Apparatus for preparing and dispensing an active ingredient solution

Abstract

To provide a device for preparing and dispensing active ingredient solutions, preferably a wound-irrigating solution.SOLUTION: A device 100 is provided for preparing and dispensing an active ingredient solution, the device including: a connection element 109 which is designed and configured for liquid-tight connection to a container 200; a mandrel 102 designed and configured for piercing a septum of a container; a liquid-permeable filter 106 which can be connected via an outlet of a reservoir 103 containing an active ingredient in solid form in a fluid-conducting manner to the connection element and which is arranged at the outlet of the reservoir, and is configured to retain the active ingredient 104 in solid form in the reservoir; and a fluidic element 108 which is configured to receive a liquid from a container into the reservoir, and / or is configured to dispense a liquid from the reservoir. The device is designed and configured to receive a liquid from a container into the reservoir, to dissolve the active ingredient in the liquid, and to dispense the dissolved active ingredient to a patient via the connection element.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] The present invention relates to the field of medical technology, and in particular to a device for preparing and dispensing active ingredient solutions (for example wound cleansing solutions). [Background technology]

[0002] Disinfectant active ingredients and disinfectant solutions have been known since the 19th century. Examples of such active ingredients are hypochlorite salts and their solutions. Hypochlorite solutions have a limited shelf life. This is mainly due to the slow conversion of hypochlorite ions to chloride ions. This means that the hypochlorite content of the solution decreases with increasing storage time. Furthermore, hypochlorite ions can also be decomposed into chloride ions and oxygen.

[0003] Disinfecting hypochlorite solutions are known in the prior art and various solutions have been proposed to improve storage stability.

[0004] Such solutions are described, for example, in the following publications: U.S. Pat. No. 8,945,630, U.S. Patent Application Publication No. 2011 / 0236490, WO 2021001789, U.S. Patent Application Publication No. 2019328776, WO 2021134041, WO 2022 / 038507, WO 2020252433, WO 2020174436, U.S. Patent Application Publication No. 243781, and U.S. Patent Application Publication No. 3,749,672. , U.S. Patent Application Publication No. 6162371, WO 1991 / 003936, U.S. Patent Application Publication No. 641974, U.S. Patent Application Publication No. 2009 / 0258083, WO 2010148004, WO 2010148004, U.S. Patent Application Publication No. 2009 / 0148342, WO 2016 / 100543, WO 2020 / 089693, and WO 2021 / 162736.

[0005] However, complete protection from decomposition of hypochlorite ions in aqueous solutions remains difficult.

[0006] A further challenge is to provide such solutions in sterile form, with the objective that the containers are also sterile and stable. For example, U.S. Patent No. 4,964,261 and U.S. Patent Application Publication No. 2005232848 address this challenge.

[0007] Solid precursors for producing hypochlorite-containing solutions are described in DE-A-2712574 and US Pat. No. 4,104,190. Summary of the Invention [Problem to be solved by the invention]

[0008] Preferred Embodiments The present invention aims to solve one or more of the problems mentioned above and further problems of the prior art. For example, the present invention provides an active ingredient-containing device in which a ready-to-use active ingredient solution can be quickly, easily, and economically produced using commercially available containers containing sterile saline or an equivalent solution. Because the devices according to the present invention contain the active ingredient in solid form, the devices can be stored for longer periods, even if they contain active ingredients that are not permanently stable in aqueous solution. Furthermore, sterilization of the liquid is omitted during the manufacture of the devices according to the present invention. Some active ingredients are better sterilized in solid form because they degrade more easily in solution during sterilization. In some embodiments, the devices according to the present invention allow for the direct dispensing of the liquid produced within the device to a patient, for example, using a nozzle that can be attached to the device according to the present invention.

[0009] These objects are achieved by the methods and apparatus described herein, particularly as claimed.

[0010] Preferred embodiments of the present invention are described below.

[0011] Embodiment 1 is a device for generating an active ingredient solution, preferably an antiseptic wound cleansing solution, comprising: a connection element designed and configured for a liquid-tight connection to the container; a mandrel designed and configured to pierce a septum of a container; a reservoir containing an active ingredient in solid form, the reservoir being fluidically connectable to a connecting element via an outlet of the reservoir; a liquid-permeable filter disposed at the outlet of the reservoir and configured to retain the active ingredient in solid form within the reservoir; a fluidic element configured to receive liquid from a container into the reservoir and / or to dispense liquid from the reservoir; The device is designed and configured to receive a liquid from a container into a reservoir, dissolve an active ingredient in the liquid, and dispense the dissolved active ingredient to a patient via a connecting element.

[0012] Embodiment 2 relates to a device according to embodiment 1, wherein the mandrel has a hollow interior configured to receive liquid from a container into the reservoir.

[0013] Embodiment 3 relates to a device according to any one of the previous embodiments, in which the fluidic element has a plunger movably arranged in the reservoir and liquid-tightly closing the reservoir.

[0014] Embodiment 4 relates to a device according to any one of the previous embodiments, having a first component and a second component that are removably connectable to each other.

[0015] Embodiment 5 relates to a device according to embodiment 4, wherein the first component contains a connecting element and a mandrel, and / or the second component contains a reservoir, a filter, and a fluidic element.

[0016] Embodiment 6 relates to a device according to embodiment 4 or 5, which also has a thread capable of connecting the first component to the second component.

[0017] Embodiment 7 relates to a device according to any one of the preceding embodiments, wherein the device is fully sterile and preferably fully apyrogenic.

[0018] Embodiment 8 relates to a device according to any one of the preceding embodiments, wherein the device also has a spray nozzle configured to dispense the active ingredient in dissolved form.

[0019] Embodiment 9 relates to the device according to embodiment 8, wherein the spray nozzle is removably connectable in a fluid-conductive manner to the connecting element.

[0020] Embodiment 10 relates to a device according to any one of the preceding embodiments, wherein the active ingredient is a disinfectant preferably selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium peroxide, calcium peroxide, urea peroxide, triisocyanuric chloride, sodium-N-chloro-4-methylbenzenesulfonamide, sodium-N-chlorobenzenesulfonamide, octenidine, polyhexanide, and chlorhexidine digluconate.

[0021] Embodiment 11 relates to a device according to any one of the preceding embodiments, in which the connecting element has a first feedthrough configured to receive liquid from a container into the reservoir.

[0022] Embodiment 12 relates to a device according to any one of the preceding embodiments, in which the connection element has a second feedthrough configured to dispense liquid from a container, and dispensing is preferably possible when the device is connected to a reservoir via a first feedthrough according to embodiment 11.

[0023] Embodiment 13 relates to a device according to any one of the preceding embodiments, wherein the reservoir is transparent to gamma rays and / or electron beams.

[0024] A further aspect relates to a kit comprising a device according to one of embodiments 1 to 13 and a container with a medically compatible liquid, wherein the device is removably connectable to the container, and the kit is packaged together in a sterile manner, preferably completely sterile, more preferably completely pyrogen-free.

[0025] Another aspect relates to an active ingredient for use in a medical treatment method, wherein the active ingredient is dissolved in a liquid and then administered in dissolved form by a device according to any one of the preceding embodiments immediately prior to administration to a patient.

[0026] A further aspect is a method for preparing an active ingredient solution, comprising the steps of: a) receiving a liquid from a container into a reservoir of the device using a device according to any one of embodiments 1 to 13; b) mixing the active ingredient in the reservoir with the liquid received in step a); c) thereby obtaining an active ingredient solution; d) optionally dispensing the active ingredient solution into the container.

[0027] Another aspect relates to the use of the device according to any one of embodiments 1 to 13 for producing an active ingredient solution. [Brief explanation of the drawings]

[0028] [Figure 1] FIG. 1 shows a first part of the device that can be connected to a container. [Figure 2] FIG. 2 shows a container that can be connected to a device according to the invention. [Figure 3] FIG. 3 shows a first part of the device according to the invention attached to a container. [Figure 4] FIG. 4 shows a second part of the device according to the invention, which comprises a reservoir for the active ingredient and a fluidic element for transporting the liquid from the container. [Figure 5] FIG. 5 shows a device according to the invention connected to a container. [Figure 6] FIG. 6 shows a first part of a device according to the invention having threads for connecting to a closure or a second part of the device. [Figure 7] FIG. 7 shows a first part of the device according to the invention according to FIG. 6, which is connected to a second part of the device via a screw thread. [Figure 8] FIG. 8 shows a first part of the device according to the invention according to FIG. 6, which is connected to a nozzle via a screw thread. [Figure 9] FIG. 9 shows the device connected to a dispensing device. [Figure 10] FIG. 10 shows the device with the nozzle and shield. [Figure 11] FIG. 11 shows a nozzle with a joint that can be used with the device according to the invention. DETAILED DESCRIPTION OF THE INVENTION

[0029] With respect to the embodiments described herein, elements that "have," "contain," or "comprise" a particular feature (e.g., material) always contemplate further embodiments in which, in principle, the associated element consists solely of that feature, i.e., no other components. The terms "comprise" or "comprising" are used interchangeably herein with the terms "contain," "containing," "have," or "having."

[0030] In one embodiment, when an element is referred to in the singular, an embodiment in which there are two or more such elements is also contemplated. The use of a term for a plural element essentially encompasses embodiments in which only a single corresponding element is included. Unless otherwise indicated or clearly excluded from the context, it is in principle possible, and hereby expressly contemplated, that features of different embodiments may also be present in other embodiments described herein. Similarly, it is contemplated that, in principle, all features described herein in relation to methods are also applicable to the products and devices described herein, and vice versa. Merely for the sake of brevity, all such possible combinations are not explicitly listed in all cases. Technical solutions known to be equivalent to features described herein are also intended to be encompassed, in principle, by the scope of the present invention.

[0031] Embodiment 1 is an apparatus for producing an active ingredient solution, comprising: a connection element designed and configured for a liquid-tight connection to the container; a mandrel designed and configured to pierce a septum of a container; a reservoir containing an active ingredient in solid form, the reservoir being fluidically connectable to a connecting element via an outlet of the reservoir; a liquid-permeable filter disposed at the outlet of the reservoir and configured to retain the active ingredient in solid form within the reservoir; a fluidic element configured to receive liquid from a container into the reservoir and / or to dispense liquid from the reservoir; The device is described as being designed and configured to receive a liquid from a container into a reservoir, dissolve an active ingredient in the liquid, and dispense the dissolved active ingredient to a patient via a connecting element.

[0032] The device comprises an active ingredient. The active ingredient is preferably an antiseptic active ingredient. The active ingredient solution is preferably an antiseptic wound cleansing solution. The terms "antiseptic" and "antibacterial" are used interchangeably herein to refer to the bactericidal or fungicidal effect of the active ingredient, i.e., germicidal effect. The device may further contain excipients. The active ingredient may be present in a mixture with such excipients. The excipient may include, for example, a buffer substance. In one embodiment, the excipient is selected from the group consisting of glucuronic acid, galacturonic acid, gluconic acid lactone, sodium gluconate, sodium hydrogen sulfate, sodium dihydrogen phosphate, calcium dihydrogen phosphate, citric acid, and monosodium citrate.

[0033] The device has a connecting element designed and configured to fluid-tightly connect the device to a container. Such a container can be, for example, a package in which saline, infusion solution, and similar liquid medical products are commercially available. For example, bottles or film bags are used for this purpose. These containers are often made of plastic. The container can be a container with a flexible, preferably elastically deformable, outer wall so that the liquid contained therein can be released from the container by compressing the container. The container can include a septum that can be pierced by the mandrel of the device.

[0034] The connection element of the device may preferably be connectable to the container in a form-fitting manner, for example the connection element may be attachable to the opening of a plastic bottle or the connection of a film pouch.

[0035] The device further includes a mandrel designed and configured to pierce the septum of the container. To this end, the mandrel can have a tapered shape, the tip of which can be penetrated through the septum of the container by manually applying pressure of the mandrel to the septum. A similar structure is used to connect an infusion set to a container with an infusion solution.

[0036] The device further comprises a reservoir containing the active ingredient in solid form (e.g., powder). The reservoir may have a substantially cylindrical shape similar to the interior of a syringe.

[0037] The device can be configured to dispense the contained active ingredient in dissolved form into the container.

[0038] A filter is disposed at the outlet of the reservoir. This filter is configured to retain the active ingredient in the reservoir unless the active ingredient dissolves in the liquid. In this way, the active ingredient can be prevented from being delivered to the patient in an undissolved form. However, it is desirable that only the active ingredient be delivered to the patient in a dissolved form. For this purpose, the filter can preferably be liquid-permeable. The filter is preferably gas-permeable. A gas-permeable filter allows, for example, easier filling of the reservoir with the active ingredient, particularly during the manufacture of the device according to the present invention. For this purpose, the active ingredient can preferably be introduced into the reservoir using compressed air or a vacuum, and the gas-permeable filter allows gas to pass through but retains the active ingredient in the reservoir.

[0039] The filter can have, for example, a disk shape.The filter preferably has open porosity.In some embodiments, the filter has an open pore with a pore size of less than 5 μm, preferably less than 3 μm, particularly preferably less than 1 μm.This pore size can be determined by excluding spherical particles with corresponding particle size.Therefore, it is the nominal pore size.

[0040] The filter can be fixed by a holder in the reservoir, which can be designed for example in the form of a clamping ring. Optionally, the filter can be fixed in a recess in the wall of the reservoir.

[0041] The filter may comprise, for example, polyethylene, polyurethane, polyimide, polyethersulfone, polyvinylidene fluoride, or polytetrafluoroethylene.

[0042] The filter may be a woven or non-woven filter.

[0043] In some embodiments, the reservoir includes a second filter that divides the reservoir into two separate regions, i.e., a first region and a second region. The second filter can be fixed in the reservoir by a second holder. The first region can contain a first active ingredient, and the second region can contain a second active ingredient that is different from the first active ingredient. The first active ingredient and the second active ingredient are preferably each in solid form, for example, in powder form. Such an embodiment allows for the production of an active ingredient solution containing two different active ingredients without the two active ingredients coming into contact with each other in solid form during storage of the device.

[0044] The reservoir can be dimensioned such that the ratio of reservoir to container volume is 1:25 to 1:500. The container volume can be, for example, 250 mL, 500 mL, or 1,000 mL. Thus, the reservoir volume can be, for example, 0.5 to 10 mL, 1 to 20 mL, or 2 to 40 mL.

[0045] The device also comprises a fluidic element. The fluidic element is preferably configured to receive liquid from a container into a reservoir. Alternatively or additionally, the fluidic element may be configured to dispense liquid from the reservoir. The fluidic element is preferably configured to actively deliver liquid. The fluidic element may, for example, comprise a plunger for delivering liquid. The fluidic element may comprise a syringe or a pump.

[0046] In one embodiment, the mandrel has a hollow interior configured to receive liquid from the container into the reservoir. In this case, the mandrel can be designed, for example, in the form of a hollow needle. The mandrel can, for example, consist of or include plastic.

[0047] Preferably, the mandrel is sufficiently rigid to penetrate the septum of a commercially available container for saline solution, but not so hard and rigid as to pose a risk of injury to a healthcare professional. In one embodiment, the mandrel is not a metal needle.

[0048] In one embodiment, the fluidic element has a plunger that is movably arranged in the reservoir and closes the reservoir in a liquid-tight manner. The fluidic element can therefore be designed, for example, as a syringe or a syringe pump. The fluidic element can also have other types of means for moving liquid, for example a membrane pump, a peristaltic pump, a compressed air cartridge, or a connection for an external pressure or vacuum source.

[0049] In one embodiment, the device has a first component and a second component that can be removably connected to each other. For example, the first component can include a connecting element and a mandrel, and / or the second component can include a reservoir, a filter, and a fluidic element. The first component and the second component can be connected to each other by a connecting element, preferably a form-fitting connecting element, such as a thread or a snap hook. A preferred thread is a Luer Lock thread. The first component can preferably have an external thread that can be connected to the internal thread of the second component. The second component can have an external thread that can be connected to the internal thread of the first component.

[0050] In one embodiment, the first component can be configured to be fluidly connected to a container, while the second component can be disconnected from the first component and optionally replaced by another device, such as a closure or nozzle. Thus, the first component can function as a kind of multi-function quick connector for the other components. The second component can include a syringe, particularly preferably a Luer-Lock syringe.

[0051] As indicated above, the device may include connecting elements for connecting the individual components of the device according to the invention, in particular the first and second components, to one another, or for connecting the device to a further device, or both. In this case, a single connecting element may be configured to be alternatively connected to several different components, or several connecting elements may be provided at different locations on the device. The connecting elements are preferably form-fit connecting elements. An example of such a connecting element is a screw thread. In some embodiments, the connecting element is a Luer lock thread.

[0052] In one embodiment, the device has a connecting element capable of connecting a first component to a second component. In some embodiments, the same connecting element is further configured to connect the device to a closure, a nozzle, or another dispensing device. Alternatively, distinct individual connecting elements can be provided for these purposes.

[0053] In one embodiment, the device is completely sterilized. In one embodiment, the device is completely pyrogen-free. The term "sterilized" refers to a device that has been subjected to a method to remove or destroy pathogens so that the device can be used medically, in accordance with conventional standards, such as the DIN EN 556-1 standard. Methods for sterilization include, for example, autoclaving, irradiation with an electron beam or gamma rays, or treatment with a disinfectant (e.g., ethylene oxide). Similarly, the term "non-pyrogenic" refers to a device that has been subjected to a method conventional in the art to remove or destroy pyrogens. Whether the device is non-pyrogenic can be tested using the Reynolds Amebocyte Lysate (LAL) test according to Ph.Eur. Chapter 2.6.14. The standards or documents that are current as of the priority date of this application apply in each case.

[0054] In one embodiment, the device further comprises a nozzle configured to dispense the active ingredient in dissolved form. The nozzle may have a substantially cylindrical hollow body pointed at one end. The nozzle may optionally include a joint that allows for the dispensing of liquid in different directions by bending the nozzle opening laterally relative to the overall device.

[0055] The nozzle is preferably removably and fluidly connectable to a connecting element, which may be possible via a form-fit connecting element, for example a thread, preferably a Luer Lock thread.

[0056] The device may further include a shield. The shield may be configured to protect components of the device from splashing of the emitted liquid, particularly the active ingredient solution. The shield may be positioned on or in spatial proximity to the nozzle. The shield may have a disk shape. The shield may have a concave curvature similar to a parabolic antenna. The shield may have a centrally located recess configured to attach the shield to the output of the device.

[0057] In one embodiment, the active ingredient contained in the device is a disinfectant. In one embodiment, the disinfectant is selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium peroxide, calcium peroxide, urea peroxide, triisocyanuric acid chloride, sodium-N-chloro-4-methylbenzenesulfonamide, sodium-N-chlorobenzenesulfonamide, octenidine, polyhexanide, and chlorhexidine digluconate. In one embodiment, the disinfectant is a hypochlorite.

[0058] In one embodiment, the active ingredient is present as a powder with an average particle size of less than 300 μm, preferably less than 200 μm, particularly preferably less than 100 μm.Due to the small particle size, the particles of the active ingredient can be rapidly dissolved.The particle size of the active ingredient can preferably exceed the excluded volume of the filter.This average particle diameter can be determined by fractional screening, as is customary in the art.In one embodiment, the active ingredient is present as a cylindrical press blank or as a cylindrical solidified melt.

[0059] In one embodiment, the connecting element has a first feedthrough configured to receive liquid from a container into the reservoir, the first feedthrough preferably forming a fluid-conducting connection between the connecting element (particularly the mandrel) and the reservoir.

[0060] In one embodiment, the device is configured to dispense a liquid from a container. In this case, dispensing is preferably possible while the device is fluidly connected to the reservoir via the first feedthrough described above. For example, using such an embodiment, liquid from a container connected to the device can be first received in the device's reservoir, the active ingredient contained in the liquid can be dissolved, and then the dissolved active ingredient can be dispensed into the container while the device is connected to the container. The dissolved active ingredient can then be dispensed from the container to the patient through the device while the device, particularly the first component of the device, is still connected to the container. If necessary, the device can be connected to a nozzle or another dispensing device for dispensing the released active ingredient, and the second component of the device can optionally be replaced with a nozzle or other dispensing device. The liquid is preferably a medically compatible liquid. The liquid is preferably suitable for internal application.

[0061] In one embodiment, the reservoir is transparent to gamma radiation and / or electron beam radiation, which allows for sterilization of the interior of the device and the active ingredients contained therein using gamma radiation and / or electron beam radiation to obtain a completely sterile device.

[0062] In one embodiment, the mandrel and reservoir together define a transfer axis along which liquid may be dispensed from and / or received into the reservoir. In one embodiment, the container and reservoir together define a transfer axis along which liquid may be dispensed from and / or received into the reservoir.

[0063] Another aspect relates to a kit comprising a device according to any one of the preceding embodiments and a container with a medically compatible liquid, the device being removably connectable to the container. In one embodiment, the components of the kit, i.e., the device and the container, are packaged together in a sterile manner. In one embodiment, each of the components of the kit is completely sterilized. In one embodiment, each of the components of the kit is completely pyrogen-free. The kit may further contain a dispensing device for dispensing the liquid, such as a nozzle or a rinsing device, such as a rinsing device according to EP 4035605, which is fully incorporated herein by reference. The medically compatible liquid may comprise an infusion solution or a medical rinsing solution. The medically compatible liquid may comprise saline, Ringer's solution, or an equivalent salt-containing solution. The medically compatible liquid is preferably sterile and / or pyrogen-free.

[0064] A further aspect relates to an active ingredient for use in a medical treatment method, wherein the active ingredient is dissolved in a liquid immediately prior to administration to a patient and then administered in dissolved form. The active ingredient may be a substance having a pharmacological effect. The active ingredient may, for example, have an antibacterial effect.

[0065] Another aspect relates to a medical treatment method in which an active agent is dissolved in a liquid using a device described herein immediately prior to administration to a patient as described herein, and then administered in dissolved form. The liquid is preferably a medically compatible liquid as described herein. The treatment method can include, for example, disinfecting fabrics. The treatment method can include surgical joint surgery, for example, implanting or replacing a joint implant. The joint implant can be, for example, a spacer. The joint surgery can include, for example, surgical hip, knee, shoulder, or back surgery. The treatment method can further include treatment of an inflammatory condition. The treatment method can include, for example, treatment of arthritis or joint infection.

[0066] A further aspect is a method for preparing an active ingredient solution, comprising the steps of: a) receiving a liquid from a container into a reservoir of the device using a device as described herein; b) mixing the active ingredient in the reservoir of the device with the liquid received in step a); c) thereby obtaining an active ingredient solution; d) optionally dispensing the active ingredient solution into the container.

[0067] The method can preferably be carried out in the order of a), b), c), or a), b), c), d). The method can further comprise the step of releasing the active ingredient solution from the device or container. The active ingredient solution can preferably be released from the container via a device, as described in more detail elsewhere herein.

[0068] A further aspect relates to an active ingredient solution that can be produced according to the method set out above.

[0069] A further aspect relates to the use of a device as described herein or a kit as described herein for producing an active ingredient solution. [Example]

[0070] The present invention will now be further described using examples, but it should be understood that the present invention is not limited to these examples. It will be apparent to those skilled in the art that other equivalent means can be used in place of the features described herein.

[0071] drawing FIG. 1 shows, by way of example, a first component 150 of the device 100, which can be connected to a container 200. The first component 150 of the device has a connecting element 101 that can be connected to the container in a form-fitting manner; for example, a connection is provided at the head of an infusion bottle or a film pouch for this purpose. The device also has a mandrel 102 that can pierce the septum 201 of the container. The mandrel 102 has an internal cavity 115 for guiding the liquid from the container into the device. The internal cavity is connected to a feedthrough 111 of the device. The first component 150 of the device 100 also has a connecting element 109 that can connect the first component 150 of the device to a second component 160 of the device. The connecting element 109 in this example is designed as a Luer lock thread.

[0072] 2 shows a container 200 that can be connected to a device according to the invention. The container 200 contains a medically compatible liquid 202 and has a septum 201 that seals the container from the outside. The septum 201 is made from an elastic material, for example silicone. The septum can be further protected by a seal that can be removed before connection to a device according to the invention.

[0073] 3 shows a first component 150 of the device according to the invention attached to a container 200. The mandrel 102 penetrates the bulkhead 201 of the container 200 so that a liquid 202 can be transferred from the container through the cavity 115 and the first feedthrough 109 into the device. The device comprises a first thread 109 and a second thread 113. Both threads (109, 113) of the first component 150 are here designed as external threads.

[0074] 4 shows a second part 160 of the device 100 according to the invention, which comprises a reservoir 103 for the active ingredient 104 and a fluidic element 107 for transporting the liquid 202 from the container 200. The fluidic element 107 is designed here as a syringe. The active ingredient 104 is disposed in the reservoir 103 as a solid powder. The device also comprises a filter 106 for retaining the active ingredient 104 in the reservoir 103. The active ingredient 104 can only pass through the filter 106 in dissolved form. The filter 106 is fixed in the reservoir 103 by a holder 116, sealing the reservoir 103 from the outside and preventing the solid active ingredient 104 from passing through the filter 106 and leaving the reservoir 103. The second component 160 comprises a connecting element for connecting to the first component 150. This connecting element of the second component 160 is complementary to the connecting element of the first component 150. In the example shown here, the second component 160 has an internal luer lock thread.

[0075] 5 shows a device 100 according to the invention connected to a container 200. A first component 150 of the device is fluidly and liquid-tightly connected to a second component 160 of the device via a connecting element 109. A connecting element 101 is connected to the container 200, and a mandrel 102 is inserted into the container through a bulkhead of the container. The interior of the container is fluidly connected to a reservoir 103 via a cavity 115 in the mandrel. A fluidic element having a plunger 108 can now be used to dispense liquid from the container 200 into the reservoir 103.

[0076] 6 shows a first component 150 of a device according to the invention, having a connecting element 109 for connection to a closure 114 or to a second component of the device 160. In the embodiment shown here, the connecting element 109, designed as a thread, can alternatively be connected to a different element. The thread 109 can either be fluidly connected to the second component of the device 160 or can be closed fluid-tight using the closure 114.

[0077] 7 shows the first component 150 of the device according to the invention according to FIG. 6, which is connected to the second component 160 of the device by a screw thread 109. In this configuration, the interaction of the two components 150 and 160 of the device allows liquid to be removed from the container 200. The liquid can be pumped from the container 200 through the first feedthrough 111 into the reservoir 103. In the reservoir 103, the active ingredient 104 contained therein can be dissolved with the liquid, and the active ingredient solution thus obtained can be guided into the container 200 through the filter 106. The second component 160 of the device can then be removed, and the active ingredient solution can be dispensed from the container by the first component 150 of the device, for example to a patient.

[0078] Figure 8 shows a first component 150 of the device according to the invention according to Figure 6, which can be connected to a nozzle 110 via a screw thread 109. The nozzle 110 and the feed-through 111 can be used to dispense the active ingredient solution produced using the device from a container 200. If necessary, the feed-through 111 can be sealed liquid-tight by attaching a closure 114 to the connecting element 109.

[0079] 9 shows a device according to the invention simultaneously connected to a container 200 and to an external dispensing device. For this purpose, the device comprises, in addition to a first feedthrough 111, here closed fluid-tight by a closure 114, a second feedthrough 112 configured for connection to an external dispensing device. In the configuration shown here, the first component 150 is fluidically connected to the container 200 by a connecting element 101, so that the active ingredient solution produced with the device can be dispensed from the container 200 via the second feedthrough 112.

[0080] 10 shows a first component of the device comprising a nozzle 110 and a shield 117. The first component is configured to dispense the active ingredient solution from a container 200. The shield 117 in the example shown here has a central cylindrical recess for securing to the first component 150 and / or the nozzle 110. The shield can act as a splash guard when the active ingredient solution is released by the nozzle 110.

[0081] 11 shows a nozzle 110 with a joint 118 that can be used with the device according to the invention. By means of the joint 118, the nozzle 110 can be bent so that the nozzle outlet opening forms an angle other than 180° with the nozzle connection. This allows the active ingredient solution to be released in different directions without having to rotate the entire device. [Explanation of symbols]

[0082] 100 devices 101 Connection Elements 102 Mandrel 103 Reservoir 104 Active Ingredients 105 Reservoir outlet 106 filters 107 Fluid Elements 108 Plunger 109 First connecting element (for connecting components) 110 nozzle 111 First feedthrough (for receiving from container) 112 Second feedthrough (for connection to pump etc.) 113 Second connecting element (for nozzle) 114 Closure 115 Mandrel Cavity 116 Filter holder 117 Shield 118 Joint 150 First Component 160 Second Component 200 containers 201 Next Door 202 Liquid

Claims

1. An apparatus (100) for producing an active ingredient solution that is a disinfectant wound cleansing solution, comprising: a connection element (101) designed and configured for a liquid-tight connection to a container (200); a mandrel (102) designed and configured to pierce the septum (201) of said container; a reservoir (103) containing an active ingredient (104) in solid form, the reservoir (103) being fluidically connectable to said connecting element (101) via an outlet (105) of said reservoir; a liquid-permeable filter (106) disposed at the outlet (105) of the reservoir and configured to retain the active ingredient (104) in solid form within the reservoir (103); a fluidic element (107) configured to receive a liquid (202) from the container (200) into the reservoir (103) and / or to dispense a liquid (202) from the reservoir (103); The device (100) is designed and configured to receive the liquid (202) from the container (200) into the reservoir, dissolve the active ingredient (104) in the liquid (202), and dispense the dissolved active ingredient to a patient via the connecting element (101).

2. 10. The device of claim 1, wherein the active ingredient is a disinfectant selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium peroxide, calcium peroxide, urea peroxide, triisocyanuric acid chloride, sodium-N-chloro-4-methylbenzenesulfonamide, sodium-N-chlorobenzenesulfonamide, octenidine, polyhexanide, and chlorhexidine digluconate.

3. 3. The apparatus of claim 2, wherein the mandrel (102) has a hollow interior (115) configured to receive the liquid (202) from the container (200) into the reservoir (103).

4. 3. The device of claim 2, wherein the fluid element (107) comprises a plunger (108) movably disposed within the reservoir (103) for closing the reservoir in a fluid-tight manner.

5. The device has a first component (150) and a second component (160) that are removably connectable to each other; 3. The device of claim 2, wherein the first component (150) includes the connecting element (101) and the mandrel (102), and / or the second component (160) includes the reservoir (103), the filter (106), and the fluid element (107).

6. The apparatus of claim 5, further comprising a connecting element (109) capable of connecting the first component (150) to the second component (160).

7. The device of claim 2 , wherein the device is completely sterilized.

8. The device described in claim 2, wherein the device is completely non-pyrogenic.

9. 3. The device of claim 2, wherein the device also comprises a nozzle (110) configured to dispense the active ingredient in dissolved form.

10. 10. The device according to claim 9, wherein the nozzle (110) is removably connectable in fluid conductance to the connecting element (101).

11. 3. The device of claim 2, wherein the connecting element (101) comprises a first feedthrough (111) configured to receive the liquid (202) from the container (200) into the reservoir (103).

12. 12. The device of claim 11, wherein the connection element (101) has a second feedthrough (112) configured to dispense the liquid (202) from the container (200), the dispensing being possible when the device (100) is connected to the reservoir (103) via the first feedthrough (111).

13. 13. The device of claim 12, wherein the reservoir (103) is transparent to gamma rays and / or electron beams.

14. 13. The apparatus of claim 12, wherein the reservoir (103) further comprises a second filter that divides the reservoir (103) into a first region and a second region.

15. 10. A kit comprising the device (100) of claim 2 and a container (200) containing a medically compatible liquid, said device (100) being removably connectable to said container (200), said kit being packaged together in a sterile condition.

16. An active ingredient for use in a medical treatment method, wherein the active ingredient, which is a disinfectant wound cleansing ingredient, is dissolved in the liquid and then administered in dissolved form by the device of claim 2 or the kit of claim 15 immediately prior to administration to a patient.

17. 1. A method for producing an active ingredient solution, comprising: a) receiving the liquid (202) from the container (200) into the reservoir (103) of the device (100) using the device (100) of claim 2; b) mixing the active ingredient (104) in the reservoir (103) with the liquid (202) received in step a); c) thereby obtaining an active ingredient solution; d) optionally dispensing said active ingredient solution into said container (200).

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