Application nozzle for cleaning an implant part

Abstract

The invention relates to an application nozzle (20, 20´, 20´´) for dispensing a dental active substance in the oral cavity of a patient, in particular for a system (1, 1´) for cleaning an implant part (2) contaminated with biofilm, comprising a main body or nozzle body (54) into which, on the one hand, at least one media channel (56) is integrated for supplying a cleaning electrolyte from a connection region (50) to a treatment end (52) and, on the other hand, a number of electrical conductor elements (86) are integrated. According to the invention, the or each media channel (56) is guided in a carrier body (70, 70´) of the main body or nozzle body (54), wherein at least one side wall (84) of the particular media channel (56) is formed by a functional film (72) integrally bonded to the carrier body (70, 70´).

Description

[0001] Description

[0002] APPLICATION NOZZLE FOR CLEANING AN IMPLANT PART

[0003] The invention relates to an application nozzle for delivering a dental agent into a patient's oral cavity, particularly for a system for cleaning an implant component contaminated with biofilm. The application nozzle comprises a base or nozzle body into which, on the one hand, at least one media channel is integrated for supplying a cleaning electrolyte from a connection area to a treatment end, and, on the other hand, a number of electrical conductor elements are integrated. It further relates to a system for cleaning a component contaminated with biofilm, particularly an implant component, using such an application nozzle.

[0004] From WO 2014 / 075755 A1, WO 2014 / 122187 A1, WO 2014 / 122188 A1, WO 2016 / 023998 A1 and WO 2021 / 018871 A1, the disclosures of which are incorporated by reference in their entirety, a treatment element, in particular for use with an implant part, and a method for cleaning a dental implant part are each known. Such cleaning of an implant part may be desirable or necessary to ensure the preservation of the inserted implant in the bone substance. A biofilm containing bacteria that can ultimately lead to chronic and recurring infections can form on the solid surface of implants, which is surrounded by tissue and tissue fluid. This clinical picture is referred to as peri-implantitis.Particularly in the dental field, similar to periodontitis, a combination of neglected oral hygiene, adhesion of biofilm to the typically micro-rough surface of the dental implant, and other factors are responsible for the full-blown picture of peri-implantitis, which is characterized by increasing stress and destruction of the hard and soft tissue. The areas where the hard and / or soft tissue recedes are usually covered with a biofilm. The cleaning procedure described in the cited publications is based on the concept of killing and removing the contaminating biofilm or germs from the implant surface without damaging it. This process involves an electrolytic process in which ions (cations and / or anions) are transported through the biofilm using electrostatic forces.These ions react chemically or electrochemically on the implant surface. These reactions create new chemical compounds and / or convert the ions themselves and / or parts of these ions into the atomic state. Furthermore, there is the possibility that the ions react with the surface material (e.g., formation of an oxide layer or material removal). This process not only kills germs due to the chemical substances formed, but also causes the formation of gas bubbles that mechanically remove the biofilm. This effect, which provides the mechanical component in addition to the chemical component, can be the most important component in biofilm removal, as the biofilm can be comparatively resistant to chemical or biological influences due to its complex properties and the bond formed.However, the mechanical lifting effect caused by the gas bubbles formed breaks up the bond, so that the components of the biofilm are again made accessible to chemical or biological influences.

[0005] The treatment element described in the cited publications is specifically designed to perform this cleaning procedure directly on the inserted dental implant, preferably while the post is in the bone in the patient's mouth. For this purpose, the treatment element is intended to be connected directly to the inserted post. A suitable treatment fluid, which, when exposed to an electric current, can serve as the basis for the desired electrolytic process, is then applied to the affected area of ​​the adjacent bone substance in the immediate vicinity of the inserted post and subjected to the electric current. Therefore, the use of this treatment element requires the establishment of both mechanical and electrical contact with the inserted post.For this purpose, the design of the treatment element described in the cited publications generally requires the temporary removal of the prosthetics on the dental implant and, if necessary, its abutment in order to fix it to the post. The performance of such a procedure is therefore primarily considered therapeutic in the sense that inflammation already exists in the oral area near the implant, and an existing biofilm must be detached and removed.

[0006] Furthermore, WO 2023 / 222913 A1 discloses an application nozzle with which the described treatment concept—i.e., the combined application of electrical current and an electrolytic cleaning fluid to the affected implant—can also be used for preventative or prophylactic treatments. In contrast to therapeutic treatment, which can be associated with corresponding expenditures, this treatment concept is particularly flexible and can be implemented with minimal expenditures. Against this background, there is now a need to design an application nozzle suitable for use in large quantities, based on the concept of WO 2023 / 222913 A1.

[0007] The invention is therefore based on the object of providing an application nozzle for a treatment system of the aforementioned type, which enables the application of the aforementioned treatment concept, particularly in prophylaxis, even with a particularly simple and thus cost-effective design. Furthermore, a treatment system particularly suitable for use with the application nozzle is to be provided.

[0008] With regard to the application nozzle of the above-mentioned type, this object is achieved according to the invention in that the or each media channel is guided in a carrier body of the base or nozzle body, wherein at least one side wall of the respective media channel is formed by a functional film which is integrally connected to the carrier body.

[0009] Advantageous embodiments of the invention are the subject of the dependent claims. Further and / or alternative advantageous embodiments of the invention, as well as further embodiments considered independent inventions, are also apparent from the description of the figures.

[0010] The invention is based on the consideration that, especially when using the application nozzle in prophylaxis, a particularly simple design should be aimed for in view of the associated large quantities, while on the other hand, particular reliability of the components is desirable while also being particularly easy to handle. As has surprisingly been found, the nozzle body of the application nozzle mentioned at the outset should have a high level of intrinsic stability and a certain degree of rigidity, in particular in order to reliably enable precise and accurately positioned application of the cleaning fluid. In order to take this into account even with a simple design, according to one aspect of the invention, the application nozzle should have a carrier body that is in particular comparatively stiff or rigid, into which the media channels provided for transporting the cleaning electrolyte can be integrated.According to one aspect of the invention, this fundamentally shaping and stability-promoting support body can then be additionally provided with a number of film pieces attached in a materially bonded manner, i.e., in particular, by gluing or welding, which can each form one of the side walls of the respective media channel. Thus, the support body can be designed in the manner of a shaping skeleton for forming the media channels. However, to keep production particularly simple, complex perforations, undercuts, or the like should be avoided as far as possible in the design of the support body. Instead, externally attached film pieces can be provided for the final production of the media channels, in particular for providing any side walls that may still be missing.

[0011] According to one aspect of the invention, the application nozzle or treatment head is designed as a substantially flat component. This does not mean that the treatment head could or should be designed two-dimensionally; rather, it is to be understood that the application nozzle or the nozzle body forming it should be a body extending substantially along a basal plane or base plane, while still exhibiting a certain thickness in the third spatial direction. Viewed in cross-section, however, this also means that the lateral extent of the nozzle body in the basal plane is significantly greater than the thickness in the direction perpendicular to it.For use in, for example, prophylactic treatment of a dental implant, this means that the free or treatment end of this nozzle body can be relatively easily inserted into the periodontal pockets by aligning the basal plane of the nozzle body, for example, essentially parallel to the outer surface of the implant. To further facilitate this handling, according to an advantageous aspect of the invention, the base or nozzle body is designed as a body extending flatly in a longitudinal direction from a connection area to a free treatment end, in which both the width and the thickness taper towards the treatment end.In other words, in this embodiment, the free or treatment end of the nozzle body essentially has a flat contour that tapers to a point in both width and thickness, making insertion into the periodontal pockets particularly easy. In a particularly advantageous embodiment, the carrier body is also designed as a stiffening body, with a width of at least 0.8 mm transverse to the longitudinal direction of the base or nozzle body in the area of ​​the treatment end.

[0012] In a particularly advantageous embodiment, and to particularly support a particularly cost-effective design, the carrier body is designed as an injection-molded part. This enables mass production of such a carrier body without any problems and using widely established manufacturing methods. The carrier body is advantageously made of a thermoplastic, a thermoset, or an elastomer, in particular PA6, PA66, PBT, PES, POM, or PSU. In an alternative advantageous embodiment, the carrier body can also be made of PC (polycarbonate), PET (polyethylene terephthalate), PETG, or a COC (cycloolefin copolymer).

[0013] Depending on the individual design, the application nozzle could comprise one or more of the aforementioned carrier bodies. Advantageously, the or each carrier body is constructed in one piece, with a media channel formed into each carrier body to form the respective media channel, which is covered by the functional film integrally bonded to the carrier body. This allows the routing of the media channels in the carrier body to be defined during its manufacture by the corresponding molding in the form of a channel. The channel shape facilitates production and allows access "from the outside" at any time.The final completion of the media channels can then be achieved by attaching the functional film to the carrier piece, for example by gluing or welding (in particular laser or ultrasonic welding) or generally by laminating it to the edge region. The functional film then covers and closes the respective channel, with its side facing the carrier body forming a side wall of the media channel formed in combination with the underlying media channel. In particular, according to one aspect of the invention, the carrier body can be designed as a flat, extending central body, the base and top surfaces of which are each provided with a media channel. In other words, the carrier body in this embodiment can be provided in the manner of a central stiffening and shaping element, into which a media channel is incorporated on each side to form a media channel.The functional film can be provided for covering both sides of the central body in the sense of a particularly simple and cost-effective production, in that the central body is provided with a common functional film which is connected to both the base and the cover surface and folded over at the treatment end of the carrier body.

[0014] According to one aspect of the invention and with regard to the desired functional principle of the combined electrolytic-chemical treatment of a dental implant, the media channels should each be provided with conductor elements such that they are wetted by the cleaning electrolyte flowing in the respective media channel. This reliably ensures reliable electrical contact and thus the desired process control in the sense described above. To enable this in a particularly simple manner, according to one aspect of the invention, the side of the functional film facing the respective media channel is provided with a conductor element in its region forming a side wall of the media channel. In a particularly preferred embodiment, this can be designed as an electrically conductive film coating covering the respective media channel.

[0015] According to one aspect of the invention, direct electrical contact with the implant is important for the intended mode of action during implant treatment. This should also be achieved via the application nozzle, since, unlike the concepts described above, disassembly of the prosthetic is not provided for in this case, and thus electrical contact with the implant via its interior or the area exposed at the top is not possible.To nevertheless enable reliable direct electrical contacting of the implant, according to one aspect of the invention, the conductor element arranged on the side of the functional foil facing the respective media channel is assigned a first electrical polarity, wherein the base or nozzle body additionally has a conductor element assigned a second electrical polarity, which, viewed in the longitudinal direction, projects beyond the treatment end formed by the media channel and thus enables the intended electrical contacting of the implant. This conductor element is thus exposed at its end and can therefore be brought into direct contact with an exposed outer surface of the implant, for example, even within the periodontal pocket, and thus electrically contacted.This is intended to form, in a sense, the electrical counterpole to the conductor elements described above, so that the current flow can be adjusted by connecting a suitable current or voltage source. In order to enable the delivery of even comparatively larger quantities of cleaning electrolyte into the periodontal pocket with a particularly compact design, in particular to be able to literally flood it if necessary, according to one aspect of the invention, the carrier body provided with the media channels or the media channels forming them can be provided with a plurality of outflow openings in an outflow area arranged in the region of the treatment end, which can be used jointly to deliver the electrolyte.For this purpose, according to one aspect of the invention, a branching media channel is integrated into the carrier body, which opens into a plurality of application openings on the output side, so that these can be supplied with electrolyte via a common supply. Alternatively, several media channels can be present on the input side, which transport the same medium or are connected to the same media container or to different media containers, all of which contain virtually the same or the same medium.

[0016] In an advantageous development, several of the outlet openings are arranged in an outflow direction aligned laterally with the longitudinal axis. This allows the entire space in the periodontal pocket around the free or treatment end of the nozzle body to be easily flooded with cleaning electrolyte.

[0017] This allows the electrolyte to be applied in a targeted manner in the area of ​​the free or treatment end of the treatment head or the application nozzle, particularly enabling precise introduction into the periodontal pocket.

[0018] According to one aspect of the invention, the application nozzle can generally be used as a treatment head in a system for cleaning a component contaminated with biofilm or can be intended for this use.

[0019] Polyamide is advantageously used as the base material for the functional films or film pieces; alternatively, however, another suitable film material such as PVC, PP or PE, or even a combination of different film materials, may also be considered suitable.

[0020] In a particularly advantageous embodiment, which is also considered to be independently inventive, the application nozzle is also designed, with regard to its geometric design and dimensions, for the intended use for the precise introduction of electrolytes into the oral area of ​​a patient. In this case, it is advantageously taken into account in particular that application could also be provided into the interdental spaces or the periodontal pockets of the patient. According to one aspect of the invention, an application nozzle designed particularly well for this purpose has a nozzle body constructed as a laminate from the carrier body and the functional film pieces, with a total thickness of 0.3 - 2 mm, preferably 0.5 - 1.5 mm, particularly preferably 0.7 - 1.2 mm in the region of its treatment end.

[0021] In an advantageous development, the application nozzle according to the type described above is designed as a disposable or single-use product and is therefore intended for single use only. This can be achieved, for example, by destroying the treatment head after use, i.e., after removing it from the other components of the treatment system, or otherwise rendering it unusable.

[0022] According to an aspect considered to be independently inventive, the application nozzle is used in a system for cleaning a component contaminated with biofilm, in particular an implant part.

[0023] With regard to the system for cleaning a component contaminated with biofilm, in particular an implant part, with such an application nozzle, the stated object is achieved with a handle which is provided with a number of electrical and media connections in such a way that both the electrical conductor elements and the media channels of the application nozzle can be connected to corresponding electrical or media supply lines in the handle.

[0024] In a particularly advantageous embodiment, the treatment system is designed as a mobile device, eliminating the need for fixed connections to external peripherals. For this purpose, a replaceable reservoir for cleaning electrolyte is advantageously arranged in the handle.

[0025] The advantages achieved by the invention lie, in particular, in the fact that, by combining a carrier body, also intended as a stiffening body or for shape stabilization, with a functional film integrally bonded to it, various channel geometries, and in particular the intended media channels themselves, can be provided in a particularly simple and cost-effective manner. The carrier body, even with the aid of the additional film pieces, allows for the provision of an overall dimensionally stable application nozzle, which enables particularly precise and accurately positioned handling even in sensitive environments, such as during treatment within a periodontal pocket.

[0026] An embodiment of the invention is explained in more detail with reference to a drawing. In the drawing:

[0027] FIG. 1 shows a dental implant inserted into the oral bone of a patient,

[0028] FIG. 2 shows a schematic view of a mobile treatment system,

[0029] FIG. 3 shows a schematic diagram of a stationary treatment system,

[0030] FIG. 4 shows an application nozzle of the treatment system according to FIGS. 2 and 3 in a perspective view,

[0031] FIG. 5 shows a nozzle body of the application nozzle according to FIG. 4 in a side view,

[0032] FIG. 6 shows the nozzle body according to FIG. 5 in plan view,

[0033] FIG. 7 shows the application nozzle according to FIG. 4 in exploded view,

[0034] FIG. 8 shows the nozzle body. FIG. 4 with the functional foil partially mounted on the carrier body,

[0035] FIG. 9 shows the functional film as shown in FIG. 8 in the unfolded state, inside (FIG. 9a) and outside (FIG. 9b),

[0036] FIG. 10 shows an alternative embodiment of an application nozzle in perspective view,

[0037] FIG. 11 shows a nozzle body of the application nozzle according to FIG. 10 in perspective view,

[0038] FIG. 12 shows a carrier element of the application nozzle in FIG. 10 in a perspective view, FIG. 13 shows another alternative embodiment of an application nozzle in a perspective view,

[0039] FIG. 14 shows the treatment end of the application nozzle according to FIG. 13 in an enlarged view, and

[0040] FIG. 15 shows the application nozzle according to FIG. 13 in an exploded view.

[0041] Identical parts are provided with the same reference numerals in all figures.

[0042] In general, dental implant systems, especially two-part implant systems, are subject to the problem that the penetration of bacteria or germs into the tissue near the insertion site, particularly in the area of ​​the external thread inserted into the jaw, can lead to inflammation or foci of inflammation. Such inflammation, particularly as a result of peri-implantitis, can lead to serious damage to the tissue and bone in the area of ​​the insertion site, especially if it develops and solidifies over a longer period of time. Without appropriate countermeasures, these damages can result in the entire implant system having to be removed from the bone. After bone augmentation, it must be re-fitted with an implant system or replaced with other prosthetics.This highly undesirable effect caused by peri-implantitis can lead to total loss of the implant system, necessitating further surgical interventions such as scraping out the affected area of ​​the jawbone and replacing it with a new implant system. Such removal can also result in bone loss or other tissue loss, which, in extreme cases, can lead to the point where a new implant is no longer possible. Such a need for replacement caused by peri-implantitis can also arise relatively long periods after the initial insertion of the implant system—for example, up to several years or even decades.

[0043] The germs or bacteria observed in connection with peri-implantitis can in principle colonize the interior of the implant components, but usually adhere preferentially directly to the surface of the dental implant inserted into the jawbone in the contact area with the surrounding tissue or bone material, i.e. particularly in the area of ​​the external thread. In this area, the surface of the dental implant can be roughened or similarly to particularly promote ingrowth into the tissue or bone and to support the healing of the dental implant after insertion. However, it is precisely in the area of ​​such a roughened surface, which is actually considered particularly beneficial for the implant system, that the colonization of germs or bacteria can occur more frequently, whereby the roughness makes targeted removal of the existing germs or bacteria even more difficult.

[0044] There is therefore an urgent need for suitable countermeasures to effectively combat the source of inflammation in the event of impending or already occurring peri-implantitis, while preserving the implant system in place, and to kill and / or remove the invading germs so that healthy tissue or healthy bone substance can subsequently form in the area around the external thread. To this end, it is desirable, in addition to specifically killing the germs or bacteria in the affected area, to also reliably remove their material residues and fragments from the affected space so that the affected area can subsequently be filled with healthy tissue or bone material, and a close connection can again form between the outer surface of the dental implant and the surrounding tissue or bone material.In addition, the biofilm formed by the bacterial coating, including the organic residues of killed bacteria, should be reliably removed.

[0045] To enable this, a treatment concept for cleaning a component contaminated with biofilm, in particular an implant part, is known from the publications WO 2014 / 075755 A1, WO 2014 / 122187 A1, WO 2014 / 122188 A1, WO 2016 / 023998 A1, and WO 2021 / 018871 A1, the disclosures of which are incorporated by reference in their entirety. In this concept, the contaminated surface of the implant is wetted with an electrolytic cleaning fluid and subjected to a current flow. The combination of a suitably selected electrolyte and current application causes, among other things, gas bubbles to form directly on the implant surface, which blast off any adhering biofilm and thus contribute to cleaning the surface. A continuous supply of the electrolyte rinses the area to be cleaned (e.g. the pocket) and thus removes the dissolved concretions.In contrast to the aforementioned publications, however, the present invention does not primarily intend or aim for therapeutic treatment of peri-implantitis or tissue inflammation that has already occurred, but rather prophylactic treatment in which the onset of inflammation or its further expansion and spread is to be prevented within the framework of a standardized, preventative treatment. This can, for example, prevent existing mucositis from developing into peri-implantitis. An application nozzle suitable for such preventative treatment is known from WO 2023 / 222913 A1. Improvements and further developments of this known application nozzle are described here, which are considered inventive either independently or in combination with other design features of the known application nozzle.The disclosure content of WO 2023 / 222913 A1 is therefore fully incorporated.

[0046] The use of a treatment system 1 intended particularly for prophylactic treatment is shown schematically in FIG. 1. This shows a dental implant 2 inserted into the oral bone of a patient. For clarification, FIG. 1 shows a so-called dental pocket 8 adjacent to the dental implant 2 in the region of its external thread 4 and the jawbone 6, which usually forms in the form of an increasingly widening gap between the tooth substance or the jawbone 6 and the surrounding soft tissue 10. Bacteria tend to accumulate in such a pocket 8, which can lead to later inflammation, in the case of healthy teeth in the form of periodontitis, and in the case of an inserted dental implant 2, to the aforementioned peri-implantitis.

[0047] The treatment system 1 is intended to counteract this in the form of prophylaxis and at an early stage, i.e. when bacterial infestation is imminent or already spreading or when a biofilm is forming. In terms of its mode of action, it is designed according to the concept of the aforementioned publications: On the one hand, it is designed to specifically kill the germs or bacteria present in the insertion area of ​​the dental implant 2 by specifically administering a bactericidal but harmless cleaning or disinfectant agent. On the other hand, it is designed to detach any residues or fragments of germs and / or bacteria that may already be adhering to the surface of the dental implant 2, in particular in the area of ​​the external thread 4, from the outer surface of the dental implant 2 by applying a suitable current or electric shocks, so that they can then be washed out.

[0048] In a first embodiment, which is independently considered inventive both with regard to the design of the system and with regard to the intended method steps of the treatment method, the treatment system 1 is designed as a mobile system, as schematically illustrated in FIG. 2. The system 1 comprises a handle 12, which is provided with suitable reservoirs and storage elements with regard to the intended mode of operation, i.e., the application of both electrical current pulses and a suitably selected electrolytic cleaning fluid to the dental implant 2 in the region of the periodontal pocket 8. For this purpose, a suitable battery 14 (or any other suitable current or voltage source) and a storage container 16 for cleaning electrolyte are integrated into the handle 12.The storage container 16 is designed as a replaceable container, allowing for easy refilling after the contents have been used up. The storage container 16 could, in particular, be designed in the manner of an ampoule for a medicinal agent, whereby the media-side connection can be implemented via a Lüer connection, using established filling and connection concepts.

[0049] In the illustrated embodiment, the handle 12 is connected to a transition piece 18 on the media side and also electrically. These components, which could in principle also be designed as a single functional part, form a reusable component that can be used in a variety of treatments, for example, as part of a standardized preventive measure for a large number of patients. To enable the actual treatment, the actual application nozzle 20, also referred to as the treatment head, is connected to it. In the illustrated embodiments, the application nozzle 20 is designed for single use only due to hygiene and care considerations and is therefore designed as a single-use or disposable product.The application nozzle 20 is provided with a number of electrical and media connections such that both its electrical conductor elements and its media channels can be connected to corresponding electrical or media supply lines 22, 24 in the handle 12 or in the transition piece 18. In an alternative embodiment, the treatment system 1' can also be designed as a stationary system, as shown in the exemplary embodiment in FIG. 3. This can be intended, in particular, for use in the context of a dental treatment, such as a cleaning or prophylactic measure, or even a therapeutic treatment.The treatment system 1' comprises a central supply unit 26, to which the application nozzle 20 is connected via an intermediate handle or handpiece 28 as the actual treatment head or actual treatment element, which, with regard to hygiene and care considerations, is also designed in this embodiment for only one-time use and thus as a single-use or disposable product.

[0050] In the stationary treatment system 1', the application nozzle 20 is connected via connecting elements, in the exemplary embodiment via PVC or silicone hoses 30, for the media-side connection to an electrolyte cartridge or ampoule 32 arranged in the supply unit 26. Furthermore, it is connected via electrical connecting lines 34 to a control unit 36 ​​arranged in the supply unit 26. The electrolyte ampoule 32 and the control unit 36 ​​are arranged together with a buffer battery 38 provided for the on-demand power supply of the control unit 36 ​​and with a pump 40 in a common outer housing 42 of the supply unit 26. The application nozzle 20 is provided with a number of electrical and media connections such that both the electrical conductor elements 34 and the media-side connecting hose 30 formed by the PVC / silicone hoses can be suitably connected.

[0051] The electrolyte ampoule 32 of the treatment system 1', like the storage container 16 of the treatment system 1, is provided for providing a cleaning electrolyte, as disclosed, for example, in the documents WO 2014 / 075755 A1, WO 2014 / 122187 A1, WO 2014 / 122188 A1, WO 2016 / 023998 A1, and WO 2021 / 018871 A1, the disclosures of which are incorporated by reference in their entirety. The connecting hose 30 connecting the electrolyte ampoule 32 to the application nozzle 20 on the media side can be shut off by a hose valve 44 arranged in the region of its passage through the outer housing 42, which can be controlled by the control unit 36 ​​and can start the electrolyte flow when opened and stop it again when closed.According to one aspect of the invention, the hose valve 44 can be designed in particular as a pinch valve which, in the blocking mode for blocking, uses the comparatively soft hose material to deform it in a squeezing manner until it is completely blocked.

[0052] According to one aspect of the invention, the electrolyte ampoule 32 is designed as a disposable product and thus as an exchangeable storage container, so that it can be disposed of after its contents have been consumed and replaced with a new ampoule. The electrolyte ampoule 32 could, in particular, be designed in the manner of an ampoule for a medicinal active ingredient, wherein, using established filling and connection concepts, the media-side connection can be implemented via a Lüer connection. In the exemplary embodiment, the electrolyte ampoule 32 is designed, in an embodiment considered to be independently inventive, with a comparatively soft ampoule body, which can be compressed, for example, during manual use by the user, in order to dispense the contained active ingredient.

[0053] According to a further aspect considered to be independently inventive, a pressure chamber 46 is positioned in the interior of the outer housing 42. The pressure chamber 46 is connected to the pump 40 designed as an air pump. As soon as the internal pressure in the pressure chamber 46 is sufficiently increased via the pump 40, this overpressure, utilizing the deformability of the ampoule body, results in the ampoule body being compressed and the active ingredient contained being released. This independently inventive embodiment thus enables an "encapsulated" release of the active ingredient, for which no direct contact with the ampoule body is necessary. Especially in combination with the pinch valve described above, this enables particularly simple access and process control from the outside, via electrical signal lines, and thus allows for automation.

[0054] According to this aspect of the invention, the electrolyte ampoule 32 is thus inserted into the pressure chamber 46 for the operation of the system 1'. In the pressure chamber 46, an overpressure of 0.8 - 1.5 bar, preferably 1.0 - 1.2 bar, is built up via the pump 40 and kept as constant as possible. The resulting outflow of the electrolyte is controlled via the hose valve 44. When open, the hose valve 44 allows the flow and stops it by squeezing the hose. Through the interaction and suitable control of the pump 40 on the one hand and the hose valve 44 on the other hand, the media flow from the electrolyte ampoule 32 can be suitably controlled and, if necessary, regulated. Furthermore, the electrolyte ampoule 32 can also be pressed out using other mechanical, pneumatic or hydraulic systems.

[0055] The application nozzle 20, which is intended and suitable for use in both the mobile treatment system 1 and the stationary treatment system 1', is shown in a perspective view in FIG. 4. With regard to the intended preferred use in the field of dental care or prophylaxis, the application nozzle 20 is specifically designed for high functionality with a particularly simple construction, so that production is possible even in extremely large quantities with only limited manufacturing costs. For this purpose, the application nozzle 20 has, as an essential functional component, a base or nozzle body 54 extending in a longitudinal direction from a connection side 50 to a free treatment end 52, into which a number of media channels 56 for supplying the cleaning electrolyte from the connection side 50 to the treatment end 52 and a number of electrical conductor elements 58 are integrated.The media channels 56 are connected on the outlet side to application openings 60 for the active ingredient to be applied, in particular the cleaning electrolyte. The conductor elements 58 are provided to generate the intended current flow through the cleaning electrolyte. The nozzle body 54 is arranged in a housing 62 in the area of ​​its connection side 50.

[0056] The application nozzle 20 is designed in a particularly simple manner, in a manner considered to be independently inventive, specifically for its intended use in a prophylactic treatment, i.e., the electrical contacting of the dental implant 2 and the targeted delivery of the cleaning electrolyte into the pocket 8. In particular, the fact that the practitioner should be able to contact the implant 2 with pinpoint accuracy despite very limited space is taken into account. To enable this, according to one aspect of the invention, the spatial shape of the nozzle body 54 is suitably selected, taking into account the fact that a pocket 8 is usually formed in the form of a gap extending along the implant surface.

[0057] To take this into account, according to one aspect of the invention, the nozzle body 54 is designed in the manner of a flat spatial body as a substantially planar component extending in a longitudinal direction from the connection region 50 to the free treatment end 52. The nozzle body 54 is thus designed as a body extending substantially along a basal plane or ground plane. According to one aspect of the invention, and in order to enable handling even within the pocket 8, this body is designed such that both the width and the thickness taper towards the treatment end 52. This design can be clearly seen in the side view of the nozzle body 54 in FIG. 5 and its top view in FIG. 6.For the application, this means that the free or treatment end 52 of the nozzle body 54 can be introduced comparatively easily into the tooth pockets 8 by aligning the basal plane of the nozzle body 54, for example, substantially parallel to the outer surface of the implant 2.

[0058] The dimensions of the nozzle body 54 are also specifically adapted to the intended use within a dental pocket 8 in a design considered to be independently inventive. In the region of the treatment end 52 it has a width b of less than 3 mm, preferably less than 2.5 mm, according to one aspect of the invention of 1.5 mm, in particular of at most 2 mm, and a thickness d of at most 1 mm, according to one aspect of the invention of 0.9 mm. In the connection region 50, however, the component forming the nozzle body 54 has, according to one aspect of the invention, a thickness D of approximately 1.5 mm and a width B of approximately 1.5 times to 2 times the width b at the treatment end 52.

[0059] The application nozzle 20 is deliberately designed in a particularly simple and thus cost-effective manner. According to a fundamental concept of the invention, it is constructed using foil material that can be easily provided in large quantities and modified using a variety of available processing methods, for example, embossed, punched, or processed in some other way, specifically and selectively coated with functional materials such as conductor tracks, spatially modified, such as folded, and otherwise processed in a variety of ways suitable for mass production. However, a certain degree of dimensional stability is necessary, particularly in the area of ​​the treatment end 52 of the nozzle body 54, in order to carry out the intended treatment safely and reliably.According to a general concept of the invention, the application nozzle 20 is therefore designed using a functional film that is stabilized in the region of the treatment end 52 by a suitable stabilizing or stiffening body. This aspect is considered to be independently inventive within the scope of the present disclosure.

[0060] In the exemplary embodiment, as can be seen from the exploded view according to FIG. 7, this is achieved in a manner regarded as independently inventive in that the nozzle body 54 of the application nozzle 20, which is arranged at the end in the housing 62, comprises two basic components, namely, on the one hand, a carrier body 70 designed as a stiffening body or shaping and dimensionally stable element and, on the other hand, a functional film 72 combined with the carrier body 70 and integrally connected to it, preferably glued or welded. According to one aspect of the invention, the or each media channel 56 is guided in the carrier body 70, wherein at least one side wall of the respective media channel 56 is formed by the functional film 70 integrally connected to it.

[0061] According to one aspect of the invention, the carrier body 70 is provided as a stiffening body and is accordingly made of a suitable dimensionally stable, sufficiently rigid, and mechanically stable material, according to one aspect of the invention as an injection-molded part. Accordingly, the carrier body 70 preferably consists of a material suitable for injection molding, such as, in particular, a thermoplastic, a thermoset, or an elastomer, in particular PA6, PA66, PBT, PES, POM, or PSU. In an alternative advantageous embodiment, the carrier body can also be made of PC (polycarbonate), PET (polyethylene terephthalate), PETG, or a COC (cycloolefin copolymer).

[0062] The selection of an injection-molded body is considered particularly advantageous and independently inventive because the use of injection molding as a manufacturing process enables cost-effective production of even enormous quantities of the carrier body 70, even if it should have a comparatively complex geometry and, in particular, surface due to the intended routing of the media channels 56. However, in order to keep this particularly simple, according to an independently inventive aspect, the combination of the carrier body 70 - comparatively rigid and preferably designed as an injection-molded body - with the functional film 72 is provided, in which the media channels 56 or other geometric formations are only introduced superficially into the injection-molded body, and the channels or the like are only completed and "closed" by the attachment of the functional film 72, which then forms a side wall of the channel.Accordingly, this concept of the invention encompasses a wide variety of configurations with regard to the number, positioning, and connection of the components carrier body 70 and functional film 72 to one another, provided that corresponding media channels 56 are formed and completed by attaching the functional film 72 to the carrier body 70. In particular, a stack of films, a number of film pieces, or the like could also be provided for the functional film 72.

[0063] Polyamide is preferably provided as the base material for the functional film 72; alternatively, however, another suitable film material such as PP or PE or even a combination of different film materials may be considered advantageous.

[0064] According to one aspect of the invention, as can be seen from the illustration in FIG. 7, the carrier body 70 is constructed in one piece. To form the respective media channel 56, a media channel 74 is formed into the carrier body 70, in the illustrated embodiment both on the top and bottom sides, which is covered after the assembly of the functional film 72 by means of the functional film 72, which is then integrally bonded to the carrier body 70.

[0065] In the illustrated embodiment, the support body 70 is thus designed as a stiffening body, having a width of approximately 0.9 mm transversely to the longitudinal direction of the nozzle body 54 in the region of the treatment end 52. The support body 70 is designed as a flat, extending central body 76, the base and top surfaces 78, 80 of which are each provided with at least one molded-in media channel 74.

[0066] On the inlet side, the media channels 74 are connected to a connecting piece 81, which, when the application nozzle 20 is mounted, is arranged within the housing 62 and can be connected via this to the corresponding media lines, such as the hose package 30. As can be seen from the illustration, in the exemplary embodiment, the media channel 74 provided to form a media channel 56 branches within the nozzle body 54, so that on the outlet side it opens into a plurality of the application openings 60 arranged in the outflow area 82 provided in the region of the treatment end 52. Some of the application openings 60 are arranged in an outflow direction aligned laterally to the longitudinal direction, so that the electrolyte can be distributed particularly effectively in the region of the dental pocket 8 during application.As a result, the application nozzle 20 is particularly designed for the precise and comprehensive application of the cleaning electrolyte into the pocket 8, so that the pocket 8 can be flooded particularly efficiently and as comprehensively as possible, thus reliably establishing the desired current path via the cleaning electrolyte. For this purpose, the media channel 56 integrated into the carrier body 70 and provided for supplying the cleaning electrolyte is branched in such a way that the media channel 56 extending from the connecting piece 81 splits into several channels at a branching point within the nozzle body 54 and is connected via these channels on the outlet side to a plurality of application openings 60 arranged in an outflow area 82 provided in the region of the treatment end 52.

[0067] In the exemplary embodiment shown in FIG. 4, the application openings 60, which are connected in parallel on the media side, are positioned on both sides and with a lateral outflow direction at the treatment end 52, allowing a uniform discharge of the cleaning electrolyte to both sides of the application nozzle 20. This allows the electrolyte to be applied in a targeted manner to the entire spatial surroundings of the treatment end 52 of the application nozzle 20 and thus, if necessary, directly into the respective pocket 8. Specifically, it is thus possible to flood the pocket 8 from the apical side via the treatment end 52 and laterally somewhat further upwards, in each case via the outflow or application openings 60.

[0068] According to an aspect considered to be independently inventive, the functional film 72 is provided as a film element for the entire central body 76, wherein the central body 76 is provided with a common functional film 72 which is connected to both the base and the cover surface 78, 80 and folded over at the treatment end 52 of the carrier body 70.

[0069] The central body 76 forms the media channels 74. It is embedded or folded into the surrounding functional film 72, as is particularly clearly visible in the partially assembled illustration according to FIG. 8. The functional film 72, which is punched out of a piece of film with a suitable contour, is folded over the carrier body 70 at a folding point 83 so that it covers the latter on both sides and, while forming the media channels 56 provided on the top and bottom, seals the inserted media channels 74. On the inside, to ensure the intended electrical function when the electrolyte carried in the media channels 56 is supplied with current, the side of the functional film 72 facing the respective media channel 56 or the media channel 74 forming it is provided with a film coating 88 forming a conductor element 86 in the area intended to form a side wall 84 of the media channel 56.In the surrounding area, however, the inside of the functional film 72, as can be seen in particular from the illustration of the functional film 72 in the unfolded state in FIG. 9a (inside), is provided according to one aspect of the invention with an adhesive coating 90, by means of which the functional film 72 can be materially bonded to the carrier body 70 in the areas provided for this purpose.

[0070] In the exemplary embodiment, the foil coating 88 forming the conductor element 86 is a metal coating, preferably made of gold or platinum, applied to the underlying foil layer, for example by vapor deposition (sputtering, galvanization, etc.). A conductor element 86 formed by such a metal coating has the particular advantage that it can be contoured and shaped particularly flexibly. In particular, its surface contour can be adapted to the projection of the respective media channel 56 onto the foil layer. This makes a particularly large contact surface, namely essentially the entire base area of ​​the respective media channel 56, available for electrically contacting the cleaning electrolyte flowing in the media channel 56 in a material-saving manner. If necessary, e.g., in the event of product developments or adaptations, it can be varied and modified very easily.In a particularly advantageous embodiment, which is considered to be independently inventive, the conductor element 86 is applied using a printing process, preferably a screen printing process. According to one aspect of the invention, the conductor element 86, optionally in addition to further conductor tracks, can be manufactured using a suitable screen printing paste, for example, based on titanium. The conductor tracks preferably comprise silver, gold, or titanium as the base material.

[0071] Thus, the foil coating 88 is adapted to the media channels 74 so that, during operation, electrical contact is established with the electrolyte conducted in the media channel 56. According to one aspect of the invention, the foil coating 88 can be printed on the inside of the functional foil 72 and, according to a further aspect of the invention, consists of a suitably selected conductive material, in particular a metal such as gold or titanium. Preferably, and according to a further aspect of the invention and with a view to favorable manufacturing costs, particularly for large quantities, the foil coating 88 consists essentially of silver, which, in a preferred and inventive development, is provided with a carbon coating - preferably also printed - for corrosion protection with a view to the expected contact with the electrolyte.

[0072] On the outside, the functional film 72, as can be seen from the illustration in FIG. 9b, is provided with a cathode conductor track layer 92 for the intended electrical contacting of the implant 2 and thus to complete the current path, which cathode conductor track layer 92 forms a contacting area 96 for targeted contacting of the implant 2 in a central area 94 in the vicinity of the transition point 83. As a result, the conductor element 86 arranged on the side of the functional film 72 facing the respective media channel 56 and formed by the film coating 88 is intended for anodic wiring and is thus assigned a first electrical polarity, wherein the nozzle body 524 in the form of the cathode conductor track layer 92 additionally comprises a conductor element 92 assigned a second electrical polarity. As a result of the intended folding during assembly, this jumps in the longitudinal direction, as shown in the illustration in FIG.4, protrudes beyond the treatment end 52 formed by the media channel 56, beyond the nozzle body 54, so that it can be easily brought into contact with the implant 2. Furthermore, this design also enables the provision of a free space between the functional film 72 and the carrier body 70 in its end region 52, through which the treatment medium guided in the central media channel 56 can flow out.

[0073] To enable electrical contacting, but on the other hand, to avoid unintentional electrical contacts or even unwanted short circuits, the functional foil 72 and the cathode conductor layer 92 applied to its exterior are provided with an insulating layer 98 outside the central implant contacting area 94. According to one aspect of the invention, the insulating layer 98 can also be applied using a printing process, preferably a screen printing process.

[0074] For the electrical contacting of the application nozzle 20 or its conductor element 86 provided for anodic wiring on the one hand, and the cathode conductor layer 92 on the other hand, the targeted use of the deformability of the functional film 72 is provided according to an aspect considered to be independently inventive. This is based on the knowledge that a resilient element is usually provided for electrical plug connections, with which, after a mechanical contact has been established, the electrical contact is to be reliably established and maintained using the spring force of such an element. In order to utilize this for the nozzle body 54 in a particularly reliable and simple manner, the use of the spring force of the already fundamentally elastic functional film 72 is provided.For this purpose, the conductor element 86 is each conductively connected to a first contact field 100 and the cathode conductor layer 92 is each conductively connected to a second contact field 102 on the functional film 72. Evasive grooves 104 are formed in the carrier body 70, associated with these grooves, so that when the functional film 72 is mounted on the carrier body 70, the contact fields 100, 102 each fit precisely above them. When the functional film 72 is mounted, these grooves form free spaces, in a manner considered to be independently inventive, into which the film 72 can escape when local pressure loads occur. To create a reliable electrical connection in the sense of a plug-in connection, a suitable contact plug (not shown in detail) designed with a slightly undersized design can be plugged in laterally, whereby the film is slightly deformed locally and escapes into the aforementioned free spaces.The foil thus tensioned fits snugly against the pins of the contact plug, establishing a reliable electrical contact. The contact plug (not shown in detail) is then located within the housing 62 when assembled. According to one aspect of the invention, it comprises a front contact area with the aforementioned contact pins and a rear contact area that can be connected to corresponding downstream systems.

[0075] Further design features of the contact plug are described in WO 2023 / 222913 A1, the disclosure content of which is also fully incorporated in this regard.

[0076] Furthermore, the application nozzle 20 (see FIGS. 4 et seq.) is designed, with regard to the routing of the cathode conductor layer 92 in the contact region 96, according to one aspect of the invention, for automated contact detection with the component to be treated, in particular the dental implant 2. The principle of this automated contact detection is also described in WO 2023 / 222913 A1, the disclosure content of which is also fully incorporated in this regard. In this embodiment, which is considered to be independently inventive, the individual conductors of the cathode conductor layer 92 in the region 94 of the transition point 83 are not designed to be in continuous contact with one another, but are divided into two comb-like, interlocking conductor groups.The conductors of the first conductor group, which are arranged in the region of the transition point 83 alternating with the conductors of the second conductor group, are connected exclusively to only one of the outer contact fields 102, and the conductors of the second conductor group are connected exclusively to the other contact field 102. In the "normal" state, there is therefore no electrically conductive connection between the two contact fields 102, which are actually assigned the same electrical polarity, and the detection of mechanical and / or electrical contact with the component 2 to be treated can be carried out by detecting an electrically conductive connection between the two contact fields 102. An alternative embodiment of the application nozzle 20' is shown in FIG. 10 in a perspective view. As can be seen from the illustration of the nozzle body 54' in FIG. 11 and the carrier element 70' in FIG.12, in this variant, the media channel 74 formed in the carrier body 70' is not branched in the basal plane; the lateral outflow can be provided through the free space in the region of the transition point 83 as well as via additional application openings 60 in the functional film 72. In this embodiment, according to one aspect of the invention, an information element 106, in the exemplary embodiment in the form of a visually perceptible marking 108, is arranged on the outside of the functional film 72, by means of which the practitioner can determine how deeply the treatment end 52 of the application nozzle 20' has penetrated into the periodontal pocket 8.

[0077] In a further embodiment of an application nozzle 20'', which is also considered to be independently inventive, an electrically conductive, preferably metallic, contact pin 110 provided in the manner of a separate component can also be provided to establish electrical contact with the implant 2. This can be arranged at the end of the carrier body 70 and electrically connected in a suitable manner to the cathodic conductor tracks 92. This exemplary embodiment is shown in FIGS. 13 to 15. Instead of the folded-over functional film 72, a set of two functional films 72' is provided, each of which covers one of the top and bottom sides of the carrier body 70. The treatment end 52 is kept free of the functional film, so that the contact pin 110 is freely accessible and can thus be used for contacting.

[0078] List of reference symbols

[0079] 1, 1' treatment system

[0080] 2 dental implants

[0081] 4 external threads

[0082] 6 jaw bones

[0083] 8 bag

[0084] 10 Soft tissue

[0085] 12 Handle

[0086] 14 Battery

[0087] 16 storage containers

[0088] 18 Transition piece

[0089] 20 Application nozzle

[0090] 22, 24 supply lines

[0091] 26 supply unit

[0092] 28 Handle

[0093] 30 PVC or silicone hoses

[0094] 32 electrolyte ampoules

[0095] 34 connecting line

[0096] 36 Control unit

[0097] 38 buffer battery

[0098] 40 Pump

[0099] 42 housings

[0100] 44 Hose valve

[0101] 46 pressure chamber

[0102] 50 connection side

[0103] 52 End of treatment

[0104] 54 nozzle bodies

[0105] 56 Media Channel

[0106] 58 electrical conductor element

[0107] 60 application opening

[0108] 62 housings

[0109] 70 carrier bodies

[0110] 72, 72' functional film

[0111] 74 Media channel

[0112] 76 Central body 78 Base area

[0113] 80 deck area

[0114] 81 connecting pieces

[0115] 82 Outlet area

[0116] 83 transshipment point

[0117] 84 side wall

[0118] 86 ladder element

[0119] 88 film coating

[0120] 90 adhesive coating

[0121] 92 Cathode conductor layer

[0122] 94 Area

[0123] 96 Contact area

[0124] 98 Insulation layer

[0125] 100 contact field

[0126] 102 Contact field

[0127] 104 Avoidance groove

[0128] 106 Information element

[0129] 108 Marking

[0130] 110 Contact pin b Width at treatment end

[0131] B Width at the connection area d Film thickness

[0132] D Total thickness

Claims

Claims 1. An application nozzle (20, 20', 20") for applying a dental active agent in the oral cavity of a patient, in particular for a system (1, 1') for cleaning an implant part (2) contaminated with biofilm, comprising a base or nozzle body (54) into which, on the one hand, at least one media channel (56) and, on the other hand, a number of electrical conductor elements (86) are integrated for supplying a cleaning electrolyte from a connection area (50) to a treatment end (52), wherein the or each media channel (56) is guided in a carrier body (70, 70') of the base or nozzle body (54), wherein at least one side wall (84) of the respective media channel (56) is formed by a functional film (72) integrally bonded to the carrier body (70, 70').

2. Application nozzle (20, 20', 20") according to claim 1, whose carrier body (70, 70') is designed as a stiffening body and has a width of at least 0.8 mm transversely to the longitudinal direction of the base or nozzle body (54) in the region of the treatment end (53).

3. Application nozzle (20, 20', 20") according to claim 1 or 2, whose carrier body (70, 70') is designed as an injection-molded part.

4. Application nozzle (20, 20', 20") according to one of claims 1 to 3, whose carrier body (70, 70') is formed from a thermoplastic, a thermoset or an elastomer, in particular from PA6, PA66, PBT, PES, POM or PSU.

5. Application nozzle (20, 20', 20") according to one of claims 1 to 4, in which the or each carrier body (70, 70') is in each case designed in one piece, wherein in each case a media channel (74) is formed into the respective carrier body (70, 70') to form the respective media channel (56), which is covered by means of the functional film (72) integrally connected to the carrier body (70, 70').

6. Application nozzle (20, 20', 20") according to one of claims 1 to 5, wherein the side of the functional film (72) facing the respective media channel (56) is provided with a conductor element (86) in its region forming a side wall (84) of the media channel (56).

7. Application nozzle (20, 20', 20") according to claim 6, wherein the conductor element (86) is designed as an electrically conductive film coating (88) covering the respective media channel (56).

8. Application nozzle (20, 20', 20") according to claim 6 or 7, wherein the conductor element (86) arranged on the side of the functional film (72) facing the respective media channel (56) is assigned a first electrical polarity, wherein the base or nozzle body (54) additionally has a conductor element (92) assigned a second electrical polarity, which, viewed in the longitudinal direction, projects beyond the treatment end (52) formed by the media channel (56).

9. Application nozzle (20, 20', 20") according to one of claims 1 to 8, whose carrier body (70) is designed as a flatly extending central body (76), the base and / or cover surface (78, 80) of which are each provided with at least one molded-in media channel (74).

10. Application nozzle (20, 20', 20") according to claim 9, the central body (76) of which is provided with a common functional film (72) connected to both the base and the cover surface (78, 80) and folded over at the treatment end (52) of the carrier body (70).

11. Application nozzle (20, 20', 20") according to one of claims 1 to 10, wherein the base or nozzle body (54) is designed as a body extending flatly in a longitudinal direction from a connection region (50) to a free treatment end (52), in which both the width and the thickness taper towards the treatment end (52).

12. Application nozzle (20, 20', 20") according to one of claims 1 to 11, wherein at least one of the media channels (56) branches within the base or nozzle body (54) and opens on the output side into a plurality of application openings (60) arranged in an outflow region (82) provided in the region of the treatment end (52).

13. Application nozzle (20, 20', 20") according to claim 12, wherein a number of the application openings (60) are arranged in an outflow direction aligned laterally to the longitudinal direction.

14. Application nozzle (20, 20', 20") according to one of claims 1 to 13, which is designed as a disposable product.

15. System (1, 1') for cleaning a component contaminated with biofilm, in particular an implant part, with an application nozzle (20, 20', 20") according to one of claims 1 to 14, and with a handle (12, 28) which is provided with a number of electrical and media connections such that both the electrical conductor elements (86) and the media channels (56) of the application nozzle (20, 20', 20") can be connected to corresponding electrical or media supply lines in the handle (12, 28) or in an associated transition piece.

16. System (1) according to claim 15, in whose handle (12) an exchangeable storage container (16) for cleaning electrolyte is arranged.

Images