Wound irrigation solution for removing biofilm

Abstract

The invention relates to a device (100) for preparing an antiseptic wound irrigation solution, the device having an antiseptic oxidizing agent (104) and a surfactant (124). The invention likewise relates to a method for preparing an antiseptic wound irrigation solution. Such a wound irrigation solution is particularly useful for treating a biofilm. The antiseptic oxidizing agent and the surfactant are each arranged as a solid and separately from one another in the device. The device can also allow the wound irrigation solution to be dispensed via a nozzle or using a jet lavage system.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and in particular to an apparatus for preparing and dispensing solutions of active ingredients (e.g., wound irrigation solutions). Background Technology

[0002] Preservative active ingredients and solutions have been known since the 19th century. Examples of such active ingredients are hypochlorites and their solutions. The shelf life of aqueous hypochlorite solutions is limited, primarily due to the slow conversion of hypochlorite ions to chloride ions. This means that the hypochlorite content of the solution decreases with increasing storage time. Hypochlorite ions may also decompose into chloride ions and oxygen.

[0003] Preservative hypochlorite solutions are known in the prior art, among which various solutions have been proposed to improve storage stability.

[0004] Such solutions have been described in publications such as: US 8945630B2, US 2011 / 0236490A1, WO2021001789, US 2019328776A1, WO2021134041A1, WO 2022 / 038507 A1, WO2020252433, WO 2020174436A1, US 243781, US 3749672, US 6162371, WO 1991 / 003936, US641974, US 2009 / 0258083, WO 2010148004, WO 2010148004, US 2009 / 0148342 A1, WO2016 / 100543 A2, WO 2020 / 089693 A1 and WO 2021 / 162736 A1.

[0005] However, completely preventing the decomposition of hypochlorite ions in aqueous solutions remains a challenge.

[0006] Another challenge is providing such solutions in a sterile form, where the container is also sterile and stable. For example, US4964261A and US2005232848A1 address this task.

[0007] Solid precursors for the production of hypochlorite-containing solutions are described in DE2712574A1 and US4104190A.

[0008] Biofilms pose a particular challenge to preservatives. Depending on the type of microorganism causing the disease, these biofilms are composed of a mucus of polysaccharides, proteins, and eDNA. This mucus film surrounds the microorganisms colonizing within it and protects them from external influences. The encapsulated microorganisms also have reduced accessibility to preservatives. Summary of the Invention

[0009] The objective of this invention is to solve one or more of the aforementioned and additional problems of the prior art. For example, the invention provides a device containing an active ingredient, by virtue of which a ready-to-use active ingredient solution can be rapidly, easily, and economically produced using a commercially available container containing a sterile saline solution or similar solution. Because the device according to the invention preferably contains the active ingredient in solid form, it can be stored for a longer period of time even if it contains an active ingredient that is not persistently stable in aqueous solutions. Furthermore, when manufacturing the device according to the invention, if the substances contained therein are provided in solid form, sterilization of the liquid is unnecessary. Some active ingredients can be better sterilized when in solid form because they are more easily decomposed in solution during sterilization. In some embodiments, the device according to the invention allows the liquid produced therein to be directly dispensed to a patient, for example, using a nozzle attachable to the device according to the invention.

[0010] This invention is specifically based on improving the accessibility of microorganisms in biofilms through the use of surfactants. Surfactants can both loosen and dissolve biofilms. Such improved antiseptic wound irrigation solutions may contain preservatives, such as hypochlorite solutions or solutions containing hydrogen peroxide, which also contain surfactants. However, aqueous hypochlorite solutions, aqueous chlorite solutions, and hydrogen peroxide solutions are very strong oxidizing agents and can oxidize and attack dissolved surfactants. This makes the shelf life of such solutions challenging. Separating the substances can improve their shelf life.

[0011] Therefore, this document describes devices for intraoperative preparation of oxidative preservative solutions containing surfactants, wherein the known decomposition of hypochlorite ions, chlorite ions, and hydrogen peroxide in aqueous solutions is effectively avoided during solution storage. The aqueous solutions prepared by this device may contain hypochlorite ions and / or hydrogen peroxide and / or chlorite ions, as well as at least one surfactant. Furthermore, the resulting solutions may have a physiologically acceptable pH. The decomposition of surfactants during device storage is effectively prevented by the device described herein. The device can be sterilized together with the oxidative preservatives and surfactants contained therein.

[0012] Preferred embodiments of the present invention are described below.

[0013] A first embodiment relates to an apparatus for preparing an antiseptic wound irrigation solution, the apparatus comprising an antiseptic oxidant and a surfactant. A second embodiment relates to the apparatus according to the first embodiment, wherein the antiseptic oxidant and the surfactant are present separately in the apparatus. A third embodiment relates to the apparatus according to any one of the preceding embodiments, wherein the antiseptic oxidant and / or surfactant are present as solids. A fourth embodiment relates to the apparatus according to any one of the preceding embodiments, the apparatus further comprising a first reservoir and a second reservoir separate therefrom, wherein the antiseptic oxidant is disposed in the first reservoir and the surfactant is disposed in the second reservoir. A fifth embodiment relates to the apparatus according to any one of the preceding embodiments, wherein the apparatus further comprises an intermediate filter that fluidly connects the first reservoir to the second reservoir, wherein the intermediate filter preferably allows only liquid antiseptic oxidant and / or surfactant to permeate. A sixth embodiment relates to the apparatus according to any one of the preceding embodiments, wherein the apparatus further comprises a connecting element configured to establish a fluidly conductive connection with a container. A seventh embodiment relates to an apparatus according to a sixth embodiment, wherein the preservative oxidant and / or surfactant are present as solids, and wherein the connecting element includes a connecting filter configured to retain the preservative oxidant and / or surfactant as solids in a first reservoir and / or a second reservoir. An eighth embodiment relates to an apparatus according to a sixth or seventh embodiment, further comprising a dispensing element preferably configured to dispense a disinfectant wound irrigation solution prepared from the apparatus by the preservative oxidant and surfactant independently of the connecting element. A ninth embodiment relates to an apparatus according to any of the preceding embodiments, further comprising a mandrel adapted to puncture a diaphragm, wherein the mandrel preferably includes a hollow interior adapted to receive liquid from the container into a first reservoir and a second reservoir. A tenth embodiment relates to an apparatus according to any of the preceding embodiments, further comprising a jetting element arranged and designed to deliver liquid into the apparatus. An eleventh embodiment relates to an apparatus according to any of embodiments four to ten, wherein the apparatus includes an adapter portion and a mixer portion, wherein the adapter portion is adapted to connect to a container, and the mixer portion is adapted to mix the preservative oxidant and surfactant with liquid from the container. The twelfth embodiment relates to an apparatus according to any one of the preceding embodiments, wherein the corrosion-preventing oxidant is selected from the group consisting of chlorite, hypochlorite, and peroxide, and more preferably from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium chlorite, sodium hypochlorite, sodium peroxide, and calcium peroxide. The thirteenth embodiment relates to an apparatus according to any one of the preceding embodiments, wherein the surfactant comprises a fatty alcohol sulfate and / or a quaternary ammonium salt; wherein the surfactant further preferably comprises sodium dodecyl sulfate and / or benzalkonium chloride.The fourteenth embodiment relates to an apparatus according to any one of the foregoing embodiments, the apparatus further comprising a pH adjuster selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium bisulfate and sodium bicarbonate.

[0014] The second aspect relates to a method for preparing an antiseptic wound irrigation solution using the apparatus according to any one of the preceding claims in the first embodiment, wherein the method comprises the following steps:

[0015] a) Optionally, the device can be used to dissolve or dilute the preservative oxidant and / or surfactant using a medically compatible liquid.

[0016] b) The antiseptic oxidant is mixed with a surfactant using the apparatus to obtain an antiseptic wound irrigation solution. In a second embodiment of the method, the method according to the first embodiment is provided, wherein the concentration of the antiseptic oxidant in the prepared wound irrigation solution is from 100 ppm to 4000 ppm (mass / mass), and / or the concentration of the surfactant in the prepared wound irrigation solution is from 25 ppm to 2000 ppm (mass / mass). In a third embodiment of the method, the method according to the first or second embodiment is provided, wherein the pH of the prepared wound irrigation solution is from 4 to 8, preferably from 5 to 7.

[0017] In a third aspect, in the first embodiment, an apparatus for preparing an active ingredient solution, preferably an antiseptic wound irrigation solution, is described, the apparatus comprising:

[0018] - A connecting element designed and configured for a liquid-tight connection to a container;

[0019] - A mandrel, designed and configured to puncture the diaphragm of a container.

[0020] - A first reservoir containing an active ingredient in solid form, such as a corrosion inhibitor or oxidant, and which can be connected to a connecting element via a fluid-conducting outlet of the reservoir;

[0021] - A connecting filter is arranged at the outlet of the first reservoir and is adapted to retain the active ingredient in solid form in the reservoir;

[0022] - An intermediate filter that connects the first reservoir to the second reservoir, wherein the second reservoir contains a surfactant;

[0023] - A jet element adapted to receive liquid from a container into a first reservoir and a second reservoir, and / or adapted to dispense liquid from the first reservoir and the second reservoir;

[0024] The device is designed and configured to receive liquid from a container into a first reservoir and a second reservoir, dissolve active ingredients and surfactants in the liquid, and deliver the dissolved active ingredients and dissolved surfactants to a patient via a connecting element.

[0025] The second embodiment of the third aspect relates to the apparatus according to embodiment 1, wherein the mandrel includes a hollow interior adapted to receive liquid from a container into a first reservoir.

[0026] The third embodiment of the third aspect relates to a device according to any one of the foregoing embodiments, wherein the jet element includes a piston movably arranged within a first reservoir and / or a second reservoir, wherein the plunger preferably seals the first reservoir and / or the second reservoir in a liquid-tight manner.

[0027] The fourth embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, the apparatus comprising an adapter portion and a mixer portion capable of being detachably connected to each other.

[0028] The fifth embodiment of the third aspect relates to the apparatus according to embodiment 4, wherein the adapter portion includes a connecting element and a spindle, and / or wherein the mixer portion includes a reservoir, a filter, and a jet element.

[0029] The sixth embodiment of the third aspect relates to the apparatus according to embodiment 4 or 5, wherein the apparatus further includes a thread through which the adapter portion can be connected to the mixer portion.

[0030] The seventh embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, wherein the apparatus is completely sterilized and preferably completely pyrogen-free.

[0031] The eighth embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, wherein the apparatus further includes a nozzle adapted to dispense the active ingredient in a dissolved form.

[0032] The ninth embodiment of the third aspect relates to the apparatus according to embodiment 8, wherein the nozzle is detachably connected to the connecting element in a fluid conduction manner.

[0033] The tenth embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, wherein the active ingredient is a preservative preferably selected from the group consisting of: calcium hypochlorite, magnesium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium peroxide, calcium peroxide, urea peroxide, triisocyanuric acid chloride, sodium N-chloro-4-methylbenzenesulfonamide, sodium N-chlorobenzenesulfonamide, oteninidine, polyhexylguanidine, and chlorhexidine digluconate.

[0034] The eleventh embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, wherein the connecting element includes a first feeder adapted to receive liquid from a container into a first reservoir.

[0035] The twelfth embodiment of the third aspect relates to a device according to any one of the foregoing embodiments, wherein the connecting element includes a second feeder arranged for dispensing liquid from a reservoir, wherein dispensing is preferably possible when the device is connected to the reservoir via the first feeder according to embodiment 11.

[0036] The thirteenth embodiment of the third aspect relates to an apparatus according to any one of the foregoing embodiments, wherein the first and second reservoirs are transmissible with gamma rays and / or electron rays.

[0037] The fourth aspect relates to a kit comprising a device according to any one of embodiments 1 to 13 of the third aspect or an embodiment of the first aspect and a container having a medically compatible liquid, wherein the device is detachably connected to the container, and wherein the kit is aseptically packaged together, preferably completely sterile, and more preferably completely pyrogen-free.

[0038] The fifth aspect relates to an active agent for use in a medical treatment, wherein the active agent is dissolved in a liquid using the device according to any one of the foregoing embodiments prior to administration to a patient, and is subsequently administered in dissolved form.

[0039] The sixth aspect relates to a method for preparing an active ingredient solution, the method comprising the following steps:

[0040] a) Receiving liquid from a container into a first and second reservoir of the apparatus by means of any one of embodiments 1 to 13 of the third aspect or the embodiment of the first aspect.

[0041] b) Mix the active ingredient in the first reservoir and the surfactant in the second reservoir with the liquid received in step a).

[0042] c) This yields a solution of the active ingredient.

[0043] d) Optionally dispense the active ingredient solution into the container.

[0044] The seventh aspect relates to the use of the apparatus described in any one of embodiments 1 to 13 of the third aspect or the embodiment of the first aspect for preparing solutions of active ingredients.

[0045] The eighth aspect relates to a medical wound irrigation solution in a method for preventing or treating wound infections, wherein the medical wound irrigation solution contains an antiseptic oxidant and a surfactant. Attached Figure Description

[0046] Figure 1 A mixer section is shown, which has a first reservoir for the active ingredient, a second reservoir for the surfactant, and a jet element for conveying liquid from the container.

[0047] Figure 2 The adapter section that can be connected to the container is shown.

[0048] Figure 3 The adapter section is shown in a closed and sealed state.

[0049] Figure 4 A container with a diaphragm is shown, which can be connected to a device according to the invention.

[0050] Figure 5 The adapter section that connects to the container is shown.

[0051] Figure 6 A device according to the invention, connected to a container, is shown.

[0052] Figure 7 An apparatus according to the invention for receiving liquid from a container is shown.

[0053] Figure 8 An apparatus according to the invention is shown, which dispenses a wound irrigation solution formed therein into a container.

[0054] Figure 9 An apparatus according to the invention is shown, which has completely dispensed the wound irrigation solution prepared therein into a container.

[0055] Figure 10 The container with the adapter section and nozzle installed is shown.

[0056] Figure 11 The kit includes a container, an adapter section, a mixer section, a nozzle, and a dispensing device. Detailed Implementation

[0057] Regarding the embodiments described herein, where an element "has," "contains," or "comprises" a particular feature (e.g., a material), it is always anticipated in principle that another embodiment exists in which the relevant element consists solely of that feature, i.e., excluding any other components. The word "comprises" is used synonymously with the words "contains" or "has" herein.

[0058] In one implementation, if an element is represented by a singular number, it is also expected that there are implementations containing more than one such element. The use of the terminology for plural elements also, in principle, includes implementations containing only a single corresponding element.

[0059] Unless otherwise indicated or clearly excluded from the context, it is generally possible, and thus clearly anticipated, for features of different embodiments to also exist in other embodiments described herein. Similarly, it is generally expected that any feature incorporated herein in connection with a method or used to describe substances in a method will also apply to the articles and apparatus described herein, and vice versa. Not all combinations of such considerations are explicitly listed in all cases, merely for the sake of brevity. In principle, the scope of the invention is also intended to cover technical solutions known to be equivalent to the features described herein.

[0060] The first embodiment relates to an apparatus for preparing an antiseptic wound irrigation solution. The apparatus includes an antiseptic agent, such as an antiseptic oxidant. The apparatus also includes a surfactant.

[0061] The term "antiseptic" refers to the bactericidal or fungicidal effect, i.e., the antimicrobial effect, of a substance, particularly an active ingredient or composition such as a wound irrigation solution. Wound irrigation solutions are medically compatible aqueous compositions suitable for intraoperative irrigation (also known as irrigation).

[0062] Surfactants are amphiphilic substances comprising both hydrophilic and hydrophobic molecular moieties and thus possessing surface-active properties. Therefore, surfactants improve the solubility of hydrophobic substances in aqueous solutions. The use of surfactants in wound irrigation solutions can reduce biofilm stability, thereby improving the effectiveness of antiseptic oxidants on biofilms. 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. Examples of fatty alcohol sulfates are sodium dodecyl sulfate, also known as sodium lauryl sulfate or SDS. Examples of quaternary ammonium salts are benzalkonium chloride. Surfactants can be anionic, cationic, or neutrally charged surfactants, such as nonionic or zwitterionic surfactants. Surfactants that do not form calcium-containing precipitates in aqueous solutions of calcium salts are preferred. Medically compatible surfactants for internal use during surgical procedures are also preferred. 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.

[0063] Preferably, the corrosion inhibitor and the surfactant can be present separately in the device.

[0064] The corrosion inhibitor / oxidant may be present in the device as a solid. The surfactant may be present in the device as a solid. Preferably, both the corrosion inhibitor / oxidant and the surfactant are present in the device as solids.

[0065] Preferably, the preservative oxidant is water-soluble. The surfactant is preferably water-soluble. Particularly preferably, both the preservative oxidant and the surfactant are water-soluble. According to the invention, "water-soluble" should be understood to mean a substance with a solubility in water of at least 1 g substance / liter of water at 25°C and 1025 hPa.

[0066] In one embodiment, the device further includes a pH adjuster. The pH adjuster is a substance used to bring a wound irrigation solution prepared using the device to a medically compatible pH value. The medically compatible pH value is pH 4 to 8, preferably 5 to 7, wherein the pH value is measured at 25°C and 1025 hPa. The pH adjuster is preferably an acid. In some embodiments, the pH adjuster is selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium bisulfate, and sodium bicarbonate. In one embodiment, a first reservoir includes the pH adjuster. In one embodiment, a second reservoir includes the pH adjuster. In one embodiment, both the first and second reservoirs include the pH adjuster. The pH adjuster may be present in the device as a solid. The pH adjuster may be present as a mixture with an antiseptic oxidant and / or a surfactant.

[0067] When using preservative oxidants containing hypochlorite and peroxide, a weakly acidic to neutral pH may be particularly advantageous in order to achieve the desired balance between hypochlorite ions and hypochlorous acid, or between peroxide ions and hydroperoxide ions. This allows for effective preservative action in the prepared wound irrigation solution.

[0068] The device according to the invention may include an adapter portion and a mixer portion. The adapter portion may be connected to the mixer portion. The adapter portion may be detachably connected to the mixer portion, preferably by a positive fit, such as using a threaded or snap-fit ​​connection.

[0069] Preferably, the device according to the invention comprises a first reservoir and a second reservoir separate therefrom. Preferably, the corrosion inhibitor / oxidant is disposed in the first reservoir of the device, and the surfactant is disposed in the second reservoir. The first and second reservoirs may be disposed in a mixer section.

[0070] The device may include an intermediate filter that connects the first reservoir to the second reservoir via fluid conduction. The intermediate filter preferably allows only liquid anti-corrosion oxidants and / or surfactants to pass through. This means that the anti-corrosion oxidants or surfactants cannot pass through the intermediate filter as solids, but only in a dissolved state, for example. For example, if the oxidant and surfactant are each present as solids in the device, the intermediate filter can thus keep these two substances separate until they dissolve in a liquid, preferably an aqueous solution. In this case, they are first brought into contact by dissolving the oxidant and surfactant in an aqueous solvent to produce a wound irrigation solution. Therefore, embodiments of the device with an intermediate filter are advantageous if the anti-corrosion oxidants and surfactants are provided in solid form (e.g., in powder form). The intermediate filter can be movably arranged in the device; for example, it can be displaceable to allow liquid to drain from the device as completely as possible. Preferably, the intermediate filter is arranged and configured such that its position cannot be changed unintentionally (e.g., during transport of the device), but can only be changed by a user's targeted action, such as by applying force directly to the intermediate filter using a syringe plunger. For this purpose, the filter may be installed in the cylindrical interior of the mixer section of the device with a correspondingly adapted clamping force, such that it can only move when a predetermined force is applied to the filter.

[0071] A partition wall can be arranged between the first and second reservoirs instead of an intermediate filter. The partition wall can be designed to separate the first and second reservoirs in a liquid-tight manner. By removing or breaking the partition wall, the contents of the first and second reservoirs (e.g., corrosion inhibitors and surfactants) can be mixed together. In this way, corrosion inhibitors and / or surfactants in liquid form (e.g., in an aqueous solution) can be arranged separately in the device.

[0072] The device preferably includes a connecting element. The connecting element may be arranged in an adapter section. The connecting element is preferably designed and configured to connect the device to a container in a liquid-tight and fluid-conductive manner. The connecting element may interact with a mandrel as described below. This allows fluid exchange between the device and the container without leakage to the outside. The connecting element may provide a positive connection between the adapter section and the container. Such containers may be, for example, packages in which saline solutions, infusion solutions, and similar liquid medical products are commercially available. Bottles or film bags are used for this purpose, for example. These containers are typically made of plastic. The container may be a container with a flexible, preferably elastically deformable outer wall, such that the fluid contained therein can be released from the container by compressing it in the open state. The container may include a diaphragm that can be punctured by a mandrel attached to the device.

[0073] Preferably, the connecting element of the device can be connected to the container in a form-fit manner. The connecting element can be detachably connected to the container. For example, the connecting element can be attached to the opening of a plastic bottle or the connection of a film pouch. The connecting element may include a threaded or snap-fit ​​connection.

[0074] The device may also include a mandrel designed and configured to pierce the diaphragm of a container. For this purpose, the mandrel may have a tapered shape, and with its tip, the diaphragm of the container can be pierced by manually applying pressure to the diaphragm using the mandrel. A similar structure is used to connect an infusion set to a container containing an infusion solution. The mandrel may be arranged in an adapter section.

[0075] In one embodiment, the mandrel includes a hollow interior configured to receive liquid from a container into a reservoir. In this case, the mandrel may be designed, for example, in the form of a hollow needle. The mandrel may be made of or contain plastic, for example.

[0076] Preferably, the mandrel is rigid enough to penetrate the diaphragm of a commercially available container for saline solution, but not so hard and strong as to pose a risk of injury to medical personnel. In one embodiment, the mandrel is not a metal needle.

[0077] The device preferably includes a first reservoir. The first reservoir preferably contains a substance in solid form, such as a powder. This substance may be a corrosion-resistant oxidizing agent. The first reservoir may have a substantially cylindrical shape, similar to the interior of a syringe.

[0078] The device can be configured to release contained substances, particularly preservatives and oxidants, into the container in a dissolved form.

[0079] The device may also include a second reservoir. The second reservoir may contain a substance different from that in the first reservoir. The second reservoir may preferably contain a surfactant. The second reservoir may have a substantially cylindrical shape. In one embodiment, both the first and second reservoirs have a cylindrical shape. In one embodiment, the first and second reservoirs are arranged along a common axis.

[0080] In one embodiment, the corrosion inhibitor / oxidant is disposed in a first reservoir, and the surfactant is disposed in a second reservoir. In another embodiment, the corrosion inhibitor / oxidant is disposed in the second reservoir, and the surfactant is disposed in the first reservoir.

[0081] The device preferably includes a filter. Such a filter is preferably adapted to retain solid substances (e.g., preservatives, oxidants, or surfactants) in a reservoir (e.g., a first and / or second reservoir of the device) as long as the substance is not dissolved in the liquid. This prevents the substance from being delivered to the patient in an undissolved form. According to the invention, it is preferred that the substance be delivered to the patient only in liquid form (e.g., in a form completely dissolved in water). For this purpose, the filter may preferably be liquid-permeable. The filter is preferably gas-permeable. For example, a gas-permeable filter makes it easier to fill the reservoir with the substance, especially when manufacturing the device according to the invention. For this purpose, it is preferable to use compressed air or a vacuum to introduce the substance into the reservoir, wherein the gas-permeable filter allows gas to pass through but retains the substance in the reservoir.

[0082] The filter may, for example, be in the shape of a disc. The filter preferably has an open porosity. In some embodiments, the filter has open pores with a diameter less than 5µm, preferably less than 3µm, and particularly preferably less than 1µm. This pore size can be determined by excluding spherical particles with the corresponding particle size. Therefore, it is the nominal pore size.

[0083] The filter can be installed within a reservoir (e.g., the first and / or second reservoir of the device) via a retainer. The retainer can be designed, for example, in the form of a clamping ring. Optionally, the filter can be secured in a recess in the reservoir wall.

[0084] Filters may include, for example, polyethylene, polyurethane, polyimide, polyethersulfone, polyvinylidene fluoride, or polytetrafluoroethylene.

[0085] The filter can be a woven filter or a nonwoven filter.

[0086] In some embodiments, the reservoir includes a second filter that divides the internal space of the device into two separate areas, namely a first reservoir and a second reservoir.

[0087] The device may include two copies of the aforementioned filter, such as a connecting filter and an intermediate filter.

[0088] A connecting filter may be disposed at the outlet of the first reservoir. The connecting filter may be configured to retain solid substances (such as corrosion inhibitors, oxidants, and / or surfactants) in the device, provided that the substance is not dissolved in the liquid.

[0089] An intermediate filter may be disposed between the first and second reservoirs, connecting the first reservoir to the second reservoir via fluid conduction. The intermediate filter may be mounted there using a retainer. The first reservoir may contain an anti-corrosion oxidant. The second reservoir may contain a surfactant.

[0090] In one embodiment, the first reservoir contains a corrosion inhibitor / oxidant, and the second reservoir contains a surfactant. In another embodiment, the first reservoir contains a surfactant, and the second reservoir contains a corrosion inhibitor / oxidant. The corrosion inhibitor / oxidant and the surfactant are preferably each in solid form, such as powder form. Such embodiments allow for the preparation of solutions of active ingredients comprising the corrosion inhibitor / oxidant and the surfactant, where the two substances do not come into contact with each other in solid form during device storage.

[0091] The dimensions of the reservoir can be designed such that the ratio of the total volume of the first and second reservoirs to the volume of the container (i.e., [V(first reservoir) + V(second reservoir)] : V(container)) is a ratio of 1:25 to 1:500. The volume of the container can be, for example, 250 mL, 500 mL, or 1000 mL. Therefore, the total volume of the first and second reservoirs can be, for example, 0.5 mL to 10 mL, 1 mL to 20 mL, or 2 mL to 40 mL.

[0092] The device may also include a jetting element. The jetting element is preferably configured to receive liquid from the container into a first reservoir and / or a second reservoir. Alternatively or additionally, the jetting element may be configured to dispense liquid from the reservoir. The jetting element is preferably configured to actively deliver liquid. The jetting element may, for example, include a plunger for delivering liquid. The jetting element may include a syringe or a pump.

[0093] In one embodiment, the jet element includes a plunger movably disposed within the device (e.g., within a first reservoir and / or a second reservoir). The plunger preferably liquid-tightly seals the device, such as the first and / or second reservoir. Thus, the jet element can be designed, for example, as a syringe or syringe pump. The jet element may also include other types of components for delivering fluid, such as diaphragm pumps, peristaltic pumps, compressed air cylinders, or ports for external pressure or vacuum sources.

[0094] In one embodiment, the device includes an adapter portion and a mixer portion that are preferably detachably connectable to each other. Components of the device described herein may be arranged within such an adapter portion or mixer portion. For example, the adapter portion may include connecting elements and a spindle, and / or the mixer portion may include a reservoir, a filter, and jet elements. The adapter portion and the mixer portion may be connected to each other via connecting elements, preferably via positive-locking connecting elements, such as using threads or hooks. Preferably, the connecting elements allow the adapter portion to be detachably connected to the mixer portion. A preferred connecting element is a Luer lock connector. A Luer lock connector enables a threaded connection of two tightly interlocking tapered connecting parts. A Luer lock connector is disclosed in US1742497A. The adapter portion may preferably include an external thread that connects to an internal thread of the mixer portion. The mixer portion may include an external thread that connects to an internal thread of the adapter portion.

[0095] In one embodiment, the adapter portion may be configured to connect to the container in a fluid-conductive manner, while the mixer portion is separate from the adapter portion, and the adapter portion may connect to another device, such as a closure or nozzle. Thus, the adapter portion can serve as a versatile quick connector for other components. The mixer portion may include a syringe, such as a syringe with a Luer lock connector. In particular, the mixer portion may be configured to mix an anti-corrosion oxidant and a surfactant with a liquid.

[0096] In some embodiments, the device further includes a dispensing element. The dispensing element may be arranged in an adapter portion. The dispensing element may be configured to dispense an antiseptic wound irrigation solution prepared from an antiseptic oxidant and a surfactant from the device. The dispensing element may be configured to dispense the prepared wound irrigation solution in a device state where the device is connected to a container, wherein the device preferably includes an adapter portion connected to a mixer portion. The dispensing element may include a feeder. The feeder may be arranged parallel to the mandrel in the adapter portion.

[0097] As shown above, the device may include connecting elements to connect various parts of the device according to the invention (particularly the adapter and mixer parts), or to connect the device to other devices, or both. Here, either a single connecting element may be configured to optionally connect to multiple different devices, or multiple connecting elements may be provided at different locations on the device. The connecting elements are preferably form-fitting connecting elements. An example of such connecting elements is a thread. In some embodiments, the connecting elements include Luer lock connectors.

[0098] In one embodiment, the device includes a connecting element through which the adapter portion can be connected to the mixer portion. In some embodiments, the same connecting element is additionally configured to connect the device to a closure, nozzle, or another dispensing device. Alternatively, separate, different connecting elements may be provided for these purposes.

[0099] In one embodiment, the device is completely sterilized. In another embodiment, the device is completely pyrogen-free. The term "sterilized" means that the device has been subjected to methods for removing or killing pathogens, making the device usable according to common standards (such as DIN EN 556-1). Methods for sterilization include, for example, autoclaving, irradiation with an electron beam or gamma rays, or treatment with a disinfecting substance (e.g., ethylene oxide). Similarly, the term "pyrogen-free" means that the device has been subjected to conventional treatments in the art for removing or decomposing pyrogens. Whether the device is pyrogen-free can be determined using the horseshoe crab cell lysate (LAL) test according to Ph.Eur. 2.6.14. In each case, the current standards or documents applicable as of the priority date of this application apply.

[0100] In one embodiment, the device further includes a nozzle configured to dispense the active ingredient in dissolved form. The nozzle may include a generally cylindrical hollow body that tapers to a point at one end. Optionally, the nozzle may include a connector that allows dispensing of liquid in different directions through an opening that bends laterally relative to the entire device.

[0101] Preferably, the nozzle can be detachably connected to the adapter portion in a fluid conduction manner. This can be achieved via a form-fitting connecting element (e.g., a thread, preferably a Luer lock connector).

[0102] The device may also include a shield. The shield may be configured to protect portions of the device from splashes of discharged liquids, particularly solutions of the active ingredient. The shield may be positioned on or near the nozzle. The shield may have a disc shape. The shield may have a concave curvature similar to that of a parabolic antenna. The shield may include a centrally located recess configured to attach the shield to the device's output port.

[0103] The device preferably contains an anti-corrosion oxidant. In one embodiment, the anti-corrosion oxidant is selected from the group consisting of chlorite, hypochlorite, and peroxide. Chlorite is preferably an alkali metal chlorite. Peroxide is preferably a peroxide salt of alkali metal or alkaline earth metal. Hypochlorite is preferably an alkaline earth metal hypochlorite. In one embodiment, the anti-corrosion oxidant 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 dissolves in water, releasing hypochlorite ions, wherein the aqueous solution of these salts is strongly alkaline. The pH of these solutions can be lowered to a physiologically acceptable pH range of pH 4 to pH 8 by the action of acid. For this purpose, the device may preferably include a pH adjuster, particularly an acid. In neutral and acidic environments, hypochlorite ions are in equilibrium with hypochlorous acid. Sodium peroxide and calcium peroxide also dissolve in water and form an alkaline solution containing dissolved peroxide anions. By adding acid to lower the pH, the peroxide anions are in equilibrium with hydroperoxide ions and hydrogen peroxide in neutral and acidic environments.

[0104] In some embodiments, the corrosion-preventing oxidant comprises sodium chlorite and hypochlorite. In some embodiments, the corrosion-preventing oxidant comprises sodium chlorite and peroxide. In some embodiments, the corrosion-preventing oxidant comprises sodium chlorite, hypochlorite, and peroxide. The device may preferably include an acid. When exposed to acid, sodium chlorite (NaClO2) forms chlorogenic acid, which balances with chlorine dioxide. Chlorous acid and chlorine dioxide are oxidants with strong corrosion-preventing effects.

[0105] In one embodiment, the corrosion inhibitor and / or surfactant are 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. Due to the small particle size, rapid dissolution of the substance in question is achieved. The particle size of the substance in question is preferably larger than the discharge volume of the filter. The average diameter of the particles can be determined by grading and screening, as is conventional in the art. The particle size distribution is preferably narrow enough that as little as possible (e.g., less than 1%) of the particle mass can pass through the filter. In one embodiment, the substance in question is present as a cylindrical compact or as a cylindrical solidified melt.

[0106] In one embodiment, the connecting element includes a first feeder configured to receive liquid from the container into the reservoir. The first feeder preferably forms a fluid conduction connection between the connecting element (particularly the mandrel) and the reservoir.

[0107] In one embodiment, the device is configured to dispense liquid from a container. In this case, dispensing is preferably possible while the device is fluidly connected to the reservoir via the aforementioned first feeder. For example, with such an embodiment, liquid from a container connected to the device can first be received into the device's reservoir, the active ingredient contained in the liquid can be dissolved, and the dissolved active ingredient can then be dispensed into the container when the device is connected. The dissolved active ingredient can then be dispensed from the container to the patient via the device, while the device (particularly the adapter portion 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, such as a jet irrigation system, wherein the mixer portion of the device can be replaced with a nozzle or other dispensing device if desired. Examples of delivery systems are described in EP2619415A1 and EP2662146A2. The liquid is preferably a medically compatible liquid. The liquid is preferably suitable for internal use. In the case of a multi-part design, the entire device need not be connected to the container for dispensing liquid from the container. For example, it may be sufficient if the adapter portion described herein is connected to the container for dispensing liquid. For example, the mixer section may be temporarily connected to the device to remove liquid from the container and generate a wound rinsing solution.

[0108] In one embodiment, the first and / or second reservoirs are permeable to gamma rays and / or electron beams. This allows the interior of the device and the substances contained within it (particularly preservatives, oxidants, and surfactants) to be sterilized using gamma rays and / or electron beams to obtain a completely sterilized device.

[0109] In one embodiment, the mandrel and the first reservoir together define a transfer axis along which liquid can be dispensed from and / or into the reservoir. In another embodiment, the container and the first reservoir jointly define a transfer axis along which liquid can be dispensed from and / or into the first reservoir. Alternatively or additionally, such a transfer axis may be defined by a mandrel and a second reservoir in a corresponding manner.

[0110] Another aspect relates to an apparatus for preparing an active ingredient solution, the apparatus comprising:

[0111] - A connecting element designed and configured for a liquid-tight connection to a container;

[0112] - Mandrel, which is designed and configured to puncture the diaphragm of a container;

[0113] - A first reservoir containing a solid form of anti-corrosion oxidant, and which can be connected to a connecting element via a fluid conduction through the reservoir's outlet;

[0114] - A liquid-permeable connecting filter, which is arranged at the outlet of the first reservoir and is adapted to retain the anti-corrosion oxidant in solid form in the reservoir;

[0115] - A second reservoir containing a surfactant in solid form;

[0116] - An intermediate filter that connects the first reservoir to the second reservoir via fluid conduction;

[0117] - A jet element configured to receive liquid from a container into a first reservoir and / or a second reservoir, and / or configured to dispense liquid from a reservoir;

[0118] The device is designed and configured to receive liquid from a container into the reservoir, dissolve the active ingredient in the liquid, and dispense the dissolved active ingredient to the patient via the connecting element.

[0119] On the other hand, a kit is disclosed that includes a device according to one of the foregoing embodiments and a container comprising a medically compatible fluid, wherein the device is detachably connected to the container. The device may include an adapter portion as described herein and a mixer portion as described herein. The adapter portion is detachably connected to the mixer portion. The adapter portion is detachably connected to the container. In one embodiment, the components of the kit, i.e., the device and the container, are aseptically packaged together. In one embodiment, each component of the kit is completely sterilized. In one embodiment, each component of the kit is completely pyrogen-free. The kit may also include a dispensing device for dispensing the fluid, such as a nozzle or a rinsing device, such as the rinsing device according to EP4035605A1. The medically compatible fluid may include an infusion solution or a medical rinsing solution. The medically compatible fluid may include physiological saline solution, Ringer's solution, or a similar saline solution. The medically compatible fluid is preferably sterile and / or pyrogen-free.

[0120] Another aspect relates to an active ingredient for use in medical treatments, wherein the active ingredient is dissolved in a liquid prior to administration to a patient and subsequently administered in a dissolved form. The active ingredient may be a substance with pharmacological activity. The active ingredient may have, for example, antimicrobial activity. The active ingredient may contain preservative oxidants and may also contain surfactants. In one embodiment, the preservative oxidant is selected from the group consisting of chlorites, hypochlorites, and peroxides. Chlorites are preferably alkali metal chlorites. Peroxides are preferably peroxide salts of alkali metals or alkaline earth metals. Hypochlorites are preferably hypochlorites of alkaline earth metals. In one embodiment, the antiseptic oxidant 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 applied using the apparatus described herein. For example, the adapter portion used herein can be connected to a nozzle or jet irrigation system. The treatment method can be, for example, the treatment of surgical wound infections, as explained in more detail below.

[0121] On the other hand, a medical treatment method is involved, wherein the active ingredient, particularly a preservative oxidant, and a surfactant are dissolved in a liquid prior to administration to a patient via the device described herein, and subsequently administered in dissolved form. The liquid is preferably a medically compatible liquid as described herein. The treatment method may, for example, include the sterilization of fabrics. The treatment method may include surgical joint procedures, such as the implantation or replacement of a joint implant. For example, a joint implant may be an isolator. Joint procedures may include, for example, surgical hip, knee, shoulder, or back procedures. The treatment method may also include therapies for inflammatory conditions. The treatment method may include, for example, treatment of arthropathy or joint infection.

[0122] On the other hand, this relates to a composition in a method for treating surgical wounds, particularly infected wounds, wherein the method includes applying the composition using the device described herein. The composition preferably contains an antiseptic oxidant and a surfactant. Treatment may involve surgical joint procedures, such as the implantation or replacement of a joint implant. For example, a joint implant may be an isolation device. Joint procedures may include, for example, surgical hip, knee, shoulder, or back procedures. Treatment may also include therapies for inflammatory conditions. Treatment may include, for example, treatment of arthropathy or joint infection.

[0123] Another aspect relates to a method for preparing an active ingredient solution, the method comprising the following steps:

[0124] a) The apparatus described herein receives liquid from a container into the first and second reservoirs of the apparatus.

[0125] b) Mix the corrosion inhibitor and surfactant in the device with the liquid received in step a).

[0126] c) This yields a solution of the active ingredient.

[0127] d) If necessary, dispense the active ingredient solution from the device into a container.

[0128] The method may preferably be carried out in the order of a), b), c) or a), b), c), d). The method may also include the step of discharging the active ingredient solution from the device or from the container. The active ingredient solution may preferably be discharged from the container via the device, as described in more detail elsewhere herein. The active ingredient solution may be a wound irrigation solution. The solution may also contain a pH adjuster. The preservative oxidant may contain chlorite, hypochlorite, and / or peroxide. The surfactant may contain quaternary ammonium salts and / or fatty alcohol sulfates.

[0129] Another aspect involves active ingredient solutions that can be produced according to the methods shown above. The active ingredient solution may contain preservatives, oxidants, and surfactants. The active ingredient solution may be a wound irrigation solution. The solution may also contain a pH adjuster. Preservatives and oxidants may contain chlorites, hypochlorites, and / or peroxides. Surfactants may contain quaternary ammonium salts and / or fatty alcohol sulfates.

[0130] On the other hand, this relates to the use of the apparatus or kit described herein for preparing active ingredient solutions, particularly antiseptic wound irrigation solutions. The active ingredient solution may contain an antiseptic oxidant and a surfactant. The active ingredient solution may be a wound irrigation solution. The solution may also contain a pH adjuster. The antiseptic oxidant may contain chlorite, hypochlorite, and / or peroxide. The surfactant may contain quaternary ammonium salts and / or fatty alcohol sulfates.

[0131] Another aspect relates to a medical wound irrigation solution for a method of preventing or treating wound infections, wherein the medical wound irrigation solution comprises an antiseptic oxidant and a surfactant. Wound infections can be internal wound infections, such as surgical wounds. Wound infections can include bone tissue infections. Bone tissue can include bones, particularly joints and cartilage. The solution may also contain a pH adjuster. The antiseptic oxidant may contain chlorite, hypochlorite, and / or peroxide. The surfactant may contain quaternary ammonium salts and / or fatty alcohol sulfates.

[0132] On the other hand, the invention relates to a medical wound irrigation solution for use as a disinfectant, wherein the medical wound irrigation solution comprises an antiseptic oxidant and a surfactant. The solution may also contain a pH adjuster. The antiseptic oxidant may comprise chlorite, hypochlorite, and / or peroxide. The surfactant may comprise quaternary ammonium salts and / or fatty alcohol sulfates.

[0133] Example

[0134] The invention is further illustrated below with examples; however, these examples should not be construed as limiting. It will be apparent to those skilled in the art that other equivalent means may be used in place of the features described herein.

[0135] Attached Figure

[0136] Figure 1A mixer portion 160 of the device according to the invention is shown, having a first reservoir 103, a second reservoir 123, and a jet element 107 for conveying liquid 202 from a container 200 (not shown). The jet element 107 is designed herein as a syringe, which includes a syringe plunger 108. An active ingredient, such as an anti-corrosion oxidant 104, is disposed as a powder in the first reservoir 103. The device also includes a connecting filter 106 to retain the active ingredient 104 in the first reservoir 103. The outlet 105 of the first reservoir is configured to establish a fluid conduction connection between the first reservoir 103 and the adapter portion of the device. The active substance 104 can only pass through the connecting filter 106 in dissolved form. The connecting filter 106 is mounted to the first reservoir 103 via a retainer 116 to seal the reservoir 103 to the outside, such that no solid active substance 104 can pass from the first reservoir 103 through the filter 106. The mixer section 160 includes a first connecting element 109 for connection to the adapter section 150. The connecting element of the mixer section 160 is designed to be complementary to the connecting element of the adapter section 150. In the example shown here, the mixer section 160 includes an internal Luer lock thread. The first connecting element 109 is also detachably connectable to a first closure 119 to liquid-tightly seal the first reservoir 103 and the outlet 105. The first connecting element 109 includes threads to form a detachable liquid-tight connection. The mixer section 160 includes a second reservoir 123 containing a surfactant 124 in powder form. An intermediate filter 126 is arranged between the first reservoir 103 and the second reservoir 123, establishing a fluid conduction connection between the first reservoir 103 and the second reservoir 123. An intermediate filter 126 is mounted on the first reservoir 103 via a retainer to seal the reservoir 103 to the outside, preventing any solid active material 104 from passing through the filter 106 from the first reservoir 103. A jet element 107 is configured to deliver liquid into the first reservoir 103 and the second reservoir 123 to dissolve the active ingredient 104 and surfactant 124 in the liquid to produce a wound irrigation solution. The jet element 107 is also configured to dispense the wound irrigation solution from the device.

[0137] Figure 2An example of an adapter portion 150 of a device that can be connected to container 200 is shown. The adapter portion 150 includes a connecting element 101 that can be positively connected to the container, such as to a port provided for this purpose on the head of an infusion bottle or foil bag. The device also includes a mandrel 102 that can pierce the diaphragm 201 of the container. The mandrel 102 includes an inner cavity 115 for guiding liquid from the container into the device. The inner cavity 115 is fluidly connected to a feedthrough 111 of the device. The adapter portion 150 of device 100 also includes a connecting element 109, by which the adapter portion 150 can be connected to a mixer portion 160 of the device. In this example, the connecting element 109 is designed with a Luer lock external thread.

[0138] Figure 3 An example of an adapter portion 150 is shown, which includes a cap for packaging and shipping purposes that surrounds the mandrel 102 and thus liquid-tightly seals a portion of the mandrel's cavity 115 on a first side of the cavity. In the embodiment shown here, the adapter portion includes only a single thread that can optionally be detachably connected to a mixer portion, a second closure 129, a nozzle, or another dispensing device, such as a jet irrigation system. This means that the thread can simultaneously combine the functions of the first connecting element 109 and the second connecting element 113. The closure 129 liquid-tightly seals a portion of the mandrel's cavity 115 on a second side of the cavity. The dispensing device can also be connected to the adapter portion via a dispensing element 120. The dispensing element 120 here includes a feeder extending parallel to the mandrel 102 in the direction of the container. For example, a dispensing device including a similar hollow mandrel can be connected to the dispensing element 120 and pierce the diaphragm of the container parallel to the mandrel 102 of the adapter portion.

[0139] Figure 4 A container 200, which can be connected to a device according to the invention, is shown. The container 200 contains a medically compatible fluid 202 and includes a diaphragm 201 that seals the container to the outside. The diaphragm 201 is formed of an elastic material (e.g., silicone). The diaphragm 201 can be punctured using the mandrel 102 of the device. The diaphragm may be additionally 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, such as tubular foil bags, may also be used, wherein medical solutions such as sterile saline solutions are commercially available and can be punctured using the mandrel 102.

[0140] Figure 5An adapter portion 150 of the device according to the invention is shown, which is attached to a container 200. A spindle 102 penetrates the diaphragm 201 of the container 200, allowing liquid 202 to be conveyed from the container through a cavity 115 and a first feeder 109 into the device, particularly when the adapter portion is connected to the mixer portion. The adapter portion 150 is detachably connected to the container 200 using a snap-lock. The snap-lock surrounds the neck of the plastic bottle.

[0141] Figure 6 A device 100 according to the invention is shown connected to a container 200. An adapter portion 150 of the device is connected to a mixer portion 160 of the device via a connecting element 109 (designed herein as a thread) in a fluid-conductive and liquid-tight manner. A connecting element 101 is connected to the container 200, wherein a mandrel 102 is inserted into the container 200 through a diaphragm 201. The interior of the container is connected to a reservoir 103 in a fluid-conductive manner via a cavity 115 of the mandrel 102. Therefore, Figure 6 It also refers to the first step in a method for preparing a wound irrigation solution.

[0142] Figure 7 A device 100 according to the invention, connected to a container 200, is shown. By means of a jet element (designed herein as a syringe including a plunger 108), liquid 201 can be drawn from the container 200 into a first reservoir 103 and a second reservoir 203, such that the anti-corrosion oxidant 103 disposed in the first reservoir 103 and the surfactant 124 disposed in the second reservoir 203 dissolve in the liquid 201. The arrows indicate the direction of movement of the syringe plunger as the liquid is drawn into the mixing section of the device. Only after dissolution can these two substances pass through an intermediate filter 126 located between the first reservoir 103 and the second reservoir 203. These dissolved substances, together with the liquid, form an anti-corrosion wound irrigation solution containing the anti-corrosion oxidant and the surfactant. Therefore, Figure 7 It also refers to the second step in the method for preparing a wound irrigation solution.

[0143] Figure 8 A device 100 according to the invention, connected to container 200, is shown. The syringe plunger 107 moves here in the direction of the arrow to dispense the wound irrigation solution prepared in the mixing device from the first reservoir 103 and the second reservoir 123 of the mixer section 160 into container 200 via adapter section 150. Therefore, Figure 8 It also describes a third optional step in the method for preparing a wound irrigation solution, wherein the wound irrigation solution is obtained in a container.

[0144] Figure 9A device 100 according to the invention, connected to container 200, is shown. In the embodiment shown here, an intermediate filter 126 is movably arranged in the mixer section such that the first reservoir 103 and the second reservoir 123 can be completely emptied, and all wound irrigation solution generated in the device can be dispensed from device 100 into container 200. For this purpose, the intermediate filter 126 is moved in the direction of the output port 105 of the first reservoir using syringe plunger 107 until the intermediate filter 126 is flush with the output port 105. Therefore, Figure 9 It also describes a fourth optional step in the method for preparing a wound irrigation solution, wherein the wound irrigation solution is obtained in a container.

[0145] Figure 10 An adapter portion 150 is shown, which is connected to both the container 200 and the nozzle 110. For this purpose, the adapter portion 150 includes a first feeder 111 configured for connection to the nozzle 110 or another external dispensing device. In the configuration shown here, the adapter portion 150 is fluidly connected to the container 200 using a connecting element 101, such that the active ingredient solution produced by the device can be dispensed from the container 200 via the first feeder 111.

[0146] Figure 11 A kit is shown that, in addition to the device according to the invention including an adapter portion 150 and a mixer portion 160, the kit also contains a container 200 containing a medically compatible liquid (e.g., a sterile saline solution). Furthermore, the kit includes a jet irrigation device 300, which can be used, for example, during surgical procedures, to directly administer a wound irrigation solution prepared using the device to a patient. Figures 6 to 9 As shown, after preparing the wound irrigation solution using the device and dispensing it into container 200, the jet irrigation device 300 can be connected to container 200 via the second closure 129 of adapter portion 150. Alternatively, the wound irrigation solution can be dispensed via nozzle 110, such as... Figure 10 As shown, the nozzle can be connected to the adapter section 150.

[0147] Exemplary Implementation

[0148] The following substances were used: calcium hypochlorite (CAS 7778-54-3; hypochlorite content 68%), anhydrous citric acid (CAS 77-92-9), anhydrous glucuronic acid (576-37-4), sodium chlorite (7758-19-2), benzalkonium chloride (CAS 63449-41-2), and sodium dodecyl sulfate (CAS 151-21-3), each purchased from Sigma-Aldrich, and commercially available sterile 500ml plastic infusion bottles, each containing 500ml of 0.9% saline solution. Each plastic infusion bottle had two diaphragms at the top. All ppm values ​​given in the table are mass fractions (i.e., solute mass per mass of solution). The peroxide content of calcium peroxide was 44%. The chlorite content of sodium chlorite was 67%.

[0149] The syringe interior is divided into a first reservoir and a second reservoir by installing a PE-hole separator. A mixing device is constructed using a commercially available 20ml medical plastic syringe. The corresponding components for tests 1 through 24 are weighed into the first or second reservoir, as indicated in the table below. The syringe is then screwed onto the adapter portion described herein. Figure 2 As shown. The adapter portion is pressed onto the head of the plastic infusion bottle, where the puncture is aimed at the septum perforation of the plastic infusion bottle. After connecting the adapter portion to the plastic infusion bottle, the bottle is tilted toward the bottle head, and liquid is drawn from the plastic infusion bottle five times using the plunger of the syringe, then pushed back into the plastic bottle. The components in the first and second reservoirs completely dissolve, producing a freshly prepared antiseptic wound irrigation solution containing an antiseptic oxidant, a pH adjuster, and a surfactant. In all embodiments, the liquid received in the plastic infusion bottle is noticeably clear. The syringe is then unscrewed from the adapter portion, and the injection nozzle is screwed onto the adapter portion. The pH of the solution prepared in this way is between pH 5 and pH 7. The concentrations of the antiseptic oxidant, pH adjuster, and surfactant used in each case, and the concentrations of the corresponding substances in the resulting wound irrigation solution (ppm figures are given as mass / mass ratios in each case) are shown in the table below.

[0150] Table 1: Amounts of calcium hypochlorite, citric acid, and sodium lauryl sulfate used in Examples 1 to 13 .

[0151]

[0152] Table 2: Concentrations of hypochlorite, citric acid, and sodium lauryl sulfate in the solutions prepared in Examples 1 to 13 Spend .

[0153]

[0154] Table 3: Amounts of calcium hypochlorite, citric acid, and benzalkonium chloride used in Examples 14 to 16 .

[0155]

[0156] Table 4: Concentrations of hypochlorite, citric acid, and sodium lauryl sulfate in the solutions prepared in Examples 14 to 16 Spend 。

[0157]

[0158] Table 5: Amounts of calcium hypochlorite, glucuronic acid, and sodium lauryl sulfate used in Examples 17 to 19 。

[0159]

[0160] Table 6: Hypochlorite, glucuronic acid, and sodium lauryl sulfate in the solutions prepared in Examples 17 to 19 concentration 。

[0161]

[0162] Table 7: Amounts of calcium peroxide, citric acid, and sodium lauryl sulfate used in Examples 20 to 22 。

[0163]

[0164] Table 8: Concentrations of peroxide, citric acid, and sodium lauryl sulfate in the solutions prepared in Examples 20 to 22 Spend 。

[0165]

[0166] Table 9: Amounts of sodium chlorite, citric acid, and sodium lauryl sulfate used in Examples 23 and 24 。

[0167]

[0168] Table 10: Chlorite, citric acid, and sodium lauryl sulfate in the solutions prepared in Examples 23 and 24 concentration 。

[0169]

[0170] List of icon numbers

[0171]

Claims

1. An apparatus (100) for preparing an antiseptic wound irrigation solution, the apparatus comprising an antiseptic oxidant (104) and a surfactant (124).

2. The apparatus of claim 1, wherein the corrosion inhibitor and the surfactant are present separately in the apparatus.

3. The apparatus according to any one of the preceding claims, wherein the corrosion inhibitor and / or the surfactant are present as solids.

4. The apparatus according to any one of the preceding claims, the apparatus further comprising a first reservoir (103) and a second reservoir (123) separate therefrom, wherein the anti-corrosion oxidant is disposed in the first reservoir (103) and the surfactant is disposed in the second reservoir (123).

5. The apparatus according to any one of the preceding claims, wherein the apparatus further comprises an intermediate filter (106) that connects the first reservoir (103) to the second reservoir (123) in a fluid conduction manner, wherein the intermediate filter preferably allows only liquid of the anti-corrosion oxidant and / or the surfactant to pass through.

6. The apparatus according to any one of the preceding claims, wherein the apparatus further comprises a connecting element (101) configured to establish a fluid conduction connection with the container (200).

7. The apparatus of claim 6, wherein the corrosion inhibitor and / or the surfactant are present as solids, and wherein the connecting element (101) comprises a connecting filter (106) configured to retain the corrosion inhibitor and / or the surfactant as solids in the first reservoir (103) and / or the second reservoir (123).

8. The apparatus according to claim 6 or 7, further comprising a dispensing element (120), wherein the dispensing element is preferably configured to dispense from the apparatus a disinfectant wound irrigation solution prepared from the antiseptic oxidant and the surfactant.

9. The apparatus according to any one of the preceding claims, the apparatus further comprising a mandrel (102) configured to pierce the diaphragm of the container (200), wherein the mandrel preferably comprises a hollow interior (115) configured to receive liquid (202) from the container (200) into the first reservoir (103) and the second reservoir (123).

10. The apparatus according to any one of the preceding claims, further comprising a jetting element (107) configured and designed to deliver liquid into the apparatus.

11. The apparatus according to any one of claims 4 to 10, wherein the apparatus comprises an adapter portion (150) and a mixer portion (160), wherein the adapter portion is configured to connect to a container (200), and wherein the mixer portion is configured to mix the preservative oxidant (104) and the surfactant (124) with liquid from the container (200).

12. The apparatus according to any one of the preceding claims, wherein the corrosion-preventing oxidant is selected from the group consisting of chlorite, hypochlorite and peroxide, and more preferably from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium chlorite, sodium hypochlorite, sodium peroxide and calcium peroxide.

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

14. The apparatus according to any one of the preceding claims, further comprising a pH adjuster, wherein the pH adjuster is selected from the group consisting of citric acid, citrate, glucuronic acid, gluconate, sodium bisulfate, and sodium bicarbonate.

15. A method for preparing an antiseptic wound irrigation solution using the apparatus according to any one of the preceding claims, wherein the method comprises the following steps: a) Optionally, the preservative oxidant and / or the surfactant can be dissolved or diluted with a medically compatible liquid using the device. b) The anti-corrosion oxidant is mixed with the surfactant using the device to obtain an anti-corrosion wound irrigation solution.

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

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

18. A medical wound irrigation solution in a method for preventing or treating wound infection, wherein the medical wound irrigation solution comprises an antiseptic oxidant and a surfactant.

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