Drug Delivery Device Subassembly

Abstract

11. A subassembly for a medication delivery device, comprising: a tubular outer cap extending along a longitudinal axis; an inner cap at least partially surrounded by the tubular outer cap and configured to be removably attached to a housing of the medication delivery device via a rotational attachment; and a clutch formed by a driver and a follower, the follower being attached to the inner cap and positioned between the tubular outer cap and the inner cap in a transverse direction to the longitudinal axis, wherein the outer cap is axially movable relative to the inner cap between a proximal position and a distal position, the tubular outer cap comprising a driver extending from a body of the tubular outer cap, the follower extending in a transverse direction to the longitudinal axis towards the tubular outer cap, wherein when the tubular outer cap is in a proximal position, the driver is spaced apart from the follower in the direction of the longitudinal axis, and when the tubular outer cap is in a distal position, the driver is adjacent to the follower, whereby the inner cap can be removed from the housing of the medication delivery device via rotation of the outer cap relative to the housing of the medication delivery device.

Description

[Technical field]

[0001] The present disclosure relates generally to a subassembly of a medication delivery device, and more particularly to a subassembly having a clutch. [Background technology]

[0002] Drug delivery devices such as manual or auto-injector pens are commonly known for self-administration of drugs by patients without formal medical training. For example, a patient suffering from diabetes may require multiple injections of insulin or may require regular injections of other types of drugs, such as growth hormone.

[0003] Therefore, a clear surgical guide for the patient is important. However, not all users always carefully read the user guide or instructions on the package before performing the drug delivery operation, and sometimes the drug delivery device may be unintentionally accessed, for example, by accidentally removing the cap of the drug delivery device, and some end users may need to perform multiple drug delivery operations with multiple different drug delivery devices, which may lead to confusion or mix up the drug delivery device operation instructions between different drug delivery devices.

[0004] Therefore, it is desirable to have a structural design for a medication delivery device that ensures that users follow the operating instructions of the medication delivery device. Summary of the Invention

[0005] The invention is defined by the appended claims, to which reference should be made below.

[0006] In this disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the injection device. When the term "distal part / end" is used, it refers to the part / end of the delivery device, or the part / end of a member thereof, that is located the furthest from the dose delivery site during use of the injection device. Correspondingly, when the term "proximal direction" is used, it refers to the direction approaching the dose delivery site during use of the injection device. When the term "proximal part / end" is used, it refers to the part / end of the delivery device, or the part / end of a member thereof, that is located the closest from the dose delivery site during use of the injection device.

[0007] Additionally, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction extending along a device or component thereof from a proximal end to a distal end, generally in the direction of the greatest extension of the device and / or component.

[0008] Similarly, the terms "transverse," "transversal," and "transversally" refer to a direction generally perpendicular to the longitudinal direction.

[0009] Additionally, "circumference," "circumferential," or "circumferentially" refers to the circumferential or circumferential direction relative to an axis, typically a central axis extending in the direction of greatest extension of a device and / or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotation," "rotational," and "rotationally" refer to rotation relative to an axis.

[0010] Accordingly, a subassembly of a medication delivery device is provided, the subassembly comprising a tubular outer cap extending along a longitudinal axis and an inner cap at least partially surrounded by the tubular outer cap. The inner cap is configured to be removably attached to a housing of the medication delivery device via a rotational attachment. The clutch is formed by a driver and a follower. The follower is attached to the inner cap and positioned between the tubular outer cap and the inner cap in a transverse direction to the longitudinal axis. The outer cap is axially movable relative to the inner cap between a proximal position and a distal position. The tubular outer cap comprises a driver extending from a body of the tubular outer cap. The follower extends transverse to the longitudinal axis towards the tubular outer cap. When the tubular outer cap is in a proximal position, the driver is spaced from the follower in the direction of the longitudinal axis. When the tubular outer cap is in a distal position, the driver is adjacent to the follower, whereby the inner cap can be removed from the housing of the medication delivery device via rotation of the outer cap relative to the housing of the medication delivery device.

[0011] According to another embodiment, the follower preferably extends from the body wall of the inner cap transversely to the longitudinal axis.

[0012] Alternatively, according to another embodiment, the subassembly includes a connection sleeve having a body extending along a longitudinal axis, a rotating sleeve fastener that engages with a counter rotating sleeve fastener of the inner cap, and a follower extending from the body of the connection sleeve transverse to the longitudinal axis.

[0013] According to another embodiment, the connecting sleeve preferably comprises an axial sleeve fastener which engages with a counter axial sleeve fastener of the inner cap. According to another embodiment, the engagement formed between the rotating sleeve fastener which engages with the counter rotating sleeve fastener of the inner cap is preferably formed by a rib and a counter rib, by a rib and a groove, or by a non-circular cross-section and another non-circular cross-section.

[0014] According to another embodiment, the engagement formed between the axial sleeve fastener which engages with the counter-rotating sleeve fastener of the inner cap is preferably formed by a snap-fit ​​engagement.

[0015] According to another embodiment, one of the driver and follower is a recess and the other of the driver and follower is preferably a protrusion that is positioned within the recess when the tubular outer cap is in the distal position.

[0016] According to another embodiment, the recesses are preferably oriented transversely to the longitudinal axis.

[0017] According to another embodiment, the recess is preferably formed by a ratchet.

[0018] Alternatively, according to another embodiment, the clutch engagement formed between the driver and driven parts is preferably formed by a non-circular cross-section of the driver part matching a non-circular cross-section of the driven part.

[0019] According to another embodiment, the clutch engagement formed between the driver and driven parts is preferably a friction mesh engagement.

[0020] According to another embodiment, the subassembly preferably includes a retainer.

[0021] According to another embodiment, the retainer preferably comprises a retainer body and a mounting portion extending from the retainer body, the mounting portion configured to be mounted to a counter mounting portion of the medication delivery device, and the inner cap is removably mounted to the retainer via a rotational mounting such that the inner cap is removably mounted to the medication delivery device via the retainer.

[0022] According to another embodiment, the attachment of the retainer is preferably one of a snap fit attachment, a screw thread attachment, and a bayonet attachment.

[0023] According to another embodiment, the rotational attachment is preferably formed by threads on the retainer body and a thread follower on the inner cap which engages with the threads on the retainer.

[0024] According to another embodiment, the subassembly preferably comprises a delivery member hub configured to be attached to the medication delivery member. The delivery member hub comprises a first engagement member that engages with a first counter engagement member of the retainer, and the delivery member hub comprises a second engagement member that engages with a counter second engagement member of the inner cap. The delivery member hub is axially movable relative to the retainer body between a proximal position and a distal position.

[0025] According to another embodiment, rotation of the inner cap relative to the retainer is preferably configured to move the delivery member hub from a proximal position to a distal position.

[0026] According to another embodiment, the engagement formed between the first engagement member and the counter first engagement member is preferably a threaded engagement, whereas the engagement formed between the second engagement member and the counter second engagement member is a rotational engagement.

[0027] According to another embodiment, the threaded engagement between the delivery member hub and the retainer is preferably oriented in an opposite longitudinal direction relative to the threaded engagement between the inner cap and the retainer.

[0028] According to another embodiment, the delivery member hub is preferably rotatably fixed to the retainer body. One of the second engagement member and the counter second engagement member is a helical cam and the other of the second engagement member and the counter second engagement member is a cam follower. The engagement formed between the first engagement member and the counter first engagement member is a snap-fit ​​engagement.

[0029] Alternatively, according to another embodiment, the outer cap is axially movable relative to the housing of the medication delivery device from an initial proximal position to a proximal position, and the outer cap is immovable axially relative to the inner cap as the outer cap moves from the initial proximal position to the proximal position.

[0030] According to another embodiment, axial movement of the inner cap relative to the retainer is preferably configured to move the delivery member hub from a proximal position to a distal position.

[0031] According to another embodiment, the delivery member hub is preferably configured to snap-fit ​​into the retainer.

[0032] According to another embodiment, the subassembly preferably comprises a delivery member guard and a locking member. The delivery member guard comprises a proximally facing surface adjacent the distally facing surface of the tubular outer cap. The delivery member guard comprises a distally facing surface. The locking member comprises a body having a proximally facing surface. The locking member is movable relative to the delivery member guard between a locked position in which the proximally facing surface of the locking member is aligned with the distally facing surface of the delivery member guard to prevent distal movement of the delivery member guard relative to the locking member, and an unlocked position in which the proximally facing surface of the locking member is offset relative to the distally facing surface of the delivery member guard to allow the delivery member guard to move distally relative to the locking member.

[0033] According to another embodiment, the locking member is preferably rotatable relative to the delivery member guard about the longitudinal axis between a locked position and an unlocked position.

[0034] Alternatively, according to another embodiment, the locking member is slidable relative to the delivery member guard transverse to the longitudinal axis.

[0035] According to another embodiment, the drug delivery device is preferably a disposable drug delivery device.

[0036] Alternatively, according to another embodiment, the drug delivery device is a reusable drug delivery device.

[0037] According to another embodiment, a reusable medication delivery device is preferably formed by a disposable cassette and a reusable drive unit.

[0038] According to another embodiment, the drug delivery device is preferably an autoinjector.

[0039] Another aspect of the present invention provides a cassette unit of a medication delivery device comprising a subassembly.

[0040] According to another embodiment, the cassette unit preferably comprises a housing of the medication delivery device, the housing extending along a longitudinal axis, and the locking member being axially fixed to the housing.

[0041] According to another embodiment, the delivery member guard is preferably rotatably fixed to the housing. The housing comprises a bayonet protrusion configured to move along a bayonet track of the drive unit of the medication delivery device, thereby attaching the cassette unit to the drive unit. The locking member comprises a protrusion extending away from the longitudinal axis from the body. The protrusion is next to the bayonet protrusion of the housing in the direction of the longitudinal axis. The protrusion is configured to be rotatably fixed to a wall of the drive unit when the cassette unit is attached to the drive unit.

[0042] According to another embodiment, the drug delivery device preferably comprises a multi-chamber drug container disposed within a carrier.

[0043] According to another embodiment, the drug delivery device is preferably an autoinjector or a manual insulin pen.

[0044] According to another embodiment, the drug container is preferably a drug container without a drug delivery member.

[0045] According to another embodiment, the drug container is preferably a glass cartridge, a plastic cartridge, or a collapsible bag.

[0046] In another aspect of the invention there is provided a method for uncapping a medication delivery device, the medication delivery device comprising a cassette unit and a drive unit, the method comprising the following steps in the following order: moving the locking member from a locked position to an unlocked position; moving the delivery member guard together with the tubular outer cap distally relative to the inner cap to a position distal of the tubular outer cap; Rotating the tubular outer cap together with the inner cap relative to the housing of the cassette unit, thereby removing the tubular outer cap and the inner cap from the housing of the cassette unit.

[0047] According to another embodiment, moving the locking member from the locked position to the unlocked position preferably includes rotating the locking member relative to the delivery member guard from the locked position to the unlocked position.

[0048] According to another embodiment, the step of rotating the locking member from the locked position to the unlocked position relative to the delivery member guard preferably includes the step of rotating the locking member from the locked position to the unlocked position relative to the delivery member guard while attaching the cassette unit to the drive unit via the bayonet connection.

[0049] According to another embodiment, the step of rotating the tubular outer cap together with the inner cap relative to the housing preferably includes the further step of moving the delivery member hub from a proximal position to a distal position while rotating the tubular outer cap together with the inner cap relative to the housing, thereby mounting the delivery member attached to the delivery member hub to the drug container together with the housing of the drug delivery device.

[0050] The delivery devices described herein can be used for the treatment and / or prevention of one or more of many different types of disorders. Exemplary disorders include, but are not limited to, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia, diabetes (e.g., type 2 diabetes), psoriasis, migraines, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that may be included in the injection devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogs, protein variants, protein precursors, and / or protein derivatives. Exemplary drugs that may be included in the injection devices described herein include etanercept (rheumatoid arthritis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin (antimyelitis), and valproate (valproate). In some cases, the following drugs may be used: chin alfa (anemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycemia), epinephrine (anaphylaxis), insulin (diabetes), atropine, and vedolizumab (inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)), but are not limited to these (and are not limited to the examples of related disorders in parentheses). Pharmaceutical formulations including, but not limited to, any of the drugs described herein, for example, a pharmaceutical formulation including a drug listed herein (or a pharma- ceutical acceptable salt of the drug) and a pharma- ceutical acceptable carrier, are also contemplated for use with the injection devices described herein.A pharmaceutical formulation containing a drug (or a pharma- ceutically acceptable salt of the drug) listed herein may contain one or more other active ingredients, or may be the only active ingredient present.

[0051] Moreover, all terms used in the claims are to be interpreted according to their ordinary meaning in the art, unless expressly defined otherwise herein. All references to "a / an, the, element, device, member, component, means, etc." are to be interpreted broadly as referring to at least one instance of the element, device, member, component, means, etc., unless expressly stated otherwise. [Brief description of the drawings]

[0052] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1] 1 shows a schematic perspective view of a subassembly of the present invention; [Diagram 2] 1 shows a schematic perspective view of a subassembly of the present invention; [Diagram 3] FIG. 3 shows a schematic of the inner cap and delivery member hub of the subassembly of FIGS. 1-2; [Figure 4] 3 shows a schematic diagram of an inner cap and a connecting sleeve of the subassembly of FIGS. 1-2; [Diagram 5] FIG. 3 shows a schematic diagram of a connecting sleeve and a tubular outer cap of the subassembly of FIGS. 1-2; [Figure 6A] 3 illustrates a schematic diagram of an operational sequence of the subassemblies of FIGS. [Figure 6B] 3 illustrates a schematic diagram of an operational sequence of the subassemblies of FIGS. [Figure 7] FIG. 3 shows a schematic perspective view of the subassembly, delivery member guard, and locking member of FIGS. 1-2; [Figure 8] FIG. 8 shows a schematic perspective view of the delivery member guard and locking member of FIG. 7; [Figure 9A] FIG. 9 shows a schematic perspective view of the delivery member guard and locking member of FIG. 8; [Figure 9B] FIG. 9 shows a schematic perspective view of the delivery member guard and locking member of FIG. 8; [Figure 10] 1 shows a schematic perspective view of a drug delivery device having a subassembly of the present invention; [Figure 11A] 11 illustrates a schematic diagram of an operational sequence of the drug delivery device of FIG. 10. [Figure 11B] 11 illustrates a schematic diagram of an operational sequence of the drug delivery device of FIG. 10. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] 1 to 6B show a subassembly of a drug delivery device. The subassembly 1 comprises a tubular outer cap 10, an inner cap 12 and a clutch.

[0054] As shown in Figs. 1-2, the tubular outer cap 10 extends along a longitudinal axis L between a proximal end and a distal end. The tubular outer cap 10 comprises a body 100. The tubular outer cap 10 is configured to be gripped by a user and to be moved away from a drug delivery device prior to a drug delivery operation. As shown in Fig. 1, the outer cap 10 is generally cylindrical. In one example, the outer surface of the body 100 includes an indication mark to indicate to a user an action, e.g., rotation, to remove the cap. In another example, the outer surface of the body includes a plurality of recesses and protrusions to allow a user to firmly and easily grip the outer cap. Alternatively, the outer cap can be formed in different shapes depending on the demand, e.g., of a patient group.

[0055] The inner cap 12 comprises a body 120 configured to surround at least a portion of the drug delivery member of the drug delivery device. In the example shown in FIG. 2, the body 120 of the inner cap 12 is generally cylindrical. The body 120 of the inner cap is at least partially surrounded by the tubular outer cap 10. The inner cap 12 is configured to be removably attached to the housing of the drug delivery device via a rotational attachment. In one example, as shown in FIG. 2, the rotational attachment is a threaded engagement. In this example, one of the inner cap and the housing of the drug delivery device comprises a thread, and the other of the inner cap and the housing of the drug delivery device comprises a thread follower, e.g., a protrusion or a thread. In this example, as shown in FIGS. 2-3, the inner cap 12 comprises a thread 123 extending through the body 120 of the inner cap, and the housing of the drug delivery device operably comprises a counter thread 111. The counter thread can be disposed in an integral part of the housing of the drug delivery device. Alternatively, the counter thread may be located on a separate component independent of the housing of the drug delivery device and configured to be attached to the housing of the drug delivery device prior to use of the drug delivery device.

[0056] In a preferred example, the subassembly 1 comprises a retainer 11 comprising a retainer body 110 with a counter thread 111 extending from an outer surface of the retainer 11 configured to be attached to a housing of a drug delivery device. For example, a mounting portion 11a extending from the retainer body 110 is configured to be attached to a counter mounting portion of the drug delivery device as shown in Figure 1, where the mounting portion 11a is a snap-fit ​​hook and the counter mounting portion can be a snap-fit ​​recess / notch. Alternatively, the mounting portion and the counter mounting portion can be a thread and a thread follower, for example a protrusion or another compatible thread.

[0057] Alternatively, the rotational attachment can be a bayonet attachment. In this example, one of the inner cap and the housing of the drug delivery device includes a bayonet track and the other of the inner cap and the housing of the drug delivery device includes a bayonet follower, e.g., a protrusion. Similarly, the bayonet track or bayonet follower can be formed on the retainer 11 configured to be attached to the housing or can be formed as an integral part of the housing. The outer cap 10 is axially movable relative to the inner cap 12 between a proximal position and a distal position.

[0058] The clutch is formed by the driver 101 and the driven part 132. The driven part 132 is attached to the inner cap 12 and is positioned transversely to the longitudinal axis L between the tubular outer cap 10 and the inner cap 12.

[0059] The tubular outer cap 10 includes a driver 101 extending from a body 100 of the tubular outer cap 10. A follower 132 extends transversely to the longitudinal axis toward the tubular outer cap 10. Thus, when the driver 101 is adjacent to the follower 132, a user can rotate the inner cap 12 together with the outer cap 10 via a clutch engagement between the driver 101 and the follower 132.

[0060] When the tubular outer cap 10 is in the proximal position, the driver 101 is spaced apart from the follower 132 in the direction of the longitudinal axis L, so that a rotation of the outer cap 10 about the longitudinal axis L relative to the housing of the drug delivery device is not transferred as a rotation of the inner cap 12, in other words, when the outer cap is in the proximal position, the outer cap 10 rotates relative to the inner cap 12. When the tubular outer cap 10 is in the distal position, the driver 101 is adjacent to the follower 132, so that the inner cap 12 can be removed from the housing of the drug delivery device via a rotation of the outer cap 10 relative to the housing of the drug delivery device.

[0061] Optionally, the subassembly 1 includes a connecting sleeve 13. The connecting sleeve 13 includes a body 130 extending along a longitudinal axis L. The connecting sleeve is configured to be attached to the inner cap 12 and positioned between the inner cap 12 and the outer cap 10 in a transverse direction to the longitudinal axis L. In a preferred example, the shape of the body 130 of the connecting sleeve 13 depends on the shape of the inner cap 12 and the shape of the outer cap 10. For example, as shown in Figs. 2 and 5, when the outer cap 10 and the inner cap 12 are both substantially cylindrical, the body 130 of the connecting sleeve 13 is also substantially cylindrical. Since the connecting sleeve 13 is non-rotatable relative to the inner cap 12, the inner cap 12 can be removed from the housing of the drug delivery device via rotation of the connecting sleeve 13 relative to the housing.

[0062] Optionally, the connection sleeve 13 is also immovable axially relative to the inner cap 12. In one example, the connection sleeve 13 includes an axial sleeve fastener 131 that engages with the counter axial sleeve fastener 122 of the inner cap 12, and the connection sleeve includes a rotating sleeve fastener 133 that engages with the counter rotating sleeve fastener 121. In one example, as shown in FIG. 2, the axial sleeve fastener 131 is a snap-fit ​​hook and the counter axial sleeve fastener 122 is a snap-fit ​​recess. In one example, as shown in FIGS. 4-5, the rotating sleeve fastener 133 of the connection sleeve is a non-circular cross-section portion of the body 130 of the connection sleeve 12, and the counter rotating sleeve fastener 121 of the inner cap 12 is a non-circular cross-section portion of the body 120 of the inner cap 12 that fits the rotating sleeve fastener 133 of the connection sleeve 13.

[0063] It should be noted that when a non-circular cross-section of one component is used to match another non-circular cross-section of another component, a rotational engagement is formed, meaning that the two components can now only rotate together with one another. For example, the non-circular cross-section could be a polygonal cross-section, a star cross-section, or a heart cross-section.

[0064] In this example, the follower 132 extends from the body 130 of the connecting sleeve 13 transversely to the longitudinal axis L. Alternatively, the follower extends from the body wall of the inner cap transversely to the longitudinal axis L, so that in this example, there is no need to use a connecting sleeve.

[0065] In one example, one of the driver 101 and the driven part 132 is a recess, and the other of the driver 101 and the driven part 132 is a protrusion that is positioned in the recess when the tubular outer cap 10 is in the distal position. For example, as shown in FIG. 5, the driver 101 is a recess and the driven part is a protrusion. In one example, the recess is oriented transversely to the longitudinal axis L. In a preferred example, the recess is formed by a ratchet, which prevents a user from twisting the inner cap in the wrong direction and accidentally tightening the inner cap to the housing of the drug delivery device. Alternatively, the clutch engagement formed between the driver and the driven part is formed by a non-circular cross-section of the driver matching a non-circular cross-section of the driven part. Alternatively, the clutch engagement formed between the driver and the driven part is a friction fit engagement.

[0066] The subassembly 1 of the present invention can be used in a drug delivery device comprising a drug container with an integrated drug delivery member. In this example, the subassembly 1 prevents the user from accidentally removing the inner cap, for example by twisting the inner cap. Alternatively, the subassembly 1 can be used in a drug delivery device comprising a drug container without a drug delivery member, for example a cartridge or a collapsible bag, and in particular in a drug delivery device with a drug container without a drug delivery member and a pre-assembled drug delivery member, for example a needle or nozzle. The subassembly 1 of the present invention can be used without the drug delivery member and with a mechanism for establishing fluid communication between the drug delivery member and the drug container.

[0067] In one example where the subassembly comprises the retainer 11, the subassembly comprises a delivery member hub 14 configured to be attached to a drug delivery member. The delivery member hub has a body 140 extending along a longitudinal axis L between a proximal end and a distal end. The delivery member is configured to extend through the proximal end of the body 140 of the delivery member hub 14 and through the distal end of the body 140 of the delivery member hub 14. In a preferred example, the drug delivery member is adhered to the body 140 of the delivery member hub 14.

[0068] In this example, the retainer body 110 comprises a central cavity configured to receive the body of the delivery member hub 14. In this example, the central cavity of the retainer body 110 is configured to align with a drug container of a drug delivery device in the direction of the longitudinal axis L such that the delivery member can be attached to the drug container through the central cavity. In this example, the delivery member hub 14 comprises a first engagement member 141 that engages with the first counter engagement member 112 of the retainer 11 and a second engagement member 142 that engages with the counter second engagement member 124 of the inner cap 12. The delivery member hub 14 is axially movable relative to the retainer body 110 between a proximal position and a distal position.

[0069] In one example, as shown in FIG. 2, rotation of the inner cap 12 relative to the retainer 11 is configured to move the delivery member hub 14 from a proximal position to a distal position. In one example, the engagement formed between the first engagement member and the counter first engagement member is a threaded engagement. The engagement formed between the second engagement member and the counter second engagement member is a rotational engagement. In this example, the threaded engagement between the delivery member hub and the retainer is oriented in an opposite longitudinal direction to the threaded engagement between the inner cap and the retainer. For example, as shown in FIG. 2, the first engagement member 141 is a helical 141 protrusion extending from the body 140 of the delivery member hub 14, and the counter first engagement member 112 is a thread 112 extending from an inner surface of a central cavity of the retainer body 110. 3, the second engagement member 142 is a notch in the wall of the body 140 of the delivery member hub 14, preferably at the proximal end of the body 140 of the delivery member hub 14, and the counter second engagement member 124 is a protrusion 124 extending from the inner surface of the body 120 of the inner cap 12. Thus, when the inner cap 12 is rotated relative to the retainer 11 to remove it from the retainer 11, the delivery member hub 14 rotates in the opposite direction with the delivery member, causing the delivery member hub 14 and delivery member to move distally of the outer cap into engagement with the retainer 11 and establish fluid communication with the drug container of the drug delivery device.

[0070] Alternatively, the delivery member hub is rotatably fixed to the retainer body. In this example, one of the second engagement member and the counter second engagement member is a helical cam and the other of the second engagement member and the counter second engagement member is a cam follower. Furthermore, the engagement formed between the first engagement member and the counter first engagement member is a snap-fit ​​engagement. Thus, rotation of the inner cap relative to the retainer moves the delivery member hub from a proximal position to a distal position, thereby establishing fluid communication between the drug container of the drug delivery device and the delivery member.

[0071] Alternatively, rotation of the inner cap can be used only to remove the inner cap from the retainer. In this example, the inner cap has a distally facing surface adjacent to a proximally facing surface of the delivery member hub, and the outer cap is not axially movable relative to the inner cap between the initial proximal position and the proximal position. For example, the outer cap has a bump extending transversely from the inner surface of the outer cap to the longitudinal axis, and the inner cap has a counter bump that engages with the bump of the outer cap when the outer cap is in the initial proximal position and disengages with the bump of the outer cap when the outer cap is in the proximal position. In a preferred example, the interface between the bump and the counter bump is chamfered relative to the longitudinal axis L. In this example, one of the first engagement member of the hub and the counter first engagement member of the retainer is a snap-engagement hook, and the other of the first engagement member of the hub and the counter first engagement member of the retainer is a recess / notch. In this example, when a user pushes the outer cap distally relative to the housing of the medication delivery device, the outer cap, the inner cap, and the delivery member hub move in unison distally relative to the retainer until the delivery member hub snaps into the retainer. When the delivery member hub snaps into the retainer, the delivery member hub cannot move distally relative to the retainer, and therefore the inner cap cannot move distally relative to the retainer. Thus, when the user continues to push the outer cap distally relative to the housing of the medication delivery device, the bumps on the outer cap move past the counter bumps on the inner cap. In this example, the engagement between the inner cap and the retainer is preferably an engagement between a track and a protrusion. For example, the inner cap comprises a protrusion that is positioned within the track of the retainer. The track comprises a longitudinal portion extending along the longitudinal axis between a proximal end and a distal end, and a circumferential portion extending around the longitudinal axis between a first end and a second end. A proximal end of the longitudinal portion of the track is a closed end and a distal end of the longitudinal portion of the track connects to a first end of the circumferential portion, a second end of the circumferential portion is an open end and the protrusion is movable out of the track at the second end.

[0072] In this example, when the outer cap moves from the initial proximal position to the proximal position, the bayonet protrusion of the inner cap moves along the longitudinal portion of the bayonet track of the retainer. When the outer cap moves further from the proximal position to the distal position, the inner cap is immovable relative to the retainer, and when the outer cap is in the distal position, the outer cap rotatably engages with the inner cap via the clutch as described above. Thus, the user rotates the outer cap, which causes the protrusion of the inner cap to move along the circumferential portion of the track from the first end to the second end, allowing the inner cap to disengage from the retainer.

[0073] It should be noted that the structure on the retainer may be located on the housing of the medication delivery device, depending on the design. When the subassembly 1 is used with this type of medication delivery device, the subassembly does not have a retainer.

[0074] Additionally, the subassembly may optionally include a secondary safety mechanism. In this example, the subassembly includes a delivery member guard 2 and a locking member 3, as shown in FIG. 7. In a preferred example, the delivery member guard includes a tubular proximal portion 20 and a distal body portion 21. The distal body portion may be a distally extending arm extending from the tubular proximal portion 20, as shown in FIG. 8. Alternatively, the distal body portion may be cylindrical. The delivery member guard 2 includes a proximal facing surface 20a adjacent to the distal facing surface 102 of the tubular outer cap 10. In a preferred example, the proximal facing surface 20a is defined by the proximal end of the tubular proximal portion of the delivery member guard 2. Alternatively, the delivery member guard includes a protrusion extending transversely to the longitudinal axis from an outer surface of the tubular proximal portion, the proximal facing surface being defined by the protrusion. The delivery member guard 2 includes a distal facing surface 22a. The locking member 3 comprises a body 30 having a proximal facing surface 31a. The locking member 3 is movable relative to the delivery member guard 2 between a locked position in which the proximal facing surface 31a of the locking member 3 is aligned with the distal facing surface 22a of the delivery member guard 2 to prevent the delivery member guard 2 from moving distally relative to the locking member 3, as shown in FIG. 9A, and an unlocked position in which the proximal facing surface 31a of the locking member 3 is offset relative to the distal facing surface 22a of the delivery member guard 2 to allow the delivery member guard 2 to move distally relative to the locking member 3, as shown in FIG. 9B. Thus, when the locking member 3 is in the locked position, the outer cap 10 cannot move from a proximal position to a distal position. In one example where the outer cap includes an initial proximal position, the outer cap also cannot move from an initial proximal position to a proximal position. In one example, the delivery member guard 2 comprises a rib 22 extending transversely to the longitudinal axis L from a distal body portion of the delivery member guard 2.

[0075] In one example, the locking member 3 is rotatable relative to the delivery member guard 2 about the longitudinal axis L between a locked position and an unlocked position. For example, the locking member 3 can be a rotatable knob. In another example, the locking member is linearly slidable transversely to the longitudinal axis L from the locked and unlocked positions. For example, the locking member can be a removable pin configured to be removed by a user prior to use.

[0076] The subassembly can be used in a disposable drug delivery device, for example a hand-held autoinjector or an on-body injection pump. Alternatively, the subassembly can be used in a reusable drug delivery device, formed by a disposable cassette unit C and a reusable power pack R, as shown in FIG. 10. The disposable cassette unit C is configured to accommodate a drug container. In one example where the subassembly is used in a reusable drug delivery device, the subassembly is used in a disposable cassette unit C. For example, the cassette unit comprises a housing 4 of the drug delivery device. The housing 4 extends along a longitudinal axis L. In this example, the locking member 3 is axially fixed to the housing 4. In a preferred example, the delivery member guard 2 is rotatably fixed to the housing 4. In a preferred example, the housing 4 comprises a bayonet protrusion 40 configured to move along a bayonet track of the drive unit R of the drug delivery device, thereby attaching the cassette unit C to the drive unit R. The locking member 3 comprises a protrusion 32 extending away from the body 30 along the longitudinal axis L. The protrusion 32 is next to the bayonet protrusion 40 of the housing 4 in the direction of the longitudinal axis L. The protrusion 32 is configured to be rotatably fixed to a wall of the drive unit R when the cassette unit is mounted in the drive unit R.

[0077] The subassembly can be operated with the reusable medication delivery device in the following steps: moving the locking member 3 from the locked position to the unlocked position, moving the delivery member guard 2 together with the tubular outer cap 10 in a distal direction relative to the inner cap 12 to a position distal to the tubular outer cap 10, and rotating the tubular outer cap 10 together with the inner cap 12 relative to the housing 4 of the cassette unit, thereby removing the tubular outer cap 10 and the inner cap 12 from the housing 4 of the cassette unit. Furthermore, the step of moving the locking member 3 from the locked position to the unlocked position includes the step of rotating the locking member 3 from the locked position to the unlocked position relative to the delivery member guard. In an example where the cassette unit C connects to the drive unit R via a bayonet connection, the step of rotating the locking member 3 from the locked position to the unlocked position relative to the delivery member guard 2 includes the step of rotating the locking member 3 from the locked position to the unlocked position relative to the delivery member guard 2 while attaching the cassette unit C to the drive unit R via the bayonet connection. Furthermore, when the subassembly is used with a mechanism for establishing fluid communication between a drug delivery member and a drug container without a drug delivery member, the step of rotating the tubular outer cap 10 together with the inner cap 12 relative to the housing 4 includes the further step of moving the delivery member hub 14 from a proximal position to a distal position while rotating the tubular outer cap 10 together with the inner cap 12 relative to the housing 4, thereby mounting the delivery member attached to the delivery member hub 14 to the drug container together with the housing 4 of the drug delivery device.

[0078] The inventive concept has been described primarily with reference to a few examples, however, as those skilled in the art will readily appreciate, other embodiments than those disclosed above are equally possible within the scope of the inventive concept as defined by the appended claims.

[0079] Certain aspects of the invention are described in the following clauses. 1. A drug delivery device subassembly (1), comprising: a tubular outer cap (10) extending along a longitudinal axis (L); an inner cap (12) at least partially surrounded by a tubular outer cap (10) and configured to be removably attached to a housing of a medication delivery device via a rotational attachment; It is formed by a driving part (101) and a driven part (132), The follower (132) is attached to the inner cap (12) and includes a clutch positioned transversely to the longitudinal axis (L) between the tubular outer cap (10) and the inner cap (12); Equipped with The outer cap (10) is axially movable relative to the inner cap (12) between a proximal position and a distal position; the tubular outer cap (10) comprises a driver (101), the driver (101) extending from a body (100) of the tubular outer cap (10), and a follower (132), the follower (132) extending transversely to the longitudinal axis towards the tubular outer cap (10), the driver (101) being spaced apart from the follower (132) in the direction of the longitudinal axis (L) when the tubular outer cap (10) is in a proximal position, and the driver (101) being adjacent to the follower (132) when the tubular outer cap (10) is in a distal position, whereby the inner cap can be removed from the housing of the drug delivery device via rotation of the outer cap (10) relative to the housing of the drug delivery device; Subassembly(1). 2. The subassembly (1) as described in clause 1, wherein the follower extends from the body wall of the inner cap transversely to the longitudinal axis (L). 3. The subassembly (1) of clause 1, wherein the subassembly comprises a connecting sleeve (13), the connecting sleeve (13) having a body (130) extending along a longitudinal axis (L), the connecting sleeve (13) having a rotating sleeve fastener (133) that engages with a counter rotating sleeve fastener (121) of the inner cap (12), and the follower portion (132) extends transversely to the longitudinal axis (L) from the body (130) of the connecting sleeve (13). 4. The subassembly described in any one of clauses 1 to 3, wherein one of the driver (101) and the follower (132) is a recess, and the other of the driver (101) and the follower (132) is a protrusion that is positioned within the recess when the tubular outer cap (10) is in a distal position. 5. The subassembly of clause 4, wherein the recess is oriented transversely to the longitudinal axis. 6. The subassembly of clause 4 or 5, wherein the recess is formed by a ratchet. 7. A subassembly as described in any one of clauses 1 to 6, wherein the clutch engagement formed between the driver and driven parts is formed by a non-circular cross-section of the driver matching the non-circular cross-section of the driven part. 8. The subassembly of any one of clauses 1-7, wherein the clutch engagement formed between the drive portion and the driven portion is a friction fit engagement. 9. The subassembly of any one of clauses 1 to 8, wherein the subassembly comprises a retainer (11), the retainer comprising a retainer body (110) and a mounting portion (11a) extending from the retainer body (110), the mounting portion (11a) being configured to be mounted to a counter mounting portion of a medication delivery device, and an inner cap (12) removably attached to the retainer (11) via a rotational mounting, whereby the inner cap (12) is removably attached to the medication delivery device via the retainer (11). 10. The subassembly of claim 9, wherein the rotational attachment is formed by the threads (111) of the retainer body (110) and a thread follower (123) of the inner cap (12) engaging with the threads (111) of the retainer (11). 11. The subassembly described in clause 9 or 10, wherein the subassembly comprises a delivery member hub (14) configured to be attached to a drug delivery member, the delivery member hub (14) having a first engagement member (141) that engages with the first counter engagement member (112) of the retainer (11) and a second engagement member (142) that engages with the counter second engagement member (124) of the inner cap (12), and the delivery member hub (14) is axially movable relative to the retainer body (110) between a proximal position and a distal position. 12. The subassembly of clause 11, wherein rotation of the inner cap (12) relative to the retainer (11) is configured to move the delivery member hub (14) from a proximal position to a distal position. 13. A subassembly as described in clause 12 dependent on clause 10, wherein the engagement formed between the first engagement member and the counter-first engagement member is a threaded engagement and the engagement formed between the second engagement member and the counter-second engagement member is a rotational engagement, and the threaded engagement between the delivery member hub and the retainer is oriented in an opposite longitudinal direction to the threaded engagement between the inner cap and the retainer. 14. The subassembly described in clause 12, wherein the delivery member hub is rotatably fixed to the retainer body, one of the second engagement member and the counter-second engagement member is a helical cam, the other of the second engagement member and the counter-second engagement member is a cam follower, and the engagement formed between the first engagement member and the counter-first engagement member is a snap-fit ​​engagement. 15. The subassembly of any one of clauses 9-14, wherein the mounting portion (11a) of the retainer (11) is one of a snap-fit ​​mounting, a thread mounting, and a bayonet mounting. 16. The subassembly comprises a delivery member guard (2) and a locking member (3), the delivery member guard (2) having a proximal facing surface (20a) adjacent a distal facing surface (102) of the tubular outer cap (10), the delivery member guard (2) having a distal facing surface (22a), and the locking member (3) having a body (30) having a proximal facing surface (31a); The subassembly of any one of clauses 1-15, wherein the locking member (3) is movable relative to the delivery member guard (2) between a locked position in which the proximally facing surface (31 a) of the locking member (3) is aligned with the distally facing surface (22 a) of the delivery member guard (2) to prevent the delivery member guard (2) from moving distally relative to the locking member (3), and an unlocked position in which the proximally facing surface (31 a) of the locking member (3) is offset relative to the distally facing surface (22 a) of the delivery member guard (2) to allow the delivery member guard (2) to move distally relative to the locking member (3). 17. The subassembly of clause 16, wherein the locking member (3) is rotatable relative to the delivery member guard (2) about the longitudinal axis (L) between a locked position and an unlocked position. 18. The subassembly of clause 16, wherein the locking member is slidable relative to the delivery member guard in a direction transverse to the longitudinal axis. 19. A drug delivery device comprising an autoinjector, the drug delivery device comprising a subassembly according to any one of clauses 1 to 18. 20. A cassette unit (C) of a drug delivery device comprising a housing (4) of the drug delivery device, the housing (4) extending along a longitudinal axis (L), and a locking member (3) axially fixed to the housing (4), comprising the subassembly described in clause 17 or 18. 21. A cassette unit (C) as described in clause 20 when dependent on clause 17, wherein the delivery member guard (2) is rotatably fixed to the housing (4), the housing (4) having a bayonet protrusion (40) configured to move along a bayonet track of the drive unit (R) of the medication delivery device thereby attaching the cassette unit (C) to the drive unit (R), and the locking member (3) has a protrusion (32) extending away from the body (30) along the longitudinal axis (L), the protrusion (32) being next to the bayonet protrusion (40) of the housing (4) in the direction of the longitudinal axis (L), and the protrusion (32) being configured to be rotatably fixed to a wall of the drive unit (R) when the cassette unit is attached to the drive unit (R). 22. A method for removing a cap from a medication delivery device, the medication delivery device comprising a cassette unit and a drive unit as described in clause 20, the method comprising the following steps in the following order: moving the locking member from a locked position to an unlocked position; and moving the delivery member guard together with the tubular outer cap distally relative to the inner cap to a position distal of the tubular outer cap; Rotating the tubular outer cap together with the inner cap relative to the housing of the cassette unit, thereby removing the tubular outer cap and the inner cap from the housing of the cassette unit. 23. The method of clause 22, wherein the drug delivery device comprises a cassette unit as described in clause 21, wherein the step of moving the locking member from the locked position to the unlocked position comprises the step of rotating the locking member from the locked position to the unlocked position relative to the delivery member guard. 24. The step of rotating the locking member from a locked position to an unlocked position relative to the delivery member guard comprises: rotating the locking member from a locked position to an unlocked position relative to the delivery member guard while attaching the cassette unit to the drive unit via the bayonet connection. 24. The method of claim 23, comprising: 25. The step of rotating the tubular outer cap together with the inner cap relative to the housing comprises: moving the delivery member hub from a proximal position to a distal position while rotating the tubular outer cap together with the inner cap relative to the housing, thereby mounting the delivery member attached to the delivery member hub together with the housing of the medication delivery device to the medication container. 24. The method according to any one of clauses 22-23, wherein the cassette unit comprises a subassembly according to any one of clauses 11-14, further comprising:

Claims

1. A subassembly (1) of a drug delivery device, comprising: a tubular outer cap (10) extending along a longitudinal axis (L); an inner cap (12) at least partially surrounded by the tubular outer cap (10) and configured to be removably attached to a housing of the medication delivery device via a rotational attachment; It is formed by a driver (101) and a follower (132), the follower (132) is attached to the inner cap (12) and a clutch positioned transversely to the longitudinal axis (L) between the tubular outer cap (10) and the inner cap (12); Equipped with the outer cap (10) is axially movable relative to the inner cap (12) between a proximal position and a distal position; the tubular outer cap (10) comprises the driver (101), the driver (101) extending from a body (100) of the tubular outer cap (10), and the follower (132), the follower (132) extending transversely to the longitudinal axis towards the tubular outer cap (10), the driver (101) being spaced apart from the follower (132) in the direction of the longitudinal axis (L) when the tubular outer cap (10) is in the proximal position, and the driver (101) being adjacent to the follower (132) when the tubular outer cap (10) is in the distal position, whereby the inner cap can be removed from the housing of the drug delivery device via rotation of the outer cap (10) relative to the housing of the drug delivery device; Subassembly (1).

2. The subassembly comprises a connection sleeve (13), the connection sleeve (13) comprising a body (130) extending along the longitudinal axis (L), the connection sleeve (13) comprising a rotating sleeve fastener (133) that engages with a counter rotating sleeve fastener (121) of the inner cap (12), and the follower (132) extending transversely from the body (130) of the connection sleeve (13) to the longitudinal axis (L); A subassembly (1) according to claim 1.

3. 3. The subassembly of claim 1 or 2, wherein one of the driver portion (101) and the follower portion (132) is a recess and the other of the driver portion (101) and the follower portion (132) is a protrusion positioned within the recess when the tubular outer cap (10) is in the distal position.

4. The subassembly of claim 3 , wherein the recess is oriented transversely to the longitudinal axis.

5. the subassembly comprises a retainer (11), the retainer comprising a retainer body (110) and a mounting portion (11a) extending from the retainer body (110), the mounting portion (11a) configured to be mounted to a counter mounting portion of the medication delivery device, and the inner cap (12) removably attached to the retainer (11) via the rotational mounting, whereby the inner cap (12) is removably attached to the medication delivery device via the retainer (11); A subassembly according to any one of claims 1 to 4.

6. 6. The subassembly of claim 5, wherein the rotational attachment is formed by threads (111) of the retainer body (110) and a thread follower (123) of the inner cap (12) engaging the threads (111) of the retainer (11).

7. The subassembly comprises a delivery member hub (14) configured to be attached to a drug delivery member, the delivery member hub (14) comprising a first engagement member (141) that engages with a first counter engagement member (112) of the retainer (11) and a second engagement member (142) that engages with a counter second engagement member (124) of the inner cap (12), the delivery member hub (14) being axially movable relative to the retainer body (110) between a proximal position and a distal position. A subassembly according to claim 5 or 6.

8. The subassembly of claim 7, wherein rotation of the inner cap (12) relative to the retainer (11) is configured to move the delivery member hub (14) from a proximal position to a distal position.

9. the engagement formed between the first engagement member and the counter first engagement member is a threaded engagement and the engagement formed between the second engagement member and the counter second engagement member is a rotational engagement, and the threaded engagement between the delivery member hub and the retainer is oriented in an opposite longitudinal direction to the threaded engagement between the inner cap and the retainer. A subassembly according to claim 8 when dependent on claim 6.

10. the delivery member hub is rotatably fixed to the retainer body, one of the second engagement member and the counter second engagement member is a helical cam, the other of the second engagement member and the counter second engagement member is a cam follower, and the engagement formed between the first engagement member and the counter first engagement member is a snap-fit ​​engagement. The subassembly of claim 8.

11. The subassembly according to any one of claims 5 to 10, wherein the mounting portion (11a) of the retainer (11) is one of a snap-fit ​​mounting, a thread mounting, and a bayonet mounting.

12. The subassembly comprises a delivery member guard (2) and a locking member (3), the delivery member guard (2) having a proximal facing surface (20a) adjacent a distal facing surface (102) of the tubular outer cap (10), the delivery member guard (2) having a distal facing surface (22a), the locking member (3) comprising a body (30) having a proximal facing surface (31a), and the locking member (3) configured to prevent the delivery member guard (2) from moving distally relative to the locking member (3). and an unlocked position in which the proximally facing surface (31 a) of the locking member (3) is offset relative to the distally facing surface (22 a) of the delivery member guard (2) such that the delivery member guard (2) is movable distally relative to the locking member (3). A subassembly according to any one of the preceding claims.

13. 13. The subassembly of claim 12, wherein the locking member (3) is rotatable relative to the delivery member guard (2) about the longitudinal axis (L) between a locked position and an unlocked position.

14. A cassette unit (C) of a medication delivery device, comprising: a housing (4) of the medication delivery device, the housing (4) extending along the longitudinal axis (L), and the locking member (3) being axially fixed to the housing (4). A cassette unit (C) comprising a subassembly according to claim 13.

15. the delivery member guard (2) is rotatably fixed to the housing (4), the housing (4) comprising a bayonet protrusion (40) configured to move along a bayonet track of a drive unit (R) of the medication delivery device, thereby attaching the cassette unit (C) to the drive unit (R); the locking member (3) comprises a protrusion (32) extending away from the longitudinal axis (L) from the body (30), the protrusion (32) being next to the bayonet protrusion (40) of the housing (4) in the direction of the longitudinal axis (L), the protrusion (32) being configured to be rotatably fixed to a wall of the drive unit (R) when the cassette unit is attached to the drive unit (R); A cassette unit (C) according to claim 14 when dependent on claim 13.

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