Wound-rinsing solution for removing biofilm

Abstract

The invention relates to a device (100) for producing an antiseptic wound-rinsing solution, having an antiseptic oxidizing agent (104) and a surfactant (124). The invention likewise relates to methods for producing an antiseptic wound-rinsing solution. Such wound-rinsing solutions can be used in particular to treat biofilm. The antiseptic oxidizing agent and the surfactant are each provided as a solid substance and separately from each other in the device. The device can also allow the wound-rinsing solution to be dispensed via a nozzle or using a jet-lavage system.

Description

[0001] DESCRIPTION

[0002] Wound irrigation solution for the removal of biofilms

[0003] FIELD OF THE INVENTION

[0004] 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.

[0005] TECHNICAL BACKGROUND

[0006] 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.

[0007] Antiseptic hypochlorite solutions are known in the art, and various solutions have been proposed to improve storage stability.

[0008] Such solutions have been described, for example, in the following publications: US8945630B2, US2011 / 0236490A1 , WO2021001789, US2019328776A1, WO2021134041 A1, WG2022 / 038507A1, WO2020252433, WO2020174436A1, US243781 , US3749672, US6162371, W01991 / 003936, US6471974, US2009 / 0258083, W02010148004, W02010148004, US2009 / 0148342 A 1 , W02016 / 100543A2, W02020 / 089693A1, and WO2021 / 162736A1.

[0009] However, complete protection against decomposition of hypochlorite ions in aqueous solution remains challenging.

[0010] 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.

[0011] Solid precursors for the preparation of hypochlorite-containing solutions are described in DE2712574A1 and US4104190A.

[0012] Biofilms pose a particular challenge for antiseptics. Depending on the type of microorganism causing the biofilm, they consist of a slime composed of polysaccharides, proteins, and eDNA. This slime film surrounds the microorganisms within and protects them from external influences. The accessibility of the embedded microorganisms to antiseptics is also reduced.

[0013] BRIEF DESCRIPTION OF THE INVENTION

[0014] 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 a device containing an active ingredient with the aid of which a ready-to-use active ingredient solution can be prepared quickly, easily, and cost-effectively using commercially available containers with sterile saline solution or comparable solutions. Since the device according to the invention preferably 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 necessary during the manufacture of the device according to the invention if the substances contained therein are provided in solid form. Some active ingredients can be sterilized better in solid form because they decompose more easily in solution during sterilization.In some embodiments, the device according to the invention provides the possibility of delivering the liquid produced therein directly to a patient, for example by means of a nozzle that can be attached to the device according to the invention.

[0015] The present invention is based in particular on improving the accessibility of microorganisms in biofilms through the use of surfactants. Surfactants can loosen and detach biofilms. Such an improved antiseptic wound irrigation solution can contain an antiseptic such as hypochlorite solutions or hydrogen peroxide-containing solutions that also contain surfactants. However, aqueous hypochlorite solutions, aqueous chlorite solutions, and hydrogen peroxide solutions are very strong oxidizing agents and can oxidatively attack dissolved surfactants. This makes the storage life of such solutions challenging. By separating the substances, their storage life can be improved.

[0016] Therefore, devices are described herein with the aid of which oxidizing antiseptic solutions containing surfactants can be prepared intraoperatively, and in which the known decomposition of aqueous solutions of hypochlorite ions, chlorite ions, and also hydrogen peroxide can be effectively prevented during storage of the solutions. An aqueous solution producible with the device can contain hypochlorite ions and / or hydrogen peroxide and / or chlorite ions and at least one surfactant. Furthermore, the solutions produced can have a physiologically acceptable pH. With the aid of the devices described herein, decomposition of the surfactant can be effectively prevented during storage of the device. The device can be sterilized together with the oxidizing antiseptics and the surfactant contained therein.

[0017] Preferred embodiments of the invention are described below.

[0018] A first embodiment relates to a device for producing an antiseptic wound irrigation solution, comprising an antiseptic oxidizing agent and a surfactant. A second embodiment relates to a device according to the first embodiment, wherein the antiseptic oxidizing agent and the surfactant are present separately from one another in the device. A third embodiment relates to a device according to one of the preceding embodiments, wherein the antiseptic oxidizing agent and / or the surfactant are present as a solid. A fourth embodiment relates to a device according to one of the preceding embodiments, which further comprises a first reservoir and a separate second reservoir, wherein the antiseptic oxidizing agent is arranged in the first reservoir and the surfactant is arranged in the second reservoir.A fifth embodiment relates to a device according to one of the preceding embodiments, wherein the device further comprises an intermediate filter that fluidically connects the first reservoir to the second reservoir, wherein the intermediate filter is preferably permeable to the antiseptic oxidizing agent and / or the surfactant only in the liquid state. A sixth embodiment relates to a device according to one of the preceding embodiments, wherein the device further comprises a connecting element, wherein the connecting element is configured to establish a fluid-conducting connection with a container.A seventh embodiment relates to a device according to the sixth embodiment, wherein the antiseptic oxidizing agent and / or the surfactant is present as a solid, and wherein the connecting element has a connecting filter configured to retain the antiseptic oxidizing agent and / or the surfactant as a solid in the first reservoir and / or the second reservoir. An eighth embodiment relates to a device according to the sixth or seventh embodiment, further comprising a dispensing element, wherein the dispensing element is preferably configured to dispense a disinfecting wound irrigation solution prepared from the antiseptic oxidizing agent and the surfactant from the device independently of the connecting element.A ninth embodiment relates to a device according to one of the preceding embodiments, which further comprises a mandrel configured to pierce a septum, wherein the mandrel preferably has a hollow interior configured to receive a liquid from a container into the first reservoir and the second reservoir. A tenth embodiment relates to a device according to one of the preceding embodiments, which further comprises a fluidic element configured and designed to convey a liquid into the device. An eleventh embodiment relates to a device according to one of the fourth to tenth embodiments, wherein the device comprises an adapter part and a mixer part, wherein the adapter part is configured for connection to a container, and the mixer part is configured to mix the antiseptic oxidizing agent and the surfactant with a liquid from the container.A twelfth embodiment relates to a device according to one of the preceding embodiments, wherein the antiseptic oxidizing agent is selected from the group consisting of chlorite, hypochlorite, and peroxide, more preferably selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium chlorite, sodium hypochlorite, sodium peroxide, and calcium peroxide. A thirteenth embodiment relates to a device according to one of the preceding embodiments, wherein the surfactant comprises a fatty alcohol sulfate and / or a quaternary ammonium salt; more preferably, the surfactant comprises sodium dodecyl sulfate and / or benzalkonium chloride. A fourteenth embodiment relates to a device according to one of the preceding embodiments, which further comprises a pH regulator, wherein the pH regulator is selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium hydrogen sulfate, and sodium hydrogen carbonate.

[0019] A second aspect relates, in a first embodiment, to a method for producing an antiseptic wound irrigation solution using a device according to any one of the preceding claims, the method comprising the following steps: a) optionally dissolving or diluting the antiseptic oxidizing agent and / or the surfactant using a medically acceptable liquid using the device, b) mixing the antiseptic oxidizing agent with the surfactant using the device, and thereby obtaining an antiseptic wound irrigation solution.In a second embodiment of the method, a method according to the first embodiment is provided, wherein the concentration of the antiseptic oxidizing agent in the prepared wound irrigation solution is 100 ppm to 4000 ppm (mass / mass), and / or the concentration of the surfactant in the prepared wound irrigation solution is 25 ppm to 2000 ppm (mass / mass); in a third embodiment of the method, a method according to the first or second embodiment is provided, wherein the pH of the prepared wound irrigation solution is 4 to 8, preferably 5 to 7.

[0020] In a third aspect, in a first embodiment, a device for producing an active ingredient solution, preferably an antiseptic wound irrigation solution, is described, comprising

[0021] - a connecting element designed and arranged for liquid-tight connection to a container;

[0022] - a mandrel designed and arranged to pierce a septum of a container,

[0023] - a first reservoir containing an active ingredient, such as an antiseptic oxidizing agent, in solid form and fluidly connectable to the connecting element via an outlet of the reservoir;

[0024] - a connecting filter arranged at the outlet of the first reservoir and designed to retain the active ingredient in solid form in the reservoir;

[0025] - an intermediate filter connecting the first reservoir to a second reservoir, the second reservoir containing a surfactant;

[0026] - a fluidic element configured to receive a liquid from a container into the first and second reservoirs and / or to dispense a liquid from the first and second reservoirs; wherein the device is designed and configured to receive a liquid from a container into the first and second reservoirs, to dissolve the active ingredient and the surfactant in the liquid, and to dispense the dissolved active ingredient and the dissolved surfactant to a patient via the connecting element.

[0027] A second embodiment of the third aspect 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 first reservoir.

[0028] A third embodiment of the third aspect relates to a device according to one of the preceding embodiments, wherein the fluidic element comprises a piston movably arranged within the first and / or second reservoir, wherein the piston preferably seals the first and / or second reservoir in a liquid-tight manner. A fourth embodiment of the third aspect relates to a device according to one of the preceding embodiments, which comprises an adapter part and a mixer part that can be releasably connected to one another.

[0029] A fifth embodiment of the third aspect relates to a device according to embodiment 4, wherein the adapter part contains the connection element and the mandrel, and / or wherein the mixer part contains the reservoir, the filter and the fluidic element.

[0030] A sixth embodiment of the third aspect relates to a device according to embodiment 4 or 5, wherein the device further comprises a thread by means of which the adapter part can be connected to the mixer part.

[0031] A seventh embodiment of the third aspect relates to a device according to one of the preceding embodiments, wherein the device is completely sterilized, preferably completely pyrogen-free.

[0032] An eighth embodiment of the third aspect relates to a device according to one of the preceding embodiments, wherein the device further comprises a nozzle which is configured to dispense the active ingredient in dissolved form.

[0033] A ninth embodiment of the third aspect relates to a device according to embodiment 8, wherein the nozzle can be detachably connected to the connection element in a fluid-conducting manner.

[0034] A tenth embodiment of the third aspect relates to a device according to any one of the preceding embodiments, wherein the active ingredient is an antiseptic, which is 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.

[0035] An eleventh embodiment of the third aspect 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 first reservoir.

[0036] A twelfth embodiment of the third aspect relates to a device according to one of the preceding embodiments, wherein the connecting element has a second passage which is configured 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.

[0037] A thirteenth embodiment of the third aspect relates to a device according to any one of the preceding embodiments, wherein the first reservoir and the second reservoir are transparent to gamma rays and / or electron beams.

[0038] A fourth aspect relates to a kit comprising a device according to one of embodiments 1 to 13 of the third aspect, or an embodiment of the first aspect, and a container with a medically acceptable liquid, wherein the device is detachably connectable to the container, wherein the kit is jointly packaged in a germ-tight manner, preferably completely sterilized, more preferably completely pyrogen-free.

[0039] A fifth aspect relates to 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.

[0040] A sixth aspect relates to a method for producing an active ingredient solution, which comprises the following steps: a) taking up a liquid from a container using a device according to one of embodiments 1 to 13 of the third aspect, or an embodiment of the first aspect, into the first reservoir and the second reservoir of the device, b) mixing the active ingredient in the first reservoir and the surfactant in the second reservoir 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. A seventh aspect relates to the use of a device according to one of embodiments 1 to 13 of the third aspect, or an embodiment of the first aspect, for producing an active ingredient solution.

[0041] An eighth aspect relates to a medicated wound irrigation solution for use in a method for the prophylaxis or treatment of a wound infection, wherein the medicated wound irrigation solution comprises an antiseptic oxidizing agent and a surfactant.

[0042] BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 shows a mixer part with a first reservoir for an active ingredient, a second reservoir for a surfactant, and a fluidic element for transporting a liquid from a container.

[0044] Figure 2 shows an adapter part that can be connected to a container.

[0045] Figure 3 shows an adapter part in a closed and sealed state.

[0046] Figure 4 shows a container with a septum that can be connected to a device according to the invention.

[0047] Figure 5 shows an adapter part connected to a container.

[0048] Figure 6 shows a device according to the invention connected to a container.

[0049] Figure 7 shows a device according to the invention that collects liquid from a container. Figure 8 shows a device according to the invention that dispenses a wound irrigation solution formed therein into a container.

[0050] Figure 9 shows a device according to the invention which has completely released a wound irrigation solution prepared therein into a container.

[0051] Figure 10 shows a container provided with an adapter part and a nozzle.

[0052] Figure 11 shows a kit comprising a container, an adapter part, a mixer part, a nozzle and a dispensing device.

[0053] DETAILED DESCRIPTION

[0054] For the embodiments described herein, the elements of which “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., does not comprise any further components. The word “comprise” or “comprising” is used herein synonymously with the word “contain”, “containing”, “have” or “having”. If an element is referred to in the singular in an embodiment, an embodiment is also contemplated in which a plurality of these elements are present. The use of a term for an element in the plural generally also includes an embodiment in which only a single corresponding element is contained.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 or a substance for use in 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. Technical solutions that are known to be equivalent to the features described herein are also intended to be encompassed by the scope of the invention.

[0055] A first embodiment relates to a device for producing an antiseptic wound irrigation solution. The device comprises an antiseptic agent, such as an antiseptic oxidizing agent. The device further comprises a surfactant.

[0056] The term "antiseptic" refers to the bactericidal or fungicidal, i.e., germicidal, effect of a substance, especially an active ingredient, or a composition, such as a wound irrigation solution. A wound irrigation solution is an aqueous composition that is medically acceptable and suitable for intraoperative irrigation, also known as lavage.

[0057] A surfactant is an amphiphilic substance that has a hydrophilic and a hydrophobic moiety, and therefore possesses surface-active properties. Surfactants thereby improve the solubility of hydrophobic substances in aqueous solutions. The use of surfactants in wound irrigation solutions can reduce the stability of biofilms and thereby improve the effect of an antiseptic oxidizing agent on the biofilm. Examples of surfactants that can be used according to the invention are fatty alcohol sulfates and quaternary ammonium salts. Preferred quaternary ammonium salts are chlorides of quaternary ammonium ions. An example of a fatty alcohol sulfate is sodium dodecyl sulfate, also known as sodium lauryl sulfate or SDS. An example of a quaternary ammonium salt is benzalkonium chloride. The surfactant can be an anionic, cationic, or neutrally charged surfactant, e.g., a nonionic or zwitterionic surfactant.Preferred surfactants are those that do not form calcium-containing precipitates in aqueous solutions of calcium salts. Also preferred are surfactants that are medically acceptable for internal use during a surgical procedure. In one embodiment, the surfactant comprises a fatty alcohol sulfate. In one embodiment, the surfactant comprises a quaternary ammonium salt. In one embodiment, the surfactant comprises sodium dodecyl sulfate. In one embodiment, the surfactant comprises benzalkonium chloride.

[0058] Advantageously, the antiseptic oxidizing agent and the surfactant can be present separately in the device.

[0059] The antiseptic oxidizing agent can be present in the device as a solid. The surfactant can be present in the device as a solid. Preferably, both the antiseptic oxidizing agent and the surfactant are each present in the device as solids.

[0060] The antiseptic oxidizing agent is preferably water-soluble. The surfactant is preferably water-soluble. Particularly preferably, both the antiseptic oxidizing agent and the surfactant are each water-soluble. According to the invention, "water-soluble" is understood to mean a substance whose solubility in water at 25°C and 1025 hPa is at least 1 g of substance per liter of water.

[0061] In one embodiment, the device further comprises a pH regulator. A pH regulator is a substance with the aid of which the wound irrigation solution that can be produced with the device can be brought to a medically acceptable pH. A medically acceptable pH is pH 4 to 8, preferably 5 to 7, wherein the pH is measured at 25°C and 1025 hPa. The pH regulator is preferably an acid. In some embodiments, the pH regulator is selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium hydrogen sulfate, and sodium hydrogen carbonate. In one embodiment, the first reservoir comprises a pH regulator. In one embodiment, the second reservoir comprises a pH regulator. In one embodiment, both the first reservoir and the second reservoir comprise a pH regulator. The pH regulator can be present in the device as a solid.The pH regulator can be present as a mixture with the antiseptic oxidizing agent and / or the surfactant. Slightly acidic to neutral pH values ​​can be advantageous, especially when using hypochlorite- and peroxide-containing antiseptic oxidizing agents, to achieve a desired balance of hypochlorite ions to hypochlorous acid or peroxide ions to hydroperoxide ions. This can achieve an effective antiseptic effect of the wound irrigation solution being prepared.

[0062] The device according to the invention can comprise an adapter part and a mixer part. The adapter part can be connectable to the mixer part. The adapter part can be detachably connectable to the mixer part, preferably by means of a positive connection, e.g., using a thread or a snap connection.

[0063] A device according to the invention preferably comprises a first reservoir and a separate second reservoir. Preferably, the antiseptic oxidizing agent is arranged in the first reservoir, and the surfactant is arranged in the second reservoir of the device. The first reservoir and the second reservoir can be arranged in the mixer part.

[0064] The device can have an intermediate filter that fluidically connects the first reservoir to the second reservoir. The intermediate filter is preferably only permeable to the antiseptic oxidizing agent and / or the surfactant in the liquid state. This means that the antiseptic oxidizing agent or the surfactant cannot pass through the intermediate filter as a solid, but rather only in a dissolved state, for example. If, for example, the oxidizing agent and the surfactant are each present as solids in the device, the intermediate filter can therefore keep these two substances separate from one another until they are dissolved in a liquid, preferably an aqueous solution. In this case, the oxidizing agent and the surfactant are only brought into contact with one another by dissolving them in an aqueous solvent in order to produce a wound irrigation solution.Accordingly, embodiments of the device with an intermediate filter are advantageous if an antiseptic oxidizing agent and a surfactant are provided in solid form, for example in powder form, in the device. The intermediate filter can be arranged movably in the device, for example displaceably, in order to enable the most complete possible release of liquid from the device. Preferably, the intermediate filter is arranged and configured such that the position of the intermediate filter cannot change in an undesired manner (e.g. during transport of the device), but only through targeted action by a user, for example by directly exerting a force on the intermediate filter using a syringe plunger.For this purpose, the filter can, for example, be mounted in a cylindrical interior of the mixer part of the device with a correspondingly adjusted clamping voltage, so that it can only move when a predetermined force on the filter is exceeded.

[0065] Instead of the intermediate filter, a partition wall can be arranged between the first and second reservoirs. The partition wall can be configured to separate the first reservoir from the second reservoir in a liquid-tight manner. By removing or breaking through the partition wall, the contents of the first and second reservoirs, e.g., an antiseptic oxidizing agent and a surfactant, can be mixed together. In this way, an antiseptic oxidizing agent and / or a surfactant in liquid form, e.g., in an aqueous solution, can be arranged separately from one another in the device.

[0066] The device preferably has a connecting element. The connecting element can be arranged in the adapter part. The connecting element is preferably designed and configured for the liquid-tight and fluid-conducting connection of the device to a container. In this case, the connecting element can interact with a mandrel as described below. This allows liquid to be exchanged between the device and the container without liquid leaking out. For this purpose, the connecting element can enable a positive connection between the adapter part and the container. Such containers can, for example, be packaging in which physiological saline solutions, infusion solutions and similar liquid medical products are commercially available. Commonly used for this purpose are bottles or foil bags. These containers are often made of plastic.The container may 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 in an open state. The container may comprise a septum that can be pierced with a spike attached to the device.

[0067] The connecting element of the device can preferably be connected to a container in a form-fitting manner. The connecting element can be detachably connected to a container. For example, the connecting element can be plugged onto the opening of a plastic bottle or the connection of a foil bag. The connecting element can have a thread or a snap connection.

[0068] The device can further comprise 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 for connecting infusion sets to containers containing infusion solutions. The spike can be arranged in the adapter part.

[0069] 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.

[0070] 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.

[0071] The device preferably has a first reservoir. The first reservoir preferably contains a substance in solid form, for example, as a powder. The substance can be an antiseptic oxidizing agent. The first reservoir can have a substantially cylindrical shape, similar to the interior of a syringe.

[0072] The device can be designed to release the contained substance, in particular an antiseptic oxidizing agent, in dissolved form into the container.

[0073] The device may further comprise a second reservoir. The second reservoir may contain a substance that is different from the substance in the first reservoir. The second reservoir may preferably contain a surfactant. The second reservoir may have a substantially cylindrical shape. In one embodiment, the first and second reservoirs each have a cylindrical shape. In one embodiment, the first reservoir and the second reservoir are arranged along a common axis.

[0074] In one embodiment, an antiseptic oxidizing agent is disposed in the first reservoir, and a surfactant is disposed in the second reservoir. In one embodiment, an antiseptic oxidizing agent is disposed in the second reservoir, and a surfactant is disposed in the first reservoir.

[0075] The device preferably has a filter. Such a filter is preferably designed to retain a solid substance, for example an antiseptic oxidizing agent or a surfactant, in a reservoir, for example the first and / or second reservoir of the device, as long as the substance is not dissolved in a liquid. In this way, it can be prevented that the substance is delivered to a patient in undissolved form. According to the invention, it is preferred that the substance can only be delivered to a patient in liquid form, e.g. in a completely aqueous solution. For this purpose, the filter can preferably be liquid-permeable. The filter is preferably gas-permeable. A gas-permeable filter enables, for example, easier filling of the reservoir with the substance, in particular during production of the device according to the invention.For this purpose, the substance can preferably be introduced into the reservoir using compressed air or vacuum, whereby the gas-permeable filter allows the gas to pass through but retains the substance in the reservoir.

[0076] 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.

[0077] The filter can be secured by a holder within a reservoir, for example, the first and / or second reservoir of the device. The holder can, for example, be in the form of a clamping ring. Optionally, the filter can be secured in a recess in a wall of the reservoir.

[0078] The filter can, for example, comprise polyethylene, polyurethane, polyimide, polyethersulfone, polyvinylidene fluoride or polytetrafluoroethylene.

[0079] The filter can be a woven filter or a non-woven filter.

[0080] In some embodiments, the reservoir includes a second filter that divides an interior of the device into two separate regions, the first reservoir and the second reservoir.

[0081] The device may comprise two copies of the filters described above, for example a connecting filter and an intermediate filter.

[0082] A connection filter may be arranged at an outlet of the first reservoir. The connection filter may be configured to retain a solid substance, for example, an antiseptic oxidizing agent and / or a surfactant, in the device as long as the substance is not dissolved in a liquid.

[0083] An intermediate filter can be arranged between the first reservoir and the second reservoir, and fluidly connect the first reservoir to the second reservoir. The intermediate filter can be secured there by a holder. The first reservoir can contain an antiseptic oxidizing agent. The second reservoir can contain a surfactant. In one embodiment, the first reservoir contains an antiseptic oxidizing agent, and the second reservoir contains a surfactant. In one embodiment, the first reservoir contains a surfactant, and the second reservoir contains an antiseptic oxidizing agent. The antiseptic oxidizing agent and the surfactant are preferably each in solid form, for example powder form. Such an embodiment enables the preparation of an active ingredient solution containing an antiseptic oxidizing agent and a surfactant without the two substances coming into contact with each other in solid form during storage of the device.

[0084] The reservoir can be dimensioned such that the ratio of the volumes of the total volume of the first and second reservoirs and the container (i.e., [V(first reservoir) + V(second reservoir)] : V(container)) is in a ratio of 1:25 to 1:500. The volume of the container can be, for example, 250 ml, 500 ml, or 1000 ml. Accordingly, the total volume of the first and second reservoirs can be, for example, 0.5 to 10 ml, 1 to 20 ml, or 2 to 40 ml.

[0085] The device may further comprise a fluidic element. The fluidic element is preferably configured to receive a liquid from a container into the first and / or second reservoir. Alternatively or additionally, the fluidic element may be configured to dispense a liquid from the reservoir. The fluidic element is preferably configured to actively convey a liquid. The fluidic element may, for example, comprise a piston for conveying a liquid. The fluidic element may comprise a syringe or a pump.

[0086] In one embodiment, the fluidic element comprises a piston movably arranged within the device, for example, within the first reservoir and / or within the second reservoir. The piston preferably seals the device, for example, the first reservoir and / or the second reservoir, in a liquid-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 conveying a liquid, e.g., a diaphragm pump, peristaltic pump, compressed air cartridge, or a connection for an external pressure or vacuum source.

[0087] In one embodiment, the device comprises an adapter part and a mixer part, which are preferably detachably connectable to one another. The components of the device described herein can be arranged within such an adapter part or mixer part. For example, the adapter part can contain the connection element and the mandrel, and / or the mixer part can contain the reservoir, the filter, and the fluidic element. The adapter part and the mixer part 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. The connecting element preferably enables a detachable connection of the adapter part to the mixer part. A preferred connecting element is a Luer-Lock connection. A Luer-Lock connection enables a screwed connection between two conical connecting parts that engage one another in a clamping manner.A Luer-Lock connection is disclosed in US1742497A. The adapter part can preferably have an external thread that can be connected to an internal thread of the mixer part. The mixer part can have an external thread that can be connected to an internal thread of the adapter part.

[0088] In one embodiment, the adapter part can be configured to be fluidically connected to a container, while the mixer part is detached from the adapter part and the adapter part is optionally connected to another device, for example, a closure or a nozzle. The adapter part can thus serve as a type of multifunctional quick connector for other components. The mixer part can comprise a syringe, e.g., a syringe with a Luer lock connection. The mixer part can, in particular, be configured to mix the antiseptic oxidizing agent and the surfactant with a liquid.

[0089] In some embodiments, the device further comprises a dispensing element. The dispensing element can be arranged in the adapter part. The dispensing element can be configured to dispense a disinfecting wound irrigation solution prepared from the antiseptic oxidizing agent and the surfactant from the device. The dispensing element can be configured to dispense the prepared wound irrigation solution in a state of the device in which the device is connected to a container, wherein the device preferably comprises an adapter part connected to a mixer part. The dispensing element can have a passage. The passage can be arranged in the adapter part parallel to the mandrel.

[0090] 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 adapter part and the mixer part, to one another, or to connect the device to other devices, or both. In this case, either a single connecting element can be configured to be alternatively connected to a plurality of different devices, 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 has a Luer-Lock connection.

[0091] In one embodiment, the device comprises a connecting element by means of which the adapter part can be connected to the mixer part. 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.

[0092] 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 status of the device can be determined using the Limulus Amebocyte Lysate (I_AL) test according to Ph. Eur. Chapter 2.6.14. The standards and / or regulations apply.Documents that are current as of the priority date of the present application.

[0093] 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.

[0094] Preferably, the nozzle is detachably connectable to the adapter part in a fluid-conducting manner. This can be achieved via a positive connection element, for example a thread, preferably a Luer lock connection. The device can further comprise a shield. The shield can be configured to protect parts of the device from splashes of the dispensed liquid, in particular an active ingredient solution. The shield can be arranged on or in spatial proximity to the nozzle. The shield can be in the shape of a disc. The shield can have a concave curvature, similar to a parabolic antenna. The shield can have a centrally arranged recess configured for attaching the shield to an outlet of the device.

[0095] The device preferably contains an antiseptic oxidizing agent. In one embodiment, the antiseptic oxidizing agent is selected from the group consisting of chlorite, hypochlorite, and a peroxide. The chlorite is preferably a chlorite salt of an alkali metal. The peroxide is preferably a peroxide salt of an alkali metal or alkaline earth metal. The hypochlorite is preferably a hypochlorite salt of an alkaline earth metal. In one embodiment, the antiseptic oxidizing agent is selected from the group consisting of calcium hypochlorite (CAS 7778-54-3), magnesium hypochlorite (CAS 7778-54-3), sodium chlorite (CAS 7758-19-2), sodium hypochlorite (CAS 7681-52-9), sodium peroxide (CAS 1313-60-6), and calcium peroxide (CAS 1305-79-9). The hypochlorite salts mentioned dissolve in water, releasing hypochlorite ions, whereby the aqueous solutions of these salts are strongly alkaline.By exposure to acids, the pH of these solutions can be lowered to a physiologically acceptable pH range of pH 4 to pH 8. For this purpose, the device can preferably contain a pH regulator, particularly an acid. In neutral and acidic environments, the hypochlorite ions are in equilibrium with hypochlorous acid. Sodium peroxide and calcium peroxide also dissolve in water, forming alkaline solutions containing dissolved peroxide anions. By lowering the pH through the addition of acids, the peroxide anions are in equilibrium with hydroperoxide ions and hydrogen peroxide in neutral and acidic environments.

[0096] In some embodiments, the antiseptic oxidizing agent comprises sodium chlorite and a hypochlorite salt. In some embodiments, the antiseptic oxidizing agent comprises sodium chlorite and a peroxide. In some embodiments, the antiseptic oxidizing agent comprises sodium chlorite, a hypochlorite salt, and a peroxide. The device may preferably comprise an acid. When exposed to acids, sodium chlorite (NaClO2) forms chlorous acid, which is in equilibrium with chlorine dioxide. Chlorous acid and chlorine dioxide are oxidizing agents with strong antiseptic properties. In one embodiment, the antiseptic oxidizing agent and / or the surfactant is present as a powder with an average particle size of less than 300 pm, preferably less than 200 pm, and particularly preferably less than 100 pm. The small particle size enables rapid dissolution of the substance in question.The particle size of the substance in question can preferably be above the exclusion volume of the filter. This mean particle diameter can be determined by fractional sieving, as is common practice in the art. The particle size distribution is preferably sufficiently narrow so that, if possible, none, e.g., less than 1% of the particle mass, can pass through the filter. In one embodiment, the substance in question is in the form of a cylindrical compact or a cylindrical solidified melt.

[0097] 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.

[0098] 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 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 adapter part of the device, remains connected to the container.If necessary, the device for dispensing the dissolved active ingredient can be connected to a nozzle or other dispensing device, e.g. a jet lavage system, wherein if necessary the mixer part of the device can be exchanged for the nozzle or other dispensing device. Examples of dispensing systems are described in EP2619415A1, EP2662146A2. The liquid is preferably a medically acceptable liquid. The liquid is preferably suitable for internal use. In cases where the device is designed in several parts, the entire device does not have to be connected to the container in order to dispense a liquid from a container. For example, it may be sufficient if an adapter part described herein is connected to a container in order to dispense the liquid. A mixer part can, for example, only be connected to the device temporarily in order to take up liquid from the container and use it to produce a wound irrigation solution.

[0099] In one embodiment, the first reservoir and / or the second reservoir are permeable to gamma rays and / or electron beams. This makes it possible to sterilize the interior and the substances contained within the device, in particular antiseptic oxidants and surfactants, using gamma rays and / or electron beams to obtain a completely sterilized device.

[0100] In one embodiment, the mandrel and the first reservoir jointly define a transfer axis, along which the liquid can be discharged from the reservoir and / or into the reservoir. In one embodiment, the container and the first reservoir jointly define a transfer axis, along which the liquid can be discharged from the first reservoir and / or taken up into the first reservoir. Alternatively or additionally, such a transfer axis can be defined in a corresponding manner by the mandrel and the second reservoir.

[0101] A further aspect relates to a device for producing an active ingredient solution, comprising

[0102] - a connecting element designed and arranged for liquid-tight connection to a container;

[0103] - a mandrel designed and arranged to pierce a septum of a container;

[0104] - a first reservoir containing an antiseptic oxidizing agent in solid form and fluidly connectable to the connecting element via an outlet of the reservoir;

[0105] - a liquid-permeable connection filter arranged at the outlet of the first reservoir and arranged to retain the antiseptic oxidizing agent in solid form in the reservoir;

[0106] -a second reservoir containing a surfactant in solid form;

[0107] - an intermediate filter which fluidically connects the first reservoir to the second reservoir;

[0108] - a fluidic element configured to receive a liquid from a container into the first and / or second 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, dissolve the active ingredient in the liquid, and dispense the dissolved active ingredient to a patient via the connection element. 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. The device can comprise an adapter part as described herein and a mixer part as described herein. The adapter part can be detachably connectable to the mixer part. The adapter part can be 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 fully 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. The medically acceptable liquid can comprise an infusion solution or medical rinsing solution. The medically acceptable liquid can comprise a physiological saline solution, a Ringer's solution, or a comparable saline solution. The medically acceptable liquid is preferably sterile and / or pyrogen-free.

[0109] A further aspect relates to 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 which has a pharmacological effect. The active ingredient can, for example, have an antimicrobial effect. The active ingredient can comprise an antiseptic oxidizing agent and optionally further a surfactant. In one embodiment, the antiseptic oxidizing agent is selected from the group consisting of chlorite, hypochlorite and a peroxide. The chlorite is preferably a chlorite salt of an alkali metal. The peroxide is preferably a peroxide salt of an alkali metal or alkaline earth metal. The hypochlorite is preferably a hypochlorite salt of an alkaline earth metal.In one embodiment, the antiseptic oxidizing agent is selected from the group consisting of calcium hypochlorite (CAS 7778-54-3), magnesium hypochlorite (CAS 7778-54-3), sodium chlorite (CAS 7758-19-2), sodium hypochlorite (CAS 7681-52-9), sodium peroxide (CAS 1313-60-6), and calcium peroxide (CAS 1305-79-9). The active ingredient can be administered using a device described herein. For example, an adapter part used herein can be connected to a nozzle or jet lavage system. The treatment method can be, for example, the treatment of an infection of a surgical wound, as set forth in more detail below.

[0110] A further aspect relates to a medical treatment method, wherein an active ingredient, in particular an antiseptic oxidizing agent and furthermore a surfactant, is dissolved in a liquid as described herein using a device described herein immediately before administration to a patient and is subsequently administered in dissolved form. The liquid is preferably a medically acceptable liquid as described herein. The treatment method may, for example, comprise the disinfection of a tissue. The treatment method may comprise a surgical joint operation, for example the implantation or replacement of a joint implant. The joint implant may, for example, be a spacer. The joint operation may, for example, comprise a surgical hip, knee, shoulder, or back operation. The treatment method may further comprise the therapy of an inflammatory condition.The treatment procedure may, for example, include the treatment of joint arthrosis or a joint infection.

[0111] A further aspect relates to a composition for use in a method of treating a surgical wound, in particular an infected wound, the method comprising administering the composition using a device described herein. The composition preferably comprises an antiseptic oxidizing agent and a surfactant. The treatment may comprise joint surgery, for example the implantation or replacement of a joint implant. The joint implant may, for example, be a spacer. The joint surgery may, for example, comprise hip, knee, shoulder, or back surgery. The treatment may further comprise therapy for an inflammatory condition. The treatment may, for example, comprise the treatment of joint arthrosis or a joint infection.

[0112] A further aspect relates to a method for producing an active ingredient solution, which comprises the following steps: a) taking up a liquid from a container using a device described herein into the first reservoir and the second reservoir of the device, b) mixing an antiseptic oxidizing agent and a surfactant within the device with the liquid taken up in step a), c) thereby obtaining an active ingredient solution, d) optionally dispensing the active ingredient solution from the device into the container. 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. The active ingredient solution can be a wound irrigation solution.The solution may further comprise a pH regulator. The antiseptic oxidizing agent may comprise a chlorite, a hypochlorite, and / or a peroxide. The surfactant may comprise a quaternary ammonium salt and / or a fatty alcohol sulfate.

[0113] A further aspect relates to an active ingredient solution that can be produced by a process described above. The active ingredient solution can comprise an antiseptic oxidizing agent and a surfactant. The active ingredient solution can be a wound irrigation solution. The solution can further comprise a pH regulator. The antiseptic oxidizing agent can comprise a chlorite, a hypochlorite, and / or a peroxide. The surfactant can comprise a quaternary ammonium salt and / or a fatty alcohol sulfate.

[0114] A further aspect relates to the use of a device or kit described herein for producing an active ingredient solution, in particular an antiseptic wound irrigation solution. The active ingredient solution may comprise an antiseptic oxidizing agent and a surfactant. The active ingredient solution may be a wound irrigation solution. The solution may further comprise a pH regulator. The antiseptic oxidizing agent may comprise a chlorite, a hypochlorite, and / or a peroxide. The surfactant may comprise a quaternary ammonium salt and / or a fatty alcohol sulfate.

[0115] A further aspect relates to a medicated wound irrigation solution for use in a method for the prophylaxis or treatment of a wound infection, wherein the medicated wound irrigation solution comprises an antiseptic oxidizing agent and a surfactant. The wound infection may be an infection of an internal wound, for example a surgical wound. The wound infection may include an infection of bone tissue. Bone tissue may in particular include bones, joints, and cartilage. The solution may further comprise a pH regulator. The antiseptic oxidizing agent may comprise a chlorite, a hypochlorite, and / or a peroxide. The surfactant may comprise a quaternary ammonium salt and / or a fatty alcohol sulfate. A further aspect relates to a medicated wound irrigation solution for use as a disinfectant, wherein the medicated wound irrigation solution comprises an antiseptic oxidizing agent and a surfactant. The solution may further comprise a pH regulator.The antiseptic oxidizing agent may comprise a chlorite, a hypochlorite, and / or a peroxide. The surfactant may comprise a quaternary ammonium salt and / or a fatty alcohol sulfate.

[0116] EXAMPLES

[0117] 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.

[0118] FIGURES

[0119] Figure 1 shows a mixer part 160 of a device according to the invention with a first reservoir 103, a second reservoir 123 and a fluidic element 107 for transporting a liquid 202 from a container 200 (not shown in this figure). The fluidic element 107 is designed here as a syringe having a syringe plunger 108. An active ingredient such as an antiseptic oxidizing agent 104 is contained as a powder in the first reservoir

[0120] 103. The device further comprises a connection filter 106 to filter the active ingredient

[0121] 104 in the first reservoir 103. An outlet 105 of the first reservoir is configured to establish a fluid-conducting connection between the first reservoir 103 and an adapter part of the device. The active ingredient 104 can only pass through the connecting filter 106 in dissolved form. The connecting filter 106 is attached to the first reservoir 103 by a holder 116 in order to seal the reservoir 103 to the outside, so that no solid active ingredient 104 can pass through the filter 106 from the first reservoir 103. The mixer part 160 has a first connecting element 109 for connection to an adapter part 150. This connecting element of the mixer part 160 is designed to be complementary to a connecting element of the adapter part 150. In the example shown here, the mixer part 160 has a Luer-Lock internal thread.The first connecting element 109 can also be detachably connected to a first closure 119 in order to seal the first reservoir 103 and the outlet 105 in a liquid-tight manner. The first connecting element 109 here has a thread to establish a detachable, liquid-tight connection. The mixer part 160 has a second reservoir 123, which contains a surfactant 124 in powder form. An intermediate filter 126 is arranged between the first reservoir 103 and the second reservoir 123 and establishes a fluid-conducting connection between the first reservoir 103 and the second reservoir 123. The intermediate filter 126 is attached to the first reservoir 103 by a holder in order to seal the reservoir 103 from the outside, so that no solid active ingredient 104 can pass through the filter 106 from the first reservoir 103.The fluidic element 107 is configured to pump liquid into the first reservoir 103 and the second reservoir 123 to dissolve the active ingredient 104 and the surfactant 124 in the liquid to produce a wound irrigation solution. The fluidic element 107 is further configured to dispense this wound irrigation solution from the device.

[0122] Figure 2 shows, by way of example, an adapter part 150 of a device that can be connected to a container 200. The adapter part 150 of the device has a connection element 101 that can be positively connected to a container, for example, with a connection provided for this purpose on the head of an infusion bottle or a foil bag. The device further has a mandrel 102 with which a septum 201 of a container can be pierced. The mandrel 102 has an inner cavity 115 for conducting a liquid from the container into the device. The inner cavity 115 is fluidly connected to a passage 111 of the device. The adapter part 150 of the device 100 further has a connecting element 109 with which the adapter part 150 of the device can be connected to a mixer part 160 of the device. In this example, the connecting element 109 is designed as a Luer-Lock external thread.

[0123] Figure 3 shows an example of an adapter part 150 which, for packaging and transport purposes, has a cover which surrounds the mandrel 102 and thus seals the cavity 115 of the mandrel in a liquid-tight manner on a first side of the cavity. In the embodiment shown here, the adapter part has only a single thread which can be detachably connected to a mixer part, a second closure 129, a nozzle or another dispensing device such as a jet lavage system. The thread can thus simultaneously combine the functions of the first connecting element 109 and the second connecting element 113. The closure 129 seals the cavity 115 of the mandrel in a liquid-tight manner on a second side of the cavity. A dispensing device can also be connected to the adapter part via the dispensing element 120. The dispensing element 120 here has a passage which extends parallel to the mandrel 102 in the direction of the container.For example, a dispensing device having a similar hollow spike may be connected to the dispensing member 120 and pierce the septum of the container parallel to the spike 102 of the adapter part.

[0124] Figure 4 shows a container 200 that can be connected to a device according to the invention. The container 200 contains a medically acceptable liquid 202 and has a septum 201 that seals the container to the outside. The septum 201 is made of an elastic material, for example silicone. The septum 201 can be pierced using the spike 102 of the device. The septum can additionally be protected by a seal that can be removed before connection to the device according to the invention. In the embodiment shown here, the container is a plastic infusion bottle. However, other containers can also be used, such as tubular film bags in which medical solutions, such as sterile saline solution, are commercially available and which can be pierced with a spike 102.

[0125] Figure 5 shows an adapter part 150 of a device according to the invention, which is attached to a container 200. The mandrel 102 penetrates the septum 201 of the container 200, so that the liquid 202 can be transferred from the container through the cavity 115 and the first passage 109 into the device, particularly when the adapter part is connected to the mixer part. The adapter part 150 is detachably connected to the container 200 by means of a snap closure. The snap closure surrounds the collar of the plastic bottle.

[0126] Figure 6 shows a device 100 according to the invention connected to a container 200. The adapter part 150 of the device is connected in a fluid-conducting and liquid-tight manner to the mixer part 160 of the device via a connecting element 109, which is designed here as a thread. The connecting element 101 is connected to the container 200, with the mandrel 102 being inserted into the container 200 through a septum 201 of the container. The interior of the container is fluid-conductingly connected to the reservoir 103 through a cavity 115 of the mandrel 102. Figure 6 thus also represents a first step of a method for producing a wound irrigation solution.

[0127] Figure 7 shows a device 100 according to the invention connected to a container 200. Using a fluidic element, here designed as a syringe having a piston 108, a liquid 201 can be drawn from the container 200 into the first reservoir 103 and the second reservoir 203, so that an antiseptic oxidizing agent 103, which is arranged in the first reservoir 103, and a surfactant 124, which is arranged in the second reservoir 203, dissolve in the liquid 201. The direction of the arrow indicates the direction of movement of the syringe piston when liquid is drawn into the mixer part of the device. Only in the dissolved state can these two substances pass through the intermediate filter 126, which is arranged between the first reservoir 103 and the second reservoir 203. Together with the liquid, these dissolved substances form a wound irrigation solution comprising an antiseptic oxidizing agent and a surfactant.Figure 7 thus also represents a second step of a process for producing a wound irrigation solution.

[0128] Figure 8 shows a device 100 according to the invention, which is connected to a container 200. Here, the syringe plunger 107 is moved in the direction of the arrow to dispense a wound irrigation solution prepared in the mixing device from the first reservoir 103 and the second reservoir 123 of the mixer part 160 via the adapter part 150 into the container 200. Figure 8 thus also represents a third, optional step of a method for producing a wound irrigation solution, in which a wound irrigation solution is obtained in a container.

[0129] Figure 9 shows a device 100 according to the invention, which is connected to a container 200. In the embodiment shown here, the intermediate filter 126 is movably arranged in the mixer part so that the first reservoir 103 and the second reservoir 123 can be completely emptied, and the entire wound irrigation solution produced in the device can be dispensed from the device 100 into the container 200. For this purpose, the intermediate filter 126 is moved with the aid of the syringe plunger 107 in the direction of the outlet 105 of the first reservoir until the intermediate filter 126 is flush with the outlet 105. Figure 9 thus also represents a fourth, optional step of a method for producing a wound irrigation solution, in which a wound irrigation solution is obtained in a container.

[0130] Figure 10 shows an adapter part 150, which is simultaneously connected to a container 200 and to a nozzle 110. For this purpose, the adapter part 150 comprises a first passage 111, which is designed for connection to a nozzle 110 or another external dispensing device. In the configuration shown here, the adapter part 150 is fluidically connected to a container 200 by means of the connection element 101, so that an active ingredient solution produced by the device can be dispensed from the container 200 via the first passage 111. Figure 11 shows a kit which, in addition to a device according to the invention comprising the adapter part 150 and the mixer part 160, also contains a container 200 with a medically acceptable liquid, e.g., sterile saline solution. The kit also contains a jet lavage device 300, with the aid of which a wound irrigation solution produced by the device can be administered directly to a patient, e.g.,during a surgical procedure. For this purpose, the jet lavage device 300 can be connected to the container 200 via a second closure 129 of the adapter part 150 after a wound irrigation solution has been prepared using the device and dispensed into the container 200, as shown in Figures 6 to 9. Alternatively, the wound irrigation solution can be dispensed via a nozzle 110, which can be connected to the adapter part 150, as shown in Figure 10.

[0131] EXAMPLES OF IMPLEMENTATION

[0132] For the examples, calcium hypochlorite (CAS 7778-54-3; hypochlorite content 68%), anhydrous citric acid (CAS 77-92-9), anhydrous glucuronic acid (CAS 576-37-4), sodium chlorite (CAS 7758-19-2), benzalkonium chloride (CAS 63449-41-2), and sodium dodecyl sulfate (CAS 151-21-3), each purchased from Sigma-Aldrich, were used, as well as commercially available, sterile 500-ml plastic infusion bottles, each containing 500 ml of 0.9% saline solution. The plastic infusion bottles each had two septa at the top of the bottle. All ppm values ​​given in the tables are mass fractions (i.e., mass of solute per mass of solution). The calcium peroxide had a peroxide content of 44 percent. The sodium chlorite had a chlorite content of 67%.

[0133] A mixing device was constructed from a commercially available, medical 20 ml plastic syringe by dividing the interior of the syringe into a first reservoir and a second reservoir by incorporating a PE pore disk. The respective components of experiments 1-24 were weighed into the first and second reservoirs, respectively, as indicated in the following tables. The syringe was then screwed onto an adapter part described herein as shown in Figure 2. The adapter part was pressed onto the head of the plastic infusion bottle, with the piercing spike perforating a septum of the plastic infusion bottle. After connecting the adapter part to the plastic infusion bottle, the bottle was tilted toward the bottle head, and the syringe plunger was used to draw liquid from the plastic infusion bottle five times and then push it back into the plastic bottle.The components in the first and second reservoirs dissolved completely, resulting in a freshly prepared wound irrigation solution containing antiseptic oxidizing agent, pH regulator, and surfactant. The resulting liquid in the plastic infusion bottle was visibly clear in all examples. The syringe was then unscrewed from the adapter, and a dispensing nozzle was screwed onto the adapter. The pH of the solutions prepared in this way was between pH 5 and pH 7. The concentrations of antiseptic oxidizing agent, pH regulator, and surfactant used, as well as the concentrations of the corresponding substances (ppm values ​​expressed as a mass / mass ratio) in the resulting wound irrigation solution are shown in the following tables.

[0134] Table 1: Amounts of calcium hypochlorite, citric acid and sodium lauryl sulfate used in Examples 1 to 13.

[0135] Table 2: Concentrations of hypochlorite, citric acid and sodium lauryl sulfate in the prepared solution in Examples 1 to 13.

[0136] Table 3: Amounts of calcium hypochlorite, citric acid and benzalkonium chloride used in Examples 14 to 16. Table 4: Concentrations of hypochlorite, citric acid and sodium lauryl sulfate in the prepared solution in Examples 14 to 16.

[0137] Table 5: Amounts of calcium hypochlorite, glucuronic acid and sodium lauryl sulfate used in Examples 17 to 19.

[0138] Table 6: Concentrations of hypochlorite, glucuronic acid and sodium lauryl sulfate in the prepared solution in Examples 17 to 19. Table 7: Amounts of calcium peroxide, citric acid and sodium lauryl sulfate used in the

[0139] Examples 20 to 22.

[0140] Table 8: Concentrations of peroxide, citric acid and sodium lauryl sulfate in the prepared solution in Examples 20 to 22. Table 9: Amounts of sodium chlorite, citric acid and sodium lauryl sulfate used in Examples 23 and 24.

[0141] Table 10: Concentrations of chlorite, citric acid and sodium lauryl sulfate in the prepared solution in Examples 23 and 24.

[0142] LIST OF REFERENCE SYMBOLS

[0143] 100 device

[0144] 101 connecting element

[0145] 102 Thorn

[0146] 103 first reservoir

[0147] 104 antiseptic oxidizing agent

[0148] 105 Exit of the first reservoir

[0149] 106 connection filters

[0150] 107 Fluidic element

[0151] 108 pistons

[0152] 109 first connecting element

[0153] 110 nozzle

[0154] 111 first implementation

[0155] 112 second implementation

[0156] 113 second connecting element

[0157] 114 Closure

[0158] 115 Mandrel cavity

[0159] 116 Filter holder

[0160] 119 first closure

[0161] 120 Dispensing element 123 Second reservoir

[0162] 124 Surfactant

[0163] 126 intermediate filters

[0164] 129 second closure 150 adapter part

[0165] 160 mixer part

[0166] 200 containers

[0167] 201 Septum

[0168] 202 Liquid 203 Container closure

Claims

CLAIMS 1. Device (100) for producing an antiseptic wound irrigation solution, comprising an antiseptic oxidizing agent (104) and a surfactant (124).

2. Device according to claim 1, wherein the antiseptic oxidizing agent and the surfactant are present separately in the device.

3. Device according to one of the preceding claims, wherein the antiseptic oxidizing agent and / or the surfactant is present as a solid.

4. Device according to one of the preceding claims, which further comprises a first reservoir (103) and a separate second reservoir (123), wherein the antiseptic oxidizing agent is arranged in the first reservoir (103) and the surfactant is arranged in the second reservoir (123).

5. Device according to one of the preceding claims, wherein the device further comprises an intermediate filter (106) which fluidically connects the first reservoir (103) to the second reservoir (123), wherein the intermediate filter is preferably permeable to the antiseptic oxidizing agent and / or the surfactant only in the liquid state.

6. Device according to one of the preceding claims, wherein the device further comprises a connecting element (101), wherein the connecting element is configured to establish a fluid-conducting connection with a container (200).

7. Device according to claim 6, wherein the antiseptic oxidizing agent and / or the surfactant is present as a solid, and wherein the connecting element (101) has a connecting filter (106) which is configured to retain the antiseptic oxidizing agent and / or the surfactant as a solid in the first reservoir (103) and / or the second reservoir (123).

8. The device according to claim 6 or 7, further comprising a dispensing element (120), wherein the dispensing element is preferably configured to dispense a disinfecting wound irrigation solution made from the antiseptic oxidizing agent and the surfactant from the device.

9. Device according to one of the preceding claims, further comprising a mandrel (102) adapted to pierce a septum of a container (200), wherein the mandrel preferably has a hollow interior (115) adapted to receive a liquid (202) from the container (200) into the first reservoir (103) and the second reservoir (123).

10. Device according to one of the preceding claims, which further comprises a fluidic element (107) which is arranged and designed to convey a liquid into the device.

11. Device according to one of claims 4 to 10, wherein the device comprises an adapter part (150) and a mixer part (160), wherein the adapter part is adapted for connection to a container (200), and wherein the mixer part is adapted for mixing the antiseptic oxidizing agent (104) and the surfactant (124) with a liquid from the container (200).

12. Device according to one of the preceding claims, wherein the antiseptic oxidizing agent is selected from the group consisting of chlorite, hypochlorite and peroxide, more preferably selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium chlorite, sodium hypochlorite, sodium peroxide and calcium peroxide.

13. A device according to any one of the preceding claims, wherein the surfactant comprises a fatty alcohol sulfate and / or a quaternary ammonium salt; further preferably, the surfactant comprises sodium dodecyl sulfate and / or benzalkonium chloride.

14. A device according to any one of the preceding claims, further comprising a pH regulator, wherein the pH regulator is selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium hydrogen sulfate, and sodium hydrogen carbonate.

15. A method for preparing an antiseptic wound irrigation solution using a device according to any one of the preceding claims, the method comprising the following steps: a) optionally dissolving or diluting the antiseptic oxidizing agent and / or the surfactant using a medically acceptable liquid using the device, b) Mixing the antiseptic oxidizing agent with the surfactant using the device, thereby obtaining an antiseptic wound irrigation solution.

16. The method according to claim 15, wherein the concentration of the antiseptic oxidizing agent in the prepared wound irrigation solution is 100 ppm to 4000 ppm (mass / mass), and / or the concentration of the surfactant in the prepared wound irrigation solution is 25 ppm to 2000 ppm (mass / mass).

17. The method according to any one of claims 15 or 16, wherein the pH of the wound irrigation solution prepared is 4 to 8, preferably 5 to 7.

18. A medicated wound irrigation solution for use in a method for the prophylaxis or treatment of a wound infection, the medicated wound irrigation solution comprising an antiseptic oxidizing agent and a surfactant.

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