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JP-2026514280-A - Method for assembling an assembly for a drug delivery device and drug delivery device

JP2026514280AJP 2026514280 AJP2026514280 AJP 2026514280AJP-2026514280-A

Abstract

A method for assembling an assembly for a drug delivery device is provided. The method includes: - guiding a container holder in which a drug container is placed distal to the device body until the drug container engages with a deformable engagement structure; - moving the container holder distal to the device body, the engagement structure, and the drug container toward the terminal position of the container holder relative to the device body; and - moving the container holder and drug container distal to the terminal position relative to the device body and the engagement structure, thereby deforming the engagement structure.

Inventors

  • アンドリュー・ラバト－ロチェコウスト
  • ケヴィン・ラヌチ
  • ウィリアム・ティミス
  • ロバート・ウィルソン

Assignees

  • サノフイ

Dates

Publication Date
20260508
Application Date
20231031
Priority Date
20221031

Claims (20)

  1. A method for assembling an assembly for a drug delivery device, - A step of guiding a container holder in which a drug container is placed toward the distal side relative to the device body until the drug container engages with a deformable engagement structure, - A step of moving the container holder distal to the device body, distal to the engagement structure, and distal to the drug container, toward the terminal position of the container holder relative to the device body, A method comprising the steps of moving the container holder and the drug container distal to the device body and the engagement structure to the terminal position, thereby deforming the engagement structure.
  2. The method according to claim 1, wherein the force that moves the container holder, which is equipped with the drug container, distal to the engagement structure to the terminal position is greater than the engagement force between the deformable engagement structure and the drug container, thereby overcoming the engagement force that acts in opposition to the movement of the container toward the terminal position.
  3. The method according to claim 1 or 2, wherein the engaging structure engages with the distal portion of the drug container at the terminal position.
  4. The method according to any one of claims 1 to 3, wherein, in order to move the container holder distal to the drug container toward the terminal position, the container holder is moved with a force smaller than the engagement force between the drug container and the deformable engagement structure, thereby moving only the container holder relative to the device body and not the container.
  5. The method according to any one of claims 1 to 4, further comprising the preceding step of inserting the container holder proximal to the device body from the proximal aperture of the device body until it reaches a first holder position relative to the device body, wherein at the first holder position, the container holder is releasably connected to the device body.
  6. The method according to claim 5, wherein the container holder is inserted until the proximal holder connection feature on the container holder engages with the respective proximal body connection feature on the device body, in order to releasably connect the container holder to the device body.
  7. For example, the method according to any one of claims 1 to 6, comprising the step of positioning the drug container in the container holder by inserting the drug container into the container holder until the container holder reaches a first container position in which it engages with the drug container, while the container holder is releasably connected to the device body.
  8. The method according to any one of claims 1 to 7, wherein, at the terminal position, the proximal holder connection feature portion of the container holder engages with the respective distal body connection feature portions on the device body.
  9. The method according to any one of claims 1 to 8, wherein the drug container is provided with a needle shield at its distal end, and when the drug container engages with the deformable engagement structure, the needle shield of the drug container engages with the deformable engagement structure.
  10. The method according to any one of claims 1 to 9, wherein the deformable engagement structure comprises a radially inwardly oriented flexible barb arranged to penetrate the outer surface of the needle shield.
  11. The method according to claim 10, wherein the deformable structure is located distal to the device body and provided within a cap connected to the device body.
  12. The method according to claim 10 or 11, comprising bending the flexible barb radially outward so that deforming the engagement structure overcomes the engagement force of the flexible barb with respect to the drug container.
  13. The method according to claim 11 or 12, wherein the drug delivery device further comprises a needle cover, and the cap comprises an engaging element that engages with the needle cover.
  14. The method according to any one of claims 1 to 13, wherein at least the steps of guiding the container holder, moving the container holder relative to the drug container, and moving the container holder and the drug container to the terminal position are performed using an assembly tool, such as a press head, that acts on the container holder and/or the container, and the assembly tool is configured to contact only the container holder, for example, to move the container holder and the container distally, but the drug container is moved distally by engagement with the container holder, or to contact the container holder and the drug container, for example, to act on the container holder and the drug container with force from the assembly tool.
  15. A drug delivery device comprising a container holder and a drug container assembled by the method described in any one of claims 1 to 14, wherein the drug container contains a drug.
  16. A method for assembling an assembly for a drug delivery device, - A step of guiding a container holder in which a drug container is placed toward the distal side relative to the device body until the drug container engages with a deformable engagement structure, - A step of moving the container holder distal to the device body, distal to the engagement structure, and distal to the drug container, toward the terminal position of the container holder relative to the device body, - The process includes the step of moving the container holder and the drug container distal to the device body and the engagement structure to the terminal position, thereby deforming the engagement structure. A method wherein the force that moves the container holder, which is equipped with the drug container, distal to the engagement structure toward the terminal position is greater than the engagement force between the deformable engagement structure and the drug container, thereby overcoming the engagement force that acts in opposition to the movement of the container toward the terminal position.
  17. A method for assembling an assembly for a drug delivery device, - A step of guiding a container holder in which a drug container is placed toward the distal side relative to the device body until the drug container engages with a deformable engagement structure, - A step of moving the container holder distal to the device body, distal to the engagement structure, and distal to the drug container, toward the terminal position of the container holder relative to the device body, - The process includes the step of moving the container holder and the drug container distal to the device body and the engagement structure to the terminal position, thereby deforming the engagement structure. The drug container is provided with a needle shield at its distal end, and when the drug container engages with the deformable engagement structure, the needle shield of the drug container engages with the deformable engagement structure. The deformable engagement structure comprises a radially inwardly oriented flexible barb positioned to penetrate the outer surface of the needle shield, in a method.
  18. A method for assembling an assembly for a drug delivery device, - A step of guiding a container holder in which a drug container is placed toward the distal side relative to the device body until the drug container engages with a deformable engagement structure, - A step of moving the container holder distal to the device body, distal to the engagement structure, and distal to the drug container, toward the terminal position of the container holder relative to the device body, - The process includes the step of moving the container holder and the drug container distal to the device body and the engagement structure to the terminal position, thereby deforming the engagement structure. The force that moves the container holder, which is equipped with the drug container, distal to the engagement structure toward the terminal position is greater than the engagement force between the deformable engagement structure and the drug container, thereby overcoming the engagement force that acts in opposition to the movement of the container toward the terminal position. In order to move the container holder distal to the drug container toward the terminal position, the container holder is moved with a force smaller than the engagement force between the drug container and the deformable engagement structure, thereby moving only the container holder relative to the device body without moving the container. The deformable engagement structure comprises a radially inwardly oriented flexible barb positioned to penetrate the outer surface of the needle shield, A method wherein the deformable structure is provided within a cap that is located distal to the device body and connected to the device body.
  19. A method for delivering a drug from a drug delivery device, comprising using the drug delivery device described in claim 15.
  20. A drug for use in a method of treating a patient, wherein the method includes delivering the drug to the patient using the drug delivery device described in claim 15.

Description

Methods for assembling injection devices, particularly drug delivery devices such as autoinjectors, are known. These methods may involve complex steps that make assembly complicated, time-consuming, and cumbersome. Figure 1A-1D shows cross-sectional views of a drug delivery device in different operating states according to the first embodiment.This is an exploded view of an example of a drug delivery device, with or without an optional separate syringe holder.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.Any cap and any cap cover.These are perspective views and cross-sectional views of an arbitrary graba, respectively.These are perspective views and cross-sectional views of an arbitrary graba, respectively.This is an exemplary embodiment of a single sheet capable of forming a grabber carrier.This is a grabber that engages with the syringe needle shield.This is a grabber that engages with the syringe needle shield.This is a cutaway view of the grabber from the previous embodiment, assembled inside the cap.This details the interaction between grabber-holding bosses, for example, between the boss of a cap and the opening of an exemplary grabber.This is a cross-sectional view of the front end of an injection device having a fitted cap and a grabber mounted on the cap that interacts with the needle shield.This is any needle cover (needle shroud).This is the needle cover spring.This is a cross-sectional view of the needle cover spring assembled inside the drug delivery device in its pre-use state.This is the device itself.This is a cross-sectional view of the device itself.This is a perspective cross-sectional view of the distal end of the device body.This is a cross-sectional view of the central portion of the device body having a syringe holder.This is a perspective view of the syringe holder front stopper on the device body.This is a cross-sectional view of the distal end of the device body with the needle cover in the third cover position.This is a perspective view of the needle cover locking structure interacting with the flexible arm of the needle cover.Any syringe holder.A perspective view of any syringe holder.This is a detail diagram of a further exemplary embodiment of the flexible holder arm.This is an arbitrary syringe holder including the flexible holder arm shown in Figure 8C.Any pre-filled syringe.It's a plunger.This is the plunger release mechanism in its first state.This is the plunger release mechanism in its second state.This is the plunger release mechanism during the assembly of the drive subassembly.This is the plunger release mechanism during final assembly.This is a further state of the plunger release mechanism.This is a schematic diagram of the plunger release mechanism after the sleeve has been pushed into the retracted position.This is a schematic detail diagram of the plunger release mechanism after final assembly, before the sleeve is pushed in.This is a schematic detail diagram of the plunger release mechanism while the sleeve is being pushed in.This is a longitudinal rib located on the inside of the rigid arm of the drive spring holder.This is a perspective view of the plunger according to the second embodiment.This is a distal view of the plunger according to the second embodiment.This is a cross-sectional view along the radial direction through the shaft of the plunger according to the second embodiment.This is a cross-sectional view along the longitudinal direction through which the plunger shaft passes.This is a drive spring according to one embodiment of the present disclosure.This is the drive spring shown in Figure 11A, which is incorporated into the drug delivery device and operates the plunger.These are the drive springs shown in Figures 11A and 11B, which are assembled within the drug delivery device, before the plunger is activated.This is a perspective view of the drive spring holder.This is a perspective view of the drive spring holder.This is a syringe return prevention mechanism.This is a cross-sectional view of the proximal portion of the drive spring holder.This is a different embodiment of the flexible portion of the drive spring holder.This is a different embodiment of the flexible portion of the drive spring holder.This is a different embodiment of the flexible portion of the drive spring holder.It is any audible indicator (clicker).An example is an indicator holder included on a drive spring holder.This is a perspective view of the support structure at the distal end of the flexible support arm.This is a perspective view of the guide structure of the indicator holder.This is a cross-sectional view of the indicator holder, passing through the longitudinal axis of symmetry.This is the rear sub-assembly (RSA) after the audible indicator has been installed, but before priming the audible indicator.Preferab