A dosing nozzle for delivering a dental active agent to the oral cavity of a patient and an active agent applicator equipped with the dosing nozzle

Abstract

This invention provides a delivery nozzle (16, 16') for delivering dental active agents into the oral cavity of a patient. The delivery nozzle has a nozzle body (22) extending longitudinally from a connecting area (36) to a free treatment end (38). At least two media channels (34) are integrated inside the nozzle body, each media channel extending independently from the connecting area (36) to the free treatment end. This delivery nozzle has the advantage of low production cost. To achieve the above effect, the media channels (34) are inserted into the support base (50) of the nozzle body (22), and at least one sidewall of each media channel (34) is composed of a functional film (52) bonded to the material of the support base (50).

Description

Technical Field

[0001] This invention discloses a drug delivery nozzle for delivering dental active agents into a patient's oral cavity. The nozzle includes a nozzle body extending longitudinally from a connecting area to a free treatment end. The nozzle body integrates at least two media flow channels, each independent of the others, extending from the connecting area towards the treatment end. This invention also discloses an active agent applicator equipped with the aforementioned drug delivery nozzle. Background Technology

[0002] In various dental clinical treatments, preoperative care, and postoperative maintenance scenarios, it is often necessary to deliver dental active agents such as oral rinsing solutions, medical disinfectants, and therapeutic agents into the patient's oral cavity with high precision and accuracy. These drug delivery procedures cover various oral care processes and clinical treatments, such as preoperative care and postoperative maintenance procedures associated with periodontal treatment. The industry generally desires a simple application device that can conveniently perform targeted drug delivery within the patient's oral cavity. This device not only needs to be suitable for clinical treatment procedures but also needs to meet the requirements of preventative oral health care and daily oral maintenance. Therefore, the core component that directly extends into the patient's oral cavity and performs the actual drug delivery function—the delivery nozzle—should be easy to process and inexpensive to manufacture, suitable for large-scale mass production. Furthermore, this drug delivery system should be simple to operate and reliable in use, even for users without a medical background, and should be easy to operate, especially suitable for home oral care scenarios, with an ease of operation comparable to that of a toothbrush.

[0003] Furthermore, in oral care, preoperative treatment, and postoperative care scenarios, the industry has the following usage requirements: a powerful rinsing action to effectively remove food debris, biofilms, and secretions from severely affected areas such as periodontal pockets, maximally inhibiting the colonization and reproduction of bacteria and microorganisms at the lesion site. An unpublished patent application, PCT / EP2023 / 071323, discloses a drug delivery nozzle with the aforementioned design specifically adapted to these usage requirements. Summary of the Invention

[0004] The core objective of this invention is to provide a delivery nozzle for infusing dental active pharmaceutical agents into a patient's oral cavity. This nozzle maintains a remarkably simple structure and low manufacturing cost, while still achieving the complete treatment regimen described in the prior patent, making it particularly suitable for preventative oral health care. Furthermore, the objective of this invention is to provide an active pharmaceutical agent applicator suitable for self-administration by ordinary individuals.

[0005] For the drug delivery nozzles of the type described above, the present invention adopts the following technical solution to solve the problems existing in the prior art: the medium flow channel is inserted into the support substrate of the base or nozzle body, and at least one sidewall of each medium flow channel is formed by a functional film, wherein the functional film is bonded to the support substrate material.

[0006] Various preferred embodiments of the present invention are described in the dependent claims. Further alternative or alternative preferred embodiments of the present invention, as well as other embodiments that can stand alone as independent inventive points, can also be derived from the description in conjunction with the accompanying drawings.

[0007] The design concept of this invention is as follows: Drug delivery nozzles are used extensively in preventative oral healthcare treatments, and their application scenarios are numerous, thus requiring a simplified overall structure. However, even with extremely simple operation, each component still needs to possess high reliability. Surprisingly, to meet these requirements, the nozzle body of the aforementioned drug delivery nozzle needs to possess high inherent stability and a certain degree of rigidity to ensure accurate and targeted infusion of dental active agents. This design advantage contrasts with drug delivery nozzles that are too soft and prone to deformation: softer nozzles are easily twisted and deformed when inserted into the patient's periodontal pocket for treatment, resulting in insufficient infusion accuracy of the therapeutic solution. To solve this problem with a simple design, according to one aspect of this invention, the drug delivery nozzle incorporates a rigid support base, which maintains dimensional stability even when subjected to external forces inside the periodontal pocket. The medium flow channel for delivering the cleaning electrolyte can be integrated within the support base.

[0008] To simplify the structure and reduce production costs, according to one aspect of the present invention: the supporting substrate serves to shape and enhance structural stability. Multiple thin-film components are bonded to its outer surface using a material bonding process (adhesion or welding, preferably laser welding or ultrasonic welding), with each thin-film component forming a single sidewall of a media flow channel. Thus, the supporting substrate can act as a forming skeleton, enclosing and forming a complete media flow channel. To minimize processing steps, the structural design of the supporting substrate should avoid complex cuts, undercuts, and other special structures as much as possible; any missing sidewalls of the media flow channel can be filled in by bonding thin-film components to the outside of the substrate, ultimately completing the media flow channel formation.

[0009] According to one aspect of the invention, the drug delivery nozzle or treatment head is entirely a flat component. The term "flat" here does not refer to the treatment head being a two-dimensional planar structure, but rather to the nozzle body constituting the drug delivery nozzle extending along a reference plane while retaining a certain thickness in the third dimension of three-dimensional space. From a cross-sectional perspective, it can be seen that the lateral extension dimension of the nozzle body within the reference plane is much greater than its thickness perpendicular to the reference plane. If this drug delivery nozzle is used for preventative oral health care of dental implants, the user only needs to place the reference plane of the nozzle body approximately parallel to the outer surface of the implant to easily insert the treatment tip of the nozzle body into the periodontal pocket.

[0010] To further facilitate operation, according to a preferred aspect of the invention, the base / nozzle body extends longitudinally from the connecting area towards the free treatment end in a planar shape, with its width and thickness gradually narrowing towards the free treatment end. In other words, in this embodiment, the overall contour of the treatment end of the nozzle body is flat, with its width and thickness narrowing simultaneously in both directions, allowing it to smoothly extend into the periodontal pocket; specifically, the end area has a sword / blade shape, easily entering the periodontal pocket and interdental space. Furthermore, the lateral spraying inlet can stably and comprehensively complete the rinsing treatment of the medication in areas such as tooth surface depressions and interdental spaces with inverted structures.

[0011] In a preferred embodiment of the present invention, the support base also serves as a rigid reinforcement base; in the treatment tip region, the width of the support base transverse to the longitudinal direction of the base / nozzle body is not less than 0.8 mm.

[0012] To significantly reduce manufacturing costs and adapt to large-scale mass production, a preferred embodiment designs the support substrate as an injection-molded part. Leveraging mature existing processing technologies, the support substrate can be mass-produced without hindrance. Preferably, the support substrate is made of materials suitable for injection molding, including thermoplastics, thermosetting plastics, or elastomers, particularly polyamide 6 (PA6), polyamide 66 (PA66), polybutylene terephthalate (PBT), polyethersulfone (PES), polyoxymethylene (POM), and polysulfone (PSU). In another alternative preferred embodiment, the support substrate can also be made of polycarbonate (PC), polyethylene terephthalate (PET), ethylene glycol-modified polyethylene terephthalate (PETG), or cyclic olefin copolymers (COC).

[0013] Depending on the specific structural design requirements, a single drug delivery nozzle may include one or more of the aforementioned support substrates. Preferably, each support substrate is an integral component; a pre-formed media groove is formed on the support substrate, and a functional film bonded to the support substrate material covers the outside of the groove, with the two working together to form a complete media flow channel. When processing the support substrate, the layout of the media flow channel can be directly determined by pre-forming the groove; the groove forming process is simple, and the entire processing can be performed from the outside of the substrate. Subsequently, the functional film can be assembled onto the support substrate to complete the final forming and sealing of the media flow channel. The assembly method can be bonding, welding (specifically laser welding or ultrasonic welding), or an overall pressing and coating process to attach the functional film to the edge area of ​​the flow channel; after the functional film is attached, it will cover and seal the corresponding media forming flow channel, and the side of the functional film facing the support substrate cooperates with the media forming flow channel below to jointly form one sidewall of the media flow channel. Specifically, according to one aspect of the present invention, the support substrate is a flat, centrally extending substrate structure, with a media flow channel formed on its upper surface and lower bottom surface respectively. In other words, in this embodiment, the support base serves as a centrally located rigid frame, with a medium flow channel formed on each of the front and back sides of the frame.

[0014] To further simplify the processing flow and reduce production costs, the centrally located substrate can be fitted with a single functional film: the single film is simultaneously attached to the bottom and top surfaces of the substrate, and is folded and wrapped at the treatment end of the supporting substrate, covering both sides of the central substrate at one time.

[0015] According to one aspect of the invention, the drug delivery nozzle contains two (or more) media-isolated delivery channels; different dental active agents can be delivered through these independent channels without mixing during delivery, and are ultimately applied to the same spatial area near the free treatment tip without mixing. The corresponding design concept of the invention is as follows: this structure can not only deliver various agents individually, but also selectively utilize the chemical reaction between two agents at the location of oral lesions, such as inside the periodontal pocket. Users can achieve therapeutic effects not only through the agents themselves, but also by utilizing the reaction process between the agents and the various products generated by the reaction to achieve preset treatment goals.

[0016] For example, according to one aspect of the present invention, which can be considered an independent inventive point, two agents / components that can react to form a foam upon contact are directly mixed at the administration point; the bubbles generated by the reaction can strip away and remove various impurities such as oral contaminants and food debris. This design is adapted to targeted oral cleaning and maintenance procedures and can simultaneously complete the rinsing and care of periodontal pockets. For example, according to one aspect of this invention, the reaction agents or components used are divided into two categories: the first category is bicarbonate, preferably sodium bicarbonate or potassium bicarbonate; the second category is acid, preferably carboxylic acid, such as citric acid, lactic acid, etc. The two types of agents are delivered simultaneously, come into contact with each other at the administration point, and react to generate carbon dioxide bubbles. This foaming effect can be efficiently applied to oral cleaning and rinsing operations.

[0017] To implement one of the technical solutions of this invention, and to ensure the stable and precise interaction between two or more dental active agents or components within a selected drug delivery area such as a periodontal pocket, the drug delivery ports corresponding to the two media channels are preferably arranged as close to each other as possible. This allows the drug components to be stably and precisely mixed within the designated space area after the user adjusts the position of the treatment tip, according to the design requirements. Therefore, in a preferred embodiment, the minimum distance between the drug delivery ports of the two media channels is 0.01 mm, and the maximum distance is 10 mm; further preferably, the minimum distance is 0.1 mm and / or the maximum distance is 2 mm; in a particularly preferred embodiment, the distance between the drug delivery ports is controlled within the range of 0.1 mm to 0.6 mm.

[0018] According to another alternative aspect of the invention, which can be considered an independent inventive point, the drug delivery nozzle has two (or more) mutually isolated delivery channels on the media side; different dental active agents can be delivered separately through each channel without mixing throughout the process, and finally converge into the same common space area, that is, a mixing node integrated inside the nozzle body. This structure enables controllable adjustment of the mixing process of dental active agents, and the mixing reaction conditions can be adjusted as needed. This allows for targeted utilization of various effects produced after agent mixing, such as chemical reactions between different active agents. Specifically, it can be designed to trigger the following reaction: multiple active agents initially in a liquid state are mixed to generate gas, and the internal pressure of the system increases significantly. For example, according to one aspect of the invention, the active agents used are divided into two groups: the first group is bicarbonate, preferably potassium bicarbonate, sodium bicarbonate, or calcium bicarbonate, with sodium bicarbonate being particularly preferred; the second group is acid or carboxylic acid (e.g., malic acid, citric acid, lactic acid, etc.), and both groups of agents are preferably prepared as aqueous solutions of concentrations suitable for the application scenario. Two sets of reagents are simultaneously delivered to the mixing node, where they come into contact and react to generate bubbles (forming CO2). This gas-generating reaction can autonomously produce high pressure within the mixing node without the need for external equipment to actively apply pressure; the liquid reagent flows out of the mixing node under high pressure and ultimately forms a directional jet through the dispensing port of the nozzle body. This characteristic is particularly suitable for cleaning and rinsing operations, as the generation of high-pressure directional jets can significantly improve the cleaning and rinsing effect. According to one aspect of the invention, the discharge side of the mixing node is connected to the discharge port through a pressurized channel, which is integrated with the media flow channel inside the support substrate.

[0019] Within the scope of this invention, the design concept of this technical solution is as follows: To achieve the desired powerful cleaning and rinsing effect, a directional pressurized media jet is required. This structure adopts a minimalist self-driven design, requiring no external equipment intervention, and is specifically designed to trigger a reaction between two active agents in a localized area of ​​the nozzle body. This structure can not only directly utilize the active agents themselves to achieve therapeutic effects, but also utilize the reaction process between the agents and the various reaction products generated during the reaction process to achieve the preset therapeutic goals. Specifically, according to one aspect of the invention, by rationally designing the geometric shape of the chamber, the geometric dimensions of the media flow channel, and adding auxiliary components such as valves as needed, the internal pressure conditions and other parameters of the final media jet can be precisely controlled.

[0020] This design is compatible with targeted oral hygiene and care procedures, and can simultaneously complete the rinsing and care of periodontal pockets.

[0021] Preferably, the mixing node is shaped into a mixing cavity, with each medium flow channel extending into and communicating with the mixing cavity. The geometry and volume of the mixing cavity can be specifically adapted and adjusted according to the target reaction kinetics, mainly by selecting a suitable shape or volume; the volume of the mixing cavity is preferably no more than 1000 mm³, more preferably no more than 500 mm³, and most preferably no more than 100 mm³. Specifically, the internal volume of the active drug reservoir can be customized according to the dosage administered to the patient in a single infusion.

[0022] Preferably, the base material of the functional film is polyamide; other suitable film materials such as polyvinyl chloride (PVC), polypropylene (PP), and polyethylene (PE) can also be used, or multiple different film materials can be combined and used in combination. According to one aspect of the invention, the following design considerations must be taken into account when selecting film materials: the drug delivery nozzle can be used not only by professionally trained medical personnel in conjunction with dental clinical treatment, but also by ordinary people without professional training, and is especially suitable for patients to carry out home oral care. Specifically, when screening film materials, physical properties such as material rigidity and strength must be considered to ensure that the overall rigidity of the composite matrix after splicing multiple films is not too high, minimizing the risk of scratching the internal tissues of the oral cavity.

[0023] According to one aspect of the invention, a light guide or a light-guiding film can be integrated inside the nozzle body. This structure is an independent inventive point that can be established on its own, capable of identifying the tooth side or the soft tissue side. Specifically, a centrally located optical fiber guides white light into the film-covered area, i.e., the drug delivery area such as the periodontal pocket; the light is reflected in the drug delivery area, and the reflected light is then reversed and recovered via an optical fiber arranged on the outside. If the light irradiates the surface of the tooth or dental implant and is reflected, the red light component in the reflected light will be lower than the red light component when the light irradiates the soft tissue. By comparing the red light component in the reflected light, it can be determined which side of the nozzle body faces the tooth / dental implant and which side faces the soft tissue. Based on this identification result, the medium can be supplied to the medium flow channels arranged on both sides of the central film in a targeted manner to match the specific care needs corresponding to different tissues. Furthermore, the brightness of the reflected light can also be compared to distinguish between the tooth and the dental implant: the relatively brighter reflected light corresponds to the tooth, and the relatively lower bright reflected light corresponds to the dental implant.

[0024] Preferably, one or more drug delivery ports and the "dual nozzle" structure formed therefrom are arranged within the fluid outflow area of ​​the treatment end region of the nozzle body. The flow direction of the drug solution from a single drug delivery port can be designed so that the outflow direction is substantially parallel to the longitudinal direction of the nozzle body, or it can be designed to flow out at an angle. The fluid outflow area of ​​each medium channel can be designed as a straight shape, or it can be made into a bent or angled shape. Furthermore, the outline of the nozzle body from a top view is preferably triangular; to optimize usability, it can also be designed as an arc-shaped triangle.

[0025] In another aspect of the invention, which can be considered an independent inventive point, the drug delivery nozzle is specifically adapted for oral care applications, allowing users to easily operate the device and achieve stable rinsing of areas difficult to clean, such as periodontal pockets. This function has extremely high practical value. To achieve this rinsing effect, in addition to a media channel with an outlet connected to the drug delivery port and serving as a drug delivery medium channel, the device preferably has at least one additional media channel, which is configured as a suction channel. The drug delivery medium channel can accurately deliver the rinsing medium into the periodontal pockets; solid particles, food debris, and various oral contaminants washed away by the rinsing can be directionally removed through the suction channel. This channel structure has outstanding practical value in dental clinical treatment; according to one aspect of the invention, the suction channel can be connected to a dental saliva aspirator, a dental chair-mounted suction unit, a medical surgical suction device, or other various external suction systems.

[0026] In another aspect of the invention, which can be considered an independent inventive point, the drug delivery nozzle, in addition to various media flow channels, also integrates a pressurization channel internally. This pressurization channel is arranged inside the nozzle body and communicates with the mixing node. This pressurization channel can be connected to an external pressure source such as a pump, thereby enabling targeted pressure application to the mixing node to assist in establishing fluid pressure during the media delivery process. The pressurization medium can be air, water, or a mixture of both, and powder or solid particles can be mixed into the fluid as needed. The pressurization operation preferably employs a pulsed intermittent pressurization mode, which can output a stronger impact jet of media according to actual usage requirements.

[0027] In a preferred embodiment, the drug delivery nozzle of the structure described above is designed as a single-use product, usable only once. Examples of ways to achieve single-use include: after a single use, removing the treatment head from the rest of the treatment system and destroying it, or otherwise rendering it unusable.

[0028] A variant structure that can be considered an independent inventive point: the rest of the nozzle body is largely consistent with the previously described scheme, but this component is not used as a drug delivery nozzle, but rather as an intermediate adapter; the medium is not delivered into the patient's oral cavity through a drug delivery port located at the treatment end of the nozzle body, but is delivered via an independent external drug delivery component such as a tubing assembly and a treatment suction tip. In this variant structure, the independent drug delivery component can be adapted to the fluid outflow area of ​​the nozzle body; the pressurized therapeutic medium generated in the mixing node (especially the mixing chamber) can be delivered to the target drug delivery point inside the patient's oral cavity through the pressurized tubing inside the drug delivery component. Accordingly, an additional suitable medium flow channel can be added inside the drug delivery component to deliver the remaining medium guided by the nozzle body; this portion of the medium only comes into contact with each other and mixes at the drug delivery point in the patient's oral cavity.

[0029] For active pharmaceutical agent applicators, the present invention solves the problems existing in the prior art by equipping them with a drug delivery nozzle of any of the structures described above; two media channels (connecting the discharge port or the mixing chamber) are respectively connected to a dedicated active pharmaceutical agent storage chamber on the media delivery side.

[0030] This structure enables the intended use effect of the invention: dental active agents stored inside the active agent reservoir can be delivered independently and without interference. According to one embodiment of the invention, the two types of agents are delivered to the target location via the administration port and mixed only at that location; according to another alternative embodiment of the invention, the two types of agents are pre-mixed inside the mixing chamber before being dispensed. This active agent applicator can be manufactured in various structural forms: a nozzle-equipped cartridge for manual dispensing, a handheld device resembling an electric toothbrush, or a desktop device equipped with a flexible hose connecting the handheld component / oral end; the desktop device can integrate a lighting module as needed.

[0031] The active pharmaceutical agent applicator can configure the drug delivery nozzle as an independent, detachable component, which connects to the active pharmaceutical agent reservoir via an adapter. The active pharmaceutical agent reservoir has two assembly options: one is permanent installation; the other is as an independent component, pre-assembled with the drug delivery nozzle during the manufacturing stage, allowing the nozzle and the pre-assembled reservoir to be delivered to the user as a pre-assembled set. This structure provides users with pre-measured, quantitatively dispensed dental active pharmaceutical agents. In particular, standard and conventional packaging solutions can easily meet all hygiene control requirements, including disinfection and sterilization. The drug delivery nozzle can be designed as a replaceable, disposable component, requiring the user to assemble a brand-new, unused nozzle into the device before each use.

[0032] However, according to one aspect of the invention, the active pharmaceutical agent applicator can also adopt an integrated, one-piece molded structure, with the active pharmaceutical agent reservoir and the nozzle body integrated together within a common substrate. If necessary, a connecting tubing can also be integrated within this structure. In this integrated structure, the "drug delivery nozzle" is merely the end section of the common substrate facing the treatment end, not a physically separable independent component. A particularly prominent advantage of this structure is that the common substrate uses a support substrate of the type described above, with a coating or functional film fitted to its surface. By adapting the shape of the support substrate, the media flow channel, the active pharmaceutical agent reservoir, and various connecting components configured as needed can all be integrated integrally within the substrate; simultaneously, the internal spatial arrangement can be adjusted according to actual needs by utilizing the material properties of the film itself and its flexibility after molding. Specifically, the applicator can be made in the form of an ampoule; relying on the flexibility of each film itself and the active pharmaceutical agent reservoir formed by the films, patients can manually squeeze out the medication at home. This applicator can be used by patients for home care or by dentists for clinical use. Its overall appearance is similar to a toothbrush with a built-in ampoule reservoir.

[0033] In another aspect of the invention, which can be considered an independent inventive point, the drug delivery nozzle is capable of dispensing pre-measured or quantitatively dispensed dental active agents. To achieve this quantitative drug delivery function, according to one aspect of the invention, the internal volume of each active agent reservoir is specifically designed to match the preset dosage to be delivered to the patient in a single administration. The reservoir can pre-store a fixed dose of dental active agent, such as chlorhexidine for disinfection or oral rinsing solution. Patients can perform the drug delivery independently at home: on the one hand, the structural design of the drug delivery nozzle ensures precise positioning within the oral cavity; on the other hand, the pre-quantitatively stored drug reservoir within the nozzle body allows for precise control of the dosage. The user squeezes the composite molding matrix, utilizing the inherent flexibility of the material, to expel the drug stored in the active agent reservoir or to load the active agent into the reservoir; the drug flows through the corresponding medium channel and is output from the matching delivery port.

[0034] Preferably, a sealing or airtight plug is provided between the active pharmaceutical agent reservoir and the corresponding medium flow channel to prevent accidental leakage of the agent. The sealing plug adopts an adaptive structural design: when pressure is applied to the active pharmaceutical agent reservoir, or when the sealing plug is separated from the drug delivery nozzle, the seal will tear, break, or fail in other ways. Preferably, the film component is processed by a lamination or heat-sealing process, and a local area is thinned by an embossing process to form a stress-weak tear point; when the component is subjected to force, a separation or tearing area will form at this location, thereby opening the medium flow channel. Under the action of pressure or separation, the medium flow channel for delivering the corresponding agent is opened, and the dental active pharmaceutical agent can be delivered normally to complete the drug delivery.

[0035] The aforementioned quantitative dispensing structure can also optimize the overall storage and transportation process of active pharmaceutical agents, enabling patients to administer some dental active pharmaceutical agents and drugs at home.

[0036] An excellent embodiment, which can be considered an independent inventive point, involves filling an active pharmaceutical ingredient reservoir with bicarbonate as the active agent; the bicarbonate is preferably potassium bicarbonate, calcium bicarbonate, or sodium bicarbonate, with sodium bicarbonate being the most preferred. Using this pre-filled drug delivery nozzle, patients or users can monitor and assess the recovery effect of periodontal treatment and subsequent home care. When bicarbonate is delivered into the infected periodontal pocket through the nozzle, it reacts with the acidic environment created by the infection within the pocket, generating bubbles. This bubbling effect within the periodontal pocket serves as an indicator for the user: bubbles only appear when the pocket environment is acidic, indicating the presence of inflammation and infection. Thus, the bubbles provide simultaneous tactile and visual feedback to the user, visually demonstrating the presence of infection and reflecting the progress of treatment recovery. Furthermore, the bubbles generated within the periodontal pocket enhance the rinsing effect, aiding in postoperative care.

[0037] The following complete set of technical solutions is considered an independent inventive point: An active agent reservoir is filled with carbonate or bicarbonate as the active agent, and this reservoir is connected to the administration port via a medium flow channel; it also includes an active agent applicator prepared using this structure. This independent inventive point covers, but is not limited to, structural forms with only one medium flow channel and / or only a single active agent reservoir (especially referring to those without additional active agents), and is preferably implemented in conjunction with all the aforementioned technical solutions regarding the spatial and functional structures of the applicator components. According to one aspect of the invention that can be considered an independent inventive point, inflammation detection and diagnosis can also be completed by inserting components such as paper pipette tips, cotton swabs, and silicone collection devices into the periodontal pocket to collect lesion samples, and then placing the collected samples in a solution containing sodium bicarbonate or potassium bicarbonate. This allows for the simple configuration of inflammation detection indicators, suitable for patients to use at home.

[0038] According to the above aspects of the present invention, the device is provided with two or more active agent reservoirs, each of which is connected to at least one administration port via a matching medium flow channel. According to one aspect of the present invention, each reservoir can store different dental active agents; when these agents are combined or interact with each other, the desired therapeutic effect can be produced. After the user initiates the administration operation, multiple active agents are simultaneously output and mix at the administration point, thereby triggering a preset agent-to-agent reaction at that location. For example, two active agent reservoirs can be provided, one containing bicarbonate and the other containing acids / carboxylic acids (such as malic acid, citric acid, lactic acid, etc.); both types of agents are preferably prepared as aqueous solutions of appropriate concentrations for the operating conditions. The two types of agents are output simultaneously, come into contact with each other at the administration point, and react to generate bubbles. This foaming effect is particularly suitable for cleaning and rinsing operations.

[0039] One of the active agent reservoirs can be specifically filled with disodium hydrogen phosphate, sodium dihydrogen phosphate, and / or sodium monohydrogen phosphate as the active agent, and the aforementioned salts can also be in dihydrate form as needed. Optionally or additionally, according to one aspect of the invention, a softener (e.g., sodium docusate) and / or an antibacterial agent (e.g., eugenol, chlorhexidine, hydrogen peroxide) may also be added to the agent system.

[0040] The core benefits of this invention lie in its use of independently separated active pharmaceutical ingredient (API) reservoirs to store two or more APIs. Each API is transported to the same spatial area via independent media channels and mixed there, enabling targeted and localized utilization of the API's reaction kinetics and the products generated by the reaction (e.g., reaction bubbles). This is particularly beneficial for periodontal pocket areas that are difficult to reach with conventional instruments, allowing even ordinary users or patients without medical expertise to perform specialized maintenance or treatment procedures in these areas themselves. The drug delivery nozzle employs a support base structure sealed with an adhesive film component (preferably an injection-molded part). This structure allows for low-cost, large-scale mass production using relatively simple processing techniques, while also offering high flexibility in its spatial design. This structure is also adaptable to various maintenance scenarios, covering clinical treatment procedures performed by professional medical personnel, as well as preventative maintenance and daily care procedures that users and patients can perform themselves.

[0041] Furthermore, it's important to consider that home users lack access to sterile media, especially sterile gases; in contrast, dentists can typically use sterile air and water to rinse periodontal pockets. This solution mixes at least two small-volume sterile active agents, reacting directly at the site of action (i.e., inside the periodontal pocket) to generate a large-volume sterile gas, allowing ordinary home users to perform sterile rinsing of periodontal pockets. This feature is crucial for scenarios where patients rinse their periodontal pockets themselves. Moreover, the technical solution of this invention can directly generate sterile gas for rinsing at the site of action.

[0042] Infusing a bicarbonate solution into the periodontal pocket not only allows for the detection of inflammation within the pocket but also raises the pH level. Specifically, biofilms cause a decrease in pH within the periodontal pocket, which triggers an inflammatory response in the tooth structure and surrounding soft and hard tissues. Therefore, this approach improves the internal environment of the periodontal pocket, tooth structure, and / or periodontal soft and hard tissues, raising the local pH level and creating favorable conditions for tissue regeneration.

[0043] Water-soluble bicarbonates (such as potassium bicarbonate and / or sodium bicarbonate) react with acids (such as water-soluble malic acid, citric acid, and lactic acid) or hydrogen ions from acid ionization, releasing carbon dioxide (CO2) and water (H2O), while simultaneously generating sodium salts of the corresponding acid radicals; for example, sodium malate (Na2C4H4O5), sodium citrate (Na3C6H5O7), or sodium lactate (NaC3H5O3) are generated. For the reagent components selected in this solution, this chemical reaction only generates carbon dioxide bubbles with a rinsing effect, without producing any toxic or harmful substances. This characteristic is considered a significant advantage and constitutes an independent inventive point.

[0044] While ammonium bicarbonate could theoretically be considered as an alternative agent, it can itself be harmful to human health. Furthermore, when ammonium bicarbonate reacts with acids or carboxylic acids, it also produces substances harmful to human health. The reaction of ammonium bicarbonate with acids or carboxylic acids produces water (H2O), carbon dioxide (CO2) which has beneficial properties and is required by this invention, and also generates harmful and toxic ammonia gas (NH3).

[0045] Therefore, apart from potassium bicarbonate and sodium bicarbonate, the only practical alternative is calcium bicarbonate, which can only exist stably in aqueous solutions.

[0046] Because the gas generated by the reaction has extremely high sterility, this rinsing method can also be applied to other medical procedures on the human or animal body. Attached Figure Description

[0047] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings. The drawings are as follows: Figure 1 A longitudinal sectional view of a single tooth inside the patient's jawbone; Figure 2 This is a schematic diagram of a multi-component active pharmaceutical agent applicator. Figure 3 for Figure 2 A three-dimensional view of the drug delivery nozzle for the active pharmaceutical agent applicator shown. Figure 4 A three-dimensional view of an integrated active pharmaceutical agent applicator; Figure 5 for Figure 2 or Figure 4 The diagram shows a three-dimensional view of the drug delivery nozzle of the active pharmaceutical agent applicator, with the treatment end highlighted in the illustration. Figure 6 for Figure 4 Disassembled view of the drug delivery nozzle; Figure 7 for Figure 2 or Figure 4 The treatment end of one embodiment of the active pharmaceutical agent applicator; Figure 8 Side view of the drug delivery nozzle support base; Figure 9 is Figure 4 A multi-view stereoscopic view of the active pharmaceutical agent applicator shown; Figure 10 Top view of the drug delivery nozzle support base; Figure 11 for Figure 10 A three-dimensional view of the uniform thickness structure of the supporting substrate shown; Figure 12 for Figure 10 A three-dimensional view of the thickness-tapered structure of the supporting substrate shown. Figure 13 is Figure 4 A modified structure of the active pharmaceutical agent applicator shown is illustrated with a three-dimensional view of multiple cross-sections. Figure 14 is Figure 4 Another variant of the active pharmaceutical agent applicator shown is illustrated with a three-dimensional view of multiple cross-sections.

[0048] In all the attached drawings, the same parts are labeled using the same reference numerals. Detailed Implementation

[0049] Figure 1 A longitudinal sectional view schematically shows a tooth 1 inside the patient's jawbone 2. This tooth 1 is only an example to illustrate the working principle of the invention; in this embodiment, the tooth is in a state after periodontal treatment, and a relatively deep periodontal pocket 6 has formed around its neck 4. Bacteria and pathogens invade human tissues and induce periodontal disease, causing inflammation of the periodontal pocket 6. The inflammatory lesions are mainly distributed in the neck 4 area and the surrounding soft tissue 8. Therefore, after completing the clinical treatment for periodontitis, a postoperative care and follow-up nursing procedure is set up, and patients can carry out self-care at home, such as using this instrument for periodontal care daily. This nursing operation can accurately deliver dental active agents (such as medical disinfectants used to kill existing bacteria and pathogens, or oral rinsing solutions) into the patient's oral cavity, and specifically deliver them to the lesion area of ​​the periodontal pocket 6 and the surrounding soft tissue.

[0050] To perform this nursing procedure, the patient will be equipped with an active medication applicator 10; this applicator is used in... Figure 1 Arranged close to the periodontal pocket 6, Figure 2 A magnified side view shows that patients can independently perform various nursing procedures at home, precisely delivering the required active agents to the oral cavity. It should be noted that this article only uses the delivery of active agents to the periodontal pocket 6 as an example to illustrate the structure and working principle of the active agent applicators 10 and 10'; however, this device obviously has many other applicable scenarios, such as non-therapeutic oral care, oral cleaning, interdental cleaning, and targeted delivery of agents to localized inflamed areas of the oral cavity. All such applications are included within the scope of protection of this invention.

[0051] Figure 2 The active pharmaceutical agent applicator 10 in the illustrated embodiment is a portable, multi-component device. The device includes a handle 12 in the shape of a housing, with a drug delivery nozzle 16 mounted at the distal end 14 of the handle. The drug delivery nozzle serves as the treatment head / functional component for actual operation. For hygiene and safety considerations, the drug delivery nozzle is designed as a disposable product for single use only. The drug delivery nozzle 16 is connected via a connecting component (in this embodiment, a flexible tube segment 18 passing through a protective sleeve 17) to a drug supply container 19 located inside the handle 12. The drug supply container 19 is used to store various required active pharmaceutical agents. The flexible tube segment 18 and the protective sleeve 17 extend from the housing formed by the handle 12 through an outlet that can be closed using a flexible tube valve 11.

[0052] Furthermore, the handle 12 is also equipped with a drug delivery container drive mechanism for automatically dispensing active pharmaceutical ingredients, such as a mechanical / pneumatic / hydraulic pressurization system 23 that can extrude drugs. The handle also integrates a control unit 20 and a power supply unit 21, which can be powered by dry cell batteries or rechargeable batteries. The pressurization mechanism can adopt various mechanical structures, such as a pressurizing plunger that presses against the drug delivery container, or a dual-syringe, dual-cannulas, dual-cartridge matching structure. From the overall structural principle, the shape and structure of this active pharmaceutical ingredient applicator 10 are generally similar to an electric toothbrush, and the various electrical functional components of the electric toothbrush are also integrated inside the handle that forms the outer shell. In this embodiment, the drug delivery nozzle 16 is mounted on the fixing member 15. Optionally, the active pharmaceutical ingredient applicator 10 can also be designed as a fixed application system, for example, placed in a dental clinic; in this design, the handle can be disassembled into multiple sections, each supporting a mouthpiece for the drug delivery nozzle 16, which is then connected to a drug supply system 19 that stores the active pharmaceutical ingredient.

[0053] Figure 3The diagram shows an enlarged perspective view of the drug delivery nozzle 16. The inlet side of the illustrated structure has four sets of inlet ports 30, each connected to a media flow channel inside the nozzle body 22. Alternatively, the number of inlet ports 30 can obviously be other, such as a single set, two sets, or more. The drug delivery nozzle 16 can be assembled with the tubing assembly 18 via the aforementioned inlet ports 30.

[0054] Figure 4 This is a perspective view showing the integrated alternative structure of the active pharmaceutical ingredient applicator 10'. In this embodiment, the drug delivery nozzle 16 is an inseparable component of the active pharmaceutical ingredient applicator 10', and the two are integrally molded, forming a single unit. Considering that the active pharmaceutical ingredient applicator 10' is primarily used in oral care, drug therapy, and home-based self-administration scenarios, Figure 2 , Figure 3 , Figure 4 Both of the drug delivery nozzles 16 shown in the two embodiments employ a design that is extremely simple in structure yet fully functional; this structure enables large-scale mass production while keeping manufacturing costs at a low level. Therefore, the core functional component of the drug delivery nozzle 16 is the nozzle body 22, which contains multiple media channels 34 for conveying the dental active agent to be applied. Each media channel is connected to a corresponding drug delivery port 32 on the discharge side.

[0055] Combination Figure 3 , Figure 4 The three-dimensional view clearly shows that the nozzle body 22 extends longitudinally, from the connecting area 36 to the free treatment tip 38. Figure 4 In the integrated structure shown, the connection area 36 is located inside the applicator base; and Figure 3 In the multi-component variant structure shown, the connection area 36 is functionally equivalent to the connection side of the drug delivery nozzle 16. In this embodiment, the connection side is provided with a suitable assembly structure that can mechanically fix the nozzle body 22 to the handle 12, while the connection side is connected to the tubing segment 18; unlike this, Figure 4 The independent, integrated structure shown does not require such docking assembly structures.

[0056] During the design phase of the nozzle body 22, a key practical need was considered: the operating space inside the oral cavity is limited, but the user still needs to be able to accurately position the treatment tip 38 in order to precisely deliver dental active agents to the designated local area. To achieve this precise drug delivery effect, the shape of the nozzle body 22 was specifically designed, taking into account the characteristic that the periodontal pockets 6 are usually distributed in a narrow slit shape along the tooth surface.

[0057] According to one aspect of the invention, the nozzle body 22 of the drug delivery nozzle 16 is designed as a flat three-dimensional component, that is, a component that is approximately flat in shape. The drug delivery nozzle 16, or more precisely, the nozzle body 22 constituting the drug delivery nozzle, is generally extended along a reference plane; viewed from a cross-sectional perspective, its thickness perpendicular to the reference plane is significantly smaller than the lateral extension dimension of the component within the reference plane. In actual use, the user only needs to place the reference plane of the nozzle body 22 approximately parallel to the outer surface of the tooth 1 to easily insert the free treatment tip 38 of the nozzle body 22 into the periodontal pocket 6.

[0058] Furthermore, the cross-sectional dimensions of the main body 22 gradually narrow from the root towards the treatment tip 38. Therefore, the overall profile of the free treatment tip 38 of the nozzle body 22 is flat, narrow, and even tapered, greatly improving the smoothness of its insertion into the periodontal pocket 6. From Figure 3 , Figure 4 As can be seen from the three-dimensional view, the nozzle body 22 of this embodiment has a triangular top view outline.

[0059] To achieve precise delivery of dental active agents into the periodontal pocket 6, the nozzle body 22 has delivery ports 32 for various active agents located in the fluid outflow area 40 of the treatment tip 38 region. Each delivery port is connected to a media flow channel 34. This structure allows for precise delivery of the corresponding dental active agent from the treatment tip 38 region of the delivery nozzle 16, and, if necessary, direct delivery of the agent into the target periodontal pocket 6. Figure 3 , Figure 4 As shown in the three-dimensional view, the flow direction of the medication from multiple administration ports 32 is oriented transversely to the longitudinal axis of the nozzle body. This structure allows the dental active agent to fully permeate the periphery of the treatment tip 38 of the nozzle body 22 and the entire internal space of the periodontal pocket 6.

[0060] Regarding the arrangement of the medium flow channel 34 inside the nozzle body 22, this invention proposes two core preferred design ideas, each of which constitutes an independent inventive point.

[0061] The first design approach: According to one aspect of the present invention, by adapting the drug delivery nozzle 16 to a specific structure, Figure 2 , Figure 4Both active pharmaceutical agent applicators 10 and 10' shown employ the following operating mode: two or more dental active pharmaceutical agents are delivered independently without mixing during delivery until they reach the administration point; at this point, the agents mix and react, and both the agents themselves and the reaction products generated by the two reactions can exert their effects at the administration point. To achieve the above operating mode, at least two media flow channels 34 are integrated inside the nozzle body 22; each channel is independently arranged, extending from the connecting area 36 to the free treatment end 38, and the discharge end of each channel is connected to an administration port 32. In the embodiment shown in the attached figure, the administration ports 32 of the two media flow channels 34 are spaced approximately 1 mm apart, ensuring that the output positions of the various active pharmaceutical agents are sufficiently close to achieve the required local mixing effect.

[0062] The second design approach that can be considered an independent inventive point is as follows: According to one aspect of the present invention, by adapting the drug delivery nozzle 16 to a specific structure, Figure 2 , Figure 4 The two active pharmaceutical agent applicators 10 and 10' shown operate in the following mode: two or more dental active pharmaceutical agents are independently delivered to the nozzle body 22 and converge and react at the mixing node 42. An additional media flow channel 34 extends from the mixing node 42 to the free treatment end 38, through which the mixed agent is delivered to the administration point for outward output. To achieve the above operating mode, at least two media flow channels 34 are integrated inside the nozzle body 22. The two channels are independent of each other and extend from the connection area 36 to the mixing node 42. At the same time, an additional media flow channel 34 is added, which extends toward the free treatment end 38, and its outlet end is connected to an administration port 32. In addition, more media flow channels 34 can be added, such as channels that extend directly from the connection area 36 to the free treatment end 38. With such additional channels, additional agents can be directly delivered to the free treatment end 38 through the nozzle body 22 according to the first design concept mentioned above. In the embodiment shown in the attached figure, the drug delivery ports 32 corresponding to the above-mentioned media channels 34 are spaced about 1 mm apart, and the output positions of various active agents are close enough to achieve the expected local mixing reaction.

[0063] Both design approaches share a common structural feature: all media channels 34 extending from the connection area 36 have their inlet ends individually connected to a dedicated active pharmaceutical agent reservoir 44 on the media delivery side (e.g., through a corresponding access port 30). According to one aspect of the invention, the internal volume of each active pharmaceutical agent reservoir 44 is specifically designed to match the dosage for a single patient administration, eliminating the need for the user to manually adjust the dosage.

[0064] Figure 2In the active pharmaceutical agent applicator 10 shown, the active pharmaceutical agent reservoir 44 is integrated inside the drug supply container; the medium flow channels 34 corresponding to each active pharmaceutical agent reservoir 44 are arranged along the entire length of the hose section 18, extending to the connection area 36. After pressure is applied to the active pharmaceutical agent reservoir 44 of this structure, the active pharmaceutical agent in the reservoir will flow sequentially through the medium flow channel 34, the drug delivery nozzle 16, and be delivered to the fluid outflow area 40, and finally be output through each drug delivery port 32. In contrast, Figure 4 The active agent reservoir 44 of the active agent applicator 10' shown is integrated inside a common base 46, which includes a nozzle body 22.

[0065] In the embodiments shown in the accompanying drawings, according to an aspect of the invention that can be considered an independent inventive point, the device is equipped with two sets of active agent reservoirs 44, each containing different dental active agents that can be combined to produce the target therapeutic effect. The desired effect is achieved by mixing or chemically reacting the various agents. For example, two sets of active agent reservoirs 44 can be provided: one set stores carbonates, preferably bicarbonates, and the other set stores acids (e.g., citric acid). The two types of agents are delivered synchronously, coming into contact with each other at the mixing node 42 and undergoing a chemical reaction to generate gas and bubbles. This allows for the directional generation of high-pressure gas at the mixing node 42, which is then transported to the treatment end 38 via the media flow channel 34 downstream of the mixing node 42 and discharged outwards. This effect is particularly suitable for cleaning and rinsing operations, as the high-pressure released gas provides excellent cleaning results.

[0066] Optionally or additionally, after the active pharmaceutical agent reservoir 44 is filled with the agent, it will be sealed and isolated from the adjacent medium flow channel 34 by a sealing or airtight plug. A fixed dose of active pharmaceutical agent, such as chlorhexidine for disinfection or oral rinsing solution, can be pre-stored in the reservoir. Patients can perform the drug administration at home: on the one hand, the structural design of the drug delivery nozzle 16 can ensure its precise positioning in the oral cavity; on the other hand, the pre-stored drug structure in the nozzle body can precisely control the dosage of the active pharmaceutical agent.

[0067] Furthermore, according to one aspect of the invention, in addition to a dispensing end having a drug delivery port 32 and a medium flow channel 34 serving as a drug delivery medium flow channel, at least one medium flow channel 34 inside the nozzle body 22 can be configured as a suction channel. This structural design is particularly suitable for... Figure 3 The embodiment shown is equipped with four feed inlet ports 30, corresponding to four media flow channels that penetrate the nozzle body 22.

[0068] To achieve the structural design requirements of low cost and adaptability to mass production, according to one aspect of the present invention, combined with Figure 5The three-dimensional view of the treatment tip 38 illustrates the core design concept of this invention. Both the drug delivery nozzle 16 and its matching nozzle body 22 are made of thin film material. This type of thin film raw material is readily available and can be modified using various mature processing techniques, including embossing, die-cutting, selective coating with functional materials, spatial shape adjustment through folding, and other processing methods suitable for large-scale mass production. However, the treatment tip 38 area of ​​the nozzle body 22 still needs to possess a certain degree of dimensional stability to ensure safe and stable treatment operations. Based on the overall design concept of this invention, the drug delivery nozzle 16 is made of a functional thin film, and through a suitable rigid reinforcement substrate, the functional film achieves structural stability in the treatment tip 38 area; this aspect is an independent inventive point under this disclosure.

[0069] Figure 6 The figure shows a disassembled view of a modified structure of the active pharmaceutical agent applicator 10', illustrating an embodiment that can be considered an independent inventive point: the drug delivery nozzles 16, 16' and their nozzle bodies 22 are composed of two types of basic components. The first type is a support substrate 50, which serves to rigidly reinforce the substrate, provide shaping, and maintain dimensional stability; the second type is multiple functional films 52, which are connected to the support substrate 50 using a material bonding process, preferably adhesive bonding or ultrasonic / laser welding. According to one aspect of the invention, each medium flow channel 34 penetrates the support substrate 50, and at least one sidewall of each medium flow channel 34 is formed from a functional film 52 that is materially bonded to the support substrate 50.

[0070] According to one aspect of the present invention, the support substrate 50, as a rigid reinforcing substrate, is made of a suitable material with stable dimensions, sufficient rigidity, and reliable mechanical properties, and the support substrate 50 is designed as an injection molded part. Preferably, the materials suitable for injection molding of the support substrate 50 include thermoplastics, thermosetting plastics, elastomers, especially polyamide 6 (PA6), polyamide 66 (PA66), polybutylene terephthalate (PBT), polyethersulfone (PES), polyoxymethylene (POM), and polysulfone (PSU). Using injection molding to process the support substrate 50 has significant advantages and constitutes an independent inventive point: even with the relatively complex overall shape and surface structure of the support substrate 50 due to the requirements of the media flow channel 34 layout, the injection molding process can still achieve mass production at low cost. According to one aspect of the invention that can be considered as an independent inventive point, the processing flow can be further simplified: a rigid, preferably injection-molded, support substrate 50 is fitted with a functional film 52; only shallow grooves are opened on the surface of the injection-molded support substrate to reserve the basic outline of the medium flow channel 34, and a completely closed channel can only be formed after the functional film 52 is attached, with the film itself constituting one side wall of the channel.

[0071] Based on the design concept of this invention, various embodiments can be derived from the support substrate 50 and the functional film 52 in terms of assembly quantity, arrangement position, and docking method. All schemes must meet the core condition: the complete medium flow channel 34 can be formed and sealed simply by attaching the functional film 52 to the surface of the support substrate 50. Specifically, the functional film 52 can also adopt multi-layer film stacking, multi-film splicing, or other similar film composite structures. In the embodiment of the active agent applicator 10' shown in the figure, the flexibility of the functional film 52 is very prominent: in the nozzle body 22 area, the functional film 52, which is joined with the support substrate 50, serves as a sealing surface layer, sealing the medium flow channel 34 arranged below it. In the area where the active agent storage cavity 44 is located, the corresponding functional film 52 is processed into an arched protrusion shape, forming the sidewall of the active agent storage cavity.

[0072] One aspect of the present invention is a composite structure combining an injection-molded part and a functional film 52 material, wherein the injection-molded part is the supporting substrate 50 in this embodiment. The accompanying drawings are only schematic diagrams of one structure; the outer component of the molded active pharmaceutical agent reservoir 44 can also be designed as an injection-molded part, with the inner film serving as the functional film bonded and fixed to it. The component of the molded active pharmaceutical agent reservoir 44 is used to contain liquid dental active pharmaceutical agents and provide storage space; according to one aspect of the present invention, this component can be formed using a deep-drawing process.

[0073] Polyamide is the preferred substrate material for functional film 52; other suitable film materials such as polypropylene (PP) and polyethylene (PE) can also be used, or multiple films can be combined and used in combination, which also have good application effects.

[0074] Depend on Figure 6 As can be seen, according to one aspect of the present invention, the support base 50 is an integral component. A pre-formed medium groove 54 is provided on the support base 50 to form a medium flow channel 34; in the embodiment shown in the drawings, medium flow channels 54 are provided on both the upper and lower surfaces of the support base. After the functional film 52 is assembled and the material bonding is completed, the film completely covers the medium flow channel 54, forming a sealed medium flow channel.

[0075] In the embodiment shown in the attached drawings, the support base 50 also serves as a rigid reinforcement base; in the treatment tip 38 region, the width of the support base transverse to the longitudinal direction of the nozzle body 22 is approximately 0.9 mm. The support base 50 is a flat central support base 56, with at least one pre-formed medium flow channel 54 on both its lower bottom surface 58 and upper surface 60.

[0076] Each media channel 54 is adapted and connected to the active agent storage cavity 44 on the feed side. Based on the overall structure and channel layout requirements, the media channel 54 can be branched within the supporting base 50, allowing multiple branches to branch off at the discharge end, each connecting to multiple drug delivery ports 32 located within the fluid outflow area 40 of the treatment end 38. The drug discharge direction of some drug delivery ports 32 is laterally oriented relative to the longitudinal direction of the nozzle body. This arrangement allows for more even and thorough distribution of the dental active agent into the periodontal pocket 6 during drug delivery. Therefore, the drug delivery nozzles 16 and 16', with their targeted structural design, can accurately and comprehensively deliver the dental active agent into the periodontal pocket 6, maximizing complete saturation of the periodontal pocket and achieving efficient rinsing and drug delivery.

[0077] The drug delivery nozzle 16 or its nozzle body 22 is composed of a rigid, dimensionally stable support substrate 50 and a functional thin film 52 bonded or laminated together to form a composite substrate. Based on this structure, the drug delivery nozzle 16 can be mass-produced at low cost using only simple processing techniques, while the spatial design of the component offers a high degree of freedom. Under this design system, only the corresponding medium flow channel 54 needs to be created during the injection molding stage; even channels with complex shapes can be smoothly processed. According to one aspect of the invention, this basic structure has significant advantages: the medium flow channel 34 can be easily integrated into the support substrate 50 using conventional injection molding processes, and the channel orientation and geometric shape have a great deal of room for adjustment. Highly flexible customization of the medium flow channel 34 inside the nozzle body 22 in terms of both shape and functional layout can be achieved using only simple processing methods.

[0078] According to one aspect of the present invention, the support base 50 can be designed as a structure with a substantially uniform overall thickness. Figure 7 The treatment tip 38 in this embodiment is an example of this configuration. In this structure, the media flow channel 54 inside the support base 50 can extend all the way to the treatment tip 38 and terminate at each administration port 32. The spacing between the administration ports 32 is determined by the thickness of the support base 50, thus allowing for precise setting in a very simple and reliable manner; in this exemplary embodiment, the administration port spacing is set to approximately 0.9 mm.

[0079] Alternatively, according to one aspect that can be considered as an independent point of invention, the width and thickness of the support base 50 together with the nozzle body 22 as a whole gradually narrow towards the treatment tip 38. Figure 8 The side view of the support base 50 provides a clear illustration of this aspect. Figure 9 also shows the three views of the active pharmaceutical agent applicator 10': top view ( Figure 9a ), side view ( Figure 9b ) and stereoscopic views ( Figure 9c ).

[0080] Based on the established structural design and processing technology of the drug delivery nozzle 16 (specifically including laser cutting, stamping, or directly processing the outline of the medium flow channel 34 in the injection molding process), the shape and layout of the internal cavity, empty chamber, and medium flow cavity of the support substrate 50 can have a very high degree of design freedom. When the operator presses the combined substrate formed by the combination of the support substrate 50 and the functional film 52, the active agent stored in the corresponding active agent storage cavity 44 can be squeezed outward by taking advantage of the deformation characteristics of the functional film 52 material itself; the agent will flow through the corresponding medium flow channel 34 in sequence and finally be discharged from the matching drug delivery port 32.

[0081] The following will describe in detail several aspects of this invention that can be considered as independent inventive points. These aspects mainly revolve around the channel arrangement inside the support base 50 and other supporting structural components; therefore, the following will be discussed in conjunction with the integrated active pharmaceutical agent applicator 10' ( Figure 4 The following description is based on a top view of the support base 50 corresponding to the illustrated embodiment; of course, these aspects also apply to... Figure 3 Another variant of the drug delivery nozzle 16 is shown.

[0082] Combining the first design approach mentioned above, from Figure 10 As can be clearly seen in the top view of the support substrate 50 according to one aspect of the present invention, two medium flow channel grooves 54 are formed on the upper side (and correspondingly on the lower side) of the support substrate 50. Each medium flow channel groove 54 is used to construct a medium flow channel 34, and each medium flow channel groove is connected to an active agent storage cavity 44 at the feed end. Furthermore, a mixing node 42 is also provided inside the support substrate 50, which is formed in the form of a mixing cavity 62 embedded inside the support substrate 50. According to one aspect of the present invention, the mixing cavity 62 differs from the medium flow channel grooves 54 and extends through the entire support substrate 50; the two types of active agents, independently fed in through the upper and lower medium grooves 54, converge into the mixing cavity to complete the collection and mixing. The discharge end of the mixing cavity 62 is connected to the drug delivery port 32 through a medium flow channel 34.

[0083] For example, according to one aspect of the invention, the active agents used are divided into two groups: the first group is bicarbonate, preferably potassium bicarbonate, sodium bicarbonate, or calcium bicarbonate, with sodium bicarbonate being particularly preferred; the second group is acid or carboxylic acid (e.g., malic acid, citric acid, lactic acid, etc.), and both groups of agents are preferably prepared as aqueous solutions with concentrations suitable for the application scenario. According to the first design concept, the two types of agents are separately delivered to the lesion area to be treated; according to the second design concept, the two types of agents are delivered together to the mixing node 42, where they come into contact and react chemically to generate carbon dioxide bubbles. This gas-generating reaction does not require external active pressure to generate high pressure inside the mixing node 42, causing the mixed agents to leave the mixing node under high pressure and be sprayed through the administration port 32 downstream of the nozzle body 22 to form a directional jet. This characteristic is particularly suitable for cleaning and rinsing operations, and the generation of high-pressure directional jets can significantly improve the cleaning and rinsing effect.

[0084] Figure 11 This is a three-dimensional view showing the support base 50 structure, which maintains a constant overall thickness and extends all the way to the treatment tip 38. In contrast, Figure 12 A three-dimensional view is used to show the sword-shaped support base 50, the thickness of which gradually decreases towards the treatment tip 38.

[0085] Next, we will focus on Figure 4 The active pharmaceutical agent reservoir 44 structure design of the active pharmaceutical agent applicator 10' shown will be described in more detail from several aspects that can be considered as independent inventive points. The following will select from... Figure 4 The partial sectional view and half-sectional perspective view are shown from the same angle, and the channel layout inside the support base 50 will not be repeated; however, all the descriptions of the channel layout above can be fully applied to the following embodiments.

[0086] Figure 13 shows the active agent applicator 10' through a perspective view and several partial sectional views. The device has two active agent storage chambers 44, which are respectively arranged on both sides of the central support substrate 50 and separated from it. This arrangement allows for convenient storage of different types of active agents in the two active agent storage chambers 44. Furthermore, as clearly seen in Figure 17a, a mixing chamber 62 can be formed in this area by specifically shaping the upper functional film 52. Using the film shaping structure shown in the figure (a design with independent creativity), the volume of the mixing chamber 62 can be adapted and adjusted according to actual usage requirements, expected gas production effect, and corresponding pressurization conditions; in this example embodiment, the designed volume of the mixing chamber 62 is approximately 100 mm³.

[0087] The other variant shown in Figure 14 is identical in overall structure except for the differences described below. This active pharmaceutical agent applicator 10' is equipped with two active pharmaceutical agent reservoirs 44 with different internal volumes. Based on this design, the agent loading amount can be selected and adjusted according to the required reaction ratio, storing the corresponding dose of active pharmaceutical agent in each of the active pharmaceutical agent reservoirs 44. The mixing chamber 62 in this variant structure is also formed by shaping the upper functional film 52 accordingly, thereby setting an appropriate volume to meet the usage requirements.

[0088] Explanation of reference numerals in the attached figures 1 tooth 2 jawbone 4. Neck of teeth 6 periodontal pockets 8 Soft tissue 10, 10', 10” active pharmaceutical agent applicator 11 Hose Valve 12-handle 14 end 15 fasteners 16, 16' Dosing nozzle 17 Protective sleeve 18 hose segments 19 Medicine supply containers 20 control units 21 power supply units 22 Nozzle Body 23 Mechanical, pneumatic or hydraulic pressurization systems 30 access ports 32 drug delivery ports 34 Medium Flow Channels 36 connecting side 38 treatment tips 40 Fluid outflow zone 42 hybrid nodes 44 Active drug reservoir 46 Common Matrix 50 Supporting substrate 52 functional thin films 54 Medium Flow Channel Groove 56-center matrix 58 bottom 60 Upper surface area 62 mixing chambers

Claims

1. A delivery nozzle (16, 16') for delivering a dental active agent into a patient's oral cavity, comprising a nozzle body (22); the nozzle body extends along its length from a connecting region (36) toward a free treatment end (38), at least two media channels (34) are integrated inside the nozzle body, the at least two media channels (34) extending independently from the connecting region (36) toward the free treatment end (38); the media channels (34) pass through a support base (50) of the nozzle body (22), and at least one sidewall of each media channel (34) is formed of a functional film (52) bonded to the material of the support base (50).

2. The drug delivery nozzle (16, 16') according to claim 1, characterized in that: The support base (50) is designed as a rigid reinforced base, and in the region where the treatment tip (38) is located, the width of the support base transverse to the length direction of the nozzle body (22) is not less than 0.8 mm.

3. The drug delivery nozzle (16, 16') according to claim 1 or 2, characterized in that: The supporting substrate (50) is an injection molded part.

4. The drug delivery nozzle (16, 16') according to any one of claims 1 to 3, characterized in that: The support matrix (50) is made of thermoplastic, thermosetting or elastomer, especially polyamide 6 (PA6), polyamide 66 (PA66), polybutylene terephthalate (PBT), polyethersulfone (PES), polyoxymethylene (POM) or polysulfone (PSU).

5. The drug delivery nozzle (16, 16') according to any one of claims 1 to 4, characterized in that: The support substrate (50) or each of the support substrates (50) is an integral component, and a medium flow channel groove (54) is formed in the corresponding support substrate to form the corresponding medium flow channel (34). The medium flow channel groove is covered by the functional film (52) bonded to the support substrate (50) by material.

6. The drug delivery nozzle (16, 16') according to any one of claims 1 to 5, characterized in that: Each of the aforementioned media channels (34) is connected to a corresponding drug delivery port (32) on the discharge side.

7. The drug delivery nozzle (16, 16') according to any one of claims 1 to 6, characterized in that: The distance between the administration ports (32) corresponding to each of the two media channels (34) is at least 0.01 mm and at most 10 mm, preferably at least 0.1 mm and / or at most 2 mm.

8. The drug delivery nozzle (16, 16') according to any one of claims 1 to 7, characterized in that: The administration port (32) is located on the nozzle body within the fluid outflow area (40) of the treatment end (38).

9. The drug delivery nozzle (16, 16') according to any one of claims 1 to 8, characterized in that: At least two media channels (34) extend independently from the connection area (36) to a mixing node (42) that connects the at least two media channels on the media side; the mixing node (42) is connected to a drug delivery port (32) on the discharge side via another media channel (34), the drug delivery port (32) being located in the fluid outflow area (40) near the treatment end (38).

10. The drug delivery nozzle (16, 16') according to claim 9, characterized in that: The mixing node (42) is configured as a mixing cavity (62), and the medium flow channel (34) extends into the mixing cavity (62) and communicates with the mixing cavity.

11. The drug delivery nozzle (16, 16') according to claim 10, characterized in that: The volume of the mixing chamber (62) is no greater than 1000 mm³, preferably no greater than 500 mm³, and most preferably no greater than 100 mm³.

12. The drug delivery nozzle (16, 16') according to any one of claims 9 to 11, characterized in that: In addition to the medium flow channel (34), the nozzle body (22) is also provided with a pressurization channel, which is also integrated inside the nozzle body (22) and connected to the mixing node (42).

13. The drug delivery nozzle (20, 20', 20) according to any one of claims 1 to 12, characterized in that: The support base (50) is a flat central base (56) arranged along the center. The bottom surface (58) and / or the upper surface area (60) of the central base are each formed with at least one molded medium groove (54).

14. The drug delivery nozzle (16, 16') according to any one of claims 1 to 13, characterized in that: The nozzle body (22) is designed as a planar object extending longitudinally from the connection area (36) toward the free treatment end (38), and the width and thickness of the nozzle body gradually narrow toward the treatment end (38).

15. The drug delivery nozzle (16, 16') according to any one of claims 1 to 14, characterized in that: In addition to the medium flow channel (34), the nozzle body (22) also integrates a suction channel.

16. The drug delivery nozzle (16, 16') according to any one of claims 1 to 15, characterized in that: The drug delivery nozzle is a single-use product.

17. An active pharmaceutical agent applicator (10, 10') for infusing a dental active pharmaceutical agent into the oral cavity of a patient, characterized in that: The active pharmaceutical agent applicator includes a drug delivery nozzle (16, 16') as described in any one of claims 1 to 16; each of the media channels (34) is connected on the media side to its respective corresponding active pharmaceutical agent reservoir (44).

18. The active pharmaceutical agent applicator (10, 10') according to claim 17, characterized in that: The active pharmaceutical agent reservoir (44) is integrated in a common substrate (46) containing the nozzle body (22).

19. The active pharmaceutical agent applicator (10, 10') according to claim 17 or 18, characterized in that: The internal volume of each of the active pharmaceutical reservoirs (44) is adapted to the dosage of the pharmaceutical agent to be administered to the patient.

20. The active pharmaceutical agent applicator (10, 10') according to any one of claims 17 to 19, characterized in that: One of the active pharmaceutical reservoirs (44) is filled with bicarbonate.

21. The active pharmaceutical agent applicator (10, 10') according to any one of claims 17 to 19, preferably according to claim 20, is characterized in that: One of the active pharmaceutical reservoirs (44) is filled with an acid, particularly malic acid, citric acid or lactic acid.

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