The present invention relates to an autoinjector.
In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the “distal direction” is to be understood as meaning the direction away from the user's hand, and the “proximal direction” is to be understood as meaning the direction toward the user's hand.
Automatic injection devices are designed for automatic injection of a medical product into an injection site. Autoinjectors usually comprise a housing for receiving a medical container having a barrel defining a reservoir for containing the medical product, the barrel having a distal end provided with an injection needle and an opened proximal end receiving a plunger rod for pushing a stopper. The opened proximal end is usually provided with a flange.
Autoinjectors also include a safety shield mechanism moving from an extended to a retracted position to shield or unveil the needle and an injection mechanism for automatically injecting the medical into an injection site. The injection mechanism is usually triggered by a an activation component, also called a holder, when the needle is unveiled by the safety shield mechanism. It is important to prevent untimely triggering of the autoinjector, that is to prevent movement of the activation component towards an active position before use of the autoinjector.
To assess the robustness of the autoinjectors, autoinjectors are subjected to drop tests as required in ISO11608. These drop tests usually consist in dropping the autoinjectors at least once from a height of 1 m onto a horizontal floor. There are three drop directions, as illustrated in
During a drop ‘cap upward’, when the autoinjector strikes the ground, the accumulated kinematic energy may cause the activation component to move towards a position where it undesirably triggers the injection mechanism.
The document WO2019011688 discloses an administration assembly for a medicament delivery device.
There is therefore a need for an autoinjector that does not transition from a deactivated condition to activated condition when falling down on the floor during a drop test ‘cap upward’ or any accidental drop.
An aspect of the invention is an autoinjector, for automatic injection of a product into an injection site, said autoinjector having a proximal end and a longitudinal axis A, the autoinjector comprising:
Therefore, the autoinjector of the invention remains in a deactivated condition, even if the autoinjector falls down on the floor ‘proximal end first’. The autoinjector of the invention however easily permits the user who voluntarily presses the autoinjector against an injection site to move the locker towards the unlocking position and thus to trigger the injection mechanism.
The holder is axially movable along the longitudinal axis A between the passive and the active position. The proximal movement of the holder from the passive to the active position is caused by the needle cover abutting against the holder when the needle cover moves towards the retracted position. In the passive position, the holder may be axially away from a locking ring, and the locking ring is in a first position in which the locking ring prevents axial movement of the plunger rod. In the active position position, the holder abuts against the locking ring and has pushed the locking ring to a second position, in which the locking ring no longer prevents axial movement of the plunger rod.
The locker is axially movable along the longitudinal axis A between an initial position, in which the locker (and more specifically a proximal abutment surface of the locker) is axially away from the first abutment surface of the housing, and an intermediate blocking position (locking position), in which the locker (and more specifically its proximal abutment surface) abuts against the first abutment surface of the housing. The locker thus stands between the first abutment surface of the housing and the holder (more specifically a proximal shoulder of the holder). The housing blocks the locker and the locker blocks the holder in the proximal direction. Inadvertent triggering of the injection mechanism, such as during a drop “cap upward” is accordingly prevented.
The locker is further rotationally movable around the longitudinal axis A between the intermediate blocking position and a release position, in which the locker (and more specifically its proximal abutment surface) is circumferentially shifted away from the first abutment surface of the housing. After said rotation, the locker is free to move in the proximal direction and the holder is thus no longer prevented from proximally moving towards the active position.
In an embodiment, the locker has a ring portion slidingly and rotatively mounted in a groove of the holder, and a cam portion provided at a distal leg protruding from said ring portion of the locker, said cam portion being configured to abut against the needle cover when the needle cover moves towards the retracted position, thereby causing movement of the locker relative to the holder and the housing towards the unlocking position.
In an embodiment, the ring portion is in the form of a C-shaped ring portion comprising an axial slit configured to allow a snap-fit assembly of the locker onto the holder.
Preferably, the distal leg of the locker is diametrically opposite the axial slit of the ring portion of the locker.
In an embodiment, the needle cover has a cam portion configured to come in abutment against the cam portion of the locker so as to cause movement of the locker from the locking to the unlocking position.
In an embodiment, the cam portion of the locker includes a slanted wall and the cam portion of the needle cover includes an abutting edge configured to form a line contact with the locker.
In an embodiment, the abutting edge is arranged at a distal end of an axial lug, said axial lug including a lateral abutment surface configured to abut against the locker when the locker is in the unlocking position, thereby preventing the locker from moving back to the locking position.
In an embodiment, the cam portion of the needle cover includes a proximal abutment surface which is orthogonal to the longitudinal axis A so as to stop rotation of the locker and allow the needle cover to push the locker together with the holder in a proximal direction.
The proximal abutment surface may be configured such that the locker stays away from a second axial rib of the housing when the locker moves together with the holder in a proximal direction.
In an embodiment, the locker has a distal abutment surface configured to abut against a first abutment surface of the housing in the locking position, and said distal abutment surface of the locker is configured to move away from the first abutment surface of the housing when the locker is rotated towards the unlocking position.
Possibly, the first abutment surface is arranged on a first axial rib of the housing.
In an embodiment, the first abutment surface is provided at a distal end of a first axial rib of the housing.
In an embodiment, the locker has a spring mechanism for urging the locker back towards the locking position.
This permits to maintain the locker in the locking position when the autoinjector is unused.
In an embodiment, the locker is made of a single piece.
In an embodiment, the locker is made of a first material including acrylonitrile butadiene styrene (ABS) and the holder is made of a second material including polyoxymethylene (POM).
The terms Fig., Figs., Figure, and Figures are used interchangeably in the specification to refer to the corresponding figures in the drawings.
The invention and the advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings as follows:
With reference to
The lower housing 201 is configured to receive a medical container 30, such as a prefilled syringe. The medical container 30 has a barrel 32 defining a reservoir for containing the product 31. The lower housing 201 may define an inspection window 203 for allowing a user to visually inspect the product 31 contained within the reservoir of the medical container 30.
The barrel 32 has a distal end 33 provided with a needle 34 and an opened proximal end 35 for receiving a plunger rod 36. The plunger rod 36 may have a threaded or preferably a non-threaded distal end. The plunger rod 36 is configured to distally push a stopper 37 arranged inside the barrel 32 so as to expel the product 31 via the distal end and the needle 34. The opened proximal end 35 of the barrel 32 includes a flange 38 as illustrated in
With reference to
The autoinjector 10 has an injection mechanism configured to automatically perform injection of the product 31 into the injection site. The injection mechanism includes an injection spring 50 for pushing the plunger rod 36 in the distal direction, locking balls 51 radially movable from a locking position wherein they block distal movement of the plunger rod 36 to an unlocking position wherein the locking balls 51 allow the plunger rod 36 to move in the distal direction under the action of the injection spring 50, thereby performing the injection. The injection mechanism has a washer 52 defining a radial cavity 53 for accommodating the locking balls 51, and a ring 54 coupled to and movable with respect to the washer 52 between a first position wherein the ring 54 maintains the locking balls 51 inside a recess 57 of the plunger rod 36 and a second position wherein the ring 54 allows the locking balls 51 to leave the plunger rod recess 57. The autoinjector 10 may further include a centerpiece 55 and an indicator 56 for providing the user with an audible, visual or tactile feedback that the injection is completed.
The autoinjector 10 has a tubular holder 60 configured to trigger the injection mechanism. The holder 60 is movable within the upper housing 202 from a passive to an active position. In the passive position, the holder 60 is away from the ring 54 and thus does not trigger the injection. In the activated position, the holder 60 moves the ring 54 from the first to the second position. The proximal movement of the holder 60 from the passive to the activated position is caused by the second proximal leg 46 of the needle cover 40 abutting against the holder 60 when the needle cover 40 moves from the first extended position (pre-use position) towards the retracted position (injection position).
In order to prevent inadvertent movement of the holder 60 towards the active position, and thus inadvertent actuation of the injection mechanism, the autoinjector 10 includes a locker 70, preferably in the form of a C-shaped ring, as illustrated in
More specifically, the locker 70 has a ring portion 72, that slides in the groove 62 of the holder 60, and a distal leg 73, that distally protrudes from the ring portion 72. The distal leg 73 has a cam portion 74 (at a distal end thereof), a proximal abutment surface 75, a first lateral abutment surface 76a, a second lateral abutment surface 76b, and a third lateral abutment surface 79. The cam portion 74 defines a slanted wall. The proximal abutment surface 75 may be arranged on a transversal rib 77, which may extend orthogonal to the longitudinal axis A, and which is configured to abut against a first abutment surface 204 of the upper housing 202. The first lateral abutment surface 76a, which may be formed on a side of the cam portion 74 (
With reference to
With reference to
With reference to
It is noted that the locker 70 is preferably made of a single piece.
Both translation and rotation of the locker 70 are caused by the first proximal leg 45 of the needle cover 40 abutting against the cam portion 74 of the locker 70. As illustrated in
Still with reference to
Between the axial lug 49 and the proximal abutment surface 45a, the cam portion 47 of the needle cover 40 may have a slanted wall having the same shape as the slanted wall of the locker cam portion 74.
With reference to
The locker 70 is movable between an initial position (
The operation of the autoinjector 10 according to the invention is described below in connection with
With reference to
The user presses the autoinjector 10 against the injection site. This causes the needle cover 40 to move in the proximal direction towards the retracted position and thus come in abutment against the cam portion 74 of the locker 70 (
Here, the locker 70 is in the intermediate blocking position and accordingly prevents the holder 60 from inadvertently moving to the active position. If movement of the needle cover 40 was caused by a drop ‘cap upward’ of the autoinjector 10, then nothing happens, the autoinjector 10 safely remains in the deactivated condition by means of the locker 70 abutting against the housing 20. If, however, movement of the needle cover 40 is caused by the user pressing the autoinjector 10 against an injection site, then the locker 70 begins to rotate as the user goes on pushing the autoinjector 10.
Indeed, due to the shape of the locker cam portion 74 and the needle cover cam portion 47, and due to the abutment between the locker 70 and the upper housing 202, further movement of the needle cover 40 in the proximal direction causes the locker 70 to rotate around the holder 60 (
The locker 70 rotates until the proximal abutment surface 45a of the needle cover 40 abuts against the cam portion 74 of the locker 70. The locker 70 is maintained by the resilient leg 81 against the lateral abutment surface 49a of the axial lug 49 which abuts against a side of the distal leg 73 of the locker 70 (
At that time, the needle cover 40 may unveil the needle 34 and the needle 34 may begin insertion into the injection site (
The second proximal leg 46 of the needle cover 40 comes against a distal end 65 of the holder 60 (
At this stage, the locking balls 51 extend in the locking recess of the plunger rod 36 and thus prevent the injection spring 50 from pushing the plunger rod 36 in the distal direction. The locking ring is in the first position such that the locking ring blocks the locking balls 51 inside the locking recess of the plunger rod 36.
However, when the needle cover 40 reaches the retracted position (injection position), as illustrated in
At the end of the injection, the centerpiece 55 cooperates with the plunger rod 36 and the indicator to provide the user with a feedback indicating that the injection is completed.
The user may take the autoinjector 10 away from the injection site. The safety spring 44 accordingly moves the needle cover 40 back in the distal direction, until the needle cover 40 reaches the second extended position (safety position) wherein the needle cover 40 shields the needle 34 and is prevented from moving back in the retracted position by the locking element 41.
Due to the locker 70, the invention permits to prevent inadvertent activation of the autoinjector 10, for example if the autoinjector 10 falls down on the floor, while still permitting easy activation of the autoinjector 10 when this activation results from the user intentional action.
Number | Date | Country | Kind |
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21305882.9 | Jun 2021 | EP | regional |
This application is the United States national phase of International Application No. PCT/EP2022/066910 filed Jun. 21, 2022, and claims priority to European Patent Application No. 21305882.9 filed Jun. 25, 2021, the disclosures of which are hereby incorporated by reference in their entireties.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2022/066910 | 6/21/2022 | WO |