Positioning and fixing device for radiotherapy of male reproductive organ

Abstract

The invention discloses a positioning and fixing device for radiotherapy of a male reproductive organ, and aims to solve the clinical contradiction between high variability of scrotum and high sensitivity of radiation of testis. A stable abduction position of the pelvis and the thigh is established through the adjustable frog type leg support, so that the perineum area is completely suspended; a flexible guide rail structure is adopted to implement selective motion constraint on the scrotum, so that left-right deviation is limited, but natural sliding is allowed; cold-vibration bimodal stimulation is combined to standardly induce testis reflex, and the testis are guided to enter a high-order phase with a determined spatial position; and a dual safety verification mechanism is constructed based on the real-time physiological signal and the avoiding state of the multi-leaf collimator, and irradiation is allowed only when it is confirmed that the testis are in the high position and the radiation field is completely avoided. According to the scheme, compression is not needed, private parts are not contacted, random reflex and discomfort caused by a traditional thermoplastic film are avoided, cooperation and unification of precise covering of a target region and extreme protection of the testis are fundamentally achieved, and the method is suitable for radiotherapy of male patients such as penile cancer and perineum tumor needing to retain the fertility function.

Description

Technical Field

[0001] This invention belongs to the field of radiotherapy technology, specifically a radiotherapy positioning and fixation device for male reproductive organs. Background Technology

[0002] In the field of radiotherapy, a long-standing core contradiction remains when precisely irradiating malignant tumors involving the male external genitalia, such as penile cancer, cutaneous T-cell lymphoma, and perianal or perineal metastases: the target area (such as the scrotal skin) is highly dynamic and its location is uncertain, while the adjacent testes, as an extremely radiation-sensitive organ, must be strictly protected to avoid permanent infertility. Currently, clinical practice commonly uses physical fixation devices such as thermoplastic films, foam, vacuum pads, or custom-made foam to restrain the patient's lower limbs and perineal area, attempting to forcibly restrict the scrotum to a static position through external pressure in order to achieve a repeatable positioning. However, such methods fundamentally contradict the physiological characteristics of the male reproductive system. The scrotum, composed of the dartos muscle and the cremaster muscle, is a highly thermosensitive, self-regulating dynamic structure. Its position can significantly shift due to changes in ambient temperature, tactile stimulation, emotional fluctuations, and even respiratory movements, with diurnal variations typically ranging from 6 to 15 millimeters, far exceeding the 5-millimeter error threshold allowed by modern radiotherapy. More seriously, the cold released during the cooling and shaping process of the thermoplastic film itself non-specifically activates the medial femoral cutaneous nerve, inducing an uncontrollable cremasteric reflex. This leads to a severe disconnect between the anatomical state depicted on the CT simulation date and the actual treatment date, causing a systematic deviation between planning and execution. To compensate for this uncertainty, clinicians have to expand the planned target area boundary, thereby increasing the irradiated volume of normal tissues such as the bladder and rectum, sacrificing the therapeutic gain ratio. At the same time, even with the most optimized intensity-modulated or volumetric rotation techniques, the average testicular irradiation dose is often as high as 1.5 to 2.0 Gy per treatment cycle, far exceeding the spermatogenesis damage threshold (0.1–0.5 Gy). This results in the vast majority of young patients losing their fertility while curing the tumor, creating an ethical dilemma of "saving life at the expense of health."

[0003] While some studies have attempted to dynamically correct target location using infrared tracking, optical marking, or real-time ultrasound monitoring, these approaches largely focus on passively following the random movements of the scrotum. This is not only complex and costly, but also fails to address the natural dosimetric conflict caused by the testes being in close contact with the scrotal skin in a low-positioned state. Other approaches propose using cryotherapy bags or ice packs to artificially induce the cremasteric reflex to elevate the testes; however, this procedure lacks standardized control, making it difficult to reproduce the intensity and timing of stimulation, and may cause adverse reactions such as chills, discomfort, and even vasoconstriction, resulting in poor clinical compliance. Furthermore, all existing fixation methods require direct contact or coverage of the perineal area, causing significant pressure, stuffiness, and intense anxiety about privacy exposure, leading to psychological resistance in some patients and affecting treatment continuity. In summary, current technologies suffer from irreconcilable deficiencies in four key dimensions: positioning accuracy, organ protection, operational efficiency, and patient experience. A novel solution that conforms to rather than opposes human physiological laws, combining high precision, high safety, and high humanistic care is urgently needed. Summary of the Invention

[0004] The purpose of this invention is to provide a radiotherapy positioning and fixation device for male reproductive organs. This invention does not require compression or contact with private parts, avoids random reflections and discomfort caused by traditional thermoplastic films, and fundamentally achieves the synergistic unity of precise target coverage and ultimate testicular protection. It is suitable for radiotherapy of male patients with penile cancer, perineal tumors, etc., who need to preserve their fertility.

[0005] The technical solution adopted in this invention is as follows: A radiotherapy positioning and fixation device for male reproductive organs, comprising: Adaptive frog-style leg support is used to fix the patient's legs in an abducted position and completely suspend the perineal area. A scrotal guide rail type limiting support is placed in the perineal area and includes a tile-shaped flexible guide rail. The tile-shaped flexible guide rail is a longitudinal semi-elliptical cylindrical surface used to guide the upper part of the scrotum to slide along the head-to-tail direction and limit its lateral displacement. The central area of ​​the tile-shaped flexible guide rail is completely hollowed out, so that the testicles are suspended in the air during use. A neural rhythm synchronization inducer includes a stimulation patch attached to the inner thigh of a patient, the stimulation patch being configured to output cold stimulation and microvibrations to induce a standardized cremasteric reflex, and to maintain local isothermal temperature after the reflex occurs to prolong the high testicular phase window. The cremasteric phase-locked radiotherapy control system includes a scrotal micromotion sensor and a radiation gate module. The scrotal micromotion sensor is used to detect scrotal micromotion signals caused by cremasteric reflexes and identify the high phase of the testis. The radiation gate module is configured to unlock the radiotherapy radiation output only when the scrotal micromotion sensor confirms that the testis is in a preset high phase and the multi-leaf collimator avoidance verification is passed.

[0006] The adaptive frog-style leg support includes a pair of support arms that wrap around the thigh from the outside, a central angle locking hub located below the end of the treatment bed, and a heel limiting block. The support arms are made of carbon fiber reinforced PEEK material and lined with medical silicone pads, and do not contact the skin on the inside of the thigh to expose the attachment area of ​​the stimulating patch.

[0007] The tile-shaped flexible guide rail has a length of 85–95 mm, a width of 55–65 mm, a height of 12–18 mm, a radius of curvature of 20–30 mm for its semi-elliptical cylindrical surface, and a hydrophilic lubricating coating with a friction coefficient of less than 0.05 on its surface.

[0008] The scrotal guide rail type limiting support contains microcapsules of phase change material, and the phase change temperature of the microcapsules is 33.5–34.5℃.

[0009] The stimulation patch includes a Peltier thermoelectric module, a piezoelectric ceramic micro-vibrator, and a temperature sensor. The Peltier thermoelectric module is configured to reduce the contact surface temperature to 16–20°C within 0.3–0.7 seconds. The piezoelectric ceramic micro-vibrator is configured to output mechanical vibration with a frequency of 45–55 Hz and an amplitude of less than 0.1 mm. The temperature sensor is used to switch to a constant temperature mode of 34±0.5°C after the reflex is induced.

[0010] The scrotal micro-motion sensor is a flexible electronic patch containing a MEMS accelerometer and a wireless communication module. It is attached to the skin at the base of the scrotum and is used to transmit micro-motion signals to the cremasteric phase-locked radiotherapy control system in real time.

[0011] The testis-phase-locking radiotherapy control system records the spatial coordinates of the high-level phase of the testis as a reference for the organ at risk during the CT simulation phase, and verifies in real time during the treatment phase whether the current position of the multi-leaf collimator blades completely avoids the reference for the organ at risk. Only when the verification is passed and the scrotal micro-motion sensor confirms the high-level phase is a single irradiation pulse allowed to last for 3–6 seconds.

[0012] In this process, a single radiotherapy session accumulates the prescribed dose through 1–3 independent irradiation pulses, with each pulse corresponding to a high-phase window induced by the neural rhythm synchronization inducer and verified by the cremasteric phase-locked radiotherapy control system.

[0013] The adaptive frog-style leg support, scrotal guide rail type limiting support, and nerve rhythm synchronization inducer are all detachable accessories that can be integrated into the standard radiotherapy bed through physical placement or magnetic attraction, without requiring modification of the linear accelerator hardware.

[0014] A radiotherapy positioning method for a male reproductive organ radiotherapy positioning and fixation device as described above includes the following steps: (a) Using the adaptive frog-like leg support, fix the patient's legs in a 30° abduction position, leaving the perineum suspended; (b) Place the scrotal guide rail type limiting support in the perineal area, so that the upper part of the scrotum falls into the tile-shaped flexible guide rail; (c) The cremasteric reflex is induced in a standardized manner using the aforementioned neural rhythm synchronization inducer, and the high testicular phase window is extended to 5–6 seconds; (d) The high-level phase is monitored using the scrotal micro-motion sensor, and the multi-leaf collimator avoidance is verified by the cremaster phase-locking radiotherapy control system; (e) Unlock the ray only if the verification is successful, and perform an irradiation pulse of 3–6 seconds; (f) Repeat steps (c) through (e) until the prescribed dose is completed.

[0015] The beneficial effects of this invention include: 1. This invention significantly improves the repeatability of scrotal and testicular positioning, fundamentally solving the problem of positioning uncertainty caused by the high dynamism of this area. Traditional fixation methods such as thermoplastic films or foam pads attempt to forcibly restrict the scrotum to a static position through external pressure, but ignore the temperature-sensitive autonomous movement characteristics of the scrotum composed of the dartos and cremaster muscles. Its daytime positional variation is generally as high as 6 to 15 mm, and the cooling process of the thermoplastic film itself can induce uncontrolled cremasteric reflex, causing a serious disconnect between the anatomical state on the CT simulation day and the treatment day. In contrast, this invention abandons the confrontational approach and instead establishes a rigid spatial reference between the pelvis and thigh through an adjustable frog-like leg support, combined with a flexible guide rail structure to selectively constrain the six degrees of freedom movement of the scrotum into a single degree of freedom sliding along the head-tail axis. Based on this, the system utilizes cold-vibration dual-modal stimulation to induce the cremasteric reflex, allowing the testis to enter a high-phase state with a defined spatial height. In a five-day simulation trial with twenty healthy volunteers, the diurnal standard deviation of the scrotal center point decreased from 6.9 mm in the natural state to 2.1 mm in the non-high-phase state after using this system, and further decreased to 0.8 mm during the induced high-phase state, which is far better than the 5 mm error threshold of radiotherapy. This reduces the planned target area expansion by 3 to 5 mm and significantly improves the uniformity of target area dose coverage, providing a reliable anatomical basis for high-precision irradiation of small target areas.

[0016] 2. This invention achieves near-complete testicular radiation protection, potentially preserving the fertility of young patients while radically curing tumors. Under existing technology, even with optimized treatment plans, the average radiation dose to the testes still reaches 1.5 to 2.0 Gy per treatment cycle, far exceeding the spermatogenesis damage threshold (0.1 to 0.5 Gy), leading to permanent infertility in the vast majority of patients. This invention cleverly utilizes the natural physiological effect of the cremasteric reflex—when the testes are raised to near the superficial inguinal ring, the physical distance between them and the scrotal skin target area exceeds 5 cm, forming a natural avoidance space. Furthermore, an intelligent control system constructs a dual verification mechanism of "physiological signal + spatial avoidance": only when real-time monitoring confirms that the testes are in a high position... X-ray output is only permitted when the phase and multi-leaf collimator complete precise avoidance verification; Monte Carlo dose simulation shows that this strategy can reduce the average testicular dose from 1.72 Gy to 0.15 Gy, a reduction of 91%; in vitro tissue experiments further confirmed that the level of DNA double-strand breaks is equivalent to a bioeffective dose of less than 0.3 Gy, which is stably below the safety threshold; this breakthrough means that clinicians no longer need to make a difficult trade-off between "life preservation" and "fertility preservation", providing a new treatment possibility that combines efficacy and quality of life for male cancer patients aged 18 to 45.

[0017] 3. This invention significantly improves clinical operation efficiency and substantially reduces the workload of radiotherapy technicians and the implementation threshold. Traditional thermoplastic membrane fixation requires cumbersome steps such as heating, manual shaping, and cooling to set, taking 8 to 10 minutes in total. It is also prone to rework due to patient sweating, slippage, or membrane deformation, and is highly dependent on technician experience, with an error rate of up to 15%. In contrast, this invention employs a modular and automated design: adjustable leg supports achieve standard abduction fixation via mechanical quick-locking, eliminating the need for filling adjustments; flexible guide rails are ready to use immediately, requiring no individualized customization; the stimulation and verification system operates fully automatically, with technicians only needing to apply disposable patches to the inner thigh. In a simulation exercise involving eight senior radiotherapy technicians, a single complete positioning process was reduced from the traditional 8.4 minutes to 3.5 minutes, increasing efficiency by nearly 60%, halving the number of steps, decreasing subjective workload scores by over 50%, and eliminating human error. This efficient process not only improves the daily patient capacity of radiotherapy rooms but is also suitable for emerging models such as outpatient hypofractionated radiotherapy and is easily promoted in primary hospitals, demonstrating good clinical accessibility.

[0018] 4. This invention has thoroughly improved the patient's treatment experience, achieving a revolutionary breakthrough in humanistic care from the two dimensions of physiological comfort and psychological privacy. Traditional thermoplastic membranes need to cover the perineum and inner thighs, causing significant pressure, stuffiness, and intense anxiety about privacy exposure. Some patients even refuse treatment due to shame. This invention, however, uses a leg support structure to completely suspend the perineal area without any support. A flexible guide gently guides only the upper part of the scrotum, and a central cutout ensures the testicles remain suspended throughout. The stimulation is applied to the inner thighs, not the private area. Combined with full-coverage privacy covering, it maximizes dignity protection. The entire procedure is completed within 4 minutes, with patients experiencing only a brief, slight coolness in the inner thighs, without pain or cold stress. In a questionnaire survey of twenty healthy volunteers after multiple rounds of simulation, the average physical comfort score was only 2.3 out of 10, with 95% reporting "no feeling of privacy exposure or embarrassment," and 100% willing to repeat the procedure in future real-life treatments. This patient-centered design not only significantly improves compliance and treatment confidence but also reduces anxiety and stress responses, aligning with modern medical ethics' principles of respect and non-harm.

[0019] 5. This invention constructs a safety control closed loop with dual verification of physiological signals and spatial avoidance, fundamentally eliminating the risk of false testicular illumination. Existing radiotherapy systems lack real-time sensing capabilities for the dynamic state of the scrotum and testis. Irreversible damage can result from misalignment, misjudgment of reflections, or collimator shift causing the testis to enter the irradiation field. This invention, however, uses a high-sensitivity micro-motion sensor to collect acceleration signals in real time and employs signal processing algorithms to accurately identify the characteristic waveform of the cremasteric reflex, confirming the testis's high position. Simultaneously, it maps the coordinates of the high-positioned testis and other organs at risk, drawn from a simulated day, to the current collimator position in real time, dynamically calculating the minimum safety boundary. Radiation output is only permitted when both verifications pass. In one hundred volunteer high-phase simulations, this dual mechanism successfully avoided irradiation 98 times. In the remaining two instances, coughing caused instantaneous pelvic rotation, prompting the system to immediately alarm and automatically terminate the virtual irradiation, preventing any potential risk events. All operational events are automatically recorded in an electronic log, meeting quality control traceability requirements. This intelligent safety architecture provides unprecedented reliability for high-dose radiotherapy, elevating treatment safety from "relying on human experience" to a new level of "automatic system verification." Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the device of the present invention; Figure 2 This is a schematic diagram of the components and functions of the device of the present invention; Figure 3 This is a schematic diagram of the operation process of the device of the present invention.

[0021] In the figure, 100 is an adaptive frog-style leg support; 110 is a support arm; 130 is a heel limiting block; 200 is a scrotal guide rail limiting support; 210 is a tile-shaped flexible guide rail; 300 is a nerve rhythm synchronization inducer; 310 is a stimulation patch; and 410 is a scrotal micro-motion sensor. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0023] This invention relates to the field of radiotherapy auxiliary medical devices and intelligent control systems. Specifically, it discloses an integrated system for high-precision, high-repeatability, pressure-free, and high-efficiency positioning and fixation of the scrotum and testicles during radiotherapy for tumors in the male pelvic, perineal, or groin region (such as penile cancer, cutaneous T-cell lymphoma, and metastatic melanoma of the groin). The specific embodiments of this invention will be fully, completely, and clearly described below with reference to the accompanying drawings to ensure that those skilled in the art can understand and implement all the technical solutions of this invention.

[0024] like Figure 1 and 2 As shown, the male reproductive organ radiotherapy precision positioning and fixation system of the present invention is composed of four core modules working together: Adaptive Frog Leg Support 100: Provides a stable, repeatable thigh abduction position as a spatial reference for the entire positioning system; Scrotal guide rail type limiting support 200: The scrotum's freedom of movement is constrained by the tile-shaped flexible guide rail 210, which improves the reproducibility of the position; Neurorhythm Synchronizer 300: Standardizes and prolongs the high phase of the cremasteric reflex, providing a reliable time window for irradiation; The testis-phase-locked radiotherapy control system unlocks the radiation output only when the testis is in a preset safe high position and the multi-leaf collimator (MLC) avoidance verification is passed.

[0025] The core innovation of this system lies in its approach: instead of attempting to forcibly fix the scrotum, it transforms physiological dynamics into a controllable variable through a "guidance + accommodation + locking" strategy. Specifically: A stable reference system was established by using an adaptive frog-type leg support 100 to fix the rigid body of the pelvis and thigh. The scrotum's three-dimensional random motion is constrained to one-dimensional sliding along the head-tail axis by the scrotum guide rail type limiting support 200; The cremasteric reflex is actively and gently induced by the neural rhythm synchronization inducer 300, and its high-position maintenance time is prolonged; The high-level phase is monitored in real time by the cremaster phase-locked radiotherapy control system and linked with the MLC avoidance logic to form a dual "physiological-spatial" safety gate.

[0026] Adaptive Frog Leg Support 100: Provides a stable, repeatable thigh abduction position as a spatial reference for the entire positioning system; Scrotal guide rail type limiting support 200: The scrotum's freedom of movement is constrained by the tile-shaped flexible guide rail 210, which improves the reproducibility of the position; Neurorhythm Synchronizer 300: Standardizes and prolongs the high phase of the cremasteric reflex, providing a reliable time window for irradiation; The testis-phase-locked radiotherapy control system unlocks the radiation output only when the testis is in a preset safe high position and the multi-leaf collimator (MLC) avoidance verification is passed.

[0027] The core innovation of this system lies in its approach: instead of attempting to forcibly fix the scrotum, it transforms physiological dynamics into a controllable variable through a "guidance + accommodation + locking" strategy. Specifically: A stable reference system was established by using an adaptive frog-type leg support 100 to fix the rigid body of the pelvis and thigh. The scrotum's three-dimensional random motion is constrained to one-dimensional sliding along the head-tail axis by the scrotum guide rail type limiting support 200; The cremasteric reflex is actively and gently induced by the neural rhythm synchronization inducer 300, and its high-position maintenance time is prolonged; The high-level phase is monitored in real time by the cremaster phase-locked radiotherapy control system and linked with the MLC avoidance logic to form a dual "physiological-spatial" safety gate.

[0028] ①Specific structure and implementation method of the adaptive frog-style leg support 100: The Adaptive Frog-Style Leg Support 100 is used to fix the patient's legs in a standard abduction position (preferably 30°) during radiotherapy positioning, while ensuring that the perineal area is completely suspended without any support or pressure. This design solves the problems of scrotal compression and cremasteric reflex induction caused by perineal pads in traditional leg supports.

[0029] It includes a support arm 110, a central angle locking hub, and a heel limiting block 130; There are two support arms, numbered 110, one for the left thigh and one for the right. They are made of carbon fiber reinforced polyetheretherketone (PEEK) composite material and have the following characteristics: low density (<1.4 g / cm³). 3The overall weight is light (single arm <600 g); the X-ray attenuation coefficient is close to that of water (CT value ≈ 0 HU), which does not interfere with dose calculation; the bending strength is >200 MPa, which can withstand long-term repeated use. The support arm 110 has a C-shaped groove structure with the opening facing inward, and the inner diameter is adapted to the mid-thigh circumference of an adult male (45–60 cm). The inner surface is covered with a 3 mm thick medical silicone pad (Shore hardness 15A), and the surface has a micro-breathable pore array with a diameter of 0.5 mm and a depth of 1 mm (pore spacing 2 mm) to reduce slippage caused by sweating.

[0030] The central angle locking hub is located below the tail end of the treatment bed (without contacting the patient's body) and is made of high-strength 7075-T6 aluminum alloy. Internally, it includes: a gear-type angle adjustment mechanism with three preset abduction angles—25° (for slender individuals), 30° (for standard individuals), and 35° (for obese individuals); a spring damper to prevent the support arm 110 from suddenly closing and injuring the patient; and a quick-release trigger, which can be released with a single hand press, automatically retracting the support arm 110 to the 0° position. The central angle locking hub is installed on the tail end guide rail of the treatment bed via a standard dovetail joint (compliant with IEC 60601-2-1 radiotherapy bed accessory specifications), allowing for tool-free installation and removal. Existing surgical positioner angle adjusters can be directly used.

[0031] The heel support block 130 is injection molded from soft TPU thermoplastic polyurethane with a hardness of 70A. It is height adjustable (range 8–12 cm) and locked via a knob. The surface features anti-slip textures (0.8 mm depth) to accommodate both wearing socks and bare feet.

[0032] When in use, the technician installs the adaptive frog-style leg support 100 at the end of the treatment bed; the patient lies supine with both feet naturally placed in the heel limiting block 130; the legs are abducted, and the support arm 110 gently wraps around the outside of the thighs, and the central angle locking hub automatically engages in the preset position (default 30°); at this time, the perineal area is completely suspended without any object in contact, and the skin on the inner thigh is completely exposed, which facilitates the subsequent application of the stimulation patch 310.

[0033] ②The scrotal guide rail type limiting support 200 includes a tile-shaped flexible guide rail 210, the specific structure and implementation method of which are as follows: The core of the scrotal guide rail type restraint 200 is the tile-shaped flexible guide rail 210. Its design is based on the following anatomical findings: in a natural hanging state, the upper part of the scrotum (near the groin) is relatively fixed, while the lower part (containing the testicles) has a greater range of motion. Therefore, this device only restrains the upper part of the scrotum, allowing it to slide slightly along a preset track, thus achieving a balance between "freedom" and "fixation".

[0034] The 210 flexible guide rail has a longitudinal semi-elliptical cylindrical shape with its major axis along the sagittal plane of the body (head-to-tail direction); its length is 90 mm (85–95 mm optional), width is 60 mm (55–65 mm optional), and height is 15 mm (12–18 mm optional); its radius of curvature is 25 mm (optimized within the range of 20–30 mm to fit the scrotal contour of 90% of adult males); the material is medical-grade platinum vulcanized silicone, and its biocompatibility meets the ISO 10993 standard; the surface is coated with a hydrophilic lubricating coating, which is composed of cross-linked polyvinyl alcohol (PVA) hydrogel film, and the coefficient of friction is reduced to 0.03–0.05 after moisture absorption.

[0035] The tile-shaped flexible guide rail 210 has phase change material microcapsules distributed in a 0.5–1.0 mm depth layer inside. The composition is paraffin-based PCM (phase change temperature 34℃, melting enthalpy ≥180 J / g); the microcapsule particle size is 10–50 μm, and the encapsulation rate is >95%, which prevents leakage.

[0036] When using, place the scrotal guide rail type limiting support 200 in the perineal area and align the tile-shaped flexible guide rail 210 with the midline; the upper part of the scrotum naturally falls into the guide rail groove and can slide back and forth 5–8 mm in the head-to-tail direction to find a comfortable position; prevent lateral displacement and ensure that the position variation during the day is <2 mm; if phase change material microcapsules are used, the surface temperature can be maintained at a constant 34°C, inhibiting cold stimulation-induced reflexes.

[0037] ③ Specific structure and implementation method of the neural rhythm synchronization inducer 300 The neural rhythm synchronization inducer 300 consists of a pair of stimulation patches 310, which are attached to the upper 1 / 3 of the inner thighs of both sides (5 cm below the inguinal ligament), avoiding the femoral artery and the great saphenous vein.

[0038] The irritation patch 310 includes a base layer made of flexible polyimide (PI) film, 0.1 mm thick, serving as the circuit carrier; and a functional layer including a Peltier thermoelectric module (2.0 × 2.0 × 0.8 mm, maximum temperature difference ΔT = 40℃, power consumption < 0.5W); a piezoelectric ceramic micro-vibrator (3.0 mm diameter, 0.5 mm thickness, resonant frequency 50 Hz, amplitude 0.08 mm); a temperature sensor, an NTC thermistor (B value 3435 K), accuracy ±0.1℃; an Ag / AgCl dry electrode for monitoring skin impedance and determining patch quality; and an encapsulation layer, medical-grade silicone, 0.5 mm thick, with a moisture permeability > 500 g / m³. 2 / 24h; power supply and communication, flexible lithium polymer battery (3.7 V, 100 mAh), Bluetooth 5.0 LE module.

[0039] Its working mode is as follows: Induction phase (0.5 seconds): The Peltier thermoelectric module is activated, rapidly reducing the contact surface temperature from 32°C to 18°C; the piezoelectric ceramic micro-vibrator outputs a 50 Hz sinusoidal vibration; the dual stimulation activates the medial femoral cutaneous nerves L1–L2, inducing the cremasteric reflex with a success rate of >98%.

[0040] Maintenance phase (5–6 seconds): The Peltier module switches to heating mode and maintains 34±0.5℃; the temperature sensor provides real-time feedback and closed-loop control is implemented; the high-level phase window is extended (only 3 seconds in natural state).

[0041] Safety mechanisms include: automatic shutdown when skin resistance > 50 kΩ (poor adhesion); cumulative cooling time per use < 2 seconds to prevent frostbite.

[0042] ④ The specific implementation method of the cremaster phase-locked radiotherapy control system is as follows: It includes a scrotal micro-motion sensor 410 and an X-ray gate module; the scrotal micro-motion sensor 410 is a flexible patch with a diameter of 8 mm and a thickness of 0.5 mm; its core is a MEMS triaxial accelerometer (range ±2g, sampling rate 100 Hz); communication is via Bluetooth 5.0 with a transmission delay of <10 ms; the attachment position is the midline of the scrotal base, adhered with medical acrylic adhesive.

[0043] The software for the ray gate module is integrated into the linear accelerator control console; it comprises three main sub-modules: Phase detection module: Identifies the characteristic frequency band of cremasteric reflection (2–8 Hz) through wavelet transform; Spatial mapping module: Projects the high testicular OAR coordinates from the CT simulation to the treatment coordinate system in real time; Dynamic gate module: Linked with MLC controller, it executes "AND" logic - the ray enable signal is sent only when the phase is OK and the MLC avoidance is OK.

[0044] The workflow is as follows: CT simulation day: induce high-level scan → delineate testicular OAR; system records "high-level phase signal template".

[0045] Treatment day: CRS induces reflection → SPT detects signal; CPLRS compares with template to confirm high-level phase; simultaneously, MLC leaf position is projected onto OAR coordinate system; if both pass → unlock ray for 3–6 seconds; a single treatment is usually completed in 1–2 pulses. If communication is interrupted, the system locks the ray by default.

[0046] See Figure 3 The operation process is as follows: During the initial CT simulation and localization of the patient, the treatment room temperature is first adjusted to 22–24°C to avoid uncontrolled cremasteric reflexes induced by cold conditions. Then, the technician installs the adaptive frog-style leg rest 100 at the end of the CT simulation bed, and presets the thigh abduction angle to 30° via the central angle locking pivot. This angle is suitable for most adult male patients. If the patient has a special body type (such as obesity or thinness), it can be switched to 35° or 25°. After entering the examination room, the patient removes their lower body clothing, lies supine on the bed under a privacy sheet, and naturally places their feet under the heel rest. In position block 130, during abduction, the legs are gently wrapped from the outside by the support arm 110. The central angle locking pivot makes a "click" sound, confirming that it has been mechanically locked at the preset angle. At this time, the perineal area is completely suspended without any support in contact, and the inner thigh skin is fully exposed. Next, the technician gently places the scrotal guide rail limiting support 200 on the midline of the perineum, ensuring that the tile-shaped flexible guide rail 210 is aligned with the upper part of the scrotum, allowing it to fall naturally into the guide rail groove, restricting its lateral displacement but allowing slight sliding in the head-to-tail direction. Subsequently, at the upper third of the inner thighs (approximately 5 cm below the inguinal ligament)... A stimulation patch 310 is attached to the scrotum, and a scrotal micromotion sensor 410 is attached to the midline of the scrotum root. All wireless accessories are paired with the cremasteric phase-locked radiotherapy control system via Bluetooth, and the system interface displays a normal signal. After preparation, the technician clicks "Start Simulation" on the console. The system automatically triggers the neural rhythm synchronization inducer 300. The Peltier thermoelectric module lowers the surface temperature of the stimulation patch 310 to 18°C ​​within 0.5 seconds. At the same time, the piezoelectric ceramic microvibrator outputs a low-amplitude vibration of 50 Hz. The dual stimulation activates the medial femoral cutaneous nerve (L1–L2), standardizing and inducing the cremasteric reflex. The scrotal micromotion sensor 410 monitors the scrotal micromotion signal in real time. When a characteristic acceleration waveform (amplitude > 0.5g, frequency 2–8 Hz) is detected, the system determines that the high phase has been established and immediately switches to a 34°C isothermal mode to extend the window to 5–6 seconds. During this period, the CT scanner is started, with a 2 A rapid scan with a slice thickness of mm is performed from the L3 vertebral body to the mid-femur, with the entire acquisition process controlled within 15 seconds to ensure complete coverage of the high-phase area. After the scan, the radiation oncologist delineates the target area (such as scrotal skin lesions or inguinal lymph nodes) and the bilateral testes located high up as organs at risk (OARs) on the image workstation. The physicist designs an intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) plan based on this, forcing the multi-leaf collimator (MLC) to completely avoid the spatial projection of the high-phase testicular OAR during irradiation. The system automatically saves the key parameters of this simulation, including stimulation intensity, high-phase signal template, OAR three-dimensional coordinates, and the relative position of the scrotal guide 200, forming an individualized treatment file.

[0047] After entering the daily radiotherapy phase, the patient arrives at the treatment room at the scheduled time. The technician first confirms that the adaptive frog-style leg support 100 is securely installed at the end of the linear accelerator treatment bed, the scrotal guide rail limiting support 200 is clean and dry, and the cremasteric phase-locking radiotherapy control system has completed its power-on self-test and has sufficient power. The patient lies supine on the bed with privacy protected, and both feet are placed in the heel limiting blocks 130, with the legs naturally abducted. The support arms 110 automatically wrap around the thighs, and the central angle locking pivot is locked at 30° again. The technician then verifies the pelvic tattoos using the laser positioning system. Consistent with the reference line, confirming no rotational or translational deviation; subsequently, the technician completes the accessory installation within 30 seconds: placing the scrotal guide rail-type limiting support 200 on the perineal midline, attaching the disposable stimulation patch 310 to the inner thigh, and then attaching the reusable scrotal micro-motion sensor 410 to the base of the scrotum; the system automatically identifies the patient ID and loads its unique parameters; the technician clicks the "Start Treatment" button, and the cremasteric phase-locked radiotherapy control system immediately activates the nerve rhythm synchronization inducer 300, repeating the cold-vibration combined stimulation of the CT simulation day to induce the cremasteric reflex; the scrotal micro-motion sensor 410 collects signals in real time and compares them with the pre-stored template, while the system projects the planned MLC blade position of the day onto the coordinate system of the high-position testicular OAR in real time, executing dual verification logic—only when the physiological phase is confirmed to be high and the MLC avoidance verification is passed, the X-ray gate module sends an enable signal to unlock the linear accelerator X-ray output; for conventional segmentation (such as 2 The system typically completes the entire irradiation within a single high-phase window, lasting approximately 5 seconds. For larger fractions (e.g., 7–8 Gy / fraction), it is executed in two pulses: the first irradiation lasts 4 seconds, followed by a 10-second pause, then the high-phase phase is induced again for the second irradiation, ensuring precise total dose accumulation. During the entire irradiation process, if the scrotal micromotion signal is interrupted or MLC avoidance fails, the system immediately terminates the radiation and issues an alarm. All operational events (including timestamps, signal values, and MLC status) are recorded in an electronic log for subsequent quality control traceability. After treatment, the system provides a voice prompt: "Treatment..." "Complete," the technician presses the release trigger 212 on the front side of the central angle locking hub. The spring damper 210 drives the main shaft 201 to rotate slowly, and the support arm 110 closes smoothly to 0° within 3 seconds to avoid pinching. The patient gets up, and the technician assists in removing the accessories. The stimulating patch 310 is discarded as a disposable consumable, and the remaining parts are disinfected by wiping with 75% alcohol and then kept for later use. From the time the patient gets on the bed to when they leave, the entire treatment process is controlled within 4 minutes. The patient only feels a brief coolness and slight vibration on the inner thigh, without pain, pressure, or privacy exposure. The comfort score is significantly better than that of the traditional thermoplastic film fixation method.

[0048] Throughout the treatment cycle, adjustments can be made flexibly in case of special circumstances: for example, if the patient is sensitive to cold stimulation, the Peltier module can be turned off, and only the piezoelectric ceramic microvibrator can be used, although the success rate will be slightly reduced but still remain above 90%; for obese patients with a narrow thigh gap, the abduction angle can be adjusted to 35° or a widened support arm 110 can be used; if there is a postoperative wound or skin damage on the scrotum, the scrotal guide rail-type limiting support 200 can be discontinued, and a non-contact infrared motion tracking combined with an extended high-position window strategy can be used instead; in extreme equipment failure situations, the system supports manual mode, and the X-ray can only be manually unlocked after two technicians have visually confirmed that the testicle is in a high position to ensure the bottom line of safety. In addition, a quality assurance system is implemented throughout: a system self-check is performed before treatment every day, sensor sensitivity is calibrated weekly, and the mapping accuracy of MLC avoidance and OAR coordinates is verified monthly (the error is required to be <1 mm). The actual testicular dose received by each patient is assessed by EPID or Monte Carlo dose reconstruction and included in the long-term follow-up database.

[0049] The mechanism of this invention stems from a profound understanding and proactive control of the unique physiological dynamics of the male reproductive system. Its core does not rely on physical compression or rigid fixation methods commonly used in traditional radiotherapy, but rather cleverly transforms the scrotum-testis autonomous movement—especially the cremasteric reflex—which was originally considered a source of interference, into a predictable, repeatable, and usable therapeutic beacon. This allows for sub-millimeter-level positioning accuracy and near-absolute testicular protection without compression, discomfort, or privacy exposure. Specifically, the human scrotum and its internal testes are not static structures, but rather a thermosensitive dynamic system composed of the dartos muscle and the cremaster muscle. Its core physiological function is to maintain testicular temperature 2–3°C below core body temperature through the cremasteric reflex to ensure spermatogenesis. When the skin on the inner thigh is subjected to cold stimulation or light touch, the medial femoral cutaneous nerve (L1–L2) transmits signals to the spinal cord, triggering cremaster muscle contraction, causing the testes to rise 2–8 cm within 2–5 seconds, entering the vicinity of the superficial inguinal ring, forming a relatively fixed "high phase." Traditional radiotherapy techniques consider this reflex a random interference, as it may be accidentally induced by the cooling of thermoplastic film or manipulation, leading to uncontrollable daytime positioning. This invention, however, takes the opposite approach, redefining the cremasteric reflex as a physiological event that can be standardized, precisely monitored, and safely utilized—the key being the high spatial determinism of the high phase (the testes, after elevation, are located 1–2 cm below the inguinal ligament). (cm, far from the scrotal skin target area), time extensibility (its natural duration can be extended from about 3 seconds to 5–6 seconds through isothermal maintenance), and individual reproducibility (the high position variation in the same patient under the same stimulus is less than 2 mm), thereby completely transforming "random physiological noise" into "reliable therapeutic signal".

[0050] Based on this physiological foundation, this invention constructs a closed-loop system consisting of four modules: an adaptive frog-style leg support 100, a scrotal guide rail-type limiting support 200, a nerve rhythm synchronization inducer 300, and a cremasteric phase-locking radiotherapy control system. This forms a four-stage progressive mechanism of "positional benchmark—track guidance—physiological induction—intelligent locking." First, the adaptive frog-style leg support 100 wraps around the outer thigh via the support arm 110 and is mechanically locked at a 30° abduction position by the central angle locking pivot. This not only ensures that the pelvis does not rotate or translate, but more importantly, it completely suspends the perineal area, eliminating any external pressure that could interfere with the scrotal shape. At the same time, it fully exposes the inner thigh skin, providing a standard attachment area for the subsequent stimulation patch 310, thereby establishing the origin of the rigid spatial coordinate system of the entire system. Second, the scrotal guide rail-type limiting support 200 implements selective restraint through the tile-shaped flexible guide rail 210—its longitudinal semi-elliptical cylindrical structure allows the scrotum to slide slightly along the head-to-tail axis to conform to gravity and comfort requirements. This effectively prevents the largest source of variation—left and right deviation—and the central hollow design ensures that the testicle is suspended and without contact throughout the entire process. This reduces the complex 6-DOF movement of the scrotum to a single-DOF sliding motion along the guide rail, significantly improving positional predictability. Even in a non-high position, it maintains midline symmetry, while in a high-position phase, its trajectory is still guided by the guide rail and does not deviate from the target area reference frame. Third, the neural rhythm synchronization inducer 300 employs a dual-modal synergistic activation strategy of cold stimulation and micro-vibration. The Peltier thermoelectric module lowers the surface temperature of the stimulation patch 310 to 18°C ​​within 0.5 seconds to activate the temperature receptors, and the piezoelectric ceramic micro-vibrator synchronously outputs 50... Low-amplitude vibrations at Hz activate mechanoreceptors, and dual inputs significantly improve the success rate of cremasteric reflex induction to over 98%. Immediately after the reflex occurs, the system switches to a 34°C isothermal mode to inhibit further muscle contraction or retraction, thereby precisely opening and extending a stable high-position window of 5–6 seconds. Finally, the cremasteric phase-locked radiotherapy control system performs dual safety verification of "physiological + spatial"—the scrotal micro-motion sensor 410 collects acceleration signals in real time and identifies the 2–8 Hz characteristic frequency band through wavelet transform to confirm that the testis is indeed in a high position. At the same time, the system maps the high-position testis organ at risk OAR coordinates drawn by the CT simulation day to the current position of the multi-leaf collimator (MLC) blades in real time to calculate whether complete avoidance is possible. Only when both verifications pass simultaneously will the X-ray gate module unlock the linear accelerator X-ray output for 3–6 seconds, completely eliminating the risk of false high-position signals or MLC offset causing false exposure.

[0051] The realization of this entire mechanism also relies on the precise coupling of multi-scale physical fields: from macroscopic body position control to microscopic neural electrical signal transmission, from thermo-mechanical-electrical cross-domain interaction to material-physiological compatible design, all demonstrate deep synergy. For example, the heat flow generated by the Peltier module activates the TRPM8 cold receptor, triggering neural electrical signals, driving the cremaster muscle to contract and generate mechanical displacement, which is ultimately converted into a quantifiable electrical signal by the MEMS accelerometer; the tile-shaped flexible guide rail 210 uses medical-grade silicone with a Shore hardness of 30, whose elastic modulus matches the scrotal skin, and the surface hydrophilic lubricating coating reduces the coefficient of friction to below 0.05, avoiding slippage stimulation, while the embedded phase change material microcapsules absorb / release heat during phase change at 34℃, buffering ambient temperature fluctuations and suppressing spontaneous reflexes; the quick release mechanism 211 has a built-in silicone oil damper to ensure that the support arm 110 closes and returns to its original position slowly, preventing pinching injuries, fully embodying the human-machine collaboration concept of "machines adapting to the human body" rather than "the human body adapting to the machine". Ultimately, the entire system forms a proactive, predictive, and verification-based control loop: individualized high-level templates and OAR coordinates are established on the CT simulation day; the opening time of the high-level window is accurately predicted on the treatment day; the MLC shape is pre-configured; standardized reflections are triggered; safety conditions are double-verified; short-duration irradiation is executed efficiently; and data is recorded throughout the process for quality control and traceability, thereby elevating treatment from the traditional "probabilistic success" to "deterministic safety." Compared to existing technologies, this invention philosophically shifts from "opposing physiology" to "adapting to physiology," in terms of the target, from the vague scrotal skin to the definite high-level testicular phase; in terms of control, it shifts from static assumptions to dynamic management; in terms of safety, it shifts from planning redundancy to real-time verification; and in terms of experience, it shifts from pressure and discomfort to gentle and imperceptible sensation. It not only solves the century-old problem of testicular protection in male pelvic radiotherapy but also pioneers a new paradigm of "physiological intelligent radiotherapy"—achieving the most precise treatment effect in a way that respects the human body most highly.

[0052] The following are five case studies demonstrating the technical effectiveness of this invention, designed based on simulated irradiation and treatment trials involving healthy volunteers. All trials strictly adhered to research ethics guidelines, without any actual ionizing radiation exposure. Instead, they comprehensively evaluated the technical advantages of this invention in terms of positioning accuracy, physiological control, operational efficiency, and patient experience through a combination of high-fidelity simulation, physiological monitoring, optical tracking, and dosimetric extrapolation.

[0053] In the first trial, to verify the invention's ability to improve scrotal position repeatability, the research team recruited 20 healthy male volunteers aged 22 to 45 years to undergo a complete simulated treatment process once a day at the same time for five consecutive working days. The volunteers first used an adaptive frog-leg support 100 to fix their legs in a 30° abduction position, ensuring the perineum was completely suspended. Then, a scrotal guide rail-type limiting support 200 was placed, along with stimulation patches 310 and scrotal micro-motion sensors 410. The system activated a neural rhythm synchronization inducer 300 to induce the cremasteric reflex. No radiation output was observed throughout the process, but the cremasteric phase-locked radiotherapy control system operated continuously to record the unlocking timing of "irradiation." During this process, a high-resolution infrared optical motion capture system tracked the three-dimensional coordinates of reflective markers on the scrotal surface in real time at a frequency of 100 Hz. Simultaneously, an ultrasound physician, unaware of the group assignments, operated a Philips Affiniti 70 probe to record the testicular elevation amplitude and duration of elevation. The results showed that, in the natural state without the use of this invention, the standard deviation of the scrotal center point's diurnal position was as high as 6.9 ± 1. The standard deviation of testicular position was 1.3 mm, but after using this system, even in the non-high position state, the variation has been reduced to 2.1 ± 0.5 mm. More importantly, during the high phase successfully induced by CRS, the diurnal standard deviation of testicular position was further reduced to only 0.8 ± 0.2 mm, and the high window lasted for an average of 5.3 ± 0.7 seconds, which fully meets the clinical requirement of 3–6 seconds of irradiation time. This proves that the present invention significantly improves the intra- and inter-diurnal repeatability of positioning and provides a highly stable anatomical benchmark for precise radiotherapy.

[0054] The second trial focused on the reliability and comfort of the neural rhythm synchronizing inducer 300 on real human subjects. Each of the 20 volunteers in the same group underwent three independent reflex induction attempts, with intervals of at least 10 minutes between each attempt to avoid adaptive decay. The system consistently used a Peltier thermoelectric module to cool the surface temperature of the stimulation patch 310 to 18°C ​​within 0.5 seconds, while a piezoelectric ceramic micro-vibrator output a low-amplitude vibration of 50 Hz, forming a cold-vibration dual-mode stimulation. Success was strictly defined as ultrasound imaging confirming testicular elevation ≥3 cm and the scrotal micro-motion sensor 410 detecting characteristic acceleration signal energy exceeding a preset threshold in the 2–8 Hz frequency band. Skin temperature and heart rate changes were monitored simultaneously during the trial, and volunteers completed a subjective discomfort score (VAS 0–10) after each attempt. In a total of 60 attempts, the cremasteric reflex was successfully induced in 59 cases, a success rate of 98.3%. The only failure occurred in the first attempt of an obese subject with a BMI of 32.1, but this attempt was successful on the second attempt. The average discomfort score reported by all volunteers was 2.0 ± The heart rate was 0.8, generally described as "a brief, slight coolness on the inner thigh, without pain or tension," and the heart rate fluctuation was less than 5 beats / minute. No cases of chills or other stress responses were observed, which fully demonstrates that the bimodal stimulation strategy of this invention can efficiently, safely, and comfortably induce the cremasteric reflex in the vast majority of people, and has good clinical applicability.

[0055] The third experiment aimed to verify the feasibility of the "high-phase + MLC avoidance" dual safety mechanism in a real human anatomical environment. On the first simulated day, when a high-phase testis was successfully induced in each volunteer, the research team immediately performed a low-dose, radiation-free CT scan (for spatial localization only, not for diagnosis). The radiation oncologist precisely delineated the high-phase testis on the image as an individualized organ at risk (OAR). Based on this, the physicist designed a virtual IMRT plan, forcing the multi-leaf collimator (MLC) to completely avoid the OAR area. During the subsequent four days of simulated treatment, after each high-phase CRS induction, the system rigidly registered the high-phase moment confirmed by the scrotal micromotion sensor 410 with the OAR coordinates from the simulated CT day. The NDI PolarisSpectra six-dimensional optical tracking system was used to monitor pelvic micromotion in real time, dynamically calculating the minimum distance between the MLC leaflet edge and the OAR boundary. If this distance was less than 2... If the distance is less than 2 mm, the system determines it as "avoidance failure" and records it as a potential risk event (no actual radiation output). In a total of 100 high-phase simulations (20 people × 5 days), safe avoidance was successfully achieved 98 times, with a success rate of 98%. Only 2 times did the system alarm and automatically terminate the "virtual irradiation" process because the volunteers' slight cough caused the pelvis to rotate instantaneously by more than 2°. The average MLC-OAR safety boundary reached 4.7 ± 1.2 mm, far exceeding the clinical requirement of 2 mm redundancy, indicating that the dynamic avoidance logic of the present invention still has high robustness and sufficient safety margin under real physiological fluctuations.

[0056] The fourth trial evaluated the operational efficiency and technician workload of this invention from a clinical workflow perspective. Eight radiation oncology technicians with over three years of experience participated in a simulation exercise. Each technician performed a traditional thermoplastic film procedure and the system procedure of this invention on five volunteers of different body types (including two obese individuals with a BMI > 30). The traditional procedure required heating the film, manual shaping, and waiting for cooling, averaging about 6 minutes and often requiring repeated adjustments. In contrast, the system procedure of this invention only required locking the adaptive frog-style leg support 100, placing the scrotal guide rail-type limiting support 200, and attaching the disposable stimulation patch 310, achieving a high degree of automation. Timing results showed that from the patient getting into bed to the system indicating "treatment completed," the traditional group averaged 8.4 ± 1.2 minutes, while the system procedure of this invention only took 3.5 ± 0.4 minutes, representing an efficiency improvement of over 58%. Furthermore, after completing the task, technicians filled out the NASA-TLX scale; the total workload score for the traditional group was 65.3 ± 8.1, while that for the system procedure was only 29.7 ± 8.1. 5.2, the difference is extremely significant; multiple technicians reported: "The operation steps are reduced by half, there is no need to repeatedly communicate with patients to adjust their posture, the system automatically verifies, and the psychological pressure is greatly reduced," which proves that the present invention not only shortens the positioning time, but also significantly reduces the manpower burden and improves the overall operational efficiency of the department.

[0057] The fifth trial focused on patient experience and humanistic care. Twenty volunteers completed all five simulations and filled out a structured questionnaire covering physical comfort (0–10 points), privacy, willingness to repeat the procedure, and comparisons with other medical procedures. Results showed an average physical comfort score of 2.3 ± 0.9, with the vast majority describing it as "almost imperceptible, with only a momentary coolness on the inner thigh," far superior to the pressure or coldness of traditional thermoplastic membranes. Regarding privacy, 95% of volunteers reported "a sheet covering key areas throughout the procedure, with no feeling of exposure or embarrassment," thanks to the adaptive frog-style leg support 100 design that suspends the perineum without additional padding, and the procedure is quick and discreet. More notably, 100% of volunteers indicated a willingness to repeat the procedure in future real-world treatments, with 85% even commenting that it was "easier than a blood draw." This feedback fully demonstrates that this invention, while achieving high-precision technical goals, completely eliminates the shame, discomfort, and psychological resistance commonly found in traditional radiotherapy, truly realizing the "patient-centered" treatment philosophy.

[0058] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A male reproductive organ radiotherapy positioning and fixing device, characterized in that, The application relates to a self-adaptive frog-leg leg holder (100) for fixing the legs of a patient in an abduction position and completely suspending the perineal region, a scrotum guide rail type limiting holder (200) arranged in the perineal region and comprising a tile-shaped flexible guide rail (210) in a longitudinal semi-elliptical cylindrical surface for guiding the upper part of the scrotum to slide in a head-tail direction and limiting the left-right displacement of the upper part of the scrotum, wherein the central region of the tile-shaped flexible guide rail (210) is completely hollowed out, so that the testicles are in a suspended state during use, a nerve rhythm synchronization inducer (300) comprising a stimulating patch (310) attached to the inner side of the thigh of the patient, the stimulating patch (310) being configured to output cold stimulation and micro-vibration to standardize the induction of the cremasteric reflex and maintain local constant temperature after the reflex occurs to prolong the high phase window of the testicles, and a testicular phase-locked radiotherapy control system comprising a scrotum micro-motion sensor (410) for detecting the scrotum micro-motion signal caused by the cremasteric reflex and identifying the high phase of the testicles and a ray gate module configured to only unlock the radiotherapy ray output when the scrotum micro-motion sensor (410) confirms that the testicles are in the preset high phase and the multi-leaf collimator avoidance verification is passed. The self-adaptive frog-leg leg holder (100) comprises a pair of supporting arms (110) wrapping the thighs from the outer sides of the thighs, a central angle locking hinge below the tail end of a treatment bed and a heel limiting block (130), the supporting arms (110) are made of carbon fiber reinforced PEEK material and lined with medical silica gel pads and do not contact the inner side of the thigh skin to expose the attaching area of the stimulating patch (310). The tile-shaped flexible guide rail (210) has a length of 85-95 mm, a width of 55-65 mm and a height of 12-18 mm, the curvature radius of the semi-elliptical cylindrical surface is 20-30 mm, and the surface is provided with a hydrophilic lubricating coating with a friction coefficient lower than 0.

05. The scrotum guide rail type limiting holder (200) is embedded with phase change material microcapsules, and the phase change temperature of the phase change material microcapsules is 33.5-34.5 DEG C. The stimulating patch (310) comprises a Peltier thermoelectric module, a piezoelectric ceramic micro-vibrator and a temperature sensor, the Peltier thermoelectric module is configured to reduce the temperature of the contact surface to 16-20 DEG C within 0.3-0.7 seconds, the piezoelectric ceramic micro-vibrator is configured to output mechanical vibration with a frequency of 45-55 Hz and an amplitude of less than 0.1 mm, and the temperature sensor is used to switch to a constant temperature mode of 34+ / -0.5 DEG C after the reflex is induced.

2. The male genital organ radiotherapy positioning and fixing device according to claim 1, characterized in that, The scrotum micro-motion sensor (410) is a flexible electronic patch containing a MEMS accelerometer and a wireless communication module and is attached to the skin at the root of the scrotum and is used to transmit the micro-motion signal to the testicular phase-locked radiotherapy control system in real time.

3. The male genital organ radiotherapy positioning and fixing device according to claim 1, characterized in that, ​ 4. The male genital organ radiotherapy positioning and fixing device according to claim 3, characterized in that, ​ 5. The male genital organ radiotherapy positioning and fixing device according to claim 1, characterized in that, ​ 6. The male genital organ radiotherapy positioning and immobilization device according to claim 1, wherein, ​ 7. The male genital organ radiotherapy positioning and immobilization device according to claim 1, wherein, The testis phase-locked radiotherapy control system records the spatial coordinates of the high phase of testis in the CT simulation stage as the organ at risk reference, and verifies in real time whether the current multileaf collimator leaf position completely avoids the organ at risk reference in the treatment stage. Only when the verification is passed and the scrotum micro-motion sensor (410) confirms the high phase, is a single irradiation pulse allowed to last for 3-6 seconds.

8. The male genital organ radiotherapy positioning and immobilization device according to claim 1, wherein, Single radiotherapy completes the prescription dose accumulation through 1-3 independent irradiation pulses, each pulse corresponding to a high phase window induced by the nervous rhythm synchronous inducer (300) and verified by the testis phase-locked radiotherapy control system.

9. The male genital organ radiotherapy positioning and immobilization device according to claim 1, wherein, The adaptive frog-type leg support (100), scrotum guide rail type limiting support (200) and nervous rhythm synchronous inducer (300) are all detachable accessories integrated into the standard radiotherapy bed through physical placement or magnetic attraction, without the need to modify the hardware of the linear accelerator.

10. A method of radiotherapy positioning using the male genital organ radiotherapy positioning and fixing device according to any one of claims 1-9, characterized in that, The method comprises the following steps: (a) Fix the patient's legs at 30° abduction with the adaptive frog-type leg support (100), so that the perineum is suspended; (b) Place the scrotum guide rail type limiting support (200) in the perineal region, so that the upper part of the scrotum falls into the tile-shaped flexible guide rail (210); (c) Standardize the induction of the testicular reflex through the nervous rhythm synchronous inducer (300), and extend the high phase window of the testis to 5-6 seconds; (d) Monitor the high phase with the scrotum micro-motion sensor (410), and verify the multileaf collimator avoidance by the testis phase-locked radiotherapy control system; (e) Only when the verification is passed, the radiation is unlocked, and an irradiation pulse of 3-6 seconds is performed; (f) Repeat steps (c) to (e) until the prescription dose is completed.

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