Abstract:
An injection device for administering a liquid medicament includes a generally elongate housing, a syringe holder in which a syringe can be placed, said syringe containing a medication, a stop and a needle on the distal area thereof, a needle protection housing which is arranged so it can be moved axially on the housing and which protrudes at a certain distance from the distal end of the housing.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a Continuation of International Patent Application No. PCT/CH2015/000028 filed Feb. 24, 2015, which claims priority to Swiss Patent Application No. 333/14 filed Mar. 6, 2014. The entire contents of each are incorporated herein by reference for any and all purposes. 
     
    
     BACKGROUND 
       [0002]    The invention is in the field of the injection devices for administering a liquid product, in particular a medicament. The invention relates to an injection device according to the preamble of claim  1 . 
         [0003]    The term “medicament” here covers any free-flowing medicinal formulation that is suitable for controlled administration through a means such as, for example, a cannula or a hollow needle, comprising, for example, a liquid, a solution, a gel or a fine suspension containing one or more medicinal active substances. A medicament can be a composition with a single active ingredient or a premixed or co-formulated composition with several active ingredients from a single container. Medicaments include drugs such as peptides (for example, insulin, insulin containing medicaments, GLP- 1  containing as well as derived or analogous preparations), proteins and hormones, biologically obtained or biologically active ingredients, active ingredients based on hormones or genes, nutrient formulations, enzymes, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, auxiliary and carrier substances. 
         [0004]    From the prior art, injection devices are known that have functions such as automatic insertion and release. Such an injection device is known from EP1349590 or US2005/0101919. These documents describe an injection device that comprises, for releasing, that is to say for starting the automatic insertion and release movement of the injection device, a release device in the form of a button in the proximal area of the injection device. Furthermore, they disclose a needle protection sleeve, which is pressed on an injection site, in order to shift the needle protection sleeve from a distal into a proximal position. The injection can only be released if the needle protection sleeve is pushed on the injection site, and the needle protection sleeve is in its proximal position and if the button was actuated subsequently. In this injection device, the button cannot be pushed before the needle protection sleeve is not in its proximal position. 
       SUMMARY 
       [0005]    The problem of the invention is to provide an improved injection device by means of which a safe release is possible. 
         [0006]    The problem is solved by the characterizing features of claim  1 . Advantageous developments result from the dependent claims. 
         [0007]    The invention relates to an injection device for administering a liquid medicament. The injection device comprises a generally elongate housing, a syringe holder wherein a syringe can be placed and wherein the syringe contains a medicament and a plug and comprises a needle in its distal area, a needle protection sleeve, which is placed axially movably on the housing and which protrudes at a certain distance from the distal end of the housing. A drive device, which comprises a piston rod and a loaded drive spring and which is coupled to a holding device and held in a stressed state by means of a release device, and which, after the release, first acts on the syringe in order to shift it in the distal direction and then acts on the plug in order to inject the medicament from the syringe, a release button assembly, which has a release button, in order to uncouple the drive device from the holding device, wherein the release button assembly is designed so that it has a site of connection to the piston rod, so that a distally directed movement of the release button assembly moves the piston rod in the distal direction from a first position into a second position, and, via the connection of the holding device to the drive device, the holding device can also be moved in the distal direction. When the release button is pushed and moved from its proximal position into a distal position, then, in particular, the piston rod can be shifted as a result together with the holding device in the distal direction from the first position into the second position. 
         [0008]    The release device comprises a releasing element and is axially movable in the housing and connected to the needle protection sleeve. When the needle protection sleeve is placed on the skin of the patient, the needle protection sleeve is moved in the proximal direction, and the resulting effect is that the release device also moves in the proximal direction. 
         [0009]    The drive device is placed in the holding device and detachably engaged to the holding device and to the releasing element. 
         [0010]    For releasing the injection device, the drive device must be uncoupled from the holding device, so that the driving device first moves the syringe in the distal direction in order to insert the needle, and then the piston is moved in the distal direction for the release of the medicament. 
         [0011]    The drive device can be released by means of two releasing modes. 
         [0012]    The patient himself/herself can select which of the two releasing modes he/she prefers. 
         [0013]    In a first releasing mode, the patient first pushes the release button from the proximal position into the distal position and then places the injection device on the skin, in order to move the needle protection sleeve in the proximal direction and thus start the injection. 
         [0014]    In the second releasing mode, the patient first pushes the injection device on the skin, and the needle protection sleeve is moved in the distal direction and thus positions the pen on the skin, and, when ready, the patient pushes the release button from the proximal position into the distal position, in order to release the injection. 
         [0015]    In both cases, a sequential shifting of the needle protection sleeve in the proximal direction and a shifting of the release button in the distal direction are needed. 
         [0016]    The two releasing modes have the following two movement courses and can occur in different sequences in order to start the injection. In the first movement course, by pushing of the release button, the release button and the piston rod in connection with the holding device, which is coupled to the piston rod, are shifted in the distal direction. In the second movement course, the needle protection sleeve in connection with the releasing element is shifted in the proximal direction. The two movement courses have the effect that the holding device is shifted by a defined distance in relation to the releasing element, and, in this way, the holding device can be released from the releasing element, in order to uncouple the driving element from the holding device and release the injection. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is an exploded view of an injection device according to the invention. 
           [0018]      FIGS. 2 and 3  are cross-sectional representations of an injection device according to the invention with a cap in place in the delivery state, wherein  FIG. 2  is a view that has been rotated with respect to  FIG. 3  by 90° about the longitudinal axis. 
           [0019]      FIGS. 4 and 5  are cross-sectional representations of an injection device according to the invention, wherein the injection device is shown placed on the injection site, and wherein  FIG. 4  is a view that has been rotated with respect to  FIG. 5  by 90° about the longitudinal axis. 
           [0020]      FIGS. 6 and 7  are cross-sectional representations of an injection device according to the invention, wherein the release button has been pushed from a proximal position into a distal position, and wherein  FIG. 6  is a view that has been rotated with respect to  FIG. 7  by 90° about the longitudinal axis. 
           [0021]      FIGS. 8 and 9  are cross-sectional representations of an injection device according to the invention, wherein the needle protection sleeve has been shifted in the proximal direction and the release button in the distal direction, and thus the injection device is shown in the released state, and wherein  FIG. 8  is a view that has been rotated with respect to  FIG. 9  by 90° about the longitudinal axis. 
           [0022]      FIGS. 10 and 11  are cross-sectional representations of an injection device according to the invention, wherein the content of the medicament has been released, and the signaling device has generated a final click, and wherein  FIG. 10  is a view that has been rotated with respect to  FIG. 11  by 90° about the longitudinal axis. 
           [0023]      FIGS. 12 and 13  are cross-sectional representations of an injection device according to the invention, wherein the injection device has been removed from the injection site, and the final locking of the needle protection sleeve has taken place, and wherein  FIG. 12  is a view that has been rotated with respective to  FIG. 13  by 90° about the longitudinal axis. 
           [0024]      FIGS. 14 and 15  are cross-sectional representations of an injection device according to the invention with another embodiment of the release button assembly, wherein  FIG. 14  is a view that has been rotated with respect to  FIG. 15  by 90° about the longitudinal axis. 
           [0025]      FIGS. 16 and 17  are cross-sectional representation of an additional injection device according to the invention with another embodiment of the release button assembly, wherein  FIG. 16  is a view that has been rotated with respect to  FIG. 17  by 90° about the longitudinal axis. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Unless otherwise indicated, identical reference numerals refer to identical parts. 
         [0027]    The injection device, for example, an autoinjector as shown in  FIGS. 1, 2 and 3 , comprises a housing with a distal housing portion  1  and a proximal housing portion  5  with a cap  6  in place in the delivery state. The distal housing portion  1  and the proximal housing portion  5  are connected to one another by latching connections or thread connection. 
         [0028]    In the distal housing portion  1 , a product container  2  is accommodated, on the distal end of which an injection needle for the release of a liquid product contained in the product container  2  is located. On the proximal end, the product container  2  has a shiftable piston  2   d,  whose movement in relation to the product container  2  and in the direction of the injection needle produces a product release, wherefore one can also speak of a release movement. 
         [0029]    The injection device moreover comprises a needle protection sleeve  8 , wherein the needle protection sleeve  8  has a distal area with a first diameter, and a proximal area with a larger diameter. In  FIG. 1 , at least one window  8   b  on the needle protection sleeve  8  can be seen, as a result of which the product container  2  (e.g., syringe) is also visible in the built-in state. On the inner side of the needle protection sleeve  8 , an injection step  8   c  is provided. On the proximal end of the needle protection sleeve  8 , two recesses are provided, which comprise inward directed needle protection abutments  8   a.  The needle protection sleeve  8  is placed in a manner so it can be shifted axially in the housing, and the distal area of the needle protection sleeve  8  protrudes from the distal end of the distal housing portion  1 . The needle protection sleeve  8  is attached by means of the needle protection sleeve abutment  8   a  and via rib abutments  14   a  on a releasing element  14 , and secured against further distal movement and via the window  8   b  against twisting. For this purpose, a frame ledge of the window ld protrudes radially inward into the window opening  8   b.    
         [0030]    The device moreover comprises a syringe holder  3 , which is placed axially movable in the needle protection sleeve  8 , wherein the syringe holder  3  has a shoulder support  2   a  for the product container  2  (e.g., prefilled syringe), and the product container  2  is positioned in the syringe holder  3  above the shoulder support  2   a.  The syringe holder  3  is coupled by means of proximally directed arms  3   a  with inward facing protrusions  3   b  to the insertion sleeve  4 . The insertion sleeve  4  is configured in the shape of a ring, and, in its distal area, it has an annular shoulder  4   c,  to which the syringe holder  3  is hooked with its proximally directed arms  3   a.  Moreover, the insertion sleeve  4  has proximally flexible arms  4   a  with an inward directed hook  4   b,  which in turn is snapped into the groove  9   a  of the piston rod  9 . 
         [0031]    Furthermore, the device comprises the releasing element  14 , which is placed axially movable in the housing and connected to the needle protection sleeve  8  (as already described herein). The releasing element  14  is configured in the shape of a sleeve and conical at the distal end, and, at the distal outer periphery, it has the rib abutment  14   a.  At a small distance from the rib abutment  14   a,  a first ring  14   c  is placed on the outer periphery, and a second ring  14   d  is placed at a greater distance from the rib abutment  14   a.  On the inner side, the releasing element  14  comprises blocking means  14   b.    
         [0032]    The injection device moreover comprises a holding device  12 , which is placed axially movable in the releasing element  14 . The holding device  12  comprises spring arms  12   a,  which, in their distal area, comprise inward projecting protuberances  12   g.  Furthermore, the holding device  12  comprises proximally directed wings which, in the proximal area, comprise a needle protection spring supporting surface  12   c  and, slightly distally therefrom and on the inner side of the wings, a gradation  12   d.    
         [0033]    The injection device also comprises a drive device, which is placed axially in the holding device  12  and which is detachably engaged to the holding device  12  and to the releasing element  14 . The drive device is controlled via the holding device  12  and via the releasing element  14  (as explained in further detail herein). The drive device is configured to store drive energy and to move the syringe holder  3  in the distal direction in a first step and then release the contents of the syringe  2 , and, after the completion of the release, move the holding device  12  in the proximal direction, in order to generate an acoustic and/or tactile signal and signal the end of the injection to the user. 
         [0034]    The drive device comprises a piston rod  9 , which acts on the plug  2   d,  and a drive spring  10 , which is loaded, in order to move the piston rod  9  and drive the syringe holder  3  in the distal direction in a first step for inserting the needle, and in order to move the plug  2   d  in the distal direction, in an additional step, for the release of the medicament. The piston rod  9  is placed axially movable in the holding device  12 , and the drive spring  10  is attached in the piston rod  9  between a distal wall  9   b  of the piston rod  9  and a proximal end of the holding device  12 . In addition, a guiding pin  11  may be positioned within the drive spring  10 . 
         [0035]    The piston rod  9  has a peripheral groove  9   a  on its peripheral sheath. The groove is designed so that the protuberances  12   g  of the spring arms  12   a  of the holding device  12 , and the hooks  4   b  of the flexible arms  4   a  of the insertion sleeve  4  can engage in the groove  9   a.    
         [0036]    Moreover, the injection device comprises a needle protection spring  13 , which is distally in contact with the second ring  14   d  of the releasing element  14  and proximally with the holding device  12  on the needle protection spring supporting surface  12   c.    
         [0037]    Furthermore, the device comprises a release button  7 . The release button is retained by means of spring arms  7   d  in the proximal area and by means of a peripheral groove  7   e  on a rib catch  12   b  of the holding device  12  in its proximal direction. The release button  7  has a button sheath  7   c  and, in the distal area of the button sheath  7   c,  on the inner side, the peripheral groove  7   e  is provided, into which the rib catch  12   b  can engage. Moreover, extension arms  7   a  extending in the distal direction, which have a supporting surface  7   b  in the distal area, are formed on the release button  7 . 
         [0038]    In the assembled state, the two housing portions are firmly connected. In the unused state, the piston rod  9  is held with the drive spring  10  in the stressed state. By means of the inward protruding spring arms  12   a  of the holding device  12 , which detachably engage from a locking connection in the peripheral groove  9   a  of the piston rod  9 , and by the sleeve-shaped releasing element  14 , which surround the spring arms  12   a  and thus prevent the opening of the arms  12   a,  the drive spring  10  is held in the stressed state. In addition, the insertion sleeve  4  also engages by means of the hooks  4   b  of the flexible arms  4   a  in the peripheral groove  9   a  of the piston rod  9 . The syringe  2 , the syringe holder  3 , and the needle protection sleeve  8  are attached in the distal housing portion  1 , so that a portion of the needle protection sleeve  8  protrudes out of the distal end of the distal housing portion  1 . Proximally directed arms  3   a  with inward facing protrusions  3   b  on the syringe holder  3  engage in the peripheral annular shoulder  4   c  on the insertion sleeve  4 . At the same time, the proximal area of the needle protection sleeve  8  is located in front of the first ring  14   c  of the releasing element  14 , whereby proximal movements of the needle protection sleeve  8  can be transmitted to the releasing element  14 , and distal movements of the releasing element  14  can be transmitted to the needle protection sleeve  8 . The releasing element  14  is applied with the distal abutment of the blocking means  14   b  against the distal area of the spring arms  12   a.  The extension arms  7   a  of the release button  7  are placed with their distal supporting surface  7   b  on the proximal area of the piston rod  9 , so that the end area of the button sheath  7   c  is at a defined distance W from the gradation  12   d  of the holding device  12  (see  FIG. 2 ). The spring arms  7   d  of the release button  7  are applied against an inclined surface in the interior of the proximal housing portion  5  and form a drive surface with the housing for a resetting of the release button  7 . 
         [0039]    The releasing element  14  and the release button  7  are arranged so that they can interact with one another independently of the sequence in which they are actuated and release the injection apparatus. 
       FIGS.  4  and  5 : 
       [0040]    The releasing element  14  is actuated first, and the release button  7  is actuated second. When, first, the distal area of the needle protection sleeve  8  is shifted against the force of the needle protection spring  13  in the proximal direction into the housing, the proximal end of the needle protection sleeve  8  comes in contact with the first ring  14   c  of the release ring element  14 , and its movement also moves the releasing element  14  in the proximal direction, and the protuberances  12   g  of the flexible spring arms  12   a  of the holding device  12  reach the distal end of the releasing element  14 . If, before pushing the release button  7 , the user removes the injection device from the injection site and thus interrupts the release of the injection apparatus, the loaded needle protection spring  13  moves the releasing element  14  and thus also the needle protection sleeve  8  back into its start position. 
       FIGS.  6  and  7 : 
       [0041]    The release button  7  is activated first, and the release element  14  is actuated second. 
         [0042]    When the release button  7  is pushed from its proximal position into a distal position, then the extension arms  7   a  with their supporting surfaces  7   b  reach the proximal area of the piston rod  9 , and thus the piston rod  9  and also the holding device  12 , which is coupled to the piston rod, are also shifted in the distal direction from a first position into a second position. As already described in  FIGS. 4 and 5 , the flexible spring arms  12   a  of the holding device  12  reach the distal end of the releasing element  14 . In the same way, the proximal area of the needle protection spring supporting surface  12   c  is moved in the distal direction by a button stroke H from the intermediate bottom  5   a.  Due to the axial shifting of the release button  7  and the simultaneous shifting or driving of the holding device  12  by means of the piston rod  9 , due to the engagement of the spring arms  12   a  in the groove  9   a,  the distance H remains between the gradation  12   d  and the distal area of the button sheath  7   c,  when the release button  7  is pushed. Furthermore, the flexible arms  7   d  of the release button  7  are bent radially inward on the inclined surface of the housing and stressed. Moreover, during the distal movement of the holding device  12 , pressure is exerted on the needle protection spring  13 , which is stressed between the needle protection spring supporting surface  12   c  and the releasing element  14 , as a result of which the releasing element  14 , and, over the first ring  14   c,  the needle protection sleeve  8  as well are moved in the distal direction. The releasing element  14  is moved in the distal direction until the blocking means  14   b  is again in the distal area of the spring arms  12   a.  If, in this case too, the user interrupts the release of the injection apparatus and takes the pressure off the release button  7 , before pushing the needle protection sleeve  8  on the injection site, the spring arms  7   d  of the release button  7 , which are stressed on the inclined housing surface, become unstressed, and the release button  7  as a result moves in the proximal direction, wherein the needle protection spring  13  also becomes unstressed and thus the holding device  12  is also pushed into its start position. The holding device  12  is shifted in the proximal direction to the distal abutment of the abutment element  14   b  of the releasing element  14 . 
       FIGS.  8  and  9 : 
       [0043]    If the release button  7  is then pushed in the distal direction, before or after the needle protection sleeve  8  has been pushed on the injection site and shifted in the proximal direction, these two movement courses have the effect that the holding device  12  is shifted in relation to the releasing element  14  by a defined distance, in particular until the distal area of the spring arms  12   a  of the holding device  12  comes out of the distal area of the release element  14 , and, as a result, the spring arms  12   a  can open radially and release the protuberances  12   g  from the peripheral groove  9   a  of the piston rod  9 , wherein the piston rod  9  is released and can be moved by the stressed drive spring  10  in the distal direction. In the process, the distally inclined outer surfaces of the spring arms  12   a  engage over the distal margin of the releasing element  14 , whereby the holding device  12  is held in position, and thus the proximal side of the needle protection spring supporting surface  12   c  is also kept at a distance equivalent to the button stroke H away from the intermediate bottom  5   a  of the housing. 
         [0044]    During the distal movement of the piston rod  9 , the proximally directed flexible arms  4   a  of the insertion sleeve  4  open, and the inward directed hooks  4   b  can be released from the peripheral groove  9   a  of the piston rod. This occurs since the flexible arms  4   a  are no longer held by the distal area of the spring arms  12   a  of the holding device, since, due to their radial movement, the spring arms  12   a  are in an outwardly open state. 
       FIGS.  10  and  11 : 
       [0045]    The force of the drive spring  10  drives the piston rod  9  in order to move the plug  2   d  of the syringe  2  in the distal direction. By means of the drive force of the drive spring  10  onto the plug  2   d  and the friction force of the plug  2   d  with the syringe  2 , the syringe  2  with the syringe holder  3  first of all moves in the distal direction and the needle is inserted in the injection site. The insertion process is terminated via the needle protection sleeve  8  when the syringe holder  3  with an offset lb is applied on the insertion ledge  8   c  provided in the distal area of the needle protection sleeve  8 . As a result, the force of the drive spring  10  acts on the plug  2   d  and drives said plug into the syringe  2  in order to release the medicament. After the medicament has been released and the proximal end of the piston rod  9  has passed the distal end of the spring arms  12   a  of the holding device  12 , the spring arms  12   a  can move radially inward and be released from the releasing element  14 . Since the force of the drive spring  10  acts proximally onto the holding device  12 , and since this holding device is no longer held via the releasing element  14 , the holding device  12  is guided axially by the releasing element  14  and moved in the proximal direction, wherein the proximal side of the needle protection spring supporting surface  12   c  is moved in the proximal direction by the piston stroke H and abuts against the intermediate bottom  5   a  of the housing. If, during or shortly before the end of the injection, the user keeps the release button  7  pressed, the holding device  12  nevertheless has an available movement distance W and can travel the desired distance in the proximal direction. The distance or movement distance between the distal end of the button sheath  7   c  and the gradation  12   d  of the holding device  12  is dimensioned so that, in the pressed state of the release button  7 , the holding device  12  is no longer impeded in its movement in the proximal direction by the release button  7 , but a movement distance or distance W remains between the holding device  12  and the button sheath  7   c,  so that the holding device  12  with its needle protection spring supporting surface  12   c  can abut against the intermediate bottom  5   a,  whereby an acoustic and/or tactile signal is generated, which lets the patient know that the injection has been completed and that the injection apparatus can be removed from the injection site. Preferably, the free movement distance or distance W is dimensioned to be greater than or equal to the button stroke H. 
       FIGS.  12  and  13 : 
       [0046]    When the injection device is removed from the injection site, the needle protection spring  13  drives the releasing element  14  in the distal direction, and the releasing element  14  pushes the needle protection sleeve  8 , which is also moved in the distal direction, and which protrudes from the distal housing portion  1  in order to cover the needle. Moreover, the blocking means  14   b  of the releasing element  14  pass by the spring arms  12   a  of the holding device  12 . Then, the proximal ends of the blocking means  14   b  and the distal surfaces of the spring arms  12   a  form proximal abutments for the releasing element  14 . Thus, the releasing element  14  can no longer be shifted in the proximal direction, and the needle protection sleeve  8  is also blocked for a renewed proximal shifting. 
       FIGS.  14  and  15 : 
       [0047]    A second injection device according to the invention comprises the same injection device subsystems as already described in  FIGS. 1 to 3 , and, in the second embodiment, the release button  7  has an extension arm  7   a ′. The extension arm  7   a ′ is applied with its distal area, a supporting surface  7   b ′, against the inner distal floor of the piston rod  9 . When the user pushes the release button  7  of the injection device and shifts it from a proximal position into a distal position, he shifts the piston rod  9  and thus also the holding device  12  from a first position into a second position in the distal direction. The subsequent steps such as, for example, the release, occur in the same way as described in the preceding embodiment. 
       FIGS.  16  and  17 : 
       [0048]    An additional injection device according to the invention also comprises the same injection device subsystems as already described in  FIGS. 1 to 3 . In this embodiment, the release button  7  comprises an extension sleeve  7   a ″ attached on the inner side, wherein the extension sleeve  7   a ″ abuts with its supporting surface  7   b ″ against the proximal area of the piston rod  9 , and wherein, upon releasing the injection device or pressing the release button  7  from a proximal position into a distal position, the piston rod  9  with the holding device  12  is also shifted in the distal direction from a first position into a second position. The other releasing steps follow as already described.