A head and neck tumor radiotherapy protection device and a method of using the same

Abstract

The application relates to a head and neck tumor radiotherapy protection device and a use method thereof, and belongs to the technical field of medical auxiliary instruments. In order to improve radiotherapy precision, the head and neck tumor radiotherapy protection device comprises a head fixing assembly, a neck fixing assembly and an oral cavity fixing assembly. The head fixing assembly comprises a support plate and a limiting frame. A lower jaw baffle is arranged on the plate body of the support plate. A plurality of fixing claws in an arc shape are arranged on the periphery of the plate body. The limiting frame is located below the plurality of fixing claws and is configured to move up and down along the vertical direction. The upward movement of the limiting frame drives the plurality of fixing claws to rotate inward and tighten. The neck fixing assembly is located on the front of the head fixing assembly and is configured to move up and down along the vertical direction. The oral cavity fixing assembly comprises a bite block and a tongue depressor connected to each other. The bite block is arranged above the support plate. The head and neck tumor radiotherapy protection device can limit the movement of the head, neck and oral cavity tissues during radiotherapy, improve the radiotherapy precision and reduce the risk of normal tissue complications.

Description

Technical Field

[0001] This invention relates to a protective device for head and neck tumor radiotherapy and its usage method, belonging to the field of medical auxiliary device technology. Background Technology

[0002] During radiotherapy for head and neck tumors, patients need to maintain a strict fixed position for extended periods to ensure precise targeting of the radiation zone while minimizing damage to surrounding healthy tissues. However, the head and neck anatomy is complex, including movable structures such as the tongue, jaw, pharynx, and cervical spine. Patients often experience discomfort, tension, pain, or involuntary reflexes during treatment, resulting in subtle, unconscious movements such as tilting the head back, tilting the head forward, clenching the jaw, retracting the tongue, or shifting it laterally. These subtle movements can shift the target area, leading to missed irradiation or excessive radiation to surrounding tissues, thus affecting the accuracy of radiotherapy and increasing the risk of complications such as radiation-induced oral mucositis.

[0003] The mainstream clinical fixation method often uses a combination of a low-temperature thermoplastic mask, a rigid foam pillow, and a resin base for fixation, which can restrict the patient's head movement to a certain extent. However, once the thermoplastic mask cools and sets, its shape cannot be changed, and the patient's position and tilt angle cannot be adjusted even slightly. If the patient becomes thin or experiences facial edema, the entire fixation device needs to be remolded, resulting in high material and time costs. Furthermore, its ability to traction and restrain oral structures such as the patient's teeth and tongue is limited, making it difficult to effectively confine the tongue outside the radiation field, which can easily lead to unnecessary irradiation of the oral mucosa and cause complications.

[0004] To overcome the above-mentioned shortcomings, this application provides a head and neck tumor radiotherapy protection device and its usage method, which includes a head fixation component, a neck fixation component, and an oral fixation component, respectively limiting the movement of the patient's head, neck, and oral tissues during radiotherapy. The fixation range can be adjusted according to the patient's condition, thereby reducing the probability of target area mis-irradiation or excessive radiation to normal tissues due to target area movement, improving radiotherapy accuracy, reducing the risk of complications in normal tissues, and expanding the application range of the device. Summary of the Invention

[0005] To overcome the shortcomings of poor fixation adaptability, insufficient positioning accuracy, and limited fixation effect in the existing technologies, this application provides a head and neck tumor radiotherapy protection device and its usage method. The device is designed to set up a head fixation component, a neck fixation component, and an oral fixation component to limit the movement of the patient's head, neck, and oral tissues during radiotherapy. The fixation range can be adjusted according to the patient's condition, thereby reducing the probability of target area omission or excessive dose to normal tissues caused by target area movement, improving radiotherapy accuracy, reducing the risk of complications in normal tissues, and expanding the application range of the device.

[0006] An embodiment of the first aspect of this application provides a head and neck tumor radiotherapy protection device, including a head fixation component, a neck fixation component, and an oral fixation component. The head fixation component includes a support plate and a limiting frame connected to a radiotherapy bed. A mandibular baffle is provided on the plate body, and multiple arc-shaped fixing claws are provided on the periphery of the plate body except for the front side. The limiting frame is located on the lower periphery of the multiple fixing claws and is configured to move up and down in the vertical direction. The upward movement of the limiting frame causes the multiple fixing claws to rotate inward and tighten. The neck fixation component is spaced apart on the front side of the head fixation component and is configured to move telescopically in the vertical direction. The oral fixation component includes a connected bite and a tongue depressor, with the bite disposed above the support plate.

[0007] In some embodiments, a total of four fixing claws are provided around the periphery of the support plate, wherein two fixing claws are spaced apart on the back of the support plate, and the other two fixing claws are respectively provided on the two opposite sides of the support plate.

[0008] In some embodiments, each fixing claw includes a connecting fixing rod and a bonding plate, and the lower end of the fixing rod is connected to the support plate via an elastic portion.

[0009] In some embodiments, the top and bottom surfaces of the chin guard are provided with arc-shaped grooves, and the openings of the two mutually opposite grooves face opposite directions.

[0010] In some embodiments, the limiting frame is U-shaped with its opening facing the front of the support plate, and multiple telescopic rods are provided between the limiting frame and the radiotherapy bed board.

[0011] In some embodiments, a connecting column is fixed to the bottom surface of the support plate, and the connecting column is universally connected to the radiotherapy bed board.

[0012] In some embodiments, the head and neck tumor radiotherapy protection device further includes a limiting cylinder and a connecting plate. The limiting cylinder is spaced below the connecting column, and the projection range of the limiting cylinder in the vertical direction is within the projection range of the connecting column. The connecting plate is located below the support plate, and its two ends are respectively connected to the limiting cylinder and the neck fixation component.

[0013] In some embodiments, the neck fixation assembly includes an elastic sleeve, a lead screw, and two hinge plates. The bottom of the elastic sleeve is connected to the radiotherapy bed board, and a bottom plate and an arc-shaped top plate are spaced apart in the inner cavity. One end of the connecting plate passes through the elastic sleeve and is connected to the arc-shaped top plate. The lead screw is rotatably mounted on the bottom plate, with one end extending out of the elastic sleeve. A slider is rotatably connected to the rod body. The two hinge plates are hinged together at their close ends to form a V-shaped plate, and the two ends of the V-shaped plate are respectively hinged to the bottom plate and the slider.

[0014] In some embodiments, the bite device includes an upper and a lower bite plate hinged at one end. A pressure bar is provided on the inner side of the upper bite plate, and a limit ring is provided on the lower bite plate. The lower end of the pressure bar passes through the limit ring and is connected to the tongue depressor. The bottom surface of the tongue depressor is provided with multiple anti-slip protrusions.

[0015] In some embodiments, the head and neck tumor radiotherapy protection device further includes a locking assembly, which includes a support platform, a locking cylinder, and a locking rod. The support platform is hollowly disposed on a support plate. The locking cylinder is rotatably disposed within the cavity of the support platform, with a first ball and a second ball respectively disposed on opposite sides of the cylinder wall, the second ball being located below the first ball. The locking rod is slidably disposed within the cavity of the locking cylinder, with a connecting rod and an extension plate disposed at the upper end of the locking rod. The other end of the connecting rod is hinged to the lower dental brace, and the other end of the extension plate is connected to the mandibular baffle. A first elastic element is disposed between the extension plate and the support platform. The lower end of the locking rod is rotatably connected to the connecting plate, and a second elastic element is disposed between the connecting plate and the support platform. A first arc-shaped protrusion and a second arc-shaped protrusion are disposed at intervals on the locking rod, the first arc-shaped protrusion being located above the first ball and the second arc-shaped protrusion being located below the second ball.

[0016] The second aspect of this application provides a method of using a head and neck tumor radiotherapy protection device, applicable to any of the head and neck tumor radiotherapy protection devices described above, the method of use including: Manually rotate the mandibular baffle and oral fixation assembly so that the head is positioned on the support plate and the neck fixation assembly is positioned below the neck; The head applies downward pressure to the support plate, and multiple fixing claws rotate inward relative to the support plate, tightening as a whole to fix the skull and the two cheekbones; Rotate the mandibular baffle and oral fixation assembly to reset them. The mandibular baffle abuts against the mandible, and the oral fixation assembly is placed inside the mouth. The teeth bite into the bite device inside, and the tongue depressor is located above the tongue. Adjust the height of the limiting frame so that it moves upward and abuts against multiple fixing claws, limiting the position of the fixing claws and preventing them from spreading out. The support plate, chin guard, neck fixation component, limiting frame and multiple fixing claws work together to limit and fix the head around and below, as well as the neck, restricting the head and neck from pitching forward and backward, turning left and right and sliding.

[0017] In this embodiment, when the patient's head applies pressure to the support plate, multiple fixing claws rotate inward at a certain angle relative to the support plate, tightening as a whole to fix the patient's skull and cheekbones. Then, the height of the limiting frame is adjusted so that it moves upward to abut against the multiple fixing claws, limiting their position and preventing them from spreading out. The fixing claws are arc-shaped to better conform to the contour of the patient's head and improve fixation stability. The chin stop rotates back and abuts against the patient's chin. The neck fixation component is located below the patient's neck to provide support for the neck.

[0018] The support plate, chin guard, neck fixation component, limiting frame and multiple fixation claws work together to limit and fix the patient's head around and below, as well as the neck, restricting the forward and backward tilting, left and right rotation and sliding of the head and neck, ensuring consistent positioning for fractionated radiotherapy, reducing positioning deviation, reducing the probability of target area missing or excessive dose to normal tissue caused by target area movement, and improving the accuracy of radiotherapy.

[0019] In this embodiment, the bite device and tongue depressor can limit the patient's teeth and tongue. When the patient unconsciously clenches their jaw, retracts or moves their tongue due to discomfort, tension, pain, or natural reflexes during radiotherapy, the bite device can act as a force-bearing and limiting component, relieving the patient's tension and reducing the probability of tooth displacement. The bite device, in conjunction with the tongue depressor, stably limits the patient's tongue between the tongue depressor and the bite device, reducing the probability of tongue retraction or lateral movement during treatment. This effectively limits the tongue outside the radiotherapy field, reducing unnecessary irradiation of the oral mucosa, the probability of complications such as radiation-induced oral mucositis, and the radiation dose received by the tongue and oral mucosa, thus reducing the severity of complications. Attached Figure Description

[0020] Figure 1 This is a schematic diagram illustrating the application of the head and neck tumor radiotherapy protection device in one embodiment of this application.

[0021] Figure 2 This is a schematic diagram of the structure of a head and neck tumor radiotherapy protection device according to one embodiment of this application.

[0022] Figure 3 This is a schematic diagram of the head fixation component in one embodiment of this application.

[0023] Figure 4 This is a schematic diagram of the oral fixation component in one embodiment of this application.

[0024] Figure 5 This is a bottom view of the oral fixation component in one embodiment of this application.

[0025] Figure 6 This is an exploded view of the neck fixation component in one embodiment of this application.

[0026] Figure 7 This is a schematic diagram showing the connection between the limiting cylinder and the connecting plate in one embodiment of this application.

[0027] Figure 8 This is a partial structural diagram of the locking component in one embodiment of this application.

[0028] Figure 9 This is a schematic diagram of the locking cylinder in one embodiment of this application.

[0029] Figure 10 This is a schematic diagram of the locking rod in one embodiment of this application.

[0030] The labels in the attached diagram are as follows: 100-Radiation therapy bed board, 1-Head fixation component, 11-Support plate, 12-Limiting frame, 13-Mandibular baffle, 14-Fixing claw, 141-Fixing rod, 142-Adhesive plate, 143-Elastic part, 15-Telescopic rod, 2-Neck fixation component, 21-Elastic sleeve, 22-Base plate, 23-Arched top plate, 24-Screw rod, 25-Slider, 26-Hinge plate, 3-Oral fixation component, 31-Occlusal appliance, 311- Upper dental brace, 312-Lower dental brace, 313-Pressure bar, 314-Limiting ring, 32-Tongue depressor, 321-Anti-slip protrusion, 41-Limiting cylinder, 42-Connecting plate, 5-Locking assembly, 51-Support platform, 52-Locking cylinder, 521-First ball, 522-Second ball, 53-Locking bar, 531-First arc-shaped protrusion, 532-Second arc-shaped protrusion, 54-Connecting bar, 55-Extension plate, 56-First elastic element, 57-Second elastic element. Detailed Implementation

[0031] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings. Preferred embodiments of this application are shown in the drawings. However, this application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of this application.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0033] When using the terms “including,” “having,” and “comprising” as described herein, another component may be added unless explicitly qualifying terms such as “only,” “consisting of,” etc. are used. Unless otherwise stated, singular terms may include plural forms and should not be construed as having a quantity of one.

[0034] It should be understood that although the terms “first,” “second,” etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the scope of this application, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element.

[0035] It should also be understood that, in interpreting an element, although not explicitly described, the element is interpreted as including a range of error, which should be within the acceptable deviation range of a particular value as determined by a person skilled in the art. For example, "approximately," "about," or "substantially" can mean within one or more standard deviations, without limitation herein.

[0036] Furthermore, the accompanying drawings are not drawn to a 1:1 scale, and the relative dimensions of the components are shown in the drawings only as examples and not necessarily to actual scale.

[0037] This invention provides a head and neck tumor radiotherapy protection device and its usage method. It is designed to set up a head fixation component 1, a neck fixation component 2, and an oral fixation component 3 to limit the movement of the patient's head, neck, and oral tissues during radiotherapy. The fixation range can be adjusted according to the patient's condition, thereby reducing the probability of target area omission or excessive dose to normal tissues caused by target area movement, improving radiotherapy accuracy, reducing the risk of complications in normal tissues, and expanding the application range of the device.

[0038] An embodiment of the first aspect of this application provides a protective device for head and neck tumor radiotherapy, hereinafter referred to as the protective device, such as... Figures 1 to 10 As shown, the protective device includes a head fixation component 1, a neck fixation component 2, and an oral fixation component 3. The head fixation component 1 includes a support plate 11 and a limiting frame 12 connected to the radiotherapy bed 100. A mandibular baffle 13 is provided on the plate body of the support plate 11. Multiple arc-shaped fixing claws 14 are provided on the periphery of the plate body except for the front side. The limiting frame 12 is located on the lower periphery of the multiple fixing claws 14 and is configured to move up and down in the vertical direction. When the limiting frame 12 moves upward, it causes the multiple fixing claws 14 to rotate inward and tighten. The support plate 11 is located inside the limiting frame 12. The neck fixation component 2 is spaced apart on the front side of the head fixation component 1 and is configured to move telescopically in the vertical direction. The oral fixation component 3 includes a connected bite block 31 and a tongue depressor 32. The bite block 31 is located above the support plate 11.

[0039] In this embodiment, the mandibular baffle 13 is rotatably connected to the support plate 11 via a locking rod 53, and the oral fixation component 3 is rotatably connected to the locking rod 53 via a connecting rod 54. Before using the protective device, the mandibular baffle 13 and the oral fixation component 3 are manually rotated so that the patient can lie on the examination bed with their head on the support plate 11. Then, the mandibular baffle 13 and the oral fixation component 3 are rotated back to their original positions, and the oral fixation component 3 is placed in the patient's mouth, with the teeth biting into the bite block 31 and the tongue depressor 32 positioned above the tongue. Openings are provided at the locations of the limiting frame 12 and the multiple fixing claws 14 to avoid obstructing the placement of the patient's neck.

[0040] In this embodiment, when the patient's head applies pressure to the support plate 11, multiple fixing claws 14 rotate inward at a certain angle relative to the support plate 11, tightening as a whole to fix the patient's skull and cheekbones on both sides. Then, the height of the limiting frame 12 is adjusted so that the limiting frame 12 moves upward to abut against the multiple fixing claws 14, limiting the position of the fixing claws 14 and preventing them from spreading out. The fixing claws 14 are arc-shaped, which can better fit the contour of the patient's head and improve fixation stability. The chin guard 13 rotates back and abuts against the patient's chin. The neck fixation component 2 is located below the patient's neck to provide support for the patient's neck. The height of the neck fixation component 2 is adjustable to adapt to different patients' neck heights, expanding the range of use while maximizing the limitation of the patient's neck from moving downward during radiotherapy.

[0041] The tightening degree of the multiple fixation claws 14 and the moving height of the limiting frame 12 can be adaptively adjusted according to the patient's head size. The multiple fixation claws 14 can evenly distribute the force on the head and neck, optimize the force distribution on the body surface, avoid local stress concentration, and reduce the probability of pressure sores and ulcerations on the auricle and occipital skin during multi-week continuous radiotherapy, thereby reducing the risk of long-term skin pressure damage while ensuring the accuracy of radiotherapy target area irradiation. Furthermore, the multiple fixation claws 14 can effectively fix patients with differences in head and neck shape, postoperative tissue defects in the head and neck, facial deformities, differences in neck thickness, emaciation, and changes in facial edema, thus expanding the scope of application of the protective device.

[0042] The support plate 11, chin guard 13, neck fixation component 2, limiting frame 12 and multiple fixing claws 14 work together to limit and fix the patient's head around and below, as well as the neck, restricting the forward and backward tilting, left and right rotation and sliding of the head and neck, ensuring consistent positioning for fractionated radiotherapy, reducing positioning deviation, reducing the probability of target area missing or excessive dose to normal tissue caused by target area movement, and improving the accuracy of radiotherapy.

[0043] In this embodiment, the bite device 31 and the tongue depressor 32 can limit the patient's teeth and tongue. When the patient unconsciously clenches their jaw, retracts or moves their tongue due to discomfort, tension, pain or natural reflexes during radiotherapy, the bite device 31 can act as a force-bearing and limiting component, relieving the patient's tension and reducing the probability of tooth displacement. The bite device 31, together with the tongue depressor 32, stably limits the patient's tongue between the tongue depressor 32 and the bite device 31, reducing the probability of tongue retraction or lateral movement during treatment. This effectively limits the tongue outside the radiotherapy field, reducing unnecessary irradiation of the oral mucosa and the probability of complications such as radiation-induced oral mucositis, as well as reducing the radiation dose received by the tongue and oral mucosa and reducing the severity of complications.

[0044] In this embodiment, an angle scale is provided on the support plate 11 around the locking rod 53 or on the locking rod 53, so that the staff can record the rotation angle of the mandibular baffle 13. The rising height of the limiting frame 12 and the neck fixation component 2 can also be recorded by measuring ruler or scale marking, so as to achieve accurate reproduction of the mandibular angle and head and neck posture in the next treatment and improve the treatment effect.

[0045] In this embodiment, the edge of the mandibular baffle 13 is also slidably connected with locking pins or locking bolts, etc. The locking components can be connected to multiple pin holes or multiple threaded holes on the support plate 11 to lock the mandibular baffle 13 and the support plate 11, preventing relative rotation between the two and further improving the fixation stability of the mandibular baffle 13. The oral fixation component 3 can be a disposable product, which meets the requirements for hospital infection control.

[0046] In some embodiments, the support plate 11 is provided with four fixing claws 14 around its periphery. Two fixing claws 14 are spaced apart on the back of the support plate 11 to fix the patient's skull, and the other two fixing claws 14 are respectively provided on opposite sides of the support plate 11 to fix the patient's cheekbones on both sides.

[0047] In some embodiments, each fixing claw 14 includes a connecting fixing rod 141 and a fitting plate 142. The fixing rod 141 is arc-shaped, and the fitting plate 142 is circular to better conform to the contour of the patient's head and improve fixation stability. The lower end of the fixing rod 141 is connected to the support plate 11 through an elastic part 143. The elastic part 143 is made of an elastic material (e.g., rubber) and can deform when the limiting frame 12 moves upward to cause the multiple fixing claws 14 to rotate inward and tighten. When the limiting frame 12 moves downward, the force is removed, and the multiple fixing claws 14 rotate outward and open to relax the patient's head.

[0048] In some embodiments, the top and bottom surfaces of the chin guard 13 are provided with arc-shaped grooves, and the openings of the two arc-shaped grooves face opposite directions. The arc-shaped grooves are designed to fit the curvature of the patient's jaw and neck, allowing for better conformity to the contours of the patient's jaw and neck during use, thus improving fixation stability and comfort.

[0049] In some embodiments, the limiting frame 12 is U-shaped with its opening facing the front of the support plate 11 to avoid the patient's neck placement position. Multiple telescopic rods 15 are provided between the limiting frame 12 and the radiotherapy bed 100. The telescopic rods 15 drive the limiting frame 12 to move up and down, thereby limiting the multiple fixing claws 14. The telescopic rods 15 can be electrically operated or manually extended and then locked by locking pins.

[0050] In some embodiments, a connecting column is fixed to the bottom surface of the support plate 11, and the connecting column is universally connected to the radiotherapy bed plate 100. The universal connection can be achieved through a ball joint structure, which includes a ball head and a ball socket. The ball head is connected to either the connecting column or the radiotherapy bed plate 100, and the ball socket is connected to the other. The ball head can freely deflect within the ball socket in multiple degrees of freedom, thereby adjusting the support angle of the support plate 11 to accommodate different patient head postures and improve user comfort.

[0051] In some embodiments, the protective device further includes a limiting cylinder 41 and a connecting plate 42. The limiting cylinder 41 is spaced apart below the connecting column, and the projection range of the limiting cylinder 41 in the vertical direction is within the projection range of the connecting column. The connecting plate 42 is located below the support plate 11. The connecting plate 42 has a multi-segment structure, and its two ends are respectively connected to the limiting cylinder 41 and the neck fixing component 2.

[0052] In this embodiment, when the neck fixation component 2 moves upward, it drives the connecting plate 42 to move upward. The connecting plate 42 then drives the side of the support plate 11 closest to the neck fixation component 2 and the limiting cylinder 41 to move upward simultaneously. When the neck fixation component 2 elevates the patient's neck, the patient's head posture changes synchronously, with the patient's chin tilting upward. The upward movement of one side of the support plate 11 can adapt to the change in the patient's head posture, allowing it to better fit the patient's head and improve support stability and comfort.

[0053] In this embodiment, the limiting cylinder 41 moves upward to abut against the connecting column, thereby limiting the rotation of the ball joint structure and achieving the limiting of the support plate 11 after posture adjustment, further improving support stability. The limiting cylinder 41 can also realize the centering adjustment of the support plate 11, thereby realizing the centering adjustment of the patient's head and neck. Combined with the consistency of the lifting height of the neck fixation component 2 during each treatment, it can ensure the consistency of the patient's head and neck posture during each treatment, improving radiotherapy accuracy and repeatability. The shape and size of the limiting cylinder 41 can be customized according to the head fixation posture of different patients, further improving fixation stability.

[0054] In some embodiments, the neck fixation assembly 2 includes an elastic sleeve 21, a lead screw 24, and two hinge plates 26. The bottom of the elastic sleeve 21 is connected to the radiotherapy bed board 100, and a bottom plate 22 and an arc-shaped top plate 23 are spaced apart in the inner cavity. One end of the connecting plate 42 passes through the elastic sleeve 21 and is connected to the arc-shaped top plate 23. The lead screw 24 is rotatably mounted on the bottom plate 22, and one end extends out of the elastic sleeve 21. A slider 25 is rotatably connected to the rod body. The two hinge plates 26 are hinged together at their close ends to form a V-shaped plate. The two ends of the V-shaped plate are respectively hinged to the bottom plate 22 and the slider 25.

[0055] In this embodiment, the periphery of the elastic sleeve 21 extending vertically is a corrugated folded tube structure, capable of vertical telescopic movement. The material of the elastic sleeve 21 includes silicone, rubber, and their compounds. Two bases are provided on the base plate 22: one base supports one end of the lead screw 24 located inside the elastic sleeve 21, and the other base is a hinge seat connected to the hinge plate 26. When the neck fixing assembly 2 is in its initial state, the slider 25 is located to the left of the lead screw 24, and the right side of the lead screw 24 is located in the middle region of the base plate 22.

[0056] In this embodiment, the lead screw 24 rotates, causing the slider 25 to move from left to right. The slider 25 causes one side of the V-shaped plate to move, and the included angle of the V-shaped plate gradually decreases. The middle hinge point of the two hinge plates 26 rises, raising the arc-shaped top plate 23, thereby realizing the height adjustment of the neck fixing component 2.

[0057] In some embodiments, the neck fixation assembly 2 includes an elastic sleeve 21 and at least one electrically operated telescopic rod 15. The bottom of the elastic sleeve 21 is connected to the radiotherapy bed board 100, and the inner cavity is provided with a bottom plate 22 and an arc-shaped top plate 23. One end of the connecting plate 42 passes through the elastic sleeve 21 and is connected to the arc-shaped top plate 23. The electrically operated telescopic rod 15 is disposed between the bottom plate 22 and the arc-shaped top plate 23. The arc-shaped top plate 23 is moved up and down by the electrically operated telescopic rod 15 to realize the height adjustment of the neck fixation assembly 2.

[0058] In some embodiments, the bite device 31 includes an upper dental brace 311 and a lower dental brace 312 hinged at one end. A pressure rod 313 is provided on the inner side of the upper dental brace 311, and a limiting ring 314 is provided on the lower dental brace 312. The lower end of the pressure rod 313 passes through the limiting ring 314 and is connected to the tongue depressor 32. The bottom surface of the tongue depressor 32 is provided with a plurality of anti-slip protrusions 321 evenly and at intervals.

[0059] In this embodiment, the limiting ring 314 is used to limit the downward pressing direction of the depressor 313. When the patient bites down on the upper brace 311 and lower brace 312, the depressor 313 is forced down to press the tongue depressor 32 connected to it, allowing the tongue depressor 32 to press against the tongue below, limiting the tongue and reducing the probability of the tongue retraction or lateral displacement during treatment. This effectively confines the tongue outside the radiotherapy field, avoiding unnecessary irradiation of the oral mucosa and reducing the probability of complications such as radiation-induced oral mucositis. The anti-slip protrusion 321 can increase the friction between the tongue depressor 32 and the tongue, further improving the limiting stability.

[0060] In some embodiments, the protective device further includes a locking assembly 5, which includes a support platform 51, a locking cylinder 52, and a locking rod 53. The support platform 51 is hollowly disposed on the support plate 11. The locking cylinder 52 is rotatably disposed within the cavity of the support platform 51, and a first ball 521 and a second ball 522 are respectively disposed on opposite sides of the cylinder wall, with the second ball 522 located below the first ball 521. The locking rod 53 is slidably disposed within the cavity of the locking cylinder 52, and a connecting rod 54 and an extension plate 55 are disposed at the upper end of the locking rod 53. The other end of 54 is hinged to the lower dental brace 312, and the other end of the extension plate 55 is connected to the mandibular baffle 13. A first elastic element 56 is provided between the extension plate 55 and the support platform 51. The lower end of the locking rod 53 is rotatably connected to the connecting plate 42. A second elastic element 57 is provided between the connecting plate 42 and the support platform 51. A first arc-shaped protruding ring 531 and a second arc-shaped protruding ring 532 are provided at intervals on the locking rod 53. The first arc-shaped protruding ring 531 is located above the first ball 521, and the second arc-shaped protruding ring 532 is located below the second ball 522.

[0061] In this embodiment, the support platform 51 is fixedly connected to the support plate 11, the locking cylinder 52 is rotatably connected to the inner cavity of the support platform 51, the locking rod 53 can slide up and down inside the inner cavity of the locking cylinder 52, one end of the connecting rod 54 is rotatably connected to and engaged with the locking rod 53, and the other end is hinged to the lower dental brace 312 through a hinge ball. The two ends of the extension plate 55 are fixedly connected to the upper end of the locking rod 53 and the mandibular plate, respectively. The first elastic element 56 and the second elastic element 57 can be helical springs, and the material includes spring steel or stainless steel.

[0062] In this embodiment, before using the protective device, the locking rod 53 is manually driven to rotate. The locking rod 53 drives the extension plate 55 and the connecting rod 54 to rotate. The extension plate 55 drives the mandibular baffle 13 and the connecting rod 54 to rotate the oral fixation assembly 3, avoiding the patient's lying trajectory so that the patient's head is placed on the support plate 11. The mandibular baffle 13 is made of lightweight materials, such as one-piece molded medical-grade rigid plastic, lightweight plastic (forming a support frame) combined with medical-grade stretchable rubber (covering the arc-shaped grooves on the top and bottom surfaces), or lightweight medical carbon fiber composite material, to avoid the impact of its own weight on the subsequent feedback effect. In the initial state, under the action of the first elastic member 56 and the second elastic member 57, the first arc-shaped convex ring 531 is spaced above the first ball 521, and the second arc-shaped convex ring 532 is spaced below the second ball 522.

[0063] In this embodiment, when a patient unconsciously clenches their teeth or slightly lowers their jaw due to discomfort, tension, or pain during treatment, applying downward pressure to the bite device 31, the connecting rod 54 is forced to cause the locking rod 53, extension plate 55, and mandibular baffle 13 to slightly lower. This slight downward movement of the mandibular baffle 13 allows it to fit more closely against the patient's neck, applying pressure to remind and prevent the patient's slight movements. During this process, the first elastic element 56 is compressed, the second elastic element 57 is stretched, and the locking rod 53 causes the first arc-shaped convex ring 531 to move downward and closely abut against the first ball 521. The first ball 521 prevents the locking rod 53 from continuing to move downward, avoiding stress concentration and discomfort.

[0064] In this embodiment, when a patient unconsciously clenches their teeth or slightly moves their mandible upwards due to discomfort, tension, or pain during treatment, applying upward pressure to the bite device 31, the connecting rod 54 is forced to cause the locking rod 53, extension plate 55, and mandibular baffle 13 to move slightly upwards. The mandibular baffle 13 moves upwards and fits more closely with the patient's mandible, applying pressure to remind and prevent the patient's slight movements. During this process, the first elastic element 56 stretches, the second elastic element 57 contracts, and the locking rod 53 causes the second arc-shaped convex ring 532 to move upwards and closely abut against the second ball 522. The second ball 522 can prevent the locking rod 53 from moving further upwards, avoiding stress concentration that could cause discomfort.

[0065] In this embodiment, after the patient relaxes, the pressure applied to the locking rod 53 is removed, and the locking rod 53 is reset under the elastic force provided by the first elastic member 56 and the second elastic member 57, which drives the mandibular baffle 13 to reset, thereby avoiding stress concentration in the patient's neck or mandible due to excessive continuous force and improving fixation comfort.

[0066] In this embodiment, under the action of the locking component 5, the patient's instinctive reactions such as mandibular movement and biting caused by discomfort during treatment will not be regarded as interference. Instead, they provide a usable signal, enabling the protective device to transform the patient's uncomfortable actions into a feedback mechanism that enhances fixation and locking. Instead of attempting to completely suppress the patient's physiological reactions, the device guides, utilizes, and controls them through mechanical structures, thereby improving positioning accuracy and treatment effectiveness.

[0067] The second aspect of this application provides a method of using a head and neck tumor radiotherapy protection device, applicable to any of the head and neck tumor radiotherapy protection devices described above, the method of use including: Manually rotate the mandibular baffle 13 and the oral fixation component 3 so that the head is positioned on the support plate 11 and the neck fixation component 2 is positioned below the neck; The head applies downward pressure to the support plate 11, and multiple fixing claws 14 rotate inward relative to the support plate 11, tightening as a whole to fix the skull and the two cheekbones. Rotate the mandibular baffle 13 and the oral fixation component 3 to reset, the mandibular baffle 13 abuts against the mandible, and the oral fixation component 3 is placed in the oral cavity, the teeth bite the bite device 31 therein, and the tongue depressor 32 is located above the tongue; Adjust the height of the limiting frame 12 so that the limiting frame 12 moves upward and abuts against the multiple fixing claws 14, limiting the position of the fixing claws 14 and preventing the multiple fixing claws 14 from spreading out; The support plate 11, the chin guard 13, the neck fixation component 2, the limiting frame 12 and multiple fixing claws 14 work together to limit and fix the head around and below, as well as the neck, restricting the head and neck from tilting forward and backward, turning left and right and sliding.

[0068] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0069] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A protective device for head and neck tumor radiotherapy, characterized in that, include: The head fixation assembly (1) includes a support plate (11) and a limiting frame (12) connected to the radiotherapy bed board (100). The support plate (11) is provided with a mandibular baffle (13). The plate body is provided with multiple arc-shaped fixing claws (14) on the periphery of the plate body except for the front. The limiting frame (12) is located on the periphery below the multiple fixing claws (14) and is configured to move up and down in the vertical direction. The upward movement of the limiting frame (12) causes the multiple fixing claws (14) to rotate inward and tighten. The neck fixation component (2) is spaced apart on the front of the head fixation component (1) and is configured to extend and retract in the vertical direction; The oral fixation component (3) includes a connected bite (31) and tongue depressor (32), with the bite (31) positioned above the support plate (11).

2. The head and neck tumor radiotherapy protection device according to claim 1, characterized in that, The support plate (11) has four fixing claws (14) around its perimeter. Two fixing claws (14) are spaced apart on the back of the support plate (11), and the other two fixing claws (14) are respectively located on the opposite sides of the support plate (11).

3. The head and neck tumor radiotherapy protection device according to claim 1, characterized in that, Each fixing claw (14) includes a connecting fixing rod (141) and a bonding plate (142), and the lower end of the fixing rod (141) is connected to the support plate (11) through an elastic part (143).

4. The head and neck tumor radiotherapy protection device according to claim 1, characterized in that, The limiting frame (12) is U-shaped with its opening facing the front of the support plate (11). Multiple telescopic rods (15) are provided between the limiting frame (12) and the radiotherapy bed board (100).

5. The head and neck tumor radiotherapy protection device according to claim 1, characterized in that, A connecting column is fixed on the bottom surface of the support plate (11), and the connecting column is universally connected to the radiotherapy bed plate (100).

6. The head and neck tumor radiotherapy protection device according to claim 5, characterized in that, It also includes a limiting cylinder (41) and a connecting plate (42). The limiting cylinder (41) is spaced below the connecting column. The projection range of the limiting cylinder (41) in the vertical direction is within the projection range of the connecting column. The connecting plate (42) is located below the support plate (11) and its two ends are connected to the limiting cylinder (41) and the neck fixing component (2) respectively.

7. The head and neck tumor radiotherapy protection device according to claim 6, characterized in that, The neck fixation component (2) includes: The elastic sleeve (21) is connected to the radiotherapy bed board (100) at the bottom. The inner cavity is provided with a bottom plate (22) and an arc-shaped top plate (23). One end of the connecting plate (42) passes through the elastic sleeve (21) and is connected to the arc-shaped top plate (23). A lead screw (24) is rotatably mounted on a base plate (22), with an elastic sleeve (21) extending from one end, and a slider (25) rotatably connected to the rod body. Two hinged plates (26) are hinged together at their closest ends to form a V-shaped plate. The two ends of the V-shaped plate are respectively hinged to the base plate (22) and the slider (25).

8. The head and neck tumor radiotherapy protection device according to claim 1, characterized in that, The bite device (31) includes an upper toothed bracket (311) and a lower toothed bracket (312) hinged at one end. A pressure bar (313) is provided on the inner side of the upper toothed bracket (311), and a limit ring (314) is provided on the lower toothed bracket (312). The lower end of the pressure bar (313) passes through the limit ring (314) and is connected to the tongue depressor (32). The bottom surface of the tongue depressor (32) is provided with multiple anti-slip protrusions (321).

9. The head and neck tumor radiotherapy protection device according to claim 8, characterized in that, It also includes a locking component (5), which includes: A support platform (51) is hollowly mounted on a support plate (11); The locking cylinder (52) is rotatably installed in the inner cavity of the support platform (51). A first ball (521) and a second ball (522) are respectively provided on opposite sides of the cylinder wall. The second ball (522) is located below the first ball (521). A locking rod (53) is slidably disposed in the inner cavity of the locking cylinder (52). A connecting rod (54) and an extension plate (55) are provided at the upper end of the locking rod (53). The other end of the connecting rod (54) is hinged to the lower dental brace (312). The other end of the extension plate (55) is connected to the mandibular baffle (13). A first elastic element (56) is provided between the extension plate (55) and the support platform (51). The lower end of the locking rod (53) is rotatably connected to the connecting plate (42). A second elastic element is provided between the connecting plate (42) and the support platform (51). A first arc-shaped protrusion (531) and a second arc-shaped protrusion (532) are provided at intervals on the locking rod (53). The first arc-shaped protrusion (531) is located above the first ball (521), and the second arc-shaped protrusion (532) is located below the second ball (522).

10. A method of using a head and neck tumor radiotherapy protective device, characterized in that, The method of using the head and neck tumor radiotherapy protection device according to any one of claims 1 to 9 includes: Manually rotate the mandibular baffle (13) and oral fixation assembly (3) so that the head is on the support plate (11) and the neck fixation assembly (2) is below the neck; The head applies downward pressure to the support plate (11), and multiple fixing claws (14) rotate inward relative to the support plate (11), tightening as a whole to fix the skull and the two cheekbones; Rotate the mandibular baffle (13) and oral fixation component (3) to reset, the mandibular baffle (13) abuts against the mandible, and the oral fixation component (3) is placed in the oral cavity, the teeth bite the bite device (31) therein, and the tongue depressor (32) is located above the tongue; Adjust the height of the limiting frame (12) so that the limiting frame (12) moves up and abuts against the multiple fixing claws (14), limiting the position of the fixing claws (14) and preventing the multiple fixing claws (14) from spreading out; The support plate (11), the chin guard (13), the neck fixation component (2), the limiting frame (12) and multiple fixing claws (14) work together to limit and fix the head around and below, as well as the neck, restricting the head and neck from pitching forward and backward, turning left and right and sliding.

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