Injection device for injecting a pharmaceutical substance, and injection loading part for such an injection device

Abstract

The invention relates to an injection device (1) for injecting a pharmaceutical substance, comprising a proximal portion (5) having an actuator (7) for performing an injection, and comprising a distal portion (13) designed to receive an injection loading portion (3), which in turn has a container receiving portion (17) and a primary container (23) retained in the container receiving portion (17), in which a pharmaceutical substance is contained, wherein the pharmaceutical substance can be injected from the injection loading portion (3) if the injection loading portion (3) is disposed in the distal portion (3), wherein the distal portion (13) is designed so that the injection loading portion (3) can be axially inserted into the distal portion (13).and wherein the injection device (1) has a visual display (15) that is designed and arranged so that an injection needle (25) of the injection loading portion (3) is concealed from the user during use of the injection device (1).

Description

[0001] The invention relates to an injection device for injecting a pharmaceutical substance and an injection loading component for use in such an injection device. US 2015 / 045729 describes an injection device according to the prior art.

[0002] Injection devices of the type discussed here are used, in particular, for the single or repeated injection of a pharmaceutical substance. In a particularly simple design, similar to a conventional pen, they may have a drive unit to which a cartridge can be attached. An injection needle can then be connected to the cartridge. The drive unit moves a piston within the cartridge to administer the injection and expel the pharmaceutical substance through the injection needle. The injection needle is visible to the user when using the pen. This can lead to psychological and / or physical resistance reactions and ultimately negatively impact compliance with a treatment plan. Such a pen can be reused by detaching an empty cartridge from the drive unit and replacing it with a fresh one.It is also possible to use a single-use pen, in which the entire pen, including the drive unit, is disposed of after the injection. Such a pen has an integral design. It is therefore not adaptable to different primary packaging for pharmaceutical substances or must be newly developed for each application. Furthermore, the use of such a single-use pen is expensive and is therefore only feasible for high-priced pharmaceutical substances. With Bayer BETACONNECT®, an injection device has become known into which a specifically designed syringe can be loaded. The injection device can be used multiple times and features a shield, so that the injection needle of the syringe loaded into the device remains hidden from the user during administration.The injection device is relatively complicated to operate, as the syringe must be inserted into the device by opening it up and inserting it sideways; furthermore, this injection device - as explained - is designed for use with a specific type of syringe and is therefore not compatible with other primary packaging materials.

[0003] The invention is based on the objective of creating an injection device and an injection loading part for such an injection device, without the aforementioned disadvantages occurring.

[0004] The problem is solved by creating the present technical teaching, in particular the teaching of the independent claims and the embodiments disclosed in the dependent claims and the description.

[0005] The problem is solved, in particular, by providing an injection device configured for injecting a pharmaceutical substance. The injection device has a proximal part with a drive mechanism configured to effect the injection. The injection device also has a distal part configured to receive an injection loader, which comprises a packaging receiving part and a primary packaging element held within the packaging receiving part. The primary packaging element contains a pharmaceutical substance, which can be injected from the injection loader when the injection loader is positioned in the distal part. The distal part is designed such that the injection loader can be inserted axially into it.The injection device features a shield designed and positioned to conceal the injection needle of the injection cartridge during use. The injection device has a simple and, in particular, clearly structured design, comprising a proximal and a distal part. Specifically, a functional separation is provided between the proximal and distal parts, with the drive mechanism located in the proximal part and the distal part serving as the receptacle for the injection cartridge. This allows the distal part to be designed more simply and cost-effectively than the proximal part, ultimately reducing the overall effort and costs associated with manufacturing the injection device.Depending on the specific design, a proximal component, i.e., a drive unit, of a conventional pen can be used, supplemented by the distal component. This makes the provision of the injection device particularly simple and involves minimal development and / or manufacturing effort. Furthermore, the injection device is easy to operate and its function is easy for the user to understand.

[0006] The fact that the distal part is designed to receive the injection loading unit, which in turn receives the primary packaging material, offers the advantage that the injection device can be easily adapted to various primary packaging materials. This simply requires adjusting the injection loading unit to the corresponding primary packaging material so that, on the one hand, the primary packaging material can be received in the injection loading unit, and on the other hand, the injection loading unit can be received in the distal part. The injection device is therefore flexibly adaptable to different applications.

[0007] The injection device, in particular the distal and proximal parts, is preferably designed for the repeated injection of a pharmaceutical substance and can be configured as a reusable injection device, particularly reloadable. Specifically, the distal and proximal parts are designed as reusable components. A used injection cartridge can then be easily replaced with a fresh one. The injection cartridge is preferably designed as a disposable component.

[0008] The injection device can also be used for the single injection of a pharmaceutical substance. In this case, it can be disposed of, particularly together with a used injection cartridge. Nevertheless, the advantage remains that, due to its multi-part design with the proximal part, the distal part, and the injection cartridge, it can be easily adapted to various primary packaging materials and thus offer different application options.

[0009] The visual shield advantageously prevents the user of the injection device from seeing the injection needle, thus avoiding associated physical and / or psychological defense reactions. Therefore, compliance with the use of the injection device is also high.

[0010] The visual shield also serves as a puncture guard, ensuring that the injection needle remains hidden from the user both visually and tactilely during use of the injection device. This prevents unintentional needlestick injuries outside the intended injection area.

[0011] A visual shield is understood to mean, in particular, a device or element that is set up and arranged to conceal the injection needle, especially from the view, but preferably also from unwanted contact by the user.

[0012] The fact that the injection needle is hidden from the user during the use of the injection device means in particular that the injection needle is hidden from the user's view and preferably also from unwanted contact during the injection procedure, preferably during loading the injection loading part into the distal part and during the injection, and especially preferably also during unloading the injection loading part.

[0013] In a preferred embodiment, the visual barrier does not prevent the user from observing the injection progress or the fill level of the primary packaging. In particular, a viewing window is preferably formed in a circumferential wall of the distal part, through which the user can observe the injection progress and / or the fill level of the primary packaging, especially during the injection process.

[0014] A pharmaceutical substance is understood to be, in particular, a substance or mixture of substances that produces a pharmaceutical or medical effect and / or that is injected for a pharmaceutical and / or medical purpose. Such a pharmaceutical substance may, in particular, contain at least one active ingredient and / or excipient, and especially at least one medicinal product.

[0015] In this and the following, "proximal" refers specifically to a direction in the coordinate system of the injection device and / or the injection loading part that is intended to face away from the injection site where an injection is to be performed with the injection device. Conversely, "distal" refers to a direction in the coordinate system of the injection device and / or the injection loading part that is intended to face towards the injection site. Accordingly, when the injection device is used as intended, the proximal part faces away from the injection site, while the distal part faces towards the injection site.

[0016] The proximal part is, in particular, a backend of the injection device. Specifically, it can also be a conventional, independently known backend of an injection pen.

[0017] The distal part is, in particular, a front end of the injection device.

[0018] The distal part can be mechanically connected to or is connected to the proximal part. In a preferred embodiment, the distal part and the proximal part can be formed as a single unit.

[0019] The drive is preferably designed as a mechanical or electric drive. A mechanical drive is, in particular, a drive that is operated manually by a user. Preferably, the drive is configured to effect the injection automatically, especially as an electric drive. In a preferred embodiment, the proximal part includes a control unit configured to control the drive to effect the injection.

[0020] The fact that the drive is set up to effect the injection means, in particular, that by activating the drive, an expulsion of the pharmaceutical substance and thus an injection can be causally caused.

[0021] The injection loading element is, in particular, a part that can be inserted into the distal part and preferably removed from the distal part, and which carries the primary packaging material and thus the pharmaceutical substance. It is especially preferred that the injection loading element can be interchangeably accommodated within the distal part.

[0022] The primary packaging is specifically designed to directly contain the pharmaceutical substance. In particular, the primary packaging is preferably designed as a syringe or a cartridge. Preferably, the primary packaging carries the injection needle, which is arranged, in particular, at a distal end of the primary packaging and may be detachably or permanently connected to the primary packaging.

[0023] The distal part preferably has a prominent direction of extension, wherein its extension in the prominent direction is longer than its extension in the two directions perpendicular to the prominent direction. This prominent direction of extension is called the axial direction. The distal part is therefore elongated, particularly along the axial direction. The term "axial" refers specifically to this axial direction. A circumferential direction surrounds the axial direction concentrically. A radial direction is perpendicular to the axial direction.

[0024] The fact that the injection loading part can be inserted axially into the distal part preferably means in particular that it can be inserted into the distal part in an axial direction, especially at the end face, and preferably also removed from the distal part.

[0025] According to a further development of the invention, the injection device comprises the drive of the proximal part as its sole drive. Preferably, no further drive is provided, regardless of the potential purpose of such a further drive. The drive of the proximal part preferably acts on a piston rod of the injection device to displace the piston rod axially, in particular to expel the pharmaceutical substance from the injection loading part, and – in the opposite direction – to reposition the piston rod after the injection has been carried out. The injection device is preferably configured such that at least one other mechanical function of the injection device is effected by the displacement of the piston rod. Thus, in addition to actually effecting the injection, the drive serves at least one further function.This represents a particularly economical and simple design of the injection device.

[0026] The at least one further mechanical function is preferably selected from a group consisting of: Inserting the injection needle into the injection site under the shield; locking the injection loading part and / or the shield, in particular in an injection position to effect the injection or in a rest position to prevent unintentional injection; and unlocking the injection loading part and / or the shield, in particular to allow the injection needle to be inserted into the injection site.

[0027] According to a further development of the invention, the injection device is designed as a pen or as an autoinjector. Thus, the injection device is designed in a manner already known from other, conventional injection devices, the operation of which is also generally known. A user will therefore not experience any major difficulties in using the injection device. In particular, the injection device is designed for self-injection of the pharmaceutical substance by a patient, so that, advantageously, no medical personnel are required for its use.

[0028] The further developments and preferred embodiments disclosed below, on the one hand, develop the invention independently of one another; on the other hand, they preferably form a first preferred embodiment of the invention when combined with one another:

[0029] According to a further development of the invention, the distal part is detachably connected to the proximal part. Advantageously, this allows the distal and proximal parts to be handled and operated independently. In particular, this makes it possible to use a conventional backend for a conventional pen to provide the injection device, and to provide the injection device by connecting the known backend to the distal part designed according to the invention. The distal part can be connected to the backend instead of a conventionally connected cartridge. Of course, it is also possible for the proximal part to be specifically designed and provided for the injection device according to the invention.

[0030] If the distal part is detachably connected to the proximal part, it can be separated from the distal part. Such separation of the distal part from the proximal part may be provided, in particular, for inserting the injection loading part into the distal part, and / or for maintenance or repair purposes.

[0031] The injection device preferably has a connection mechanism designed to detachably connect the distal part to the proximal part. According to a preferred embodiment, the connection mechanism can be designed as a plug-in / twist connection, in particular as a bayonet fitting.

[0032] Alternatively, it is also possible that the distal part is inextricably connected to the proximal part. The term "inextricably" means, in particular, that the distal part cannot be separated from the proximal part without damage or at least not without the use of force.

[0033] According to a further development of the invention, the visual shield is rigidly attached to or arranged on the distal part. In this case, the visual shield cannot be moved relative to the distal part. Preferably, the visual shield is formed integrally with the distal part, preferably of the same material. In a particularly preferred embodiment, the visual shield is formed by the distal part itself. This means, in particular, that the distal part itself constitutes the visual shield, at least in part. In a particularly simple and reliable manner, the injection needle remains hidden from the user's view by the distal part, which preferably also prevents the user from unintentionally touching the injection needle. The distal part thus also serves as a puncture guard.

[0034] According to the invention, a proximal end face of the distal part has a loading opening through which the injection loading element can be inserted into the distal part. The loading opening is thus arranged and configured to allow the insertion of the injection loading element into the distal part. The injection loading element is thereby inserted into the distal part from a side opposite the intended injection site. By analogy with the conceptual description of firearms, the injection device according to this embodiment is thus designed as a breech-loading device.

[0035] To insert the injection loading part into the distal part, the distal part is preferably detached from the proximal part so that the proximal end face of the distal part is accessible. In this embodiment, the distal part is therefore preferably detachably connected to the proximal part.

[0036] According to a further development of the invention, a spring device is arranged in the distal part, against which the injection loading part rests. Against the force of this spring, the injection loading part can be displaced distally within the distal part to perform an injection. Thus, to perform an injection, the injection loading part is displaced within the distal part and relative to it in the direction of the injection site. In a preferred embodiment, to perform the injection, a distal end face of the distal part is placed on the patient's skin in the area of ​​the injection site, and the injection loading part is displaced distally within the distal part and relative to it, so that the injection needle penetrates the patient's skin and the injection can be performed.The injection loading part is then pushed back by the spring force of the spring mechanism, so that the injection needle is once again completely inside the distal part. The distal part serves as both a visual shield and a puncture guard.

[0037] The spring assembly preferably rests at a distal end against a shoulder of the distal part, while the injection loading part rests at a proximal end of the spring assembly. In a preferred embodiment, the spring assembly is designed as a spring, in particular as a helical spring.

[0038] The displacement of the injection loading part within the distal part is preferably effected by the piston rod of the proximal part and thus simultaneously by its drive.

[0039] In particular, the injection loading element within the distal part is movable between a protective position, in which the injection needle is completely enclosed within the distal part, and an injection position, in which the injection needle protrudes beyond the distal end face of the distal part, and in which the injection is performed. To perform the injection, the injection loading element is thus moved axially from the protective position into the injection position against the spring force of the spring mechanism. After the injection has been performed, particularly when the piston rod is retracted, the spring mechanism pushes the injection loading element back from the injection position into the protective position.

[0040] According to the invention, the injection device has a locking element that can be inserted into the distal part through the loading opening of the distal part and is configured to bear against a proximal contact surface of the injection loading part. The locking element has a base body and at least one locking element pivotally connected to the base body. The locking element is displaceable within the distal part, in particular between a first axial position, also referred to as the unlocking position, and a second axial position, also referred to as the locking position. In the first axial position, the locking element is arranged away from a locking opening formed in a circumferential wall of the distal part. In the second axial position, the locking element is arranged at the level of the locking opening. When the locking element is arranged in the first axial position, the locking element is pivoted into the base body.If the locking element is in the second axial position, the locking element can be pivoted out and, in particular, the locking opening can be fully engaged to prevent axial displacement of the injection loading element relative to the distal part. This advantageously prevents the injection needle from penetrating too deeply into the patient's body, unless this is already prevented by the spring mechanism, especially by the spring mechanism engaging its locking position. Furthermore, it also prevents the injection loading element from being pushed back too far towards the protective position by the force of the spring mechanism during injection, which could otherwise result in the injection needle not penetrating deeply enough into the patient's body or even slipping out of the injection site entirely.Advantageously, the locking mechanism preferably prevents axial displacement of the injection loading part during injection, both distally and proximally. The locking element and the locking opening can be designed to allow for a specific tolerance of axial displacement of the injection loading part within the distal section, with the locking opening providing axial stops for the locking element in both proximal and distal directions. Thus, any potential axial displacement of the injection loading part during injection is limited by the locking opening.

[0041] Preferably, the at least one locking element is L-shaped. In particular, the L-shaped locking element has two interconnected legs, preferably formed in one piece and / or of the same material, and is preferably pivotally connected to the base body of the locking part in a connection area of ​​the two legs.

[0042] The locking element is preferably attached to the proximal part. Advantageously, this prevents it from being lost when the distal part is separated from the proximal part, particularly for inserting the injection loading element into the distal part. However, it is also possible for the locking element to be a separate component. In this case, to insert an injection loading element into the distal part, the locking element is preferably removed manually from the distal part; the injection loading element is inserted into the distal part, and then the locking element is reinserted into the distal part – also via the proximal loading opening.

[0043] Preferably, a plurality of locking elements are pivotally hinged to the base body of the locking part; in a particularly preferred embodiment, two locking elements are hinged. The locking elements are preferably hinged to the base body at uniform angular intervals in the circumferential direction, i.e., at equal angular intervals from one another. If two locking elements are provided, they are preferably diametrically opposed to each other. The circumferential wall of the distal part preferably has at least as many locking openings as the locking part has locking elements, preferably exactly as many. The position of the locking openings in the circumferential direction is preferably aligned with the position of the locking elements so that the locking elements can engage in the locking openings in the locked position. In a particularly preferred embodiment, two diametrically opposed locking openings are provided in the circumferential wall of the distal part.

[0044] According to the invention, the locking element has an axial through-opening for the piston rod, wherein the locking element is designed such that the at least one locking element engages in the through-opening in the first axial position, so that the through-opening for the piston rod is locked and the locking element can be displaced from the piston rod - in particular together with the injection loading element and thus also the primary packaging -, wherein the locking element releases the through-opening in the second axial position, so that the piston rod can reach through the through-opening and be displaced relative to the locking element, in particular to displace a piston of the primary packaging within the primary packaging and relative to the injection needle, so that the pharmaceutical substance is expelled from the primary packaging.In the unlocked position, the locking element provides a stop for the piston rod, allowing the piston rod to move the locking element and the injection loading element together distally until the locking element reaches its second axial position, thus entering the locked position. The locking element can then pivot outwards, primarily due to the piston rod pivoting it through the locking opening. Simultaneously, this pivoting action opens the access opening, allowing the piston rod to pass the locking element, penetrate the locking element, and act upon the piston of the primary packaging. Specifically, in the unlocked position, the L-shaped locking element engages the access opening with one of its two legs, causing the piston rod to abut against this inner leg.When the locking element reaches the area of ​​the bolt opening, one of the two legs can extend through the bolt opening, while simultaneously the inner leg pivots out of the opening, thus clearing the path for the piston rod through the opening. Once the piston rod is retracted from the opening after injection is complete, the locking element is forced proximally by the force of the spring mechanism, allowing the locking element to pivot back into the base body. It then no longer extends through the bolt opening, and the locking element, along with the injection loading element, can be moved proximally.

[0045] This is where those further developments and preferred configurations end, which preferably in combination with each other form the first exemplary embodiment.

[0046] The further developments and preferred embodiments disclosed below, on the one hand, develop the invention independently of one another; on the other hand, they preferably form a second preferred embodiment of the invention in combination with one another:

[0047] According to a further development of the invention, the shield is movably mounted on the distal part. In particular, the shield is movable between a rest position and an exposure position, concealing the injection needle in the rest position as long as no injection is being performed, and exposing the injection needle for injection in the exposure position. The shield is movable, especially in the axial direction. Preferably, the shield has a projection, preferably radial, on its outer circumferential surface, which, in an extreme exposure position (i.e., when moved as far as possible in the proximal direction), abuts a distal end face of the distal part or an adjustable stop. This advantageously limits the movement of the shield in the proximal direction.

[0048] Preferably, the privacy screen is pre-tensioned into the rest position, and can be moved against this pre-tension from the rest position to the exposure position. For this purpose, the distal part preferably has a pre-tensioning device designed to pre-tension the privacy screen into the rest position. The pre-tensioning device is preferably designed as a helical spring arranged in the distal part, which interacts with the privacy screen and forces it into the rest position.

[0049] The shield is preferably moved into the exposure position when the injection device is placed on the patient's body and pressed against the patient's body for administering an injection. While the shield is being moved into the exposure position, the injection needle can simultaneously penetrate the patient's body. The injection needle remains hidden from the user's view at all times, as the portion of the needle not yet inserted is always concealed by the shield.

[0050] In the design of the injection device, in which the privacy screen is movably held on the distal part, it is particularly possible that the distal part is permanently connected to the proximal part, as explained above in connection with the first embodiment. However, it is also possible that the distal part is detachable from the proximal part – particularly for repair or maintenance purposes – as also explained above.

[0051] According to a further development of the invention, a distal end face of the distal part has the loading opening through which the injection loading element can be inserted into the distal part. In this case, the injection loading element is inserted into the distal part from the side intended to face an injection site. The injection device is thus designed almost like a muzzleloader. In particular, the injection loading element is preferably inserted into the distal part through the visual shield.

[0052] Preferably, the injection loading element is screwable into the distal part. For this purpose, the distal part and the injection loading element preferably each have complementary screw-in means. Particularly preferably, the distal part has at least one thread, especially a right-hand thread, wherein, preferably in a particularly simple embodiment, a screw-in projection is arranged on the injection loading element, which is designed to engage positively with the thread and be screwed into it. This eliminates the need for a separate thread on the injection loading element, allowing for a particularly simple design. Preferably, two such threads are arranged in the distal part, and the injection loading element also has two corresponding screw-in projections.

[0053] Alternatively or additionally, the injection loading element can preferably be axially fixed within the distal part. This provides a secure and stable axial position for the injection loading element within the distal part, holding it axially fixed relative to the distal part. In particular, the at least one thread can have a thread runout that determines the axial position of the injection loading element. Alternatively, the distal part and the injection loading element can have a locking mechanism, for example, a bayonet fitting.

[0054] According to a further development of the invention, the distal part has a locking mechanism for the shield, which is configured to lock the shield in a locked position – against axial displacement, in particular against displacement between the rest position and the exposure position – and to release the shield in a release position. Advantageously, the locking mechanism prevents the shield from being accidentally moved into the exposure position, thus preventing the injection needle from being exposed outside the injection procedure. An unwanted view of the injection needle, or even worse, an unintentional needlestick injury, can therefore be reliably avoided.

[0055] Preferably, the privacy screen locking mechanism is designed to be unlocked when the injection loading element is inserted, particularly when it is screwed or rotated, into the distal part. Specifically, it is designed to be unlocked by inserting, particularly by screwing or rotating, the injection loading element into the distal part. "Unlocking" here means that the privacy screen is released to move from its rest position to its exposure position. Thus, the corresponding movement of the privacy screen can be easily achieved without any additional effort for the user by inserting the injection loading element into the distal part as intended.

[0056] Alternatively or additionally, the privacy screen locking mechanism is preferably configured to be locked by the piston rod associated with the drive. This allows the privacy screen to be advantageously locked automatically without any further intervention from the user during or after an injection. Preferably, the privacy screen locking mechanism is locked by axial displacement of the piston rod in a distal direction, i.e., during the injection. This reliably prevents accidental needlestick injuries after the injection, when the user's attention is typically lower than before.

[0057] According to a further development of the invention, the privacy screen locking mechanism comprises a rotary disc which is rotatably arranged in the distal part about the longitudinal axis of the distal part between the locked and unlocked positions. The rotary disc has at least one through-hole, and the rotary disc with this through-hole is configured and arranged such that a locking projection of the privacy screen can be displaced through the through-hole in the unlocked position, with the locking projection abutting the rotary disc in the locked position, particularly from the distal side. The rotary disc thus provides a simple and reliable locking mechanism for the privacy screen.If the rotating disc is in the locked position, the passage opening is rotated away from the locking projection in such a way that the projection cannot be moved through the passage opening and therefore abuts the rotating disc, preventing the privacy screen from being moved from the rest position to the exposed position. In the release position, however, the rotating disc with the at least one passage opening is pivoted in such a way that it provides a path for the locking projection to move through the passage opening. The privacy screen can then be moved from the rest position to the exposed position, thus enabling injection to be carried out.

[0058] The through-hole is preferably designed as an open-edged recess in the turntable, in particular as a radial recessed area on an outer circumference of the turntable.

[0059] The locking projection is preferably ramp-shaped – sloping downwards in the distal direction – and arranged on a spring tongue or forming part of the spring tongue. This has the advantage that the shield can be moved from the exposure position back to the rest position even when the rotating disc is in the locked position. For example, if the shield locking mechanism – here the rotating disc – is moved from the release position to the locked position by the piston rod during its axial movement, this typically occurs while the shield is still in the exposure position. In particular, when the injection device is subsequently removed from a patient's skin, the shield is forced from the exposure position back to the rest position.The locking projection can then pivot radially outwards against a preload force of the spring tongue, of which it is a part or on which it is attached, and thus slide past the turntable, particularly along an outer circumferential line of the turntable, especially due to its ramp-like design. Conversely, however, precisely because of the ramp-like or wedge-shaped design of the locking projection, it cannot slide past the turntable in the locked position when an attempt is made to move the privacy screen from the rest position to the exposed position. In particular, the ramp-like design of the locking projection on the spring tongue allows it to move past the turntable from the proximal side to its distal side in the locked position, but not in the reverse direction.

[0060] In the distal part, at least two detent positions for the rotary disk are preferably provided, wherein the rotary disk engages in one of the detent positions in particular in the locking position on the one hand and in the release position on the other hand and is thus held securely with regard to its angular position.

[0061] According to a further development of the invention, the rotary disc has at least one drive surface configured to interact with a driver of the injection loading element, so that the rotary disc is rotated from the locked position to the released position when the injection loading element is screwed, in particular screwed, into the distal part. This provides a simple and reliable way to actuate the rotary disc by the injection loading element when it is screwed in.

[0062] The at least one driving surface is preferably formed on a driving projection that extends axially, particularly distally, from an end face of the rotating disk onto the rotary disk. Complementarily, the driver is preferably formed as a driving projection on the injection loading part, particularly on the functional sleeve, extending proximally from a distal end face of the injection loading part.

[0063] Preferably, the drive surface and the drive element together form a claw coupling.

[0064] Preferably, the rotary disk has two drive surfaces, in particular two drive projections, which are especially preferably diametrically opposed to each other. Correspondingly, the injection loading element preferably has two drivers, each of which interacts with one drive surface of the rotary disk.

[0065] Alternatively or additionally, the rotary disc preferably has at least one running surface on which an actuating structure of the piston rod can run, such that the rotary disc is rotated from the release position to the locked position when the piston rod is displaced in a specific direction, i.e., proximal or distal axially relative to the rotary disc. In this way, the displacement of the rotary disc from the release position to the locked position can be actuated by the piston rod in a simple and reliable manner.

[0066] The actuation structure is preferably designed as an actuator projection or actuator pin, wherein the actuator projection or actuator pin extends radially outwards from an outer circumferential surface of the piston rod.

[0067] Preferably, the rotary disk has two such run-off surfaces, the piston rod having two actuation structures, each actuation structure interacting with one of the run-off surfaces. The run-off surfaces and, correspondingly, the actuation structures are preferably arranged diametrically opposite each other.

[0068] In particular, the at least one run-off surface is designed such that the rotary disc is rotated when the piston rod with the actuating structure is axially displaced distally relative to the rotary disc, especially when the actuating structure runs along the run-off surface in the distal direction, and in particular when it slides. This means, in particular, that the rotary disc is preferably rotated from the release position to the locking position when an injection is effected by the piston rod and the pharmaceutical substance is ejected from the injection loading part.

[0069] A passage window is preferably arranged circumferentially next to the at least one runoff surface, through which the actuating structure can pass during a reverse axial displacement of the piston rod without displacing the turntable. In particular, the actuating structure can pass through the passage window when the piston rod is displaced axially in the proximal direction relative to the turntable. This prevents rotation of the turntable during a reverse axial displacement of the piston rod, especially a proximal displacement of the piston rod.Thus, the functions of locking on the one hand and unlocking on the other are separated with regard to the rotary disc: The rotary disc is unlocked when the injection loading part is screwed in, i.e., turned from the locked position to the release position; it is locked, i.e., turned from the release position to the locked position, when the piston rod is axially displaced relative to the rotary disc in a specific direction, in particular in the distal direction.

[0070] According to a further development of the invention, the injection device, in particular the distal part, has an adjustable stop for the movable shield. The shield preferably abuts the adjustable stop in the exposure position. The adjustable stop advantageously allows the penetration depth of the injection needle into the patient's body to be set, and in particular predefined. If the adjustable stop is designed such that the shield abuts the adjustable stop in the exposure position, the position of the shield relative to the distal part can be directly changed during the injection, thereby obviously influencing the penetration depth of the injection needle.

[0071] This is where those further developments and preferred configurations end, which preferably in combination with each other form the second embodiment.

[0072] The problem is also solved by providing an injection loading element configured for use in an injection device according to the invention or in an injection device according to one of the previously described embodiments. The injection loading element has a packaging receiving element in which a primary packaging element is held, wherein a pharmaceutical substance is arranged in the primary packaging element. The injection loading element is specifically configured to be received in the distal part of the injection device. The advantages of the injection loading element are particularly evident in connection with the advantages already explained in connection with the injection device.

[0073] The injection loading part is preferably designed as previously explained explicitly or implicitly in connection with the injection device.

[0074] According to a further development of the invention, the packaging receiving part comprises a functional sleeve and a locking element, wherein the primary packaging is received in the functional sleeve, and wherein the primary packaging is secured, preferably fixed, in the functional sleeve by the locking element. The functional sleeve is preferably configured to guide and hold the injection loading element in the distal part of the injection device. Alternatively or additionally—particularly in connection with the second embodiment—the functional sleeve is configured to unlock the privacy screen locking mechanism. Alternatively or additionally, the functional sleeve is preferably configured to release a needle guard for manual removal when the injection loading element is or is arranged in the distal part.

[0075] The fact that the primary packaging is received and secured within the functional sleeve means, in particular, that the primary packaging is held within the functional sleeve. This, in turn, means, in particular, that the primary packaging cannot fall out of the functional sleeve or be unintentionally detached from or separated from the functional sleeve.

[0076] The securing element is preferably designed as a clamping ring, a clip element or a clip ring, which is clamped or clipped to the functional sleeve when the primary packaging material is arranged in the functional sleeve in order to secure the primary packaging material in the functional sleeve, in particular to fix it.

[0077] According to a further development of the invention, the injection loading element has a needle guard that is detachably connected to the functional sleeve and conceals an injection needle of the primary packaging when the needle guard is connected to the functional sleeve. This has the advantage that the injection needle is concealed even when the injection loading element is not located in the distal part of the injection device. To perform an injection, the needle guard must be detached from the functional sleeve, in particular, it must be pulled off the functional sleeve.

[0078] The fact that the needle guard is detachably connected to the functional sleeve means, in particular, that it is directly connected to the functional sleeve, and / or that it is indirectly connected to the functional sleeve via the primary packaging. It can therefore also be directly connected to the primary packaging. However, since the primary packaging is in turn connected to the functional sleeve, the needle guard is then also at least indirectly connected to the functional sleeve.

[0079] The fact that the needle guard conceals the injection needle means, in particular, that it conceals it both visually and haptically, so that a user does not see the injection needle, thereby also preventing accidental needlestick injuries from touching the injection needle, since the injection needle is not visually or haptically accessible when the needle guard is connected to the functional sleeve.

[0080] According to a further development of the invention, the needle guard has an outer grip sleeve and an elastic protective element retractably arranged inside the grip sleeve. The injection needle is received in the elastic protective element when the needle guard is connected to the functional sleeve. The protective element can be made of, or consist of, pharmaceutical-grade rubber or a similar material. A user can grasp the needle guard by the outer grip sleeve and pull it off the functional sleeve when performing an injection. The needle guard with the outer grip sleeve preferably protrudes from the distal part and, in particular, also extends beyond the visor when the injection loading part is received in the distal part, so that a user can easily grasp the outer grip sleeve of the needle guard and pull the needle guard off the functional sleeve.

[0081] The fact that the elastic protective element is retractable within the handle sleeve means, in particular, that the elastic protective element is pulled away from the injection needle when the outer handle sleeve is pulled away from the functional sleeve. Specifically, the elastic protective element is thus carried along with the handle sleeve.

[0082] According to a further development of the invention, the injection loading element has at least one driver configured to interact with a drive surface of the rotary disc of the privacy screen locking mechanism, such that the rotary disc is rotated from its locked position to the released position when the injection loading element is inserted into the distal part. The driver is preferably designed as an axial projection on the injection loading element, particularly on the functional sleeve, extending in a proximal direction. Preferably, the injection loading element has two such drivers. These two drivers are preferably arranged diametrically opposite each other on the injection loading element.

[0083] According to a further development of the invention, it is preferably provided that the needle guard is locked to the functional sleeve in such a way that the needle guard can only be separated from the functional sleeve when the injection loading element is arranged in the distal part. Advantageously, the needle guard cannot then be accidentally separated from the functional sleeve as long as the injection loading element is arranged outside the distal part and thus, as intended, no injection is to be carried out. In particular, this method very effectively prevents needlestick injuries to the user.

[0084] The fact that the needle guard is locked to the functional sleeve also implies that, in a preferred embodiment, the needle guard is clamped to the functional sleeve. A positive fit between the needle guard and the functional sleeve is therefore not strictly necessary. Nevertheless, such a positive fit can be provided.

[0085] The fact that the needle guard can only be separated from the functional sleeve when the injection loading part is located in the distal part means, in particular, that only then is a non-destructive separation of the needle guard from the functional sleeve possible – especially without the use of force.

[0086] Preferably, the functional sleeve has at least one elastically radially outwardly pre-tensioned spring arm, preferably two elastically radially outwardly pre-tensioned spring arms, wherein the at least one spring arm holds the needle guard. The at least one spring arm is forced radially inward against its pre-tension, thereby releasing the needle guard, when the injection loading element is positioned in the distal part. In particular, the spring arm is then forced radially inward by an inner circumferential surface of the distal part.

[0087] At least one spring arm is preferably designed as a clamping arm or locking arm.

[0088] Preferably, at least one actuating lug is arranged on the spring arm. This actuating lug then interacts with the distal part, such that the spring arm is forced radially inwards against the preload when the injection loading part is arranged in the distal part.

[0089] The invention will be explained in more detail below with reference to the drawing. The drawing shows: Figure 1 shows a first embodiment of an injection device and a first embodiment of an injection loading part for the injection device; Figure 2 shows a detailed longitudinal section view of the injection device with the loading part according to Figure 1 in a first functional position; Figure 3 the injection device and the charging part according to Figure 1 in a second functional position; Figure 4 the injection device and the charging part according to Figure 1in a third functional position; Figure 5 a second embodiment of an injection device and a second embodiment of an injection loading part; Figure 6 a detailed longitudinal sectional view of the injection device with the injection loading part according to Figure 5 Figure 7 shows a detailed longitudinal section of the injection device with the injection loading part according to Figure 5 in a first functional position; Figure 8 the injection device and the injection loading part according to Figure 5 in a second functional position; Figure 9 shows a further detailed longitudinal section view of the injection device and the injection loading part according to Figure 5 , and Figure 10 a detailed cross-sectional view of the injection device and the injection loading part according to Figure 5 .

[0090] Fig. 1Figure a) shows a first embodiment of an injection device 1 and Figure b) shows a first embodiment of an injection loading part 3, which is configured for use with the injection device 1, in particular for use in the injection device 1.

[0091] The injection device 1 is designed for injecting a pharmaceutical substance and has a proximal part 5, also referred to as the back end. The proximal part 5, in particular, has an internal drive 7 (not visible to the observer and shown only schematically here) designed to effect the injection. The drive 7 can, for example, be an electric motor that is driven by a Figure 1 The piston rod (not shown) acts to displace the piston rod axially. The drive 7 can be powered by an accumulator or a battery. It is possible that the drive 7 is operatively connected to the piston rod via a gearbox.

[0092] The injection device 1 also preferably includes a control unit which is located in Figure 1 also not shown and is arranged internally in the proximal part 5. The control unit is configured to control the drive 7; generally, it is preferably configured to control the injection device 1 and to perform an injection. It is possible that the control unit is connected to at least one sensor in order to perform the injection depending on at least one parameter detected by the sensor.

[0093] The proximal part 5 has an actuating button 9, which is operatively connected to the control unit and preferably configured such that the injection can be started and / or stopped by actuating the actuating button 9.

[0094] Furthermore, the proximal part 5 preferably has a display device 11, in particular a display, which is preferably also connected to the control unit and configured to display instructions to the user, in particular a step-by-step guide, parameter values, and / or the injection process.

[0095] It is possible that the proximal part 5 is designed as the conventional backend of a standard injection pen.

[0096] The injection device 1 also has a distal part 13, also referred to as a front end, which is designed to receive the injection loading part 3. The distal part 13 is designed such that the injection loading part 3 can be inserted axially into the distal part 13.

[0097] An axial direction here is in particular a direction of the longest extent of the injection device 1 and preferably also of the distal part 13, in particular one extending in Figure 1a) Vertically extending direction. A circumferential direction encompasses the axial direction concentrically. A radial direction is perpendicular to the axial direction.

[0098] The injection device 1 also has a privacy screen 15, which is designed and arranged such that a Figure 1 The injection needle of the injection loading part 3 (not shown) is concealed from the user during use of the injection device 1. This makes the injection process more psychologically comfortable. At the same time, the visual shield 15 preferably provides puncture protection, preventing the user from accidentally injuring themselves on the injection needle.

[0099] The term "distal" here refers to a direction on the injection device 1 that is intended to face an injection site, in particular on the skin of a patient, i.e. in Figure 1a) especially to the lower end; the term "proximal" in contrast denotes a direction away from the injection site on the injection device 1, in Figure 1a ) therefore, in particular the upper end of the injection device 1.

[0100] In the first embodiment, the distal part 13 is detachably connected to the proximal part 5. For this purpose, a connection mechanism is provided, which may, for example, be designed in the manner of a bayonet fitting.

[0101] The injection device 1 preferably has the drive 7 as its only drive. The injection device 1 is preferably configured such that at least one other mechanical function of the injection device is effected by the displacement of the piston rod, in particular the insertion of the injection needle under the shield 15, and / or the locking and / or unlocking of the injection loading part 3 and / or the shield 15.

[0102] The injection device 1 is preferably designed as a pen or autoinjector.

[0103] The injection loading part 3 has a packaging receiving part 17 in which a Figure 1b ) concealed primary packaging. The pharmaceutical substance for injection is arranged within the primary packaging. The pharmaceutical substance can be injected from the injection port 3 when the injection port 3 is positioned in the distal part 13.

[0104] The packaging receiving part 17 preferably has a functional sleeve 19 in which the primary packaging material is received. Furthermore, the packaging receiving part 17 has a Figure 1 not shown, securing element by which the primary packaging material is secured, in particular fixed, in the functional sleeve 19.

[0105] The injection loading part 3 has a needle guard part 21 which is detachably connected to the functional sleeve 19 and conceals the injection needle of the primary packaging when the needle guard part 21 is connected to the functional sleeve 19.

[0106] Fig. 2 shows a detailed longitudinal section view of the first embodiment of the injection device 1 with the first embodiment of the injection loading part 3 according to Figure 1 , wherein the injection loading part 3 is included in the distal part 13.

[0107] Identical and functionally equivalent elements are designated with the same reference symbols in all figures, so that reference is made to the preceding description in each case.

[0108] In the sectional view of Figure 2A primary packaging element 23, designed in particular as a syringe or cartridge, is visible within the functional sleeve 19. The primary packaging element 23 has an injection needle 25, which is firmly connected here to a packaging element body 26 of the primary packaging element 23, in particular bonded to a distal end of the packaging element body 26. A pharmaceutical substance (not shown) is arranged in the primary packaging element 23, as well as a plug or piston 27 that is axially displaceable within the primary packaging element 23, by the displacement of which the pharmaceutical substance can be expelled from the primary packaging element 23 in a manner known per se.

[0109] A locking element 29 is connected to the functional sleeve 19, by which the primary packaging material 23 is held securely and stably in the functional sleeve 19. The locking element 29 is preferably designed as a clamping ring, a clip, or a clip ring.

[0110] The needle guard 21 has an outer grip sleeve 31 and an elastic protective element 33, preferably made of pharmaceutical-grade rubber, which is retractably arranged inside the grip sleeve 31. The injection needle 25 is held in the elastic protective element 33 when the needle guard 21 is connected to the functional sleeve 19. The user can grasp the needle guard 21 by the outer grip sleeve 31 and pull it off the functional sleeve 19. Simultaneously, the elastic protective element 33 is pulled off the injection needle 25, exposing it so that an injection is possible. The grip sleeve 31 projects, particularly distally, beyond a distal end face 35 of the distal part 13, allowing it to be easily grasped and pulled off by the user.Even after removing the handle sleeve 31 and the elastic protective element 33, the injection needle 25 is at least initially still arranged within the visual shield 15 and is thus optically and preferably also haptically hidden from the user.

[0111] In the first embodiment, the privacy screen 15 is rigidly attached to the distal part 13. In particular, the privacy screen 15 is formed by the distal part 13. Here, the privacy screen 15 is specifically part of a circumferential wall 61 of the distal part 13.

[0112] A proximal end face 37 of the distal part 13 has a loading opening 39 through which the injection loading part 3 can be inserted into the distal part 13. For this purpose, the user can first detach the distal part 13 from the proximal part 5 and then insert the injection loading part 3 into the distal part 13. Afterwards, the distal part 13 can be reconnected to the proximal part 5.

[0113] As in Figure 2As can be seen, in the state connected to the proximal part 5, a piston rod 41 of the proximal part 5, which can be displaced in the axial direction by the drive 7, also protrudes through the loading opening 39 into the distal part 13.

[0114] A spring assembly 43, preferably designed as a helical spring, is arranged in the distal part 13. The injection loading part 3 is supported by a flange 44 at a proximal end of the spring assembly 43. The spring assembly 43, in turn, is supported at its distal end by a shoulder 45 of the distal part 13. The injection loading part 3 is in Figure 2The device is shown in a protective position. In this position, the injection needle 25 is completely enclosed within the distal part 13 and thus, in particular, within the protective shield 15. The injection loading part 3 can be displaced distally within the distal part 13 against the spring force of the spring assembly 43 into an injection position, with the injection needle 25 partially protruding from the distal part 13 in this position, specifically projecting beyond the distal end face 35. An injection can be performed in this injection position. As will be explained below, the displacement of the injection loading part 3 within the distal part 13 is effected by the piston rod 41.

[0115] The injection device 1 has a locking element 47 that can be inserted into the distal part 13 through the loading opening 39. The locking element 47 is designed to bear against a proximal contact surface 49 of the injection loading part 3. The locking element 47 has a base body 51 and at least one locking element 53 pivotally attached to the base body 51; in the embodiment shown here, there are two locking elements 53 pivotally attached to the base body 51 in a diametrically opposed position. The function of the locking element 47 in connection with the execution of an injection is described below with reference to the Figures 3 and 4 explained in more detail.

[0116] The locking element 47 can be attached to the proximal part 5 in a way that allows it to be moved and displaced relative to the proximal part 5, such that the piston rod 41 can also be displaced relative to the locking element 47. This design has the advantage that the locking element 47 is easy to handle and cannot be lost. Alternatively, the locking element 47 can be designed as a separate element, which is inserted through the loading opening 39, particularly after the injection loading element 3 has been inserted into the distal part 13. It can then be removed from the distal part 13 through the loading opening 39 in order to remove the injection loading element 3 after the injection has been carried out.

[0117] The locking elements 53 are L-shaped, with an inner leg 55 and an outer leg 57, wherein the locking elements 53 are pivotably hinged to the base body 51 in the area of ​​a connection or intersection between the inner leg 55 and the outer leg 57. Preferably, the inner leg 55 and the outer leg 57 are perpendicular to each other.

[0118] The distal part 13 has at least one bolt opening 59, in particular two diametrically opposed bolt openings 59, which are designed in particular as windows in the circumferential wall 61 of the distal part 13. One of the bolt openings 59 is also in Figure 1a ) shown.

[0119] In Figure 2The locking element 47 is shown in a first axial position within the distal part 13, which is also referred to as the unlocking position, wherein the locking element 47 is arranged axially away from the locking openings 59. In this first axial position and unlocking position, the locking elements 53 are pivoted into the base body 51.

[0120] The locking element 47 has an axial through-opening 63 for the piston rod 41. The through-opening 63 extends through the base body 51 such that the piston rod 41 can pass through the base body 51 through the through-opening 63 at least in one functional position of the locking element 47.

[0121] In the Figure 2 In the first axial position shown, i.e. the unlocking position, the locking elements 53 - here with the inner legs 55 - engage in the through-opening 63, so that it is blocked for the piston rod 41.

[0122] The locking element 47, together with the injection loading element 3, can therefore be displaced by the piston rod 41 and is carried along by it when the piston rod 41 is displaced distally. At the same time, the primary packaging element 23 with the injection needle 25 is also displaced distally.

[0123] Fig. 3 Figure 1 shows the first embodiment of the injection device 1 with the injection loading part 3 with the needle guard part 21 removed and in a functional position in which the locking part 47 has been displaced by the piston rod 41 from the first axial position towards a second axial position, this second axial position also being referred to as the locking position. However, in Figure 3The locking element 47 has not yet reached the second axial position. However, it is evident that the injection needle 25 already protrudes beyond the sight shield 15 and, in particular, the distal end face 35, and that the spring assembly 43, in comparison to Figure 2 is compressed. During the axial displacement of the locking part 47, the locking elements 53 enter the area of ​​the locking openings 59. As in Figure 3 As shown, they can swivel radially outwards in this area.

[0124] Fig. 4Figure 1 shows the first embodiment of the injection device 3 with the injection loading part 3 in a further functional position, namely now in the second axial position of the locking part 47, that is, in the locked position, whereby the injection loading part 3 is now also arranged in the injection position. In the second axial position of the locking part 47, the locking elements 53 pivot out at the level of the locking openings 59 and engage through the locking openings 59 – in particular with the outer legs 57. At the same time, the locking elements 53 release the passage opening 63 for the piston rod 41, in particular by the inner legs 55 pivoting out of the passage opening 63 at least far enough that the piston rod 41 can pass between the inner legs 55. Thus, the piston rod 41 can also pass through the passage opening 63 and be displaced relative to the locking part 47.With the injection loading part 3 held in its axial position relative to the distal part 13, the piston rod 41 can now displace the piston 27 within the primary packaging 23 in a distal direction relative to it, thereby ejecting the pharmaceutical substance from the primary packaging 23. In this way, the injection is carried out in the injection position of the injection loading part 3.

[0125] An axial displacement of the injection loading part 3 relative to the distal part 13 is blocked or at least limited by the locking elements 53, which extend through the locking openings 59. This applies both in the distal direction, unless further distal displacement of the injection loading part 3 is already limited by the spring assembly 43, which is fully engaged, and in the proximal direction. This prevents the injection loading part 3 from being retracted within the distal part 13 under the spring force of the spring assembly 43 and thus potentially being expelled from the patient's skin, due to the reduced friction caused by the sliding of the piston 27 in the primary packaging 23. The precise position of the locking elements 53 within the locking openings 59 – in the axial direction – is determined during injection primarily by the sliding friction of the piston 27 in the primary packaging 23 on the one hand, and the restoring force of the spring assembly 43 on the other.

[0126] If the piston rod 41 is retracted in a proximal direction, particularly after injection is complete, and thereby disengages from the locking elements 53, the injection loading part 3, together with the locking part 47, is forced in a proximal direction by the force of the spring assembly 43. The locking elements 53 then pivot back into the base body 51, and the injection loading part 3 is moved back into its protective position by the spring assembly 43.

[0127] Fig. 5 Figure a) shows a second embodiment of an injection device 1 and figure b) shows a second embodiment of an injection loading part 3, which is configured to be used with the injection device 1, in particular in the injection device 1 according to the second embodiment.

[0128] In this second embodiment of the injection device 1, the screen 15 is movably held on the distal part 13, in particular axially movably, especially between a rest position and an exposure position. The screen 15 is in Figure 5 Shown in the resting position.

[0129] Preferably, in this second embodiment of the injection device 1, the distal part 13 is permanently connected to the proximal part 5. However, an embodiment in which the distal part 13 is detachably connected to the proximal part 5 is also possible, for example for maintenance or repair purposes.

[0130] The injection loading part 3, as in the first embodiment, also has, according to the second embodiment, the packaging receiving part 17 with the functional sleeve 19 and the securing part 29, which here is designed as a clip ring and engages, in particular with clip projections, in clip recesses 65 of the functional sleeve 19, of which only one faces the viewer and is therefore shown. The primary packaging 23 is arranged in the functional sleeve 19 of the packaging receiving part 17 and secured there by the securing part 29.

[0131] The injection loading part 3 according to the second embodiment has at least one driver 67, here two diametrically opposed drivers 67, the function of which will be explained below. The drivers 67 are designed in particular as proximal projections on the functional sleeve 19.

[0132] In the second embodiment, the needle guard 21 is preferably locked to the functional sleeve 19 such that the needle guard 21 can only be separated from the functional sleeve 19 non-destructively when the injection loading element 3 is arranged in the distal part 13. For this purpose, the functional sleeve 19 has, in particular, at least one, and here two, radially outwardly elastically pre-tensioned spring arms 69, which hold the needle guard 21 locked in place. An actuating lug 71 is arranged on each of the spring arms 69. When the injection loading element 3 is inserted into the distal part 13, the actuating lugs 71 are forced radially inward by the circumferential wall 61 of the distal part 13, whereby the spring arms 69 release the needle guard 21 so that it can be pulled off the functional sleeve 19.

[0133] Returning to Figure 5a) a viewing window 73 is preferably formed in the circumferential wall 61 of the distal part 13, through which the user can observe the injection progress and / or the fill level of the primary packaging material 23, especially during the execution of an injection.

[0134] Fig. 6 shows a detailed longitudinal section view of the second embodiment of the injection device 3 with the injection loading part 3 included in the distal part 13.

[0135] The representation according to Figure 6 Figure 1 shows that the privacy screen 15 is pre-tensioned into the rest position by a pre-tensioning device 75. The pre-tensioning device 75 is arranged, in particular, within the distal part 13 and is preferably designed as a helical spring. The privacy screen 15 can be displaced axially and in the proximal direction against the pre-tension of the pre-tensioning device 75 from the rest position to the exposed position.

[0136] In Figure 6It is further shown that the injection device 1 preferably has an adjustable stop 77 for the movable screen 15. The screen 15 preferably abuts the adjustable stop 77 in the exposure position. In particular, the distal part 13 has a stop sleeve 79 on its outer circumference, which has the stop 77 in particular as an inner radial projection, especially as an inner annular collar 78, or as an outer annular collar, or simply as a distal end face 80, wherein the screen 15 abuts the stop 77 with a radially outer annular collar in the exposure position. The stop 77 need not have a planar shape; in particular, at least one stop point can also be provided. An axial position of the stop sleeve 79 relative to a sleeve body 81 of the distal part 13 is changeable, whereby the axial position of the stop 77 is changed simultaneously.Preferably, the stop sleeve 79 and the sleeve body 81 have complementary, meshing threaded sections, in particular the sleeve body 81 having an external thread and the stop sleeve 79 having a corresponding internal thread. The threaded sections preferably form a self-locking thread. By adjusting the stop sleeve 79, the position of the visual shield 15 relative to the distal part 13 in the exposure position during injection is changed, and thus the penetration depth of the injection needle 25 into the patient's body is also altered.

[0137] In the second embodiment of the injection device 1, the distal end face 35 of the distal part 13 has the loading opening 39 through which the injection loading part 3 can be inserted into the distal part 13. In particular, a distal end face 83 of the shield 15 has a corresponding shield loading opening 85 through which the injection loading part 3 can be inserted into the interior of the distal part 13. The injection loading part 3 is thus inserted into the distal part 13, in particular through the shield 15. The injection loading part 3 is preferably rotatable, and in particular screwable, into the distal part 13.For this purpose, the distal part 13 preferably has a screw means, in particular at least one thread 87, into which the injection loading part 3 preferably engages with at least one screw-in projection, preferably with two screw-in projections on both sides, so that the injection loading part 3 can be screwed into the at least one thread 87.

[0138] Preferably, the injection loading part 3 can be axially fixed in the distal part 13. For this purpose, the at least one thread 87 can, in particular, have a thread run-out.

[0139] The distal part 13 has a screen locking mechanism 89, which is configured to lock the screen 15 against axial displacement between the rest position and the exposure position in a locked position of the screen locking mechanism 89, i.e., to lock it, and to release this displacement in a release position. The screen locking mechanism 89 is preferably configured to be unlocked when the injection loading part 3 is inserted, in particular by turning or screwing it into, the distal part 13, and to be locked by the piston rod 41, in particular during its axial displacement, especially in the distal direction. For this purpose, the screen displacement mechanism 89 preferably has a rotating disk 91, which rotates around a Figure 6The vertical longitudinal axis of the distal part 13 is rotatably arranged within the distal part 13 between the locking position and the release position. In the release position, a locking projection 93 of the privacy screen 15 can be moved from the distal side of the rotary disk 91 to its proximal side, with the locking projection 93 abutting the distal side of the rotary disk 91 in the locking position. Movement of the privacy screen 15 into the exposure position is then prevented.

[0140] Fig. 7Figure 1 shows a further longitudinal section detail of the second embodiment of the injection device 1 with the injection loading part 3 in a first functional position, namely the release position of the privacy screen locking mechanism 89. By turning or screwing the injection loading part 3 into the distal part 13, the rotary disk 91 has been rotated into the release position, so that the privacy screen 15 with its locking projection 93 is displaced in the proximal direction against the preload force of the preloading device 75 into the exposure position. In comparison to Figure 6The locking projection 93 is now no longer located on the distal side of the rotary disk 91, but rather on its proximal side. This exposes the injection needle 25, allowing an injection to be performed by distally displacing the piston rod 41. It should be noted that in this second embodiment, the injection loading element 3 is not displaced axially for the purpose of performing the injection.

[0141] Fig. 8 shows one of the representations of Figure 7The corresponding illustration shows the second embodiment of the injection device 1 with the injection loading part 3 in a second functional position. It is shown here that by moving the piston rod 41 axially to carry out the injection, the rotary disk 91 is rotated into the locking position by the piston rod 41. The piston rod 41 has an actuation structure 95, here in the form of two actuator pins 97, wherein the actuation structure 95 rotates the rotary disk 91 towards its locking position when the actuation structure 95 passes the rotary disk from the proximal side towards the distal side.

[0142] In contrast, no further rotation of the rotary disc 91 occurs when the piston rod 41 and, in particular, the actuating structure 95 are moved back from the distal side to the proximal side of the rotary disc 91. Nevertheless, after the injection has ended, the needle guard 15 can return from the exposure position to its rest position driven by the preload force of the preloading device 75, since the locking projection 93 is arranged on a spring tongue 94 and is ramp-shaped, so that it can deflect radially outwards in contact with the rotary disc 91 and thus pass the rotary disc 91 from the proximal direction towards the distal side.

[0143] Fig. 9Figure 1 shows a further detailed representation of the second embodiment of the injection device 1 with the injection loading part 3. This representation clearly shows that the rotary disk 91 has at least one drive surface 99, preferably two drive surfaces 99, particularly diametrically opposed to each other, wherein the drive surface 99 is configured to interact with one of the drivers 67 of the injection loading part 3, such that the rotary disk 91 is rotated from the locked position to the released position when the injection loading part 3 is screwed into the distal part 13. The drive surface 99 is particularly arranged on a drive projection that extends distally along the rotary disk 91. In particular, the driver 67 and the drive surface 99 preferably interact in the manner of a claw coupling.

[0144] Fig. 10Figure 1 shows a detailed cross-sectional view of the second embodiment of the injection device 1 with the injection loading part 3, wherein the cross-sectional plane is arranged just above, i.e. proximally, the rotary disk 91.

[0145] This illustration makes it clear, firstly, that the turntable 91 has at least one through-hole 101, in particular two diametrically opposed through-holes 101, through which, in the release position, which is in Figure 10 As shown, the barrier projection 93 of the privacy screen 15 – here two diametrically opposed barrier projections 93 – can be moved through it. The passage openings 101 are designed in particular as radial, edge-open openings.

[0146] Furthermore, the presentation of Figure 10It is evident that the rotary disk 91 preferably has at least one run-off surface 103, here in particular two, preferably diametrically opposed, run-off surfaces 103, wherein the actuating structure 95, in particular the actuator pins 97, of the piston rod 41 can run off on the run-off surfaces 103 when the piston rod 41 is displaced in a distal direction. The rotary disk 91 is rotated from the release position to the locking position when the piston rod 41 is displaced axially relative to the rotary disk 91 in a distal direction, in particular when the actuating structure 95, in particular the actuator pins 97, pass the rotary disk from the proximal side towards the distal side.

[0147] Preferably, the injection loading part 3 is also rotated back in the threaded outlet by the corresponding angle, whereby, due to the design of the threaded outlet of the at least one thread 87, preferably no or at most a slight axial displacement of the injection loading part 3 relative to the distal part 13 occurs. Rotation of the injection needle 25 in the patient's body is preferably at least largely avoided by the fact that the primary packaging element 23 is preferably freely rotatable in the functional sleeve 19.

[0148] Circumferentially, passage windows 105 are formed next to the drainage surfaces 103, through which the actuating structure 95 can be moved from the distal side back to the proximal side – preferably without contacting the rotary disc 91 – when the piston rod 41 is retracted. Thus, the rotary disc 91 does not rotate when the piston rod 41 is retracted in the proximal direction after the injection.

[0149] In Figure 10 It is also shown that the rotary disk 91 preferably has a locking lug 107 with which it can engage in corresponding locking recesses 109, 111 in the circumferential wall 61 of the distal part 13, on the one hand in the release position and on the other hand in the locking position. A first locking recess 109 is shown in Figure 10The release position is shown. A second detent recess 111 is assigned to the locking position. In particular, the detent recess 109 and the engagement of the detent lug 107 therein also serve to provide mechanical-haptic – and possibly also acoustic – feedback to the user that the injection loading part 3 is fully, i.e., ready for injection, arranged in the distal part 13.

[0150] Thus, it also becomes clear that in the direction of the viewer's gaze from Figure 10 The rotary disc 13 is seen being rotated counterclockwise from the locked position to the release position when the injection loading part 3 is being screwed in, while then, when the actuating structure 95 runs on the run-off surfaces 103, it is rotated clockwise from the release position back to the locked position.

Claims

1. An injection device (1) for injecting a pharmaceutical substance, having - a proximal part (5) which has a drive (7) to implement an injection, and having - a distal part (13) which is configured to accommodate an injection loading part (3), which has a packaging means receiving part (17) and a primary packaging means (23), which is held in the packaging means receiving part (17) and in which a pharmaceutical substance is received, wherein the pharmaceutical substance can be injected from the injection loading part (3) when the injection loading part (3) is arranged in the distal part (13), wherein - the distal part (13) is designed in such a way that the injection loading part (3) can be inserted axially into the distal part (13), wherein - the injection device (1) has a screen (15) which is designed and arranged in such a way that an injection needle (25) of the injection loading part (3) is concealed from a user during use of the injection device (1), wherein - the screen (15) is additionally designed as a puncture protection and is arranged and designed in such a way that the injection needle (25) of the injection loading part (3) is concealed haptically from the user during use of the injection device (1) apart from the actual injection, wherein - a distal end face (37) of the distal part (13) has a loading opening (39) through which the injection loading part (3) can be inserted into the distal part (13), wherein - the injection device has a locking part (47) which can be inserted through the loading opening (39) into the distal part (13) and which is configured to contact a proximal contact surface (49) of the injection loading part (3), the locking part (47) having a base body (51) and at least one locking element (53) which is pivotably articulated on the base body (51), characterized in that the locking element (53), in a first axial position inside the distal part (13), remote from a locking opening (59) which is formed in a peripheral wall (61) of the distal part (13), is pivoted into the base body (51), wherein the locking element (53) is configured to pivot out, in a second axial position inside the distal part (13), at the position of the locking opening (59), and pass through the locking opening (59) in order to block an axial displacement of the injection loading part (3), and wherein - the locking part (47) has an axial passage opening (63) for a piston rod (41) assigned to the drive (7), the at least one locking element (53), in the first axial position, engaging in the passage opening (63), such that the passage opening (63) is blocked for the piston rod (41) and the locking part (47) can be displaced by the piston rod (41), wherein the locking element (53), in the second axial position, clears the passage opening (63), such that the piston rod (41) can pass through the passage opening (63) and be displaced relative to the locking part (47).

2. The injection device (1) according to claim 1, characterized in that the injection device (1) has the drive (7) of the proximal part (5) as the only drive (7), the drive (7) acting in particular on a piston rod (41) to axially displace the piston rod (41), the injection device (1) preferably being configured in such a way that at least one other mechanical function of the injection device (1) is additionally realized by the displacement of the piston rod (41).

3. The injection device (1) according to any of the preceding claims, characterized in that the injection device (1) is designed as a pen or as an auto-injector.

4. The injection device (1) according to any of the preceding claims, characterized in that the distal part (13) is detachably connected to the proximal part (5).

5. The injection device (1) according to any of the preceding claims, characterized in that the screen (15) is rigid on the distal part (13), and is preferably formed by the distal part (13).

6. The injection device (1) according to any of the preceding claims, characterized in that a spring device (43) is arranged in the distal part (13), against which the injection loading part (3) rests, and against the spring force of which the injection loading part (3) can be displaced in the distal part (13) in the distal direction for performing an injection when the injection loading part (3) is arranged in the distal part (13).

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