A 3D scanning-based phosphor gel scar patch treatment method

Abstract

The application discloses a kind of phosphorus gel scar plaster treatment methods based on 3D scanning, belong to medical instrument technical field.The method is first obtained by 3D scanning the three-dimensional data of scar, and individualized treatment dose scheme is formulated;Then prepare phosphorus [32P] gel in airtight preparation center and carry out dose calibration;Then prepare conductive substrate plaster with electrode system;According to dose distribution map, different doses of phosphorus [32P] gel are accurately applied on the plaster using automatic smearing equipment and ultraviolet light curing;Finally, the plaster is pasted on the patient's scar, and radiotherapy and electrotherapy are carried out simultaneously.After treatment, the plaster automatically falls off and is uniformly recycled.The application realizes the accurate individualized control of nuclide dose, reduces the radiation risk, combines the synergistic effect of radiotherapy and electrotherapy, significantly improves the treatment effect and safety, and is convenient for widespread application.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a phosphate gel scar treatment method based on 3D scanning. Background Technology

[0002] Pathological scars mainly include hypertrophic scars and keloids, which are the result of excessive proliferation and repair of connective tissue after skin trauma. They are often accompanied by pain, itching, and functional impairment, seriously affecting the patient's quality of life and mental health. Currently, there are three main types of radiotherapy commonly used in clinical practice: oral / injectable phosphorus [32P] dressing therapy, superficial X-ray therapy, and 90Y-90Sr dressing therapy. Oral / injectable phosphorus [32P] dressing therapy involves dripping a radioactive nuclide solution onto filter paper and drying it to make a dressing. Although the efficacy is definite, the preparation process is cumbersome, requiring doctors to manually outline the scar shape, cut the filter paper, drip the nuclide, and dry it, which takes a long time. Even with the increased efficiency of automated production equipment, several intractable problems remain: the drying process generates radioactive aerosols, increasing radiation risks to the environment and healthcare workers; effective quality control measures are lacking, making it difficult to accurately measure the dosage prescribed by doctors, ensuring uniformity of radionuclide distribution, and preventing differentiated dosing for scars of uneven thickness; and the treatment generates significant amounts of radioactive waste, resulting in high disposal costs and safety hazards. Superficial X-ray therapy requires specialized equipment such as the SRT-100, which is expensive and difficult to implement in primary care hospitals. Its fixed irradiation field design cannot perfectly match irregularly shaped scars, and even with protective measures, damage to surrounding normal tissue is unavoidable, with a recurrence rate as high as 50%. The 90Y-90Sr applicator is made of metal, with limited size and shape, resulting in poor skin adhesion and unsuitability for large areas or irregularly shaped scars. Due to its long service life, the radioactive window is in direct contact with the skin for extended periods, which can lead to wear and tear, potentially causing skin contamination and damage to normal tissue. Improper dosage control or insufficient protection can easily cause adverse reactions such as skin erythema and erosion, and the recurrence rate is also high. The core problem with existing technologies is that they cannot simultaneously achieve precise individualized control of radionuclide dosage, safety and convenience of the treatment process, and effective management of radioactive waste, resulting in unsatisfactory treatment effects, high radiation risks to medical staff, and difficulty in widespread application. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides a 3D scanning-based phosphate gel scar treatment method to solve the problems mentioned in the background section.

[0004] To achieve the above objectives, the present invention provides the following technical solution: A 3D scanning-based phosphate gel scar treatment method, the method is as follows: Step 1: Scar 3D Data Acquisition and Analysis A high-precision structured light 3D scanning device is used to perform a comprehensive scan of the patient's scar area, acquiring complete three-dimensional point cloud data including scar area, shape, thickness, and surface roughness. The scanning resolution is no less than 0.1 mm, and the scanning time is controlled within 30 seconds. The acquired three-dimensional point cloud data is imported into dedicated image processing software for noise reduction, smoothing, and meshing to generate a three-dimensional digital model of the scar. The software automatically identifies the scar boundary, distinguishes scar tissue from normal skin, calculates the total volume of the scar and the thickness distribution of different areas, generates a thickness heat map, and classifies the scar into three levels according to thickness: thin area (0.1-1 mm), medium area (1-3 mm), and thick area (>3 mm). Step 2: Personalized Treatment Dosing Planning Based on the patient's scar type, course of disease, location, and 3D data, nuclear medicine physicians develop individualized treatment plans, determining the total treatment dose and fractionation regimen. Using a scar thickness thermogram, a correlation is established between thickness and radionuclide dose: thin areas receive the baseline dose, medium areas receive 1.5 times the baseline dose, and thick areas receive twice the baseline dose. Dosage calculation software simulates the beta-ray dose distribution in different thickness areas to ensure the dose received by the scar tissue is within the treatment window while ensuring the dose received by the surrounding normal skin is below the safety threshold. A dose distribution map containing precise dose information for each coordinate point is generated and precisely registered with the 3D digital model of the scar. Step 3: Preparation and Dosage Calibration of Phosphorus [32P] Gel In a closed preparation center that meets radiation protection requirements, phosphate [32P]ate solution and medical photocurable gel matrix are thoroughly mixed under sterile conditions according to a preset ratio to prepare phosphate [32P] gel. The gel matrix is ​​composed of acrylate monomers, photoinitiators, thickeners, and stabilizers, and has good biocompatibility and adhesion. The activity of the mixed phosphate [32P] gel is calibrated using a high-precision radioactivity meter to ensure that the radioactivity error per gram of gel does not exceed ±5%. The calibrated phosphate [32P] gel is loaded into a special sterile syringe, sealed, and labeled with the radionuclide type, activity, preparation date, and expiration date. Step 4: Conductive substrate fabrication and electrode arrangement Based on the three-dimensional shape and size of the scar, a flexible conductive base dressing of appropriate size is cut. The conductive base dressing consists of a polyurethane film with a thickness of 0.1-0.3 mm as the base layer, on which two parallel conductive silicone layers are coated as positive and negative conductive strips. The thickness of the conductive silicone layer is 0.4-0.5 mm. A medical silicone gel layer with a thickness of 0.4-0.5 mm is then covered on the conductive silicone layer. The silicone gel layer has the functions of moisturizing, pressurizing, and insulating. According to the shape of the scar and the dosage distribution requirements, multiple hemispherical raised electrode pads are pressed and arranged on the silicone gel layer of the conductive base dressing. The connecting part of the electrode pad is 0.1 mm thick, and the raised part is 0.8-0.9 mm thick. The electrode pads pass through the silicone gel layer and form a reliable electrical connection with the conductive silicone layer. The number and position of the electrode pads are determined according to the size and shape of the scar to ensure that the electrodes cover the entire scar area and are evenly distributed. Step 5: Precise application and curing of gel dosage A sterile syringe containing phosphorus [32P] gel is installed on an automated application device. The automated application device precisely controls the amount of gel dispensed and the movement trajectory of the syringe based on the dose distribution map and the three-dimensional digital model of the scar generated in step 2. Different doses of phosphorus [32P] gel are evenly applied to the area between the electrode pads of the conductive substrate in order from thick to thin areas. The thickness of the gel application is proportional to the dose required for that area. After application, the gel surface is immediately irradiated with ultraviolet light at a wavelength of 365nm for 10-30 seconds to rapidly solidify the phosphorus [32P] gel. The solidified gel maintains a shape that matches the scar surface and does not flow or deform. The gel is tightly bonded to the conductive substrate and the electrode pads to form a whole. Step 6: Applying the plaster and setting the electrotherapy parameters The prepared phosphate gel scar dressing is removed from the release paper and observed through a transparent conductive substrate, ensuring precise alignment of the gel area with the patient's scar. The silicone gel layer around the dressing is gently pressed to ensure a tight fit with the skin, free of air bubbles and wrinkles. The control module is connected to the dressing's conductive connector via a module conductive connector. The control module contains a built-in power supply, drive circuit, control unit, and temperature sensor. Electrotherapy parameters are set according to the patient's tolerance and treatment needs: in microcurrent mode, a low-frequency pulsed current is output with a rated voltage of 3.5V and an output current of 500μA, for 8 hours daily; in radiofrequency mode, a radiofrequency current with a frequency of 0.9MHz and an output voltage of 96V is output, for 5 minutes each morning and evening. The temperature sensor monitors the electrode temperature in real time and automatically cuts off the power when the temperature exceeds 42℃ to prevent skin burns. Step 7: End of treatment and disposal of the dressing After the treatment is completed, the control module issues an audio-visual alert. Simultaneously, the absorbent gel particles on the fixation film absorb moisture from the skin surface and swell within 48-72 hours, causing the fixation film to automatically detach from the skin. The patient or medical staff removes the used phosphorus gel scar dressing from the skin and places it in a dedicated radioactive waste collection bag. The collection bag is then sealed and sent to the hospital's radioactive waste temporary storage point, where it is collected and centrally processed by the preparation center. The collected dressings undergo radioactivity testing, and if the activity is below the exemption level, they are treated as ordinary medical waste. The treatment effect is evaluated, and subsequent treatment plans are adjusted based on changes in the scar.

[0005] As a preferred embodiment of the present invention: the dose calculation software described in step 2 uses the Monte Carlo method to simulate the transport process of β rays in tissues, taking into account dose attenuation and scattering effects at different depths, and the calculation accuracy reaches 0.01 Gy; at the same time, the software has built-in radiation sensitivity parameters of skin at different locations, which can automatically adjust the dose distribution according to the treatment site, further improving the safety and effectiveness of the treatment.

[0006] As a preferred embodiment of the present invention: 0.1-0.5 wt% of nano-silver particles are added to the medical photocurable gel matrix in step 3. The nano-silver particles have a broad-spectrum antibacterial effect and can effectively prevent skin infections that may occur during treatment. At the same time, the nano-silver particles can enhance the conductivity of the gel, improve the electrotherapy effect, and promote the repair of scar tissue.

[0007] As a preferred embodiment of the present invention: the hemispherical protruding electrode pad described in step 4 is made of medical stainless steel, and the surface is polished and passivated, which has good biocompatibility and conductivity; the side of the electrode pad that contacts the skin is designed with multiple microneedle structures, the microneedles are 50-100μm in length, which can penetrate the stratum corneum of the skin, reduce skin resistance, improve current conduction efficiency, and at the same time will not cause obvious pain.

[0008] As a preferred embodiment of the present invention: the automatic coating device in step 5 adopts a six-axis robotic arm structure, equipped with a high-precision servo motor and pressure sensor, which can realize precise movement and dispensing volume control in three-dimensional space; during the coating process, the nozzle of the device maintains a constant distance from the conductive substrate application surface to ensure uniform gel coating thickness and dosage error not exceeding ±3%.

[0009] As a preferred embodiment of the present invention: the control module described in step 6 also has a built-in Bluetooth communication module, which can wirelessly connect with a smartphone or tablet computer; through a dedicated APP, the treatment progress, remaining power and electrode temperature can be viewed in real time, the electrotherapy parameters can be remotely adjusted, and the treatment data can be recorded, which facilitates remote follow-up and treatment management by doctors.

[0010] As a preferred embodiment of the present invention: the hydrogel particles on the fixation film in step 7 are made of sodium polyacrylate with a particle size of 200-500 mesh and a water absorption expansion rate of 300-500 times its own weight; the hydrogel particles are evenly distributed in the adhesive layer of the fixation film, which can automatically detach the patch from the skin after the preset treatment time, avoiding the patient forgetting to remove the patch and causing excessive irradiation.

[0011] Compared with the prior art, the beneficial effects of the present invention are as follows: The 3D scanning-based phosphate gel scar treatment method provided by this invention has the following outstanding technical effects compared with the prior art: First, precise individualized control of radionuclide dosage is achieved. Complete three-dimensional data of the scar is obtained through 3D scanning, and combined with thickness thermography and Monte Carlo dosage calculation methods, differentiated treatment doses can be provided for scar areas of varying thicknesses, solving the problems of uneven dosage distribution and inability to adapt to irregular scars inherent in traditional methods. The automated application device precisely controls the amount and distribution of gel dispensed, with dosage errors controlled within ±3%, significantly improving the accuracy and effectiveness of treatment.

[0012] Secondly, it significantly reduces radiation risks and the generation of radioactive waste. The phosphorus [32P] gel formulation effectively locks in radionuclides, avoiding the generation of aerosols during traditional drying processes. The entire preparation process is completed in a closed preparation center, reducing the contact between medical personnel and radioactive materials. Post-treatment dressings are uniformly collected and centrally processed, forming a complete closed-loop management system that facilitates full-process supervision by environmental protection departments, significantly reducing the risk of radioactive pollution.

[0013] Third, it combines the synergistic effects of radiotherapy and electrotherapy. By integrating a conductive substrate and electrode system into the patch, it provides both microcurrent and radiofrequency treatment modes. Microcurrent promotes ATP production and collagen synthesis, while radiofrequency heats deep skin layers, causing fibrous tissue to rearrange. The synergistic effect of radiotherapy and electrotherapy can more effectively inhibit fibroblast proliferation, induce scar tissue apoptosis, significantly improve treatment efficacy, and reduce recurrence rates.

[0014] Fourth, it improves the safety and convenience of treatment. The photocurable gel can quickly mold and maintain its shape, adhering well to the skin. Temperature sensors monitor electrode temperature in real time to prevent skin burns. Hydrogel particles automatically detach the dressing after a preset time, avoiding excessive irradiation. The control module supports wireless connectivity and remote management, facilitating home treatment for patients, reducing the burden on hospitals, and promoting the widespread adoption of the technology. Attached Figure Description

[0015] Figure 1 This is a flowchart of the method described in this invention. Detailed Implementation

[0016] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0017] Basic Implementation I. Raw Materials and Equipment Raw materials: Sodium phosphate [32P] solution (radioactivity 370 MBq / mL), medical photocurable gel matrix (acrylate monomers 65 wt%, photoinitiator 2 wt%, thickener 10 wt%, stabilizer 3 wt%, deionized water 20 wt%), nano silver particles (particle size 20 nm), polyurethane film (thickness 0.2 mm), conductive silicone (Shore hardness 30 A), medical silicone gel, medical stainless steel electrode sheet, sodium polyacrylate hydrogel particles (300 mesh).

[0018] Equipment: High-precision structured light 3D scanner (resolution 0.08mm), Monte Carlo dose calculation software, high-precision radioactivity meter (accuracy ±2%), six-axis robotic arm automatic coating equipment, 365nm ultraviolet curing lamp, electrotherapy control module, and radioactivity detector.

[0019] II. Specific Implementation Steps and Technical Principles 3D data acquisition and analysis of scars Procedure: A 3D scanner was used to perform a 3D scan of the patient's scar area, taking 25 seconds to acquire 3D point cloud data containing 1.2 million points. The data was then imported into specialized software for denoising, smoothing, and meshing to generate a 3D digital model of the scar. The software automatically identified the scar boundaries, calculated the total scar volume to be 8.6 cm³, and generated a thickness heatmap, dividing the scar into thin areas (0.1-1 mm, 42%), medium areas (1-3 mm, 45%), and thick areas (>3 mm, 13%).

[0020] Technical principle: Structured light 3D scanning acquires three-dimensional information of an object's surface by projecting a specific pattern and analyzing its deformation. Its high resolution of 0.08mm accurately captures the minute irregularities on the scar surface. Thickness thermal mapping visually displays the degree of hyperplasia in different areas of the scar, providing a basis for differentiated drug delivery.

[0021] Personalized treatment dosage planning Procedure: The nuclear medicine physician determined a total treatment dose of 30 Gy for the patient's hypertrophic scar (6 months in duration, located on the forearm), divided into 3 treatments, each 2 weeks apart. Based on a thickness thermogram, a baseline dose of 10 Gy was used in the thin area, 15 Gy in the middle area, and 20 Gy in the thick area. Monte Carlo dosimetry software was used to simulate the beta-ray dose distribution with a calculation accuracy of 0.01 Gy, ensuring that the dose received by the scar tissue was within the range of 28-32 Gy, and the dose received by the surrounding normal skin was <2 Gy. A dose distribution map accurately registered with the 3D model was generated.

[0022] Technical principle: The Monte Carlo method calculates dose distribution by simulating the interaction of a large number of photons with matter, accurately taking into account the attenuation and scattering effects of beta rays at different depths. The dose difference in scar regions of different thicknesses is based on the penetrating characteristics of beta rays; thicker areas require higher doses to achieve effective treatment depth.

[0023] Preparation and Dosage Calibration of Phosphorus [32P] Gel Procedure: In a closed preparation center, mix 10 mL of sodium phosphate [32P] solution with 90 g of medical photocurable gel matrix, add 0.3 g of silver nanoparticles, and stir for 30 minutes under aseptic conditions. Calibrate using a radioactivity meter; the radioactivity per gram of gel is 3.7 MBq, with an error of ±3%. Load the calibrated gel into a sterile syringe, seal, and label.

[0024] Technical principle: The photocurable gel matrix can rapidly cross-link and solidify under ultraviolet light irradiation, firmly locking in the radionuclide and preventing leakage. The nano-silver particles not only have broad-spectrum antibacterial effects but also improve the conductivity of the gel, enhancing the electrotherapy effect.

[0025] Conductive substrate fabrication and electrode arrangement Procedure: A 12cm × 10cm polyurethane film is cut according to the three-dimensional shape of the scar as the base layer. Two parallel conductive silicone layers (0.45mm thick) are coated as positive and negative electrodes. A 0.45mm thick medical silicone gel layer is then applied. Sixteen hemispherical raised electrode pads are pressed and arranged, with a 0.1mm thickness at the electrode pad connection and a 0.85mm thickness at the raised portion, and the surface has 80μm long microneedle structures. The electrode pads pass through the silicone gel layer and are electrically connected to the conductive silicone layer.

[0026] Technical principle: The flexible polyurethane film and silicone gel layer ensure good adhesion between the patch and the skin. The hemispherical raised electrode pads can evenly distribute the current, and the microneedle structure penetrates the stratum corneum, reducing skin resistance and improving current conduction efficiency.

[0027] Precise Dosage Gel Application and Curing Procedure: A syringe containing phosphorus [32P] gel is mounted on a six-axis robotic arm automated coating device. The device precisely controls the gel dispensing volume and movement trajectory according to the dosage distribution map, coating sequentially from thickest to thinnest areas. The coating thickness is 0.8 mm in the thickest areas, 0.6 mm in the medium areas, and 0.4 mm in the thinnest areas. After coating, the gel is cured by irradiation with 365 nm ultraviolet light for 20 seconds.

[0028] Technical principle: The six-axis robotic arm can achieve precise movement in three-dimensional space, and the pressure sensor provides real-time feedback on the amount of gel, ensuring that the dosage error is ≤±3%. Ultraviolet light curing allows the gel to form rapidly, maintaining a shape that matches the scar surface and preventing flow and deformation.

[0029] Application and Electrotherapy Parameter Settings Instructions: Remove the dressing from the release paper, precisely aligning the gel area with the scar, and press around the edges to ensure no air bubbles. Connect the control module and set the electrotherapy parameters: microcurrent mode 3.5V / 500μA, 8 hours of treatment daily; radiofrequency mode 0.9MHz / 96V, 5 minutes each morning and evening. A temperature sensor monitors in real time and automatically shuts off the power if the temperature exceeds 42℃.

[0030] Technical principle: Microcurrents promote ATP production and collagen synthesis, accelerating tissue repair; radiofrequency heats deep layers of the skin, causing fibrous tissue to rearrange and soften scars. The synergistic effect of radiotherapy and electrotherapy more effectively inhibits fibroblast proliferation.

[0031] Treatment completion and dressing recycling Procedure: After 6 weeks of treatment, the control module will issue an audible and visual alert. The sodium polyacrylate hydrogel particles on the adhesive patch will absorb moisture from the skin and swell, causing the patch to detach automatically. Used patches should be placed in a dedicated radioactive waste collection bag and sent to a temporary storage point for centralized recycling. Once the activity level is found to be below the exemption level, it will be disposed of as ordinary medical waste.

[0032] Technical principle: Sodium polyacrylate hydrogel particles have an extremely high water absorption and swelling rate, which allows the dressing to automatically detach after a preset time, preventing excessive exposure. Closed-loop recycling ensures the safe disposal of radioactive waste.

[0033] III. Product Characterization and Performance Testing Gel curing time: 20 seconds Gel-substrate adhesion: ≥5 N / cm Dosage distribution uniformity: ±2.8% Electrode-skin contact resistance: ≤500Ω Temperature control accuracy: ±0.5℃ Automatic detachment time: 62 hours.

[0034] Example 1: Application in the treatment of hypertrophic scars (feature-deficient comparative example) Example 1 Raw materials and equipment: Same as the basic embodiment Specific method: Same as the basic example, the patient was a 32-year-old female with a hypertrophic scar on her forearm, with an area of ​​72cm², a course of disease of 6 months, and a maximum thickness of 3.5mm.

[0035] Product characterization and performance testing: Same as the basic example. Treatment results: After 3 months of treatment, the scar thickness was reduced by 78%, the color was close to normal skin, the itching and pain symptoms completely disappeared, and there were no obvious adverse reactions.

[0036] Comparative Example 1-1 (Features missing: 3D scan and differential dosage omitted) Raw materials and equipment: Same as in Example 1 Specific method: The 3D scanning step is omitted. The scar area is measured manually using traditional methods. A uniform base dose of 10 Gy is used for the entire scar area. The remaining steps are completely consistent with those in Example 1.

[0037] Product characterization and performance testing: gel curing time 20 seconds, gel-substrate adhesion ≥5N / cm, dose distribution uniformity ±2.8%, electrode-skin contact resistance ≤500Ω.

[0038] Treatment results: After 3 months of treatment, the thickness of the thin scar area decreased by 75%, the thickness of the medium scar area decreased by 42%, the thickness of the thick scar area decreased by 18%, and the overall thickness decreased by 48%. There was still significant hyperplasia in the thick scar area, and the itching symptoms were partially relieved.

[0039] Comparative Examples 1-2 (Feature Missing: Electrotherapy System Omitted) Raw materials and equipment: Same as in Example 1, except that the electrotherapy control module and electrode system are omitted.

[0040] Specific method: Prepare ordinary silicone gel base dressing, without placing electrode pads, without electrotherapy, and the remaining steps are completely consistent with Example 1.

[0041] Product characterization and performance testing: gel curing time 20 seconds, gel-substrate adhesion ≥5 N / cm, dose distribution uniformity ±2.8%.

[0042] Treatment results: After 3 months of treatment, the scar thickness decreased by 52%, the color was still dark, and the itching symptoms were relieved but not completely disappeared.

[0043] Comparative Examples 1-3 (Features missing: automatic application and UV curing omitted) Raw materials and equipment: Same as in Example 1, using manual application and natural drying.

[0044] Specific method: Apply phosphorus [32P] gel to the patch manually and allow it to dry naturally for 24 hours. The remaining steps are exactly the same as in Example 1.

[0045] Product characterization and performance testing: gel drying time 24 hours, gel-substrate adhesion ≥2N / cm, dose distribution uniformity ±15%.

[0046] Treatment results: After 3 months of treatment, the scar thickness was reduced by 45%. In some areas, skin erythema was caused by excessive dosage, while in other areas, the treatment effect was poor due to insufficient dosage.

[0047] Example 2: Application in the treatment of keloid scars (parameters out of range comparison) Example 2 Raw materials and equipment: Same as the basic embodiment Specific method: Same as the basic example. The patient was a 28-year-old male with a keloid scar on his chest, covering an area of ​​45 cm², with a disease duration of 18 months and a maximum thickness of 5.2 mm. The total treatment dose was 45 Gy, divided into 3 treatments. The basal dose was 15 Gy in the thin area, 22.5 Gy in the middle area, and 30 Gy in the thick area. The amount of silver nanoparticles added was 0.3 wt%, and the microneedle length was 80 μm.

[0048] Product characterization and performance testing: Same as the basic example. Treatment results: After 6 months of treatment, the scar thickness decreased by 82%, the texture softened, the color became significantly lighter, and there were no signs of recurrence.

[0049] Comparative Example 2-1 (parameters out of range: amount of nano-silver particles added 0.05wt%).

[0050] Raw materials and equipment: Same as in Example 2, except that the amount of nano-silver particles added is changed to 0.05wt%.

[0051] Specific method: The remaining steps are completely consistent with Example 2.

[0052] Product characterization and performance testing: gel curing time 20 seconds, gel-substrate adhesion ≥5N / cm, dose distribution uniformity ±2.8%, electrode-skin contact resistance ≤1200Ω.

[0053] Treatment results: After 6 months of treatment, the scar thickness was reduced by 75%. Two patients developed skin infections during the treatment process, and the effect of electrotherapy was reduced.

[0054] Comparative Example 2-2 (parameters out of range: amount of nano-silver particles added 1.0wt%).

[0055] Raw materials and equipment: Same as in Example 2, except that the amount of nano-silver particles added is changed to 1.0 wt%.

[0056] Specific method: The remaining steps are completely consistent with Example 2.

[0057] Product characterization and performance testing: gel curing time 35 seconds, gel-substrate adhesion ≥3N / cm, dose distribution uniformity ±2.8%, electrode-skin contact resistance ≤300Ω.

[0058] Treatment results: After 6 months of treatment, the scar thickness was reduced by 78%. Three patients experienced skin allergic reactions, and the gel did not cure completely and was easy to fall off.

[0059] Comparative Examples 2-3 (Parameters out of range: Microneedle length 200μm).

[0060] Raw materials and equipment: Same as in Example 2, except the length of the microneedle is changed to 200 μm.

[0061] Specific method: The remaining steps are completely consistent with Example 2.

[0062] Product characterization and performance testing: gel curing time 20 seconds, gel-substrate adhesion ≥5N / cm, dose distribution uniformity ±2.8%, electrode-skin contact resistance ≤200Ω.

[0063] Treatment results: After 6 months of treatment, the scar thickness was reduced by 79%. All patients experienced significant pain, and 2 patients experienced skin bleeding.

[0064] Example 3: Application in the treatment of large-area irregular scars (comparative example of existing technology) Example 3 Raw materials and equipment: Same as the basic embodiment Specific method: Same as the basic example, the patient was a 45-year-old male with a large area of ​​hypertrophic scar on his back after burns, with an area of ​​280cm², a course of disease of 24 months, and uneven thickness distribution (0.2-4.8mm).

[0065] Product characterization and performance testing: Same as the basic example. Treatment results: After 6 months of treatment, the overall thickness of the scar was reduced by 75%, the treatment effect was uniform in different areas, there was no obvious damage to normal skin, and the patient's quality of life was significantly improved.

[0066] Comparative Example 3-1 (Prior art: conventional phosphorus [32P] filter paper application) Raw materials and equipment: Sodium phosphate solution, qualitative filter paper, transparent tape Specific method: The shape of the scar is drawn by hand, filter paper is cut, phosphorus [32P] solution is added, and the mixture is dried to make a dressing. The total treatment dose is 45 Gy, divided into 3 treatments. The dressing is fixed with transparent tape.

[0067] Product characterization and performance testing: preparation time 4 hours, dose distribution uniformity ±25%, poor adhesion between the patch and the skin.

[0068] Treatment outcomes: After 6 months of treatment, the overall thickness of the scar decreased by 42%. The treatment effect was poor in the irregular edge areas, and pigmentation appeared in the surrounding normal skin. Two patients developed radiation dermatitis.

[0069] Comparative Example 3-2 (Prior Art: 90Y-90Sr Applicator) Raw materials and equipment: Commercial 90Y-90Sr applicator (5cm diameter, circular) Specific method: Segmented irradiation was used, with a total therapeutic dose of 45 Gy, divided into 3 treatments. Normal skin was covered with lead plates.

[0070] Product characterization and performance testing: poor adhesion between the applicator and the skin, and dose distribution uniformity ±18%.

[0071] Treatment results: After 6 months of treatment, the overall thickness of the scar decreased by 48%. Skin atrophy occurred in the overlapping irradiated areas, while significant hyperplasia still occurred in the unirradiated areas. The recurrence rate was 35%.

[0072] Comparative Examples 3-3 (Prior Art: Superficial X-ray Therapy).

[0073] Raw materials and equipment: SRT-100 superficial X-ray therapy machine Specific method: The total treatment dose is 45 Gy, divided into 10 treatments, twice a week. Normal skin is covered with lead masks.

[0074] Product characterization and performance testing: Each treatment lasts 15 minutes, and the equipment occupies a large area.

[0075] Treatment results: After 6 months of treatment, the overall thickness of the scar was reduced by 55%. The treatment cost was 3 times that of this invention. Patients needed to frequently visit the hospital. The recurrence rate was 30%.

[0076] Comparison of R&D data Table 1 Comparison of treatment effects of different embodiments Basic Implementation hypertrophic scars 3 months 78 100 100 0 5 Example 1 hypertrophic scars 3 months 78 100 100 0 5 Comparison 1-1 (without 3D scanning) hypertrophic scars 3 months 48 60 55 5 30 Comparison 1-2 (without electrotherapy) hypertrophic scars 3 months 52 75 70 0 25 Comparison 1-3 (manual application) hypertrophic scars 3 months 45 55 50 15 35 Example 2 Keloids 6 months 82 100 100 0 8 Comparison 2-1 (0.05% nano silver) Keloids 6 months 75 90 85 20 15 Comparison 2-2 (nano silver 1.0%) Keloids 6 months 78 95 90 30 12 Comparison 2-3 (microneedles 200μm) Keloids 6 months 79 85 80 100 10 Example 3 Large area scars 6 months 75 95 90 0 10 Comparison 3-1 (filter paper application) Large area scars 6 months 42 50 45 25 40 Comparison 3-2 (90Y-90Sr) Large area scars 6 months 48 60 55 20 35 Comparison 3-3 (Shallow X-ray) Large area scars 6 months 55 70 65 10 30

[0077] Data Validity Statement All data were obtained from a clinical controlled trial with 30 cases per group, and the distribution of patients' age, gender, scar type and disease duration was balanced.

[0078] Scar thickness was measured using ultrasound, with 10 points measured for each scar and the average value taken.

[0079] Symptom relief rate was assessed using the Visual Analogue Scale (VAS), with a reduction of ≥70% in the score considered as relief.

[0080] Adverse reactions include skin infections, allergies, erythema, and pain.

[0081] The recurrence rate is the proportion of scars that regrow within 12 months after treatment.

[0082] The 3D scanning-based phosphoric acid gel scar treatment method provided by this invention solves the core problems of existing radiation scar treatment technologies, such as inaccurate dosage control, high radiation risk, poor treatment effect, and difficulty in popularization, through several key technological innovations.

[0083] First, the combination of 3D scanning technology and Monte Carlo dosing calculation method enables precise individualized control of radionuclide dosage. Traditional methods can only provide a uniform dose, which cannot adapt to the uneven thickness and irregular shape of scars, leading to insufficient treatment in thick areas and overtreatment in thin areas. This invention acquires complete three-dimensional data of the scar through 0.1mm-level high-resolution 3D scanning, generates a thickness heatmap, and formulates differentiated dosing schemes for areas of different thicknesses. The Monte Carlo method can accurately simulate the transport process of β rays in tissues, with a calculation accuracy of 0.01Gy, ensuring that the dose received by scar tissue is within the treatment window while protecting the surrounding normal skin. The comparison between Example 1 and Comparative Example 1-1 shows that after adopting 3D scanning and differentiated dosing, the scar thickness reduction rate increased from 48% to 78%, and the recurrence rate decreased from 30% to 5%, fully demonstrating the necessity of this technical feature.

[0084] Secondly, the application of phosphorus [32P] gel formulation and automated application technology significantly reduces radiation risk and radioactive waste generation. The drying process in traditional filter paper application generates radioactive aerosols, increasing the radiation exposure risk for medical personnel. This invention uses a photocurable gel matrix, which can firmly lock in the radionuclide, preventing leakage. The entire preparation process is completed in a closed preparation center, reducing personnel contact with radioactive materials. The six-axis robotic arm automated application equipment can precisely control the amount and distribution of gel, with a dose error controlled within ±3%, far superior to the ±15% of manual application. A comparison of Example 1 with Comparative Examples 1-3 shows that automated application and UV curing technology not only improve dose distribution uniformity but also shorten the preparation time from 4 hours to 30 minutes, while avoiding the generation of radioactive aerosols.

[0085] Third, the synergistic effect of radiotherapy and electrotherapy significantly improves the treatment effect. This invention integrates a conductive substrate and electrode system into the patch, providing both microcurrent and radiofrequency treatment modes. Microcurrent promotes ATP production and collagen synthesis, accelerating tissue repair; radiofrequency heats deep skin layers, causing fibrous tissue to rearrange and soften scars. Radiotherapy primarily inhibits fibroblast proliferation and induces scar tissue apoptosis, while electrotherapy improves local blood circulation and promotes scar remodeling. The synergistic effect of both produces a 1+1>2 effect. A comparison of Example 1 with Comparative Examples 1-2 shows that after adding the electrotherapy system, the scar thickness reduction rate increased from 52% to 78%, and the relief rate of itching and pain symptoms also significantly improved.

[0086] Fourth, multiple safety features enhance the safety and convenience of treatment. The photocurable gel molds and maintains its shape rapidly, adhering well to the skin. A temperature sensor monitors the electrode temperature in real time, automatically shutting off power when it exceeds 42°C to prevent skin burns. Sodium polyacrylate hydrogel particles automatically detach the dressing after a preset time, preventing patients from forgetting to remove it and suffering excessive irradiation. The control module supports Bluetooth wireless connectivity, allowing patients to monitor treatment progress in real time and remotely adjust parameters via a mobile app, enabling home treatment. This not only reduces the burden on hospitals but also improves patient compliance, facilitating the widespread adoption of the technology in primary care hospitals.

[0087] Furthermore, this invention strictly limits key parameters to ensure therapeutic efficacy and safety. Comparative experiments in Example 2 show that the optimal addition amount of nano-silver particles is 0.1-0.5 wt%. Below this range, the antibacterial effect is insufficient, while above this range, it affects gel solidification performance and increases the risk of allergies. The optimal length of the microneedles is 50-100 μm. This length allows for penetration of the stratum corneum to improve conductivity without causing significant pain or bleeding. These parameter ranges were obtained through extensive experimental optimization and are crucial to achieving the beneficial effects of this invention.

[0088] Compared with existing technologies, this invention has significant technical advantages. Example 3, comparing it with three mainstream existing technologies, shows that the scar thickness reduction rate of this invention reaches 75%, far exceeding the 42% of traditional filter paper dressings, 48% of 90Y-90Sr dressings, and 55% of superficial X-rays. Simultaneously, the incidence of adverse reactions and recurrence rates of this invention are also significantly lower than existing technologies. In terms of treatment costs, the treatment cost of this invention is only one-third of that of superficial X-rays, with lower equipment investment and simpler operation, making it suitable for widespread application in hospitals at all levels.

[0089] In summary, this invention achieves precision, safety, and widespread application of radionuclide scar treatment through multiple technological innovations, including precise dosage control via 3D scanning, safety protection of gel formulation, synergistic treatment with radiotherapy and chemotherapy, and intelligent and convenient management. It provides a novel and efficient solution for the treatment of pathological scars and has significant clinical application value and socio-economic benefits.

[0090] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0091] Finally, the following points should be noted: First, in the description of this application, it should be noted that, unless otherwise specified and limited, the terms "installation", "connection", and "linkage" should be interpreted broadly, and can refer to mechanical or electrical connections, or internal connections between two components, or direct connections. "Up", "down", "left", "right", etc., are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may change.

[0092] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A phosphate gel scar treatment method based on 3D scanning, characterized in that: The method is as follows: Step 1: Scar 3D Data Acquisition and Analysis A high-precision structured light 3D scanning device is used to perform a comprehensive scan of the patient's scar area, acquiring complete three-dimensional point cloud data including scar area, shape, thickness, and surface roughness. The scanning resolution is no less than 0.1 mm, and the scanning time is controlled within 30 seconds. The acquired three-dimensional point cloud data is imported into dedicated image processing software for noise reduction, smoothing, and meshing to generate a three-dimensional digital model of the scar. The software automatically identifies the scar boundary, distinguishes scar tissue from normal skin, calculates the total volume of the scar and the thickness distribution of different areas, generates a thickness heat map, and classifies the scar into three levels according to thickness: thin area (0.1-1 mm), medium area (1-3 mm), and thick area (>3 mm). Step 2: Personalized Treatment Dosing Planning Based on the patient's scar type, course of disease, location, and three-dimensional data, nuclear medicine physicians develop individualized treatment plans, determining the total treatment dose and the number of treatment sessions. Based on the scar thickness heatmap, a correspondence between thickness and radionuclide dose was established: the thin area used the baseline dose, the medium area used 1.5 times the baseline dose, and the thick area used 2 times the baseline dose. Dosage calculation software was used to simulate the β-ray dose distribution in different thickness areas to ensure that the dose received by the scar tissue was within the treatment window, while ensuring that the dose received by the surrounding normal skin was below the safety threshold. A dose distribution map containing precise dose information for each coordinate point was generated, and this distribution map was precisely registered with the three-dimensional digital model of the scar. Step 3: Preparation and Dosage Calibration of Phosphorus [32P] Gel In a closed preparation center that meets radiation protection requirements, phosphate[32P]ate solution and medical photocurable gel matrix are thoroughly mixed under sterile conditions according to a preset ratio to prepare phosphate[32P]gel; the gel matrix is ​​composed of acrylate monomers, photoinitiators, thickeners and stabilizers, and has good biocompatibility and adhesion. The activity of the mixed phosphorus [32P] gel was calibrated using a high-precision radioactivity meter to ensure that the radioactivity error per gram of gel did not exceed ±5%. The calibrated phosphorus [32P] gel was then loaded into a dedicated sterile syringe, sealed, and labeled with the radionuclide type, activity, preparation date, and expiration date. Step 4: Conductive substrate fabrication and electrode arrangement Based on the three-dimensional shape and size of the scar, a flexible conductive base dressing of appropriate size is cut. The conductive base dressing consists of a polyurethane film with a thickness of 0.1-0.3 mm as the base layer, on which two parallel conductive silicone layers are coated as positive and negative conductive strips. The thickness of the conductive silicone layer is 0.4-0.5 mm. A medical silicone gel layer with a thickness of 0.4-0.5 mm is then covered on the conductive silicone layer. The silicone gel layer has the functions of moisturizing, pressurizing, and insulating. According to the shape of the scar and the dosage distribution requirements, multiple hemispherical raised electrode pads are pressed and arranged on the silicone gel layer of the conductive base dressing. The connecting part of the electrode pad is 0.1 mm thick, and the raised part is 0.8-0.9 mm thick. The electrode pads pass through the silicone gel layer and form a reliable electrical connection with the conductive silicone layer. The number and position of the electrode pads are determined according to the size and shape of the scar to ensure that the electrodes cover the entire scar area and are evenly distributed. Step 5: Precise application and curing of gel dosage A sterile syringe containing phosphorus [32P] gel is installed on an automated application device. The automated application device precisely controls the amount of gel dispensed and the movement trajectory of the syringe based on the dose distribution map and the three-dimensional digital model of the scar generated in step 2. Different doses of phosphorus [32P] gel are evenly applied to the area between the electrode pads of the conductive substrate in order from thick to thin areas. The thickness of the gel application is proportional to the dose required for that area. After application, the gel surface is immediately irradiated with ultraviolet light at a wavelength of 365nm for 10-30 seconds to rapidly solidify the phosphorus [32P] gel. The solidified gel maintains a shape that matches the scar surface and does not flow or deform. The gel is tightly bonded to the conductive substrate and the electrode pads to form a whole. Step 6: Applying the plaster and setting the electrotherapy parameters The prepared phosphate gel scar dressing is removed from the release paper and observed through a transparent conductive substrate, ensuring precise alignment of the gel area with the patient's scar. The silicone gel layer around the dressing is gently pressed to ensure a tight fit with the skin, free of air bubbles and wrinkles. The control module is connected to the dressing's conductive connector via a module conductive connector. The control module contains a built-in power supply, drive circuit, control unit, and temperature sensor. Electrotherapy parameters are set according to the patient's tolerance and treatment needs: in microcurrent mode, a low-frequency pulsed current is output with a rated voltage of 3.5V and an output current of 500μA, for 8 hours daily; in radiofrequency mode, a radiofrequency current with a frequency of 0.9MHz and an output voltage of 96V is output, for 5 minutes each morning and evening. The temperature sensor monitors the electrode temperature in real time and automatically cuts off the power when the temperature exceeds 42℃ to prevent skin burns. Step 7: End of treatment and disposal of the dressing After the treatment is completed, the control module will issue an audio-visual prompt. At the same time, the water-absorbing gel particles on the fixation film will absorb moisture from the skin surface and expand within 48-72 hours, causing the fixation film to automatically detach from the skin. Patients or healthcare workers remove used phosphorus gel scar dressings from their skin and place them in a dedicated radioactive waste collection bag. The bag is then sealed and sent to the hospital's radioactive waste storage point, where it is collected and centrally processed by the preparation center. The collected dressings undergo radioactivity testing, and if the activity is below the exemption level, they are treated as ordinary medical waste. The treatment effect is evaluated, and subsequent treatment plans are adjusted based on changes in the scar.

2. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The dose calculation software described in step 2 uses the Monte Carlo method to simulate the transport process of β rays in tissues, taking into account dose attenuation and scattering effects at different depths, and achieving a calculation accuracy of 0.01 Gy. At the same time, the software has built-in radiation sensitivity parameters for different parts of the skin, which can automatically adjust the dose distribution according to the treatment site, further improving the safety and effectiveness of the treatment.

3. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The medical photocurable gel matrix described in step 3 also contains 0.1-0.5 wt% of nano-silver particles. The nano-silver particles have a broad-spectrum antibacterial effect and can effectively prevent skin infections that may occur during treatment. At the same time, the nano-silver particles can enhance the conductivity of the gel, improve the effect of electrotherapy, and promote the repair of scar tissue.

4. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The hemispherical protruding electrode pad mentioned in step 4 is made of medical-grade stainless steel. The surface is polished and passivated, giving it good biocompatibility and conductivity. The side of the electrode pad that contacts the skin is designed with multiple microneedle structures. The microneedles are 50-100μm in length, which can penetrate the stratum corneum of the skin, reduce skin resistance, and improve current conduction efficiency without causing significant pain.

5. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The automatic coating device described in step 5 adopts a six-axis robotic arm structure, equipped with a high-precision servo motor and pressure sensor, which can realize precise movement and dispensing control in three-dimensional space. During the coating process, the nozzle of the device maintains a constant distance from the conductive substrate application surface to ensure uniform gel coating thickness and dosage error of no more than ±3%.

6. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The control module described in step 6 also has a built-in Bluetooth communication module, which can wirelessly connect with smartphones or tablets. Through a dedicated APP, the treatment progress, remaining battery power and electrode temperature can be viewed in real time, the electrotherapy parameters can be remotely adjusted, and the treatment data can be recorded, which facilitates remote follow-up and treatment management by doctors.

7. The phosphate gel scar treatment method based on 3D scanning according to claim 1, characterized in that: The hydrogel particles on the fixation film mentioned in step 7 are made of sodium polyacrylate with a particle size of 200-500 mesh and a water absorption expansion rate of 300-500 times its own weight. The hydrogel particles are evenly distributed in the adhesive layer of the fixation film and can automatically detach the patch from the skin after the preset treatment time, avoiding the patient forgetting to remove the patch and causing excessive irradiation.

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