Subassemblies of drug delivery devices

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 generally relates to sub-assemblies of drug delivery devices, and more particularly to sub-assemblies having clutches.

Background Art

[0002] Drug delivery devices such as pen-type manual injectors or auto-injectors are generally known for self-administration of drugs by patients who have not received formal medical training. For example, a patient suffering from diabetes may need to inject insulin multiple times, or may need to inject other types of drugs such as growth hormone regularly.

[0003] Therefore, a clear operating guide for the patient is important. However, not all users will carefully read the user guide or instructions on the package every time before performing a drug delivery operation, and sometimes, for example, an unintended access to the drug delivery device may occur, such as accidentally removing the cap of the drug delivery device, or for end-users who need to perform multiple drug delivery operations with multiple different drug delivery devices, it may be confusing and they may misinterpret the operating instructions of the drug delivery devices between different drug delivery devices.

[0004] Therefore, a structural design of a drug delivery device that allows the user to reliably follow the operating instructions of the drug delivery device is desirable.

Summary of the Invention

[0005] The present invention is defined by the appended claims, and reference is made thereto.

[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 / end” is used, it refers to the part / end of the delivery device or component that is 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 toward the dose delivery site during use of the injection device. When the term “proximal / end” is used, it refers to the part / end of the delivery device or component that is closest to the dose delivery site during use of the injection device.

[0007] Furthermore, the terms "longitudinal," "longitudinally," "axially," or "axial" refer to a direction that extends from the proximal end to the distal end, along the device or its components, generally in the direction of the longest elongation of the device and / or components.

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

[0009] Furthermore, "circumference," "circumferential," or "circumferentially" refers to the circumference or circumferential direction with respect to an axis, generally the central axis extending in the direction of the longest elongation of the device and / or component. Similarly, "radial" or "radially" refers to the direction extending radially with respect to an axis, and "rotation," "rotational," and "rotationally" refer to rotation with respect to an axis.

[0010] Accordingly, a subassembly of a drug delivery device is provided, comprising a tubular outer cap extending along the longitudinal axis and an inner cap at least partially enclosed by the tubular outer cap. The inner cap is configured to be removably mounted to the housing of the drug delivery device via a rotary mount. A clutch is formed by a drive and a driven part. The driven part is mounted to the inner cap and positioned between the tubular outer cap and the inner cap transversely to the longitudinal axis. The outer cap is axially movable between a proximal and distal position relative to the inner cap. The tubular outer cap comprises a drive part extending from the body of the tubular outer cap. The driven part extends transversely to the longitudinal axis toward the tubular outer cap. When the tubular outer cap is in the proximal position, the drive part is spaced apart from the driven part in the direction of the longitudinal axis. When the tubular outer cap is in the distal position, the drive part is adjacent to the driven part, thereby allowing the inner cap to be removed from the housing of the drug delivery device via rotation of the outer cap relative to the housing of the drug delivery device.

[0011] According to another embodiment, the driven portion preferably extends from the main body wall of the inner cap in a direction transverse to the longitudinal axis.

[0012] Alternatively, according to another embodiment, the subassembly comprises a connecting sleeve. The connecting sleeve comprises a body extending along the longitudinal axis. The connecting sleeve comprises a rotating sleeve fastener that engages with a counter rotating sleeve fastener of the inner cap. The driven portion extends from the body of the connecting sleeve transversely to the longitudinal axis.

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

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

[0015] In another embodiment, it is preferable that one of the driving unit and the driven unit is a recess, and the other of the driving unit and the driven unit is a projection that is positioned within the recess when the tubular outer cap is in a distal position.

[0016] According to another embodiment, the recess is preferably oriented transversely with respect 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 drive unit and the driven unit is preferably formed by the non-circular cross-section of the drive unit coinciding with the non-circular cross-section of the driven unit.

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

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

[0021] In another embodiment, the retainer preferably comprises a retainer body and a mounting portion extending from the retainer body. The mounting portion is configured to be attached to a counter mounting portion of a drug delivery device. The inner cap is removably attached to the retainer via a rotary mounting, thereby the inner cap is removably attached to the drug delivery device via the retainer.

[0022] According to another embodiment, the retainer is preferably mounted by one of snap-fit ​​mounting, thread mounting, and bayonet mounting.

[0023] According to another embodiment, rotational mounting is preferably formed by the threads of the retainer body and the threaded drive of the inner cap that engages with the threads of the retainer.

[0024] According to another embodiment, the subassembly preferably comprises a delivery member hub configured to be attached to a drug delivery member. The delivery member hub comprises a first engaging member that engages with a first counter engaging member of the retainer, and the delivery member hub comprises a second engaging member that engages with a second counter engaging 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, the 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 engaging member and the first counter engaging member is preferably a threaded engagement. The engagement formed between the second engaging member and the second counter engaging member is a rotational engagement.

[0027] According to another embodiment, it is preferable that the thread engagement between the delivery member hub and the retainer is oriented in the opposite longitudinal direction to the thread 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 spiral 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 engagement.

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

[0030] According to another embodiment, the 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 onto the retainer.

[0032] According to another embodiment, the subassembly preferably includes a delivery member guard and a lock member. The delivery member guard includes a proximal-facing surface adjacent to a distal-facing surface of the tubular outer cap. The delivery member guard includes a distal-facing surface. The lock member includes a body having a proximal-facing surface. The lock member is movable relative to the delivery member guard between a locked position where the proximal-facing surface of the lock member is aligned with the distal-facing surface of the delivery member guard to prevent the delivery member guard from moving distally relative to the lock member, and an unlocked position where the proximal-facing surface of the lock member is offset from the distal-facing surface of the delivery member guard to allow the delivery member guard to move distally relative to the lock member.

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

[0034] Alternatively, according to another embodiment, the locking member is slidable relative to the delivery member guard in a transverse direction with respect 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, the reusable drug 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 auto-injector.

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

[0040] According to another embodiment, the cassette unit preferably comprises a housing for a drug delivery device. The housing extends along a longitudinal axis. A locking member is fixed to the housing axially.

[0041] In another embodiment, the delivery member guard is preferably rotatably fixed to the housing. The housing includes a bayonet projection configured to move along the bayonet trajectory of the drive unit of the drug delivery device, thereby attaching the cassette unit to the drive unit. The locking member includes a projection extending away from the longitudinal axis from the main body. The projection is adjacent to the bayonet projection of the housing in the direction of the longitudinal axis. The projection is configured to be rotatably fixed to the 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 plurality of chambered drug containers arranged within a carrier.

[0043] According to another embodiment, the drug delivery device is preferably an auto-injector 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 foldable bag.

[0046] In another aspect of the present invention, a method is provided for removing the cap of a drug delivery device, the drug 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 the locked position to the unlocked position, Move the delivery member guard together with the tubular outer cap distal to the inner cap, towards the distal position of the tubular outer cap. Rotate the tubular outer cap together with the inner cap relative to the cassette unit housing, thereby removing the tubular outer cap and inner cap from the cassette unit housing.

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

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

[0049] In another embodiment, the step of rotating the tubular outer cap together with the inner cap relative to the housing preferably includes a further step of moving the delivery member hub from a proximal position to a distal position while the tubular outer cap is rotating together with the inner cap relative to the housing, thereby mounting the delivery member attached to the delivery member hub in 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, migraine, multiple sclerosis, anemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycemia, obesity, anaphylaxis, and allergies. Exemplary types of drugs that may be contained in the injection devices described herein include, but are not limited to, antibodies, proteins, fusion proteins, peptide bodies, 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 (migraine), alirocumab (rheumatoid arthritis), methotrexate (ametopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraine), adalimumab (rheumatoid arthritis), and darbepoe. This includes, but is not limited to, the examples of related disorders listed in parentheses. Pharmaceutical formulations including, but not limited to, any of the drugs listed herein, such as pharmaceutical formulations containing drugs listed herein (or pharmaceutically acceptable salts thereof) and pharmaceutically acceptable carriers, are also intended for use with the injection devices described herein.A pharmaceutical preparation containing any of the drugs listed herein (or a pharmaceutically acceptable salt thereof) may contain one or more other active ingredients, or it may contain only one active ingredient.

[0051] Furthermore, all terms used in the claims should be interpreted according to their ordinary meanings in the art unless otherwise expressly defined herein. All references to “a / an, the, element, apparatus, component, means, etc.” should be interpreted broadly as referring to at least one example of an element, apparatus, component, means, etc., unless otherwise expressly stated. [Brief explanation of the drawing]

[0052] Hereinafter, embodiments of the concept of the present invention will be described with reference to the attached drawings, merely as examples. [Figure 1] A schematic perspective view of the subassembly of the present invention is shown. [Figure 2] A schematic perspective view of the subassembly of the present invention is shown. [Figure 3] The inner cap and delivery member hub of the subassembly shown in Figures 1 and 2 are schematic representations. [Figure 4] The inner cap and connecting sleeve of the subassembly shown in Figures 1 and 2 are schematic representations. [Figure 5] The connecting sleeve and tubular outer cap of the subassembly shown in Figures 1 and 2 are schematic representations. [Figure 6A] The operation sequence of the subassemblies in Figures 1 and 2 is schematically shown. [Figure 6B] The operation sequence of the subassemblies in Figures 1 and 2 is schematically shown. [Figure 7] Schematic perspective views of the subassemblies, delivery member guard, and locking member shown in Figures 1 and 2 are provided. [Figure 8] Figure 7 shows a schematic perspective view of the delivery member guard and locking member. [Figure 9A] Figure 8 shows a schematic perspective view of the delivery member guard and locking member. [Figure 9B] Figure 8 shows a schematic perspective view of the delivery member guard and locking member. [Figure 10] A schematic perspective view of a drug delivery device having the subassembly of the present invention is shown. [Figure 11A] Figure 10 shows a schematic diagram of the operation sequence of the drug delivery device. [Figure 11B] Figure 10 shows a schematic diagram of the operation sequence of the drug delivery device. [Modes for carrying out the invention]

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

[0054] As shown in Figures 1 and 2, the tubular outer cap 10 extends along the longitudinal axis L between its proximal and distal ends. The tubular outer cap 10 comprises a body 100. The tubular outer cap 10 is configured to be grasped by the user and to detach from the drug delivery device before drug delivery operations. As shown in Figure 1, the outer cap 10 is generally cylindrical. In one example, the outer surface of the body 100 includes indicator marks to show the user an action for removing the cap, such as rotation. In another example, the outer surface of the body has a plurality of recesses and protrusions so that the user can firmly and easily grasp the outer cap. Alternatively, the outer cap may be formed in different shapes depending on the needs of, for example, 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 Figure 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 swivel mount. In one example, as shown in Figure 2, the swivel mount is a threaded engagement. In this example, one of the inner cap and housing of the drug delivery device has threads, and the other of the inner cap and housing of the drug delivery device has a threaded follower, such as a projection or thread. In this example, as shown in Figures 2-3, the inner cap 12 has threads 123 extending from the body 120 of the inner cap, and the housing of the drug delivery device has operable counter threads 111. The counter threads may be located in an integral part of the housing of the drug delivery device. Alternatively, the counter threads can be located on a separate component independent of the drug delivery device housing and configured to be attached to the drug delivery device housing before use.

[0056] In a preferred example, subassembly 1 comprises a retainer 11 having a retainer body 110, and a counter thread 111 extending from the outer surface of the retainer 11 configured to be attached to the housing of a drug delivery device. For example, the mounting portion 11a extending from the retainer body 110 is configured to be attached to the counter mounting portion of the drug delivery device, as shown in Figure 1, and the mounting portion 11a may be a snap-fit ​​hook, and the counter mounting portion may be a snap-fit ​​recess / notch. Alternatively, the mounting portion and the counter mounting portion may be threads and screw drivers, for example, protrusions or other suitable threads.

[0057] Alternatively, the rotary mounting can be a bayonet mounting. In this example, one of the inner cap and housing of the drug delivery device is provided with a bayonet track, and the other of the inner cap and housing of the drug delivery device is provided with a bayonet follower, such as a projection. Similarly, the bayonet track or bayonet follower can be formed on a retainer 11 configured to be attached to the housing, or it can be formed as an integral part of the housing. The outer cap 10 is axially movable between a proximal and distal position relative to the inner cap 12.

[0058] The clutch is formed by a drive unit 101 and a driven unit 132. The driven unit 132 is attached to the inner cap 12 and is positioned between the tubular outer cap 10 and the inner cap 12 in a transverse direction with respect to the longitudinal axis L.

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

[0060] When the tubular outer cap 10 is in the proximal position, the drive unit 101 is spaced apart from the driven unit 132 in the direction of the longitudinal axis L. Therefore, the rotation of the outer cap 10 about the longitudinal axis L relative to the housing of the drug delivery device is not transmitted as the 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 drive unit 101 is adjacent to the driven unit 132, thereby allowing the inner cap 12 to be removed from the housing of the drug delivery device via the rotation of the outer cap 10 relative to the housing of the drug delivery device.

[0061] Optionally, subassembly 1 includes a connecting sleeve 13. The connecting sleeve 13 comprises a body 130 extending along a longitudinal axis L. The connecting sleeve is configured to be attached to the inner cap 12 and is positioned transversely to the longitudinal axis L between the inner cap 12 and the outer cap 10. 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 outer cap 10. For example, as shown in Figures 2 and 5, if both the outer cap 10 and the inner cap 12 are substantially cylindrical, then the body 130 of the connecting sleeve 13 is also substantially cylindrical. Since the connecting sleeve 13 is immobile relative to the inner cap 12, the inner cap 12 can be removed from the housing of the drug delivery device by rotating the connecting sleeve 13 relative to the housing.

[0062] Optionally, the connecting sleeve 13 is further immovable in the axial direction relative to the inner cap 12. In one example, the connecting sleeve 13 includes an axial sleeve fastener 131 that engages with a counter axial sleeve fastener 122 of the inner cap 12, and the connecting sleeve includes a rotary sleeve fastener 133 that engages with a counter rotary sleeve fastener 121. In one example, as shown in Figure 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 Figures 4-5, the rotary sleeve fastener 133 of the connecting sleeve is a non-circular cross-sectional portion of the body 130 of the connecting sleeve 12, and the counter rotary sleeve fastener 121 of the inner cap 12 is a non-circular cross-sectional portion of the body 120 of the inner cap 12 that fits the rotary sleeve fastener 133 of the connecting sleeve 13.

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

[0064] In this example, the driven portion 132 extends transversely from the main body 130 of the connecting sleeve 13 with respect to the longitudinal axis L. Alternatively, the driven portion extends transversely from the main body wall of the inner cap with respect to the longitudinal axis L, and therefore, in this example, a connecting sleeve is not required.

[0065] In one example, one of the drive unit 101 and the driven unit 132 is a recess, and the other of the drive unit 101 and the driven unit 132 is a projection positioned within the recess when the tubular outer cap 10 is in a distal position. For example, as shown in Figure 5, the drive unit 101 is a recess and the driven unit is a projection. In one example, the recess is oriented transversely with respect to the longitudinal axis L. In a preferred example, the recess is formed by a ratchet to prevent the 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 drive unit and the driven unit is formed by the non-circular cross-section of the drive unit matching the non-circular cross-section of the driven unit. Alternatively, the clutch engagement formed between the drive unit and the driven unit is a friction fit engagement.

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

[0067] In one example where the subassembly includes a retainer 11, the subassembly includes 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 the distal end of the body 140 of the delivery member hub 14. In a preferred example, the drug delivery member is bonded to the body 140 of the delivery member hub 14.

[0068] In this example, the retainer body 110 has 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 the drug container of the drug delivery device in the direction of the longitudinal axis L, and the delivery member can be attached to the drug container through the central cavity. In this example, the delivery member hub 14 has a first engaging member 141 that engages with a first counter engaging member 112 of the retainer 11, and a second engaging member 142 that engages with a second counter engaging 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 Figure 2, the 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 engaging member and the counter first engaging member is a threaded engagement. The engagement formed between the second engaging member and the counter second engaging member is a rotational engagement. In this example, the threaded engagement between the delivery member hub and the retainer is oriented in the longitudinal direction opposite to the threaded engagement between the inner cap and the retainer. For example, as shown in Figure 2, the first engaging member 141 is a helical projection 141 extending from the body 140 of the delivery member hub 14, and the counter first engaging member 112 is a thread 112 extending from the inner surface of the central cavity of the retainer body 110. As shown in Figure 3, the second engaging member 142 is a notch in the wall of the body 140 of the delivery member hub 14, preferably located at the proximal end of the body 140 of the delivery member hub 14, and the counter second engaging member 124 is a projection 124 extending from the inner surface of the body 120 of the inner cap 12. Therefore, 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 together with the delivery member. As a result, the delivery member hub 14 and the delivery member move distally to the outer cap and attach to the retainer 11, establishing 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 engaging member and the counter second engaging member is a helical cam, and the other of the second engaging member and the counter second engaging member is a cam follower. Furthermore, the engagement formed between the first engaging member and the counter first engaging member is a snap-mesh engagement. Therefore, the 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 and the delivery member of the drug delivery device.

[0071] Alternatively, the rotation of the inner cap can be used solely to remove the inner cap from the retainer. In this example, the inner cap has a distal-facing surface adjacent to a proximal-facing surface of the delivery member hub, and the outer cap is immovable axially relative to the inner cap between an initial proximal position and a proximal position. For example, the outer cap has a bump extending transversely with respect to the longitudinal axis from the inner surface of the outer cap, 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 from 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 with respect to the longitudinal axis L. In this example, one of the first engaging member of the hub and the counter first engaging member of the retainer is a snap-fit ​​hook, and the other of the first engaging member of the hub and the counter first engaging member of the retainer is a recess / notch. In this example, when the user pushes the outer cap distally against the housing of the drug delivery device, the outer cap, inner cap, and delivery member hub move simultaneously distally relative to the retainer until the delivery member hub snaps into the retainer. Once the delivery member hub snaps into the retainer, it can no longer move distally relative to the retainer, and therefore the inner cap can no longer move distally relative to the retainer. Consequently, if the user continues to push the outer cap distally against the housing of the drug delivery device, the bump on the outer cap moves over the counterbump on the inner cap. In this example, the engagement between the inner cap and the retainer is preferably an engagement between a raceway and a projection. For example, the inner cap includes a projection positioned within the raceway of the retainer. The raceway includes a longitudinal portion extending along the longitudinal axis between the proximal and distal ends, and a circumferential portion extending around the longitudinal axis between the first and second ends. The proximal end of the longitudinal portion of the track is a closed end, and the distal end of the longitudinal portion of the track connects to the first end of the circumferential portion. The second end of the circumferential portion is an open end, and the projection can move out of the track at the second end.

[0072] In this example, as the outer cap moves from its initial proximal position to its proximal position, the bayonet projection of the inner cap moves along the longitudinal portion of the bayonet track of the retainer. As 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, it rotatably engages with the inner cap via the clutch as described above. Thus, the user can rotate the outer cap, thereby moving the projection of the inner cap from the first end to the second end along the circumferential portion of the track, and the inner cap can be disengaged from the retainer.

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

[0074] Furthermore, 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 Figure 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 can be an arm extending distally from the tubular proximal portion 20, as shown in Figure 8. Alternatively, the distal body portion can 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 projection extending transversely to the longitudinal axis from the outer surface of the tubular proximal portion, and the proximal-facing surface is defined by the projection. 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, where the proximal-facing surface 31a of the locking member 3 aligns with the distal-facing surface 22a of the delivery member guard 2, as shown in Figure 9A, to prevent the delivery member guard 2 from moving distally relative to the locking member 3, and an unlocked position, where 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, as shown in Figure 9B, to allow the delivery member guard 2 to move distally relative to the locking member 3. Therefore, when the locking member 3 is in the locked position, the outer cap 10 cannot move from the proximal position to the distal position. In one example, the delivery member guard 2 comprises a rib 22 extending transversely with respect to the longitudinal axis L from the 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 the locked position and the unlocked position. For example, the locking member 3 can be a rotatable knob. In another example, the locking member is slidable linearly transversely with respect 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 the user before use.

[0076] The subassembly can be used in a disposable drug delivery device, such as a handheld auto-injector or an on-body injection pump. Alternatively, the subassembly can be used in a reusable drug delivery device, which is formed by a disposable cassette unit C and a reusable power pack R, as shown in Figure 10. The disposable cassette unit C is configured to house a drug container. In one example where the subassembly is used in a reusable drug delivery device, the subassembly is used in the 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 projection 40 configured to move along a bayonet trajectory 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 projection 32 extending away from the longitudinal axis L from the body 30. The projection 32 is located next to the bayonet projection 40 of the housing 4 in the direction of the longitudinal axis L. The projection 32 is configured to be rotatably fixed to the wall of the drive unit R when the cassette unit is attached to the drive unit R.

[0077] The subassembly, along with the reusable drug delivery device, can be operated 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 distally to the inner cap 12; 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 one example where the cassette unit C is connected 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 the cassette unit C is attached to the drive unit R via the bayonet connection. Furthermore, when the subassembly is used in conjunction with a mechanism for establishing fluid communication between the drug delivery member and the drug container without the drug delivery member, the step of rotating the tubular outer cap 10 together with the inner cap 12 relative to the housing 4 includes a further step of moving the delivery member hub 14 from a proximal position to a distal position while the tubular outer cap 10 is rotated 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 concept of the present invention has been explained primarily by reference to several examples. However, as will be readily apparent to those skilled in the art, other embodiments not disclosed above are equally possible within the scope of the concept of the present invention as defined by the appended claims.

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

Claims

1. A subassembly (1) of a drug delivery device, A tubular outer cap (10) extending along the longitudinal axis (L), An inner cap (12) is at least partially surrounded by the tubular outer cap (10) and is configured to be removably attached to the housing of the drug delivery device via a swivel mount, It is formed by a drive unit (101) and a driven unit (132), The driven part (132) is attached to the inner cap (12) and is positioned between the tubular outer cap (10) and the inner cap (12) in a transverse direction with respect to the longitudinal axis (L), and Equipped with, The outer cap (10) is movable axially relative to the inner cap (12) between a proximal position and a distal position. The tubular outer cap (10) comprises the drive unit (101), the drive unit (101) extending from the body (100) of the tubular outer cap (10), the driven unit (132) extending toward the tubular outer cap (10) in a transverse direction with respect to the longitudinal axis, when the tubular outer cap (10) is in the proximal position, the drive unit (101) is spaced apart from the driven unit (132) in the direction of the longitudinal axis (L), and when the tubular outer cap (10) is in the distal position, the drive unit (101) is adjacent to the driven unit (132), thereby allowing the inner cap to be removed from the housing of the drug delivery device via the rotation of the outer cap (10) relative to the housing of the drug delivery device. 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 attached to a counter mounting portion of the drug delivery device, and the inner cap (12) being removably attached to the retainer (11) via the rotary mounting, thereby the inner cap (12) being removably attached to the drug delivery device via the retainer (11). Subassembly (1).

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

3. The subassembly according to claim 1, wherein one of the drive unit (101) and the driven unit (132) is a recess, and the other of the drive unit (101) and the driven unit (132) is a projection that is positioned within the recess when the tubular outer cap (10) is in the distal position.

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

5. The subassembly according to claim 1, wherein the rotational mounting is formed by the threads (111) of the retainer body (110) and the threaded driver (123) of the inner cap (12) that engages with the threads (111) of the retainer (11).

6. 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 engaging member (141) that engages with a first counter engaging member (112) of the retainer (11), and a second engaging member (142) that engages with a second counter engaging 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. The subassembly according to claim 1.

7. The subassembly according to claim 6, wherein the 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.

8. The engagement formed between the first engaging member and the first counter engaging member is a threaded engagement, the engagement formed between the second engaging member and the second counter engaging member is a rotational engagement, and the threaded engagement between the delivery member hub and the retainer is oriented in the opposite longitudinal direction to the threaded engagement between the inner cap and the retainer. A subassembly according to claim 7, dependent on claim 5.

9. The delivery member hub is rotatably fixed to the retainer body, one of the second engaging member and the counter second engaging member is a helical cam, the other of the second engaging member and the counter second engaging member is a cam follower, and the engagement formed between the first engaging member and the counter first engaging member is a snap engagement. The subassembly according to claim 7.

10. The subassembly according to claim 1, wherein the mounting portion (11a) of the retainer (11) is one of snap-fit ​​mounting, threaded mounting, and bayonet mounting.

11. The subassembly comprises a delivery member guard (2) and a locking member (3), wherein the delivery member guard (2) has a proximal-facing surface (20a) adjacent to the distal-facing surface (102) of the tubular outer cap (10), the delivery member guard (2) has a distal-facing surface (22a), and the locking member (3) comprises a body (30) having a proximal-facing surface (31a), and the locking member (3) prevents the delivery member guard (2) from moving distally relative to the locking member (3). To prevent this, the delivery member guard (2) is movable between a locked position in which the proximal side surface (31a) of the locking member (3) is aligned with the distal side surface (22a) of the delivery member guard (2), and an unlocked position in which the proximal side surface (31a) of the locking member (3) is offset from the distal side surface (22a) of the delivery member guard (2) so that the delivery member guard (2) can move distally to the locking member (3). The subassembly according to claim 1.

12. The subassembly according to claim 11, wherein the locking member (3) is rotatable with respect to the delivery member guard (2) about a longitudinal axis (L) between a locked position and an unlocked position.

13. A cassette unit (C) of a drug delivery device, comprising the housing (4) of the drug delivery device, wherein the housing (4) extends along the longitudinal axis (L), and the locking member (3) is fixed axially to the housing (4). A cassette unit (C) comprising the subassembly described in claim 12.

14. The delivery member guard (2) is rotatably fixed to the housing (4), and the housing (4) includes a bayonet projection (40) configured to move along the bayonet trajectory of the drive unit (R) of the drug delivery device, thereby attaching the cassette unit (C) to the drive unit (R), and the locking member (3) includes a projection (32) extending away from the longitudinal axis (L) from the main body (30), the projection (32) being adjacent to the bayonet projection (40) of the housing (4) in the direction of the longitudinal axis (L), and the projection (32) being configured to be rotatably fixed to the wall of the drive unit (R) when the cassette unit is attached to the drive unit (R). The cassette unit (C) according to claim 13, as dependent on claim 12.

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