JP-2026514284-A - A drug delivery device equipped with a feedback element, and a method for providing feedback to a user of the drug delivery device regarding the single-dose dispensing process.

JP2026514284AJP 2026514284 AJP2026514284 AJP 2026514284AJP-2026514284-A

Abstract

A drug delivery device for delivering a single dose of a drug during a single-dose dispensing process, wherein the drug delivery device is configured to have a first state in which the plunger rod and plunger stopper are not visible from the drug window, and a second state in which the plunger stopper is not visible from the drug window and the plunger rod is visible from the drug window, and the plunger rod is provided with at least one feedback element, which is configured to be visible from the drug window in the second state.

Inventors

アレクサンダー・ベングス
クラウス・シェヌ
オリヴァー・グレーヴェン
トビアス・スティーヴァー

Assignees

サノフイ

Dates

Publication Date: 20260508
Application Date: 20231031
Priority Date: 20221031

Claims (20)

In a drug delivery device for delivering a single dose of a drug in a single-dose dispensing process, - A device body having a distal end and a proximal end, including a drug window, and configured to receive a drug container, the drug container including a plunger stopper that seals the drug container at the proximal end, the plunger stopper being movably held within the container body of the drug container, and the inside of the container being the device body visible through the drug window, - A plunger rod, which is releasably held within the device body and is configured to be moved distally relative to the device body by energy provided by an energy member, - A plunger release mechanism configured to release the plunger rod and initiate the distal movement of the plunger rod relative to the device body, - A trigger member configured to activate the plunger release mechanism and release the plunger rod, Includes, The drug delivery device is - A first state in which the plunger rod and the plunger stopper are not visible from the drug window, - The plunger stopper is configured to be invisible from the drug window, and the plunger rod is visible from the drug window, and the drug delivery device is configured to initiate a transition from the first state to the second state when the plunger release mechanism is activated. The plunger rod is provided with at least one feedback element. The feedback element is configured to be visible from the drug window in the second state of the drug delivery device.
The drug delivery device according to claim 1, wherein the feedback element includes a visually identifiable feature on and/or on the plunger rod.
The drug delivery device according to claim 2, wherein the visually identifiable features are made to be readable by a reading device.
The drug delivery device according to any one of claims 1 to 3, wherein the feedback element includes at least one groove, for example, three grooves, located on the distal portion of the plunger rod.
In the first state, the plunger rod is shifted proximal to the plunger stopper, and the plunger rod is configured to collide with the plunger stopper when the plunger release mechanism is activated by the trigger member, thereby providing auditory and/or tactile user feedback indicating the release of the plunger rod and the commencement of the single-dose dispensing process, according to any one of claims 1 to 4.
The drug delivery device according to any one of claims 1 to 5, wherein the second state includes a first sub-state in which both the plunger stopper and the plunger rod move distally, and the feedback element is configured to visually indicate the movement of the plunger rod.
The second state includes a second sub-state configured such that the plunger stopper and the plunger rod do not move. A drug delivery device according to any one of claims 1 to 6, wherein in the second sub-state, the plunger rod is in a final position with respect to the device body, and in the final position, the feedback element is configured to be positioned at the distal end of the drug window with respect to the device body, thereby indicating the end of the single-dose dispensing process.
A drug delivery device according to any one of claims 1 to 7, further comprising a clicker configured to provide sound at the end of the single-dose dispensing process, thereby providing auditory and/or tactile user feedback indicating the end of the single-dose dispensing process.
A drug delivery device according to any one of claims 1 to 8, wherein the plunger stopper and the plunger rod are configured to have a third state visible from the drug window.
The drug delivery device according to any one of claims 1 to 9, wherein the plunger rod and the plunger stopper have two different colors.
The drug delivery device according to any one of claims 1 to 10, wherein the plunger rod is biased in a rotational direction with respect to the device body in the first state, and when the plunger rod is released by the plunger release mechanism, the plunger rod is configured to rotate and collide with a member of the drug delivery device, the collision being configured to provide the user with auditory and/or tactile feedback indicating the release of the plunger rod.
The drug delivery device according to any one of claims 1 to 11, wherein the trigger member includes a needle cover, the needle cover is configured to be movable from a first cover position to a second cover position, and the needle cover is configured to activate the plunger release mechanism in the second cover position, thereby releasing the plunger rod.
The drug delivery device according to any one of claims 1 to 12, wherein the energy member is a drive spring.
A drug delivery device according to any one of claims 1 to 13, comprising a drug container containing a drug.
A method for providing feedback to a user of a drug delivery device regarding the single-dose dispensing process, - To provide the user with first feedback indicating the start of the single-dose dispensing process, - To provide the user with a second feedback indicating the progress of the single-dose dispensing process, - To provide the user with a third feedback indicating the completion of the single-dose dispensing process, A method that includes this.
In a drug delivery device for delivering a single dose of a drug in a single-dose dispensing process, - A device body having a distal end and a proximal end, including a drug window, configured to receive or receive a drug container, the drug container including a plunger stopper that seals the drug container at the proximal end, the plunger stopper being movably held within the container body of the drug container, the inside of the container being the device body visible through the drug window, - A plunger rod, which is releasably held within the device body and is configured to be moved distally relative to the device body by energy provided by an energy member, - A plunger release mechanism configured to release the plunger rod and initiate the distal movement of the plunger rod relative to the device body, - A trigger member configured to activate the plunger release mechanism and release the plunger rod, Includes, The drug delivery device is - A first state in which the plunger rod and the plunger stopper are not visible from the drug window, - The plunger stopper is configured to be invisible from the drug window, and the plunger rod is visible from the drug window, and the drug delivery device is configured to initiate a transition from the first state to the second state when the plunger release mechanism is activated. The plunger rod is provided with at least one feedback element. The feedback element is configured to be visible from the drug window in the second state, The plunger rod and the plunger stopper are a drug delivery device having two different colors.
In a drug delivery device for delivering a single dose of a drug in a single-dose dispensing process, - A device body having a distal end and a proximal end, including a drug window, and configured to receive a drug container, the drug container including a plunger stopper that seals the drug container at the proximal end, the plunger stopper being movably held within the container body of the drug container, and the inside of the container being the device body visible through the drug window, - A plunger rod, which is releasably held within the device body and is configured to be moved distally relative to the device body by energy provided by an energy member, - A plunger release mechanism configured to release the plunger rod and initiate the distal movement of the plunger rod relative to the device body, - A trigger member configured to activate the plunger release mechanism and release the plunger rod, Includes, The drug delivery device is - A first state in which the plunger rod and the plunger stopper are not visible from the drug window, - The plunger stopper is configured to be invisible from the drug window, and the plunger rod is visible from the drug window, and the drug delivery device is configured to initiate a transition from the first state to the second state when the plunger release mechanism is activated. The plunger rod is provided with at least one feedback element. The feedback element is configured to be visible from the drug window in the second state, The second state includes a second sub-state configured such that the plunger stopper and the plunger rod do not move. In the second substate, the plunger rod is in its final position relative to the device body, and in the final position, the feedback element is positioned at the distal end of the drug window relative to the device body, thereby indicating the end of the single-dose dispensing process in the drug delivery device.
In a drug delivery device for delivering a single dose of a drug in a single-dose dispensing process, - A device body having a distal end and a proximal end, including a drug window, and configured to receive a drug container, the drug container including a plunger stopper that seals the drug container at the proximal end, the plunger stopper being movably held within the container body of the drug container, and the inside of the container being the device body visible through the drug window, - A plunger rod, which is releasably held within the device body and is configured to be moved distally relative to the device body by energy provided by an energy member, - A plunger release mechanism configured to release the plunger rod and initiate the distal movement of the plunger rod relative to the device body, - A trigger member configured to activate the plunger release mechanism and release the plunger rod, Includes, The drug delivery device is - A first state in which the plunger rod and the plunger stopper are not visible from the drug window, - The plunger stopper is configured to be invisible from the drug window, and the plunger rod is visible from the drug window, and the drug delivery device is configured to initiate a transition from the first state to the second state when the plunger release mechanism is activated. The plunger rod is provided with at least one feedback element. The feedback element is configured to be visible from the drug window in the second state, The second state includes a second sub-state configured such that the plunger stopper and the plunger rod do not move. In the second sub-state, the plunger rod is in its final position relative to the device body, and in the final position, the feedback element is positioned at the distal end of the drug window relative to the device body, thereby being configured to indicate the end of the single-dose dispensing process. A drug delivery device configured such that the plunger stopper and the plunger rod have a third state visible from the drug window.
A method for providing feedback to a user of a drug delivery device regarding a single-dose dispensing process, wherein the drug delivery device comprises a plunger rod, a plunger stopper, and a drug window, and the plunger rod and the plunger stopper are of two different colors, - To provide the user with first feedback indicating the start of the single-dose dispensing process, - To provide the user with a second feedback indicating the progress of the single-dose dispensing process, wherein the second feedback includes visual feedback that the plunger rod and the plunger stopper are moving distally along the drug window. - To provide the user with a third feedback indicating the completion of the single-dose dispensing process, A method that includes this.
A method for providing feedback to a user of a drug delivery device regarding a single-dose dispensing process, wherein the drug delivery device comprises a plunger rod and a drug window, and the plunger rod comprises at least one groove, - To provide the user with first feedback indicating the start of the single-dose dispensing process, - To provide the user with a second feedback indicating the progress of the single-dose dispensing process, - A method comprising providing the user with a third feedback indicating the completion of the single-dose dispensing process, wherein the third feedback includes visual feedback, and the plunger rod is configured such that at the completion of the single-dose dispensing process, the at least one groove is positioned in the distal portion of the drug window.

Description

Drug delivery devices, such as injectors and especially autoinjectors, typically have a syringe for dispensing a single dose of a drug. Drug delivery devices may include feedback mechanisms to provide users of such devices with feedback regarding the single-dose dispensing process. 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 h