Patent Application
20240408310
The present disclosure generally relates to a medicament delivery device for expelling medicament from a flexible medicament container. In particular, the present disclosure relates to a sub-assembly for a medicament delivery device.
A number of medical conditions require reliable provision of a medicament from a medicament delivery device. The medicament is typically comprised in a medicament container within the medicament delivery device, the medicament container being configured to expel the medicament via some type of delivery member, such as a needle or a nozzle.
These days, a number of different medicament delivery devices exist, including various types of injectors (for example pen injectors, autoinjectors, on-body devices). Although many of these devices have enabled major improvements in the management of a number of medical conditions, various drawbacks do still exist in the current technology.
Many medicament delivery devices comprise components which are movable relative each other. One type of relative movement between components may activate the medicament delivery device, e.g. exposing the delivery member or initiating expel of medicament from the medicament delivery device. Another type of relative movement between components may result in that two components are secured relative each other, e.g. by axially or radially fixating one component to another, or by means of a locking element. The relative fixation of components to avoid relative movement is often desired subsequent to using the medicament delivery device. That is, in the final state of the medicament delivery device, relative movement between components are undesired, as such relative movement may result in an unintentional actions of the medicament delivery device. Such unintentional actions may e.g. be the result of unsatisfactory relative fixation of components. In considering these problems, the applicant has appreciated that various developments could be made to help improve the medicament delivery devices on the market today, which are set out in more detail below.
An object of the present disclosure is thus to provide a medicament delivery device which solves, or at least mitigates, problems of the prior art.
There is hence according to a first aspect of the present disclosure provide a sub-assembly for a medicament delivery device configured to expel medicament from a medicament container via a delivery member, the sub-assembly comprising: a housing having a proximal end and a distal end; a holding sleeve biased towards the proximal end of the housing, the holding sleeve a pre-tensioned plunger rod operably arranged to, upon comprising a locking member; activation, act on the medicament container for expelling a medicament; an actuator having an arm arranged to lock the plunger rod in its pre-tensioned state, the actuator being operatively arranged to, upon activation, move the arm to release the plunger rod; wherein the holding sleeve comprises a surface arranged to abut the arm of the actuator to lock the plunger rod in its pre-tensioned state by restricting movement of the arm of the activator, wherein the holding sleeve is operatively configured to move distally during a medicament delivery operation, thereby allowing the arm of the actuator to be released past an end portion of the holding sleeve causing said release of the plunger rod, and wherein the holding sleeve is operatively configured to be moved proximally during a lockout operation in which the holding sleeve is axially locked by the locking member.
An effect obtainable thereby is an improved lockout of the holding sleeve. That is, after use, the holding sleeve is arranged in a final state in which it is axially locked. Thus, the holding sleeve cannot move axially subsequent to the lockout operation. As the holding sleeve is axially locked, it obstructs movement of other components which are directly linked to the axial movement of the holding sleeve.
In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the medicament delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the components thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
Further, the term “longitudinal”, “longitudinally”, “axially” or “axial” refer to a direction extending from the proximal end to the distal end, typically along the device or components thereof in the direction of the longest extension of the device and/or component.
Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.
Further, the terms “circumference”, “circumferential”, “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.
According to one embodiment the sub-assembly further comprising a lockout structure, the lockout structure is arranged to interact with the locking member in a locking engagement to axially lock the holding sleeve. Hereby, the locking member of the holding sleeve may lockingly engage with the lockout structure to axially lock the holding sleeve. Preferably, the lockout structure is arranged in a component or structure of the sub-assembly different to the holding sleeve.
According to one embodiment, the lockout structure is comprised in the actuator or the housing. The holding sleeve is typically arranged in between the housing and the actuator, such that the holding sleeve is arranged radially inwards of the housing, and radially outwards of the actuator, or the arm of the actuator. Thus, by arranging the lockout structure in one of the housing and the actuator, the axially locking of the holding sleeve if facilitated. That is, as the actuator and housing are arranged adjacent the holding sleeve, the locking member and the lockout structure will be arranged in components of the sub-assembly which are adjacent each other. Thus, as the holding sleeve moves axially within the housing in the proximal direction, i.e. moving axially relative to the housing and/or the actuator, the locking member is brought into engagement with the lockout structure to axially lock the holding sleeve.
According to one embodiment the locking member is arranged on a portion of the holding sleeve facing the actuator. Thus, preferably, the lockout structure is comprised in the actuator, such as on a portion of the actuator facing the holding sleeve. Hereby, the locking member may be brought into engagement with the lockout structure to axially lock the holding sleeve in a reliant manner. The portion of the holding sleeve facing the actuator may be referred to as an inner facing portion facing a centre axis of the sub-assembly, and the portion of the actuator facing the holding sleeve may be referred to as an outer facing portion facing away from a centre axis of the sub-assembly.
According to one embodiment, the locking member is an axial rib. Hereby, a simple yet effective structure for providing the locking functionality 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 larger than the extension in the radial direction. For example, the axial rib extends axially along the portion of the holding sleeve facing the actuator, and extends radially towards the actuator.
According to one embodiment, the arm of the actuator comprises an end hook having a first hook portion arranged to lock the plunger rod in its pre-tensioned state, and a second hook portion arranged opposite to the first hook portion, the second hook portion forming the lockout structure and being arranged to interact with the locking member to axially lock the holding sleeve. Hereby, reliable structure for providing the lockout functionality is provided. Moreover, by comprising the locking structure in the arm of the actuator, the arm of the actuator serve a dual purpose, one being to lock the plunger rod in its pre-tensioned state, the other one being to lockingly engage with the locking member of the holding sleeve to axially lock the holding sleeve during a lockout operation.
According to one embodiment, the locking member is arranged on a portion of the holding sleeve facing the housing. Thus, preferably, the lockout structure is comprised in the housing, such as on a portion of the housing facing the holding sleeve. Hereby, the locking member may be brought into engagement with the lockout structure to axially lock the holding sleeve in a reliant manner. The portion of the holding sleeve facing the housing may be referred to as an outer facing portion facing away from centre axis of the sub-assembly, and the portion of the housing facing the holding sleeve may be referred to as an inner facing portion facing toward a centre axis of the sub-assembly.
According to one embodiment, the housing comprises an opening forming the lockout structure, and is arranged to receive the locking member to axially lock the holding sleeve. Hereby, reliable structure for providing the lockout functionality is provided. The locking member is here preferably arranged as a locking protrusion or resilient tongue extending radially outwards from the portion of the holding sleeve facing the housing. Moreover, by comprising the locking structure in the housing, the housing serve a dual purpose, one being to house the components of the sub-assembly, the other one being to lockingly engage with the locking member of the holding sleeve to axially lock the holding sleeve during a lockout operation.
According to one embodiment, the locking member is operatively arranged to snap-fit into the opening of the housing. Hereby, a simple yet reliable lockout functionality is provided. For example, as previously described, the locking member is preferably arranged as a protrusion or resilient tongue extending radially outwards from the portion of the holding sleeve facing the housing. Upon axial movement of the holding sleeve in the proximal direction, the protrusion or resilient tongue is guided along an inner surface of the housing until the protrusion or resilient tongue encounters the opening the housing, whereby the protrusion or resilient tongue is snap-fitted into the opening of the housing. Hereby, the holding sleeve is axially locked.
According to one embodiment, the holding sleeve is biased towards the proximal end of the housing by means of a distal resilient member, and wherein the distal resilient member presses the holding sleeve against the actuator or housing via the locking member in the lockout operation. Thus, the biasing force in the proximal direction is transferred to the actuator or housing via the holding sleeve and the locking member and lockout structure.
According to one embodiment, the sub-assembly further comprises a drive spring biasing the plunger rod towards the proximal end of the housing. Hereby, the plunger rod may be axially fixed relative to the housing in a first axial position by means of the actuator and actuator arm, and may be released from the first axial position and moved axially inside the housing due to the biasing force from the drive spring, as the plunger rod is released from its first axial position.
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, during the medicament delivery operation, move linearly relative to the housing from a protracted position to a retracted position in which the delivery member cover is received further in the housing. Subsequent to such medicament delivery operation, the delivery member cover is configured to move axially in the proximal direction, to again be brought into the protracted position. Hereby, the delivery member is protected inside the delivery member cover.
According to one embodiment, in the retracted position of the delivery member cover, a proximal end of the delivery member cover is arranged closer to the proximal end of the housing compared to in the protracted position. For example, in the retracted position, the proximal end of the delivery member cover is distant from the proximal end of the housing by a first axial distance, which first axial distance is smaller than a second axial distance between the proximal end of the delivery member cover and the proximal end of the housing in the protracted position.
According to one embodiment, the holding sleeve is fixedly attached to the delivery member cover. Hereby, axial lockout of the delivery cover member is provided. For example, the holding sleeve is axially and rotationally fixed relative to the delivery member cover, and is thus axially movable together with the delivery member cover. The delivery member cover may be axially locked in its protracted position, subsequent to a medicament delivery operation, to safely protect the delivery member in the delivery member cover. That is, after use, the holding sleeve is arranged in a final state in which it is axially locked together with the delivery member cover. Thus, the holding sleeve and the delivery member cover cannot move axially subsequent to the lockout operation. As the delivery member cover is axially locked, the delivery member is prevented from again being exposed.
There is according to a second aspect of the present disclosure provided a medicament delivery device for expelling 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.
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. Embodiments mentioned in relation to the first aspect of the invention are largely compatible with the second aspect of the invention.
Generally, 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 member, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the member, apparatus, component, means, etc., unless explicitly stated otherwise.
The specific embodiments of the inventive concept will now be described, by way of example, with reference to the accompanying drawings, in which:
The inventive concept will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplifying embodiments are shown. The 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 by way of example 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 numbers refer to like members throughout the description.
The medicament delivery device 1 comprises a delivery member cover 5. The delivery member cover 5 is arranged in the housing 3 and extends proximally from the proximal end 3a of the housing 3. The medicament delivery device 1 further comprises a cap 2 removably arranged to the delivery member cover 5.
The delivery member cover 5 is configured to be moved linearly, or axially, relative to the housing 3 from a protracted position as shown in
The medicament delivery device 1 is triggered to discharge medicament by movement of the delivery member cover 5 further into the housing 3 towards the retracted position.
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 4b. The medicament container carrier 4 may preferably be fixedly attached to the housing 3 of the medicament delivery device 1, e.g. by a snap lock or other conventional engagement means. Alternatively, 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 house and support the medicament container 15 inside the medicament delivery device 1. The medicament container carrier 4 further comprises an activation lock 6 which will be further explained with reference to
The medicament delivery device 1 comprises the delivery member cover 5 described with reference to
The medicament delivery device 1 comprises the cap 2 described with reference to
The medicament delivery device 1 comprises a plunger rod 13 operably arranged to, upon activation, move in the proximal direction. Thus, in the embodiment of
The medicament delivery device 1 comprises a drive spring 12 configured to bias the plunger rod 13 in the proximal direction. In the embodiment of
The medicament delivery device 1 comprises an actuator 17 having an arm 17a arranged to lock the plunger rod 13 in a pre-tensioned state, and operatively arranged to, upon activation, move the arm 17a to release the plunger rod 13. In order to release the plunger rod 13, the distal end 5b of the delivery member cover 5 is arranged to engage with the actuator 17 to move the arm to release the plunger rod 13 as the delivery member cover 5 move axially into its retracted position. This will be further explained with reference to
The medicament delivery device 1 comprises a holding sleeve 9 arranged to move axially with the delivery member cover 5 inside of the housing 3. Thus, the holding sleeve 9 may be axially and rotationally fixed relative to the delivery member cover 5. When the delivery member cover 5 is moved from the protracted position towards the retracted position, linear movement of the delivery member cover 5 is transformed into linear movement of the holding sleeve 9. The holding 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 holding sleeve 9 is operatively configured to move distally as the delivery member cover 5 is pushed into its retractive position causing the arm 17a of the actuator 17 to be released passed an end portion 9a of the holding sleeve 9 to release the plunger rod 13. This will be further explained with reference to
The medicament delivery device 1 comprises a distal resilient member 20. The distal resilient member 20 may for example be a spring, such as a coil spring. The distal resilient member 20 is configured to bias the delivery member cover 5 in the proximal direction. In the embodiment of
The medicament delivery device 1 comprises a rear end 19 arranged to close the housing 3 at the distal end 3b of the housing 3.
The medicament delivery device 1 can be loaded with a medicament container 15. The medicament container 15 typically comprises a delivery member 22, such as a needle 22, and a ring needle shield, RNS, 23 arranged to protect the delivery member 22. The medicament container 15 my further comprise an RNS needle cover and an RNS plastic cap (not shown). The protrusion 2a of the cap 2, may be referred to as an RNS remover, as it may be configured to remove the RNS 23 upon cap removal from the delivery member cover 5.
Turning to
In more detail, the activation lock 6 is flexible and is configured to radially move by flexing inwards towards a centre axis of the sub-assembly 10. Preferably, the activation lock 6 forms part of the proximal end 4a of the medicament container structure 4. As shown in
As shown in
Typically, the proximal end 5a of the delivery member cover 5 is subject to the externally applied force causing the delivery member cover 5 to move distally in the axial direction such that the distally facing surface 5c abuts the activation lock 6, and the proximally facing surfaces 6a, to push the activation lock 6 into the space 80. Thus, the applied force from the distally facing surface 5c forces the activation lock 6 to move radially inwards into the space 80. Thus, the distally facing surface 5c is able to move distally beyond the activation lock 6 and thereby enable the delivery member cover 5 to be moved into its retracted position. Such configuration is shown in
The operation of the medicament delivery device 1 will now be described in more detail with reference to
The delivery member cover 5 is in the protracted position, biased in the proximal direction by the distal resilient member 20. The delivery member cover 5 is biased by the distal resilient member 20 via the holding sleeve 9. The delivery member cover 5 covers the delivery member 22 of the medicament container 15.
The plunger rod 13 is axially fixed relative to the medicament container carrier 4 and the housing 3 in the first axial position, and biased in the proximal direction by means of the drive spring 12.
The actuator 17 is arranged such that the arm 17a lock the plunger rod 13 in the pre-tensioned state. As shown in
At the beginning of medicament expulsion, the plunger rod 13 is axially positioned adjacent the actuator arms 17a, 17b, and thus the actuator arms 17a, 17b withstand the radially inwards directed force applied by the holding sleeve 9 and the biasing force from the distal resilient member 20 provided onto the holding sleeve 9. Once the plunger rod 13 has moved further in the proximal direction, and content of the medicament container 15 has been discharged, the plunger rod 13 is no more axially positioned adjacent the actuator arms 17a, 17b, and the radially inwards directed force applied by the holding sleeve 9 and the biasing force from the distal resilient member 20, forces the actuator arms 17a, 17b radially inwards. Hereby the holding sleeve 9 can move in the proximal direction together with the delivery member cover 5 to achieve a lockout, as shown in
The sub-assembly 11 comprises the housing 3 with the proximal end 3a and the distal end 3b, as previously described. In
The sub-assembly 11 comprises the actuator 17 with its actuator arms 17a, 17b, previously described and best shown in
Moreover, the sub-assembly 11 may comprise the drive spring 12 biasing the plunger rod 13 towards the proximal end 3a of the housing 3. Thus, in
As shown in
The sub-assembly 11′ comprises a housing 3′ with proximal end 3′a and distal end, as previously described, except that the housing 3′ does not comprise a corresponding opening 50 for interacting with a locking member 31 of the holding sleeve 9. The sub-assembly 11′ further comprises a holding sleeve 9′ proximally biased in housing 3′. The holding sleeve 9′ is in large corresponding to the holding sleeve 9 of
Each one of the actuator arms 17a, 17b comprises an end hook 40. As the end hook 40 is similar or corresponding for the two actuator arms 17a, 17b, it will only be described for a 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 (correspondingly that shown in
As shown in
Moreover, the sub-assemblies 11, 11′ may comprise the delivery member cover 5 previously described. Thus, the corresponding holding sleeve 9, 9′ may be fixedly attached to the delivery member cover 5, and thereby axially lock the delivery member cover 5 during the lockout operation.
The inventive concept has mainly been described above 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 could for example be motor driven or manually driven instead of having an automatic spring-loaded structure.
Some aspects are summarized in the following clauses.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21202765.0 | Oct 2021 | EP | regional |
The present application is a U.S. National Phase Application pursuant to 35 U.S.C. § 371 of International Application No. PCT/EP2022/077253 filed Sep. 30, 2022, which claims priority to (i) European Patent Application No. 21202765.0 filed Oct. 14, 2021, and (ii) U.S. Provisional Application No. 63/305,325 filed Feb. 1, 2022. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/077253 | 9/30/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63305325 | Feb 2022 | US |
