Medical device for holding a syringe comprising a visual indicator

Abstract

The medical device comprises: - a holder (100) which: - is adapted to receive a syringe body (2), - includes a proximal end part (100P) and a distal end part (100D), - a safety sleeve (200) movable between a standby position and a deployed position, - a plunger (300) which: - is manually movable from a start-of-injection position to an end-of-injection position, - includes an activation part (300A), Wherein, when the plunger (300) is moved from the start-of-injection position to the end-of- injection position, the activation part (300A) and the proximal end part (100P) at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually warn that the end-of-injection position is reached.

Description

[0001] Medical device for holding a syringe comprising a visual indicator

[0002] Description

[0003] The present disclosure relates to a medical device for holding a syringe.

[0004] Further, the disclosure relates to a manual drug delivery device that includes a medical device and to a method for using such a medical device.

[0005] More particularly, the disclosure relates to a medical device that includes a safety sleeve arranged to surround the needle of a syringe after the syringe has been actuated to deliver a medical product, or drug, to a patient and the needle is subsequently extracted from the patient. The safety sleeve prevents accidental needle injuries for users handling the syringe after it has been used, especially when the needle may be contaminated.

[0006] To this end, the medical device includes a holder arranged to receive a syringe body and the safety sleeve which is movable relative to the holder between a standby position, wherein the needle of the syringe can be inserted in a patient, and a deployed position, wherein the safety sleeve surrounds the needle. Before use, the safety sleeve is locked in the standby position and its movement between the standby position and the deployed position is unlocked when a plunger, arranged to cooperate with a plunger stopper of the syringe body to expel the medical product through the needle, is actuated to deliver the medical product to a patient. As the needle is extracted from the patient, a biasing element moves the safety sleeve from the standby position to the deployed position.

[0007] It is often difficult for a user of the medical device to know when the plunger has reached an end-of-injection position, when the medical product has been fully delivered to a patient. It’s problematic because if the user extracts the needle from the patient before the plunger arrives in the end-of-injection position, the medical product is not completely delivered and also there is a risk that the safety sleeve is not unlocked from the standby position. Indeed, if not unlocked, the safety sleeve does not move to the deployed position, thereby leaving the needle exposed when it is extracted from the patient.

[0008] An improved medical device which helps the user to know when the needle can be safely extracted from a patient is described.

[0009] To this end, the disclosure to a medical device for holding a syringe, comprising:

[0010] - a holder which:

[0011] - defines an axis around and along which the holder extends,

[0012] - is adapted to receive a syringe body of the syringe so that the syringe body extends lengthwise along the axis, and - includes a proximal end part and a distal end part, which are axially opposed to each other, the proximal end part being adapted to be attached to the syringe body to retain the syringe body relative to the holder when the syringe body is received in the holder,

[0013] - a safety sleeve that is assembled coaxially with the holder so as to be movable along the axis between a standby position, in which the safety sleeve is substantially retracted within the holder, and a deployed position, in which the safety sleeve is deployed outwardly of the holder from the distal end part of the holder to surround a needle of the syringe, when the syringe body is received in the holder, and

[0014] - a plunger which:

[0015] - is manually movable axially relative to the holder towards the distal end part of the holder from a start-of-injection position to an end-of-injection position when the syringe body is received in the holder, and

[0016] - includes an activation part which acts mechanically on the safety sleeve via the proximal end part of the holder to allow the safety sleeve to move away from the standby position when the plunger is moved from the start-of-injection position to the end-of-injection position, wherein the activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other so that when the plunger is moved from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0017] In some embodiments, the proximal end part of the holder comprises a holder skirt that is substantially centered on the axis, wherein the activation part of the plunger comprises a plunger skirt that acts mechanically on the safety sleeve via the proximal end part of the holder to allow the safety sleeve to move from the standby position to the deployed position when the plunger is moved from the start-of- injection position to the end-of-injection position, wherein the holder skirt and the plunger skirt are received coaxially one within the other when the plunger is moved from the start-of-injection position to the end-of-injection position, and wherein the plunger skirt and the holder skirt are adapted to cooperate with each other so that when the plunger is moved from the start-of-injection position to the end-of-injection position, the plunger skirt and the holder skirt at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0018] In some embodiments, the plunger skirt includes a visual indicator region which:

[0019] - contrasts visually from the holder skirt, and - is hidden within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, and then becomes visible through at least one opening of the holder skirt when the plunger is in the end-of-injection position.

[0020] In some embodiments, the visual indicator region extends on the plunger skirt all around the axis.

[0021] In some embodiments, the visual indicator region is located at a distal edge of the plunger skirt.

[0022] In some embodiments, the visual indicator region contrasts from the holder skirt in color and / or in surface texture.

[0023] In some embodiments, the at least one opening has an elongated shape orthoradial to the axis.

[0024] In some embodiments, the at least one opening includes at least two openings that are regularly angularly distributed with respect to the axis.

[0025] In some embodiments, the at least one opening includes two openings that are diametrically opposed to each other with respect to the axis, the holder being provided with two finger rests, which are diametrically opposed to each other with respect to the axis and which are located substantially at 90° around the axis with respect to the two openings.

[0026] In some embodiments, the holder skirt and the plunger skirt are adapted to engage mechanically with each other when the plunger is moved from the start-of-injection position to the end-of-injection position until the plunger skirt is locked with respect to the holder skirt when the plunger is in the end-of-injection position.

[0027] In some embodiments, the activation part of the plunger and the proximal end part of the holder are adapted to further cooperate with each other so that when the plunger is moved from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part engage mechanically with each other, until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

[0028] In some embodiments, the plunger skirt and the holder skirt are adapted to further cooperate with each other so that when the plunger is moved from the start-of-injection position to the end- of-injection position, the plunger skirt and the holder skirt engage mechanically with each other, until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

[0029] In some embodiments, the plunger skirt is received coaxially within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, and wherein the holder skirt includes at least one audible indicator tab which:

[0030] - is elastically deformable relative to the rest of the holder skirt between a relaxed configuration and a deformed configuration, the at least one audible indicator tab being more radially spaced from the axis in the deformed configuration than in the relaxed configuration, and - is moved from the relaxed configuration to the deformed configuration by the plunger skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, then returns resiliently from the deformed configuration to the relaxed configuration and so hits the activation part of the plunger to click when the plunger is in the end-of-injection position.

[0031] In some embodiments, the at least one opening is axially delimited between the at least one audible indicator tab and the rest of the holder skirt.

[0032] According to another aspect, the disclosure also relates to a manual drug delivery device, comprising the medical device as described above and a syringe pre-filled with a dose to be injected.

[0033] According to another aspect, the disclosure also relates to a method for using a medical device comprising the following steps :

[0034] - moving the plunger relative to the holder towards the distal end part of the holder from a start-of-injection position to an end-of-injection position, the activation part and the proximal end part engaging mechanically with each other, wherein, during the mechanical engagement between the activation part and the proximal end part, the activation part and the proximal end part at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0035] In one aspect, a medical device for holding a syringe is described. The medical device includes: a holder defining an axis extending axially along the holder, the holder being adapted to receive the syringe such that the syringe extends lengthwise along the axis of the holder, and the holder including a proximal end part and a distal end part which are axially opposed relative to each other, the proximal end part being adapted to be attached to the syringe to retain the syringe relative to the holder when the syringe is received in the holder; a safety sleeve coaxially coupled to the holder such that the safety sleeve is movable along the axis of the holder between a standby position in which a portion of the safety sleeve is retracted within the holder and a deployed position in which the safety sleeve is deployed outwardly from the distal end part of the holder to surround a needle of the syringe when the syringe is received in the holder; and a plunger axially movable relative to the holder towards the distal end part of the holder from a start- of-injection position to an end-of-injection position when the syringe body is received in the holder, wherein the plunger includes an activation part configured to act mechanically on the safety sleeve via the proximal end part of the holder to move the safety sleeve away from the standby position when the plunger is moved from the start-of-injection position to the end-of-injection position. The activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other such that when the plunger moves from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part at least partly disappear axially into each other until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0036] In some embodiments, the proximal end part of the holder includes a holder skirt centered on the axis of the holder. In some cases, the activation part of the plunger includes a plunger skirt that mechanically acts on the safety sleeve via the proximal end part of the holder to move the safety sleeve from the standby position to the deployed position when the plunger is moved from the start- of- injection position to the end-of-injection position. In some cases, the holder skirt and the plunger skirt are received coaxially one within the other when the plunger is moved from the start-of-injection position to the end-of-injection position. In some cases, the plunger skirt and the holder skirt are adapted to cooperate with each other so that when the plunger is moved from the start-of-injection position to the end-of-injection position, the plunger skirt and the holder skirt at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0037] In some embodiments, the plunger skirt includes a visual indicator region that contrasts visually from the holder skirt, wherein the visual indicator region is hidden within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, and then becomes visible through at least one opening of the holder skirt when the plunger is in the end-of-injection position.

[0038] In some embodiments, the visual indicator region extends on the plunger skirt around the axis of the holder.

[0039] In some embodiments, the visual indicator region is located at a distal edge of the plunger skirt.

[0040] In some embodiments, the visual indicator region contrasts from the holder skirt in color and / or in surface texture.

[0041] In some embodiments, the at least one opening has an elongated shape orthoradial to the axis of the holder.

[0042] In some embodiments, the at least one opening includes at least two openings that are evenly distributed with respect to the axis of the holder.

[0043] In some embodiments, the at least one opening includes two openings that are diametrically opposed to each other with respect to the axis of the holder, the holder being provided with two finger rests that are diametrically opposed to each other with respect to the axis of the holder and are located substantially at 90° around the axis of the holder with respect to the two openings.

[0044] In some embodiments, the holder skirt and the plunger skirt are adapted to mechanically engage with each other when the plunger is moved from the start-of-injection position to the end- of-injection position until the plunger skirt is locked with respect to the holder skirt when the plunger is in the end-of-injection position. In some embodiments, the activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other such that when the plunger is moved from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part mechanically engage with each other until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

[0045] In some embodiments, the plunger skirt and the holder skirt are adapted to further cooperate with each other so that when the plunger is moved from the start-of-injection position to the end- of-injection position, the plunger skirt and the holder skirt mechanically engage with each other until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

[0046] In some embodiments, the plunger skirt is received coaxially within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position. In some cases, the holder skirt includes at least one audible indicator tab elastically deformable relative to the rest of the holder skirt between a relaxed configuration and a deformed configuration, the at least one audible indicator tab being more radially spaced from the axis in the deformed configuration than in the relaxed configuration. In some cases, the at least one audible indicator tab is moved from the relaxed configuration to the deformed configuration by the plunger skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, then returns resiliently from the deformed configuration to the relaxed configuration and so hits the activation part of the plunger to click when the plunger is in the end-of-injection position.

[0047] In some embodiments, the at least one opening is axially delimited between the at least one audible indicator tab and the rest of the holder skirt.

[0048] In another aspects, a manual drug delivery device is described. The manual drug delivery device includes: a syringe containing medicament to be administered to a patient; a holder defining an axis extending axially along the holder, the holder being adapted to receive the syringe such that the syringe extends lengthwise along the axis of the holder, and the holder including a proximal end part and a distal end part which are axially opposed relative to each other, the proximal end part being adapted to be attached to the syringe to retain the syringe relative to the holder when the syringe is received in the holder; a safety sleeve coaxially coupled to the holder such that the safety sleeve is movable along the axis of the holder between a standby position in which a portion of the safety sleeve is retracted within the holder and a deployed position in which the safety sleeve is deployed outwardly from the distal end part of the holder to surround a needle of the syringe when the syringe is received in the holder; and a plunger axially movable relative to the holder towards the distal end part of the holder from a start-of-injection position to an end- of-injection position when the syringe body is received in the holder. The plunger includes an activation part configured to act mechanically on the safety sleeve via the proximal end part of the holder to move the safety sleeve away from the standby position when the plunger is moved from the start-of-injection position to the end-of-injection position, The activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other such that when the plunger moves from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part at least partly disappear axially into each other until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0049] In some embodiments, wherein the plunger is configured to be inserted into the syringe for dispensing a medicament from the syringe when the syringe is in the syringe holder.

[0050] In some embodiments, wherein the manual drug delivery device is configured such that a user-applied distal force on the plunger by a direct touch of the plunger causes a distal movement of the plunger relative to the syringe to dispense a medicament from the syringe when the syringe is in the holder.

[0051] In another aspect, a method for operating a medical device is described. The method includes: moving the plunger relative to the holder towards the distal end part of the holder from a start-of-injection position to an end-of-injection position, causing the activation part and the proximal end part to mechanically engage with each other. During the mechanical engagement between the activation part and the proximal end part, the activation part and the proximal end part at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0052] In another aspect, a medical device is described. The medical device includes: a holder defining an axis extending axially along the holder, the holder being adapted to receive the syringe such that the syringe extends lengthwise along the axis of the holder, and the holder including a proximal end part and a distal end part which are axially opposed relative to each other, the proximal end part being adapted to be attached to the syringe to retain the syringe relative to the holder when the syringe is received in the holder; and a plunger axially movable relative to the holder towards the distal end part of the holder from a start-of-injection position to an end-of- injection position when the syringe body is received in the holder, wherein the plunger includes an activation part. The activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other such that when the plunger moves from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part at least partly disappear axially into each other until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0053] In some embodiments, the proximal end part of the holder includes a holder skirt centered on the axis of the holder, the activation part of the plunger includes a plunger skirt, the holder skirt and the plunger skirt are received coaxially one within the other when the plunger is moved from the start-of-injection position to the end-of-injection position, and the plunger skirt and the holder skirt are adapted to cooperate with each other so that when the plunger is moved from the start- of-injection position to the end-of-injection position, the plunger skirt and the holder skirt at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

[0054] In some embodiments, the plunger skirt includes a visual indicator region that contrasts visually from the holder skirt, wherein the visual indicator region is hidden within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, and then becomes visible through at least one opening of the holder skirt when the plunger is in the end-of-injection position.

[0055] In some embodiments, the visual indicator region extends on the plunger skirt around the axis of the holder.

[0056] In some embodiments, the visual indicator region is located at a distal edge of the plunger skirt.

[0057] In some embodiments, the visual indicator region contrasts from the holder skirt in color and / or in surface texture.

[0058] In some embodiments, the at least one opening has an elongated shape orthoradial to the axis of the holder.

[0059] In some embodiments, the at least one opening includes at least two openings that are evenly distributed with respect to the axis of the holder.

[0060] In some embodiments, the at least one opening includes two openings that are diametrically opposed to each other with respect to the axis of the holder, the holder being provided with two finger rests that are diametrically opposed to each other with respect to the axis of the holder and are located substantially at 90° around the axis of the holder with respect to the two openings.

[0061] In some embodiments, the holder skirt and the plunger skirt are adapted to mechanically engage with each other when the plunger is moved from the start-of-injection position to the end- of-injection position until the plunger skirt is locked with respect to the holder skirt when the plunger is in the end-of-injection position.

[0062] In some embodiments, the activation part of the plunger and the proximal end part of the holder are adapted to cooperate with each other such that when the plunger is moved from the start-of-injection position to the end-of-injection position, the activation part and the proximal end part mechanically engage with each other until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

[0063] In some embodiments, the plunger skirt and the holder skirt are adapted to further cooperate with each other so that when the plunger is moved from the start-of-injection position to the end- of-injection position, the plunger skirt and the holder skirt mechanically engage with each other until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached. In some embodiments, the plunger skirt is received coaxially within the holder skirt when the plunger is moved from the start-of-injection position to the end-of-injection position. In some cases, the holder skirt includes at least one audible indicator tab elastically deformable relative to the rest of the holder skirt between a relaxed configuration and a deformed configuration, the at least one audible indicator tab being more radially spaced from the axis in the deformed configuration than in the relaxed configuration. In some cases, the at least one audible indicator tab is moved from the relaxed configuration to the deformed configuration by the plunger skirt when the plunger is moved from the start-of-injection position to the end-of-injection position, then returns resiliently from the deformed configuration to the relaxed configuration and so hits the activation part of the plunger to click when the plunger is in the end-of-injection position.

[0064] In some embodiments, the at least one opening is axially delimited between the at least one audible indicator tab and the rest of the holder skirt.

[0065] Other aspects and advantages of the disclosure will appear upon reading the following description, given by way of example and made in reference to the appended drawings, wherein:

[0066] - Fig. 1 is a perspective diagrammatical view of an assembly including a syringe and a medical device according to an embodiment of the disclosure, the safety sleeve being in a standby position,

[0067] - Fig. 2 is an axial cross-sectional view of the assembly of Fig. 1 in a first plane containing the axial direction,

[0068] - Fig. 3 is an axial cross-sectional view of the assembly of Fig. 1 in a second plane containing the axial direction, the second plane being perpendicular to the first plane,

[0069] - Fig. 4 is a perspective diagrammatical view of a proximal end part of a holder of the medical device of Fig. 1 ,

[0070] - Fig. 5 is a perspective diagrammatical view of a holder ring of the proximal end part of the holder of a perspective diagrammatical view of Fig. 4 according to a first embodiment,

[0071] - Fig. 6 is a side view (a), a cross section view in the first plane (b) and a cross section view in the second plane (c) of the assembly of Fig. 1 , a plunger being in a first intermediate position between a start-of-injection position and an end-of-injection position,

[0072] - Fig. 7 is a side view (a), a cross section view in the first plane (b) and a cross section view in the second plane (c) of part of the assembly of Fig. 6, the plunger being in a second intermediate position between a the first intermediate position and the end-of-injection position,

[0073] - Fig. 8 is a side view (a), a cross section view in the first plane (b) and a cross section view in the second plane (c) of part of the assembly of Fig. 6, the plunger being in the end-of-injection position,

[0074] - Fig. 9 is a side view (a), a cross section view in the first plane (b) and a cross section view in the second plane (c) of the assembly of Fig. 6, the plunger being in the end-of-injection position and the safety sleeve being in a deployed position, - Fig. 10 is a perspective diagrammatical view of a holder ring according to a second embodiment, and

[0075] - Fig. 11 is a perspective diagrammatical view of a holder ring according to a second embodiment.

[0076] A medical device for holding a syringe is hereby provided, including components and mechanisms for informing (indicating or warning) the user of the medical device that the end-of- injection position has been reached. This is done by making an activation part of the plunger and a proximal end part of a holder at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate (or warn) that the end-of-injection position is reached.

[0077] Hence, the user of the medical device knows that the needle of the syringe can be safely extracted from the patient when one of the activation part of the plunger and the proximal end part of the holder reappears through the other after having disappeared as the plunger moves from the start-of-injection position to the end-of-injection position. Indeed, this visual indication appears once the injection is completed and the safety sleeve is unlocked from the standby position. Consequently, when the user sees the visual indication, the medical product has been fully delivered to the patient and the safety sleeve moves towards the deployed position as the needle is extracted from the patient. In other words, the user is invited to stop pushing on the plunger only once the user sees the visual indication, the user then having the insurance that the needle can be safely removed from the patient.

[0078] In reference to Fig. 1 , there is described an assembly including a syringe 1 and a medical device for holding the syringe 1 . This assembly forms a manual drug delivery device. The manual drug delivery device generally extends between a proximal end and a distal end. In use, the manual drug delivery device is actuated by acting on the proximal end and the medical product is delivered through the distal end, as will become apparent upon reading the following description.

[0079] The medical device includes mainly a holder 100, a safety sleeve 200and a plunger 300.

[0080] The syringe 1 is for example a syringe 1 containing a medical product, or drug, to be delivered to a patient. To this end and as more particularly visible in Figs. 2 and 3, the syringe 1 includes a syringe body 2 defining a chamber containing pre-filled with a dose of medical product to be delivered. A plunger stopper 3 is movable inside the chamber to expel the medical product through a needle 4 in fluidic communication with the chamber of the syringe body 2, the needle 4 being mounted on a distal end of the syringe body 2. In use, the distal end of the needle 4 forms the distal end of the manual drug delivery device. The plunger 300 passes through a proximal end of the body 2 and is attached, for example by screwing, to the plunger stopper 3 and is arranged to push the plunger stopper 3 towards the distal end of the syringe body 2 when actuated by a user to expel the medical product out of the chamber through the needle as will be described in greater details subsequently. The syringe body 2, the needle 4 and the plunger 300 extend along a same syringe axis. A flange 5 extending radially around the syringe body 2 at the proximal end thereof is for example provided.

[0081] The considered syringe could be specified according to ISO 11040-4 or could be designed equivalently.

[0082] The plunger 300 includes a plunger rod 301 extending between a proximal end forming an activation part 300A of the plunger 300 and a plunger distal end 302 forming a distal end of the plunger 300. The activation part 300A is also known as the plunger head and forms, in use, the proximal end of the manual drug delivery device. The plunger rod 301 passes through a proximal end of the syringe body 2 and the plunger distal end 302 is attached, for example by screwing, to the plunger stopper 3 and is arranged to push the plunger stopper 3 towards the distal end of the body 2 when the activation part 300A is actuated by a user to expel the medical product out of the chamber through the needle 4. More particularly, the plunger 300 is movable between a start- of-injection position, shown in Figs 1 to 3, in which the chamber of full of the medical product to be injected, and an end-of-injection position, shown in Figs 8 and 9, in which the chamber has been emptied and the medical product injected through the needle 4. To this end, a user acts on the activation part 300A when the plunger 300 is in the start-of-injection position to push the plunger 300 in an axial direction X-X towards the distal end of the syringe body 2. This causes the plunger stopper 3 to move towards the distal end of the syringe body 2 such that the medical product is expelled from the chamber of the syringe body 2 through the needle 4.

[0083] In some examples, the medical device is a manual drug delivery device configured to dispense a medicament from the syringe 1 by a user-applied distally-directed force on the plunger

[0084] 300 such that the plunger 300 moves distally within the syringe 1 to push the plunger stopper 3 distally which forces the medical product out of the chamber of the syringe 1 and through the needle 4. The activation part 300A for example includes a plunger skirt 303 for example protruding in the proximal-distal direction from the periphery of a front wall 304 extending transversally to axis X-X and having a first axial side on which a user presses its thumb to push distally the plunger 300 from the start-of-injection position to the end-of-injection position. The rod

[0085] 301 extends axially from a second axial side of the front wall 304. The plunger skirt 303 extends around the rod 301 and includes an inner face 305 turned towards the rod 301 and an outer face 306, opposed to the inner face 305.

[0086] The holder 100 defines an axis X-X and is adapted to receive the syringe body 2 so that the syringe body 2 extends lengthwise along the axis X-X. In other words, when the syringe 2 is held by the medical device, the axis X-X corresponds to the syringe axis, as more particularly visible in Figs. 2 and 3. The holder 100 presents a general tubular shape extending around the syringe body 2 and defines an inner surface 102 surrounding the syringe body 2 and an outer surface 103, opposed to the inner surface 102, turned towards the exterior of the medical device. The holder 100 includes a proximal end part 100P and a distal end part 100D, which are axially opposed to each other. The proximal end part 100P is adapted to be attached to the syringe body 2. More particularly, the proximal end part 100P is arranged to cooperate with the proximal end of the syringe body 2, more particularly with the flange 5 thereof, for example by clipping as will be described subsequently, to retain the syringe body 2 relative to the holder 100 when the syringe body 2 is received in the holder 100. As shown in Figs 2 and 3, the syringe body 2 passes through the distal end part 100D of the holder 100 such that the distal end of the syringe body 2 and the needle 4 protrude axially from the distal end part 100D when the syringe body 2 is received in the holder 100.

[0087] The holder 100 for example includes a barrel piece 110 extending along axis X-X between a holder skirt 111 centered around axis X-X, the holder skirt 111 being part of the proximal end part 100P, and a guiding element 130, also called nozzle, forming a part of the distal end part 100D of the holder. In some embodiments, the barrel piece 110 and the holder skirt 111 are integral and the guiding element 130 is attached, for example by welding or clipping, to the barrel piece 110.

[0088] As shown in Figs 2 and 3, the syringe body 2 passes through the distal end part 100D of the holder 100, more particularly through the guiding element 130, such that the distal end of the syringe body 2 and the needle 4 protrude axially from the distal end part 100D when the syringe body 2 is received in the holder 100.

[0089] The syringe body 2 and the safety sleeve 200 in the standby position extend mainly through the barrel piece 110 and pass through the guiding element 130 to protrude out of the holder 100 as indicated above.

[0090] According to the embodiments shown in the figures, the holder skirt 111 includes a cylindrical wall 112 extending along axis X-X and having a diameter greater than the diameter of the barrel piece 110. The cylindrical wall 112 is connected to the barrel piece 110 by a shoulder 113 extending radially, i.e. substantially perpendicularly to axis X-X, between the cylindrical wall 112 and the barrel piece 110. The holder skirt 111 is arranged to receive and hold the proximal end of the syringe body 2, for example by cooperating with the flange 5. To this end, the proximal end part 100P for example includes a holder ring 121 extending in and attached to the holder skirt 111. The holder ring 121 is for example arranged to hold the flange 5 of the syringe body 2, as will be described subsequently.

[0091] The safety sleeve 200 is assembled coaxially with the holder 100 and includes a tubular portion 201 opened at a proximal end part 200P and at a distal end part 200D along axis X-X such that the syringe 1 can extend through the safety sleeve 200. The proximal end part 200P and the distal end part 200D are axially opposed to each other. The safety sleeve 200 is movable relative to the holder 100 along axis X-X between a standby position (Figs. 1 to 3 and 6 to 8) when the plunger 300 is in the start-of-injection position, and a deployed position (Fig .9), when the plunger 300 is in the end-of-injection position. The guiding element 130 described previously is for example arranged to guide the displacement of the safety sleeve 200 between the standby position and a deployed position and to prevent the safety sleeve 200 from coming out of the holder 100 when the safety sleeve reaches the deployed position, as will be described subsequently.

[0092] In the standby position, the safety sleeve 200 is locked to the proximal end part 100P of the holder 100 and is substantially retracted within the holder 100. More particularly, the safety sleeve 200 is for example locked to the holder skirt 111. By substantially being retracted within the holder 100, it is meant that the major part of the tubular portion 202 of the safety sleeve 200 extends inside the holder 100. According to the embodiment shown in the figures, in the standby position, only the distal end part 200D of the tubular part 201 protrudes axially from the distal end part 100D of the holder 100, in particular from the guiding element 130, and surrounds the part of the syringe body 2 protruding from the holder 100, as shown in Figs 2 and 3. The needle 4 protrudes from the distal end part 200D of the tubular portion 201 of the safety sleeve 200 in the standby position such that the needle 4 can be inserted in the skin S of a patient, as shown in Figs 6 to 8. As shown in Figs. 1 to 3, in the standby position, the needle 4 can be protected by a needle shield (or cap) 400 before use, the needle shield 400 being conformed to be removably attached to the distal end part 200D of the tubular portion 201 of the safety sleeve 200. Once the needle shield 400 is removed and the needle 4 is inserted in the skin S of a patient, a user can push on the activation part 300A of the plunger 300 to deliver the medical product contained in the chamber of the syringe body 2.

[0093] The displacement of the safety sleeve 200 away from the standby position is allowed by the plunger 300 when the plunger 300 arrives in the end-of-injection position. More particularly, when the plunger 300 approaches the end-of injection position, the activation part 300A acts mechanically on the safety sleeve 200 via the proximal end part 100P of the holder 100 to allow the safety sleeve to move away from the standby position, as will be described in greater details subsequently. In other words, the activation part 300A of the plunger is arranged to unlock the safety sleeve 200 from the standby position via the proximal end part 100P of the holder 100 and the safety sleeve 200 is than allowed to move towards its deployed position.

[0094] The safety sleeve 200 is moved in the deployed position by the action of a biasing element 500 urging the safety sleeve 200 towards the deployed position. The biasing element 500 for example extends axially inside the holder 100 and is arranged to press on the proximal end part 200P of the tubular portion 201 of the safety sleeve 200 towards the distal end part 100D of the holder 100. In the standby position, the biasing element 500 is therefore constrained and tends to push the safety sleeve 200 through the open end of the holder 100, in particular though the guiding element 130. When the safety sleeve 200 is released from its standby position, the biasing element 500 is no longer constrained and moves the safety sleeve 200 towards the deployed position. For example, the biasing element 500 is a coil spring. For instance, it is a metallic coil spring.

[0095] When moving from the standby position to the deployed position, the tubular portion 201 of the safety sleeve 200 moves axially relative to the holder 100. The proximal end part 200P of the tubular portion 202 of the safety sleeve 200 moves towards the distal end part 100D of the holder 100 until the distal end part 200D of the tubular portion 201 of the safety sleeve 200 is placed around the needle 4 of the syringe 2. More particularly, the safety sleeve 200 moves around the needle 4 under the influence of the biasing element 500 as the needle 4 is removed from the skin S of the patient once the medical product has been delivered.

[0096] In the deployed position, the safety sleeve 200 completely surrounds the needle 4, as shown in Fig. 9. In this manner, the safety sleeve 200 ensures that the needle 4 is not exposed outside after use such that it cannot cause needle sharp injuries and potentially contaminate anyone handling the syringe 1. The proximal end part 200P of tubular portion 202 of the safety sleeve 200 remains attached to the holder 100, more particularly to the distal end part 100D thereof.

[0097] The safety sleeve 200 is locked in the standby position by cooperating with the holder skirt 111 , and more particularly with an edge 114 of the shoulder opening into the barrel piece, as shown in Figs. 3 and 5c. To this end, the safety sleeve 200 includes at least one link arm 202 attached to the proximal end part 200P of the tubular portion of the safety sleeve 200 and extending axially from the tubular portion 201 towards the holder skirt 111. A free end 203 of the link arm 202 is arranged to cooperate with the edge 114 of the shoulder 113 in the standby position. To this end, the free end 203 of the link arm 202 and the edge 114 of the shoulder 113 for example have a complementary shape arranged such that the free end 203 remains engaged on the edge 114 when the safety sleeve 200 is in the standby position and that a radial force oriented towards axis X-X has to be exerted on the free end 203 to disengage the free end 203 from the edge 114. To this end, the edge 114 for example protrudes axially relative to the rest of the shoulder 113 such that the free end 203 has to pass over the edge 114 to be disengaged from it.

[0098] The link arm 202 is deformable relative to the rest of the safety sleeve 200, i.e. relative to the tubular portion 201 , between a retaining configuration (Figs 2, 3 and 6c), in which the link arm 202 is mechanically engaged with the holder 100 to axially retain the safety sleeve 200 in the standby position, and a release configuration (Fig. 7c), in which the link arm 202 is disengaged from the holder 100 to allow the safety sleeve 200 to move away from the standby position. In other words, in the retaining configuration, the free end 203 of the link arm 202 is engaged on the edge 114 of the shoulder 113 and, in the release configuration, the free end 203 of the link arm is moved radially towards axis X-X and is disengaged from the edge 114 such that the safety sleeve 200 is able to move relative to the holder 100 towards the deployed position. According to various embodiments, the safety sleeve 200 includes at least two link arms 202 regularly and angularly (e.g., evenly) distributed around axis X-X. Having more than one link arm 202 and having the link arms 202 regularly and angularly (e.g., evenly) distributed around X-X allows maintaining the safety sleeve aligned on axis X-X during its deployment. In other words, these embodiments allows maintaining the coaxiality of the safety sleeve 200 and the holder 100 when the safety sleeve 200 moves from the standby position to the deployed position. According to the embodiments shown in the figures, the safety sleeve 200 includes two diametrically opposed link arms 202.

[0099] As indicated previously, to unlock the safety sleeve 200 from the standby position, the activation part 300A of the plunger 300 acts mechanically on the safety sleeve 200 via the proximal end part 100P of the holder 100. In other words, , when the activation part 300A of the plunger 300 approaches the end-of-injection position, the activation part 300A is arranged to act mechanically on the proximal end part 100P of the holder 100, which, under this action, is in turn arranged to act on the link arm(s) 202 to move the link arm(s) 202 from the retaining configuration to the release configuration.

[0100] To this end, the proximal end part 100P of the holder 100 includes at least one movement- movement-transmitting tab 120 elastically deformable relative to the rest of the proximal end part of the holder between a resting position (Figs. 3 to 6) and an activating position (Figs 8c and 9c). According to the embodiments shown in the figures, the at least one movement-transmitting tab 120 is provided in the holder ring 121 , for example in the axial wall 122 thereof as will now be described.

[0101] According to the embodiments shown in the figures, the movement-transmitting tab 120 is delimited in the axial wall 122 by a slit 125 extending through the axial wall 122, i.e. opening in the outer surface 123 and in the inner surface 124 of the axial wall 122, the slit 125 surrounding a part of the movement-transmitting tab 120 such that the movement-transmitting tab is elastically deformable relative to the rest of the axial wall 122. As shown in Fig. 5, the slit 125 for example has a II shape and surrounds three edges of the movement-transmitting tab 120 which has a substantially rectangular shape extending in the axial wall 122. According to an embodiment, the slit 125 is further shaped such that the movement-transmitting tab 120 presents rounded corners. In other words, the corners formed between the base of the II and the branches of the II are curved such that the three edges of the movement-transmitting tab 120 surrounded by the II- shaped slit 125 define two rounded corners. Such rounded corners allow reducing the constraints on the holder ring 121 by reducing the weakening of the holder ring 121 in and around the slit 125.

[0102] The movement-transmitting tab 120 is joined with the rest of the proximal end part 100P of the holder 100, i.e. to the rest of the axial wall 122 in the present embodiment, by an elastically hingeable junction region 126 by which the movement-transmitting tab 120 is movable between the resting position and the activating position. In the present embodiment, the elastically hingeable junction region 126 forms the fourth edge of the rectangular movement-transmitting tab 120 by which the movement-transmitting tab 120 remains attached to the rest of the axial wall 122. The elastically hingeable junction region 126 includes a tilting line 127 around which the movement-transmitting tab 120 is tiltable between the resting position and the activating position.

[0103] According to the embodiment shown in Fig. 5, the tilting line 127 is substantially orthoradial to axis X-X and the movement-transmitting tab 120 extends in the axial direction between the tilting line 127 and the distal end part 100D of the holder 100. More particularly, the movementtransmitting tab 120 extends in the axial direction between the tilting line 127 and the shoulder 113 of the holder skirt 111. In other words, according to this embodiment, the movementtransmitting tab 120 extends from the tilting line 127 in the proximal-distal direction.

[0104] According to another embodiment shown in Fig. 10, wherein the various elements of the holder ring 12T are designated by the same reference numbers followed by a an apostrophe, the tilting line 127’ is substantially orthoradial to axis X-X and the movement-transmitting tab 120’ extends axially between the tilting line 127’ and the activation part 300A of the plunger 300 when the plunger 300 is in the start- of- injection position. In other words, according to this embodiment, the movement-transmitting tab 120’ extends from the tilting line 127’ in the distal-proximal direction.

[0105] According to another embodiment shown in Fig. 11 , wherein the various elements of the holder ring 121” are designated by the same reference numbers followed by a double apostrophe, the tilting line 127” is substantially parallel to axis X-X and the movement-transmitting tab 120” extends substantially according to an orthoradial direction relative to axis X-X from the tilting line 127”.

[0106] In any case, the end of the movement-transmitting tab 120, 120’, 120” opposed to the tilting line 127, 127’, 127” moves in a radial direction towards axis X-X when the movement-transmitting tab 120, 120’, 120” moves from the resting position to the activating position.

[0107] More particularly, the activation part 300A of the plunger 300 is arranged to act on the outer surface 123, 123’, 123” of the movement-transmitting tab to move it from the retracted position to the activating position and the inner surface 124, 124’, 124” of the movement-transmitting tab acts accordingly on the free end 203 of the link arm 202 to move the safety sleeve 200 away from the standby position, as will be described subsequently.

[0108] For the sake of simplicity, the rest of the description will be made in reference to the embodiment of Fig. 5, the other features of the medical device being the same for the embodiments of Figs 10 and 11 and all embodiments functioning in a similar manner.

[0109] In the resting position, the movement-transmitting tab 120 avoids the safety sleeve 200 from moving away from the standby position. In other words, in the resting position, the movementtransmitting tab 120 does not exert a force on the safety sleeve 200 able to unlock the safety sleeve 200 from the standby position. According to the embodiments shown in the figures, the movement-transmitting tab 120 faces radially the free end 203 of the link arm 202 without exerting a radial force on the free end 203 able to disengage the free end 203 from the edge 114 of the shoulder 113 of the holder skirt 111 in the resting position as more particularly visible in Figs 3 and 6c. According to an embodiment, there is a small radial gap between the movementtransmitting tab 120 and the free end 203 of the link arm 202 while the free end 203 is engaged on the edge 114 when the movement-transmitting tab 120 is in the resting position and the safety sleeve 200 is in the standby position. Alternatively, the movement-transmitting tab 120 is in contact with the free end 203 in a radial direction without exerting a radial force on the free end 203 able to disengage the free end 203 from the edge 114.

[0110] In the activating position, the movement-transmitting tab 120 acts mechanically on the safety sleeve 200 to move it away from the standby position and allow it to move towards the deployed position under the influence of the biasing element 500. In other words, in the activating position, the movement-transmitting tab 120 unlocks the safety sleeve 200 from the standby position by deactivating the mechanical cooperation between the safety sleeve 200 and the proximal end part 100P of the holder 100. More particularly, in use, as described previously, the movement-transmitting tab 120 is displaced from the resting position to the activating position by the activation part 300A of the plunger 300 when the plunger 300 arrives in the end-of-injection position by exerting a force oriented radially towards axis X-X on the movement-transmitting tab 120, the activation part 300A causing the radial displacement of the movement-transmitting tab 120. In order to allow the activation part 300A to move the movement-transmitting tab 120 radially towards axis X-X while the activation part 300A moves axially and approaches the end-of-injection position as will be described subsequently, the movement-transmitting tab 120 for example includes a ramp 128 which projects radially from the outer surface 123 of the movementtransmitting tab 120. The ramp 128 is oriented in the proximal-distal direction, meaning that the slope of the ramp 128 moves away from axis X-X in the proximal-distal direction. To this end, the plunger skirt 303 of the activation part 300A is for example arranged to act on the movementtransmitting tab(s) 120 to move the safety sleeve 200 away from the standby position when the plunger 300 is moved from the start- of- injection position to the end-of-injection position. More particularly, according to the embodiments shown in the figures, when the plunger 300 is moved from the start-of-injection position to the end-of-injection position, the plunger skirt 303 enters into the holder skirt 111 on the outer surface side of the movement-transmitting tab(s) 120 and a distal edge 307 of the plunger skirt 301 engages the ramp 128 of the movement-transmitting tab(s) 120. As the plunger 300 moves towards the end-of-injection position, the inner face 305 of the distal edge 307 presses on the ramp 128 which causes to move the movement-transmitting tab(s) from the resting position to the activating position, the activating position being reached before or when the plunger skirt 303 is fully received in the holder skirt 111 , which corresponds to the end-of- injection position, as shown in Fig. 8c and 9c. Consequently, the medical device ensures that the safety sleeve 200 is able to move towards the deployed position when the plunger 300 is in the end-of-injection position since the safety sleeve 200 has been unlocked from the standby position when the plunger 300 approaches or reaches the end-of injection position. According to an embodiment, as will be described subsequently, the plunger 300 is locked in the proximal end part 100P of the holder 100 when the plunger 300 is in the end-of-injection position.

[0111] The radial movement of the movement-transmitting tab 120, under the action of the activation part 300A of the plunger 300, in turn causes a radial displacement of the free end 203 of the link arm 202 sufficient to disengage the free end 203 from the edge 114 of the shoulder 113 of the holder skirt 111 , as more particularly visible in Figs. 7c and 8c. The link arm 202 is then moved radially towards axis X-X such that the link arm 202 and its free end 203 can enter into the barrel piece 110 of the holder 100 and the proximal end part 200P of the safety sleeve 200 can move axially towards the distal end part 100D of the holder 100.

[0112] According to a particular embodiment, the movement-transmitting tab 120 is further resiliently biased by elastic return to its resting position. Such an elastic return of the movementtransmitting tab 120 is more particularly useful during testing of the medical device, i.e. at the end of the manufacturing of the medical device before the final use of the medical device. During testing, a testing tool can be used to move the movement-transmitting tab 120 from the resting position to the activating position by exerting a radial force on the movement-transmitting tab 120 to ensure that the movement-transmitting tab unlocks the safety sleeve 200 from its standby position and that the safety sleeve 200 properly moves towards the deployed position. In other words, the testing tool is arranged to reproduce the action of the activation part 300A of the plunger 300 on the movement-transmitting tab 120. Once the test is completed, the testing tool is removed from the holder such that the mechanical force moving the movement-transmitting tab 120 to the activating position is no longer applied. Thanks to the elastic return of the movementtransmitting tab 120, the movement-transmitting tab 120 then moves from the activating position back to the resting position. In other words, when the movement-transmitting tab 120 is in any position different from the resting position and no external force is applied to the movementtransmitting tab 120, the movement-transmitting tab 120 elastically returns to its resting position. Consequently, once this test is performed and the testing tool is removed, there is no need to further act on the movement-transmitting tab to replace it in the resting position since the movement-transmitting tap automatically returns to the resting position once the testing tool no longer applies a force on thereon. The use of the testing tool or of an additional tool to place the movement-transmitting tab 120 back in the resting position is therefore no longer required such that the movement-transmitting tab 120 is not too heavily solicited. Consequently, the risks of weakening the movement-transmitting tab 120 before it is solicited during the use of the medical device on a patient are reduced. Furthermore, the costs and the time related to the testing process are reduced. According to various embodiments, there are as many movement-transmitting tabs 120 as there are link arms 202. The movement-transmitting tabs are for example regularly and angularly (e.g., evenly) distributed in the holder ring 121 such that each movement-transmitting tab 120 faces the free end 203 of one of the link arms 202. According to the embodiments shown in the figures, two movement-transmitting tabs 120 are provided and diametrically opposed to each other around the axis X-X such that each movement-transmitting tab 120 is in contact with the free end 203 of one of the link arms 202. To this end, the holder ring 121 for example includes two axial walls 122 diametrically opposed to each other around axis X-X, a movement-transmitting tab 120 being defined in each axial wall 122. According to the embodiments shown in the figures, the axial walls 122 are not joined to each other, meaning that the axial walls do not completely surround the opening of the holder skirt 111. More particularly, two diametrically opposed spaces are for example provided between the axial walls 122.

[0113] According to the embodiments shown in the figures, the holder ring 121 further includes at least one latching tong 129 arranged to retain the syringe body 2 relative to the holder 100 when the syringe body is received in the holder. Such a latching tong 129 is arranged to cooperate with the flange 5 of the syringe body 2 as more particularly visible in Fig. 4. The latching tong 129 is for example elastically deformable and includes a holding end such that the latching tong 129 allows the passage of the syringe body 2 in the holder 100 when the syringe body 2 is inserted in the holder in the proximal-distal direction and that the holding end prevents the removal of the syringe body 2 from the holder in the distal-proximal direction, the holding end resting against the flange 5 to prevent this removal. The latching tong 129 for example extends in one of the spaces extending between the axial walls 122. According the embodiments shown in the figures, the holder ring 121 includes two diametrically opposed latching tongues 129 arranged to move away from each other when the syringe body 2 is inserted in the holder 100 in the proximal-distal direction. When the syringe body 2 is received in the holder 100, the flange 5 of the syringe body 2 is locked in position between the shoulder 113 of the holder skirt 111 and the holding ends of the latching tongs 129, as can be seen for example in Fig. 2. The latching tongs 129 for example extend in the diametrically opposed spaces provided between the axial walls 122 such that the movement-transmitting tabs 120 are located at about 90° to each of the two latching tongues 129 around axis X-X. Such an arrangement allows limiting the space requirements of the holder ring 121 , in particular to allow it to be received in the holder skirt 111.

[0114] The holder ring 121 is for example attached to the proximal end part 100P of the holder 100 for example by welding. To this end, the holder ring 121 has a distal end 121 D by which the holder ring is attached to the rest of the proximal end part 100P by at least one weld bead 140 that runs on the distal end 121 D around the axis X-X, as shown in Fig. 5, 10 (weld bead 140’) and 11 (weld bead 140”). According to an embodiment, the weald bead is interrupted at the or each movementtransmitting tab 120 such that the welding operation of the holder ring 121 to the proximal end part 100P of the holder 100 does not apply stress on the movement-transmitting tab(s) 120. The holder ring 121 is for example welded to the shoulder 113 of the holder skirt 111 such that the distal end 121 D of the holder ring 121 extends radially between the cylindrical wall 112 and the edge 114 of the shoulder 113 of the holder skirt 111.

[0115] According to the disclosure, the activation part 300A of the plunger 300 and the proximal end part 100P of the holder 100 are arranged to provide a visual signal when the plunger 300 is in the end-of-injection position to visually indicate (or warn) that the end-of-injection position is reached.

[0116] To this end, the activation part 300A of the plunger 300 and the proximal end part 100P of the holder 100 are adapted to cooperate with each other so that when the plunger 300 is moved from the start-of-injection position to the end-of-injection position, the activation part 300A and the proximal end part 100P at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate (or warn) that the end-of-injection position is reached. More particularly, when the plunger 300 is moved from the start-of-injection position to the end-of-injection position, the plunger skirt 303 and the holder skirt 111 are for example arranged to at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate (or warn) that the end-of-injection position is reached.

[0117] To this end, the plunger skirt 303 for example includes a visual indicator region 309 (or a visual warning region) which- contrasts visually from the holder skirt 111 and is hidden within the holder skirt 111 when the plunger 300 is moved from the start-of-injection position to the end-of- injection position, and then becomes visible through at least one opening 150 of the holder skirt 111 when the plunger 300 is in the end-of-injection position. This contrast can for example be obtained by using a different color and / or surface texture in the visual indicator region 309 than in the holder skirt 111. According to an embodiment, the visual indicator region 309 extends on the plunger skirt 301 all around the axis X-X such that the plunger skirt 301 does not require to have a particular orientation relative to the holder skirt, and in particular relative to opening 150 in the holder skirt 111. The visual indicator region 309 is for example located at the distal edge 307 of the plunger skirt 303.

[0118] The opening 150 in the holder skirt 111 for example extends in an orthoradial direction relative to axis X-X. It is however understood that the opening 150 can be part of a window having any shape allowing rendering the visual indicator region 309 visible through the opening 150 when the plunger 300 reaches the end-of-injection position. For example, the opening 150 can be part of a circular window, an axial slit, a L, II or V shaped window or a mirror of a L, II, or V shaped window. In other variants, the window can have a more complex shape, for example an alphanumeric shape or the shape of the logo of the medical device manufacturer. When the window extends in the axial direction, the opening 150 is formed by the most distal part of the window, i.e. for example the distal end of the axial slit, the base of the L or of the II or the point of the V for a L, II or V shaped window.

[0119] According to a particular embodiment, as shown in the figures, the opening 150 is axially delimited between an audible indicator tab 115 and the rest of the holder skirt 111. The function of the audible indicator tab 115, will be described subsequently.

[0120] The audible indicator tab 115 is defined in the holder skirt 111 , for example in the cylindrical wall 112 of the holder skirt 111. In this case, the audible indicator tab 115 is delimited in the cylindrical wall 112 by a slit 116 extending through the cylindrical wall 112, i.e. opening in the outer surface 103 and in the inner surface 102 of the cylindrical wall 122, the slit 116 surrounding a part of the locking tab 115 such that the audible indicator tab is elastically deformable relative to the rest of the cylindrical wall 122, as will be described subsequently. As shown in Fig. 1 , 4 and 7a to 9a, the slit 116 for example has a II shape and surrounds three edges of the locking tab 115 which has a substantially rectangular shape extending in the cylindrical wall 112. According to an embodiment, the slit 116 is further shaped such that the audible indicator tab 115 presents rounded corners. The audible indicator tab 115 is joined with the rest of the proximal end part 100P of the holder 100, i.e. to the rest of the cylindrical wall 112 in the present embodiment, by a tilting line 117. In the present embodiment, the tilting line forms the fourth edge of the rectangular audible indicator tab 115 by which the audible indicator tab 115 remains attached to the rest of the cylindrical wall 112.

[0121] In this case, the opening 150 is for example formed by a part of the slit 116 delimiting the audible indicator tab 115, and more particularly by the most distal part of the slit 116 which extends along the edge of the audible indicator tab 115 opposite to the tilting line 117. In other word, when the slit 116 is U-shaped, the opening 150 is formed by the part of the slit 116 forming the base of the U.

[0122] According to an embodiment, the at least one opening 150 includes at least two openings 150 that are regularly and angularly (e.g., evenly) distributed around axis X-X. According to the embodiment shown in the figures, the at least one opening 150 includes two openings 150 that are diametrically opposed to each other around the axis X-X.

[0123] With such an arrangement, it is ensured that the visual indicator will be visible only when the plunger 300 is in the end-of-injection position such that the visual indicator appears only when the whole medical product has been delivered to a patient. Consequently, the user is invited to push the plunger 300 in the proximal-distal direction until the visual indicator region 306 appears in the opening 150 of the holder skirt 111 to signal that the syringe 1 has been fully emptied. In other words, the user is invited to stop pushing on the plunger 300 only once the user can see the visual indicator region 306 in the opening 150, the user then having the insurance that the medical product has been correctly delivered to the patient. According to an embodiment, the holder 100 is provided with two finger rests 160, which are diametrically opposed to each other with respect to the axis X-X. Such finger rests 160 form prehension surfaces for a user which can then hold the holder between two fingers while pushing the plunger 300 with the thumb. In this case, the finger rests 160 are for example located substantially at 90° around the axis X-X with respect to the two openings 150 such that the finger rests 160 do not impair the visibility of the visual indicator region 306 when it appears in the openings 150.

[0124] According to further embodiments, the activation part 300A of the plunger 300 and the proximal end part 100P of the holder 100 are further arranged to perform at least one of the following functions when they cooperate with each other: emitting an audible sound when the plunger 300 is in the end-of-injection position to audibly indicate (or warn) that the end-of-injection position is reached, and / or locking the plunger 300 in the end-of injection position.

[0125] To emit an audible sound when the plunger 300 is in the end-of-injection position to audibly indicate (or warn) that the end-of-injection position is reached, the activation part 300A of the plunger 300 and the proximal end part 10OP of the holder 100 are adapted to cooperate with each other so that when the plunger 300 is moved from the start-of-injection position to the end-of- injection position, the activation part 300A and the proximal end part 100P engage mechanically with each other, thereby causing a temporary elastic deformation of an elastically deformable portion of the proximal end part 10OP of the holder, the resilient return of the elastically deformable portion from its temporary deformation causing the deformable portion to hit the activation part 300A, thereby producing an audible sound. By audible sound, it is for example meant an sound emitted in the range of human auditory field, which corresponds to a frequency in the range of approximately 20 Hz to 20 000 Hz and to a volume level greater than 0 dB and lower than 120 dB. For the user to distinguish the audible sound produced by the hitting contact between the elastically deformable portion and the activation part 300A, the audible sound for example has a frequency in the range of 500 Hz to 2000 Hz and a volume level in the range of 30 dB to 80 dB. Such an audible sound can for example be obtained by choosing appropriate materials for producing the holder 100 and the activation part 300A of the plunger 300, for example rigid plastic materials.

[0126] The elastically deformable portion is for example formed by the audible indicator tab 115, described previously and which is further elastically deformable relative to the rest of the holder skirt 111 between a relaxed configuration (Figs. 2, 6b, 8b, 9b) and a deformed configuration (Fig. 7b) and the plunger skirt 303 is configured, when the plunger 300 is moved from the start-of- injection position to the end-of-injection position, to move the audible indicator tab 115 away from the relaxed configuration to the deformed configuration, as shown in Fig. 8b, then to let the audible indicator tab return resiliently from the deformed configuration to the relaxed configuration, this resilient return causing the audible indicator tab 115 to hit the plunger skirt 303, more particularly the outer face 306 of the plunger skirt 303, thereby producing the audible sound, for example a distinguishable clicking sound.

[0127] In this case, the audible indicator tab 115 is flexible between the relaxed configuration and the deformed configuration thanks to the tilting line 117. Indeed, the audible indicator tab 115 is tiltable around the tilting line 117 between the relaxed configuration and the deformed configuration.

[0128] According to the embodiment shown in the figures, the tilting line 117 is substantially orthoradial to axis X-X and the audible indicator tab 115 extends in the axial direction between the tilting line 117 and the distal end part 100D of the holder 100. More particularly, the audible indicator tab 115 extends in the axial direction between the tilting line 117 and the shoulder 113 of the holder skirt 111. In other words, according to this embodiment, the audible indicator tab 115 extends from the tilting line 117 in the proximal-distal direction.

[0129] In order to allow the plunger skirt 303 to move the audible indicator tab 115 radially while the plunger skirt 111 moves axially and approaches the end-of-injection position, the audible indicator tab 115 for example includes a ramp 118 which projects radially from the inner surface 102 of the audible indicator tab 115. The ramp 118 is oriented in the proximal-distal direction, meaning that the slope of the ramp 118 moves closer to axis X-X in the proximal-distal direction, as shown for example in Figs. 2 and 3. Consequently, when the plunger 300 is moved from the start-of-injection position to the end-of-injection position, the plunger skirt 303 enters into the holder skirt 111 on the inner surface side of the audible indicator tab 115 and the distal edge 307 of the plunger skirt 303 engages the ramp 118 of the audible indicator tab 115 which causes the audible indicator tab 115 to move from the relaxed configuration to the deformed configuration, as shown in Fig 7b, and back to the relaxed position when the plunger skirt 303 is fully received in the holder skirt 111 , which corresponds to the end-of-injection position, as shown in Fig. 8b and 9b.

[0130] According to various embodiments, the holder skirt 111 includes at least two audible indicator tabs 115 regularly and angularly (e.g., evenly) distributed around axis X-X. According to the embodiments shown in the figures, two audible indicator tabs 115 are provided and diametrically opposed to each other around the axis X-X. More particularly, the audible indicator tabs 115 are for example located at about 90° to each of the two movement-transmitting tabs around axis X-X such that different portions of the plunger skirt 303 actuate the movementtransmitting tabs 120 and the audible indicator tabs 115. These two audible indicator tabs 115 for example define the two diametrically opposed openings 150 described previously. When the plunger skirt 303 actuates the audible indicator tabs 115, the audible indicator tabs 115 simultaneously move away from each other from the relaxed configuration to the deformed configuration and then move towards each other from the deformed configuration to the relaxed configuration.

[0131] Since the audible sound is emitted when the plunger 300 is in the end-of-injection position, a user is ensured that the whole medical product has been delivered to a patient when the user hears the audible sound. Consequently, the user is invited to push the plunger 300 in the proximal- distal direction until the audible sound is emitted to signal that the syringe 1 has been fully emptied. In other words, the user is invited to stop pushing on the plunger 300 only once the user has heard the audible sound, the user then having the insurance that the medical product has been correctly delivered to the patient.

[0132] To lock the plunger 300 in the end-of-injection position, the holder skirt 111 and the plunger skirt 303 are received coaxially one within the other when the plunger 300 is moved from the start- of-injection position to the end-of-injection position and are adapted to engage mechanically with each other until the plunger skirt 303 is locked with respect to the holder skirt 111 when the plunger 300 is in the end-of-injection position.

[0133] To this end, the proximal end part 100P for example includes at least one locking tab which is elastically deformable relative to the rest of the holder skirt 111 between a relaxed configuration , and a deformed configuration and the plunger skirt 303 is configured, when the plunger 300 is moved from the start-of-injection position to the end-of-injection position, to move the locking tab away from the relaxed configuration to the deformed configuration, then to let the locking tab return resiliently from the deformed configuration to the relaxed configuration and so lock the plunger 300 in the end-of-injection position.

[0134] According to the embodiment shown in the figures, the locking tab is formed by the previously described audible indicator tab 115, such that the audible indicator tab 115 can be used to perform both the function of audibly indicating (or warning) that the end-of-injection position has been reached) and the locking function of the plunger.

[0135] According to the embodiments shown in the figures, the audible indicator tab 115 is configured so that a radial shoulder 308 of the activation part 300A of the plunger 300 abuts axially against the at audible indicator tab 115 when the plunger 300 is in the end-of-injection position, to prevent the plunger 300 from being moved from the end-of-injection position to the start-of-injection position as shown in Figs 8b and 9b. To this end, the audible indicator tab 115 for example includes an abutting surface 119 protruding radially inside the holder skirt 111 , the radial shoulder 308 of the activation part 300A abutting against the abutting surface 119 in the distal-proximal direction. The abutting surface 119 is for example formed by an end of the ramp 118 and the radial shoulder 308 of the activation part 300A for example protrudes radially from the outer face 306 of the plunger skirt 303 at the distal end 307 of the plunger skirt 303. According to an embodiment, the visible indicator region 309 extends on the outer face of the radial shoulder 308 such that the locking of the plunger 300 occurs simultaneously with the appearance of the visual indicator region 309 through the opening 150.

[0136] According to the embodiment described above, when the actuation part 300A and the audible indicator tab 115 interact with each other, three functions are performed: providing a visual indicator to the user when the plunger 300 has reached the end-of-injection position, providing an audible sound when the plunger 300 has reached the end-of-injection position and locking of the plunger 300 in the end-of-injection position.

[0137] According to an embodiment, the activation part 300A of the plunger 300 and the proximal end part 100P of the holder 100 are adapted to cooperate mechanically with each other when the plunger 300 is moved from the start-of-injection position to the end-of-injection position such that the unlocking of the safety sleeve from the standby position occurs at a first time and the visible and, possibly the audible indicator occurs at a second time, the second time being simultaneous or subsequent to the first time. In other words, since the audible and / or visible indicator occurs when the plunger 300 is in the end-of-injection position, when the second time is simultaneous with the first time, the unlocking of the safety sleeve 200 from the standby position occurs when the plunger 300 is in the end-of injection position and, when the second time is subsequent to the first time, this unlocking occurs before the plunger 300 reaches the end-of-injection position.

[0138] In other words, when the visual indicator, and, if provided, the audible indicator occur, the safety sleeve is or has been unlocked from the standby position and is allowed to move toward the deployed position. Since the time at which the visual indicator occurs is also the time at which the plunger 300 reaches the end-of-injection position, this embodiment allows ensuring that the safety sleeve is ready to move towards the deployed position when the plunger 300 reaches or has reached the end-of-injection position and that the safety sleeve 200 will move towards the deployed position as the needle 4 is removed from the skin of a patient. Consequently, the user can safely extract the needle 4 from the patient once the plunger 300 has reached the end-of- injection position since the safety sleeve 200 will then move to the deployed position as the needle 4 is extracted under the influence of the biasing element 500, as described previously.

[0139] By “the second time is simultaneous with the first time”, it is meant that the activation part 300A moves the movement-transmitting tab(s) 120 and, at the same time, the visible indicator region 309 becomes visible through the opening 150 of the holder skirt 111. According to an embodiment, at this time, the audible indicator tab hits the activation part 300A to produce an audible sound.

[0140] By “the second time is subsequent to the first time”, it is meant that the activation part 300A starts moving the movement-transmitting tab(s) 120 before the visible indicator region 309 becomes visible through the opening 150 of the holder skirt 111. The movement-transmitting tab(s) 120 is no longer in the standby position, when the visible indicator occurs. According to an embodiment, at this subsequent second time, the audible indicator tab also hits the activation part 300A. With the second time subsequent to the first time, it is therefore ensured that the safety sleeve 200 is ready to move to the deployed position before the plunger arrives in the end-of- injection position and that the safety sleeve 200 will move towards the deployed position as the needle 4 is removed from the skin of a patient, thereby reducing the risks of exposing the needle 4 when it is extracted from the patient when the plunger 300 has reached the end-of-injection position.

[0141] The unlocking of the safety sleeve 200 and the production of audible and visible indicators will now be described in reference to the embodiments shown in the figures, in which two movement-transmitting tabs 120 and two locking tabs 115 are provided and in which the second time is subsequent to the first time.

[0142] When the plunger is moved from the start-of-injection position to the end-of-injection position, the plunger skirt 303 enters into the holder skirt 111 and its distal edge 307 first engages the ramp 128 of the movement-transmitting tabs 120 and starts moving the movement-transmitting tabs 120 away from their resting position towards their activating position. If there is a small gap between the movement-transmitting tabs and the free end 203 of the link arms 202, the movement-transmitting tabs 120 contact the free ends 203 and start exerting a radial force on the free end 203 of the link arms 202, which starts moving away from its standby position.

[0143] As the plunger 300 continues moving towards the end-of-injection position, the inner face of the distal end 307 of the plunger skirt 303 continues pushing the movement transmitting tabs 120 towards the activating position. At some time during this phase, the outer face of the distal end 307 of the plunger skirt 303 engages the ramp 118 of the locking tabs 115 and starts moving the locking tabs 115 away from their relaxed configuration towards their deformed configuration.

[0144] As the plunger 300 continues moving towards the end-of-injection position, the free end 203 of the link arms 202 are disengaged from the edge 114 of the shoulder 113, which makes the safety sleeve 200 ready to move towards its deployed position under the influence of the biasing element 500. At this point, the distal end 307 of the plunger skirt 303 continues moving the locking tabs 115 towards their deformed configuration while the inner face 305 of the plunger skirt 303 prevents the movement-transmitting tabs 120 from returning to their resting position, thereby maintaining the link arms 202 ready to engage in the barrel piece 110 when the needle 4 is removed from the skin of a patient.

[0145] When the locking tabs 115 reach their deformed configuration, the distal end 307 of the plunger skirt 303 continues moving until reaching the distal part of the slits 116. When the distal end 307 faces the distal part of the slits 116, the plunger 300 is in the end-of-injection position and the locking tabs 115 are no longer constrained in their deformed configuration and resiliently return to their relaxed configuration. This return causes the locking tabs 115 to hit the outer face 306 of the plunger skirt 303, thereby emitting an audible sound indicating to the user that the end- of-injection position has been reached and that the needle 4 can be safely extracted from the patient. Simultaneously, the visual indicator region 309 becomes visible through the openings 150 which are formed by the distal parts slits 116 thereby also providing a visual indicator to the user that the end-of-injection position has been reached. The activation part 300A of the plunger 300 is also locked in this position.

[0146] The needle 4 can then be safely removed from the skin of the patient, this extraction causing the safety sleeve to move towards its deployed position.

[0147] The medical device has been described with an activation part 300A of the plunger 300 which enters into the proximal end part 100P of the holder 100 when the plunger 300 is moved from the start- of- injection position to the end-of-injection position. It should however be noted that the medical device can also be adapted to an activation part 300A that surrounds the proximal end part 100P of the holder 100 when the plunger 300 is moved from the start-of-injection position to the end-of-injection position. In this case, the movement-transmitting tab(s) can for example be implemented in the cylindrical wall 112 of the holder skirt 111 and the holder ring can be dispensed with. In this case, if provided, the visual indicator region can also be provided on the outer surface of the cylindrical wall of the holder skirt 111 while the opening(s) through which the visual indicator region appears is(are) then provided in the plunger skirt 303. The audible indicator tab can still be provided in the cylindrical wall of the holder skirt 111 but is moved from the relaxed configuration to the deformed configuration from the outer surface of the cylindrical wall instead of the inner surface as described previously.

[0148] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0149] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated. The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0150] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0151] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0152] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0153] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0154] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB- 1023, TTP-054, Langlenatide I HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX- 096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI- 70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon-Xten.

[0155] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0156] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin,

[0157] Berberine. Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0158] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0159] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0160] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art. The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

[0161] An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

[0162] “VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e., of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

[0163] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 544), to Holt et al. 2003 (Trends Biotechnol. 21 : 484); as well as to WO 2004 / 068820, WO 2006 / 030220, WO 2006 / 003388. It should also be noted that, although less preferred in the context of the present disclosure because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005 / 18629).

[0164] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0165] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0166] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0167] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present disclosure, which encompass such modifications and any and all equivalents thereof.

[0168] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0169] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non- replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0170] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non- replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0171] List of numerical references

[0172] 1 : syringe

[0173] 2: syringe body

[0174] 3: plunger stopper 4: needle

[0175] 5: flange of the syringe

[0176] 100: holder

[0177] 100P: proximal end part of the holder

[0178] 100D: distal end part of the holder

[0179] 102: inner surface of the holder

[0180] 103: outer surface of the holder

[0181] 110: barrel piece

[0182] 111 : holder skirt

[0183] 112: cylindrical wall of the holder skirt

[0184] 113: shoulder of the holder skirt

[0185] 114: edge of the shoulder

[0186] 115: audible indicator tab

[0187] 116: slit in the holder skirt

[0188] 117: tilting line of the locking tab

[0189] 118: ramp of the locking tab

[0190] 119: abutment surface of the locking tab

[0191] 120, 120’, 120”: movement-transmitting tab

[0192] 121 , 121’, 121”: holder ring

[0193] 121 D, 121 D’, 121 D”: distal end of the holder ring

[0194] 122, 122’, 122”: axial wall of the holder ring

[0195] 123, 123’, 123”: outer face of the axial all

[0196] 124, 124’, 124”: inner face of the axial wall

[0197] 125, 125’, 125”: slit in the axial wall

[0198] 126, 126’, 126”: hingeable junction region of the movement-transmitting tab

[0199] 127, 127’, 127”: tilting line of the movement-transmitting tab

[0200] 128, 128’, 128”: ramp of the movement-transmitting tab

[0201] 129, 129’, 129”: latching tongue

[0202] 130: guiding element

[0203] 140, 140’, 140”: weld bead of the holder ring

[0204] 150: opening in the holder skirt

[0205] 160: finger rest

[0206] 200: safety sleeve

[0207] 200P: proximal end part of the safety sleeve

[0208] 200D: distal end part of the safety sleeve

[0209] 201 : tubular portion of the safety sleeve

[0210] 202: link arm 203: free end of the link arm

[0211] 300: plunger

[0212] 300A: activation part

[0213] 301 : plunger rod 302: distal end of the plunger rod

[0214] 303: plunger skirt

[0215] 304: front wall of the activation part

[0216] 305: inner face of the plunger skirt

[0217] 306: outer face of the plunger skirt 307: distal end of the plunger skirt

[0218] 308: radial shoulder of the activation part

[0219] 309: visual indicator region

[0220] 400: needle shield

[0221] 500: biasing element

Claims

35CLAIMS1. A medical device for holding a syringe (1), the medical device comprising:- a holder (100) which:- defines an axis (X-X) around and along which the holder (100) extends,- is adapted to receive a syringe body (2) of the syringe (1) so that the syringe body extends lengthwise along the axis (X-X), and- includes a proximal end part (100P) and a distal end part (100D), which are axially opposed to each other, the proximal end part (100P) being adapted to be attached to the syringe body (2) to retain the syringe body relative to the holder (100) when the syringe body is received in the holder,- a safety sleeve (200) that is assembled coaxially with the holder (100) so as to be movable along the axis (X-X) between a standby position, in which the safety sleeve (200) is substantially retracted within the holder (100), and a deployed position, in which the safety sleeve (200) is deployed outwardly of the holder (100) from the distal end part (100D) of the holder (100) to surround a needle (4) of the syringe (1), when the syringe body (2) is received in the holder, and- a plunger (300) which:- is manually movable axially relative to the holder (100) towards the distal end part (100D) of the holder (100) from a start-of-injection position to an end-of-injection position when the syringe body is received in the holder, and- includes an activation part (300A) which acts mechanically on the safety sleeve (200) via the proximal end part (100P) of the holder (100) to allow the safety sleeve to move away from the standby position when the plunger (300) is moved from the start-of-injection position to the end- of-injection position, wherein the activation part (300A) of the plunger (300) and the proximal end part (100P) of the holder (100) are adapted to cooperate with each other so that when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, the activation part (300A) and the proximal end part (100P) at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

2. The medical device of claim 1 , wherein the proximal end part (100P) of the holder (100) comprises a holder skirt (111) that is substantially centered on the axis (X-X), wherein the activation part (300A) of the plunger (300) comprises a plunger skirt (303) that acts mechanically on the safety sleeve (200) via the proximal end part (100P) of the holder (100) to36 allow the safety sleeve to move from the standby position to the deployed position when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, wherein the holder skirt (111) and the plunger skirt (303) are received coaxially one within the other when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, and wherein the plunger skirt (303) and the holder skirt (111) are adapted to cooperate with each other so that when the plunger (300) is moved from the start-of-injection position to the end-of- injection position, the plunger skirt (303) and the holder skirt (111) at least partly disappear axially into each other, until one reappears through the other when the plunger (300) is in the end-of- injection position to visually indicate that the end-of-injection position is reached.

3. The medical device of claim 2, wherein the plunger skirt (303) includes a visual indicator region (309) which:- contrasts visually from the holder skirt (111), and- is hidden within the holder skirt (111) when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, and then becomes visible through at least one opening (150) of the holder skirt (111) when the plunger (300) is in the end-of-injection position.

4. The medical device of claim 3, wherein the visual indicator region (309) extends on the plunger skirt (303) all around the axis (X-X).

5. The medical device of any one of the claims 3 to 4, wherein the visual indicator region (309) is located at a distal edge (307) of the plunger skirt (303).6 The medical device of any one of the claims 3 to 5, wherein the visual indicator region (309) contrasts from the holder skirt (111) in color and / or in surface texture.

7. The medical device of any one of claims 3 to 6, wherein the at least one opening (150) has an elongated shape orthoradial to the axis (X-X).

8. The medical device of any one of the claims 3 to 7, wherein the at least one opening (150) includes at least two openings (150) that are regularly angularly distributed with respect to the axis (X-X).

9. The medical device of claim 8, wherein the at least one opening (150) includes two openings (150) that are diametrically opposed to each other with respect to the axis (X-X), the holder (100) being provided with two finger rests (160), which are diametrically opposed to each other withrespect to the axis (X-X) and which are located substantially at 90° around the axis (X-X) with respect to the two openings (150).

10. The medical device according to any one of claims 2 to 9, wherein the holder skirt (111) and the plunger skirt (303) are adapted to engage mechanically with each other when the plunger (300) is moved from the start-of-injection position to the end-of-injection position until the plunger skirt (303) is locked with respect to the holder skirt (111) when the plunger (300) is in the end-of- injection position.11 . The medical device of any one of the preceding claims, wherein the activation part (300A) of the plunger (300) and the proximal end part (100P) of the holder (100) are adapted to further cooperate with each other so that when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, the activation part (300A) and the proximal end part (100P) engage mechanically with each other, until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

12. The medical device of claim 11 taken in combination with any one of the claims 2 to 9, wherein the plunger skirt (303) and the holder skirt (111) are adapted to further cooperate with each other so that when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, the plunger skirt (303) and the holder skirt (111) engage mechanically with each other, until one clicks with the other when the plunger is in the end-of-injection position to audibly indicate that the end-of-injection position is reached.

13. The medical device of claim 12, wherein the plunger skirt (303) is received coaxially within the holder skirt (111) when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, and wherein the holder skirt (111) includes at least one audible indicator tab (115) which:- is elastically deformable relative to the rest of the holder skirt (111) between a relaxed configuration and a deformed configuration, the at least one audible indicator tab (115) being more radially spaced from the axis (X-X) in the deformed configuration than in the relaxed configuration, and- is moved from the relaxed configuration to the deformed configuration by the plunger skirt (303) when the plunger (300) is moved from the start-of-injection position to the end-of-injection position, then returns resiliently from the deformed configuration to the relaxed configuration and so hits the activation part (300A) of the plunger (300) to click when the plunger (300) is in the end-of- injection position.

14. The medical device of claim 13 taken in combination with any one of the claims 4 to 10, wherein the at least one opening (150) is axially delimited between the at least one audible indicator tab (115) and the rest of the holder skirt (111).

15. A manual drug delivery device, comprising the medical device of any one of the preceding claims and a syringe (1) pre-filled with a dose to be injected.16.- Method for using a medical device of any one of claims 1 to 14, comprising the following steps :- moving the plunger (300) relative to the holder (100) towards the distal end part (100D) of the holder (100) from a start-of-injection position to an end-of-injection position, the activation part (300A) and the proximal end part (100P) engaging mechanically with each other, wherein, during the mechanical engagement between the activation part (300A) and the proximal end part (100P), the activation part (300A) and the proximal end part (100P) at least partly disappear axially into each other, until one reappears through the other when the plunger is in the end-of-injection position to visually indicate that the end-of-injection position is reached.

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