Multifunctional adjustable oral positioning support for head and neck tumor radiotherapy

Abstract

The present application relates to the field of medical devices, and more particularly to a multifunctional adjustable oral positioning support for head and neck tumor radiotherapy. The multifunctional adjustable oral positioning support for head and neck tumor radiotherapy comprises a first occlusion part, a second occlusion part, a connecting part and a filling assembly. The first occlusion part and the second occlusion part are oppositely arranged, the two ends of the connecting part are connected with the first occlusion part and the second occlusion part respectively, and the filling assembly is arranged between the first occlusion part and the second occlusion part. The filling assembly is arranged between the first occlusion part and the second occlusion part, water is injected into the filling assembly through a syringe, the excess gas in the oral cavity is completely discharged, and the irregular air cavity around the radiotherapy target area is greatly reduced. The problems of dose distribution fluctuation and large dosimetry error caused by the cavity residual of the traditional support are solved, the radiotherapy dose delivery accuracy is improved, the local control effect of the tumor is improved, and the damage of the normal tissue such as the oral cavity, the tongue and the buccal mucosa is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to a multifunctional adjustable oral positioning stent for radiotherapy of head and neck tumors. Background Technology

[0002] Radiotherapy for head and neck tumors often requires the use of an oral radiotherapy frame to push healthy oral tissue away from the target area (to protect oral function) and to fix the position of the tongue (to ensure reproducibility of positioning and precision of treatment).

[0003] However, existing technologies have the following drawbacks: on the one hand, oral contact pain caused by radiotherapy can easily lead to positional displacement of the stent when it is worn; on the other hand, conventional stents cannot completely fill the oral cavity, and their actual position is difficult to monitor without image guidance. Due to the complex and drastic dose distribution at the edge of the air cavity during head and neck radiotherapy, stent displacement and changes in the air cavity can lead to serious dosimetric errors, thereby affecting tumor control rates and increasing the risk of damage to normal tissues. Summary of the Invention

[0004] To address the technical problems of positional displacement when patients wear stents, the inability of conventional stents to completely fill the oral cavity, and the difficulty in monitoring their actual position without image guidance, one objective of this invention is to provide a multifunctional adjustable oral positioning stent for radiotherapy of head and neck tumors.

[0005] To achieve the above objectives, embodiments of the present invention provide a multifunctional adjustable oral positioning bracket for radiotherapy of head and neck tumors, comprising a first occlusal portion, a second occlusal portion, a connecting portion, and a filling component; the first occlusal portion and the second occlusal portion are disposed opposite to each other, the two ends of the connecting portion are respectively connected to the first occlusal portion and the second occlusal portion, and the filling component is disposed between the first occlusal portion and the second occlusal portion.

[0006] In the above technical solution, both the first biting part and the second biting part are U-shaped. One end of the connecting part extends into the inner side of the first biting part and is fixedly connected to the first biting part, and the other end extends into the inner side of the second biting part and is fixedly connected to the second biting part.

[0007] In the above technical solution, a first occlusal groove is formed on the upper surface of the first occlusal part, and a second occlusal groove is formed on the lower surface of the second occlusal part.

[0008] In the above technical solution, the filling component includes a water bladder and a positive pressure sealed infusion connector. The water bladder is disposed between the first and second interlocking parts, and one end of the positive pressure sealed infusion connector is fixedly connected to the water bladder.

[0009] In the above technical solution, an air passage is provided on the first occlusal part and / or the second occlusal part.

[0010] In the above technical solution, a support portion is provided between the first and second occlusal portions, and a through hole is provided on the support portion, through which the positive pressure sealed infusion connector passes.

[0011] In the above technical solution, a first positioning groove is provided on both sides of the support part, and the two first positioning grooves cooperate with the first biting part and the second biting part respectively.

[0012] In the above technical solution, the distance between the bottoms of the two first positioning grooves is 1-4cm.

[0013] In the above technical solution, a second positioning groove is provided on the first occlusal part and / or the second occlusal part, and the second positioning groove cooperates with the first positioning groove.

[0014] Additional aspects and advantages of the invention will become apparent in the following description or may be learned by practice of the invention. Attached Figure Description

[0015] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a schematic cross-sectional view of the overall structure of the present invention; Figure 2 This is a schematic diagram of the mating structure of the first biting part, the second biting part, and the supporting part of the present invention; Figure 3 This is a schematic diagram of the mating structure of the first biting part, the second biting part, and the supporting part of the present invention; Figure 4 This is a schematic diagram of the folded structure of the first and second biting parts of the present invention; Figure 5 This is a schematic diagram of the unfolded structure of the first and second biting parts of the present invention; Figure 6 This is a schematic diagram of the support structure of the present invention; in, Figures 1 to 6 The correspondence between the reference numerals and component names in the attached drawings is as follows: 1. First occlusal part; 11. First occlusal groove; 2. Second occlusal part; 21. Second occlusal groove; 22. Airway; 23. Second positioning groove; 3. Connecting part; 4. Filling assembly; 41. Water bag; 42. Positive pressure sealed infusion connector; 5. Support part; 51. Through hole; 52. First positioning groove. Detailed Implementation

[0016] To better understand the above-mentioned objectives, features, and advantages of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0017] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and therefore the scope of protection of the invention is not limited to the specific embodiments disclosed below.

[0018] The following reference Figures 1 to 6 This invention describes a multifunctional adjustable oral positioning stent for radiotherapy of head and neck tumors according to some embodiments of the present invention.

[0019] like Figures 1 to 6 As shown, an embodiment of the present invention provides a multifunctional adjustable oral positioning bracket for radiotherapy of head and neck tumors, including a first occlusal part 1, a second occlusal part 2, a connecting part 3 and a filling component 4; the first occlusal part 1 and the second occlusal part 2 are disposed opposite to each other, the two ends of the connecting part 3 are fixedly connected to the first occlusal part 1 and the second occlusal part 2 respectively, and the filling component 4 is disposed between the first occlusal part 1 and the second occlusal part 2.

[0020] Both the first biting part 1 and the second biting part 2 are U-shaped. One end of the connecting part 3 extends into the inside of the first biting part 1 and is fixedly connected to the first biting part 1, and the other end extends into the inside of the second biting part 2 and is fixedly connected to the second biting part 2.

[0021] The first occlusal part 1, the second occlusal part 2, and the connecting part 3 are made of rubber and are integrally molded. The first occlusal part 1 corresponds to the upper teeth in the oral cavity, and the second occlusal part 2 corresponds to the lower teeth in the oral cavity. When in use, the first occlusal part 1, the second occlusal part 2, and the connecting part 3 are folded into a V shape and placed in the oral cavity. After being placed in the oral cavity, the connecting part 3 is V-shaped. The first occlusal part 1 fits against the upper teeth, the second occlusal part 2 fits against the lower teeth, the connecting part 3 extending into the inside of the first occlusal part 1 fits against the hollow palate, and the connecting part 3 extending into the inside of the second occlusal part 2 fits against the tongue. Then, the filling component 4 is placed between the first occlusal part 1 and the second occlusal part 2, and water is injected into the filling component 4. After the filling component 4 gradually enlarges and fills the oral cavity, the air in the oral cavity is squeezed out to ensure that the filling component 4 fills the oral cavity and avoids measurement errors caused by air cavities.

[0022] like Figure 1As shown in Figure 5, in one embodiment of the present invention, a first occlusal groove 11 is formed on the upper surface of the first occlusal portion 1, and a second occlusal groove 21 is formed on the lower surface of the second occlusal portion 2. When the first occlusal portion 1 and the second occlusal portion 2 are placed in the oral cavity, the upper teeth can extend into the first occlusal groove 11, and the lower teeth can extend into the second occlusal groove 21. Through the cooperation of the first occlusal groove 11 and the second occlusal groove 21 with the teeth, the first occlusal portion 1 and the second occlusal portion 2 can be prevented from shifting, thereby improving the stability of the first occlusal portion 1 and the second occlusal portion 2.

[0023] like Figure 1 As shown, in one embodiment of the present invention, the filling component 4 includes a water bladder 41 and a positive pressure sealed infusion connector 42. The water bladder 41 is disposed between the first engagement portion 1 and the second engagement portion 2, and one end of the positive pressure sealed infusion connector 42 is fixedly connected to the water bladder 41.

[0024] After placing the first occlusal part 1, the second occlusal part 2, and the connecting part 3 into the oral cavity, the water-filled balloon 41 is placed between the first occlusal part 1 and the second occlusal part 2. Since the connecting part 3 is V-shaped at this time, the water-filled balloon 41 is held by the connecting part 3. One end of the positive pressure closed infusion connector 42 is fixedly connected to the water-filled balloon 41, and the other end extends outside the oral cavity. Then, an external syringe is connected to the positive pressure closed infusion connector 42, and water is injected into the water-filled balloon 41 through the positive pressure closed infusion connector 42. The water-filled balloon 41 enlarges and applies pressure to the connecting part 3, so that the connecting part 3 is tightly attached to the tongue and the palate of the oral cavity, and the water-filled balloon 41 will adhere to both cheeks. Through the process of the water-filled balloon 41 enlarging, it gradually fills the oral cavity, avoiding air cavities from affecting the tumor control rate and increasing the risk of damage to normal tissues.

[0025] like Figure 4 and Figure 5 As shown, in one embodiment of the present invention, an airway 22 is provided on the first occlusal portion 1 and / or the second occlusal portion 2. An airway 22 may be provided only on the first occlusal portion 1, only on the second occlusal portion 2, or on both the first occlusal portion 1 and the second occlusal portion 2. This embodiment takes the provision of an airway 22 on both the first occlusal portion 1 and the second occlusal portion 2 as an example. Since the connecting portion 3 forms a V-shape when the first occlusal portion 1, the second occlusal portion 2, and the connecting portion 3 are placed in the oral cavity, the connecting portion 3 may block the trachea in the larynx, causing difficulty in oxygen intake for the patient. Therefore, by providing an airway 22 on the first occlusal portion 1 and / or the second occlusal portion 2, an airway 22 is provided on both the first occlusal portion 1 and / or the second occlusal portion 2. An airway 22 is provided on the second occlusal part 2. When airways 22 are provided on both the first occlusal part 1 and the second occlusal part 2, the air inlet of the airway 22 is located at the right end of the first occlusal part 1 and the second occlusal part 2, that is, the end of the first occlusal part 1 and the second occlusal part 2 close to the lips, and the air outlet of the airway 22 is located at the left end of the first occlusal part 1 and the second occlusal part 2, that is, the end of the first occlusal part 1 and the second occlusal part 2 close to the larynx. The air outlet is aligned with the trachea of ​​the larynx, thereby ensuring that the patient's breathing is unobstructed.

[0026] like Figure 1 , Figure 2 , Figure 3 and Figure 6 As shown, in one embodiment of the present invention, a support portion 5 is provided between the first biting portion 1 and the second biting portion 2. The support portion 5 is located at the right end of the first biting portion 1 and the second biting portion 2. A through hole 51 is provided on the support portion 5, and the positive pressure sealed infusion connector 42 passes through the through hole 51.

[0027] The upper and lower surfaces of the support part 5 are provided with first positioning grooves 52. The first positioning grooves 52 are arc-shaped. The shape of the first positioning grooves 52 on the upper surface of the support part 5 is adapted to the upper teeth, and the shape of the first positioning grooves 52 on the lower surface of the support part 5 is adapted to the lower teeth. The lower surface of the right end of the first occlusal part 1 extends into the first positioning grooves 52 on the upper surface of the support part 5, and the upper surface of the right end of the second occlusal part 2 extends into the first positioning grooves 52 on the lower surface of the support part 5. This can limit the position of the support part 5, prevent the support part 5 from shifting in the left and right directions, and improve the stability of the support part 5.

[0028] By setting the support part 5, the first occlusal part 1 and the second occlusal part 2 can be engaged on the support part 5. The support part 5 can ensure that the oral cavity reaches a proper opening state, and at the same time prevent the mouth from opening and closing randomly during radiotherapy, ensuring that the mouth remains in a stable state during radiotherapy.

[0029] In addition, since the degree of mouth opening and closing varies from person to person, the distance between the bottom of the first positioning groove 52 on the upper surface of the support part 5 and the bottom of the first positioning groove 52 on the lower surface of the support part 5 is set to 1-4cm. By making support parts 5 of different sizes, different sizes of support parts 5 can be selected for different patients, thereby improving the applicability of the overall structure.

[0030] like Figures 1 to 5 As shown, in one embodiment of the present invention, a second positioning groove 23 is provided on the first biting part 1 and / or the second biting part 2, and the second positioning groove 23 cooperates with the first positioning groove 52.

[0031] A second positioning groove 23 is provided on the lower surface of the right end of the first biting part 1 and / or the upper surface of the right end of the second biting part 2. The second positioning groove 23 can be provided only on the lower surface of the right end of the first biting part 1, or only on the upper surface of the right end of the second biting part 2, or both the lower surface of the right end of the first biting part 1 and the upper surface of the right end of the second biting part 2. In this embodiment, the second positioning groove 23 is provided only on the upper surface of the right end of the second biting part 2. The lower end of the support part 5 is placed in the lower second positioning groove 23, and the bottom of the first positioning groove 52 is in contact with the bottom of the second positioning groove 23. By setting the second positioning groove 23, the side wall of the second positioning groove 23 can limit the support part 5, prevent the support part 5 from shifting in the front-back direction, and further improve the stability of the support part 5.

[0032] The present invention has the following advantages: 1. A water-filled balloon with a positive-pressure sealed infusion connector is installed between the first and second occlusal regions. The balloon's expansion volume can be controlled by injecting water using a syringe, completely filling the oral cavity and expelling excess air, significantly reducing irregular air pockets around the radiotherapy target area. This solves the problems of dose distribution fluctuations and large dosimetric errors caused by residual cavities in traditional stents, improving the accuracy of radiotherapy dose delivery. It enhances local tumor control while reducing excessive radiation damage to normal tissues such as the oral cavity, tongue, and buccal mucosa.

[0033] 2. The positive pressure closed infusion connector can realize the integration of water injection, pressure maintenance and sealing. No additional sealing is required after water injection. The water pressure in the water bag is stable, and there will be no leakage or pressure loss throughout the radiotherapy process. It continuously maintains the oral cavity filling state and avoids the formation of new air cavities due to water bag contraction during treatment. The connector extends outward through the support hole, and the operating end is exposed outside the mouth. Medical staff can adjust the filling degree without repeatedly removing the support, which is convenient to operate.

[0034] 3. The first and second occlusal parts are respectively provided with first and second occlusal grooves, which can precisely fit with the patient's upper and lower teeth. The teeth are locked in the grooves to form mechanical restraint, which relieves the problems of occlusal loosening and structural slippage caused by oral mucosal pain during radiotherapy. The overall structural position is stable and does not shift during a single radiotherapy session.

[0035] 4. The detachable support part and the second positioning groove are matched and the upper and lower first positioning grooves of the support part are engaged and limited in both directions. The first positioning groove restricts the left and right sliding of the support part, and the second positioning groove constrains the front and back displacement of the support part. The double limiting structure firmly fixes the support component and prevents the overall bracket from shifting due to the shaking of the support component.

[0036] 5. The distance between the bottom of the two first positioning slots of the support is set to 1~4cm in multiple sizes to match different patients' mouth opening range and oral cavity depth. The clinical support can be replaced as needed to maintain a standardized mouth opening posture, ensure consistent positioning height between fractions of radiotherapy, reduce repeated positioning errors, and adapt to individualized radiotherapy needs.

[0037] 6. A through-type airway is opened at the first and second occlusal regions, with the airway inlet close to the lips and the outlet aligned with the pharynx and trachea. Even if the connecting part is close to the palate and tongue, or the water sac is full and compresses the oral soft tissue, the airway can still form an independent breathing pathway, avoiding airway blockage caused by the connecting part folding and resulting in shortness of breath, hypoxia, nausea and discomfort. It is especially suitable for patients with long radiotherapy duration, difficulty opening their mouths, and sensitive throats, reducing patient discomfort and minimizing the interruption of radiotherapy due to breathing difficulties.

[0038] 7. The first occlusal part, the second occlusal part, and the connecting part are made of one piece of rubber. The material is soft and has no hard edges. When in contact with teeth, palate, tongue, and buccal mucosa, it will not rub or damage the radiotherapy-sensitive oral mucosa. The connecting part can be folded into a V-shape, making it easy to insert into the oral cavity. After folding, it naturally fits the palate and tongue surface, which can not only stabilize and fix the tongue away from the radiotherapy target area and protect the tongue tissue from high dose irradiation, but also help the water bag to fit evenly into the soft tissues on both sides of the oral cavity, further eliminating local gaps.

[0039] 8. It integrates multiple functions such as oral fixation, mouth opening adjustment, cavity filling, ventilation and oxygen supply, and dose error control into one unit, eliminating the need for multiple auxiliary instruments such as occlusal pads, inflatable liners, and independent ventilation tubes, thus reducing the types of consumables; the support unit can be disassembled separately, the water bag is replaceable, and the entire structure can be repeatedly sterilized and reused, reducing the cost of clinical consumables; the overall structure is easy to disassemble, assemble, and adjust for water injection, shortening the radiotherapy positioning preparation time and improving the work efficiency of the radiotherapy room.

[0040] 9. The water-filled balloon is continuously filled with constant pressure, which can stably eliminate variable air cavities in the oral cavity. Even in conventional radiotherapy without real-time image guidance, it can maintain the stability of oral anatomy and avoid dose deviation caused by dynamic changes in air cavities. This broadens the applicable scenarios of the equipment, and it can also be used stably in primary care without image-guided radiotherapy equipment, making it more universal.

[0041] In this invention, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; "linking" can be a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of these terms in this invention according to the specific circumstances.

[0042] In the description of this invention, it should be understood that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or unit referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0043] In the description of this specification, the terms "one embodiment," "some embodiments," "specific embodiment," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0044] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A multifunctional adjustable oral positioning stent for radiotherapy of head and neck tumors, characterized in that, It includes a first occlusal portion (1), a second occlusal portion (2), a connecting portion (3), and a filling component (4); the first occlusal portion (1) and the second occlusal portion (2) are arranged opposite to each other, the two ends of the connecting portion (3) are respectively connected to the first occlusal portion (1) and the second occlusal portion (2), and the filling component (4) is disposed between the first occlusal portion (1) and the second occlusal portion (2).

2. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 1, characterized in that, The first biting part (1) and the second biting part (2) are both U-shaped. One end of the connecting part (3) extends into the inner side of the first biting part (1) and is fixedly connected to the first biting part (1), and the other end extends into the inner side of the second biting part (2) and is fixedly connected to the second biting part (2).

3. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 2, characterized in that, The first biting part (1) has a first biting groove (11) on its upper surface, and the second biting part (2) has a second biting groove (21) on its lower surface.

4. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 3, characterized in that, The filling component (4) includes a water bladder (41) and a positive pressure closed infusion connector (42). The water bladder (41) is located between the first engagement part (1) and the second engagement part (2). One end of the positive pressure closed infusion connector (42) is fixedly connected to the water bladder (41).

5. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 4, characterized in that, An airway (22) is provided on the first occlusal part (1) and / or the second occlusal part (2).

6. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 5, characterized in that, A support part (5) is provided between the first biting part (1) and the second biting part (2), and a through hole (51) is provided on the support part (5), and the positive pressure sealed infusion connector (42) passes through the through hole (51).

7. The multifunctional adjustable oral positioning frame for head and neck tumor radiotherapy according to claim 6, characterized in that, The support part (5) has a first positioning groove (52) on both sides, and the two first positioning grooves (52) respectively cooperate with the first biting part (1) and the second biting part (2).

8. The multifunctional adjustable oral positioning bracket for head and neck tumor radiotherapy according to claim 7, characterized in that, The distance between the bottoms of the two first positioning grooves (52) is 1-4cm.

9. The multifunctional adjustable oral positioning stent for head and neck tumor radiotherapy according to claim 8, characterized in that, A second positioning groove (23) is provided on the first biting part (1) and / or the second biting part (2), and the second positioning groove (23) cooperates with the first positioning groove (52).

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