Autoinjector with product container receptacle

Abstract

The invention relates to a product container receptacle (90) and to an autoinjector comprising: - a syringe holder (12) designed to receive a pre-filled ready-to-use syringe (11) defining a longitudinal axis (L) which extends from proximal to distal, with a cylindrical product container (11c) which tapers at its distal end via a shoulder (11d), and with a needle-protecting cap (11a), and the syringe holder (12) having a distally coaxially arranged guide sleeve (12b), a blocking surface (12a) configured on the inner wall thereof, - an insert (30) having a snap arm with snap hook (30a) radially deflectable with respect to the longitudinal axis from a relaxed position, - a detachable device cap (16) in which the insert (30) is connectably received, wherein the insert (30) is movable from a first latching position to a second latching position relative to the device cap (16), and the connection of the device cap (16) to the insert (30), in at least the second latching position, is designed to be latching in a form-fitting manner with respect to tensile forces, - and a method for assembling a product container receptacle (90) of an autoinjector.

Description

[0001] AUTOINJECTOR WITH PRODUCT CONTAINER HOLDER

[0002] TECHNICAL FIELD

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

[0004] BACKGROUND OF THE INVENTION

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

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

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

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

[0009] A mainspring as a drive is characterized by high forces and is therefore suitable for a delay-free start of dispensing, even in auto-injectors with a long storage life. A variable thread pitch of the threaded rod can compensate for a variable characteristic of the mainspring to ensure the most constant dispensing force possible. This allows even large dispensed quantities of 5 ml or more to be dispensed evenly and continuously within a maximum of 60 s. With a dispensing time of more than 10 s, which is longer than with conventional auto-injectors, the user should be able to verify at any time that the injection is progressing as intended to avoid inadvertently aborting the injection prematurely. Patent application WO 2012 / 173554 shows a rotating indicator at the proximal end of an auto-injector, which is driven by a torsion spring during dispensing.The display comprises several segments with different colors to indicate an initial state before the start of delivery and a final state after delivery. The segments are visible through at least one window at the proximal end of the auto-injector, the extent of which corresponds to the angular range of a segment.

[0010] The patent application published as CH714527 A2 shows an injection device with a cap for removing a needle protection cap from a product container and a method for assembling an injection device, wherein the cap comprises an engagement element to effect removal of the needle protection cap from the product container upon removal of the cap from the injection device.

[0011] The term "product," "medicine," or "medicinal substance" in this context encompasses any flowable medicinal formulation suitable for controlled administration via a cannula or hollow needle into subcutaneous or intramuscular tissue, for example, a liquid, a solution, a gel, or a fine suspension containing one or more medicinally active ingredients. A medicament can therefore be a composition containing a single active ingredient or a premixed or co-formulated composition containing multiple active ingredients from a single container. The term particularly includes medicinal products such as peptides (e.g., insulins, insulin-containing medications, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active ingredients, hormone- or gene-based active ingredients, nutritional formulations, enzymes, and other substances in both solid (suspended) and liquid form.The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable base, auxiliary and carrier substances.

[0012] The term "distal" refers to a side or direction directed toward the front, insertion-side end of the delivery device or the tip of the injection needle. In contrast, "proximal" refers to a side or direction directed toward the rear end of the delivery device, opposite the insertion-side end. In this description, the term "injector" refers to a device in which the injection needle is removed from the tissue after a controlled amount of the medicinal substance has been delivered. Thus, in an injector, unlike an infusion system, the injection needle does not remain in the tissue for an extended period of several hours.

[0013] PRESENTATION OF THE INVENTION

[0014] It is an object of the invention to create a display for an auto-injector of the type mentioned at the beginning, which can visually indicate to the user the continuation or progression of a dispensing process in a wide variety of grip positions. The display should be designed in such a way that even in unfavorable, in particular unintended, grip positions of the user's hand on the auto-injector, the user can recognize the continuation of the dispensing without having to change the grip position. A further object is to create an improved and more cost-effective auto-injector. The assembly of the auto-injector or its components and the insertion of a product container during final assembly should be more reliable and the operation and handling of the auto-injector should be simpler and safer. The pre-assembly of components or components, which is carried out at a time and location separate from the final assembly of the auto-injector.Storage, transport and supply of the same should be made easier and safer, and in particular the integrity of the assemblies should be maintained during transport and supply.

[0015] This object is achieved by devices having the features of the independent claims. Preferred embodiments of the invention are the subject of the dependent claims.

[0016] An auto-injector according to the invention comprises a one-piece or multi-piece housing with a longitudinal axis and a prefilled syringe with a product container and an injection needle or cannula permanently attached thereto. The prefilled syringe is accommodated in the housing in an axially fixed manner, with a tip of the injection needle protruding distally beyond a distal housing end by at least one insertion depth. The auto-injector further comprises a torsion spring preloaded for a single dispensing of the maximum contents of the product container, a drive element, a propulsion element, and a needle protection sleeve. To dispense liquid from the product container through the injection needle, the torsion spring causes the drive element to rotate about the longitudinal axis, and the rotating drive element causes a linear movement of the propulsion element to displace a piston in the product container.When the auto-injector is pressed against an injection site, causing the injection needle to penetrate the injection site, the needle shield is moved proximally by one actuation stroke, thereby starting or enabling the dispensing of fluid. The actuation stroke of the needle shield corresponds at least to the insertion depth of the injection needle.

[0017] The auto-injector finally comprises a display for signaling the continuation of a dispensing, comprising a display element driven by the drive element and rotating about the longitudinal axis, with an optical contrast pattern, and a window at the proximal end of the auto-injector through which the rotating contrast pattern is visible. The window runs completely 360° around the longitudinal axis, i.e., it is not interrupted by a frame or web parallel to the longitudinal axis, which would create a blind spot for the view of the display element. The window is made of a transparent and preferably stable or load-bearing material. As long as even the smallest part of the window remains visible, i.e., even if the user inadvertently covers a large part of the window with the hand holding the auto-injector, for example, by resting the ball of the hand on the proximal end, the rotating display element can be recognized.

[0018] The contrast pattern is at most discretely rotationally symmetrical about the longitudinal axis, but not continuously rotationally symmetrical, so that a rotation of the contrast pattern can also be recognized. The contrast pattern comprises at least one area or one graphic element in a color or shade of gray different from a background color, preferably in the form of graphic elements repeating in the direction of rotation, such as parallel lines.

[0019] An auto-injector according to the invention is suitable for dispensing the product quantity contained in the product container during a dispensing time of more than 10 s, preferably more than 20 s or 30 s, which is longer than with known auto-injectors. As a result, even with product quantities exceeding 2.25 ml and preferably at least 3 ml or 4 ml, a continuous or average dispensing rate is relatively low, so that the injected quantity of medication can be continuously absorbed or absorbed by the subcutaneous tissue. Maintaining a minimum holding time between the end of dispensing and moving the auto-injector away from the injection site is therefore less critical. Accordingly, no optical, acoustic, or tactile signaling is required to indicate the end of a holding time to the user.

[0020] In a preferred embodiment, the rotating display element is driven directly or immediately, in particular without a gear, by the drive element. The display element thus rotates at the same rotational speed as the drive element.

[0021] In a further preferred embodiment, the display element performs less than one rotation, preferably less than half a rotation, or even less than a third of a rotation per second during the dispensing process. This ensures that the rotational movement of the contrast pattern is easily tracked by the eye and does not blur into an indeterminate, rotationally symmetrical pattern for the observer.

[0022] In a preferred embodiment, neither the window nor the adjacent housing provide an optical marking for determining the relative rotational position of the contrast pattern. The indicator element does not indicate an initial or final state, nor does it provide a relative indication of the progress of the release; it serves exclusively to signal the progress or continuation of the release.

[0023] In a preferred embodiment, the rotating display element and the housing or the window are designed to generate a dispensing sound, which additionally acoustically signals the continuation of the dispensing process to the user. The dispensing sound is preferably a continuous clicking sound, which is generated by a grid on the window or on the housing and a radially or axially flexible engagement element on the display element engaging therein, or conversely by a rotating grid on the display element and a stationary engagement element. A separate optical, acoustic, and / or tactile signaling of the end of dispensing, for example by a mechanically or electronically generated signal, can be dispensed with in this case, as is the case with a purely optical movement indicator.

[0024] In a preferred embodiment, the window has a first, cylindrical region parallel to the longitudinal axis, and a second region, which adjoins the first seamlessly in the proximal direction and has a steadily or continuously decreasing diameter. The first region enables a view of the display element from any lateral viewing direction perpendicular to the longitudinal axis, and the second region enables a view of the display element in the distal viewing direction from behind, or from above when the auto-injector is held vertically. The second region is rounded or constricted in the proximal direction and can end in a third region perpendicular to the longitudinal axis. The display element can have a convex display surface following the shape of the window, or a conical display surface with a moderate inclination relative to the longitudinal axis.Preferably, the window is rotationally symmetrical with respect to the longitudinal axis, i.e. with circular cross-sections in cutting planes perpendicular to the longitudinal axis.

[0025] In an advantageous variant, the auto-injector comprises a needle protection sleeve which, in the delivered state of the auto-injector, protrudes distally beyond the housing and is pre-tensioned in the distal direction by a needle protection spring. When the auto-injector is pressed against an injection site, the needle protection sleeve executes an actuating movement in the proximal direction and when the auto-injector is removed from the injection site, a needle protection movement in the distal direction in order to surround the injection needle laterally and radially cover it with a sleeve-shaped, preferably rotationally symmetrical section. The needle protection sleeve has an annular flange or foot at a distal end as an enlarged contact surface with the tissue around the injection site. The flange is permanently connected to the sleeve-shaped section and is preferably formed integrally with it. A maximum diameter of the flange is greater than a maximum diameter of the sleeve-shaped section.

[0026] Preferably, the outer edge or periphery of the flange is adapted to the shape of a distal opening in the housing. When inserted, the flange thus forms a closure of the housing. More preferably, the flange is concavely curved, so that the outer edge is located further distal than the transition between the flange and the sleeve-shaped section. Compared to a flange with a strictly flat, annular contact surface with an identical outer diameter, firstly, tilting of the attached auto-injector is less likely, and secondly, the concentration of the pressure load on the periphery of the flange furthest from the puncture site leads to less counterpressure in the tissue and thus less pain for the user.

[0027] The auto-injector further preferably comprises a threaded rod as the drive element and a drive sleeve with an internal thread as the drive element, or alternatively, a drive sleeve with an internal thread as the drive element and a threaded rod as the drive element, wherein the drive element has a groove or a cam as an axial guide element for an exclusively linear propulsion movement in the housing. The auto-injector is preferably dimensioned to accommodate a prefilled syringe comprising the product container and the injection needle, and having a filling volume of at least 3 ml, preferably at least 5 ml.

[0028] In summary and in other words, an autoinjector according to aspects of the invention can be designed as follows:

[0029] Autoinjector comprehensive

[0030] - a housing (10a, 10b) with a longitudinal axis L and for receiving a

[0031] product container (11),

[0032] - a propulsion member (22) and a rotating drive element (21) for moving the propulsion member (22) in the longitudinal direction and for automatically dispensing a liquid product contained in the product container (11) through an injection needle (11b),

[0033] - a display for signaling the continuation of a release, comprising a rotating display element (25a) driven by the drive element (21) and having an optical contrast pattern (), and comprising a lenster (25b) at the proximal end of the auto-injector, through which the rotating contrast pattern is visible, characterized in that the lenster (25b) is a lenster that completely rotates around the longitudinal axis.

[0034] Auto-injector wherein the rotating display element (25 a) is directly driven by the drive element (21).

[0035] Auto-injector, wherein the display element (25a) performs less than one, preferably less than half a rotation per second during a dispensing.

[0036] Auto-injector where no optical marking is provided to determine the rotational position of the contrast pattern.

[0037] Auto-injector wherein the rotating display element (25a) is designed to generate a dispensing noise.

[0038] Autoinjector, wherein the window (25b) has a first, cylindrical region parallel to the longitudinal axis, and a second region, seamlessly adjoining the first in the proximal direction, with a continuously decreasing diameter. Autoinjector further comprising

[0039] - a needle protection sleeve (14) which, in the delivery state of the auto-injector, projects distally beyond the housing, wherein when the auto-injector is pressed against an injection site, the needle protection sleeve (14) executes an actuating movement in the proximal direction and when the auto-injector is removed from the injection site, executes a needle protection movement in the distal direction in order to surround the injection needle (11b) laterally with a sleeve-shaped section (14b), wherein the needle protection sleeve (14) has an annular flange (14c) at a distal end for contact with the injection site, with a maximum diameter which is greater than the maximum diameter of the sleeve-shaped section (14b).

[0040] Autoinjector wherein an outer edge of the flange (14c) is adapted to a distal opening in the housing (10b).

[0041] Auto-injector wherein the flange (14c) is concavely curved.

[0042] Auto-injector wherein the drive element (21) is a threaded rod and the propulsion element (22) is a propulsion sleeve with an axial guide element for an exclusively linear propulsion movement in the housing (10b).

[0043] Auto-injector further comprising a pre-filled syringe comprising the product container (11) and the injection needle (11b), and having a filling volume of at least 3 ml, preferably at least 5 ml.

[0044] Further preferred embodiments of the invention, in particular of product container receiving devices for an improved auto-injector, are described below.

[0045] In a preferred embodiment, a product container receiving device for an auto-injector comprises a syringe holder designed to receive a pre-filled ready-to-use syringe defining a longitudinal axis which extends from distal to proximal with a cylindrical product container which tapers at its distal end via a shoulder and with a needle protection cap, wherein the syringe holder has a distally coaxially arranged guide sleeve, on the inner wall of which a blocking surface is formed, in particular the blocking surface can also be formed by individual or connected ribs or spokes.Furthermore, a sleeve-shaped insert having a snap arm with snap hooks that can be deflected radially with respect to the longitudinal axis from a relaxed position, and a device cap in which the insert is received in a connectable manner, wherein the insert is movable from a first to a second locking position relative to the device cap and the connection of the device cap to the insert is designed to be locking and positively responding to tensile forces along the longitudinal axis in at least the second locking position, wherein the snap arm with snap hooks can be deflected radially in the first locking position and is prevented from radial deflection by the locking surface in the second locking position.

[0046] Preferably, the product container receiving device is further developed in that the snap-in arm with snap-in hook can be deflected radially outward through the needle protection cap in the first locking position of the insert. This minimizes the joining forces during assembly of the pre-filled syringe and does not compromise the product container's closure security.

[0047] Preferably, the product container receiving device is further developed in that the snap-in arm with snap-in hooks is designed to axially engage the needle protection cap in the distal direction in a form-fitting manner when the insert is in the second locking position. This allows for secure separation of the needle protection cap when removed from the syringe, and avoids unnecessarily high removal forces due to additional friction.

[0048] The product container receiving device is preferably further developed in that the syringe holder is designed such that a distal portion of the pre-filled syringe, in particular the needle protection cap, is axially movable in the guide sleeve, and this mobility of the pre-filled syringe in the distal direction is limited by a positive fit. This radially centeres the pre-filled syringe during assembly and allows it to be positioned at the intended axial location in the device without play.

[0049] Preferably, the product container receiving device is further developed in that the guide sleeve, with its proximal end, forms a stop for the cylindrical product container, in particular for its shoulder. This positions the pre-filled syringe at the intended axial location in the device during assembly.

[0050] Preferably, the product container receiving device further comprises a needle protection sleeve with a retaining snap, wherein, in the first locking position, the retaining snap connects the insert to the needle protection sleeve in a force-fitting manner relative to the needle protection sleeve by engaging in the first snap connection, and / or, in the second locking position, the retaining snap connects the insert to the needle protection sleeve in a force-fitting manner relative to the needle protection sleeve by engaging in the second snap connection or moving in the first snap connection. As a result, the needle protection sleeve or insert is held in the auto-injector in the intended axial position and rotational orientation, and the holding force also increases safety against unintentional triggering due to high accelerations, for example, during transport or if the device falls to the ground.

[0051] Preferably, the product container receiving device is further developed in that the device cap can be separated from the product container receiving device by a pulling movement, taking the insert with it and releasing the force-locking connection between the needle shield and the insert. This results in a defined initial resistance, which reduces unintentional release or unwanted play.

[0052] Preferably, the product container receiving device further comprises a housing or housing part, wherein the syringe holder is immovably received therein, at least under axial tension in the distal direction or axial pressure from the proximal direction, or is formed integrally therewith. This ensures that the syringe holder is securely held at the intended axial location in the device when the needle protection cap is removed or during dispensing.

[0053] In a further embodiment of the invention, the product container receiving device is preferably formed in that the insert is axially movable from proximal to distal from the first to the second locking position relative to the device cap and is guided in a rotationally fixed manner by a rib in a guide groove and / or the snap cam changes from the first snap connection to the second snap connection. As a result, the insert is captively secured in a pre-assembly position in a subassembly of the device before assembly of the pre-filled syringe and can be secured in its final assembly position during assembly of the pre-filled syringe. The movement of the insert can be brought about by a tool or by another part which is moved axially during assembly. In particular, the movement from the first to the second locking position can be brought about or derived from the joining movement of the pre-filled syringe.

[0054] The product container receiving device is preferably further developed in that the insert can be pushed axially in the distal direction through the shoulder via a proximally provided end face. The insert is thus brought into its final assembly position directly by the axial joining movement of the pre-filled syringe during assembly, and there is no need for a complex tool that would have to reach into the interior of the device. The product container receiving device is preferably further developed in that the locking surface formed on the inner wall of the guide sleeve is limited to an axial section. This section is selected such that at the start of the joining movement of the pre-filled syringe during assembly, the snap arm with snap hook can be deflected radially freely and with little friction by the outer profile of the needle protection cap until it compresses elastically behind the proximal edge of the needle protection cap and towards the end orafter the joining movement, it remains positively secured in this position by the locking surface or another suitable locking geometry against radial breakout.

[0055] In a further embodiment of the invention, the product container receiving device is preferably formed in that the insert is rotatably movable about the longitudinal axis from the first to the second locking position relative to the device cap and is axially fixedly guided in a snap groove by a snap cam and / or is rotationally fixedly secured in the second locking position by the groove. As a result, the insert is captively secured in a pre-assembly position in a subassembly of the device before assembly of the pre-filled syringe and can be secured in its final assembly position during assembly of the pre-filled syringe.

[0056] The product container receiving device is preferably further developed in that the insert can be rotated about the longitudinal axis via one or more distally provided mounting cams. A torque can be temporarily applied via the mounting cams using a rotating tool or static structures in the mounting device (relative to which the device can be rotated), which causes the rotational movement. For this purpose, openings are provided in the device cap.

[0057] Preferably, the product container receiving device is further developed in that the locking surface formed on the inner wall of the guide sleeve has one or more recesses in sectors. This recess is selected such that during the joining movement of the pre-filled syringe during assembly, the snap arm with snap hook can be freely deflected radially by the outer profile of the needle protection cap until it elastically compresses behind the proximal edge of the needle protection cap. After the joining movement, the rotational movement of the insert is carried out as described above, so that the snap arm with snap hook remains positively secured in this position by the locking surface or another suitable locking geometry against radial breakout. Preferably, an auto-injector further developed according to the invention for administering a liquid product comprises

[0058] - a product container receiving device according to the invention

[0059] - a propulsion member and a drive element for moving the propulsion member in the longitudinal direction and for automatically dispensing a liquid product contained in the product container of the pre-filled syringe through an injection needle, wherein the needle protection sleeve, which protrudes distally beyond the housing in the delivery state of the auto-injector, carries out an actuating movement in the proximal direction when the auto-injector is pressed onto an injection site and carries out a needle protection movement in the distal direction when the auto-injector is removed from the injection site in order to surround the injection needle laterally with a sleeve-shaped section.

[0060] FIGURES

[0061] Preferred embodiments of the invention are described below in conjunction with the attached figures. These are intended to illustrate basic possibilities of the invention and are in no way to be interpreted as limiting.

[0062] Fig.l the components of an autoinjector,

[0063] Fig.2 two longitudinal sections through the autoinjector from Fig.l before injection,

[0064] Fig.3 two views of the display element,

[0065] Fig.4 a view of the distal end of the needle shield.

[0066] Fig.5 the components of a first embodiment of a product container receiving device

[0067] Fig.6 two longitudinal and cross-sectional views of the device from Fig.5 in the state before

[0068] final assembly,

[0069] Fig.7 shows a longitudinal and cross-sectional view of the device from Fig.5 in the state of joining the pre-filled syringe,

[0070] Fig.8 two longitudinal and one cross-section of the device from Fig.5 in the state after

[0071] Locking movement of the insert

[0072] Fig.9 is a longitudinal section of the device from Fig.5 in the state before removing the

[0073] Needle protection cap and a longitudinal and a cross-section of the device from Fig.5 in the state after removal of the needle protection cap Fig.10 the components of a second embodiment of a product container receiving device

[0074] Fig.11 two longitudinal and cross-sectional views of the device from Fig.10 in the state before final assembly,

[0075] Fig.12 shows a longitudinal and cross-sectional view of the device from Fig.10 in the state of joining the pre-filled syringe,

[0076] Fig.13 two longitudinal and one cross-section of the device from Fig.10 in the state after the locking movement of the insert; and

[0077] Eig.14 two longitudinal and one cross-section of the device from Fig.10 in the state after removal of the needle protection cap

[0078] FIGURE DESCRIPTION

[0079] Fig.l is an exploded view of the components of an auto-injector according to the invention, and Fig.2 shows two longitudinal sections rotated by 90° to each other about the longitudinal axis through the auto-injector according to Fig.l in the inserted state and ready for dispensing.

[0080] The auto-injector has a sleeve-shaped, elongated housing with a longitudinal axis L and comprising a distal housing part 10b and a proximal housing part 10a in the form of a handle that is permanently snapped onto the distal housing part. A product container in the form of a pre-filled syringe 11 with an injection needle permanently attached to the product container is held in a syringe holder 12, wherein the syringe holder is axially and rotationally fixedly received in the housing. The pre-filled syringe 11 is pressed distally into engagement with a shoulder of the syringe holder 12 by a retaining spring section 13a firmly anchored in the housing part 10a.The pre-filled syringe 11 is arranged with respect to the housing part 10b such that the tip of the injection needle protrudes beyond the distal end of a proximal intermediate position of a needle protection sleeve 14 by a length corresponding to the subcutaneous or intramuscular insertion depth and is at least laterally protected or covered by the needle protection sleeve 14 before and after the injection. When the injection needle is inserted into the injection site, the needle protection sleeve 14 is pushed in the proximal direction along the longitudinal axis L by an actuating stroke and against the force of a needle protection spring 15, thereby triggering a product release. For this purpose, the needle protection sleeve comprises two sleeve arms 14a, which are arranged offset or rotated by 90° around the longitudinal axis L with respect to two recesses 10c of the housing, referred to as viewing windows.After the injection has been completed, the needle protection sleeve 14 can be moved relative to the housing part 10b from the actuated position along the longitudinal axis L in the distal direction into a needle protection position, where it can be locked against further retraction. The needle protection sleeve comprises a sleeve-shaped or hollow-cylindrical section 14b and a flange 14c at the distal end. The cross-section of the hollow-cylindrical section 14b is oval, just like the outer circumference of the flange, so that in this case the flange has a constant width or radial extension.

[0081] A spring assembly comprises a spiral spring 20a and a spring coil 20b. The spiral spring 20a is non-rotatably attached at its outer end to a spring sleeve 13b as part of a mechanism holder 13 firmly anchored in the housing. The inner end of the spiral spring 20a is non-rotatably connected to the spring coil 20b. The spring coil 20b comprises a spring shaft and a distal spring flange. The spiral spring 20a or the spring coil 20b sets a drive element 21 in a rotational movement and a propulsion element 22 in a preferably purely axial propulsion movement. For this purpose, a threaded element engages a thread with a variable thread pitch extending over the discharge stroke.

[0082] The pre-filled syringe 11 comprises a cylindrical syringe body as a product container, at the distal end of which a hollow injection needle is firmly connected to a syringe shoulder. The injection needle of the pre-filled syringe is covered by a needle protection cap 11a, which is designed as a so-called Rigid Needle Shield (RNS) and comprises a rubber-elastic needle protection element and a hard plastic shell. The needle protection cap protects the injection needle against mechanical influences and contamination, and keeps the injection needle and the product sterile. In its delivery state, a two-part device or pull-off cap 16 is arranged at the distal end of the auto-injector. This cap is axially pulled off and / or twisted off and completely removed together with the needle protection cap 11a before use of the auto-injector.

[0083] A switching sleeve 17 is arranged in a form-fitting manner with a proximal end of the sleeve arms 14a of the needle protection sleeve 14 and with a distal end of the needle protection spring 15, and is at least partially surrounded by the latter. The switching sleeve 17 is preferably snapped to the proximal end of the sleeve arms of the needle protection sleeve 14. The movement of the switching sleeve 17 in the distal direction is limited by the retaining spring section 13a, which in turn snaps to the mechanism holder 13 after the switching sleeve 17 has been installed. Arranged within and coaxial with the switching sleeve 17 is a locking sleeve 18, which is coupled to the switching sleeve 17 via a sawtooth-shaped locking member 18a spring-mounted on an arm pointing in the distal direction in such a way that an actuating movement of the needle protection sleeve 14 and the switching sleeve 17 also moves the locking sleeve 18 proximally.Through an additional proximal locking stroke of the locking sleeve 18 relative to the switching sleeve 17 into a proximal end position, the locking member 18a is safely released by the switching sleeve 17 for inward movement. Due to the spring action of the arm, the locking member 18a engages behind a proximally directed edge of the auto-injector or engages in an axially fixed recess of the auto-injector, thus locking the locking sleeve 18 against distal movement. When the auto-injector is removed from the puncture site, the switching sleeve 17 is pushed distally over the locking member 18a by the needle protection spring 15, whereupon the locking member, due to the spring action of the arm, engages behind a proximally directed edge of the switching sleeve 17 in a locking position and locks or blocks the switching sleeve and the needle protection sleeve against further movement in the proximal direction.

[0084] A coupling sleeve 23 with two retaining cams 23a is coupled to the spring coil 20b via coupling elements. Before dispensing, the retaining cams 23a engage in recesses of the axially fixed mechanism holder 13 and are prevented from moving outward by an inner circumference of the locking sleeve 18, thus preventing the coupling sleeve 23 from moving axially. Upon triggering dispensing, the locking sleeve 18 is moved away from the position of the recesses by a proximal movement of the needle protection sleeve 14, allowing the retaining cams 23a to be released radially, releasing the coupling sleeve 23. The latter moves in the proximal direction and releases the spring coil 20b for rotation, as described in detail in patent application PCTEP2021076923.At the proximal end of the auto-injector is the display with a rotating display element 25a with a contrast pattern in the form of parallel stripes, a circumferential transparent window 25b, and a proximal, non-transparent end 25c.

[0085] Fig. 3 shows two views of the display element 25a with an engagement element 25d for engaging a non-rotating grid on the inside of the window 25b or the closure 25d. The engagement element 25d is spring-mounted and, when the display element rotates during dispensing, generates a number of clicks corresponding to the grid. The display element has a shape that follows that of the window or is adapted to it, with a first, distal region and a second region adjoining it in the proximal direction. The first region is cylindrical, parallel to the longitudinal axis, while the second region has a continuously decreasing diameter.

[0086] Fig. 4 shows the distal end of the needle shield with the sleeve-like section 14b and the flange 14c. The shape of the flange with the concavely curved support surface is clearly visible, the outer, oval edge of which protrudes distally from the inner edge of the support surface at the transition to the axially parallel section.

[0087] Fig. 5 is an exploded view of the components of a first embodiment of a product container receiving device 90, comprising a pre-filled syringe 11 with a product container 11c which terminates distally by the shoulder 11d and with a needle protection cap 11a which encloses the injection needle, and comprising a device cap 16 which receives an insert 30. Formed on the sleeve-shaped insert 30 are two elastic snap arms with snap hooks 30a, two first and second snap grooves 30b, 30c, two windows as snap connections 30d, 30e, two proximal end faces 30h, and four grooves 30g. The pre-filled syringe 11 can be received in the syringe holder 12 through the proximal opening, and on the inside of the guide sleeve 12b, ten longitudinal ribs are attached which form a blocking surface 12a. Furthermore, the needle protection sleeve 14 and a housing part 10b are shown.

[0088] Fig. 6 shows two longitudinal and cross-sectional views of the device from Fig. 5 in the state prior to final assembly of the auto-injector. The snap-in cams 16b inside the device cap 16 engage frictionally in the snap-in grooves 30b of the insert 30. Furthermore, the four grooves 30g are visible, in which a rib 16a is slidably received. The locking surface 12a is visible as a section through one of the ten ribs. The needle protection sleeve 14 engages with its two retaining snaps 14d in the two openings 30d of the insert 30, thus forming the first snap connection that releasably secures the needle protection sleeve and the insert to one another.

[0089] Fig.7 shows a longitudinal and cross-sectional view of the device from Fig.5 in the state of joining the pre-filled syringe 11 immediately before the locking movement of the insert 30. This locking movement from a first to a second locking position of the insert 30 in the device cap 16 is brought about by the joining movement of the pre-filled syringe 11. The snap cams 16b inside the device cap 16 engage in the first locking position with a force fit in the snap grooves 30b of the insert 30. Before and at the start of the joining movement, the two elastic snap arms with snap hooks 30a do not overlap with the locking surface 12a and can therefore be deflected radially by the outer profile of the needle protection cap 11a until the snap hooks 30a spring in at the proximal end of the needle protection cap 11a.

[0090] Fig. 8 shows two longitudinal views and one cross-section of the device from Fig. 5 in the state after the locking movement of the insert 30. The locking movement is brought about during assembly by the pre-filled syringe 11 in that the shoulder 11d displaces the insert 30 distally over its end faces 30h, whereby the two elastic snap arms with snap hooks 30a on the insert 30 overlap with the locking surface 12a and are thus locked against radial deflection. After the locking movement, the snap cams 16b inside the device cap 16 now engage in the snap grooves 30c of the insert 30 in the second locking position, and the needle protection sleeve 14 now engages with its two retaining snaps 14d in the two further openings 30e of the insert 30 and thus forms the second snap connection which releasably fixes the needle protection sleeve and the insert to one another.

[0091] Fig. 9 shows a longitudinal section of the device from Fig. 5 in the state before the device cap 16 is removed, and a longitudinal and a cross-section of the device from Fig. 5 in the state after the device cap 16 has been removed. The withdrawal forces are transmitted from the pre-filled syringe 11 via its shoulder 11d to the stop 12c of the guide sleeve 12b of the syringe holder 12 and from there to the housing. When the device cap 16 is removed, the insert 30 remains firmly connected to the device cap due to the positive connection of the snap cams 16b inside the device cap 16 with the snap grooves 30c of the insert 30, and the two snap hooks 30a take the needle protection cap 11a with them and separate it from the pre-filled syringe 11. The injection needle 11b is thus exposed.

[0092] Fig. 10 is an exploded view of the components of a second embodiment of a product container receiving device 90, comprising a pre-filled syringe 11 with product container 11c which terminates distally by the shoulder 11d, a needle protection cap 11a which encloses the injection needle, and a device cap 16 which receives the insert 30. Formed on the sleeve-shaped insert 30 are two elastic snap arms with snap hooks 30a, two snap grooves 30b, two windows or openings as snap fasteners 30d, two grooves 30g, and two mounting cams 30i. The pre-filled syringe 11 can be received in the syringe holder 12 through a proximal opening, and on the inside of the guide sleeve 12b, a plurality of longitudinal ribs distributed over the circumference are attached, which form the blocking surface 12a. The locking surface 12a is interrupted by two recesses 12d in that the longitudinal ribs are missing at two opposite points on the inside of the guide sleeve 12b.The needle protection sleeve 14 and a housing part 10b are also shown.

[0093] Fig. 11 shows two longitudinal and cross-sectional views of the device from Fig. 10 prior to final assembly of the auto-injector. The two snap-action cams 16b inside the device cap 16 engage positively with the snap-action grooves 30b of the insert 30. The recess 12d of the locking surface 12a is visible in the section and exposes the two elastic snap-action arms with snap-action hooks 30a for radial deflection. The needle protection sleeve 14 engages with its two retaining snaps 14d in the two openings 30d of the insert 30, thus forming the first snap-action connection that releasably secures the needle protection sleeve and the insert to one another.

[0094] Fig. 12 shows a longitudinal and cross-sectional view of the device from Fig. 10 in the state in which the pre-filled syringe 11 is assembled, immediately before the locking movement of the insert 30. The two snap-action cams 16b inside the device cap 16 engage axially in the snap-action grooves 30b of the insert 30, while the insert 30 remains rotatable in the device cap. The assembly cams 30i are accessible to a turning tool via two openings in the device cap, and the two elastic snap-action arms with snap-action hooks 30a on the insert 30 can be deflected in the region of the recess 12d and thus radially through the outer profile of the needle protection cap 11a until the snap-action hooks 30a spring in at the proximal end of the needle protection cap 11a.

[0095] Fig.13 shows two longitudinal and one cross-section of the device from Fig.10 in the state after the locking movement of the insert, wherein the insert 30 has been rotated relative to the device via the mounting cams 30i, so that the two elastic snap arms with snap hooks 30a on the insert 30 overlap through the locking surface 12a formed by the longitudinal ribs and are thus locked against radial deflection, wherein this new rotational position of the insert 30 is secured by a snap connection between the device cap 16 and the groove 30g.

[0096] Fig. 14 shows a longitudinal section of the device from Fig. 10 in the state after the needle protection cap has been removed. The withdrawal forces are transmitted from the pre-filled syringe 11 via its shoulder 11d to the stop 12c of the guide sleeve 12b of the syringe holder 12 and from there to the housing. Due to the positive connection of the two snap-fit ​​cams 16b inside the device cap 16 with the snap-fit ​​grooves 30b of the insert 30, the insert 30 remains firmly connected to the device cap when the device cap 16 is removed, and the two snap-fit ​​hooks 30a take the needle protection cap 11a with them and separate it from the pre-filled syringe 11. The injection needle 11b is thus exposed.

[0097] LIST OF REFERENCE SYMBOLS

[0098] 10a, 10b Housing part 16 Device cap

[0099] 10c Recess 17 Switch sleeve

[0100] 11 Pre-filled syringe 18 Locking sleeve

[0101] 11a Needle protection cap 18a Locking link

[0102] 11b injection needle 20a spiral spring

[0103] 12 syringe holder 20b spring coil

[0104] 13 Mechanism holder 21 Drive element

[0105] 13a Retaining spring section 22 Propulsion element

[0106] 13b Spring sleeve 23 Coupling sleeve

[0107] 14 Needle protection sleeve 23 a Holding cam

[0108] 14a Arm 25a Display element

[0109] 14b Section 25b Window

[0110] 14c flange 25c end

[0111] 15 Needle protection spring 25d Engagement element

[0112] 30 Insert 14d retaining snap

[0113] 30a snap arm with snap hook 16a rib

[0114] 30b First snap groove 16b Snap cam

[0115] 30c Second snap groove 16c Locking cam

[0116] 30d opening first snap

[0117] 30e opening second snap

[0118] 30f guide groove

[0119] 30g Nut

[0120] 30h front side

[0121] 30i mounting cam L longitudinal axis

[0122] 11c Cylindrical product container 1 Autoinjector l ld Shoulder

[0123] 12a Barrier area, longitudinal ribs

[0124] 12b Guide sleeve

[0125] 12c stop

[0126] 12d recess

[0127] 90 Product container holding device

Claims

PATENT CLAIMS 1. Product container receiving device (90) for an autoinjector comprising - a syringe holder (12) designed to receive a pre-filled syringe (11) defining a longitudinal axis (L) which extends from distal to proximal, and comprising a cylindrical product container (11c) which tapers at its distal end over a shoulder (1 Id) and a needle guard cap (11a), , - comprising a sleeve-shaped insert (30) and a snap arm with snap hook (30a) that is radially deflectable with respect to the longitudinal axis (L), - a device cap (16) in which the insert (30) is connectably received, wherein the insert (30) is movable from a first to a second detent position relative to the device cap (16), in particular by a tool and / or an joining movement of the prefilled syringe (11) into the syringe holder (12), and the connection of the device cap (16) with the insert (30) in the second detent position is designed to be detent-fit and positively interlocking against tensile forces along the longitudinal axis (L), and the device cap (16) can be separated from the product container receiving device (90) by a pull-off movement, whereby the insert (30) and the needle guard cap (11a) are carried along, characterized in that the snap arm with snap hook (30a) is radially deflectable in the first detent position and in the second detent position by a locking surface (12a),preferably by a locking surface (12a) formed on the inner wall of a distally coaxially arranged guide sleeve (12b) of the syringe holder (12), is prevented from radial deflection.

2. Product container receiving device (90) according to the preceding claim, characterized in that the snap arm with snap hook (30a) can be deflected radially outwards through the needle guard cap (11a) in the first detent position of the insert (30).

3. Product container receiving device (90) according to one of the preceding claims, characterized in that the snap arm with snap hook (30a) is designed to axially engage the needle guard cap (11a) in the distal direction in the second detent position of the insert (30).

4. Product container receiving device (90) according to one of the preceding claims, characterized in that the syringe holder (12) is designed such that a distal section of the pre-filled syringe (11), in particular the needle protection cap (11a), is axially movable in the guide sleeve (12b) and this mobility of the pre-filled syringe (11) is positively limited in the distal direction.

5. Product container receiving device (90) according to the preceding claim, characterized in that the guide sleeve (12b) forms a stop (12c) with its proximal end for the cylindrical product container (11c) in particular for its shoulder (1 Id).

6. Product container receiving device (90) according to one of the preceding claims, further comprising a needle guard sleeve (14) with a retaining snap (14d) characterized in that, in the first detent position, the retaining snap (14d) connects the insert (30) by engaging a first snap (30d) in a force-fit manner relative to the needle guard sleeve (14) and / or, in the second detent position, the retaining snap (14d) connects the insert (30) by engaging a second snap (30e) or by movement in the first snap (30d) in a force-fit manner relative to the needle guard sleeve (14), wherein the force-fit connection (14d, 30e) between the needle guard sleeve (14) and the insert (30) is released by the removal movement of the device cap (16).

7. Product container receiving device (90) according to one of the preceding claims, further comprising a housing or housing part (10a, 10b) characterized in that the syringe holder (12) is immovably received in it, at least under tension in the distal direction or pressure from the proximal direction, or is formed integrally with it.

8. Product container receiving device (90) according to one of the preceding claims, characterized in that the insert (30) is axially movable from proximal to distal from the first to the second detent position relative to the device cap (16) and a snap cam (16b) of the device cap (16) snaps into a snap groove (30c) of the insert (30), preferably switching from a first snap groove (30b) of the insert (30) to a second snap groove (30c). Product container receiving device (90) according to the preceding claim, wherein the insert (30) can be axially forced distally through the shoulder (1 Id) via a proximally provided end face (30h). Product container receiving device (90) according to the two preceding claims, characterized in that the locking surface (12a) formed on the inner wall of the guide sleeve (12b) is limited to an axial section. Product container receiving device (90) according to any one of the preceding claims 1 to 7, characterized in that the insert (30) is rotatable about the longitudinal axis (L) from the first to the second detent position relative to the device cap (16) and is axially guided in a fixed position by a snap cam (16b) in a snap groove (30b) and / or can be secured in a rotationally fixed position by the groove (30g) in the second detent position.Product container receiving device (90) according to the preceding claim, characterized in that the insert (30) is rotatable about the longitudinal axis via one or more distally provided mounting cams (30i). Product container receiving device (90) according to the two preceding claims, characterized in that the locking surface (12a) formed on the inner wall of the guide sleeve (12b) has one or more recesses (12d) sector by sector. Autoinjector (1) comprising for the administration of a liquid product. - a product container receiving device (90) according to one of claims 1 - 14 - a propulsion element (22) and a drive element (21) for moving the propulsion element (22) longitudinally and for automatically dispensing a liquid product contained in the product container (11c) of the pre-filled syringe (11) through an injection needle (11b), wherein the needle guard sleeve (14), which projects distally beyond the housing (10a, 10b) in the delivered state of the autoinjector (1), performs an actuating movement in a proximal direction when the autoinjector (1) is pressed against an injection site and performs a needle guard movement in a distal direction when the autoinjector (1) is removed from the injection site The method for assembling a product container receiving device (90) of an autoinjector (1) for administering a liquid product comprises the steps: Providing a syringe holder (12) with a distally coaxially arranged guide sleeve (12b) and a device cap (16) that can be separated from the product container receiving device (90) by a pull-off movement, the product container receiving device (90) designed to receive a pre-filled pre-filled syringe (11) defining a longitudinal axis (L) which extends from distal to proximal with a cylindrical product container which tapers at its distal end over a shoulder and with a needle protection cap (11a) Holding a sleeve-shaped insert (30) in the device cap (16) by snapping it into a first axial detent position Positioning the pre-filled syringe (11) coaxially to the syringe holder (12) The pre-filled syringe (11) is mounted in an axial joining movement in a distal direction through a proximal opening into the syringe holder (12), wherein the needle guard cap (11a) guided by the guide sleeve (12b) deflects at least one snap arm with snap hook (30a) on the insert (30) radially outwards until it springs in behind a proximal edge of the needle guard cap (11a). Securing the sleeve-shaped insert (30) in the device cap (16) by snapping it into a second axial detent position, wherein the movement of the insert (30) from the first to the second detent position is caused or derived from the joining movement of the prefilled syringe (11), and wherein the at least one snap arm with the snap hooks (30a) is no longer deflectable outwards in the second detent position of the insert (30). is, since it is formed on the inner wall of the guide sleeve (12b) Restricted area (12a) is prevented from

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