Modular wound lavage system with cleaning brush
Patent Information
- Application Number
- PCT/EP2025/087006
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-03-11
- Filing Date
- 2025-12-15
- Publication Date
- 2026-09-17
Smart Images

Figure EP2025087006_17092026_PF_FP_ABST
Abstract
Description
[0001] 2025PF00012
[0002] 1
[0003] DESCRIPTION
[0004] Modular wound irrigation system with cleaning brush
[0005] AREA OF INVENTION
[0006] The present invention relates to the field of medical technology, in particular devices and methods for use in the surgical cleaning of infected tissue.
[0007] The invention relates in particular to a surgical cleaning device that can be used for the mechanical cleaning and rinsing of infected joint endoprostheses in the context of DAIR procedures.
[0008] TECHNICAL BACKGROUND
[0009] In septic bone surgery, the cleaning of debrided bone and soft tissue areas during revision of infected joint endoprostheses and the cleaning of infected osteosynthesis plates by lavage is a well-established procedure. Medical irrigation devices, so-called lavage systems, are used for this purpose. These lavage systems are also referred to here as "lavage devices." Some of these lavage systems are described as "jet lavage systems." These systems generate a jet of fluid that assists in the removal of infected tissue. Commonly used cleaning fluids include physiological saline solution, Ringer's solution, and Ringer's lactate solution. The goal of lavage is to remove remnants of infected tissue, biofilm, blood, and wound exudate. Lavage systems are described by way of example in patent specifications EP3187208A1, US4583531A, US5779702A, US6059754A and US2019151531A1.
[0010] In septic surgery, the so-called DAIR procedures (debridement, antibiotics, and implant retention) are gaining increasing importance for the treatment of infected knee, hip, and shoulder joint replacements. One goal of this surgical technique is to treat the infection of the joint prosthesis and surrounding tissue after opening the joint through debridement and subsequent local application of antibiotics, thus preserving the artificial joint. This avoids the costly and burdensome implantation of a revision joint replacement.
[0011] 2
[0012] These treatment methods are used particularly for artificial joint prostheses that become infected early in the process. First, movable implant components, such as PE inlays, are removed from the artificial joint. Infected tissue is removed ("debrided"), and biofilms adhering to the metal surfaces of the joint prosthesis are removed as completely as possible by brushing and lavage. Afterward, new movable joint components, such as PE inlays, are inserted into the cleaned joint prosthesis. A particular challenge is the removal of biofilms from metal surfaces, especially on the condyles (articular processes) of the knee joint.
[0013] Biofilms can exhibit strong adhesion to surfaces. As a result, despite brushing and subsequent lavage, biofilms or biofilm remnants can remain on implant surfaces. These biofilm remnants contain living microorganisms and can lead to reinfection of the joint prosthesis and surrounding tissue.
[0014] Antimicrobial compositions can be used to treat biofilms. WO2017027418A1 describes an antimicrobial composition containing a glycosidase. Further antimicrobial compositions are described in US9668989B2, W09300100A2, WO2024118545A1, WO2022081737A1, WO2017027418A1, and WO2014179754A2.
[0015] EP4458343A1 describes a device for producing a wound irrigation solution, comprising a syringe containing the active ingredient and an adapter for connecting it to a container with a liquid. The liquid can be drawn from the container, mixed with the active ingredient within the syringe, and then returned to the container.
[0016] Wound irrigation solutions can be administered using a syringe bottle or other lavage systems.
[0017] Wound irrigation systems with a compressible bottle are described in US6468253B1, EP1113829B1, US8021346B2, US7662125B2, US9629953B2 and EP3117849B1.
[0018] PREFERRED EXECUTION FORMS
[0019] One object of the present invention is to solve one or more of the problems described above and further problems of the prior art. One object of the invention is to remove biofilms from an implant surface by means of a cleaning fluid. This prevents the sticky biofilms from re-adhering to the implant surface after removal. Another object of the invention is to remove biofilms particularly effectively by mechanical action and simultaneous rinsing, and2025PF00012
[0020] 3
[0021] To provide a device that is as handy, cost-effective and easy to use as possible.
[0022] A further object of the invention is to prevent the release of foreign bodies, such as broken bristles, into patient tissue and / or to prevent these foreign bodies from remaining in the patient. A further object of the invention is to prevent contact between biofilm residues mixed with cleaning fluid and the surrounding tissue.
[0023] Another task is the provision of a modular rinsing system that features an interchangeable nozzle. This allows, for example during a DAI R procedure, a microbiologically contaminated nozzle to be replaced with a clean, preferably sterile, nozzle, while the rest of the device can continue to be used.
[0024] Another object of the invention is to provide a modular flushing system consisting of several parts, which ensures a stable fluid-conducting connection within the system when the flushing fluid is pressurized.
[0025] Another task is the development of a rinsing device that allows ulcers and similar wounds on the body surface to be cleaned in such a way that contamination of the surrounding body surface and the patient's environment by microbiologically contaminated rinsing fluid is reduced or largely avoided.
[0026] Another object of the invention is the targeted dispensing of a liquid to a locally limited area. A further object of the invention is the targeted dispensing of a liquid to one or more positions within a limited area.
[0027] The device should preferably be manufactured as simply and cost-effectively as possible from plastic parts. Furthermore, the device should preferably be sterilizable by auto-sterilization, electron beam sterilization, or gamma sterilization.
[0028] Some or all of the problems are solved by the methods and devices described herein, in particular those described in the patent claims.
[0029] Preferred embodiments of the invention are described below.
[0030] A first embodiment describes a device for dispensing a medical fluid to a patient, comprising
[0031] an elastically deformable container for holding a liquid,
[0032] an adapter that can be connected to the container via a fluid conductor,
[0033] and a dispensing element for dispensing a liquid from the device, 2025PF00012
[0034] 4
[0035] wherein the dispensing element has a second opening for dispensing a liquid from the device,
[0036] and wherein the dispensing element has a brush head with a plurality of bristles arranged at the end of the dispensing element,
[0037] wherein the device is designed and configured to apply pressure to a liquid by compressing the container, and thereby deliver the liquid from the device to a patient.
[0038] A second embodiment describes a device according to the first embodiment, wherein the container, the adapter and the dispensing element are designed as parts that can be detachably connected to one another, wherein the device is preferably designed as a set of parts arranged in a sealed, sterile packaging medium, and comprises the container, the adapter and the dispensing element as parts that are each separate from one another.
[0039] A third embodiment describes a device according to the first or second embodiment, further comprising a suction element for removing a liquid, wherein the bristles preferably have a suitable size to be able to be removed through the suction element.
[0040] A fourth embodiment describes a device according to the third embodiment, wherein the suction element is arranged in direct connection with the dispensing element, preferably the suction element together with the dispensing element forming a stem element.
[0041] A fifth embodiment describes a device according to the fourth embodiment, wherein the stem element has a flexible or curved conduit area.
[0042] A sixth embodiment describes a device according to the third, fourth or fifth embodiment, wherein the dispensing element has an outlet opening and the extraction element has an extraction opening, wherein the outlet opening has a cross-sectional area that is smaller than or equal to the cross-sectional area of the extraction opening.
[0043] A seventh embodiment describes a device according to one of the preceding embodiments, wherein the bristles extend from the brush head in the direction of 2025PF00012
[0044] 5
[0045] of the container, and / or extend in the opposite direction of the container, or wherein the bristles are arranged circumferentially around the brush head in the manner of a round brush.
[0046] An eighth embodiment describes a device according to one of the preceding embodiments, wherein the brush head has one or more outlet openings arranged between the bristles.
[0047] A ninth embodiment describes a device according to one of the preceding embodiments, wherein the bristles are colored to provide optical contrast to blood and body tissue, wherein the bristles preferably have a dye with an absolute emission maximum in the range of 490 nm to 575 nm.
[0048] A tenth embodiment describes a device according to one of the preceding embodiments, wherein the bristles have a length of 1.5 mm to 20 mm, preferably 5.0 to 15 mm, and / or a diameter of at least 1 mm.
[0049] An eleventh embodiment describes a device according to the tenth embodiment, wherein the device is designed and configured to dispense a liquid from the container to or adjacent to the brush head, and simultaneously to discharge a liquid from or adjacent to the brush head.
[0050] A twelfth embodiment describes a device according to one of the preceding embodiments, further comprising a septum that seals the container in a liquid-tight manner, wherein the adapter has a first passage for dispensing a liquid from the container, and wherein the adapter is designed and configured to penetrate the septum by bringing the adapter into contact with the container in order to establish a fluid-conducting connection between the container and the first passage.
[0051] A thirteenth embodiment describes a device according to one of the preceding embodiments, wherein the container is filled with a sterile liquid, the liquid preferably comprising an antiseptic agent selected from the group consisting of chlorhexidine gluconate, benzalkonium chloride, octenidine dihydrochloride, an alkali hypochlorite, an alkaline earth hypochlorite, an alkali chlorite, and / or wherein the liquid comprises sodium dodecyl sulfate or physiological saline solution. 2025PF00012
[0052] 6
[0053] A fourteenth embodiment describes a device according to the thirteenth embodiment, wherein the sterile liquid comprises an aqueous solution selected from the group consisting of
[0054] a solution of benzalkonium chloride with a benzalkonium chloride concentration of 50 to 1500 ppm;
[0055] a solution of chlorhexidine digluconate and benzalkonium chloride, wherein the concentration of chlorhexidine digluconate is 50 to 600 ppm and the concentration of benzalkonium chloride is 50 to 250 ppm;
[0056] a solution of octenidine dihydrochloride with a concentration of 50 to 2000 ppm; a solution of alkali hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0057] a solution of alkaline earth hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0058] a solution of alkali chlorite with a chlorite concentration of 50 to 2000 ppm, a solution of sodium dodecyl sulfate with a sodium dodecyl sulfate concentration of 50 to 2000 ppm; and
[0059] a physiological saline solution with a sodium chloride concentration of 0.9 wt%;
[0060] where the ppm values refer to a mass / mass fraction in the ratio of the respective dissolved substances to the total mass of the aqueous solution.
[0061] A fifteenth embodiment describes a device according to one of the preceding embodiments, wherein the container has a first connecting element, and wherein the adapter has a second connecting element and a third connecting element, and
[0062] wherein the delivery element has a fourth connecting element,
[0063] wherein the device is designed and configured to create a pressure-resistant fluid-conducting connection between the container, the adapter and the dispensing element by engaging the first connecting element with the second connecting element and by engaging the third connecting element with the fourth connecting element.
[0064] DETAILED DESCRIPTION
[0065] The embodiments described herein, whose elements "have" or "comprise" a certain feature (e.g., a material), always include a further 2025PF00012
[0066] 7
[0067] Embodiments are considered in which the element in question consists solely of the feature, i.e., does not include any further components. The word "comprise" or "comprising" is used herein synonymously with the word "exhibit" or "exhibiting".
[0068] If an element in an embodiment is designated in the singular, an embodiment containing several such elements is also considered. The use of a plural term for an element generally also includes an embodiment containing only a single corresponding element.
[0069] Unless otherwise stated or clearly excluded from the context, it is generally possible, and hereby expressly considered, that features of different embodiments may also be present in the other embodiments described herein. Likewise, it is generally considered that all features described herein in connection with a method are also applicable to the products and devices described herein, and vice versa.
[0070] For the sake of brevity, not all of these considered combinations are explicitly listed in every case. Technical solutions that are known to be equivalent to the features described herein are also generally considered to be within the scope of the invention.
[0071] One aspect of the invention relates to a device for dispensing a medical fluid to a patient. The device may comprise a container, an adapter, and a dispensing element. The container is preferably elastically deformable. The container is preferably designed and configured to hold a fluid. The adapter may be fluid-conducting and connectable to the container. The dispensing element may be designed and configured to dispense a fluid from the device. The container may have a first connecting element. The adapter may have a second connecting element. The adapter may have a third connecting element. The adapter may have a first opening for dispensing a fluid from the container. The dispensing element may have a fourth connecting element. The dispensing element may have a second opening for dispensing a fluid from the device.
[0072] In one embodiment, the device is designed and configured to create a pressure-resistant, fluid-conducting connection between the container, the adapter, and the dispensing element by engaging the first connecting element with the second connecting element and the third connecting element with the fourth connecting element. 2025PF00012
[0073] 8
[0074] In one embodiment, the device is designed and configured to pressurize a liquid by compressing the container, and thereby deliver the liquid from the device to a patient via the first opening of the adapter and the second opening of the delivery element.
[0075] In one embodiment, the device for dispensing a medical fluid to a patient comprises an elastically deformable container for receiving a fluid, an adapter that can be fluidly connected to the container,
[0076] and a dispensing element for dispensing a liquid from the device,
[0077] wherein the container has a first connecting element,
[0078] wherein the adapter has a second connecting element, a third connecting element, and a first opening for dispensing a liquid from the container,
[0079] wherein the dispensing element has a fourth connecting element and a second passage for dispensing a liquid from the device,
[0080] wherein the device is designed and configured to create a pressure-resistant fluid-conducting connection between the container, the adapter and the dispensing element by engaging the first connecting element with the second connecting element and by engaging the third connecting element with the fourth connecting element, and wherein the device is designed and configured to apply pressure to a liquid by compressing the container, and thereby dispense the liquid from the device to a patient via the first opening of the adapter and the second opening of the dispensing element.
[0081] One embodiment relates to a device for dispensing a medical fluid to a patient, comprising
[0082] an elastically deformable container for holding a liquid,
[0083] an adapter that can be connected to the container via a fluid conductor,
[0084] and a dispensing element for dispensing a liquid from the device,
[0085] wherein the dispensing element has a second opening for dispensing a liquid from the device,
[0086] and wherein the dispensing element has a brush head with a plurality of bristles arranged at the end of the dispensing element,
[0087] wherein the device is designed and configured to pressurize a liquid by compressing the container, and thereby deliver the liquid from the device to a patient. 2025PF00012
[0088] 9
[0089] The device according to the invention is suitable for dispensing a medical fluid to a patient. The device is particularly intended for cleaning bacterially infected tissue, for example, during a surgical procedure. The device can preferably be used for cleaning infected implants.
[0090] The device is particularly suitable for effectively removing adhesions to external and internal wounds, such as blood, wound secretions and debris (i.e., tissue debris).
[0091] The device is preferably suited for delivering a fluid to a patient's tissue and for draining the fluid used for cleaning in order to prevent contamination of adjacent patient tissue. This can be either superficial or internal patient tissue. For example, the device can be suitable for treating ulcers and similar external wounds in the epidermis or dermis. The device can also be suitable for treating internal patient tissue, such as surgical wounds, particularly in the area of a joint or joint implant.
[0092] A “liquid,” in particular a “medicinal fluid,” as described herein, is preferably a biocompatible fluid, i.e., it is compatible with direct contact with body tissue. In particular, a medical fluid described herein is suitable for cleaning a surgical wound, for example, an infected joint or joint implant. The fluid may be an aqueous solution with molecularly dispersed, i.e., dissolved, components. The fluid is preferably clear. The device may also be used with aqueous dispersions and emulsions. The fluid is preferably sterile, as further described below.
[0093] A "patient" can be a human or an animal patient. Therefore, the device according to the invention can be used in human medicine and / or in veterinary medicine.
[0094] The device according to the invention has an elastically deformable container suitable for holding a liquid, in particular a medical liquid.
[0095] Examples of suitable containers include plastic bottles and foil pouches. In the context of the present invention, an "elastically deformable container" means that the container can be squeezed by manual force to dispense a liquid contained therein. Such containers are used, for example, as wash bottles in laboratories or medical treatment facilities. The container may be made of or consist of a plastic. The plastic may be a thermoplastic. Examples of usable plastics include polyethylene, polypropylene, and polyethylene terephthalate. 2025PF00012
[0096] 10
[0097] The container can have a circular or elliptical cross-section. It can have an outer diameter ranging from 7 cm to 13 cm. This size allows for good manual handling. The container can have a wall thickness of 1.5 mm to 4.0 mm. This allows the container to be manually deformed, enabling a user to compress the liquid inside without additional tools. Furthermore, this wall thickness, especially when using the materials mentioned above and similar ones, allows for an elastic recovery force, so that the container automatically returns to its original shape after being compressed by the user.
[0098] In one embodiment, the container is sealed, in particular sealed to prevent germs from entering the container. For this purpose, the container can have a septum, as explained in more detail elsewhere.
[0099] Alternatively or additionally, the container can be sealed with a film. In one embodiment, the container has a septum which is sealed by a film applied directly to it.
[0100] The container may have a screw cap designed and configured to provide a liquid-tight seal. The screw cap is preferably detachably connected to the container. The screw cap may have a separate lid part or be connectable to such a lid part.
[0101] The device according to the invention further comprises an adapter that can be fluidly connected to the container. The adapter can, for example, have the form of a cap and be designed for attachment to an opening of the container. For example, the adapter can be attached to the neck or to the top of a plastic bottle. According to the invention, the adapter serves to create a pressure-resistant, fluid-conducting connection between the container and a dispensing element described herein. A "pressure-resistant, fluid-conducting connection" according to the invention means that the relevant elements of the device, in particular the container, the adapter, and the dispensing element, remain fluidly connected to one another when a liquid is pressurized by compressing the container, for example, by a pressure of 1 bar above atmospheric pressure outside the device, in order to dispense the liquid from the device.The term "pressure-resistant fluid-conducting connection" further implies that the fluid cannot escape from the device in an undesirable manner between the container and the adapter or between the adapter and the dispensing element. In other words, a pressure-resistant fluid-conducting connection can prevent unwanted leakage of the 2025PF00012.
[0102] 11
[0103] Prevent the device from malfunctioning and ensure that the liquid to be dispensed from the container can only be released via the dispensing element.
[0104] To produce such a pressure-resistant, fluid-conducting connection, the container can, according to the invention, have a first connecting element which is arranged and configured to engage with a second connecting element, wherein the second connecting element is arranged on the adapter. Similarly, a third connecting element can further be arranged on the adapter, which is arranged and configured to engage with a fourth connecting element, wherein the fourth connecting element is arranged on the dispensing element.
[0105] In one embodiment, the first connecting element has a locking element. In another embodiment, the second connecting element has a locking element. In yet another embodiment, both the first and second connecting elements each have a locking element. As used herein, the term "locking element" refers to a structure designed and configured to engage with another element at a predefined location, thereby creating a mechanical connection that is secured against accidental disengagement. Preferably, the first and second connecting elements are designed and configured to engage with each other to create a positive-locking and / or force-locking connection. In one embodiment, the locking element is elastically deformable, in particular flexible.
[0106] In one embodiment, the first connecting element is designed as a flexible hook, and the second connecting element is designed as a projection into which the hook can engage. In another embodiment, the adapter has several hooks for connecting to the container, and the container has one or more projections into which the hooks can engage. The projection can, for example, be designed as a circumferential ring on the container or the adapter.
[0107] In one embodiment, the first and second connecting elements are each designed as threads.
[0108] In one embodiment, the device has a bayonet fitting designed and configured to connect the adapter to the container.
[0109] In one embodiment, the device has a bayonet fitting which is designed and configured to connect the adapter to the dispensing element.
[0110] In one embodiment, the locking element is designed and configured to connect the container and the adapter to each other in a pressure-resistant, fluid-conducting manner when the adapter is connected to the 2025PF00012
[0111] 12
[0112] The container is brought into contact and the adapter is pressed against the container.
[0113] For example, the first connecting element can be designed as a hook, which is shaped and configured to engage with a second connecting element, designed as a projection, when the adapter is brought into contact with the container and pressed against it. This allows the adapter to be connected and locked to the container, so that these two parts form a pressure-tight, fluid-conducting connection. This ensures a leak-free, i.e., fluid-tight, transfer of fluid from the container into the first opening of the adapter.
[0114] The device may further include a rubber-elastic sealing element. The sealing element is preferably arranged on the adapter or on the dispensing element. The sealing element can further improve the formation of a pressure-resistant and fluid-conducting connection between the adapter and the dispensing element. Accordingly, in one embodiment, the sealing element is designed and configured to form a liquid-tight connection between the adapter and the dispensing element.
[0115] For example, the adapter can have an annular seal. The annular seal can be designed in the manner of an "O-ring." The sealing element can be arranged in a circumferential groove of the adapter. The sealing element can also have a disc-shaped form. The sealing element can therefore be designed in the manner of a flat seal, also referred to as a "flat gasket." Such a sealing element can be arranged to rest on an outer surface of the adapter or the dispensing element. In one embodiment, the device has a sealing element to assist the first connecting element, the second connecting element, the third connecting element, the fourth connecting element, and / or the fifth connecting element in forming a liquid-tight connection. The sealing element can be attached at any suitable location on the device, in particular on the adapter or on the dispensing element.The “rubber-elastic sealing element” herein refers in particular to an element of the device which differs from the “septum” described herein in terms of its shape and / or arrangement on the device.
[0116] The adapter can have a first opening for dispensing a liquid from the container to the dispensing element. The dispensing element can have a second opening for receiving a liquid from the adapter and dispensing it from the device. The first opening preferably extends through an interior of the adapter. The second opening preferably extends through an interior of the 2025PF00012
[0117] 13
[0118] Dispensing element. The first and / or second penetration can be designed, in particular, as internal cavities or channels. The first and / or second penetration can be formed directly by the material of the adapter or the dispensing element, or can each have its own hose or pipe.
[0119] The first opening can have an inner diameter (i.e., clear opening) of 0.5 mm to 3 mm. The second opening can have an inner diameter of 0.5 mm to 3 mm.
[0120] In one embodiment, the device further comprises a septum that seals the container in a liquid-tight manner. The septum is preferably arranged on the container. For example, the septum can be arranged at an opening of the container. The septum is preferably connected to the container in a liquid-tight manner. The septum can be connected to the container by friction, e.g., by means of a holder. The septum can be connected to the container by a material bond, e.g., by a fusion bond (e.g., foil welding). In some embodiments, the septum comprises a flexible, self-sealing polymer. The polymer can be a polyhalogenated olefin, a silicone, or a thermoplastic elastomer. In one embodiment, the septum comprises butyl rubber. In another embodiment, the septum comprises silicone rubber.The septum is preferably designed to seal the housing liquid-tight after it has been punctured with a cannula, except for the housing outlets. The septum is preferably stretchable and rubber-elastic, as is known, for example, from septa in chemical bottles. This allows the septum to preferably self-heal after a puncture.
[0121] Preferably, the septum is made of a biocompatible material.
[0122] The septum can, for example, have a substantially flat or a convex shape. The septum can also have a circular shape.
[0123] In one embodiment, the septum has a material that can be pierced with a medical injection needle according to ISO 7864:2016 with a force of less than 100 N.
[0124] The septum can be provided with a cover having one or more openings. Through such an opening, a user of the device can connect the adapter fluid according to the invention to the container. The cover can be integrated into the aforementioned septum holder.
[0125] Furthermore, appropriate openings may be provided at suitable locations on the adapter, which provide a first piercing position and, if necessary, a second piercing position. 2025PF00012
[0126] 14
[0127] define. The first piercing position can be designed to introduce a hollow mandrel through the septum into the container, with the hollow mandrel preferably being arranged on the adapter.
[0128] If the cover has multiple openings, additional accessories can be connected to the container via a fluid-conducting connection. For this purpose, a pointed fitting, such as a hollow mandrel, can be inserted through a second opening in the cover, passing through the septum. This second penetration point can thus be designed for connecting an accessory.
[0129] A plastic membrane may also be arranged on the septum, which is suitable to prevent direct contact between a liquid contained in the container and the septum, as long as the septum is undamaged.
[0130] Accessories that can be used in conjunction with the present invention include, for example, a hose, a splash guard, or a lavage device. The devices described herein are, in some embodiments, suitable for operation with an external lavage device. In one embodiment, such an external lavage device can be connected to the device via a second opening at a second puncture position of the septum, as described above. Examples of lavage devices with which the devices described herein can be operated are described, for example, in EP2662146A2, US4,583,531A, US4,278,078A, and US5,542,918A. Such lavage devices may include a pump, which may, for example, be equipped with an electric motor or a pneumatic motor. Preferably, the devices described herein can be operated with lavage devices capable of generating pulsed spray bursts.The lava devices may include, for example, pumps such as those described in EP2619415A1, EP2910270A1 or EP2873856A1.
[0131] For connection to such a lavage device, the device described herein can be equipped with a suitable additional connecting element. Such a connecting element can be positively locked or force-locked to an external lavage device. For example, the connecting element can have a locking feature to connect the device to a lavage device, preferably in a pressure-resistant, fluid-conducting manner.
[0132] In one embodiment, the adapter further comprises a stem-shaped nozzle. Preferably, the stem-shaped nozzle is fluid-conductingly connected to the first feedthrough. In a 2025PF00012
[0133] 15
[0134] In this embodiment, the nozzle is designed and arranged to extend outwards when the adapter is connected to the container by the engagement of the first connecting element with the second connecting element. In other words, the nozzle can extend as an elongated element from the adapter towards the dispensing element, or towards the part of the adapter intended for connection with the dispensing element. The stem-shaped nozzle of the adapter can thus serve to dispense a liquid from the container. Furthermore, the stem-shaped nozzle of the adapter can preferably be positively inserted into a nozzle of a dispensing element of the device.
[0135] The stem-shaped nozzle can have the shape of a cylinder, preferably a rounded cylinder. In one embodiment, the stem-shaped nozzle is designed and configured to dispense a liquid from the container. The nozzle can be configured to dispense a liquid to the dispensing element. The nozzle can be configured to dispense a liquid to a patient. The nozzle can have a substantially cylindrical hollow body tapering to a point at one end. The nozzle can have a cylindrical base body that transitions into a tapered, rounded tip at one end.
[0136] In one embodiment, the stem-shaped nozzle of the adapter is designed and configured to establish a pressure-tight, fluid-conducting connection with the second opening when the adapter is connected to the dispensing element by the engagement of the third connecting element with the fourth connecting element. This prevents unwanted fluid from escaping from the device between the adapter and the dispensing element when the container is pressurized to release fluid from the device. Furthermore, this ensures that the dispensing element does not detach from the device during this process, but rather maintains a secure connection between the adapter and the dispensing element.
[0137] The adapter can have a cap with a C-shaped cross-section. The adapter can be designed and configured to positively engage the container from multiple sides. The adapter can be designed and configured to create a positive fit with the container, this positive fit preferably being achievable independently of the first connecting element and / or the second connecting element. Accordingly, in one embodiment, the adapter can be connected to the container by a first positive fit, which is achievable through the C-shaped cross-section of the adapter, and further by a second positive fit with the container.
[0138] 16
[0139] be connectable to the container, which can be produced by the first connecting element and the second connecting element.
[0140] The adapter can have a hollow mandrel. This allows a septum to be pierced to create a fluid-conducting connection between the container and the adapter. The hollow mandrel is preferably fluid-conducting and connected to the first feedthrough. The hollow mandrel preferably has an interior space that allows a liquid to pass through it. The interior space can, for example, have a diameter of 1 mm to 3 mm. The hollow mandrel can have an outlet opening with a diameter of less than 1.5 mm, and particularly preferably less than 1 mm. The hollow mandrel can have a beveled tip, similar to a ground cannula, with an outlet opening of the hollow mandrel preferably located in a bevel of the tip. The hollow mandrel can have a rounded tip. In this case, one or more openings can be arranged near the tip, which are connected to the interior of the hollow mandrel. The hollow mandrel can be made of plastic or metal, e.g.Stainless steel. Examples of usable plastics include polyethylene, polypropylene and polyethylene terephthalate, polyamide 12, polyamide 6, polyamide 66 and polyethersulfone. The hollow mandrel, especially the tip of the hollow mandrel, may be covered by a removable protective cap.
[0141] The hollow mandrel can have a length of 0.8 cm to 3.0 cm. Such a hollow mandrel is advantageous when the device is used "upside down," i.e., in an arrangement where the container is oriented upwards (against the direction of gravity). The hollow mandrel can also have a length that allows its tip to be positioned near the bottom of the container. Alternatively, the hollow mandrel can have a length that is approximately 70% to 90% of the container's length. Such a hollow mandrel is advantageous when the device is used "upright," i.e., in an arrangement where the container is oriented downwards (in the direction of gravity). This can be helpful in directing as much of the liquid contained in the container as possible outwards through the hollow mandrel.
[0142] In one embodiment, the dispensing element is designed and configured to completely cover the adapter on the outside in order to protect it from external contamination. This can ensure that the adapter remains sterile, or at least better protected from contamination, when the device is used as intended, provided the dispensing element is attached to the adapter. This allows the user of the device to replace a contaminated dispensing element with a new, clean, and preferably sterile one.
[0143] 17
[0144] to replace the delivery element, while continuing to use the remaining parts of the device, particularly during the treatment of the same patient, e.g. when different positions of the patient are to be treated with the device according to the invention.
[0145] The dispensing element can have a shape that is complementary to a surface of the adapter. This can enable a positive-locking connection between the dispensing element and the adapter. The dispensing element can have a cap with a C-shaped cross-section. The dispensing element can be designed and configured to positively lock around the adapter from multiple sides. The dispensing element can be designed and configured to create a positive-locking connection with the adapter, whereby this positive lock can be created independently of the third and / or fourth connecting element.
[0146] In one embodiment, the dispensing element further comprises a fifth connecting element, which can be connected to an accessory independently of the third and fourth connecting elements. In one embodiment, the accessory is selected from the group consisting of a hose, a splash guard, a lavage device, and a cleaning brush. The fifth connecting element can, for example, have a hose connection. A hose can be connected to the dispensing element, for example, to drain contaminated fluid and / or tissue to be removed from the patient using the device. The tissue to be removed can, for example, be microbiologically infected tissue from a patient that is removed during treatment of an infected joint or implant, in particular DAIR treatment.
[0147] A connecting element intended for connection to a hose, in particular the fifth connecting element of the device, may preferably have one or more projections or barbs to prevent accidental detachment of the hose from the connecting element. Such a connecting element may be permanently attached to the device or may be detachably attachable to the device.
[0148] For example, the device may have a hose connector for connecting one hose of the device to another hose. Such hose connectors are also called "hose couplings". They may have stem-shaped connections for a hose on two opposite sides, each connection having projections or barbs to hold a hose securely in position. 2025PF00012
[0149] 18
[0150] A splash guard can include a device that reduces or prevents the unwanted spread of microbially contaminated liquid. The splash guard can be disc-shaped. The splash guard can have a concave curvature, similar to a parabolic antenna. The splash guard can have a conical shape. The splash guard can have a centrally located recess designed and configured for attaching the splash guard to a dispensing element of the device. The splash guard can be made of plastic. The splash guard can be transparent or translucent. The plastic can be an elastomer.
[0151] Suitable cleaning brushes that can be connected to the device according to the invention are described in more detail elsewhere herein. The cleaning brushes may have one or more of the features described herein in connection with a "cleaning brush" or a "brush head". The device may comprise a cleaning brush that is permanently connected to a dispensing element of the device, such as a brush head described herein, or a cleaning brush that is detachably connectable to the device.
[0152] In one embodiment, the container is filled with a sterile liquid. The liquid is preferably aqueous. Preferably, the liquid comprises an antiseptic agent. Suitable antiseptic agents include cationic, anionic, neutral, and oxidizing agents.
[0153] Examples of cationic antiseptics include benzalkonium chloride (CAS 8001-54-5), octenidine dihydrochloride (CAS 70775-75-6), polyhexanide (CAS 32289-58-0), and chlorhexidine digluconate (CAS 18472-5-0). An example of an anionic antiseptic is sodium dodecyl sulfate (CAS 151-21-3). Examples of oxidizing agents are sodium hypochlorite (CAS 10022-70-5), for example in the form of Dakin's solution, aqueous solutions containing sodium chlorite (CAS 49658-21-1) and iodine (CAS 7553-56-2), for example in the form of iodine-potassium iodide (CAS 7681-11-0) or povidone-iodine (CAS 25655-41-8).
[0154] In one embodiment, the antiseptic agent is selected from the group consisting of chlorhexidine gluconate, benzalkonium chloride, octenidine dihydrochloride, an alkali hypochlorite, an alkaline earth hypochlorite, and an alkali chlorite. In one embodiment, the liquid comprises sodium dodecyl sulfate or physiological saline solution. 2025PF00012
[0155] 19
[0156] In one embodiment, the liquid comprises an aqueous solution selected from the group consisting of
[0157] a solution of benzalkonium chloride with a benzalkonium chloride concentration of 50 to 1500 ppm;
[0158] a solution of chlorhexidine digluconate and benzalkonium chloride, wherein the concentration of chlorhexidine digluconate is 50 to 600 ppm and the concentration of benzalkonium chloride is 50 to 250 ppm;
[0159] a solution of octenidine dihydrochloride with a concentration of 50 to 2000 ppm; a solution of alkali hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0160] a solution of alkaline earth hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0161] a solution of alkali chlorite with a chlorite concentration of 50 to 2000 ppm, a solution of sodium dodecyl sulfate with a sodium dodecyl sulfate concentration of 50 to 2000 ppm; and
[0162] a physiological saline solution with a sodium chloride concentration of 0.9 wt.%.
[0163] Unless expressly stated otherwise, the above and other concentration values mentioned herein in % or ppm refer to a mass / mass fraction in the ratio of the respective dissolved substances to the total mass of the aqueous solution.
[0164] In one embodiment, the liquid contains a buffer substance. In another embodiment, the liquid is free of buffer substances. In one embodiment, the buffer substance is selected from the group consisting of citric acid (CAS 77-92-9), sodium dihydrogen citrate (CAS 18996-35-5), disodium hydrogen citrate (CAS 6132-05-4), sodium dihydrogen phosphate (CAS 7558-80-7), calcium dihydrogen phosphate (CAS 7758-23-8), sodium hydrogen sulfate (CAS 7681-38-1), disodium hydrogen phosphate (CAS 7558-79-4), and trisodium phosphate (CAS 760-54-9).
[0165] In one embodiment, the liquid consists of ultrapure water and one active ingredient. In another embodiment, the liquid consists of ultrapure water and two active ingredients. In one embodiment, the ultrapure water is water for injection.
[0166] In one embodiment, the liquid is free of organic solvents. In another embodiment, the liquid contains no other liquid substance besides water. In2025PF00012
[0167] 20
[0168] In this context, dissolved solids or gases, especially dissociated salts, are not to be understood as "liquid substances".
[0169] In a further embodiment, the device according to the invention is provided as a kit, wherein the kit comprises a container, an adapter, and a dispensing element as described herein, each as separate parts. In one embodiment, the kit is provided in a sealed, sterile package. Accordingly, the invention also relates to a kit in a sealed, sterile package, which includes, within a sterile interior of the package, a container, an adapter, a dispensing element, and optionally further parts of the device or accessories thereof.
[0170] The component set can have one or more dispensing elements, which are described herein. For example, the component set can have several dispensing elements of different shapes.
[0171] The parts kit may include several accessories.
[0172] In some embodiments, the device is sterilizable. This means that the device can be subjected to a sterilization process without significantly affecting its material properties, compatibility, and functionality.
[0173] Such sterilization methods include, for example, auto-kiaving, irradiation with electron beams or gamma rays, or treatment with disinfecting substances such as ethylene oxide.
[0174] In some embodiments, the device is sterilizable according to DIN EN ISO 11135 and / or DIN EN ISO 11137. This also applies to the corresponding packaging materials if the device is provided in sterile packaging as described herein. Preferably, the device is sterilizable together with any liquid it may contain.
[0175] In one embodiment, the device is completely sterilized. In another embodiment, the device is completely pyrogen-free. The term "sterilized" refers to the fact that the device has been subjected to a process to remove or kill pathogens so that the device can be used medically in accordance with the standard DIN EN 556-1. Sterilization processes include, for example, auto-cavitation, irradiation with electron beams or gamma rays, or treatment with disinfectants.
[0176] 21
[0177] Substances such as ethylene oxide. Similarly, the term "pyrogen-free" refers to the fact that the device has undergone a treatment customary in the field to remove or decompose pyrogens. Whether the device is pyrogen-free can be verified using the Limulus amoebocyte lysate (LAL) test according to Ph. Eur. Chapter 2.6.14. The standards and documents applicable on the priority date of this application shall apply.
[0178] If the device is provided as a kit in sterile packaging, the above definitions of the terms "sterilized" and "pyrogen-free" apply accordingly to the sterile packaging. In embodiments where the container is filled with a liquid, autokiaving or irradiation with electron beams or gamma rays are preferred sterilization methods, since disinfecting substances such as ethylene oxide cannot readily penetrate the container wall to sterilize its contents. Autokiaving involves treating an item to be sterilized with steam at elevated pressure and temperature. For example, temperatures of 125°C to 135°C and pressures of 200 to 300 kPa may be used. The duration of autokiaving may be, for example, 15 to 30 minutes.
[0179] The device can be designed and configured to deliver a liquid to a patient either with or without the delivery element. Thus, the delivery of a liquid to a patient can occur either directly through the adapter, or through the delivery element, as described herein. This allows the user greater flexibility in the use of the device according to the invention, particularly in the event of microbial contamination of the delivery element.
[0180] In one embodiment, the device has a suction element for draining a fluid. In one embodiment, the device is designed and configured to drain a fluid from the patient through the suction element.
[0181] In one embodiment, the device is designed and configured to pressurize a liquid by compressing the container, thereby dispensing the liquid from the device to a patient, and simultaneously removing the dispensed liquid from the patient via the suction element. This means that the liquid dispensed from the delivery element and used for rinsing, after coming into contact with patient tissue, can be removed via the suction element. 2025PF00012
[0182] 22
[0183] In one embodiment, the container, the adapter, and the dispensing element are each designed as parts that can be detachably connected to one another. As already described in more detail herein, the device can be provided as a kit comprising the container, the adapter, and the dispensing element as separate parts.
[0184] In other embodiments, the adapter and dispensing element together form a monolithic unit. This means that the adapter and dispensing element are permanently connected and cannot be separated by a user.
[0185] The extraction element can consist of a hose or a pipe.
[0186] A hose can be attached to the device directly or via a hose connector. The hose connector can be detachably connected to the device. The hose connector can have protrusions and / or barbs to prevent the hose from slipping off and becoming detached.
[0187] The suction element may have a suction opening which is designed and configured to receive and remove a liquid through the suction element.
[0188] In one embodiment, the device has a clamp that holds the suction element. The clamp is preferably rotatably mounted on the device. In one embodiment, the clamp is rotatably mounted about the longitudinal center axis of the adapter. In another embodiment, the suction element has a flexible or curved section. For example, the suction element can have a pipe with a curved section.
[0189] In one embodiment, the extraction element has a joint. The joint can be designed, for example, as a hinge or a ball joint. The hinge can be designed and configured to rotate the extraction element about a fixed axis of the device. The ball joint can be designed and configured to rotate the extraction element about a fixed point of the device, preferably allowing rotation about several different axes.
[0190] The clamp or joint can be designed and configured to automatically align the suction element to a lowest point. For example, the suction element can be rotatably mounted, with sufficient freedom of movement so that gravity causes the suction element to move downwards automatically. This makes it easier for the user of the device to drain fluid from the lowest point of patient tissue being treated. 2025PF00012
[0191] 23
[0192] In one embodiment, the first connecting element and the second connecting element are designed and configured to allow rotation of the adapter relative to the container when a pressure-resistant fluid-conducting connection between the container and the adapter is formed by the engagement of the first connecting element with the second connecting element.
[0193] In one embodiment, the third and fourth connecting elements are designed and configured to allow rotation of the dispensing element relative to the adapter when the engagement of the third connecting element with the fourth connecting element forms a pressure-tight, fluid-conducting connection between the adapter and the dispensing element. This can be achieved, for example, if the first connecting element has a circumferential projection and the second connecting element has a detent hook, the detent hook being movable along the projection while engaging the projection.
[0194] The embodiments described above can be helpful in positioning a delivery element and a suction element of the device relative to each other in different ways, in order to remove a fluid delivered by means of the device at the most suitable location after contact with patient tissue.
[0195] In one embodiment, the device is designed and configured to dispense a liquid at a first position and to receive the dispensed liquid at a second position, wherein the second position is variable relative to the first position without moving the entire device. This can be achieved, for example, as shown above, by a suction element that has a joint or a flexible section, allowing the suction element to be deformed. Alternatively or additionally, the dispensing element can have a joint or a flexible section. Furthermore, the dispensing element can have a movable dispensing opening to dispense a liquid from the device in a variable direction. The suction element can have a movable suction opening to drain a liquid from a patient in a variable direction.
[0196] In one embodiment, the device is designed and configured to collect a liquid at the lowest point of a patient tissue area to be treated. In particular, the device can be designed such that the suction element, and especially a suction opening of the suction element, is located at a correspondingly protruding position on the device. In particular, the 2025PF00012
[0197] 24
[0198] The suction opening should be located in a position that is furthest from the container within the device.
[0199] In one embodiment, the dispensing orifice can have a diameter of 0.5 mm to 3 mm. In another embodiment, the extraction orifice can have a diameter of 0.5 mm to 3 mm. In yet another embodiment, the extraction orifice can have a diameter that is at least equal to or larger than the diameter of the dispensing orifice.
[0200] In one embodiment, a device according to the invention comprises a container, an adapter, a dispensing element, a first connecting element, a second connecting element, a third connecting element, a fourth connecting element, a first through-passage and a second through-passage, wherein the container has the first connecting element, wherein the adapter has the second connecting element, the third connecting element and the first through-passage for dispensing a liquid from the container, and wherein the dispensing element has the fourth connecting element and the second through-passage for dispensing a liquid from the device.
[0201] The third and / or fourth connecting element may preferably have a thread. The third connecting element is preferably designed and configured to form a positive-locking connection with the fourth connecting element. The positive-locking connection is preferably a pressure-resistant, fluid-conducting connection.
[0202] In one embodiment, the third connecting element is arranged on an outer surface of the adapter. In another embodiment, the fourth connecting element is arranged on an inner surface of the dispensing element. The term "inner surface" here refers to a surface that points in the direction of the central axis of the dispensing element.
[0203] In one embodiment, the third connecting element is designed as an external thread, and the fourth connecting element is designed as an internal thread. The third and fourth connecting elements can together form a bayonet fitting.
[0204] The device is designed and configured in one embodiment to create a pressure-resistant, fluid-conducting connection between the container, the adapter, and the dispensing element by engaging the first connecting element with the second connecting element and by engaging the third connecting element with the fourth connecting element.
[0205] In one embodiment, the device is designed and configured to apply pressure to a liquid by compressing the container, thereby causing the 2025PF00012
[0206] 25
[0207] To deliver fluid from the device to a patient via the first opening of the adapter and the second opening of the delivery element.
[0208] In one embodiment, the dispensing element has one outlet opening. In another embodiment, the dispensing element has multiple outlet openings. The multiple outlet openings can preferably point in different directions. In one embodiment, a dispensing opening can have a diameter of 0.5 mm to 3 mm.
[0209] In one embodiment, the suction element has a suction opening. In another embodiment, the outlet opening has a cross-sectional area that is smaller than or equal to the cross-sectional area of the suction opening. This ensures that the liquid discharged from the device and the dissolved or suspended contaminants in it can be removed as completely as possible.
[0210] In some embodiments, the device is configured to achieve a flow rate ratio of at least 1 between the suction element and the delivery element. This means that the device is designed and configured to simultaneously discharge at least as much fluid through the suction element as is delivered through the delivery element. This helps to ensure that detached biofilms and detached (i.e., debrided) infected tissue are effectively removed from the patient. In some embodiments, the flow rate ratio between the suction element and the delivery element is at least 1.0, 1.2, 1.5, or at least 2. In this context, it may also be advantageous for the inner diameter of the suction element to be correspondingly larger than the inner diameter of the delivery element.
[0211] In one embodiment, the suction opening is arranged at a distance of at most 4 cm, preferably at most 3 cm, at most 2 cm or at most 1 cm from the outlet opening.
[0212] The suction element and / or the delivery element may have a curved section. In particular, the suction element and / or the delivery element may have a curved conduit section, as described herein. This is especially advantageous when the suction element and the delivery element together form a stem element. This allows, for example, areas of the posterior condyles to be reached and treated more easily. Accordingly, in one embodiment, the device has a 2025PF00012
[0213] 26
[0214] A stem element with a curved conduit area, wherein the suction element and the discharge element are arranged in the stem element.
[0215] In one embodiment, the outlet opening is arranged at a distance of at most 8 mm, preferably at most 7 mm, at most 6 mm or at most 5 mm from the fourth connecting element.
[0216] In one embodiment, the extraction opening is arranged at a distance of at most 8 mm, preferably at most 7 mm, at most 6 mm or at most 5 mm from the fourth connecting element.
[0217] This proximity of the outlet or suction opening to the fourth connecting element, especially in conjunction with a curved delivery or suction element, makes it possible for the outlet or suction opening to pass more easily through the gap between the femoral component and the tibial component of a knee implant.
[0218] In one embodiment, the device has a dispensing element with a brush head having a plurality of bristles arranged at the end of the dispensing element.
[0219] In one embodiment, the device has a suction element, and the bristles are of a suitable size to be removed by the suction element. This allows any bristles that may have detached from the device to be removed from a treated wound.
[0220] The device can include a suction element for draining a fluid and a dispensing element, the suction element being arranged in direct connection with the dispensing element. The suction element and the dispensing element can together form a stem element. Within this stem element, the suction element and the dispensing element can each have passages that may be arranged parallel to each other in sections. The stem element can have a flexible or curved conduit section. This can enable a user to treat difficult-to-reach areas of a patient with the device. The device can include a dispensing element with an outlet opening and a suction element with a suction opening, the outlet opening having a cross-sectional area that is smaller than or equal to the cross-sectional area of the suction opening.
[0221] The brush head can have one or more outlet openings arranged between the bristles. The outlet openings are preferably designed and configured to dispense a liquid from the container. The outlet openings are preferably connected to the container via a fluid-conducting connection. The outlet openings can be defined by the following: 2025PF00012
[0222] 27
[0223] The first procedure described herein and the second procedure described herein shall be connected to the container fluid.
[0224] In one embodiment, the bristles are colored to provide optical contrast to blood and body tissue. Preferably, the bristles contain a dye. The dye preferably has an absolute emission maximum in the range of 490 nm to 575 nm.
[0225] In one embodiment, the bristles have a length of 1.5 to 20 mm. In another embodiment, the bristles have a length of 5 to 15 mm. In another embodiment, the bristles have a diameter of at least 1 mm.
[0226] In one embodiment, the device is designed and configured to dispense a liquid from the container to or adjacent to the brush head and simultaneously drain a liquid from or adjacent to the brush head. This allows a user of the device to dispense a liquid from the device at a target location, particularly a surgical wound, and to use the bristles and the dispensed liquid to remove microbially contaminated tissue. The removed tissue can be simultaneously removed by means of a suction element of the device. This allows infected tissue and biofilms to be removed from a patient, thus preventing the risk of pathogens remaining in the patient or being spread. For example, this method can prevent bacteria from biofilms from reattaching to an implant or joint.
[0227] In one embodiment, the device is designed and configured to dispense a liquid from the container onto a patient's tissue and to clean the patient's tissue using the brush head.
[0228] The bristles are preferably made of a biocompatible polymer, for example polyethylene, polypropylene, polyamide or similar.
[0229] The brush head can have bristles of varying lengths to facilitate cleaning undercuts. For example, the bristles of different lengths can be arranged in an arc on the brush head. The bristles in the distal part of the brush head can be longer than those in the proximal part. The distal part of the brush head is the side furthest from the adapter. The proximal part of the brush head is the side facing the adapter. 2025PF00012
[0230] 28
[0231] In some embodiments, the device has a plurality of outlet openings for dispensing a liquid from the container. The outlet openings may be located on the brush head near the bristles, on the bristles themselves, or both. The bristles may be hollow to facilitate the transport of a liquid. The device may be configured to guide a liquid from the dispensing element through the interiors of the individual bristles and release it at the bristle tips.
[0232] In one embodiment, the dispensing element has a tubular brush head with several outlet openings arranged around its circumference. The tubular brush head can also have bristles arranged around its circumference. The suction opening of the suction element can be located in close proximity to the outlet openings. Such embodiments can be particularly advantageous, for example, for treating femoral canals.
[0233] The bristles can be arranged in various ways to suit the anatomical conditions of the desired application area. In one embodiment, the bristles extend from the brush head towards the container. This means that the tips of the bristles point towards the container. In this case, the bristles point inwards relative to the device, as shown by way of example in Figure 15. In another embodiment, the bristles extend from the brush head in the opposite direction to the container. In this case, the bristles point outwards relative to the device, as shown by way of example in Figure 8. In a third embodiment, the bristles are arranged around the entire circumference of the brush head. In this case, the bristles are arranged on the brush head in the manner of a round brush, as shown by way of example in Figure 16.
[0234] In some embodiments, the brush head includes an angled outflow channel. The outflow channel can be arranged at an angle greater than 15° relative to the bristle orientation, for example, approximately 45°. This allows a liquid, for example, in the form of sprays or a continuous stream, to be dispensed into the area adjacent to the brush head to enhance the brush's cleaning performance. The liquid can be discharged at an outlet opening at the outer end of the outflow channel.
[0235] In one embodiment, the device has a dispensing element which includes a bowl-shaped funnel. Such a funnel can be designed and configured to define an area at which a liquid is dispensed from the device. 2025PF00012
[0236] 29
[0237] The funnel can define a volume element to which a liquid from the device can be dispensed.
[0238] The funnel can have a rim element designed and configured to seal against a patient's tissue surface, thereby forming a closed interior within the funnel. The rim element can be designed as a rubber-elastic sealing lip. The rim element is preferably arranged at the edge of the funnel. The funnel preferably has a central axis. The central axis can be arranged parallel to the second opening, i.e., the opening of the dispensing element. The central axis can correspond to the flow direction of a liquid dispensed from the device. In one embodiment, the device is designed and configured to dispense a liquid at various positions within the funnel. In another embodiment, the device is designed and configured to dispense a liquid in different directions relative to the central axis of the funnel.Preferably, the various positions are located within a closed interior space of the funnel, which is defined by the funnel as described above, when a rim element of the funnel is sealed against a patient's tissue surface. The term "closed interior space," as used herein in connection with the funnel, does not exclude the presence of the dispensing element, a vent, and / or a suction element. The term "closed interior space" is defined herein as the funnel, together with a patient's tissue surface, forming a substantially enclosed space within which fluid can be dispensed from the device and / or from which fluid can be drained.
[0239] The funnel can be made of a rubber-elastic material, or be constructed entirely of such material. This allows the funnel to be manually deformed by the user. Such deformation enables control of the liquid's dispensing direction. As described above, this allows the liquid to be dispensed to different positions without moving the entire device.
[0240] In one embodiment, the funnel has a joint. Similar to the above, such a joint can serve to control the direction of dispensing of a liquid from the device. The joint can, for example, be designed as a flexible section of the funnel. Such a section can be made of a material that has higher elasticity and / or greater deformability than the surrounding material of the funnel. Alternatively or additionally, such a section can be a 2025PF00012
[0241] 30
[0242] exhibiting a lower thickness, i.e., material strength, compared to the adjacent parts of the funnel.
[0243] The joint can advantageously be located adjacent to the adapter. The joint can be located at a neck region of the funnel. The joint can be located adjacent to the fourth connecting element, i.e., the connecting element of the dispensing element, which serves to connect to the adapter.
[0244] The funnel can be rotatably mounted on the device. Preferably, the funnel can be rotatably mounted about an axis that is parallel to a longitudinal axis of the container, a longitudinal axis of the first through-hole, and / or a longitudinal axis of the second through-hole.
[0245] The funnel may have a funnel wall that surrounds the dispensing element.
[0246] In one embodiment, the device has a suction element for removing a liquid. The suction element is preferably arranged on the dispensing element. The suction element may have a suction opening. The suction opening may be designed and configured to receive a liquid. The funnel may have a wall. The suction opening may be arranged in the wall of the funnel.
[0247] The funnel may also have a ventilation opening. The ventilation opening may be located in a wall of the funnel. In a usage scenario of the device in which an edge element of the funnel seals against a patient's tissue surface, thus defining a closed interior of the funnel as described above, such a ventilation opening can serve to equalize pressure for the suction element.
[0248] The vent opening is preferably located on the opposite side of the funnel from the suction opening. For a funnel with a substantially circular rim, this angle can preferably be 180° between the vent opening and the suction opening. This ensures sufficient distance between the vent opening and the suction opening. If, on the other hand, the vent opening is located in the immediate vicinity of the suction opening, effective drainage of the liquid from the funnel could be hindered, since in this case air could flow directly from the vent opening into the suction opening without exerting a suction effect on the liquid along the way. The suction opening can be located in the immediate vicinity of a sealing lip of the funnel. 2025PF00012
[0249] 31
[0250] The dispensing element can have a stem-shaped nozzle. The stem-shaped nozzle can be fluid-conducting and connected to the second opening. The nozzle can be pivotable around the central axis of the funnel. This allows a liquid to be dispensed from the device to different positions within the interior of the funnel.
[0251] The stem-shaped nozzle is preferably designed and arranged to prevent direct contact between the nozzle and a patient's tissue. For this purpose, the nozzle can be recessed within the funnel so that it does not extend from the adapter or container over the full distance to the opposite end of the funnel, for example, the rim, and in particular a sealing lip of the funnel. In one embodiment, the dispensing element, especially the stem-shaped nozzle, is colored. This can make it easier for a user to track the position and / or orientation of the dispensing element within the funnel. Preferably, the dispensing element incorporates a dye for this purpose. The dye preferably has an absolute emission maximum in the range of 490 nm to 575 nm. A colored dispensing element can be particularly advantageous in embodiments where the funnel is translucent or transparent.
[0252] The adapter nozzle is preferably connectable to the dispensing element nozzle. In one embodiment, the adapter nozzle is positively connected to the dispensing element nozzle. In another embodiment, the adapter nozzle is detachably connected to the dispensing element nozzle. In yet another embodiment, the adapter nozzle can be inserted into the dispensing element nozzle.
[0253] Another aspect of the invention relates to a method for dispensing a liquid using a device described herein. The method can be carried out using any of the devices described herein.
[0254] The device can comprise a container, an adapter, and a dispensing element. The container is preferably elastically deformable. The container is preferably designed and configured to hold a liquid. The container can contain a liquid. The adapter can be fluidly connected to the container. The dispensing element can be designed and configured to dispense a liquid from the device. The container can have a first connecting element. The adapter can have a second connecting element. The adapter can have a third connecting element. The adapter can have a first opening for dispensing a liquid from the container. The dispensing element can have a fourth connecting element. 2025PF00012
[0255] 32
[0256] The dispensing element may have a second opening for dispensing a liquid from the device.
[0257] In one embodiment, the device is designed and configured to create a pressure-resistant, fluid-conducting connection between the container, the adapter, and the dispensing element by engaging the first connecting element with the second connecting element and by engaging the third connecting element with the fourth connecting element.
[0258] In one embodiment, the device is designed and configured to pressurize a liquid by compressing the container, and thereby deliver the liquid from the device to a patient via the first opening of the adapter and the second opening of the delivery element.
[0259] In one embodiment, the method for dispensing a liquid comprises the following steps: connecting the container to the adapter, forming a pressure-tight, fluid-conducting connection between the container and the adapter; connecting the adapter to the dispensing element, forming a pressure-tight, fluid-conducting connection between the adapter and the dispensing element; and pressurizing a liquid within the container to dispense the liquid from the device via the adapter and the dispensing element. Pressurizing the liquid is preferably achieved by compressing the container. The method may further include removing a liquid using a suction element described herein. The method may include connecting the suction element to an external vacuum source.Connecting the adapter to the container may involve engaging the first connecting element with the second connecting element. Forming a pressure-tight, fluid-conducting connection between the adapter and the container may involve piercing a septum using a hollow mandrel, as described herein. In one embodiment, the method is performed in vitro. In another embodiment, the method involves bringing a fluid from the device into contact with a patient.
[0260] Another aspect concerns a therapeutic procedure in which a device described herein is used to remove biofilms or infected tissue. In this procedure, biofilms or infected tissue are dissolved or suspended using the fluid dispensed from the device. The therapeutic procedure may include any of the steps and features of the fluid dispensing method described above. 2025PF00012
[0261] 33
[0262] Another aspect concerns an active ingredient for use in the treatment of a surgical wound, in particular for disinfecting a surgical wound, wherein the active ingredient is delivered to the wound by means of a device described herein.
[0263] In one embodiment, the active ingredient is selected from the group consisting of chlorhexidine gluconate, benzalkonium chloride, octenidine dihydrochloride, an alkali hypochlorite, an alkaline earth hypochlorite, and an alkali chlorite. In one embodiment, the liquid comprises sodium dodecyl sulfate or a physiological saline solution.
[0264] In one embodiment, the active ingredient is provided as an aqueous solution, wherein the solution is selected from the group consisting of
[0265] a solution of benzalkonium chloride with a benzalkonium chloride concentration of 50 to 1500 ppm;
[0266] a solution of chlorhexidine digluconate and benzalkonium chloride, wherein the concentration of chlorhexidine digluconate is 50 to 600 ppm and the concentration of benzalkonium chloride is 50 to 250 ppm;
[0267] a solution of octenidine dihydrochloride with a concentration of 50 to 2000 ppm; a solution of alkali hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0268] a solution of alkaline earth hypochlorite with a hypochlorite concentration of 50 to 2000 ppm;
[0269] a solution of alkali chlorite with a chlorite concentration of 50 to 2000 ppm, a solution of sodium dodecyl sulfate with a sodium dodecyl sulfate concentration of 50 to 2000 ppm; and
[0270] a physiological saline solution with a sodium chloride concentration of 0.9 wt.%.
[0271] In one embodiment, the method comprises debridement, preferably a DAIR procedure. In another embodiment, the method comprises the delivery of a fluid during knee or hip joint surgery, particularly during revision surgery.
[0272] EXAMPLES
[0273] The invention is further illustrated below by means of examples, which, however, are not to be understood as limiting. It will be apparent to those skilled in the art that other equivalent means can be used in a similar manner instead of the features described here. 2025PF00012
[0274] 34
[0275] FIGURES
[0276] Figure 1 shows an exemplary embodiment of a device 100 according to the invention. The device has a container 101 suitable for holding a liquid. The container can be pre-filled with a liquid. The container is elastically deformable so that it can be squeezed by a user's hand to pressurize the liquid contained within and thereby dispense the liquid from the device. In the example shown here, the container has a surface structure with several trough-like circular depressions. This makes it easier for a user to grip and hold the container securely. In the example shown here, the container is designed as a plastic bottle. The container has a bottle neck to which a connector with a first connecting element 110 is attached.The first connecting element 110 is designed here as an annular projection. The container is closed by a seal 112, which here is designed as an adhesive or welded film that can be manually removed by a user. The device also includes an adapter 200, which in the embodiment shown here is designed as a separate part. The adapter 200 has the form of a cap that surrounds the connecting piece of the container 101 from several sides, thereby forming a positive-locking connection between the container 101 and the adapter 200.
[0277] The adapter 200 is detachably connectable to the container 101. For this purpose, the adapter 201 has a second connecting element 210, which can be connected to the first connecting element 110 of the container 101. The second connecting element 210 is designed here as a flexible locking hook. Several such locking hooks can be arranged on the adapter 200. For example, the adapter 200 can have two or four identical locking hooks for connection to the first connecting element 110. The first connecting element 110 is arranged on a first side of the adapter 200, the first side of which is intended for connection to the container 101. A nozzle 203, which here has a stem-like shape, is arranged on a second side of the adapter 200. The nozzle 203 is designed to dispense a liquid from the container 101.A third connecting element 211 is arranged between the first connecting element 110 and the nozzle 203, which is intended for connection with a dispensing element (not shown in this drawing).
[0278] Figure 2 shows a cross-sectional view of a device with a container 101, which is pressure-resistant and fluid-conducting, connected to an adapter 200. The first connecting element 2025PF00012
[0279] 35
[0280] 110 is engaged with the second connecting element 210 to create a positive connection between the container 101 and the adapter 200.
[0281] Container 101 is filled with a liquid 102. The container also has a septum 103 made of a rubber-elastic material. Adapter 200 has a hollow mandrel 202 that is inserted through the septum into an interior of container 101 to form a fluid-conducting connection between container 101 and adapter 200. A first passage 201 is arranged within the hollow mandrel 202 to direct the liquid 102 from container 101 through adapter 200 to the outside and discharge it through nozzle 203.
[0282] The third connecting element 211 remains accessible in the configuration shown here, in which the container 101 is connected to the adapter 200 in a pressure-resistant and fluid-conducting manner, in order to allow a connection to a dispensing element 300.
[0283] Figure 3 shows a cross-sectional view of a device comprising a container 101, an adapter 200, and a dispensing element 300. The container 101, the adapter 200, and the dispensing element 300 are each designed as separate parts that can be detachably connected to one another. The container has a first connecting element 110 for connection to the adapter 200. The adapter 200 has a second connecting element 210 for connection to the container 101. The adapter 200 also has a third connecting element 211, which is designed and configured for connection to the dispensing element 300. The third connecting element 211 is designed here as an external thread. The adapter 200 has a stem-shaped nozzle 203. The dispensing element 300 has a fourth connecting element 310 for connection to the adapter 200. The fourth connecting element 310 is designed here as an internal thread. The dispensing element 300 also has a stem-shaped nozzle 303.Nozzle 203 can be positively connected to nozzle 303. For this purpose, nozzle 203 can be inserted into nozzle 303.
[0284] Figure 4 shows a section of a cross-sectional view of a device according to the invention, wherein a container 101 is pressure-tightly and fluidly connected to an adapter 200, and the adapter 200 is pressure-tightly and fluidly connected to a dispensing element 300 to dispense a liquid 102 from the container 101. The first connecting element 110 of the container 101 engages in the second connecting element 210 of the adapter. The third connecting element 211 of the adapter engages in the fourth connecting element 310 of the dispensing element 300. The hollow mandrel 202 is inserted through the septum 103 into the interior of the container 101. A liquid 102 can be dispensed from the container 101 through a first 2025PF00012
[0285] 36
[0286] The feedthrough 201 of the adapter 200 and a second feedthrough 301 of the delivery element 300 are led outwards and delivered to a patient through an outlet opening 320 of the delivery element 300 from the device.
[0287] Figure 5 shows a section of a cross-sectional view of a device according to the invention, which further comprises a suction element 500. The device has a container 101 which is pressure-tight and fluidly connected to an adapter 200 via a first connecting element 110 and a second connecting element 210. The device further comprises a dispensing element 300 which is connected to the adapter 200 by means of a third connecting element 211 and a fourth connecting element 310. The dispensing element 300 has a nozzle 303 with an outlet opening 320 for dispensing a liquid 102 from the device. A suction element 500 is arranged on the device directly adjacent to the dispensing element. The suction element 500 has a suction opening 520, which is arranged adjacent to the outlet opening 320. The suction opening 520 is designed and configured for discharging a liquid.Thus, a liquid dispensed from the container, which is used to irrigate a surgical wound, can be suctioned from the wound area after contact with patient tissue. The device also has a fifth connecting element 311 for connection to an accessory 400. The accessory 400 is designed as a hose which can be connected to an external vacuum source. This allows the used irrigation fluid to be effectively removed.
[0288] Figure 6 shows a cross-sectional view of a dispensing element 300 connected to a suction element 500. A joint 503 is arranged on the dispensing element 300, which movably connects a clamp 502 to the dispensing element 300. The clamp 502 is designed and configured to hold a suction element 500, which has a hose 501. The clamp 502 surrounds the hose 501 and forms a force-fit connection with it.
[0289] Figure 7 shows a cross-sectional view of a dispensing element 300 connected to a suction element 500. The dispensing element 300 is connected to a clamp 502, which holds a hose 501 that is part of the dispensing element 500. In some embodiments, the clamp 502 is rotatably arranged about a longitudinal axis A of the dispensing element 300. The longitudinal axis A is here the longitudinal center axis of a stem-shaped nozzle 303 of the dispensing element 300. The longitudinal axis A runs parallel to the 2025PF00012
[0290] 37
[0291] Flow direction of a liquid that is dispensed from the container to the outside via the dispensing element 300. For this purpose, the clamp 502 can, for example, be attached to a rotatable ring, which is rotatably mounted on the dispensing element 300. The device can be designed and configured to automatically position the clamp 502 at the lowest point of the adapter element 200 due to the influence of gravity. For this purpose, it may be advantageous to design a rotatable ring, or a comparable retaining element, which is designed and configured for the rotatable mounting of the clamp 502, to be mounted in a correspondingly smooth manner.
[0292] Figure 8 shows a cross-sectional view of a device comprising a container 100 and a pressure-resistant, fluid-conducting dispensing element 300 with a brush head 600 connected to it. The container 100 is connected to the dispensing element 300 via an intermediate adapter 200. The first connecting element 110 and the second connecting element 210 are not shown in this drawing but may be present. The adapter 200 has a third connecting element 211, which is configured here as an external thread. The dispensing element 300 has a fourth connecting element 310 for connection with the third connecting element 211. The fourth connecting element 310 is configured here as an internal thread. The adapter 200 has a hollow mandrel 202 to penetrate a septum 103 of the container and to form a fluid-conducting connection between the container 100, the adapter 200, and the dispensing element 300.The device is designed and configured to dispense a liquid 102 from the container 101 via the adapter 200 and the dispensing element 300 in the area of the brush head 600. This allows a medical rinsing fluid to be released in the area of the brush head in order to treat patient tissue by means of this rinsing fluid and simultaneous mechanical action of the bristles of the brush head 600.
[0293] Figure 9 shows a section of a dispensing element 300 with a brush head 600. The brush head 600 has bristles 601 and outlet openings 320 arranged between them for dispensing a liquid from the device. In the example shown here, several outlet openings 320 are arranged on the brush head 600 at substantially equal intervals, i.e., with comparable distances between them. 2025PF00012
[0294] 38
[0295] Figure 10 shows a section of a dispensing element 300 with a brush head 600 in cross-sectional view. Several outlet openings 320 are arranged between the bristles 601 to dispense a liquid from the device.
[0296] Figure 11 shows a device 100 according to the invention, comprising a container 101, an adapter 200, and a dispensing element 300. The dispensing element 300 has a funnel 700. The funnel 700 is designed and configured to define a treatment area of a patient within which a liquid can be dispensed from the device. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as separate parts that can be detachably connected to each other. This design makes it possible to replace a contaminated dispensing element 300 with a new, clean dispensing element 300 during an operation.
[0297] Container 100 has a septum 103, which in the example shown here already has a pre-formed opening, this opening being closed with a seal 112. Container 101 also has a first connecting element 110 for connection to adapter 200. The first connecting element 110 is designed here as a circumferential projection. Adapter 200 has a second connecting element 210 for connection to the first connecting element 110. The second connecting element 210 is designed here as a flexible locking hook. Adapter 200 also has a first opening 201, which extends through a hollow mandrel 202 of adapter 200. The hollow mandrel 202 is designed and configured to create a fluid-conducting connection with container 101. The adapter has a stem-shaped nozzle 203, which is fluid-conductingly connected to the first opening 201.The adapter 200 further comprises a third connecting element 211 for connection to the dispensing element 300. This third connecting element 211 is designed as an external thread. The dispensing element 300 comprises a fourth connecting element 310 for connection to the adapter 200. This fourth connecting element 310 is designed as an internal thread. The dispensing element 300 has a stem-shaped nozzle 303 with a second through-hole 301 and an outlet opening 320. The nozzle 203 of the adapter 200 is designed and configured to establish a positive-locking connection with the nozzle 303 of the dispensing element 300. This simultaneously creates a fluid-conducting connection between the first through-hole 201 of the adapter and the second through-hole 301 of the dispensing element 300. The dispensing element 300 has a funnel with a vent opening 702 and a sealing lip 703.The sealing lip 703 is preferably designed to form a substantially fluid-tight seal with a patient tissue surface. The dispensing element is 3002025PF00012.
[0298] 39
[0299] The device further features a fifth connecting element 311 for connection to an accessory 400. The fifth connecting element 311 is configured here as a hose connection, and the accessory 400 is configured as a hose. The hose can be used to aspirate fluid that was previously dispensed from the device and used to clean patient tissue. When the funnel seals flush with a surface of patient tissue by means of the sealing lip 703, pressure equalization can occur via the vent 702 during aspiration. As shown here, it is advantageous to arrange the vent 702 in such a way that the rinsing fluid dispensed by the device does not reach the vent 702 during normal use of the device.For this purpose, it may be advantageous to arrange the ventilation opening 702 on a side of the funnel 700 opposite the side on which the sealing lip 703 is located. Furthermore, it may be advantageous to arrange the ventilation opening 702 and the fifth connecting element 311, e.g., a hose connection, opposite each other on the funnel 700. The fifth connecting element 311 can be located near the sealing lip 703. If the funnel 700 does not have a sealing lip 703, these provisions apply accordingly to the corresponding open end of the funnel.
[0300] Figure 12 shows a section of a device 100 according to the invention, comprising a container 101, an adapter 200, and a dispensing element 300, wherein the dispensing element 300 has a funnel 700, in a cross-sectional view. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as parts rigidly connected to one another.
[0301] The container 101 has a first connecting element 110 for connection to the adapter 200. The adapter 200 has a second connecting element 210 for connection to the container. In the embodiment shown here, a third and a fourth connecting element are unnecessary and not present, since the adapter 200 is permanently connected to the dispensing element 300. The adapter 200 has a hollow mandrel 202 for insertion into a septum 103 of the container 101. Unlike the embodiment shown in Figure 11, the septum 103 shown here is closed and can be pierced by the hollow mandrel 202. For this purpose, the container 101 has a first piercing position 104, which is defined by one or more openings in the container's housing. For example, the container may have a permanently attached attachment which provides a holder for the septum 103, a 2025PF00012
[0302] 40
[0303] has an opening for piercing with the hollow mandrel 202 and the first connecting element 110.
[0304] The adapter 200 is directly connected to a dispensing element 300, which has a funnel 700. In the embodiment shown here, the hollow mandrel 202 of the adapter is integrated into the dispensing element 300.
[0305] Figure 13 shows a cross-sectional view of a device 100 according to the invention, comprising a container 101, an adapter 200, and a dispensing element 300. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as fixedly connected parts. The container 101 has a fixedly connected attachment which includes a holder for the septum 103 and two openings, these two openings defining a first puncture position 104 and a second puncture position 105. This makes it possible to connect the container 101 fluidically to the adapter 200, the dispensing element 300, and an accessory 400 (not shown in this figure).For this purpose, the adapter 200 or the dispensing element 300 can have a corresponding opening so that the second puncture position 105 of the container 101 remains accessible even when the container 101 is connected to the adapter 200 and, if applicable, the dispensing element 300. Thus, at the first puncture position 104, the adapter 200 can be fluidly connected to the container 101 using the hollow mandrel 202, and at the second puncture position 105, an accessory 400 can additionally be fluidly connected to the container 101. The accessory 400 can have a hollow mandrel for this purpose, similar to the adapter 200.
[0306] Figure 14 shows a cross-sectional view of a device 100 according to the invention, comprising an adapter 200 and a dispensing element 300. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as parts rigidly connected to one another. The adapter 200 has a second connecting element 210 for connection to the container 101. The adapter 200 also has a hollow mandrel 202. The adapter 200 is rigidly connected to a dispensing element 300, and the dispensing element 300 is integrated into the adapter 200. The dispensing element 300 also has a joint 503 for movable connection to a clamp 502. The clamp surrounds and holds a hose 501. Due to the joint 503, the hose 501 can be moved relative to the dispensing element 300. This allows a user of the device to drain used irrigation fluid from a suitable location on patient tissue. 2025PF00012
[0307] 41
[0308] Figure 15 shows a cross-sectional view of a device 100 according to the invention, comprising an adapter 200 and a dispensing element 300. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as parts rigidly connected to one another. The dispensing element 300 has a brush head 600. The dispensing element is designed and configured to dispense a liquid from the device in the area of the brush head 600. The dispensing element 300 has a curved section. This can enable a user of the device to position the brush head 600 more precisely in certain treatment situations than would be the case with a dispensing element 300 having a substantially linear geometry.
[0309] Figure 16 shows a dispensing element 300 in a cross-sectional view. The dispensing element 300 has a brush head 600. The dispensing element is designed and configured to dispense a liquid from the device in the area of the brush head 600. The dispensing element 300 also has a suction element 500 with a hose 501. The hose 501 is attached to the dispensing element 300 by means of a clamp 502. The brush head 600 has bristles 601 arranged circumferentially. In the example shown here, the bristles 601 are arranged on the brush head 600 in the manner of a round brush. In this embodiment, a fluid-conducting passage extends through an interior space of each bristle 601, each opening into a discharge opening 320. Thus, the device is designed and configured to dispense a liquid through the bristles 601 to a patient.
[0310] Figure 17 shows an embodiment of a device according to the invention, designed and configured for dispensing a liquid to a patient and simultaneously draining a liquid from the patient. The device comprises a container 101, which is connected to an adapter 200 via a first connecting element 110 and a second connecting element 210. In the embodiment shown here, the adapter 200 and the dispensing element 300 are designed as fixedly connected parts. The adapter 200 has a hollow mandrel 202, which here is guided through a septum 103 of the container 101. The device further comprises a dispensing element 300 with an outlet opening 320 from which a liquid 102 can be dispensed. The device further comprises a suction element 500, which is connected to the dispensing element 300. The suction element 500 has a suction opening 520 for draining a liquid.
[0311] 42
[0312] Figure 18 shows an embodiment of a device according to the invention, which has an additional seal 220. The device comprises a container 101 with a first connecting element 110. An adapter 200, designed as a separate part, has a second connecting element 210, which is designed and configured for connection with the first connecting element 110. The adapter 200 has a circumferential groove in which an annular seal 220, similar to an O-ring, is inserted. This allows the adapter 200 to form a liquid-tight connection with a dispensing element 300. The adapter can be connected to the dispensing element 300 by means of a thread. A threaded connection can be formed by a third connecting element 211 on the adapter 200 and a fourth connecting element 310 on the dispensing element 300.Due to the sealing effect of the seal 220, the tightness of the pressure-resistant fluid-conducting connection between the adapter 200 and the dispensing element 300, which is achieved by this threaded connection, can be further improved.
[0313] EXAMPLE 1
[0314] A commercially available bottle containing sterile saline solution was connected using a cap-shaped adapter and a cap-shaped dispensing element described herein.
[0315] The following two variants were compared:
[0316] In variant A, the connection between the bottle and the cap-shaped adapter was established using a simple positive fit, based solely on the corresponding inner shape of the adapter cap and the outer shape of the bottle head. Similarly, a connection between the adapter and the cap-shaped dispensing element was established using a simple positive fit, based solely on the corresponding outer shape of the adapter cap and the inner shape of the cap-shaped dispensing element.
[0317] The adapter cap was equipped with a stem-shaped nozzle which was inserted into a similarly shaped nozzle of the dispensing element.
[0318] Several tests were conducted in which manual pressure was applied to the bottle to dispense the liquid inside via the adapter cap and dispensing element. However, the connection between the bottle and the adapter cap, as well as the connection between the adapter cap and the dispensing element, proved to be leaky, and in some cases the adapter cap detached from the bottle or the dispensing element. 2025PF00012
[0319] 43
[0320] Variant B was essentially identical to variant A, except that in variant B the adapter cap was attached to a projection on the bottle head using an elastic locking hook. Furthermore, in variant B the adapter cap was connected to the dispensing element via a thread. It was observed that when manual pressure was applied to the bottle, no liquid leaked between the adapter cap and the bottle or between the adapter cap and the dispensing element, and the adapter cables remained firmly connected to the bottle and the dispensing element. Variant B essentially corresponded to the device shown in Figure 3.
[0321] This established that by using the aforementioned connecting elements between the container, adapter, and dispensing element, a pressure-resistant, fluid-conducting connection between these three parts could be created. 2025PF00012
[0322] 44
[0323] LIST OF REFERENCE MARKS
[0324] 100 Device
[0325] 101 containers
[0326] 102 Liquid
[0327] 103 Septum
[0328] 104 first penetration position
[0329] 105 second penetration position
[0330] 110 first connecting element
[0331] 112 seals
[0332] 200 adapters
[0333] 201 first implementation
[0334] 202 Hollow mandrel
[0335] 203 Nozzle
[0336] 210 second connecting element
[0337] 211 third connecting element
[0338] 220 Seal
[0339] 300 delivery element
[0340] 301 second execution
[0341] 303 Nozzle
[0342] 310 fourth connecting element
[0343] 311 fifth connecting element
[0344] 320 Exit opening
[0345] 400 accessory
[0346] 500 extraction element
[0347] 501 Hose
[0348] 502 Schelle
[0349] 503 Joint
[0350] 520 Extraction opening
[0351] 600 brush heads
[0352] 601 bristles
[0353] 602 Stem element
[0354] 700 funnels
[0355] 701 Joint
[0356] 702 Ventilation opening
[0357] 703 Sealing lip
Claims
2025PF00012 45 PATENT CLAIMS 1. Device (100) for dispensing a medical fluid to a patient, comprising an elastically deformable container (101) for holding a liquid (102), an adapter (200) that can be fluidly connected to the container (101), and a dispensing element (300) for dispensing a liquid (101) from the device (100), wherein the dispensing element (300) has a second passage (301) for dispensing a liquid (102) from the device (100), and wherein the dispensing element (300) has a brush head (600) arranged at the end of the dispensing element (300) with a plurality of bristles (601), wherein the device (100) is designed and configured to pressurize a liquid (102) by compressing the container (101) and thereby deliver the liquid (102) from the device (100) to a patient.
2. Device according to claim 1, wherein the container (101), the adapter (200) and the dispensing element (300) are designed as parts that can be detachably connected to one another, wherein the device is preferably designed as a set of parts arranged in a sealed, sterile packaging medium, and comprises the container (101), the adapter (200) and the dispensing element (300) as parts that are each separate from one another.
3. Device according to one of the preceding claims, further comprising a suction element (500) for the removal of a liquid, wherein the bristles (601) preferably have a suitable size to be able to be removed through the suction element (500).
4. Device according to claim 3, wherein the suction element (500) is arranged in direct connection with the delivery element (300), wherein preferably the suction element (500) together with the delivery element (300) forms a stem element (602).
5. Device according to claim 4, wherein the stem element has a flexible or curved conduit section (503). 2025PF00012 46 6. Device according to one of claims 3 to 5, wherein the dispensing element (300) has an outlet opening (320), and the extraction element (500) has an extraction opening (520), wherein the outlet opening (320) has a cross-sectional area that is smaller than or equal to the cross-sectional area of the extraction opening (520).
7. Device according to one of the preceding claims, wherein the bristles (601) extend from the brush head (600) in the direction of the container (101), and / or extend in the opposite direction of the container, or wherein the bristles (601) are arranged circumferentially on the brush head (600) in the manner of a round brush.
8. Device according to one of the preceding claims, wherein the brush head (600) has one or more outlet openings (320) arranged between the bristles (601).
9. Device according to one of the preceding claims, wherein the bristles (601) are colored to provide optical contrast to blood and body tissue, wherein the bristles (601) preferably have a dye having an absolute emission maximum in the range of 490 nm to 575 nm.
10. Device according to one of the preceding claims, wherein the bristles (601) have a length of 1.5 mm to 20 mm, preferably 5.0 to 15 mm, and / or have a diameter of at least 1 mm.
11. Device according to one of the preceding claims, wherein the device is designed and configured to dispense a liquid (102) from the container (101) to or adjacent to the brush head (600), and simultaneously to discharge a liquid from or adjacent to the brush head (600).
12. Device according to one of the preceding claims, further comprising a septum (103) that seals the container (101) in a liquid-tight manner, wherein the adapter (200) has a first passage (201) for dispensing a liquid (102) from the container (101), and wherein the adapter (200) is designed and configured to penetrate the septum (103) by bringing the adapter (200) into contact with the container (101) in order to establish a fluid-conducting connection between the container (101) and the first passage (201). 2025PF00012 47 13. Device according to one of the preceding claims, wherein the container (101) is filled with a sterile liquid (102), wherein the liquid preferably comprises an antiseptic agent selected from the group consisting of chlorhexidine gluconate, benzalkonium chloride, octenidine dihydrochloride, an alkali hypochlorite, an alkaline earth hypochlorite, an alkali chlorite, and / or wherein the liquid comprises sodium dodecyl sulfate or physiological saline solution.
14. Device according to claim 13, wherein the sterile liquid comprises an aqueous solution selected from the group consisting of a solution of benzalkonium chloride with a benzalkonium chloride concentration of 50 to 1500 ppm; a solution of chlorhexidine digluconate and benzalkonium chloride, wherein the concentration of chlorhexidine digluconate is 50 to 600 ppm and the concentration of benzalkonium chloride is 50 to 250 ppm; a solution of octenidine dihydrochloride with a concentration of 50 to 2000 ppm; a solution of alkali hypochlorite with a hypochlorite concentration of 50 to 2000 ppm; a solution of alkaline earth hypochlorite with a hypochlorite concentration of 50 to 2000 ppm; a solution of alkali chlorite with a chlorite concentration of 50 to 2000 ppm, a solution of sodium dodecyl sulfate with a sodium dodecyl sulfate concentration of 50 to 2000 ppm; and a physiological saline solution with a sodium chloride concentration of 0.9 wt%; where the ppm values refer to a mass / mass fraction in the ratio of the respective dissolved substances to the total mass of the aqueous solution.
15. Device according to one of the preceding claims, wherein the container (101) has a first connecting element (110), and wherein the adapter (200) has a second connecting element (210) and a third connecting element (211), and wherein the delivery element (300) has a fourth connecting element (310), wherein the device is designed and set up by engaging the first connecting element (110) with the second connecting element (210) and by engaging the 2025PF00012 48 to create a pressure-resistant fluid-conducting connection between the container (100), the adapter (200) and the dispensing element (300) by connecting the third connecting element (211) to the fourth connecting element (310).