Improved autoinjector

Abstract

The invention relates to an autoinjector, comprising:-a drive device (80) having a first housing part (10a); a product container receiving device (90) having a second housing part (10b), comprising a syringe holder (12), which is designed to receive a pre-filled syringe (11) and a movable plunger (26) for pouring the drug from the product container (11c), the first housing part (10a) and the second housing part (10b) can be coaxially connected in the joining direction in such a way that a connection-side end section (10w) of one of the two housing parts (10a, 10b) forms a step in such a way that the end section can be pushed into the other of the two housing parts (10a, 10b), a first latching connection (10u, 10v), a second latching connection and a third latching connection (10f, 10 g) are provided in the region of the end section (10w), which latching connections can be individually latched one behind the other in an engagement direction, and wherein the first latching connection of the latching connections (10u, 10v) can release and at least lock the third or final latching connection (10f, 10 g) counter to the engagement direction, and wherein the second latching connection of the latching connections (10u, 10v) can release and at least lock the third or final latching connection (10f, 10 g). The invention also relates to a method for the final assembly of an autoinjector.

Description

Technical Field

[0001] The present invention relates to the field of medical injection devices for administering liquid substances, in particular medicines or medical substances, such as insulin preparations and hormone preparations. The present invention relates to an automatic injector with an energy storage device for pouring a predetermined dose from a disposable product container. Background Art

[0002] The injection device or injection equipment for simplified delivery of substances mainly includes a so-called automatic syringe, which has an energy accumulator, with which pouring can be performed automatically, that is, without the need for external force to be supplied or consumed by the user. The energy accumulator advantageously stores the energy required for automatic material output in a mechanical form. Such an energy accumulator can be a spring, which is loaded into the injection device under tension and outputs energy by relaxation. The energy output is realized at the piston rod or pressure element, which pushes the piston into the product container. The energy accumulator can also be arranged to automate the piercing process of the injection needle. Alternatively, the piercing process can be realized manually, that is, only realized by the user, without the need to use the energy stored in the injection device for this purpose.

[0003] The injection device can include a product container holder for receiving a product container, wherein the product container can be radially, axially and preferably also held in the product container holder in a rotationally fixed manner. The product container holder can be axially and rotationally connected to the housing of the injection device, or can move relative to the housing during piercing and / or needle retraction. The product container can be a cartridge for repeatedly releasably connecting to a disposable injection needle, or a disposable prefilled syringe with an injection needle that is non-releasably connected thereto. The product container has a hollow cylindrical product container section, which supports a piston or plunger in a displaceable manner. The piston can form a sealing gap with the inner circumference of the product container section and be displaced in a distal direction by means of a piston rod so as to output the product from the product container through the injection needle.

[0004] The injection device can have a needle guard which, after the injection has been completed, is distally protruding beyond the distal end of the injection needle or is moved relative to the housing into this position when the needle guard spring is relaxed, in order to prevent unintentional contact with the injection needle and reduce the risk of injury. In an autoinjector, the needle guard can also be used as a trigger element for triggering the pouring of the product, wherein the needle guard is moved relative to the housing in the proximal direction for this purpose. Alternatively, the triggering of the autoinjector can be achieved by actuating a trigger button of the autoinjector, wherein the needle guard serves at least as a visual protection before the autoinjector is used.

[0005] Patent application WO 2016 / 205963 describes an exemplary automatic injector, which includes a housing with a longitudinal axis and a product container axially firmly arranged in the housing. The automatic injector also includes a needle protection sleeve that can be pushed between a proximal position and a distal position in the longitudinal direction, and the needle protection sleeve is coupled to a needle protection spring. The energy for automatically pouring the product can be stored in a spiral or drive spring, which is connected to a drive element in the form of a rotating screw arranged coaxially with respect to the longitudinal axis by a first end and a second end. The screw is threadedly embedded in a propulsion mechanism in the form of a propulsion sleeve that does not rotate in the housing, and the propulsion mechanism moves the plunger of the product container together at a nearly constant pouring speed when it is pushed in the distal direction.

[0006] The drive spring as a drive is characterized by a high force and is therefore suitable for starting pouring without delay even when the autoinjector has a long storage period. The variable pitch of the screw can compensate for the variable characteristic curve of the drive spring in order to ensure a pouring force that is as constant as possible. This also allows large pouring amounts of 5 ml or more to be poured uniformly and continuously within a maximum of 60 seconds. In the case of a pouring duration of more than 10 seconds, which is extended compared to conventional autoinjectors, the user should be able to check the correct continuous process of the injection at any time so as not to accidentally interrupt the injection prematurely.

[0007] Patent application WO 2012 / 173554 shows a rotating display at the proximal end of an automatic injector, which is driven by a torsion spring during pouring. The display comprises a plurality of segments with different colors for signaling an initial state before the start of pouring and a final state after the pouring is completed. The segments can be seen through at least one window at the proximal end of the automatic injector, which window corresponds in its extension to the angular range of the segments.

[0008] The patent application published as CH 714527 A2 shows an injection device with a cover for removing the needle protection cover from a product container and a method for assembling an injection device, wherein the cover comprises an engagement element to cause the needle protection cover to be removed from the product container when the cover is removed from the injection device.

[0009] Patent application US2014 / 0330214 A1 shows a display in the form of a rotating disk and a plurality of window openings and a wall at the proximal end of an automatic injector. The rotating disk has a structure of alternating protrusions for visual signaling and is driven by a torsion spring during pouring. The wall in an alternating manner with the window openings allows an intermittent view to the rotating disk or to the structure that rotates past.

[0010] The patent application published as EP 3241580 A1 shows an improved snap-in connection between a cartridge holder and a device body. The reduced radial dimensions of the snap-in element reduce deformation of the cartridge holder during final assembly and thus increase safety against glass breakage of the cartridge.

[0011] The published patent application as WO 2013 / 076246 A1 shows an autoinjector having a front housing and a rear housing telescopically coupled in a first position or a second position, the coupling being openable by a user in the second position in order to use a new syringe.

[0012] The patent application published as WO 2013 / 153011 A1 shows a cartridge holder which can be connected to a device housing by means of a snap-in connection. The snap-in connection has an improved force flow in that a projection in the device housing engages in a window with rounded corners on the cartridge holder.

[0013] The patent application published as WO 2016 / 055625 A1 shows an improved coupling of a cartridge holder to an external housing of a delivery device. Here, a first snap-in connection between the cartridge holder and the external housing is supplemented by a second, independent, axially offset connection between the cartridge holder and the external housing and by a third connection as a rotational stop at a distally extending projection of the external housing.

[0014] The terms "product", "drug" or "medical substance" in this context include any flowable medical preparation suitable for controlled delivery in subcutaneous or intramuscular tissue by means of a cannula or a hollow needle, such as a liquid, solution, gel or a fine suspension comprising one or more medically effective substances. Thus, the drug can be a composition with a single active substance or a premixed or co-formulated composition with a plurality of active substances from a single container. The term includes in particular medicaments, such as peptides (e.g. insulin, drugs containing insulin, GLP-1-containing and obtained or similar preparations), proteins and hormones, biologically obtained or active active substances, hormone- or gene-based active substances, nutritional preparations, enzymes and other substances in solid (suspended) or liquid form. In addition, the term also includes polysaccharides, vaccines, DNS or RNS or oligonucleotides, antibodies or antibody parts and suitable basic materials, auxiliary materials and carrier materials.

[0015] The term "distal end" refers to the side or direction pointing toward the front, piercing-side end of the delivery device or toward the tip of the injection needle. In contrast, the term "proximal end" refers to the side or direction pointing toward the rear, opposite end of the delivery device.

[0016] The term "syringe" is understood in this specification as a device in which the injection needle is removed from the tissue after the controlled amount of the medical substance has been delivered. Thus, unlike an infusion system, in a syringe the injection needle does not remain in the tissue for a long period of several hours. Summary of the invention

[0017] The object of the present invention is to realize an improved and more cost-effective automatic injector of the type mentioned at the beginning. It should be possible to more reliably realize the assembly of the automatic injector or its structural components and the insertion of the product container for the purpose of final assembly, and the operation or manipulation of the automatic injector is easier and more reliable. It should be easier and more reliable to ensure the pre-assembly of the structural components or the storage, transportation and supply of the structural components separated from the final assembly of the automatic injector in time and position, and in particular, the integrity of the structural components during transportation and supply should be maintained. Another object of the present invention is to realize a display part for the type of automatic injector mentioned at the beginning, which can optically show the user the continuation or progress of pouring in various holding positions. The display part should be designed so that even in the case of an unfavorable, especially non-specified holding position of the user's hand on the automatic injector, the user can recognize the continuation of pouring, and the user does not have to change the holding position for this.

[0018] This object is achieved by a device having the features of the independent claim. Preferred embodiments of the invention are the subject matter of the dependent claims.

[0019] The automatic injector according to the present invention comprises a one-piece or multi-piece housing with a longitudinal axis and a prefilled prefilled syringe, which has a product container and an injection needle or cannula that is non-releasably fastened to the product container. The prefilled syringe is received in the housing in an axially non-displaceable manner, wherein the tip of the injection needle protrudes beyond the distal housing end in the distal direction with at least one puncture depth. The automatic injector also comprises: a preloaded torsion spring for pouring the maximum content of the product container in one time; a drive element, a propulsion element and a needle protection sleeve. In order to pour liquid from the product container through the injection needle, the torsion spring places the drive element in a rotation around the longitudinal axis, and the rotating drive element causes a linear movement of the propulsion element to push the piston in the product container. When the automatic injector is pressed to the injection site and the injection needle is thereby caused to penetrate into the injection site, the needle protection sleeve moves in the proximal direction with an operating stroke, and the pouring of the liquid is started or can be achieved thereby. The operating stroke of the needle protection sleeve corresponds at least to the penetration depth of the injection needle.

[0020] Finally, the autoinjector comprises a display for signaling the continuation of pouring, which has: a display element with an optical contrast pattern, which rotates around the longitudinal axis and is driven by a drive element; and a window at the proximal end of the autoinjector, through which the rotating contrast pattern can be seen. The window completely surrounds 360° around the longitudinal axis, that is, it is not interrupted by a frame or a tab parallel to the longitudinal axis, which would create a blind spot for the view on the display element. The window is made of a transparent and preferably stable or load-bearing material. As long as a small part of the window remains visible, the user can recognize the rotating display element even if he or she clumsily covers a large part of the window with his or her hand holding the autoinjector, for example because he or she supports it with the fingertips at the proximal end.

[0021] The contrast pattern is at most rotationally symmetrical about the longitudinal axis, but not continuously, so that the rotation of the contrast pattern can also be recognized. The contrast pattern includes at least one surface, area or graphic element in the form of a color or gray tone or brightness different from the background color, preferably in the form of a graphic element repeated in the direction of rotation, such as, for example, parallel lines, especially parallel lines extending inclined and / or curved relative to the longitudinal axis of the automatic injector. The contrast pattern can have at least 1 to about 60, especially 8 to 16 lines or surfaces or graphic elements. The contrast pattern especially includes one of the colors that can be well perceived physiologically, green or black.

[0022] To this end, the display element can be manufactured or obtained in the following manner.

[0023] The contrast pattern can be applied to the substrate of the display element in a printing process.

[0024] The contrast pattern can be produced in different colors by means of two-component injection molding. The two components are preferably divided in such a way that the first component, preferably made of PBT, contains functional elements, such as, for example, snap-fit ​​parts. The functional elements are thus always produced with the same material and preferably with the same color. Visual, aesthetic elements, such as contrast patterns, can be produced with the second component, preferably from dyed ABS or PP, and vary in color.

[0025] The contrast pattern can be produced by means of a laser process, preferably by means of a UV laser, in the following manner, namely: locally removing material on the visible surface at the display element, thereby producing a modified, especially gray structure. It is also possible to melt the surface of the display element by means of a laser process and a suitable material selection, whereby the pigment becomes visible, or the plastic foams due to its inclusion components and thereby changes the optical properties in a contrasting manner. Alternatively, by means of a laser or corrosion, material can be locally and finely structured removed on the previously polished visible surface of the injection molding mold, whereby a structure, especially a top structure or a cubic structure, can be produced, which is later transferred to the plastic part during injection molding. Such a structure can have a depth or protrusion of 0.01 to 0.5 mm. This is an advantageous embodiment for durability reasons, because for the component, it is neither necessary to mix different materials, nor to apply pigments to the material or to locally change the material by laser marking.

[0026] The contrast pattern can also be realized by means of a perforation in the visible surface of the display element. Here, the perforation allows to see the dark interior of the automatic injector, in particular to see on a metallic spiral torsion spring.

[0027] The automatic injector according to the present invention is suitable for pouring the product amount contained in the product container during the pouring duration period that is increased relative to the known automatic injectors, exceeding 10s, preferably exceeding 20s or 30s. Thus, even in the case of a product amount exceeding 2.25ml and preferably at least 3ml or 4ml, the continuous or average pouring rate is relatively low, so that the amount of medicine injected can be continuously received or absorbed by the subcutaneous tissue. The compliance with the minimum holding time between the end of pouring and the automatic injector leaving the puncture site is therefore not so critical. Correspondingly, there is no need to indicate to the user optically, acoustically or tactilely that the signal indicating the end of the holding time is indicated.

[0028] In a preferred embodiment, the rotating display element is driven directly or immediately by the drive element, in particular without a gear mechanism. The display element then rotates at the same rotational speed as the drive element.

[0029] In a further preferred embodiment, the display element is designed to rotate less than one revolution per second, preferably less than half a revolution or even less than one third of a revolution per second during pouring. This ensures that the rotational movement of the contrast pattern can be well followed from the perforation and is not blurred, for example, to an observer into an indefinite rotationally symmetrical pattern.

[0030] In a preferred embodiment, no optical markings are provided either at the window or at the adjacent housing for determining the relative rotational position of the contrast pattern. Neither an initial state nor an end state nor relative data on the progress of pouring are displayed by the display element, which serves only to signal the progress or continuation of pouring.

[0031] In a preferred embodiment, the rotating display element and the housing or window are designed to generate a pouring sound, thereby additionally acoustically signaling the continuation of the pouring process to the user. Preferably, the pouring sound is a continuous clicking sound, which is generated by a grid at the window or at the housing and radially or axially flexible engagement elements at the display element that are embedded in the grid, or vice versa by a rotating grid at the display element and a fixed engagement element. In this case, as in the case of a purely optical motion display, for example, a separate optical, acoustic, and / or tactile signaling of the pouring by a mechanically or electronically generated signal can also be omitted.

[0032] In a preferred embodiment, the window has a first cylindrical area parallel to the longitudinal axis and a second area with a continuously or continuously reduced diameter that is seamlessly connected to the first area in the proximal direction. The first area enables the field of view on the display element from each lateral line of sight perpendicular to the longitudinal axis, and the second area enables the field of view on the display element from the rear along the distal line of sight or from the top in the case of a vertically held automatic syringe. The second area is rounded or contracted in the proximal direction and can end in a third area perpendicular to the longitudinal axis. The display element can have a convex display surface that follows the trend of the window or a cone-shaped display surface, which has an inclined portion in the middle with respect to the longitudinal axis. The window is preferably rotationally symmetrical about the longitudinal axis, i.e., has a circular cross-section in a sectional plane perpendicular to the longitudinal axis.

[0033] In an advantageous variant, the autoinjector comprises a needle protection sleeve, which in the delivery state of the autoinjector extends beyond the housing at the distal end and is preloaded in the distal direction by a needle protection spring. When the autoinjector is pressed onto the injection site, the needle protection sleeve performs an actuation movement in the proximal direction, and when the autoinjector is removed from the injection site, performs a needle protection movement in the distal direction, so as to laterally surround and radially cover the injection needle with a sleeve-shaped, preferably rotationally symmetrical section. The needle protection sleeve has an annular flange or base at the distal end as an enlarged bearing surface for tissue around the injection site. The flange is permanently connected to the sleeve-shaped section and is preferably constructed in one piece with the sleeve-shaped section. The maximum diameter of the flange is greater than the maximum diameter of the sleeve-shaped section.

[0034] Preferably, the outer edge or periphery of the flange is adapted to the shape of the distal opening in the housing. In the inserted state, the flange thus forms a stop for the housing. It is further preferred that the flange is concavely curved so that the outer edge is further distal than the transition between the flange and the sleeve-shaped section. Thus, firstly, the placed automatic injector is less prone to tilting than a flange with a strictly flat annular bearing surface with the same outer diameter, and secondly, the concentration of the pressure load on the periphery of the flange that is farthest from the insertion site causes less counterpressure in the tissue and therefore less pain for the user.

[0035] It is further preferred that the automatic injector comprises a screw as a drive element and a push sleeve with an internal thread as a push element, alternatively a drive sleeve with an internal thread as a drive element and a screw as a push element, wherein the push element has a groove or a projection as an axial guide element for a purely linear push movement in the housing. The automatic injector is preferably designed to receive a prefilled prefilled syringe comprising a product container and an injection needle and having a filling volume of at least 3 ml, preferably at least 5 ml.

[0036] In summary and in other words, the autoinjector can be implemented according to aspects of the present invention in the following manner:

[0037] An automatic injector comprising:

[0038] a housing having a longitudinal axis L and adapted to receive the product container,

[0039] an advancement mechanism and a rotating drive element for moving the advancement mechanism in the longitudinal direction and for automatically pouring the liquid product contained in the product container through the injection needle,

[0040] a display for signaling the continuation of pouring, the display comprising a rotating display element with an optical contrast pattern driven by a drive element and comprising a window at the proximal end of the autoinjector through which the rotating contrast pattern is visible,

[0041] The feature is that the window is a window which completely surrounds the longitudinal axis.

[0042] Automatic injector in which the rotating display element is driven directly by the drive element.

[0043] An automatic injector, wherein the display element is designed to rotate less than one revolution per second, preferably less than half a revolution per second during pouring.

[0044] An automatic injector in which no optical markings are provided for determining the rotational position of the contrast pattern.

[0045] An automatic syringe, wherein the rotating display element is designed to produce a pouring sound.

[0046] An automatic injector, wherein the window has a cylindrical first region parallel to the longitudinal axis and a second region seamlessly adjoining the first region in the proximal direction and having a continuously decreasing diameter.

[0047] An automatic injector comprising, inter alia:

[0048] a needle guard which, in the delivery state of the autoinjector, projects distally beyond the housing, wherein when the autoinjector is pressed onto the injection site, the needle guard performs an actuation movement in the proximal direction and when the autoinjector is removed from the injection site, performs a needle protection movement in the distal direction in order to laterally surround the injection needle with the sleeve-shaped section,

[0049] Therein, the needle guard has at the distal end an annular collar for contacting the injection site, which collar has a maximum diameter that is greater than the maximum diameter of the sleeve-shaped section.

[0050] An autoinjector wherein an outer edge of the flange mates with a distal opening in the housing.

[0051] An automatic injector in which the collar is concavely curved.

[0052] An automatic injector in which the drive element is a screw and the advancement element is an advancement sleeve with an axial guide element for a purely linear advancement movement in the housing.

[0053] An autoinjector which, among other things, has a prefilled prefilled syringe with a product container and an injection needle and has a filling volume of at least 3 ml, preferably at least 5 ml.

[0054] Further preferred embodiments of the present invention, in particular for an improved autoinjector, are described below.

[0055] In a preferred embodiment, the automatic injector comprises:

[0056] a drive device having: a first sleeve-shaped housing part, which comprises a drive assembly; a spring coil with a drive spring; a drive element, in particular a threaded rod; an advance element, in particular a piston rod, having an internally arranged thread, which is suitable for automatic advance of a plunger,

[0057] - a product container receiving device, the product container receiving device having: a sleeve-shaped second housing part defining a longitudinal axis extending from a distal end to a proximal end, comprising a syringe holder, the syringe holder being configured to receive a prefilled prefilled syringe having a cylindrical product container and a plunger that can be moved along the longitudinal axis by a drive structure assembly, the product container being tapered at its distal end by a shoulder, the product container having a needle protection cover for a needle, the plunger being used to pour a drug from the product container; an instrument cover, the needle protection cover being receivable in the instrument cover, wherein the first housing part and the second housing part can be coaxially connected in a joining direction by the following means, namely: in the two housing parts, The end section of the connection side at one of the body parts is stepped so that the end section can be pushed 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 a first latching connection and a second or middle latching connection and a third or last, final latching connection are provided in the region of the end section, which can be individually latched one after another in the joining direction, and wherein the first of the latching connections can be released in a non-destructive manner against the joining direction, and at least the third or final latching connection is locked, in particular, by form locking. The housing parts can thus be connected to one another in a predetermined position or a predetermined linear movement step in the joining direction, or can be released in a direction opposite to the joining direction, which is advantageous for storage, transportation and further handling on an automatic device. The locking achieved by at least the third or final latching connection cannot be opened in a non-destructive manner, thereby improving the handling and manipulation safety of the automatic injector. In this case, the autoinjector achieves its configuration and / or dimensions for delivery or use with the locked third or final latching connection.

[0058] The automatic syringe is preferably improved in the following manner, that is, the first housing part and the second housing part can be connected to each other along the engagement direction by a linear motion parallel to the longitudinal axis, or can be released against the engagement direction. In particular, all push-in motions or motions for engaging the housing part along the engagement direction and releasing the housing part against the engagement direction are aligned and especially only extend along the longitudinal axis or parallel to the longitudinal axis. The more complex motions of the housing part, such as those caused by bayonet locks, spiral locks or thread locks, are not included. Thus, it is possible to realize low-cost and accurate operation of the parts on the assembly automatic device, and by connectability-releasability, the parts can be stored or transported together relative to each other before the final assembly, that is, before the product container is placed in the specified position. The interior of the automatic syringe preassembled in this way is protected. The parts connected in this way can be stored and transported in a space-saving and reliable manner in the structural component carrier as a unit. The parts or structural components connected in this way can be easily picked up by the automatic device, separated for placing the prefilled syringe in the specified position, and then connected again and finally assembled.

[0059] The automatic injector is preferably improved in that the first, second and third latching positions of the first housing part relative to the second housing part are defined along the longitudinal axis by means of the first, second and third latching connections. This allows simplified automation and positioning on the assembly robot.

[0060] The automatic injector is preferably improved in that the first, second and third latching connections are formed by projections and recesses, which are respectively formed on the first housing part and the second housing part and are located in the interior of the gap guide, thereby increasing the protection against unauthorized opening or increasing the handling safety.

[0061] The automatic injector is preferably improved in such a way that one of the housing parts can completely abut the end of the connection side of the other housing part with its radial step introduced into the tapering end section, and the two housing parts thus jointly form a circumferential side surface without a shoulder, whereby the handling of the automatic injector becomes more reliable, wherein the radial step is applied straight or continuously in a wavy shape or discontinuously in the circumferential direction. The latter improves the torsion lock and can support the rotational positioning of the housing part. In addition, the radial step can be around at a right angle or inclined to the axis. Alternatively, the step formed on the housing part can abut the end of the connection side of the other housing part around and discontinuously.

[0062] The autoinjector is preferably improved in that, if the third or final snap-in connection of the snap-in connection is locked in a form-fitting manner, one of the housing parts with its radial step of the introduction end section circumferentially abuts against the connection-side end of the other housing part. Since the abutment gap thus formed is kept closed by the locking, better dirt-tightness and handling safety are achieved.

[0063] The autoinjector is preferably improved in that the two housing parts have longitudinal guides in the region of the end sections and / or the gap guides are designed with non-circular cross sections. This results in a rotational lock of the two housing parts and a defined mutual assembly position, preferably the gap guides are not circularly symmetrical in cross section, in particular not 2-fold or 4-fold symmetrical, that is to say not every 180° or 90° to produce a possible assembly position. It is further preferred that the axially extending structures of the latching connection are mutually aligned on the two housing parts with respect to the longitudinal axis of the autoinjector and thus form a longitudinal guide.

[0064] The automatic injector is preferably improved in such a way 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 latching position and is completely covered by the other housing part in at least the third or final latching position. As a result, the assembly tool for the final assembly can be inserted and removed before the final connection, and the opening required for this purpose is then completely closed and no longer visible from the outside. The assembly tool that extends into the interior of the housing part can be used to fix a component that is movably supported in the interior of the housing and / or is loaded with force or torque during the assembly movement in a specified position and then release it again. For example, the bite or anchoring of the component can then be ensured.

[0065] The autoinjector is preferably developed in that the two housing parts can assume exactly three locking positions along the longitudinal axis.

[0066] The automatic injector is preferably improved in that, as an alternative or in addition to the latching connection, the two housing parts are fastened to each other in the third or final latching position by bonding or welding. This increases the stability and precision of the connection and ensures the tightness of the abutment gap between the two housing parts.

[0067] The autoinjector is preferably improved in that it also has a syringe adapter, which can be brought into contact with the proximal end of the prefilled syringe with its distal end, wherein the proximal end of the syringe adapter is formed by a spring element which is operatively connected to the first housing part. The syringe is thereby held in the syringe holder without play and force-loaded in the distal direction, which reduces the risk of glass breakage.

[0068] The autoinjector is preferably improved in that the elastic element of the syringe adapter is connected to the bearing surface and is prestressed or further tensioned by a second joining step or by a movement into a third or final latching position, thereby simplifying the final assembly process.

[0069] The autoinjector is preferably improved in that the advancing element can be screwed onto the drive element in the desired starting position. In this way, the free play between the piston in the prefilled syringe and the advancing element can be eliminated in the finally assembled autoinjector and / or the starting position of the advancing element can be adapted to the piston position of the partially filled prefilled syringe.

[0070] The invention shown furthermore comprises a method for the final assembly of an autoinjector, the longitudinal axis of which is defined, the method comprising the steps:

[0071] - providing a product container receiving device having a first housing part,

[0072] - providing a drive device having a second housing part,

[0073] - joining the housing part in the joining direction into a first latching position defined by the first latching connection,

[0074] - inserting an assembly tool, in particular laterally, through an assembly opening in one of the housing parts when the housing parts are in the first latching position,

[0075] - engaging the housing part in the engaging direction into a second latching position which is held by a second latching connection of the housing part,

[0076] - removing the assembly tool from the assembly opening in one of the housing parts when the housing parts are in the second latching position,

[0077] - engaging the housing part in the engaging direction into a third latching position which is held and locked by a third latching connection of the housing part,

[0078] when the housing parts are in the third or final latching position, the assembly opening in one of the housing parts is completely covered by the other of the housing parts,

[0079] - setting or preparing an axial starting position for the push element by screwing onto the drive element. In this way, the free play between the piston in the prefilled syringe and the push element can be eliminated in the finally assembled autoinjector and / or the starting position of the push element can be variably adapted to the piston position of a partially filled prefilled syringe,

[0080] - positioning the product container receiving device and the drive device coaxially with respect to the longitudinal axis and engaging the housing parts in an engaging direction into a latching position which is held by a releasable latching connection of the housing parts in and against the engaging direction,

[0081] - storing and / or transporting the product container receiving device and the drive device which are connected together in a locked position of the housing parts,

[0082] - Available in pre-filled syringes,

[0083] - releasing the latching connection of the housing parts in the direction opposite to the joining direction and separating the drive device from the product container receiving device,

[0084] - inserting the prefilled syringe coaxially or axially parallel to the longitudinal axis into the product container receiving device,

[0085] - holding and / or positioning the component movable in the interior of the housing part by means of an assembly tool inserted through the assembly opening,

[0086] When the housing parts are brought from the second latching position into the third or final latching position, the elastic syringe adapter is clamped.

[0087] As an alternative or in addition, the method for final assembly of an autoinjector with a defined longitudinal axis can have a plurality of the following steps:

[0088] - providing a product container receiving device, the product container receiving device having a first housing part

[0089] - providing a drive device having a second housing part

[0090] - positioning the product container receiving device and the drive device coaxially with respect to the longitudinal axis and engaging the housing parts along the longitudinal axis by a linear movement into a first of at least three latching positions, which is held by a first latching connection of the housing parts which is releasable non-destructively in and against the engagement direction,

[0091] - storing and / or transporting the product container receiving device and the drive device which are connected together in the first latching position of the housing parts, whereby the integrity and the relative position of the parts of the device are reliably ensured during storage or transport and subsequent processing on an automatic assembly device can be easily and precisely carried out,

[0092] - Available in pre-filled syringes,

[0093] - releasing the latching connection of the housing parts and separating the drive device from the product container receiving device,

[0094] - inserting the prefilled syringe coaxially or axially parallel to the longitudinal axis into the product container receiving device,

[0095] - engaging the housing part into a first latching position by a linear movement along the longitudinal axis,

[0096] - engaging the housing part by a linear movement along the longitudinal axis into a second latching position which is held by a second latching connection of the housing part,

[0097] - engaging the housing part by a linear movement along the longitudinal axis into a third latching position which is held and locked by a third latching connection of the housing part,

[0098] - releasing the assembly opening on one of the housing parts when the housing parts are in the first latching position,

[0099] - holding and / or positioning the component movable in the interior of the housing part by means of an assembly tool which can be inserted through the released assembly opening, in particular an assembly tool which can be inserted laterally,

[0100] before or while the housing parts are in the second latching position, removing the assembly tool from the assembly opening in one of the housing parts,

[0101] when the housing parts are in the third or final latching position, the assembly opening is completely covered by the other of the housing parts,

[0102] During the engagement or by the engagement movement of the housing parts from the second latching position into the third or final latching position, the elastic syringe adapter is clamped. The syringe adapter is arranged in this case such that the elastic element at least partially participates in the engagement movement. BRIEF DESCRIPTION OF THE DRAWINGS

[0103] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. These embodiments should in principle indicate the feasible solutions of the present invention and are not to be interpreted as limiting. Among them:

[0104] Figure 1 shows the components of an automatic injector,

[0105] Figure 2 Shown is the Figure 1 Two longitudinal cross-sectional views of an automatic injector,

[0106] Figure 3 Two views of the display element are shown,

[0107] Figure 4 A view showing the distal end of the needle guard,

[0108] Figure 5 Two views showing a second embodiment of an automatic injector, rotated by 90° relative to one another,

[0109] Figure 6 Shown from Figure 5 A component of an automatic injector or a structural component thereof,

[0110] Figure 7 Shows the delivery status from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0111] Figure 8 Shows the trigger lock state from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0112] Fig. 9 The device cover including the needle protection cover is removed. Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0113] Fig.10 Shows the penetration state from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0114] Fig.11a Shows the state of releasing the drive from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0115] Fig.11b Shows the state of releasing the drive from Figure 5 A partial cross-sectional view of the coupling sleeve and spring coil of an automatic injector,

[0116] Fig.12a In the pouring state, the Figure 5Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0117] Figure 12b Shown from Figure 5 A view of a proximal end view of a spring coil of an automatic injector having a helical spring,

[0118] Fig.12c Shown from Figure 5 A cross section of a distal view of a display element of an automatic injector having a display window,

[0119] Fig.13 Shows the state at the end of pouring from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0120] Fig.14 Shows the state from which the needle protection lock is activated Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0121] Fig.15a shows the state of interrupted pouring from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other,

[0122] Fig.15b shows the state of interrupted pouring from Figure 5 A partial cross-sectional view of the coupling sleeve and spring coil of an automatic injector,

[0123] Fig.16 Shows the pre-occlusal state from Figure 5 view and longitudinal section of an automatic injector,

[0124] Fig.17 Two longitudinal sections of a product container receiving device are shown, which are rotated by 90° relative to one another, wherein the insert is preassembled.

[0125] Fig.18 Two longitudinal sectional views of a product container receiving device, which are rotated by 90° relative to one another, are shown, wherein a prefilled syringe is preassembled,

[0126] Fig.19 Two longitudinal sectional views of the product container receiving device, which are rotated by 90° relative to each other, are shown, in which the insert and the prefilled syringe are finally assembled,

[0127] Fig.20a shows the Figure 5 A longitudinal cross-sectional view of an automatic injector,

[0128] Fig.20b shows the final bonding step after the second step. Figure 5 A longitudinal cross-sectional view of an automatic injector,

[0129] Fig.21a shows a longitudinal section through a product container receiving device in a delivery state for an exemplary penetration depth of 8 mm,

[0130] Figure 21b shows a longitudinal section through a product container receiving device in a pierced state for an exemplary piercing depth of 8 mm,

[0131] Fig.22a shows a longitudinal section through the distal end of the product container receiving device in the delivery state for an exemplary penetration depth of 5 mm,

[0132] Figure 22b shows a longitudinal sectional view of the distal end of the product container receiving device in the pierced state for an exemplary piercing depth of 5 mm,

[0133] Fig.23a shows a longitudinal section through the drive device and a view of the drive spring and the display window, respectively,

[0134] Figure 23b A longitudinal section showing a proximal end of a drive device and a view showing a variant of a drive spring and a display window, respectively,

[0135] Fig.24a A fully filled prefilled syringe from Figure 5 A longitudinal cross-sectional view of an automatic injector,

[0136] Figure 24b A partially filled prefilled syringe from Figure 5 A longitudinal cross-sectional view of an automatic injector,

[0137] Fig.25 Shown is a diagram of a Figure 5 Two views of a variant of an autoinjector. DETAILED DESCRIPTION

[0138] Figure 1 An exploded view of the components of an automatic injector according to the invention is shown in a first embodiment, and Figure 2 Shown in the inserted state and ready to pour according to Figure 1 Two longitudinal sections of an automatic injector rotated by 90° relative to one another about the longitudinal axis.

[0139] The autoinjector 1 has a sleeve-shaped, elongated housing with a longitudinal axis L and comprises a distal housing part 10b and a proximal housing part 10a in the form of a handle that is non-detachably engaged therewith. A product container in the form of a prefilled syringe 11 is held in a syringe holder 12, which has an injection needle that is non-detachably fastened to the product container, wherein the syringe holder is received in the housing in an axially fixed and rotationally fixed manner. The prefilled syringe 11 is pressed in the distal direction by a retaining spring section 13a that is firmly anchored in the housing part 10a in an engaging manner with a shoulder of the syringe holder 12. The prefilled syringe 11 is arranged in relation to the housing part 10b in such a way that the tip of the injection needle protrudes beyond the distal end of the proximal middle position of the needle protection sleeve 14 by a length corresponding to the subcutaneous or intramuscular penetration depth and is protected or covered at least laterally by the needle protection sleeve 14 before and after the injection. When the injection needle is inserted into the injection site, the needle guard sleeve 14 is pushed in the proximal direction along the longitudinal axis L with an operating stroke and against the force of the needle protection spring 15, and the product pouring is triggered. For this purpose, the needle guard sleeve includes two sleeve arms 14a, which are arranged at 90° offset or twisted around the longitudinal axis L relative to two recesses 10c of the housing, which are called observation windows. After the injection is completed, the needle guard sleeve 14 can be pushed in the distal direction to the needle protection position along the longitudinal axis L relative to the housing part 10b from the operated position, and is blocked there to prevent the return movement. The needle guard sleeve includes a sleeve-shaped or hollow cylindrical section 14b and a flange 14c at the distal end. Like the outer periphery of the flange, the cross section of the hollow cylindrical section 14b is elliptical, so that the flange has a constant width or radial extension in this article.

[0140] The spring assembly comprises a helical spring 20a and a spring coil 20b. The helical spring 20a is fixedly secured with its outer end to the spring sleeve 13b in a rotationally fixed manner as part of a mechanical support 13 firmly anchored in the housing. The inner end of the helical spring 20a is connected to the spring coil 20b in a rotationally fixed manner. The spring coil 20b comprises a spring rod and a distal spring flange. The helical spring 20a or the spring coil 20b places the drive element 21 in a rotational motion and places the propulsion element 22 in a preferably purely axial propulsion motion. For this purpose, the threaded element engages in a thread extending over the pouring stroke with a variable pitch.

[0141] The prefilled 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 the syringe shoulder. The injection needle of the prefilled syringe is covered by a needle protection cover 11a, which is constructed as a so-called rigid needle shield (Rigid Needle Shield, RNS) and comprises a rubber-elastic needle protection element and a sleeve made of hard plastic. The needle protection cover protects the injection to prevent mechanical action and dirt, and keeps the injection needle and the product sterile. A two-piece device cover or removal cover 16 is arranged at the distal end of the automatic syringe in its delivery state, and before using the automatic syringe, the device cover or removal cover is removed and / or twisted off axially together with the needle protection cover 11a and completely removed.

[0142] The switching sleeve 17 is arranged in a form-fitting manner with the proximal end of the sleeve arm 14a of the needle guard sleeve 14 and with the distal end of the needle protection spring 15 and is at least partially surrounded by the latter. The switching sleeve 17 preferably engages with the proximal end of the sleeve arm of the needle guard sleeve 14. The movement of the switching sleeve 17 in the distal direction is limited by the retaining spring section 13a, which in turn engages with the mechanical support 13 after the switching sleeve 17 is mounted. A locking sleeve 18 is arranged inside the switching sleeve 17 and coaxially therewith, and is coupled to the switching sleeve 17 by a sawtooth-shaped locking mechanism 18a elastically mounted on the arm pointing in the distal direction, so that the operating movement of the needle guard sleeve 14 and the switching sleeve 17 also causes the locking sleeve 18 to move proximally. By the additional proximal locking stroke of the locking sleeve 18 relative to the switching sleeve 17 into the proximal end position, the locking mechanism 18a is reliably released from the switching sleeve 17 for inward movement. By the elastic force of the arm, the locking mechanism 18a engages behind the proximally directed edge of the autoinjector or snaps into an axially fixed recess of the autoinjector and thus locks the locking sleeve 18 against distal movement. When the autoinjector is removed from the puncture site, the switching sleeve 17 is pushed in the distal direction onto the locking mechanism 18a by the needle protection spring 15, and then the locking mechanism engages behind the proximally directed edge of the switching sleeve 17 in the locking position by the elastic force of the arm, and the switching sleeve and the needle protection sleeve are locked or blocked against further movement in the proximal direction.

[0143] The coupling sleeve 23 with two retaining projections 23a is coupled to the spring coil 20b by a coupling element. Before pouring, the retaining projections 23a are embedded in the recess of the axially fixed mechanical support 13 and the inner circumference of the locking sleeve 18 is prevented from moving outward, so that the coupling sleeve 23 cannot move axially. When triggering pouring, the locking sleeve 18 leaves the position of the recess by the proximal movement of the needle protection sleeve 14, so that the retaining projections 23a can be loosened radially and the coupling sleeve 23 can be released. The latter moves in the proximal direction and releases the spring coil 20b for rotation, as described in detail in patent application PCTEP2021076923. There is a display at the proximal end of the automatic injector, which has a rotating display element 25a with a contrasting pattern in the form of parallel strips, a surrounding transparent window 25b and a near-end opaque stop 25c.

[0144] Figure 3 Two views of a display element 25a with an engagement element 25d are shown, which is used to engage in a non-rotating grid located on the inside of the window 25b or the stop 25c. The engagement element 25d is elastically supported and generates a number of clicks corresponding to the grid structure when the display element is rotated during pouring. The display element has a shape that follows the shape of the window or is adapted thereto, with a first distal region and a second region adjacent thereto in the proximal direction. The first region is cylindrical and parallel to the longitudinal axis, while the second region has a continuously decreasing diameter.

[0145] Figure 4 The distal end of the needle guard is shown with a sleeve-shaped section 14b and a flange 14c. The shape of the flange with a concavely curved support surface can be clearly seen, the outer elliptical edge of which projects distally relative to the inner edge of the support surface at the transition to the axially parallel section.

[0146] Figure 5 Two views of a second embodiment of an autoinjector 1 according to the invention are shown, rotated by 90° relative to one another.

[0147] Figure 6 Is from Figure 5Exploded view of the components of the second embodiment of the improved automatic injector. The automatic injector 1 has a product container receiving device 90, a prefilled syringe 11 and a drive device 80 as a structural component. The product container receiving device 90 has the following components: a device cover 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 mechanical support 13, a spring coil 20b, a spiral or drive spring 20a, a display element 25a, a display window 25b and a display cover 25c. The autoinjector 1 can be assembled ready for storage and / or ready for use from two preassembled components 80 , 90 by inserting the prefilled syringe 11 into the product container receiving device 90 and subsequently firmly connecting, in particular snapping, the drive device 80 to the product container receiving device 90 .

[0148] Figure 7 (See also Figure 6 , Fig.11b , Figure 12b ) shows the state in which it is delivered or before use. Figure 5 1 and 2. The device cover 16 is non-releasably positioned axially relative to the insert 30 by means of a retaining projection 16b which engages in a correspondingly arranged retaining opening 30c of the insert 30. The rotational positioning of the device cover 16 is achieved by means of its rotation-locking rib 16a (inside the device cover, not shown), which engages in a correspondingly arranged rotation-locking groove 30g of the insert 30 and in a rotation-locking groove 14e of the needle guard 14.

[0149] In order to position the insert 30, the insert has a second retaining opening 30e, into which a correspondingly arranged retaining snap 14d of the needle guard 14 engages, which can be released when force is dissipated. In addition, a retaining projection of the retaining arm 30a, which is arranged at the proximal end of the insert 30, engages with a shoulder 11d of the needle guard cap 11a of the prefilled syringe 11.

[0150] The needle guard sleeve 14 is positioned and stopped to prevent axial displacement in the distal direction by its holding opening 14f, into which the holding projection 10d of the syringe housing part 10b arranged correspondingly engages. The needle guard sleeve 14 also has another holding opening 14g, into which the holding projection 12e of the syringe support 12 arranged correspondingly and releasable under the condition of force consumption engages. The needle guard spring 15 applies a predetermined preload force to the needle guard sleeve 14 through the switching sleeve 17 with its distal spring end 15a, thereby defining the axial positioning of the needle guard sleeve. The rotational positioning of the needle guard sleeve 14 is achieved by its rotation locking groove 14h, into which the rotation locking rib 10e of the syringe housing part 10b arranged correspondingly engages.

[0151] The syringe housing part 10b together with the drive housing part 10a is regarded as a fixed part or as a housing forming a reference for the description in this specification. The syringe housing part is connected to the drive housing part in an axially non-detachable manner by means of its double snap-in groove 10f, the distal and proximal grooves of which engage with the double retaining projections 10g of the drive housing part 10a arranged accordingly. The rotational positioning of the syringe housing part 10b is achieved by means of its rotation-locking rib 10h, which is in contact with the rotation-locking surface 10i of the drive housing part 10a arranged accordingly.

[0152] The syringe holder 12 is positioned axially by its retaining snap-fit ​​12f and by its bearing surface 12g, which is in contact with the correspondingly arranged bearing surfaces 10k, 101 of the syringe housing part 10b. The rotational positioning of the syringe holder 12 is achieved by its torsion locking rib 12h, which engages with the correspondingly arranged torsion locking groove 10m of the syringe housing part 10b. In addition, the rotational positioning of the syringe holder 12 is ensured by its torsion locking rib 12i, which is in contact with the correspondingly implemented viewing window edge 10n of the syringe housing part 10b.

[0153] The prefilled syringe 11 is positioned axially in the distal direction by its bearing surface 11d, which is in contact with the correspondingly arranged bearing edge 12c of the syringe holder 12, and in the proximal direction by its bearing surface 11e, which is in contact with the correspondingly arranged bearing surface 13c of the syringe adapter 13a, wherein the flexible element 13d of the syringe adapter 13a, to which the bearing surface 13c is connected, applies a defined preload force to the prefilled syringe 11. The prefilled syringe 11 is freely rotatable.

[0154] The syringe housing part 10 b together with the drive housing part 10 a is regarded as forming a fixed part of the reference housing.

[0155] The mechanical support 13 is positioned axially by its retaining snap-fitting element 13e and the bearing surface 13f, which is in contact with the corresponding retaining projection 10o and the bearing surface 10p of the drive housing part 10a. The rotational positioning is ensured by the rotation-locking rib 13g that engages with the correspondingly arranged rotation-locking groove 10q (not shown) of the drive housing part 10a.

[0156] The axial position of the advancing element 22 is determined by its internally disposed threaded portion 22a, which engages with the correspondingly configured externally disposed threaded portion 21a of the drive element 21. The rotational positioning of the advancing element 22 is achieved by its axially extending rotation-locking rib 22b, which is guided in a correspondingly arranged rotation-locking groove 13h (not shown) of the mechanical support 13.

[0157] The drive element 21 is positioned axially by its circumferential shoulder 21b, at the distal end of which the correspondingly arranged retaining snap 13i of the mechanical support 13 engages, 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 rotation-stop surface 21d, which is in contact with the correspondingly designed rotation-stop surface 20d of the spring coil 20b.

[0158] The syringe adapter 13a is positioned axially by its retaining snaps 13j, which are in contact with the correspondingly arranged retaining openings 13k, and by its bearing surfaces 13l, which are in contact with the correspondingly designed bearing surfaces 13m of the machine support 13. The rotational positioning of the syringe adapter 13a is achieved by its rotation-locking grooves 13n, which engage with correspondingly arranged rotation-locking ribs 13o of the machine support 13.

[0159] The switch sleeve 17 rests at its distal end with its bearing surface 17a, which is in contact with a correspondingly designed contact surface 14i of the needle guard sleeve 14, and is prestressed by a defined spring force of the needle guard spring 15 via a distal spring end 15a of the needle guard spring 15, which rests on a correspondingly designed spring support 17b of the switch sleeve 17. The rotational positioning of the switch sleeve 17 is achieved via its guide surface 17c, which engages with a correspondingly designed guide rib 10r of the drive housing part 10a.

[0160] The locking sleeve 18 is positioned axially in the switching sleeve 17 with a defined clearance. The locking sleeve 18 is defined in the distal direction by its inwardly directed retaining projections 18b, by contact with the correspondingly arranged bearing surfaces 13p of the mechanical support 13. In the proximal direction, the locking sleeve 18 is defined by the outwardly directed retaining projections 18c, by contact with the correspondingly implemented 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 with the correspondingly implemented guide surfaces 13r of the mechanical support 13 and engage with the switching sleeve 17 by form locking.

[0161] The needle protection spring 15 is positioned by its distal spring end 15a, which rests on a correspondingly designed spring support 17b of the switching sleeve 17, and its proximal spring end 15b, which rests on a correspondingly designed spring support 23b of the coupling sleeve 23, wherein the needle protection spring 15 exerts a defined preload force by its spring force between the switching sleeve 17 and the coupling sleeve 23. In addition, the needle protection spring 15 is guided with its outer circumferential side by guide ribs 10s disposed inwardly of the drive housing part 10a and is supported laterally by a surrounding stop 23i.

[0162] The coupling sleeve 23 abuts with its inwardly directed retaining projection 23c, which contacts the correspondingly arranged retaining surface 13s of the mechanical support 13, wherein the outwardly directed contact surface 23d, which contacts the correspondingly designed contact surface 18e of the locking sleeve 18, prevents the retaining arms 23e of the coupling sleeve 23 from being able to deflect outwardly. The axial position of the coupling sleeve 23 is determined by the defined preload of the spring force of the needle protection spring 15, which abuts with its proximal spring end 15b on the correspondingly designed spring support 23b. The torque of the helical spring 20a applied to the spring coil 20b is locked by the inclined contact surface 20f of the coupling protrusion 20e, which contacts the contact surface 23f of the coupling protrusion 23a of the coupling sleeve 23, which is arranged correspondingly thereto, wherein the inclination angle of the contact surfaces 20f, 23f is defined in such a way that a part of the applied torque acts on the coupling sleeve 23 as an axial force, thereby prestressing the coupling sleeve 23 in the proximal direction. The rotational positioning of the coupling sleeve 23 is achieved by the retaining arm 23e and by the contact of the coupling protrusion 20e with the coupling protrusion 23a, which retaining arm engages with the guide opening 13t of the mechanical support 13, which is designed correspondingly thereto.

[0163] The spring coil 20b, with its bearing surface 20g arranged at the distal end, abuts against a corresponding bearing surface 13q of the mechanical support 13. The torque of the helical spring 20a applied to the spring coil 20b is locked by the inclined contact surface 20f of the coupling protrusion 20e, which contacts the correspondingly arranged contact surface 23f of the coupling protrusion 23a of the coupling sleeve 23, wherein the inclination angle of the contact surfaces 20f, 23f is specified so that a part of the applied torque acts on the spring coil 20b as an axial force, whereby the spring coil 20b is pressed against the mechanical support 13 with a low preload and fixed in the axial direction.

[0164] The helical spring 20a engages with its outer spring end 20h in a spring receiving portion 13u of the mechanical support 13, which is implemented accordingly, and engages with its inner spring end 20i in a spring receiving portion 20j of the spring coil 20b, which is designed accordingly. The helical spring 20a is positioned axially between the spring coil 20b and the display element 25a. The outer spring end 20h is formed integrally by the end section of the spring clip. The outermost turns of the spring clip are connected to form a sleeve-shaped ring (for example, by spot welding or stamping and bending or by mechanical anchoring) so that the spring housing is formed integrally by the spring clip.

[0165] The display element 25a is positioned axially relative to the spring coil by its bearing surface 25e, which contacts the correspondingly designed contact surface 20k, and by its retaining projection 25f, which engages with the correspondingly designed retaining projection 201 of the spring coil 20b. The rotational positioning of the display element 25a is achieved by the rotation-locking rib 20m of the spring coil 20b, which engages with the correspondingly designed rotation-locking groove 25g of the display element 25a.

[0166] The display window 25b is non-detachably positioned axially relative to the mechanical support by its retaining opening 25h, which engages with a correspondingly designed retaining projection 13v, and by its bearing surface 25i, which is in contact with a correspondingly designed contact surface 13w of the mechanical support 13. The rotational positioning of the display window 25b is achieved by its rotation-locking groove 25j, which engages with a correspondingly designed rotation-locking rib 13x of the mechanical support 13.

[0167] The display cover 25c is positioned axially non-detachably and rotationally fixedly relative thereto via its retaining snaps 25k which engage with correspondingly designed retaining openings 251 and via its bearing surfaces 25m which contact correspondingly designed contact surfaces 25n.

[0168] Figure 8Shows the state of triggering the lock from Figure 5 FIG. 2 is a longitudinal section through an autoinjector of FIG. 1 , which is rotated by 90° relative to one another and which can be activated, for example, by a strong acceleration of the autoinjector.

[0169] When the needle guard 14 moves in the proximal direction, the retaining snap 14d is deflected through the retaining opening 30e at the insert 30. The locking surface 14j abuts against the locking surface 12j of the syringe holder 12, which is limited in the proximal direction by the contact of the retaining snap 12f with the bearing surface 10k of the syringe housing part 10b. The proximal movement of the switching sleeve 17 and thus also the locking sleeve 18 is limited by the locking snap 17e that engages in the retaining opening 14k, so that the retaining arm 23e of the coupling sleeve 23 is always locked against deflection. It is thus ensured that the injection cannot be triggered as long as the device cover 16 is not removed.

[0170] Fig. 9 The device cover including the needle protection cover is removed. Figure 5 Two longitudinal sections of an automatic injector rotated by 90° relative to each other.

[0171] In use, the device cover 16 is removed from the autoinjector in the distal direction. The insert 30 is removed together with the device cover 16, which is connected via its retaining opening 30c to the retaining projection 16b of the device cover 16 in a non-detachable manner relative to the retaining projection. In the process, the releasable connection between the retaining snap 14d of the needle guard 14 and the correspondingly designed retaining opening 30e of the insert 30 is released when force is dissipated.

[0172] The needle guard cap 11a, which is non-detachably connected to the retaining projection 30a of the insert 30 via its shoulder 11f and retaining arms, is removed together with the device cover 16 and the insert 30. In the process, the clamping region 11g between the needle guard cap 11a and the prefilled syringe 11, which can be detached when exerting force, is released.

[0173] Fig.10 Shows the penetration state from Figure 5 1 and 2. Two longitudinal sections of an automatic injector of FIG. 1 are rotated by 90° relative to one another, wherein the torque at the spring coil 20 b is still blocked.

[0174] In order to insert the injection needle 11b of the prefilled syringe 11 into the injection site, the automatic injector is pressed against the injection site with its distal end during use. During the needle insertion process, the needle protection sleeve 14 is pushed in the proximal direction, thereby inserting the needle previously blocked by the needle protection sleeve 14 into the skin. At the beginning of the needle insertion process, a prescribed triggering resistance must be overcome. For this purpose, the releasable connection between the retaining protrusion 12e of the syringe holder 12 and the correspondingly implemented retaining opening 14g of the needle protection sleeve 14 is released under the condition of force consumption. The switching sleeve 17 contacts the correspondingly implemented contact surface 14i of the needle protection sleeve 14 with its supporting surface 17a, and the switching sleeve is pushed in the proximal direction together with the needle protection sleeve 14. The needle protection spring 15 rests with its distal spring end 15a on a correspondingly designed spring support 17b of the switching sleeve 17 and with its proximal spring end 15b on a correspondingly designed spring support 23b of the coupling sleeve 23, and is preloaded during the displacement of the needle protection sleeve 14 and the switching sleeve 17. The locking sleeve 18, which is displaced in the proximal direction together with the needle protection sleeve 14 and the switching sleeve 17, contacts with its locking projection 18f a correspondingly designed retaining surface 17f of the switching sleeve 17. As a result of the displacement of the locking sleeve 18 relative to the coupling sleeve 23, the contact surface 18e of the locking sleeve 18 moves away from the contact surface 23d of the retaining arm 23e of the coupling sleeve 23, whereby the retaining arm 23e of the coupling sleeve 23 is no longer secured against deflection and can therefore be deflected outwards.

[0175] Fig.11a Shows the state of releasing the drive from Figure 5 Two longitudinal sectional views of the automatic injector rotated 90° relative to each other, and Fig.11b The diagram shows the state of the drive being released immediately after the release of the spring energy. Figure 5 A partial cross-sectional view of the coupler sleeve and spring coil of an auto-injector.

[0176] The needle protection spring 15 is in contact with the correspondingly designed spring support 23b of the coupling sleeve 23 with its proximal spring end 15b, and the coupling sleeve 23 is pushed in the proximal direction relative to the mechanical support 13 and the spring coil 20b by the spring force of the needle protection spring. The retaining arms 23e of the coupling sleeve 23, which were previously released by the locking sleeve 18, are here deflected outwardly by their inwardly directed, oblique retaining projections 23c, which were previously in contact with the correspondingly designed retaining surfaces 13s of the mechanical support 13, whereby the outwardly directed retaining surfaces 23g are now in contact with the correspondingly designed retaining surfaces 18g of the retaining arms 18h of the locking sleeve 18. The contact between the contact surface 18i and the correspondingly designed contact surface 17g of the switching sleeve 17 prevents the retaining arms 18h of the locking sleeve 18 from being able to expand outwards, whereby the coupling sleeve 23 is held in position relative to the machine support 13 and the spring coil 20b by the locking sleeve 18. Due to the contact between the outwardly directed retaining surfaces 23g of the coupling sleeve 23 and the correspondingly arranged retaining surfaces 18g of the retaining arms 18h of the locking sleeve 18, the locking sleeve is entrained by the coupling sleeve 23 in the proximal direction relative to the machine support 13 until the locking sleeve with its contact surface 18j is located at the correspondingly designed contact surface 13y of the machine support 13.

[0177] By pushing the coupling sleeve 23 in the proximal direction relative to the spring coil 20b, the connection between the contact surface 23f of the coupling projection 23a of the coupling sleeve 23 and the correspondingly implemented contact surface 20f of the coupling projection 20e of the spring coil 20b arranged at the distal end has been released, thereby now releasing the stored spring energy of the spiral spring 20a. Fig.11b Since the spring coil 20b is no longer rotationally locked by the connection to the coupling sleeve 23 and is therefore no longer axially prestressed relative to the mechanical support 13, the spring coil 20b is displaced in the proximal direction relative to the mechanical support 13 and the display window 25b by the reaction force of the drive element 21 until the spring coil is located with its bearing surface 20n on the correspondingly designed bearing surface 25o of the display window 25b.

[0178] Fig.12a Shows the pouring state from Figure 5 Two longitudinal sectional views of an automatic injector rotated 90° relative to each other, Figure 12b Shown from Figure 5 A proximal end view of a spring coil 20b having a helical spring (also referred to as a drive spring) 20a of an automatic injector 1 of FIG. Fig.12c Shown from Figure 5Cross section of the distal view of the display element 25a with the display window 25b of the automatic injector 1. The spring energy stored in the helical spring 20a is transmitted to the spring coil via its inner spring end 20i (which is engaged with the spring receiving portion 20j of the spring coil 20b which is implemented accordingly), whereby the spring coil 20b rotates. The spring coil 20b outputs its rotational movement to the drive element via its rotation stop surface 20d (which is in contact with the rotation stop surface 21d of the drive element 21 which is designed accordingly), Figure 12b The drive element 21 in turn drives the propulsion element 22 in the distal direction via its externally disposed threaded portion 21a, which is in contact with an internally disposed threaded portion 22a of the propulsion element 22 and implemented correspondingly thereto, wherein the propulsion element 22 is prevented from twisting by its external twist-stop rib 22b, which is engaged with an internal twist-stop groove 13h (not shown) of the mechanical support and designed correspondingly thereto.

[0179] The plunger 26 in the prefilled syringe 11 is in contact with its contact surface 11h with the correspondingly designed bearing surface 22c of the advancing element 22 and is displaced together with the advancing element 22 in the distal direction, whereby the drug present in the prefilled syringe 11 is poured through its injection needle 11b.

[0180] During the injection, the injection progress can be seen by the user through the viewing window 10c of the syringe housing part 10b through the view onto the plunger 26. Since the injection speed is very slow and can therefore be difficult to perceive visually (for example, an injection duration of 60 seconds for a completely filled prefilled syringe), an additional injection movement display is integrated at the proximal end of the automatic injector. The display element 25a, which abuts with the correspondingly designed contact surface 20k of the spring coil with its bearing surface 25e, engages axially with the retaining projection 201 of the spring coil 20b by means of the retaining projection 25f, and engages with the torsion-stop rib 20m of the spring coil 20b through its torsion-stop groove 25g, 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 the user through the transparent display window 25b via the applied pattern 25p, thereby providing the user with additional and improved visual feedback about the injection being performed.

[0181] As a supplementary solution to the visual feedback, the user receives continuous acoustic feedback about the injection being performed in the form of a click, which is generated between the rotating display element 25a and the fixed display window 25b. The latching protrusion 25q arranged at the radially deflectable spring arm 25d of the display element 25a slides on the grid structure 25r of the display window 25b, which is implemented radially corresponding to it, during the injection, wherein the spring arm 25d of the display element 25a is radially preloaded and relaxed relative to the display window 25b during the rotation, so that the continuous acoustic click can be perceived by the user. If the click frequency should be adapted to the pouring speed, the number of grid structures 25r can be changed. It should be taken into account that the spacing is consistent with the assembly position of the spring arm 25d. It is conceivable that, for example, 2, 4 or 8 grid structures are provided per turn. Fig.12c An embodiment with four grid structures 25r and two spring arms 25d is shown.

[0182] The injection force presses the two sub-components, namely the product container receiving device 90 and the drive device 80, apart from each other, which are combined together by the double snap groove 10f and the double retaining protrusion 10g at the syringe housing part 10b or the drive housing part 10a. In the distal direction, the injection force is transmitted from the prefilled syringe 11 to the syringe housing part 10b via the syringe support 12 through the interfaces 11d / 12c and 12g / 10l. In the proximal direction, the injection force is transmitted from the propulsion element 22 to the drive element 21, the spring coil 20b, the display window 25b and the mechanical support 13 through the interfaces 22a / 21a, 21c / 20c, 20n / 25o, 25h / 13v and 13e / 10o to the drive housing part 10a.

[0183] Fig.13 Shows the state at the end of pouring from Figure 5 Two longitudinal sections of an automatic injector rotated by 90° relative to each other.

[0184] As soon as the plunger 26 with its contact surface 11j arranged at the distal end abuts against the correspondingly designed contact surface 11i of the prefilled syringe 11, the displacement of the plunger in the distal direction stops automatically. The automatic injection is thus terminated. The end of the pouring is apparent to the user through the stationary display element 25a and the absence of a click sound caused by the relative movement of the display element 25a and the display window 25b fixed to the housing can be perceived.

[0185] Fig.14 Shows the state from which the needle protection lock is activated Figure 5 Two longitudinal sections of an automatic injector rotated by 90° relative to each other.

[0186] After the injection is completed or the pouring is finished, the needle guard 14 together with the switching sleeve 17 is pushed to its original position in the distal direction again by the spring force of the needle protection spring 15 and locked to prevent further penetration by the locking sleeve 18. The outwardly directed locking projections 18f of the locking arms 18a and the locking surfaces 18k of the outwardly deflected retaining arms 18h of the locking sleeve 18 contact the correspondingly designed locking surfaces 17h and the locking surfaces 17i of the switching sleeve 17, thereby preventing the switching sleeve 17 and thus the needle guard 14 from being pushed again in the proximal direction, in that the bearing surface 17a and the correspondingly designed contact surface 14i contact in a form-fitting manner.

[0187] During the removal of the automatic injector 1 from the injection site, the needle protection sleeve 14 and the switch sleeve 17 are pushed distally into their original positions again due to the spring force of the needle protection spring 15 (the needle protection spring is in contact with the correspondingly implemented spring support 17b of the switch sleeve 17 with its distal spring end 15a, and the switch sleeve is in contact with the correspondingly designed contact surface 14i of the needle protection sleeve 14 via its support surface 17a), until the retaining opening 14f of the needle protection sleeve 14 is in contact with the retaining protrusion 10d of the syringe housing part 10b again.

[0188] The switching sleeve 17 is pushed into its original position together with the needle guard 14 in the distal direction by the spring force of the needle guard spring 15. 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 projections 18f of the locking arms 18a, whereby the locking projections 18f of the locking arms 18a are now located behind the proximal end of the switching sleeve 17.

[0189] The displacement of the switching sleeve 17 relative to the locking sleeve 18 causes the retaining arms 18h of the locking sleeve, which were previously in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17 and were therefore blocked from displacement, to now be deflected outward. The coupling sleeve 23, which was previously in contact with the correspondingly designed retaining surfaces 18g of the retaining arms 18h of the locking sleeve 18 and was therefore blocked from displacement, can now be displaced in the proximal direction relative to the locking sleeve 18 and the mechanical support 13 by the retaining surfaces 23g of the retaining arms 23e of the coupling sleeve 23.

[0190] The needle protection spring 15 contacts with its proximal spring end 15b a correspondingly designed spring support 23b of the coupling sleeve 23, and due to the spring force of the needle protection spring, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until the coupling sleeve is located with its supporting surface 23h on the correspondingly designed supporting surface 13z of the mechanical support 13. In this process, the retaining arms 18h of the locking sleeve 18 are deflected outwards by the retaining surfaces 23g of the retaining arms 23e of the coupling sleeve 23.

[0191] Fig.15a shows the state of interrupted pouring from Figure 5 Two longitudinal sectional views of the automatic injector rotated 90° relative to each other, and Fig.15b shows the state of interrupted pouring from Figure 5 A partial cross-sectional view of the coupler sleeve and spring coil of an auto-injector.

[0192] If the user removes the automatic injector 1 from the injection site before the end of pouring, an injection interruption or pouring stop is performed, thereby also activating the automatic needle protection lock. At the same time, the automatic pouring is stopped and the undesirable leakage of the remaining drug from the injection needle 11b is therefore prevented.

[0193] During the removal of the automatic injector from the injection site, the needle protection sleeve 14 and the switch sleeve 17 are pushed distally into their original positions again due to the spring force of the needle protection spring 15 (the needle protection spring contacts with its distal spring end 15a a spring support 17b of the switch sleeve 17 which is implemented accordingly, and the switch sleeve in turn contacts with its support surface 17a a contact surface 14i of the needle protection sleeve 14 which is designed accordingly), until the retaining opening 14f of the needle protection sleeve 14 contacts the retaining protrusion 10d of the syringe housing part 10b again.

[0194] The switching sleeve 17 is pushed into its original position together with the needle guard 14 in the distal direction by the spring force of the needle guard spring 15. 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 projections 18f of the locking arms 18a, whereby the locking projections 18f of the locking arms 18a are now located behind the proximal end of the switching sleeve 17.

[0195] The displacement of the switching sleeve 17 relative to the locking sleeve 18 causes the retaining arms 18h of the locking sleeve, which were previously in contact with the correspondingly arranged contact surfaces 17g of the switching sleeve 17 and were therefore blocked from displacement, to now be deflected outward. The coupling sleeve 23, which was previously in contact with the correspondingly designed retaining surfaces 18g of the retaining arms 18h of the locking sleeve 18 and was therefore blocked from displacement, can now be displaced in the proximal direction relative to the locking sleeve 18 and the mechanical support 13 by the retaining surfaces 23g of the retaining arms 23e of the coupling sleeve 23.

[0196] The needle protection spring 15 contacts with its proximal spring end 15b a correspondingly designed spring support 23b of the coupling sleeve 23, and due to the spring force of the needle protection spring, the coupling sleeve 23 is now displaced in the proximal direction relative to the locking sleeve 18 until the coupling sleeve is located with its supporting surface 23h on the correspondingly designed supporting surface 13z of the mechanical support 13. In this process, the retaining arms 18h of the locking sleeve 18 are deflected outwards by the retaining surfaces 23g of the retaining 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 the contact surface 23f of the coupling projection 23a of the coupling sleeve to engage with the correspondingly designed contact surface 20o of the proximally arranged coupling projection 20p of the spring coil 20b. Fig.15b The rotation of the spring coil 20b is thereby prevented and automatic pouring is stopped.

[0198] After the injection is interrupted by the user, the axial position of the plunger 26 of the prefilled syringe 11 is apparent through the viewing window 10c of the syringe housing component, whereby the user can estimate how much injection volume has been dispensed or how much residual drug remains.

[0199] Fig.16 Shows the pre-occlusal state from Figure 5and a longitudinal sectional view of the automatic injector 1. The pre-occluded state is the starting state for the assembly of the prefilled syringe and the final assembly of the automatic injector 1. In the pre-occluded state, the two sub-components, namely the drive device 80 and the product container receiving device 90, can be detachably connected to each other and can be reliably supported in a specified position relative to each other and transported by force-locking axial and form-locking rotational fixation. The sub-components, namely the product container receiving device 90 and the drive device 80, are pre-occluded by means of a releasable snap connection 10v / 10u between the syringe housing part 10b and the drive housing part 10a. To this end, the locking protrusion 10u at the drive housing part 10a engages the proximal edge of the locking groove 10v in the syringe housing part 10b behind it. In addition, the distal side of the double retaining protrusion 10g abuts the proximal edge of the double retaining groove 10f, and the housing parts 10a, 10b are thus positioned axially relative to each other at a specified spacing, such as Fig.16 . A circumferential step 10y is introduced into the distal end section 10w at the drive housing part 10a. The assembly window 10t in the distal end section 10w of the drive housing part 10a is visible and accessible from the outside. The end section 10w is partially pushed into the proximal end of the syringe housing part 10b, wherein a circumferential gap guide 10x acting in the axial direction is formed between the two housing parts 10a, 10b in the region of the end section 10w.

[0200] Fig.17 Two longitudinal sectional views of a product container receiving device 90, which are rotated by 90° relative to each other, are shown, wherein the insert 30 is preassembled. In a first step, the drive device 80 is removed from the pre-engaged automatic injector, and the product container receiving device 90 is thus ready to receive a prefilled syringe through the proximal opening during the joining process. The insert 30 engages with its distal retaining opening 30b in the preassembled state with the correspondingly designed retaining projection 16b of the device cover 16. In addition, the retaining snap 14d of the needle guard 14, which can be released when force is dissipated, engages in the correspondingly designed retaining opening 30d of the insert 30, whereby the insert is positioned relative to the other components of the product container receiving device 90. In this state, the retaining slot 30j of the retaining arm 30a is positioned relative to the correspondingly arranged retaining rib 12a of the syringe holder 12 so that the flexible retaining arm with the retaining protrusion 30a can be deflected outward, wherein the retaining rib 12a of the syringe holder 12 moves into the retaining slot 30j of the retaining arm 30a, or the retaining arm 30a is received in an axially extending recess near the retaining rib 12a.

[0201] Fig.18Two longitudinal sectional views of a product container receiving device 90, which are rotated by 90° relative to each other, are shown, wherein a prefilled syringe 11 is preassembled (PFS with RNS). The prefilled syringe 11 is engaged in the product container receiving device 90 in a certain axial direction in the distal direction until it contacts with its supporting surface 11d a correspondingly designed holding arm with a holding projection 30a and a supporting surface 30h of the insert 30. During this engagement process of the prefilled syringe 11, the holding projection of the flexible holding arm 30a of the insert 30 slides on the circumferential side of the needle protection cap 11a of the prefilled syringe 11 until the holding projection on the holding arm 30a engages elastically or is located proximal to the shoulder 11f of the needle protection cap 11a.

[0202] Fig.19 Two longitudinal sectional views of the product container receiving device 90, which are rotated relative to each other by 90°, are shown, wherein the insert 30 and the prefilled syringe 11 (PFS with RNS) are finally assembled. For this final assembly step, the prefilled syringe 11 is further engaged in the autoinjector in the axial direction in the distal direction until the support surface or shoulder 11d of the prefilled syringe contacts the correspondingly arranged support edge 12c of the syringe holder 12. Through the contact of the support surface 11d of the prefilled syringe 11 and the correspondingly implemented retaining projection 30a and the end-side support surface 30h of the insert 30, the insert is pushed together in the distal direction relative to the device cover 16. In this case, the retaining projection 16b is changed from the distal retaining opening 30b to the proximal retaining opening 30c. In addition, the retaining snap 14d of the needle guard 14 is changed from the retaining opening 30d to the proximal retaining opening 30e of the insert 30, which is designed accordingly. By this final assembly step, the holding arm with the holding projection 30a now reaches below the holding rib 12a of the syringe holder 12, or the holding slot 30j of the holding arm no longer releases the holding rib 12a of the syringe holder 12, thereby preventing the flexible holding arm with the holding projection 30a of the insert 30 from being able to deflect outwards. The engagement of the holding projection 30a with respect to the RNS shoulder 11f of the prefilled syringe 11 is thus prevented in a form-fitting manner.

[0203] Fig.20a 1 shows a longitudinal section through a product container receiving device 90 with an assembled prefilled syringe 11 after a first engagement step of the drive device 80. During this first engagement step, the assembly window 10t (see Fig.16 ) is inserted laterally into an assembly tool (not shown), and the switching sleeve 17 is engaged in the assembly groove 17j (see Figure 6) is fixed axially relative to the housing part 10a, thereby ensuring that the locking snap-fit ​​piece 17e on the fixed switching sleeve 17 can be deflected into the retaining opening 14k of the needle guard sleeve 14 during the first engagement step.

[0204] Fig.20b A longitudinal section through a product container receiving device 90 with an assembled prefilled syringe 11 is shown after the final second engagement step of the drive device 80. Prior to this second engagement step, the assembly tool (not shown) is removed. In this second engagement step, the drive device 80 is pushed into the product container receiving device 90 along the gap guide 10x in the axial direction with a linear movement until it abuts against the step 10y, wherein the double retaining projections 10g snap into their respective corresponding double snapping grooves 10f, and the drive device 80 is connected to the product container receiving device 90 in a form-locking and therefore non-detachable manner. By means of the second engagement step, the assembly window 10t at the distal end section 10w of the drive housing part 10a is covered by the surrounding sleeve-shaped end of the syringe housing part 10b, whereby the housing of the finally assembled automatic injector 1 cannot be penetrated by the interfering opening and the interior of the automatic injector 1 remains protected. The bearing surface 13c of the syringe adapter 13a is axially positioned at the proximal end of the prefilled syringe 11 by the bearing surface 11e, wherein the flexible element 13d of the syringe adapter 13a to which the bearing surface 13c is connected is preloaded by the second joining step.

[0205] With the autoinjector variant it should be possible to achieve a needle penetration depth of, for example, approximately 3-15 mm into the skin. Fig.21a In delivery state and Figure 21b The autoinjector variant is shown in the inserted state for an exemplary insertion depth of 8 mm. Fig.22a In delivery state and Figure 22b The autoinjector variants are shown in the inserted state for an exemplary insertion depth of 5 mm. These two variants differ from the other variants only by the different needle guards 14, wherein the axially extending section 14b is respectively shorter or longer, whereby the flange 14c to be placed on the skin is positioned differently, whereby the insertion depth of the needle 11b is correspondingly limited.

[0206] Fig.23a and Figure 23bA longitudinal sectional view of the proximal end of the drive device 80 and a view of the drive spring 20a and the display window 25b are shown respectively. In order to achieve different torques or injection forces, different drive springs can be installed. The drive springs have different spring clip widths and thus provide different levels of spring torque. Complementary to the spring clip width, a filling profile 25s extending in the axial direction of different lengths can be provided at the far end at the display window 25b, thus limiting the installation space for the spring in the axial direction. This avoids the spring spiral from breaking in the axial direction.

[0207] Fig.24a and Figure 24b A longitudinal cross-sectional view of an autoinjector with a prefilled syringe prefilled with different volumes of a medicinal product is shown. Fig.24a In the case of a partially filled syringe, the stroke of the advancing element 22 is maximum. Figure 24b In the case of, the stroke can be reduced by means of different assembly positions, wherein the same components can be used. The propulsion element 22 can be screwed onto the drive element 21 in the desired starting position. The grading of different starting positions for the propulsion element is generated by the axially extending torsion stop rib 22b of the propulsion element 22, which is guided in the torsion stop groove 13h arranged correspondingly thereto of the mechanical support 13. The grading of different starting positions of the propulsion element 22 further depends on the design of the coupling 23 or the spring coil 20b in terms of the number of retaining protrusions 23c, the distal coupling protrusions 20e, and the proximal coupling protrusions 20p, and depends on the pitch and the number of thread lines at the threaded portion 21a placed outside the drive element 21. In addition, for a smaller filling volume or a smaller stroke of the propulsion element 22, an adapted syringe housing component 10b with a shorter observation window 10c can be used.

[0208] like Fig.25 As shown in the figure, as a variant, a removal sleeve 30k with a claw 301 at the distal end and inclined relative to the axis L (instead of the insert 30) can be engaged and fastened in the device cover 16 in a form-locking manner, especially irreversibly. When the prefilled syringe is engaged, the claw 301 slides along the circumferential side of the needle protection cover 11a. When the device cover 16 is removed, the claw engages in the circumferential side and drives the needle protection cover 11a, thereby exposing the clamping area 11g and the injection needle 11b of the prefilled syringe 11.

[0209] List of reference numerals:

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Claims

1. An automatic injector (1), comprising: - a drive device (80) having a first housing part (10a) which includes a drive assembly (20, 21, 22), - a product container receiving device (90), the product container receiving device having a second housing part (10b), the second housing part defining a longitudinal axis (L) extending from a distal end to a proximal end, comprising a syringe holder (12), the syringe holder being configured to receive a prefilled prefilled syringe (11) having a cylindrical product container (11c) and a plunger (26) movable along the longitudinal axis (L) by the drive structure assembly (20, 21, 22), the plunger being used to pour a drug from the product container (11c), wherein the first housing part (10a) and the second housing part (10b) can be connected coaxially in a joining direction in such a way that a connection-side end section (10w) is stepped on one of the two housing parts (10a, 10b) so that the end section can be pushed into the other of the two housing parts (10a, 10b), wherein a circumferential gap guide (10x) is formed between the two housing parts (10a, 10b) in the region of the end section (10w), It is characterized in that In the region of the end section (10w), a first latching connection (10u, 10v) and a second latching connection as well as a third or final latching connection (10f, 10g) are provided, which can be individually latched one after another along a joining direction, and wherein, counter to the joining direction, the first of the latching connections (10u, 10v) can be released and at least the third or final latching connection (10f, 10g) can be locked.

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

3. An automatic injector (1) according to any one of the preceding claims, characterized in that The first latching connection (10u, 10v), the second latching connection and the third or final latching connection (10f, 10g) define a first latching position, a second latching position and a third or final latching position of the first housing part (10a) relative to the second housing part (10b) along the longitudinal axis (L).

4. Automatic injector (1) according to any one of the preceding claims, characterized in that The first, second and third or final latching connections are formed by projections and recesses in the interior of the gap guide (10x) which are respectively formed on the first and second housing parts (10a, 10b).

5. Automatic injector (1) according to any one of the preceding claims, characterized in that One of the housing parts (10a, 10b) can be circumferentially abutted against the end of the connection side of the other housing part (10a, 10b) by introducing a radial step (10y) into the end section (10w), wherein the radial step (10y) can be applied continuously in a wavy shape or discontinuously in the circumferential direction.

6. Automatic injector (1) according to the preceding claim, characterized in that When the third or final latching connection in the latching connection (10f, 10g) is locked, one of the housing parts (10a, 10b) utilizes the radial step (10y) introduced into the end section (10w) to circumferentially abut against the end of the connection side of the other housing part (10a, 10b).

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

8. Automatic injector (1) according to any 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 latching position and is completely covered by the other housing part (10a, 10b) at least in the third or final latching position.

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

10. Automatic injector (1) according to any one of the preceding claims, characterized in that In the third or final latching position, the two housing parts (10a, 10b) are fastened to one another by adhesive bonding or welding in addition to the latching connection (10f, 10g).

11. Automatic injector (1) according to any one of the preceding claims, characterized in that The automatic injector further comprises a syringe adapter (13a) which can abut the proximal end of the prefilled syringe (11) with its distal end (13c), 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. Automatic injector (1) according to the preceding claim, characterized in that The elastic element (13d) of the syringe adapter (13a) which is connected to the contact surface (13c) is clamped by the movement into the third or final locking position.

13. A method for final assembly of an autoinjector (1) having: - a drive device (80) having a first housing part (10a) which includes a drive assembly (20, 21, 22), a product container receiving device (90) having a second housing part (10b) defining a longitudinal axis (L) extending from a distal end to a proximal end, comprising a syringe holder (12) configured to receive a prefilled prefilled syringe (11), in, The first housing part (10a) and the second housing part (10b) can be coaxially connected in a joining direction into a first of at least three locking positions and are held in the first locking connection for storage and / or transportation purposes by means of a first locking connection (10u, 10v) that can be released along and against the joining direction, The method has the steps: - providing a prefilled syringe (11), - releasing the first latching connection (10u, 10v) of the housing parts (10a, 10b) counter to the joining direction and separating the drive device (80) from the product container receiving device (90), - inserting the prefilled syringe (11) into the product container receiving device (90) coaxially or axially parallel to the longitudinal axis (L), - when releasing the assembly opening (10t) at one of the housing parts (10a, 10b), the housing parts (10a, 10b) are joined in a joining direction into a first latching position defined by the first latching connection (10u, 10v), - with the assembly opening released, the housing parts (10a, 10b) are joined in the joining direction into a second of the at least three latching positions, the second latching position being maintained by a second latching connection (10f, 10g) of the housing parts (10a, 10b), - the housing parts (10a, 10b) are joined in a joining direction to a third or final latching position, the third or final latching position being maintained and locked by a third or final latching connection (10f, 10g) of the housing parts (10a, 10b), and when the housing parts (10a, 10b) are in the third or final latching position, an assembly opening (10t) at one of the housing parts (10a, 10b) is completely covered by the other housing part.

14. Method for final assembly of an autoinjector (1) according to the preceding claim, the method further comprising one or more of the following steps: - setting the starting position for the advancing element (22) by screwing onto the drive element (21), - holding and / or positioning a component (17) movable in the interior of one of the housing parts (10a, 10b) by means of an assembly tool which can be inserted through the released assembly opening (10t) - before or while the housing parts (10a, 10b) are in the second latching position, removing the assembly tool from an assembly opening (10t) in one of the housing parts, - when the housing parts (10a, 10b) are brought from the second latching position into the third or final latching position, a resilient syringe adapter (13a) is clamped.

15. Method for the final assembly of an autoinjector (1) according to any of the two preceding claims, the method being carried out on a device according to any of claims 1 to 12.

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