Autoinjector with product container receiving device

Abstract

The invention relates to a product container receiving device (90) and an automatic syringe, comprising:-a syringe holder (12) configured to receive a pre-filled pre-filled syringe (11) defining a longitudinal axis (L) extending from a distal end to a proximal end, the pre-filled syringe having a cylindrical product container (11c) and a needle protective cap (11a), the syringe holder (12) has a cylindrical product container which is tapered at the distal end thereof by a shoulder (11d), and the syringe holder (12) has a guide sleeve (12b) which is arranged coaxially at the distal end and on the inner wall of which a locking surface (12a) is formed; an insert (30) having a latching arm with a latching hook (30a) that can be deflected radially with respect to the longitudinal axis from a relaxed position; an extractable device cover (16), in which the insert (30) can be received in a connectable manner, the insert (30) being movable relative to the device cover (16) from a first latching position into a second latching position, and the connection of the appliance cover (16) to the insert (30) is formed in a latching manner and in a tension-locking manner at least in the second latching position, and to a method for mounting a product container receiving device (90) for an automatic injector.

Description

Technical Field

[0001] The invention relates to the field of medical injection devices for administering liquid substances, in particular drugs or medical substances such as insulin and hormone preparations. The 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 storage device, and can be used to automatically, that is, to pour without the force that can be supplied or applied by the user. The energy storage device advantageously stores the energy necessary for automatic material output in a mechanical form. Such an energy storage device can be a spring, which is loaded into the injection device under tension and outputs energy by relaxing. The energy output is completed at the piston rod or the pressure element, which pushes the piston into the product container. The energy storage device can also be arranged to automate the piercing process of the injection needle. Alternatively, the piercing process can be manually realized, that is, only realized by the user, without using 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 an injection container (karpule) that can be repeatedly detachably connected to a disposable injection needle, or a disposable prefilled syringe with an injection needle that cannot be detachably connected thereto. The product container has a hollow cylindrical product container section that supports a piston or a stopper in a slidable manner. The piston can form a sealing gap with the inner periphery of the product container section and is moved toward the distal end 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 positioned 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 autoinjector can be triggered by actuating a trigger button of the autoinjector, wherein the needle guard serves at least as a visual protection before the use of the autoinjector.

[0005] Patent application WO2016 / 205963 describes an exemplary automatic injector, which comprises a housing with a longitudinal axis and a product container arranged axially firmly in the housing. The energy for automatically pouring the product can be stored in a spiral or transmission spring, which is connected to the housing via a first end and to a drive element in the form of a rotating screw arranged coaxially with respect to the longitudinal axis via a second end in a rotationally fixed manner. The screw is threadedly engaged in a non-rotating propulsion mechanism in the form of a propulsion sleeve in the housing, which propulsion mechanism causes the stopper of the product container to move together at a nearly constant pouring speed when it is pushed in the distal direction.

[0006] The transmission spring as a drive device is distinguished by its 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 transmission spring in order to ensure a pouring force that is as constant as possible. This also makes it possible to pour large pouring amounts of 5 ml or more evenly and continuously within a maximum of 60 seconds. In the case of pouring durations of more than 10 seconds, which are extended compared to conventional autoinjectors, the user should be able to check at any time that the injection is continuing in accordance with the regulations in order not to accidentally interrupt the injection prematurely.

[0007] Patent application WO2012 / 173554 shows a rotating mark at the end of the proximal end of an automatic injector, which is driven by a torsion spring during pouring. The mark 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 are visible through at least one window at the end of the proximal end of the automatic injector, which window corresponds in its range to the angular range of the segments.

[0008] Patent application published as CH714527A2 shows an injection device with a cover for removing the needle protection cover from a product container; and shows a method for installing an injection device, wherein the cover includes an engagement element to enable the needle protection cover to be removed from the product container when the cover is removed from the injection device.

[0009] The terms "product", "drug" or "medical substance" in the present case 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, a solution, a gel, or a fine suspension comprising one or more medically effective substances. Thus, the drug can be a composition with a single effective substance, or a premixed or co-formulated composition with a plurality of effective substances from a single container. The term includes in particular medicaments, such as peptides (e.g. insulin, drugs containing insulin, containing GLP-1 and obtained or similar preparations), proteins and hormones, biologically obtained or active effective substances, hormone- or gene-based effective 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.

[0010] The term "distal end" refers to the side or direction that the end of the injection side points to, which is toward the front of the delivery device or toward the tip of the injection needle. In contrast, the term "proximal end" refers to the side or direction that the end of the injection side opposite to the end of the injection side points to, which is toward the rear of the delivery device.

[0011] 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, in a syringe unlike an infusion system, the injection needle does not remain in the tissue for a long period of time of many hours. Summary of the invention

[0012] The object of the present invention is to realize a marking for an automatic injector of the type mentioned at the beginning, which can visually show the user the duration or progress of pouring in various holding positions. The marking should be designed so that even in the case of an unfavorable, especially unpredetermined holding position of the user's hand on the automatic injector, the user can recognize the continuation of pouring without the user having to change the holding position for this purpose. Another object is to realize an improved and more cost-effective automatic injector. The installation of the automatic injector or its structural components and the insertion of the product container during the final installation should be more reliable, and the operation or manipulation of the automatic injector is simpler and more reliable. The pre-installation of the structural components, which are separated in time and position from the final installation of the automatic injector, or their storage, transportation and supply should be ensured more simply and reliably, and in particular the integrity of the structural components should be maintained during transportation and supply.

[0013] This object is achieved by a device having the features of the independent claim. Preferred embodiments of the invention are subject matter of the dependent claims.

[0014] The automatic injector according to the present invention comprises a one-piece or multi-piece housing with a longitudinal axis, and a pre-filled prefilled syringe having a product container and an injection needle or injection cannula that is fixed thereon in a non-releasable manner. The prefilled syringe is received in the housing in an axially non-displaceable manner, wherein the tip of the injection needle extends in a distal direction beyond the distal housing end by at least one piercing depth. The automatic injector also comprises a torsion spring, a drive element, a propulsion element, and a needle protection sleeve that are preloaded in order to pour out the maximum content of the product container at one time. 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 the linear movement of the propulsion element to be used to push the piston in the product container. When the automatic injector is pressed against the injection site and the injection needle is thereby caused to penetrate into the injection site, the needle protection sleeve moves in a proximal direction by an operating stroke, and thereby starts or enables the pouring of liquid. In this case, the actuation travel of the needle guard corresponds at least to the penetration depth of the injection needle.

[0015] Finally, the automatic injector includes a sign for indicating the duration of pouring, which has an indicator element with a visual contrast pattern driven by a drive element and rotated around the longitudinal axis, and a window at the proximal end of the automatic injector, through which the rotating contrast pattern can be seen. The window completely surrounds 360° around the longitudinal axis, i.e., it is not interrupted by a frame or a tab parallel to the longitudinal axis, which creates a blind spot for the line of sight of the indicator element. The window is made of a transparent and preferably stable or load-bearing material. As long as there is still such a small part of the window that remains visible, even if the user is unskilled in covering the main part of the window with his hand holding the automatic injector, for example, by supporting it with the fingertips at the proximal end, the rotating indicator element can be identified.

[0016] The contrast pattern is at most discretely rotationally symmetrical about the longitudinal axis, but not continuously rotationally symmetrical, so that rotation of the contrast pattern can also be recognized. The contrast pattern comprises at least one surface or graphic element, which has a different color tone or grayscale than the background color, preferably in the form of a graphic element that repeats in the direction of rotation, such as parallel lines.

[0017] 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 greater than 10 seconds, preferably greater than 20 seconds or 30 seconds relative to known automatic injectors. Thus, even if the product amount exceeds 2.25ml and preferably at least 3ml or 4ml, the continuous or average pouring rate is relatively small, so that the injection amount of the drug can be continuously absorbed or reabsorbed by the subcutaneous tissue. Therefore, it is not so critical to maintain the minimum holding time between the end of pouring and the automatic injector moving away from the piercing site. Accordingly, it is not urgent to indicate the visual, acoustic or tactile signal representation scheme of the end of the holding time for the user.

[0018] In a preferred embodiment, the rotating display element is driven directly or subsequently, in particular without a gear mechanism, by the drive element. The display element then rotates at the same rotational speed as the drive element.

[0019] In another preferred embodiment, the indicator element performs less than one revolution per second, preferably less than half a revolution per second or even less than one third of a revolution per second during pouring, thereby ensuring that the rotational movement of the contrast pattern can be well observed by the eye and is not blurred, for example, to an observer into an unclear rotationally symmetrical pattern.

[0020] In a preferred embodiment, no visual markings are provided for determining the relative rotational position of the contrast pattern, either at the window or at the housing adjacent thereto. The indicator element does not provide an indication of the initial or final state, nor a relative indicator for the pouring progress, but is merely used to signal the progress or duration of pouring.

[0021] In a preferred embodiment, the rotating indicator element and the housing or window are configured to generate a pouring sound, thereby additionally emitting an acoustic signal to the user that the pouring process is ongoing. Preferably, the pouring sound is a continuous clicking sound, which is generated by a grid at the window or housing and a radially or axially flexible coupling element at the indicator element engaged therein, or conversely by a rotating grid at the indicator element and a fixed coupling element. As with a purely visual motion indicator, in this case, it is also possible to dispense with a separate visual, acoustic, and / or tactile signal of the end of pouring, for example by a mechanically or electronically generated signal.

[0022] In a preferred embodiment, the window has a cylindrical first area parallel to the longitudinal axis, and a second area with a continuously or continuously reduced diameter that is seamlessly adjacent to the first area in the proximal direction. The first area enables the indicator element to be viewed from each lateral line of sight perpendicular to the longitudinal axis, and the second area enables the indicator element to be viewed from the rear, or from above when the automatic injector remains vertical, in the line of sight toward the distal end. The second area is rounded or contracted toward the proximal direction and can end in a third area perpendicular to the longitudinal axis. The indicator element can have a convex marking surface according to the trend of the window, or a marking surface with a conical side shape with a medium inclination about the longitudinal axis. Preferably, the window is rotationally symmetrical about the longitudinal axis, i.e., has a circular transverse section in a cutting plane perpendicular to the longitudinal axis.

[0023] In an advantageous variant, the automatic injector comprises a needle protection sleeve, which in the delivery state of the automatic injector extends beyond the housing at the distal end and is preloaded in the distal direction by a needle protection spring. When the automatic injector is pressed against the injection site, the needle protection sleeve performs an operating movement in the proximal direction, and when the automatic injector 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 foot at the distal end as an enlarged bearing surface for the tissue around the injection site. The flange is permanently connected to the sleeve-shaped section and is preferably constructed in one piece with it. The maximum diameter of the flange is greater than the maximum diameter of the sleeve-shaped section.

[0024] Preferably, the outer edge or periphery of the flange is adapted to the shape of the distal opening in the housing. Therefore, in the piercing state, the flange forms a closure of the housing. In addition, preferably, the flange is concavely curved so that the outer edge is at a more distal end than the transition between the flange and the sleeve-shaped section. Thus, with respect to flanges with strictly flat, annular bearing surfaces and with the same outer diameter, firstly, the placed automatic injector is less likely to tilt, and secondly, the concentration of the pressure load on the periphery of the flange farthest from the piercing site results in less back pressure in the tissue and therefore less pain at the user.

[0025] Furthermore, the autoinjector preferably 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. Preferably, the autoinjector is dimensioned for receiving 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.

[0026] In summary and in other words, the automatic injector according to aspects of the present invention can be implemented as follows:

[0027] Auto-injectors include:

[0028] a housing (10a, 10b) having a longitudinal axis L and adapted to receive a product container (11),

[0029] - an advancement mechanism (22) and a rotating drive element (21) for moving the advancement mechanism (22) in the longitudinal direction and for automatically pouring the liquid product contained in the product container (11) through the injection needle (11b),

[0030] - A sign for signaling a pouring continuation condition, comprising an indicator element (25a) having a visual contrasting pattern () which rotates and is driven by a drive element (21), and comprising a window (25b) at the proximal end of the automatic injector through which the rotating contrasting pattern can be seen, characterized in that the window (25b) is a window which completely surrounds the longitudinal axis.

[0031] An automatic injector, wherein a rotating indicator element (25a) is driven directly by a drive element (21).

[0032] Automatic injector, wherein the indicator element (25a) performs less than one revolution per second, preferably less than half a revolution per second during pouring.

[0033] An automatic injector wherein no visual markings are provided for determining the rotational position of the contrast pattern.

[0034] An automatic injector, wherein a rotating indicator element (25a) is designed to generate a pouring sound.

[0035] An automatic injector, wherein the window (25b) has a cylindrical first region parallel to the longitudinal axis and a second region with a continuously decreasing diameter adjoining the first region seamlessly in the proximal direction.

[0036] An auto-injector also includes:

[0037] - a needle protection sleeve (14) which, in the delivery state of the automatic injector, projects distally beyond the housing, wherein, when the automatic injector is pressed against the injection site, the needle protection sleeve (14) performs an actuation movement in the proximal direction and, when the automatic injector is removed from the injection site, performs a needle protection movement in the distal direction in order to laterally surround the injection needle (11b) with a sleeve-shaped section (14b), wherein the needle protection sleeve (14) has an annular flange (14c) at the distal end, which is used for contacting the injection site and has a maximum diameter that is greater than the maximum diameter of the sleeve-shaped section (14b).

[0038] An automatic injector, wherein the outer edge of a flange (14c) is adapted to fit with a distal opening in a housing (10b).

[0039] An automatic injector, wherein the flange (14c) is concavely curved.

[0040] An automatic injector, wherein the drive element (21) is a screw and the advancement element (22) is an advancement sleeve with an axial guide element for a purely linear advancement movement in the housing (10b).

[0041] The autoinjector also has a pre-filled pre-filled syringe, which comprises a product container (11) and an injection needle (11b) and has a filling volume of at least 3 ml, preferably at least 5 ml.

[0042] Further preferred embodiments of the product container receiving device of the invention, in particular for an improved autoinjector, are described below.

[0043] In a preferred embodiment, a product container receiving device for an automatic syringe includes a syringe holder, which is configured to receive a prefilled syringe, the prefilled syringe defining a longitudinal axis extending from a distal end to a proximal end, the prefilled syringe having a cylindrical product container and a needle protection cover, the cylindrical product container gradually narrowing at its distal end by a shoulder, wherein the syringe holder has a guide sleeve arranged coaxially at the distal end, and a locking surface is configured on its inner wall, and the locking surface can especially also be formed by separate or combined ribs or spokes. In addition, there is a sleeve-shaped insert, which has a retaining arm with a retaining hook that can be deflected radially about the longitudinal axis from a relaxed position, and an instrument cover, in which the insert is received in a connectable manner, wherein the insert can be moved relative to the instrument cover from a first locking position to a second locking position, and the connection between the instrument cover and the insert is formed in a locked manner and in a tensile form-fitting manner along the longitudinal axis at least in the second locking position, wherein the retaining arm with the retaining hook can be deflected radially in the first locking position and is prevented from deflecting radially by a locking surface in the second locking position.

[0044] The product container receiving device is preferably improved in that the latching arms with the latching hooks can be deflected radially outwards by the needle protection cover in the first latching position of the insert, thereby minimizing the engagement forces when installing the prefilled syringe and not compromising the closure security of the product container.

[0045] The product container receiving device is preferably improved in that the latching arm with the latching hook is designed to carry the needle protection cover axially in the distal direction in a form-fitting manner in the second latching position of the insert part. This allows the needle protection cover to be reliably separated when it is pulled out of the syringe and does not generate unnecessarily high extraction forces due to additional friction.

[0046] The product container receiving device is preferably improved in that the syringe holder is designed in such a way that the distal section of the prefilled syringe, in particular the needle protection cap, can be moved axially in the guide sleeve, and this movability of the prefilled syringe is positively limited in the distal direction. As a result, the prefilled syringe is radially centered during installation and can be positioned without play at a predefined axial position in the device.

[0047] The product container receiving device is preferably improved in such a way that the guide sleeve forms a stop with its proximal end for a cylindrical product container, in particular for its shoulder. Thus, the prefilled syringe is positioned at a predetermined axial position in the device during installation.

[0048] Preferably, the product container receiving device further comprises a needle protection sleeve with a retaining clip, wherein in a first latching position of the retaining clip, the insert is connected to the needle protection sleeve in a force-fitting manner by engaging in the first retaining part, and / or in a second latching position of the retaining clip, the insert is connected to the needle protection sleeve in a force-fitting manner by engaging in the second retaining part or by a movement in the first retaining part. The needle protection sleeve or the insert is thereby held in a predetermined axial and rotational position in the automatic injector, and the retaining force also increases safety against accidental triggering due to high accelerations, for example during transport or when the device falls to the ground.

[0049] The product container receiving device is preferably improved in that the device cover can be separated from the product container receiving device by a pull-out movement, wherein the insert part is entrained and the friction-locking connection between the needle protection sleeve and the insert part is released. This results in a defined starting resistance which reduces accidental release or undesired play.

[0050] Preferably, the product container receiving device further comprises a housing or a housing part, wherein the syringe holder is received in the housing or housing part in a manner immovable at least for axial pulling forces in the distal direction or axial compressive forces from the proximal direction or is constructed integrally therewith, thereby ensuring that the syringe holder is reliably held in a predetermined axial position in the device when the needle protection cap is pulled out or when pouring.

[0051] Preferably, in a further embodiment of the invention, the product container receiving device is formed in such a way that the insert can be moved axially from the proximal end to the distal end relative to the device cover from a first latching position into a second latching position, by means of a rib in a guide groove that is non-rotatably guided, and / or the latching projection is transformed from a first latching portion into a second latching portion. As a result, the insert is inseparably fixed in a pre-installed position in a subordinate component of the device before the pre-filled syringe is installed, and can be fixed in its final installed position during the installation of the pre-filled syringe. In this case, the movement of the insert can be caused by a tool or by other components that move axially during installation. In particular, the movement from the first latching position into the second latching position can be caused or derived by the engagement movement of the pre-filled syringe.

[0052] The product container receiving device is preferably improved in that the insert can be pushed axially in the distal direction via a shoulder via a proximally arranged end side. As a result, the insert is brought into its final installation position during installation directly via an axial engagement movement of the prefilled syringe, and complex tools that must be engaged in the interior of the device can be omitted.

[0053] The product container receiving device is preferably improved in that the locking surface formed on the inner wall of the guide sleeve is limited to an axial section. The section is selected so that the locking arm with the locking hook can be freely and low-frictionally deflected radially at the beginning of the engagement movement of the prefilled syringe by the outer contour of the needle protection cover until the locking arm elastically springs in behind the proximal edge of the needle protection cover and is positively held in this position near the end or after the engagement movement by the locking surface or other suitable locking geometry to prevent radial breakage.

[0054] Preferably, in a further embodiment of the invention, the product container receiving device is formed in such a way that the insert can be moved relative to the device cover in a rotational manner about the longitudinal axis from a first latching position into a second latching position and is firmly guided in the axial direction by a latching projection in the latching groove and / or can be fixed in a rotationally fixed manner in the second latching position by a groove. As a result, the insert is non-detachably fixed in a pre-installed position in a subordinate component of the device before the pre-filled syringe is installed and can be fixed in its final installed position during the installation of the pre-filled syringe.

[0055] The product container receiving device is preferably improved in that the insert can be moved in a rotational manner about the longitudinal axis via one or more distally arranged mounting projections. A torque can be temporarily coupled in via the mounting projections by means of a rotating tool or by means of a stationary structure in the mounting device relative to which the device can be rotated, which torque causes the rotational movement. For this purpose, an aperture is provided in the device cover.

[0056] The product container receiving device is preferably improved in that the locking surface formed on the inner wall of the guide sleeve has one or more recesses in a section-like manner. The recesses are selected so that the locking arms with the locking hooks can be freely deflected radially during the engagement movement of the prefilled syringe by the outer contour of the needle protection cover until the locking arms elastically snap in behind the proximal edge of the needle protection cover, and after the engagement movement, the insertion part is rotated as described above, so that the locking arms with the locking hooks are positively fixed in this position by the locking surfaces or other suitable locking geometries to prevent radial breakage.

[0057] The improved automatic injector for delivering liquid products according to the present invention preferably comprises:

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

[0059] - an advancement mechanism and a drive element, which is used to move the advancement mechanism in the longitudinal direction and to automatically pour the liquid product contained in the product container of the prefilled prefilled syringe through the injection needle, wherein the needle protection sleeve in the delivery state of the automatic injector extends distally beyond the housing, the needle protection sleeve performs an actuation movement in the proximal direction when the automatic injector is pressed onto the injection site, and performs a needle protection movement in the distal direction when the automatic injector is removed from the injection site, so as to laterally surround the injection needle with a sleeve-shaped section. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Preferred embodiments of the present invention are described below in conjunction with the accompanying drawings, which should illustrate the feasible solutions of the present invention in principle and should not be interpreted as limiting in any way. Among them:

[0061] Figure 1 shows the components of an automatic injector,

[0062] Figure 2 Shows Figure 1 Two longitudinal cross-sectional views of the automatic injector before injection,

[0063] Figure 3 Two views of the indicating element are shown,

[0064] Figure 4 A view showing the distal end of the needle guard,

[0065] Figure 5 Components of a first embodiment of a product container receiving device are shown,

[0066] Figure 6 Shows Figure 5 Two longitudinal and two transverse sections of the equipment in the state before final installation,

[0067] Figure 7 Shows Figure 5 a longitudinal section and a transverse section of the device in a state where the prefilled syringe is engaged,

[0068] Figure 8 Shows Figure 5 Two longitudinal sections and one transverse section of the device in the state after the locking movement of the insert,

[0069] Fig. 9 Shows Figure 5 A longitudinal sectional view of the device in the state before the needle protection cover is pulled out and Figure 5 The longitudinal section and the transverse section of the device in the state after the needle protection cover is pulled out,

[0070] Fig.10 Components of a second embodiment of a product container receiving device are shown,

[0071] Fig.11 Shows Fig.10 Two longitudinal and two transverse sections of the equipment in the state before final installation,

[0072] Fig.12 Shows Fig.10 a longitudinal section and a transverse section of the device in a state where the prefilled syringe is engaged,

[0073] Fig.13 Shows Fig.10 two longitudinal sections and one transverse section of the device in the state after the locking movement of the insert; and

[0074] Fig.14 Shows Fig.10 Two longitudinal sections and one transverse section of the device in the state after the needle protection cover is pulled out. DETAILED DESCRIPTION

[0075] Figure 1 is an exploded view of an automatic injector according to the present invention, Figure 2 Shown according to Figure 1 Two longitudinal sections, rotated by 90° relative to one another about the longitudinal axis, of an autoinjector in the inserted state and ready for pouring.

[0076] The automatic injector 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 grip that is non-releasably engaged therewith. A product container in the form of a prefilled syringe 11 is held in a syringe holder 12 together with an injection needle that is non-releasably fastened to the product container, wherein the syringe holder is received in the housing in an axial and rotationally fixed manner. The prefilled syringe 11 is pressed in the distal direction by a retaining spring section 13a that is firmly fixed in the housing part 10a into engagement 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 injection. When the injection needle is inserted into the injection site, the needle protection sleeve 14 moves along the longitudinal axis L with the operating stroke as the amplitude and against the force of the needle protection spring 15 toward the proximal direction and thus triggers the pouring of the product. For this purpose, the needle protection sleeve includes two sleeve arms 14a, which are arranged around the longitudinal axis L offset or twisted 90° relative to two recesses 10c of the housing, which are called observation windows. After the injection is completed, the needle protection sleeve 14 can be moved from the operating position along the longitudinal axis L toward the distal direction to the needle protection position relative to the housing part 10b and blocked there to prevent re-moval. The needle protection sleeve includes 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 elliptical like the outer periphery of the flange, so that the current flange has a constant width or radial expansion.

[0077] The spring assembly comprises a helical spring 20a and a spring coil 20b. The helical spring 20a is fixed with its outer end in a rotationally fixed manner to a spring sleeve 13b, which is a part of a mechanical holder 13 firmly fixed 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 spring flange at the distal end. 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 threaded portion with a variable pitch extending within the range of the pouring stroke.

[0078] 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 configured as a so-called rigid needle shield (Rigid Needle Shield (RNS)) and comprises a rubber-elastic needle protection element and a cover sleeve made of hard plastic. The needle protection cover protects the injection needle from mechanical influences and dirt and keeps the injection needle and the product sterile. A two-piece device cover or extraction cover 16 is arranged at the distal end of the automatic syringe in its delivery state, which is pulled out axially and / or screwed off and completely removed together with the needle protection cover 11a before using the automatic syringe.

[0079] The switch sleeve 17 is arranged in a form-fitting manner with the proximal end of the sleeve arm 14a of the needle protection sleeve 14 and with the distal end of the needle protection spring 15 and is at least partially surrounded by the latter. The switch sleeve 17 preferably engages with the proximal end of the sleeve arm of the needle protection sleeve 14. The movement of the switch sleeve 17 in the distal direction is limited by the retaining spring section 13a, which, for its part, engages with the mechanical holder 13 after the switch sleeve 17 is installed. The locking sleeve 18 is arranged inside the switch sleeve 17 and coaxially with it, and is coupled to the switch 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 protection sleeve 14 and the switch sleeve 17 also causes the locking sleeve 18 to move proximally. By means of an additional proximal locking stroke of the locking sleeve 18 relative to the proximal end position of the switch sleeve 17, the locking mechanism 18a is reliably released from the switch sleeve 17 inwardly for movement. By means of the elastic action of the arms, 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 switch sleeve 17 is pushed in the distal direction over the locking mechanism 18a by the needle protection spring 15, whereupon the locking mechanism engages behind the proximally directed edge of the switch sleeve 17 by means of the elastic action of the arms in the locked position and locks or blocks the switch sleeve and the needle protection sleeve against further movement in the proximal direction.

[0080] The coupling sleeve 23 with two retaining projections 23a is coupled with the spring coil 20b by a coupling element. Before pouring, retaining projection 23a is engaged in the recess of the axially fixed mechanical retainer 13, and the inner periphery of locking sleeve 18 is hindered for outward movement, so that coupling sleeve 23 cannot move axially. When triggering pouring, locking sleeve 18 is moved away from the position of the recess by the motion of the proximal end of needle protection sleeve 14, so that retaining projection 23a can be loosened radially and release coupling sleeve 23. The latter moves towards the proximal direction and releases spring coil 20b so as to rotate, as described in detail in patent application PCTEP2021076923. There is a sign with a rotating indicator element 25a at the end of the proximal end of the automatic syringe, and the indicator element has a contrast pattern in the form of parallel strips, a transparent window 25b surrounding and an opaque closure 25c at the proximal end.

[0081] Figure 3 Two views of an indicator element 25a are shown, which has an engagement element 25d for engagement in a non-rotating grid at the inner side of a window 25b or a closure 25d. The engagement element 25d is elastically supported and generates a number of clicks corresponding to the grid structure during pouring when the indicator element is rotated. The indicator element has a shape that is adapted to the shape of the window or adapted thereto, with a distal first 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.

[0082] Figure 4 The distal end of the needle guard is shown, which has a sleeve-shaped section 14b and a flange 14c. It can be clearly seen that the shape of the flange has a concavely curved support surface, whose outer elliptical edge projects distally relative to the inner edge of the support surface at the transition to the axis-parallel section.

[0083] Figure 5The exploded view of a first embodiment of a product container receiving device 90 is shown, which comprises a prefilled syringe 11 having a product container 11c which is closed at the distal end by a shoulder 11d and having a needle protection cover 11a surrounding an injection needle; and an apparatus cover 16 for receiving an insert 30. Two elastic clamping arms with clamping hooks 30a, two first and second clamping grooves 30b, 30c, two windows as clamping parts 30d, 30e, two proximal end sides 30h and four grooves 30g are formed on the sleeve-shaped insert 30. The prefilled syringe 11 can be received in the syringe holder 12 through the proximal opening, and ten longitudinal ribs forming a locking surface 12a are provided on the inner side of the guide sleeve 12b. In addition, a needle protection sleeve 14 and a housing part 10b are shown.

[0084] Figure 6 Shows Figure 5 1 and 2. The device in the embodiment of the present invention is shown in two longitudinal and transverse sections in the state before the final installation of the automatic injector. The clamping projection 16b in the interior of the device cover 16 engages in a force-fitting manner in the clamping groove 30b of the insert 30. In addition, four grooves 30g can be seen, in which the ribs 16a are movably received. The locking surface 12a can be regarded as a cross section of one of the ten ribs. The needle guard 14 engages with its two retaining clamps 14d in the two openings 30d of the insert 30 and thus forms a first clamping section, which allows the needle guard and the insert to be releasably fixed relative to each other.

[0085] Figure 7 Shows Figure 5 The device in the figure shows a longitudinal and transverse section respectively before the locking movement of the insert 30 in the state of the engaged prefilled syringe 11. This locking movement of the insert 30 from the first locking position to the second locking position in the device cover 16 is caused by the engagement movement of the prefilled syringe 11. The locking protrusion 16b in the interior of the device cover 16 engages with the locking groove 30b of the insert 30 in a force-fitting manner in the first locking position. Before the engagement movement and at the beginning of the engagement movement, the two elastic locking arms with the locking hooks 30a do not overlap with the locking surface 12a and can therefore be deflected radially through the outer contour of the needle protection cover 11a until the locking hooks 30a spring into the proximal end of the needle protection cover 11a.

[0086] Figure 8 Shows Figure 5Two longitudinal sections and one transverse section of the device in the state after the locking movement of the insert 30. During the engagement, the locking movement is caused by the prefilled syringe 11 in that the prefilled syringe is pushed distally with its shoulder 11d against the insert 30 via its end side 30h, wherein two elastic locking arms with locking hooks 30a overlap at the insert 30 via the locking surface 12a and are thus locked against radial deflection. In this case, the locking projection 16b in the interior of the device cover 16 engages in a form-fitting manner in the locking groove 30c of the insert 30 in the second locking position after the locking movement, and the needle protection sleeve 14 now engages with its two retaining clips 14d in two other openings 30e of the insert 30 and thus forms a second locking portion, which allows the needle protection sleeve and the insert to be releasably fixed relative to each other.

[0087] Fig. 9 Shows Figure 5 A longitudinal sectional view of the device in the state before the device cover 16 is pulled out and Figure 5 The longitudinal section and the transverse section of the device in the state after the device cover 16 is pulled out. The pulling force is transmitted from the prefilled syringe 11 to the stopper 12c of the guide sleeve 12b of the syringe holder 12 through its shoulder 11d, and is guided from the stopper to the housing. When the device cover 16 is pulled out, due to the shape-fitting connection between the locking protrusion 16b in the interior of the device cover 16 and the locking groove 30c of the insert 30, the insert 30 remains firmly connected to the device cover and the two locking hooks 30a drive the needle protection cover 11a and separate the needle protection cover from the prefilled syringe 11. As a result, the injection needle 11b is exposed.

[0088] Fig.10 The exploded view of the second embodiment of the product container receiving device 90 is shown, which comprises: a prefilled syringe 11 with a product container 11c, which is closed at the distal end by a shoulder 11d; a needle protection cover 11a, which surrounds the injection needle; and a device cover 16, which receives an insert 30. Two elastic clamping arms with clamping hooks 30a, two clamping grooves 30b, two windows or openings as clamping parts 30d, two grooves 30g and two mounting protrusions 30i are formed on the sleeve-shaped insert 30. The prefilled syringe 11 can be received in the syringe holder 12 through the proximal opening and a plurality of longitudinal ribs distributed in the circumferential range are installed on the inner side of the guide sleeve 12b, which form a locking surface 12a. The locking surface 12a is interrupted by two recesses 12d, in that the longitudinal ribs are omitted at two opposite locations on the inner side of the guide sleeve 12b. Also shown are the needle guard 14 and the housing part 10 b .

[0089] Fig.11 Shows Fig.10 1 and 2. The device in the state before the final installation of the automatic injector is shown in two longitudinal and transverse sections. The two fastening projections 16b in the interior of the device cover 16 engage in a form-fitting manner in the fastening grooves 30b of the insert 30. The recess 12d of the locking surface 12a can be seen in the cross section and exposes two elastic fastening arms with the fastening hooks 30a for radial deflection. The needle guard 14 engages with its two retaining clips 14d in the two openings 30d of the insert 30 and thus forms a first fastening portion, which allows the needle guard and the insert to be releasably fixed relative to each other.

[0090] Fig.12 Shows Fig.10 The device in the embodiment of the present invention is shown in a longitudinal and transverse section immediately before the locking movement of the insert 30 in the state of the prefilled syringe 11 being engaged. Two latching projections 16b in the interior of the device cover 16 engage in a form-fitting manner in the axial direction in the latching grooves 30b of the insert 30, wherein the insert 30 is rotatably held in the device cover. The mounting projections 30i can be accessed through two openings in the device cover for rotating tools, and two elastic latching arms with latching hooks 30a on the insert 30 can be deflected in the region of the recess 12d and thus radially through the outer contour of the needle protection cover 11a until the latching hooks 30a spring into the proximal end of the needle protection cover 11a.

[0091] Fig.13 Shows Fig.10 Two longitudinal sections and one transverse section of the device in the state after the locking movement of the insert, wherein the insert 30 has been rotated relative to the device via the mounting protrusion 30i, so that the two elastic clamping arms with the clamping hooks 30a on the insert 30 overlap via the locking surface 12a formed by the longitudinal ribs and are thus locked to prevent radial deflection, wherein this new rotational position of the insert 30 is fixed by the clamping connection between the device cover 16 and the groove 30g.

[0092] Fig.14 Shows Fig.10The longitudinal section of the device in the state after the needle protection cover is pulled out. The pulling force is transmitted from the prefilled syringe 11 to the stopper 12c of the guide sleeve 12b of the syringe holder 12 through its shoulder 11d and is guided from the stopper to the housing. When the device cover 16 is pulled out, the insert 30 remains firmly connected to the device cover due to the shape-fitting connection between the two fastening protrusions 16b in the interior of the device cover 16 and the fastening grooves 30b of the insert 30, and the two fastening hooks 30a drive the needle protection cover 11a and separate the needle protection cover from the prefilled syringe 11. As a result, the injection needle 11b is exposed.

[0093] List of reference numerals:

[0094] 10a, 10b Housing part 16 Device cover

[0095] 10c Notch 17 Switch sleeve

[0096] 11 Prefilled Syringe 18 Locking Sleeve

[0097] 11a Needle protection cover 18a Locking mechanism

[0098] 11b Injection needle 20a Coil spring

[0099] 12 Syringe holder 20b Spring coil

[0100] 13 Mechanical holder 21 Driving element

[0101] 13a Retaining spring section 22 Advancing element

[0102] 13b Spring sleeve 23 Coupling sleeve

[0103] 14 Needle protection sleeve 23a keeps protrusion

[0104] 14a Arm 25a Indicator element

[0105] 14b Section 25b Window

[0106] 14c Flange 25c Closure

[0107] 15 Needle protection spring 25d Engagement element

[0108] 30 Insert 14d Retaining card fastener

[0109] 30a Clamping arm with clamping hook 16a Rib

[0110] 30b First locking groove 16b Locking protrusion

[0111] 30c Second locking groove 16c Locking protrusion

[0112] 30d opening, first fixing portion

[0113] 30e opening, second fixing portion

[0114] 30f Guide groove

[0115] 30g Groove

[0116] 30h End side

[0117] 30i Mounting boss L Longitudinal axis

[0118] 11c Cylindrical product container 1 Automatic syringe

[0119] 11d Shoulder

[0120] 12a Locking surface, longitudinal ribs

[0121] 12b Guide sleeve

[0122] 12c Stopper

[0123] 12d Notch

[0124] 90 Product container receiving equipment

Claims

1. A product container receiving device (90) for an automatic injector, the product container receiving device comprising: - a syringe holder (12) configured to receive a prefilled syringe (11) defining a longitudinal axis (L) extending from a distal end to a proximal end and having a cylindrical product container (11c) tapering at its distal end by a shoulder (11d) and a needle protection cover (11a), - a sleeve-shaped insert (30) having a snap-in arm which can be deflected radially about the longitudinal axis (L) and has a snap-in hook (30a), - an apparatus cover (16), in which the insert (30) is received in a connectable manner, wherein the insert (30) can be moved relative to the apparatus cover (16) from a first latching position into a second latching position, which is caused in particular by an engagement movement of a tool and / or a prefilled prefilled syringe (11) into the syringe holder (12), and the connection of the apparatus cover (16) to the insert (30) is formed in a latching manner and in a tensile form-fitting manner along the longitudinal axis (L) in the second latching position, and the apparatus cover (16) can be separated from the product container receiving device (90) by a pulling-out movement, wherein the insert (30) and the needle protection cover (11a) are entrained, It is characterized in that a locking arm with a locking hook (30a) can be radially deflected in a first locking position and is blocked from radially deflecting in a second locking position by a locking surface (12a), preferably by a locking surface (12a) constructed on the inner wall of a guide sleeve (12b) arranged coaxially at the distal end of the syringe holder (12).

2. The product container receiving device (90) according to the preceding claim, characterized in that In a first latching position of the insert (30), a latching arm having a latching hook (30a) can be deflected radially outward by the needle protection cover (11a).

3. The product container receiving device (90) according to any one of the preceding claims, characterized in that The latching arm with the latching hook (30a) is designed to axially carry the needle protection cover (11a) in a form-fitting manner in the distal direction in the second latching position of the insert (30).

4. A product container receiving device (90) according to any one of the preceding claims, characterized in that The syringe holder (12) is constructed in such a way that a distal section of the prefilled syringe (11), in particular the needle protection cover (11a), can move axially in a guide sleeve (12b), and this movability of the prefilled syringe (11) is limited in a form-fitting manner in the distal direction.

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

6. The product container receiving device (90) according to any one of the preceding claims, further comprising a needle protection sleeve (14) having a retaining clip (14d), characterized in that: In the first locking position of the retaining clamp (14d), the insert (30) is connected relative to the needle protection sleeve (14) in a force-fitting manner by engaging in the first locking portion (30d), and / or in the second locking position of the retaining clamp (14d), the insert (30) is connected relative to the needle protection sleeve (14) in a force-fitting manner by engaging in the second locking portion (30e) or by movement in the first locking portion (30d), wherein the force-fitting connection (14d, 30e) between the needle protection sleeve (14) and the insert (30) is released by pulling out the device cover (16).

7. The product container receiving device (90) according to any one of the preceding claims, further comprising a housing or a housing part (10a, 10b), characterized in that The syringe holder (12) is received in the housing or housing part in a manner immovable at least with respect to a tensile force in the distal direction or a compressive force from the proximal direction or is constructed integrally therewith.

8. The product container receiving device (90) according to any one of the preceding claims, characterized in that The insert (30) can move axially from the proximal end to the distal end from a first locking position to a second locking position relative to the device cover (16), and the locking protrusion (16b) of the device cover (16) is snapped into the locking groove (30c) of the insert (30), preferably changing from the first locking groove (30b) of the insert (30) to the second locking groove (30c).

9. The product container receiving device (90) according to the preceding claim, wherein: The insert (30) can be pushed axially in the distal direction via a proximally arranged end side (30h) via a shoulder (11d).

10. The product container receiving device (90) according to the two preceding claims, characterized in that The blocking surface (12a) formed on the inner wall of the guide sleeve (12b) is limited to an axial section.

11. The product container receiving device (90) according to any one of the preceding claims 1 to 7, characterized in that The insert (30) can be moved relative to the device cover (16) from a first locking position to a second locking position by rotating about the longitudinal axis (L) and can be firmly guided axially by a locking protrusion (16b) in a locking groove (30b) and / or can be fixed in the second locking position in a rotationally non-resistant manner by a groove (30g).

12. The product container receiving device (90) according to the preceding claim, characterized in that The insert (30) is movable in a rotational manner about the longitudinal axis by means of one or more mounting protrusions (30i) provided at the distal end.

13. The product container receiving device (90) according to the two preceding claims, characterized in that The blocking surface (12a) formed on the inner wall of the guide sleeve (12b) has one or more recesses (12d) in sections.

14. An automatic injector (1) for administering a liquid product, comprising: - a product container receiving device (90) according to any one of claims 1 to 14, - an advancement mechanism (22) and a drive element (21), which is used to move the advancement mechanism (22) in the longitudinal direction and to automatically pour the liquid product contained in the product container (11c) of the prefilled prefilled syringe (11) through the injection needle (11b), wherein the needle protection sleeve (14) in the delivery state of the automatic injection syringe (1) extends distally beyond the housing (10a, 10b), the needle protection sleeve performs an actuating movement in the proximal direction when the automatic injection syringe (1) is pressed against the injection site, and performs a needle protection movement in the distal direction when the automatic injection syringe (1) is removed from the injection site, so as to laterally surround the injection needle (11b) with a sleeve-shaped section (14b).

15. A method for installing a product container receiving device (90) of an automatic injector (1) for administering a liquid product, the method comprising the following steps: - providing a syringe holder (12) having a guide sleeve (12b) arranged coaxially at the distal end and an instrument cover (16) which can be separated from a product container receiving device (90) by a withdrawal movement, the product container receiving device (90) being configured to receive a prefilled prefilled syringe (11), the prefilled syringe defining a longitudinal axis (L) extending from the distal end to the proximal end, the prefilled syringe having a cylindrical product container which tapers at its distal end by a shoulder, and a needle protection cover (11a), - holding the sleeve-shaped insert part (30) in the device cover (16) by snapping it into a first axial snap-in position, - positioning the prefilled syringe (11) coaxially with the syringe holder (12), - installing the prefilled syringe (11) into the syringe holder (12) through the proximal opening with an axial engagement movement in the distal direction, wherein: The needle protection cover (11a) guided through the guide sleeve (12b) causes at least one retaining arm with a retaining hook (30a) on the insert (30) to deflect radially outward until the retaining arm springs in behind the proximal edge of the needle protection cover (11a), - The sleeve-shaped insert (30) is fixed in the device cover (16) by being locked in a second axial locking position, wherein the movement of the insert (30) from the first locking position to the second locking position is caused or derived from the engagement movement of the prefilled syringe (11), and wherein at least one locking arm having a locking hook (30a) can no longer be deflected outwards in the second locking position of the insert (30) because the locking surface (12a) formed on the inner wall of the guide sleeve (12b) prevents the locking arm from performing such a deflection.

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