington&#39;s Pharmaceutical Sciences” 17, ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. 
     Pharmaceutically acceptable solvates are for example hydrates. 
     Those of skill in the art will understand that modifications (additions and/or removals) of various components of the apparatuses, methods and/or systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof. 
     REFERENCES 
     
         
           10  medicament delivery device 
           20  medicament container 
           22  barrel 
           24  stopper 
           26  needle 
           28  flange 
           29  needle shield 
           29 . 1  sheath 
           29 . 2  casing 
           30  safety device 
           31  first sheath 
           31 . 1  stop surface 
           32  second sheath 
           33  spring 
           34  engagement arrangement 
           34 . 1  support surface 
           34 . 2  resilient hook 
           35  inner ledge 
           36  outer ledge 
           37  resilient arm 
           40  plunger 
           41  distal end 
           42  proximal end 
           42 . 1  bearing surface 
           42 . 2  radial surface 
           42 . 3  ramp 
           43  stem 
           50  finger flange 
           51  support portion 
           52  central portion 
           53  support surface 
           54  outer radial surface 
           55  inner radial surface 
           60  cap 
           61  cylindrical portion 
           61 . 1  thru hole 
           62  disc portion 
           62 . 1  thru hole 
           63  gripping surface 
           63 . 1  proximal portion 
           63 . 2  distal portion 
           63 . 2 . 1  ramp feature 
           70  hole 
           71  central recess 
           71 . 1  bearing surface 
           71 . 2  retaining wall 
           71 . 3  protrusion 
           72  resilient clip 
           72 . 1  transverse beam 
           72 . 1 . 1  hinge 
           72 . 2  longitudinal beam 
           72 . 3  slope surface 
           72 . 4  block surface 
           73  lateral recess 
           500  finger flange 
           501  support portion 
           502  central portion 
           503  support surface 
           504  outer radial surface 
           505  inner radial surface 
         D distal direction 
         I radial inward direction 
         O radial outward direction 
         P proximal direction 
         R radial distance