Abstract
The present disclosure relates to an injection device for expelling of a dose of a medicament. The injection device includes an elongated housing with a distal end and a proximal end opposite to the distal end. The elongated housing has a body and a protective cap. A medicament container has a barrel having a first cavity in a proximal direction by a first stopper slidably arranged inside the barrel. The protective cap is configured to abut on a distally facing abutment portion of the barrel. The body is configured to abut on a proximally facing abutment portion of the first stopper. The first stopper is movable in distal direction relative to the barrel from an initial position into a priming position by moving the protective cap along the proximal direction relative to the body from a preset position into an activation position.
Claims
1-16. (canceled)
17. An injection device for expelling a dose of a medicament, the injection device comprising: an elongated housing with a distal end and a proximal end opposite to the distal end, the elongated housing comprising a body and a protective cap, a medicament container comprising a barrel having a first cavity sealed in a proximal direction by a first stopper slidably arranged inside the barrel, the first stopper including a proximally facing abutment portion and the barrel including a distally facing abutment portion, wherein the protective cap is configured to abut the distally facing abutment portion of the barrel, wherein the body is configured to abut the proximally facing abutment portion of the first stopper, wherein the first stopper is movable in distal direction relative to the barrel from an initial position into a priming position by moving the protective cap along the proximal direction relative to the body from a preset position into an activation position.
18. The injection device according to claim 17, further comprising an activation lock detachably or movably arranged on the elongated housing and operable to block a movement of the protective cap from the preset position towards the activation position.
19. The injection device according to claim 18, wherein the activation lock is frangibly connected to at least one of the body and the protective cap.
20. The injection device according to claim 18, wherein the activation lock is connected to at least one of the body and the protective cap by at least one of a perforated structure and a structurally weakened connector comprising a predetermined breaking structure.
21. The injection device according to claim 18, wherein the activation lock comprises a ring enclosing an outside surface of the housing.
22. The injection device according to claim 18, wherein the activation lock comprises a distally facing abutment portion to abut a proximally facing abutment portion of the protective cap.
23. The injection device according to claim 18, wherein the activation lock comprises a proximally facing abutment portion to abut a distally facing abutment portion of the body.
24. The injection device according to claim 17, wherein a proximally facing abutment portion of the protective cap is configured to abut a distally facing abutment portion of the body when the protective cap is in or approaches the activation position relative to the body.
25. The injection device according to claim 17, wherein the protective cap and the body are telescopically displaceable in a longitudinal direction, wherein one of the protective cap and the body comprises a receptacle and wherein the other one of the protective cap and the body comprises an insert portion and wherein the receptacle is sized to receive the insert portion.
26. The injection device according to claim 25, wherein an activation lock is arranged on the insert portion, the activation lock being detachably or movably arranged on the elongated housing and operable to block a movement of the protective cap from the preset position towards the activation position.
27. The injection device according to claim 17, wherein the protective cap is detachably coupled to the body via a fastening mechanism, wherein the fastening mechanism is transferable from a locked configuration, in which the protective cap is in the preset position, to a release configuration, in which the protective cap is in or approaches the activation position.
28. The injection device according to claim 27, wherein the fastening mechanism comprises a slot in a sidewall of one of the protective cap and the body and wherein the fastening mechanism (40) comprises a pin protruding from the sidewall of the other one of the protective cap and the body, wherein the pin is slidably displaceable along the slot.
29. The injection device according to claim 28, wherein the slot comprises a dead end portion forming a stop for the pin and wherein the slot comprises an escape portion to enable removal of the pin from the slot and wherein the dead end portion extends at a predefined direction relative to the escape portion.
30. The injection device according to claim 17, wherein the medicament container comprises a second stopper to separate a second cavity from the first cavity.
31. The injection device according to claim 17, wherein at least one of a lyophilized medicament, a liquid medicament, a diluent and a solvent is arranged inside the medicament container.
32. The injection device according to claim 17, wherein the protective cap is detachably connected to the body.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0084] The following description is with reference to the following Figures:
[0085] FIG. 1 schematically shows an example of an injection device,
[0086] FIG. 2 is a cross-section through the injection device of FIG. 1 in an initial or preset configuration,
[0087] FIG. 2A schematically illustrates the frangible connection of the activation lock,
[0088] FIG. 3 is a cross-section through the device of FIG. 2 with the activation lock removed,
[0089] FIG. 4 is a cross-section through the device of FIG. 3 after moving the protective cap into the activation position,
[0090] FIG. 5 shows the device of FIG. 4 after removal of the protective cap,
[0091] FIG. 6 shows the injection device after expelling of the liquid medicament,
[0092] FIG. 7 shows another example of an injection device in an initial configuration,
[0093] FIG. 8 shows another example of the injection device in a longitudinal cross-section,
[0094] FIG. 9 shows the device of FIG. 8 with the protective cap removed,
[0095] FIG. 10 shows the device of FIG. 9 with a sleeve in a retracted position during or for injecting of the medicament,
[0096] FIG. 11 is indicative of one example of a fastening mechanism to fix the protective cap to the body,
[0097] FIG. 12 shows the fastening mechanism with the protective cap approaching the activation position,
[0098] FIG. 13 shows the fastening mechanism during detachment of the protective cap from the body,
[0099] FIG. 14 is another example of the fastening mechanism,
[0100] FIG. 15 shows a further example of the fastening mechanism with the protective cap in the preset position,
[0101] FIG. 16 shows the fastening mechanism of FIG. 15 with the protective cap in the activation position,
[0102] FIG. 17 shows the first day mechanism of FIG. 16 during removal or detachment of the protective cap from the body,
[0103] FIG. 18 is a schematic longitudinal section of an exemplary embodiment of a medicament delivery device prior to use,
[0104] FIG. 19 is a schematic longitudinal section of an exemplary embodiment of a medicament delivery device prior to use,
[0105] FIG. 20 is a schematic perspective view of an exemplary embodiment of a container carrier,
[0106] FIG. 21 is a schematic longitudinal section of an exemplary embodiment of a medicament delivery device prior to use,
[0107] FIG. 22 is a schematic longitudinal detail section of an exemplary embodiment of a medicament delivery device during use,
[0108] FIG. 23 is a schematic longitudinal detail section of an exemplary embodiment of a medicament delivery device during use,
[0109] FIG. 24 is a schematic view of an exemplary embodiment of a medicament delivery device during interruption of delivery,
[0110] FIG. 25 is a schematic longitudinal section of an exemplary embodiment of a medicament delivery device after use, and
[0111] FIG. 26 is a schematic longitudinal detail section of an exemplary embodiment of a medicament delivery device after use.
DETAILED DESCRIPTION
[0112] In FIG. 1, an example of a handheld injection device 1 is schematically illustrated. The injection device 1 may be configured as an injection pen. It may be also configured as a so-called auto injector. The injection device 1 comprises an elongated housing 5. The housing 5 may comprise a tubular shape. The housing 5 comprises a distal end 2 and an oppositely located proximal end 3. With its distal end 2 the injection device is configured to expel or to inject a liquid medicament located inside a medicament container 79 as illustrated in FIG. 2.
[0113] The medicament container 79 may be a component of a syringe 80. As illustrated in FIG. 2 the medicament container 79 comprises a barrel 82. The barrel is of tubular shape. The barrel 82 comprises an outlet 88 at a distal end. The outlet 88 may be provided with a needle hub 92. The needle hub 92 may be fixed to the outlet 88 of the barrel 82. The needle hub 92 is typically provided with an injection needle 90. The injection needle 90 may be covered by a needle shield 94. The needle shield 94 may comprise or provide an inner needle cap.
[0114] The barrel 82 further comprises a radially narrowing shoulder portion 86 towards the distal end. At least one of the shoulder portion 86, the outlet 88 and the needle hub 92 serves as or provides a distally facing abutment portion 87.
[0115] Inside the barrel 82 there are located a first stopper 10 and a second stopper 12. The sidewall of the barrel 82 and the two stoppers 10, 12 delimit or confine a first cavity 83. Inside the first cavity 83 there may be located a liquid substance, such as a solvent or diluent. There is provided a second cavity 84. The second cavity 84 may be provided with a lyophilized medicament or with a powdered substance. The second cavity 84 is delimited in proximal direction by the second stopper 12. It is delimited in distal direction by the outlet 88 of the barrel 82.
[0116] As further indicated in FIG. 2 the barrel 82 comprises a bypass 85. In the region of the bypass 85 The inner diameter of the barrel 82 is increased compared to longitudinal sections of the barrel 82 located offset from the bypass 85.
[0117] The syringe 80 further comprises a piston rod 11 or plunger. The piston rod 11 is configured to abut in longitudinal direction with an abutment portion 17 located or formed by a proximal end face of the first stopper 10. The barrel 82 is further connected to or mounted in a flange 81. By way of the flange 81 the barrel 82 is arranged and/or fixed inside the housing 5 of the injection device 1. As indicated in the FIGS. 1-10 the housing 5 comprises a proximal housing component, denoted as body 20. The housing 5 further comprises a distal housing component, denoted as protective cap 30. The protective cap 30 is detachably connected to the body 20. When assembled or attached to the body 20 the protective cap 30 covers the outlet end of the syringe 80.
[0118] In an initial and/or preset configuration as illustrated in FIG. 2 the distally facing abutment portion 87 of the barrel 82 is in direct or indirect longitudinal abutment with the protective cap 30. As illustrated in FIG. 2, the distal end 38 of the protective cap 30 comprises a closed end face 39 being in longitudinal or axial abutment with the needle shield 94. The needle shield 94 is further in direct abutment with the outlet 88 of the barrel 82. The end face 39 and hence the distal end 38 provide a proximally facing abutment 36 to engage with the distal end of the needle shield 94.
[0119] In a similar manner also the piston rod 11 is in direct abutment with a proximal end 25 of the body 20. Here, the body 20, which may be of tubular shape, comprises a closed end face 27 at a proximal end 25 in direct longitudinal abutment with a proximal end of the piston rod 11. Hence, the proximal end 25 and hence the proximal end face 27 of the body 20 forms a distally facing abutment 26 for the piston rod 11. The opposite distal end of the piston rod 11 is in abutment with the proximally facing abutment portion 17 of the first stopper 10. In this way, the body 20 is in indirect longitudinal abutment with the proximally facing abutment portion 17 of the first stopper 10. The protective cap 30 is in indirect longitudinal abutment with the distally facing abutment portion 87 of the barrel 82.
[0120] Instead of separate pieces that provide an effective abutment between the protective cap 30 and the barrel 82 or providing an abutment between the body 20 and the stopper 10 it is also conceivable, that the piston rod 11 is integrally formed with the body 20. Likewise, also the needle shield 94 may be integrally formed with or rigidly connected to the protective cap 30. Hence, the needle shield 94 may be alternatively provided by an inwardly extending protrusion of the distal end face 39 of the protective cap 30.
[0121] Similarly, also the piston 11 may be integrally formed with the body 20. It may be rigidly connected to the body 20.
[0122] When in the initial configuration as illustrated in FIG. 2 there is provided an activation lock 50 between a proximal end 35 of the protective cap 30 and a stepped portion 22 of the body 20. As it becomes apparent from FIGS. 2-4 the protective cap 30 comprises a receptacle 33 at the proximal end 35. The receptacle 33 is open towards the proximal direction and is sized to receive an insert portion 23 of the body 20. The insert portion 23 of the body 20 is a stepped down portion. Hence, the sidewall 21 of the body 20 proximally adjacent to the insert portion may comprise an outer diameter or outer structure that is somewhat equivalent or even identical to the outside diameter or structure of the sidewall 31 of the protective cap 30. The stepped down portion 22 and hence the diameter-reduced insert portion 23 is sized to become slidably received inside the receptacle 33 as it is apparent from a comparison of FIGS. 3 and 4.
[0123] As long as the activation lock 50 is located in the interface of the telescopic engagement of the protective cap 30 and the body 20 the protective cap 30 is hindered to move in proximal direction relative to the body 20. As indicated in FIG. 2A the activation lock 50 is frangibly connected to at least one of the body 20 and the protective cap 30. The activation lock 50 may comprise an annular structure and may fill or traverse a longitudinal gap between the proximal end 35 of the protective cap 30 and the stepped down portion 22 of the body 20. As shown in FIG. 2 the activation lock 50 comprises a distally facing abutment portion 51, hence a distal end face to abut or to engage with a correspondingly shaped proximally facing abutment portion 34 of the protective cap 30.
[0124] The proximally facing abutment portion 34 may be provided by an end face of the sidewall 31 of the receptacle 33. In the opposite direction the activation lock 50 comprises a proximally facing abutment portion 52. The abutment portion 52 may be provided by a distal end face of the receptacle 33 forming the activation lock 50. The stepped down insert portion 23 is delimited in proximal direction by a distally facing abutment portion 24 of the body 20. As indicated in FIG. 2 the proximally facing abutment portion 52 of the activation lock 50 is in abutment with the distally facing abutment portion 24 of the body 20. In this way the activation lock fills or traverses the gap between the distally facing abutment portion 24 and the proximally facing abutment portion 34 of the body 20 and the protective cap 30, respectively.
[0125] As indicated in FIG. 2A the activation lock 50 comprises a ring 53 with numerous individual segments 54, 55, e.g., implemented as ring segment 54, 55. The segments 54, 55 are mutually connected by a perforated structure 56. In addition, at least one of the segments 54, 55 is connected to at least one sidewall 21, 31 of the body 20 or protective cap 30, respectively. Hence, the activation lock 50 may be detachably and frangibly connected to the protective cap 30 by a perforated structure 58. It may be further detachably or frangibly connected to the body 20 via the perforated structure 57. The perforated structure(s) 56, 57, 58 may each comprises one or more separate connectors 59.
[0126] Optionally, the activation lock 50 may be provided with a gripping flap 72 that facilitates an easy gripping and handling of the activation lock by a user. By gripping of the e.g., radially outwardly protruding gripping flap a user may easily invoke and induce a disruption of at least one of the perforated structures 56, 57, 58 thus enabling to detach or to remove the activation lock 50 of the housing 5.
[0127] The distal end 28 of the body 20 is provided with an insert portion 23.
[0128] The resulting configuration after detachment and removal of the activation lock 50 is illustrated in FIG. 3. Starting from the initial or preset position a user may now move the protective cap 30 relative to the body 20 in proximal direction. Due to the longitudinal or axial abutment of the protective cap 30 with the distally facing abutment portion 87 of the barrel 82 and due to the abutment of the proximally facing abutment portion 17 of the first stopper 10 with the body 20 the first stopper 10 will be subject to a distally directed movement relative to the barrel 82 as the protective cap 30 and the body 20 approach the activation position as illustrated in FIG. 4.
[0129] Since the first cavity 83 is filled with a substantially non-compressible medium a respective movement of the first stopper 10 relative to the barrel 82 equally transfers to a respective movement of the second stopper 12. As shown in FIG. 4, the second stopper 12 is moved into the region of the bypass 85. Consequently, the liquid substance initially located inside the first cavity 83 is transferred into the second cavity 84 via the bypass. In this configuration the medicament located inside the medicament container 79 can be mixed and/or prepared for a subsequent injection procedure.
[0130] The proximally directed movement of the protective cap 30 relative to the body 20 is delimited by the proximally facing abutment portion 34 of the protective cap 30 getting in abutment with the corresponding shaped distally facing abutment portion 24 of the body 20. In this way, the movement from the preset position into the activation position is stopped.
[0131] FIG. 5 is illustrative of the configuration of the injection device 1 after the protective cap 30 has been removed. The device 1 then ready for dispensing of the liquid medicament located inside the second cavity 84. FIG. 6 is indicative of a final configuration of the injection device 1 after dispensing or expelling of the medicament from the second cavity 84. During and/or for expelling of the medicament, the flange 81 and hence the barrel 82 is subject to a proximally directed movement relative to the body 20. In other words, the body 20 and/or the piston rod 11 is subject to a distally directed movement relative to the barrel 82, thereby moving both, the first and the second stoppers 10, 12 in distal direction. The liquid substance previously contained in the second cavity 84 is expelled via the injection needle 90.
[0132] In FIG. 7 another example of an injection device 1 is shown. This injection device 1 is highly similar to the injection device as described and explained with regard to FIGS. 2-6. There is only one difference, namely that the protective cap 30 comprises an abutment portion 32 protruding radially inwardly from the sidewall 31 of the protective cap 30. The abutment portion 32 may comprise a radially inwardly extending flange configured to engage with the shoulder portion 86 of the barrel 82. Here, the shoulder portion 86 effectively provides the distally facing abutment portion 87 of the barrel 82.
[0133] In FIGS. 8-10 another example of an injection device 1 is illustrated. Again, this example is somewhat similar to the example as illustrated in FIGS. 2-6. But here, the body 20 further comprises a sleeve 60 displaceably, e.g., slidably arranged to the proximal portion of the body 20. The sleeve 60 is a kind of a needle sheath a needle shield. When the protective cap 30 is removed as illustrated in FIG. 9, the sleeve 60 form a distal end of the body 20. The distal end 68 of the sleeve 60 is located distally from the tip of the injection needle 90. In this way, a stitch danger may be effectively reduced.
[0134] For conducting an injection, the distal end 68 of the sleeve 60 is pressed against the skin of the patient and the proximal portion of the body 20 is moved in distal direction relative to the sleeve 60 thus inducing a respective forward movement of the syringe 80 or barrel 82. This is schematically illustrated in FIG. 10. A rather detailed example of such an injection mechanism is further explained below with regard to FIGS. 18-26.
[0135] As becomes further apparent from FIGS. 9 and 10 a proximal end 65 of the sleeve 60 comprises an abutment 64 configured to engage with the flange 81 or with the barrel 82 of the syringe 80. In this way a distally directed movement of the barrel 82 and hence of the syringe 80 with the injection needle 90 mounted thereon in distal direction relative to the sleeve 60 can be delimited, namely when the abutment 64 at the proximal end 65 of the sleeve 60 abuts against a distally facing abutment portion of the flange 81. Here, and in the course of expelling of the medicament the sleeve 60 provides an effective abutment for the flange 81 relative to the skin of the patient. A holding force for the flange relative to the distally moving piston rod 11 can be provided by the abutment of the sleeve 60 on the patient's skin. The sleeve 60 is a component of the body 20. Insofar, the above-described abutment of the protective cap 30 may equally apply to the sleeve 60.
[0136] In FIGS. 11-13 one example of a fastening mechanism 40 is illustrated. The fastening mechanism 40 is active between the protective cap 30 and the body 20. The fastening mechanism 40 may be implemented as a slotted link. In the example as illustrated, the inside facing portion of the sidewall 31 of the protective cap 30 comprises a radially inwardly protruding pin 46 engaged with a slot 42 provided on an outside surface of the sidewall 21 of the body 20. In the example of FIGS. 11-13, the slot 42 is provided on an outside facing portion of a sidewall 61 of the sleeve 60. The sleeve is hindered to separate distally from the proximal portion of the body 20. From the configuration as illustrated in FIG. 9 it may only move in proximal direction.
[0137] The slot 42 comprises a dead end portion 43, an intermediate curved portion 45 and an escape portion 44. The escape portion 44 is open towards the distal direction. It comprises a free end portion 49 and enables a removal of the pin 46 as it moves from the intermediate portion 45 through the escape portion 44 as illustrated in FIG. 13. The dead end portion 43 comprises a dead end stop 41 located in a longitudinal end of the slot 42 opposite to the free end portion 49.
[0138] In the initial configuration as illustrated in FIG. 11 the pin 46 is located in the dead end portion 43. Upon and during movement of the protective cap 30 towards and into the activation position, which is illustrated in FIG. 12 the pin 46 is located in the intermediate portion 45. The pin 46 may enter the escape portion 44 only via the intermediate portion 45. Insofar, a detachment of the protective cap 30 from the body 20 is only possible by initially moving the protective cap 30 from the preset position as shown in FIG. 11 into the activation position. Only from the activation position, in which e.g., the medicament is appropriately mixed inside the syringe 80 the protective cap 30 can be detached by transferring the pin 46 from the intermediate portion 45 into the escape portion 44.
[0139] In FIG. 14 another example of a fastening mechanism 40 is illustrated. Also here, the fastening mechanism 40 comprises a dead end portion 43 with a dead end stop 41 and an escape portion 44. As illustrated in FIG. 14, the escape portion 44 extends in longitudinal direction. It runs substantially parallel to a longitudinal center axis of the housing 5. The dead end portion 43 is somewhat slanted or angled. In this way, the dead end portion 43 and the escape portion 44 mutually emerging in the intermediate portion 45 form a kind of a bayonet coupling for the pin 46. Hence, for the pin 46 sliding along the dead end portion 43, the protective cap 30 is subject to a helical movement, i.e., a combined rotational and longitudinal displacement relative to the body 20. Such a bayonet type coupling provided by the fastening mechanism 40 may be even beneficial to increase the longitudinal force exerted by the body 20 and the protective cap 30 to move the first stopper 10 and/or the second stopper 12 in distal direction relative to the barrel 82.
[0140] In the sequence of FIGS. 15-17 another example of a fastening mechanism 40 is described. Here, there are provided two separate slots 42, 47, each of which serving as a slotted link for a respective pin 48, 46. The slot 42 is somewhat equivalent to the slot 42 as illustrated in connection with FIGS. 11-13. The further slot 47 is somewhat skewed or slanted relative to the elongation of the dead end portion 43 and the escape portion 44 of the other slot 42. In this way and as the protective cap 30 is moved from the preset position as indicated in FIG. 15 towards and into the activation position as shown in FIG. 16 the slanted slot 47 induces an angular momentum or torque onto the protective cap 30 that leads to a respective tangential movement of the pin 46 through the intermediate portion 45 so as to ensure that the pin 46 is transferred from the dead end portion 43 into the escape portion 44 as the protective cap 30 reaches the activation position. The slanted slot may induce a flexible deformation of the protective cap as it moves towards the activation position. The tangential distance between the pins 46, 48 make radially reduce during this movement. As soon as the activation position has been reached, the mechanical biasing or tensioning may relax, thereby transferring the pin 46 into the escape portion 44.
[0141] In the example of FIGS. 18-26 an injection mechanism and the assembly of a syringe 180 inside a body 120 of a further injection device 101 is illustrated. With these illustrations the above-described mutual displacement of the protective cap 103 relative to the body 120 from the preset position into the activation position is not shown in detail. Moreover, the syringe 180 as illustrated in FIGS. 18-26 only comprises a single cavity 183.
[0142] The injection device 101 as illustrated in FIGS. 18-26 comprises a cap 103 that may include a viewing window 104 (e.g., an opening or a substantially transparent piece of material). The cap 103 may further include one or more indicia for providing a visual and/or tactile indication of use (e.g., which end of the device 101 should be applied to an injection site, etc.). For example, in an exemplary embodiment, the indicia include one or more arrows (painted or embossed) pointing toward a distal end of the device 101.
[0143] The injection device 101 is shown with the cap 103 already being in the activation position. As particularly illustrated in FIGS. 18 and 19, the cap 103 comprises longitudinally inwardly protruding abutment 36 engaged with the needle shield 140 thereby exerting a proximally directed pressure onto the barrel 182.
[0144] The activation lock 50 as illustrated and described in connection with FIGS. 1-17 is equally applicable to and/or usable with the injection device 101. The activation lock 50 may be arranged between a proximally facing abutment portion of the protective cap 103 and a distally facing abutment portion of the body 120. In effect, all features, examples and effects of the activation lock as described above are equally a correspondingly applicable to the injection device 101 as described in connection with FIGS. 18-26.
[0145] FIGS. 18 and 19 show a longitudinal section of an exemplary embodiment of such a medicament delivery device 101. A sleeve 160 is slidably coupled to the body 120. For example, the sleeve 160 may be telescoped within the body 120. In an exemplary embodiment, the sleeve 160 comprises one or more lateral sleeve windows 162 adapted to axially align with the viewing windows 104 (e.g., an opening or a substantially transparent piece of material) in the cap 103 when the sleeve 160 is in an extended position (as shown in FIG. 18) relative to the body 120.
[0146] In an exemplary embodiment, a container carrier 170 slidably disposed in the body 120. The container carrier 170 is adapted to retain a medicament container, e.g., a syringe 180, an ampoule, a cartridge, etc. For example, the syringe 180 includes a syringe barrel 182 arranged as a hollow cylinder defining a cavity 183 for receiving a medicament. A needle 190 is arranged at a distal end of the syringe barrel 182 in a manner to be in fluid communication with the cavity 183. A stopper 10 is disposed within the syringe barrel 182 for proximally limiting the cavity 183. The stopper 10 may be displaced within the syringe barrel 182 for ejecting the medicament from the cavity 183 through the needle 190.
[0147] FIG. 20 shows an exemplary embodiment of a container carrier 170 according to the present disclosure. The container carrier 170 comprises a proximal portion 171 One or more first legs 172 extend distally from the proximal portion 171 In an exemplary embodiment, the first leg 172 comprises a radially inwardly directed first protrusion 173 arranged on a distal end of the first leg 172 and an aperture 174 (or recess). One or more second legs 175 extend distally from the proximal portion 171. The second leg 175 is biased radially inward.
[0148] In an exemplary embodiment, the container carrier 170 comprises one or more clamps 150 with a distal hook 151 and a proximal hook 152, wherein the proximal hook 152 is adapted to proximally engage a medicament container.
[0149] Referring again to FIGS. 18 and 19, the body 120 comprises one or more longitudinal first ribs 122 having a first axial length and adapted to radially outwardly abut the clamps 150 when the carrier 170 is in a first position P1 relative to the body 120. When the carrier 170 is moved from the first position P1 in the proximal direction P the clamps 150 slide along the first ribs 122.
[0150] In an exemplary embodiment, the sleeve 160 comprises one or more sleeve legs 166 extending in the proximal direction P beyond a collar 161. The sleeve legs 166 are adapted to radially outwardly support the clamps 150 such that they cannot deflect radially outwards depending on the axial position of the sleeve 160 relative to the clamps 150. The sleeve 160 comprises a proximal stop 164 and a distal stop 165. The proximal stop 164 is adapted to engage the sleeve 160 for limiting axial movement of the sleeve 160 in the distal direction D. In an exemplary embodiment the distal stop 165 may be part of the collar 161.
[0151] In an exemplary embodiment, a piston rod 110 is arranged within the body 120 in a manner to engage the stopper 10 for displacing it within the syringe barrel 182. In an exemplary embodiment, the piston rod 110 is attached to the body 120, preventing relative movement between the piston rod 110 and the body 120. In an exemplary embodiment the piston rod 110 may be integrally shaped with the body 120, or in another exemplary embodiment, the piston rod 110 may be secured to the body 120 by latches 112. In an exemplary embodiment, prior to use, an axial gap may be present between a distal end of the piston rod 110 and a proximal end of the stopper 10. The axial gap may prevent force being applied to the stopper 10 prior to use.
[0152] In an exemplary embodiment, a spring 130 is arranged over the piston rod 110 between a proximal end face 111 of the piston rod 110 and a spring seat 163 on the sleeve 160 thus biasing the sleeve 160 in the distal direction D relative to the piston rod 110 and body 120.
[0153] In an exemplary embodiment, the piston rod 110 comprises a ratchet toothing 113 adapted to be engaged by the second legs 175 of the carrier 170 in such a manner that the carrier 170 can move in the proximal direction P but is prevented from moving in the distal direction D relative to the piston rod 110.
[0154] In an exemplary embodiment, a syringe retarder 114 is provided on the piston rod 110. The syringe retarder 114 comprises one or more resilient arms which in a relaxed state define a diameter greater than an internal diameter of the syringe barrel 182. In the initial state shown in FIG. 21, the syringe retarder 114 abuts the proximal end of the syringe barrel 182 such that the syringe 180 cannot move in the proximal direction P relative to the piston rod 110. On application of a predefined force to the syringe 180 in the proximal direction P relative to the piston rod 110, the resilient arms may be deflected radially inward, such that the piston rod 110 can enter the syringe barrel 182 thus allowing movement of the piston rod 110 relative to the syringe 180 in the distal direction D.
[0155] In an exemplary embodiment, a protective needle shield 140 is arranged over the needle 190. The cap 103 is adapted to engage the needle shield 140, e.g., by a barb, in manner to remove it from the needle as the cap 103 is removed from the body 102 by pulling it in the distal direction D. A snap feature 126 may be arranged on the body 102 for releasably snap fitting the cap 103 to the body 102.
[0156] In order to perform an injection, the medicament delivery device 101 may be operated according to the following exemplary method.
[0157] The cap 103 is pulled in the distal direction D relative to the body 102 thereby also pulling the protective needle shield 140 off the needle 190. The syringe 180 is prevented from moving in the distal direction D as its proximal flange 181 abuts the first protrusion 173 of the carrier 170 being in the first position P1. The carrier 170 is prevented from moving in the distal direction D by the second legs 175 being engaged to the ratchet 113. The collar 161 on the sleeve 160 distally abuts an axial stop 121 on the body 102 such that the sleeve 160 is also prevented from moving in the distal direction D.
[0158] FIG. 21 is a schematic longitudinal section of the medicament delivery device 101 after removal of the cap 103 and the protective needle shield 140. The needle 190 is located within the sleeve 160 preventing a user from touching and seeing it. In this state the medicament delivery device 101 may be held at the body 102 and the sleeve 160 may be pushed against an injection site, e.g., a patient's skin. Consequently, the sleeve 160 moves in the proximal direction P relative to the body 102 against the force of the spring 130, as the spring 130 is applying a biasing force on the spring seat 163 of the sleeve 160. Due to the movement of the sleeve 160 in the proximal direction P, the spring 130 is compressed. The syringe 180 remains in position relative to the body 102 due to the syringe retarder 114. As the syringe 180 and the needle 190 stay in position relative to the body 102 while the sleeve 160 moves in the proximal direction P, the needle 190 protrudes beyond a distal end of the sleeve 160 and is inserted into the injection site. Once the distal stop 165 abuts the flange 181 on the syringe 180, movement of the sleeve 160 relative to the syringe 180 and needle 190 stops. The needle 190 has reached its insertion depth. Any further movement of the sleeve 160 relative to the body 102 in the proximal direction P hence causes deformation of the syringe retarder 114, and the container carrier 170 moves proximally out of the first position P1 relative to the body 102.
[0159] FIGS. 22 and 23 are schematic longitudinal detail sections in different section planes of the medicament delivery device 101 with the syringe 180 having moved in the proximal direction P relative to the piston rod 110. The increase in force required to deform the syringe retarder 114 may be a tactile feedback experienced by a user. As the piston rod 110 is coupled to the body 102, movement of the syringe 180 in the proximal direction P causes the piston rod 110 to abut the stopper 10 and displace it within the syringe barrel 182 ejecting the drug from the cavity 183 through the needle 190 into the injection site. As the sleeve 160 keeps moving relative to the body 102 the spring 130 is further compressed thus increasing its force according to Hooke's law thus providing a tactile feedback to the user about the state of the injection. As the syringe 180 moves in the proximal direction P relative to the body 102 and the piston rod 110, the flange 181 engages the proximal hook 152 within the carrier 170. Hence, the carrier 170 is also moved in the proximal direction P relative to the piston rod 110 thereby causing the second legs 175 to move along the ratchet toothing 113. As the second legs 175 disengage and engage successive teeth in the ratchet, an audible feedback may be provided in the form of a “click” sound.
[0160] If the medicament delivery device 101 was removed from the injection site after use, the spring 130 would return the sleeve 160 in the distal direction D, as in FIG. 23, until the proximal stop 164 of the sleeve 160 abuts the flange 181. As the second legs 175 of the carrier 170 are engaged in the ratchet toothing 113 the carrier 170, the syringe 180 and the needle 190 are prevented from returning in the distal direction D. The needle 190 would be hence covered again by the sleeve 160 despite the changed axial position of the syringe 180 relative to the body 102.
[0161] FIG. 24 is a schematic view of the medicament delivery device 101 having been removed from the injection site after partial delivery of the medicament. The overall length of the medicament delivery device 101 is shorter than in the initial state and the sleeve windows 162 are partially hidden within the body 102 thus providing a visual feedback as to the progress of the injection and as to the state of use of the device 101.
[0162] If the medicament delivery device 101 is in this state it can be re-applied against the injection site and the injection can be continued. The sleeve 160 will again move relative to the syringe 180 thus inserting the needle 190 into the injection site before the sleeve 160 abuts the syringe 180 moving it relative to the body 102 and piston rod 110 for delivering the drug thereby also moving the clamps 150 and the carrier 170.
[0163] If after the initial start or after restart of the injection the body 102 is at least nearly fully depressed relative to the sleeve 160, the piston rod 110 will displace the stopper 10 until the stopper 10 bottoms out within the syringe 180 thereby at least nearly fully emptying the cavity 183. At this point the force opposing the movement of the body 102 in the distal direction D relative to the sleeve 160 considerably increases indicating to the user that the injection is finished. At this point the container carrier 170 has travelled to or beyond a second position P2 such that the clamps 150 could deflect radially outwards. However, as long as the sleeve 160 is maintained depressed the sleeve legs 166 still outwardly support the clamps 150 preventing their outward deflection. FIG. 25 is a schematic longitudinal section of the medicament delivery device 101 with the carrier 170 in the second position P2. FIG. 26 is a schematic longitudinal detail section of the medicament delivery device 101 with the carrier 170 in the second position P2, wherein the sleeve 160 is shown transparently to allow seeing the rib 122.
[0164] When the medicament delivery device 101 is been removed from the injection site, the spring 130 returns the sleeve 160 in the distal direction D relative to the carrier 170, syringe 180 and needle 190 until the proximal stop 164 on the sleeve 160 abuts the flange 181 of the syringe 180 thereby axially removing the sleeve legs 166 from the clamps 150 allowing them to radially outwardly deflect. Due to the movement of the sleeve 160 relative to the carrier 170, the needle 190 is covered again by the sleeve 160. On an attempt to again move the sleeve 160 in the proximal direction P relative to the body 102, the sleeve legs 166 would axially abut the outwardly deflected clamps 150 preventing re-exposure of the needle 190. The length of the first rib 122 can be modified in order to adapt the position and hence the percentage of drug delivered at which the clamps 150 are allowed to deflect radially outwards and lock out the sleeve 160.
[0165] The cap 103 of the medicament delivery device 101 serves for keeping the needle sterile prior to use, for removing the protective needle shield 140, for preventing unintended use of the medicament delivery device 101 prior to removal of the cap 103 and for providing rigid packaging.
[0166] The medicament delivery device 101 allows for application by a user, e.g., a patient or caregiver, wherein the body 102 can be held in one hand. The needle 190 of the medicament delivery device 101 is hidden from view during all states of operation.
[0167] The forces required to insert the needle 190 into the injection site and to deliver the drug can be adjusted by respectively selecting the spring 130, wherein the force for delivering the drug depends on the spring 130 and on the characteristics of the syringe 180, stopper 10, needle 190 and drug as well as on the friction between the syringe retarder 114 on the inner wall of the syringe barrel 182.
[0168] The function of the ribs 122 could likewise be provided by a step in the inner surface of the body 102.
REFERENCE NUMBERS
[0169] 1 injection device [0170] 2 distal end [0171] 3 proximal end [0172] 5 housing [0173] 10 stopper [0174] 11 piston rod [0175] 12 stopper [0176] 17 abutment portion [0177] 20 body [0178] 21 sidewall [0179] 22 stepped portion [0180] 23 insert portion [0181] 24 abutment [0182] 25 proximal end [0183] 26 abutment [0184] 27 end face [0185] 28 distal end [0186] 30 protective cap [0187] 31 sidewall [0188] 32 abutment portion [0189] 33 receptacle [0190] 34 abutment [0191] 35 proximal end [0192] 36 abutment [0193] 38 distal end [0194] 39 end face [0195] 40 fastening mechanism [0196] 41 dead end stop [0197] 42 slot [0198] 43 dead end portion [0199] 44 escape portion [0200] 45 intermediate portion [0201] 46 pin [0202] 47 slot [0203] 48 pin [0204] 49 free end portion [0205] 50 activation lock [0206] 51 abutment [0207] 52 abutment [0208] 53 ring [0209] 54 segment [0210] 55 segment [0211] 56 perforated structure [0212] 57 perforated structure [0213] 58 perforated structure [0214] 59 connector [0215] 60 sleeve [0216] 61 sidewall [0217] 64 abutment [0218] 65 proximal end [0219] 68 distal end [0220] 72 flap [0221] 79 medicament container [0222] 80 syringe [0223] 81 flange [0224] 82 barrel [0225] 83 cavity [0226] 84 cavity [0227] 85 bypass [0228] 86 shoulder portion [0229] 87 abutment portion [0230] 88 outlet [0231] 90 needle [0232] 92 needle hub [0233] 94 needle shield [0234] 101 injection device [0235] 103 protective cap [0236] 104 window [0237] 110 piston rod [0238] 111 end face [0239] 112 latch [0240] 113 toothing [0241] 114 retarder [0242] 120 body [0243] 121 stop [0244] 122 rib [0245] 126 snap feature [0246] 130 spring [0247] 140 needle shield [0248] 150 clamp [0249] 151 hook [0250] 152 hook [0251] 160 sleeve [0252] 161 collar [0253] 162 window [0254] 163 spring seat [0255] 164 proximal stop [0256] 165 distal stop [0257] 166 sleeve leg [0258] 170 container carrier [0259] 171 proximal portion [0260] 172 leg [0261] 173 protrusion [0262] 174 aperture [0263] 175 leg [0264] 180 syringe [0265] 181 flange [0266] 182 barrel [0267] 183 cavity [0268] 190 needle
