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CN118103095A - Subassembly for a medicament delivery device - Google Patents

Subassembly for a medicament delivery device Download PDF

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Publication number
CN118103095A
CN118103095A CN202280068704.5A CN202280068704A CN118103095A CN 118103095 A CN118103095 A CN 118103095A CN 202280068704 A CN202280068704 A CN 202280068704A CN 118103095 A CN118103095 A CN 118103095A
Authority
CN
China
Prior art keywords
retaining sleeve
housing
medicament
actuator
locking
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202280068704.5A
Other languages
Chinese (zh)
Inventor
O·亚历山德森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Astor Medical
Original Assignee
Astor Medical
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Astor Medical filed Critical Astor Medical
Priority claimed from PCT/EP2022/077253 external-priority patent/WO2023061769A1/en
Publication of CN118103095A publication Critical patent/CN118103095A/en
Pending legal-status Critical Current

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Abstract

A sub-assembly (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 (3 a) and a distal end (3 b, 3' b); -a retaining sleeve (9, 9 '), the retaining sleeve (9, 9') being biased towards the proximal end (3 a) of the housing (3, 3 '), the retaining sleeve (9, 9') comprising a locking member (30, 31); a pre-tensioned plunger rod (13) operatively arranged to act on said medicament container (15) upon activation to expel a medicament; an actuator (17), the actuator (17) having arms (17 a, 17 b), the arms (17 a, 17 b) being arranged to lock the plunger rod (13) in its pre-tensioned state, the actuator being operatively arranged to move the arms upon activation to release the plunger rod (13); wherein the retaining sleeve (9, 9 ') is operably configured to move proximally during a locking operation in which the retaining sleeve (9, 9') is axially locked by the locking member (30, 31).

Description

Subassembly for a medicament delivery device
Technical Field
The present disclosure relates generally to a medicament delivery device for expelling a medicament from a flexible medicament container. In particular, the present disclosure relates to a sub-assembly for a medicament delivery device.
Background
Many medical conditions require reliable delivery of a medicament from a medicament delivery device. The medicament is typically contained in a medicament container within the medicament delivery device, the medicament container being configured to expel the medicament via a delivery member of some type, such as a needle or a nozzle.
Currently, there are many different medicament delivery devices, including various types of syringes (e.g. pen-type syringes, auto-injectors, in-body devices). While many of these devices have achieved significant improvements in the management of a large number of medical conditions, various drawbacks remain in the current art.
Many medicament delivery devices comprise parts that are movable relative to each other. One type of relative movement between the components may activate the medicament delivery device, e.g. expose the delivery member or start expelling medicament from the medicament delivery device. Another type of relative movement between the parts may result in the two parts being fixed relative to each other, for example by axially or radially fixing one part to the other, or by means of a locking element. After use of the drug delivery device, a relative fixation of the components is often required to avoid relative movement. That is, in the final state of the medicament delivery device, a relative movement between the components is undesirable, as such a relative movement may result in an unintentional action of the medicament delivery device. Such unintentional action may, for example, be the result of unsatisfactory relative fixing of the components. In view of these problems, the applicant has appreciated that various developments can be made to help improve the medicament delivery devices on the market today, which will be explained in more detail below.
Disclosure of Invention
It is therefore an object of the present disclosure to provide a medicament delivery device that solves or at least alleviates the problems of the prior art.
Thus, according to a first aspect of the present disclosure, there is provided a subassembly for a medicament delivery device configured to expel a medicament from a medicament container via a delivery member, the subassembly comprising: a housing having a proximal end and a distal end; a retaining sleeve biased toward the proximal end of the housing, the retaining sleeve including a locking member; a pre-tensioned plunger rod operatively arranged to act on the medicament container upon activation to expel medicament; an actuator having an arm arranged to lock the plunger rod in its pre-tensioned state, the actuator being operably arranged to move the arm to release the plunger rod upon activation; wherein the retaining sleeve comprises a surface arranged to abut an arm of the actuator to lock the plunger rod in its pre-tensioned state by limiting movement of the arm of the actuator, wherein the retaining sleeve is operatively configured to move distally during a medicament delivery operation allowing the arm of the actuator to be released past an end of the retaining sleeve resulting in the release of the plunger rod, and wherein the retaining sleeve is operatively configured to move proximally during a locking operation in which the retaining sleeve is axially locked by the locking member.
The effect obtainable thereby is an improved locking of the retaining sleeve. That is, after use, the retaining sleeve is arranged in its final state in which it is axially locked. Thus, the retaining sleeve cannot move axially after the locking operation. When the retaining sleeve is axially locked, it resists movement of other components directly associated with the axial movement of the retaining sleeve.
In the present disclosure, when the term "distal direction" is used, this refers to a direction towards a distal dose delivery site during use of the drug delivery device. When the term "distal portion/end" is used, this refers to the portion/end of the delivery device or the portion/end of a member thereof which is located furthest away from the dose delivery site when the drug delivery device is used. Accordingly, when the term "proximal direction" is used, this refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal portion/end" is used, this refers to the portion/end of the delivery device or the portion/end of the member thereof which is located closest to the dose delivery site when the drug delivery device is used.
Furthermore, the terms "longitudinal", "longitudinally", "axially" or "axial" refer to a direction extending from a proximal end to a distal end, typically along the device or component thereof in the longest direction of extension of the device and/or component.
Similarly, the terms "transverse", "transverse" and "transversely" refer to directions substantially perpendicular to the longitudinal direction.
Furthermore, the term "circumferential", "circumferential" or "circumferentially" refers to a circumferential or circumferential direction relative to an axis, which is typically a central axis extending in the longest direction of extension of the device and/or component. Similarly, "radial" or "radially" refers to a direction extending radially relative to an axis, and "rotating", "rotating" and "rotationally" refer to rotation relative to an axis.
According to one embodiment, the sub-assembly further comprises a locking structure arranged to interact with the locking member in a locking engagement to axially lock the retaining sleeve. Thus, the locking member of the retaining sleeve may be lockingly engaged with the locking structure to axially lock the retaining sleeve. Preferably, the locking structure is arranged in a different part or structure of the sub-assembly than the retaining sleeve.
According to one embodiment, the locking structure is comprised in the actuator or the housing. The retaining sleeve is typically arranged between the housing and the actuator such that the retaining sleeve is arranged radially inside the housing and radially outside the actuator or the arms of the actuator. Thus, by arranging the locking structure in one of the housing and the actuator, the axial locking of the sleeve is facilitated to be maintained. That is, when the actuator and the housing are arranged in the vicinity of the retaining sleeve, the locking member and the locking structure will be arranged in mutually adjacent parts of the sub-assembly. Thus, when the retaining sleeve is moved axially in the proximal direction within the housing, i.e. axially with respect to the housing and/or the actuator, the locking member is brought into engagement with the locking structure to axially lock the retaining sleeve.
According to one embodiment, the locking member is arranged on the portion of the retaining sleeve facing the actuator. Thus, preferably, the locking structure is comprised in the actuator, for example on a part of the actuator facing the retaining sleeve. Thus, the locking member may engage with the locking structure, thereby axially locking the retaining sleeve in a reliable manner. The portion of the retaining sleeve facing the actuator may be referred to as an inwardly facing portion facing the central axis of the subassembly, and the portion of the actuator facing the retaining sleeve may be referred to as an outwardly facing portion facing away from the central axis of the subassembly.
According to one embodiment, the locking member is an axial rib. Thus, a simple but efficient structure for providing a locking function is provided. The axial rib has an extension in the axial direction and an extension in the radial direction, wherein the extension in the axial direction is greater than the extension in the radial direction. For example, the axial ribs extend axially along the portion of the retaining sleeve facing the actuator and radially toward the actuator.
According to one embodiment, the arm of the actuator comprises an end hook having a first hook part arranged to lock the plunger rod in its pre-tensioned state and a second hook part arranged opposite the first hook part, the second hook part forming a locking structure and being arranged to interact with the locking member to axially lock the retaining sleeve. Thereby, a reliable structure for providing a locking function is provided. Furthermore, by including a locking structure in the arms of the actuator, the arms of the actuator serve a dual purpose, one purpose being to lock the plunger rod in its pre-tensioned state and another purpose being to lockingly engage with the locking member of the retaining sleeve to axially lock the retaining sleeve during the locking operation.
According to one embodiment, the locking member is arranged on a housing-facing portion of the retaining sleeve. Thus, preferably, the locking structure is comprised in the housing, for example on a portion of the housing facing the retaining sleeve. Thus, the locking member may be brought into engagement with the locking structure, thereby axially locking the retaining sleeve in a reliable manner. The portion of the retention sleeve facing the housing may be referred to as an outward facing portion facing away from the central axis of the subassembly, and the portion of the housing facing the retention sleeve may be referred to as an inward facing portion facing toward the central axis of the subassembly.
According to one embodiment, the housing comprises an opening forming a locking structure and is arranged to receive a locking member to axially lock the retaining sleeve. Thereby, a reliable structure for providing a locking function is provided. The locking member is here preferably arranged as a locking projection or a resilient tongue extending radially outwards from the housing-facing portion of the retaining sleeve. Furthermore, by including a locking structure in the housing, the housing serves a dual purpose, one purpose being to accommodate the components of the subassembly, and another purpose being to lockingly engage with the locking member of the retaining sleeve to axially lock the retaining sleeve during a locking operation.
According to one embodiment, the locking member is operatively arranged to be snap-fitted into the opening of the housing. Thus, a simple and reliable locking function is provided. For example, as previously mentioned, the locking member is preferably arranged as a projection or resilient tongue extending radially outwards from the housing-facing portion of the retaining sleeve. As the retaining sleeve moves axially in the proximal direction, the projection or resilient tongue is guided along the inner surface of the housing until the projection or resilient tongue encounters the opening of the housing, whereby the projection or resilient tongue snap fits into the opening of the housing. Thereby, the retaining sleeve is axially locked.
According to one embodiment, the retaining sleeve is biased towards the proximal end of the housing by means of a distal resilient member, and wherein, in a locking operation, the distal resilient member presses the retaining sleeve against the actuator or the housing via the locking member. Thus, the biasing force in the proximal direction is transferred to the actuator or housing via the retaining sleeve and the locking member and locking structure.
According to one embodiment, the subassembly further comprises a drive spring biasing the plunger rod towards the proximal end of the housing. Thereby, the plunger rod may be axially fixed in a first axial position with respect to the housing by the actuator and the actuator arm, and when the plunger rod is released from its first axial position, the plunger rod may be released from the first axial position due to the biasing force from the drive spring and axially moved within the housing.
According to one embodiment, the sub-assembly further comprises a delivery member cover arranged in the housing and extending proximally from the proximal end of the housing, the delivery member cover being configured to move linearly relative to the housing from an extended position to a retracted position during a medicament delivery operation, in which the delivery member cover is further received in the housing. After such a medicament delivery operation, the delivery member shield is configured to move axially in a proximal direction to re-enter the extended position. Thereby, the conveying member is protected within the conveying member protecting cover.
According to one embodiment, in the retracted position of the transport member cover, the proximal end of the transport member cover is arranged closer to the proximal end of the housing than in the extended position. For example, in the retracted position, the proximal end of the delivery member cover is a first axial distance from the proximal end of the housing that is less than a second axial distance between the proximal end of the delivery member cover and the proximal end of the housing when in the extended position.
According to one embodiment, the retaining sleeve is fixedly attached to the delivery member protecting cover. Thereby, an axial locking of the delivery cover member is provided. For example, the retaining sleeve is axially and rotationally fixed relative to the transport member protective cover and is therefore axially movable with the transport member protective cover. After a medicament delivery operation, the delivery member protecting cover may be axially locked in its extended position to safely protect the delivery member in the delivery member protecting cover. That is, after use, the retaining sleeve is arranged in a final state in which the retaining sleeve is axially locked with the delivery member cover. Thus, the retaining sleeve and the delivery member protecting cover cannot move axially after the locking operation. When the transport member cover is axially locked, the transport member is prevented from being re-exposed.
According to a second aspect of the present disclosure, there is provided a medicament delivery device for expelling a medicament from a medicament container via a delivery member, the medicament delivery device comprising a sub-assembly according to the first aspect of the present disclosure.
The effects and features of the second aspect of the invention are largely analogous to those described above in connection with the first aspect of the invention. The embodiments mentioned in relation to the first aspect of the invention are largely compatible with the second aspect of the invention.
In general, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a/an/the element, device, component, means, etc" are to be interpreted openly as referring to at least one instance of the element, device, component, means, etc., unless explicitly stated otherwise.
Drawings
Specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
fig. 1 schematically shows a perspective view of an example of a medicament delivery device;
Fig. 2 shows an exploded view of the medicament delivery device of fig. 1;
FIG. 3A is a detailed cross-sectional view of at least a portion of a subassembly of the medicament delivery device of FIG. 2, wherein the subassembly is in its pre-activation prevention state;
FIG. 3B shows the subassembly of FIG. 3A in its activated-tolerance state with the transport member cover in its extended position;
FIG. 3C illustrates the subassembly of FIG. 3A in a state in which the transport member protective cover is disposed in its retracted position;
fig. 4A is a cross-sectional view of the medicament delivery device in a default state after removal of the cap;
fig. 4B is a cross-sectional view of the medicament delivery device in an activated state at the beginning of a medicament delivery operation;
Fig. 4C is a cross-sectional view of the medicament delivery device during a medicament delivery operation;
Fig. 4D is a cross-sectional view of the medicament delivery device after a medicament delivery operation;
Fig. 5A is a detailed cross-sectional view of at least a portion of another sub-assembly of the medicament delivery device of fig. 2;
FIG. 5B shows a cross-sectional view in a plane at a 90 degree angle relative to the cross-sectional view shown in FIG. 5A; and
Fig. 5C is a detailed cross-sectional view of at least a portion of yet another sub-assembly of the medicament delivery device.
Detailed Description
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This inventive concept may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided as examples so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. Like reference numerals refer to like elements throughout the specification.
Fig. 1 shows an example of a medicament delivery device 1, which medicament delivery device 1 is configured to expel a medicament from a medicament container 15 loaded in a housing 3 of the medicament delivery device 1. The housing 3 has a proximal end 3a and a distal end 3b, and a window 3c or opening arranged between the proximal end 3a and the distal end 3b for visual inspection of the medicament container 15.
The medicament delivery device 1 comprises a delivery member protecting cover 5. A delivery member cover 5 is disposed in the housing 3 and extends proximally from the proximal end 3a of the housing 3. The medicament delivery device 1 further comprises a protective cap 2 removably arranged on the delivery member protective cover 5.
The transport member cover 5 is configured to move linearly or axially relative to the housing 3 from an extended position as shown in fig. 1 to a retracted position in which the transport member cover 5 is further received into the housing 3. Typically, the delivery member shield 5 is biased in a proximal direction towards the extended position.
By further movement of the delivery member cover 5 into the housing 3 towards the retracted position, the medicament delivery device 1 is triggered to expel the medicament.
Fig. 2 shows an exploded view of the medicament delivery device 1. First, the general construction of the medicament delivery device 1 will be described, and then embodiments and certain aspects of the various sub-assemblies 10, 11' will be described in more detail. The sub-assembly of the medicament delivery device 1 may be defined by combining specific components of the medicament delivery device 1.
The medicament delivery device 1 comprises a medicament container carrier 4 extending along a longitudinal axis from a proximal end 4a to a distal end 4 b. The medicament container carrier 4 may preferably be fixedly attached to the housing 3 of the medicament delivery device 1, e.g. by means of a snap lock or other conventional engagement means. Or the medicament container carrier 4 may form an integral part of the housing 3. The medicament container carrier 4 and the housing 3 are preferably made of the same material, e.g. plastic. The medicament container carrier 4 is configured to receive and support a medicament container 15 within the medicament delivery device 1. The medicament container carrier 4 further comprises an activation lock 6, which activation lock 6 will be further explained with reference to fig. 3A-3C.
The medicament delivery device 1 comprises a delivery member protecting cover 5 as described with reference to fig. 1. The delivery member housing 5 includes a proximal end 5a and a distal end 5b. The activation lock 6 of the medicament container carrier 4 is preferably arranged between the proximal end 5a and the distal end 5b of the delivery member protecting cover 5.
The medicament delivery device 1 comprises a cap 2 as described with reference to fig. 1. The cap 2 is removably arranged with respect to the delivery member cover 5. In the embodiment of fig. 2, the cap 2 comprises a grip portion 2b and a protrusion 2a extending distally in the longitudinal direction at the grip portion 2 b. The grip portion 2b comprises a grip surface with which a user can interact in order to remove the cap 2 from the transport member cover 5. In fig. 2, the protrusion 2a is a protruding sleeve 2a. The protruding sleeve 2a extends distally in the longitudinal direction.
The medicament delivery device 1 comprises a plunger rod 13, the plunger rod 13 being operably arranged to move in a proximal direction upon activation. Thus, in the embodiment of fig. 2, plunger rod 13 is configured to move axially within housing 3 and medicament container carrier 4. During a medicament delivery operation, the plunger rod 13 is moved from the first axial position towards the medicament container 15 for expelling medicament. Plunger rod 13 may have a cylindrical body.
The medicament delivery device 1 comprises a drive spring 12, which drive spring 12 is configured to bias the plunger rod 13 in the proximal direction. In the embodiment of fig. 2, the plunger rod 13 is axially fixed in relation to the medicament container carrier 4 and the housing 3 in the first axial position when the delivery member shield 5 is in the extended position prior to a medicament delivery operation.
The medicament delivery device 1 comprises an actuator 17, the actuator 17 having an arm 17a, the arm 17a being arranged to lock the plunger rod 13 in a pre-tensioned state and being operatively arranged to move the arm 17a to release the plunger rod 13 upon activation. To release the plunger rod 13, the distal end 5b of the delivery member protecting cover 5 is arranged to engage with the actuator 17 to move the arm to release the plunger rod 13 when the delivery member protecting cover 5 is axially moved to its retracted position. This will be further explained with reference to fig. 4A-4D.
The medicament delivery device 1 comprises a retaining sleeve 9, which retaining sleeve 9 is arranged to move axially within the housing 3 together with the delivery member protecting cover 5. The retaining sleeve 9 can thus be axially and rotationally fixed relative to the transport component protective cover 5. When the transport member cover 5 moves from the extended position to the retracted position, the linear movement of the transport member cover 5 is converted into a linear movement of the retaining sleeve 9. The retaining sleeve 9 comprises a surface arranged to abut the arm 17a of the actuator 17 to lock the plunger rod 13 in its pre-tensioned state, wherein the retaining sleeve 9 is operably configured to move distally as the delivery member protecting cover 5 is pushed into its retracted position such that the arm 17a of the actuator 17 is released past the end 9a of the retaining sleeve 9, thereby releasing the plunger rod 13. This will be further explained with reference to fig. 4A-4D.
The medicament delivery device 1 comprises a distal elastic member 20. The distal elastic member 20 may be, for example, a spring, such as a coil spring. The distal resilient member 20 is configured to bias the delivery member cover 5 in a proximal direction. In the embodiment of fig. 2, the distal resilient member 20 is configured to bias the delivery member cover 5 via the retaining sleeve 9.
The medicament delivery device 1 comprises a rear end 19, the rear end 19 being arranged to close the housing 3 at a distal end 3b of the housing 3.
The medicament delivery device 1 may be loaded with a medicament container 15. The medicament container 15 generally comprises a delivery member 22 (e.g. a needle 22) and an annular needle shield RNS23 arranged to protect the delivery member 22. The medicament container 15 may also include an RNS needle shield and an RNS plastic shield cap (not shown). The protrusion 2a of the cap 2 may be referred to as RNS remover, as it may be configured to remove the RNS23 when the cap is removed from the delivery member protecting cover 5.
Fig. 3A shows a detailed cross-sectional view of at least a portion of the sub-assembly 10 of the medicament delivery device 1 of fig. 2. The sub-assembly 10 comprises at least a medicament container carrier 4, a delivery member protecting cover 5 and a protecting cap 2. In the detailed view of fig. 3A, the activation lock 6 of the medicament container carrier 4 is shown adjacent to the protrusion 2a or protrusion sleeve 2a of the cap 2. In fig. 3A, the subassembly 10 is shown in a pre-activation prevention state in which the projection 2a is adjacent to the activation lock 6 to prevent the activation lock 6 from moving radially inward, thereby preventing the transport component protective cover 5 from moving axially to its retracted position. In more detail, a space 80 is arranged in the vicinity of the activation lock 6, wherein in the pre-activation prevention state shown in fig. 3A, the projection 2a is arranged in this space 80, whereby any radially induced movement of the activation lock 6 will be stopped by the projection 2 a. As shown in fig. 3A, the distally facing surface 5c of the delivery member protecting cover 5 is arranged to abut the activation lock 6 preventing the delivery member protecting cover 5 from moving axially beyond the activation lock 6. The distally facing surface 5c partially defines a sleeve portion of the delivery member protecting cover 5, the distally facing surface 5c being arranged along a circumferential direction of the sleeve portion. In more detail, the activation lock 6 comprises a proximal facing surface 6a aligned with the distal facing surface 5c in the axial direction. Due to the alignment of the proximally facing surface 6a and the distally facing surface 5c, the delivery member protecting cover 5 is prevented from moving axially to its retracted position.
Turning to fig. 3B, which shows the same detailed cross-sectional view as fig. 3A, but shows an activation tolerant state of removal of the cap 2 from the delivery member protecting cover 5. When the cap 2 is removed, the projection 2a is withdrawn from the space 80. Further, the RNS23 has been removed from the medicament container 15 together with the protrusion 2a, thereby exposing the delivery member 22. In fig. 3B, space 80 is configured to receive activation lock 6. Thus, the radially induced force applied to the activation lock 6 will cause the activation lock 6 to move radially inward into the space 80, thereby enabling the transport component protective cover 5 to move axially to its retracted position (as shown in fig. 3C). Thus, the subassembly 10 is movable from a pre-activation prevention state, as shown in fig. 3A, in which the projection 2a is adjacent to the activation lock 6 to prevent the activation lock 6 from moving radially inwardly, to an activation tolerance state, as shown in fig. 3B, in which the activation lock 6 is allowed to move radially, thereby enabling the transport member cover 5 to move axially to its retracted position.
In more detail, the activation lock 6 is flexible and is configured to move radially by bending inwards towards the central axis of the subassembly 10. Preferably, the activation lock 6 forms part of the proximal end 4a of the medicament container structure 4. As shown in fig. 3B, the activation lock 6 comprises two oppositely arranged longitudinal arms 4c, 4d extending proximally from a main portion of the medicament container carrier. Each of the longitudinal arms 4c, 4d is configured with a corresponding proximally facing surface 6a and is configured to move radially by bending inwards towards the central axis of the subassembly 10. The main part of the medicament container carrier is configured to accommodate the body of the medicament container 15. Each of the two oppositely arranged longitudinal arms 4c, 4d has an end flexibly arranged with respect to the space 80.
As shown in fig. 3B, each of the proximally facing surfaces 6a is at least partially chamfered. Thereby, the action of pushing the activation lock 6 into the space 80 is facilitated. That is, by each proximally facing surface 6a being at least partially chamfered, externally applied forces in the distal direction may be at least partially converted into radial forces due to the interaction of the distally facing surface 5c with the proximally facing surface 6 a. As shown in fig. 3B, the proximally facing surface 6a is chamfered to slope away from the distally facing surface 5 c.
Typically, the proximal end 5a of the delivery member cover 5 is subjected to an externally applied force such that the delivery member cover 5 is moved axially distally such that the distally facing surface 5c abuts the activation lock 6 and the proximally facing surface 6a pushes 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 inwardly into the space 80. Thus, the distally facing surface 5c can be moved distally beyond the activation lock 6, thereby enabling the transport member cover 5 to be moved to its retracted position. This configuration is shown in fig. 3C. In the retracted position of the delivery member cover 5, the delivery member 22 is exposed and ready to expel a medicament. As shown in fig. 3B-3C, the housing 3 is arranged outside the medicament container carrier 4 and at least partly accommodates the delivery member protecting cover 5. Thus, the conveyance member cover 5 is also configured to move linearly or axially relative to the housing 3 from the extended position shown in fig. 3B to the retracted position shown in fig. 3C, in which the conveyance member cover 5 is further housed in the housing 3.
The operation of the medicament delivery device 1 will now be described in more detail with reference to fig. 4A-D. It will mainly relate to the medicament delivery device 1 even though certain components of the medicament delivery device 1 may belong to the sub-assembly 10 of the medicament delivery device 1 described with reference to fig. 3A-3C or may belong to any of the sub-assemblies 11, 11' described with reference to fig. 5A-5C.
Fig. 4A shows a cross-sectional view of the medicament delivery device 1 in a default state before medicament delivery and after removal of the protective cap 22. Accordingly, the subassembly 10 is arranged in its activation-tolerant state, as described with reference to fig. 3B.
The delivery member shield 5 is in an extended position biased in a proximal direction by a distal resilient member 20. The delivery member cover 5 is biased by a distal resilient member 20 via a retaining sleeve 9. The delivery member cover 5 covers the delivery member 22 of the medicament container 15.
The plunger rod 13 is axially fixed in a first axial position relative to the medicament container carrier 4 and the housing 3 and is biased in a proximal direction by means of the drive spring 12.
The actuator 17 is arranged such that the arm 17a locks the plunger rod 13 in a pre-tensioned state. As shown in fig. 4B, the actuator 17 includes two longitudinally extending arms 17a, 17B arranged opposite each other, hereinafter referred to as actuator arms 17a, 17B. The structure and function of the two actuator arms 17a, 17b are similar, so that only one of the actuator arms 17a, 17b will be described occasionally. The actuator arms 17a, 17b are locked in place by the retaining sleeve 9. As described with reference to fig. 2, the surface of the retaining sleeve 9 is arranged to abut the actuator arms 17a, 17b to lock the plunger rod 13 in its pre-tensioned state. The retaining sleeve 9 engages the distal end 5b of the delivery member protective cover 5 such that the retaining sleeve 9 is axially fixed to the delivery member protective cover 5 and is movable with the delivery member protective cover 5.
Fig. 4B shows a cross-sectional view of the medicament delivery device 1 in an activated state at the point in time when the plunger rod 13 is released. The medicament delivery device 1 is pressed against the injection site by the operator. Thus, the resulting externally applied force causes the delivery member cover 5 to move to its retracted position in which the delivery member 22 is exposed to penetrate tissue, as also shown in fig. 3C. Thus, the proximal end 5a of the delivery member cover 5 has been subjected to an externally applied force such that the delivery member cover 5 is moved axially distally such that the distally facing surface 5C abuts the activation lock 6 and the proximally facing surface 6a pushes the activation lock 6 into the space 80, as described with reference to fig. 3C. The retaining sleeve 9 is axially fixed and movable together with the delivery member protecting cover 5 and when the delivery member protecting cover 5 is moved to its retracted position, the retaining sleeve 9 is moved distally such that the actuator arms 17a, 17b are released past the end 9a of the retaining sleeve 9, thereby releasing the plunger rod 13.
Fig. 4C shows the medicament delivery device 1 during a medicament delivery operation. Plunger rod 13 is released from its first axial position shown in fig. 4B and moves proximally towards medicament container 15. Thus, due to the biasing force from the drive spring 12, the plunger rod 13 is axially moved towards the proximal end 3a of the housing 3 and towards the proximal end 4a of the medicament container carrier 4. This proximal movement causes plunger rod 13 to encounter medicament container 15 to expel medicament through delivery member 22 by pushing the contents of the medicament container through delivery member 22.
At the beginning of medicament discharge, the plunger rod 13 is positioned axially adjacent the actuator arms 17a, 17b, whereby the actuator arms 17a, 17b are subjected to a radially inwardly directed force exerted by the retaining sleeve 9 and a biasing force from a distal resilient member 20 provided on the retaining sleeve 9. Once the plunger rod 13 has moved further in the proximal direction and the content of the medicament container 15 has been expelled, the plunger rod 13 is no longer positioned axially near the actuator arms 17a, 17b and the radially inwardly directed force exerted by the retaining sleeve 9 and the biasing force from the distal resilient member 20 forces the actuator arms 17a, 17b radially inwards. Thereby, the retaining sleeve 9 can be moved in the proximal direction together with the delivery member protecting cover 5 to achieve locking, as shown in fig. 4D. Thus, fig. 4D shows the medicament delivery device 1 when the actuator arms 17a, 17B have collapsed into the void left by the plunger rod 13 (also shown in fig. 5B). As a result, the retaining sleeve 9 is moved in the proximal direction by the biasing force from the distal elastic member 20. The delivery member 22 is again covered by the delivery cover member 5, which delivery cover member 5 shows the final state of the medicament delivery device 1 after use. Thus, the transport member cover 5 again enters its extended position. The medicament delivery device 1 may be discarded in this final state, in which the delivery member 22 is protected within the delivery member cover 5. The transport member cover 5 is axially locked in the extended position by the locking members 30, 31 and locking structures 42, 50 as will be further described with reference to fig. 5A-5C.
Fig. 5A is a detailed cross-sectional view of at least a portion of the sub-assembly 11 of the medicament delivery device 1 of fig. 2. Fig. 5B shows a cross-sectional view in a plane at a 90 degree angle relative to the cross-sectional view shown in fig. 5A. In fig. 5A and 5B, a final state of the medicament delivery device 1, i.e. a state after use, is shown, wherein medicament has been expelled from the medicament container, corresponding to the state shown in fig. 4D.
As previously described, the subassembly 11 includes the housing 3 having the proximal end 3a and the distal end 3b. In fig. 5A and 5B, only a portion of the housing 3 including the distal end 3B is shown. The subassembly 11 further comprises a holding sleeve 9 biased proximally in the housing 3. The retaining sleeve 9 comprises a locking member 31, the locking member 31 being in the form of a locking protrusion 31, the locking protrusion 31 extending radially outwards from a portion 9c of the retaining sleeve facing the housing 3.
The subassembly 11 includes an actuator 17 with its actuator arms 17a, 17B, as previously described and best shown in fig. 5B. Subassembly 11 further includes a plunger rod 13, in fig. 5A and 5B, plunger rod 13 has been moved proximally to interact with a medicament container (not shown). Thus, when the plunger rod 13 is moved further in the proximal direction and any content of the medicament container 15 has been expelled, the plunger rod 13 is no longer positioned axially adjacent to the actuator arms 17a, 17B in fig. 5B and the radially inward force exerted by the retaining sleeve 9 and the biasing force from the distal resilient member 20 forces the actuator arms 17a, 17B radially inward. Thus, the retaining sleeve 9 may be arranged radially outside the actuator arms 17a, 17 b. Further, when support from the plunger rod 13 to the actuator arms 17a, 17b is removed, the actuator 17 is pushed by the drive spring 12 towards the distal end 3b of the housing 3. When the actuator 17 hits the rear end 19 of the medicament delivery device 1, an audible and/or tactile feedback to the user is achieved.
Further, subassembly 11 may include a drive spring 12 biasing plunger rod 13 toward proximal end 3a of housing 3. Thus, in fig. 5A and 5B, the retaining sleeve 9 has been moved proximally during a locking operation in which the retaining sleeve 9 is axially locked by the locking member 31, the locking member 31 here being in the form of a locking protrusion 31.
As shown in fig. 5A, the housing 3 includes a locking structure 50, the locking structure 50 interacting with the locking projection 31 in locking engagement to axially lock the retaining sleeve 9. In more detail, the locking structure 50 is formed by an opening 50 in the housing. The opening 50 is arranged to receive the locking projection 31 to axially lock the retaining sleeve 9. That is, when the locking protrusion 31 is arranged on the portion 9c of the holding sleeve 9 facing the housing 3, the locking protrusion 31 may be in contact with the opening 50 during the axial and proximal movement of the holding sleeve 9 during the locking operation. Preferably, the locking protrusion 31 is snap-fitted into the opening 50.
Fig. 5C is a detailed cross-sectional view of at least a portion of another sub-assembly 11' of the medicament delivery device. The subassembly 11' of fig. 5C largely corresponds to the subassembly 11 of fig. 5A and 5B, mainly because of the differences described below. Thus, the sub-assembly 11' may form part of the medicament delivery device 1 of fig. 2. For example, the actuator 17, plunger rod 13 and optional drive spring 12 of subassembly 11 of fig. 5A and 5B are included in subassembly 11' of fig. 5C. In fig. 5C, the final state of the medicament delivery device is shown, i.e. after use, wherein the medicament has been expelled from the medicament container, corresponding to the state shown in fig. 4D.
As previously mentioned, the subassembly 11 'comprises a housing 3' having a proximal end 3'a and a distal end, except that the housing 3' does not comprise a corresponding opening 50 for interaction with the locking member 31 of the retaining sleeve 9. The subassembly 11' further comprises a retaining sleeve 9' biased proximally in the housing 3 '. The retaining sleeve 9' largely corresponds to the retaining sleeve 9 of fig. 5A and 5B, but the locking member 30 is arranged on the portion 9'c of the retaining sleeve 9' facing the actuator 17 instead of comprising a locking member in the portion 9c facing the housing 3. In fig. 5C, the locking member 30 is formed by an axial rib 30. The axial ribs extend in the axial direction and radially outwards from the portion 9'c of the retaining sleeve 9'.
Each of the actuator arms 17a, 17b includes an end hook 40. Since the end hook 40 is similar to or corresponds to the two actuator arms 17a, 17b, only the first actuator arm 17a will be described. The end hook 40 comprises a first hook portion 41 and a second hook portion 42, the first hook portion 41 being configured to lock the plunger rod 13 in its pretensioned state (corresponding to the state shown in fig. 4A), the second hook portion 42 being arranged opposite the first hook portion 41. The second hook portion 42 forms a locking structure 42 and is thus configured to interact with the axial rib 30 to axially lock the retaining sleeve 9'. The subassembly 11 may include the same actuator 17 with a first hook 41 and a second hook 42, as shown in fig. 5B.
As shown in fig. 5A-5C, the subassembly 11, 11' may include the distal resilient member 20 previously described. The distal elastic member 20 is configured to press the respective retaining sleeve 9, 9' against the actuator 17 (for the embodiment in fig. 5C) or the housing 3 (for the embodiment in fig. 5A and 5B) via the locking member 30, 31.
In addition, the sub-assembly 11, 11' may comprise the aforementioned delivery member protection cover 5. Accordingly, the respective retaining sleeve 9, 9' may be fixedly attached to the transport member protection cover 5, thereby axially locking the transport member protection cover 5 during the locking operation.
The inventive concept was described above mainly with reference to a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims. For example, the drive member may be motor driven or manually driven, for example, rather than having an automatic spring-loaded structure.
Some aspects are summarized in the following.
1. A sub-assembly (10) for a medicament delivery device (1), the sub-assembly (10) comprising:
a medicament container carrier (4) extending along a longitudinal axis from a proximal end (4 a) to a distal end (4 b), the medicament container carrier (4) comprising an activation lock (6);
-a delivery member cover (5) arranged at least partially proximal to the medicament container carrier (4), the delivery member cover (5) being configured to be axially moved relative to the medicament container carrier (4) from an extended position to a retracted position;
-a cap (2), the cap (2) being removably arranged at least partially proximal to the delivery member protecting cover (5), the cap (2) comprising a protrusion (2 a);
Wherein the subassembly (10) is configured to move from a pre-activation prevention state in which the projection (2 a) is adjacent the activation lock (6) to prevent radial movement of the activation lock, thereby preventing axial movement of the transport member cover (5) to its retracted position; into an activation-permitted state in which the protective cap is removed to space the projection (2 a) from the activation lock (6) to allow radial movement of the activation lock (6) to enable axial movement of the transport member protective cover (5) to its retracted position.
2. The subassembly (10) according to claim 1, wherein the delivery member cover (5) comprises a distally facing surface (5 c), and wherein the activation lock (6) comprises a proximally facing surface (6 a), the proximally facing surface (6 a) being aligned with the distally facing surface (5 c) in an axial direction to prevent the delivery member cover (5) from moving axially to its retracted position in the pre-activation prevention state.
3. The subassembly (10) according to any one of the preceding claims, wherein the activation lock (6) is flexible, and wherein in the activation-tolerant state the activation lock (6) is configured to move radially by bending inwards towards a central axis of the subassembly (10).
4. The subassembly (10) according to any one of the preceding claims, further comprising a space (80) adjacent to the activation lock (6), wherein in the pre-activation prevention state the protrusion (2 a) is arranged in the space (80).
5. The sub-assembly (10) according to item 4, wherein in the activation-tolerant state, the space (80) is arranged to receive the activation lock (6) to achieve the activation-tolerant state.
6. The subassembly (10) according to claims 2 and 5, wherein the delivery member cover (5) is configured such that upon application of an external force in a distal direction, the distal facing surface (5 c) abuts the proximal facing surface (6 a) pushing the activation lock (6) into the space (80).
7. The subassembly (10) of claim 6, wherein the proximal-facing surface (6 a) is at least partially chamfered.
8. The sub-assembly (10) according to any of the preceding claims, wherein the medicament container carrier and the activation lock (6) form part of a housing (3) of a medicament delivery device.
9. The subassembly (10) according to any of the preceding claims, further comprising a plunger rod (13), the plunger rod (13) being operatively arranged to move towards the proximal end (4 a) of the medicament container carrier (4) upon activation.
10. The subassembly (10) of claim 9, further comprising an actuator (17) having an arm arranged to lock the plunger rod (13) in a pre-tensioned state and being operably arranged to move the arm upon activation to release the plunger rod (13).
11. The subassembly (10) according to any one of the preceding claims, wherein the delivery member cover (5) comprises a proximal end (5 a) and a distal end (5 b), and wherein the activation lock (6) is arranged between the proximal end (5 a) and the distal end (5 b) of the delivery member cover (5).
12. The subassembly (10) according to claims 10-11, wherein the distal end (5 b) of the delivery member cover (5) is arranged to engage with the actuator (17) for moving the plunger rod (13) when the delivery member cover (5) is axially moved to its retracted position.
13. The subassembly (10) of claim 12, further comprising a retaining sleeve (9), the retaining sleeve (9) being arranged to move axially with the delivery member protecting cover (5), wherein the retaining sleeve (9) comprises a surface arranged to abut an arm of an actuator (17) to lock the plunger rod (13) in its pre-tensioned state, wherein the retaining sleeve is operably configured to move distally as the delivery member protecting cover (5) is pushed into its retracted position such that the arm of the actuator (17) is released past an end (9 a) of the retaining sleeve (9) releasing the plunger rod (13).
14. A medicament delivery device (1) configured to expel a medicament from a medicament container (15) via a delivery member (22), the medicament delivery device (1) comprising a sub-assembly (10) according to any of claims 1-13.

Claims (14)

1. A sub-assembly (11, 11 ') for a medicament delivery device (1), the medicament delivery device (1) being configured to expel medicament from a medicament container (15) via a delivery member (22), the sub-assembly (11, 11') comprising:
a housing (3, 3 ') having a proximal end (3 a) and a distal end (3 b, 3' b);
-a retaining sleeve (9, 9 '), the retaining sleeve (9, 9') being biased towards the proximal end (3 a) of the housing (3, 3 '), the retaining sleeve (9, 9') comprising a locking member (30, 31);
a pre-tensioned plunger rod (13) operatively arranged to act on said medicament container (15) upon activation to expel a medicament;
An actuator (17), the actuator (17) having arms (17 a, 17 b), the arms (17 a, 17 b) being arranged to lock the plunger rod (13) in its pre-tensioned state, the actuator being operatively arranged to move the arms upon activation to release the plunger rod (13);
Wherein the retaining sleeve (9, 9 ') comprises a surface arranged to abut an arm (17 a, 17 b) of the actuator (17) to lock the plunger rod (13) in its pre-tensioned state by limiting movement of the arm (17 a, 17 b) of the actuator (17), wherein the retaining sleeve (9, 9 ') is operatively configured to move distally during a medicament delivery operation allowing the arm (17 a, 17 b) of the actuator (17) to be released past an end (9 a) of the retaining sleeve (9, 9 '), causing the release of the plunger rod (13), and wherein the retaining sleeve (9, 9 ') is operatively configured to move proximally during a locking operation in which the retaining sleeve (9, 9 ') is axially locked by the locking member (30, 31).
2. The subassembly (11, 11 ') according to claim 1, further comprising a locking structure (42, 50) arranged to interact with the locking member (30, 31) in locking engagement to axially lock the retaining sleeve (9, 9').
3. The subassembly (11, 11') according to claim 2, wherein the locking structure (42, 50) is comprised in the actuator (17) or the housing (3).
4. The subassembly (11 ') according to any one of the preceding claims, wherein the locking member (30) is arranged on a portion (9'c) of the retaining sleeve (9 ') facing the actuator (17).
5. The subassembly (11') according to claim 4, wherein the locking member (30) is an axial rib (30).
6. A sub-assembly (11 ') according to claim 3 and any of claims 4-5, wherein the arm of the actuator (17) comprises an end hook (40), the end hook (40) having a first hook portion (41) and a second hook portion (42), the first hook portion (41) being arranged to lock the plunger rod (13) in its pre-tensioned state, the second hook portion (42) being arranged opposite the first hook portion (41), the second hook portion (42) forming the locking structure (42) and being arranged to interact with the locking member (30) to axially lock the retaining sleeve (9').
7. A sub-assembly (11) according to any of claims 1 to 3, wherein the locking member (31) is arranged on a portion (9 c) of the retaining sleeve (9) facing the housing (3).
8. The sub-assembly (11) according to claims 3 and 7, wherein the housing (3) comprises an opening (50), the opening (50) forming the locking structure (50) and being arranged to receive the locking member (31) to axially lock the retaining sleeve (9).
9. The sub-assembly (11) according to claim 8, wherein the locking member (31) is operatively arranged to be snap-fitted into the opening (50) of the housing (3).
10. The subassembly (11, 11 ') according to any of the preceding claims, wherein the retaining sleeve (9, 9') is biased towards the proximal end (3 a) of the housing (3, 3 ') by means of a distal resilient member (20), and wherein in the locking operation the distal resilient member (20) presses the retaining sleeve (9, 9') against the actuator (17) or the housing (3) via the locking member (30, 31).
11. The subassembly (11, 11 ') according to any of the preceding claims, wherein the subassembly (11, 11 ') further comprises a drive spring (12), the drive spring (12) biasing the plunger rod (13) towards the proximal end (3 a) of the housing (3, 3 ').
12. The subassembly (11, 11 ') according to any one of the preceding claims, further comprising a delivery member cover (5), the delivery member cover (5) being arranged in the housing (3, 3') and extending proximally from a proximal end (3 a) of the housing (3, 3 '), the delivery member cover (5) being configured to be linearly moved relative to the housing (3) from an extended position to a retracted position in which the delivery member cover (5) is further accommodated in the housing (3, 3') during a medicament delivery operation.
13. The subassembly (11, 11 ') according to claim 12, wherein the retaining sleeve (9, 9') is fixedly attached to the transport member cover (5).
14. A medicament delivery device (1) for expelling a medicament from a medicament container (15) via a delivery member (22), the medicament delivery device (1) comprising a sub-assembly (11, 11') according to any of claims 1-13.
CN202280068704.5A 2021-10-14 2022-09-30 Subassembly for a medicament delivery device Pending CN118103095A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP21202765.0 2021-10-14
US202263305325P 2022-02-01 2022-02-01
US63/305,325 2022-02-01
PCT/EP2022/077253 WO2023061769A1 (en) 2021-10-14 2022-09-30 Sub-assembly for a medicament delivery device

Publications (1)

Publication Number Publication Date
CN118103095A true CN118103095A (en) 2024-05-28

Family

ID=91142533

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202280068704.5A Pending CN118103095A (en) 2021-10-14 2022-09-30 Subassembly for a medicament delivery device

Country Status (1)

Country Link
CN (1) CN118103095A (en)

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