Oral care device for cancer chemotherapy

Abstract

To provide an oral care device that is easy to operate, has gentle cleaning action, allows control of drug delivery, and is suitable for the fragile oral mucosa of chemotherapy patients. [Solution] An oral care device for tumor chemotherapy includes a gripping part (1), a flexible cleaning body (2), a medicinal solution storage and release structure, and a fluid guide channel (8). The flexible cleaning body is connected to the front end of the gripping part, and its surface is provided with blunted micropillars (3), forming point contacts that reduce shear stress on the fragile mucosa. The medicinal solution storage and release structure is built into the gripping part and consists of a pouch (4), a one-way valve group (5), and a sliding pressure plate (6), and includes a pressure adjustment component driven by a push rod connected to the sliding pressure plate, realizing manual controllable medicinal solution release. The fluid guide channel guides the medicinal solution from the storage and release structure to a cavity inside the flexible cleaning body, and further branches into multiple branches to ensure the medicinal solution is evenly covered over the target mucosal area.

Description

[Technical Field]

[0001] The present invention belongs to the field of medical equipment technology, and particularly relates to an oral care device for tumor chemotherapy. [Background technology]

[0002] Cancer chemotherapy often causes complications such as oral mucositis, pain, and secondary infections, significantly affecting patients' quality of life. For this special population, oral care must simultaneously meet multiple requirements: gentle cleansing, mucosal protection, drug delivery, and ease of use. Currently, most commercially available oral care products are designed for the general population and are inadequately adapted to address chemotherapy-induced oral mucosal fragility, reduced tolerance, and bacterial flora imbalance. The structural design of existing oral care devices lacks consideration for the sensitive oral environment of chemotherapy patients. Their cleaning methods and drug release mechanisms struggle to simultaneously meet the requirements for both mildness and effective care. This limits their ability to coordinate the control of mucosal damage risk and the optimization of local therapeutic effects. Summary of the Invention [Problem to be solved by the invention]

[0003] This device provides a type of oral care device for cancer chemotherapy. Addressing the special physiological conditions of the oral mucosa after chemotherapy, such as fragility, reduced resistance, and susceptibility to inflammation and infection, the device's physical structure design allows for gentle and controllable cleaning action, fixed-point sustained drug release, and an operating process that does not require complex coordinated actions, thereby completing effective local treatment while reducing the risk of mechanical irritation. [Means for solving the problem]

[0004] To achieve the above objectives, the present invention adopts the following technical solutions:

[0005] A type of oral care device for tumor chemotherapy includes a gripping portion, a flexible cleaning body, a drug solution storage and release structure, and a fluid guide channel, wherein:

[0006] The flexible cleaning body is fixedly connected to the front end of the handle, and its outer contour fits the oral vestibule and buccal mucosa. Its surface is provided with a number of protruding micropillars, the height of which does not exceed 3 mm, the top ends of which are hemispherically blunted, and the spacing between adjacent micropillars is 2 mm or more, so that when it comes into contact with the mucosa, it forms a point-like distributed pressure rather than a continuous friction surface; a through cavity is provided inside the flexible cleaning body, which is connected to the fluid guide channel and is used to receive and guide the medicinal solution to the contact area.

[0007] The medicinal liquid storage and release structure is built into the gripping part and consists of a pouch, a one-way valve group, and a pressure adjustment component; the pouch is molded using medical silicone material and has a volume of 5 mL to 8 mL. Its outer wall is in close contact with the inner wall of the gripping part, and the open end of the pouch is connected to the input port of the one-way valve group; the one-way valve group includes two independent valve bodies, the first valve body controls the injection of medicinal liquid into the pouch from the outside, and the second valve body controls the output of medicinal liquid from the pouch to the fluid guide channel. Both valve bodies adopt an umbrella valve structure and only allow one-way flow of liquid. The umbrella valve is made of silicone and its operating pressure is designed to be 0.5 kPa to 1.5 kPa, ensuring reliable operation and anti-backflow when manually compressed; the pressure-regulating component is a sliding pressure plate, which is installed on the side of the pouch away from the outer shell of the handle. The outer side of the pressure plate is connected to a push rod, which penetrates the side wall of the handle and extends to the outside. A finger pressure platform is provided at the end of the push rod, so that the user can apply force with their thumb to press the pressure plate and deform the pouch to push out the medicinal solution.

[0008] The fluid guide channel starts from the output end of the medicinal liquid storage and release structure, extends forward along the axis of the gripper, and branches into three branches after entering the inner cavity of the flexible cleaning body. The terminal openings of each branch are located between the bases of the micropillars in different regions, with an opening diameter of 0.5 mm and facing the center of the micropillar gaps, ensuring that the medicinal liquid directly covers the target mucosa after ejection without impacting the tops of the micropillars.

[0009] Optionally, the outer surface of the gripping portion is covered with a non-slip textured layer, the texture being 0.3 mm deep and distributed in a circular ripple pattern to enhance the stability of the gripping portion; the gripping portion is 12 cm long and 1.5 cm in diameter, which is an ergonomic size suitable for one-handed gripping by an adult.

[0010] Optionally, the flexible cleaning body and the handle adopt a kernel-type detachable connection, with an annular flange at the bottom of the cleaning body and a corresponding groove at the front end of the handle, which can be locked by inserting the flange into the groove and rotating it 30 degrees, facilitating replacement and disinfection; a sealing gasket is provided at the connection to prevent chemical solution from leaking from the connecting surface. The connection between the fluid guide channel and the internal cavity of the flexible cleaning body adopts a quick-connect interface with an O-ring seal, which allows the chemical solution line to be separated when the cleaning body is removed while maintaining its own seal, eliminating the need for adhesive fixation.

[0011] Optionally, an observation window is provided on the outside of the pouch, made of transparent polycarbonate material and embedded in the outer shell of the handle, allowing the user to visually check the amount of medicinal liquid remaining in the pouch; volume scale lines are engraved on the inside of the observation window, with the minimum scale value being 0.5 mL. Optionally, the push rod in the pressure adjusting component is provided with a stroke limiting structure, with two parallel guide ribs machined on the outer wall of the push rod and a guide groove drilled at the position corresponding to the grip portion, the guide ribs sliding within the guide groove and restricting the push rod to only moving in the axial direction; the maximum stroke of the push rod is 10 mm, which, combined with the deformation characteristics of the capsule bag (silicone hardness Shore 30A to 40A), ensures that the capsule bag compression rate at the maximum stroke is approximately 40%, ensuring that the amount of medicinal liquid output with each compression is stable within the range of 0.2 mL to 0.3 mL.

[0012] Optionally, among the three branches of the fluid guide channel, the outlet of the middle branch is located in the central region of the cleaning body, and the outlets of the two side branches are symmetrically distributed at positions 5 mm away from the edges, with the spacing between each outlet being 8 mm or more, to avoid local excessive concentration due to concentrated spraying of the chemical solution.

[0013] Optionally, the back of the flexible cleaning device is provided with a negative pressure suction area. This area has a circular recessed structure and a built-in porous sponge layer. The sponge layer is 2 mm thick and has a porosity of 70%. It is connected to an external micro-negative pressure pump via an independent capillary tube. This gently suctions loose tissue particles during the cleaning process, preventing them from remaining in the oral cavity and causing secondary infection. As a preferred, simplified solution, the end of the independent capillary tube can be configured with a standardized interface with a one-way valve, facilitating connection to a standard ward-specific negative pressure system or a portable negative pressure suction device. After positioning the cleaning device, the user can activate the negative pressure with the assistance of another person or with their own hand, simplifying synchronized operation.

[0014] Optionally, a medicinal liquid injection port is provided at the rear end of the gripping portion, the injection port is sealed with a rotating cap, and a silicone seal packing is provided inside the rotating cap, and the injection port communicates with the first valve body of the one-way valve group, so that the user can puncture the rotating cap with a syringe to refill the medicinal liquid into the pouch, without removing any parts.

[0015] Optionally, the flexible cleaning outer surface is coated with an antibacterial coating, the coating component being a nano-silver composite with a thickness of 5 μm, and according to the ISO 22196 standard, a 24-hour contact antibacterial rate against common oral pathogens (Staphylococcus aureus, Escherichia coli, Candida albicans, etc.) is 95% or more, and the cytotoxicity test results show no cytotoxicity.

[0016] Optionally, a partition plate is provided inside the gripper to separate the liquid medicine storage and release structure from the negative pressure suction line and prevent the liquid medicine from contaminating the negative pressure system; the partition plate is made of ABS engineering plastic and is fixed to the inner wall of the gripper by ultrasonic welding. [Effects of the Invention]

[0017] This device uses a micropillar array design with a specific array configuration (e.g., rectangular or diamond array) on the surface of the flexible cleaning body, which converts the large-area friction caused by traditional brush bristles or sponge blocks into point contact. Finite element analysis simulations have shown that this reduces the contact area by more than 60% under the same pressing force, significantly reducing the shear stress on the fragile mucosa. The drug storage and release structure, combined with a pressure-regulating component, allows users to independently control the single-dose dose and prevents excess drug from chemically irritating damaged tissue. The multi-point, distributed outlet layout of the fluid guide channel ensures that the drug solution is evenly distributed over the target area, improving local treatment efficiency. The negative pressure suction area synchronously removes sloughed tissue, reducing the base for bacterial colonization and lowering the risk of secondary infection. The entire structure contains no motorized components, and cleaning and drug administration are mainly completed by pressing with the thumb of one hand. The negative pressure suction function can be used according to the patient's physical condition, making it suitable for independent use by chemotherapy patients with weakness or reduced hand coordination. This invention does not require a power source or a complex control system, has low manufacturing costs, is easy to maintain, and has strong clinical applicability. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a diagram showing the overall structure of the present invention. [Figure 2] FIG. 2 is an enlarged view showing the structure of a connecting portion between the flexible cleaning body and the grip portion. [Figure 3] Figure 3 shows the internal layout of the drug storage and release structure and the fluid guide channel. DETAILED DESCRIPTION OF THE INVENTION

[0019] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the following, the technical solutions in the embodiments of the present invention will be clearly and completely described with reference to the accompanying drawings.

[0020] Please refer to Figures 1 to 3. This invention provides an oral care device for cancer chemotherapy. The overall structure of this device is composed of a gripping part 1, a flexible cleaning body 2, a medicinal solution storage and release structure, and a fluid guide channel 8, all of which work together to provide gentle cleansing and sustained drug release therapy for the oral mucosa after chemotherapy.

[0021] As shown in Figure 1, the handle 1 is a cylindrical main structure with a total length of 12 cm and an outer diameter of 1.5 cm, making it ergonomically sized for one-handed grip by an adult. Its outer surface is covered with a non-slip textured layer, which has a circular ripple pattern and a depth of 0.3 mm. This texture enhances grip stability and prevents slipping due to hand sweat or medication during use. The handle 1 has a hollow interior that houses the medication storage and release structure and fluid guide channel 8. A partition plate is installed within the cavity. The partition plate is made of a single-piece molded ABS engineering plastic and is fixed to the inner wall of the handle 1 by ultrasonic welding. This completely separates the area where the medication storage and release structure is located from the negative pressure suction line, preventing medication from entering the negative pressure system and causing contamination or malfunction.

[0022] As shown in Figure 2, the flexible cleaning body 2 is located at the front end of the handle 1, and the two are connected using a kernel-type detachable connection. An annular flange is provided at the bottom of the flexible cleaning body 2, and a matching groove is provided at the front end of the handle 1. The flange is inserted into the groove and then rotated 30 degrees to lock in place. A sealing gasket made of medical-grade silicone rubber with a thickness of 1 mm is provided at the connection, ensuring no leakage of medicinal fluid from the connection surface. The front end of the fluid guide channel 8 is connected to the inlet of the flexible cleaning body 2's internal cavity via a quick-connect fitting with an O-ring silicone seal. This automatically seals the channel when the cleaning body is removed and ensures reliable communication when reattached. The overall contour of the flexible cleaning body 2 conforms to the curved surfaces of the oral vestibule and buccal mucosa. It is injection-molded using a medical-grade thermoplastic elastomer material with a Shore hardness of 30A, providing good resilience and biocompatibility. The flexible cleaning body 2 has a plurality of protruding micropillars 3 uniformly arranged on its surface, all 2.5 mm high, with hemispherical blunted tips and a 0.8 mm radius of curvature, and a 3.5 mm center-to-center spacing between adjacent micropillars 3, forming a rectangular array that provides dispersed point contact rather than a continuous friction surface, reducing shear stress on the fragile mucosa. A through cavity is provided inside the flexible cleaning body 2, and this cavity communicates with the fluid guide channel 8 to receive and guide the medicinal solution to the contact area.

[0023] As shown in Figure 3, the drug storage and release mechanism is built into the gripping part 1 and mainly consists of a capsular bag 4, a one-way valve group 5, and a sliding pressure plate 6. The capsular bag 4 is molded using medical-grade silicone material with a volume of 7 mL and a silicone hardness of Shore 35A. Its outer wall is tightly attached to the inner wall of the gripping part 1, and its open end is connected to the input port of the one-way valve group 5. The one-way valve group 5 contains two independent umbrella-shaped valve bodies. The first valve body controls the infusion of drug solution into the capsular bag 4 from the outside, and the second valve body controls the discharge of drug solution from the capsular bag 4 to the fluid guide channel 8. The umbrella valve body is made of silicone sheet, with a base thickness of 0.2 mm and a tip thickness of 0.1 mm. The measured operating pressure is approximately 1.0 kPa. Both valve bodies allow only one-way flow of liquid and prevent backflow. The sliding pressure plate 6 is located on the side of the capsular bag 4 away from the outer shell of the handle 1. The outer side of the pressure plate is connected to the push rod 7, which extends outward through the side wall of the handle 1. The end of the push rod 7 is equipped with a pressure platform. The platform has a diameter of 8 mm and is equipped with anti-slip recesses on its surface. Two parallel guide ribs are machined on the outer wall of the push rod 7, and a guide groove is drilled at the corresponding position on the handle 1. The guide ribs slide within the guide groove, restricting the push rod 7 to axial movement only. The maximum stroke is 10 mm. Under conditions of a capsular bag hardness of Shore 35A, the corresponding compression rate of the capsular bag 4 is approximately 40%, allowing approximately 0.25 mL of medicinal solution to be consistently dispensed with each compression. A hard limiting stopper is installed at the end of the push rod 7's stroke to prevent damage to the capsular bag 4 structure due to excessive compression.

[0024] An observation window is provided on the outside of the pouch 4. Made of transparent polycarbonate, the observation window is embedded in the outer shell of the handle 1, allowing the user to visually check the remaining amount of medication in the pouch 4. A volume scale is engraved on the inside of the observation window, with a minimum graduation of 0.5 mL. The scale is laser-etched for clarity and durability. A medication injection port is provided at the tail end of the handle 1. The injection port is sealed with a rotating cap, and a silicone seal packing is provided inside the rotating cap. The injection port communicates with the first valve element of the one-way valve group 5. The user can puncture the rotating cap with a standard syringe to refill the medication into the pouch 4. This operation is simple and does not require the removal of any parts, and the system maintains its tightness.

[0025] The fluid guide channel 8 begins at the output end of the second valve element of the one-way valve group 5, extends forward along the axis of the gripper 1, and then branches into three branches after entering the internal cavity of the flexible cleaning element 2. The terminal openings of each branch are located between the bases of the micropillars 3 in different regions. They have a diameter of 0.5 mm and are oriented toward the center of the gaps between the micropillars 3, ensuring that the medicinal solution directly covers the target mucosa after injection without impacting the tips of the micropillars 3. Of the three branches, the outlet of the middle branch is located in the central region of the cleaning element, and the outlets of the side branches are symmetrically distributed 5 mm from the edges, with a spacing of 9 mm between each outlet, preventing localized excessive medicinal solution concentration due to concentrated injection. The entire fluid guide channel 8 is injection-molded using medical-grade polypropylene, with a smooth, burr-free inner wall, reducing medicinal solution residue.

[0026] The back of the flexible cleaning body 2 is equipped with a negative pressure suction zone 9. This zone has a circular recessed structure and a built-in porous sponge layer. The sponge layer is 2 mm thick, has a porosity of 70%, and is made of hydrophilic polyurethane foam, which has good liquid absorption and biological inertness. The negative pressure suction zone 9 is connected to an external micro-negative pressure pump via an independent capillary tube. The capillary tube interface is located on the side wall of the handle 1 and uses a Luer connector, facilitating quick connection to commonly used negative pressure devices in clinical practice. To simplify operation, this interface can be designed with an automatic sealing valve that automatically closes when the negative pressure line is disconnected and automatically opens when connected, allowing the user to complete the connection with one hand or with simple assistance from another person. During the cleaning process, the negative pressure suction zone 9 gently suctions loose tissue fragments, preventing them from remaining in the oral cavity and causing secondary infection. The negative pressure suction zone 9 is physically isolated from the drug delivery system and does not interfere with each other.

[0027] The outer surface of the flexible cleaning body 2 is coated with an antibacterial coating. The coating is a nano-silver composite with a thickness of 5 μm, deposited by a vacuum sputtering process, and is uniform and dense. Tests conducted by a third-party testing organization based on the ISO 22196 standard showed that the antibacterial rate against common oral pathogens such as Staphylococcus aureus, Escherichia coli, and Candida albicans all exceeded 95%, and cytotoxicity tests showed no cytotoxicity.

[0028] When assembling the device, first place the pouch bag 4 into the inner cavity of the gripping part 1 so that its outer wall is tightly attached to the inner wall; then install the one-way valve group 5 and ensure that the first valve body is properly mated with the drug injection port and the second valve body is properly mated with the inlet of the fluid guide channel 8; then place the sliding pressure plate 6 on the back of the pouch bag 4 and pass the push rod 7 through the guide groove on the side wall of the gripping part 1 so that the guide rib fits into the guide groove; then connect the front end of the fluid guide channel 8 to the inlet of the internal cavity of the flexible cleaning body 2 via a quick connect coupling; finally, insert the annular flange at the bottom of the flexible cleaning body 2 into the groove at the front end of the gripping part 1 and rotate it 30 degrees to complete the locking, while ensuring that the sealing gasket is fully crimped.

[0029] Before use, the user opens the rotating cap at the tail end of the handle 1, aspirates the desired medicinal solution with a disposable sterile syringe, punctures the silicone seal packing with the needle tip, and injects it into the pouch 4 until the liquid level in the observation window reaches the desired graduation line. Then, the rotating cap is tightened. To use the device, the patient sits or semi-sits, opens their mouth, and gently places the flexible cleaning body 2 on the target mucosal area (e.g., cheek, tongue, soft palate), maintaining light pressure so that the micropillars 3 make point-like contact with the mucosa. Press the acupressure platform at the end of the push rod 7 with their thumb, move the sliding pressure plate 6, and compress the pouch 4. The medicinal solution then passes through the one-way valve group 5, the three branches of the fluid guide channel 8, and evenly sprays out from the openings between the bases of the micropillars 3, covering the mucosal surface. To use the negative pressure suction function, connect the negative pressure line to an external negative pressure source and activate it. This activates the negative pressure suction section 9, which then sucks away any necrotic tissue or secretions lost during the cleaning process. Each compression lasts approximately 2 seconds, and can be repeated every 5 seconds. The total number of compressions can be controlled according to the doctor's instructions. After use, the flexible cleaning body 2 can be removed and sterilized with high-temperature steam or replaced with a new disposable cleaning body.

[0030] When cleaning or maintaining the device, first disconnect the negative pressure line, open the rotary cover at the tail end to drain any remaining chemicals, and then rotate the flexible cleaning body 2 counterclockwise 30 degrees to remove it. The connection between the fluid guide channel 8 and the cleaning body is automatically separated and sealed using a quick-connect design, so the flexible cleaning body 2 can be cleaned and disinfected separately. The internal structure of the gripper 1 does not need to be disassembled; simply wipe the exterior with a sterile wet tissue. The chemical storage and release structure has good sealing properties, eliminating the risk of leakage even with long-term use.

[0031] This device takes into full consideration the fragility of the oral mucosa of chemotherapy patients, and avoids sharp angles, hard edges, and high-speed moving parts to ensure safety in use. [Explanation of symbols]

[0032] 1 Gripping part 2. Flexible cleaning body 3 Micropillar 4 sac bag 5 One-way valve group 6 Sliding pressure plate 7 Push Rod 8 Fluid Conduction Channel 9 Negative Pressure Suction Area

Claims

1. An oral care device for tumor chemotherapy, characterized in that it comprises a grip portion (1), a flexible cleaning body (2), a medicinal solution storage and release structure, and a fluid guide channel (8): The flexible cleaning body (2) is fixedly connected to the front end of the grip part (1), its outer contour fits the oral vestibule and buccal mucosa, a plurality of protruding micropillars (3) are arranged on its surface, the height of the micropillars (3) is not more than 3 mm, the top ends are blunted to a hemispherical shape, the spacing between adjacent micropillars (3) is 2 mm or more, and a through cavity is provided inside the flexible cleaning body (2), which cavity communicates with the fluid guide channel (8); The medicinal liquid storage and release structure is built into the grip part (1) and comprises a capsular bag (4), a one-way valve group (5), and a sliding pressure plate (6). The outer wall of the capsular bag (4) is attached to the inner wall of the grip part (1), and its open end is connected to the input port of the one-way valve group (5). The one-way valve group (5) includes two independent valve bodies with umbrella-shaped valve structures, which respectively control the injection of medicinal liquid into the capsular bag (4) and the output of medicinal liquid from the capsular bag (4) to the fluid guide channel (8). The sliding pressure plate (6) is located on the side of the capsular bag (4) away from the outer shell of the grip part (1), and its outside is connected to a push rod (7). The push rod (7) extends outward through the side wall of the grip part (1), and is provided with a pressure platform at its end; The fluid guide channel (8) starts from the output end of the one-way valve group (5), extends forward along the axis of the gripping portion (1), enters the internal cavity of the flexible cleaning body (2), and then branches into three branches, the terminal opening of each branch being located between the bases of the micropillars (3), and the opening direction is directed toward the center of the gaps between the micropillars (3).

2. The oral care device for tumor chemotherapy according to claim 1, characterized in that the flexible cleaning body (2) and the gripping part (1) adopt a kernel-type detachable connection, the bottom of the flexible cleaning body (2) is provided with an annular flange, the front end of the gripping part (1) is provided with a corresponding groove, the flange is inserted into the groove and then rotated 30° to complete the locking, and a sealing gasket is provided at the connecting part.

3. The oral care device for tumor chemotherapy according to claim 1, characterized in that two parallel guide ribs are provided on the outer wall of the push rod (7), a guide groove is opened at the corresponding position of the gripping part (1), and the guide ribs slide within the guide groove.

4. The oral care device for tumor chemotherapy according to claim 1, characterized in that, among the three branches of the fluid guide channel (8), the outlet of the middle branch is located in the central region of the flexible cleaning body (2), the outlets of the side branches are symmetrically distributed at positions 5 mm away from the edges, and the spacing between each outlet is greater than 8 mm.

5. The oral care device for tumor chemotherapy according to claim 1, characterized in that the rear surface of the flexible cleaning body (2) is provided with a negative pressure suction area (9), which has an annular recessed structure and a built-in porous sponge layer, and the negative pressure suction area (9) is connected to an external micro negative pressure pump via an independent thin tube.

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