Improved autoinjector

Abstract

The invention relates to an autoinjector comprising: - a drive device (80) which has a first housing part (10a); - a product-container receiving device (90) which has a second housing part (10b) comprising a syringe holder (12) designed to receive a pre-filled complete syringe (11) and a movable stopper (26) for pouring a medication from the product container (11c); wherein the first housing part (10a) and the second housing part (10b) can be coaxially connected in the joining direction by a connection-side end portion (10w) being stepped on one of the two housing parts (10a, 10b) such that said end portion can be pushed into the other of the two housing parts (10a, 10b); wherein a first clip-in connection (10u, 10v) as well as a second and a third clip-in connection (10f, 10g) are provided in the region of the end portion (10w) and can be separately successively clipped in in the joining direction; and wherein, counter to the joining direction, the first of the clip-in connections (10u, 10v) is releasable and at least the third or final clip-in connection (10f, 10g) locks. The invention also relates to a method for the final assembly of an autoinjector.

Description

[0001] IMPROVED AUTOINJECTOR

[0002] TECHNICAL FIELD

[0003] The present invention relates to the field of medical injection devices for administering liquid substances, in particular medications or medicinal substances such as insulin and hormone preparations. The invention relates to an auto-injector with an energy storage device for dispensing a predetermined dose from a single-use product container.

[0004] BACKGROUND OF THE INVENTION

[0005] Injection devices or injection apparatuses for the simplified administration of a substance include, among others, so-called auto-injectors, which have an energy storage device with which the delivery can be carried out automatically, i.e., without any external force being applied or exerted by a user. The energy storage device advantageously stores the energy required for automatic substance delivery in mechanical form. Such an energy storage device can be a spring, which is installed in the injection device in a tensioned state and releases energy when released. The energy is delivered to a piston rod or a pressure element, which pushes a piston into a product container. The energy storage device can also be provided to automate the process of inserting an injection needle.Alternatively, the injection process can be carried out manually, i.e. exclusively by a user, without using energy stored in the injection device.

[0006] The injection device can comprise a product container holder for receiving a product container, wherein the product container can be held radially, axially, and preferably also rotationally fixed in the product container holder. The product container holder can be connected axially and rotationally fixed to the housing of the injection device, or can be movable relative to the housing during a piercing and / or needle retraction process. The product container can be a carpule for repeatedly detachable connection to disposable injection needles or a disposable pre-filled syringe with an injection needle permanently connected thereto. The product container has a hollow cylindrical product container section that slidably supports a piston or stopper. The piston can form a sealing gap with the inner circumference of the product container section and can be displaced in a distal direction by means of a piston rod in order to dispense product from the product container via the injection needle.

[0007] The injection device can have a needle protection sleeve which, after the injection has been completed, extends distally over the distal end of the injection needle or is moved into this position relative to the housing while a needle protection sleeve spring is released in order to prevent accidental access to the injection needle and reduce the risk of injury. In an auto-injector, the needle protection sleeve can also serve as a trigger element for initiating the product dispensing, with the needle protection sleeve being moved in the proximal direction relative to the housing for this purpose. Alternatively, the auto-injector can be triggered by pressing a trigger button on the auto-injector, with the needle protection sleeve serving at least as a visual screen before use of the auto-injector.

[0008] Patent application WO 2016 / 205963 describes an exemplary auto-injector comprising a housing with a longitudinal axis and a product container arranged axially fixedly within the housing. The auto-injector further comprises a needle protection sleeve which is displaceable in a longitudinal direction between a proximal and a distal position and is coupled to a needle protection spring. A spiral or drive spring, in which energy for the automatic dispensing of the product can be stored, is connected via a first end to the housing and via a second end in a rotationally fixed manner to a drive element in the form of a rotating threaded rod arranged coaxially to the longitudinal axis. The threaded rod engages via a thread in a drive element in the form of a drive sleeve which, when displaced in the distal direction, moves the plug of the product container at an approximately constant dispensing speed.

[0009] A mainspring drive unit is characterized by high forces and is therefore suitable for a delay-free start of dispensing, even in auto-injectors with a long storage life. A variable thread pitch of the threaded rod can compensate for a variable characteristic of the mainspring to ensure the most constant dispensing force possible. This allows even large dispensed volumes of 5 ml or more to be dispensed evenly and continuously within a maximum of 60 seconds. With a dispensing time of more than 10 seconds, which is longer than with conventional auto-injectors, the user should be able to verify at any time that the injection is progressing as intended to avoid inadvertently aborting the injection prematurely.

[0010] Patent application WO 2012 / 173554 shows a rotating display at the proximal end of an auto-injector, which is driven by a torsion spring during dispensing. The display comprises several segments with different colors to signal an initial state before dispensing begins and a final state after dispensing has completed. The segments are visible through at least one window at the proximal end of the auto-injector, the extent of which corresponds to the angular range of a segment.

[0011] The patent application published as CH 714527 A2 shows an injection device with a cap for removing a needle protection cap from a product container and a method for assembling an injection device, wherein the cap comprises an engagement element to effect removal of the needle protection cap from the product container upon removal of the cap from the injection device.

[0012] Patent application US 2014 / 0330214 A1 shows a display in the form of a rotating disc with multiple window openings and wall plates at the proximal end of an auto-injector. The rotating disc features alternating raised structures for visual signaling and is driven by a torsion spring during dispensing. The wall plates, alternating with window openings, allow an interrupted view of the rotating disc and the passing structures.

[0013] The patent application published as EP 3241580 A1 shows an improved snap connection between the cartridge holder and the device body. Reduced radial dimensions of the snap elements reduce the deformation of the cartridge holder during final assembly, thus increasing the protection against glass breakage of the cartridge.

[0014] The patent application published as WO 2013 / 076246 A1 shows an auto-injector with a front and rear housing telescopically coupled in a first or second position, which coupling can be opened by the user in the second position in order to insert a new syringe.

[0015] The patent application published as WO 2013 / 153011 A1 shows a cartridge holder that can be connected to a device housing via a snap connection. The snap connection provides improved force flow by engaging the projections in the device housing with rounded-corner windows on the cartridge holder.

[0016] The patent application published as WO 2016 / 055625 A1 shows an improved coupling of a cartridge holder to the outer housing of a delivery device. A first snap connection between the cartridge holder and the outer housing is supplemented by a separate, axially offset second connection between the cartridge holder and the outer housing, as well as by a third connection as an anti-twist device on a distally extending projection of the outer housing.

[0017] The term "product," "medicine," or "medicinal substance" in this context encompasses any flowable medicinal formulation suitable for controlled administration via a cannula or hollow needle into subcutaneous or intramuscular tissue, for example, a liquid, a solution, a gel, or a fine suspension containing one or more medicinally active ingredients. A medicament can therefore be a composition containing a single active ingredient or a premixed or co-formulated composition containing multiple active ingredients from a single container. The term particularly includes medicinal products such as peptides (e.g., insulins, insulin-containing medications, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active ingredients, hormone- or gene-based active ingredients, nutritional formulations, enzymes, and other substances in both solid (suspended) and liquid form.The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, auxiliary and carrier substances.

[0018] The term "distal" refers to a side or direction directed toward the front, piercing end of the delivery device or the tip of the injection needle. In contrast, "proximal" refers to a side or direction directed toward the rear, opposite end of the delivery device.

[0019] In this description, the term "injector" refers to a device in which the injection needle is removed from the tissue after a controlled amount of the medicinal substance has been delivered. Thus, unlike an infusion system, the injection needle in an injector does not remain in the tissue for a prolonged period of several hours.

[0020] PRESENTATION OF THE INVENTION

[0021] It is an object of the invention to create an improved and at the same time more cost-effective auto-injector of the type mentioned above. The assembly of the auto-injector or its components and the insertion of a product container during final assembly should be possible more reliably and the operation and handling of the auto-injector should be simpler and safer. The pre-assembly of components, or storage and transport as well as feeding thereof, which are separated in time and place from the final assembly of the auto-injector, should be ensured more simply and safely, in particular the integrity of the components should be maintained during transport and feeding. It is a further object of the invention to create a display for an auto-injector of the type mentioned above, which can visually indicate to the user the continuation or progression of a dispensing process in a wide variety of grip positions.The display should be designed in such a way that even in the case of unfavourable, in particular unintended, grip positions of the user's hand on the auto-injector, the user can see the continuation of the dispensing without having to change the grip position.

[0022] The objects are achieved by devices having the features of the independent claims. Preferred embodiments of the invention are the subject of the dependent claims.

[0023] An auto-injector according to the invention comprises a one-piece or multi-piece housing with a longitudinal axis and a prefilled syringe with a product container and an injection needle or cannula permanently attached thereto. The prefilled syringe is accommodated in the housing in an axially fixed manner, with a tip of the injection needle protruding distally beyond a distal housing end by at least one insertion depth. The auto-injector further comprises a torsion spring preloaded for a single dispensing of the maximum contents of the product container, a drive element, a propulsion element, and a needle protection sleeve. To dispense liquid from the product container through the injection needle, the torsion spring causes the drive element to rotate about the longitudinal axis, and the rotating drive element causes a linear movement of the propulsion element to displace a piston in the product container.When the auto-injector is pressed against an injection site, causing the injection needle to penetrate the injection site, the needle shield is moved proximally by one actuation stroke, thereby starting or enabling the delivery of fluid. The actuation stroke of the needle shield corresponds at least to the insertion depth of the injection needle.

[0024] Finally, the auto-injector comprises a display for signaling the continuation of a dispensing, comprising a display element driven by the drive element and rotating about the longitudinal axis, with an optical contrast pattern, and a window at the proximal end of the auto-injector through which the rotating contrast pattern is visible. The window extends completely 360° around the longitudinal axis, i.e., it is not interrupted by a frame or web parallel to the longitudinal axis, which would create a blind spot for the view of the display element. The window is made of a transparent and preferably stable or load-bearing material. As long as even the smallest part of the window remains visible, i.e., even if the user inadvertently covers a large part of the window with the hand holding the auto-injector, for example, by resting the ball of the hand on the proximal end, the rotating display element can be recognized.

[0025] The contrast pattern is at most discretely rotationally symmetrical about the longitudinal axis, but not continuously rotationally symmetrical, so that a rotation of the contrast pattern can also be detected. The contrast pattern comprises at least one area, zone or graphic element in a color or gray tone or brightness different from a background color, preferably in the form of graphic elements repeating in the direction of rotation, such as parallel lines, in particular parallel lines which are inclined and / or curved to the longitudinal axis of the auto-injector. The contrast pattern can have at least one to approximately 60, in particular 8 to 16 lines or areas or graphic elements. The contrast pattern contains in particular one of the physiologically easily perceptible colors green or black.

[0026] The display element can be manufactured or designed as follows.

[0027] The contrast pattern can be applied to the base body of the display element using the pad printing process.

[0028] The contrast pattern can be produced using two-component injection molding in different colors. The two components are preferably divided so that the first component, preferably made of PBT, contains the functional elements, such as the snap fasteners. This ensures that the functional elements are always produced using the same material and preferably in the same color. The visual, aesthetic elements, such as the contrast pattern, can be produced using the second component, preferably made of colored ABS or PP, and can vary in color.

[0029] The contrast pattern can be created using a laser process, preferably a UV laser, by locally removing material from the display element on the visible surface, creating a modified, particularly gray, structure. A laser process and suitable material selection can also be used to melt the surface of the display element, making pigments visible or causing the plastic to foam due to its ingredients, thereby changing the optical properties to create a contrasting effect. Alternatively, a laser or erosion can be used to locally remove finely structured material from the previously polished visible surface of the injection mold. This can create structures, particularly roof or cube structures, which are later transferred to the plastic part during injection molding. Such structures can have a depth or elevation of 0.01 to 0.5 mm.This is an advantageous design for sustainability reasons, as neither different materials are mixed for the component, nor is paint applied to the material, nor is the material locally modified by laser marking.

[0030] The contrast pattern can also be created by openings in the visible surface of the display element. These openings allow a view into the dark interior of the auto-injector, particularly the metallic spiral torsion spring.

[0031] An auto-injector according to the invention is suitable for dispensing the product quantity contained in the product container during a dispensing time of more than 10 s, preferably more than 20 s or 30 s, which is longer than known auto-injectors. As a result, even with product quantities of more than 2.25 ml and preferably at least 3 ml or 4 ml, a continuous or average dispensing rate is relatively low, so that the injected amount of medication can be continuously absorbed or absorbed by the subcutaneous tissue. Maintaining a minimum holding time between the end of dispensing and the movement of the auto-injector away from the puncture site is therefore less critical. Accordingly, no optical, acoustic, or tactile signaling is required to inform the user of the end of a holding time. In a preferred embodiment, the rotating display element is driven directly or immediately, in particular without a gear, by the drive element.The display element therefore rotates at the same speed as the drive element.

[0032] In a further preferred embodiment, the display element performs less than one rotation, preferably less than half a rotation, or even less than a third of a rotation per second during the dispensing process. This ensures that the rotational movement of the contrast pattern is easily tracked by the eye and does not blur into an indeterminate, rotationally symmetrical pattern for the observer.

[0033] In a preferred embodiment, neither the window nor the adjacent housing provide an optical marking for determining the relative rotational position of the contrast pattern. The indicator element does not indicate an initial or final state, nor does it provide a relative indication of the progress of the release; it serves exclusively to signal the progress or continuation of the release.

[0034] In a preferred embodiment, the rotating display element and the housing or the window are designed to generate a dispensing sound, which additionally acoustically signals to the user that the dispensing process is ongoing. The dispensing sound is preferably a continuous clicking sound generated by a grid on the window or housing and a radially or axially flexible engagement element on the display element engaging therein, or conversely by a rotating grid on the display element and a stationary engagement element. A separate optical, acoustic, and / or tactile signaling of the end of dispensing, for example, by a mechanically or electronically generated signal, can be dispensed with in this case, as is the case with a purely optical movement indicator.

[0035] In a preferred embodiment, the window has a first, cylindrical region parallel to the longitudinal axis, and a second region, which adjoins the first region seamlessly in the proximal direction and has a steadily or continuously decreasing diameter. The first region enables a view of the display element from any lateral viewing direction perpendicular to the longitudinal axis, and the second region enables a view of the display element in the distal viewing direction from behind, or from above when the auto-injector is held vertically. The second region is rounded or constricted in the proximal direction and can end in a third region perpendicular to the longitudinal axis. The display element can have a convex display surface following the shape of the window, or a conical display surface with a moderate inclination relative to the longitudinal axis.Preferably, the window is rotationally symmetrical with respect to the longitudinal axis, i.e. with circular cross-sections in cutting planes perpendicular to the longitudinal axis.

[0036] In an advantageous variant, the auto-injector comprises a needle protection sleeve which, in the delivered state of the auto-injector, protrudes distally beyond the housing and is pretensioned in the distal direction by a needle protection spring. When the auto-injector is pressed against an injection site, the needle protection sleeve executes an actuating movement in the proximal direction and, when the auto-injector is removed from the injection site, a needle protection movement in the distal direction in order to surround the injection needle laterally and radially cover it with a sleeve-shaped, preferably rotationally symmetrical section. The needle protection sleeve has an annular flange or foot at a distal end as an enlarged contact surface with the tissue around the injection site. The flange is permanently connected to the sleeve-shaped section and is preferably formed integrally with it. A maximum diameter of the flange is greater than a maximum diameter of the sleeve-shaped section.

[0037] Preferably, the outer edge or periphery of the flange is adapted to the shape of a distal opening in the housing. When inserted, the flange thus forms a closure of the housing. More preferably, the flange is concavely curved, so that the outer edge is located further distal than the transition between the flange and the sleeve-shaped section. Compared to a flange with a strictly flat, annular contact surface with an identical outer diameter, firstly, tilting of the attached auto-injector is less likely, and secondly, the concentration of the pressure load on the periphery of the flange furthest from the puncture site leads to less counterpressure in the tissue and thus less pain for the user.

[0038] The auto-injector further preferably comprises a threaded rod as the drive element and a drive sleeve with an internal thread as the drive element, or alternatively, a drive sleeve with an internal thread as the drive element and a threaded rod as the drive element, wherein the drive element has a groove or a cam as an axial guide element for an exclusively linear propulsion movement in the housing. The auto-injector is preferably dimensioned to accommodate a prefilled syringe comprising the product container and the injection needle, and having a filling volume of at least 3 ml, preferably at least 5 ml.

[0039] In summary and in other words, an autoinjector according to aspects of the invention can be designed as follows:

[0040] Autoinjector comprehensive

[0041] - a housing with a longitudinal axis L and for receiving a product container,

[0042] - a propulsion member and a rotating drive element for moving the propulsion member in the longitudinal direction and for automatically dispensing a liquid product contained in the product container through an injection needle,

[0043] - a display for signaling the continuation of a release, comprising a rotating display element driven by the drive element and having an optical contrast pattern, and comprising a window at the proximal end of the auto-injector through which the rotating contrast pattern is visible, characterized in that the window is a window which completely encircles the longitudinal axis.

[0044] Autoinjector where the rotating display element is directly driven by the drive element.

[0045] Auto-injector wherein the display element performs less than one, preferably less than half a rotation per second during a dispensing.

[0046] Auto-injector where no optical marking is provided to determine the rotational position of the contrast pattern.

[0047] Auto-injector wherein the rotating display element is designed to generate a dispensing sound.

[0048] Auto-injector, wherein the window has a first, cylindrical region parallel to the longitudinal axis, and a second region, seamlessly adjoining the first in the proximal direction, with a continuously decreasing diameter.

[0049] Autoinjector further comprehensive

[0050] - a needle protection sleeve which, in the delivery state of the auto-injector, projects distally beyond the housing, wherein when the auto-injector is pressed against an injection site, the needle protection sleeve executes an actuating movement in the proximal direction and when the auto-injector is removed from the injection site, executes a needle protection movement in the distal direction in order to surround the injection needle laterally with a sleeve-shaped section, wherein the needle protection sleeve has an annular flange at a distal end for contact with the injection site, with a maximum diameter which is greater than the maximum diameter of the sleeve-shaped section.

[0051] Autoinjector with an outer edge of the flange adapted to a distal opening in the housing.

[0052] Auto-injector with a concave flange.

[0053] Auto-injector wherein the drive element is a threaded rod and the propulsion element is a propulsion sleeve with an axial guide element for an exclusively linear propulsion movement in the housing.

[0054] Auto-injector further comprising a prefilled syringe comprising the product container and the injection needle, and having a filling volume of at least 3 ml, preferably at least 5 ml.

[0055] Further preferred embodiments of the invention, in particular for an improved autoinjector, are described below.

[0056] In a preferred embodiment, an auto-injector comprises a drive device having a sleeve-shaped first housing part comprising a drive assembly, having a spring coil with a mainspring, a drive element, in particular a threaded rod, a propulsion element, in particular a piston rod with an internal thread suitable for automatically propelling the plug, a product container receiving device having a sleeve-shaped second housing part defining a longitudinal axis which extends from distal to proximal, comprising a syringe holder designed to receive a pre-filled syringe with a cylindrical product container which tapers at its distal end over a shoulder with a needle protection cap of a needle and a plug which can be moved along the longitudinal axis by the drive assembly to dispense a medication from the product container, a device cap in which the needle protection cap can be received,wherein the first housing part and the second housing part are coaxially connectable in a joining direction, in that on one of the two housing parts, the connection-side end section is stepped so that it can be inserted into the other of the two housing parts, wherein an axially acting circumferential gap guide is formed between the two housing parts in the region of the end section, wherein in the region of the end section a first locking connection and a second or middle and a third or last, final locking connection are provided, which can be locked one after the other in the joining direction and wherein the first of the locking connections can be released non-destructively against the joining direction and at least the third or last locking connection is locked, in particular by positive locking. As a result, the housing parts,Can be connected sequentially in defined positions or defined linear movement steps in the joining direction, or can be released counter to the joining direction, which offers advantages for storage, transport, and further processing on a machine. The locking mechanism by at least the third or last locking connection cannot be opened non-destructively, thus improving the operating and tamper-proof nature of the auto-injector. With the third or last locking connection locked, the auto-injector achieves its configuration and / or dimension for delivery or use.

[0057] The auto-injector is preferably further developed in that the first housing part and the second housing part can be mutually connected in the joining direction by a linear movement parallel to the longitudinal axis or can be detached against the joining direction. The, in particular all insertion movements or the movements for joining the housing parts in and detaching the housing parts against the joining direction are aligned and in particular run exclusively in or parallel to the longitudinal axis. This does not include more complex movements of the housing parts which are caused, for example, by bayonet, screw or threaded closures. This enables cost-effective and precise handling of the parts on automatic assembly machines and the connectability / detachability means that the parts can be stored or transported together in a defined position relative to one another before final assembly, i.e. before a product container is inserted. The interior of the auto-injector pre-assembled in this way is protected.The parts connected in this way can be stored and transported as a unit in a module carrier in a space-saving and safe manner. The parts or assemblies connected in this way can be easily picked up by a machine, separated in a defined position for inserting the pre-filled syringe, then reconnected and finally assembled. The auto-injector is preferably further developed in such a way that the first snap-in connection, and the second and third snap-in connections define a first, second, and third snap-in position of the first housing part relative to the second housing part along the longitudinal axis. This allows for simplified automation and positioning on the assembly machine.

[0058] The auto-injector is preferably further developed in that the first, second, and third locking connections are formed from cams and grooves formed on the first and second housing parts, respectively, inside the gap guide. This increases protection against unauthorized opening and tamper resistance.

[0059] The auto-injector is preferably further developed in that one of the housing parts, with its radial step introducing the tapered end section, can be fully abutted all the way around the connection-side end of the other housing part, so that the two housing parts together form a seamless outer surface, which makes handling of the auto-injector safer. The radial step can be straight or continuously undulated or discontinuously stepped in the circumferential direction. The latter improves the anti-twist protection and can support the rotational positioning of the housing parts. Furthermore, the radial step can run at a right angle or at an angle to the axis. Alternatively, the step formed on one housing part can be interrupted all the way around the connection-side end of the other housing part.

[0060] The autoinjector is preferably further developed in that one of the housing parts, with its radial step introducing the end section, abuts the connection-side end of the other housing part all the way around when the third or last of the locking connections is positively locked. Because the joint thus formed remains closed by the locking mechanism, improved contamination resistance and tamper-proofing are achieved.

[0061] The auto-injector is preferably further developed in that the two housing parts have longitudinal guides in the region of the end section and / or form a non-circular cross-section of the gap guide. This results in an anti-twist lock and a defined mutual mounting position of the two housing parts. Preferably, the gap guide is not circularly centrally symmetrical in cross-section, in particular 2-fold or 4-fold centrally symmetrical, i.e., possible mounting positions arise every 180° or 90°. Further preferably, axially extending structures of the locking connections are mutually aligned on both housing parts with respect to the longitudinal axis of the auto-injector, thus forming longitudinal guides.

[0062] The auto-injector is preferably further developed in that one of the housing parts has at least one assembly opening at its end section, which is accessible from the outside at least in the first locking position and is completely covered by the other of the housing parts in at least the third or last locking position. This allows an assembly tool for final assembly to be inserted and removed before the final joining, and the opening required for this is then completely closed and is no longer visible from the outside. The assembly tool extending into the interior of the housing part can be used to hold a component that is movably mounted inside the housing and / or is subjected to force or torque in a defined location during an assembly movement and to release it again afterwards. For example, this can ensure that the component is snapped into place or anchored.

[0063] Preferably, the auto-injector is further developed in that the two housing parts can assume exactly three locking positions along the longitudinal axis.

[0064] Preferably, the auto-injector is further developed in that the two housing parts are secured to each other in the third or final locking position by adhesive bonding or welding, either alternatively or in addition to the locking connection. This increases the stability and precision of the connection and ensures the tightness of the butt joint between the two housing parts.

[0065] The autoinjector is preferably further developed by further comprising a syringe adapter, the distal end of which can be abutted against the proximal end of the pre-filled syringe. The proximal end of the syringe adapter is formed by an elastic element that is operatively connected to the first housing part. As a result, the syringe is held in the syringe holder without play and subjected to force in the distal direction, which reduces the risk of glass breakage.

[0066] The autoinjector is preferably further developed in that the elastic element of the syringe adapter, to which the support surface is connected, is pre-tensioned or further tensioned by the second joining step or by the movement into the third or final locking position. This simplifies the final assembly process.

[0067] The auto-injector is preferably further developed in such a way that the propulsion element can be screwed onto the drive element in a desired starting position. This allows the free play between the piston in the pre-filled syringe and the propulsion element to be eliminated in the fully assembled auto-injector and / or the starting position of the propulsion element to be adapted to the piston position of a partially filled pre-filled syringe.

[0068] In addition, the invention comprises a method for the final assembly of an auto-injector which defines a longitudinal axis, comprising several of the steps:

[0069] Providing a product container receiving device comprising a first housing part

[0070] Providing a drive device comprising a second housing part

[0071] Joining the housing parts in the joining direction into a first locking position defined by a first locking connection

[0072] Insertion, in particular lateral insertion of an assembly tool through a mounting opening on one of the housing parts when these are in the first locking position

[0073] Joining the housing parts in the joining direction into a second locking position which is held by a second locking connection of the housing parts

[0074] Removing the assembly tool from the assembly opening on one of the housing parts when they are in the second locking position

[0075] Joining the housing parts in the joining direction into a third locking position which is held and locked by a third locking connection of the housing parts

[0076] Completely covering the mounting opening on one of the housing parts by the other of the housing parts when they are in the third or last locking position

[0077] Setting or preparing an axial starting position for a propulsion element by screwing it onto a drive element. This allows the free play between the plunger in the pre-filled syringe and the propulsion element to be eliminated in the fully assembled auto-injector and / or the starting position of the propulsion element to be variably adjusted to the plunger position of a partially filled pre-filled syringe.

[0078] Positioning the product container receiving device and the

[0079] Drive device coaxial with the longitudinal axis and joining the housing parts in the joining direction into a locking position which is held by a locking connection of the housing parts that can be released in and against the joining direction

[0080] Storing and / or transporting the product container receiving device and the drive device connected together in the locking position of the housing parts

[0081] Providing a pre-filled syringe

[0082] Loosen the locking connection of the housing parts against the joining direction and separate the drive device from the product container holder. Insert the pre-filled syringe coaxially or axially parallel to the longitudinal axis into the product container holder.

[0083] Holding and / or positioning a component that is movable inside one of the housing parts by means of the assembly tool inserted through the assembly opening

[0084] Clamping an elastic syringe adapter when joining the housing parts from the second to the third or last locking position

[0085] Alternatively or additionally, the method for the final assembly of an auto-injector which defines a longitudinal axis may comprise several of the following steps:

[0086] Providing a product container receiving device comprising a first housing part

[0087] Providing a drive device comprising a second housing part

[0088] Positioning the product container receiving device and the

[0089] Drive device coaxial with the longitudinal axis and joining the housing parts by a linear movement into a first locking position of at least three locking positions along the longitudinal axis, which first locking position is held by a first locking connection of the housing parts which can be released non-destructively in and against the joining direction

[0090] Storing and / or transporting the product container holding device and the drive device connected together in the first locking position of the housing parts. This ensures the integrity and relative positioning of the device parts during storage or transport and enables simple and precise subsequent processing on an assembly machine.

[0091] Providing a pre-filled syringe

[0092] Loosen the locking connection of the housing parts and separate the drive device from the product container receiving device

[0093] Insert the pre-filled syringe coaxially or parallel to the longitudinal axis into the product container holder

[0094] Joining the housing parts by a linear movement along the longitudinal axis into the first locking position

[0095] Joining the housing parts by a linear movement along the longitudinal axis into a second locking position which is held by a second locking connection of the housing parts

[0096] Joining the housing parts by a linear movement along the longitudinal axis into a third locking position which is held and locked by a third locking connection of the housing parts

[0097] Clearing a mounting opening on one of the housing parts when they are in the first locking position

[0098] Holding and / or positioning a component that is movable inside one of the housing parts by means of an assembly tool that can be inserted through the exposed assembly opening, in particular a laterally insertable assembly tool

[0099] Removing the assembly tool from the assembly opening on one of the housing parts before or when they are in the second locking position

[0100] Completely covering the mounting opening by the other of the housing parts when they are in the third or last locking position

[0101] Clamping of an elastic syringe adapter during joining or through the joining movement of the housing parts from the second to the third or final locking position. The syringe adapter is arranged so that the elastic elements at least partially follow the joining movement.

[0102] FIGURES

[0103] Preferred embodiments of the invention are described below in conjunction with the attached figures. These are intended to illustrate basic possibilities of the invention and are in no way to be interpreted as limiting.

[0104] Fig. 1 the components of an autoinjector,

[0105] Fig. 2 two longitudinal sections through the autoinjector from Fig.1 before injection,

[0106] Fig. 3 two views of the display element,

[0107] Fig. 4 a view of the distal end of the needle protection sleeve,

[0108] Fig. 5 two views of a second embodiment of an auto-injector rotated by 90° against each other,

[0109] Fig. 6 the components of the autoinjector or the assemblies from Fig.5,

[0110] Fig. 7 two longitudinal sections of the autoinjector from Fig. 5 rotated by 90° against each other in the delivery state,

[0111] Fig. 8 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° in the trigger lock state,

[0112] Fig. 9 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° to each other in the state with the device cap including the needle protection cap removed, Fig. 10 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° to each other in the state with the needle protection cap removed,

[0113] Fig. 11a two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° in the drive release state,

[0114] Fig. 11b Partial section view of the coupling sleeve and the spring coil of the auto-injector from Fig. 5 in the drive release state,

[0115] Fig. 12a two longitudinal sections of the autoinjector from Fig. 5 rotated by 90° in the discharge state,

[0116] Fig. 12b Proximal view of the spring coil with the spiral spring of the auto-injector from Fig. 5,

[0117] Fig. 12c Cross-section from distal view of the display element with display window of the auto-injector from Fig. 5,

[0118] Fig. 13 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° relative to each other in the discharge state,

[0119] Fig. 14 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° relative to each other in the state needle protection lock activated,

[0120] Fig. 15a two longitudinal sections of the autoinjector from Fig. 5, rotated by 90° against each other, in the dispensing state, broken off,

[0121] Fig. 15b Partial section of the coupling sleeve and the spring coil of the auto-injector from Fig. 5 in the dispensing state,

[0122] Fig. 16 a view and a longitudinal section of the autoinjector from Fig. 5 in the pre-snapped state,

[0123] Fig. 17 two longitudinal sections of the product container receiving device with insert pre-assembled, rotated by 90° to each other,

[0124] Fig. 18 two longitudinal sections of the product container holding device with pre-assembled pre-filled syringe, rotated by 90° to each other,

[0125] Fig. 19 two longitudinal sections of the product container holding device with insert and pre-filled syringe, rotated by 90° to each other,

[0126] Fig. 20a a longitudinal section of the autoinjector from Fig. 5 after the first joining step,

[0127] Fig. 20b a longitudinal section of the autoinjector from Fig. 5 after the second final joining step,

[0128] Fig. 21a shows a longitudinal section of the product container receiving device for an exemplary piercing depth of 8 mm in the delivery state, Fig. 21b shows a longitudinal section of the product container receiving device for an exemplary piercing depth of 8 mm in the pierced state,

[0129] Fig. 22a shows a longitudinal section through the distal end of the product container receiving device for an exemplary piercing depth of 5 mm in the delivery state,

[0130] Fig. 22b shows a longitudinal section through the distal end of the product container receiving device for an exemplary piercing depth of 5 mm in the pierced state,

[0131] Fig. 23a shows a longitudinal section of the drive device as well as a view of the mainspring and the display window,

[0132] Fig. 23b shows a longitudinal section through the proximal end of the drive device as well as a view of a variant of the mainspring and the display window,

[0133] Fig. 24a shows a longitudinal section of the autoinjector from Fig. 5 with a fully filled pre-filled syringe,

[0134] Fig. 24b shows a longitudinal section of the autoinjector from Fig. 5 with a partially filled pre-filled syringe,

[0135] Fig. 25 shows two views of a variant of the autoinjector from Fig. 5 with a trigger sleeve

[0136] FIGURE DESCRIPTION

[0137] Fig. 1 is an exploded view of the components of an auto-injector according to the invention in a first embodiment, and Fig. 2 shows two longitudinal sections rotated by 90° to each other about the longitudinal axis through the auto-injector according to Fig. 1 in the inserted state and ready for dispensing.

[0138] The auto-injector 1 has a sleeve-shaped, elongated housing with a longitudinal axis L and comprising a distal housing part 10b and a proximal housing part 10a in the form of a handle, which is permanently snapped onto the distal housing part 10b. A product container in the form of a pre-filled syringe 11 with an injection needle permanently attached to the product container is held in a syringe holder 12, wherein the syringe holder is axially and rotationally fixedly received in the housing. The pre-filled syringe 11 is pressed distally into engagement with a shoulder of the syringe holder 12 by a retaining spring section 13a firmly anchored in the housing part 10a.The pre-filled syringe 11 is arranged with respect to the housing part 10b such that the tip of the injection needle protrudes beyond the distal end of a proximal intermediate position of the needle protection sleeve 14 by a length corresponding to the subcutaneous or intramuscular insertion depth and is at least laterally protected or covered by a needle protection sleeve 14 before and after the injection. When the injection needle is inserted into the injection site, the needle protection sleeve 14 is pushed in the proximal direction along the longitudinal axis L by an actuating stroke and against the force of a needle protection spring 15, thereby triggering a product release. For this purpose, the needle protection sleeve comprises two sleeve arms 14a, which are arranged offset or rotated by 90° around the longitudinal axis L relative to two recesses 10c of the housing, referred to as viewing windows.After the injection has been completed, the needle protection sleeve 14 can be moved relative to the housing part 10b from the actuated position along the longitudinal axis L in the distal direction into a needle protection position, where it can be locked against further retraction. The needle protection sleeve comprises a sleeve-shaped or hollow-cylindrical section 14b and a flange 14c at the distal end. The cross-section of the hollow-cylindrical section 14b is oval, just like the outer circumference of the flange, so that in this case the flange has a constant width or radial extension.

[0139] A spring assembly comprises a spiral spring 20a and a spring coil 20b. The spiral spring 20a is non-rotatably attached at its outer end to a spring sleeve 13b as part of a mechanism holder 13 firmly anchored in the housing. The inner end of the spiral spring 20a is non-rotatably connected to the spring coil 20b. The spring coil 20b comprises a spring shaft and a distal spring flange. The spiral spring 20a or the spring coil 20b sets a drive element 21 in a rotational movement and a propulsion element 22 in a preferably purely axial propulsion movement. For this purpose, a threaded element engages a thread with a variable thread pitch extending over the discharge stroke.

[0140] The pre-filled syringe 11 comprises a cylindrical syringe body as a product container, at the distal end of which a hollow injection needle is firmly connected to a syringe shoulder. The injection needle of the pre-filled syringe is covered by a needle protection cap 11a, which is designed as a so-called Rigid Needle Shield (RNS) and comprises a rubber-elastic needle protection element and a hard plastic shell. The needle protection cap protects the injection needle against mechanical influences and contamination, and keeps the injection needle and the product sterile. In its delivery state, a two-part device or pull-off cap 16 is arranged at the distal end of the auto-injector. This cap is axially pulled off and / or twisted off and completely removed together with the needle protection cap 11a before use of the auto-injector.

[0141] A switching sleeve 17 is arranged in a form-fitting manner with a proximal end of the sleeve arms 14a of the needle protection sleeve 14 and with a distal end of the needle protection spring 15, and is at least partially surrounded by the latter. The switching sleeve 17 is preferably snapped to the proximal end of the sleeve arms of the needle protection sleeve 14. The movement of the switching sleeve 17 in the distal direction is limited by the retaining spring section 13a, which in turn snaps to the mechanism holder 13 after the switching sleeve 17 has been installed. Arranged within and coaxial with the switching sleeve 17 is a locking sleeve 18, which is coupled to the switching sleeve 17 via a sawtooth-shaped locking member 18a spring-mounted on an arm pointing in the distal direction in such a way that an actuating movement of the needle protection sleeve 14 and the switching sleeve 17 also moves the locking sleeve 18 proximally.Through an additional proximal locking stroke of the locking sleeve 18 relative to the switching sleeve 17 into a proximal end position, the locking member 18a is safely released by the switching sleeve 17 for inward movement. Due to the spring action of the arm, the locking member 18a engages behind a proximally directed edge of the auto-injector or engages in an axially fixed recess of the auto-injector, thus locking the locking sleeve 18 against distal movement. When the auto-injector is removed from the puncture site, the switching sleeve 17 is pushed distally over the locking member 18a by the needle protection spring 15, whereupon the locking member, due to the spring action of the arm, engages behind a proximally directed edge of the switching sleeve 17 in a locking position and locks or blocks the switching sleeve and the needle protection sleeve against further movement in the proximal direction.

[0142] A coupling sleeve 23 with two retaining cams 23a is coupled to the spring coil 20b via coupling elements. Before release, the retaining cams 23a engage in recesses of the axially fixed mechanism holder 13 and are prevented from moving outward by an inner circumference of the locking sleeve 18, thus preventing the coupling sleeve 23 from moving axially. When release is triggered, the locking sleeve 18 is moved away from the position of the recesses by a proximal movement of the needle protection sleeve 14, so that the retaining cams 23a can be released radially and the coupling sleeve 23 is released. The latter moves in the proximal direction and releases the spring coil 20b for rotation, as described in detail in patent application PCTEP2021076923.At the proximal end of the auto-injector is the display with a rotating display element 25a with a contrast pattern in the form of parallel stripes, a circumferential transparent window 25b, and a proximal, non-transparent end 25c.

[0143] Fig. 3 shows two views of the display element 25a with an engagement element 25d for engaging a non-rotating grid on the inside of the window 25b or the closure 25c. The engagement element 25d is spring-mounted and, when the display element rotates during dispensing, generates a number of clicks corresponding to the grid. The display element 25a has a shape that follows that of the window 25b or is adapted to it, with a first, distal region and a second region adjoining it in the proximal direction. The first region is cylindrical, parallel to the longitudinal axis, while the second region has a continuously decreasing diameter.

[0144] Fig. 4 shows the distal end of the needle shield with the sleeve-like section 14b and the flange 14c. The shape of the flange with its concavely curved support surface is clearly visible, the outer, oval edge of which protrudes distally from the inner edge of the support surface at the transition to the axially parallel section.

[0145] Fig. 5 shows two views rotated by 90° relative to each other of a second embodiment of an auto-injector 1 according to the invention.

[0146] Fig. 6 is an exploded view of the components of a second embodiment of the improved auto-injector from Fig. 5. The auto-injector 1 has as assemblies a product container receiving device 90, a pre-filled syringe 11 and a drive device 80. The product container receiving device 90 has the following components: a device cap 16, an insert 30, a needle protection sleeve 14, a syringe housing part 10b and a syringe holder 12. The drive device 80 has the following components: a drive housing part 10a, a propulsion element 22, a drive element 21, a syringe adapter 13a, a switching sleeve 17, a locking sleeve 18, a needle protection spring 15, a coupling sleeve 23, a mechanism holder 13, a spring coil 20b, a spiral or mainspring 20a, an indicator element 25a, an indicator window 25b and an indicator cap 25c.The auto-injector 1 can be fully assembled from the two pre-assembled assemblies 80, 90, ready for storage and / or use, by inserting the pre-filled syringe 11 into the product container receiving device 90 and then firmly connecting, in particular snapping, the drive device 80 to the product container receiving device 90.

[0147] Fig. 7 (see also Figs. 6, 11b, 12b) shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90° relative to each other, in its delivery state and prior to use. The device cap 16 is permanently positioned axially relative to the insert 30 by the retaining cams 16b, which engage in the correspondingly arranged retaining openings 30c of the insert 30. The rotational positioning of the device cap 16 is achieved by its anti-rotation ribs 16a (inside the device cap, not shown), which engage with the correspondingly arranged anti-rotation grooves 30g of the insert 30, as well as the anti-rotation grooves 14e of the needle protection sleeve 14.

[0148] For positioning the insert 30, it has second retaining openings 30e, into which the correspondingly arranged and force-releasable retaining snaps 14d of the needle protection sleeve 14 engage. Furthermore, the retaining cams of the retaining arms 30a arranged at the proximal end of the insert 30 engage with the shoulder 11d of the needle protection cap 11a of the pre-filled syringe 11.

[0149] The needle protection sleeve 14 is positioned and secured against axial displacement in the distal direction by its holding openings 14f, into which the correspondingly arranged holding cams 10d of the syringe housing part 10b engage. The needle protection sleeve 14 also has further holding openings 14g, into which the correspondingly arranged and force-releasable holding cams 12e of the syringe holder 12 engage. The needle protection spring 15 exerts a defined preload force via the switching sleeve 17 onto the needle protection sleeve 14 with its distal spring end 15a, thereby defining its axial positioning. The rotational positioning of the needle protection sleeve 14 is achieved by its anti-rotation grooves 14h, into which the correspondingly arranged anti-rotation ribs 10e of the syringe housing part 10b engage.

[0150] The syringe housing part 10b, together with the drive housing part 10a, is considered a fixed part or, for information in this description, a reference housing. It is axially and permanently connected to the drive housing part 10a by its double snap groove 10f, whose distal and proximal grooves engage with the correspondingly arranged double retaining cams 10g of the drive housing part 10a. The rotational positioning of the syringe housing part 10b is achieved by its anti-rotation ribs 10h, which are in contact with the correspondingly arranged anti-rotation surfaces 10i of the drive housing part 10a. The syringe holder 12 is axially positioned by its retaining snaps 12f and by its bearing surfaces 12g, which are in contact with the correspondingly arranged bearing surfaces 10k, 10l of the syringe housing part 10b.The rotational positioning of the syringe holder 12 is achieved by its anti-rotation ribs 12h, which engage with the correspondingly arranged anti-rotation grooves 10m of the syringe housing part 10b. In addition, the rotational positioning of the syringe holder 12 is ensured by its anti-rotation ribs 12i, which are in contact with the correspondingly designed viewing window edge 1On of the syringe housing part 10b.

[0151] The pre-filled syringe 11 is axially positioned in the distal direction by its support surface 11d, which contacts the correspondingly arranged support edges 12c of the syringe holder 12, and in the proximal direction by its support surface 11e, which contacts the correspondingly arranged support surface 13c of the syringe adapter 13a. The flexible elements 13d of the syringe adapter 13a, to which the support surface 13c is connected, exert a defined preload on the pre-filled syringe 11. The pre-filled syringe 11 is rotationally free.

[0152] The syringe housing part 10b is considered together with the drive housing part 10a as a fixed part of the reference-forming housing.

[0153] The mechanism holder 13 is axially positioned by its retaining catches 13e and the support surfaces 13f, which are in contact with the correspondingly designed retaining cams 10o and the support surfaces 10p of the drive housing part 10a. The rotational positioning is ensured by the anti-rotation ribs 13g, which engage with the correspondingly arranged anti-rotation grooves 10q (not shown) of the drive housing part 10a.

[0154] The axial position of the propulsion element 22 is defined by its internal threaded portion 22a, which engages with the correspondingly designed external threaded portion 21a of the drive element 21. The rotational positioning of the propulsion element 22 is achieved by its axially extending anti-rotation rib 22b, which is guided in the correspondingly arranged anti-rotation groove 13h (not shown) of the mechanism holder 13.

[0155] The drive element 21 is axially positioned by its circumferential shoulder 21b, at the distal end of which the correspondingly arranged retaining snaps 13i of the mechanism holder 13 engage, and by its proximal bearing surface 21c, which is in contact with the correspondingly designed bearing surface 20c of the spring coil 20b. The rotational positioning of the drive element 21 is achieved by its anti-rotation surfaces 21d, which are in contact with the correspondingly designed anti-rotation surfaces 20d of the spring coil 20b.

[0156] The syringe adapter 13a is axially positioned by its retaining snaps 13j, which contact the correspondingly arranged retaining openings 13k, as well as by its bearing surfaces 131, which contact the correspondingly designed bearing surfaces 13m of the mechanism holder 13. The rotational positioning of the syringe adapter 13a is achieved by its anti-rotation grooves 13n, which engage the correspondingly arranged anti-rotation ribs 13o of the mechanism holder 13.

[0157] The switching sleeve 17 rests at its distal end with its support surfaces 17a, which are in contact with the correspondingly designed contact surfaces 14i of the needle protection sleeve 14, and is preloaded by the distal spring end 15a of the needle protection spring 15, which rests on the correspondingly designed spring support 17b of the switching sleeve 17, by the defined spring force of the needle protection spring 15. The rotational positioning of the switching sleeve 17 is achieved by its guide surfaces 17c, which engage with the correspondingly designed guide ribs lOr of the drive housing part 10a.

[0158] The locking sleeve 18 is axially positioned within the switching sleeve 17 with a defined amount of play. The locking sleeve 18 is limited in the distal direction by its inwardly directed retaining cams 18b, which engage the correspondingly arranged support surfaces 13p of the mechanism holder 13. In the proximal direction, the locking sleeve 18 is limited by the outwardly directed retaining cams 18c, which engage the correspondingly designed retaining openings 17d of the switching sleeve 17. The rotational positioning of the locking sleeve 18 is achieved by its inwardly directed guide surfaces 18d (not shown), which engage the correspondingly designed guide surfaces 13r of the mechanism holder 13, as well as by a positive fit with the switching sleeve 17.

[0159] The needle protection spring 15 is positioned by its distal spring end 15a, which rests on the correspondingly designed spring support 17b of the switching sleeve 17, and its proximal spring end 15b, which rests on the correspondingly designed spring support 23b of the coupling sleeve 23. The needle protection spring 15 exerts a defined preload between the switching sleeve 17 and the coupling sleeve 23 through its spring force. In addition, the needle protection spring 15 is guided with its outer surface by the internal guide ribs 10s of the drive housing part 10a and is laterally supported by circumferential aprons 23i.

[0160] The coupling sleeve 23 rests with its inwardly directed retaining cams 23c, which are in contact with the correspondingly arranged retaining surfaces 13s of the mechanism holder 13. The outwardly directed contact surfaces 23d, which are in contact with the correspondingly designed contact surfaces 18e of the locking sleeve 18, prevent the retaining arms 23e of the coupling sleeve 23 from deflecting outward. The axial position of the coupling sleeve 23 is defined by the defined preload of the spring force of the needle protection spring 15, which rests with its proximal spring end 15b against the correspondingly designed spring support 23b.The torque of the spiral spring 20a applied to the spring coil 20b is blocked by the inclined contact surfaces 20f of the coupling cams 20e, which are in contact with the correspondingly arranged contact surfaces 23f of the coupling cams 23a of the coupling sleeve 23. The angle of inclination of the contact surfaces 20f, 23f is defined such that the applied torque acts partly as an axial force on the coupling sleeve 23, whereby the coupling sleeve 23 is preloaded in the proximal direction. The rotational positioning of the coupling sleeve 23 is achieved by the holding arms 23e, which engage with the correspondingly designed guide openings 13t of the mechanism holder 13, as well as by the contact of the coupling cams 20e with the coupling cams 23a.

[0161] The spring coil 20b rests with its support surface 20g attached to the distal end against the correspondingly designed support surface 13q of the mechanism holder 13. The torque of the spiral spring 20a applied to the spring coil 20b is blocked by the inclined contact surfaces 20f of the coupling cams 20e, which are in contact with the correspondingly arranged contact surfaces 23f of the coupling cams 23a of the coupling sleeve 23. The angle of inclination of the contact surfaces 20f, 23f has been defined such that the applied torque acts partly as an axial force on the spring coil 20b, whereby the spring coil 20b is pressed against the mechanism holder 13 with a slight preload force and axially fixed.

[0162] The spiral spring 20a engages with its outer spring end 20h in the correspondingly designed spring receptacle 13u of the mechanism holder 13, and with its inner spring end 20i in the correspondingly designed spring receptacle 20j of the spring coil 20b. The spiral spring 20a is positioned axially between the spring coil 20b and the display element 25a. The outer spring end 20h is formed in one piece from the end section of the spring band. The outermost coil of the spring band is connected (for example, by spot welding or stamping or by mechanical anchoring) to form a sleeve-shaped ring, whereby a spring housing is integrally formed from the spring band.

[0163] The indicator element 25a is axially positioned by its support surface 25e, which contacts the correspondingly designed contact surface 20k, and by its retaining cams 25f, which engage with the correspondingly designed retaining cams 201 of the spring coil 20b. The rotational positioning of the indicator element 25a is achieved by the anti-rotation ribs 20m of the spring coil 20b, which engage with the correspondingly designed anti-rotation grooves 25g of the indicator element 25a.

[0164] The display window 25b is permanently positioned axially relative to the mechanism holder 13 by its retaining openings 25h, which engage with the correspondingly designed retaining cams 13v, and by its support surface 25i, which contacts the correspondingly designed contact surface 13w of the mechanism holder 13. The rotational positioning of the display window 25b is achieved by its anti-rotation grooves 25j, which engage with the correspondingly designed anti-rotation ribs 13x of the mechanism holder 13.

[0165] The indicator cap 25c is axially non-detachably and rotationally fixedly positioned to the latter by its retaining snaps 25k, which are in engagement with the correspondingly designed retaining openings 251, as well as by its support surface 25m, which is in contact with the correspondingly designed contact surface 25n.

[0166] Fig. 8 shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90° relative to each other, in the state of the trigger lock, which can be activated, for example, by a strong acceleration of the auto-injector.

[0167] When the needle protection sleeve 14 is moved in the proximal direction, the retaining catches 14d are deflected via the retaining openings 30e on the insert 30. The locking surface 14j abuts the locking surface 12j of the syringe holder 12, which is limited in the proximal direction by contact of the retaining catches 12f on the support surfaces 10k of the syringe housing part 10b. The locking catches 17e, which engage in the retaining openings 14k, limit the proximal movement of the switching sleeve 17 and thus also of the locking sleeve 18 to such an extent that the retaining arms 23e of the coupling sleeve 23 are always locked against deflection. This ensures that the injection cannot be triggered as long as the device cap 16 has not been removed.

[0168] Fig. 9 shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90° to each other, with the device cap including the needle protection cap removed.

[0169] During use, the device cap 16 is pulled distally from the auto-injector. The insert 30, which is permanently connected to the auto-injector by its retaining openings 30c and the retaining cams 16b of the device cap 16, is pulled off together with the device cap 16. This releases the force-releasable connection between the retaining snaps 14d of the needle protection sleeve 14 and the correspondingly designed retaining openings 30e of the insert 30.

[0170] The needle protection cap 11a, which is permanently connected to the insert 30 by its shoulder 11f and the retaining arms with retaining cams 30a, is pulled off together with the device cap 16 and the insert 30. In doing so, the clamping area 11g between the needle protection cap 11a and the pre-filled syringe 11, which can be released with force, is released.

[0171] Fig. 10 two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° relative to each other in the pierced state, with the torque on the spring coil 20b still blocked.

[0172] In order to insert the injection needle 11b of the pre-filled syringe 11 into the injection site, the auto-injector is pressed onto the injection site with its distal end during use. During the needle insertion process, the needle protection sleeve 14 is displaced in the proximal direction, whereby the needle, previously covered by the needle protection sleeve 14, is inserted into the skin. At the beginning of the needle insertion process, a defined release resistance must be overcome. For this purpose, the connection between the holding cams 12e of the syringe holder 12 and the correspondingly designed holding openings 14g of the needle protection sleeve 14, which can be released with the application of force, is released. The switching sleeve 17, the bearing surfaces 17a of which are in contact with the correspondingly designed contact surfaces 14i of the needle protection sleeve 14, is displaced together with the needle protection sleeve 14 in the proximal direction.The needle protection spring 15, which rests with its distal spring end 15a on the correspondingly designed spring support 17b of the switching sleeve 17 and with its proximal spring end 15b on the correspondingly designed spring support 23b of the coupling sleeve 23, is preloaded during the displacement of the needle protection sleeve 14 and the switching sleeve 17. The locking sleeve 18, which is in contact with the correspondingly designed holding surfaces 17f of the switching sleeve 17 with its locking cams 18f, is displaced together with the needle protection sleeve 14 and the switching sleeve 17 in the proximal direction. By displacing the locking sleeve 18 relative to the coupling sleeve 23, the contact surfaces 18e of the locking sleeve 18 are moved away from the contact surfaces 23d of the holding arms 23e of the coupling sleeve 23, whereby the holding arms 23e of the coupling sleeve 23 are no longer secured against deflection and can therefore deflect outwards.

[0173] Fig. 11a shows two longitudinal sections of the auto-injector from Fig. 5 in the drive release state, rotated by 90° relative to each other, and Fig. 11b shows a partial section view of the coupling sleeve and the spring coil of the auto-injector from Fig. 5 in the drive release state, immediately after the spring energy is released.

[0174] Due to the spring force of the needle protection spring 15, which has contact with its proximal spring end 15b to the correspondingly designed spring support 23b of the coupling sleeve 23, the coupling sleeve 23 is displaced in the proximal direction relative to the mechanism holder 13 and the spring coil 20b. The holding arms 23e of the coupling sleeve 23, previously released by the locking sleeve 18, deflect outwardly through their inwardly directed, inclined holding cams 23c, which previously had contact with the correspondingly designed holding surfaces 13s of the mechanism holder 13, whereby the outwardly directed holding surfaces 23g now make contact with the correspondingly designed holding surfaces 18g of the holding arms 18h of the locking sleeve 18.The contact between the contact surfaces 18i and the correspondingly designed contact surfaces 17g of the switching sleeve 17 prevents the holding arms 18h of the locking sleeve 18 from spreading outwards, whereby the coupling sleeve 23 is held in position relative to the mechanism holder 13 and the spring coil 20b by the locking sleeve 18. Due to the contact between the outwardly directed holding surfaces 23g of the coupling sleeve 23 and the correspondingly arranged holding surfaces 18g of the holding arms 18h of the locking sleeve 18, the locking sleeve is pulled by the coupling sleeve 23 in the proximal direction relative to the mechanism holder 13 until its bearing surfaces 18j rest against the correspondingly designed bearing surfaces 13y of the mechanism holder 13.

[0175] Due to the displacement of the coupling sleeve 23 relative to the spring coil 20b in the proximal direction, the coupling between the contact surfaces 23f of the coupling cams 23a of the coupling sleeve 23 and the correspondingly designed contact surfaces 20f of the distally arranged coupling cams 20e of the spring coil 20b has been released, whereby the stored spring energy of the spiral spring 20a is now released - Fig. 11b. Since the spring coil 20b is now no longer rotationally locked by the coupling to the coupling sleeve 23 and thus no longer axially preloaded relative to the mechanism holder 13, the spring coil 20b is displaced relative to the mechanism holder 13 and the display window 25b in the proximal direction due to the counterforce of the drive element 21 until its support surface 20n rests against the correspondingly designed support surface 25o of the display window 25b.

[0176] Fig. 12a shows two longitudinal sections of the auto-injector from Fig. 5 in the dispensing state, rotated by 90° to one another, Fig. 12b shows a view proximal to the spring coil 20b with the spiral spring (also called mainspring) 20a of the auto-injector 1 from Fig. 5 and Fig. 12c shows a cross-section from a distal view of the display element 25a with display window 25b of the auto-injector 1 from Fig. 5. The spring energy stored in the spiral spring 20a is passed on to the spring coil 20b via its inner spring end 20i, which is in engagement with the correspondingly designed spring receptacle 20j of the spring coil, whereby the spring coil 20b rotates. The spring coil 20b transmits its rotational movement to the drive element 21 via its anti-rotation surfaces 20d, which are in contact with the correspondingly designed anti-rotation surfaces 21d of the drive element 21 - Fig. 12b.The drive element 21 in turn drives the propulsion element 22 in the distal direction via its outwardly facing threaded portion 21a, which is in contact with the correspondingly designed inner threaded portion 22a of the propulsion element 22, wherein rotation of the propulsion element 22 is prevented by its outer anti-rotation ribs 22b, which are in engagement with the correspondingly designed inner anti-rotation grooves 13h (not shown) of the mechanism holder.

[0177] The plug 26 in the pre-filled syringe 11, which has contact with its contact surface 11h to the corresponding support surface 22c of the propulsion element 22, is displaced together with the propulsion element 22 in the distal direction, whereby the medication present in the pre-filled syringe 11 is dispensed through its injection needle 11b.

[0178] During the ongoing injection, the injection progress is visible to the user through the viewing window 10c of the syringe housing part 10b by looking at the stopper 26. Since the injection speed can be very slow and therefore difficult to perceive visually (e.g., 60 seconds of injection time for a fully filled pre-filled syringe), an additional injection movement indicator is integrated at the proximal end of the auto-injector. The indicator element 25a, with its support surface 25e abutting the correspondingly designed contact surfaces 20k of the spring coil, is axially snapped to the retaining cams 201 of the spring coil 20b by means of retaining cams 25f, and engages through its anti-twist grooves 25g in the anti-twist ribs 20m of the spring coil 20b, rotates together with the spring coil 20b relative to the display window 25b during the injection.This rotational movement of the display element 25a is visible to a user through the transparent display window 25b by an applied pattern 25p, thereby providing a user with additional and improved visual feedback on the ongoing injection.

[0179] In addition to the visual feedback, a user receives continuous, acoustic feedback on the ongoing injection in the form of clicking sounds generated between the rotating display element 25a and the stationary display window 25b. During the injection, the locking cams 25q attached to the radially deflectable spring arms 25d of the display element 25a slide over the corresponding radially designed notches 25r of the display window 25b. The spring arms 25d of the display element 25a are radially pretensioned and then released during rotation relative to the display window 25b, whereby a continuous, acoustic click becomes perceptible to the user. If the click frequency is to be adapted to a dispensing speed, the number of notches 25r can be varied. It is important to ensure that the pitch corresponds to the mounting positions of the spring arms 25d.For example, 2, 4, or 8 detents per revolution would be conceivable. - Fig. 12c shows a design with 4 detents 25r and two spring arms 25d.

[0180] The injection force pushes apart the two subassemblies, product container receiving device 90 and drive device 80, which are held together by the double snap groove 10f and double retaining cam 10g on the syringe housing part 10b and drive housing part 10a, respectively. In the distal direction, the injection force is transmitted via the interfaces 11d / 12c and 12g / 10l from the pre-filled syringe 11 via the syringe holder 12 to the syringe housing part 10b. In the proximal direction, the injection force is transmitted via the interfaces 22a / 21a, 21c / 20c, 20n / 25o, 25h / 13v and 13e / 10o from the propulsion element 22 via the drive element 21, the spring coil 20b, the display window 25b and the mechanism holder 13 to the drive housing part 10a.

[0181] Fig. 13 shows two longitudinal sections of the auto-injector from Fig. 5, rotated by 90° relative to each other, in the discharge completed state.

[0182] The displacement of the stopper 26 in the distal direction stops automatically as soon as its contact surface 11j located at the distal end strikes the corresponding contact surface 11i of the pre-filled syringe 11. The automatic injection is thus completed. The completed dispensing is visible to a user through the motionless display element 25a and the absence of the clicking sound caused by the relative movement of the display element 25a and the housing-mounted display window 25b.

[0183] Fig. 14 shows two longitudinal sections of the auto-injector from Fig. 5 rotated by 90° relative to each other in the state with the needle protection lock activated.

[0184] After the injection has been completed or the dispensing has ended, the needle protection sleeve 14, together with the switching sleeve 17, is moved back to its original position in the distal direction by the spring force of the needle protection spring 15 and is blocked against further insertion by the locking sleeve 18. The outwardly directed locking cams 18f of the locking arms 18a, as well as the locking surfaces 18k of the outwardly deflected holding arms 18h of the locking sleeve 18 come into contact with the correspondingly designed locking surfaces 17h and the locking surfaces 17i of the switching sleeve 17, whereby a further displacement of the switching sleeve 17 and thus the needle protection sleeve 14 in the proximal direction is prevented by the contact surfaces 17a being in positive contact with the correspondingly designed contact surfaces 14i.

[0185] During removal of the auto-injector 1 from the injection site, the needle protection sleeve 14 and the switching sleeve 17 are displaced distally back into their original positions by the spring force of the needle protection spring 15, which is in contact with the correspondingly designed spring support 17b of the switching sleeve 17 by its distal spring end 15a, and which in turn is in contact with the correspondingly designed contact surfaces 14i of the needle protection sleeve 14 by its support surfaces 17a, until the holding openings 14f of the needle protection sleeve 14 come into contact again with the holding cams 10d of the syringe housing part 10b. The switching sleeve 17 is displaced distally into its original position by the spring force of the needle protection spring 15, together with the needle protection sleeve 14.During the displacement of the switching sleeve 17 relative to the locking sleeve 18, the locking arms 18a of the locking sleeve 18 are briefly deflected inwards until the switching sleeve 17 has completely moved away from the locking cams 18f of the locking arms 18a, whereby the locking cams 18f of the locking arms 18a are now behind the proximal end of the switching sleeve.

[0186] 17 will come to rest.

[0187] The displacement of the switching sleeve 17 relative to the locking sleeve 18 causes its holding arms 18h, which were previously secured against deflection by their contact surfaces 18i, which were in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17, can now deflect outwards. The holding surfaces 23g of the holding arms 23e of the coupling sleeve 23, which were previously in contact with the correspondingly arranged holding surfaces 18g of the holding arms 18h of the locking sleeve

[0188] 18 contact and thus secured against displacement, the coupling sleeve 23 is now displaceable in the proximal direction relative to the locking sleeve 18 and the mechanism holder 13.

[0189] Due to the spring force of the needle protection spring 15, which is in contact with the correspondingly designed spring support 23b of the coupling sleeve 23 with its proximal spring end 15b, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until its support surfaces 23h rest against the correspondingly designed support surfaces 13z of the mechanism holder 13. In this case, the support arms 18h of the locking sleeve 18 are deflected outward by the support surfaces 23g of the support arms 23e of the coupling sleeve 23.

[0190] Fig. 15a shows two longitudinal sections of the auto-injector from Fig. 5 in the dispensing state, rotated by 90° relative to each other, and Fig. 15b shows a partial section view of the coupling sleeve and the spring coil of the auto-injector from Fig. 5 in the dispensing state.

[0191] An injection is aborted or the dispensing stopped if a user removes the auto-injector 1 from the injection site before the dispensing is complete, which also activates the automatic needle protection lock. At the same time, the automatic dispensing is stopped, thus preventing unwanted dripping of the remaining medication from the injection needle 11b.During removal of the auto-injector from the injection site, the needle protection sleeve 14 and the switching sleeve 17 are displaced distally back into their original positions by the spring force of the needle protection spring 15, which is in contact with the correspondingly designed spring support 17b of the switching sleeve 17 with its distal spring end 15a, and which in turn is in contact with the correspondingly designed contact surfaces 14i of the needle protection sleeve 14 through its support surfaces 17a, until the holding openings 14f of the needle protection sleeve 14 come into contact again with the holding cams 10d of the syringe housing part 10b.

[0192] The switching sleeve 17 is displaced distally into its original position by the spring force of the needle protection spring 15 together with the needle protection sleeve 14. During the displacement of the switching sleeve 17 relative to the locking sleeve 18, the locking arms 18a of the locking sleeve 18 are briefly deflected inwards until the switching sleeve 17 has completely moved away from the locking cams 18f of the locking arms 18a, whereby the locking cams 18f of the locking arms 18a are now behind the proximal end of the switching sleeve

[0193] 17 will come to rest.

[0194] The displacement of the switching sleeve 17 relative to the locking sleeve 18 causes its holding arms 18h, which were previously secured against deflection by their contact surfaces 18i, which were in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17, can now deflect outwards. The holding surfaces 23g of the holding arms 23e of the coupling sleeve 23, which were previously in contact with the correspondingly arranged holding surfaces 18g of the holding arms 18h of the locking sleeve

[0195] 18 contact and thus secured against displacement, the coupling sleeve 23 can now move in the proximal direction relative to the locking sleeve 18 and the mechanism holder 13.

[0196] Due to the spring force of the needle protection spring 15, which is in contact with the correspondingly designed spring support 23b of the coupling sleeve 23 with its proximal spring end 15b, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until its support surfaces 23h rest against the correspondingly designed support surfaces 13z of the mechanism holder 13. In this case, the support arms 18h of the locking sleeve 18 are deflected outward by the support surfaces 23g of the support arms 23e of the coupling sleeve 23.

[0197] The displacement of the coupling sleeve 23 in the proximal direction relative to the spring coil 20b causes its contact surfaces 23f of the coupling cams 23a to engage with the corresponding contact surfaces 20o of the proximally arranged coupling cams 20p of the spring coil 20b - Fig. 15b. This blocks the rotation of the spring coil 20b and stops the automatic release.

[0198] After an injection has been aborted by a user, the axial position of the stopper 26 of the pre-filled syringe 11 can be seen through the viewing window 10c of the syringe housing part, whereby a user can estimate how much injection volume has been delivered or how much residual medication is still left.

[0199] Fig. 16 shows a view and a longitudinal section of the auto-injector 1 from Fig. 5 in the pre-snapped state. The pre-snapped state is the initial state for the assembly of a pre-filled syringe and the final assembly of the auto-injector 1. In the pre-snapped state, the two sub-assemblies, drive device 80 and product container receiving device 90, are separably connected to one another and can be securely stored and transported in a defined position relative to one another thanks to the force-fitting axial and form-fitting rotational fixation. The sub-assemblies, product container receiving device 90 and drive device 80, are pre-snapped between the syringe housing part 10b and the drive housing part 10a by means of the releasable snap connection 10v / 10u. For this purpose, the locking cam 10u on the drive housing part 10a engages behind the proximal edge of the locking groove 10v in the syringe housing part 10b.Furthermore, the distal side of the double retaining cam 10g abuts the proximal edge of the double retaining groove 10f, thus positioning the housing parts 10a, 10b axially relative to one another at a defined distance, as shown in Fig. 16. A circumferential step 10y introduces a distal end section 10w on the drive housing part 10a. The mounting windows 10t in the distal end section 10w of the drive housing part 10a are visible and accessible from the outside. The end section 10w is partially inserted into the proximal end of the syringe housing part 10b, whereby a circumferential, axially acting gap guide 10x is formed between the two housing parts 10a, 10b in the region of the end section 10w.

[0200] Fig. 17 shows two longitudinal sections of the product container receiving device 90 with the pre-assembled insert 30, rotated by 90° relative to each other. The drive device 80 was removed from the pre-snapped auto-injector in a first step, and the product container receiving device 90 is thus ready to receive a pre-filled syringe through the proximal opening in a single joining process. In the pre-assembled state, the insert 30, with its distal retaining openings 30b, engages with the correspondingly designed retaining cams 16b of the device cap 16. Furthermore, the retaining snaps 14d of the needle protection sleeve 14, which can be released with force, engage the correspondingly designed retaining openings 30d of the insert 30, thereby positioning the insert 30 relative to the other parts of the product container receiving device 90.In this state, the holding slots 3 Qj of the holding arms 30a are positioned relative to the correspondingly arranged holding ribs 12a of the syringe holder 12 in such a way that the flexible holding arms with the holding cams 30a can deflect outwards, whereby the holding ribs 12a of the syringe holder 12 move into the holding slots 3 Qj of the holding arms 30a or the holding arms 30a find space in the axially running recesses next to the holding ribs 12a.

[0201] Fig. 18 shows two longitudinal sections of the product container receiving device 90 with pre-assembled pre-filled syringe 11 (PFS with RNS), rotated by 90° relative to one another. The pre-filled syringe 11 is inserted axially in the distal direction into the product container receiving device 90 until its support surface 11d comes into contact with the correspondingly designed holding arms with holding cams 30a as well as the support surfaces 30h of the insert 30. During this joining process of the pre-filled syringe 11, the holding cams of the flexible holding arms 30a of the insert 30 slide over the outer surface of the needle protection cap 11a of the pre-filled syringe 11 until the holding cams elastically snap into place or come to rest on the holding arm 30a proximal to the shoulder 11f of the needle protection cap 11a.

[0202] Fig. 19 shows two longitudinal sections of the product container receiving device 90 with insert 30 and pre-filled syringe 11 (PFS with RNS) finally assembled, rotated by 90° to one another. For this final assembly step, the pre-filled syringe 11 is inserted further axially in the distal direction into the auto-injector until its contact surfaces or shoulder 11d come into contact with the correspondingly arranged contact edges 12c of the syringe holder 12. Due to the contact of the contact surface 11d of the pre-filled syringe 11 with the correspondingly designed retaining cams 30a and the front-side contact surfaces 30h of the insert 30, the insert 30 is pushed distally relative to the device cap 16. In this process, the retaining cams 16b switch from the distal retaining openings 30b to the proximal retaining openings 30c. In addition, the retaining snap 14d of the needle protection sleeve 14 changes from the retaining opening 30d into the correspondingly designed proximal retaining openings 30e of the insert 30.Through this final assembly step, the holding arms with the holding cams 30a now reach under the holding ribs 12a of the syringe holder 12, or the holding slots 30j of the holding arms no longer expose the holding ribs 12a of the syringe holder 12, thereby preventing the flexible holding arms with the holding cams 30a of the insert 30 from deflecting outward. Thus, the engagement of the holding cams 30a with the RNS shoulder 11f of the pre-filled syringe 11 is secured in a form-fitting manner.

[0203] Fig. 20a shows a longitudinal section of the product container receiving device 90 with mounted pre-filled syringe 11 after a first joining step of the drive device 80. During this first joining step, an assembly tool (not shown) can be inserted laterally through the assembly window 10t (see Fig. 16) and fix the switching sleeve 17 axially relative to the housing part 10a by engaging in the assembly groove 17j (see Fig. 6), thus ensuring that the locking snap 17e on the held switching sleeve 17 can deflect into the holding opening 14k of the needle protection sleeve 14 during the first joining step.

[0204] Fig. 20b shows a longitudinal section of the product container receiving device 90 with the pre-filled syringe 11 mounted after a second final joining step of the drive device 80. Before this second joining step, the assembly tool (not shown) is removed. In this second joining step, the drive device 80 is inserted axially in a linear movement along the gap guide 10x until it stops at the step 10y into the product container receiving device 90, wherein the double retaining cams 10g snap into their respective corresponding double snap grooves 10f and connect the drive device 80 in a form-fitting and thus non-detachable manner to the product container receiving device 90.During the second joining step, the mounting windows 10t at the distal end section 10w of the drive housing part 10a are covered by the circumferential sleeve-shaped end of the syringe housing part 10b, whereby the outer shell of the finally assembled auto-injector 1 is not interrupted by any disturbing openings and the interior of the auto-injector 1 remains protected. The support surface 13c of the syringe adapter 13a is axially positioned by the support surface 11e at the proximal end of the pre-filled syringe 11, whereby the flexible elements 13d of the syringe adapter 13a, to which the support surface 13c is connected, are pre-tensioned by the second joining step. With auto-injector variants, needle penetration depths of, for example, approximately 3-15 mm into the skin should be possible. Fig. 21a shows an autoinjector variant for an exemplary penetration depth of 8 mm in the delivery state and Fig. 21b in the inserted state. Fig.Fig. 22a shows an autoinjector variant for an exemplary insertion depth of 5 mm in the delivery state, and Fig. 22b shows the inserted state. These two and other variants differ only in the different needle protection sleeves 14, in each of which the axially extending section 14b is shorter or longer, whereby the flange 14c to be placed on the skin is positioned differently, thus limiting the insertion depth of the needle 11b accordingly.

[0205] Figs. 23a and 23b each show a longitudinal section through the proximal end of the drive device 80, as well as a view of the mainspring 20a and the indicator window 25b. To achieve different torques or injection forces, different mainsprings can be installed. The mainsprings have different spring widths and thus deliver different spring torques. Complementary to the spring width, axially extending filler profiles 25s of different lengths can be provided distally on the indicator window 25b to axially limit the installation space for the spring. This prevents the spring coil from breaking out in the axial direction.

[0206] Fig. 24a and Fig. 24b each show a longitudinal section through auto-injectors with pre-filled syringes which are pre-filled with different volumes of medication. When the syringe is fully filled - Fig. 24a, the stroke of the propulsion element 22 is at its maximum. When the syringe is only partially filled - Fig. 24b, the stroke can be reduced by means of different mounting positions, whereby the same parts can be used. The propulsion element 22 can be screwed onto the drive element 21 in a desired starting position. The different starting positions for the propulsion element 22 are achieved by its axially extending anti-twist rib 22b, which is guided in the corresponding anti-twist groove 13h of the mechanism holder 13. The gradation of the different starting positions of the propulsion element 22 is further dependent on the design of the coupling 23 orthe spring coil 20b with regard to the number of holding cams 23c, distal coupling cams 20e, proximal coupling cams 20p as well as the thread pitch and the number of threads on the external threaded section 21a on the drive element 21. In addition, an adapted syringe housing part 10b with a shorter viewing window 10c can be used for smaller filling volumes or smaller strokes of the propulsion element 22.

[0207] As shown in Fig. 25, as a variant, a removal sleeve 30k with claws 301 inclined distally to the axis L can be positively secured, in particular irreversibly snapped, in the device cap 16 (instead of the insert 30). The claws 301 slide along the outer surface of the needle protection cap 11a when the pre-filled syringe is inserted. When the device cap 16 is removed, the claws grip the outer surface and take the needle protection cap 11a with them, thereby exposing the clamping area 11g and the injection needle 11b of the pre-filled syringe 11.

[0208] LIST OF REFERENCE SYMBOLS

[0209]

Claims

PATENT CLAIMS 1. Autoinjector (1) comprising - a drive device (80) comprising a first housing part (10a) comprising a drive assembly (20, 21, 22), - a product container receiving device (90) having a second housing part (10b) defining a longitudinal axis (L) which extends from distal to proximal, comprising a syringe holder (12) designed to receive a prefilled syringe (11) with a cylindrical product container (11c) and a plug (26) which can be moved along the longitudinal axis (L) by the drive assembly (20, 21, 22) for dispensing a medicament from the product container (11c), wherein the first housing part (10a) and the second housing part (10b) can be connected coaxially in the joining direction by a connection-side end section (10w) on one of the two housing parts (10a, 10b) being stepped such that it can be inserted into the other of the two housing parts (10a, 10b), wherein between the two housing parts (10a, 10b) in the region of the end section (lOw) forms a circumferential gap guide (lOx), characterized in thatthat in the region of the end section (lOw) a first locking connection (lOu, 10v) and a second and third or last locking connection (lOf, 10g) are provided, which can be locked one after the other in the joining direction and wherein the first of the locking connections (lOu, lOv) is releasable against the joining direction and at least the third or last locking connection (lOf, 10g) is locked.

2. Auto-injector (1) according to the preceding claim, characterized in that the first housing part (10a) and the second housing part (10b) can be mutually connected in the joining direction or can be released against the joining direction by a linear movement parallel to the longitudinal axis (L).

3. Auto-injector (1) according to one of the preceding claims, characterized in that a first, second and third or last locking position of the first housing part (10a) relative to the second housing part (10b) along the longitudinal axis (L) is defined by the first locking connection (10u, 10v) and the second and third or last locking connection (10f, 10g).

4. Auto-injector (1) according to one of the preceding claims, characterized in that the first, second and third or last locking connection are formed from cams and grooves formed on the first and second housing parts (10a, 10b) in the interior of the gap guide (10x).

5. Auto-injector (1) according to one of the preceding claims, characterized in that one of the housing parts (10a, 10b) can be circumferentially abutted with a radial step (10y) introducing the end section (10w) on the connection-side end of the other housing part (10a, 10b), wherein the radial step (10y) can be continuously corrugated or discontinuously offset in the circumferential direction.

6. Auto-injector (1) according to the preceding claim, characterized in that one of the housing parts (10a, 10b) with the radial step (10y) introducing the end section (10w) abuts the connection-side end of the other housing part (10a, 10b) in a circumferential manner when the third or last of the locking connections (10f, 10g) is locked.

7. Auto-injector (1) according to one of the preceding claims, characterized in that the two housing parts (10a, 10b) have longitudinal guides in the region of the end section (10w) and / or form a non-circular cross-section of the gap guide (10x).

8. Auto-injector (1) according to one of the preceding claims, characterized in that one of the housing parts (10a, 10b) has at least one assembly opening (10t) at its end section (10w), which is accessible from the outside at least in the first locking position and is completely covered by the other of the housing parts (10a, 10b) in at least the third or last locking position.

9. Auto-injector (1) according to one of the preceding claims, characterized in that the two housing parts (10a, 10b) can assume exactly three locking positions along the longitudinal axis (L).

10. Auto-injector (1) according to one of the preceding claims, characterized in that the two housing parts (10a, 10b) are mutually fastened by gluing or welding in the third or last locking position in addition to the locking connection (10f, 10g).

11. Auto-injector (1) according to one of the preceding claims, characterized in that it further comprises a syringe adapter (13a) which can be abutted with its distal end (13c) against the proximal end of the pre-filled syringe (11), wherein the proximal end of the syringe adapter (13a) comprises an elastic element (13d) which is operatively connected to the first housing part (10a).

12. Auto-injector (1) according to the preceding claim, characterized in that the elastic element (13d) of the syringe adapter (13a), to which a support surface (13c) is connected, is tensioned by the movement into the third or last locking position.

13. Method for the final assembly of an auto-injector (1) with - a drive device (80) comprising a first housing part (10a) comprising a drive assembly (20, 21, 22), - a product container receiving device (90) having a second housing part (10b) defining a longitudinal axis (L) which extends from distal to proximal, comprising a syringe holder (12) designed to receive a prefilled ready-to-use syringe (11)), wherein the first housing part (10a) and the second housing part (10b) are coaxially connectable in a joining direction into a first of at least three locking positions, and are held in the first wheel connection for storage and / or transport purposes by a first locking connection (10u, 10v) which is releasable in and against the joining direction, comprising the steps: - Providing a pre-filled syringe (11) - releasing the first locking connection (10u, 10v) of the housing parts (10a, 10b) against the joining direction and separating the drive device (80) from the product container receiving device (90) - Inserting the pre-filled syringe (11) coaxially or axially parallel to the longitudinal axis (L) into the product container receiving device (90) - joining the housing parts (10a, 10b) in the joining direction into the first locking position defined by the first locking connection (10u, 10v), while leaving a mounting opening (10t) on one of the housing parts (10a, 10b) - joining the housing parts (10a, 10b) with the assembly opening exposed in the joining direction into a second of at least three locking positions which are held by a second locking connection (10f, 10g) of the housing parts (10a, 10b) - Joining the housing parts (10a, 10b) in the joining direction into a third or final locking position, which is held and locked by a third or final locking connection (10f, 10g) of the housing parts (10a, 10b), and completely covering the assembly opening (10t) on one of the housing parts (10a, 10b) with the other of the housing parts (10a, 10b) when they are in the third or final locking position. A method for the final assembly of an auto-injector (1) according to the preceding claim, further comprising one or more of the following steps: - Setting a starting position for a propulsion element (22) by screwing it onto a drive element (21) - Holding and / or positioning a component (17) movable inside one of the housing parts (10a, 10b) by means of an assembly tool insertable through the exposed assembly opening (10t) - Removing the assembly tool from the assembly opening (10t) on one of the housing parts (10a, 10b) before or when they are in the second locking position - Clamping an elastic syringe adapter (13a) when joining the housing parts (10a, 10b) from the second to the third or last locking position. Method for the final assembly of an auto-injector (1) according to one of the two preceding claims carried out on the device according to one of claims 1 to 12.

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