CONTAINER HOLDER ASSEMBLY FOR MEDICAMENT DELIVERY DEVICE, AND MEDICAMENT DELIVERY DEVICE

Abstract

A container holder assembly for a medicament delivery device is provided having a container holder and a needle assembly, where the container holder has a distal tubular body for receiving a multi-chamber container therein, the distal tubular body comprising a distal body engaging structure on an external surface configured to movably engage an actuator device of the medicament delivery device in order to releasably connect the container holder to the actuator device, and a proximal tubular part having a proximal body engaging structure connected to the needle assembly, where the needle assembly has a hub having an injection needle with a distal needle end and a proximal needle end, the distal needle end being isolated from the multi-chamber container when the multi-chamber container is received in the distal tubular body. A medicament delivery device having a container holder assembly is also provided.

Claims

1-14. (canceled)

15. A container holder assembly for a medicament delivery device, the container holder assembly comprising a container holder and a needle assembly, wherein the container holder comprises: a distal tubular body for receiving a multi-chamber container therein, the distal tubular body comprising an external surface and a distal body engaging structure on the external surface configured to movably engage an actuator device of the medicament delivery device in order to releasably connect the container holder to the actuator device; and a proximal tubular part comprising a proximal body engaging structure connected to the needle assembly wherein the needle assembly is pre-assembled to the container holder before the multi-chamber container is received in the distal tubular body; wherein the needle assembly comprises a hub having an injection needle with a distal needle end and a proximal needle end, the distal needle end being isolated from the multi-chamber container when the multi-chamber container is received in the distal tubular body.

16. The container holder assembly according to claim 15, wherein the distal tubular body is elongated along a longitudinal axis of the container holder assembly.

17. The container holder assembly according to claim 15, wherein the distal body engaging structure is an external thread.

18. The container holder assembly according to claim 15, wherein the distal body engaging structure is configured to threadingly engage a housing part of the medicament delivery device.

19. The container holder assembly according to claim 18, wherein the distal tubular body comprises at least one engaging body structure arranged to releasably engage at least one engageable device feature in the housing part.

20. The container holder assembly according to claim 19, wherein each of the at least one engaging body structure is a flexible protrusion.

21. The container holder assembly according to claim 15, wherein the proximal body engaging structure is an external thread for threadingly engaging the needle assembly.

22. The container holder assembly according to claim 15, wherein the proximal tubular part comprises a proximal internal engaging structure for threadingly engaging the hub.

23. The container holder assembly according to claim 15, wherein the needle assembly further comprises a cap, and wherein the cap is arranged to cause axial distal displacement of the hub by manual rotation of the cap.

24. The container holder assembly according to claim 23, wherein the distal needle end is arranged to penetrate a membrane arranged at a proximal end of the multi-chamber container by means of the axial distal displacement of the hub.

25. The container holder assembly according to claim 15, wherein the needle assembly further comprises a needle cover covering the injection needle, the needle cover comprising a distal cover engaging structure engaging the proximal body engaging structure to connect the proximal tubular part to the needle assembly.

26. The container holder assembly according to claim 15, wherein the needle assembly further comprises a tamper indication member.

27. A medicament delivery device comprising a container holder assembly according to claim 15.

28. The medicament delivery device according to claim 27, further comprising an actuator device having a housing part, wherein the medicament delivery device is arranged to cause mixing of at least two substances in the multi-chamber container by manually moving the container holder into the housing part.

29. A container holder assembly for a medicament delivery device, the container holder assembly comprises: a container holder; and a needle assembly, wherein the container holder comprises: a distal tubular body for receiving a multi-chamber container therein, the distal tubular body comprising an external surface having an external thread helically engaged with a housing part of the medicament delivery device such that the distal tubular body movably engages an actuator device of the medicament delivery device in order to releasably connect the container holder to the actuator device; and a proximal tubular part comprising a proximal body engaging structure connected to the needle assembly, wherein the needle assembly is pre-assembled to the container holder before the multi-chamber container is received in the distal tubular body, and wherein the needle assembly comprises: a hub having an injection needle with a distal needle end and a proximal needle end, the distal needle end being isolated from the multi-chamber container when the multi-chamber container is received in the distal tubular body.

30. The container holder assembly according to claim 29, wherein the distal tubular body further comprises a flexible protrusion that releasably engages a engageable device feature in the housing part.

31. The container holder assembly according to claim 29, wherein the needle assembly further comprises a cap configured to cause axial distal displacement of the hub when the cap is manually rotated.

32. The container holder assembly according to claim 31, wherein the rotation of the cap causes the distal needle end to penetrate a membrane arranged at a proximal end of the multi-chamber container.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Further details, advantages and aspects of the present disclosure will become apparent from the following embodiments taken in conjunction with the drawings, wherein:

[0036] FIG. 1 schematically represents a perspective view of a medicament delivery device comprising a container holder assembly and an actuator device;

[0037] FIG. 2 schematically represents a further perspective view of the medicament delivery device;

[0038] FIG. 3 schematically represents a cross-sectional side view of the medicament delivery device;

[0039] FIG. 4 schematically represents a cross-sectional and partially exploded perspective view of the container holder assembly;

[0040] FIG. 5 schematically represents a cross-sectional partial side view of the container holder assembly;

[0041] FIG. 6 schematically represents a cross-sectional and perspective partial side view of the container holder assembly;

[0042] FIG. 7 schematically represents a cross-sectional and partially exploded perspective view of the actuator device;

[0043] FIG. 8 schematically represents a cross-sectional partial side view of the actuator device; and

[0044] FIG. 9 schematically represents a cross-sectional and perspective partial side view of the actuator device.

DETAILED DESCRIPTION

[0045] In the following, a container holder assembly for a medicament delivery device and a medicament delivery device comprising a container holder assembly, will be described. The same or similar reference numerals will be used to denote the same or similar structural features.

[0046] FIG. 1 schematically represents a perspective view of a medicament delivery device 10. FIG. 2 schematically represents a further perspective view of the medicament delivery device 10. With collective reference to FIGS. 1 and 2, the medicament delivery device 10 of this example is an injection device. The medicament delivery device 10 comprises a container holder assembly 12 and an actuator device 14. In FIGS. 1 and 2, a longitudinal axis 16 of the medicament delivery device 10 is shown.

[0047] The container holder assembly 12 comprises a container holder 18 and a needle assembly 20. The container holder 18 is connected to the needle assembly 20. FIGS. 1 and 2 illustrate the medicament delivery device 10 as received by the user. Thus, the medicament delivery device 10 is delivered with the needle assembly 20 connected to the container holder 18. The actuator device 14 may be for multiple use and the container holder assembly 12 may be disposable.

[0048] The container holder 18 comprises a distal tubular body 22 and a proximal tubular part 24. A multi-chamber container (not shown) is accommodated inside the distal tubular body 22. The distal tubular body 22 comprises an external surface. On the external surface of the distal tubular body 22, a distal body engaging structure 26 is provided. The distal body engaging structure 26 is exemplified as an external thread, here a continuous external thread.

[0049] The distal tubular body 22 of this example further comprises a first indicator 28, a second indicator 30 and a third indicator 32, indicated by the numbers “1”, “2” and “3”, respectively. The first indicator 28 and the second indicator 30 are arranged on one side of the distal tubular body 22, and the third indicator 32 is arranged on an opposite side of the distal tubular body 22. The first indicator 28 is arranged distally of the second indicator 30 and the third indicator 32, the second indicator 30 is arranged between the first indicator 28 and the third indicator 32, and the third indicator 32 is arranged proximally of the first indicator 28 and the second indicator 30.

[0050] The container holder 18 further comprises two wings 34. In this example, the wings 34 are provided on the distal tubular body 22. The wings 34 assist the user to rotate the container holder 18.

[0051] The needle assembly 20 of this example comprises a cap 36. The cap 36 is provided around an injection needle (not shown). The cap 36 is generally cylindrical.

[0052] The container holder assembly 12 further comprises a tamper indication member 38. In FIGS. 1 and 2, the tamper indication member 38 is unbroken. When the cap 36 is removed from the container holder 18, the tamper indication member 38 breaks to indicate tampering.

[0053] The actuator device 14 comprises a housing part 40. The medicament delivery device 10 is configured to cause mixing of at least two substances in the multi-chamber container by manually moving the container holder 18 into the housing part 40.

[0054] By means of the distal body engaging structure 26, the distal tubular body 22 can movable engage the housing part 40 and the distal tubular body 22 is releasably connected to the housing part 40. Thus, the container holder 18 or the entire container holder assembly 12 can be entirely separated from the housing part 40. In this example, the distal tubular body 22 threadingly engages the housing part 40 by means of the distal body engaging structure 26.

[0055] The housing part 40 of this example is cylindrical. The container holder 18 can be at least partly received inside the housing part 40.

[0056] The actuator device 14 of this example further comprises a housing part 42. Thus, the housing part 40 is a proximal housing part and the housing part 42 is a distal housing part. In this example, the distal housing part 40 is threadingly connected to the proximal housing part 40.

[0057] The actuator device 14 of this example further comprises a button 44. The button 44 is arranged at a distal end of the actuator device 14.

[0058] The housing part 40 comprises an opening 46. As shown in FIG. 1, the first indicator 28 is aligned with the opening 46 and is visible through the opening 46. Since the first indicator 28 is aligned with the opening 46, the container holder 18 is in a first position with respect to the housing part 40. The second indicator 30 and the third indicator 32 can also be aligned with, and visible through, the opening 46 when the container holder 18 adopts a second position and a third position, respectively, along the longitudinal axis 16 with respect to the housing part 40.

[0059] The housing part 40 further comprises a first engageable device feature here exemplified as a first recess 48, a second engageable device feature here exemplified as a second recess 50, and a third engageable device feature here exemplified as a third recess 52. The distal tubular body 22 comprises an engaging body structure, here exemplified as a flexible tab 54. In the illustrated first position of the container holder 18, the flexible tab 54 releasably engages the first recess 48. The flexible tab 54 further engages the second recess 50 and the third recess 52 when the container holder 18 adopts the second position and the third position, respectively. In this way, the container holder 18 can be accurately positioned relative to the housing part 40 and the user is provided with tactile and audible feedback when the flexible tab 54 engages the respective recess 48, 50 and 52.

[0060] FIG. 3 schematically represents a cross-sectional side view of the medicament delivery device 10. In FIG. 3, the multi-chamber container 56 can be seen. The multi-chamber container 56 of this example is a dual-chamber container comprising a proximal stopper 58 and a distal stopper 60.

[0061] As shown in FIG. 3, the needle assembly 20 comprises, in addition to the cap 36, a hub 62 having an injection needle 64. Also the hub 62 and the injection needle 64 are concentric with respect to the longitudinal axis 16. The injection needle 64 is fixedly held by the hub 62. The needle assembly 20 is configured such that manual rotation of the cap 36 in one direction is translated to a distal movement of the hub 62 along the longitudinal axis 16.

[0062] The needle assembly 20 of this example further comprises a needle cover 66. The needle cover 66 is generally cylindrical and covers the injection needle 64. The needle cover 66 is provided radially outside the injection needle 64 and the hub 62, and radially inside the cap 36 (with respect to the longitudinal axis 16).

[0063] The needle assembly 20 of this specific example further comprises a clutch 68. The clutch 68 is provided between the cap 36 and the needle cover 66. The clutch 68 transmits rotation of the cap 36 in one direction to a rotation of the needle cover 66, the hub 62 and the injection needle 64, but does not transmit rotation of the cap 36 in an opposite direction to any rotation of the needle cover 66, the hub 62 or the injection needle 64.

[0064] As shown in FIG. 3, the distal tubular body 22 is elongated along the longitudinal axis 16. A length of the distal tubular body 22 along the longitudinal axis 16 is more than five times an interior diameter of the distal tubular body 22.

[0065] As further shown in FIG. 3, the housing part 40 comprises a housing engaging structure 70, here exemplified as a relatively short threaded portion at a proximal interior end of the housing part 40. The distal body engaging structure 26 threadingly engages the housing engaging structure 70.

[0066] FIG. 3 further shows that the actuator device 14 comprises an actuator 72, an actuator sleeve 74, a locking spring 76, a plunger rod 78, a plunger spring 80 and a guide rod 82. The plunger spring 80 surrounds the guide rod 82. The plunger rod 78 surrounds the plunger spring 80. The actuator 72, the actuator sleeve 74 and the locking spring 76 surround the plunger rod 78. In the first position of the container holder 18 illustrated in FIG. 3, the actuator sleeve 74 surrounds the actuator 72.

[0067] FIG. 4 schematically represents a cross-sectional and partially exploded perspective view of the container holder assembly 12, FIG. 5 schematically represents a cross-sectional partial side view of the container holder assembly 12, and FIG. 6 schematically represents a cross-sectional and perspective partial side view of the container holder assembly 12. With collective reference to FIGS. 4-6, a proximal needle end 84 and a distal needle end 86 of the injection needle 64 can be seen. The proximal needle end 84 extends proximally from the hub 62 and the distal needle end 86 extends distally from the hub 62.

[0068] As shown in FIGS. 4-6, the multi-chamber container 56 comprises a membrane 88 at a proximal end thereof. The multi-chamber container 56 is entirely accommodated inside the container holder 18. A major part of the multi-chamber container 56 is accommodated inside the distal tubular body 22 and a proximal end of the multi-chamber container 56 is accommodated inside the proximal tubular part 24. The multi-chamber container 56 of this example is attached to the container holder 18 by means of a snap-fit connection to the interior of the proximal tubular part 24.

[0069] The container holder 18 further comprises a sterile barrier 90, here exemplified as a transverse wall. The barrier 90 sealingly closes a proximal interior portion of the proximal tubular part 24 from a distal interior portion of the proximal tubular part 24.

[0070] In FIGS. 5 and 6, it is shown that the distal needle end 86 is isolated from the multi-chamber container 56 when the multi-chamber container 56 is received in the distal tubular body 22. The distal needle end 86 is separated from the multi-chamber container 56 by means of the membrane 88 and the barrier 90.

[0071] As shown in FIGS. 4-6, the proximal tubular part 24 comprises a proximal body engaging structure 92, here exemplified as a proximal external thread. The needle cover 66 comprises a distal cover engaging structure 94, here exemplified as a distal interior thread. The needle cover 66 is connected to the proximal tubular part 24 by means of a threaded engagement between the distal cover engaging structure 94 and the proximal body engaging structure 92. In this way, the needle assembly 20 is connected to the proximal tubular part 24 by means of the proximal body engaging structure 92.

[0072] The proximal tubular part 24 further comprises a proximal internal engaging structure 96, here exemplified as a proximal internal thread. The hub 62 comprises a distal external engaging structure 98, here exemplified as a distal external thread. The hub 62 is connected to the proximal tubular part 24 by means of a threaded engagement between the distal external engaging structure 98 and the proximal internal engaging structure 96.

[0073] The hub 62 further comprises proximal external grooves 100. The needle cover 66 further comprises interior ribs 102. The interior ribs 102 extend parallel with the longitudinal axis 16, in this example along more than half of a length of the needle cover 66. The proximal external grooves 100 engage a respective interior rib 102. By means of this engagement, rotation of the needle cover 66 is transmitted to a rotation of the hub 62. The engagement however enables the hub 62 to move along the longitudinal axis 16 relative to the needle cover 66.

[0074] FIG. 6 further shows that an arrow 104 is provided on the cap 36. The arrow 104 indicates a rotational direction of the cap 36 in order to remove the cap 36.

[0075] FIG. 7 schematically represents a cross-sectional and partially exploded perspective view of the actuator device 14, FIG. 8 schematically represents a cross-sectional partial side view of the actuator device 14, and FIG. 9 schematically represents a cross-sectional and perspective partial side view of the actuator device 14. With collective reference to FIGS. 7-9, the actuator 72 comprises two hooks 106, here provided at a distal end of the actuator 72. The distal housing part 42 comprises a stop 108. The stop 108 protrudes radially inwards (with respect to the longitudinal axis 16). When the container holder 18 is in the first position with respect to the actuator device 14, the actuator 72 is locked since the hooks 106 engage the stop 108.

[0076] The actuator 72 of this example further comprises two flexible arms 110 projecting proximally. Each flexible arm 110 comprises a protrusion 112. The plunger rod 78 comprises a circumferential groove 114. When the container holder 18 is in the first position with respect to the actuator device 14, the protrusions 112 are seated in the groove 114 and held in the groove 114 by the actuator sleeve 74.

[0077] In the following, one exemplifying use of the medicament delivery device 10 will be described. The user may receive the medicament delivery device 10 with the container holder 18 connected to the housing part 40, the needle assembly 20 connected to the container holder 18, and a multi-chamber container 56 loaded into the distal tubular body 22.

[0078] As an alternative, the user may receive the container holder assembly 12 comprising the container holder 18 and the needle assembly 20, where the needle assembly 20 is connected to the container holder 18, and where a multi-chamber container 56 is loaded into the distal tubular body 22. In this case, the user may connect the container holder assembly 12 to the actuator device 14 by manually screwing the container holder 18 into the housing part 40 to the first position. The user knows when the housing part 40 has adopted the first position since the flexible tab 54 releasably engages the first recess 48 with a clicking sound and since the first indicator 28 (number “1”) is visible through the opening 46.

[0079] In order to mix different substances contained in the multi-chamber container 56, the container holder 18 is manually rotated relatively to the housing part 40, e.g. by means of the wings 34. The container holder 18 thereby moves into the housing part 40 in a distal direction along the longitudinal axis 16. During movement of the container holder 18 from the first position towards the second position, the plunger rod 78, which is static in relation to the housing part 40, eventually shifts the distal stopper 60 proximally into the multi-chamber container 56 such that medicaments inside the multi-chamber container 56 become completely mixed.

[0080] The manual rotation continues until the container holder 18 has moved from the first position to the second position. The user knows when the housing part 40 has adopted the second position and that mixing has been completed since the flexible tab 54 releasably engages the second recess 50 with a clicking sound and since the second indicator 30 (number “2”) is visible through the opening 46.

[0081] In order to prime the medicament delivery device 10, the user manually rotates the container holder 18 further relative to the housing part 40. As the container holder 18 moves from the second position towards the third position, the container holder 18 pushes the actuator sleeve 74 distally. The distal movement of the actuator sleeve 74 forces the hooks 106 inwardly away from the stop 108 to thereby unlock the actuator 72.

[0082] The manual rotation continues until the container holder 18 has moved from the second position to the third position. The user knows when the housing part 40 has adopted the third position and that priming has been completed since the flexible tab 54 releasably engages the third recess 52 with a clicking sound and since the third indicator 32 (number “3”) is visible through the opening 46.

[0083] Either before or after priming, the user grabs and rotates the cap 36 in the direction illustrated by arrow 104 (FIG. 6) about the longitudinal axis 16. The rotation of the cap 36 in this direction is transmitted by the clutch 68 to a rotation in the same direction of the needle cover 66. As the needle cover 66 is rotated, the needle cover 66 moves proximally relative to the proximal tubular part 24 due to the engagement between the distal cover engaging structure 94 and the proximal body engaging structure 92. Due to this relative movement between the needle cover 66 and the proximal tubular part 24, the tamper indication member 38 breaks.

[0084] Furthermore, as the needle cover 66 is rotated, the hub 62 is rotated in the same direction due to the engagement between the interior ribs 102 and the proximal external grooves 100. As the hub 62 is rotated, the hub 62 travels distally along the longitudinal axis 16 due to the engagement between the distal external engaging structure 98 and the proximal internal engaging structure 96. As the hub 62 travels distally, the distal needle end 86 pierces the barrier 90 and the membrane 88.

[0085] When the cap 36 is rotated further, the needle cover 66 eventually disengages completely from the proximal tubular part 24. The cap 36, the clutch 68 and the needle cover 66 can then be removed to expose the proximal needle end 84.

[0086] The proximal needle end 84 of the injection needle 64 then pierces an injection site of a user. When the user pushes the button 44, the button 44 pushes the plunger rod 78 and forces the plunger rod 78 proximally. Since the protrusions 112 of the flexible arms 110 are engaged in the groove 114 of the plunger rod 78, the actuator 72 is moved proximally by the plunger rod 78. When the flexible arms 110 pass the proximal end of the actuator sleeve 74, the plunger rod 78 is released and thereby delivers the medicament through the injection needle 64. Thus, by pressing the button 44, the medicament is automatically expelled into the injection site.

[0087] When the medicament has been expelled from the multi-chamber container 56, the plunger spring 80 forces the actuator 72 distally against the button 44 and thereby produces an audible and tactile feedback to the user indicating injection completion. The container holder 18 may then be screwed out from the housing part 40 until the container holder 18 is disconnected from the actuator device 14. The container holder 18 and the empty multi-chamber container 56 can then be discarded and the actuator device 14 can be loaded with a new container holder assembly 12 comprising a new container holder 18 holding a full multi-chamber container 56 and being connected to a new needle assembly 20.

[0088] While the present disclosure has been described with reference to exemplary embodiments, it will be appreciated that the present disclosure is not limited to what has been described above. For example, it will be appreciated that the dimensions of the parts may be varied as needed. Accordingly, it is intended that the present disclosure may be limited only by the scope of the claims appended hereto.