DEVICE AND METHOD FOR DISTRIBUTING AT LEAST ONE SUBSTANCE

Description

TECHNICAL AREA

[0001] The present invention relates to a device and a method for administering at least one substance, in particular to a patient. More precisely, the present invention relates in particular to a device and a method for the self-injection of at least one substance by the user, usually the patient, wherein the device according to the invention can also be referred to as an autoinjector and the method according to the invention as self-injection using the device according to the invention, i.e., using the autoinjector. An autoinjector here typically corresponds to a medical instrument used for administering a medical substance, usually in liquid formulation / dosage form, by parenteral injection.Autoinjectors are traditionally used for treatment by injection of the medicinal substance in circumstances where the injection of a pharmaceutically active agent is desired even in the absence of a physician or other healthcare professional, for example, in emergency situations where the injectable agent needs to be administered as quickly as possible. When using an autoinjector, the injection is usually performed by the user / patient themselves, but can also be performed by a third party, for example, if the patient is no longer able to administer the autoinjector themselves. BACKGROUND OF THE INVENTION

[0002] When administering liquid formulations of medicinal substances or pharmaceutical agents, it is usually necessary to deliver precisely defined amounts of the substance to a patient. These substances, typically medications, often need to be injected into the patient's body. Parenteral injections are usually administered using syringes, drug pens, or drug pumps. However, there are also many emergency situations where it is desirable to treat a patient with a liquid medication or a liquid solution. Even if circumstances in such a situation preclude an intravenous injection, it can be essential to administer a drug solution by injection as quickly as possible.However, the various substances that need to be injected, depending on the type of emergency, usually differ significantly. For example, commercially available insulin, even in liquid form, can be stored for extended periods, carried by the user, and then injected directly into the body as needed without significant preparation. In contrast, preparations that cannot be stored in liquid form for extended periods require more stringent precautions before or during administration. For instance, biotechnologically produced drugs are often only stable for extended periods in freeze-dried or lyophilized form. Due to their typically powdery solid state, they cannot be administered by parenteral injection and must be converted into an injectable liquid form before administration.Such lyophilisates are dissolved in an injection solution, such as an aqueous saline solution, only shortly before administration, then drawn into a syringe and subsequently injected. However, this procedure may also be necessary for preparations that require mixing two liquids. In emergency situations, the problem is usually that the user is either already in shock or cannot afford to lose much time administering the drug. Accordingly, manually preparing the injection solution with the lyophilisate, drawing the solution into a syringe, and then injecting it can take too long or require overly complex procedures, ultimately hindering the injection of the often life-saving drug.

[0003] As a solution to the problem described above, automatic injection devices or autoinjectors have been used for some time. These devices can generally be stored safely before use and carried by the user / patient. They are usually safe and easy to handle and typically contain the correct pre-set dose of the substance to be injected in liquid form, tailored to the specific emergency or the user's individual medical condition. For example, WO 1986 / 006965 A1 describes an automatic injection device that allows a patient to reconstitute and administer a lyophilisate themselves.The operation of the injection device described herein is such that a diluent is mixed with a dry drug component by means of a predetermined manual actuation procedure. Subsequently, a second manual actuation procedure must be performed to insert an injection needle into the patient's muscle tissue and inject the liquefied drug through the injection needle into the muscle tissue. An embodiment described herein shows, in particular, an arrangement of two carpules, each with a spring-operated stopper. By turning a safety key and additionally releasing a first pin, the stopper of the first carpule transfers a liquid into the other carpule, in which the liquid is then mixed with the lyophilisate by shaking. By releasing a second pin, the stopper of the second carpule is then moved by the spring, thereby transferring the mixture.The solution of liquid and lyophilisate is dispensed through the injection needle, which is exposed by the same actuation. However, the injection device described here, with its two separate cartridges, has a significant disadvantage: the two cartridges are essentially already in contact with each other, thus compromising sterile transport of the lyophilisate within the device. Furthermore, the two cartridges cannot be exchanged or replaced separately before use while maintaining the sterility of their respective contents. Consequently, with this injection device, expiration of either the lyophilisate or the diluent necessitates a complete replacement of the entire device.

[0004] In view of the aforementioned problems of the prior art, the object of the present invention is therefore to provide a device and a corresponding method for dispensing at least one substance that overcomes the disadvantages of the prior art, preferably with simplified handling. This relates in particular to the automatic mixing of two substances located in two different containers while maintaining their respective sterility. However, depending on the embodiment, the overall handling of the device during auto-injection of the substance should also be simplified, with the auto-injection being made less painful, gentler, and safer by the combined triggering of various piston springs. SUMMARY OF THE INVENTION

[0005] The aforementioned problems of the prior art are solved according to the present invention by means of a device for dispensing a substance and by means of a corresponding method as described in the attached claims.

[0006] More precisely, the present invention provides a device for delivering at least one substance, wherein the substance to be delivered consists of a mixture of two other substances, namely a first substance containing at least one pharmaceutically active ingredient and a second substance which is in liquid form and, when mixed with the first substance, forms an injectable substance.

[0007] The first substance can be a pure pharmaceutically active ingredient or a mixture of a pure pharmaceutically active ingredient and one or more other chemical (especially pharmaceutically acceptable) compounds, wherein the first substance can be in liquid or solid form. Preferably, the first substance is in solid form, particularly in amorphous form. A lyophilisate is especially preferred. The first substance can optionally contain one or more other pharmaceutically active ingredients. It is preferred that the first substance does not contain any other pharmaceutically active ingredient.

[0008] The second substance may be a liquid consisting of only one (particularly pharmaceutically acceptable) chemical compound, or a liquid or emulsion consisting of a mixture of two or more (particularly pharmaceutically acceptable) chemical compounds, such as a solution, for example, an aqueous saline solution or the like. If the second substance is a liquid, it is also referred to as the resolving liquid. A reconstitution solution for dissolving a lyophilisate is particularly preferred. The second substance may optionally contain one or more further pharmaceutically active ingredients. It is preferred that the second substance does not contain any further pharmaceutically active ingredients.

[0009] The substance to be released, resulting from mixing the first and second substances, can be a liquid or an emulsion, in particular a solution.

[0010] The delivery of the substance to be dispensed is preferably automatic, in the sense of an autoinjector, and is particularly directed to a patient, such as the user of the device according to the invention. The device according to the invention comprises a first container containing a first substance, and is provided with a first piston and a so-called first piston rod connected thereto, wherein the first container is movably arranged within the device, i.e., it can move within the device at least in its longitudinal direction or along its longitudinal axis. The first piston and the first piston rod are preferably formed in one piece.The device according to the invention further comprises a second container containing a second substance, which is provided with a second piston and a so-called second piston rod connected thereto, wherein the second container is also movably arranged within the device, i.e., it can also move within the device at least in its longitudinal direction or along its longitudinal axis. The second piston and the second piston rod are preferably formed in one piece. The preferably cylindrical containers can be movably guided within the device, for example, by guide rails or guide walls in the device in the respective longitudinal direction of each container, i.e., along the axial extent of each container, wherein the device accordingly limits the maximum axial movement of each container.To prevent the containers from interfering with each other's movement, they can be arranged essentially parallel to each other, and in particular, aligned in the same direction, within the device. This design allows for a wide range of options regarding the type of second container and its positioning relative to the first, resulting in a more compact and ergonomic device compared to the prior art. This device offers improved handling and is easier for the patient to carry. The first and second containers can be standard cartridges or vials. Such containers are well-established in the prior art and, particularly in the case of pharmaceuticals, which are typically subject to approval and registration procedures, meet regulatory requirements.

[0011] The device according to the invention further comprises an injection device for the final injection of the at least one substance, i.e., the contents of the two containers, into the patient, and a piping device for directing the contents of the second container to the first container and for directing the contents of the first container to the injection device. The injection device can be suitable for subcutaneous, intramuscular, intravenous, intra-arterial, intra-articular, intracardiac, intradermal, intraosseous, intraperitoneal, intrapulmonary, intrathecal, intravitreal, or intraceliac (preferably subcutaneous or intramuscular) administration. Subcutaneous administration is particularly preferred.The injection device may be a simple injection cannula or a more complex structure, such as that known from WO 2017 / 211851 A2, the contents of which can be incorporated into the present description.

[0012] In the device according to the invention, the piston of the first container, i.e., the so-called first piston, and the piston of the second container, i.e., the so-called second piston, are each movable by means of at least one pre-tensioned spring element after its release. This means that the first piston of the first container can be moved by a so-called first spring element, and the second piston of the second container by a so-called second spring element, as soon as the respective spring element is released and its pre-tension is converted into an extension of the spring element. Each of the pre-tensioned spring elements can be in the form of a pre-tensioned coil spring, the pre-tension of which is converted into an axial spring deflection of the respective spring element after its release. More precisely, the first spring element is connected to the first piston, i.e., the piston of the second container.The first container is directly connected to the piston and is guided by the first piston rod. When using a coil spring, for example, the first piston rod can be located within the first spring element or coil spring, thereby maintaining a preload on the first coil spring. A similar design can be used for the second spring element. Providing such a preloaded spring element or elements allows for the independent movement of the respective piston or container in a structurally simple manner, without requiring a separate drive mechanism.

[0013] In the device according to the invention, a free end of the first piston rod and a free end of the second piston rod are detachably held by a common retaining element. This common retaining element is designed such that movement of the common retaining element leads to the successive release of the first and second piston rods, i.e., first the release of the first piston rod and then the release of the second piston rod. This has the advantage that the first piston is moved first via the first piston rod and the first spring element in its longitudinal direction or along its longitudinal axis within the device, before the second piston is subsequently moved via the second piston rod and the second spring element in its longitudinal direction or along its longitudinal axis within the device.According to a preferred embodiment of the present invention, a longitudinal axis of the common retaining component is arranged substantially perpendicular to the longitudinal axes of the first and second piston rods, and a direction of movement of the common retaining component can be substantially perpendicular to the directions of movement of the two piston rods. Accordingly, the arrangement of the common retaining component and the two piston rods in the device according to the invention is preferably designed such that a mechanical movement of the common retaining component in its longitudinal direction leads to a successive release of the first piston rod and the second piston rod, i.e., first to a release of the first piston rod and a subsequent spring-induced movement of the first piston rod in its longitudinal direction or along its longitudinal axis, that is, substantially perpendicular to the longitudinal axis.essentially at right angles to the movement of the common holding component, and subsequently to a release of the second piston rod and a subsequent spring-induced movement of the second piston rod in its longitudinal direction or along its longitudinal axis, that is, essentially perpendicular or essentially at right angles to the movement of the common holding component.

[0014] Due to the fact that both containers are movably arranged within the device as described above, it follows that a movement of the first piston triggered by the first spring element causes a movement of the first container within the device, and that a subsequent movement of the second piston triggered by the second spring element causes a subsequent movement of the second container within the device. Accordingly, by actuating the common retaining component, which can also be referred to as the trigger component, and the resulting successive release of the first piston rod and then the second piston rod, a movement of the first container following the spring force or spring deflection of the first spring element can be initiated, followed by a movement of the second container following the spring force or spring deflection of the second spring element.The common holding component is thus able to trigger successive movements of the two pistons of the device according to the invention, which are caused by the two pre-tensioned spring elements.

[0015] Accordingly, in a preferred embodiment of the present invention, the common retaining element holds the first piston rod and the second piston rod against the preload of the respective preloaded spring element, i.e., it holds the first piston rod against the preload of the first spring element and the second piston rod against the preload of the second spring element. The respective spring element can be arranged in preload between the common retaining element and the respective piston, whereby releasing the respective free end of the piston rod by the common retaining element releases the spring element, thus enabling its preload to be converted into a spring deflection and thereby causing the respective piston movement.According to a further preferred embodiment, the common retaining element is essentially plate-shaped, i.e., it essentially has the form of a preferably flat plate which, depending on its use or additional functions, may have recesses, projections, or the like, including those resulting from the manufacturing process. Alternatively, it is also conceivable that the common retaining element could be disc-shaped, semicircular, or the like, as long as a releasable retaining function for the free piston rod ends can be implemented.

[0016] According to a further preferred embodiment of the present invention, the common retaining component has at least one recess for the free end of the first piston rod, i.e., a so-called first recess, and at least one recess for the free end of the second piston rod, i.e., a so-called second recess. The free end of the first piston rod, which is arranged opposite to the end of the first piston rod with the first piston attached thereto, i.e., arranged away from the first container, has a depression, i.e., a so-called first depression, preferably in the form of a groove or the like.Accordingly, the free end of the second piston rod, which is positioned opposite the end of the second piston rod with the attached second piston, i.e., away from the second container, also has a recess, a so-called second recess, preferably in the form of a groove or the like. Both recesses of the first and second piston rods are detachably engaged with the common retaining component.Accordingly, at least one section of the respective recess overlaps with a section of the common retaining component, with this retaining component section surrounding the respective recess, so that a mechanical withdrawal of the corresponding section of the common retaining component from the respective piston rod recess releases the connection between the respective free piston rod end and the common retaining component and thereby releases the respective piston rod for its spring-driven movement as described above.

[0017] To implement the previously described sequential release of the first piston rod and subsequently the second piston rod, the size of the free ends of the first and second piston rods, as well as the size of the respective recesses and / or the depth of the respective depressions, are selected such that the free ends of the first and second piston rods interact differently with the common retaining element. This means that the respective recess-depression combinations are chosen so that the combination of the first recess and the first depression is released from the piston rod end depressions at a different time than the combination of the second recess and the second depression when the common retaining element moves out.A sequential release of the two free piston rod ends can be achieved either by selecting the appropriate size of each free piston rod end, resulting in different overlaps between the respective free piston rod end and the respective recess, or by selecting different depths of the recesses in the piston rod ends, or by a combination of these methods. Overlap, or overlap area, refers to the region in which one of the free piston rod ends engages with the circumference of the corresponding recess at the same time that the common retaining component holds both piston rod ends in engagement.Accordingly, the underside of the free piston rod end covers a corresponding portion of the circumference of the recess in the common retaining component at the corresponding recess, so that one can speak of an engagement area, an overlap area, or an overlap surface. As the common retaining component is pulled out of the recesses in the piston rod ends, the corresponding overlap area decreases, and the common retaining component continuously disengages until ultimately no overlap area remains and the corresponding free piston rod end is no longer engaged and is thus detached from the common retaining component.This process occurs simultaneously at both free piston rod ends by pulling out the common retaining component, whereby a temporal sequence of the release of the two free piston rod ends one after the other can be achieved by either selecting different sizes of the free piston rod ends or the corresponding recesses and thus their overlap areas, or by selecting different depths of the recesses in the piston rod ends, which also results in different overlap areas, or by a combination of these.

[0018] With regard to the aforementioned selected dimensions of the free piston rod ends and the respective recesses, the first recess in the common holding component for the free end of the first piston rod preferably has a substantially triangular shape, and the second recess in the common holding component for the free end of the second piston rod preferably has a substantially semicircular shape, wherein the free end of the first piston rod also has a substantially triangular shape, and the free end of the second piston rod also has a substantially semicircular shape. This allows for easier and more error-free assembly of the device during manufacturing, thanks to the clear, shape-related assignment of each recess to the respective piston rod end, and also enables different overlaps between each recess and its corresponding circumference.This means, in particular, that the overlap of the recess in the semicircular piston rod end and the semicircular recess circumference is greater than the overlap of the recess in the triangular piston rod end and the triangular recess circumference, whereby alternative shape combinations with the same effect can also be chosen. Additionally or alternatively, the depth of the recess in the free end of the second piston rod can be deeper than the depth of the recess in the free end of the first piston rod, thereby also achieving a temporal sequence of releasing the free end of the first piston rod followed by releasing the free end of the second piston rod.Furthermore, the free end of the second piston rod, due to its semicircular and thus rotatable cross-sectional shape, can have a projection, for example in the form of a rib or a lug, as an anti-rotation device. This, in conjunction with a corresponding recess as its counterpart, prevents the free end of the second piston rod from twisting. In contrast, a corresponding projection on the free end of the first piston rod is unnecessary, as its triangular shape and the corresponding counterpart already largely prevent it from twisting.

[0019] According to a further preferred embodiment of the present invention, the at least one pre-tensioned spring element of the first piston, i.e., the first spring element, moves the first piston together with the first container relative to the device after the first piston rod is released by the common retaining element. Furthermore, the at least one pre-tensioned spring element of the second piston, i.e., the second spring element, moves the second piston together with the second container relative to the device after the second piston rod is released, and subsequently moves the second piston relative to the second container. According to a further preferred embodiment of the present invention, the first substance present in the first container is different from the second substance present in the second container.Accordingly, mixing the first and second substances results in a mixture consisting of both substances, as described in detail previously. Provided that the two containers are connected to each other via fluid, moving the second piston towards the corresponding end of the second container forces the liquid substance out of the second container and into the first container. There, the liquid mixes with the first substance, forming a solution. The resulting solution of the first substance and the liquid can then be dispensed from the first container via the injection device, which is connected to the first container via fluid, by moving the first piston towards the corresponding end of the first container.

[0020] The first substance can be a solid, such as a lyophilisate, so that mixing the solution liquid and the lyophilisate leads to reconstitution of the lyophilisate, which can then be injected from the device into the patient via the injection device. In such an application, the first container can also be referred to as the lyophilisate container, and the second container as the liquid container. Reconstitution of the lyophilisate is possible regardless of the orientation of the device relative to gravity.In general, with regard to the piston movements described above, according to a further preferred embodiment of the present invention, the first container can have a first container end and a second container end, and the second container can have a corresponding first and second container end, wherein the first and second pistons are axially displaceable between the respective first container end and the respective second container end.

[0021] Accordingly, by moving the first piston towards the first end of the first container, the contents of the first container can be dispensed from the first container, and by moving the second piston towards the first end of the second container, the contents of the second container can be dispensed from the second container, wherein, in particular, if there is a fluid connection between the injection device and the first container, by moving the first piston towards the first end of the first container, the contents of the first container can be dispensed to the outside via the injection device.

[0022] According to a further preferred embodiment of the present invention, the piping device can have a first connection element for a fluid connection with the first container and a second connection element for a fluid connection with the second container, each connection element being designed as a needle-like projection for penetrating a septum of the respective container. A septum enables a particularly reliable and tight seal of a container. In both cases, the needle-like projection can be in the form of a needle, in particular an obliquely ground hollow cannula. To reduce the risk of contamination of the substance to be dispensed, it is particularly advantageous in sterile applications if the penetration means used, such as the aforementioned needles, are designed to be penetrating the container.Hollow cannulas are each provided with a flexible protective cap or sleeve, which can also be pierced together with the corresponding septum. The use of such protective caps or sleeves allows, in particular, final assembly of the device under non-sterile conditions. Furthermore, the tubing assembly can have a fluid connection to the injection device, wherein a valve element in the form of a one-way valve is provided in the tubing assembly, for example, a check valve, such as a flip-top valve, which acts as a one-way valve, particularly in the fluid connection to the injection device.The valve element is positioned in the piping system such that fluid transfer from the second container to the first container is possible, subsequent fluid transfer from the first container to the second container is prevented, but fluid transfer from the first container to the injection device is permitted. Preferably, the connection for the first container and the connection for the injection device are located on the same side of the one-way valve, whereas the connection for the second container is located on the opposite side of the one-way valve. According to a further preferred embodiment of the present invention in this respect, the release of the free end of the first piston rod and the resulting movement of the first piston by the first spring element establishes a fluid connection between the piping system and the first container, for example by puncturing or...Docking of the first container by means of the needle-like projection belonging to the piping device, which penetrates the septum of the first container. Subsequently, releasing the free end of the second piston rod and the resulting movement of the second piston by the second spring element establishes a fluid connection between the piping device and the second container, for example, also by piercing or docking the second container using the needle-like projection belonging to the piping device, which penetrates the septum of the second container. Both needle-like projections can be in the form of a needle, which is provided on the piping device in fluid connection with it and is oriented towards the respective container or the respective end of the first container, where a septum or the like may be located to enable a fluid connection between the needle and the container contents.In addition, the second spring element, which preferably has a larger spring deflection than the first spring element due to its design, ensures that not only is the second container, together with the second piston, pressed against the corresponding needle-like projection, but also that, after the second container docks with the needle-like projection and thus its axial movement has ended, the second piston is further moved by the second spring element and pressed against the end of the second container, thereby transferring the second substance from the second container into the first container via the piping system. The staggered docking of the two containers to the piping system achieved in this way ensures that the liquid from the second container is only dispensed into the piping system once the first container is already docked.

[0023] For the further movement of the first piston towards the corresponding first end of the first container, in order to transfer the contents of the first container to the injection device and be dispensed by it, the inventive device requires an additional movement device, which can, for example, be in the form of an additional pre-tensioned spring element. This spring element is attached to the first piston alongside the first spring element and is operatively connected to it. Subsequent activation of the additional spring element results in the contents of the first container being dispensed to the outside via the injection device when a fluid connection exists between the injection device and the first container by moving the first piston towards the first end of the first container.

[0024] According to a further preferred embodiment of the present invention, the device can also include an activation component that is mechanically connected to the common holding component. This means that the activation component and the common holding component can interact mechanically with each other, wherein, in particular, a movement of the activation component leads to the previously described movement of the common holding component in its longitudinal direction. Similarly, the movement of the common holding component in its longitudinal direction, which triggers the successive release of the first piston rod and the second piston rod, can be caused by a movement of the activation component.In a further preferred embodiment of the present invention, a longitudinal axis of the activation component is arranged substantially perpendicular to the longitudinal axis of the common holding component, i.e., substantially parallel to the longitudinal axes of the two piston rods and thus of the two containers, wherein a direction of movement of the activation component in its longitudinal direction preferably extends substantially perpendicular or substantially at right angles to the direction of movement of the common holding component in its longitudinal direction. Preferably, the activation component can have a cascade surface, and the common holding component can have an activation recess, wherein the activation component with the cascade surface is arranged in the activation recess, and pulling the activation component out of the activation recess causes an axial movement of the common holding component.For example, the activation component can be extracted by removing a cover of the device according to the invention; in particular, the activation element can be connected to the cover and thus removed by unpacking and activating the device, thereby eliminating the need for any further separate step or action by the user to reconstitute the lyophilisate in the device.Alternatively, the activation described above by moving the common holding component in its longitudinal direction to trigger the successive release of the first piston rod and the second piston rod can be achieved by an alternative operating mechanism, which is achieved, for example, by a pin-shaped actuating element connected to the common holding component and a corresponding control groove in the cover, as can be seen in more detail in the figure description below.

[0025] According to a further aspect of the present invention, a method for providing a mixed substance is also provided, wherein a device as described above is used for the method according to the invention. In a further method not according to the invention, autoinjection can be carried out using the device described above, and the features and procedures already described above for the device are correspondingly also applicable to the method according to the invention.

[0026] The method according to the invention comprises, in particular, a step of moving the activation component, which is operatively connected to the common holding component, along its longitudinal axis, thereby moving the common holding component essentially in its longitudinal direction, in particular perpendicular to the direction of movement of the activation component, and thereby first releasing the engagement between the common holding component and the free end of the first piston rod and subsequently the engagement between the common holding component and the free end of the second piston rod. Accordingly, the movement of the common holding component in its longitudinal direction, which triggers the successive release of the first piston rod and the second piston rod, can be brought about by a movement of the activation component in its longitudinal direction or along its longitudinal axis.The release of the free end of the first piston rod, due to the corresponding first spring element, can create a fluid connection between the piping device and the first container. Subsequent release of the free end of the second piston rod, due to the corresponding second spring element, can also create a fluid connection between the piping device and the second container. The deflection of the second spring element then transfers the contents of the second container into the first container via the piping device. Furthermore, the method can include an additional step of moving the first piston towards the first end of the first container, thereby dispensing the contents of the first container via the injection device.This has the advantage that, after the contents of the two containers have been mixed by a single action of the user—namely, by moving the activation component—and after the device has been attached to the user's body, only a second action is required to trigger the injection. In particular, this injection triggering step can consist of pressing a button. This allows mechanical forces to be transferred to components of the device in a predefined sequence. The present invention thus requires a minimum of action from the user. This makes operating the device simpler, more convenient, and less prone to error. Details of the respective processes have already been described in connection with the preceding description of the device according to the invention and are therefore not repeated here.

[0027] As may be used here and also in the attached claims, the singular forms "ein" / "eine" / "einer" and "der" / "die" / "das" can also include their plurals, unless the context clearly indicates otherwise. Similarly, the words "umfassen" (to include), "haltenten" (to contain), and "aufweisen" (to exhibit) are to be understood as both "exclusively" and "not exclusively," i.e., in the sense of "including, but not limited to...". The terms "mehrere" (several), "Vielfaches" (multiple), or "Vielzahl" (multiple) usually refer to two or more, i.e., 2 or >2, including further integer multiples of 1, where the terms "einn" (single) or "allein" (alone) refer to one (1), i.e., "=1". Furthermore, the expression "mindestens eins" (at least one) or "wenigstens eins" (at least one) is to be understood as one or more, i.e., 1 or >1, also including integer multiples.When the word "between" is used to describe a numerical range, the boundary points of the said range should be explicitly considered part of the range. Furthermore, the words "herein," "above," "before," and "below" or "following," and words of similar meaning, when used in this description, should refer to the description as a whole and not to specific parts of it.

[0028] The following descriptions of specific embodiments in this description are not intended to be exhaustive, nor is the disclosure given herein intended to be limited to the exact form disclosed. While the specific embodiments and examples described herein serve to illustrate the disclosure, various equivalent modifications are possible within the scope of protection of the disclosure, as would be apparent to a person skilled in the art in the present technical field. Specific technical elements of described embodiments may be combined with or replaced by technical elements in other embodiments. In the drawings, identical reference numerals denote identical elements to avoid repetition, and parts that a person skilled in the art can implement without special knowledge may be omitted for the sake of clarity.While advantages associated with certain embodiments of the disclosure are described in connection with those embodiments, other embodiments may also have these advantages without explicitly mentioning them.

[0029] The following examples are intended to illustrate specific embodiments of the present invention with reference to the figures. All specific modifications, as also discussed below, are not to be construed as limitations of the scope of the present invention. It is obvious to the person skilled in the art that various variations, changes, and modifications can be made without departing from the scope of protection of the present disclosure as defined by the appended claims. Further aspects and advantages of the present invention will become apparent from the following description of the preferred embodiments shown in the figures. FIGURE DESCRIPTION

[0030] They show: Figure 1 is a perspective schematic view of a device according to the invention in a preferred embodiment in exploded view; Figure 2 is a perspective schematic view of a main body of the device shown in Figure 1 The device shown is in a longitudinal section; Figure 3 is a top view of the device shown in Figure 3. Figure 2 The view shown; Figure 4 is a top view of part of the in Figure 2 The exploded view shown illustrates, in particular, the interaction between the common retaining component and the two piston rods; Figure 5 is a perspective view of the Figure 4Figures 6a to 6c show a release process of the two piston rod ends by a movement of the common retaining component in three exemplary steps; Figure 7 shows an activation of the common retaining component of the device of the preferred embodiment shown in the previous figures by an activation component; Figures 8a to 8c show a release process of the two piston rod ends by a movement of an alternative embodiment of the common retaining component in three exemplary steps, triggered by an alternative action mechanism; Figure 9a shows a perspective schematic view of an alternative embodiment of a cover of the device according to the invention; and Figure 9 shows a perspective schematic view of an inside of a lower half of the Fig. 9a The cover shown is depicted in a top view of a section plane running along the section line BB. PREFERRED FORMS OF THE INVENTION

[0031] In the following description of preferred embodiments of the invention, the figures represent the subject matter of the invention only schematically. The preferred embodiments of the invention are illustrated in the drawings and are described in more detail below.

[0032] Figure 1Figure 1 shows a perspective schematic view of a device 9 according to a preferred embodiment of the invention in an exploded view. The device 9 is shown in two disassembled main components: a main body 91 of the device 9 and a cover 92, which, in the assembled state of the device 9, at least partially covers the main body 91. In the preferred embodiment shown here, the main body 91 has a substantially rectangular shape with rounded edges. The cover 92 has a hollow shape corresponding to the shape of the main body 91 to be inserted, with one open side, and recesses 921 provided on both sides of the open side of the cover.Handle strips 911 provided at the appropriate location on the main body 91 are inserted into these recesses 921 in the assembled state to facilitate the pulling out of the main body 91 from the cover 92 or the removal of the cover 92 from the main body 91 by a user.

[0033] The in Figure 1 The main body 91 shown is in Figure 2The main body 91 is shown in a section cut along line AA along its longitudinal axis. This section shows that the main body 91 has an opening 912 at one end, which, in the assembled state, is to be inserted into the cover 92. Furthermore, another opening (not shown), covered by a seal, is provided on the main body 91, for example, on the underside of the main body 91, the function of which will be explained later. The otherwise essentially closed main body 91 contains, among other things, a first container 1 in which a first substance A is contained and sealed by a stopper 11, the substance A being in the form of a lyophilisate in the present embodiment. The other end of the first container 1, i.e.,The end of the first container 1 opposite the stopper 11, which can also be referred to as the first end of the first container 1, is closed, for example, by a septum 12. The first container 1, which in this sense can also be referred to as the lyophilisate container 1, is located on the left side in the present case. Fig. 2arranged. The main body 91 also contains a second container 2, in which a second substance B is contained and sealed by a stopper 21, wherein, in the present embodiment, substance B is in the form of a solvent for reconstitution of the lyophilisate. The other end of the second container 2, i.e., the end opposite the stopper 21, which can also be referred to as the first end of the second container 2, is closed, for example, by a septum 22. The second container 2, which in this sense can also be referred to as the solvent container 2, is in the present case on the right side in Fig. 2 arranged. Both containers 1 and 2 are interchangeably arranged in the main body 91.

[0034] As it continues both in Figure 2 as well as in the corresponding top view in Figure 3As can be seen, a first piston 3 with a first piston rod 31 is arranged in the main body 91, wherein the first piston 3, or rather its piston crown, is guided essentially within the container 1 such that the piston crown can come into contact with the opposite side of the plug 11, so that the plug 11 can be pressed against the septum-bearing end of the first container 1, which represents a first end of the first container 1. Furthermore, a second piston 4 with a so-called second piston rod 41 is arranged in the main body 91, wherein the second piston 4, or rather its piston crown, is guided essentially within the second container 2 such that the piston crown can come into contact with the opposite side of the plug 21, so that the plug 21 can be pressed against the septum-bearing end of the second container 2, which represents a first end of the second container 2.Both containers 1 and 2 are mounted in the main body 91 in such a way that they are movably mounted or guided in the main body 91 in their longitudinal direction, as shown in . Figures 2 and 3 As indicated, when containers 1 and 2 move towards their septum-bearing ends, the respective septum 12, 22 is pressed onto a respective fixed needle 51, 52, causing the septa 12, 22 to be pierced by the needles 51, 52. This piercing of the septa 12, 22, and thus the piercing of the containers 1, 2, establishes a fluid connection between the contents of the containers 1, 2 and a conduit 53 of a conduit assembly 5, which is connected to a [missing information] in the Figures 2 and 3 The left end shown is fixedly arranged on the inside of the main body 91. The conduit assembly 5, which may consist of several wall components due to manufacturing requirements, as shown in the Figures 2 and 3As indicated, the component not only holds the needles 51 and 52 in place, aligned with their respective septums 12 and 22, but also forms the conduit 53 within it. A one-way valve 54 is also provided in the conduit 53, here in the form of a rubber lip that, like a flap, rests against an inner wall of the conduit 53 on one side. In the present embodiment, this valve allows fluid flow from the second container 2 into the first container 1, but prevents backflow of fluid from the first container 1 into the second container 2. In addition to the components already described, the conduit 53 also includes a preferably sealed opening (not shown) for connecting an injection device (not shown), specifically in the section of the conduit 53 located on the side of the first container 1, extending from the one-way valve 54.The injection device (not shown) can be designed such that it can also pierce the sealed opening with a needle or the like, or that the injection device is already connected to the sealed opening. The injection device serves to deliver a substance located in the conduit 53 and / or in the container 1 to a user by injection, preferably autoinjection. For this purpose, the previously mentioned opening (not shown), covered by a seal, is used, which is provided, for example, on the underside of the main body 91, and through which the injection device can eject the substance to be delivered.

[0035] The piercing of the containers 1, 2 described above by piercing the septa 12, 22 with the needle 51, 52 is effected, as discussed, by moving the containers 1, 2 in their axial direction. To bring about such a movement of the first container 1, the first container 1, in the preferred embodiment shown, is provided with a first pre-tensioned spring element 32, here in the form of a coil spring 32, which is held at one end facing away from the first container 1 by contact with a guide component 7 and is operatively connected to the first container 1 at one end facing the first container 1 via an intermediate component 33, so that a deflection of the pre-tensioned coil spring 32 causes a longitudinal displacement of the first container 1 in the direction towards the needle 51 in order to pierce the septum 12 of the first container 1 with the needle 51.The coil spring 32 is pre-tensioned by a clamping between the intermediate component 33 and the guide component 7, the coil spring 32 being arranged around the first piston rod 31, and a free end 311 of the first piston rod 31 of the first piston 3 being held in place by a retaining component 6. The retaining component 6 is also referred to as the common retaining component 6, since it holds not only the free end 311 of the first piston rod 31 of the first piston 3, but also the free end 411 of the second piston rod 41 of the second piston 4 in place by engaging with it.In the embodiment described here, a further pre-tensioned spring element 34 in the form of a coil spring 34 is also arranged on the piston assembly of the first piston 3 of the first container 1, which can be released after being triggered, for example by a separate mechanism to be actuated by the user, so that a deflection of the further pre-tensioned coil spring 34 is caused, which causes a movement of the first piston 3, guided by the first piston rod 31, in the direction of the fluid connection already established by the first pre-tensioned spring element 32 between the first container 1 and the conduit 53, so that the contents of the first container 1 can be forced into the conduit 53 and beyond through the injection device (not shown) and out of the main body 91 of the device 9.A detailed description of the interaction between piston 3, piston rod 31, first pre-tensioned spring element 32, intermediate component 33 and further pre-tensioned spring element 34 can also be used to... Figures 4 and 5 can be extracted, in which the general interaction between the two piston structures of pistons 3 and 4 and their spring elements 32, 34 and 42 and the common holding component 6 is shown in an exploded view perspective and in top view for simplified representation.

[0036] In order to cause a piercing movement of the second container 2, the second container 2 in the preferred embodiment shown is provided with a second pre-tensioned spring element 42, here in the form of a coil spring 42, which is held at one end facing away from the second container 2 by contact with the guide component 7 and at one end facing the second container 2 is in operative connection with the second container 2 by the second piston 4, so that a deflection of the pre-tensioned coil spring 42 causes a longitudinal displacement of the second piston 4 against the plug 21 and thereby a longitudinal displacement of the second container 2 in the direction towards the needle 52 in order to pierce the septum 22 of the second container 2 with the needle 52.The coil spring 42, which is arranged around the second piston rod 41, is pre-tensioned by a clamping action between the inside of the piston 4 and the guide element 7. A free end 411 of the second piston rod 41 of the second piston 4 is held in place by the common retaining element 6, which also holds the free end 311 of the first piston rod 31 of the first piston 3. Accordingly, releasing the pre-tensioned coil spring 42 causes the second piston 4 to move and strike the plug 21. Together with the plug, the pressure of the incompressible fluid in the container 2 moves the container 2 axially against the needle 52, thereby establishing the fluid connection between the conduit 53 and the contents of the container 2, which provides an outlet for the pressure in the container 2.The coil spring 42 then pushes the piston 4 together with the stopper 21 further, causing the contents of the second container 2 to be conveyed into the conduit 53, past the one-way valve 54, and further into the first container 1. Accordingly, in the present embodiment, the incompressible solution liquid, which is present as the contents of the second container 2 (i.e., the solution liquid container 2), is forced into the first container 1 (i.e., the lyophilisate container 1), where the solution liquid mixes with the lyophilisate, thus reconstitutes the lyophilisate. The resulting solution can then be conveyed out of the first container 1 as the substance to be dispensed (injected) by releasing the further coil spring 34 and dispensed to the outside through the injection device (not shown), preferably by self-injection into the user. The illustrations in the figures... Figures 2 to 5It can already be seen that the pre-tensioned coil spring 32 for puncturing the first container 1 is significantly smaller than the two coil springs 34 and 42, which results in a significantly smaller deflection or elongation of the coil spring 32 compared to the other two coil springs 34 and 42. This is because only a small axial displacement of the container 1 is necessary for the coil spring 32 to puncture the first container 1.

[0037] In the Figures 6a to 6c The figure shows a process of releasing, at different times, first the first pre-tensioned coil spring 32 and then the second pre-tensioned coil spring 42. Figure 6a is an initial state as also shown in the Figures 2 and 3as can be seen. In this initial state, the common retaining component 6 holds the two free ends 311, 411 of the two piston rods 31, 41 in engagement, so that the two coil springs 32, 42 are held in their pre-tensioned state, and no movement of either the pistons 3, 4 or the containers 1, 2 takes place. As is shown, among other things Fig. 6a The free end 311 of the first piston rod 31 has a triangular shape. A corresponding recess 61, provided in the common retaining element 6 for holding the free end 311 of the first piston rod 31, also has a triangular shape. However, the triangular shape of the recess 61 is larger than the triangular shape of the free end 311 of the first piston rod 31, as can be seen from each of the Figures 6a to 6c can be removed. Furthermore, a recess in the form of a groove 312 is provided in the free end 311 of the first piston rod 31, see also Figure 3 , into which a circumferential area of ​​the triangular recess 61 in the Figure 6a The initial state shown is inserted. Similarly, the free end 411 of the second piston rod 41 has a semicircular shape. A recess 62 corresponding to the free end 411 of the second piston rod 41, which is provided in the common retaining element 6 for holding the free end 411 of the second piston rod 41, also has a semicircular shape. However, the semicircular shape of the recess 62 is again larger than the semicircular shape of the free end 411 of the second piston rod 41, as each of the Figures 6a to 6c can be removed. A recess in the form of a groove 412 is also provided in the free end 411 of the second piston rod 41, see also Figure 3 , into which a circumferential area of ​​the semicircular recess 62 in the Figure 6aThe initial state shown is inserted. The size difference between the recesses 61, 62 and the respective free ends 311, 411 is due to the fact that the free ends 311, 411 should pass freely through the corresponding recess 61, 62 after being released, without becoming jammed, thus ensuring the release process of the free ends 311, 411.

[0038] In the present embodiment, the ratio between the triangular shape of the free end 311 of the first piston rod 31 and the triangular shape of the recess 61 is chosen such that their overlapping area in the initial state is smaller than the overlapping area between the semicircular shape of the free end 411 of the second piston rod 41 and the semicircular shape of the recess 62. To release the two free ends 311, 411 of the two piston rods 31, 411, the common retaining element 6 can be moved in its longitudinal direction, and thus essentially perpendicular to the longitudinal directions of the two piston rods 31, 411, so that the common retaining element 6 is pulled out of the grooves 312, 412. This pulling-out process occurs at both free piston rod ends 311, 411 by pulling out the common retaining element 6 parallel to each other.Due to the fact that the overlap area between groove 312 and the surroundings of recess 61 is smaller for the first piston rod 31 than the overlap area between groove 412 and the surroundings of recess 62 for the second piston rod 41, the gradual pulling out of the common retaining component 6 first leads to the free end 311 of the first piston rod 31 being released, see also . Figure 6b , and thus to a punctuation of the first container 1. Only then does the further withdrawal of the common retaining component 6 proceed as in Figure 6cThe diagram shows the release of the free end 411 of the second piston rod 41, thus puncturing the second container 2 and subsequently forcing the contents of the second container 2 through the conduit 53 past the one-way valve 54 into the fluid-connected container 1, resulting in the reconstitution of the lyophilisate. The contents of container 1 increase accordingly by the volume forced in, so that the stopper 11 of the first container 1 is pushed backward toward the first piston 3. This occurs in the initial state, as shown in the diagram. Figures 2 and 3 As shown, sufficient space is left between the plug 11 and the piston 3 so that the plug 11 has room to move backwards. For this to happen, it is obviously necessary to allow the displaced air to escape past the piston 3, as is shown, among other things, in Figure 3 shown.

[0039] Upon closer examination of the representations in Figures 6a to 6c On the upper side of the common holding component 6, an arrangement of three detent recesses 64 can be seen, which can be engaged in preferably three different positions by a detent lug 71 integrally attached to the guide component 7. Accordingly, the combination of detent recesses 64 and detent lug 71 serves to control the movement of the common holding component 6 in a generally horizontal direction from an initial position as shown in the diagram. Figure 6a shown in an intermediate position for triggering the first piston rod 31 as in Figure 6b The movement of the common retaining element 6 is guided, as shown here, by guide rails 72, which are attached to the guide element 7, until it is guided in stages to a final position for triggering the second piston rod 41, i.e., in the three positions mentioned. The general movement of the common retaining element 6 is guided, as shown here, by guide rails 72, which are attached to the guide element 7. As is finally shown in Figure 7As shown, the device 9, particularly in the present preferred embodiment, has an inner surface of the cover 92 and an activation component 8, optionally associated therewith, which, in the assembled state of the device 9, passes through the opening 912 in the main body 91 and through a recess 63 or an activation recess 63 in the common retaining component 6. The guide component 7 also has a recess corresponding to the activation recess 63 (not shown) to allow the activation component 8 to pass through the opening 912, the activation recess 63, and the (not shown) guide component recess.The activation component 8, which is preferably formed by two longitudinal webs, has a projection 81 in the form of a cascade surface on the front face of each web such that pulling the activation component 8 out in its axial direction triggers the pushing of the common holding component 6 in the axial direction of the common holding component 6, which is substantially perpendicular to the axial direction of the activation component 8, thereby moving the common holding component 6 to release the two free ends 311, 411 of the two piston rods 31, 41. Accordingly, in the present preferred embodiment, a longitudinal axis of the activation component 8 is arranged substantially perpendicular to the longitudinal axis of the common holding component 6, i.e.substantially parallel to the longitudinal axes of the two piston rods 31, 41 and thus of the two containers 1, 2, wherein the pull-out direction of the activation component 8 in its longitudinal direction preferably runs substantially perpendicular or substantially at right angles to the direction of movement of the common holding component 6 in its longitudinal direction. Due to the combination of cascade surface and activation recess, the activation component 8 and the common holding component 6 are in mechanical operative connection, so that the movement of one component, for example the activation component 8, causes a movement of the other component, in this case the common holding component 6.

[0040] In the Figures 8a to 8c An alternative embodiment of a combination of guide component 7' and common retaining component 6' is shown, wherein the Figures 8a to 8c similar to in the Figures 6a to 6cThe figure shows a process of releasing, sequentially, first the first pre-tensioned coil spring 32 and then the second pre-tensioned coil spring 42. The basic sequence of the release process remains essentially unchanged compared to the previously described embodiment, with the only difference being the actuation of the common retaining element 6' and the guidance of the common retaining element 6' on the guide element 7', as described in more detail below.

[0041] With regard to the alternative guidance of the common retaining element 6' on the guide element 7', in the embodiment described here, the common retaining element 6' is guided by two internally arranged guide rails 72' instead of the externally arranged guide rails 72. These guide rails each run in a further internally arranged recess 63', for example, in the form of a continuous guide groove. The guide rails 72' each have essentially the shape of an inverted letter L (= Γ) and each extend from an outwardly facing surface of the guide element 7' towards and through the common retaining element 6', more precisely through the respective recess 63'.Each recess 63' has at a first end, shown on the right in the figures, a so-called through-extension for the free passage of the respective guide rail 72', as well as a correspondingly narrowed guide groove adjoining the through-extension, which receives and guides the axially extending, longer section of the respective L-shaped guide rail 72'.

[0042] Regarding the alternative actuation of the common retaining component 6', in Figure 8aAn initial state prior to the release process is shown, in which the common retaining element 6' engages the free end 311 of the first piston rod 31 and an alternative embodiment of a free end 411' of the second piston rod 41, so that the two coil springs 32, 42 are held in their pre-tensioned states and, accordingly, no movement of either the pistons 3, 4 or the containers 1, 2 can take place. The aforementioned alternative embodiment of the free end 411' of the second piston rod 41 differs from the previously described embodiment of the free end 411 of the second piston rod 41, in particular, in that it additionally has an outwardly projecting projection 4111' in the form of a rib or the like, which is arranged opposite to the round portion of the essentially semi-circular shape of the free end 411' of the second piston rod 41.The projection 4111', also referred to as anti-rotation device or anti-rotation projection, runs in a corresponding groove 73', which is provided in the guide component 7' and is adapted to the shape of the projection 4111', and serves to prevent rotation of the free end 411' of the second piston rod 41, and thus of the entire second piston rod 41, whereby such rotation can occur, for example, during assembly of the device according to the invention or also during vibration caused by shock during transport of the device according to the invention.

[0043] As it is among other things Figure 8aThe free end 311 of the first piston rod 31, similar to the embodiment described above, also has a triangular shape, which in itself provides anti-rotation protection due to its shape. A recess 61' corresponding to the free end 311 of the first piston rod 31, which is provided in the common retaining element 6' for holding the free end 311 of the first piston rod 31, has a substantially similar, triangular shape, with a front tip that is rounded to match, for example, the semicircular shape of the groove 312.In the present alternative embodiment, the ratio between the triangular shape of the free end 311 of the first piston rod 31 and the substantially triangular shape of the recess 61' is selected similarly to the embodiment described above, such that their overlapping area in the initial state is smaller than the overlapping area between the semicircular shape of the free end 411' of the second piston rod 41 and the semicircular shape of the recess 62'. To release the two free ends 311, 411' of the two piston rods 31, 41, the common retaining element 6' can be moved in its longitudinal direction, and thus substantially perpendicular to the longitudinal directions of the two piston rods 31, 41, so that the common retaining element 6' is pulled out of the grooves 312, 412. This pulling out of the common retaining element 6' from the grooves 312, 412 is also referred to as the release process.The release process takes place at both free piston rod ends 311, 411' by the in the . Figures 8a to 8c The depicted pulling of the common retaining component 6' to the left in the plane of the figure, see also the in Figures 8b and 8c The arrows shown indicate this. Due to the fact that, in the first piston rod 31, the overlap area between groove 312 and the surroundings of recess 61' is smaller than in the previously described embodiment, the overlap area between groove 412 and the surroundings of recess 62' in the alternative free end 411' of the second piston rod 41, the illustrated stepwise withdrawal of the common retaining element 6' first leads to a loosening / releasing of the free end 311 of the first piston rod 31, as shown in Figure 8b as shown, and thus to a punctuation of the first container 1. Only then does the further movement of the common holding component 6' as shown in Figure 8cdepicted as releasing the free end 411' of the second piston rod 41, and thus piercing the second container 2 and subsequently forcing the contents of the second container 2 through the conduit 53 past the one-way valve 54 into the fluid-connected container 1, which leads to the reconstitution of the lyophilisate.

[0044] Upon closer examination of the representations in Figures 8a to 8cAn actuating element 65' in the form of an outwardly projecting pin or bolt can be identified on an underside of the common retaining component 6'. This actuating element is connected to the common retaining component 6' via a spring mechanism 651'. Actuating / moving the pin-shaped actuating element 65' causes the desired movement of the common retaining component 6' and thus the previously described release process of the two free ends 311, 411' of the piston rods 31, 41. To actuate the actuating element 65' accordingly, an inner surface of an alternative embodiment of a cover 92', as described in Figures 9a and 9bAs shown, a so-called guide or control groove 922' is provided, which in the embodiment described here is, for example, formed in two parts. In an assembled state of the device 9, the actuating element 65' is accordingly arranged within a first section of the control groove 922'. In an initial state, as described in Fig. 8a As shown, the actuating element 65' is located at a first end 9221' of the longer, first section of the control groove 922', as shown in Figure 9bon a right-hand side of the inside of the lower half of the alternative cover 92' is shown. When the cover 92' is removed from the main body 91 of the device 9, the actuating element 65' moves away from the first end 9221' towards a subsequent inclined surface or ramp 9222' of the control groove 922'. The movement of the actuating element 65' along this ramp 9222', caused by the further removal of the cover 92' from the main body 91, results in the movement of the retaining component 6', which is integrally connected to the actuating element 65', as shown in the Figures 8a to 8c is shown. After the actuating element 65' has been completely moved along the entire slope 9222', the following finally occurs: Figure 8c The illustrated state is reached in which both free ends 311, 411' of the piston rods 31, 41 are detached from the retaining component 6'.

[0045] From a certain stage of the release movement, more precisely from the point at which the free end 311 of the first piston rod 31 of the first piston 3 is released, the common retaining element 6' must no longer be able to return to its original starting position. This is to prevent a user from getting the impression that the device 9 is unused, even though significant reconstitution processes have already taken place. To prevent the actuating element 65' and thus the common retaining element 6' from being moved back by an accidental or intentional retraction of the cover 92', the control groove 922' has a first stop 9223' on one side opposite the inclined plane 9222'. The actuating element 65' comes into contact with this stop when the cover 92' is pushed back, thus preventing any further retraction of the actuating element 65'.

[0046] If the removal process of the cover 92' from the main body 91 is to progress as desired, the actuating element 65' leaves the first section of the control groove 922' after the slope 9222' and, for example, supported by a ramp or the like, and subsequently optionally enters a shorter, second section of the control groove 922', as shown on the left side in Fig. 9bThis shorter section of the control groove 922', like the first, longer section of the control groove 922' including the ramp 9222', has a second stop 9224' against which the actuating element 65' can engage when the cover 92' is pushed back after the removal process of the cover 92' from the main body 91 has progressed, thus reliably preventing the actuating element 65' from moving back from this point. As the removal process of the cover 92' from the main body 91 continues, the actuating element 65', for example assisted by a ramp or the like, leaves the second section of the control groove 922', and the main body 91 then completely leaves the cover 92' to expose the opening of the injection device, which is covered by a seal, so that the reconstituted substance to be dispensed by the injection device can be expelled.

[0047] Preferred embodiments of the present invention have been described above, but the present invention is not limited to these previously described preferred embodiments. Various modifications to the design can be made without deviating from the invention as defined in the following claims. Reference symbol list

[0048] A. First substance (e.g., a lyophilisate) B. Second substance (e.g., a reconstitution liquid) 1. First container 11. First container stopper 12. First container 2. Second container 21. Second container stopper 22. Second container 3. First piston 31. First piston rod 311. Free end of first piston rod 312. Groove in the free end of first piston rod 32. First pre-tensioned spring element for first piston rod 33. Intermediate component 34. Further spring element 4. Second piston 41. Second piston rod 411. Free end of second piston rod 411'Free end of second piston rod (alternative design) 4111'Anti-rotation projection of the free end of second piston rod 412. Groove in the free end of second piston rod 42. Second pre-tensioned spring element for second piston rod 5. Conduit assembly 51. First needle 52 Second needle 53 Conduit 54 One-way valve (e.g. a rubber lip check valve) 6 Common retaining component / trigger 6' Common retaining component / trigger(alternative version) 61 First recess for free end of first piston rod 61' First recess for free end of first piston rod (alternative version) 62 Second recess for free end of second piston rod 62' Second recess for free end of second piston rod (alternative version) 63 Recess for activation component 63' Recesses for guide rails 64 Detent recesses 65' Trigger actuating element 651' Spring mechanism 7 Guide component 7' Guide component (alternative version) 71 Detent lug 72 Guide rails 72' Guide rails (alternative version) 73' Anti-rotation groove 8 Activation component 81 Projection in the form of a cascade surface 9 Device 91 Main body 911 Handle strip 912 Opening 92 Cover 92' Cover (alternative version) 921 Recess in the cover 922'control groove 9221'first end of the control groove 9222'angle of the control groove 9223'first stop of the control groove 9224'second stop of the control groove

Claims

1. Device (9) for dispensing at least one substance, in particular to a patient, comprising a first container (1) which contains a first substance (A) and has a first piston (3) having a first piston rod (31), a second container (2) which contains a second substance (B) and has a second piston (4) having a second piston rod (41), an injection apparatus, and a conduit apparatus (5) for conveying the contents of the second container (2) to the first container (1) for mixing therein, and for conveying the contents of the first container (1) to the injection apparatus, wherein the first and the second container (2) are movably arranged in the device (9) to establish a fluid connection, via a relevant first and second connection element (51, 52), with the conduit apparatus (5), wherein the first and the second piston (3, 4) can each be moved via at least one preloaded spring element (32, 34, 42), wherein a free end (311) of the first piston rod (31) and a free end (411) of the second piston rod (41) are releasably held by a common holding component (6), and wherein the common holding component (6) is designed such that a movement of the common holding component (6) leads to a successive release of the first piston rod (31) and the second piston rod (41) and to a movement of the first piston rod (31) and the second piston rod (41) substantially perpendicular to the direction of movement of the common holding component (6), wherein successively, by means of the movement of the first piston rod (31), the first container (1), via the first connection element (51) and via the conduit apparatus (5), is brought into fluid communication with the second container (2), via the second connection element (52), by means of the subsequent movement of the second piston rod (41), wherein the first substance (A) is mixed with the second substance (B), wherein the conduit apparatus (5) includes a one-way valve (54) which allows fluid flow from the second container (2) into the first container (1), but prevents backflow of a fluid from the first container (1) into the second container (2).

2. Device (9) according to claim 1, wherein the common holding component (6), which is preferably substantially planar, holds back the first piston rod (31) and the second piston rod (41) against the preloading of the relevant preloaded spring element (32, 42).

3. Device (9) according to either of the preceding claims, wherein the common holding component (6) has at least one recess (61) for the free end (311) of the first piston rod (31) and at least one recess (62) for the free end (411) of the second piston rod (41), the free end (311) of the first piston rod (31) and the free end (411) of the second piston rod (41) each have a depression (312, 412) which is releasably engaged with the common holding component (6), and a size of the free end (311, 411) of the first and the second piston rod (31, 41) as well as a size of the relevant recess (61, 62) and / or a depth of the relevant depression (312, 412) is selected such that the free ends (311, 411) of the first and the second piston rod (31, 41) interact differently with the common holding component (6).

4. Device (9) according to claim 3, wherein the recess (61) in the common holding component (6) for the free end (311) of the first piston rod (31) has a substantially triangular shape and the recess (62) in the common holding component (6) for the free end (411) of the second piston rod (41) has a substantially semicircular shape, and the free end (311) of the first piston rod (31) has a substantially triangular shape and the free end (411) of the second piston rod (41) has a substantially semicircular shape, and / or the depth of the depression (412) in the free end (411) of the second piston rod (41) is deeper than the depth of the depression (312) in the free end (311) of the first piston rod (31).

5. Device (9) according to any of the preceding claims, wherein the at least one preloaded spring element (32) of the first piston (3) moves the first piston (3) together with the first container (1) relative to the device (9) after the first piston rod (31) has been released, and the at least one preloaded spring element (42) of the second piston (4) moves the second piston (4) together with the second container (2) relative to the device (9), and subsequently the second piston (4) relative to the second container (2), after the second piston rod (41) has been released.

6. Device (9) according to any of the preceding claims, wherein the first substance (A) is different from the second substance (B).

7. Device (9) according to any of the preceding claims, wherein the second substance (B) is a liquid, preferably wherein the liquid is transferred into the first container (1) by pushing the second piston (4) against a container end of the second container (2), the liquid is mixed with the first substance (A) in the first container and they form a solution, and wherein the solution in the first container (1) can be dispensed via the injection apparatus by pushing the first piston (3) against a container end of the first container (1).

8. Device (9) according to claim 7, wherein the first substance (A) is a solid, in particular a lyophilizate.

9. Device (9) according to any of the preceding claims, wherein the release of the free end (311) of the first piston rod (31) establishes a fluid connection between the conduit apparatus (5) and the first container (1) due to the corresponding spring element (32), and wherein a subsequent release of the free end (411) of the second piston rod (41) establishes a fluid connection between the conduit apparatus (5) and the second container (2) due to the corresponding spring element (42) and additionally causes a transfer of the second substance (B) from the second container (2), via the conduit apparatus (5), into the first container (1).

10. Device (9) according to any of the preceding claims, wherein a longitudinal axis of the common holding component (6) is substantially perpendicular to the longitudinal axes of the first and the second piston rod (31, 41).

11. Device (9) according to any of the preceding claims, wherein the device (9) further has an activation component (8) which is in mechanical operative connection with the common holding component (6), and wherein a movement of the activation component (8) leads to the movement of the common holding component (6), preferably wherein a longitudinal axis of the activation component (8) is substantially perpendicular to the longitudinal axis of the common holding component (6), and wherein a direction of movement of the activation component (8) preferably extends substantially perpendicularly to the direction of movement of the common holding component (6).

12. Device (9) according to any of the preceding claims, wherein the conduit apparatus (5) has a first connection element (51) for a fluid connection with the first container (1) and a second connection element (52) for a fluid connection with the second container (2), and wherein each connection element (51, 52) is preferably designed as a needle-like projection for penetrating a septum (12, 22) of the relevant container (1, 2).

13. Device (9) according to any of the preceding claims, wherein the conduit apparatus (5) has a fluid connection with the injection apparatus, and / or wherein the conduit apparatus (5) preferably has a valve element (54), more preferably a one-way valve (54), in particular a check valve (54).

14. Device (9) according to any of the preceding claims, wherein the first container (1) has a first container end and a second container end, and the second container (2) has a first container end and a second container end, wherein the first and the second piston (3, 4) can be pushed between the relevant first container end and the relevant second container end, and wherein contents of the first container (1) can be dispensed via the injection apparatus by pushing the first piston (3) against the first container end of the first container (1).

15. Device (9) according to any of the preceding claims, wherein each container (1,2) is cylindrical, and / or the second container (2) is parallel to, in particular in the same direction as, the first container (1) in the device (9).

16. Method for providing a mixed substance using a device (9) according to any preceding claim, comprising a step of moving the activation component (8), which is in operative connection with the common holding component (6), along its longitudinal axis, as a result of which the common holding component (6) is moved substantially in its longitudinal direction, in particular perpendicularly to the direction of movement of the activation component (8), and thereby first releases the engagement between the common holding component (6) and the free end (311) of the first piston rod (31) and subsequently releases the engagement between the common holding component (6) and the free end (411) of the second piston rod (41), preferably wherein the release of the free end (311) of the first piston rod (31) due to the corresponding spring element (32) causes a fluid connection between the conduit apparatus (5) and the first container (1), and the subsequent release of the free end (411) of the second piston rod (41) due to the corresponding spring element (42) causes a fluid connection between the conduit apparatus (5) and the second container (2) and then the second substance (B) is transferred from the second container (2), via the conduit apparatus (5), into the first container (1).

17. Method according to claim 16, wherein the first substance (A) is a solid, in particular a lyophilizate, and the second substance (B) is a liquid, and wherein the liquid is transferred into the first container (1) by pushing the second piston (4) against the first container end of the second container (2), the liquid is combined with the solid in the first container and they form a solution.