MEDICAMENT PACKAGING ASSEMBLY
20210379287 · 2021-12-09
Inventors
Cpc classification
A61M5/326
HUMAN NECESSITIES
A61M5/002
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M2005/312
HUMAN NECESSITIES
International classification
A61M5/24
HUMAN NECESSITIES
A61M5/00
HUMAN NECESSITIES
Abstract
A medicament packaging assembly for installation in a medicament delivery device is disclosed. The packaging assembly comprises a cartridge having a medicament chamber, a sealing element for sealing a distal end of the medicament chamber, a sealing element release member, a cannula and a removable cap member. The assembly is switchable from a starting configuration in which the release member is spaced from the sealing element to an activated configuration in which the release member cooperates with the sealing element to connect the medicament chamber to the cannula. The packaging assembly further comprises a first chamber defined in part by the cap member and arranged for receiving the cannula such that at least a distal end of the cannula is sealed in the first chamber when the cap member is in place, and a second chamber defined in part by the sealing element and arranged for receiving the release member such that at least a proximal end of the release member is sealed in the second chamber when the assembly is in the starting configuration. The assembly can be pre-assembled in the starting configuration for subsequent installation in the device.
Claims
1. A medicament packaging assembly for installation in a medicament delivery device, the packaging assembly comprising: a cartridge having a medicament chamber for containing a medicament; a sealing element for sealing a distal end of the medicament chamber; a sealing element release member; a cannula for delivery of the medicament; and a removable cap member; the assembly being switchable by relative movement between the release member and the cartridge from a starting configuration in which the release member is spaced from the sealing element to an activated configuration in which the release member cooperates with the sealing element to connect the medicament chamber to the cannula; the packaging assembly further comprising: a first chamber defined in part by the cap member and arranged for receiving the cannula such that at least a distal end of the cannula is sealed in the first chamber when the cap member is in place; and a second chamber defined in part by the sealing element and arranged for receiving the release member such that at least a proximal end of the release member is sealed in the second chamber when the assembly is in the starting configuration; wherein the assembly can be pre-assembled in the starting configuration for subsequent installation in the device.
2. A packaging assembly according to claim 1, wherein the cap member is arranged for engagement with an outer cap of the device.
3. A packaging assembly according to claim 2, wherein the cap member comprises one or more engagement formations for engagement with the outer cap.
4. A packaging assembly according to claim 2 or claim 3, wherein the cap member is arranged to engage with the outer cap of the device upon application of a distally-directed force to the assembly.
5. A packaging assembly according to any preceding claim, wherein the cap member comprises at least one blocking formation for limiting relative movement between the release member and the cartridge in at least one direction, thereby to keep the assembly in the starting configuration when the cap member is in place.
6. A packaging assembly according to claim 5 when dependent on claim 4, wherein the blocking formation is arranged to keep the assembly in the starting configuration during application of the distally-directed force.
7. A packaging assembly according to any preceding claim, wherein the cap member comprises a vent for venting the first chamber, the vent comprising an air permeable sterile barrier material.
8. A packaging assembly according to any preceding claim, wherein the cap member has a diameter equal to or less than the diameter of the cartridge.
9. A packaging assembly according to claim 8, wherein the maximum diameter of the packaging assembly is equal to the diameter of the cartridge.
10. A packaging assembly according to any preceding claim, further comprising a hub subassembly including a hub body, the cannula and the release member.
11. A packaging assembly according to claim 10, further comprising a coupling element attached to the cartridge, wherein the second chamber is defined in part by the coupling element and wherein an aseptic seal is formed between the hub body and the coupling element to seal the second chamber at least when the assembly is in the starting configuration.
12. A packaging assembly according to claim 11, comprising a seal member arranged to provide the aseptic seal between the hub body and the coupling element.
13. A packaging assembly according to claim 11 or claim 12, wherein the hub body comprises a proximally-projecting boss for the release member and wherein the second chamber is defined in part by a distally-projecting tubular member of the coupling element, the tubular member being arranged to receive the boss and the aseptic seal being formed between the tubular member and the boss at least when the assembly is in the starting configuration.
14. A packaging assembly according to claim 13 when dependent on claim 12, in which the seal member comprises an elastomeric cap mounted on the boss, wherein the release member projects through the elastomeric cap and wherein the elastomeric cap forms the aseptic seal between the tubular member and the boss.
15. A packaging assembly according to any of claims 11 to 14, wherein the cap member is engageable with the hub body and wherein the or each blocking formation extends proximally from the cap member to cooperate with the coupling element to limit relative movement between the release member and the cartridge.
16. A packaging assembly according to claim 15, wherein a tip of the or each blocking formation is arranged to abut the coupling element to limit relative movement between the release member and the cartridge.
17. A packaging assembly according to any of claims 11 to 16, wherein the or each blocking formation extends through a corresponding aperture in the hub body.
18. A packaging assembly according to any of claims 11 to 17, wherein the coupling element is attached to a collar of the cartridge by a crimp fitting.
19. A packaging assembly according to claim 18, wherein the coupling element comprises a skirt that extends over the collar to form the crimp fitting.
20. A packaging assembly according to any of claims 11 to 19, wherein the sealing element comprises a septum, and wherein the coupling element clamps the septum against a distal end of the cartridge.
21. A packaging assembly according to any of claims 11 to 20, comprising a clip formation arranged to allow engagement of the hub subassembly with the coupling element during assembly of the packaging assembly and to prevent subsequent disengagement of the hub subassembly from the coupling element.
22. A packaging assembly according to claim 21, wherein the hub body comprises one or more inwardly-extending clips that cooperate with a collar of the coupling element to provide the clip formation.
23. A packaging assembly according to any preceding claim, wherein the release member comprises a tubular element arranged to pierce the sealing element upon switching of the assembly into the activated configuration.
24. A packaging assembly according to claim 23, wherein the cannula comprises a distal part of a needle and the release member comprises a proximal part of the needle.
25. A method for assembling a medicament delivery device, comprising: assembling a medicament packaging assembly according to any preceding claim; and inserting the assembled packaging assembly into the medicament delivery device.
26. A method according to claim 25, further comprising engaging the cap member of the packaging assembly with an outer cap of the delivery device.
27. A method according to claim 26, wherein the step of inserting the packaging assembly comprises applying a distally-directed force to the packaging assembly to engage the cap member with the outer cap.
28. A medicament delivery device comprising: a housing for receiving a medicament packaging assembly according to any of claims 1 to 24; and a removable outer cap provided on a distal end of the housing, the outer cap being engageable with the cap member of the packaging assembly when the packaging assembly is inserted into the housing.
29. A medicament delivery device according to claim 26, comprising an activation mechanism operable to cause relative movement between the cartridge and the hub subassembly, thereby to switch the packaging assembly from the starting configuration to the activated configuration to allow delivery of the medicament through the cannula.
30. A cannula module for use in a packaging assembly in which a medicament is contained in a medicament chamber of a cartridge, the cannula module comprising: a sealing element for sealing an end of the medicament chamber, a coupling element, a cap sleeve member and a hub subassembly, the hub subassembly comprising a hub body, a cannula for delivery of the medicament and a sealing element release member; wherein at least a distal end of the cannula is received in a first chamber defined in part by the cap member and in part by the hub body; and wherein at least a proximal end of the release member is received in a second chamber defined in part by the coupling element and in part by the sealing element; wherein the cannula module can be pre-assembled for subsequent attachment to the medicament cartridge to form the packaging assembly.
31. A cannula module according to claim 30, further comprising a crimp fitting for attaching the cannula module to the medicament cartridge.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which like reference numerals are used for like features, and in which:
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045] Throughout this specification, the term “distal” and related terms are used to refer to the end of the packaging assembly or device that is closest to the injection site in use (i.e. to the right in
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0046]
[0047] Referring first to
[0048] Referring again to
[0049] The coupling element 114 is attached to the cartridge 102 by a crimp fitting, which in this embodiment comprises a crimp ring 122, preferably formed of a ductile metal such as aluminium. During assembly, the tubular crimp ring 122 is mounted over the skirt 120 and the clamping portion 116 of the coupling element 114 and the ends of the ring 122 are bent inwardly around the proximal side of the collar 108 and the distal side of the clamping portion 116, as can be seen most clearly in
[0050] The coupling element 114 cooperates with a hub subassembly 124. The hub subassembly 124 comprises a hub body 126, a cannula in the form of a double-ended hypodermic needle 128, an elastomeric sealing cap 130 for forming a seal between the hub body 126 and the coupling element 114, and a cannula seal 132 for forming a seal between the hub body 126 and the needle 128.
[0051] The hub body 126 comprises a generally tubular proximal part 126a and a bell-shaped distal part 126b. The distal end of the hub body 126 has an end face 126c with a central aperture for receiving the needle 128. A tubular cap retaining part 126d surrounds the aperture and extends distally from the end face 126c. The needle 128 is fixed in the aperture by the cannula seal 132, which may for example be of a suitable elastomeric material. A distal end part 128a of the needle 128 projects away from the hub body 126.
[0052] A generally tubular boss 134 extends proximally from the end face 126c of the hub body 126, towards the proximal part 126a. The sealing cap 130 fits over the proximal end of the boss 134, and a proximal end part 128b of the needle 128 extends through the cap 130 to project into a chamber 136 defined by the septum 112, the tubular throat 118 of the coupling element 114 and the elastomeric cap 130 of the hub subassembly 124. The sealing cap 130 forms a seal against the inner wall of the throat 118 of the coupling element 114, and is shaped to locate with an inward projection in the form of an annular ridge 138 formed on the inner wall of the throat 118.
[0053] The chamber 136 provides an aseptically sealed compartment for the proximal end part 128b of the needle 128. Thus, provided the packaging assembly 100 is assembled in sterile conditions, the proximal end part 128b of the needle 128 remains sterile until the packaging assembly 100 is activated, as will be described below.
[0054] Distal movement of the hub subassembly 124 away from the coupling element 114 is prevented by a clip formation. As can be seen most clearly in
[0055] A cap sleeve member 140 is fitted to the distal end of the packaging assembly 100. The cap sleeve member 140 has a distally-extending bore 142 that defines, in part, a cap chamber 144 for receiving the distal end part 128a of the needle 128. The cap retaining part 126d of the hub body 126 engages with an interference fit in a proximal end of the bore 142, to form a seal between the cap sleeve member 140 and the hub body 126. In an alternative arrangement (not shown), an O-ring seal is provided between the cap sleeve member 140 and the cap retaining part 126d of the hub body 126.
[0056] A small-diameter bore 146 extends proximally from the distal end of the cap sleeve member 140 to connect with the distally-extending bore 142. The small-diameter bore 146 is plugged with a cylindrical closure 148 comprising an air-permeable sterile barrier material, such as available under the registered trade marks Tyvek (DuPont, DE, USA) and Vyon (Porvair PLC., Norfolk, UK). The closure 148 allows air to flow into or out of the cap chamber 144 and the release member chamber 136 (through the flow path provided by the cannula 128) to equalise the pressure in the chambers 136, 144. This eliminates pressure gradients across the seals between the septum 112 and the coupling element 114, between the coupling element 144 and the hub body 126, and between the hub body 126 and the cap sleeve member 140, reducing the risk of failure of these seals. The sterile barrier properties of the material of the closure 148 prevent microbial contamination of the cap chamber 144. In some cases (not illustrated), where equalisation of pressure is not required, the small-diameter bore 146 may be omitted so that the cap chamber 144 is closed and sealed by the distal end of the cap sleeve member 140.
[0057] The cap chamber 144 therefore provides an aseptically sealed compartment for the distal end part 128a of the needle 128. Again, provided the packaging assembly 100 is assembled in sterile conditions, the distal end part 128a of the needle 128 remains sterile until the packaging assembly 100 is activated, as will be described further below.
[0058] The cap sleeve member 140 is provided with a plurality of ribs 150. The ribs 150 extend parallel to the longitudinal axis of the cap sleeve member 140 and are disposed in an equi-angular arrangement around the outside of the cap sleeve member 150. In the illustrated example, three ribs 150 are provided, but fewer or more ribs 150 may be present.
[0059] Each rib 150 is extended proximally to form a blocking member or blocking finger 150a. As can be seen most clearly in
[0060] Referring to
[0061] Each rib 150 is also extended distally to form a clip formation 150c. The clip formations 150c are separated from the distal end region of the cap sleeve member 140 by slots 150d, so that the clip formations 150c are flexible. The clip formations 150c are used to couple the packaging assembly 100 to an outer cap of a medicament delivery device 200, as will be explained below.
[0062] Once the packaging assembly 100 has been assembled in its starting configuration in a sterile environment, all of the components of the packaging assembly 100 that will come into contact with the medicament in use, as well as the medicament in the medicament chamber 104 and the distal end part 128a of the needle 128 (which passes into the injection site) remain sterile.
[0063] One convenient way of pre-assembling the packaging assembly comprises first attaching the septum 112, the crimp ring 122, the coupling element 114 and the cap sleeve member 140 to the hub subassembly 124 and sterilising these components to from a sterile cannula module. The cannula module can then be secured to the distal end of the cartridge 102 by crimping the crimp ring 122.
[0064] The packaging assembly 100 as a whole can then be installed in a medicament delivery device 200. Advantageously, the maximum diameter of the packaging assembly 100 corresponds to the diameter of the cartridge 102, with the cap sleeve member 140, the hub body 126 and the coupling element 114 all having smaller diameters than the diameter of the cartridge 102. In this way, the packaging assembly 100 can be inserted into a device housing from the proximal end of the housing.
[0065]
[0066] The housing 202 has a generally cylindrical interior space 203 to accept the packaging assembly 100. At a distal end of the housing 202, an outer cap 208 is provided. The outer cap 208 engages with the housing 202 and is removable in use of the device 200.
[0067] Referring additionally to
[0068] In either case, a distally-directed force (i.e. a direct force or a reaction force) acts on the packaging assembly 100 to engage the cap sleeve member 140 with the outer cap 208. The presence of the blocking formations 150a prevents the packaging assembly 100 from moving out of its starting configuration during the insertion process.
[0069] The proximal end fitting 204 clips into the proximal end of the housing 202 to retain the packaging assembly 100 in the housing 202. The proximal end fitting 204 also provides a guide bore 212 for an elongate plunger rod 214 of the plunger 206. A distal tip 216 of the plunger rod 214 is formed to engage with a corresponding recess 111 in the proximal side of the bung 110.
[0070] To prepare the device 200 for use, the outer cap 208 can be removed from the housing 202, as shown in
[0071] To operate the device 200, the plunger 206 is pushed distally with respect to the housing 202. The force initially applied to the packaging assembly 100, via the plunger rod 214 and the bung 110, causes the cartridge 102, the septum 112 and the coupling element 114 to move distally with respect to the hub subassembly 124, moving the throat 118 of the coupling element 114 into the distal part 126b of the hub body 126 as shown in
[0072] The elastomeric sealing cap 130 disengages from the ridge 138, and the proximal end part 128b of the needle 128 pierces the septum 112 to connect the needle 128 to the medicament chamber 104. The packaging assembly 100, and hence the device, is now in an activated state in which a flow path from the medicament chamber 104 to the distal end of the needle 128 has been established.
[0073] Delivery of the medicament through the needle 128 can then take place by further displacement of the plunger 206 in the distal direction.
[0074]
[0075] In the packaging assembly 300 of
[0076] Also, instead of an elastomeric sealing cap, in this embodiment an elastomeric O-ring seal 330 is used to provide the aseptic seal between the boss 134 of the hub body 126 and the throat 318 of the coupling element 314. The O-ring seal 330 is kept in place by the ridge 338 on the interior wall of the throat 318. It will be appreciated that other arrangements are possible and that any suitable seal between the coupling element 314 and the hub subassembly to seal the proximal part 128b of the needle 128 in the chamber 136.
[0077]
[0078] In this case, the cap sleeve member 340 is provided with arcuate ramp formations 354 that extend radially outwardly from a distal end portion 340a of the cap sleeve member 340. The ribs 350 do not extend into the distal end portion 340a of the cap sleeve member 340. Instead, the distal end surface of each rib 350 provides a stop 351.
[0079] The outer cap 408 is provided with clip formations 418 arranged around the perimeter of a circular aperture 420 in the distal end wall 409. Each clip formation 418 extends proximally from the distal end wall 409 of the outer cap 408 and includes a ramped, inwardly-facing head 422 at its proximal end.
[0080] To engage the cap sleeve member 340 with the outer cap 408, the distal end of the cap sleeve member 340 is pushed into the aperture 420 so that the clip formations 418 of the outer cap 408 flex outwardly and pass over the ramp formations 354 of the cap sleeve member 340. The clip formations 418 engage with the proximal sides of the ramp formations 354 as shown in
[0081] Because the clip formations 418 of the outer cap are arranged around the circular periphery of the aperture 420, the cap sleeve member 340 can be engaged with the outer cap 408 irrespective of the relative angular orientation of the components about the longitudinal axis of the cap sleeve member 340.
[0082] Although not illustrated, other means for engaging the cap sleeve member and the outer cap are possible. Preferably, both the cap sleeve member and the outer cap are provided with complementary engagement formations to allow engagement of the cap sleeve member with the outer cap when the cap sleeve member is inserted into the outer cap. At least one of the engagement formations may be arranged to flex in order to engage the cap sleeve member with the outer cap. Examples of suitable engagement formations include clips, ramp formations, projections, recesses, apertures, slots and so on.
[0083] Although
[0084] For example,
[0085]
[0086]
[0087] In the examples of
[0088] Further variations and modifications may be contemplated. For example, in the illustrated examples, the cannula is a double-ended needle, and the proximal end part of the needle acts as a piercing member for the septum. However, a single-ended needle could be provided for delivery of the medicament, with a separate piercing member being formed integrally with the hub body or as a separate component. It is also conceivable that, instead of a septum, the distal end of the cartridge could be sealed by a valve, rupturable membrane or other sealing device. In such cases the sealing element may be released by a suitable release member, which need not be a piercing member but could instead be arranged to open a valve, rupture a membrane and so on.
[0089] The cannula need not be a needle, but could instead be a flexible cannula or other suitable infusion or injection device. The cannula need not be mounted directly in the hub body but could instead be connected to the hub body by a flexible tube or the like.
[0090] Further modifications and variations not explicitly described above are also possible without departing from the scope of the invention as defined in the appended claims.