Subassemblies of drug delivery device cassette units, and methods for operating drug delivery device cassette units including the subassemblies.

Abstract

A subassembly of a drug delivery device cassette unit, the subassembly including: a tubular body for attachment to a drive unit of a drug delivery device, the tubular body extending along a longitudinal axis between a proximal end and a distal end; and a tubular carrier for holding a drug container, the tubular carrier being at least partially disposed within the tubular body, the tubular carrier and the tubular body being coaxial, the tubular carrier including a distally oriented surface for contacting a drive unit of the drug delivery device when the tubular body is attached to the drive unit of the drug delivery device, the tubular carrier being movable relative to the tubular body in the direction of the longitudinal axis from a distal position to a proximal position by the drive unit when the distally oriented surface is in contact with the drive unit of the drug delivery device.

Description

Technical Field

[0001] The present disclosure generally relates to a subassembly of a drug delivery device cassette unit and a method of operating a drug delivery device cassette unit including the subassembly, and more particularly to a subassembly having a component that is moved when the drug delivery device cassette unit is attached to a drug delivery device drive unit.

Background Art

[0002] Drug delivery devices, such as pen-type manual or automatic injectors, are commonly known for self-administration of drugs by patients without formal medical training. For example, patients with diabetes may require repeated insulin injections, or patients may require regular injections of other types of drugs, such as growth hormone.

[0003] Some drug delivery devices have two parts that are connected by the patient before use for drug administration. A drug container (e.g., a cartridge or syringe, etc.) is often inserted into or pre-installed in one part. This part can usually be called a cassette or cassette unit. The other part often includes a driver for actuating the discharge of the drug. In many cases, a drug container containing a drug (e.g., a cartridge or syringe, etc.) will be inserted into or pre-installed in one part of the delivery device. The part that receives the drug container containing the drug is often called a cassette or cassette unit.

[0004] Drug delivery devices designed in this way are generally reusable. The cassette is a disposable part, while the other part, which includes the driver, is usually reusable. The driver may contain a power unit (e.g., a spring or motor) and thus can be reused for several drug deliveries.

[0005] For example, there is room for improvement in current cassette designs on the market, such as adding more automated features and minimizing or reducing the cost of the cassette. [Overview of the project] [Means for solving the problem]

[0006] The present invention is defined by the appended claims, which should be referenced herein.

[0007] 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 drug delivery device. When the term “distal part / end” is used, it refers to the part / end of the delivery device (or part / end of its component) that is located furthest away from the dose delivery site during use of the drug delivery device. Correspondingly, when the term “proximal direction” is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term “proximal part / end” is used, it refers to the part / end of the delivery device (or part / end of its component) that is located closest to the dose delivery site during use of the drug delivery device.

[0008] Furthermore, the terms “longitudinal,” “axial,” or “axial” refer to a direction extending from the proximal end to the distal end, and typically refer to a direction extending along the device or its components in the direction of the longest extension of the device and / or component.

[0009] Similarly, the terms "transverse," "transversal," and "transversally" generally refer to directions perpendicular to the longitudinal direction.

[0010] Furthermore, the terms “circumferential,” “circumferential,” or “circumferentially” refer to the circumference or circumferential direction relative to the axis (typically the central axis extending in the direction of the longest extension of the device and / or component). Similarly, “radial” or “radially” refers to the direction extending radially relative to the axis, and “rotation,” “rotational,” and “rotational” refer to rotation relative to the axis.

[0011] Therefore, a subassembly of a drug delivery device cassette unit, the subassembly comprising a tubular body portion for mounting to a drive unit of a drug delivery device, the tubular body portion extending along a longitudinal axis between a proximal end and a distal end, and a tubular carrier for holding a drug container, the tubular carrier being at least partially located within the tubular body portion, the tubular carrier and the tubular body portion being coaxial, the tubular carrier including a distally oriented surface for contacting the drive unit of a drug delivery device when the tubular body portion is mounted to the drive unit of a drug delivery device, the tubular body portion including a flexible section at the distal end of the tubular body portion, the flexible section is A subassembly is provided which includes a hook extending radially with respect to the longitudinal axis and a locking projection extending radially away from the tubular body with respect to the longitudinal axis, the tubular carrier includes a carrier body, a cutout or recess located within the wall of the carrier body, the flexible section is movable relative to the tubular body between an engaged position and a released position, in which case the hook of the flexible section is positioned within the cutout or recess of the tubular carrier, and in the released position the hook of the flexible section is positioned outside the cutout or recess of the tubular carrier, the flexible section of the tubular body is moved from the engaged position to the released position when the locking projection of the flexible section is pressed from the outside of the tubular body.

[0012] Another aspect of the present invention provides a subassembly of a drug delivery device cassette unit, the subassembly comprising a tubular body for mounting to a drive unit of a drug delivery device, the tubular body extending along a longitudinal axis between a proximal end and a distal end, and a tubular carrier for holding a drug container, the tubular carrier being at least partially located within the tubular body, the tubular carrier and the tubular body being coaxial, the tubular carrier including a distally oriented surface for contacting the drive unit of a drug delivery device when the tubular body is mounted to the drive unit of a drug delivery device, the tubular carrier being movable relative to the tubular body in the longitudinal axis direction from a distal position to a proximal position when the distally oriented surface is in contact with the drive unit of a drug delivery device.

[0013] Preferably, according to another embodiment, the tubular carrier is engaged with the tubular body through engagements of grooves and ledges.

[0014] Preferably, according to another embodiment, the tubular carrier includes a ledge portion extending radially with respect to the longitudinal axis from the outer surface of the wall portion of the tubular carrier, a groove portion positioned on the inner wall portion of the tubular body portion, and the ledge portion positioned within the groove portion.

[0015] Alternatively, according to another embodiment, the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis from the inner surface of the wall portion of the tubular body portion, and a groove portion is located on the outer surface of the tubular carrier, with the ledge portion positioned within the groove portion.

[0016] Preferably, according to another embodiment, the groove is a recess or a slot.

[0017] Preferably, according to another embodiment, the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis from the inner surface of the wall portion of the tubular body portion, and the tubular carrier includes a counterledge portion located on the outer surface of the tubular carrier, the ledge portion being positioned within the counterledge portion.

[0018] Preferably, according to another embodiment, the tubular carrier is configured to immobilely hold the drug container of the drug delivery device.

[0019] Preferably, according to another embodiment, the subassembly includes a delivery member assembly, the delivery member assembly includes a delivery member and a delivery member holder, the delivery member being attached to the delivery member holder, and the delivery member holder being attached to the proximal end of a tubular body.

[0020] Preferably, according to another embodiment, the tubular carrier is axially movable with respect to the delivery member assembly between a distal position and a proximal position, and the tubular carrier is configured to hold the drug container in a non-fluid connection with the delivery member when the tubular carrier is in the distal position, and to hold the drug container in a fluid connection with the delivery member when the tubular carrier is in the proximal position.

[0021] Preferably, according to another embodiment, the tubular body portion includes a flexible section at the distal end of the tubular body portion, the flexible section including a hook extending radially with respect to the longitudinal axis and a lock projection extending radially away from the tubular body portion with respect to the longitudinal axis.

[0022] Preferably, according to another embodiment, the tubular carrier includes a carrier body portion, and a cutout or recess is disposed within the wall portion of the carrier body portion. The flexible section is movable relative to the tubular body portion in a direction transverse to the longitudinal axis between an engaged position and a released position. In the engaged position, the hook of the flexible section is positioned within the cutout or recess of the tubular carrier. In the released position, the hook of the flexible section is positioned outside the cutout or recess of the tubular carrier.

[0023] Preferably, according to another embodiment, the flexible section of the tubular body portion is moved from the engaged position to the released position when the locking protrusion of the flexible section is pressed from outside the tubular body portion.

[0024] Preferably, according to another embodiment, the subassembly includes a delivery member guard telescopically disposed within the tubular body portion and a biasing member extending along the longitudinal axis between a proximal end and a distal end. The delivery member guard includes a distally directed surface adjacent to the proximal end of the biasing member.

[0025] Preferably, according to another embodiment, the tubular carrier includes a proximally directed surface adjacent to the distal end of the biasing member.

[0026] Alternatively, according to another embodiment, the tubular body portion includes a proximally directed surface adjacent to the distal end of the biasing member.

[0027] Preferably, according to another embodiment, the tubular carrier includes a flange extending in a direction transverse to the longitudinal axis. The distally directed surface is defined by the flange, and the flange extends outwardly from the tubular body portion.

[0028] Preferably, according to another embodiment, the tubular body portion includes a fastener on an outer surface thereof for attachment to a portion of the drug delivery device.

[0029] Preferably, according to another embodiment, the fastener is a snap-fit connector, a thread screw, or a bayonet connector.

[0030] Preferably, according to another embodiment, the flange of the tubular carrier is disposed adjacent to the fastener.

[0031] Preferably, according to another embodiment, the tubular carrier is movable relative to the tubular body portion in a direction along the longitudinal axis from a distal position to a proximal position by the drive unit when a surface oriented distally is in contact with the drive unit of the drug delivery device.

[0032] Preferably, according to another embodiment, the surface oriented distally is in contact with the drive unit of the drug delivery device when the tubular body portion is attached to a portion of the drug delivery device via the fastener.

[0033] Preferably, according to another embodiment, the flange is circumferentially offset relative to the bayonet connector of the tubular body portion with respect to the longitudinal axis.

[0034] Preferably, according to another embodiment, the delivery member is a needle, and the delivery member assembly includes a flexible sheath that encloses the needle.

[0035] Preferably, according to another embodiment, the sub-assembly includes a rotator that is rotatable about the longitudinal axis relative to the delivery member guard between a locked position and an unlocked position.

[0036] Preferably, according to another embodiment, the cassette unit subassembly includes a biasing member positioned between the first distally oriented surface of the delivery member guard and the proximally oriented surface of the main body.

[0037] Another aspect of the present invention is a subassembly of a drug delivery device cassette unit, the subassembly comprising a tubular body, a delivery member guard, and a rotator, wherein the tubular body extends along a longitudinal axis between a proximal end and a distal end, the tubular body is tubular in shape, the delivery member guard is retractably arranged within the tubular body, the delivery member guard includes a distally oriented surface, the rotator is prevented from moving in any direction along the longitudinal axis by the tubular body, the rotator includes a proximal oriented surface, and the rotator is a drug delivery device cassette unit. A subassembly is provided which, when the unit is mounted on the drive unit, is configured to be rotated by the drive unit of a drug delivery device, and the rotator is configured to rotate relative to the delivery member guard from a locked position to an unlocked position, in which case the distally oriented surface of the delivery member guard is aligned with the proximal oriented surface of the rotator, and in the unlocked position the distally oriented surface of the delivery member guard is not aligned with the proximal oriented surface of the rotator, and the delivery member guard is configured to move freely distally relative to the rotator.

[0038] Therefore, the subassembly can provide a safety mechanism for the drug delivery cassette unit. In particular, it is possible to provide a drug delivery cassette unit without a front protective cap. The rotator prevents the delivery member guard from moving distally relative to the tubular body before the cassette unit is properly mounted to the drive unit of the drug delivery device, thereby preventing the end user from accidentally coming into contact with the drug delivery member shielded by the drug delivery member guard.

[0039] Preferably, according to another embodiment, the rotator includes a tubular rotator body.

[0040] Preferably, according to another embodiment, the rotator includes a ledge portion extending radially with respect to the longitudinal axis, the ledge portion being configured to engage with a portion of the drive unit, so that when the drive unit rotates with respect to the tubular body portion of the subassembly, the rotator rotates together with the drive unit with respect to the tubular body portion of the subassembly.

[0041] Alternatively, according to another embodiment, the rotator includes a ledge portion extending from a first end to a second end in a helical direction with respect to the longitudinal axis, the ledge portion being configured to engage with a portion of a drive unit, thereby causing the rotator to rotate when the drive unit of the drug delivery device moves axially with respect to the rotator from a distal position to a proximal position, with a portion of the drive unit adjacent to the first end of the ledge portion at the distal position and a portion of the drive unit adjacent to the second end of the ledge portion at the proximal position.

[0042] Preferably, according to another embodiment, the subassembly includes a locking member, which is rotatably fixed to the tubular body, and one of the rotator and the locking member includes a projection extending radially with respect to the longitudinal axis, and the other of the rotator and the locking member includes a ledge adjacent to the projection, which extends spirally with respect to the longitudinal axis from a first end to a second end, and the locking member is axially movable relative to the rotator from a distal position where the projection is adjacent to the first end of the ledge to a proximal position where the projection is adjacent to the second end of the ledge, and the locking member is configured to engage with a part of a drive unit, so that when the drive unit of the drug delivery device moves axially relative to the tubular body, the locking member moves with the drive unit, thereby causing the rotator to rotate by the engagement between the projection and the ledge.

[0043] Preferably, according to another embodiment, one of the rotator and the delivery member guard includes a projection, and the other of the rotator and the delivery member guard includes a cutout or recess, and the distally oriented surface of the delivery member guard and the proximally oriented surface of the rotator are defined by the projection and the cutout or recess, respectively.

[0044] Preferably, according to another embodiment, the cutout or recess is located on the tubular body of the rotator.

[0045] Preferably, according to another embodiment, the ledge portion extends radially with respect to the longitudinal axis from the tubular body portion of the rotator.

[0046] Alternatively, according to another embodiment, the second cutout or recess is located on the tubular body of the rotator, and the ledge is defined by the edge of the second cutout or recess.

[0047] Alternatively, according to another embodiment, the circumferential ledge extends circumferentially with respect to the longitudinal axis from a second end of the ledge.

[0048] Preferably, according to another embodiment, the first end of the ledge portion includes a longitudinal part extending in the direction of the longitudinal axis.

[0049] Preferably, according to another embodiment, the subassembly includes a biasing member extending along a longitudinal axis between a proximal end and a distal end, the delivery member guard includes a distally oriented surface, the locking member includes a proximal oriented surface, the proximal end of the biasing member is adjacent to the distally oriented surface of the delivery member guard, and the distal end of the biasing member is adjacent to the proximal oriented surface of the locking member.

[0050] Preferably, according to another embodiment, the subassembly includes a biasing member positioned between the first distally oriented surface of the delivery member guard and the proximally oriented surface of the main body.

[0051] Preferably, according to another embodiment, the tubular body portion includes a fastener on the outer surface of the tubular body portion for attachment to a part of a drug delivery device.

[0052] Preferably, according to another embodiment, the fastener can be a screw, a snap-fit ​​connector, or a bayonet connector.

[0053] Preferably, according to another embodiment, the locking member includes a locking member body and a flange extending from the locking member body, the flange protruding from the outer surface of the tubular body, and the flange is positioned next to the fastener.

[0054] Preferably, according to another embodiment, the flange is circumferentially offset with respect to the longitudinal axis with respect to the bayonet connection of the tubular body.

[0055] Preferably, according to another embodiment, the tubular body portion includes a flexible arm extending from the distal end of the tubular body portion toward the proximal end of the tubular body portion, the flexible arm including a hook extending radially with respect to the longitudinal axis and a lock projection extending radially outward from the tubular body portion with respect to the longitudinal axis.

[0056] Preferably, according to another embodiment, the locking member includes a locking member body, the cutout or recess is located within the wall of the locking member body, the hook of the flexible section of the tubular body is configured to be positioned within the cutout or recess, the locking projection of the flexible section is configured to engage with a portion of the driver unit of the drug delivery device, and when the tubular body is attached to the drive unit of the drug delivery device, the section of the drive unit presses the locking projection inward relative to the tubular body, so that the hook bends outward from the cutout or recess.

[0057] Preferably, according to another embodiment, the rotator is rotatable around its longitudinal axis relative to the delivery member guard between a locked position and an unlocked position.

[0058] Preferably, according to another embodiment, the delivery member guard includes a projection extending radially with respect to the longitudinal axis, and the proximal oriented surface of the delivery member guard is part of the projection.

[0059] Preferably, according to another embodiment, the delivery member guard is movable relative to the tubular body between a distal trigger position and a proximal post-use position, and the delivery member guard includes a distally oriented surface.

[0060] Another embodiment of the present invention provides a cassette unit subassembly for a drug delivery device, the cassette unit subassembly comprising: a main body extending along a longitudinal axis from a proximal end to a distal end; a delivery member guard, the delivery member guard being coaxially mounted to the main body and biased proximal to move axially with respect to the main body from a distal position to a proximal position; and a rotator mounted to the main body, the rotator being movable relative to the delivery member guard between a locked position and an unlocked position, the rotator being configured to lock the delivery member guard in the distal position when the rotator is in the locked position.

[0061] Preferably, according to another embodiment, the rotator is configured to lock the delivery member guard in the proximal post-use position when the delivery member guard moves to the proximal post-use position.

[0062] Preferably, according to another embodiment, the cassette unit subassembly of the present invention can be used with a cassette unit for a drug delivery device. The drug delivery device includes a cassette unit. The cassette unit can be attached to and detached from a drug delivery device drive unit.

[0063] Preferably, according to another embodiment, the cassette unit of the present invention can be used in conjunction with a drug delivery device including a reusable drive assembly, the reusable drive assembly including a tubular housing extending along the longitudinal axis from a proximal end and a distal end, and the cassette unit is removably attached to the reusable drive assembly via bayonet connections on the inner surface at the proximal end of the reusable drive assembly and on the outer surface at the distal end of the body of the cassette unit.

[0064] According to another embodiment, the inner surface at the proximal end of the reusable drive assembly includes a bayonet groove, and the outer surface at the distal end of the main body of the cassette unit includes a bayonet projection.

[0065] Preferably, according to another embodiment, the rotator includes a track with a lockout section, and the projection of the delivery member guard is configured to move into the lockout section toward the proximal post-use position of the delivery member guard as the delivery member guard moves distally.

[0066] Preferably, according to another embodiment, the protrusion is located in the flexible section of the delivery member guard.

[0067] Preferably, according to another embodiment, the drug delivery device is an infusion device, an inhalation device, or a medical sprayer.

[0068] Preferably, according to another embodiment, the drug delivery device cassette unit is for housing a drug container.

[0069] Preferably, according to another embodiment, the drive unit includes a driver for forcibly ejecting the drug contained in the drug container within the cassette unit.

[0070] Preferably, according to another embodiment, the subassembly includes a distal cover that can be attached to the distal end of the main body.

[0071] Preferably, according to another embodiment, the distal cover is part of the main body of the subassembly.

[0072] Preferably, according to another embodiment, the distal lid includes a lid body formed in a shape that conforms to the shape of the drug container that is received inside the main body.

[0073] Preferably, according to another embodiment, the lid body includes a tubular section.

[0074] Preferably, according to another embodiment, the distal lid includes a container support for supporting a drug container to be received in the main body, and the container support includes a surface oriented proximal to the lid.

[0075] Preferably, according to another embodiment, the container support is a flexible arm.

[0076] Preferably, according to another embodiment, the flexible arm of the container support can be formed by a cutout on the lid body that opens in a direction transverse to the longitudinal axis on the lid body.

[0077] Preferably, according to another embodiment, the flexible arm can extend distally from the lid body.

[0078] Preferably, according to another embodiment, the proximal oriented surface of the container support is formed on the inner surface of the flexible arm or on the distal tip of the flexible arm.

[0079] Preferably, according to another embodiment, the container support is configured to prevent distal axial movement of the drug container received within the main body and / or to be used to allow for variations in the dimensions of the received drug container (e.g., a particular length and / or width of the received drug container) with respect to engineering tolerances.

[0080] Preferably, according to another embodiment, a drug delivery device using the subassembly of the subject of the present invention can be operated by a method that includes the step of connecting a cassette unit to a drive unit.

[0081] Another aspect of the present invention provides a method for operating a drug delivery device including a drug delivery device cassette unit and a drive unit, wherein the drug delivery device cassette unit includes a body and a carrier, and the method includes the following steps in sequence: providing the drug delivery device cassette unit; providing the drive unit; and using the drive unit to move the carrier of the drug delivery device cassette unit along its longitudinal axis relative to the body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on the drive unit.

[0082] Preferably, according to another embodiment, the step of using a drive unit to move the carrier of the drug delivery device cassette unit along the longitudinal axis relative to the body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on a drive unit includes the steps of moving the drug delivery device cassette unit in the direction of the longitudinal axis relative to the drive unit and rotating the drug delivery device cassette unit about the longitudinal axis relative to the drive unit.

[0083] Preferably, according to another embodiment, the step of using a drive unit to move a carrier includes the steps of connecting the carrier to a part of the drive unit and moving the carrier while rotating the drug delivery device cassette unit around a longitudinal axis relative to the drive unit.

[0084] Preferably, according to another embodiment, the step of using a drive unit to move the carrier of the drug delivery device cassette unit along its longitudinal axis relative to the body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on the drive unit includes the step of using the movement of the carrier relative to the body to establish a fluid connection between the delivery member and the drug container while the drug delivery device cassette unit is mounted on the drive unit.

[0085] Another aspect of the present invention provides a method for operating a drug delivery device including a drug delivery device cassette unit and a drive unit, wherein the drug delivery device cassette unit includes a tubular body, a delivery member guard, and a rotator, and the method includes the following steps in sequence: providing the drug delivery device cassette unit; providing the drive unit; and using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit while the drug delivery device cassette unit is mounted on the drive unit.

[0086] Preferably, according to another embodiment, the step of using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit while the drug delivery device cassette unit is mounted on the drive unit includes the following sequence of steps: moving the drug delivery device cassette unit along its longitudinal axis relative to the drive unit, and rotating the drug delivery device cassette unit about its longitudinal axis relative to the drive unit.

[0087] Preferably, according to another embodiment, while the drug delivery device cassette unit is mounted on the drive unit, the step of using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit includes the steps of establishing a connection between the rotator and a part of the drive unit, and rotating the drug delivery device cassette unit around its longitudinal axis relative to the drive unit, thereby causing the rotator to be rotated by the drive unit through the connection between the rotator and the drive unit.

[0088] Preferably, according to another embodiment, the step of establishing a connection between a rotator and a portion of a drive unit includes the steps of indirectly connecting the rotator to a portion of a drive unit via a locking member of the drug delivery device cassette unit, and rotating the drug delivery device cassette unit about a longitudinal axis relative to the drive unit, thereby moving the locking member axially in the proximal direction of the rotator by the drive unit, thereby causing the rotator to be rotated by the locking member.

[0089] In general, all terms used in the claims should be interpreted according to their ordinary meaning in the art unless expressly defined otherwise herein. All references to “elements, apparatus, components, means, etc.” should be openly interpreted as referring to at least one instance of elements, apparatus, components, means, etc. unless expressly stated otherwise.

[0090] Herein, embodiments of the concept of the present invention will be described merely as examples with reference to the accompanying drawings. [Brief explanation of the drawing]

[0091] [Figure 1]This figure schematically shows a perspective view of a drug delivery device cassette unit including the subassembly of the present invention. [Figure 2] This figure schematically shows an exploded view of the subassembly shown in Figure 1. [Figure 3] This figure schematically shows a perspective view of a drug delivery device cassette unit including a subassembly of the present invention in another example. [Figure 4] This figure schematically shows an exploded view of the subassembly shown in Figure 3. [Figure 5] This figure schematically shows a perspective view of the tubular main body of the subassembly of the present invention in a different example. [Figure 6] This figure schematically shows a perspective view of the tubular main body of the subassembly of the present invention in a different example. [Figure 7A] This figure schematically shows a perspective view of the delivery member assembly of the subassembly of the present invention. [Figure 7B] This figure schematically shows a perspective view of the delivery member assembly of the subassembly of the present invention. [Figure 8] This figure schematically shows a perspective view of a tubular carrier of a subassembly of the present invention in a different example. [Figure 9] This figure schematically shows a perspective view of a tubular carrier of a subassembly of the present invention in a different example. [Figure 10] This figure schematically shows the tubular carrier in Figure 9 and the outer shell of the tubular main body in Figures 5 and 6. [Figure 11A] This figure schematically shows a perspective view of the delivery member guard, biasing member, and tubular carrier of the subassembly of the present invention. [Figure 11B] This figure schematically shows a cross-sectional view of the delivery member guard, biasing member, and tubular body portion of a subassembly of the present invention in another example. [Figure 11C] This figure schematically shows a cross-sectional view of the arrangement in Figure 11A, which includes the delivery member assemblies shown in Figures 7A and 7B. [Figure 12A]This figure schematically shows a side view of the sub-assembly of the present invention before the cassette unit is attached to the drive unit. [Figure 12B] This figure schematically shows a cross-sectional view of the sub-assembly of the present invention before the cassette unit is attached to the drive unit. [Figure 13A] This figure schematically shows a side view of the sub-assembly of the present invention after the cassette unit has been attached to the drive unit. [Figure 13B] This figure schematically shows a cross-sectional view of the sub-assembly of the present invention after the cassette unit has been attached to the drive unit. [Figure 14A] This figure schematically shows a perspective view of a rotator of a subassembly of the present invention in a different example. [Figure 14B] This figure schematically shows a perspective view of a rotator of a subassembly of the present invention in a different example. [Figure 15A] This figure schematically shows a perspective view of a rotator of a subassembly of the present invention in a different example. [Figure 15B] This figure schematically shows a perspective view of a rotator of a subassembly of the present invention in a different example. [Figure 16] This figure schematically shows a perspective view of the delivery member guard shown in Figure 11B. [Figure 17A] This figure schematically shows a perspective view of the connection between the rotator in Figures 14A to 15B and the delivery member guard in Figure 16. [Figure 17B] This figure schematically shows a perspective view of the connection between the rotator in Figures 14A to 15B and the delivery member guard in Figure 16. [Figure 18A] This figure schematically shows a perspective view of a locking member of a subassembly of the present invention in a different example. [Figure 18B] This figure schematically shows a perspective view of a locking member of a subassembly of the present invention in a different example. [Figure 19A]These figures schematically show perspective views of the locking members in Figures 18A to 18B and the rotators in Figures 14A to 15B. The locking members in different examples, such as those shown in Figures 18A to 18B, can be used with rotators, such as those shown in either Figures 14A to 14B or Figures 15A to 15B, by connections as shown in Figures 19A to 19B. [Figure 19B] These figures schematically show perspective views of the locking members in Figures 18A to 18B and the rotators in Figures 14A to 15B. The locking members in different examples, such as those shown in Figures 18A to 18B, can be used with rotators, such as those shown in either Figures 14A to 14B or Figures 15A to 15B, by connections as shown in Figures 19A to 19B. [Figure 20A] This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 20B] This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 20C]This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 20D] This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 20E] This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 20F] This diagram schematically shows the interaction sequence between the locking member and the rotator. The locking members shown in Figures 20A to 20F can be the exemplary locking members shown in either Figure 18A or Figure 18B. The rotators shown in Figures 20A to 20F can be the exemplary rotators shown in either Figures 14A to 14B or Figures 15A to 15B. [Figure 21] This figure schematically shows a perspective view of the connection between the rotator shown in Figures 14A to 15B and the tubular main body shown in Figures 5 to 6. [Figure 22]This figure schematically shows a perspective view of a cassette unit equipped with a drive unit and a subassembly of the present invention. [Figure 23] This diagram schematically shows perspective views of the tubular main body, tubular carrier, and delivery member guard in different examples. [Figure 24] This diagram schematically shows perspective views of the tubular main body, tubular carrier, and delivery member guard in different examples. [Modes for carrying out the invention]

[0092] Figures 1 to 24 illustrate a subassembly of a drug delivery device cassette unit. The subassembly of the present invention provides a mechanism for moving the tubular carrier proximal to the tubular body when the cassette unit is attached to the drive unit D (the cassette unit includes the subassembly of the present invention). Furthermore, the subassembly of the present invention provides a safety mechanism to prevent the end user from being injured by the drug delivery member or from the drug delivery member being damaged / contaminated by the end user.

[0093] The term “drug delivery device cassette unit” may, in some cases, be abbreviated as “cassette unit” in this specification. It should be noted that both the term “drug delivery device cassette unit” and the term “cassette unit” are used interchangeably in this specification.

[0094] Cassette units are typically used with drug delivery devices that have two detachable parts, as shown in Figure 22. There may be specific technical requirements for fabricating a drug delivery device, such as a controllable drug delivery rate, high power for delivering high-volume and / or high-viscosity drugs, multiple indications for different drug delivery stages, and / or data recording and / or communication (e.g., for tracking prescription compliance). However, the cost of manufacturing a drug delivery device that can perform all functions and meet the technical requirements described above is typically high, which makes the use of such drug delivery devices for frequent treatments unaffordable. Drug delivery devices with two detachable parts are typically fabricated from reusable and disposable parts. Reusable parts include most of the mechanical and / or electronic components. For example, a reusable part typically includes a power pack, i.e., an assembly containing a power source and components configured to transmit output from the power source to the drug. Disposable parts typically lack electronics to reduce manufacturing costs. Disposable parts (or commonly referred to as cassette units C) are typically designed to house a drug container (e.g., a syringe or cartridge) in which the drug is contained. Syringes or cartridges can be made from glass or plastic. A syringe or cartridge may include a septum or drug delivery member with a rubber stopper that seals the distal end of the syringe or cartridge and a rubber sheath that seals the proximal end of the syringe or cartridge. Alternatively, a syringe or cartridge may be disintegrable, comprising only a septum or drug delivery member with a rubber delivery member sheath that seals the proximal end of the syringe or cartridge (i.e., without a stopper).

[0095] The reusable parts of the drug delivery device (i.e., the drive unit D) typically include a driver for ejecting the drug contained in the drug container proximal to the drug delivery device. The drive unit D may include a plunger rod for pushing the drug container. In one example, the drug container stopper can therefore be moved proximal to the rest of the drug container. In another example, the plunger rod can collapse the drug container by pushing it proximal to the cassette unit C. The drive unit D also includes a power source (e.g., a spring, gas canister, or motor-driven gear set) to provide the power required to eject the drug. The focus of the concepts described herein is on the subassemblies for the drug delivery device cassette (not the drive units), and various types of drive units can be used with cassette units having the subassemblies described herein. For this reason, the drive units will not be described comprehensively.

[0096] The subassembly of the present invention includes tubular main body portions 1, 1', and 1''. The subassembly further includes one or more optional components, namely tubular carriers 2, 2', and 2'', a locking member, a delivery member guard 3, rotators 4 and 4', a delivery member assembly 5, and a biasing member 6, as shown in Figures 1 to 4. The optional components in the subassembly and their arrangement will be described in detail later.

[0097] The tubular body portions 1, 1', and 1'' are configured to house a drug container within the outer shell 10. In one example, the tubular body portion is a single component. In another example, the tubular body portions 1, 1', and 1'' are formed by one or more components attached to one another. For example (see Figure 2), the tubular body portions 1, 1' include the outer shell 10 and distal lids 11, 11'. In the former example, the drug container can be inserted into the tubular body portions 1, 1' from the proximal end of the tubular body portions 1, 1', while in the latter example, the drug container can be inserted into the tubular body portions 1, 1' from the distal end of the outer shell 10, and then the distal lids 11, 11' are attached to the distal end of the outer shell 10 to support the drug container. In a preferred example, the distal lids 11, 11' are fixed immovably to the distal ends of the main body portions 1, 1', and the distal lids 11, 11' are immovable relative to the tubular main body portions 1, 1' in the direction of the longitudinal axis L and in the circumferential direction about the longitudinal axis L. For example, the distal lids 11, 11' are attached to the distal ends of the tubular main body portions 1, 1' by a snap fit between a snap arm 10a on the tubular main body portions 1, 1' and a snap recess (not shown) on the distal lids 11, 11', thereby preventing distal movement of the drug container relative to the tubular main body portions 1, 1'.

[0098] If there is a requirement that the user needs to be able to see the drug container, the outer shell 10 may include a window 12, which is aligned with the drug container and allows the end user to observe the drug through the window 12. Alternatively, the outer shell 10 may be transparent, so that the tubular body does not require a window 12. The cassette unit C is configured to be attached to and detached from the drive unit D by a releasable connection between the tubular body parts 1, 1', 1'' and the drive unit D when the end user plans to perform a drug delivery operation. The tubular body parts 1, 1', 1'' include a fastener, which is configured to connect to a counter fastener on the drive unit D. In one example, the fastener and counter fastener may form a bayonet connection, meaning that one of the tubular body parts 1, 1', 1'' or the drive unit D has a bayonet projection and the other of the tubular body parts 1, 1', 1'' and the drive unit D has a bayonet recess or cutout. The bayonet recess or cutout opens in a direction transverse to the longitudinal axis L. The bayonet recess or cutout includes a longitudinal section and a circumferential section. The longitudinal section extends in the direction of the longitudinal axis L, and the circumferential section extends in the direction around the longitudinal axis L. The bayonet projection extends in a direction transverse to the longitudinal direction.

[0099] For example, the outer body parts 1, 1' may have a bayonet connector 13 as a fastener on either the outer shell or distal lid 11, 11' of the tubular body part, such as a bayonet projection as shown in Figures 5-6 and 22 (in the example shown in Figure 22, the bayonet connector is a bayonet projection), and the drive unit D will then have a counter bayonet connector D0 (in the example shown in Figure 22, the counter bayonet connector is a bayonet recess). In this example, the tubular body parts 1, 1', 1'' are configured to be axially inserted into the proximal part of the drive unit D along the longitudinal axis L through the bayonet connector 13 and the counter bayonet connector D0, and then the tubular body parts 1, 1', 1'' need to be rotated relative to the drive unit D around the longitudinal axis L so that the cassette unit C is properly mounted on the drive unit.

[0100] Alternatively, the connection between the tubular body sections 1, 1', 1'' and the drive unit D can use another suitable connection (e.g., a snap-fit ​​connection or a screw connection), or the cassette unit can be fully receptacled into the drive unit. In this example, the section of the drive unit for receiving the cassette unit can be a form-fit connection for receiving the cassette unit. If the cassette unit is fully receptacled into the drive unit, the shape of the body section can depend on the shape of the section of the drive unit for receiving the cassette unit.

[0101] In one example, where the tubular body portions 1, 1' include distal caps 11, 11', the bayonet connector is positioned on top of the distal caps 11, 11', and the tubular body portions 1, 1' are configured to be attached to the drive unit D by rotation around a longitudinal axis L relative to the drive unit D. The distal caps may have reinforced walls 15 (as shown in Figure 6), made from, for example, rigid or thick material, so that the torque transmission of the distal caps 11, 11' to the connectors as the tubular body portions 1, 1' are rotated relative to the drive unit D does not damage the rest of the parts of the distal caps 11, 11'.

[0102] The shape of the distal lids 11, 11' typically depends on the shape of the distal end of the tubular body 1, 1'. The distal lids 11, 11' include a lid body which may be formed to conform to the shape of the drug container to be received in the tubular body 1, 1', for example, a tubular lid body for use with a cylindrical drug container. Furthermore, the distal lids 11, 11' typically include an opening axially aligned with a portion of the distal end of the drug container, so that when the cassette unit C is attached to the drive unit D, a plunger rod can pass through the opening and act on the drug container to deliver the contained drug.

[0103] The distal lids 11, 11' optionally include a label (e.g., an RFID tag, barcode, QR code®, or mechanical code) which contains information about the cassette unit C or the contained drug, allowing a reader in the drive unit D to obtain information for further use.

[0104] The distal lids 11, 11' optionally include a container support for supporting a drug container received within the tubular body portions 1, 1'. The container support includes a proximal-oriented surface. In one example, the container support is a flexible arm. The flexible arm can be formed by a cutout on the lid body that opens transversely to the longitudinal axis L. Alternatively, the flexible arm can extend distally from the lid body. In this example, the container support can prevent distal axial movement of the drug container received within the tubular body portions 1, 1'. The proximal-oriented surface of the container support can be formed on the inner surface of the flexible arm or on the distal tip of the flexible arm. The container support can also be used to allow for variations in the dimensions of the received drug container (e.g., a specific length and / or width of the received drug container) with respect to engineering tolerances.

[0105] The subassembly of the present invention provides a mechanism by which the tubular carriers 2, 2', and 2'' are moved proximal to the tubular body when the cassette unit is attached to the drive unit D (the cassette unit includes the subassembly of the present invention).

[0106] The tubular carriers 2, 2', and 2" are for holding drug containers. The tubular carriers 2, 2', and 2" are at least partially located within the tubular body portions 1, 1', and 1". The tubular carriers 2, 2', and 2" and the tubular body portions 1, 1', and 1" are coaxial. The tubular carriers 2, 2', and 2" include distally oriented surfaces 24a for contact with the drive unit D of the drug delivery device when the tubular body portions 1, 1', and 1" are attached to the drive unit D of the drug delivery device. The tubular carriers 2, 2', and 2" are movable by the drive unit D from a distal position to a proximal position in the direction of the longitudinal axis L when the distally oriented surfaces 24a are in contact with the drive unit D of the drug delivery device.

[0107] The tubular carriers 2, 2', and 2'' can be any suitable shape that can contain a drug container. For example, the tubular carrier can be cylindrical because many drug containers (e.g., cartridges or syringes) have a cylindrical body. In another example, the tubular carrier is a ring or circlip because it can simply grip the flange or shoulder portion of the drug container. Alternatively, as shown in Figures 8 and 9, the tubular carrier can be formed by two arms extending in the direction of the longitudinal axis L and a joint connected between them. In the example where the tubular carriers 2, 2', and 2'' include two arms, the tubular carriers 2, 2', and 2'' can be formed by a carrier body 20 including the arm section and the joint section. In this example, the tubular carrier 2 includes the carrier body 20 and the carrier cap 21 as shown in Figure 8. It is possible to include the following. The carrier body 20 is configured to receive the distal part of the drug container, and the carrier cap 21 is configured to receive the proximal part of the drug container. The carrier cap 21 can be attached to the carrier body 20 through a snap-fit ​​engagement, as shown in Figure 8. In one example, the snap-fit ​​engagement includes a snap-fit ​​arm 21 on the carrier cap 21 and a snap-fit ​​recess or cutout 20a on the carrier body 20. The snap-fit ​​engagement can also be achieved by the snap-fit ​​arm on the carrier body, along with the snap-fit ​​recess or cutout on the carrier cap. Alternatively, the carrier cap can be attached to the carrier body through a screw connection or bayonet connection. The carrier cap can be any suitable shape depending on the shape of the carrier body and the shape of the drug container (e.g., tubular or dome-shaped).An aperture is located at the proximal end of the carrier cap, allowing the delivery member to pass through. In a preferred example, the carrier cap includes a support ledge extending from the inner surface in a direction transverse to the longitudinal axis L. The support ledge is configured to support the drug container at the shoulder portion of the drug container. In another example, the tubular carrier 2' is formed by the carrier body 20 alone, without a carrier cap. In this example, the carrier body 20 includes support fingers 20b extending from the inner surface of the carrier body 20 at the proximal end of the carrier body 20, as shown in Figure 9. The support fingers 20b are configured to support the shoulder portion of the drug container, as shown in Figures 11C and 12B.

[0108] In a preferred example, the tubular carrier is engaged with the tubular body through engagements of grooves and ledges. Preferably, the tubular carriers 2, 2' include a ledge 22 which extends from the outer surface of the wall of the tubular carriers 2, 2', preferably radially with respect to the longitudinal axis L, onto the outer surface of the wall of the carrier body 20. The groove for connecting the tubular carrier and the tubular body can be a recess or cutout located on the inner surface of the tubular body (as shown in Figure 10), or alternatively, the groove can be located on the outer wall of the carrier body of the tubular carrier. In one example, the groove 16 is located on the inner wall of the tubular body 1, 1', preferably on the inner wall of the outer shell 10 of the tubular body 1, 1', as shown in Figure 10. The ledge 22 is positioned within the groove when the tubular carriers 2, 2' are attached to the tubular body 1, 1'. Alternatively, the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis L from the inner surface of the wall portion of the tubular body portion. The groove portion is located on the outer surface of the tubular carrier. The ledge portion is positioned within the groove portion. Furthermore, the groove portion is a recess or a slot. Alternatively, the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis from the inner surface of the wall portion of the tubular body portion. The tubular carrier includes a counterledge portion located on the outer surface of the tubular carrier. The ledge portion is positioned within the counterledge portion. This engagement between the tubular carriers 2, 2' and the tubular body portions 1, 1', 1'' allows the tubular carriers 2, 2' to move relative to the tubular body portions 1, 1' in the direction of the longitudinal axis L without rotation.

[0109] In a preferred example, the tubular carriers 2, 2', 2'' are preferably configured to immobilely hold the drug container of the drug delivery device in the direction of the longitudinal axis L, so that the drug container is immobile relative to the tubular carriers 2, 2', 2'' in the direction of the longitudinal axis L. Alternatively, instead of fixedly holding the drug container, the tubular carriers merely restrict the movement of the drug container beyond a predetermined distance, i.e., the drug container of the drug delivery device is preferably movable relative to the tubular carriers over a predetermined distance in the direction of the longitudinal axis L.

[0110] The tubular carriers 2, 2', and 2'' are configured to be moved proximal to the tubular main body portions 1, 1', and 1'' by a portion of the drive unit D during the process of attaching the cassette unit, which includes the subassembly of the present invention, to the drive unit D. The tubular carriers 2, 2', 2'' include distally oriented surfaces 24a, 24a'. The distally oriented surfaces 24a, 24a' are configured to contact a portion of the drive unit D. Thus, the drive unit D can move the tubular carriers 2, 2', 2'' proximal to the tubular body portions 1, 1', 1'' during the process of mounting the cassette unit to the drive unit D (the cassette unit includes the subassembly of the present invention). In one example, the tubular carriers 2, 2' include a flange 24 extending in a direction transverse to the longitudinal axis L. In one example, the flange extends from the outer surface of the carrier body portion. The distally oriented surface 24a is defined by the flange 24 as shown in Figures 8-9. In a preferred example, the flange 24 is defined by the tubular body portion 1, 1' extends outward from the tubular body portions 1, 1', i.e., the flange 24 is accessible from the outside of the tubular body portions 1, 1'. The flange can be positioned on the outer surface of the carrier body portion 20, preferably closer to the distal end of the carrier body portion 20 than to the proximal end of the carrier body portion 20. In another example, the tubular carrier 2, 2' includes an arm 23, which extends proximal to the carrier body portion 20 from a ledge portion 22 in the direction of the longitudinal axis. In this example, the flange 24 is positioned on the outer surface of the arm, as shown in Figures 8-9. In yet another example, as shown in Figure 10, a recess 17 is positioned on the tubular body portions 1, 1', 1'', and the recess 17 is configured to receive the flange 24 when the tubular carrier 2, 2' is in the proximal position.

[0111] Alternatively, the distally oriented surface is located at the distal end of the tubular carrier, for example, at the edge of the tubular carrier, as shown in Figures 23-24. In this example, the tubular carrier does not need to have a flange 24. In this example, the distally oriented surface 24' can be completely surrounded by the tubular body, or extend from the distal end of the tubular body 1'', as shown in Figure 23. In an example where a cassette unit including the subassembly of the present invention is attached to a drive unit by a bayonet connection, and the tubular carriers 2, 2', 2'' include a flange 24, the flange 24 is located next to the bayonet connector 13 (as a fastener for the tubular body), and preferably the flange 24 is circumferentially offset from the bayonet connector 13 of the tubular body in the direction of the longitudinal axis. In the example where the bayonet connector 13 is a bayonet projection and the counter fastener of the driver unit D is a bayonet groove, the flange 24 abuts against the proximal edge D1 of the drive unit D as the bayonet connector 13 moves into the longitudinal part of the bayonet groove. As the bayonet connector 13 moves into the circumferential part of the bayonet groove, the flange 24 is pushed proximal to the drive unit by the proximal edge D1 of the drive unit D. Thus, the tubular carriers 2, 2' are moved proximal to the tubular main body 1, 1' from the distal position to the proximal position.

[0112] Alternatively, the fasteners and counter fasteners can be attached by snap-fit, screw-fit or bayonet-fit, and any of the described arrangements is suitable for both the tubular carrier including flange 24, or the tubular carrier 2" where the distally oriented surface 24' is located at the distal end of the tubular carrier 2" as shown in Figures 23-24. In this example, the relative axial movement along the longitudinal axis between the fastener and counter fastener allows a portion of the drive unit D to push the distally oriented surface 24, 24' proximal to the tubular body portions 1, 1', 1''. Thus, the tubular carriers 2, 2', 2'' are moved proximal to the tubular body portions 1, 1', 1'' during the process of attaching the cassette unit C to the drive unit D (the cassette unit includes the subassembly of the present invention).

[0113] Furthermore, the subassembly of the present invention may include an initial locking mechanism that locks the tubular carriers 2, 2', 2'' to their proximal positions until the cassette unit including the subassembly is attached to the drive unit D. In one example, the initial locking arrangement includes a flexible section 14 at the distal end of the tubular body portion 1'. The flexible section 14 can be positioned on the outer shell 10 or the distal lid 11'. In the example shown in Figure 6, the flexible section 14 is , positioned on top of the distal cover 11'. The flexible section 14 includes a bending part, a locking projection 14a, and a hook 14b. The bending part can be a flexible arm or a part of the distal cover made of an elastic material. The locking projection 14a extends radially away from the tubular body 1' with respect to the longitudinal axis L. The hook 14b extends radially with respect to the longitudinal axis L. The cutout or recess 26 is located within the wall of the carrier body. Alternatively, The cutout or recess 26 is located within the wall of the arm 23 of the tubular carrier 2'. The flexible section 14 is movable between the engaged position and the released position in a direction transverse to the longitudinal axis L relative to the tubular body 1'. In the engaged position, the hook 14b of the flexible section 14 is positioned within the cutout or recess 26 of the tubular carrier 2', and in the released position, the hook 14b of the flexible section 14 is positioned outside the cutout or recess 26 of the tubular carrier 2'. The flexible section 14 of the tubular body portion 1' is preferably moved from an engaged position to a released position when the locking projection 14a of the flexible section 14 is pressed from the outside of the tubular body portion by a part of the drive unit D (for example, the inner wall portion of the drive unit D). When the locking projection 14a is pressed, the deformation of the flexible section 14 causes the hook 14b to bend out of the cutout or recess 26 of the tubular carrier 2', preventing the tubular carrier 2' from locking into the tubular body portion 1'.Therefore, before the cassette unit including the subassembly is mounted to the drive unit D, the tubular carrier 2' is locked to the tubular body 1' by the engagement between the hook 14b of the flexible section 14 and the cutout or recess 26 of the tubular carrier 2'. Until the cassette unit including the subassembly is mounted to the drive unit D, the tubular carrier 2' is released from the tubular body 1' and can therefore be moved to a proximal position, as shown in Figures 12B and 13B.

[0114] In another example, instead of an initial locking mechanism, the subassembly includes a biasing member 6, which faces a proximal-oriented surface of the tubular carrier 2 and is connected to either a portion of the tubular body 1 or a portion of the delivery member guard 3. The biasing member 6 can be a spring or a flexible arm. In the former example, the biasing member 6 is adjacent to a proximal-oriented surface of the tubular carrier 2, 2' and adjacent to either a portion of the tubular body 1 or a portion of the delivery member guard 3. In the latter example, the biasing member faces a proximal-oriented surface of the tubular carrier, meaning that the biasing member can be either adjacent to a proximal-oriented surface of the tubular carrier or spaced away from a proximal-oriented surface of the tubular carrier, such that the biasing member blocks only the tubular carrier when the tubular carrier moves proximal to the tubular body over a predetermined distance. Furthermore, in this example, the biasing member extends from either a portion of the tubular body 1 or a portion of the delivery member guard 3.

[0115] In one example, the proximal-oriented surface 22a of the tubular carrier 2 is defined by a ledge portion 22. A biasing member 6 is configured to support the tubular carrier 2 at a distal position to prevent it from unintentionally moving to the proximal position, for example, by shaking or dropping. In a preferred example, the subassembly includes a delivery member guard 3, which is coaxially mounted to the tubular body portions 1, 1', 1'' and is axially movable relative to the tubular body portions 1, 1', 1'' along the longitudinal axis L. The delivery member guard 3 includes a front shield 30, which is configured to surround the drug delivery member of the drug delivery device. The front shield 30 of the delivery member guard 3 is expandable and contractible relative to the proximal ends of the tubular main body portions 1, 1', and 1''. In this example, the proximal end of the biasing member 6 is adjacent to the distally oriented surface of the delivery member guard 3, and the distal end of the biasing member 6 is adjacent to the proximally oriented surface of the tubular carrier 2, as shown in Figure 11A. Therefore, the biasing member 6 is configured to bias the delivery member guard 3 in the proximal direction of the tubular main body portion 1 and to support the tubular carrier 2 at its distal position.

[0116] Alternatively, the biasing member 6 may function solely as a delivery member guard biasing member. In this example, the tubular body portion includes a proximal-oriented surface adjacent to the distal end of the biasing member, regardless of whether the subassembly includes an initial locking mechanism and / or initial support.

[0117] In another example, the subassembly includes a delivery member assembly 5. The delivery member assembly 5 includes a delivery member 50 and a delivery member holder 51. The delivery member 50 is attached to the delivery member holder 51. The delivery member holder 51 is attached to the proximal end of the tubular body portions 1, 1'. This illustrated subassembly is suitable for a cassette unit with a cartridge as a drug container.

[0118] In one example, as shown in Figures 7A and 7B, the delivery member assembly 5 includes a flexible sheath enclosing the delivery member. The flexible sheath is configured to seal at least one end of the delivery member. In a preferred example, the delivery member 50 is a needle. In this example, the needle 50 is held by a delivery member holder 51 and enclosed by a flexible sheath 50a. The delivery member holder 51 includes a fastener 51a (e.g., a hook) configured to engage with a proximal ledge portion 18 of a tubular body. Preferably, the proximal ledge portion defines a central passage for receiving the delivery member 50 and the flexible sheath. For example, the proximal ledge portion 18 extends radially with respect to a longitudinal axis L, and the proximal ledge portion 18 is either a ring or two ledge portions facing each other.

[0119] In an example where the subassembly includes a delivery member assembly 5, the proximal movement of the tubular carriers 2, 2', and 2'' allows for the establishment of fluid communication between the received drug container and the delivery member 50. Alternatively, in another example, the proximal movement of the tubular carriers 2, 2', and 2'' allows the proximal end of the drug container to move out of the tubular body, enabling the user to attach the drug delivery device to the drug container.

[0120] In one example, the tubular carriers 2, 2', and 2" are capable of establishing fluid communication between the received drug container and the delivery member 50, as shown in Figures 12A to 13B. In this example, the tubular carriers 2, 2', and 2" are axially movable relative to the delivery member assembly 5 between a distal position and a proximal position. The tubular carriers 2, 2', and 2" are configured to hold the drug container M in a non-fluid connection with the delivery member 50 when the tubular carriers 2, 2', and 2" are in the distal position, and to hold the drug container M in a fluid connection with the delivery member 50 when the tubular carriers 2, 2', and 2" are in the proximal position.

[0121] When the cassette unit including the subassembly is attached to the drive unit D, the drive unit D moves the tubular carriers 2, 2', 2" proximal to the tubular main body portions 1, 1', 1'' as described above. In this example, preferably, the drug container is fixed to the tubular carriers 2, 2', 2'' so that when the tubular carriers 2, 2', 2'' are moved proximal to the tubular main body portions 1, 1', 1'', the drug container M also moves proximal to the tubular main body portions 1, 1', 1''. As the tubular carriers 2, 2', and 2” reach their proximal positions, the delivery member 50 moves into the drug container M, establishing fluid communication between the delivery member 50 and the drug container M. In one example, a flexible sheath 50b seals the distal end of the delivery member, and as shown in Figure 13B, the flexible sheath 50b is compressed between the delivery member holder 51 and the proximal end of the drug container M when fluid communication is established between the drug container M and the delivery member. In one example, the delivery member assembly includes a cap that seals the proximal end of the delivery member, and the cap can be removed by the user before performing the drug delivery operation.

[0122] Alternatively, in another example, the delivery member assembly 5 includes another flexible sheath 50a configured to seal the proximal end of the delivery member. In this example, either the proximal end of the delivery member guard 3 or the proximal end of the tubular body includes a proximal wall portion with an opening sized to allow only the passage of the delivery member. In one example, the proximal end of the delivery member guard 3 includes a proximal wall portion 33, which has an opening designed to allow the passage of the delivery member when the user performs a drug delivery operation by pressing the proximal wall portion 33 of the delivery member guard 3 against the drug delivery site, and the flexible sheath 50a sealing the proximal end of the delivery member is compressed between the delivery member holder 51 and the rear surface 33b of the proximal wall portion of the delivery member guard, as shown in Figure 11C. Thus, the delivery member 50 can extend outward from the opening above the proximal wall portion 33 of the delivery member guard.

[0123] The subassembly of the present invention can be operated by the following sequence of steps: providing a drug delivery device cassette unit C; providing a drive unit D; and using the drive unit D to move the tubular carriers 2, 2', 2" of the drug delivery device cassette unit C along the longitudinal axis L relative to the tubular body portions 1, 1', 1'' of the drug delivery device cassette unit C until the drug delivery device cassette unit C is mounted on the drive unit D.

[0124] Preferably, the cassette unit C is attached to the drive unit D by a bayonet or screw connection. The step of the drive unit D moving the carrier of the drug delivery device cassette unit C along the longitudinal axis with respect to the tubular body portions 1, 1', 1'' of the drug delivery device cassette unit C until the drug delivery device cassette unit C is attached to the drive unit D includes the steps of moving the drug delivery device cassette unit C along the longitudinal axis with respect to the drive unit D and rotating the drug delivery device cassette unit C about the longitudinal axis L with respect to the drive unit D.

[0125] Furthermore, the step of using the drive unit D to move the tubular carriers 2, 2', 2'' includes the steps of connecting the tubular carriers 2, 2', 2'' to a portion of the drive unit D and moving the tubular carriers 2, 2', 2'' while rotating the drug delivery device cassette unit C around the longitudinal axis L relative to the drive unit D.

[0126] In an example where the subassembly includes a delivery member assembly 5, the step of using the drive unit to move the tubular carriers 2, 2', 2" of the drug delivery device cassette unit C along the longitudinal axis relative to the tubular body portions 1, 1', 1" of the drug delivery device cassette unit C until the drug delivery device cassette unit C is mounted to the drive unit D includes the step of using the movement of the tubular carriers 2, 2', 2" relative to the tubular body portions 1, 1', 1" to establish a fluid connection between the delivery member 50 and the drug container M while the drug delivery device cassette unit C is mounted to the drive unit D.

[0127] The subassembly of the present invention further provides a safety mechanism for a cassette unit. To provide the safety mechanism, the subassembly includes tubular body portions 1, 1', a delivery member guard 3, and rotators 4, 4'. The safety mechanism is configured to prevent the delivery member guard 3 from moving distally relative to the tubular body portions 1, 1', 1'' before the cassette unit including the subassembly is mounted on the drive unit D.

[0128] It should be noted that the safety mechanism can be used in conjunction with a mechanism configured such that, when the cassette unit is mounted on the drive unit D (the cassette unit includes the subassembly of the present invention), the tubular carriers 2, 2', and 2'' move proximal to the tubular body, as described above. Alternatively, the safety mechanism can be used independently of the above-described mechanism, and vice versa.

[0129] The tubular body portions 1, 1', 1'' and the delivery member guard 3 are the same as the tubular body portions 1, 1' and the delivery member guard 3 described above. The delivery member guard 3 includes a front shield 30, which is configured to protrude from the proximal ends of the body portions 1, 1'. The front shield 30 is configured to shield the drug delivery member, which is either integrated with the drug container or can be attached to the drug container when the drug delivery device is used by the user. In a preferred example, the front shield 30 has an opening at the proximal end of the front shield 30. The element is tubular in shape, and the front shield 30 of the delivery member guard 3 is coaxially attached to the tubular body portions 1, 1', 1'' and is axially movable relative to the tubular body portions 1, 1', 1'' along the longitudinal axis L between the distal and proximal positions. Similarly, the front shield 30 of the delivery member guard has a similar shape to the tubular body portions 1, 1', 1'' to make the device compact, but the delivery member guard can also be formed in any other suitable shape that is axially movable relative to the tubular body portions 1, 1', 1'' along the longitudinal axis L.

[0130] The delivery member guard 3 includes an arm 31, which extends distally from the distal end of the front shield 30 to the tubular body portions 1, 1', 1'' of the subassembly. The delivery member guard 3 includes a distally oriented surface 34. Preferably, the delivery member guard 3 includes a projection 35 that defines the distally oriented surface 34, extending radially with respect to the longitudinal axis L, as shown in Figure 16. In a preferred example, the projection 35 is located on a flexible section 36 of the delivery member guard.

[0131] In a preferred example, the delivery member guard 3 is partially located within the tubular body portions 1, 1', 1'', i.e., the delivery member guard 3 is partially located within the outer shell 10 of the body portions 1, 1'. In this example, preferably, the arm 31 is fully located within the body portions 1, 1', and the front shield 30 fully or partially protrudes from the proximal end of the tubular body portions 1, 1', 1'', so that the front shield 30 can cover the drug delivery member. In one example, the arm 31 of the delivery member guard 3 is configured to interact with a part of the drive unit D. For example, when a cassette unit C including a subassembly is assembled into the drive unit D, further distal movement of the delivery member guard 3 is possible to move the arm 31 into the drive unit D to release a plunger rod connected to a power source (e.g., a spring, gas canister, motor) or to switch on the power source.

[0132] As shown in Figures 14A to 15B, the rotators 4 and 4' are prevented from moving in any direction along the longitudinal axis L by the tubular body portions 1, 1', and 1''. The rotators 4 and 4' include a proximal-oriented surface 41. The rotators 4 and 4' are configured to be rotated by the drug delivery device drive unit D when the drug delivery device cassette unit C is attached to the drive unit D, so that the rotators 4 and 4' can be rotated relative to the delivery member guard 3 from a locked position to an unlocked position. In the locked position, the distal-oriented surface 34 of the delivery member guard 3 is aligned with the proximal-oriented surface 41 of the rotators 4 and 4'. In the unlocked position, the distal-oriented surface 34 of the delivery member guard 3 is not aligned with the proximal-oriented surface 41 of the rotators 4 and 4', allowing the delivery member guard 3 to move freely distally relative to the rotators 4 and 4'. 4' can be tubular, ring-shaped, or circlip-shaped. In one example, the rotator 4, 4' includes a tubular rotator body 40. In one example, the proximal edge 40a of the tubular rotator body 40 is adjacent to the inner ledge 10b of the tubular body 1, 1', 1'' as shown in Figures 17A-17B and 21, and the distal edge of the rotator body is adjacent to the proximal oriented surface of the distal lid 11, 11'. The rotators 4 and 4' are fixed axially to the tubular body portions 1, 1', and 1''. The proximal oriented surfaces 41 of the rotators 4 and 4' can be positioned on ribs extending radially from the rotators, or on the edges of cutouts or recesses 410 of the rotators 4 and 4', as shown in Figures 14A to 14B and Figure 17B. The cutouts or recesses 410 are positioned on the tubular rotator body portion 40.

[0133] In one example, the rotator includes a ledge portion that extends radially with respect to the longitudinal axis L. The ledge portion is configured to engage with a portion of the drive unit D, so that when the drive unit D rotates relative to the tubular body of the subassembly, the rotator rotates together with the drive unit relative to the tubular body of the subassembly.

[0134] In another example, the rotators 4, 4' include a ledge portion 42 extending spirally from a first end 42a to a second end 42b with respect to the longitudinal axis L. In one example, the ledge portion extends from the outer surface of the rotator body. Alternatively, the ledge portion 42 is defined by the edge of a cutout or recess in the wall of the tubular rotator body 40. The ledge portion 42 is configured to engage with a portion of the drive unit D so that the rotators 4, 4' are rotated as the drive unit D of the drug delivery device moves axially relative to the rotators 4, 4' from distal and proximal positions, with a portion of the drive unit D adjacent to the first end 42a of the ledge portion 42 in the distal position and a portion of the drive unit D adjacent to the second end 42b of the ledge portion 42 in the proximal position.

[0135] Alternatively, in another example, the subassembly includes a locking member. In one example, the locking member 2, 2' can be integrated with the tubular carrier 2, 2', for example, the distal part of the tubular carrier 2, 2' is positioned to have a structure for acting as the locking member 2, 2'. In another example, the locking member can be a separate component. The latter example is suitable for cassette units that do not require a drug container carrier, although it can also be used in cassette units that do include a drug container carrier. The following description of examples in which the subassembly includes a locking member will use diagrams in which the locking member is integrated with the tubular carrier. However, since the tubular carrier (i.e., the component configured to receive the drug container) is not required to form a safety mechanism, and the reference symbols presented below will be the same as the reference symbols for the tubular carrier and its structure (e.g., reference symbol "2, 2'") described above, the components and structures below will refer to the locking member instead of the tubular carrier. Furthermore, even if the explanation below uses a diagram in which the locking member is integrated with the tubular carrier, the structure of the locking member is also suitable for forming a locking member that is an independent component of the tubular carrier.

[0136] Furthermore, some of the aforementioned structural arrangements relating to the tubular carriers 2, 2' apply to the locking member whether it is part of the tubular carrier or an independent component. In particular, these include the initial locking arrangement and structural arrangements that are not related to supporting the drug container, such as the connection between the biasing member 6 and the tubular carriers 2, 2'.

[0137] The locking members 2 and 2' are configured to directly engage with the rotators 4 and 4' and with a portion of the drive unit D. Therefore, when the cassette unit is mounted on the drive unit D, the drive unit D moves the locking members 2 and 2', and thus rotates the rotators 4 and 4'. The locking members 2 and 2' can be moved by the drive unit D in the manner described above, which moves the tubular carriers 2 and 2' relative to the tubular body portions 1, 1', and 1''. Therefore, only the method of rotating the rotators 4 and 4' by the locking members 2 and 2' will be described in detail later.

[0138] As shown in Figure 10, the locking members 2 and 2' are fixed to the tubular body portions 1, 1', and 1'' in the rotational direction by engagement between, for example, the ledge portion 22 of the locking members 2 and 2' and the groove portion 16 of the tubular body portions 1, 1', and 1''.

[0139] The safety mechanism includes a projection extending radially with respect to the longitudinal axis L on either the rotator 4, 4' or the rocking member 2, 2', and a ledge adjacent to the projection on the other component. Either the projection appears on the rotator 4, 4', and the ledge appears on the rocking member 2, 2', or vice versa.

[0140] The ledge extends spirally from the first end to the second end with respect to the longitudinal axis L. In one example, the locking members 2, 2' are shown in Figures 8 and 8. 24As shown, it includes projections 25, 25'. In an example where the locking members 2, 2' are part of the tubular carriers 2, 2', projections 25 can be positioned on the outer surface of the carrier body 20 (also named the locking member body 20), and alternatively, projections 25' can be positioned on the inner surface of the arms 23 of the tubular carriers 2, 2'. In this example, the rotators 4, 4' include the helically extending ledge 42 described above. Instead of engaging with a part of the drive unit D, the ledge 42 of the rotators 4, 4' is configured in this example to engage with projections 25, 25' of the locking members 2, 2'. Therefore, when the locking member moves axially relative to the rotator 4, 4' from a distal position (in the distal position, the protrusions 25, 25' are adjacent to the first end 42a of the ledge portion 42, as shown in Figures 19A and 20-20B) and a proximal position (in the proximal position, the protrusions 25, 25' are adjacent to the second end 42b of the ledge portion 42) while the cassette unit is being mounted to the drive unit (the cassette unit includes the subassembly of the present invention), the axial movement of the locking member causes the rotator to rotate due to the engagement between the protrusions 25, 25' and the ledge portion 42. As shown in Figures 20A to 20C, when the rotators 4 and 4' move to the unlocked position, the distally oriented surface 34 of the delivery member guard 3 (shown by dashed lines in Figures 20A to 20F) is not aligned with the proximal oriented surface 41 of the rotators 4 and 4', allowing the delivery member guard 3 to move distally relative to the tubular main body portions 1, 1', and 1''.

[0141] In examples where the rotators 4, 4' include a spirally extending ledge portion 42, whether the ledge portion 42 is configured to directly engage with a part of the drive unit D or to engage with the projections 25, 25' of the locking members 2, 2', the first end 42a of the ledge portion optionally includes a longitudinal part 46 extending in the direction of the longitudinal axis L, as shown in Figures 14A and 15A. The longitudinal part 46 is configured to allow rotation of the rotators 4, 4' only when the cassette unit has reached a predetermined position relative to the drive unit D (e.g., a properly mounted position), and the rotators 4, 4' remain in the locked position if the user decides not to perform a drug operation before the cassette unit is properly mounted to the drive unit D. Furthermore, the circumferential ledge portion 47 optionally extends circumferentially from the second end 42b of the ledge portion with respect to the longitudinal axis L, as shown in Figures 14A and 15A. When the rotators 4, 4' are directly rotated by the drive unit D, the ledge portion 42 with the circumferential ledge portion 47 is capable of replacing the fasteners 13 on the tubular body portions 1, 1', 1'', i.e., the cassette unit is attached to the drive unit D through the circumferential ledge portion 47 of the rotators 4, 4' and the counter fastener of the drive unit D. When the rotators 4, 4' are rotated by the locking members 2, 2', the circumferential ledge portion 47 is configured to prevent the locking members 2, 2' from moving distally relative to the tubular body portions 1, 1', 1'', as shown in Figures 20A to 20F.

[0142] The subassembly optionally includes a delivery member guard lockout mechanism, which is configured to lock the delivery member guard in the proximal post-use position, preventing the delivery member guard from moving distally relative to the tubular body portions 1, 1', 1''. The front shield 30 of the delivery member guard 3 is configured to completely surround the delivery member 50 when the delivery member guard is in the proximal post-use position. In this example, the rotators 4, 4' include a track 44 positioned on the wall of the tubular rotator body portion 40. The track can be formed by cutouts, recesses, or multiple transversely extending ledges positioned on the tubular rotator body portion. The projection 35 of the drug delivery member guard 3 is configured to follow the track 44 of the rotators 4, 4' as the drug delivery member guard 3 moves distally relative to the tubular body portions 1, 1', 1'' during drug delivery operations. Track 44 includes a lockout section 45, and the projection 35 of the delivery member guard 3 is configured to move into the lockout section 45 as a result of distal movement of the delivery member guard 3 toward its proximal post-use position, as shown in Figures 20D to 20F. Subsequently, the distally oriented surface 34 of the delivery member guard 3 is brought into contact with the blocking surface 45a of the rotator, preventing the delivery member guard 3 from moving distally relative to the rotator 4, 4'. In one example, distal movement of the delivery member guard 3 is caused by a biasing member 6.

[0143] Rotators 4, 4' optionally include bridge surfaces 43, 43', which connect the track 44 to the second end 42b of the ledge 42. The bridge surface is a ramp surface inclined from the track 44 to the second end 42b of the ledge 42. The bridge surface 43 can extend circumferentially to the track 44, as shown in Figure 14A, or it can extend longitudinally toward the track 44, as shown in Figure 14B.

[0144] As one example of initiating the operation of the drug delivery device by the drive unit D and cassette unit C, the delivery member guard 3 is moved by the user to a distal trigger position toward the drive unit D. This distal movement of the delivery member guard 3 can also trigger the drive unit D to exert force on the contained drug by exposing the drug delivery member that connects to the contained drug. Thus, when the delivery member guard 3 is in the distal trigger position, the drug delivery member is exposed to the user. This distal movement of the delivery member guard 3 can be performed by pressing the proximal end of the front shield 30 of the delivery member guard 3 against the drug delivery site.

[0145] In an example where the subassembly includes a biasing member 6, the biasing member 6 is configured to bias the delivery member guard 3 proximal to the tubular body portions 1, 1', 1'' of the subassembly. When the drug delivery operation is performed, the user can remove the drug delivery device from the drug delivery site, and the biasing member 6 is therefore able to bias the delivery member guard 3 proximal to the tubular body portions 1, 1', 1'' so that the front shield 30 of the delivery member guard 3 can shield the drug delivery member.

[0146] The delivery member guard 3 is therefore biased by the biasing member 6 to a proximal post-use position. Depending on the design of the drug delivery device, the proximal post-use position can be the proximal position of the delivery member guard 3 as described above, or it can be a second proximal position of the delivery member guard 3 instead of the proximal position described above. For example, in drug delivery devices that include an automatic needle insertion mechanism, if the drug delivery member of the drug delivery device is configured to move beyond its initial position in the proximal direction of the drug delivery device after use, the delivery member guard can also move to a second proximal position as the proximal post-use position.

[0147] The concept of the present invention has been described above primarily with reference to several examples. However, as will be readily apparent to those skilled in the art, other embodiments not disclosed above are also possible within the scope of the concept of the present invention as defined by the appended claims.

[0148] Some aspects of the present invention are described in the following sections.

[0149] 1. A subassembly of a drug delivery device cassette unit, wherein the subassembly comprises: A tubular body portion for attachment to a drive unit of a drug delivery device, wherein the tubular body portion extends along the longitudinal axis between a proximal end and a distal end, A tubular carrier for holding a drug container, wherein the tubular carrier is at least partially disposed within a tubular body, the tubular carrier and the tubular body are coaxial, and the tubular carrier includes a distally oriented surface for contact with the drive unit of a drug delivery device when the tubular body is attached to the drive unit of a drug delivery device. Includes, A tubular carrier is a subassembly that is movable relative to the tubular main body in the longitudinal axis direction from the distal position to the proximal position by a drive unit, when the distally oriented surface is in contact with the drive unit of the drug delivery device.

[0150] 2. The subassembly described in Clause 1, wherein the tubular carrier is engaged with the tubular body through engagements of grooves and ledges.

[0151] 3. The subassembly according to Clause 2, wherein the tubular carrier includes a ledge portion extending radially with respect to the longitudinal axis from the outer surface of the wall portion of the tubular carrier, and a groove portion is located on the inner wall portion of the tubular body portion, with the ledge portion positioned within the groove portion.

[0152] 4. The subassembly according to Clause 2, wherein the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis from the inner surface of the wall portion of the tubular body portion, and a groove portion is located on the outer surface of the tubular carrier, with the ledge portion positioned within the groove portion.

[0153] 5. The groove is a recess or slot in the subassembly as described in Clause 3 or 4.

[0154] 6. The subassembly according to Clause 1, wherein the tubular body portion includes a ledge portion extending radially with respect to the longitudinal axis from the inner surface of the wall portion of the tubular body portion, and the tubular carrier includes a counterledge portion positioned on the outer surface of the tubular carrier, the ledge portion being positioned within the counterledge portion.

[0155] 7. A subassembly according to any one of Clauses 1 to 6, wherein the tubular carrier is configured to immobilely hold the drug container of the drug delivery device.

[0156] 8. A subassembly according to any one of Clauses 1 to 7, wherein the subassembly includes a delivery member assembly, the delivery member assembly includes a delivery member and a delivery member holder, the delivery member being mounted on the delivery member holder, and the delivery member holder being mounted on the proximal end of a tubular body.

[0157] 9. The subassembly according to Clause 8, wherein the tubular carrier is axially movable relative to the delivery member assembly between a distal and proximal position, and the tubular carrier is configured to hold the drug container in a non-fluid connection with the delivery member when the tubular carrier is in the distal position, and the tubular carrier is configured to hold the drug container in a fluid connection with the delivery member when the tubular carrier is in the proximal position.

[0158] 10. A subassembly according to any one of Clauses 1 to 9, wherein the tubular body portion includes a flexible section at the distal end of the tubular body portion, the flexible section including a hook extending radially with respect to the longitudinal axis and a lock projection extending radially away from the tubular body portion with respect to the longitudinal axis.

[0159] 11. The subassembly according to Clause 10, wherein the tubular carrier includes a carrier body, a cutout or recess located within the wall of the carrier body, and the flexible section is movable relative to the tubular body in a direction transverse to the longitudinal axis between an engaged position and a released position, the hook of the flexible section being positioned within the cutout or recess of the tubular carrier in the engaged position, and the hook of the flexible section being positioned outside the cutout or recess of the tubular carrier in the released position.

[0160] 12. The subassembly according to Clause 11, wherein the flexible section of the tubular body is moved from an engaged position to a released position when the locking projection of the flexible section is pressed from the outside of the tubular body.

[0161] 13. A subassembly according to any one of Clauses 1 to 12, comprising a delivery member guard that is expandable and retractable within a tubular main body, and a biasing member that extends along a longitudinal axis between a proximal end and a distal end, wherein the delivery member guard includes a distally oriented surface adjacent to the proximal end of the biasing member.

[0162] 14. The subassembly according to Clause 13, wherein the tubular carrier includes a surface oriented proximal to the distal end of the biasing member.

[0163] 15. The subassembly according to Clause 13, wherein the tubular body portion includes a surface that is oriented proximal to the distal end of the biasing member.

[0164] 16. A subassembly according to any one of Clauses 1 to 15, wherein the tubular carrier includes a flange extending in a direction transverse to the longitudinal axis, the distally oriented surface being defined by the flange, and the flange extending outward from the tubular body.

[0165] 17. A subassembly according to any one of Clauses 1 to 16, wherein the tubular body includes a fastener on the outer surface of the tubular body for attachment to a part of a drug delivery device.

[0166] 18. The fastener is a bayonet connector, as described in Clause 17.

[0167] 19. The flange of the tubular carrier is located next to the fastener, as specified in the subassembly described in Clause 17 or 18, as referenced in Clause 16.

[0168] 20. The flange is circumferentially offset with respect to the longitudinal axis of the bayonet connector of the tubular body, as described in Clause 19, by reference to Clause 18.

[0169] 21. The delivery member is a needle, and the delivery member assembly is a subassembly as described in any one of clauses 9 to 20, as referenced by clause 8, including a flexible sheath enclosing the needle.

[0170] 22. A drug delivery device cassette unit comprising a subassembly as described in any one of the clauses 1 to 21.

[0171] 23. A method for operating a drug delivery device including a drug delivery device cassette unit and a drive unit, wherein the drug delivery device cassette unit includes a main body and a carrier, and the method comprises the following sequence of steps: The steps include providing a drug delivery device cassette unit, The steps include providing a drive unit and The steps include using the drive unit to move the carrier of the drug delivery device cassette unit along its longitudinal axis relative to the main body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on the drive unit, Methods that include...

[0172] 24. The method according to Clause 23, wherein the step of using a drive unit to move the carrier of a drug delivery device cassette unit along the longitudinal axis relative to the body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on a drive unit includes the steps of moving the drug delivery device cassette unit in the direction of the longitudinal axis relative to the drive unit and rotating the drug delivery device cassette unit about the longitudinal axis relative to the drive unit.

[0173] 25. The step of using a drive unit to move the carrier is: The steps include connecting the carrier to a part of the drive unit, The steps include moving the carrier while rotating the drug delivery device cassette unit around the longitudinal axis relative to the drive unit, The method described in Clause 24, including the method described in Clause 24.

[0174] 26. The method according to any one of the clauses 23 to 25, wherein the step of using a drive unit to move the carrier of a drug delivery device cassette unit along its longitudinal axis relative to the body of the drug delivery device cassette unit until the drug delivery device cassette unit is mounted on the drive unit includes the step of using the movement of the carrier relative to the body to establish a fluid connection between the delivery member and the drug container while the drug delivery device cassette unit is mounted on the drive unit.

[0175] Other aspects of the present invention are described in the following sections.

[0176] 1. A subassembly of a drug delivery device cassette unit, the subassembly comprising a tubular body, a delivery member guard, and a rotator, The tubular main body extends along the longitudinal axis between the proximal and distal ends, and the tubular main body is tubular in shape. The delivery member guard is retractably arranged within the tubular main body, and the delivery member guard includes a surface oriented distally. The rotator is prevented from moving in any direction along its longitudinal axis by a tubular body, and the rotator includes a proximal oriented surface. A subassembly comprising a rotator configured to be rotated by the drive unit of a drug delivery device when the drug delivery device cassette unit is mounted on the drive unit, the rotator being able to rotate relative to the delivery member guard from a locked position to an unlocked position, in which the distally oriented surface of the delivery member guard is aligned with the proximally oriented surface of the rotator, and in the unlocked position the distally oriented surface of the delivery member guard is not aligned with the proximally oriented surface of the rotator, allowing the delivery member guard to move freely distally relative to the rotator.

[0177] 2. The rotator is a subassembly as described in Clause 1, including a tubular rotator body.

[0178] 3. The subassembly according to Clause 1 or 2, wherein the rotator includes a ledge portion extending radially with respect to the longitudinal axis, the ledge portion being configured to engage with a portion of the drive unit, so that when the drive unit rotates with respect to the tubular body portion of the subassembly, the rotator rotates together with the drive unit with respect to the tubular body portion of the subassembly.

[0179] 4. The subassembly according to Clause 1 or 2, wherein the rotator includes a ledge portion extending from a first end to a second end in a helical direction with respect to the longitudinal axis, the ledge portion being configured to engage with a portion of a drive unit, and the rotator is rotated as the drive unit of the drug delivery device moves axially with respect to the rotator from a distal position to a proximal position, with the portion of the drive unit adjacent to the first end of the ledge portion at the distal position and the portion of the drive unit adjacent to the second end of the ledge portion at the proximal position.

[0180] 5. The subassembly according to Clause 1 or 2, comprising a locking member, the locking member being rotatably fixed to the tubular body, one of the rotator and the locking member comprising a projection extending radially with respect to the longitudinal axis, the other of the rotator and the locking member comprising a ledge adjacent to the projection, the ledge extending spirally with respect to the longitudinal axis from a first end to a second end, the locking member being axially movable relative to the rotator from a distal position where the projection is adjacent to the first end of the ledge to a proximal position where the projection is adjacent to the second end of the ledge, the locking member being configured to engage with a portion of a drive unit, such that when the drive unit of the drug delivery device moves axially relative to the tubular body, the locking member moves with the drive unit, thereby causing the rotator to rotate by the engagement between the projection and the ledge.

[0181] 6. A subassembly according to any one of Clauses 1 to 5, wherein one of the rotator and the delivery member guard includes a projection, and the other of the rotator and the delivery member guard includes a cutout or recess, and the distally oriented surface of the delivery member guard and the proximally oriented surface of the rotator are defined by the projection and the cutout or recess, respectively.

[0182] 7. A cutout or recess is located on the tubular body of the rotator, as described in Clause 6 by reference to Clause 2, or as described in Clause 6, which is dependent on Clause 2 and by reference to any one of Clauses 3 through 5.

[0183] 8. The ledge portion is a subassembly extending radially from the tubular body of the rotator with respect to the longitudinal axis, as described in any one of clauses 3 to 5 as referenced in clause 2, or as described in any one of clauses 3 to 5 as referenced in clause 6 to 7, which is subordinate to clause 2.

[0184] 9. A subassembly as described in any one of Clauses 3 to 5 by reference to Clause 2, or as described in any one of Clauses 3 to 5 by reference to Clause 2 and Clause 6 or 7, wherein the second cutout or recess is located on the tubular body of the rotator, and the ledge is defined by the edge of the second cutout or recess.

[0185] 10. A circumferential ledge is a subassembly described in any one of clauses 3 to 5 or 8 to 9, or in clause 6 or 7, as referenced from any one of clauses 3 to 5, extending circumferentially with respect to the longitudinal axis from the second end of the ledge.

[0186] 11. The first end of the ledge portion includes a longitudinal part extending in the direction of the longitudinal axis, as described in any one of clauses 3 to 5 or 8 to 10, or as described in clause 6 or 7, by reference to any one of clauses 3 to 5.

[0187] 12. A subassembly as described in Clause 5, or any one of Clauses 6 to 11 as referenced from Clause 5, comprising a biasing member extending along a longitudinal axis between a proximal end and a distal end, wherein the delivery member guard comprises a distally oriented surface, the locking member comprises a proximal oriented surface, the proximal end of the biasing member is adjacent to the distally oriented surface of the delivery member guard, and the distal end of the biasing member is adjacent to the proximal oriented surface of the locking member.

[0188] 13. A subassembly according to any one of Clauses 1 to 12, wherein the tubular body includes a fastener on the outer surface of the tubular body for attachment to a part of a drug delivery device.

[0189] 14. The fastener is a bayonet connector, as described in Clause 13.

[0190] 15. A locking member comprising a locking member body and a flange extending from the locking member body, wherein the flange protrudes from the outer surface of the tubular body and is positioned next to the fastener, as described in Clause 13 or 14 as referenced by Clause 5, or as described in Clause 13 or 14 as referenced by any one of Clauses 6 to 12 as referenced by Clause 5.

[0191] 16. A subassembly as described in Clause 15, by reference to Clause 14, wherein the flange is offset circumferentially with respect to the longitudinal axis of the bayonet connection of the tubular body.

[0192] 17. A subassembly according to any one of Clauses 1 to 16, wherein the tubular body includes a flexible arm extending from the distal end of the tubular body toward the proximal end of the tubular body, the flexible arm including a hook extending radially with respect to the longitudinal axis and a lock projection extending radially outward from the tubular body with respect to the longitudinal axis.

[0193] 18. A subassembly as described in Clause 17 as referenced in Clause 5, or as described in Clause 17 as referenced in any one of Clauses 6 to 12 as referenced in Clause 5. The locking member includes a locking member body, the cutout or recess is located within the wall of the locking member body, the hook of the flexible section of the tubular body is configured to be positioned within the cutout or recess, the locking projection of the flexible section is configured to engage with a portion of the driver unit of the drug delivery device, and when the tubular body is attached to the drive unit of the drug delivery device, the section of the drive unit presses the locking projection inward relative to the tubular body, so that the hook bends outward from the cutout or recess.

[0194] 19. A drug delivery device cassette unit comprising a subassembly as described in any one of clauses 1 to 18.

[0195] 20. A method for operating a drug delivery device including a drug delivery device cassette unit and a drive unit, wherein the drug delivery device cassette unit includes a tubular body, a delivery member guard, and a rotator, and the method comprises the following sequence of steps: The steps include providing a drug delivery device cassette unit, The steps include providing a drive unit and The step of using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit while the drug delivery device cassette unit is being attached to the drive unit, Methods that include...

[0196] 21. The method according to Clause 20, wherein the step of using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit while the drug delivery device cassette unit is mounted on the drive unit includes the following steps in sequence: moving the drug delivery device cassette unit along its longitudinal axis relative to the drive unit, and rotating the drug delivery device cassette unit about its longitudinal axis relative to the drive unit.

[0197] 22. While the drug delivery device cassette unit is being attached to the drive unit, the step of using the drive unit to rotate the rotator of the drug delivery device cassette unit relative to the tubular body of the drug delivery device cassette unit is: The steps include establishing a connection between the rotator and a part of the drive unit, A step of rotating a drug delivery device cassette unit around its longitudinal axis relative to a drive unit, wherein the rotator is rotated by the drive unit through a connection between the rotator and the drive unit, and The method described in Article 21, including the method described in Article 21.

[0198] 23. The step of establishing a connection between the rotator and a part of the drive unit is: The steps include indirectly connecting the rotator to a part of the drive unit via the locking member of the drug delivery device cassette unit, A step of rotating a drug delivery device cassette unit about a longitudinal axis relative to a drive unit, wherein the locking member is moved axially by the drive unit in the proximal direction of the rotator, thereby causing the rotator to rotate by the locking member. The method described in Article 22, including the method described in Article 22. [Explanation of Symbols]

[0199] 1, 1', 1" tubular main body 10 Outer shell 10a Snap Arm 10b Inner ledge 11, 11' Distal lid 12 windows 13 Bayonet connector 14 Flexible Section 14a Locking protrusion 14b Hook 15 Reinforced wall section 16 groove 17 recess 18. Proximal Ledge 2, 2', 2" tubular carrier 20 Carrier main unit 20a Snap-fit ​​recess, cutout 20b Support Finger 21 Carrier Cap 22 Ledge section 22a Surface oriented proximal to the surface 23 Arms 24 flange 24a, 24a' Surfaces oriented distally 25, 25' protrusion 26 cutouts, recesses 3. Delivery Member Guard 30 Front Shield 31 Arm 33 Proximal wall 33b Posterior surface 34 Surfaces oriented distally 35 Protrusion 36 Flexible Section 4, 4' Rotator 40 Rotator main body 40a Proximal margin 41 Proximal oriented surface 410 Cutout, Recess 42 Ledge section 42a First end 42b Second end 43, 43' Bridge surface 44 tracks 45 Lockout Section 45a Blocking surface 46 Longitudinal parts 47 Circumferential ledge section 5. Delivery Member Assembly 50 Delivery members 50a Flexible sheath 50b flexible sheath 51 Delivery component holder 51a Fastener 6. Biasing member C Cassette Unit D Drive Unit D0 Counterbayonet Connector D1 Proximal margin L Longitudinal axis M Drug Container

Claims

1. A subassembly of a drug delivery device cassette unit, wherein the subassembly is: A tubular body portion (1, 1', 1") for attachment to a drive unit (D) of a drug delivery device, wherein the tubular body portion (1, 1', 1") extends along the longitudinal axis between the proximal end and the distal end, A tubular carrier (2, 2', 2") for holding a drug container (M), wherein the tubular carrier (2, 2', 2") is at least partially disposed within the tubular body (1, 1', 1"), the tubular carrier (2, 2', 2") and the tubular body are coaxial, the tubular carrier (2, 2', 2") is movable relative to the tubular body (1, 1', 1") along the longitudinal axis, and the tubular carrier (2, 2', 2") includes distally oriented surfaces (24a, 24a') for contacting the drive unit (D) of the drug delivery device when the tubular body (1, 1', 1") is attached to the drive unit (D) of the drug delivery device, Includes, The tubular body portion (1, 1', 1") includes a flexible section at the distal end of the tubular body portion (1, 1', 1"), the flexible section includes a hook extending radially with respect to the longitudinal axis and a lock projection extending radially away from the tubular body portion (1, 1', 1") with respect to the longitudinal axis, the tubular carrier (2, 2', 2") includes a carrier body portion, the cutout or recess being located within the wall portion of the carrier body portion, the flexible section being movable relative to the tubular body portion between an engaged position and a released position, the hook of the flexible section being positioned within the cutout or recess of the tubular carrier in the engaged position, and the hook of the flexible section being positioned outside the cutout or recess of the tubular carrier (2, 2', 2") in the released position. The flexible section of the tubular body is a subassembly that moves from the engaged position to the released position when the locking projection of the flexible section is pressed from the outside of the tubular body.

2. The subassembly according to claim 1, wherein the tubular carrier is engaged with the tubular main body through engagement of the groove and ledge portions.

3. The subassembly according to claim 2, wherein the tubular carrier includes a ledge portion extending radially with respect to the longitudinal axis from the outer surface of the wall portion of the tubular carrier, a groove portion is positioned on the inner wall portion of the tubular body portion, and the ledge portion is positioned within the groove portion.

4. The subassembly according to any one of claims 1 to 3, wherein the tubular carrier is configured to immobilely hold the drug container of the drug delivery device.

5. The subassembly according to claim 1, wherein the subassembly includes a delivery member assembly, the delivery member assembly includes a delivery member and a delivery member holder, the delivery member is attached to the delivery member holder, and the delivery member holder is attached to the proximal end of the tubular main body.

6. The subassembly according to claim 5, wherein the tubular carrier is movable axially with respect to the delivery member assembly between a distal position and a proximal position, the tubular carrier is configured to hold the drug container in a non-fluid connection with the delivery member when the tubular carrier is in the distal position, and the tubular carrier is configured to hold the drug container in a fluid connection with the delivery member when the tubular carrier is in the proximal position.

7. The subassembly according to claim 1, comprising a delivery member guard that is expandable and retractable within the tubular main body, and a biasing member that extends along the longitudinal axis between a proximal end and a distal end, wherein the delivery member guard includes a distally oriented surface adjacent to the proximal end of the biasing member.

8. The subassembly according to claim 7, wherein the tubular main body portion includes a surface adjacent to the distal end of the biasing member and oriented proximal.

9. The subassembly according to claim 1, wherein the tubular carrier includes a flange extending in a direction transverse to the longitudinal axis, the distally oriented surface is defined by the flange, and the flange extends outward from the tubular body.

10. The subassembly according to claim 1, wherein the tubular body portion includes a fastener on the outer surface of the tubular body portion for attachment to a part of a drug delivery device.

11. The subassembly according to claim 10, wherein the fastener is a bayonet connector.

12. The subassembly according to claim 9, wherein the tubular body includes a fastener on the outer surface of the tubular body for attachment to a part of a drug delivery device, and the flange of the tubular carrier is positioned next to the fastener.

13. The subassembly according to claim 1, wherein the tubular carrier (2, 2', 2") is movable by the drive unit (D) in the direction of the longitudinal axis from the distal position to the proximal position relative to the tubular main body (1, 1', 1") when the distally oriented surface (24a, 24') is in contact with the drive unit (D) of the drug delivery device.

14. The subassembly according to claim 13, wherein the tubular body portion includes a fastener on the outer surface of the tubular body portion for attachment to a part of a drug delivery device, and the distally oriented surfaces (24a, 24') are in contact with the drive unit (D) of the drug delivery device when the tubular body portion is attached to a part of the drug delivery device via the fastener.

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