Subassemblies for drug delivery devices

Abstract

A subassembly (11, 11') for a medicament delivery device (1) configured to expel a medicament from a medicament container (15) via a delivery member (22). The subassembly (11, 11') comprises a housing (3, 3') having a proximal end (3a) and a distal end (3b, 3'b), a retaining sleeve (9, 9') biased towards the proximal end (3a) of the housing (3, 3') and comprising locking members (30, 31), a pre-tensioned plunger rod (13) operatively configured to act on a medicament container (15) to expel a medicament when activated, and an actuator (17) having arms (17a, 17b) configured to lock the plunger rod (13) in its pre-tensioned state and configured operatively to move the arms to release the plunger rod (13) when activated, wherein the retaining sleeve (9, 9') is operatively configured to move proximally during a lockout operation in which the retaining sleeve (9, 9') is axially locked by the locking members (30, 31).

Description

Technical Field

[0001] The present disclosure generally relates to a drug delivery device for discharging a drug from a flexible drug container. Specifically, the present disclosure relates to a sub-assembly for a drug delivery device.

Background Art

[0002] In some medical conditions, it is necessary to provide drugs from a drug delivery device with high reliability. The drug is usually contained in a drug container within the drug delivery device, and the drug container is configured to discharge the drug by some type of delivery member such as a needle or a nozzle.

[0003] In recent years, there are several different drug delivery devices including various types of syringes (e.g., pen syringes, auto-injectors, on-body devices, etc.). Many of these devices enable many improvements in the management of some medical conditions, but there are still various drawbacks in the current technology.

[0004] Many drug delivery devices have components that are movable relative to each other. One type of relative movement between components can activate the drug delivery device, for example, by exposing a delivery member from the drug delivery device or initiating drug dispensing. Another type of relative movement between components can fix two components relative to each other, for example, in the axial or radial direction, by fixing one component to the other, or by using a locking element. Fixing components relative to each other to avoid relative movement is often desirable after the drug delivery device has been used. That is, relative movement between components is undesirable in the final state of the drug delivery device, and such relative movement can result in unintended operation of the drug delivery device. Such unintended operation may be, for example, a result of unsatisfactory relative fixing of components. Considering these issues, the applicant understands that various developments can be made to improve drug delivery devices in the current market, which will be described in more detail below. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] The purpose of this disclosure is therefore to provide a drug delivery device that solves, or at least mitigates, the problems of the prior art. [Means for solving the problem]

[0006] Accordingly, according to a first aspect of the present disclosure, a subassembly for a drug delivery device configured to dispense a drug from a drug container via a delivery member is provided, the subassembly comprising: a housing having a proximal end and a distal end; a retaining sleeve biased toward the proximal end of the housing and having a locking member; a pre-tensioned plunger rod configured to act on a drug container to dispense a drug when activated; and an actuator having an arm configured to lock the plunger rod in its pre-tensioned state, and configured to move the arm to release the plunger rod when activated, wherein the retaining sleeve has a surface configured to abut against the arm of the actuator and restrict the movement of the arm of the actuator, thereby locking the plunger rod in its pre-tensioned state; the retaining sleeve is configured to move distally during a drug delivery operation, thereby allowing the arm of the actuator to move past the end of the retaining sleeve and release the plunger rod; and the retaining sleeve is configured to move proximal during a lockout operation in which the retaining sleeve is axially locked by the locking member.

[0007] The resulting effect is an improved lockout of the retaining sleeve. That is, after use, the retaining sleeve is configured to a final state where it is locked axially. Therefore, the retaining sleeve cannot move axially after the lockout operation. Because the retaining sleeve is locked axially, it prevents the movement of other components directly linked to the axial movement of the retaining sleeve.

[0008] 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 portion / end” is used, it refers to a portion / end of the delivery device or a portion / end of its component, which is located furthest 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 toward the dose delivery site during use of the drug delivery device. When the term “proximal portion / end” is used, it refers to a portion / end of the delivery device or a portion / end of its component, which is located closest to the dose delivery site during use of the drug delivery device.

[0009] Furthermore, the terms “longitudinal,” “axial,” or “axial” refer to the direction extending from the proximal end to the distal end, typically the direction along the device or its components that extends the longest.

[0010] Similarly, the terms “lateral,” “lateral,” and “laterally” generally refer to a direction perpendicular to the longitudinal direction.

[0011] Furthermore, the terms “circumferential,” “circumferential,” and “circumferentially” typically refer to the circumference or circumferential direction relative to an axis, which is the central axis extending in the direction in which the device and / or component extends the longest. Similarly, “radial” or “radially” refers to the direction extending radially relative to an axis, and “rotational,” “rotational,” and “rotationally” refer to rotation relative to an axis.

[0012] According to one embodiment, the subassembly further comprises a lockout structure configured to interact with a locking member by lock engagement to lock the retaining sleeve axially. Thus, the locking member of the retaining sleeve can lock engage with the lockout structure to lock the retaining sleeve axially. Preferably, the lockout structure is located on a component or structure of the subassembly that is different from the retaining sleeve.

[0013] According to one embodiment, the lockout structure is included in the actuator or housing. The retaining sleeve is typically located between the housing and the actuator; therefore, the retaining sleeve is located radially inward of the housing and radially outward of the actuator, or outside the arms of the actuator. Thus, by positioning the lockout structure on either the housing or the actuator, it is useful to lock the retaining sleeve axially, where applicable. That is, since the actuator and the housing are positioned adjacent to the retaining sleeve, the locking member and the lockout structure are composed of components of adjacent subassemblies. Therefore, when the retaining sleeve moves axially proximal within the housing, i.e., axially relative to the housing and / or actuator, the locking member engages with the lockout structure to lock the retaining sleeve axially.

[0014] According to one embodiment, the locking member is positioned on the portion of the retaining sleeve facing the actuator. Preferably, the lockout structure is included in the actuator, such as on the portion of the actuator facing the retaining sleeve. Thereafter, the locking member engages with the lockout structure to lock the retaining sleeve axially in a dependent state. The portion of the retaining sleeve facing the actuator can be called the inward-facing portion facing the central axis of the subassembly, and the portion of the actuator facing the retaining sleeve can be called the outward-facing portion facing away from the central axis of the subassembly.

[0015] According to one embodiment, the locking member is an axial rib. This provides a simple yet effective structure for providing a locking function. The axial rib has an axial extension and a radial extension, with the axial extension being greater than the radial extension. For example, the axial rib extends axially along the portion of the retaining sleeve facing the actuator and radially toward the actuator.

[0016] According to one embodiment, the actuator arm comprises an end hook having a first hook portion configured to lock the plunger rod in a pre-tensioned state, and a second hook portion located opposite the first hook portion, the second hook portion being configured to form a lockout structure and to interact with a locking member to axially lock the retaining sleeve. This provides a highly reliable structure for providing a lockout function. Furthermore, by providing the locking structure on the actuator arm, the actuator arm serves two purposes: firstly, to lock the plunger rod in a pre-tensioned state, and secondly, to axially lock the retaining sleeve by engaging with the locking member of the retaining sleeve to lock during the lockout operation.

[0017] According to one embodiment, the locking member is positioned on the portion of the retaining sleeve facing the housing. Therefore, preferably, the lockout structure is provided on the housing, such as on the portion of the housing facing the retaining sleeve. As a result, the locking member engages with the lockout structure to reliably lock the retaining sleeve in the axial direction. The portion of the retaining sleeve facing the housing can be called the outward-facing portion that faces away from the central axis of the subassembly, and the portion of the housing facing the retaining sleeve can be called the inward-facing portion that faces in the direction of the central axis of the subassembly.

[0018] According to one embodiment, the housing is configured to have an opening that forms a lockout structure, receiving a locking member to axially lock the retaining sleeve. This provides a highly reliable structure that offers a lockout function. The locking member is preferably configured as a locking projection or resilient projection extending radially outward from the portion of the retaining sleeve facing the housing. Furthermore, by providing a locking structure within the housing, the housing serves two purposes: firstly, to accommodate the components of a subassembly, and secondly, to axially lock the retaining sleeve by engaging with the locking member of the retaining sleeve to lock during the lockout operation.

[0019] According to one embodiment, the locking member is configured to operate to snap into the opening of the housing. This provides a simple yet reliable lockout function. For example, as previously mentioned, the locking member is preferably configured as a projection or resilient projection extending radially outward from the portion of the retaining sleeve facing the housing. When the retaining sleeve moves proximal in the axial direction, the projection or resilient projection is guided along the inner surface of the housing until it encounters the opening of the housing, thereby snapping into the opening of the housing. This locks the retaining sleeve in the axial direction.

[0020] According to one embodiment, the retaining sleeve is biased toward the proximal end of the housing by a distal elastic member, and the distal elastic member presses the retaining sleeve against the actuator or housing via a locking member during the lockout operation. Thus, the biasing force in the proximal direction is transmitted to the actuator or housing via the retaining sleeve, the locking member, and the lockout structure.

[0021] According to one embodiment, the subassembly further comprises a drive spring that biases the plunger rod toward the proximal end of the housing. This allows the plunger rod to be axially fixed in a first axial position relative to the housing by the actuator and actuator arm, and when the plunger rod is released from its first axial position, it can be released from the first axial position and moved axially inward of the housing due to the biasing force from the drive spring.

[0022] According to one embodiment, the subassembly further comprises a delivery member cover positioned in a housing and extending proximal to the proximal end of the housing, wherein the delivery member cover is configured to move linearly relative to the housing from an extended position to a retracted position where the delivery member cover is further received by the housing during drug delivery. After such drug delivery, the delivery member cover is configured to move axially in the proximal direction to be extended again. This protects the delivery member inside the delivery member cover.

[0023] According to one embodiment, in the retracted position of the delivery member cover, the proximal end of the delivery member cover is positioned closer to the proximal end of the housing compared to the extended position. For example, in the retracted position, the proximal end of the delivery member cover is separated from the proximal end of the housing by a first axial distance, and this first axial distance is smaller than the second axial distance between the proximal end of the delivery member cover and the proximal end of the housing in the extended position.

[0024] According to one embodiment, the retention sleeve is fixedly attached to the delivery member cover. Thereby, axial lockout of the delivery member cover is provided. For example, the retention sleeve is fixed axially and rotationally relative to the delivery member cover, and thus is axially movable together with the delivery member cover. After the drug delivery operation, the delivery member cover is axially locked in its extended position, and the delivery member in the delivery member cover can be safely protected. That is, after use, the retention sleeve is arranged in a final state that is axially locked together with the delivery member cover. Therefore, the retention sleeve and the delivery member cover cannot move axially after the lockout operation. Since the delivery member cover is axially locked, the delivery member is prevented from being exposed again.

[0025] According to a second aspect of the present disclosure, there is provided a drug delivery device for discharging a drug from a drug container through a delivery member, the drug delivery device comprising a sub-assembly according to the first aspect of the present disclosure.

[0026] The effects and features of the second aspect of the present invention are largely similar to those described above with respect to the first aspect of the present invention. The embodiments described with respect to the first aspect of the present invention are largely compatible with the second aspect of the present invention.

[0027] Generally, all terms used in the claims are to be construed according to their ordinary meaning in the technical field, unless otherwise explicitly defined herein. All references to "a / an / the member, device, component, means, etc." are to be construed openly as referring to at least one example of the member, device, component, means, etc., unless otherwise explicitly stated in another form.

[0028] Specific embodiments of the concepts of the present invention are described below by way of example, with reference to the accompanying drawings.

Brief Description of the Drawings

[0029] [Figure 1]This is a schematic perspective view of an example of a drug delivery device. [Figure 2] Figure 1 is an exploded view of a drug delivery device. [Figure 3A] Figure 2 is a detailed cross-sectional view of at least a portion of the drug delivery device subassembly, showing the subassembly in its pre-activation-blocked state. [Figure 3B] This figure shows the partial assembly of Figure 3A with the delivery member cover in its extended position and in the activated state. [Figure 3C] This figure shows the partial assembly of Figure 3A with the delivery member cover in its retracted position. [Figure 4A] This is a cross-sectional view of the drug delivery device in its initial state after the cap has been removed. [Figure 4B] This is a cross-sectional view of a drug delivery device in the activated state at the start of drug delivery operation. [Figure 4C] This is a cross-sectional view of a drug delivery device during drug delivery operation. [Figure 4D] This is a cross-sectional view of the drug delivery device after the drug delivery operation. [Figure 5A] Figure 2 is a detailed cross-sectional view of at least a portion of another subassembly of the drug delivery device. [Figure 5B] This is a cross-sectional view taken in a plane at a 90-degree angle to the cross-sectional view shown in Figure 5A. [Figure 5C] This is a detailed cross-sectional view of at least a portion of yet another subassembly of a drug delivery device. [Modes for carrying out the invention]

[0030] The concept of the present invention is then described more fully below with reference to the accompanying drawings illustrating exemplary embodiments. However, the concept of the present invention can be carried out in many different forms and should not be construed as being limited to the embodiments described herein, but rather these embodiments are provided as examples so that this disclosure may be sufficient and complete and so as to fully convey the scope of the concept of the present invention to those skilled in the art. Similar numbers refer to similar components throughout this description.

[0031] Figure 1 shows an example of a drug delivery device 1 configured to dispense a drug from a drug container 15 mounted in a housing 3 of the drug delivery device 1. The housing 3 has a proximal end 3a and a distal end 3b, as well as a window 3c, or opening, located between the proximal end 3a and the distal end 3b for visual inspection of the drug container 15.

[0032] The drug delivery device 1 includes a delivery member cover 5. The delivery member cover 5 is located in the housing 3 and extends proximal from the proximal end 3a of the housing 3. The drug delivery device 1 further includes a cap 2 that is removably located on the delivery member cover 5.

[0033] The delivery member cover 5 is configured to move linearly or axially relative to the housing 3, from the extended position shown in Figure 1 to a retracted position where the delivery member cover 5 is further received within the housing 3. Typically, the delivery member cover 5 is biased proximally toward the extended position.

[0034] The drug delivery device 1 is triggered to release the drug by further movement of the delivery member cover 5 into the housing 3 toward the retracted position.

[0035] Figure 2 shows an exploded view of the drug delivery device 1. First, the overall configuration of the drug delivery device 1 is described, and then various embodiments and some aspects of the subassemblies 10, 11, 11' are described in more detail. The subassemblies of the drug delivery device 1 can be defined by combining specific components of the drug delivery device 1.

[0036] The drug delivery device 1 comprises a drug container carrier 4 extending along the longitudinal axis from a proximal end 4a to a distal end 4b. The drug container carrier 4 can preferably be fixedly attached to the housing 3 of the drug delivery device 1, for example, by a snap lock or other conventional engaging means. Alternatively, the drug container carrier 4 can form an integral part of the housing 3. The drug container carrier 4 and the housing 3 can preferably be made from the same material, for example, plastic. The drug container carrier 4 is configured to house and support a drug container 15 inside the drug delivery device 1. The drug container carrier 4 further comprises an activation lock 6, which is further described with reference to Figures 3A to 3C.

[0037] The drug delivery device 1 comprises a delivery member cover 5 as described with reference to Figure 1. The delivery member cover 5 has a proximal end 5a and a distal end 5b. The activation lock 6 of the drug container carrier 4 is preferably located between the proximal end 5a and the distal end 5b of the delivery member cover 5.

[0038] The drug delivery device 1 comprises a cap 2 as described with reference to Figure 1. The cap 2 is detachably positioned relative to the delivery member cover 5. In the embodiment shown in Figure 2, the cap 2 comprises a gripping portion 2b and a projection 2a extending longitudinally distal to the gripping portion 2b. The gripping portion 2b has a gripping surface that a user can interact with to remove the cap 2 from the delivery member cover 5. In Figure 2, the projection 2a is a protruding sleeve 2a. The protruding sleeve 2a extends distally in the longitudinal direction.

[0039] The drug delivery device 1 includes a plunger rod 13 configured to move proximal when activated. Thus, in the embodiment shown in Figure 2, the plunger rod 13 is configured to move axially inside the housing 3 and inside the drug container carrier 4. During drug delivery, the plunger rod 13 moves from a first axial position toward the drug container 15 to dispense the drug. The plunger rod 13 may have a cylindrical body.

[0040] The drug delivery device 1 includes a drive spring 12 configured to bias the plunger rod 13 in the proximal direction. In the embodiment shown in Figure 2, the plunger rod 13 is fixed in a first axial position axially relative to the drug container carrier 4 and housing 3 when the delivery member cover 5 is in the extended position prior to the drug delivery operation.

[0041] The drug delivery device 1 has an arm 17a configured to lock a plunger rod 13 in a pre-tensioned state, and also includes an actuator 17 configured to move the arm 17a to release the plunger rod 13 when activated. To release the plunger rod 13, the delivery member cover 5 moves axially to its retracted position, and the distal end 5b of the delivery member cover 5 is configured to engage with the actuator 17 to move the arm and release the plunger rod 13. This is further illustrated with reference to Figures 4A to 4D.

[0042] The drug delivery device 1 includes a retaining sleeve 9 configured to move axially with the delivery member cover 5 inside the housing 3. Thus, the retaining sleeve 9 can be fixed axially and rotationally with respect to the delivery member cover 5. When the delivery member cover 5 moves from the extended position to the retracted position, the linear movement of the delivery member cover 5 is converted into the linear movement of the retaining sleeve 9. The retaining sleeve 9 has a surface configured to abut against the arm 17a of the actuator 17, locking the plunger rod 13 in its pre-tensioned state. The retaining sleeve 9 is configured to move distally when the delivery member cover 5 is pushed into its retracted position, allowing the end 9a of the retaining sleeve 9 to pass through, releasing the arm 17a of the actuator 17 and releasing the plunger rod 13. This is further illustrated with reference to Figures 4A to 4D.

[0043] The drug delivery device 1 includes a distal elastic member 20. The distal elastic member 20 can be, for example, a spring such as a coil spring. The distal elastic member 20 is configured to bias the delivery member cover 5 in the proximal direction. In the embodiment shown in Figure 2, the distal elastic member 20 is configured to bias the delivery member cover 5 via a retaining sleeve 9.

[0044] The drug delivery device 1 includes a rear end 19 at the distal end 3b of the housing 3, which is configured to close the housing 3.

[0045] The drug delivery device 1 can be equipped with a drug container 15. The drug container 15 typically comprises a delivery member 22, such as a needle 22, and a ring needle shield (RNS) 23 configured to protect the delivery member 22. The drug container 15 may further comprise an RNS needle cover and an RNS plastic cap (not shown). The protruding portion 2a of the cap 2 may be configured to remove the RNC 23 when the cap is removed from the delivery member cover 5, and can therefore be called an RNS remover.

[0046] Figure 3A shows a detailed cross-sectional view of at least a portion of a subassembly 10 of the drug delivery device 1 of Figure 2. The subassembly 10 comprises at least a drug container carrier 4, a delivery member cover 5, and a cap 2. In the detailed view of Figure 3A, the activation lock 6 of the drug container carrier 4 is shown adjacent to a protrusion 2a, i.e., a protruding sleeve 2a, of the cap 2. In Figure 3A, the subassembly 10 is shown in a pre-activation-blocked state, in which the protrusion 2a is adjacent to the activation lock 6 so as to prevent radially inward movement of the activation lock 6, thereby preventing axial movement of the delivery member cover 5 to its retracted position. More specifically, a space 80 is located adjacent to the activation lock 6, and in the pre-activation-blocked state shown in Figure 3A, the protrusion 2a is positioned in this space 80 so that any radially guided movement of the activation lock 6 is stopped by the protrusion 2a. As shown in Figure 3A, the distal surface 5c of the delivery member cover 5 is configured to abut against the activation lock 6, thereby preventing axial movement of the delivery member cover 5 beyond the activation lock 6. The distal surface 5c partially defines the sleeve portion of the delivery member cover 5, and is positioned circumferentially over the sleeve portion. More specifically, the activation lock 6 comprises a proximal surface 6a that is axially aligned with the distal surface 5c. The alignment of the proximal surface 6a and the distal surface 5c prevents axial movement of the delivery member cover 5 to its retracted position.

[0047] Referring to Figure 3B, which shows the same detailed cross-section as in Figure 3A, the cap 2 is in the activated state, removed from the delivery member cover 5. Removing the cap 2 causes the protrusion 2a to be withdrawn from the space 80. Furthermore, the RNS 23 is removed from the drug container 15 along with the protrusion 2a, thereby removing the cover of the delivery member 22. In Figure 3B, the space 80 is configured to receive the activation lock 6. Thus, the radially guided force applied to the activation lock 6 causes the activation lock 6 to move radially inward into the space 80, thereby allowing the delivery member cover 5 to move axially to its retracted position (shown in Figure 3C). Thus, the partial assembly 10 can move from the pre-activation-blocked state shown in Figure 3A, i.e., the protrusion 2a is adjacent to the activation lock 6 and the activation lock 6 is prevented from moving radially inward, to the activation-enabled state shown in Figure 3B, i.e., the activation lock 6 can move radially, thereby allowing the delivery member cover 5 to move axially to its retracted position.

[0048] More specifically, the activation lock 6 is flexible and configured to move radially by bending inward toward the central axis of the subassembly 10. Preferably, the activation lock 6 forms part of the proximal end 4a of the drug container structure 4. As shown in Figure 3B, the activation lock 6 comprises two longitudinal arms 4c, 4d positioned opposite each other and extending proximal from the main portion of the drug container carrier. Each of the longitudinal arms 4c, 4d is configured to have a corresponding proximal-facing surface 6a and to move radially by bending inward toward the central axis of the subassembly 10. The main portion of the drug container carrier is configured to house the main body of the drug container 15. Each of the two longitudinal arms 4c, 4d positioned opposite each other has an end positioned to bend toward the space 80.

[0049] As shown in Figure 3B, each of the proximal-facing surfaces 6a is at least partially chamfered. This facilitates the operation of pushing the activation lock 6 into space 80. That is, by at least partially chamfering each of the proximal-facing surfaces 6a, externally applied forces in the distal direction can be at least partially converted into radial forces due to the interaction between the distal-facing surface 5c and the proximal-facing surface 6a. As shown in Figure 3B, the proximal-facing surface 6a is chamfered so as to be inclined away from the distal-facing surface 5c.

[0050] Typically, the proximal end 5a of the delivery member cover 5 receives an externally applied force that moves the delivery member cover 5 distally in the axial direction, and thus the distally facing surface 5c abuts against the activation lock 6 and the proximal facing surface 6a, pushing the activation lock 6 into the space 80. Thus, the force applied from the distally facing surface 5c forces the activation lock 6 to move radially inward into the space 80. Thus, the distally facing surface 5c can move distally beyond the activation lock 6, thereby moving the delivery member cover 5 to its retracted position. Such a configuration is shown in Figure 3C. In the retracted position of the delivery member cover 5, the delivery member 22 is exposed and ready for dispensing the drug. As shown in Figures 3B to 3C, the housing 3 is located outside the drug container carrier 4 and at least partially houses the delivery member cover 5. Therefore, the delivery member cover 5 is further configured to move linearly or axially relative to the housing 3, from the extended position shown in Figure 3B to the retracted position shown in Figure 3C, where the delivery member cover 5 is further received by the housing 3.

[0051] The operation of the drug delivery device 1 will now be described in more detail with reference to Figures 4A to 4D. The references are primarily to the drug delivery device 1, but some of its components may belong to either the subassembly 10 of the drug delivery device 1 described with reference to Figures 3A to 3C, or to the subassemblies 11, 11' described with reference to Figures 5A to 5C.

[0052] Figure 4A shows a cross-sectional view of the drug delivery device 1 in its initial state before drug delivery and after the removal of cap 2. Thus, the partial assembly 10 is configured to its activation-enabled state as described with reference to Figure 3B.

[0053] The delivery member cover 5 is in its extended position, biased proximal by the distal elastic member 20. The delivery member cover 5 is biased by the distal elastic member 20 via the retaining sleeve 9. The delivery member cover 5 covers the delivery member 22 of the drug container 15.

[0054] The plunger rod 13 is fixed axially to the drug container carrier 4 and housing 3 in a first axial position and is biased proximal by the drive spring 12.

[0055] The actuator 17 is configured such that arm 17a locks the plunger rod 13 in a pre-tensioned state. As shown in Figure 4B, the actuator 17 comprises two longitudinally extending arms 17a and 17b, positioned opposite each other and hereafter referred to as actuator arms 17a and 17b. Since the structure and function of the two actuator arms 17a and 17b are similar, sometimes only one of the actuator arms 17a and 17b is described. The actuator arms 17a and 17b are locked in place by retaining sleeves 9. As illustrated with reference to Figure 2, the surface of the retaining sleeves 9 is configured to abut against the actuator arms 17a and 17b, locking the plunger rod 13 in its pre-tensioned state. The retaining sleeves 9 engage with the distal end 5b of the delivery member cover 5, and thus the retaining sleeves 9 are fixed axially and can move together with the delivery member cover 5.

[0056] Figure 4B shows a cross-sectional view of the drug delivery device 1 in the activated state at the time of release of the plunger rod 13. The drug delivery device 1 is pushed by the operator against the injection site. The resulting externally applied force moves the delivery member cover 5 to its retracted position, exposing the delivery member 22 for tissue puncture, as also shown in Figure 3C. The proximal end 5a of the delivery member cover 5, in response to the externally applied force, moves the delivery member cover 5 distally in the axial direction, so that the distally facing surface 5c abuts against the activation lock 6 and the proximal facing surface 6a, pushing the activation lock 6 into the space 80, as described with reference to Figure 3C. The retaining sleeve 9 is fixed axially and can move with the delivery member cover 5. When the delivery member cover 5 moves to its retracted position, the retaining sleeve 9 moves distally, releasing the actuator arms 17a, 17b past the end 9a of the retaining sleeve 9 and releasing the plunger rod 13.

[0057] Figure 4C shows the drug delivery device 1 during drug delivery operation. The plunger rod 13 is released from the first axial position shown in Figure 4B and moves proximal toward the drug container 15. Thus, the plunger rod 13 moves axially toward the proximal end 3a of the housing 3 and toward the proximal end 4a of the drug container carrier 4 due to the biasing force from the drive spring 12. This proximal movement causes the plunger rod 13 to encounter the drug container 15 and push the contents of the drug container through the delivery member 22, thereby discharging the drug through the delivery member 22.

[0058] At the start of drug dispensing, the plunger rod 13 is axially positioned adjacent to the actuating arms 17a and 17b, and therefore the actuating arms 17a and 17b withstand the radially inward force applied by the retaining sleeve 9 and the biasing force from the distal elastic member 20 provided on the retaining sleeve 9. As the plunger rod 13 moves further proximal and the contents of the drug container 15 are released, the plunger rod 13 is no longer axially positioned adjacent to the actuating arms 17a and 17b, and the radially inward force applied by the retaining sleeve 9 and the biasing force from the distal elastic member 20 force the actuating arms 17a and 17b radially inward. This allows the retaining sleeve 9 to move proximal together with the delivery member cover 5, as shown in Figure 4D, to achieve lockout. Thus, Figure 4D shows the drug delivery device 1 when the actuating arms 17a and 17b are folded into the gap left by the plunger rod 13 (also shown in Figure 5B). As a result, the retaining sleeve 9 is moved proximal by a biasing force from the distal elastic member 20. The delivery member 22 is again covered by the delivery member cover 5, which represents the final state of the drug delivery device 1 after use. Thus, the delivery member cover 5 returns to its extended position. The drug delivery device 1 can be positioned in this final state, and the delivery member 22 can be protected inside the delivery member cover 5. The delivery member cover 5 is axially locked in the extended position by locking members 30, 31 and lockout structures 42, 50, as further described with reference to Figures 5A to 5C.

[0059] Figure 5A is a detailed cross-sectional view of at least a portion of the partial assembly 11 of the drug delivery device 1 shown in Figure 2. Figure 5B shows a cross-sectional view in a plane at a 90-degree angle to the cross-sectional view shown in Figure 5A. In Figures 5A and 5B, the final state of the drug delivery device 1 is shown, i.e., after use, with the drug dispensed from the drug container, corresponding to the state shown in Figure 4D.

[0060] As previously described, the partial assembly 11 comprises a housing 3 having a proximal end 3a and a distal end 3b. Figures 5A and 5B show only a portion of the housing 3 including the distal end 3b. The partial assembly 11 further comprises a retaining sleeve 9 biased proximally within the housing 3. The retaining sleeve 9 comprises a locking member 31 in the form of a locking projection 31 extending radially outward from the portion of the retaining sleeve 9c facing the housing 3.

[0061] The subassembly 11 comprises an actuator 17 having its actuator arms 17a, 17b, as previously described and best shown in Figure 5B. The subassembly 11 also comprises a plunger rod 13, which is moved proximal in Figures 5A and 5B to interact with a drug container (not shown). Thus, the plunger rod 13 is moved further proximal, and as the contents of either drug container 15 are released, the plunger rod 13 is no longer positioned axially adjacent to the actuator arms 17a, 17b in Figure 5B, and the radially inward force applied by the retaining sleeve 9 and the biasing force from the distal elastic member 20 forces the actuator arms 17a, 17b radially inward. This allows the retaining sleeve 9 to be positioned radially outward of the actuator arms 17a, 17b. Furthermore, when the support for the actuator arms 17a and 17b from the plunger rod 13 is removed, the actuator 17 is pushed by the drive spring 12 toward the distal end 3b of the housing 3. As the actuator 17 collides with the rear end 19 of the drug delivery device 1, audible and / or tactile feedback is achieved to the user.

[0062] Furthermore, the subassembly 11 may include a drive spring 12 that biases the plunger rod 13 toward the proximal end 3a of the housing 3. Thus, in Figures 5A and 5B, the retaining sleeve 9 is moved proximal during the lockout operation, in which case the retaining sleeve 9 is axially locked by the locking member 31, which here takes the form of a locking projection 31.

[0063] As shown in Figure 5A, the housing 3 includes a lockout structure 50 that interacts with a locking projection 31 in a locking engagement to lock the retaining sleeve 9 axially. More specifically, the lockout structure 50 is formed by an opening 50 in the housing. The opening 50 is configured to receive the locking projection 31 to lock the retaining sleeve 9 axially. That is, the locking projection 31 is positioned on the portion 9c of the retaining sleeve 9 facing the housing 3 so that the locking projection 31 can contact the opening 50 during the axial and proximal movement of the retaining sleeve 9 during the lockout operation. Preferably, the locking projection 31 is snap-fitted into the opening 50.

[0064] Figure 5C is a detailed cross-sectional view of at least a portion of another subassembly 11' of the drug delivery device. Since subassembly 11' in Figure 5C largely corresponds to subassembly 11 in Figures 5A and 5B, the differences will be mainly described below. Thus, subassembly 11' can form part of the drug delivery device 1 in Figure 2. For example, the actuator 17, plunger rod 13, and optionally the drive spring 12 of subassembly 11 in Figures 5A and 5B are included in subassembly 11' in Figure 5C. Figure 5C shows the final state of the drug delivery device, i.e., the post-use state, with the drug being dispensed from the drug container, corresponding to the state shown in Figure 4D.

[0065] The partial assembly 11' comprises a housing 3' having the proximal end 3'a and distal end described above, except that the housing 3' does not have a corresponding opening 50 for interacting with the locking member 31 of the retaining sleeve 9. The partial assembly 11' further comprises a retaining sleeve 9' in the housing 3' that is biased proximal. The retaining sleeve 9' largely corresponds to the retaining sleeve 9 in Figures 5A and 5B, but instead of having a locking member in the portion 9c facing the housing 3, the locking member 30 is configured in the portion 9'c of the retaining sleeve 9' that faces the actuator 17. In Figure 5C, the locking member 30 is formed by an axial rib 30. The axial rib extends axially and radially outward from the portion 9'c of the retaining sleeve 9'.

[0066] Each of the actuator arms 17a and 17b is provided with an end hook 40. Since the end hook 40 is the same as or corresponds to that of the two actuator arms 17a and 17b, it will be described only with respect to the first actuator arm 17a. The end hook 40 comprises a first hook portion 41 configured to lock the plunger rod 13 in its pre-tensioned state (corresponding to that shown in Figure 4A), and a second hook portion 42 configured on the opposite side of the first hook portion 41. The second hook portion 42 forms a lockout structure 42 and is therefore configured to interact with the axial rib 30 to lock the retaining sleeve 9' in the axial direction. The partial assembly 11 may comprise the same actuator 17 as shown in Figure 5B, having the first and second hook portions 41 and 42.

[0067] As shown in Figures 5A to 5C, the subassemblies 11, 11' may include the distal elastic member 20 described above. The distal elastic member 20 is configured to press the corresponding retaining sleeves 9, 9' against the actuator 17 (in the embodiment of Figure 5C) or to press the housing 3 via the locking members 30, 31 (in the cases of Figures 5A and 5B).

[0068] Furthermore, the subassemblies 11, 11' may include the previously described delivery member cover 5. Thus, the corresponding retaining sleeves 9, 9' are fixedly attached to the delivery member cover 5, thereby allowing the delivery member cover 5 to be locked axially during the lockout operation.

[0069] 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 may also be included within the scope of the concept of the present invention as defined by the appended claims. For example, the drive member may be motor-driven or manually driven instead of, for example, an automatic spring-mounted structure.

[0070] Several aspects are summarized in the following sections.

[0071] 1. A subassembly (10) for a drug delivery device (1), wherein the subassembly (10) is A drug container carrier (4) extends along the longitudinal axis from the proximal end (4a) to the distal end (4b) and is equipped with an activation lock (6), A delivery member cover (5) is positioned at least partially proximal to the drug container carrier (4) and is configured to move axially with respect to the drug container carrier (4) from an extended position to a retracted position, A cap (2) is provided near the delivery member cover (5), at least partially removable, and has a protruding portion (2a). Equipped with, The subassembly (10) is configured such that the protruding portion (2a) is adjacent to the activation lock (6), preventing the activation lock from moving radially and thereby preventing the delivery member cover (5) from moving axially to its retracted position. The subassembly (10) is configured such that the cap is removed, moving the protruding portion (2a) away from the activation lock (6), allowing the activation lock (6) to move radially, thereby moving the subassembly (10) to its retracted position.

[0072] 2. The partial assembly (10) described in Section 1, wherein the delivery member cover (5) has a distal surface (5c), and the activation lock (6) has a proximal surface (6a) that is axially aligned with the distal surface (5c) to prevent the delivery member cover (5) from moving axially to its retracted position in the prior activation prevention state.

[0073] 3. The subassembly (10) according to Section 1 or 2, wherein the activation lock (6) is flexible and, in the activation-permitted state, is configured to move radially by bending inward toward the central axis of the subassembly (10).

[0074] 4. A partial assembly (10) according to any one of sections 1 to 3, further comprising a space (80) adjacent to the activation lock (6), wherein, in the prior activation prevention state, the protruding portion (2a) is positioned in the space (80).

[0075] 5. In the start-up enabled state, the space (80) is configured to accept the start-up lock (6) and achieve the start-up enabled state, as described in Section 4, the sub-assembly (10).

[0076] 6. The delivery member cover (5) is configured such that when an external force is applied in the distal direction, the distal surface (5c) comes into contact with the proximal surface (6a), thereby pushing the activation lock (6) into the space (80), as described in Section 5 when referenced from Section 2.

[0077] 7. The proximal surface (6a) of the subassembly (10) described in Section 6 is at least partially chamfered.

[0078] 8. The drug container carrier and activation lock (6) are a subassembly (10) as described in any one of Sections 1 to 7, which form part of the housing (3) of the drug delivery device.

[0079] 9. A subassembly (10) according to any one of sections 1 to 8, further comprising a plunger rod (13) configured to move operably toward the proximal end (4a) of a drug container carrier (4) when activated.

[0080] 10. The subassembly (10) described in Section 9, further comprising an arm configured to lock a plunger rod (13) in a pre-tensioned state, and an actuator (17) configured to move the arm to release the plunger rod (13) upon activation.

[0081] 11. The delivery member cover (5) comprises a proximal end (5a) and a distal end (5b), and the activation lock (6) is positioned between the proximal end (5a) and the distal end (5b) of the delivery member cover (5), as described in any one of sections 1 to 10.

[0082] 12. The distal end (5b) of the delivery member cover (5) is configured to engage with the actuator (17) to move the arm and release the plunger rod (13) when the delivery member cover (5) moves axially to its retracted position, as described in sections 10 to 11 of the subassembly (10).

[0083] 13. The subassembly (10) described in Section 12, further comprising a retaining sleeve (9) configured to move axially with the delivery member cover (5), the retaining sleeve (9) having a surface configured to abut against the arm of the actuator (17) and lock the plunger rod (13) in its pre-tensioned state, the retaining sleeve being configured to move distally when the delivery member cover (5) is pushed into its retracted position, thereby releasing the arm of the actuator (17) past the end (9a) of the retaining sleeve (9) and releasing the plunger rod (13).

[0084] 14. A drug delivery device (1) configured to dispense a drug from a drug container (15) via a delivery member (22), comprising a subassembly (10) as described in any one of sections 1 to 13. [Explanation of symbols]

[0085] 1. Drug delivery device 2 caps 2a Protruding part 2b Gripping part 3, 3' Housing 3a Proximal end 3b distal end 3c window 3'a Proximal end 4. Drug container carrier 4a Proximal end 4b Distal end 4c Longitudinal Arm 4D longitudinal arm 5. Delivery component cover 5a Proximal end 5b Distal end 5c Surface facing distal 6. Startup Lock 6a Surface facing the proximal side 9, 9' retaining sleeve 9a end 9c, 9'c Parts facing the housing 10 subassemblies 11 Subassembly 11' subassembly 12. Drive spring 13 Plunger Rod 15. Medication container 17. Actuator 17a Actuator Arm 17b Actuator Arm 19 Rear end 20 Distal elastic member 22 Delivery Member 23 Ring Needle Shield 30 Locking member 31 Locking member 40 End hooks 41 First hook section 42 Second hook section 50 Lockout structure, opening 80 spaces

Claims

1. A subassembly (11) for a drug delivery device (1) configured to dispense a drug from a drug container (15) via a delivery member (22), wherein the subassembly (11) is A housing (3) having a proximal end (3a) and a distal end (3b), A retaining sleeve (9) is biased toward the proximal end (3a) of the housing (3) and includes a locking member (31), A plunger rod (13), which is pre-tensioned and configured to act on the drug container (15) to dispense the drug when activated, The actuator (17) has arms (17a, 17b) configured to lock the plunger rod (13) in a state where tension has been applied to it in advance, and when activated, is configured to move the arms to release the plunger rod (13), Equipped with, The retaining sleeve (9) has a surface configured to lock the plunger rod (13) in a pre-tensioned state by contacting the arms (17a, 17b) of the actuator (17) and restricting the movement of the arms (17a, 17b) of the actuator (17), and the retaining sleeve (9) is configured to move distally during drug delivery operation, thereby releasing the arms (17a, 17b) of the actuator (17) past the end (9a) of the retaining sleeve (9). The plunger rod (13) can be released, the retaining sleeve (9) is configured to move proximal during the lockout operation and to achieve lockout by being axially locked with the housing (3) by the locking member (31), and the housing (3) has a lockout structure (50) formed by an opening (50) configured to receive the locking member (31) and lock the retaining sleeve (9) axially, the partial assembly (11).

2. The locking member (31) is positioned on the portion (9c) of the retaining sleeve (9) facing the housing (3), as described in claim 1, for the partial assembly (11).

3. The partial assembly (11) according to claim 1, wherein the locking member (31) is configured to be operable to snap into the opening (50) of the housing (3).

4. The retaining sleeve (9) is biased toward the proximal end (3a) of the housing (3) by a distal elastic member (20), and the distal elastic member (20) pushes the retaining sleeve (9) toward the housing (3) via the locking member (31) during the lockout operation, as described in claim 1, for the partial assembly (11).

5. The subassembly (11) according to claim 1, further comprising a drive spring (12) that biases the plunger rod (13) toward the proximal end (3a) of the housing (3).

6. The partial assembly (11) according to claim 1, further comprising a delivery member cover (5) disposed in the housing (3) and extending proximal from the proximal end (3a) of the housing (3), wherein the delivery member cover (5) is configured to move linearly relative to the housing (3) from an extended position to a retracted position in which the delivery member cover (5) is further received by the housing (3) during drug delivery operation.

7. The retaining sleeve (9) is fixedly attached to the delivery member cover (5). The partial assembly (11) according to claim 6.

8. A drug delivery device (1) for dispensing a drug from a drug container (15) via a delivery member (22), comprising a partial assembly (11) according to any one of claims 1 to 7.

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