DEVICE FOR THE PREPARATION AND DISPENSING OF AN ANTISEPTIC WOUND RINSE SOLUTION

Description

FIELD OF THE INVENTION

[0001] The present invention relates to the field of medical technology, in particular to devices for preparing and dispensing active substance solutions, for example wound irrigation solutions. TECHNICAL BACKGROUND

[0002] Antiseptic agents and antiseptic solutions have been known since the 19th century. Hypochlorite salts and their solutions are an example of such an agent. The shelf life of aqueous hypochlorite solutions is limited. This is primarily due to the slow conversion of hypochlorite ions to chlorate ions. This means that the hypochlorite content of the solutions decreases with increasing storage time. In addition, decomposition of hypochlorite ions into chloride ions and oxygen is also possible.

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

[0004] Such solutions have been described, for example, in the following publications: US8945630B2, US2011 / 0236490A1, WO2021001789, US2019328776A1, WO2021134041A1, WO2022 / 038507A1, WO2020252433, WO2020174436A1, US243781, US3749672, US6162371, WO1991 / 003936, US6471974, US2009 / 0258083, WO2010148004, WO2010148004, US2009 / 0148342A1, WO2016 / 100543A2, WO2020 / 089693A1, and WO2021 / 162736A1.

[0005] However, complete protection against decomposition of hypochlorite ions in aqueous solution remains challenging.

[0006] A further challenge is the provision of such solutions in sterile form, with the aim of ensuring that the containers are also sterile and stable. US4964261A and US2005232848A1, for example, address this task.

[0007] Solid precursors for the preparation of hypochlorite-containing solutions are described in DE2712574A1 and US4104190A1.

[0008] US 2013 / 289530 A1 discloses a device for withdrawing premixed pharmaceuticals or for reconstituting freeze-dried pharmaceuticals and for injecting the reconstituted

[0009] drug into the patient. The device includes a syringe assembly and an adapter assembly removably connectable to a medicament container containing a premixed or freeze-dried medicament. The syringe assembly of the device includes a fluid chamber between the front end of the body portion and the plunger, and a syringe needle assembly. The syringe needle assembly, removably connectable to the body portion, includes a needle holder and an injection needle sealingly connected to the needle holder. The adapter assembly includes an adapter, preferably molded from a moldable plastic, and having a top wall, an adapter cannula connected to and extending from the top wall, and a plurality of connectors connected to the top wall for removably connecting the adapter to the medicament container.

[0010] US 7 900 659 B2 discloses a pressure-equalizing access device and method for delivering vial contents, allowing for a closed and sealed reconstitution of the vial contents. A rigid container with a fixed internal volume is connected to a vent lumen extending into the vial. As the pressure in the ampoule increases, it is equalized to atmospheric pressure by varying the volume of a compartment within the rigid container. The compartment is provided with a volume control device that automatically varies the volume of the compartment in the rigid container to adjust and equalize the pressure in the ampoule by increasing or decreasing the compartment volume. In one case, the volume control device consists of a sliding disc and in another case, a bladder that compresses when the container volume increases and expands when the container volume decreases.

[0011] FR2773735A1 discloses a chamber for transferring a liquid into or dispensing from a container. The chamber has a flexible wall that is substantially impermeable to the external medium and is provided with separate couplings for connecting a container to transfer and dispensing units. It can also be connected to a vessel containing another substance, for example, for mixing with the product in the container.

[0012] US 2007 / 249996 A1 discloses a device having a chamber within a syringe. A fluid passage extends through a syringe plunger. A valve is connected to the passage and controls the fluid passage through the plunger. The invention comprises a piercing structure having a head segment and a body portion with a channel through the body portion and through at least one surface of the head without passing through the tip. In another aspect, the invention comprises a method of manufacturing an agent for administration to an individual. A first component is contained in a syringe and a second component is contained in an ampoule. A closed valve is connected to a fluid passage between the vial and the syringe barrel via a plunger.Repositioning the valve allows fluid to pass through, and sliding the plunger connects the first and second components. Repeated sliding of the plunger mixes the components and produces the drug.

[0013] US7195623B2 discloses a kit and needle assembly for reconstituting a quantity of a freeze-dried medicament. The kit of the invention may comprise a reconstitution device having a non-transparent needle cover portion with a cavity adapted to receive the inserted, plugged end of the injection pen cartridge, the needle cover portion extending around a side-firing cannula to conceal the cannula from side view. A slidable alignment element retained within the needle cover portion in a first axial position and slidable to a second axial position when the injection pen cartridge abuts it during insertion may be included.The kit includes an injection pen cartridge with a barrel filled with a specific amount of freeze-dried drug, a sliding plunger used to expel the reconstituted drug during pen operation, and a plug through which the needle can be penetrated during drug reconstitution. The needle assembly of the invention may include a needle forming an axial passage therethrough that communicates with a reservoir of diluent fluid.

[0014] US 2011 / 171283 A1 discloses a composition containing at least one nutritive, at least one disinfecting or decontaminating and / or at least one protease-inhibiting active ingredient and / or active ingredient complex for the external care and / or treatment of wounds of the human or animal body. PREFERRED EMBODIMENTS

[0015] The invention comprises a device for producing an antiseptic wound irrigation solution according to claim 1, a kit according to claim 13, a method according to claim 14 and, according to claim 15, the use of the device according to claim 1. An object of the present invention is to solve one or more of the above-described and other problems of the prior art. For example, the invention provides an active substance-containing device with the aid of which a ready-to-use active substance solution can be prepared quickly, easily and inexpensively using commercially available containers with sterile saline solution or comparable solutions.

[0016] Because the device according to the invention contains the active ingredient in solid form, the device can be stored for extended periods, even if it contains an active ingredient that is not permanently stable in aqueous solution. Furthermore, the sterilization of liquids is not required during the manufacture of the device according to the invention. Some active ingredients are easier to sterilize in solid form because they decompose more easily in solution during sterilization. In some embodiments, the device according to the invention provides the option of delivering the liquid prepared therein directly to a patient, for example, using a nozzle that can be attached to the device according to the invention.

[0017] These objects are achieved by the methods and devices described herein, in particular those described in the patent claims.

[0018] Preferred embodiments of the invention are described below.

[0019] A first embodiment relates to a device for producing an antiseptic wound irrigation solution, comprising a connection element designed and configured for liquid-tight connection to a container; a mandrel designed and configured for piercing a septum of a container; a reservoir containing an active ingredient in solid form and fluidically connectable to the connection element via an outlet of the reservoir; a liquid-permeable filter arranged at the outlet of the reservoir and configured to retain the active ingredient in solid form in the reservoir; a fluidic element configured to receive a liquid from a container into the reservoir and / or to dispense a liquid from the reservoir; wherein 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 deliver the dissolved active ingredient to a patient via the connecting element, wherein the active ingredient is an antiseptic 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.

[0020] A second embodiment relates to a device according to embodiment 1, wherein the mandrel has a hollow interior adapted to receive a liquid from a container into the reservoir.

[0021] A third embodiment relates to a device according to one of the preceding embodiments, wherein the fluidic element has a piston movably arranged within the reservoir, which seals the reservoir in a liquid-tight manner.

[0022] A fourth embodiment relates to a device according to one of the preceding embodiments, which has a first component and a second component which can be detachably connected to one another.

[0023] A fifth embodiment relates to a device according to embodiment 4, wherein the first component contains the connection element and the mandrel, and / or wherein the second component contains the reservoir, the filter and the fluidic element.

[0024] A sixth embodiment relates to a device according to embodiment 4 or 5, wherein the device further comprises a thread by means of which the first component can be connected to the second component.

[0025] A seventh embodiment relates to a device according to one of the preceding embodiments, wherein the device is completely sterilized, preferably completely pyrogen-free.

[0026] An eighth embodiment relates to a device according to one of the preceding embodiments, wherein the device further comprises a spray nozzle which is designed to dispense the active ingredient in dissolved form.

[0027] A ninth embodiment relates to a device according to embodiment 8, wherein the spray nozzle can be detachably connected to the connecting element in a fluid-conducting manner.

[0028] A further embodiment relates to a device according to one of the preceding embodiments, wherein the connecting element has a first passage which is designed to receive a liquid from a container into the reservoir.

[0029] A further embodiment relates to a device according to one of the preceding embodiments, wherein the connecting element has a second passage which is designed to dispense a liquid from a container, wherein the dispensing is preferably possible in a state in which the device is connected to the reservoir via the first passage according to embodiment 11.

[0030] A further embodiment relates to a device according to one of the preceding embodiments, wherein the reservoir is permeable to gamma rays and / or electron beams.

[0031] A further aspect relates to a kit comprising a device according to one of embodiments 1 to 13 and a container with a medically acceptable liquid, wherein the device is detachably connectable to the container, wherein the kit is packaged together in a germ-tight manner, preferably completely sterilized, more preferably completely pyrogen-free.

[0032] Also disclosed is an active ingredient for use in a medical treatment method, wherein the active ingredient is dissolved in a liquid immediately before administration to a patient and is then administered in dissolved form using a device according to one of the preceding embodiments.

[0033] A further aspect relates to a method for producing an antiseptic wound irrigation solution, which comprises the following steps, a) taking a liquid from a container into the reservoir of the device using a device according to one of the above-mentioned embodiments, b) mixing the active ingredient within the reservoir with the liquid taken up in step a), c) thereby obtaining an antiseptic wound irrigation solution, d) optionally dispensing the antiseptic wound irrigation solution into the container.

[0034] A further aspect relates to the use of a device according to one of embodiments 1 to 13 for producing an antiseptic wound irrigation solution. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 shows a first part of a device which can be connected to a container. Figure 2 shows a container that can be connected to a device according to the invention. Figure 3 shows a first part of a device according to the invention, which is attached to a container. Figure 4shows a second part of a device according to the invention with a reservoir for an active ingredient and a fluidic element for transporting a liquid from a container. Figure 5 shows a device according to the invention which is connected to a container. Figure 6 shows a first part of a device according to the invention, which has a thread for connection to a closure or a second part of the device. Figure 7 shows a first part of a device according to the invention according to Figure 6 , which is connected to a second part of the device via the thread. Figure 8 shows a first part of a device according to the invention according to Figure 6 , which is connected to a nozzle via the thread. Figure 9 shows a device connected to a dispensing device. Figure 10 shows a device equipped with a nozzle and a shield. Figure 11shows a nozzle with a joint which can be used with a device according to the invention. DETAILED DESCRIPTION

[0036] For the embodiments described herein, whose elements "have," "contain," or "comprise" a particular feature (e.g., a material), a further embodiment is always contemplated in which the element in question consists solely of the feature, i.e., comprises no further components. The word "comprise" or "comprising" is used herein synonymously with the word "contain," "containing," "have," or "having."

[0037] When an embodiment refers to an element in the singular, an embodiment in which multiple elements are present is also contemplated. The use of a plural term for an element generally encompasses an embodiment in which only a single corresponding element is included.

[0038] Unless otherwise stated or clearly excluded by the context, it is fundamentally possible and hereby clearly contemplated that features of different embodiments may also be present in the other embodiments described herein. Likewise, it is fundamentally contemplated that all features described herein in connection with a method are also applicable to the products and devices described herein, and vice versa. Merely for the sake of conciseness, all of these contemplated combinations are not explicitly listed in all cases.

[0039] A first embodiment describes a device for producing an active ingredient solution, comprising a connection element designed and configured for liquid-tight connection to a container; a mandrel designed and configured for piercing a septum of a container; a reservoir containing an active ingredient in solid form and fluidically connectable to the connection element via an outlet of the reservoir; a liquid-permeable filter arranged at the outlet of the reservoir and configured to retain the active ingredient in solid form in the reservoir; a fluidic element configured to receive a liquid from a container into the reservoir and / or to dispense a liquid from the reservoir; wherein 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 deliver the dissolved active ingredient to a patient via the connecting element, wherein the active ingredient is an antiseptic 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.

[0040] The device comprises an active ingredient. According to the invention, the active ingredient is an antiseptic.

[0041] The active ingredient solution is therefore an antiseptic wound irrigation solution. The terms "antiseptic" and "antimicrobial" are used synonymously herein and refer to a bactericidal or fungicidal, i.e., germicidal, effect of an active ingredient. The device may further contain an excipient. The active ingredient may be present as a mixture with such an excipient. The excipient may, for example, comprise 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.

[0042] The device has a connecting element. The connecting element is designed and configured for the liquid-tight connection of the device to a container. Such containers can, for example, be packaging in which physiological saline solutions, infusion solutions, and similar liquid medical products are commercially available. Common examples for this purpose are bottles or foil bags. These containers are often made of plastic. The container can be a container with a flexible, preferably elastically deformable, outer wall so that a liquid contained therein can be released from the container by squeezing the container. The container can comprise a septum which can be pierced with the spike of the device. The connecting element of the device can preferably be connectable to a container in a form-fitting manner.For example, the connecting element can be attached to the opening of a plastic bottle or the connection of a foil bag.

[0043] The device further includes a spike designed and configured to pierce a septum of a container. For this purpose, the spike can have a tapered shape, with the tip of which a septum of a container can be penetrated by manually exerting pressure of the spike on the septum. Similar structures are used to connect infusion sets to containers containing infusion solutions.

[0044] The device further comprises a reservoir. The reservoir contains an active ingredient in solid form, for example, as a powder. The reservoir can have a substantially cylindrical shape, similar to the interior of a syringe.

[0045] The device can be designed to release the active ingredient contained therein in dissolved form into the container.

[0046] A filter is arranged at an outlet of the reservoir. This filter is designed to retain the active ingredient in the reservoir as long as the active ingredient is not dissolved in a liquid. In this way, it can be prevented that the active ingredient is delivered to a patient in undissolved form. However, it is desirable that the active ingredient can only be delivered to a patient exclusively in dissolved form. For this purpose, the filter can preferably be permeable to liquids. The filter is preferably permeable to gases. A gas-permeable filter enables, for example, easier filling of the reservoir with active ingredient, in particular during production of the device according to the invention. For this purpose, the active ingredient can preferably be introduced into the reservoir using compressed air or a vacuum, whereby the gas-permeable filter allows the gas to pass through but retains the active ingredient in the reservoir.

[0047] The filter can, for example, be shaped like a disc. The filter preferably has open porosity. In some embodiments, the filter has open pores with a pore size of less than 5 µm, preferably less than 3 µm, and particularly preferably less than 1 µm. This pore size can be determined by excluding spherical particles with a corresponding particle diameter. It is therefore a nominal pore size.

[0048] The filter can be secured within the reservoir by a holder. The holder can be designed, for example, in the form of a clamping ring. Optionally, the filter can be secured in a recess in a wall of the reservoir.

[0049] The filter can, for example, comprise polyethylene, polyurethane, polyimide, polyethersulfone, polyvinylidene fluoride or polytetrafluoroethylene.

[0050] The filter can be a woven filter or a non-woven filter.

[0051] In some embodiments, the reservoir comprises a second filter that divides the reservoir into two separate regions, a first region and a second region. The second filter can be secured within 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 powder form. Such an embodiment enables the preparation of an active ingredient solution containing two different active ingredients without the two active ingredients in solid form coming into contact with each other during storage of the device.

[0052] The reservoir can be dimensioned such that the ratio of the volumes of the reservoir and the container is 1:25 to 1:500. The volume of the container can be, for example, 250 ml, 500 ml, or 1000 ml. Accordingly, the volume of the reservoir can be, for example, 0.5 to 10 ml, 1 to 20 ml, or 2 to 40 ml.

[0053] The device further comprises a fluidic element. The fluidic element is preferably configured to receive a liquid from a container into the reservoir. The fluidic element can alternatively or additionally be configured to dispense a liquid from the reservoir. The fluidic element is preferably configured to actively convey a liquid. The fluidic element can, for example, comprise a piston for conveying a liquid. The fluidic element can comprise a syringe or a pump.

[0054] In one embodiment, the mandrel has a hollow interior designed to receive a liquid from a container into the reservoir. The mandrel can be configured, for example, in the form of a hollow needle. The mandrel can be made of plastic, for example, or comprise a plastic.

[0055] Preferably, the spike is sufficiently stiff to penetrate the septum of a standard saline container, but not so hard and rigid that it poses a risk of injury to medical personnel. In one embodiment, the spike is not a metal needle.

[0056] In one embodiment, the fluidic element comprises a piston movably arranged within the reservoir, which seals the reservoir in a fluid-tight manner. The fluidic element can thus be designed, for example, as a syringe or syringe pump. The fluidic element can also comprise other types of means for moving a fluid, e.g., a diaphragm pump, peristaltic pump, compressed air cartridge, or a connection for an external pressure or vacuum source.

[0057] In one embodiment, the device comprises a first component and a second component, which can be detachably connected to one another. For example, the first component can contain the connection element and the mandrel, and / or the second component can contain the reservoir, the filter, and the fluidic element. The first component and the second component can be connected to one another by a connecting element, preferably a form-fitting connecting element, for example by means of a thread or snap hook. A preferred thread is a Luer-Lock thread. The first component can preferably have an external thread that can be connected to an internal thread of the second component. The second component can have an external thread that can be connected to an internal thread of the first component.

[0058] In one embodiment, the first component can be configured to be fluidically connected to a container, while the second component can be detached from the first component and optionally replaced with another device, for example, a closure or a nozzle. The first component can thus serve as a type of multifunctional quick connector for other components. The second component can comprise a syringe, particularly preferably a Luer-Lock syringe.

[0059] As explained above, the device can comprise a connecting element to either connect individual parts of the device according to the invention, in particular the first component and the second component, to one another, or to connect the device to further devices, or both. In this case, either a single connecting element can be configured to be alternatively connected to a plurality of different parts, or multiple connecting elements can be provided at different positions on the device. Preferably, a connecting element is a positive-locking connecting element. An example of such a connecting element is a thread. In some embodiments, the connecting element is a Luer-Lock thread.

[0060] In one embodiment, the device comprises a connecting element by means of which the first component can be connected to the second component. In some embodiments, the same connecting element is additionally configured to connect the device to a closure, a nozzle, or another dispensing device. Alternatively, separate, mutually different connecting elements can be provided for these purposes.

[0061] In one embodiment, the device is fully sterilized. In one embodiment, the device is completely pyrogen-free. The term "sterilized" refers to the device having undergone a process to remove or destroy pathogens, so that the device can be used medically according to common standards, such as DIN EN 556-1. Sterilization processes include, for example, autoclaving, irradiation with electron beams or gamma rays, or treatment with disinfectant substances such as ethylene oxide. Similarly, the term "pyrogen-free" refers to the device having undergone a treatment customary in the art to remove or decompose pyrogens. The pyrogen-free nature of the device can be determined using the Limulus Amebocyte Lysate (LAL) test according to Ph. Eur. Chapter 2.6.14. The relevant standards apply.Documents that are current as of the priority date of the present application.

[0062] In one embodiment, the device further comprises a nozzle configured to dispense the active ingredient in dissolved form. The nozzle may comprise a substantially cylindrical hollow body tapered at one end. The nozzle may optionally comprise a joint that allows the dispensing of a liquid in different directions by laterally bending a nozzle opening relative to the entire device.

[0063] Preferably, the nozzle is detachably fluid-conductingly connectable to the connecting element. This can be achieved via a positive connection element, for example, a thread, preferably a Luer-Lock thread.

[0064] The device may further comprise a shield. The shield may be configured to protect parts of the device from splashes of the dispensed liquid, in particular an active ingredient solution. The shield may be arranged on or in close proximity to the nozzle. The shield may be in the shape of a disc. The shield may have a concave curvature, similar to a parabolic antenna. The shield may have a centrally arranged recess configured for attaching the shield to an outlet of the device.

[0065] According to the invention, the active ingredient contained in the device is an antiseptic 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. In one embodiment, the antiseptic is a hypochlorite salt.

[0066] 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, and particularly preferably less than 100 µm. The small particle size allows for rapid dissolution of the active ingredient particles. The particle size of the active ingredient can preferably be above the exclusion volume of the filter. This average particle diameter can be determined by fractional sieving, as is common in the art. In one embodiment, the active ingredient is present as a cylindrical pellet or as a cylindrical solidified melt.

[0067] In one embodiment, the connecting element has a first passage configured to receive a liquid from a container into the reservoir. The first passage preferably forms a fluid-conducting connection between the connecting element, in particular the mandrel, and the reservoir.

[0068] In one embodiment, the device is designed to dispense a liquid from a container. In this case, dispensing is preferably possible in a state in which 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 first be taken up into the reservoir of the device, the active ingredient contained therein can be dissolved in the liquid, and the dissolved active ingredient can then 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 a patient via the device while the device, in particular the first component of the device, remains connected to the container.If desired, the device for dispensing the dissolved active ingredient can be connected to a nozzle or other dispensing device, whereby the second component of the device can be replaced with the nozzle or other dispensing device if necessary. The liquid is preferably a medically acceptable liquid. The liquid is preferably suitable for internal use.

[0069] In one embodiment, the reservoir is permeable to gamma rays and / or electron beams. This makes it possible to sterilize the interior and the active ingredient contained within the device using gamma rays and / or electron beams to obtain a fully sterilized device.

[0070] In one embodiment, the mandrel and the reservoir jointly define a transfer axis, along which transfer axis the liquid can be discharged from the reservoir and / or into the reservoir. In one embodiment, the container and the reservoir jointly define a transfer axis, along which transfer axis the liquid can be discharged from the reservoir and / or taken up into the reservoir.

[0071] A further aspect relates to a kit comprising a device according to one of the preceding embodiments and a container with a medically acceptable liquid, wherein the device is detachably connectable to the container. In one embodiment, the components of the kit, namely the device and the container, are packaged together in a germ-tight manner. In one embodiment, the components of the kit are each completely sterilized. In one embodiment, the components of the kit are each completely pyrogen-free. The kit can further contain a dispensing device for dispensing a liquid, for example a nozzle or rinsing device, for example a rinsing device according to EP4035605A1, which is hereby incorporated in its entirety by reference. The medically acceptable liquid can comprise an infusion solution or medical rinsing solution.The medically acceptable fluid may include physiological saline, Ringer's solution, or a comparable saline solution. The medically acceptable fluid is preferably sterile and / or pyrogen-free.

[0072] Also disclosed is an active ingredient for use in a medical treatment method, wherein the active ingredient is dissolved in a liquid using a device described herein immediately before administration to a patient and is then administered in dissolved form. The active ingredient can be a substance that has a pharmacological effect. For example, the active ingredient can have an antimicrobial effect.

[0073] Furthermore, a medical treatment method is disclosed, wherein the active ingredient is dissolved in a liquid using a device described herein immediately before administration to a patient as described herein and is then administered in dissolved form. The liquid is preferably a medically acceptable liquid as described herein.

[0074] A further aspect relates to a process for producing an active ingredient solution, which comprises the following steps, a) taking a liquid from a container into the reservoir of the device using a device described herein, b) mixing the active ingredient within the reservoir of the device with the liquid taken up in step a), c) thereby obtaining an active ingredient solution, d) optionally dispensing the active ingredient solution into the container.

[0075] The method can preferably be carried out in the order a), b), c) or a), b), c), d). The method can further comprise a step in which the active ingredient solution is dispensed from the device or from the container. Preferably, the active ingredient solution can be dispensed from the container via the device, as described in more detail elsewhere herein.

[0076] Furthermore, an active ingredient solution is disclosed which can be produced by a process described above.

[0077] A further aspect relates to a use of a device or kit described herein for preparing an active ingredient solution. EXAMPLES

[0078] The invention is further illustrated below by examples, which, however, are not to be construed as limiting. It will be apparent to those skilled in the art that other equivalent means may be used in a similar manner instead of the features described here. FIGURES

[0079] Figure 1 shows an example of a first component 150 a device 100, which with a container 200 The first component 150 the device has a connecting element 101 which can be connected to a container in a form-fitting manner, for example, with a connection provided on the head of an infusion bottle or a foil bag. The device also has a mandrel 102 with which a septum 201 a container can be pierced. The spike 102 has an internal cavity 115to direct a liquid from the container into the device. The inner cavity is provided with a passage 111 the device is fluidly connected. The first component 150 the device 100 also has a connecting element 109 with which the first component 150 the device with a second component 160 the device. The connecting element 109 In this example it is designed as a Luer-Lock thread.

[0080] Figure 2 shows a container 200, which can be connected to a device according to the invention. The container 200 contains a medically acceptable liquid 202, and has a septum 201 which seals the container to the outside. The septum 201is made of an elastic material, such as silicone. The septum can be additionally protected by a seal that can be removed before connection to the device according to the invention.

[0081] Figure 3 shows a first component 150 a device according to the invention, which is connected to a container 200 is attached. The mandrel 102 penetrates the septum 201 of the container 200, so that the liquid 202 from the container through the cavity 115 and the first implementation 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 designed here as external threads.

[0082] Figure 4 shows a second part 160 a device according to the invention 100 with a reservoir 103for an active ingredient 104 and a fluidic element 107 for transporting a liquid 202 from a container 200. The fluidic element 107 is designed here as a syringe. The active ingredient 104 is a solid powder in the reservoir 103 The device further comprises a filter 106, about the active ingredient 104 in the reservoir 103 The active ingredient 104 can filter 106 only in dissolved form. The filter 106 is secured by a bracket 116 in the reservoir 103 attached to the reservoir 103 to seal it from the outside so that no solid active ingredient 104 through the filter 106 from the reservoir 103 The second component 160 has a connecting element for connection to the first component 150 This connecting element of the second component 160is complementary to the connecting element of the first component 150 In the example shown here, the second component 160 a Luer-Lock internal thread.

[0083] Figure 5 shows a device according to the invention 100, which with a container 200 The first component 150 The device is connected via a connecting element 109 with the second component 160 The device is connected in a fluid-conducting and liquid-tight manner. The connecting element 101 is with a container 200 connected, whereby the mandrel 102 through a septum of the container into the container. The interior of the container is formed by a cavity 115 the mandrel with the reservoir 103 fluidically connected. Using a fluidic element, which here is a piston 108 a liquid can now be drawn from the container 200 into the reservoir 103be directed.

[0084] Figure 6 shows a first component 150 a device according to the invention, which comprises a connecting element 109 for connection with a closure 114 or a second component of the device 160 In the embodiment shown here, the connecting element is designed as a thread 109 alternatively connectable with various elements. The thread 109 can be connected either to the second component of the device 160 be connected in a fluid-conducting manner, or with a closure 114 be sealed liquid-tight.

[0085] Figure 7 shows a first component 150 a device according to the invention according to Figure 6 , which is over the thread 109 with a second component 160 of the device. In this configuration, the interaction of the two components 150 and 160the device liquid from the container 200 The liquid can be removed from the container 200 about a first implementation 111 into the reservoir 103 pumped. Within the reservoir 103 can be used with the help of the fluid in the reservoir 103 active ingredient contained 104 dissolved, and the resulting active ingredient solution is passed through the filter 106 into the container 200 The second component 160 of the device can then be removed and the active ingredient solution can be 150 the device from the container, for example to a patient.

[0086] Figure 8 shows a first component 150 a device according to the invention according to Figure 6 , which has a thread 109 with a nozzle 110 can be connected. Using the nozzle 110 and implementation111 The active ingredient solution produced by the device can be removed from the container 200 If necessary, the implementation 111 by attaching a closure 114 on the connecting element 109 be sealed liquid-tight.

[0087] Figure 9 shows a device according to the invention which simultaneously with a container 200 and is connected to an external delivery device. For this purpose, the device comprises a first feedthrough 111, which is closed here by a closure 114 is sealed liquid-tight, a second passage 112, which is designed for connection to an external dispensing device. In the configuration shown here, the first component 150 using the connecting element 101 with a container 200fluidly connected so that an active ingredient solution produced by the device can be extracted from the container 200 about the second implementation 112 can be submitted.

[0088] Figure 10 shows a first component of a device which is provided with a nozzle 110 and a sign 117 The first component is used to dispense an active ingredient solution from the container 200 set up. The sign 117 In the example shown here, it has a central, cylindrical recess for attachment to the first component 150 and / or the nozzle 110. The shield can serve as a splash guard when an active ingredient solution is sprayed using the nozzle 110 is submitted.

[0089] Figure 11 shows a nozzle 110 with a joint 118, which can be used with a device according to the invention. Using the joint 118 the nozzle can 110be bent so that the nozzle outlet forms an angle with the nozzle connection that is different from 180°. This allows the drug solution to be dispensed in different directions without rotating the entire device. LIST OF REFERENCE SYMBOLS

[0090] 100Device 101Connecting element 102Mandrel 103Reservoir 104Active substance 105Reservoir outlet 106Filter 107Fluidic element 108Piston 109First connecting element (for connecting the components) 110Nozzle 111First feedthrough (for receiving from container) 112Second feedthrough (for connection to pump or similar) 113Second connecting element (for nozzle) 114Closure 115Mandrel cavity 116Filter holder 117Shield 118Joint 150First component 160Second component 200Container 201Septum 202Liquid

Claims

1. A device (100) for producing an antiseptic wound irrigation solution, comprising - a connection element (101) which is designed and configured for liquid-tight connection to a container (200); - a mandrel (102) which is designed and configured for piercing a septum (201) of a container; - a reservoir (103) which contains an active ingredient (104) in solid form, and can be connected via an outlet (105) of the reservoir in a fluid-conducting manner to the connection element (101); - a liquid-permeable filter (106) which is arranged at the outlet (105) of the reservoir, and is configured to retain the active ingredient (104) in solid form in the reservoir (103); - a fluidic element (107) which is configured to receive a liquid (202) from a container (200) into the reservoir (103), and / or is configured to dispense a liquid (202) from the reservoir (103); wherein the device (100) is designed and configured to receive a liquid (202) from a container (200) into the reservoir, to dissolve the active ingredient (104) in the liquid (202), and to dispense the dissolved active ingredient to a patient via the connection element (101), wherein the active ingredient is an antiseptic, which is 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-methylbenzene sulfonamide, sodium-N-chlorobenzene sulfonamide, octenidine, polyhexanide, and chlorhexidine digluconate.

2. The device according to claim 1, wherein the mandrel (102) has a hollow interior (115) which is configured to receive a liquid (202) from a container (200) into the reservoir (103).

3. The device according to either of the preceding claims, wherein the fluidic element (107) comprises a plunger (108) which is movably arranged within the reservoir (103) and closes off the reservoir in a liquid-tight manner.

4. The device according to any of the preceding claims, which comprises a first component (150) and a second component (160) which can be detachably connected to one another.

5. The device according to claim 4, wherein the first component (150) contains the connection element (101) and the mandrel (102), and / or wherein the second component (160) contains the reservoir (103), the filter (106), and the fluidic element (107).

6. The device according to claim 4 or claim 5, wherein the device also comprises a connecting element (109) by means of which the first component (150) can be connected to the second component (160).

7. The device according to any of the preceding claims, wherein the device is completely sterilized, and preferably is completely non-pyrogenic.

8. The device according to any of the preceding claims, wherein the device also comprises a nozzle (110) which is configured to dispense the active ingredient in dissolved form.

9. The device according to claim 8, wherein the nozzle (110) can be detachably connected in a fluid-conducting manner to the connection element (101).

10. The device according to any of the preceding claims, wherein the connection element (101) comprises a first feedthrough (111) which is configured to receive a liquid (202) from a container (200) into the reservoir (103).

11. The device according to any of the preceding claims, wherein the connection element (101) comprises a second feedthrough (112) which is configured to dispense a liquid (202) from a container (200), wherein the dispensing is preferably possible in a state in which the device (100) is connected to the reservoir (103) via the first feedthrough (111) according to claim 10.

12. The device according to any of the preceding claims, wherein the reservoir (103) is permeable to gamma rays and / or electron beams.

13. A kit, comprising a device (100) according to any of claims 1 to 12 and a container (200) having a medically compatible liquid, wherein the device (100) can be detachably connected to the container (200), wherein the kit is packed together in a germ-tight manner, preferably is completely sterilized, and more preferably is completely non-pyrogenic.

14. A method for producing an antiseptic would irrigation solution which comprises the following steps a) receiving a liquid (202) from a container (200) using a device (100) according to any of claims 1 to 13 into the reservoir (103) of the device, b) mixing the active ingredient (104) within the reservoir (103) with the liquid (202) received in step a), c) thereby obtaining an antiseptic wound irrigation solution, d) optionally dispensing the antiseptic wound irrigation solution into the container (200).

15. The use of a device (100) according to any of claims 1 to 12 for producing an antiseptic wound irrigation solution.