• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    DRUG RELEASE DEVICE. A drug delivery device for a reconstituted drug, comprising a proximal coupling part (12; 12 ??; 12 ???), a distal coupling part (10; 10 ??; 10 ???), a medication release drive unit and actuation means, where the medication release drive unit is mounted on said distal coupling part and where the actuation means also includes an activation member (74; 101; 201) which is displaceable between an inactive position, in which the actuator is prevented from engaging the medication release drive unit, and an active position, in which the actuator is capable of engaging the medication release drive unit, for example whereby the actuator is able to interact with said drug release drive unit to carry out a reconstituted drug release only in the active position of the activation member and in the second position of the release drive unit of medicine.
    公开号:BR112013019932B1
    申请号:R112013019932-6
    申请日:2012-01-31
    公开日:2021-01-19
    发明作者:Anders Holmqvist；Stefan Lööf
    申请人:Shl Medical Ag；
    IPC主号:
    专利说明:

    Field of invention
    The present invention relates to a medication delivery device and, in particular, a medication delivery device arranged to handle medication containers containing at least two chambers to contain agents to be mixed manually before being administered. Background of the invention
    There are a variety of devices on the market for self-administration of drugs, where the drug is stored in powder form in a medicine container. This is due to the fact that many drugs, when mixed with a diluent, tend to degenerate, if stored. There is, therefore, a growing market for so-called multi-chamber medicine containers, that is, containers with at least two chambers, in which at least one chamber contains the medicine in powder form, that is, the medicine agent and a chamber containing the diluent agent with which the drug must be mixed before release.
    In many devices, mixing the drug with the diluent is done manually when operating a drug delivery device, such as an injection device.
    Such a device is described in WO2009100550, where a proximal coupling part is turned in relation to a distal coupling part, through which the first or proximal coupling part containing a multi-chamber medicine container is fitted and moved to the distal coupling part. This, in turn, causes a plunger rod, through a first piston-like member, to push the diluting agent from one of the chambers to a second chamber through channels in the container, where the channels interconnect the two chambers with fluidity. The powdered medicine and diluting agent are mixed, creating a reconstituted medicine.
    To activate the drug release, that is, to inject the drug, an activation member in the form of a push button at one end of the injector is activated. In order to prevent activation of the device before the mixing step or process is completed, the actuating member or push button at the distal end of the device is locked by a locking mechanism, which blocks the axial movement of the push button in in relation to the coupling, that is, the push button is prevented from being pressed. At the end of the mixing sequence, the locking mechanism is activated and moved out of its locked position. After mixing, the dose release is thus activated by manual operation of the actuating member. Summary of the invention
    An object of the present invention is to obtain and offer a reconstituted drug in a safe and reliable manner, where a step of complete and uninterrupted mixing of a drug agent and a diluent agent is achieved to obtain the reconstituted drug, and where an involuntary release of the reconstituted drug is avoided until the mixing step has been fully reached.
    This and other objects are achieved by providing a drug delivery device that has the characteristics defined in the independent claim. Exemplary embodiments of the invention are defined in the dependent claims.
    According to a first aspect of the invention, a drug delivery device is provided comprising a proximal coupling part, adapted to accommodate a multi-chamber container containing at least two agents; a distal coupling part connected to said proximal coupling part; a drug delivery drive unit accommodated in the distal coupling part, where the proximal coupling part and the distal coupling part are configured to be movable, relative to each other, from an extended position to a retracted position , wherein the drug delivery drive unit acts on said multi-chamber container to mix at least two of said agents and thus obtain the reconstituted drug; and actuating means provided on the distal coupling part and including an actuator provided to fit the drug release drive unit, when operated by a user to release the reconstituted drug; wherein the drug delivery drive unit is mounted on said distal coupling part so as to be moved by the proximal coupling part, when the proximal and distal coupling parts are moved from the extended position to a retracted position, from a first spaced position of the actuator to a second position in which the said drug delivery drive unit can be fitted by the actuator, and in which the actuation means also include an activating member, which is displaceable between a position inactive, in which the actuator is prevented from engaging the drug release drive unit, and an active position, in which the actuator is capable of engaging the drug release drive unit, whereby the actuator is able to interact with the said drug release drive unit to release the reconstituted drug only in the active position of the limb and activation and in the second position of the drug release drive unit.
    Thus, the present invention is based on the knowledge that, by allowing said drug release drive unit to move between the first and second position, that is, separating the drug release drive unit and the actuation means from each other, complete mixing is ensured before a reconstituted drug release can be carried out. In addition, due to the distance between the drug delivery drive unit and the activation means, an accidental release is prevented. Brief description of the drawings
    In the following detailed description of the invention reference will be made to the accompanying drawings, in which: drug delivery device according to a first embodiment of the invention; Figure 2 is an expanded view of the device of Figure 1; Figures 3 and 4 are detailed views of the components that are part of the embodiment of Figure 1; Figures 5 to 7 are detailed views of different functional positions of the device of Figure 1; Figure 8 is a perspective view of a drug delivery device according to a second embodiment of the invention; Figure 9 is an expanded view of the device of Figure 8; Figures 10 to 12 are detailed expanded views of components of the device of Figure 8; Figures 13 and 14 are detailed views of different functional positions of the device of Figure 8; Figure 15 is an expanded view of a drug delivery device according to a third embodiment of the invention; and Figures 16 to 23 are detailed views of different functional positions of the device of Figure 15. Detailed description of the invention
    In the present application, when the term "distal part / end" is used, it refers to the part / end of the medication delivery device, or to the parts / ends of the limbs of the same, which is / are located further away ( s) in relation to the drug release site. Likewise, when the term "proximal part / end" is used, it refers to the part / end of the medication delivery device, or the parts / ends of the limbs of the same, which is / are located closest (s) ( s) the place of drug release.
    In addition, it should be noted that the term "axially" or "axially", as used herein, is intended to refer to a direction along the central axis of the drug delivery device, when assembled. In other words, the central axis extends through the drug delivery device along the direction in which a proximal part and a distal coupling part are mobile and interconnected. Thus, the central axis extends in the direction in which the drug is released. It should also be noted that the term "distally", as used herein, is intended to refer to a direction along the central axis of the drug delivery device towards the distal end of the device, that is, towards the part / end of the medication delivery device that is located farthest away from the medication delivery site, and the term "proximally" as used herein is intended to refer to a direction along the central axis of the medication delivery device towards to the proximal end of the device, that is, towards the part / end of the medication delivery device that is located closest to the medication delivery site.
    In addition, in the second embodiment, the same components or features, as in the first embodiment, have the same reference numbers, but with a double apostrophe ’’; and in the third embodiment, the same components or features, as in the first embodiment, have the same reference numbers, but with a triple apostrophe ’’ ’.
    The drug delivery device of the present invention comprises a proximal coupling part 12; 12 ’; 12 ’’ ’adapted to accommodate a multi-chamber container 22; 22 ’; 22 ’’ ’; containing at least two agents; a distal coupling part 10; 10 ’’; 10 ’’ ’connected to said proximal coupling part; a drug delivery drive unit accommodated in the distal coupling part, where the proximal part and the distal coupling part are configured to be movable, relative to each other, from an extended position to a retracted position, from so that the drug delivery drive unit acts on said multi-chamber container to mix at least two of said agents, thus obtaining the reconstituted drug; and actuation means provided on the distal coupling part, and including an actuator 74; 74 ’’; 74 ’’ ’provided to engage the drug delivery drive unit, when operated by a user to release the reconstituted drug; wherein the drug delivery drive unit is mounted on said distal coupling part, so as to be moved by the proximal coupling part, when the proximal and distal coupling parts are moved from the extended position to the retracted position, from a first position remote from the actuator to a second position in which said drug delivery drive unit can be fitted by the actuator, and in which the actuation means further include an activating member 74; 101; 201 that is displaceable between an inactive position, where the actuator is prevented from engaging the medication release drive unit and an active position in which the actuator is able to fit into the medication release unit, so that the actuator is able to interact with said drug release drive unit to release the reconstituted drug only in the active position of the activation member and in the second position of the drug release drive unit.
    Figures 1 to 7 show a first embodiment of the present invention, where Figure 1 is a perspective view of the drug delivery device according to the first embodiment of the invention and Figure 2 is an expanded view of the device of Figure 1. Figures 3 and 4 are detailed views of some components of the device in Figure 1. In Figure 4, the connecting member 46 is shown when connected to a spring loaded plunger member 34. Figure 5 shows when the proximal and distal parts coupling units are in an extended position and the drug delivery drive unit is in the first position. Figure 6 shows when the proximal and distal coupling parts are in a retracted position and the drug delivery drive unit is still in the first position. Figure 7 shows when the drug delivery drive unit is in the second position.
    Figures 8 to 14 show a second embodiment of the present invention, where Figure 8 is a perspective view of the drug delivery device according to the second embodiment of the invention and Figure 9 is an expanded view of the device of Figure 8. Figures 10 to 12 are detailed views of some components of the device of Figure 8. In Figure 10, the connecting member 46 '' is shown when connected to the spring loaded piston rod 34 ''. In Figure 13 it is shown when the activating member 101 is in an inactive position, where the actuator 74 ’’ is prevented from engaging the drug delivery drive unit. In Figure 14 it is shown when the activating member 101 is in an active position, and where the actuator 74 ’’ is engaged in the drug delivery drive unit.
    Figures 15 to 23 show a third embodiment of the present invention, where Figure 15 is an expanded view of the third embodiment of the present invention. Figure 16 shows a detailed perspective view of the 74 '' 'actuator and activation member 201. In Figure 17 it is shown when the proximal coupling part is in a retracted position and the drug delivery drive unit is still in the first position. In Figure 18 it is shown when the drug delivery drive unit is in the second position, and where the activation member 201 is in an inactive position such that the 74 '' 'actuator is prevented from engaging the delivery unit. triggering medication release. In Figures 19 and 22 it is shown when the activation member 201 is in an active position. In Figures 20 and 23 it is shown when the actuator 74 ’’ ’is fitted to the medication delivery drive unit. In Figure 21 it is shown when the activating member 201 is in an inactive position, so that the actuator 74 ’’ ’is prevented from engaging the drug delivery drive unit.
    In Figure 1, a drug delivery device according to a first embodiment of the invention is shown. The proximal coupling part 12 is inserted and interconnected with the distal coupling part 10, that is, the coupling parts are in the retracted position. Although not shown, the proximal coupling part is screwed into the distal coupling part along an axial direction of the drug delivery device, that is, the coupling parts have been moved, relative to each other, from one position extended to a stowed position. The proximal end of the proximal coupling part is provided with a neck portion 24 having fixing means in the form of screw threads, to which a medicament-releasing member is releasably connected. It should be understood that other types of fastening members can be used, such as bayonet inserts, attachment clips and the like. The medication release member can be selected from a group consisting of a needle, a mouthpiece or a nasal one, a nebulizer and a syringe cannula.
    In all three embodiments, see Figures 2, 9 and 15, it is shown that the assembled drug delivery device has a body which, in turn, comprises the distal coupling part 10; 10 ’’; 10 ’’ ’and the proximal coupling part 12; 12 ’’; 12 ’’ ’which are connected by screws, that is, they are interconnected by means of screws. The connection means between the coupling parts comprise grooves 14; 14 ’’; 14 '' '' arranged on the inner surface of the distal coupling part, cooperating with the grooves 16; 16 ’’; 16 ’’ ’on the outer surface of the proximal coupling part. The proximal coupling part 12; 12 ’’; 12 ’’ ’is arranged with at least one locking member directed distally or axially 18; 18 ’’; 18 ’’ ’connected to, or made integral with, a distal end surface of the proximal coupling part 12; 12 ’’; 12 ’’ ’.
    In addition, in all three embodiments, see Figures 2, 9 and 15, it is shown that within the multi-chamber container 22; 22 ’’; 22 ’’ ’, a first axially movable cap 26; 26 ’’; 26 ’’ ’is arranged to divide the container into a first chamber or compartment 28; 28 ’’; 28 ’’ ’and a second chamber or compartment 30; 30 ’’; 30 ’’ ’. One chamber or compartment is arranged to contain the powdered medicine agent, and the other chamber or compartment is arranged to contain the diluent agent, which must be mixed with the powdered medicine during a mixing step. A second axially movable lid 32; 32 ’’; 32 ’’ ’is arranged at the distal end of the container to seal the distal compartment.
    In all three embodiments, see Figures 2 to 4, 9, 10, 15 and 17, the medication release drive unit comprises a spring loaded piston member 34; 34 ’’; 34 ’’ ’equipped with a hollow space within which an actuation spring 38; 38 ’’; 38 ’’ ’is arranged to press the plunger, an actuating spring support 40; 40 ’’; 40 ’’ ’configured to partially surround the spring loaded piston member, a connecting member 46; 46 ’’; 46 ’’ ’through which said actuating spring support is axially disposed, and an actuating member 70; 70 ’’; 70 ’’ ’being co-axially slidable on said connecting member to support said spring loaded piston rod in a preloaded state.
    In all three embodiments, see Figures 2, 3, 9, 11 and 15, connecting member 46; 46 ’’; 46 '' '' comprises a tubular proximal part 48; 48 ’’; 48 ’’ ’; and a distal tubular part 64; 64 ’’; 64 ’’ ’connected to each other by two axially extending interconnecting portions 62; 62 ’’; 62 ’’ ’. The tubular proximal part 48; 48 ’’; 48 '' '' comprises an outer circumferential surface, an annular proximal surface and an annular distal surface. Connecting member 46; 46 ’’; 46 ’’ ’further comprises at least one radially flexible arm 56; 56 ’’; 56 ’’ ’extending distally from the annular distal surface of the tubular proximal part, between the two axially extending interconnecting portions 62; 62 ’’; 62 ’’ ’. The distal ends of at least one radially flexible arm 56; 56 ’’; 56 ’’ ’are arranged with an inward facing hook 60; 60 ’’; 60 ’’ ’. The drive spring support 40; 40 ’’; 40 ’’ ’is configured with a general U shape, with proximally directed legs 42; 42 ’’; 42 ’’ ’and wherein each leg comprises an outwardly extending radial protrusion 44; 44 ’’; 44 ’’ ’. When the drug delivery drive unit is mounted, the drive spring 38; 38 ’’; 38 '' '' is pressed between a surface of the proximal inner end of the plunger member 34; 34 ’’; 34 ’’ ’and a transverse contact end of the drive spring support 40; 40 ’’; 40 ’’ ’; the outwardly extending radial projections 44 are involved with the annular proximal surface of the tubular proximal part 48; 48 ’’; 48 ’’ ’to prevent the actuation spring support from being moved distally by the actuation spring; and the actuating member 70; 70 ’’; 70 ’’ ’, which is a ring-shaped member, is arranged so as to surround said at least one radially flexible arm 56; 56 ’’; 56 '' '' such that the hook is turned inward 60; 60 ’’; 60 ’’ ’is engaged in a corresponding slot with a cutout 36; 36 ’’; 36 '' '' on said spring loaded piston member to secure said spring loaded piston member with respect to said distal coupling part.
    In addition, in all three embodiments, see Figures 2, 3, 9, 11 and 15, connecting member 46; 46 ’’; 46 ’’ ’comprises counter connecting means 50; 50 ’’; 50 ’’ ’on the outer circumferential surface of the tubular proximal part 48; 48 ’’; 48 ’’ ’. Said opposite connection means 50; 50 ’’; 50 '' '' in the form of a thread segment are arranged to cooperate with the connection means 14; 14 ’’; 14 '' 'in the form of threads on the inner surface of the distal coupling part, such that when the drug release drive unit is in the first position, the drug release drive unit is fixed in relation to the part distal coupling, and the proximal outer end of the spring loaded piston member 34; 34 ’’, 34 ’’ ’is arranged to confine the second axially movable lid 32; 32 ’’, 32 ’’ ’. Then, when the distal and proximal coupling parts move in relation to each other, from the extended position to the retracted position, the medication release drive unit acts on the said multi-chamber container, that is, the second axially movable cover 32; 32 ’’; 32 ’’ ’is pressed against the outer proximal end of the spring loaded piston member 34; 34 ’’; 34 ’’ ’, whereby at least two of said agents are mixed, thus obtaining the reconstituted drug.
    In addition, in all three embodiments, see Figures 5, 10 and 15, connecting member 46; 46 ’’; 46 '' '' further comprises at least one counter-engaging member proximally or axially directed 54; 54 ’’; 54 '' '' arranged to interact with at least one of said engaging member distally or axially directed 18; 18 ’’; 18 ’’ ’of said proximal coupling part, after the reconstituted drug is obtained, so that the drug delivery drive unit is moved from the first position to the second position.
    In the first embodiment, see Figures 3 to 6, the distal tubular part 64 is arranged with an end surface 66. On said end surface 66, two inwardly facing hooks 68 are connected and arranged to fit or secure a spring of counter compression 78, which is arranged to cooperate with actuator 74. Actuator 74 is arranged as a push button that extends through an opening at the distal end of the distal coupling part 10. Actuator 74 is arranged to be pressed or pushed in the axial direction to the distal coupling part. The act of pushing or pressing the actuator is neutralized by the counter compression spring 78, which is attached or fixed by the hooks turned inwards 68 on the connection member 46. In addition, the actuator 74 and the activation member 74 are configured to they are part of a single component, called, from now on, as the actuation medium and which will use the common reference number 74. The actuation medium 74 comprises through holes 81 in its external circumferential surface, in such a way that a rotation movement of the actuation means 74, in relation to the distal coupling part, is prevented by the interaction between said through holes 81 and the flexible radial projections directed inwards (not shown) on the inner surface of the distal coupling part. In addition, the actuation means 74 comprises slits 80 in their outer circumferential surface, such that a longitudinal or axial movement of the actuation means 74, in relation to the distal coupling part, is limited by the interaction between said slits 80 and the flexible radial projections directed inward (not shown) on the inner surface of the distal coupling part. The through holes 81 and the slits 80 are interconnected by a transverse guide groove (not shown) on the outer circumferential surface of the actuation means, the functioning of which will be explained below.
    The function of the device as described in the first embodiment is as follows. When the device is delivered to a user, the first thing to do is to attach a medication release member. For example, an injection needle is attached to the neck portion 24 of the proximal coupling part 12. Next, the user needs to mix the drug agent with the diluent agent, i.e., a mixing sequence or step. The user then engages the two coupling parts 10 and 12 and screw them together. In this first embodiment, this causes the proximal coupling part 12 to be axially displaced within the distal coupling part 10, due to the connection by the threads 14, 16, that is, the proximal and distal coupling parts, are moved one by one. towards the other, from the extended position to the retracted position, in order to propel the spring loaded plunger into the medicine container, that is, the second axially movable cap 32 is pressed against the external proximal end of the plunger member spring loaded 34 through which at least two of said agents are mixed, thus obtaining the reconstituted drug. During the sequence or mixing step, the actuating member 70 is coaxially arranged on the arms 56 in such a way that the hooks 60 are engaged with the cutouts 36 of the spring loaded piston member 34, that is, the actuation spring it is kept in a compressed state during the sequence or mixing step. Also during the mixing sequence or step, the actuation means 74 is prevented from being pressed into the distal coupling part, due to the interaction between the through holes 81 on the outer circumferential surface of the actuation means, and the radial projections inwardly flexible on the inner surface of the distal coupling part 12. As shown in Figure 6, after the mixing step is performed, the engaging member distally or axially directed 18 of the proximal coupling part is now in contact with the coupling member opposite fitting 54 of the connecting member 46. Thus, as shown in Figures 5 and 6, the medication release drive unit is in the first position, where the actuating member 70 is positioned away from the actuation means 74, or that is, the actuating member 70 is positioned at a predetermined distance from the actuation means 74, in such a way as to prevent the release of said spring loaded piston. A new rotation of the proximal coupling part 12 in relation to the distal coupling part 10 causes the connecting member 46 to also be distally displaced due to the interaction between the thread segment 50 and the threads 14 of the distal coupling part. The tubular distal part 64 of the connecting member 46 is then moved to the actuation means 74, such that the outer circumferential surface of the tubular distal part 64 forces the flexible radial projections directed inward (not shown) on the inner surface of the distal coupling part to move radially outwardly. Thus, the actuating means 74 can be rotated in relation to the distal coupling part from the inactive position by means of the transverse guide groove to the active position. In the inactive position, the actuation means are prevented from being pressed into the distal coupling part, due to the interaction between the flexible radial projections directed inward (not shown) on the inner surface of the distal coupling part and the through hole 81 on the outer circumferential surface of the actuation medium. In the active position, the flexible radial projections directed inward (not shown) on the inner surface of the distal coupling part interact with the grooves 80 to allow axial movement of the actuation means 74. In addition, when the release drive unit of medicine is moved from the first position to the second position, the connecting member 46 is moved to a position in which the actuation member 70 is closer to the actuation means 74 (see Figure 7).
    Subsequently, when the mixing step was completed, the drug was reconstituted, the drug release drive unit was moved from the first position to the second position, and the actuation medium was rotated from the inactive position to the active position; the device is prepared to be activated by pressing the actuation means 74 on the distal coupling part.
    Now, the reconstituted medication can be released. The proximal end of the device, with the medication release member, is positioned at the dose release site, which can be an injection site if an injection needle is used, where penetration is performed manually. Then, the user operates the actuation means 74, pressing it axially in the proximal direction. This, in turn, causes the actuating member 70 to be moved proximally due to the contact between the actuating means 74 and the actuating member 70. The proximal movement of the actuating member 70 causes it to slide along the arms 56. In then the arms 56 return elasticly to their vertical or resting position, that is, the arms are now free to move in the outwardly radial direction, which causes the hooks 60 to come out of contact with their elastic fit with the cutouts 36 of the spring loaded piston rod 34. This, in turn, releases the spring loaded piston rod 34 to move in the proximal direction due to the compressed spring force 38. The movement of the spring loaded piston rod 34 forces the caps 26, 32 to move inside the container 22 and thus expel the reconstituted drug through the drug release member. When the caps 26, 32 reach their final position, that is, the proximal position of the end, within the medication container 22, the medication delivery operation is completed.
    The medication delivery device is also provided with a technical characteristic to indicate, and thus inform the user when the delivery operation is completed. In response to a signal indicating the completion of the release operation, the technical characteristic is arranged to generate an audible signal. At the end of the medication release sequence, the distal end of the spring loaded piston rod 34 is moved out of contact with the proximal end of the arms 42 of the actuation spring support 40. Thus, the arms 42 and the projections 44 they are free to move radially inward, whereby the projections 44 move out of contact with the connecting member 46. Due to a remaining force on the actuation spring 38 acting on the actuation spring support 40, the latter moves in the distal direction until the actuating spring support contacts the end surface 66 of the actuating device 46. When the spring support reaches the end surface 66 of the actuating device 46, a beep is produced . The user can now remove the device from the release location and safely dispose of it.
    It should also be understood that other types of movements can be performed after mixing, in order to move the drug delivery drive unit from the first position to the second position. For example, the coupling parts can be slidably arranged with respect to each other.
    In addition, the actuating means may have designs other than a push button and may be positioned in other areas of the body, in addition to the distal end. For example, the actuating means can be a member disposed on the side of the body and being slidable in the longitudinal direction of the device.
    In the second embodiment, see Figures 9 to 14, the actuator 74 ’’ and the activating member 101 are configured to be separate components. The activating member 101 being in the form of a generally cylindrical locking ring, is arranged at the distal end of the distal coupling part 12 '', and is connected to the latter in such a way that it is rotatable. The proximal end surface of the activation member 101 is arranged with arms 102 (see Figure 12), which generally extend in the peripheral direction of the activation member 101. The arms 102 are radially flexible, that is, flexible in the radial direction. The free ends of the arms 102 are provided with inwardly directed radial protrusions 104. These protrusions 104 fit into slots 106 that are arranged in a ring-shaped coupling part 108 of the distal coupling part 12 '' (see Figure 11) . The actuator 74 ’’ is arranged with projections that axially extend 110 over its outer surface, fitting into grooves that extend axially 112 arranged on the inner surface of the ring-shaped coupling part 108 (see Figure 11). In addition, the actuator 74 ’’ is arranged with arms 114 that extend in the circumferential direction, and are flexible in the radial direction. The outer surface of the arms 114 is arranged with protrusions 116 which have a general wedge shape, the function of which will be explained below. In addition, the tubular distal part 64 ’’ of the connecting member 46 ’’ has a beveled transition surface 118.
    Figure 13 shows when the activation member 101 is in the inactive position, in which the actuator 74 '' is prevented from being pressed into the distal coupling part and Figure 14 shows when the activation member 101 is in the active position, and where the 74 '' actuator is pressed into the distal coupling part. The second embodiment is intended to function as follows. When the device is supplied to the user, the agents within the container must be mixed in the same manner as described in conjunction with the first embodiment. However, actuator 74 '' is prevented from being pressed into the distal coupling part by the interaction between protrusions 116 of actuator 74 '' and a circumferential protrusion 120 on the inner surface at the distal end of the distal coupling part 12 ' '(Figure 13). Thus, the circumferential protrusion 120 forms a mechanical lock for axial movement of the actuator 74 ’’, thereby blocking the actuator 74 ’’ from moving towards the proximal end of the device. In addition, when the activating member 101 is in the inactive position, as shown in Figure 13, the activating member 101 is prevented from being displaced, that is, it is prevented from rotating, since the outer circumferential surface of the second tubular member 64 '' is confining the inner surface of the arms 114, and the protrusions 116 on the outer surface of the arms 114 are obstructing the radial protrusions directed inward 104 of the activating member. However, when the agents within the container are mixed and the drug delivery drive unit has been moved from the first position to the second position after the completion of the mixing sequence or step, as described above for the first embodiment, the second tubular part 64 '' of connecting member 46 '' has been moved distally, such that the outer circumferential surface of the second tubular part 64 '' of connecting member 46 '' no longer confines the inner surface of arms 114 of the actuator 74 ''. Thus, it is possible to turn the activating member 101 into the active position, whereby the protrusions 104 of the activating member 101 fit or connect with the wedge-shaped protrusions 116 of the actuator 74 ’’. When the activating member 101 is rotated, the protrusions 116 are moved radially inward, causing the protrusions 116 to move out of contact with edge 120 (see Figure 14). The activation member is now in the active position, whereby the actuator 74 ’’ is no longer blocked. The actuator 74 'is now able to be pushed or pressed axially towards the proximal end of the device in order to initiate a drug release, through which the protrusions 116 are able to pass the edge 120 without being blocked. Then, the movement of the actuator 74 ’’ toward the proximal end of the device causes the actuator member 70 ’’ to move in the same manner as described above for carrying out a drug release.
    In the third embodiment, see Figures 15 to 23, the actuator 74 ’’ ’and the activating member 201 are also configured to be separate components. The activating member 201 being in the form of a generally cylindrical locking ring is disposed at the distal end of the distal coupling part 12 '' '' and is connected to the latter in such a way that it is rotatable. The activation member 201 in the third embodiment is shown as two components 201 (1) and 201 (2), see Figure 15. However, this is simply due to the production and assembly aspects. When assembled, the two components function as a single component. The activation member 201 comprises, on its internal circumferential surface, protrusions directed inward 202 and projections 212. The projections 212 comprise a first projection segment 212 (1) with a generally circumferential extension and a second projection segment 212 (2 ), with a generally axial extension (see Figure 16). In addition, the actuator 74 '' '' comprises, on its outer circumferential surface, axially directed protrusions 204, a set of protrusions or protrusions directed outward 210, and flexible arms 206 extending in the circumferential direction. The outer surfaces of the arms 206 are provided with wedge-shaped protrusions 208. The projections 204 cooperate with grooves that extend axially (not shown) on the inner surface of the distal coupling part 12 '' 'in the same manner as in the second embodiment , and the protrusions 210 are arranged to interact with the projection segments 212 (1).
    In Figure 21, it is shown when the actuator 74 '' 'is prevented from being pressed into the distal coupling part, since the activation member 201 is in the inactive position, in which the first projection segment 212 (1) is positioned close to protrusion 210 of actuator 74 '' '. In addition, when the activation member 201 is in the inactive position, as shown in Figure 17, the activation member 201 is prevented from being displaced, that is, it is prevented from rotating, since the outer circumferential surface of the second tubular member 64 '' 'is confining the inner surface of the arms 206, and the protrusions 208 on the outer surface of the arms 206 are obstructing the radial protrusions directed inward 202 of the activating member. However, when the agents inside the container are mixed and the drug release drive unit is moved from the first position to the second position, after the completion of the mixing sequence or step, as described above for the first embodiment, the second tubular part 64 '' 'of the connecting member 46' '' has been moved distally, such that the outer circumferential surface of the second tubular part 64 '' 'of the connecting member 46' '' is no longer confining the inner surface of the arms 206 of the 74 '' 'actuator, Figure 18. Thus, it is possible to rotate the activation member 201 to the active position, whereby the protrusions 202 of the activation member 201 fit or connect with the protrusions in the form of wedge 208 of the 74 '' actuator. When the activating member 201 is rotated, the protrusions 202 push the arms 206 radially inward, Figure 19.
    In addition, the rotation of the activation member 201 also causes the projection segment 212 (1) to be moved out of line with the protrusions 210 of the actuator 74 '' ', Figure 22. The activation member 201 is now in the active position, whereby the 74 '' 'actuator is no longer blocked, Figure 22. The 74' '' actuator is now able to be pushed or pressed axially towards the proximal end of the device in order to initiate a release of medication, see Figures 20 and 23. Then, the movement of the 74 '' 'actuator towards the proximal end of the device causes the actuating member 70' '' to be moved in the same manner as described above for the realization of a medication release.
    After drug delivery is performed, the device can be safely disposed of.
    The medication delivery device, according to any of the embodiments as described above, is an injection device, preferably being an auto-injector, where the auto-injector is an injection device that has a piston rod loaded by spring.
    It is to be understood that the embodiments described above and shown in the drawings are to be considered only as non-limiting examples of the invention, and that they can be modified in many ways within the scope of the patent application claims.
    权利要求:
    Claims (17)
    [0001]
    1. Drug delivery device for obtaining and releasing a reconstituted drug comprising: - a proximal coupling part (12; 12 ''; 12 '' ') adapted to accommodate a multi-chamber container (22; 22' '; 22 '' ') containing at least two agents; - a distal coupling part (10; 10 '' '; 10' '' ') connected to said proximal coupling part; - a drug delivery drive unit accommodated in the distal coupling part, where the proximal coupling part and the distal coupling part are configured to be movable, relative to each other, from an extended position to a position retracted, whereby the drug release drive unit acts on said multi-chamber container to mix at least two of said agents, thus obtaining the reconstituted drug; e - actuating means provided on the distal coupling part, and including an actuator (74, 74 ''; 74 '' ') provided to fit the medication release drive unit, when operated by a user to release the medication reconstituted; where: - the drug delivery drive unit is mounted on said distal coupling part, so as to be moved through the proximal coupling part, when the proximal and distal coupling parts are moved from the extended position to the retracted position, from a first position away from the actuator to a second position, in which the aforementioned drug release drive unit can be fitted by the actuator, and in which - the actuation means also include an activating member (74; 101 ; 201) which can be moved between an inactive position, in which the actuator is prevented from engaging the medication release drive unit, and an active position, in which the actuator is capable of engaging the medication release unit, by means of from which the actuator is able to interact with the aforementioned drug release drive unit to release the reconstituted drug only in the active position of the limb. activation and in the second position of the medication release drive unit, characterized by the fact that: said medication release drive unit which comprises a spring loaded piston member (34; 34 ’’; 34 '' ') provided with a hollow space in which an actuation spring (38; 38' '; 38' '') is arranged to press the plunger, an actuation spring support (40; 40 ''; 40 ' '') configured to surround the spring loaded piston member, a connecting member (46; 46 ''; 46 '' ') through which the said actuation spring support is axially disposed, and an actuating member (70 ; 70 ''; 70 '' '), being co-axially slid over said connecting member to support said spring loaded piston member in a preloaded state.
    [0002]
    2. Drug delivery device, according to claim 1, characterized by the fact that said actuator (74; 74 ''; 74 '' ') is configured to be axially movable in relation to said distal coupling part in towards the medication release drive unit.
    [0003]
    Medication delivery device according to claim 2, characterized in that the multi-chamber container (22; 22 ''; 22 '' ') comprises a first axially movable lid (26; 26' '; 26 '' ') arranged to divide the container into a first compartment (28; 28' '; 28' '') and a second compartment (30; 30 ''; 30 '' '), and a second axially movable lid ( 32; 32 ''; 32 '' ') to seal the second compartment.
    [0004]
    4. Drug delivery device according to claim 3, characterized by the fact that the connecting member (46; 46 ''; 46 '' ') comprises a proximal tubular part (48; 48' '; 48' '') and a distal tubular part (64; 64 ''; 64 '' ') connected to each other through two axially extending interconnecting portions (62, 62' '; 62' ''), and at least a radially flexible arm (56; 56 ''; 56 '' '), which extends distally from a distal annular surface of the proximal tubular part (48; 48' '; 48' '') between the two interconnecting portions that extend axially (62; 62 ''; 62 '' ').
    [0005]
    5. Medication delivery device according to claim 4, characterized by the fact that at least one of the radially flexible arm (56; 56 ''; 56 '' ') is arranged with an inward facing hook (60; 60 ''; 60 '' ') configured to fit into a corresponding slot with a cutout (36; 36' '; 36' '') on said spring loaded piston member, to secure said member with loaded piston by spring in relation to said distal coupling part by the actuating member (70; 70 ''; 70 '' '), which is arranged around at least one of said radially flexible arm (56; 56' '; 56' ' ').
    [0006]
    6. Medication delivery device according to claim 5, characterized by the fact that the actuating spring support (40; 40 ''; 40 '' ') is configured with a general U shape, with legs proximally (42; 42 ''; 42 '' '), with each leg comprising an outwardly extending radial protrusion (44; 44' '; 44' '') such that when the unit medication release drive is mounted, the drive spring (38; 38 ''; 38 '' ') is compressed between a surface of the inner proximal end of the plunger member (34; 34' '; 34' '') and a transverse contact end of the actuation spring support (40; 40 ''; 40 '' ').
    [0007]
    7. Medication delivery device according to claim 6, characterized by the fact that the radial protrusions extending outwards (44; 44 ''; 44 '' ') are embedded in an annular proximal surface of the proximal part tubular (48; 48 ''; 48 '' ') to prevent the actuation spring holder from being moved in the distal direction by the actuation spring.
    [0008]
    8. Medication delivery device according to claim 7, characterized by the fact that the connecting member (46; 46 ''; 46 '' ') further comprises opposite connection means (50; 50' '; 50 '' ') on the external circumferential surface of the tubular proximal part (48; 48' '; 48' ''), arranged to cooperate with the connection means (14; 14 '', 14 '' ') on the internal surface of the distal coupling part, such that when the drug delivery drive unit is in the first position, the drug delivery drive unit is fixed in relation to the distal coupling part and an external proximal end of the plunger member spring loaded (34; 34 ''; 34 '' ') is arranged to confine the second axially movable cover (32; 32' '; 32' '') and when the distal and proximal coupling parts are moved, one in In relation to the other, from the extended position to the retracted position, the second axially movable cover (32; 32 ''; 32 '' ') is pre sited against the external proximal end of the limb with spring loaded plunger (34; 34 ’’; 34 '' '', whereby at least two of said agents are mixed.
    [0009]
    Medication delivery device according to claim 8, characterized in that the connecting member (46; 46 ''; 46 '' ') further comprises at least one counter-engaging member proximally or axially directed ( 54; 54 ''; 54 '' '), arranged to interact with at least one engaging member distally or axially directed (18; 18' '; 18' '') of said proximal coupling part after at least two of the said agents are mixed in such a way that the drug delivery drive unit is moved from the first position to the second position.
    [0010]
    10. Medication delivery device according to claim 9, characterized in that said distal coupling part and said proximal coupling part are configured to be connected together by screws to move towards each other .
    [0011]
    11. Drug delivery device according to any one of claims 1 to 10, characterized by the fact that said actuating means (74), including the actuator and the actuating member, are configured to be integrated as a component single.
    [0012]
    12. Drug delivery device, according to claim 11, characterized by the fact that said actuation means (74) comprise flexible locking members configured to interact with both the distal coupling part and the actuation unit of drug release when said drug release drive unit is in the first position and said activation member is in the inactive position, so that said activation member is prevented from moving between the inactive position and the active position.
    [0013]
    13. Drug delivery device according to claim 12, characterized in that said flexible locking members are configured to be free of interaction with both the distal coupling part and the drug delivery drive unit , when said drug delivery drive unit is in the second position and said activation member is in the active position.
    [0014]
    14. Medication delivery device according to any one of claims 1 to 11, characterized by the fact that said actuator (74 ''; 74 '' ') and said activation member (101, 201) are configured to be separate components.
    [0015]
    15. Drug delivery device according to claim 14, characterized by the fact that said actuator (74 '', 74 '' ') comprises flexible locking members (114, 116, 206, 208) configured to be releasably attached to the distal coupling part, and to interact with the activation member (101, 201).
    [0016]
    16. Drug delivery device according to claim 15, characterized by the fact that said activation member (101, 201) is configured to interact with the drug delivery drive unit when said drug drive unit drug release is in the first position and said activation member is in the inactive position, so that said activation member is prevented from moving between the inactive position and the active position.
    [0017]
    17. Drug delivery device according to claim 16, characterized by the fact that said activation member (101; 201) comprises opposing flexible locking members (104; 202) configured to interact with said flexible medication members lock (114, 116; 206, 208) when said drug delivery drive unit is in the second position and said activation member (101; 201) is in the active position, such that said flexible lock members (114, 116; 206, 208) are disengaged from the distal coupling part.
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    同族专利:
    公开号 | 公开日
    TW201244769A|2012-11-16|
    US9320855B2|2016-04-26|
    CN103458942B|2015-07-22|
    AU2012212720B2|2015-01-22|
    CN103458942A|2013-12-18|
    JP2014507219A|2014-03-27|
    JP5732549B2|2015-06-10|
    RU2013140579A|2015-03-10|
    EP2670458A4|2016-09-21|
    KR101521742B1|2015-05-19|
    BR112013019932A2|2016-12-13|
    CA2825351A1|2012-08-09|
    TWI478745B|2015-04-01|
    KR20130118969A|2013-10-30|
    IL227712D0|2013-09-30|
    AU2012212720A1|2013-08-15|
    WO2012105898A1|2012-08-09|
    CA2825351C|2016-10-04|
    EP2670458A1|2013-12-11|
    IL227712A|2017-04-30|
    EP2670458B1|2019-05-29|
    US20140371670A1|2014-12-18|
    RU2545910C2|2015-04-10|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-05| B25A| Requested transfer of rights approved|Owner name: SHL MEDICAL AG (CH) |
    2020-07-21| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2020-12-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-01-19| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 31/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161439001P| true| 2011-02-03|2011-02-03|
    SE1150076-6|2011-02-03|
    US61/439,001|2011-02-03|
    SE1150076|2011-02-03|
    PCT/SE2012/050096|WO2012105898A1|2011-02-03|2012-01-31|Medicament delivery device|
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