RU2778422C2 - Automatic drug delivery device - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: present invention relates to medical equipment, namely to automatic drug delivery device (10), in particular to an automatic drug delivery device intended for dosing of a fluid product, in particular a fluid drug. The device contains longitudinal case (104) extending along a longitudinal axis and having a proximal end near a dosing site, a distal end opposite to the proximal end, and a hollow inner part; removable lid (50) made with the possibility of installation on the proximal end of case (104); syringe node (200) located in an installation position inside case (104) and having hollow main part (204) of the syringe and injection needle (206) connected to hollow main part (204) of the syringe, containing the fluid product; drive mechanism (300), which can be actuated by a starting element to start dosing of the fluid product. At the same time, the loaded drive mechanism is functionally connected to protective casing (102) made with the possibility of movement inside longitudinal case (104). Moreover, protective casing (102) is shifted to a proximal position, in which it protrudes outward from the proximal end of longitudinal case (104) to close tip (348) of a needle, which is injection needle (206), while protective casing (104) is made with the possibility of movement to a distal position, in which injection needle (206) is opened for an injection. At the same time, the device additionally contains a feedback mechanism providing visual feedback for a user, indicating an actual operation state. Moreover, the feedback mechanism contains a visual indicator, which appears in a transparent window at the distal end of the case. In this case, the visual indicator contains a part of a casing retention indicator, retained with the possibility of release in an invisible position, in which the indication surface is not visible through the transparent window of the case, wherein the part of casing retention indicator is shifted in a distal direction by means of a spring of the protective casing for movement, when released, to a visible position, in which the indication surface is visible through the transparent window of the case.

EFFECT: obtaining an automatic drug device.

19 cl, 90 dwg

Description

Field and state of the art of the invention

The present invention relates to an automatic drug delivery device, in particular an auto-injector, for dispensing a fluid product, in particular a fluid drug, to a patient.

Automated drug delivery devices designed as autoinjectors are well known in the art. Various types of automatic drug delivery devices are available on the market. While current state of the art automated drug delivery devices provide reliable performance, they still have a number of disadvantages that must be overcome.

EP 2 745 866 B1 describes an automatic drug delivery device having a protective cover that acts as a trigger. The automatic drug delivery device is activated by pressing the protective sheath against the injection site on the patient's skin where the injection is to be performed. The protective cover is pushed into the longitudinal housing of the automatic drug delivery device and thereby starts the injection process. When the injection is completed and when the automatic drug delivery device is removed from the injection site, the guard is pushed out of the longitudinal housing and locked by a locking mechanism in a secure position covering the needle tip. The locking mechanism is formed inside the protective casing and contains flexible tabs in a variety of components. Because of this design, the protective cover becomes complex in geometry and manufacture. Moreover, the flexible tabs of this particular shroud do not provide sufficient protection against movement of the shroud into the longitudinal housing after use.

EP 2 903 670 B1 describes an automatic drug delivery device that is activated by rotating a blocking part relative to an activating part. Thus, rotational relative movements between different components of the actuator are required. Such rotary movements for activating the automatic drug delivery device are often not intuitive, which makes the use of such automatic drug delivery devices inconvenient for users. Other automatic drug delivery devices having rotatable components are known from EP 2 583 711 A1.

Moreover, there are automatic drug delivery devices in which the injection process is started by pressing a button on the distal end or circumferential side of the device. Such devices can be misused because the triggering mechanism can be activated despite the fact that the drug delivery device is incorrectly placed at the injection site.

European patent EP 2 978 471 B1 describes an automatic drug delivery device which is also triggered by pressing the protective cover on the injection site. However, the actuator is complex and requires multiple parts to interact with each other during relative movements. As a result, manufacturing and assembly are complex.

US 2016/0331905 A1 describes an automatic drug delivery device comprising a ratchet activation mechanism assembly. Various flexible legs interact with a rack having recesses. Due to the many components and moving elements, the device is susceptible to misuse and erroneous activation. Moreover, manufacturing and assembly are complex.

In addition to the assembly and operation of the activation mechanism, another task of automatic drug delivery devices is to position and hold the pre-filled syringe assemblies. Such pre-filled syringe assemblies typically comprise a glass body pre-filled with the fluid product to be dispensed. During assembly, the glass body must be handled with extreme care to avoid damaging or otherwise affecting the glass body. To avoid direct handling of the glass body, this prior art document suggests the use of a syringe holder.

Reference is also made to WO 2016/193374 A1 which describes a particular syringe holder having flexible tabs that flex when pre-assembled and which relax when an axial force is applied to the syringe support. An alternative syringe support is described in WO 206/193355 A1. This syringe support provides axial shear force to the syringe within the housing of the auto drug delivery device. Another syringe holder providing axial force against the syringe is known from WO 2007/083115 A1. Moreover, document WO 2015/015230 A2 describes a syringe holder with a protective element for transferring axial loads to the syringe support. Another prior art syringe support is known from WO/089620 A1, which provides an annular piece interconnected by two connecting tabs to a C-shaped proximal receiving piece.

Another problem with automatic drug delivery devices is providing feedback to the user. Such feedback signals may be audible, visible, or tactile. WO 2016/193343 A1 describes an automatic drug delivery device with an audible indicator including resilient tabs which deflect radially outward during use and then relax to generate an audible signal.

Moreover, another aspect of automatic drug delivery devices is the use of a removable cap which, when removed from the body of the automatic drug delivery device, removes the rigid needle sheath from the needle of the pre-filled syringe assembly. Such removable covers are known from WO 2012/103140 A1. This document describes a relatively complex design of a removable lid having a plurality of lid engagement mechanisms.

Brief description of the invention

Features of the end of dosing

The automatic drug delivery device may further comprise a feedback mechanism providing tactile and/or audible and/or visual feedback to the user to indicate the state of operation, wherein the feedback mechanism may comprise a visual indicator that appears within the distal end of the body. . The visual indicator may appear in a window, which may be provided with an opening or may be made of a transparent or translucent material. Said window and/or distal end of the body may be transparent or translucent around its entire circumference so that the visual indicator appears over an angular range of up to 360°. The window and/or the distal end of the housing may be provided by the housing or a separate portion connected to the housing, such as an end cap.

The present invention also provides an automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the housing;

a syringe-like assembly located at a mounting position within the housing and having a hollow syringe body and an injection needle connected to a hollow syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

at the same time, the drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing,

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the device further comprises a feedback mechanism providing visual feedback to the user indicating the actual state of operation, the feedback mechanism comprising a visual indicator that appears in a transparent window at the distal end of the body.

The visual indicator can be moved distally to appear in a transparent window. The visual indicator may be formed by a radial inner indicator component and a radial outer indicator component slid into the indicator position by an indicator spring. The outer indicator may be released to the indication position after delivery of a predetermined dose of drug to the patient. The predetermined dose may be any predetermined dose, but may be a majority of the dose, more than 70% of the dose, more than 90% of the dose, or substantially all of the dose. The predetermined dose may be a large enough fraction of the dose such that the appearance of a visual indicator indicates the end of the injection. A visual indicator may appear in a transparent window at the distal end of the body to indicate the end of the injection.

The outer indicator component may have a visible surface. The visible surface is a surface that is intended for visual indication. The visible surface may contain one or more colors, shapes, patterns, symbols, and images so that the visible surface can be easily distinguished from other surfaces or device components. The internal indicator component may interact with the housing or a separate area, such as an end cap connected to the housing, to provide an audible and/or tactile signal.

The device may include a distal end cap that is closed by a distal surface. The distal end cap may be made of a transparent material to provide a transparent window. The distal surface may be made of a transparent material.

The hood spring may be supported between the hood holding trigger and the hood holding indicator piece. The case retainer actuating member may support the proximal end of the guard spring and may apply a shearing force to the distal end of the longitudinal leg of the guard or each leg to move them proximally. The sheath retaining indicator piece may support the distal end of the sheath spring.

The present invention also provides an automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the housing;

a syringe-like assembly located at a mounting position within the housing and having a hollow syringe body and an injection needle connected to a hollow syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

at the same time, the drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing,

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the protective cover has at least one longitudinal tab extending in the distal direction, guided inside the longitudinal body, while the protective cover interacts with the protective cover spring shifting the protective cover in the proximal direction by means of at least one longitudinal tab, and at the same time the spring of the guard retainer is supported between the guard retainer trigger piece and the guard retainer indicator piece, wherein the guard retainer trigger piece supports the proximal end of the guard spring and applies shearing force to the distal end of the guard retainer legs, and the guard retainer indicator piece supports the distal end protective cover springs.

The drive mechanism may include a plunger that is driven by a drive spring in a proximal direction. The plunger may act on a plug sealed within the syringe body and exposed to a fluid product contained within the syringe body. The syringe holder can absorb axial forces applied by the plunger to the main body of the syringe and can transmit the forces to the longitudinal body.

The loaded or activated drive mechanism may include a holding device. The retainer may extend from the distal end of the device to the main body of the syringe. The holding device may include at least one flexible tab that deforms in the radial direction. At least one flexible tab may be used to hold the plunger in a loaded position in which it is displaced in the proximal direction.

The retainer may be elastically deformable to shift the main body of the syringe in a proximal direction. The retainer may include a proximal portion in the form of an annular head having two opposing protrusions. The protrusions may contact the syringe body and may be configured to fit within the larger diameter syringe body so that the proximal annular head portion contacts the syringe body. For example, the protrusions may contact the main body of the syringe, which is a 1 ml syringe, and may be configured to fit within the main body of the 2 ml syringe, which has a larger diameter such that the proximal portion in the form of a ring-shaped head contacts with the main part of a 2 ml syringe.

At least one flexible tab can be additionally provided with a beveled radial outer ledge and a bevelled radial inner ledge. A beveled radial inward projection may be provided to engage with a corresponding plunger engagement surface to hold the plunger in a loaded position. At least one flexible tab can interact through a beveled radial outer ledge with the inner circumferential surface of the housing holding trigger.

The guard, when pushed distally to begin dispensing fluid product, can move the guard holding trigger distally to compress the guard spring. After a predetermined travel of the guard, the trigger of the guard retainer may release at least one flexible tab for radial outward movement, whereby the plunger is released to move under the shear force of the drive spring in a proximal direction to expel and dispense fluid product from the syringe body through the needle. .

The housing holding indicator may include at least one longitudinal holding tab, wherein the housing holding indicator may be held by at least one holding tab in an invisible position in which the indication surface is not visible through the housing (either through a window-like opening or through a transparent area). corps). Thus, the shroud retention indicator provides a visual indicator. At least one holding tab may be held by the holding device until the plunger has reached a predetermined dispensing position. The plunger releases at least one holding tab from the holding device upon reaching a predetermined dispensing position. After at least one holding tab is released, the case holding indicator may be pushed by the protective case spring to a visible position in which that indication surface is visible through the case. A tactile and/or audible signal may be generated when the housing holding indicator reaches its final visible position.

Once the sheath retention indicator has been released and moved to a visible position, and the guard has been moved to a position where it covers the needle tip, the sheath retention indicator may prevent distal movement of the sheath retention trigger piece, and the sheath retention trigger piece may interfere with distal movement. movement of the protective cover. Thus, a closed chain of components can be formed from one end of the device to the other to prevent movement of the protective sheath in a distal direction.

The housing retention indicator may be formed by a hollow cylindrical body having an annular cylindrical element which can be expanded by an arcuate extension or tab adapted to the geometry of the housing. It can slip but still fit positively within the flared portion of the hollow cylindrical body of the longitudinal body. It has a smooth outer circumferential surface. At its proximal end, the housing retention indicator may be provided with a plurality of longitudinal flexible tabs, preferably four, each having a proximal free end. The free ends of the flexible legs may be provided with projections extending radially inwards and reinforced with short longitudinal bevelled ribs. The distal end of the case holding indicator may be provided with a round hole.

The tabs of the shroud retention indicator, as mentioned above, are flexible and therefore damp to some very limited extent the amount of distal movement of the shroud after use. However, in addition to this small damping movement, these tabs block the movement of the protective cover in the distal direction, and they are made with the possibility of bending radially outward relative to the hollow cylindrical main part of the longitudinal body. Thus, the device provides a very secure lock after use, preventing easy access to the needle.

The circumferential outer surface of the case retention indicator has a signal color, i.e. yellow, orange or red, or a signal pattern that is clearly visible to the user. Thus, as will be discussed in detail with respect to the operation of the drug delivery device of the present invention, the user of the auto-injector, i.e. the healthcare professional or patient or caregiver, can easily recognize when the sheath retention indicator has moved to the signal position, in which it is clearly visible through the longitudinal body from the outside.

The inner member of the housing retention indicator may be formed by a stepped tubular main body having a first hollow cylindrical part with a smaller diameter and an enlarged second hollow cylindrical part with a larger diameter. At its proximal end, the inner housing retention indicator element may be provided with two opposite flexible longitudinal tabs extending in the proximal direction, with the first part extending in the longitudinal direction, the second part slightly inclined radially inward, and the third part extending in the longitudinal direction, however, on a radial level that is further radially inward than the first part. At its proximal end, each of the tabs may have an inclined retaining protrusion extending radially outward.

The distal portion of the inner member of the case retention indicator may be provided with an end plate having approximately the same rounded and flared cross-sectional area as the distal end of the case retention indicator. The diameter of the outer circumferential surface of the second hollow cylindrical portion may be adapted to fit within a circular hole provided at the distal end of the case holding indicator.

To improve the security level of the device, the device may additionally provide a retaining ring inside the longitudinal housing in the initial position. The retaining ring can be secured to the guard during operation, with the retaining ring blocking distal movement of the guard when the guard closes the needle after the fluid product has finally been dispensed and the automatic drug delivery device has been removed from its position. injections.

The retaining ring can be initially retained by the containing component, with the retaining ring engaging with the guard after the guard has been pushed distally. The retaining ring moves with the guard in a proximal direction under the action of the force of the spring, which is the spring of the guard, when the automatic drug delivery device is removed from the injection site. Moreover, the retaining ring can block any movement of the guard relative to the enclosing component in the distal direction when the needle is closed.

Once the plunger is released from the retainer, proximal movement of the guard can be prevented until the plunger reaches a predetermined dispensing position. This predetermined position may be the same as the predetermined position in which the case holding indicator is located, but need not be the same. This may allow accidental withdrawal and then re-insertion of the needle rather than accidental withdrawal leading to needle shielding and thus loss of the remainder of the dose. Keeping the shroud retracted can also make it easier for the user to hold the device against the skin, since the shear force acting on the shroud does not act to move the device away from the skin.

The protective sheath can be pressed by the end cap by means of longitudinal tabs, overcoming the resistance of the sheath spring in the distal direction, partially into the housing. The trigger element may act as an intermediate element between the longitudinal tabs and the casing spring. The trigger element in the assembled state can be permanently connected by its protrusions and any clamping elements inside to the distal ends of the tabs of the protective casing. The protrusions can be accommodated within the inner guide profile at the distal end of the longitudinal tabs. Moreover, the chamfered protrusions of any of the clip elements can engage with the through holes or recesses, respectively, and thereby prevent, in the assembled state, the separation of the tabs of the protective casing under the action of an axial force from the trigger element. The lug cavities and the guide profile of the distal end of the tabs simplify the assembly process.

The proximal end of the housing spring may engage with respect to the distal portion of the trigger and may abut the circumferential or lateral ribs of the trigger. The distal end of the sheath spring may be pressed by the distal end of the sheath retention indicator against the flanged proximal surface of the sheath retention indicator inner member plate.

The case retaining indicator with its cylindrical body can contain and surround the inner member of the case retained indicator as well as the case spring. The longitudinal tabs of the housing retention indicator may extend proximally through gaps provided between any of the lateral lugs and/or box structures, each of which may project radially outward from the trigger. The longitudinal tabs can extend past the trigger so that the protrusions of the tabs of the housing retention indicator engage the outer circumferential surface of the retainer.

The retainer and associated components may be rigidly held within the distal end cap, for example, by a hollow cylindrical body clamped by an inner circumferential ridge into an outer circumferential groove of the retainer in a positive fit. In this way, the holding device can be secured inside the device from any movement in the axial direction, as well as from tilting.

The case retaining indicator, together with the case retaining indicator inner member, can be held in an axial position by the inner tabs of the case retained indicator despite the compressed case spring and the resulting axial driving forces. This can be achieved by having the tabs extend through the longitudinal recesses of the retainer and engage with their radial retainer projections behind the lateral retainer projections overlapping the respective retainer recesses. Moreover, in this state, the outer circumferential surface of the plunger located radially inside the tabs can prevent the tabs from bending radially inward and out of the holding function on the lateral protrusions.

The plunger can hold the main spring in a compressed state. The proximal end of the compressed mainspring may be pressed against the proximal end of the plunger. The proximal end of the plunger can be slidably received within the hollow glass body of the syringe near the stopper element. The distal end of the main spring may protrude outside the plunger and may fit within the hollow interior of the retainer where support is provided relative to its distal end. The plunger can be held in its axial position with respect to the driving force of the main spring due to engagement between flexible tabs with radial internal projections that engage through holes provided in the plunger. Since the flexible legs are held in position by contact between their outwardly extending radial projections and the inner circumferential surface of the trigger, the flexible legs cannot flex radially outward in response to the driving force of the compressed mainspring. Thus, the plunger is held by the flexible tabs of the retainer and their inwardly extending radial projections.

Lid Features

The present invention relates to an automatic drug delivery device for dispensing a fluid product, in particular a fluid drug product, comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the housing;

a syringe-like assembly disposed at a mounting position within the body, the syringe-like assembly having a hollow body and an injection needle connected to the hollow syringe body, the syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

at the same time, the loaded drive mechanism is functionally connected to the protective casing, which is movable inside the longitudinal housing,

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the removable cover is axially held at the proximal end of the longitudinal body due to the engagement of the holding elements between the cover and the longitudinal body, and the holding elements are disengaged by turning the cover relative to the longitudinal body to provide axial movement of the cover relative to the body to remove said cover, and the axial movement of the cover relative to the housing is supported by a shear force applied to the protective casing.

The removable cover is axially held at the proximal end of the longitudinal body by engagement of the retaining elements between the cover and the longitudinal body. The longitudinal body may include one retaining structure for engaging at least one engaging structure provided on the removable cover. The engaging structure can be engaged with the holding structure to hold the removable cover on the longitudinal body. Such an arrangement can improve the secure fit between the lid and the longitudinal body.

The structure of the retaining members, such as the retaining structure or the engaging structure, may be configured to define a method for removing the lid, or at least to provide a preferred method of removal. For example, the removal of the lid by tearing off can be blocked, thus resulting only in unscrewing. Removal of the lid by tearing may be permitted and the proper force is usually set for this. The user can choose one of two withdrawal methods. The force required to remove the cover by tearing off can be set to a level that is lower than when unscrewing.

The removable cover may comprise a main part of the end cover having at least one inner surface that defines the open containing part in the axial direction, and having an inner ring that is connected to the main part of the end cover, while the inner surface of the removable end cover and the inner ring form space to accommodate the proximal end of the longitudinal body. This space between the inner surface and the inner ring can provide a secure way to receive the proximal end of the longitudinal housing, which reduces the risk that the closure may be misaligned or accidentally removed or knocked off. The formation of an inner ring in the cap is potentially advantageous, but may be considered optional in relation to other features provided by the present invention.

In order to realize a suitable retaining function, the retaining structure may be formed by at least one projection, for example a U-shaped projection, formed on the outer circumferential surface of the longitudinal body near the proximal end and protruding radially outward, while the recess of the U-shaped projection opens in the distal direction. . The engaging structure may be formed by at least one retaining rib on the radial inner circumferential surface of the removable cover. The holding action between the removable cover and the longitudinal body is provided by engaging the holding rib into a U-shaped protrusion formed on the longitudinal body.

A suitable holding function can also be realized provided that the longitudinal body and the removable cover comprise at least one engagement protrusion and an enclosing formation for holding the removable cover in a locked position relative to the longitudinal body.

The longitudinal housing may comprise at least one radial internal engagement projection formed on the inner circumferential surface of the proximal end of the longitudinal housing, and the engagement projection may be adapted to engage with at least one corresponding radial external projection formed on the outer circumferential surface of the inner ring.

At least one radial internal engagement projection may be formed by a rib, preferably with a guiding portion such as a bevel or rounded edge, and at least one enclosing formation may be formed by two opposite chamfered projections and one axial projection. Retaining elements that axially hold the removable cover at the proximal end of the longitudinal body may include internal protrusions formed at the proximal end of the longitudinal body and protrusions formed inside the main part of the end cap, and the protrusions inside the main part of the cover contain a recess, inside which the inner protruding part is limited in circumference by bevelled projections.

The cap, the guard may, for example, during removal of the cap, engage the cap with a proximal contact surface formed at or near the proximal end of the needle sheath when the cap is mounted on the longitudinal body. The proximal contact surface may be the proximal front surface of the needle sheath, or a stepped surface or step provided near the proximal end of the needle sheath. The automatic drug delivery device may further provide that said proximal end of the longitudinal body engages a removable end cap on at least one inner surface and/or on the inner ring.

The removable cover may comprise at least one guide surface or cam path surface, which may be formed as a guide surface inclined about a longitudinal axis to guide the removable cover in a proximal direction along at least a portion of its twisting movement. At least one guide surface or cam path surface may be located on the outer circumferential surface of the inner ring. The cam path surface may be adapted or inclined with respect to the longitudinal axis to guide the removable cover in a proximal direction (away from the longitudinal body) along at least a portion of its pivoting or twisting movement. As an additional option, the guide surface may be in the form of a harmonically closed curved front surface at the proximal end of the removable body or formed on the inner circumferential surface of the removable cover, while the corresponding guide protrusion engaging the guide surface is formed on the inner circumferential surface of the removable cover or on the front surface of the longitudinal body.

The protective cover may comprise a cylindrical hollow body and/or a ring-shaped hollow body at its proximal end, wherein at least one protrusion of the protective cover is provided on the hollow body. At least one protrusion of the protective cover may be adapted to engage with the protrusion or recess of the removable cover to limit movement of the protective housing in a distal direction with respect to the removable cover. In this way, the protective cover can be prevented from inadvertently starting the automatic drug delivery device, i.e. such that it begins to deliver the drug, when it is subjected to an unintentional impact, in particular after a free fall and subsequent impact on a hard surface.

The removable cover, when mounted in its retained position on the longitudinal body, may be attached to the longitudinal body by means of a burst seal. The burst seal, which may be a sticker affixed overlapping the outer circumferential surfaces of the longitudinal housing and with the removable cover, may act as a visible seal indicating whether the device has already been used if there is a tear at the interface between the longitudinal housing and the removable cover, or is whether it is in its initial unused state if there is no damage in the specified seam area. Rupture of the seal may also require a certain threshold force to unscrew the removable cover from the housing, which may be felt by the user.

The present invention also provides a method for removing a removable cap from an automatic drug delivery device as described herein, the method comprising:

pivoting the removable cover relative to the longitudinal body to disengage the retaining members between the cover and the longitudinal body;

providing a removal force for separating the removable cover from the longitudinal body;

applying a shear force applied to the protective cover to facilitate separation of the removable cover from the longitudinal body.

Rotation of the removable lid beyond the position where the retaining members between the lid and the longitudinal housing are disengaged may cause the cam path of the removable lid or housing to engage with a portion of the longitudinal housing or removable lid and provide at least some of the removal force for separating the removable cover from the longitudinal main body.

Once the retaining elements are disengaged, the removable cover can be pushed proximally under shear force acting on the guard, audible or tactile feedback may indicate that engagement between the engaging structure and the retaining structure is released. Feedback may be provided by the user's feeling that the initial resistance to unscrewing the cap relative to the housing due to engagement is overcome in response to the application of a sufficiently large unscrewing force, such as a manual unscrewing force. Once the engagement is disengaged by the application of a sufficiently high threshold unscrewing force, the removable cover can be rotated further. After a certain level of rotation, the axial force acting on the protective cover supports and pushes the removable cover in the proximal direction from the longitudinal body. This provides another tactile feedback that the user experiences that may indicate the correct way to handle the device.

When installed at the proximal end of the body, the removable cover can contact and hold the protective cover in the closed position of the cover, so that when the cover is removed, the shear force that moves the protective cover to the proximal position helps to remove the cover. It should be noted that the removable cover cannot be axially held at the proximal end of the longitudinal body by engagement of holding elements between the cover and the longitudinal body, which can be disengaged by rotating the cover relative to the longitudinal body to allow axial movement of the cover relative to the body to remove said cover. .

The lidded position of the shroud may be between the proximal position to which the shroud is shifted when not constrained by the lid and the distal position. In this way, the protective cover is held in position within its expected operating range. As noted above, the lidded position may be such that additional offset relative to the shear force is required to move the shroud to the distal position.

In the closed position, the tip of the injection needle may protrude beyond the protective cover. The cap holds the protective cover in the capped position and prevents access to the injection needle. When the cover is removed, the protective cover is moved to its proximal position, where it protrudes out of the proximal end of the longitudinal body to cover the tip of the needle, which is an injection needle.

The body of the removable end cap may be formed to have a cylindrical body integral with an extension, such as an arcuate extension or tab, such that the body has a non-circular cross-sectional shape to provide an anti-rolling shape when the end cap is placed on a flat or slightly inclined surface. The outer surface of the body can be textured or grooved to improve grip. For example, the outer surface of the body may have a series of integrally formed radial grip recesses or projections extending longitudinally between the proximal and distal ends of the body. The proximal portion of the body may be formed by a smooth outer surface. This surface may include arrow-shaped through holes, recesses or protrusions or other indicia that indicate the direction of movement for unscrewing and/or retracting the end cap relative to the longitudinal housing.

The interior of the end cap body may comprise a cylindrical surface forming an axially open containing portion with a smooth containing surface. Next to the enclosing part, there may be a one-piece inner part in the form of a ring. The annular portion may comprise a substantially flat, distally facing surface. Between the annular part and the inner circumferential surface of the main part of the end cap, one or more open sections and one or more connecting structures connecting both elements can be provided. The annular portion may have, on its outer circumferential surface, one or more protrusions extending radially outward into open sections. On both sides of the protrusions, the outer circumferential surface of the annular portion may be provided with inclined lifting formations which have a most distal level near the protrusions and which are inclined distally so as to converge at the apex.

The outer circumferential surface of the annular part may have two protrusions with guiding portions such as a bevel or a radius, which form an enclosing space therebetween. This enclosing space may be provided to receive and secure a protrusion formed on the inner circumferential surface of the longitudinal body at its proximal end so that it is hidden when the device is viewed and handled. This provides a hidden connection between the housing and the removable cover, which cannot be influenced in any way. Moreover, reclosing of the autoinjector cap can be prevented or avoided.

On its radial inner surface, the annular body may comprise one or more opposed protrusions protruding radially inwards. These protrusions are provided to interact with and secure corresponding radial external protrusions formed on the outer circumferential surface of the proximal end of the protective casing.

The main part of the removable end cap near its proximal end may face two annular arches located opposite to each other and attached to the inner circumferential surface of the main part of the end cap by means of a connecting part and connecting ribs.

The end cap plug provided for the removable end cap body may have a proximal end cap portion having the same base surface with a slightly sloping ridge as the end cap body. The annular cylindrical body may extend from the proximal surface of the end cap portion. The annular cylindrical body may be provided on its outer circumferential surface with a plurality of longitudinal ribs that protrude above the distal end of the annular cylindrical body. At the free end of these longitudinal ribs, snap-in protrusions may be provided, protruding radially outwards, if necessary, which engage in a corresponding (annular) recess inside the body of the detachable end cap. The inner part of the annular cylindrical body may be provided with beveled radially extending ribs extending into the inner cylindrical body which is also integrally formed with the distal surface of the end cap part. The distal front surface of the arrangement formed by the cylindrical body, the rib protrusions, the radially internal ribs, and the inner cylindrical body may form a conical or truncated-conical profile.

Element to capture

The syringe assembly may be provided with a preferably rigid needle sheath. The needle sheath may be attached to the proximal end of the hollow body of the syringe. The needle sheath may cover the needle along with its preferably pointed needle tip. The presence of a needle sheath can mean that the needle and fluid product, such as fluid drug, are kept clean and sterile.

In addition to the closing and feedback functions of the removable cover, it may have other uses for the device. The detachable cover can also engage the needle guard. When removing the detachable cover, the hard needle cover can be grasped and removed together with the cover, so that the user does not have to directly touch the hard needle cover. Because the injection needle and the glass body of the syringe are sensitive components, the rigid needle sheath must be handled with care both during assembly and removal from the syringe assembly. The detachable cover may include a flexible gripping member for engaging the needle sheath with its outer profile.

The present invention also provides an automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the body;

a syringe-like assembly located at a mounting position within the housing and having a hollow syringe body and an injection needle connected to a hollow syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

wherein the drive mechanism is operatively connected to the protective casing, which is movable inside the longitudinal housing;

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the syringe assembly is provided with a needle sheath attached to the proximal end of the hollow body of the syringe and enclosing the needle;

wherein the removable cover comprises a flexible gripping member for engaging the needle sheath at its outer circumferential surface such that removal of the removable cover results in removal of the needle sheath, the flexible gripping member having a larger diameter than the proximal end of the protective sheath.

Providing a flexible grip member having a larger diameter than the proximal end of the shroud achieves less assembly force because longer flexible grip members such as legs or lobes can be used. Because the gripper has a larger diameter than the proximal end of the shroud, the grapple may not extend into the shroud and this may provide packaging benefits. In the initially capped state with the removable cap on the device, the shield can be held in a position where at least a portion of the needle shield extends past the proximal end of the shield, as this can facilitate assembly.

The needle sheath can engage the hollow conical glass part by means of a sleeve. In order to accommodate the needle and needle tip in a shock-absorbing and sterile manner, the needle sheath may include a soft sleeve into which the injection needle is received. The soft sleeve securely covers the needle and maintains the sterility of the injection needle and the drug contained inside the syringe and needle. The needle sheath may include a tubular piece that contains a soft sleeve. The outer surface of the tubular may comprise transverse gripping ribs and, alternatively, simply a relatively soft outer surface. The gripping ribs or the soft outer surface may be engaged by the gripping element.

The needle sheath may be designed to be gripped by its outer circumferential surface. The needle sheath may be provided with at least one gripping structure on its profile of the outer circumferential surface, for example formed by at least one projection or recess and engaged with the flexible gripping member. The flexible gripping member is formed to engage with the outer profile of the needle sheath. Alternatively, the grip may be achieved by engaging the grip member with the softer outer surface of the hard needle sheath hub.

The flexible gripping element may be rigidly mounted or may be axially and/or radially spaced within the removable cover. Positioning the flexible axially spaced gripper in a floating position within the removable cover facilitates bending of the rim during assembly when the gripper contacts the needle sheath. The gripping member may typically be designed to reduce axial forces on the rigid needle sheath. This is necessary to minimize disruption and ensure that the integrity of the closure of the pre-filled syringe container is maintained. If the grip member is held rigidly, the bending forces can be increased and the axial forces acting on the needle sheath are much higher. Providing little gap float and having edge contact with the gripping member are design features that reduce assembly effort and help maintain container closure integrity. The gap may also allow rotation of the gripping element during removal of the cover. This is also an advantageous feature that reduces the likelihood of core formation.

The flexible gripping member may be formed by a component such as a flexible gasket, such as a toothed gasket, having a mounting section to be installed inside the removable cover. A flexible gripping member, such as a flexible pad type component, may include at least one gripping tab or tab projecting in a radially inward direction for engaging the needle sheath. The toothed spacer may have a generally frusto-conical shape when installed.

The flexible gripping member may have an outer circumference, such as a circular outer circumference, surrounding the annular main body. The flexible gripping member may comprise at least two radially inwardly extending tabs or tabs that are integrally formed with the ring-shaped main portion, which may terminate in a radially inwardly circular gripping portion.

The flexible gripping element may be flat or frusto-conical, and in use any gripping tabs or tabs can be adapted to flex so as to provide axial spring action and/or gripping force, i.e. the force with which the gripping is performed. outer surface of the rigid needle cover. Such a gripping force may be a force that shifts the curved gripping tabs towards the radially central position and thus towards the rigid needle sheath.

The outer geometry of the gripper may be circular or any other geometry to suit assembly loads or available packaging space. There may be two or more extending lobes formed on the radial portion of the gripping element and the tooth geometry may be of any format to achieve certain insertion forces during assembly and the ability to withstand forces from the rigid needle sheath when removing the removable cover from the longitudinal body. The grip element may also have some preforming. It may be advantageous to form a rib along the outer circumference of the gripping element. This may allow the grip member to rotate within the removable cover during removal of the cover. If the removable cover is rotated and the gripping element is only pulled longitudinally, then an unfavorable condition called coring can be eliminated. Inadvertent coring occurs, for example in the prior art, when the rigid needle sheath material is rotated relative to the needle cannula of the syringe assembly. In this case, an inadvertently removed plug of rubber may remain inside the needle, which should be completely avoided in order to prevent blockage that interferes with the correct functioning of the device.

The removable cover may comprise a proximal end cover plug configured to be mounted on or inside the removable cover, wherein the flexible gripping element is located in the installation space between the enclosing structure formed on or inside the removable cover and the proximal end cover plug.

The rigid needle sheath may be configured to be engaged by the gripping element during assembly with minimal resistance forces, preferably in the range of 1 N to 50 N, in the axial direction, applied by the gripping element.

The present invention also provides a method for assembling an automatic drug delivery device according to any one of the preceding claims, the method comprising:

providing a power block subassembly, a syringe assembly, a syringe holder, and a proximal subassembly;

wherein the proximal subassembly comprises a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior, and a removable lid fitted to the proximal end of the body, the removable lid comprising a flexible gripping element , and moreover, the proximal sub-assembly further comprises a protective casing, while the flexible element for gripping has a larger diameter than the proximal end of the protective casing;

the first syringe assembly comprising a hollow syringe body and an injection needle formed with a hollow syringe body containing a fluid product, the syringe assembly having a needle sheath attached to a proximal end of the hollow syringe body and covering the needle;

wherein the power block subassembly comprises a drive mechanism that can be actuated by the trigger to begin dosing of the fluid product;

installing the syringe assembly in the syringe holder;

inserting the syringe assembly and syringe holder into the proximal subassembly such that the needle sheath extends through the flexible grip member, whereby the flexible grip member engages the needle sheath on its outer circumferential surface; and

placing the power block subassembly on the proximal subassembly so that the drive mechanism is operatively connected to the protective housing.

The removable lid may comprise a proximal end cap plug configured to fit onto the removable lid, wherein the flexible gripping member is positioned in the mounting space between the accommodating portion inside the removable end cap and the proximal end cap plug.

The grip member may provide an asymmetric grip force such that the needle shield slides into a non-aligned position, such as out of axial alignment within the removable cover. This can be achieved in various ways, for example, one or more tabs of the gripping member can have a shape and/or length that is different from the other tabs so that an asymmetrical force load is applied to the rigid needle shield when the rigid needle shield is engaged. This results in a tilting or pivoting action such that the rigid needle shield is deflected from its initial position. Thus, it is possible to prevent or avoid re-closing of the lid, ie, re-attachment of the lid to the housing after it has been removed.

Platform Features

The present invention also provides an automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the body;

a syringe-like assembly located at a mounting position within the housing and having a hollow syringe body and an injection needle connected to a hollow syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

at the same time, the drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing,

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the longitudinal body provides an inner containing component attached thereto to receive the syringe holder and provide a predetermined radial and axial position of the syringe holder within the longitudinal body;

wherein the syringe assembly is a first syringe assembly and is accommodated within the longitudinal body by a first syringe holder, the first syringe holder providing an interface between the longitudinal body and the syringe assembly; and

wherein the longitudinal body and the accommodating component are sized and configured to receive the second syringe holder and the second syringe assembly, the second syringe assembly having a different diameter than the first syringe assembly.

This ability to adapt the device to a different syringe diameter by changing one section, in this case the syringe holder, may allow the device to be used as a platform device for a number of syringe assemblies. The longitudinal body and the accommodating component may be sized and configured to receive a second syringe holder and a second syringe assembly, the second syringe assembly having a larger diameter than the first syringe assembly.

The inner containing component may be rigidly mounted on the inner circumferential surface of the longitudinal housing and may provide a predetermined radial and axial position of the syringe holder within the longitudinal housing. The syringe holder may fit at its proximal end within the accommodating component. The enclosing component may be integrally formed within the housing. Alternatively, the enclosing component can be made as at least one separate part rigidly mounted on the inner surface of the longitudinal body.

The use of a syringe holder may allow prefabrication of the subassembly formed by the syringe holder and the syringe assembly. In the subsequent assembly process, this sub-assembly can be used and installed inside the longitudinal housing. This prevents direct contact with the glass body of the syringe assembly during assembly. Instead, the syringe holder already covers, at least partially, the glass body of the syringe assembly and protects it during assembly. Moreover, the syringe holder according to the present invention is designed to take up the forces acting on the syringe assembly and to transmit these forces to the body, while the stresses acting on the glass body can be avoided, or at least significantly reduced.

The enclosing component can be made in the form of an annular part containing, with the help of its inner circumferential surface, the proximal end of the syringe holder. The outer circumferential surface of the annular part can be mounted on the inner peripheral surface of the longitudinal body by means of at least two interconnecting tabs. The interconnecting tabs between the enclosing component and the longitudinal body may be formed by a rigid structure having sufficient wall thickness to avoid any inadvertent movement of the enclosing structure relative to the body due to axial loads acting on it during operation.

The syringe holder may further be provided at a distance from its proximal end, preferably at its distal end, with at least one contact structure for contact with the inner circumferential surface of the longitudinal housing. Thus, the syringe holder can be supported in two axially spaced positions within the longitudinal body, ie at its proximal front end, by the enclosing structure and, moreover, by the contact structure. The syringe holder thus provides a stable position for the syringe assembly within the longitudinal housing.

The contact structure may be formed by two opposing support arches extending radially from the distal end of the syringe holder. The recess between the two arches can be used to guide additional functional components of the trigger or the like, such as the longitudinal tabs of the protective cover, as discussed in this document. The two longitudinal tabs can be guided through recesses formed in the syringe holder between the support arches.

As noted above, the drive mechanism may include a plunger that can be moved by the drive spring in the proximal direction. The plunger may act on a plug sealed within the syringe body and exposed to a fluid product contained within the syringe body. The syringe holder can absorb axial forces applied by the plunger to the main body of the syringe and can transmit the forces to the longitudinal body.

The syringe holder can resiliently engage the glass body of the syringe near its proximal end via at least two resilient tabs. In particular, the syringe holder may be adapted to wrap around the proximal front shoulder of the glass syringe body so that the resilient tabs flex slightly during assembly and engage the glass syringe body on a radially stepped surface formed radially around the needle cannula of the glass syringe body. .

In order to allow the use of the same device according to the present invention for different pre-filled syringes having different volumes of fluid product, i.e. to provide a platform device suitable for different sizes of pre-filled syringes, according to another aspect of the present invention, the syringe holder can be made in different sizes, adapted to different sizes of the main body of the syringe. Thus, the syringe holder can be configured in different configurations to accommodate different sized syringes and accommodate these different sized syringes within the device of the present invention without the need to modify the longitudinal housing or any other component thereof.

The present invention also relates to a syringe holder for an automatic drug delivery device as described herein, wherein the syringe holder is adapted to receive a syringe assembly within a longitudinal housing, the syringe holder providing an interface between the longitudinal housing and an assembly in the form of a syringe, while the longitudinal body provides an internal containing component rigidly mounted on the inner circumferential surface of the longitudinal body, providing a predetermined radial and axial position of the syringe holder inside the longitudinal body, while the syringe holder fits with its proximal end inside the containing component.

The syringe holder may receive the syringe in a radial or axial direction. The syringe holder may form a portion of the syringe assembly and may act as an interface, spacer, or adapter to allow various combinations of syringe cores and injection needles to be used with a particular auto drug delivery device. In particular, the syringe holder may allow a device designed to receive a syringe body having a first outer dimension (with or without a syringe holder) to receive a syringe body having a second outer dimension that is smaller than the first outer dimension by changing adding only one component. The outer dimension of the main body of the syringe may be a diameter or may be a length.

The syringe holder may be configured to provide points of contact, interface, or mounting whereby the syringe assembly interacts with other portions of the automatic drug delivery device. The points of contact, interface, or attachment provided by the syringe holder may mimic the points of contact, interface, or attachment of another syringe assembly, such as one that does not require a syringe holder or one that contains a different syringe holder. Thus, an automatic drug delivery device can be designed to receive and interact with a syringe assembly of a first size and shape, possibly without a syringe holder, and still be able to receive another syringe assembly by using proper syringe holder and interact with it.

Points of contact, interface, or mounting may be provided at any suitable location on the syringe holder. Points of contact, junction, or mounting may be provided on one or more surfaces of one or more flanges, ridges, or other extensions from the body of the syringe holder. There may be at least two points of contact, joint or installation, and they can be longitudinally divided along the length of the syringe holder. One point of contact, joint or installation may be located at one end of the syringe holder and the other at the opposite end of the syringe holder. For example, the syringe holder may include a first interface that substantially follows the flange of the syringe.

The ability of automatic drug delivery to accommodate and interact with various syringe-like assemblies is important because it allows a single device structure to be used to administer drugs from different syringe majors and possibly in different volumes. A plurality of syringe holders may be provided for the device so that the proper syringe holder can be selected for use with a particular syringe body and needle combination.

Therefore, the present invention further provides an automatic drug delivery device for dispensing a fluid product, in particular a fluid drug product, comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the body;

a syringe-like assembly positioned within the housing, the syringe-like assembly having a hollow syringe body and an injection needle connected to the hollow syringe body, the hollow syringe body containing a fluid product;

a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

at the same time, the loaded drive mechanism is functionally connected to the protective casing, which is movable inside the longitudinal housing,

wherein the guard is moved to a proximal position where it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position where the injection needle is exposed for injection;

wherein the syringe assembly further comprises a syringe holder, the syringe holder supporting the main body of the syringe within the housing.

The present invention further provides a method for manufacturing an automatic drug delivery device, comprising the following steps:

providing a housing, a drive mechanism and a protective cover;

providing a hollow syringe body and an injection needle connected to the hollow syringe body, the hollow syringe body containing a fluid product;

determining whether a syringe holder is required to support the combination of the hollow body of the syringe and the injection needle;

if required, selecting an appropriate syringe holder and creating a syringe assembly comprising a syringe holder, a hollow syringe body and an injection needle; and

installation of a drive mechanism, a protective casing and a syringe-like assembly into the body to create an automatic drug delivery device.

A plurality of syringe holders may be provided. Syringe holders can have different geometries and can be adapted to accommodate different syringes with different volumes of drug, while, regardless of the syringe to be accommodated, the corresponding syringe holder is adapted to fit in the same housing of the specified automatic drug delivery device. In other words, the syringe holder of the present invention can be made with different geometries and designs so that it can accommodate syringes of different sizes (for example, 1 ml and 2 ml), in the sense that it can be easily and consistently assembled, and that it securely holds the syringe inside the housing. In particular, syringe holders of different geometries are adapted to fit in the same housing without further modification. This makes it possible to provide a platform system, i.e., a drug delivery device that has the same external dimensions and assembly requirements for different doses and drugs. It may also be necessary to replace the plunger or provide an accommodating piece at the proximal end of the plunger, for example to accommodate different syringe and/or syringe stopper bores.

The syringe holder may include at least one flexible portion capable of elastic deformation in the circumferential or radial direction. This may allow the syringe holder to receive and resiliently hold the syringe body and/or injection needle within the syringe holder.

The syringe holder may comprise a longitudinal body which, at its proximal end and/or at its distal end, has a rigid and substantially inelastic U-shaped member such that a pre-filled syringe can be introduced into the syringe holder from a radial direction transverse to the axial direction.

The syringe holder may be formed by two longitudinal sheaths connected by at least one flexible V-shaped portion which provides circumferential flexibility to the syringe holder and allows the sheaths to elastically expand upon insertion of the syringe.

The syringe holder may include a radial internal projection to support the main body of the syringe in an axial direction, in particular in a proximal axial direction. The radial inner projection of the syringe holder may support a proximal shoulder of the syringe body.

The syringe assembly may include a possibly rigid needle sheath attached to the proximal end of the hollow body of the syringe and enclosing the needle. The syringe holder can accommodate the syringe assembly in the radial direction such that the radial inward projection is positioned between the syringe body and the needle sheath. The radial inward projection may have a smaller diameter than the rigid needle sheath.

The syringe holder may be provided with one, two or more flexible zones or parts, in particular z-shaped flexible parts, which can be bent in radial and/or circumferential directions. The flexible portions/zones can support the syringe in an axial direction when it is inserted from the distal direction and received there, while allowing some degree of axial movement, for example, to absorb shock energy and deflection during assembly.

The drive mechanism can hold the plunger in its original position by engaging the radial internal projection with a groove in the plunger. The plunger may be provided with a plurality of retaining slots to accommodate different syringe sizes or filling options. The plurality of retaining slots may include slots at different axial positions. One or more retaining slots may engage with the drive mechanism and thereby determine the initial position of the plunger relative to the movable plug or other element of the syringe assembly. By having slots having different longitudinal positions, this allows the plunger to engage with the drive mechanism in different longitudinal positions during manufacture. The plunger may include retaining slots that are longitudinally and circumferentially offset. This can facilitate manufacturing since the slots can only engage with the drive mechanism in a particular rotational orientation. By moving around the circumference of the slots, the plunger can be aligned with the drive mechanism for assembly, rotated into the correct orientation so that the longitudinal slots in the desired position are aligned with the areas of engagement of the drive mechanism. The plunger can then be assembled by linear movement into the drive mechanism such that the desired slots engage with the drive mechanism. If the slots have not been displaced circumferentially, the movement during assembly can be difficult, requiring linear and rotary movements, and this may lead to assembly errors.

The plunger may contain an alignment marker to facilitate rotational alignment. The alignment marker can be any suitable marker, such as a visible mark, such as one that can be printed or etched onto the piston, or the marker can be a physical marker, such as a ridge or groove, that can be engaged by the assembly device. The alignment marker may be the alignment slot at the end of the plunger. The alignment groove may extend all the way across the diameter of the end of the substantially cylindrical plunger. An alignment slot may be located at the plug engagement end or plunger head for ease of assembly.

The plunger head associated with the plunger stem may contain an adapter to increase the diameter of the plunger head for some plug diameters. The plunger adapter may be integrally molded with the plunger. As with syringe holders, the variety of options may mean that a variety of plungers are available for installation in a particular device.

This means that the method of manufacturing the above mentioned automatic drug delivery device may further include the step of determining what size of plunger head is required for a particular combination of syringe body and injection needle, and selecting the appropriate plunger to be inserted into the device. The selection may be based on more than just head size, so the manufacturing method may include the following step:

determining which of the plurality of plungers is required for use with the selected syringe assembly;

installation of the selected plunger in the device.

If the plunger has longitudinally offset slots for engagement with a drive mechanism, the method of manufacturing the above-mentioned automatic drug delivery device may further include the step of determining which of the longitudinal slots should engage with the drive mechanism of a particular syringe assembly, and engaging the appropriate longitudinal slot with the drive mechanism. assembly mechanism. If the longitudinal slots are circumferentially offset, the method may further include the step of rotating the plunger to a predetermined rotation relative to the actuator prior to assembly.

As noted above, providing a plurality of plungers and syringe holders for a particular device structure can provide a platform device that can be used to deliver drug from a plurality of syringe main parts having different sizes and fill volumes.

Therefore, the present invention provides a set of parts for assembling an automatic drug delivery device for delivering a drug from a hollow syringe body having an injection needle connected thereto, the hollow syringe body containing a fluid product, the kit comprising a standard body, a standard drive a mechanism and standard guard, a plurality of syringe holders and/or a plurality of plungers. This means that a combination of parts can be put together to create an automatic drug delivery device that is appropriate for a particular hollow syringe body and injection needle. This "platform" type architecture allows the device to be adapted for use with syringe/needle body combinations having different sizes/shapes/fill volumes by replacing only one or two parts.

The present invention also provides a set of parts for assembling an automatic drug delivery device as described herein, the kit comprising a power block subassembly, a first syringe assembly, a second syringe assembly, and a proximal subassembly;

wherein the proximal sub-assembly comprises a longitudinal housing extending along the longitudinal axis and having a proximal end proximal to the dispensing site, a distal end opposite the proximal end, and a hollow interior, and a removable cover fitted to the proximal end of the housing;

and the first node in the form of a syringe contains a hollow body of the syringe and an injection needle formed together with a hollow body of the syringe containing a fluid product;

the second syringe assembly comprising a hollow syringe body having a diameter greater than the diameter of the syringe body of the first syringe assembly and an injection needle connected to the hollow syringe body containing the fluid product;

wherein the power block subassembly comprises a drive mechanism that can be actuated by the trigger to begin dosing of the fluid product;

a first syringe holder for providing an interface between the longitudinal body and the first syringe assembly; and

a second syringe holder for providing an interface between the longitudinal body and the second syringe assembly; wherein

the assembled automatic drug delivery device comprises a power unit subassembly and a proximal subassembly, as well as either a first syringe assembly and a first syringe holder, or a second syringe assembly and a second syringe holder.

The present invention also provides a method for assembling an automatic drug delivery device using a kit of parts as described above, the method comprising:

selecting either a first syringe assembly and a first syringe holder, or a second syringe assembly and a second syringe holder;

installing the selected syringe assembly in the selected syringe holder;

placing the syringe and syringe holder in the proximal subassembly; and

installation of the subassembly in the form of a power block on the proximal subassembly.

As discussed herein, the syringe holder is designed to receive and hold a pre-filled syringe within the housing. It is adapted to accommodate different types of syringes with different volumes of drug without the need to change other components of the subassembly. Therefore, different syringe holders must be provided to accommodate different types/volumes of syringes.

The syringe holder may include a longitudinal body. At its proximal end, the syringe holder may have a substantially rigid and inelastic U-shaped member. The U-shaped element can be opened in one radial direction. This rigid U-shaped element at the proximal end can be reinforced with parallel surrounding ribs. On the proximal front surface of the U-shaped element may be provided with transverse ribs or projections. At its distal end, the syringe holder may be provided with a substantially rigid and inelastic similar U-shaped member. The distal U-shaped element can be reinforced with surrounding ribs. The surrounding ribs may be provided with notches facing radially outward at opposite positions. Rigid U-shaped elements can be connected by two, possibly essentially rigid and longitudinal, connecting tabs. Each of the connecting tabs may extend linearly. Each of the tabs may include a protrusion projecting radially inward to releasably hold the syringe in the syringe holder, the tabs being deformable to allow the main body of the syringe to pass between the protrusions. The inner surface of the protrusions may be shaped so that the glass body of the syringe may be positioned and held in them.

When positioned within the longitudinal body, the syringe holder holding the pre-filled syringe assembly may be positioned such that any projections engage in matching cutouts of the double ring structure. The syringe holder can be positioned by an annular or double ring structure inside the longitudinal body in a proper axial and pivotal position about the longitudinal axis.

According to some examples of the syringe holder, the syringe holder may be formed by two or more longitudinal shells with a longitudinal slot therebetween. The sheaths may be connected by flexible V-shaped portions at the distal and proximal regions, respectively, which provide circumferential flexibility to the syringe holder and thereby allow the sheaths to elastically expand upon insertion of the syringe. The syringe holder may further comprise, at its distal end and near its proximal end, radially outward protruding structures for securing the syringe holder within the body of the autoinjector.

Within both shells, an internal radial protrusion may be formed to support the syringe in the axial direction after it has been inserted from the distal direction and placed inside the syringe holder.

Alternatively, the syringe holder may have a hollow cylindrical containing tube with a distal end and a proximal end. Like other examples described herein, this syringe holder may also include radial outwardly projecting structures for retaining the syringe holder within the body of the autoinjector.

Near its proximal end, the syringe holder may be provided with one or more double-z shaped pieces which comprise inclined flexible tabs interconnected by a circumferential rib. On its inner circumferential surface, the syringe holder comprises a radially inward protrusion that can be formed circumferentially inside both flexible parts in the form of a double z to support the syringe in the axial direction after insertion from the distal direction and accommodation in it. In this example of a syringe holder, the syringe is pushed from its distal end with little radial play within a hollow cylindrical containing tube. To grip the proximal front end of the glass body of the syringe, due to the elastic flexibility of the two double-z-shaped parts, the tabs are slightly arched so that the circumferential ribs move radially outward.

The examples of the syringe holder described herein are of a circumferentially closed design with features that provide some flexibility in the radial or circumferential direction. Thus, it is possible to easily assemble the pre-filled syringe with the syringe holder. The syringe is held by simply bending members that deform radially outward during assembly. In this way, variations in the tolerances of the syringe assembly can be compensated for both radially and axially. However, the syringe holder is of robust construction due to the rigid sheaths or the cylindrical containing tube.

The plunger may be formed by a longitudinal cylindrical hollow element which has a plunger head at its proximal end. The plunger head may be provided with a front surface and a transverse groove. The front surface may include a small cylindrical through hole. The front surface, with optional transverse groove and cylindrical through hole, can be connected to or formed by a larger diameter plunger head element if desired, for example for syringes having a larger internal diameter with which a correspondingly larger plug interacts. This extra enlarged plunger head feature can be used for larger syringes, eg suitable for a fluid volume of 2.25 ml. In the case of smaller syringes, such as those suitable for a fluid volume of 1 ml, the enlarged plunger head element or component is omitted and the plunger is only a parallel cylindrical shape at its proximal end.

In the middle part of the plunger, a pair of opposite rectangular through holes may be provided in the wall of the hollow element. It should be noted that a pair of through holes or slots is not required, a single through hole can be used. The plunger may have additional through-holes or pairs of through-holes comparable to through-holes in different axial positions to allow adaptation to different syringe sizes or drug fill volumes. At its distal end, the hollow element may be provided with a circular opening to allow longitudinal access to receive an actuating spring. The proximal end of the hollow element may include a plug to engage with the end or head of the plunger, as discussed above, and may include a pivot alignment portion.

The holding device may act as a control piece for a plurality of control functions of the power unit. The holding device may be formed from a hollow cylindrical body. On two opposite sides, the cylindrical body may comprise a U-shaped notch forming a longitudinal flexible tab, respectively. The longitudinal flexible leg may be integrally connected to the hollow cylindrical body at its distal end. At its proximal end, the flexible tab can be provided with a beveled portion protruding radially outwards and, on the opposite side, i.e. its radial inner side, with a corresponding beveled portion projecting radially inwards. Moreover, the cylindrical body can be provided with two opposite longitudinal cuts in a region rotated by 90° relative to the flexible tabs formed by the cuts. The longitudinal notches may extend at approximately the same longitudinal extension as the U-notch, or further distally. In the region of approximately one third of the longitudinal length of the cutouts near their proximal end, the cylindrical body may contain lateral projections transversely overlapping the cutouts. These lateral overlapping ridges continue near the proximal end with additional ridges having the same outer circumferential shape.

At its proximal end, the cylindrical body of the holding device may be provided with two or more flexible tabs integrally formed with the cylindrical body and inclined at an angle relative to the proximal front surface of the hollow cylindrical body. These flexible tabs can be connected to a ring-shaped head part. The annular head portion may be provided as an insert, together with a cylindrical portion and two opposing proximal arcuate projections. The head part can be made in one piece with the flexible legs or made as a separate part, rigidly connected to the flexible legs, for example, by means of an intermediate connecting ring.

Flexible legs provide a certain degree of error and compensation for different syringe sizes. Moreover, these flexible legs axially move the syringe in a proximal direction by acting on the distal end of the syringe to keep it in a more or less fixed position. On the contrary, the shifting element ensures that the holding device and the connected components are shifted distally.

At its distal end, the cylindrical body of the holding device may be provided with a circumferential groove. The distal end may be provided with a distal end surface having a central opening. In its interior near the distal end, the cylindrical body may be provided with internal guide ribs extending in the axial or longitudinal direction between the surface of the distal end and the longitudinal section having a circumferential groove. The cylindrical body may have varying diameters, transitioning appropriately between diameter sizes, for the purpose of being assembled within the constraints of other system components arranged or connected concentrically around the holding device.

Moreover, the protective cover is held in the assembled initial state by a removable cover in an axial position. In particular, this is to avoid unintentional movement in the distal direction, i.e. if the device is dropped and it experiences an impact when it hits the ground. This is achieved by engagement between protrusions formed on the outer circumferential surface of the cylindrical main body at the proximal end of the protective casing and two protrusions formed on the inner circumferential surface of the annular inner part of the removable cover main body. Thus, the protrusions can block any axial movement of the protective cover in the distal direction relative to the removable cover mounted on the body, and thus relative to the body.

At the distal end, the distal end cap can be rigidly and inseparably attached by a snap-fit arrangement to the longitudinal body, wherein the protrusions formed on the outer circumferential surface of the skirt portion of the distal end cap engage into and with the through holes formed at the distal end. corps.

Moreover, in the assembled state, the syringe can be held inside the syringe holder, which is housed in the annular housing structure. As described above, the syringe holder may be positioned relative to the body by an annular structure, wherein the transverse projections may engage in corresponding cutouts, and the additional projection may protrude into a hollow space provided by the U-shaped syringe holder member. The syringe may be assembled axially or laterally into a syringe holder before the syringe holder is assembled into the body, or after the syringe holder is assembled into the body, depending on the geometry of the syringe. Any U-shaped element of the syringe holder must be rigid and must not buckle during assembly or during operation of the syringe to allow passage of the rigid needle sheath. It should be noted that the syringe may be held rotatably within the syringe holder, or may be freely rotatable.

Assembling the syringe inside the device can be problematic given the breakage of the glass and the difficulty of checking the final position. With the side loading of the syringe in the syringe holder, better control and access to critical parts can be achieved. Assembly can be done by visual positioning and inspection. Assembly can be done through dimensional and force control and inspection.

Moreover, the syringe together with the syringe holder can be pressed by the syringe flange through the head part of the retainer in the proximal direction to the conical and stepped annular body structure, and when fully assembled with the power block, the flexible tabs of the retainer act as an axial shifting mechanism, providing a spring force axially in the proximal direction to hold the syringe in place within the syringe holder and thereby positioned there.

Additional Features

The syringe-like assembly may comprise a hollow syringe body containing a fluid product and an injection needle formed with the hollow syringe body. The term "hollow syringe body" should be understood to include a hollow cartridge or other hollow body within which a plunger or movable plug can move to create a variable volume chamber from which fluid can be expelled through an outlet. The outlet port may comprise an integral injection needle, such as those present in a fixed needle syringe, or the injection needle may be connected to the hollow body in another manner, such as by a luer lock, screw connection, or other suitable connection. It is also possible that an outlet from which fluid can be expelled is created during actuation of the automatic drug delivery device, for example by means of the back of an injection needle piercing the membrane.

The housing may have a non-circular shape in cross section of at least a portion of the housing to provide an anti-rolling function. The housing may be made of an opaque or transparent material in whole or in part.

The fluid product is typically a pharmaceutical composition/formulation suitable for parenteral administration to a human or animal subject. The pharmaceutical composition/composition contains one or more pharmaceutically active substances, including low molecular weight compounds and/or biopharmaceutical substances such as recombinant products. Examples of pharmaceutically active substances include antibodies (their full-length or active fragments), polypeptides/peptides and their derivatives, as well as nucleic acid molecules that can be part of vectors, viral particles, optionally in combination with delivery media such as lipids. Nucleic acids and polypeptides/peptides can be obtained by biological processes or synthetically. In one example, the fluid product contains pharmaceutical actives selected from secukinumab, cankinumab, bimagrumab, omalizumab, tesidolumab, iodelcizumab, elgemtumab, laknotuzumab, ofatumumab, ligelizumab, ranibizumab, brolucizumab, and ianalumab.

The present invention also relates to an automatic drug delivery device, in particular an auto-injector, for dosing a fluid product, in particular a fluid drug product, comprising:

a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior;

a removable cover configured to be installed on the proximal end of the body;

a syringe-like assembly mounted at a mounting position within the housing and having a hollow syringe body and an injection needle formed together with the hollow syringe body containing a fluid product;

a loaded or actuated drive mechanism that can be triggered by the trigger element to start dispensing the fluid product;

a feedback mechanism providing tactile and/or audible and/or visual feedback to the user indicating the actual state of the operation;

wherein the injection needle protrudes with a pointed needle tip from the proximal end of the body when the syringe assembly is in its mounting position;

at the same time, the loaded or activated drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing,

wherein the guard is shifted to a proximal position where it protrudes out of the proximal end of the longitudinal body to cover the injection needle with its pointed needle tip, and the guard is movable against the shear force to a distal position in which the injection needle with its pointed needle tip exposed for injection;

while during use, the automatic drug delivery device includes the following operating states:

the initial state in which the automatic drug delivery device is fully assembled and the removable end cover is installed on the longitudinal body;

a ready-to-use state in which the removable end cap has been removed from the body and the protective cover covers the tip of the needle;

a running state in which the automatic drug delivery device is pressed against the patient's skin, whereby the protective cover is pressed into the longitudinal body and releases the tip of the injection needle;

a dosing state in which the fluid product is dosed into the patient's tissue; and

a used state in which the fluid product has been fully dosed, the automatic drug delivery device has been removed from the patient's skin, and the needle guard covers the needle tip.

The protective cover may be provided with at least one, possibly two longitudinal tabs extending in the distal direction, directed inside the longitudinal body. The guard may co-operate with a guard spring that biases the guard in a proximal direction via one or each of the longitudinal tabs. This can provide a relatively simple and compact trigger mechanism. The functions of standard mechanical triggering and shearing can be concentrated at the distal end of the body, separate from the guard and syringe assembly.

The loaded or actuated actuator mechanism may comprise a plunger that is proximally biased by an actuator spring. The plunger may act on a stopper which may be hermetically guided within the main body of the syringe. The plunger may act on the fluid product contained within the main body of the syringe.

The proximal end of the drive spring may act on the distal end of the plunger. The distal end of the drive spring may act on a fixed end cap which may be attached to the distal end of the longitudinal body. The fixed end cap may include a stem-like piece for guiding the drive spring in the longitudinal direction. The fixed end cap may also be mounted on the longitudinal body by snap-in engagement.

The distal end of the drive spring, together with the distal end of the plunger, may be housed within a pivoting click member pivotally positioned within the fixed end cap. The rotary clicker and the fixed end cap may engage and corresponding sawtooth profiles to allow relative rotation of the rotary clicker relative to the fixed end cap in one direction of rotation and prevent relative rotation in the opposite direction of rotation. The rotary click element can be mounted in its axial position depending on the position of rotation of the rotary click element relative to the fixed end cover. Depending on the initially selected rotary position of the rotary click element, the intensity of the audible or tactile signal can be selected.

The autoinjector of the present invention may be formed from various subassemblies, such as a proximal subassembly containing an end cap, a pre-filled syringe compartment, and a power block subassembly. These three sub-assemblies may be provided as separate pre-assembled modules to assemble the apparatus of the present invention. This allows pre-assembly of the syringe chamber and power unit. Moreover, an appropriate pre-filled syringe can be used with the desired medicament provided therein in a sealed manner and in a predetermined volume to deliver the medicament.

The three sub-assemblies can be assembled to form a finished auto-injector by inserting a pre-filled syringe into a syringe holder (if required) with or without a syringe compartment, and then inserting a distal power block into the open distal end of the main syringe compartment until until it is locked in a predetermined inseparable position. Due to this modular design, the device according to the present invention can be easily assembled without error. It should be understood that the term "compartment for pre-filled syringe" or "pre-filled syringe" is used in this document to refer to the main part of the syringe, which is connected to the injection needle. The main body of the syringe contains a variable volume chamber filled with drug that can be expelled through an injection needle.

Optionally, the syringe may be attached or connected inside or outside the body to the syringe holder to provide a syringe assembly or syringe subassembly.

The proximal syringe compartment sub-assembly may include a removable end cap formed by the end cap body, a toothed gasket, and a proximal end cap plug. Moreover, the proximal syringe compartment subassembly may include a protective cover, a longitudinal housing, and a syringe holder.

The syringe subassembly may comprise a rigid needle sheath with a hub, a glass body with a non-removable needle, a medicament, and a stopper.

The power block subassembly may include a firing element, a firing spring, a case retaining indicator, a plunger, an actuating spring, a retainer, an internal member of the case retaining indicator, and a distal end cap.

The plunger may have a proximal end, wherein the proximal end may be adapted to accommodate different syringe sizes, preferably by being connected to an adapter portion.

The device may have a label on the outside of the case, the label having a black inner surface that restricts light and ability to see the end of the usage indicator before use. The device may have a label on the outside of the housing that is either opaque and thus prevents the end of the usage indicator from being seen before use, or is sufficiently opaque to restrict the user from seeing the end of the usage indicator before use.

The protective cover may comprise a hollow cylindrical body in the form of a ring at its proximal end with two diametrically opposed longitudinal legs. This arrangement of the main body and the longitudinal legs can be made in one piece or formed from separate parts, i.e. the cylindrical body may contain a separate plug, which may be made of a colored material.

The annular body may have one or more protrusions near its distal end. The distal end of the annular body may be provided with an annular collar having a rounded outer circumferential ring with one or more opposed grooves. The longitudinal hollow portion may extend distally from this annular collar, being divided by grooves into two separate halves. Two longitudinal tabs can be integrally formed with the distal end of the shoulder and have a stepped course, so that the first transition between the shoulder and the first part of the longitudinal tab forms the first ledge, and while the second transition between the first part of the longitudinal tab and the second part of the longitudinal tab forms the second inclined ledge. Each of the second parts of the longitudinal legs may have on its outer circumferential surface a protrusion protruding radially outward and having a sharp radial surface facing in the proximal direction and an inclined beveled surface facing in the distal direction. On the same line with the protrusion, the part of the longitudinal tab has a rectangular through hole near its distal end.

The outer circumferential surface of each second part of the longitudinal tab may contain an internal guide ledge. Moreover, the inner circumferential surface of the cylindrical body may include guiding ribs protruding radially inward. These internal guide ribs may be provided to guide the rigid needle sheath during assembly of the syringe. Alternatively, the outer circumferential surface of each second portion of the longitudinal tab may have guiding ribs, and the inner circumferential surface of the cylindrical main portion may comprise a guide protrusion.

The cylindrical body can be smoothly formed and bevelled at its anterior (proximal) end so that it does not injure or scratch the patient's skin. As mentioned above, the cylindrical main body, together with the longitudinal legs, may be a one-piece arrangement or a composite assembly.

The housing is intended to form the main part of the device. It is formed from a durable, rigid, transparent or opaque material. While not completely transparent, the body may be provided with cutouts or clear drug viewing windows to make the liquid content of the syringe and the state of the device visible to the user. Additionally or alternatively, the position of the plug may be visible to the user through such windows. The state of the device may include the position of the stopper within the body of the syringe. The body is formed by a longitudinal tubular piece. At its proximal end, the tubular piece may be provided with a hollow cylindrical portion having a generally circular cross section and a front surface. At a distance from the proximal end, the longitudinal piece may be provided with an arcuate extension or tab having the same general shape and cross-section as the end cap plug to provide additional geometry with anti-roll function on a flat surface, for example where a removable end cap cover removed.

At the proximal end of the housing, the cylindrical part may be provided on its circumferential inner surface with two rib-like opposite projections protruding radially inward, which may be hidden or closed from the outside and adapted to cooperate with a removable end cap. Moreover, in its middle section, the body can be provided with two opposite longitudinal through holes, having the function of guide grooves. Alternatively, these through holes can be replaced by guide channels which are open into the housing but which are closed on its outer circumferential surface. In line with the guide slots, but closer to the distal end, the body may be provided with additional opposite through holes, which may alternatively also be provided as internal recesses which are closed on the outer circumferential surface. Near its distal end, the body may be provided with a pair of opposing transverse through holes, which may alternatively also be provided as internal recesses which are closed on the outer circumferential surface, for the purpose of being attached to the power block subassembly. The distal end may be further provided with a distal anterior surface which has two opposing short recesses to improve the swivel connection to the power block.

On its inner part, the body can be provided with a ring or a double ring structure, connected in one piece with the tubular part in the area of the cylindrical part by means of at least one rigid connecting tab. The connecting tab may be formed by a strong U-shaped structure with two lateral longitudinal connecting ribs and one transverse connecting rib extending in the circumferential direction. The size of the connecting ribs and the U-shape are designed to provide structural rigidity to the hull. This connection geometry is also important for material flow when the component is being molded.

Moreover, an annular or double ring structure may have an outer ring extending with a tapered adapter into a hollow inner ring. From the proximal end, the reinforcing ribs can reinforce the connection between the outer ring and the inner ring. At the distal end, the conical adapter may be provided with one or more notches and/or rib-like axial projections. The arrangement of cutouts and axial protrusions may be provided for positioning the pre-filled syringe directly or in connection with the syringe holder.

The trigger element may be formed by a hollow body in a generally cylindrical shape. At its proximal end, it has an anterior surface surrounded by a bevelled rim and provided with two opposite lateral lugs extending radially. From the anterior surface of these lateral lugs, two rectangular projections may extend in the longitudinal axial direction. The protrusions may be provided with bevelled protrusions extending radially outward to move the protective cover. The hollow, tube-shaped body may extend distally and provides on its middle portion a surrounding annular reinforcing rib connected to the reinforcing proximal end by longitudinal ribs. Between the proximal end and the reinforcing rib, two opposite rectangular hollow box-like elements or recesses, which are formed by other wall-like structures, may be provided on the outer circumferential surface of the firing element, wherein these box-like or recessed elements provide a hollow space, respectively, which may be provided with additional components, such as electronic sensors or the like. The trigger acts as a temporary blocking element for the sheath retention indicator, described below, during use of the drug delivery device.

Further distally, the outer circumferential surface of the tubular hollow body may be provided with an additional annular and circumferential reinforcing rib, for example having an L-shaped profile, to support the spring. The distal end of the tubular hollow body of the trigger element may be formed by a hollow cylindrical part having a front surface. In its inner part, the firing element may be provided with a plurality, preferably four, longitudinal guide ribs, two pairs of these guide ribs being connected by an arcuate connecting rib, respectively, which extends circumferentially along the inner circumferential surface of the tubular hollow body.

The end plate can make it difficult to easily see the colored surface of the indicator when the label is on the outside of the transparent case.

A case spring that biases the inner member of the case retention indicator in a distal direction may be discreetly positioned between the inner member of the case retention indicator and the case retention indicator. The entire indicator arrangement may be located in the distal end portion of the drug delivery device, which, in use, faces the user and is clearly visible.

The distal end cap may have a main portion of the distal end cap having the same cross-sectional profile as the distal end of the longitudinal body, i.e. rounded with an arcuate extension or tab. The main part of the distal end cap may be made of a transparent material and covered by the distal surface. The transition between the circumferential surface and the distal surface may be rounded or beveled. At its proximal end, the distal end cap may be provided with a skirt portion which can fit in an assembled state within the distal end of the longitudinal housing. Therefore, the skirt portion has a reduced outer diameter and merges into the main portion of the distal end cap via a stepped surface.

In the region of the stepped surface, the distal end cap may provide longitudinal protrusions corresponding to the recesses described for the longitudinal housing. Through the interaction of the protrusions and recesses, the distal end cap can be positioned relative to the longitudinal body. Moreover, grooves can be provided in the skirt portion to provide two or more longitudinal projections. The outer circumferential surface of these longitudinal projections has beveled projections for snap-on connection, respectively. These protrusions are provided to snap-engage with corresponding through holes provided in the longitudinal housing when the device is assembled.

It should be mentioned that the snap-in engagement between the projections and the through holes should not be easily separable after assembly. The device of the present invention is a disposable device and eliminates the need to remove the distal end cap from the housing again after being attached to the longitudinal housing. There is no provision or provision for replacing or refilling the syringe after use, or providing any other access to the interior and components of the device after use.

Returning to the interior of the distal end cap, the end cap may be provided with a hollow cylindrical body integrally formed with the bottom surface of the distal end cap. Preferably, the distal end cap is formed from a transparent or opaque material, providing a window around the circumference to display an indicator in the state of use of the device. In its interior, the distal end cap comprises a hollow containing portion, such as a cylindrical hollow main portion, for receiving the distal end of a drive spring housed within the distal end of the holding device. However, when choosing a neutral color for the retainer, this arrangement is not visible from the outside through the transparent distal end cap.

In the assembled or initial state of the device, the end cover is fixed to the longitudinal body, while the end cover is held in the circumferential direction by engaging each of the internal protrusions formed at the proximal end of the body inside the corresponding enclosing space between two protrusions formed inside the main part of the end cover. Moreover, the end cap can be held in the longitudinal direction by engaging each of the inner protrusions formed at the proximal end of the body behind the protrusions formed on the annular inner portion of the end cap body, respectively. In this way, the detachable cover can be held on the housing against an axial removal force by the projections, as well as against small unscrewing forces below the loosening force threshold, by the opposing projections forming the housing space.

The longitudinal body may be made of a transparent or opaque material having at least a transparent part or window through which the user can see the actual state of the operation.

Detailed description

The present invention will be further described by way of example only with reference to the following figures, in which:

fig. 1 - a perspective view of the drug delivery in the assembled state;

fig. 2 is an exploded view of the drug delivery device of FIG. 1 showing its sub-assemblies, in particular the detachable cover, the protective cover, the longitudinal body and the syringe holder;

fig. 3 is an exploded view of the drug delivery device of FIG. 1 showing its sub-assemblies, in particular the pre-filled syringe;

fig. 4 is an exploded view of the drug delivery device of FIG. 1 showing its sub-assemblies, in particular the firing element, the firing spring, the sheath retention indicator, the plunger and actuating spring, the retention device, the internal sheath retention indicator, and the distal end cap;

in fig. 5-7 show different perspective views of the lid body, and FIG. 8 and FIG. 9 shows different perspective views of the cover sleeve;

in fig. 10-13 show various perspective views of examples of a needle sheath gripper;

in fig. 14-18 show different types of protective cover;

in fig. 19-22 show different views of the longitudinal body;

in fig. 23 and FIG. 24 shows perspective views of the syringe holder;

in fig. 25 shows an assembled pre-filled syringe;

in fig. 26 and FIG. 27 is an exploded perspective view of the rigid needle sheath and its hub;

in fig. 28 is a perspective view of the main body of the syringe;

fig. 29 is a perspective view of the cork;

fig. 30-33 - different types of starting element;

in fig. 34 and FIG. 35 shows different perspective views of the housing retention indicator;

fig. 36 and FIG. 37 - perspective views of the plunger;

fig. 38 is a perspective view of the inner member of the housing retention indicator;

fig. 39-41 - different types of holding device;

fig. 42 and FIG. 43 are different perspective views of the distal end cap;

fig. 44a-44d are a side view (FIG. 44a) and different longitudinal sectional views of the device according to the present invention in its original state, wherein FIG. 44b is a longitudinal sectional view rotated 90° with respect to FIG. 44a, fig. 44c is a longitudinal sectional view rotated 180° from FIG. 44a and FIG. 44d is a longitudinal sectional view rotated 45° with respect to FIG. 44a;

fig. 45a-45d are views according to FIG. 44a-44d in a state in which the detachable cover is partially unscrewed from the longitudinal body;

fig. 46a-46d are views according to FIG. 44a-44d in a state in which the removable cover is completely removed from the longitudinal body and the device is ready to dispense a fluid product;

fig. 47a-47d are views according to FIG. 44a-44d in a state in which the device is already pressed against the patient's skin with the protective cover partially pressed into the longitudinal body;

fig. 48a-48d are views according to FIG. 44a-44d in a state in which the device is pressed against the patient's skin, the injection needle has pierced the patient's skin, the protective cover is fully pressed into the longitudinal body, and the dosing of the fluid product is started;

fig. 49a-49d are views according to FIG. 44a-44d in a state in which the fluid product is partially dispensed;

fig. 50a-50d are views according to FIG. 44a-44d in a state in which the fluid product is almost completely dispensed with the indicator mechanism running;

fig. 51a-51d are views according to FIG. 44a-44d in a state in which the fluid indicator reaches its end position;

fig. 52a-52d are views according to FIG. 44a-44d in a state in which the fluid product is fully dosed;

fig. 53a-53d are views according to FIG. 44a-44d in a state in which the device is in the process of being removed from an injection site on the patient's skin, with the needle partially withdrawn from the patient's tissue and the protective cover partially released;

fig. 54a-54d are views according to FIG. 44a-44d in a state in which the device is in the process of being removed from an injection site on the patient's skin, with the needle fully withdrawn from the patient's tissue and the protective cover more released;

fig. 55a-55d are views according to FIG. 44a-44d in a state in which the device is completely removed from the injection site on the patient's skin, while the needle is completely pulled out of the patient's tissue, and the protective cover is completely released;

fig. 56a-56d are views according to FIG. 44a-44d in a state in which the device is completely removed from the injection site on the skin of the patient, while the protective cover is locked against subsequent axial indentation;

fig. 57-60 show various views of further examples of syringe holders;

fig. 61 is a perspective view of another drug delivery device in an assembled state;

fig. 62 is an exploded view of the drug delivery device of FIG. 1 showing its subassemblies;

fig. 63 is an exploded view showing the components of the syringe chamber subassembly including the front cover of FIG. 62;

fig. 64 is an exploded view showing the components of the syringe subassembly of FIG. 62;

fig. 65 is an exploded view showing the components of the power block subassembly of FIG. 62;

fig. 66a and FIG. 66b are different perspective views of the main body of the distal end cap;

fig. 67 is a perspective view of the distal end cap plug;

fig. 68 is a perspective view of the toothed spacer;

fig. 69a and FIG. 69b are perspective views of the protective cover of the sub-assembly in the form of a compartment for the syringe;

fig. 70 is a perspective view of the protective cover indicator;

fig. 71a and FIG. 71b are perspective views of the retaining ring of the syringe chamber subassembly;

fig. 72a and FIG. 72b are perspective views of the syringe holder of the syringe compartment sub-assembly;

fig. 73a and FIG. 73b are perspective views of the housing of the subassembly in the form of a compartment for the syringe;

fig. 73c is a right side side view of the syringe chamber subassembly body showing the internal structure;

fig. 74 is a perspective side view of a rigid needle sheath;

fig. 75 is a perspective side view of a needle housing sleeve for a rigid needle sheath;

fig. 76 is a perspective view of the glass body containing the needle;

fig. 17 - perspective view of the cork;

fig. 78a and FIG. 78b are different perspective views of the plunger rod of the power block subassembly;

fig. 79a and FIG. 79b is a perspective view of the power pack housing holding trigger;

fig. 80a and FIG. 80b are perspective views of a power block subassembly housing retention indicator;

fig. 81a and FIG. 81b are perspective views of the holding device of the sub-assembly in the form of a power block;

fig. 82a and FIG. 82b are perspective views of the rotary click element of the power block subassembly;

fig. 83a and FIG. 83b are perspective views of the distal snap-on end cap of the power block subassembly;

in fig. 84a and FIG. 84b shows the drug delivery device in a ready-to-use state, with FIG. 84a is a side view and FIG. 84b shows a longitudinal sectional view;

fig. 85a and FIG. 85b are longitudinal sectional views of the drug delivery device in the state in which the end cap has just been removed, wherein FIG. 85a is a longitudinal section along plane A indicated in FIG. 61, while FIG. 85b is a longitudinal section along the plane B indicated in FIG. 61;

fig. 86a and FIG. 86b are longitudinal sectional views of FIG. 85a and FIG. 85b in a state where the drug delivery device is fully pressed against the patient's skin and drug delivery has just begun;

fig. 87a and FIG. 87b are longitudinal sectional views of FIG. 85a and FIG. 85b in an intermediate state when the drug delivery device delivers the drug to the patient;

fig. 88a and FIG. 88b are longitudinal sectional views of FIG. 85a and FIG. 85b in an intermediate state when drug delivery is close to completion;

fig. 89a and FIG. 89b are longitudinal sectional views of FIG. 85a and FIG. 85b in a state where the drug delivery device has completely delivered the drug to the patient;

fig. 90a and FIG. 90c are longitudinal sectional views of FIG. 85a and FIG. 85b in a state where the drug delivery device is removed from the patient's skin and secured in a locking state after use; and

fig. 90c is a perspective view of the drug delivery device in a locked state after use.

In FIG. 1 shows an automatic mechanical drug delivery device 10 configured as an auto-injector according to the present invention in a perspective side view. The device 10 includes a longitudinal main body 12 extending along the X axis and a removable end cap 50 at the proximal end of the device 10. The end of the device 10 on which the removable end cap 50 is located is referred to in this description as the proximal end, which will be in contact with patient. The opposite end, shown in Fig. 1 on the right side is referred to as the distal end within this description.

In FIG. 1 furthermore schematically shows two different viewing directions A, B, C and D representing views (top view of A) and longitudinal section planes B, C and D. In the following, when describing the construction and operation of the device 10, reference is made to these particular views A and longitudinal section planes B, C, D.

In FIG. 2, fig. 3 and FIG. 4 shows subassemblies 100, 200 and 300 of device 10. FIG. 2, the proximal subassembly 100 can be seen including the end cap 50. In FIG. 3, a subassembly can be seen containing a compartment 200 in the form of a pre-filled syringe. In FIG. 4, subassembly 300 can be seen as a power unit. These three subassemblies 100, 200 and 300 are provided as separate pre-assembled modules when the device 10 of the present invention is assembled. This allows the syringe compartment 200 and the power unit 300 to be pre-assembled, and to provide the respective pre-filled syringe 204 with the desired drug provided therein in a sealed manner and in a predetermined volume for drug delivery.

As will be seen below, the three subassemblies 100, 200, and 300 can be assembled into the device 10 by inserting the pre-filled syringe 200 into the syringe housing 100 and then inserting the power block 300 from the right side, i.e., the distal side, into the open distal the end of the body 12 of the syringe compartment 100 until it is locked in a predetermined inseparable position. Due to this modular design, the device according to the present invention can be easily assembled without error.

It should be noted that while a specific example of device 10 is described below with respect to its construction and operation with respect to the figures, the components of device 10 as described below can also be used independently of the respective design. In particular, each of the three subassemblies 100, 200 and 300 and their components can be used separately and independently of the other subassemblies. For example, the proximal subassembly 100 and its components may be used alone in another autoinjector regardless of the particular design of the syringe compartment 200 or the power block 300. Therefore, the following description should not be construed as a limiting disclosure in the sense that any and all components may be used only in conjunction with the optional components described in the following context. Instead, the present invention should be understood in the sense that all components disclosed therein, without exception, can be separately claimed with their respective features, regardless of the interacting components of the respective subassemblies.

The components of the subassemblies are described in detail below.

In FIG. 2 shows an exploded view of the proximal sub-assembly 100. This proximal sub-assembly 100 includes a removable end cap 50 formed by the end cap body 52, the toothed gasket 54, and the proximal end cap plug 56. Moreover, the proximal sub-assembly 100 includes a protective cover 102, a longitudinal housing 104 and a syringe holder 106. These components will be described in detail with respect to FIG. 4-24 onward.

In FIG. 3 is an exploded view of the components of a subassembly forming a pre-filled syringe 200. This syringe subassembly 200 includes a rigid needle sheath 202 with a hub 207, a glass body 204 with an integrally provided needle 206, a drug 208 shown as a column of liquid. , and stopper 210. These components of the pre-filled syringe 200 will be described in detail with respect to FIG. 25-29.

In FIG. 4 is an exploded view of the components of the power block subassembly 300. This power block subassembly 300 includes a trigger element 302, a trigger spring 304, a case retaining indicator 306, a plunger 308, an actuating spring 310, a retainer 312, an inner case retaining indicator member 314 and a distal end cap 316. These components will be described in detail with respect to FIG. 30-43 further.

In FIG. 5-7 show the removable end cap body 52 in various perspective views. It can be seen that the cylindrical body 58 is integrally formed with the arcuate extension 60 such that the cylindrical body 58 forms a non-circular circle providing a rolling-resistant shape when the end cap is placed on a flat or slightly sloped surface. The outer circumferential surface of the body 58 has a series of integrally formed radial gripping recesses 62 extending longitudinally between the proximal and distal ends of the body 58. arrows that indicate the direction of movement for screwing or unscrewing the end cap 50 relative to the longitudinal body 12.

In its interior, the end cap main body 52 comprises a circular cylindrical surface 68 forming an axially open containing portion 70 with a smooth containing surface. Adjacent to the enclosing portion 70 is an integrally formed annular portion 72. The annular portion 72 comprises a substantially flat cylindrical upper front surface 74 facing distally. Between the annular portion 72 and the inner circumferential surface 68 of the end cap body 52, there is an open gap 75 and a connecting structure 76 connecting both components. The annular portion 72 has on its outer circumferential surface two protrusions 78 extending radially outward into the gap 74. On both sides of the protrusions 78, the outer circumferential surface of the annular portion 72 is provided with inclined lifting formations 80 and 82 which have the most distal level near the protrusions 78 and which are inclined distally so as to converge at the apex 84.

As can be seen in FIG. 6, just below each protrusion 78, the outer circumferential surface of the annular portion 72 has two beveled protrusions 86 and 88 which form a housing space 90 therebetween. This enclosing space 90 is provided to receive and secure a protrusion 198 formed on the inner circumferential surface of the longitudinal body 104 at its proximal end, as will be described with respect to FIG. 19 and FIG. twenty.

On its radial inner surface, the annular main body 72 has two opposing protrusions 92 protruding radially inwards. These two protrusions 92 are provided to engage with and secure respective radial outward protrusions 156 formed on the outer circumferential surface of the proximal end of the shroud 102, as will be described with respect to FIG. 14-18.

Focusing on FIG. 6, it can be seen that the main body 52 of the end cap near its proximal end faces two annular arches 94 located opposite each other and attached to the inner circumferential surface 68 of the main body 52 of the end cap through the connecting part 96 and connecting ribs 98.

In FIG. 8 and FIG. 9 shows the plug 56 of the end cover. The end cap plug 56 has a proximal end cap portion 110 having the same base surface with a slightly sloping protrusion 112 as the main end cap portion 52. An annular cylindrical body 114 extends from the proximal surface of the end cap portion 110. The annular cylindrical body 114 is provided on its outer circumferential surface 116 with a plurality of longitudinal ribs 118 which protrude above the distal end of the annular cylindrical body 114. At the free end of these longitudinal ribs 118, projections for snap-in connection protruding radially outward, if necessary, may be provided. which engage with the corresponding (annular) recess inside the main part 52 of the end cap. In its interior, the annular cylindrical body 114 is provided with beveled radially extending ribs 120 extending into the inner cylindrical body 122, which is also integrally formed with the distal surface of the end cap portion 110. The distal front surface of the arrangement formed by the cylindrical body 114, the protrusions of the ribs 118, the radially inner ribs 120, and the inner cylindrical body 122 form a conical profile.

In FIG. 10-13 show two different examples of a toothed shim 54. The toothed shim 54 has a circular outer circumference 130 surrounding a ring-shaped main body 132. The toothed pad 54 includes four radially inwardly extending tabs 134 integrally formed with the annular main body 132 and terminating in a circular radially inner gripping surface 136 . In side view, it can be seen that the toothed shim 54 according to the example shown in FIG. 10 and FIG. 11 is flat, while the toothed shim 54 according to the example shown in FIG. 12 and FIG. 13 has a truncated conical shape. In both examples, the tabs 84 provide axial spring action, ie the tabs 84 can be elastically deflected in the axial direction.

In the assembled state of the end cap 50, the toothed pad 54 is positioned on the proximal surface of the annular arches 94. The end cap plug 56 is pressed into the proximal end of the main body 52 of the end cap, whereby the protruding ends of the ribs 118 engage the ring-shaped main body 132 of the toothed pad 54 and press it (as an optional feature) to the annular arches 94. The toothed pad 54 is thereby rigidly held and shifted, or it is alternatively located with some axial gap, between the proximal front surface of the annular arches 94 and the conical structure formed on the distal side of the end cap plug 56. The conical structure formed on the distal side of the end cap plug 56 provides sufficient distance to the petals 84 so that the petals can flex proximally in the axial direction within this assembly.

Optionally, one or two tabs 134 may have a different length than the other tabs 134 so that when the rigid needle sheath 202 is engaged, the load of the asymmetric force on the rigid needle sheath 202 is balanced. This results in a tilting or pivoting action such that the rigid needle shield 202 deviates from its initial position. Thus, it is possible to avoid reclosing with the lid, ie, reattaching the lid 50 to the housing after it has been removed.

In FIG. 14-18 show the protective cover 102 in various perspective views. The protective cover 102 comprises a hollow cylindrical body 150 in the form of a ring at its proximal end with two diametrically opposed longitudinal tabs 152, 154. This arrangement of the main body 150 and the longitudinal tabs 152, 154 can be made in one piece or formed from separate parts, i. i.e. the cylindrical main body may contain a separate plug, which may be made of a colored material.

The ring-shaped body 150 has two protrusions 156 near its distal end. The distal end of the ring-shaped body 150 is provided with an annular collar 158 having a rounded outer circumferential ring 160 with two opposing slots 162. A longitudinal hollow portion 164 extends distally from this annular collar 158, being divided by slots 162 into two distinct halves. Two longitudinal tabs 152, 154 are formed in one piece with the distal end of the shoulder 158 and have a stepped course, so that the first transition 166 between the shoulder 158 and the first longitudinal tab part 168 forms a first ledge, and the second transition 170 between the first longitudinal tab part 168 and the second part 172 of the longitudinal tab forms a second inclined ledge. Each of the second longitudinal tab portions 172 has, on its outer circumferential surface, a protrusion 174 protruding radially outward and having a sharp radial surface facing in the proximal direction and an oblique sloping surface facing in the distal direction. In line with the protrusion 174, the longitudinal leg portion 172 has a rectangular through hole 176 near its distal end.

The inner circumferential surface at the distal end of each second longitudinal tab portion 172 includes an inner guide profile 178. Moreover, the inner circumferential surface of the cylindrical body 150 includes four guide ribs 180 protruding radially inward. These inner guide ribs 180 are provided for guiding the rigid needle cover 202.

The cylindrical body 150 is smoothly formed and rounded in radius at its anterior (proximal) end so that it does not injure or scratch the patient's skin. As mentioned above, the cylindrical main body 150, together with the longitudinal tabs 152, 154, may be a one-piece arrangement or a composite assembly.

In FIG. 19-22 show housing 104 in various views. The body 104 is intended to form the main body 12 of the device 10. It is formed from a strong, rigid, transparent or opaque material. While not completely transparent, the body may be provided with cutouts or clear drug viewing windows to make the drug and device status visible to the user. The body 104 is formed by a longitudinal tubular piece 190. At its proximal end, the tubular piece 190 is provided with a hollow cylindrical portion 192 having a circular cross section and a front surface 194. At a distance from the proximal end, the longitudinal piece 190 is provided with a rounded hollow extension 196 that has the same shape and cross-section, as well as the extension 60 of the removable cover, to provide a geometry with anti-roll function on a flat surface. At its proximal end, the cylindrical portion 192 is provided on its circumferential inner surface with two rib-like opposing protrusions 198 protruding radially inwards, which are thereby hidden from the outside and which are adapted to cooperate with the removable end cap 50. Moreover, in its middle section, the body 104 is provided with two opposed longitudinal through holes 220 having the function of guide slots. Alternatively, these through holes 220 can be replaced by guide channels that are open into the housing 104 but that are closed on its outer circumferential surface. In line with the guide slots 220, but closer to the distal end, the body is provided with two additional opposing through holes 222, which may alternatively also be provided as internal recesses that are closed on the outer circumferential surface. Near its distal end, housing 104 is provided with a pair of opposing transverse through holes 224, which may alternatively also be provided as internal recesses that are closed on the outer circumferential surface. The distal end is further provided with a distal anterior surface 226 which has two opposing short notches 228.

On its interior, the housing 104 is provided with a double ring structure 230 which is integrally connected to the tubular piece 190 in the region of the cylindrical portion 192 by means of a pair of opposing rigid connecting tabs 232. The connecting tabs 232 are formed by a strong U-shaped structure with two lateral longitudinal connecting ribs. 234 and one transverse connecting rib 236 extending in the circumferential direction. The size of the connecting ribs and the U-shape are designed to provide the housing 104 with structural rigidity. This connection geometry is also important for material flow when the component is being molded.

Moreover, the double ring structure 230 has an outer ring 238 extending over the tapered adapter 240 into the hollow inner ring 242. Proximal to the end, two reinforcing ribs 244 reinforce the connection between the outer ring 238 and the inner ring 242. Viewed from the distal end, the tapered adapter portion 240 is provided with two opposing notches 246 and one rib-like axial protrusion 248. An arrangement of two opposing notches 246 and an axial protrusion 248 are provided for positioning the pre-filled syringe 200 in connection with the syringe holder 106. For some embodiments, lug 248 may or may not be included.

In FIG. 23 and FIG. 24 shows one example for a syringe holder 106. Other examples of a syringe holder are described with respect to FIG. 57-60.

The syringe holder 106 is designed to receive and hold the pre-filled syringe 204 within the housing 104. It is adapted to accommodate different types of syringes with different volumes of drug without the need to resize other components of the device 10. Therefore, different sizes for the syringe holders 106 must be provided. when adapted to different types / volumes of syringes.

The syringe holder 106 provides a longitudinal body 260. At its proximal end, the syringe holder 106 has a rigid and inelastic U-shaped member 262 that is open in one radial direction, as can be seen in FIG. 23. This rigid U-shaped member 262 is reinforced at its proximal end by two parallel surrounding ribs 264, 266. At its proximal front surface, the U-shaped member 262 is provided with two transverse ribs or projections 268. At its distal end, the syringe holder 106 is provided with a rigid and inelastic a similar U-shaped member 270 reinforced with two parallel surrounding ribs 272, 274. The two surrounding ribs 272, 274 are provided with notches 276, 278 facing radially outward at opposite positions. The two rigid U-shaped elements 262 and 272 are connected by two longitudinal and rigid connecting tabs 280, 282. Each of the connecting tabs extends straight and contains in its middle section in FIG. 23 at the upper end is a protrusion 284, 286 projecting radially inward so that they face each other. The inner surface 288 of the projections 284, 286 is rounded, as can be seen in FIG. 23 and FIG. 24 so that the glass body of the syringe 200 can be positioned and held therein.

When placed within the longitudinal body 104, the syringe holder 106 holding the pre-filled syringe 200, preferably rotatably, is positioned such that the two projections 268 engage into the cutouts 246 of the double ring structure 230 and the projection 248 engages into the cavity. provided by the proximal U-shaped member 262. Thus, the syringe holder 106 is positioned by the double ring structure 230 within the longitudinal body 104 in a proper axial and pivotal position about the longitudinal axis.

In FIG. 25 shows a pre-filled syringe 200 in an assembled state with a rigid needle sheath 202 placed on the proximal front end of the syringe to cover the injection needle 206.

In FIG. 26 and FIG. 27 shows a perspective view of a rigid needle sheath 202 with a hub 207. The rigid needle sheath 202 is formed by a tubular member 320 with an open distal end 322 and a closed proximal end 324. In its anterior portion it has a surface defined by transverse gripping ribs 326. Near its distal end, it has two opposite rectangular through holes 328.

The sleeve 207 is formed from a soft deformable material and can be pressed into the rigid needle sheath 202 so that it is rigidly held therein. It has an annular collar 330 near its distal end that engages with rectangular through holes 328 of the rigid needle sheath 202.

In FIG. 28 shows a syringe 204. The syringe 204 is formed by a hollow cylindrical glass body 332 having an open distal end 334 which is surrounded by a circumferential annular collar 336 with two flattened opposite side surfaces 338. At its proximal portion, the cylindrical glass body 332 has a rounded tapered portion 340 and passes into a hollow conical glass part 342 terminating in a stepped cannula 344 for a needle with a spherical or rounded proximal head 346. The proximal head 346 rigidly holds the specified injection needle 206 with a pointed needle tip 348.

In FIG. 29 shows a plug-like element 210 formed from a flexible material such as rubber. At its proximal portion it has a smooth cylindrical outer circumferential surface 350 which has a diameter adapted to the inner diameter of the hollow cylindrical glass body 332 of the syringe 204 so that the plug member 210 slidably engages the inner circumferential surface of the hollow cylindrical glass body 332 impermeable for fluid way. On the distal portion of the outer surface, the plug element 210 is provided with four circumferential annular recesses forming three circumferential sealing ribs 352. The plug element 210 is cup-shaped with a closed proximal end 354 and an open distal end 356.

Moving on to the components of the power block or drive assembly, FIG. 30-33 show the firing element 302 in different views. The trigger element is formed by a hollow main body 360 in the shape of a tube. At its proximal end it has an anterior surface 362 surrounded by a beveled rim 363 and provided with two opposite lateral lugs 364, 366 extending in the radial direction. From the front surface 362 of these lateral lugs 364, 366, two rectangular raised plates 368, 370 extend in the longitudinal axial direction. The protruding plates 368, 370 are provided with bevelled protrusions 372 extending radially outward. The tube-shaped hollow body 360 extends distally and provides on its middle portion a surrounding annular reinforcing rib 374 connected to the proximal reinforcing end by longitudinal ribs 376. boxes or recesses which are formed by other wall structures are provided on the outer circumferential surface of the firing element 302, these box or recess elements 378 providing a hollow space 379, respectively, in which additional components such as electronics may be provided. sensors or the like.

Further distally, the outer circumferential surface of the tubular hollow body 360 is provided with an additional annular and circumferential L-shaped reinforcing rib 380 to support the spring 304. The distal end of the tubular hollow body 360 of the firing element 302 is formed by a hollow cylindrical part 382 having a surface 384. In its interior, the firing member 302 is provided with four longitudinal guide ribs 386, the two pairs of these guide ribs 386 being connected by an arcuate connecting rib 388, respectively, which extends circumferentially along the inner circumferential surface of the tubular hollow body 360.

In FIG. 34 and FIG. 35 shows a case holding indicator 306. The housing holding indicator 306 is formed by a hollow cylindrical body 400 having an annular cylindrical component 402 that expands due to a rounded extension 404 adapted to the geometry of the housing 104. the main body 190 of the longitudinal body 190. It has a smooth outer circumferential surface 406. At its proximal end, the casing holding indicator 306 is provided with four longitudinal flexible tabs 408, each of which has a proximal free end 410. The free ends 410 of the flexible tabs 408 are provided with projecting parts 412, extending radially inward and reinforced with short longitudinal beveled ribs 414. The distal end of the case holding indicator 306 is provided with a round hole 416.

The circumferential outer surface 406 of the housing retention indicator 306 has a signal color, ie, yellow, orange, or red, or a signal pattern that is clearly visible to the user. Thus, as will be discussed in detail with respect to the operation of the drug delivery device 10 of the present invention, the user, i.e., healthcare professional or patient, of the device 10 can easily recognize when the sheath holding indicator 306 has moved to the signal position in which it is clearly visible through the longitudinal housing 104 from the outside.

In FIG. 36 and FIG. 37 shows the plunger 308 in various perspective views. The plunger 308 is formed by a longitudinal hollow tube-shaped element 420 which has a plunger head 422 at its proximal end. The plunger head 422 is provided with a front surface 424 and a transverse slot 426. The front surface 424 includes a small cylindrical through hole 428. The front surface with a transverse slot 426 and a cylindrical through hole 428 can be connected to an additional element in the form of a plunger head, if necessary, for example, for syringes having a larger internal diameter with which a correspondingly larger plug 210 interacts. This additional enlarged plunger head can be used for larger syringes, such as those having a drug volume of 2.25 ml. In the case of smaller syringes, as shown in the example, for example syringes having a drug volume of 1 ml, the enlarged plunger head is omitted and the plunger 308 is only a straight cylindrical shape at its proximal end.

In the middle portion of the plunger 308, a pair of opposite rectangular through holes 430 are provided in the wall of the hollow member 420. In another example, the plunger may have additional pairs of through holes comparable to the through holes 430 to allow adjustment to different syringe sizes or drug fill volumes. At its distal end, the hollow member 420 is provided with a circular opening 432 to allow longitudinal access to receive the actuating spring 310.

In FIG. 38 shows the inner member 314 of the case holding indicator. This element is formed by a stepped tubular main body 440 having a first hollow cylindrical part 442 with a smaller diameter and an enlarged second hollow cylindrical part 444 with a larger diameter. At its proximal end, the housing retention indicator inner member 314 is provided with two opposing flexible longitudinal tabs 446 extending in the proximal direction, with the first portion 448 extending longitudinally, the second portion 450 slanting slightly radially inward, and the third portion 452 extending longitudinally, however, at a radial level that is further radially inward than the first portion 448. At its proximal end, each of the tabs 446 has an inclined retaining protrusion 454 extending radially outward.

The distal portion of the inner member 314 of the case retention indicator is provided with an end plate 456 having the same rounded and flared cross-sectional surface as the distal end of the case retention indicator 306 . The diameter of the outer circumferential surface of the second hollow cylindrical portion 444 is adapted to fit inside a circular hole 416 provided at the distal end of the housing holding indicator 306 .

In FIG. 39-41 depict the holding device 312 of the power unit 300 or drive assembly. The holding device 312 acts as a control part having a plurality of control functions of the power unit 300. The holding device 312 is formed from a hollow cylindrical body 470. On two opposite sides, the cylindrical body 470 includes a U-shaped notch 472 forming a longitudinal flexible tab 474, respectively. The longitudinal flexible tab 474 is integrally connected to the hollow cylindrical main body 470 at its distal end 476. Moreover, the cylindrical main body 470 is provided with two opposite longitudinal cuts 482 in a region rotated 90° relative to the flexible tabs 474 formed by the cuts 472. The longitudinal cuts 482 extend with approximately the same longitudinal elongation as the U- shaped cut 472, however, slightly further in the distal direction. In the region of approximately one third of the longitudinal length of the cutouts 482 near their proximal end, the cylindrical body 470 includes lateral projections 484 transversely overlapping the cutouts 482. These lateral overlapping projections 484 are extended near the proximal end by additional projections 486 having the same outer circumferential shape.

At its proximal end, the cylindrical body 470 is provided with two flexible tabs 490 integrally formed with the cylindrical body 470 and inclined at an angle of approximately 45° relative to the proximal front surface of the hollow cylindrical body 470. These flexible tabs 490 are connected to the part 492 in the form ring-shaped heads. An annular head portion 492 is formed as a liner together with a cylindrical portion 494 and two opposing proximal arcuate projections 496. The head portion 492 may be integral with the flexible tabs 490 or formed as a separate part rigidly connected to the flexible tabs. 490, for example, by means of an intermediate connecting ring.

At its distal end, the cylindrical body 470 has a circumferential groove 500. The distal end is provided with a distal end surface 502 having a central opening 504. At its interior near the distal end, the cylindrical body 470 is provided with internal guide ribs 498 extending axially or longitudinally between distal end surface 502 and a longitudinal section having a circumferential groove 500.

In FIG. 42 and FIG. 43 shows the distal end cap 316 of the device 10. The distal end cap 316 has a distal end cap main body 510 having the same cross-sectional profile as the distal end of the longitudinal body 104, i.e., rounded with elongation. The main portion 510 of the distal end cap is made of a transparent material and is covered by a distal surface 512. The transition 516 between the circumferential surface 514 and the distal surface 512 is rounded or bevelled. At its proximal end, the distal end cap 316 is provided with an insertion portion 520 which, with a positive fit, fits assembled within the distal end of the longitudinal body 104. Therefore, the insertion portion 520 has a reduced outer diameter and merges into the main distal end cap portion 510 by means of a stepped surfaces 522.

In the region of the stepped surface 522, the distal end cap 316 provides longitudinal projections 524 corresponding to the recesses 228 described with respect to FIG. 19-22 for the longitudinal body 104. Through the interaction of the projections 524 and the notches 228, the distal end cap 316 is positioned relative to the longitudinal body 104. Moreover, the insertion portion 520 provides two longitudinal projections 526 at the proximal end. The outer circumferential surface of these longitudinal projections 526 has beveled projections 528 for snap-in connection, respectively. These protrusions 528 are provided to snap-engage with corresponding through holes 224 provided in the longitudinal body 104 when the device is assembled.

It should be mentioned that the snap-in engagement between the protrusions 528 and the through holes 224 is inseparable after assembly. The device of the present invention is a disposable device and precludes the re-removal of the distal end cap 316 from the housing 104 after being attached to the longitudinal housing 104. No provision or provision is made for replacing or refilling the syringe 200 after use or providing any other access to the interior and components. device 10 after its use.

Returning to the interior of the distal end cap 316, can be seen in FIG. 43 that the end cap is provided with a hollow cylindrical body 530 integrally formed with the bottom surface 532 of the distal end cap 316.

Next, the assembled state of the device 10 is described with reference to FIG. 44a and FIG. 44d. In FIG. 44a is a side view and FIG. 44b-44d show different longitudinal sectional views of the device according to the present invention in its original state, with FIG. 44b is a longitudinal sectional view rotated 90° with respect to FIG. 44a, fig. 44c is a longitudinal sectional view rotated 180° from FIG. 44a and FIG. 44d is a longitudinal sectional view rotated 45° with respect to FIG. 44a. Reference is made to the planes and arrows A, B, C, D depicted in FIG. 1. The state shown is also the initial state of the device 10, ie the state of the device in which it is delivered to the user.

In the assembled or resting state of the device 10, the end cap 50 is screwed onto the longitudinal body 104, with the end cap 50 held in the circumferential direction by engagement of each of the internal projections 198 formed at the proximal end of the body 104 within a respective enclosing space 90 between two projections 86 and 88 formed inside the main body 52 of the end cap. Moreover, the end cap 50 is held longitudinally by the engagement of each of the inner projections 198 formed at the proximal end of the body 104 located beyond the projections 78 formed on the annular inner portion 72 of the end cap main body 52, respectively. Thus, the removable cover 50 is held on the housing against axial removal force by the projections 78, and also against small loosening forces that are below the loosening force threshold by the opposing projections 86 and 88 forming the containing space 90.

Moreover, the protective cover 102 is held in the assembled initial state as shown in FIG. 44a-44d with removable cover 50 in axial position as shown in FIG. 44b-44d. In particular, this aims to avoid unintentional movement in the distal direction, ie if the device 10 is dropped and experiences an impact when it hits the ground. This is achieved by engagement between protrusions 156 formed on the outer circumferential surface of the cylindrical body 150 at the proximal end of the protective cover 102, and two protrusions 92 formed on the inner circumferential surface of the annular inner portion 72 of the removable cover main body 52. Thus, the protrusions 92 block any axial movement of the protective cover 102 in the distal direction relative to the removable cover 50 mounted on the housing 104, and thereby relative to the housing 104.

At the distal end, the distal end cap 316 is rigidly and inseparably attached in a snap-fit arrangement to the longitudinal body 104, with protrusions 526 formed on the outer circumferential surface of the insertion portion 520 of the distal end cap 316 engagingly engaging through holes 224 formed on the distal end of building 104.

Moreover, in the assembled state, the syringe 204 is held within the syringe holder 106, which is received in the annular structure 230 of the body 104. notches 246, and the protrusion 248 protrudes into the hollow space provided by the syringe holder U-shaped member 262 (see above). The syringe 204 is pressed axially into the syringe holder 106. U-shaped elements 262 and 272 are rigid and do not buckle during assembly or during operation. It should be noted that the syringe 204 is held pivotally within the syringe holder 106.

Moreover, the syringe 204 together with the syringe holder 106 is pressed by the syringe flange 336 through the head portion 494 of the retainer 312 in the proximal direction against the conical and stepped annular structure 230 of the body 104, with the flexible tabs 490 of the retainer acting as an axial spring mechanism, providing a spring force in the axial proximal direction to hold the syringe 204 in place within the syringe holder 106 and thereby located there. The rigid needle sheath 202 engages the hollow conical glass portion 344 via the sleeve 207. The soft sleeve 207 securely covers the needle 206 and maintains the sterility of the injection needle 206 and the medicament contained within the syringe 204 and needle 206. As can be seen in FIG. 44b, the outer surface of the tubular 320, with transverse gripping ribs 326 or alternatively only a soft outer surface, is engaged by the flexible tabs 134 of the toothed pad 54, which is tapered in this example. As mentioned above, the flexible tabs 134 may have different radial lengths to provide an unbalanced force on the rigid needle sheath 202. The toothed spacer 54 is held within the removable end cap 50 by a cap plug 56 .

Moreover, in FIG. 44b-44d show the cylindrical main body 150 in the form of a ring of the protective cover 102. The protective cover 102 is pressed by the end cap 50 through the longitudinal tabs 152, 154, against the resistance of the casing spring 308 in the distal direction, partially into the housing 104. The trigger element 302 acts as an intermediate element between longitudinal legs 152, 154 and the casing spring 304. As can be seen in FIG. 44c, the assembled trigger 302 is permanently connected via its protruding plates 368, 370 to the distal ends of the tabs 152, 154 of the guard 102. The protruding plates 368, 370 are housed within the inner guide profile 178 at the distal end of the tabs 152, 154. More In addition, the bevelled projections 372 engage with the through holes 176, respectively, and thereby prevent the tabs 152, 154 of the protective cover 102 from separating under axial force from the projection plates 368, 370 of the trigger element 302 when assembled. tabs 152, 154 simplify the assembly process.

The proximal end of the housing spring 304 engages with respect to the distal portion 382 of the trigger 302 and abuts the circumferential rib 380 of the trigger 302, with the L-shaped circumferential rib 380 tightly holding the proximal end of the housing spring 304. The distal end of the case spring 304 is pressed by the distal end of the case retention indicator 306 against the flanged proximal surface of the plate 456 of the inner member 314 of the case retention indicator.

In addition, the case holding indicator 306 with its cylindrical body 406 accommodates and surrounds the case holding indicator inner member 314 as well as the case spring 308 . Four longitudinal tabs 408 of the case holding indicator 306 extend proximally through the gaps provided between the lateral tabs 364, 366 and the box structures 378, each protruding radially outward from the trigger 302. The four longitudinal tabs 408 extend past the trigger. member 302 such that the protrusions 412 of the tabs 408 engage the outer circumferential surface of the retainer 314, as can be seen in FIG. 44b and FIG. 44c.

The retainer 312 is rigidly held within the distal end cap 316 by a hollow cylindrical body 530 clamped by the inner circumferential lug into the outer circumferential groove 500 of the retainer in a positive fit. Thus, the holding device 312 is secured inside the device 10 from any movement in the axial direction, as well as from tilting.

The case holding indicator 306, together with the case holding indicator inner member 314, are held in an axial position by tabs 446 despite the compressed case spring 304 and the resulting axial driving forces. This is achieved by the fact that the tabs 446 extend through the longitudinal cutouts 482 of the retainer 312 and engage with their radial retainer lugs 454 behind the lateral lugs 484 of the retainer 312 overlapping the cutouts 382 of the retainer 312. Moreover, in this state, the outer circumferential surface of the plunger 308 located radially within the tabs 446 prevents the tabs 446 from bending radially inward and out of their holding function on the lateral projections 484.

The plunger 308 holds the main spring 310 in a compressed state, as described below. The proximal end of the compressed mainspring 310 is pressed against the proximal end of the plunger 308. It can be seen that the proximal end 422 of the plunger 308 is slidably accommodated within the hollow glass body 332 of the syringe 204 proximate the plug member 210. Moreover, the drug 208 can be seen as a column of liquid contained within the syringe 204. The distal end of the main spring 310 protrudes out of the plunger 308 and fits within the hollow interior of the retainer 310 where it is supported relative to its distal end. Plunger 308 is held in its axial position relative to the driving force of mainspring 310 by engagement between flexible tabs 474 with radial inward projections 480 that engage through holes 430 provided in plunger 308. As noted in the description above, additional through holes can be provided. 430 or slots with which the projections 480 engage. The longitudinal position of the projections 480 is fixed within the device, as is the longitudinal position of the through holes 430 defining the initial position of the plunger within the device. As shown, the plunger head 422 is fairly close to the plug 210, but with a smaller fill volume, the plug 210 may be closer to the proximal end and therefore further away from the plunger head 422. This can result in an undesirably violent impact between the plunger head 422 and 210. In such cases, additional through holes 430 longitudinally offset from the initial through holes 430 may be included in the plunger 308 to offset the initial position of the plunger 308. Because the flexible tabs 474 are held in position due to the contact between their radial outer lugs 478 and the inner circumferential surface of the firing element 302, the flexible legs 474 cannot flex radially outward in response to the driving force of the compressed mainspring 310. Thus, the plunger 308 is held by the flexible lugs and their radial inner lugs 480 on place.

From this fully assembled home position, the device 10 according to this example of the present invention is used as follows.

Unscrewing the removable end cap 50

In FIG. 45a-45d are views according to FIG. 44a-44d in a state in which the detachable cover is partially unscrewed from the longitudinal body. The removable end cap 50 has been rotated slightly with respect to the housing 104. No axial movement has occurred. The relative rotation was performed to such an extent that the engagement between the protrusions 198 formed inside the proximal end of the body 104 and the protrusions 86 and 88 formed on the annular inner portion 72 of the end cap body 52 was broken. To achieve this, it is necessary to provide a certain threshold of loosening force in order to overcome the engagement between the protrusions 198 of the body 104 and the protrusions 86, 88 of the removable end cap 50. 52 of the end cap is also broken during this relative movement. In this state, there is no axial engagement between the detachable end cap 50 and the body 104.

During further rotation between the removable end cap 50 and the housing 104, the protrusions 198 are guided along the inclined surfaces of the lifting formations 80, 82. is pressed out by the guard spring 304 in the proximal axial direction. While the protective cover 102 is pressed out of the longitudinal body 104 by its proximal portion 150, this force supports the removal of the removable end cap 50, and also maintains, through the use of mechanical advantages, the relative rotation between the removable end cap 50 and the body 104. Thus, sensing the force created by the spring 304, the user continues to further rotate the end cap 50 relative to the housing 104 and separates the two components from each other.

The proximal portion 150 of the guard 102, moving out of the housing 104, covers the needle. The relative movement between the guard 102 and the housing 104 is guided by the interaction between the protrusions 174 formed on each tab 152, 154 of the guard and the longitudinal through holes 220 which act as longitudinal guide channels.

Moreover, during the removal of the end cap 50, the rigid needle shield 202, which is engaged by the tabs 134 of the toothed spacer 54, is withdrawn, together with its sleeve 207, from the hollow conical glass portion 344 of the syringe 204. Due to the fact that the syringe 204 is supported pivotally within the holder for the syringe, unwanted coring can be avoided and the syringe is not damaged by removing the hard needle cover 202. Finally, the needle 206 with its needle tip 348 is exposed within the proximal body 150 in the form of a guard ring 102.

Removable end cap 50 separated from body 102

In FIG. 46a-46d are views according to FIGS. 44a-44d in a state in which the removable cover is completely removed from the longitudinal body and the device is ready to dispense a fluid product. It can be seen that the removable end cap 50 is completely separated from the body 104. The proximal portion 150 of the protective cover 102 fully protrudes from the body 104 and covers the injection needle 206 with its needle tip 348.

Initiating an injection by pressing the device against the patient's skin

In FIG. 47a-47d are views according to FIGS. 44a-44d in a state in which the device 10 is already pressed against the patient's skin with the protective cover partially pressed into the longitudinal body 104.

As can be seen, the proximal front surface of the proximal portion 150 of the protective cover 102 is in contact with the patient's skin S. The device 10, while holding the body 104, is pressed against the skin S of the patient. Thus, the protective cover 102 is pressed into the body 104, resulting in relative movement between the two components. Again, protrusions 174 formed on tabs 152, 154 of the guard 102 and engaging with the longitudinal holes 220 of the housing 104 guide the protective housing 102 along its relative linear movement with respect to the housing 104.

Due to the movement of the protective cover 102 into the housing 104 tabs 152, 154 press the trigger element 302 in the distal direction. Thus, the firing element 302 moves with its bevelled proximal rim 363 under the tabs 408 of the case holding indicator 306 . As a consequence, the tabs 408 bulge as shown in FIG. 47d.

Starting drug dosing by further pressing the device against the patient's skin

When the device 10 is pressed against the patient's skin S more strongly, so that the guard 102 moves further distally into the body 104, the needle 206 pierces the patient's skin, and finally the state as shown in FIG. 48a-48d. In FIG. 48a-48d are views according to FIGS. 44a-44d in a state in which the device is pressed against the patient's skin, the injection needle has pierced the patient's skin, the protective cover 102 is fully pressed into the longitudinal body 104, and the dosing of the fluid product is started.

Due to the relative movement between the guard 102 and the body 104, the needle 206 is exposed and protrudes into the patient's skin S. The protective cover 102 is pressed into the housing 104 to such an extent that when the spring 304 is compressed, it moves the trigger element 302 with its front surface 362 over the protrusions 478 of the flexible legs 474 of the retainer 314. Under the action of the main spring 310, the plunger 308 is pressed against the surrounding surface of the through holes 430 in axial direction. The surrounding surface of the through holes 430 engaging with the bevel of the radial inner protrusions 480 of the flexible tabs 474 presses the flexible tabs 474 of the holding device 312 in a radially outward direction under the force of the main spring 310. This is possible because the retainer has moved beyond the outer projections 478 of the flexible tabs 474 as shown in FIG. 48c. As a result, the flexible tabs 474 flex and release the plunger 308 for axial movement in the proximal direction.

Dosing the drug into the patient's tissue

In FIG. 49a-49d are views according to FIGS. 44a-44d in a state in which the fluid product has already been partially dosed. Since the plunger 308 is no longer held in an axial position by the flexible legs 374 of the retainer 312, the plunger 308 moves in the proximal direction, engages the plug member 210, and presses the locking member 210 in the proximal direction under the action of the main spring 310. Thus, the drug is squeezed out of the glass body 332 of the syringe 204 through the injection needle 206 into the patient's tissue as indicated by the three thin arrows.

This process continues until complete dosing of the drug into the patient's tissue.

Reaching the end of the dosing process and starting the indicator mechanism

In FIG. 50a-50d are views according to FIG. 44a-44d in a state in which the fluid product is almost completely dosed. At this stage of the device, the indicator mechanism starts. As can be seen, the plug-like member 210 has almost reached the proximal bottom surface of the cylindrical glass body 332 of the syringe 204. The plunger 308 has moved correspondingly far in the proximal direction due to the expansion of the main spring 310. Thus, the distal end of the plunger 308 has moved in the proximal direction beyond the end flexible longitudinal legs 446 of the inner element 314 of the casing holding indicator. Thus, the outer circumferential surface of the plunger 308 no longer blocks the radial inward flexion of the longitudinal legs 446.

Due to the compressed state of the spring 304, which is supported by the trigger 302 on the guard 104 and which tends to stretch in the distal direction, the distal end of the spring 304 is pressed against the distal end of the case holding indicator 306 and pushes the combined arrangement of the case holding indicator 306 together with the inner element 314 indicator holding the casing in the distal direction. Thus, the longitudinal flexible tabs 446, due to the inclined retaining projections 454, bend radially inward and pass the lateral projections 484 overlapping the cutouts 482. In this way, the combined housing retention indicator 306 arrangement, together with the casing retention indicator inner member 314, can move freely distally. direction.

As stated above, the outer circumferential surface 406 of the case holding indicator 306 has a signal color or pattern. As soon as it enters the transparent area of the distal end cap 316, which is transparent around the entire circumference, the user can see the signal color or pattern.

Indicator reaches end position

In FIG. 51a-51d are views according to FIGS. 44a-44d in a state in which the case holding indicator 306 reaches its end position. It can be seen that from the state of FIG. 50a-50d to the state of FIG. 51a-51d, the shroud retention indicator 306 is fully pressed into the distal end cap 316 by the action of the extension spring 304.

Upon reaching the distal inner bottom surface of the end cap 316, the inner sheath retention indicator member 314 strikes its end plate 456 against the inner bottom surface 532 of the distal end cap 316 and thereby generates an audible and/or tactile signal. This impact contact, achieved by the relaxation of the spring 304, acts in the axial direction and is clearly felt by the user. Furthermore, the sound it generates is loud enough to be heard by the user under normal conditions as a distinctly audible clicking signal. Thus, the user receives feedback from the device 10 immediately after reaching a state close to the end of the fluid dosing process.

It should be mentioned that the force of the spring 304 when releasing the combination from the combination of the case holding indicator 306 together with the case holding indicator inner member 314 in the distal direction is large enough to start this triggering function within a very short period of time, for example, milliseconds. or tenths of a second.

Reaching the end of the dosing process

As mentioned above, the alarm mechanism starts shortly before the end of the dosing process is reached. This is because the plug element 210 has not yet reached its end position within the glass syringe body 332 as shown in FIG. 51a when the alarm mechanism is triggered.

In FIG. 52a-52d are views according to FIG. 44a-44d in a state in which the fluid product is fully dosed. In this state, the plug 210 has reached the proximal end of the glass body 332 of the syringe 204. As a result, a full dose of drug is squeezed out of the syringe 204.

Start removing the device 10 from the patient's skin

When the dose has been fully dosed into the patient's tissue, the device 10 can be removed from the injection site. In FIG. 53a-53d are views according to FIGS. 44a-44d in a state in which the device is in the process of being removed from an injection site on the patient's skin, with the needle partially withdrawn from the patient's tissue and the protective cover partially released.

It can be seen that the body 104 of the device 10 is partially retracted from the skin of the patient, while the proximal front portion 150 of the protective cover 102 is still in contact with the skin S of the patient. This is because the still compressed spring 304 acts through the trigger 302 on the longitudinal tabs 152, 154 of the protective cover 102 and thereby extrudes the protective cover 102 from the housing 104 under the action of the compressed spring 304. Thus, the injection needle 206, which is pulled together with the body 104 of the patient's skin S, is permanently closed during this pulling process.

This can be seen in FIG. 53a-53d. When the housing 104 is retracted, the guard 102 with its proximal end portion 150 remains in contact with the skin S of the patient, so that the needle is permanently closed.

Complete removal of the device 10 from the patient's skin

Finally, the body 104 has been raised so far from the patient's skin that the needle is completely covered by the proximal end portion 150 of the guard 102, and the proximal end portion 150 extends beyond the pointed tip 348 of the needle, which is an injection needle. In other words, due to the action of the stretching spring 304, the guard 102 is pressed out of the body 104 to such an extent that it completely covers the needle and protrudes above the tip 348 of the needle.

In FIG. 54a-54d are views of FIG. 44a-44d in an intermediate state in which the device is in the process of being removed from an injection site on the patient's skin, with the needle fully withdrawn from the patient's tissue and the protective sheath more released.

In FIG. 55a-55d are views according to FIG. 44a-44d in a state in which the device is completely removed from the injection site on the patient's skin, while the needle is completely pulled out of the patient's tissue, and the protective cover is completely released. The axial end position of the protective cover 102, i.e. its final position after extrusion from the housing 104 under the action of the stretching spring 304, is determined by the abutment of the sharp proximal edges of the protrusions 174 to the proximal end of the longitudinal through holes 220. In this position, despite the force of the spring, all still applied by the spring 304 in the proximal direction, the guard 102 cannot be moved further in the proximal direction. The proximal portion 150 of the guard 102 has reached its position where it protrudes as much as possible out of the housing 104. In this position, the pointed tip 348 of the needle is positioned far beyond the proximal end of the portion 150 and is securely closed there.

Blocking the distal movement of the protective cover 102 after use

When the protective sheath 102 is pushed out of the housing 104 as described above, the combined arrangement formed by the sheath retention indicator 306 and the sheath retention indicator inner member 314 is held in the distal end position within the distal end cap 316. However, as described above, due to the spring the action of the spring 304 trigger element 302 moves in the proximal direction. Thus, the firing member 302 is forced out by the force of the spring, which is the spring 304, from the engagement of the tabs 408 of the casing holding indicator 306 . In other words, the tabs 408 flex again, as can be seen in FIG. 52a-52d to overcome the proximal beveled rim 363 of the trigger 302.

As trigger 302 continues to move proximally, the radially inner projections 412 of tabs 408 slide along the outer circumference of trigger 302 until they reach the beveled annular reinforcing rib 374 of trigger 302. This can be seen in FIG. 53a-53d. In response to further movement, as can be seen in FIG. 54a-54d, tabs 408 again flex radially outward to overcome beveled annular reinforcing rib 374.

Having passed the beveled annular reinforcing rib 374, the tabs 408, due to their inherent elasticity, snap radially inward and are gripped distally just behind the beveled annular reinforcing rib 374. The distal surface of the beveled annular reinforcing rib 374 is slightly inclined so that it has a concave conical profile. In addition, the protrusions 412 are suitably inclined so that they engage this concave conical profile with a positive fit. This engagement prevents any inadvertent further flexing of the tabs 408. Instead, it keeps the tabs 408 engaged with the concave conical distal surface of the annular reinforcing rib 374. Thus, the shroud retention indicator 306 blocks any distal movement of the trigger 302. As a consequence, any distal movement of the guard housing 102 is also blocked. This means that the protective cover 102, which has reached the state as shown in FIG. 55a-55d cannot be pressed into the longitudinal body 104.

This is shown in FIG. 56a-56d, which are views of FIG. 44a-44d in a state in which the device is completely removed from the injection site on the patient's skin, while the protective cover is locked against subsequent axial indentation. Once a force is applied in this state to the proximal portion 150 of the guard 102, tabs 408 of the guard holding indicator 306 block any distal movement. The case holding indicator 306 is maintained in this state by the inner member 314 of the case holding indicator, in particular its end plate 456, against the bottom surface 532 of the distal end cap 316. The latter, as mentioned above, is inseparably connected to the housing 104.

As a result, the guard 104 with its proximal portion 150 safely and permanently covers the needle 206 from any misuse.

Advantages

The device 10 according to the above-described example of the present invention, among other things, has the following advantageous features:

• The device 10 can be easily assembled from three different pre-assembled sub-assemblies: the syringe holder 100, the pre-filled syringe 200 and the power block 300.

• The pre-filled syringe 200 can be provided in a variety of shapes and sizes, requiring only the syringe holder 106 to be adapted.

• The distal end cap 50 can be easily removed from the housing 104 with the unscrewing operation supported by the action of the housing spring 304.

• During use of the device, the device emits an audible and/or tactile and/or visible signal of various operation states.

• As long as the drug is not delivered, the user can recognize this condition through the transparent case 104 or the window provided therein.

• The device does not display any visible indicator until the drug delivery is complete.

• When drug delivery is started by triggering the device by pressing it against the patient's skin, there is no way to stop drug delivery. This prevents the device from being reused.

• The device is simple and intuitive to use because it does not have a separate trigger, such as a button or the like. The trigger is caused by simply pressing the device with its protective cover 104 against the patient's skin.

• The device does not have turning sections and, accordingly, complex turning movements. This makes the device simple to manufacture, as well as simple and reliable to use.

Thus, the device provides an easy-to-assemble design with the ability to use different types of syringes. The device can be used simply and intuitively in a trouble-free manner. The device provides several feedback signals to the user.

Alternative examples for syringe holder

In FIG. 57 and 58 show an alternative example for a syringe holder 600. The syringe holder 600 is formed by two longitudinal shells 602, 604 which form a longitudinal slot 606, 608 therebetween. The two sheaths 602, 604 are connected by two flexible V-tabs 610, 612 at the distal and proximal portions, respectively, which provide circumferential flexibility to the syringe holder 600 and thereby allow the sheaths 602, 604 to elastically expand when the syringe is inserted. The syringe holder 600 further comprises, at its distal end 614 and near its proximal end 616, radial, outwardly protruding structures 618, 620 for securing the syringe holder within the body of the autoinjector.

In FIG. 58, a radial internal projection 622 can be seen which is formed within both sheaths 602, 604 to support the syringe in the axial direction after being inserted from the distal direction and received within the syringe holder 600.

In FIG. 59 and 60 show a further alternative example of a syringe holder 640. This syringe holder has a hollow cylindrical containing tube 642 with a distal end 644 and a proximal end 646. Similar to the example of FIG. 57 and 58, this syringe holder 640 also includes radial, outwardly projecting structures 648, 650 to retain the syringe holder within the body of the autoinjector.

Near its proximal end, the syringe holder is provided with two double-z shaped portions 652, 654 which comprise inclined flexible tabs 656, 658 connected to each other by a circumferential rib 660. , which is formed circumferentially within both flexible portions 652, 654 in a double-z shape to support the syringe in the axial direction after insertion from the distal direction and accommodation therein. In this syringe holder 640, the syringe is pushed from its distal end 644 with slight radial play inside the hollow cylindrical containing tube 642. 656, 658 are slightly arched so that the circumferential ribs 660 move in a radially outward direction.

Both alternative examples for the syringe holder according to FIG. 57-60 have a circumferentially closed design with features that provide some flexibility in the radial or circumferential direction. Thus, it is possible to easily assemble the pre-filled syringe with the syringe holder. The syringe is held by simply bending elements that are fed in a radially outward direction. In this way, tolerance variations of the glass syringe can be compensated for both in the radial outward direction and in the axial direction. However, the syringe holder is of a robust construction due to sheaths or a cylindrical containing tube.

In FIG. 61 shows an automatic mechanical drug delivery device 1010 configured as an auto-injector according to the present invention in a perspective side view. The device 1010 includes a longitudinal main body 1012 extending along the X axis and a removable end cap 1050 at the proximal end of the device. The end of the device 1010 on which the removable end cap 1050 is located is referred to in this description as the proximal end that will be in contact with the patient. The opposite end, shown in Fig. 61 on the right side, is called the distal end within this description.

The portion of the body 1012 is covered by a label 1014 that extends from the middle portion to the distal end portion of the device 1010. In the ready-to-use state shown in FIG. 61, a tamper-evident label 1016 can be seen which is adhered to the body 1012 as well as to the distal portion of the end cap 1050. When the end cap 1050 is removed, the tamper-evident label 1016 is torn and thus indicates that the end cap 1050 has been removed. .

In FIG. 61 also shows schematically two different planes A and B representing the planes of the longitudinal sections. Further, in describing the design and operation of the device 1010, reference will be made to these specific planes of the longitudinal sections.

In FIG. 62 shows three subassemblies of the device 1010. On the left, a syringe bay subassembly 1100 can be seen containing an end cap 1050. Near the syringe bay subassembly 1100, a subassembly can be seen containing a bay for the pre-filled syringe 1200. On the right, the subassembly can be seen as power block 1300. These three subassemblies 1100, 1200, and 1300 are provided as separate pre-assembled modules when the device 1010 of the present invention is assembled. This allows the syringe compartment 1100 and the power unit 1300 to be pre-assembled and to provide the respective pre-filled syringe 1200 with the desired drug provided therein in a sealed manner and a predetermined volume for drug delivery.

As will be seen below, the three subassemblies 1100, 1200, and 1300 can be assembled into a device by inserting a pre-filled syringe 1200 into the syringe housing 1100 and then inserting the power block 1300 from the right side into the open distal end of the main portion 1012 of the syringe compartment 1100 until until it is locked in a predetermined position. Due to this modular design, the device according to the present invention can be easily assembled without errors.

It should be noted that while a specific example of device 1010 is described below with respect to its construction and operation with respect to the figures, the components of device 1010 as described below can also be used independently of the respective design. In particular, each of the three subassemblies 1100, 1200 and 1300 and their components can be used separately and independently of the other subassemblies. For example, the proximal subassembly 1100 and its components may be used alone in another auto-injector, regardless of the specific design of the syringe compartment 1200 or the power block 1300. Therefore, the following description should not be construed as a limiting disclosure in the sense that any and all components may be used only in conjunction with the optional components described in the following context. Instead, the present invention should be understood in the sense that all components disclosed therein, without exception, can be separately claimed with their respective features, regardless of the interacting components of the respective subassemblies.

The components of the subassemblies are described in detail below.

In FIG. 3 is an exploded view of the syringe chamber subassembly 1100. This syringe chamber subassembly 1100 includes an end cap 1050 formed by an end cap body 1052, a toothed gasket 1054, and a proximal end cap plug 1056. Moreover, the syringe compartment subassembly 1100 includes a guard indicator 1102, a guard 1104, a retaining ring 1106, a longitudinal body 1108, and a syringe holder 1110. These components will be described in detail with respect to FIG. 66a-73 onward.

In FIG. 64 is an exploded view of the components of a subassembly forming a prefilled syringe 1200. This syringe subassembly includes a rigid needle sheath 1202, a glass body 1204 with an integral needle 1206, a drug 1208 shown as a liquid column, and a stopper 1210. These components of the pre-filled syringe 1200 will be described in detail with respect to FIG. 74-77.

In FIG. 65 shows an exploded view of the components of the subassembly forming the power block 1300. This power block subassembly 1300 includes a plunger 1302, an actuating spring 1304, a case retaining trigger 1306, and a case spring 1308. Moreover, the power block subassembly 1300 includes a case holding indicator 1310, a holding device 1312, a pivoting flip 1314, and a distal end cap 1316. These components will be described in detail with respect to FIG. 78a-83b onward.

In FIG. 66a and 66b show the end cap body 1052 in various perspective views. The cylindrical body can be seen having a series of integrally formed radial gripping ridges 1058 extending longitudinally from the proximal end of the body 1052 towards its middle. The distal portion is formed by a cylindrical main body having a smooth outer surface 1060. This surface contains arrow-shaped through holes 1059 that indicate the direction of movement for unscrewing the end cap 1050 relative to the main body 1012. Moreover, in FIG. 66a and 66b, two opposite retaining ribs 1061 can be seen which are provided on the inner peripheral surface of the end cap body 1052 and which are interrupted by through holes 1059, respectively. These retaining ribs 1061 are provided to retain the end cap body 1052 on the body 1108 when engaging the U-protrusion 1178, as will be discussed below with respect to FIG. 73.

In its inner part, the main part 1052 of the end cap contains an axially open containing part 1062 with a smooth containing surface. Adjacent to the enclosing portion 1062 is a portion formed as radial, inwardly extending ribs 1064. Following the portion containing the ribs 1064, the end cap main portion 1052 includes a stepped surface 66 dramatically increasing the inside diameter of the end cap main portion 1052. The stepped surface 1066 axially follows the shape of a closed sinusoid, acting as a drive curve, when it engages with a corresponding drive protrusion of the body 1108 to screw or unscrew the end cap 1050 relative to the main body 1012. additional radially inwardly extending ribs 1068 acting as contact means that engage with the outer circumferential surface of the body 1108.

In FIG. 67 shows a lid plug 1056. It contains a cylinder from the outer circumferential surface 1070 for insertion into the currently open containing part 1062 of the main part 1052 of the end cap with engagement with a press fit. The lid plug 1056 has a closed proximal end wall 1072. Extending axially distally from this end wall 1072, the lid plug 1056 provides an inner cylindrical ring 1074 to form radially inner ribs 1076. formation of a circumferential chamfer.

In FIG. 68 shows a toothed spacer 1054. The toothed spacer 1054 has a circular outer circumference 1080 surrounding a ring-shaped main body 1082. The toothed pad 1054 includes four radially inwardly extending tabs 1084 integrally formed with the annular body 1082 and terminating in a circular radially inner gripping surface 1086. In side view, it can be seen that the toothed pad 1054 has a frusto-conical shape, while the petals 1084 provide axial spring action, i.e., the petals 1084 can be elastically deflected in the axial direction.

In general, outer geometry 1080 of toothed spacer 1054 may be circular or any other geometry to suit assembly loads or available packaging space. There may be two or more extending tabs 1084 and the geometry of the teeth may be of any format to achieve certain insertion forces and any ability to withstand forces from the rigid needle sheath when the end cap is removed from the housing. In general, toothed spacer 1054 may be planar or flat. In other examples, the toothed spacer could also have some non-planar preformation, such as being tapered or wavy. To ensure this, it may be possible, for example, to form a rib around the outer rim of the toothed spacer. This may be to allow the toothed washer to rotate during cover removal. If the cover is rotated and the toothed gasket is only pulled longitudinally, an unfavorable condition called coring can be eliminated. Core formation occurs when the rubber of the rigid needle sheath rotates around the needle. After that, a rubber stopper may remain inside the needle, which is undesirable. This may cause a blockage preventing the device from functioning properly.

In the assembled state of the end cover 1050, the toothed gasket 1054 is located on the proximal surface of the ribs 1064 and is clamped by the ribs 1064 by pressing the cover plug 1056 into the housing portion 1062. The toothed gasket 1054 is thus rigidly held or located with some axial gap between the front surface 1086 of the cylindrical radially the outer portion of the cover plug 1056 and ribs 1064 to allow axial resilient deflection to grip the rigid needle sheath 1202 described below. The inner ring 1074 is located at a sufficient distance from the petals 1084 so that the petals can bend proximally in the axial direction.

In FIG. 69a and 69b show the protective cover 1104 in various perspective views. The protective cover 1104 includes a ring-shaped body 1112 with two diametrically opposed longitudinal tabs 1114, 1116. The ring-shaped body has a stepped and rounded outer surface profile so that it decreases in diameter from the cylindrical part 1118 to the projecting rounded front end part 1120 having an axial hole 1122. The inner diameter of the axial hole is slightly larger than the outer diameter of the rigid needle sheath 1202 to allow frictionless movement of the syringe with the rigid needle sheath 1202 through it. The front end portion 1120 of the protective cover 1104 is rounded and free of sharp edges, while being provided to come into contact with the patient's skin. Moreover, the protective cover 1104 of the device 1010 according to the present invention forms a trigger element when pressed with sufficient trigger force against the patient's skin. Therefore, this anterior end portion 1120 is formed to be smooth so that it does not injure or scratch the patient's skin.

The two longitudinal tabs 1114 and 1116 have a slightly rounded shape and contain, next to the cylindrical portion 1118, a longitudinal slotted through hole 1124, respectively. Therefore, the two through holes 1124 are provided in a position opposite from each other. These through holes 1124 act as guide means to guide the longitudinal movement of the needle sheath 1104 within the device 1010.

The ring-shaped main body 1112 of the needle sheath 1104 includes four radially inwardly extending ribs 1126. These internal ribs 1126 are provided to support the deflection resistance of the rigid needle sheath 1202 and thereby support the assembled position of the pre-filled syringe 1200, i.e. . during the transportation. Moreover, the ring-shaped body 1112 of the needle sheath 1104 includes two opposite through holes 1128 with a proximal wall 1129 and a distal wall 1130, each of which extends substantially in a direction perpendicular to the major X axis.

In FIG. 70 shows a guard indicator 1102. The guard indicator 1102 is formed as a thin-walled member capable of being connected to the ring-shaped proximal body 1112 of the needle guard 1104 by press-fit and/or snap-fit engagement. Alternatively, the guard indicator may be provided as simply a colored coating on the front surface of the needle guard 1104, or may be integrally molded as a colored portion of the needle guard 1104. To this end, the guard indicator 1102 has an inner surface profile corresponding to the outer surface profile of the ring-shaped body 1112 of the needle case 1104. The shield indicator 1102 is provided with a circumferential outer surface having a signal color, ie yellow, orange or red, which is clearly visible to the user. Thus, as will be discussed in detail with respect to the operation of the drug delivery device 1010 of the present invention, the user, i.e., healthcare professional or patient, of the device 1010 can readily recognize when the guard indicator 1102 protrudes outside the housing 1108 and covers the needle 1206.

In FIG. 71a and 71b show the design of the retaining ring 1106. The retaining ring 1106 is provided to engage with the guard 1104 during use when the guard 1104 is fully pressed into the housing 1108 when the device 1010 is started to deliver medication to a patient. Once engaged with the guard 1104, the retaining ring 1106 is permanently connected to the guard 1104 and prevents the guard 1104 from being pushed back into the housing 1108 a second time when the device has been used and after complete drug delivery.

The circlip 1106 includes a closed ring 1132 with two opposite recesses 1134. Radially within these recesses 1134, the circlip 1106 is provided with two flexible tabs 1136 formed on opposite tabs 1138 protruding radially inward from the circlip. In addition, the retaining ring includes two additional, radially inward protruding tabs 1140. Two flexible tabs 1136 protrude proximally and have a radially outwardly extending latch pin 1142, respectively. Moreover, at the proximal end, the flexible tabs 1136 have a front surface extending in a substantially radial direction.

In other examples, the ring may have a different cross-sectional geometry and the number of legs may be from one to several.

On the distal side of the closed ring 1132, the stop ring 1106 is provided with four slightly flexible tabs 1146 extending distally. Each of the flexible tabs 1146 has a snap-in tenon 1148 at its distal end extending radially inward with a slightly sloping distal wall 1150. Thus, each flexible tab 1146 provides a sharp, scalloped profile at its distal end. It is important to mention that the degree of flexibility of the tabs 1146 must be adapted to the spring rate 1308 so that the sliding forces of these tabs 1146 are less than the force of the guard spring. This is to ensure that post-injection blocking and removal of the device from the skin always works. This will be discussed further in the description of the operation.

In FIG. 72a and 72b show one example for a syringe holder 1110. The syringe holder 1110 is designed to receive and hold the pre-filled syringe 1204 within the housing 1108. It is adapted to accommodate different types of syringes with different volumes of drug without the need to significantly change the dimensions of other components of the device 1010. Therefore, the different sizes for the syringe holders 1110 should be provided for adaptation to different types of syringes.

The syringe holder 1110 provides a longitudinal tubular body 1152. At its proximal end, the tubular body 1152 has four protruding flexible tabs, with each tab 1154 of the first pair of two opposing tabs 1154 having a radially inward protruding tongue 1156 forming a gripping element. Each tab 1158 of the second pair of two opposite tabs 1158 has a chamfered tenon 1160 that is supported by an intersecting transverse support rib 1162. The chamfered tenon 1160 is provided with an inclined surface 1164 at its proximal portion. The distal end of the syringe holder 1110 has an angled bead 1166 with two recesses 1168 on opposite sides thereof. Bead 1166 has a radial portion 1170 and a longitudinal portion 1172, which are connected by a rounded transition. The radial portion 1170 may be rounded or chamfered at its transition to the longitudinal portion 1172 to facilitate assembly, in particular the insertion of the syringe holder 1110 together with the syringe 1200 into the housing 1108.

In FIG. 73a-73c show housing 1108 in different views. The body 1108 is intended to form the main body 1012 of the device 1010. It is formed from a strong, rigid, transparent or opaque material. While not completely transparent, the housing may be provided with cutouts or transparent medicament viewing windows to make the medicament and the actual state of the device visible to the user. The housing 1108 is formed by a longitudinal tubular piece 1174. At its proximal end, the tubular piece is provided with a front surface 1176 having a contour in the form of a closed sinusoid. Near the proximal end and front surface 1176, the body 1108 is provided with two U-shaped lateral projections 1178 that are opposite each other and project radially outward. U-shaped lateral projections 1178 are provided to receive retainer ribs 1061 of the end cap body 1052 described with respect to FIG. 66a to hold the end cap body 1052 in position on the body 1108 before use. At its distal end, the body has a circular front surface 1180. Near the end surface and in substantially longitudinal alignment with the projections 1178, the body 1108 has two opposing transverse slots 1182. In the area between the distal end and the slots 1182, the body is integrally formed with two pairs of raised bumps 1184. The raised bumps 1184 can also have an alternative shape. They function to provide anti-rolling features of the device 1010 on a flat surface. Each pair of bulges 1184 is aligned with a corresponding transverse slot 1182.

On its interior, the body 1108 is provided with a ring structure 1186 that is integrally connected to the tubular member 1174 by a pair of opposing rigid connecting tabs 1188. The connecting tabs 1188 are formed by a strong E-shaped structure with three longitudinal connecting ribs and one transverse connecting rib. The size of the connecting ribs and the E-shape are designed to provide the body 1108 with structural rigidity. This connection geometry is also important for material flow when the component is being molded. Moreover, the annular structure 1186 has a longitudinal apex 1190 with two V-notches 1192 opening distally and ending proximally on a radial circular base surface 1194. V-shaped cutouts 1192 are provided to accommodate the beveled studs 1160 with transverse support ribs 1162 of the syringe holder 1110. The longitudinal shoulder 1196 extends in the proximal direction from the base surface 1194. This geometry guides the movement of the guard 1104 during operation of the device 1010 and furthermore positions the syringe holder 1110 in place within the body 1108. The shoulder 1196 has a level of stiffness to withstand the loads applied by the syringe 1200 when the device is activated, as will be discussed. below.

In FIG. 74 and 75 show perspective views of the rigid needle sheath 1202 and its hub 1212. The rigid needle sheath 1202 is formed by a tubular member 1214 with an open distal end 1216 and a closed proximal end 1218. In its anterior portion it has a surface defined by transverse gripping ribs 1220 . Near its distal end, it has two opposite rectangular through holes 1222.

Sleeve 1212 shown in FIG. 75 is formed from a soft, deformable material and can be pressed into the rigid needle sheath 1202 so that it is rigidly held therein. It has an annular collar 1224 near its distal end that engages with rectangular through holes 1222 of the rigid needle sheath 1202.

In FIG. 76 shows a syringe 1204. The syringe 1204 is formed by a hollow cylindrical glass body 1230 having an open distal end 1232 which is surrounded by a circumferential annular collar 1234 with two flattened opposite side surfaces 1235. At its proximal portion, the cylindrical glass body 1230 has a rounded tapered portion 1233 and passes into a hollow conical glass part 1236. The hollow conical glass part 1236 ends in the proximal head 1238, in which said needle 1206 with a pointed needle tip 1240 is rigidly accommodated.

In FIG. 77 shows a plug-like element 1210 formed from a flexible material such as rubber. At its proximal portion, it has a smooth cylindrical outer circumferential surface 1242 that has a diameter adapted to the inner diameter of the hollow cylindrical glass body 1230 of the syringe, such that the plug member 1210 slidably engages the inner circumferential surface of the hollow cylindrical glass body 1230 impervious to fluid way. On the distal portion of the outer surface, the plug element 1210 is provided with four circumferential annular recesses defining three circumferential sealing ribs 1244. The plug element 1210 is cup-shaped with a closed proximal end 1246 and an open distal end 1248.

Moving on to the components of the power block, in FIG. 78a and 78b show the plunger 1302 in various perspective views. The plunger 1302 is formed by a longitudinal hollow element 1320 in the form of a pipe, which has at its proximal end the head 1322 of the plunger. The head 1322 of the plunger, which may be integral with the hollow element 1320 or as a separate part, has a cylindrical portion 1324 with an increased outer diameter in the example shown. This enlarged plunger head 1322 is used for large syringes, such as those having a drug volume of 2.25 ml instead of only 1 ml. In the case of smaller syringes, such as those having a drug volume of 1 ml, the enlarged plunger head 1322 can be omitted and the plunger 1302 is only a straight cylindrical shape at its proximal end. In the middle part of the plunger 1302, a pair of opposite rectangular through holes 1326 are provided in the wall of the hollow element 1320. At the distal end of the hollow element 1320, four longitudinal ribs 1328 are provided equidistantly around the circumference of the hollow element 1320. Moreover, the distal end of the plunger 1302 provides two slotted paths 1330 , opening to the distal end surface 1331, each of which has an inclined part 1332 and a longitudinal end part 1334.

In FIG. 79a and 79b show the case holding trigger 1306. The housing retention trigger 1306 is formed by a hollow liner 1340 having a radial annular collar 1342 integrally formed at its proximal end. The liner 1340 is provided with two opposing slits 1344 opening towards its distal end. Two opposing cuts 1344 provide longitudinal guide surfaces 1346 extending through the entire liner 1340.

In FIG. 80a and 80b depict a case holding indicator 1310. The case holding indicator 1310 is intended to provide a visible indicator for the actual state of use, in particular an indicator showing that the device 1010 has already been used to deliver a drug. It comprises an annular cylindrical body 1350 having on its proximal inner circumferential surface protruding radially inward ribs 1352. , the second part 1358 is inclined radially inward, and the third part 1360 extends in the longitudinal direction, however, at a level that is further radially inward than the first part 1356. At its proximal end, each of the tabs 1354 has a holding ledge 1362 extending radially outward.

In its middle portion, the annular cylindrical body 1350 has an annular flange 1364 extending in a radially outward direction. Two opposing arcuate wall members 1366 extend distally from the flange 1364. The outer circumferential surfaces 1368 of these arcuate wall members 1366 are provided with a signal color and/or a signal visible pattern.

In FIG. 81a and 81b, the holding device 1312 of the power block 1300 is shown. The holding device 1312 acts as a control part having a plurality of control functions of the power block 1300. The holding device is formed from a hollow cylindrical body 1370. On two opposite sides, the cylindrical body 1370 includes a U-shaped cutout 1372 forming a longitudinal flexible tab 1374. The longitudinal flexible tab 1374 is integrally connected to the hollow cylindrical body 1370 at its distal end 1376. protrusion 1380. Moreover, the cylindrical main body 1370 is provided with two opposite longitudinal cuts 1382 in a region rotated 90° relative to the flexible tabs 1374 formed by the cuts 1372. The longitudinal cuts 1382 extend at approximately the same length. longitudinal extension, as well as the U-shaped notch 1372. In the region of approximately one third of the longitudinal length of the notches 1382 near their proximal end, the cylindrical body 1370 contains lateral projections 1384 transversely overlapping the notches 1382.

At its proximal end, the cylindrical body 1370 is provided with two flexible tabs 1390 integrally formed with the cylindrical body 1370 and inclined at an angle of approximately 45° relative to the proximal front surface of the hollow cylindrical body 1370. These flexible tabs 1390 are connected to the part 1392 in the form ring-shaped heads. The annular head portion 1392 is formed as an insert together with the cylindrical portion 1394 and the proximal flange portion 1396. The head portion 1392 may be integral with the flexible tabs 1390, or formed as a separate part rigidly connected to the flexible tabs 1390, such as through an intermediate connecting ring.

At its distal end, the cylindrical body 1370 is formed with two opposing sets of outer longitudinal ridges 1400, 1402, 1404 extending radially outward from the cylindrical body 1370. enlarged diameter. This enlarged diameter cylindrical portion 1406 includes two opposing rounded lateral cutouts 1408 that are longitudinally aligned with the cutouts 1382 of the cylindrical body 1370. shape when viewed from the side. These protrusions 1410 are provided with a transverse slot 1412 in their middle portion, respectively.

In FIG. 82a and 82b depict a rotary clicker 1314. The rotary clicker is provided for changing the driving force of the mainspring 1304. It is formed by a hollow cylindrical bushing 1420 having a smooth proximal front surface 1422 and a distal surface formed with an annular top with shark teeth 1424. Radially inward from shark tooth vertices 1424, the pivoting flip member 1314 comprises two opposite cylindrical wall shaped portions 1426 that are separated by a transverse slot 1428. On the inner circumferential surface, the bushing 1420 is provided with protrusions to engage the main spring 1304 for common rotation with it.

In FIG. 83a and 83b depict the distal end cap 1316 of the device 1010. The distal end cap 1316 has a plate-shaped distal end cap main portion 1440 covering the distal opening of the housing 1108. To this end, the end cap main portion 1440 is formed with two protruding flexible tabs 1442 having projections. 1444 to engage at their proximal ends. These flexible tabs 1442 act as snap hooks to engage with corresponding openings 1182 of the body 1174. Moreover, radially inward from the flexible tabs 1442, the end cap body 1440 is formed with a hollow cylindrical body 1446. The hollow cylindrical body 1446 is provided with two opposing elements 1448 in in the form of a spout that extend in a radially outward direction. Moreover, the hollow cylindrical body 1446 is provided with two proximal elements 1450 with bevels extending in the longitudinal direction. Within the hollow cylindrical body 1446, on the surface of the end cap body 1440, an additional shark tooth apex 1452 is provided adapted to engage with the shark tooth apex 1424 formed on the rotary snap member 1314. shark teeth 1452 from the surface of the main part 1440 of the end cap in the proximal direction.

Next, the assembled state of the device 1010 is described with respect to FIG. 84a and FIG. 84b. This is also the initial state of the device 1010, i.e. the state of the device in which it is delivered to the user. In the assembled state of the device 1010, the end cap 1050 is removably attached to the longitudinal body 1108, with the end cap 1050 held by its retaining ribs 1061 and a corresponding recess within the U-shaped projections 1178 of the body 1108. The syringe 1204 is held within the syringe holder 1110, which is accommodated into the annular structure 1186 of the body 1108. Moreover, the syringe 1204 is pressed by its annular shoulder 1234 or flange through the head portion 1392 in the proximal direction against the structure 1186 with the ring of the body 1108, while the flexible tabs 1390 act as a spring mechanism providing the spring force axially to hold the syringe 1204 in place within the syringe holder 1110. The rigid needle sheath 1202 engages the hollow conical glass portion 1236 via the sleeve 1212. The soft sleeve 1212 securely covers the needle 1206 and maintains the sterility of the contacting needle and the medicament contained within. As can be seen, the outer surface of the tubular piece 1214 with the transverse ribs 1220 for gripping is engaged by the flexible tabs 1084 of the toothed gasket 1054. The toothed gasket 1054 is held within 1050 by the cover plug 1056.

Moreover, in FIG. 84b shows the main body 1112 in the form of a ring of the protective casing 1104. The protective casing 1104 is pressed by the end cover 1050 through the longitudinal tabs 1114, 1116 against the resistance of the casing spring 1308, while the casing holding trigger 1306 acts as a contact area between the longitudinal tabs 1114, 1116 and spring 1308 casing. The proximal end of the case spring 1308 engages with respect to the flange 1342 of the case holding trigger 1306 while the distal end of the case spring 1308 is pressed against the flange 1364 of the case holding indicator 1310.

The case holding indicator 1310 is held by its tabs 1354 in its axial position despite the compressed case spring 1308 and the resultant forces. This is achieved due to the fact that the tabs 1354 pass through the longitudinal cutouts 1382 of the retainer 1312 and engage with their radial retaining projections 1362 behind the lateral projections 1384 overlapping the cutouts 1382 of the retainer 1312. Moreover, in this state, the plunger 1302 located radially inside the tabs 1354, the tabs 1354 are prevented from bending radially inward.

The plunger 1302 holds the main spring 1304 in a compressed state. The proximal end of the main spring 1304 is pressed against the proximal end of the plunger 1302, which is attached to the head 1322 of the plunger. It can be seen that the plunger head 1322 is slidable within the hollow glass body 1230 of the syringe 1204 near the stopper element 1210. Moreover, in FIG. 84b shows drug 1208 as a liquid column contained within syringe 1204.

The distal end of the main spring 1304 protrudes from the plunger 1302 and fits inside the hollow interior of the rotary clicker 1314 where it is also non-rotatably engaged. The pivoting flipper 1314 is in turn housed within the hollow cylindrical body 1446 of the distal end cap 1316, with two sharktooth formations 1424 and 1452 engaging with each other. The relative rotation of the rotary click element 1314 and the distal end cap 1316 causes clicking sounds that are heard or felt by the user.

As can be seen in FIG. 84b on the right side, a cylindrical pin piece 1454 extends proximally into the hollow interior of the mainspring 1304 and acts as an axial guide for the compressed mainspring 1304. The distal end cap 1316 is inserted into the housing 1108, with the flexible tabs 1442 pointing radially outward. the engagement projections 1444 are engaged with the body transverse slots 1182 and thereby hold the distal end cap 1316 in place against the resulting spring forces.

From this fully assembled home position, the device 1010 according to this example of the present invention is used as follows.

To remove the end cap 1050, it is unscrewed from the body 1108 according to the direction of the arrow-shaped hole 1059. Thus, the tamper-evident label 1016 is torn. The unscrewing force must be large enough to overcome the interaction between the U-shaped protrusions 1178 on the housing 1108 containing the retaining ribs 1061 provided on the inner surface of the main body 1052 of the end cap. The unscrew movement follows the profile of the front surface 1176 in the form of a sinusoid of the body 1108. Due to the fact that the protective cover 1104 in the ready-to-use state is shifted by the casing spring 1308 towards the end cap 1050, the unscrewing movement of the end cover 1050 is supported by this shearing force of the casing spring 1308. Thus, after overcoming the initial resistance also provided by the tamper-evident label 1016, the unscrewing movement of the end cap 1050 is supported by the spring force and the user experiences a supported removal of the end cap 1050. 1050, the sheath spring 1308 expands axially and forces the sheath 1104 out of the sheath 1108 until it finally reaches its fully extended position where it covers the needle 1206. Moreover, during removal of the end cap 1050, the hard sheath 1202 for the needle, which is captured by the petals 1084 of the toothed gasket 1054, is removed with its sleeve 1212 from the hollow conical glass part 1236 of the syringe 1204. Thus, the needle 1206 with its needle tip 1240 is exposed inside the main body 1112 in the form of a ring of the protective cover 1104.

In other words, the removable end cap 1050 is held on the housing 1108 by the U-shaped projections 1178. A U-shape is shown, but many other geometric formats can be envisioned. Their function is to limit the middle part of the U-shape. This creates a pull force for the removable end cap 1050 in the event of a pull. The removable end cap 1050 has ribs 1061 in the middle of the arrow-shaped notch that contacts the middle of the U-shaped ledge 1178. An appropriate aligned corner that stops tearing and to corners that, when larger, require less tearing force. The ability of the 1059 plastic cutout area to form an arrow and an angle in combination allows the tear force to be adjusted to desired levels. The sides of the U-protrusion 1178 are rotated through a certain angle to adjust the initial torque required to initiate removal of the removable end cap 1050.

In FIG. 85a and 85b are longitudinal sectional views of a drug delivery device according to an example of the present invention in a state in which the end cap 1050 has just been completely removed, wherein FIG. 85a is a longitudinal section along plane A indicated in FIG. 61, while FIG. 85b is a longitudinal section along the plane B indicated in FIG. 61.

In this state, the protective cover 1104 protrudes with its annular main body 1112 from the housing 1108. The user can see the protective housing indicator 1102 with its signal color protruding from the housing. The case spring 1308 is in a partially relaxed but still substantially compressed state. The main spring 1304 is still fully compressed and is maintained in this fully compressed state due to the fact that the flexible legs 1374 of the retainer 1312 engage with the chamfered radial inward projections 1380 into the opposite rectangular through holes 1326 of the plunger 1302. Thus, the plunger 1302 is held with overcoming the resistance of the main spring 1304 in the axial position, preventing the main spring 1304 from stretching. The power block 1300 is preloaded.

The possible range of axial movement of the protective cover 1104 is determined by the length of the longitudinal slotted through holes 1124 in each of the longitudinal tabs 1114, 1116, which accommodate the spike 1160 with chamfers holder 1110 for the syringe. This can also be achieved in an alternative manner, i.e., with projections guided in longitudinal slots within the housing 1108 or the like. As discussed above, when assembled, the syringe holder 1110 is rigidly held within the housing 1108.

To use the device 1010, as shown in FIG. 85a and 85b, the device is placed on the patient's skin S at the site where the patient intends to administer the drug, for example, the patient's thigh. The device 1010 is then pushed by the user in a proximal direction against the patient's skin S. Thus, the guard 1104 is pressed into the body 1108 against the shear force of the case spring 1308, while due to the pushing movement of the device, the needle tip 1240 penetrates the patient's skin S and the needle 1206 is pushed through the patient's skin S into the patient's tissue. Finally, when fully pressed into the body 1108, the shroud 1104 strikes the distal end surface of its annular body 1112 against the proximal front surface of the connecting tabs 1188 that connect the body 1108 to the annular structure 1186. At this point, further axial movement of the guard 1104 into the housing 1108 is not possible and the guard 1104 is locked.

This position of the fully depressed guard 1104 is shown in FIG. 86a and 86b, which are longitudinal sectional views of the state when the drug delivery device has just been fully pressed against the patient's skin and drug delivery through it has just started.

In this state, the two flexible tabs 1136 of the retaining ring 1106 engage with their snapping pins 1142 into the respective holes 1128 of the ring-shaped body 1112 of the protective casing 1104. Thus, the retaining ring 1106 is rigidly attached to the protective casing 1104, allowing joint movement in axial direction during further use. Moreover, in this state, the protective case indicator 1102 is largely covered by the housing 1108 because the ring-shaped main body 1112 is substantially contained within the housing 1108.

As can be seen in FIG. 86b, by pushing the guard 1104 into the body, the two longitudinal tabs 1114, 1116 are moved distally while being guided by the engagement of the chamfered studs 1160 and the slots 1124. Thus, the case holding trigger 1306 is moved against the compression force of the case spring 1308 in distal direction. The casing retainer trigger 1306 is moved distally to the extent that it unlocks the beveled radial outer projections 1378 of the flexible legs 1374 of the retainer 1312. As a result, the flexible legs 1372 are free to flex radially outward. Due to the shift of the main spring 1304 pressing the plunger 1302 in the proximal direction, and due to the beveled design of the radial internal projections 1380 interacting with the correspondingly beveled rim of the through holes 1326 of the plunger 1302, the flexible legs 1374 are pushed radially outward by the plunger 1302 and thereby disengage from the holes 326 The plunger 1302 can then move proximally, contact the plug element 1210, move the plug element 1210 proximally within the glass body of the syringe 1204, and begin delivery, i.e., expel the drug through the needle 1206 into the patient's tissue. .

In FIG. 87a and 87b show longitudinal sectional views in an intermediate state when the drug delivery device delivers the drug to the patient, while the plunger 1302 has contacted the plug element 1210 and moved inside the syringe 1204 a certain distance to extrude the drug through the needle. In FIG. 87b, it can be clearly seen that the flexible tabs 1374 have been bent radially outward and released from the holes 1326. During this, the plunger 1302 moves in the proximal direction under the force of the main spring 1304, which tends to stretch.

Finally, the main spring 1304 brought the plunger 1302, and thereby the plug 1210, into close proximity to the rounded tapered portion 1233 of the syringe 1204. FIG. 88a and 88b are longitudinal sectional views showing this state when drug delivery is close to completion. In this state, the distal end of the plunger 1302, with its end surface 1331, extends only the proximal side of the radial, inwardly extending protrusions 1380 of the flexible legs 1374 of the retainer 1312. 1331. Moreover, this radially inward movement of the flexible tabs 1374 may provide some audible and/or tactile signal to the user as the proximal front of the flexible tabs 1374 strikes the circumferential outer surface of the distal end of the plunger 1302.

Moreover, as can be seen in FIG. 88b, in this state near the end of drug delivery, when the plunger 1302 is almost fully extended in the proximal direction within the syringe 1204, the plunger 1302 has also passed with its distal end surface 1331 the proximal end of the flexible legs 1354 of the sheath retention indicator 1310. Thus, the plunger 1302 unlocks in the radially inward direction the flexible tabs 1354 of the case holding indicator 1310. As a consequence, due to the shearing force of the housing compressed spring 1308, the beveled retaining lugs 1362 of the tabs 1354 slide along the proximal front surface of the lateral lugs 1384 transversely overlapping the notches 1382 of the retainer 1312. Thus, the flexible tabs 1354 are pushed radially inward and bent inward. The flexible legs 1354 can now freely pass the lateral projections 1384 in the distal direction. As the sheath compression spring 1308 seeks to expand, it moves the sheath holding indicator 1310 distally until it strikes the distal end cap 1316, resulting in an audible and/or tactile signal to the user.

Moreover, opposing arcuate wall pieces 1366 with their signal-coloured outer circumferential surfaces extend into the free circumferential space between the flexible tabs 1442. As mentioned above, the body 1108 is made of a transparent material. The label 1014 terminates at a significant distance, such as greater than 6-20 mm, from the proximal end of the body 1108, thereby providing a circular transparent window 1198 allowing the user to see the interior of the body 1108.

In the states shown in FIG. 84a, 84b-87a, 87b, the window is transparent. However, as shown in FIG. 89b, as soon as the casing retaining indicator 1310 is released by moving radially inward of the tabs 1354 and pressed by the casing spring 1308 in the distal direction, arcuate wall pieces 1366 with colored or patterned circumferential surfaces 1368 enter the circumferential void and are visible through said circular transparent window 1198. Thus, the user also fits a visible indication into window 1198 indicating that drug delivery has come to an end. In another example, this could be one or more windows if the label or package created opaque and transparent areas.

In FIG. 89a and 89b are longitudinal sectional views in a state where the drug delivery device has completely delivered the drug to the patient. It can be seen that the main spring 1304 is substantially weakened and has pressed the plunger 1302 together with the plug element 1210 completely against the inner surface of the rounded tapered portion 1233 of the syringe 1204. The medicament is completely extruded through the needle 1206 into the patient's tissue. The case holding indicator 1310 is fully pressed by the case spring 1308 to the distal end and can be viewed by the user through the window 1198.

The user knows from an audible and/or tactile signal, as well as a visual indication through the window 1198, that drug delivery has come to an end. The user then removes the device 1010 from their skin by retracting it axially, thereby removing the needle from their tissue. During removal of the device 1010 from his skin, i.e. during the removal of the needle from his tissue, the protective sheath 1104 remains in constant contact with the skin S of the patient until it completely closes and protrudes above the needle 1206 with its the tip of a 1240 needle. This is because the needle sheath is forced by the sheath spring 1308 along with the proximal sheath hold trigger 1306 out of the sheath 1108.

In FIG. 90a-90c show different views of the state when the drug delivery device has been removed from the patient's skin and secured in a locking state after use. The protective cover 1104, which is permanently connected to the retaining ring 1106 (see Fig. 86a), protrudes from the housing 1108. The retaining ring 1106, engaged by means of its flexible tabs 1136 with the corresponding holes 1128 in the main body 1112 in the form of a ring, blocks any further distal movement of the guard 1104 within the housing 1108. In other words, the retaining ring 1106 prevents the protective housing 1104 from being pushed back into the housing. Thus, the protective cover 1104 safely covers the needle 1206 with its needle tip 1240, which is contaminated with the patient's blood, from any manipulation or any contact with the patient or worker.

Blocking any movement in the distal direction of the guard 1104 is achieved by four flexible tabs 1146 formed on the distal side of the retaining ring 1106. due to the permanent engagement of the tabs 1136 with the guard 1104, the guard 1104 engages the circlip 1106 with this movement. Thus, the lock ring 1106 moves with its four flexible tabs 1146 through the outer circumferential surface of the structure 1186 with the ring formed in one piece inside the body 1108. bend radially inwards. Thus, the four flexible tabs 1146, with their distal wall 1150, snap radially inward in front of the proximal surface of the ring structure 1186. As a consequence, the flexible tabs 1146 act as fixed spacers between the guard 1104 and the proximal anterior surface of the ring structure 1186. The retaining ring 1106 prevents any relative distal movement of the guard 1104 into the housing 1108. Moreover, any further proximal movement of the guard 1104 out of the housing 1104, i.e., removal from the housing, is also prevented, since it is locked by the radial distal surface of the spikes 1160 c chamfers included with engagement in the longitudinal grooves 1124 tabs 1114, 1116.

Thus, any further use of the device 1010 is prevented. It is also not possible to unscrew or extrude the end cap 1050 onto the housing 1108, since it is blocked by the protruding and protective protective casing 1104. The user can see the colored casing indicator 1102, as well as the colored segments 1366 of the wall of the casing holding indicator 1310 through window 1198.

The device 1010 according to the above-described example of the present invention, among other things, has the following advantageous features:

• The device 1010 can be easily assembled from three different pre-assembled sub-assemblies: the syringe holder 1100, the pre-filled syringe 1200 and the power block 1300.

• The pre-filled syringe 1200 can be provided in a variety of shapes and sizes, requiring only adaptation of the syringe holder 1110.

• The distal end cap 1050 can be easily removed from the housing 1108 with the unscrewing operation supported by the action of the housing spring 1308.

• During use of the device, the device provides a variety of opportunities to emit an audible and/or tactile and/or visible signal of various operation states.

• While the drug is not delivered, the user can recognize this condition through the window 1198, which does not show any visible indicator until the drug delivery is completed.

• When drug delivery is started by triggering the device by pressing it against the patient's skin, there is no way to stop drug delivery. This prevents the device from being reused.

• The device is simple and intuitive to use because it does not have a separate trigger, such as a button or the like. The trigger is caused by simply pressing the device against the patient's skin with its protective cover 1104.

Thus, the device provides an easy-to-assemble design with the ability to use different types of syringes. The device can be used simply and intuitively in a trouble-free manner. The device provides several feedback signals to the user.

Claims (34)

1. An automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising: a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior; a removable cover configured to be installed on the proximal end of the housing; a syringe-like assembly disposed at a mounting position within the housing and having a hollow syringe body and an injection needle formed together with the hollow syringe body containing a fluid product; a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product; at the same time, the drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing, while the protective cover is shifted by means of the spring of the protective cover to a proximal position in which it protrudes outward from the proximal end of the longitudinal body to cover the tip of the needle, which is an injection needle, and the protective cover is movable to a distal position in which the injection the needle is exposed for injection; wherein the device further comprises a feedback mechanism providing visual feedback to the user indicating the actual state of operation, the feedback mechanism comprising a visual indicator that appears in a transparent window at the distal end of the housing, wherein the visual indicator comprises a case retention indicator piece releasably held in an invisible position in which the indication surface is not visible through the body's transparent window, the case retention indicator piece being displaced distally by the guard spring to move, upon release, to a visible position , in which the indication surface is visible through the transparent window of the case. 2. The device of claim. 1, in which a visual indicator appears in a transparent window at the distal end of the housing, indicating the end of the injection. 3. The device according to any one of the preceding claims, characterized in that the visual indicator is formed by a radial inner indicator component and a radial outer indicator component, shifted by the indicator spring into the indicator position, where the indicator is released into the indicator position shortly before the end of the delivery of a predetermined dose of medication to the patient. 4. The device of claim. 3, characterized in that the radial outer component of the indicator includes a visible surface and where the radial inner component of the indicator interacts with the housing or additional housing element, thereby producing an audible and/or tangible signal. 5. A device according to any one of the preceding claims, wherein the window is transparent around the entire circumference of the device, whereby the visual indicator appears over an angular range of up to 360°. 6. The device of claim. 5, in which the device includes a distal end cap, which is closed by a distal surface, and in which the distal end cap is made of a transparent material, forming a transparent window. 7. Device according to claim. 6, in which the distal surface is made of a transparent material. 8. The device according to any one of the preceding claims, characterized in that the retaining ring is placed inside the longitudinal housing in the initial position, where the retaining ring is fixed to the guard during operation, and where the retaining ring blocks the movement of the guard in the distal direction when the guard closes the needle after finishing dosing of the fluid product and removing the automatic drug delivery device from the injection site. 9. The device of claim. 8, characterized in that the retaining ring in its original position is held by a containing component holding the holder for the syringe, while the retaining ring is engaged with the protective casing after the protective casing has been pushed in the distal direction, while the retaining ring moves with the guard in a proximal direction when the AAD is removed from the injection site, and where the retaining ring blocks any movement of the guard relative to the enclosing component in a distal direction when the needle is closed after use. 10. The device according to any one of paragraphs. 1-7, characterized in that the protective casing has at least one longitudinal tab extending in the distal direction, guided inside the longitudinal casing, while the protective casing interacts with the protective casing spring, which shifts the protective casing in the proximal direction by means of at least one longitudinal tabs, and wherein the guard spring is supported between the case retainer trigger piece and the case retainer indicator piece, the case retainer trigger member supports the proximal end of the guard spring and applies a shearing force to the distal end of the longitudinal tabs of the guard, and the member The sheath hold indicator supports the distal end of the sheath spring. 11. The device according to claim 10, characterized in that the protective casing, when pushed in the distal direction in order to start dosing the fluid product, moves the part of the starting device for holding the casing in the distal direction so that it compresses the spring of the protective casing, where after a given stroke of the protective casing the sheath retainer actuating member releases the plunger from the retainer to move under the shear force of the drive spring in a proximal direction to expel and dispense fluid from the syringe body through the needle. 12. The device according to claim. 11, characterized in that the casing holding indicator includes at least one longitudinal holding tab, while the casing holding indicator is held by at least one holding tab in an invisible position using a holding device, and the indication surface is not visible through body, and at least one holding tab is held until the plunger reaches a predetermined dispensing position, and the plunger initiates the release of at least one holding tab from the holding device when the predetermined dispensing position is reached, and where after releasing at least one holding tab tabs, the case holding indicator is pushed by the protective case spring to a visible position, in which the indicated indication surface is visible through the case. 13. The apparatus of claim 12 wherein the sheath retention indicator piece has been released and moved to a visible position and the guard has been moved to a position where it covers the tip of the needle, the sheath retention indicator piece preventing distal movement of the sheath retention trigger piece, and the shroud retaining trigger piece prevents distal movement of the shroud. 14. The device according to any one of paragraphs. 11-13, wherein once the plunger is released from the retainer, proximal movement of the guard is prevented until the plunger has reached a predetermined dispensing position. 15. An automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising: a longitudinal body extending along the longitudinal axis and having a proximal end near the dispensing site, a distal end opposite the proximal end, and a hollow interior; a removable cover configured to be installed on the proximal end of the housing; a syringe-like assembly disposed at a mounting position within the housing and having a hollow syringe body and an injection needle formed together with the hollow syringe body containing a fluid product; a drive mechanism that can be triggered by the trigger element to start dispensing the fluid product; at the same time, the drive mechanism is functionally connected to the protective casing, made with the possibility of movement inside the longitudinal housing, wherein the guard is shifted to a proximal position in which it protrudes outward from the proximal end of the longitudinal body to cover the tip of a needle constituting an injection needle, and the guard is movable to a distal position in which the injection needle is exposed for injection ; wherein the protective cover has at least one longitudinal tab extending in the distal direction, guided inside the longitudinal body, while the protective cover interacts with the protective cover spring, which shifts the protective cover in the proximal direction by means of at least one longitudinal tab, and the spring of the guard retainer is supported between the guard retainer trigger piece and the guard retainer indicator piece, wherein the guard retainer trigger piece supports the proximal end of the guard spring and applies shearing force to the distal end of the guard retainer legs, and the guard retainer indicator piece supports the distal end protective cover springs. 16. The device according to claim 15, characterized in that the protective casing, when pushed in the distal direction in order to start dosing the fluid product, moves the part of the starting device for holding the casing in the distal direction so that it compresses the spring of the protective casing, where after a given stroke of the protective casing the sheath retainer actuating member releases the plunger from the retainer to move under the shear force of the drive spring in a proximal direction to expel and dispense fluid from the syringe body through the needle. 17. The device according to claim. 16, characterized in that the casing holding indicator includes at least one longitudinal holding tab, while the casing holding indicator can be held by at least one holding tab in an invisible position using a holding device, and the indication surface is not visible through the housing, wherein at least one holding tab can be held until the plunger reaches a predetermined dispensing position, wherein the plunger initiates the release of at least one holding tab from the retaining device upon reaching the predetermined dispensing position, and where after releasing at least of one holding tab, the casing holding indicator is pushed by the protective casing spring to a visible position, in which said indication surface is visible through the casing. 18. The apparatus of claim 17 wherein, after the sheath indicator piece has been released and moved to a visible position and the guard has been moved to a position where it covers the tip of the needle, the sheath retention indicator prevents distal movement of the sheath retention trigger piece , and the shroud retaining trigger piece prevents distal movement of the shroud. 19. The device according to any one of paragraphs. 16-18, wherein once the plunger is released from the retainer, proximal movement of the guard is prevented until the plunger has reached a predetermined dispensing position.

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