The present disclosure generally relates to a method of assembling a medicament delivery device, and particularly to a method of assembling a medicament delivery device that comprises the step of attaching a cap assembly to a housing.
Medicament delivery devices such as auto-injectors, inhalers and on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. Therefore, those medicament delivery devices usually comprise multiple automatic functions and are usually delivered to end-users with prefilled medicament containers. A medicament container usually comprises a glass or plastic barrel with a stopper sealing on its rear end and a delivery member arranged on its front end or a pierceable membrane arranged on its front end. Due to the medicament container filling process and/or the characteristic of the contained medicament, some prefilled medicament containers also contain an amount of air. A priming shot is therefore needed to be carried out before a medicament delivery operation. Also, some medicament containers contain substances that need to be mixed before a medicament delivery operation.
It has been appreciated that improved solutions for providing a priming shot before a medicament delivery operation would be useful. It has also been appreciated that a new method of assembling that medicament delivery device would be beneficial.
The invention is defined by the appended claims, to which reference should now be made.
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 members 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”, or “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.
There is hence provided a method of assembling a medicament delivery device, the method comprising: providing a housing of the medicament delivery device; wherein the housing extends along a longitudinal axis between a proximal end and a distal end; wherein the distal end of the housing is pointing away from a medicament delivery site during use of the medicament delivery device; and wherein the proximal end of the housing is pointing towards the medicament delivery site during use of the medicament delivery device; providing a power unit of the medicament delivery device; wherein the power unit comprises a plunger rod and a holder engaged with the plunger rod; assembling the power unit into the housing; providing a cap assembly extending along the longitudinal axis between a proximal end and a distal end; connecting the cap assembly to either the plunger rod or the holder; and moving the cap assembly relative to the housing in the distal direction of the housing until the cap assembly attaches to the proximal end of the housing, wherein during the step of moving the cap assembly relative to the housing, the cap assembly moves the plunger rod relative to the housing when the cap assembly is connected to the plunger rod; or the holder relative to the housing when the cap assembly is connected to the holder.
Another aspect of the invention provides a method of assembling a medicament delivery device, the method comprising: providing a housing of the medicament delivery device; wherein the housing extends along a longitudinal axis between a proximal end and a distal end; providing a power unit of the medicament delivery device; wherein the power unit comprises a plunger rod and a holder engaged with the plunger rod; assembling the power unit into the housing; providing a cap assembly extending along the longitudinal axis between a proximal end and a distal end; connecting the cap assembly to either the plunger rod or the holder; and moving the cap assembly relative to the housing in the distal direction of the housing until the cap assembly attaches to the proximal end of the housing, wherein during the step of moving the cap assembly relative to the housing, the cap assembly moves the plunger rod relative to the holder.
Preferably, according to another embodiment, before connecting the cap assembly to either the plunger rod or the holder, the method comprises the further steps of:
providing a medicament container; and inserting the medicament container into the housing from the proximal end of the housing.
Preferably, according to another embodiment, before assembling the power unit into the housing, the method comprises the further steps of providing a delivery member guard; and assembling both the delivery member guard and the power unit into the housing.
Preferably, according to another embodiment, the method comprises the further steps of engaging the delivery member guard to the holder either before or after assembling both the delivery member guard and the power unit into the housing.
Preferably, according to another embodiment, the step of moving the plunger rod relative to the housing comprises moving the plunger rod relative to the holder while the holder is immovable relative to the housing.
Alternatively, according to another embodiment, the step of moving the plunger rod relative to the holder comprises moving the plunger rod relative to the holder while the holder is immovable relative to the housing.
Preferably, according to another embodiment, during the step of moving the holder relative to the housing, the plunger rod is immovable relative to the housing.
Alternatively, according to another embodiment, the step of moving the plunger rod relative to the holder comprises moving the holder relative to the plunger rod while the plunger rod is immovable relative to the housing.
Preferably, according to another embodiment, the step of connecting the cap assembly to the plunger rod comprises the steps of contacting a proximal end of the medicament container with the cap assembly from the distal end of the cap assembly.
Preferably, according to another embodiment, the step of moving the plunger rod relative to the holder comprises the steps of using the cap assembly to move the medicament container in the distal direction relative to the housing; contacting a proximal end of the plunger rod with a distal end of the medicament container; using the distal end of the medicament container to move the plunger rod in the distal direction relative to the housing; disengaging the plunger rod from the holder by moving the plunger in the distal direction relative to the housing; and attaching the cap assembly to the proximal end of the housing.
Preferably, according to another embodiment, the step of connecting the cap assembly to the holder comprises the step of moving the cap assembly in the proximal direction relative to the delivery member guard, such that the cap assembly contacts a proximal end of the delivery member guard.
Preferably, according to another embodiment, the step of moving the plunger rod relative to the holder comprises the steps of: using the cap assembly to move the delivery member guard in the distal direction relative to the housing; using the distal movement of the delivery member guard to move the holder relative to the plunger rod; and attaching the cap assembly to the proximal end of the housing.
Preferably, according to another embodiment, the step of moving the holder relative to the plunger rod comprises a step of using the distal movement of the delivery member guard to rotate the holder relative to the plunger rod.
Preferably, according to another embodiment, the step of moving the holder relative to the plunger rod comprises a step of using the distal movement of the delivery member guard to linearly move the holder relative to the plunger rod in a direction transverse to the longitudinal axis.
Preferably, according to another embodiment, when the cap assembly is attached to the proximal end of the housing, the cap assembly moves axially towards the distal end of the housing relative to the housing until the cap assembly snap-fits to the housing.
Preferably, according to another embodiment, after the cap assembly is attached to the proximal end of the housing, the medicament delivery device is functionally completed.
Preferably, according to another embodiment, the medicament delivery device is an injection device, an inhalation device, or a medical sprayer.
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 element, apparatus, component, means, etc.” are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.
Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:
The rear sub-assembly 1, as shown in
The plunger rod 11, the stressed plunger rod spring 12, and the holder 13 are all arranged within the housing 10. In an example where the rear sub-assembly comprises the delivery member guard biasing member 15 and the guide rod 17, the delivery member guard biasing member 15 and the guide rod 17 are both arranged within the housing 10. In an example where the housing 10 comprises a medicament container holder 16, the medicament container holder 16 is also arranged within the housing 10. The stressed plunger rod spring 12 is engaged with the plunger rod 11 at one end, and with the housing 10, e.g. directly or indirectly, at the other end, so that the stressed plunger rod spring 12 is configured to actuate the plunger rod 11 in the proximal direction of the housing 10 to expel a medicament contained within the medicament container 3 after the rear sub-assembly 1, the cap assembly 2, and the medicament container 3 are assembled together. When the plunger rod 11 is in a start position relative to the holder, the holder 13 is configured to releasably hold the plunger rod 11 against a biasing force from the plunger rod spring 12. As shown in
The cap assembly 2 comprises a cover 20 extending along the longitudinal axis L between a proximal end (closed end) and a distal end (open end). The cover 20 is configured to cover the medicament delivery member, e.g., a needle of the medicament delivery device when the medicament delivery device is an injector, before a medicament delivery operation, namely, before use of the medicament delivery device. As the medicament delivery member is arranged at the proximal end of the medicament delivery device, the cover 20 is configured to be at least partially attached to the medicament delivery device. In a preferred example, the cover is configured to cover a needle. In a preferred example, the cover 20 comprises a sleeve-shaped body extending between the proximal end and the distal end. Alternatively, the cover comprises a flat, button-shaped body, in this example, the medicament delivery member is mainly received within the housing of the medicament delivery device, thus, the cover is configured to cover the proximal end tip of the medicament delivery device. In one example, the cap assembly comprises a delivery member shield remover arranged within the cover. In an example where the medicament delivery device is an autoinjector with a medicament container comprising a rigid needle shield and/or flexible needle shield, the delivery member shield remover of the cap assembly is configured to fixedly engage with at least one of a rigid needle shield and a flexible needle shield of the medicament container. In this example, the medicament container is a syringe (a medicament container with an integral needle or nozzle on the medicament container). In another example, as shown in
It should be noted that the description of this invention will not explain how to activate the fluid communication between the medicament container and the proximal delivery end of the delivery member by the removal of the cover in detail, because there are many different ways of activating the fluid communication between the medicament container and the proximal delivery end of the delivery member (see e.g. the disclosure of WO2009150078), and the how to activate the fluid communication between the medicament container and the proximal delivery end of the delivery member is not a part of the invention. Similarly, the description of this invention will not explain how to trigger a medicament delivery operation (completely releasing the plunger rod from the holder) in detail, because there are many different ways of triggering a medicament delivery operation (see e.g. WO2006057604), and the how to trigger a medicament delivery operation is not a part of the invention.
The method of the invention comprises the steps of providing the housing 10 of the medicament delivery device; and providing a power unit of the medicament delivery device. The power unit comprises the plunger rod 11 and the holder 13 engaged with the plunger rod 11. Assembling the power unit into the housing 10. Thus, the rear sub-assembly 1 has been assembled. The method of the invention comprises the steps of providing the cap assembly 2 extending along the longitudinal axis L between a proximal end and a distal end; connecting the cap assembly 2 to either the plunger rod 11 or the holder 13; and moving the cap assembly 2 relative to the housing 10 in the distal direction of the housing 10 until the cap assembly 2 attaches to the proximal end of the housing 10. During the step of moving the cap assembly 2 relative to the housing 10, the cap assembly 2 moves the plunger rod 11 relative to the holder 13.
In one example, the step of moving the plunger rod relative to the holder comprises a step of moving the holder 13 actively relative to the plunger rod 11. In this example, as shown in
In one example, as shown in
The next step is contacting the delivery member guard 14 with the cap assembly 2. In a preferred example, the distal end of the cover 20 of the cap assembly 2 is aligned with the proximal end of the housing 10, and the distal end of the cover 20 of the cap assembly 2 contacts a proximal end of the delivery member guard 14. Thereafter, the delivery member guard 14 is moved in the distal direction relative to the housing 10 by the cap assembly 2. The distal movement of the delivery member guard 14 causes the guide follower 141 to move along one of the diagonal portions or the helically extending portions 132b, 132d of the guiding structure 132, so that the holder 13 is rotated or moved linearly relative to the plunger rod 11, until the fastener 16a of the housing 10 engages with the counter fastener 23c of the cap assembly 2. The plunger rod 11 is now in the initial position relative to the holder 13. The delivery member guard 14 is then moved into a retracted position and thereby compresses the delivery member guard biasing member 15. The guide follower 141 is thereby positioned on an intermediate position 132c of the guide structure 132 of the holder 13. Therefore, when the end-user wants to use the medicament delivery device, the end-user will first remove the cover 20 from the medicament delivery device. Once the cover 20 has been removed, the delivery member guard 14 will move, under the biasing force of the delivery member guard biasing member 15, in the proximal direction relative to the housing 10. The guide follower 141 is thereby moved along the other one of the diagonal portions or the helically extending portions 132b, 132d of the guiding structure 132, so that the plunger rod 11 is released from the initial position and moves to the start position. The initial operation of the medicament delivery device is therefore performed. When the plunger rod 11 is in the start position, the plunger rod 11 can engage with the holder 13 or any other suitable component for holding the plunger rod against the force of the plunger rod spring before the medicament delivery operation. In a preferred example, the holder 13 comprises a second distally directed counter holding surface 13b, as shown in
In another example, the step of moving the plunger rod 11 relative to the holder 13 comprises a step of moving the plunger rod 11 actively relative to the holder 13. This example will be suitable for assembling a medicament delivery device that comprises a cartridge; and with the assembling step that, before attaching the cap assembly 2 to the proximal end of the housing 10, the method comprises further steps of providing a medicament container 3; and inserting the medicament container 3 into the housing from the proximal end of the housing 10, as shown in
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.
Number | Date | Country | Kind |
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21200415.4 | Oct 2021 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2022/073528 | 8/23/2022 | WO |
Number | Date | Country | |
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63239445 | Sep 2021 | US |