Cervical cancer anterior lesion treatment head

Abstract

The invention relates to the technical field of medical instruments, and discloses a cervical cancer precancerous lesion treatment head which comprises a treatment head body, a high-pressure balloon is arranged in the middle of the outer wall of the treatment head body, a light emitting body is arranged in the treatment head body and located in the high-pressure balloon, the high-pressure balloon is made of high-elasticity polyurethane, and the high-pressure balloon is made of high-elasticity polyurethane. Polyurethane can bear internal pressure and cannot be broken, a space is provided for treatment operation, the treatment head body is made of a high-light-transmittance light-transmitting material, the light-transmitting material has light stability, and the light-transmitting material can reduce loss of light in the transmission process. The light transmission loss is reduced through the high-light-transmittance light-transmitting material of the treatment head body, the light intensity and quality are guaranteed, the scattering points on the treatment head body are matched, the light is deeply and evenly radiated to the wrinkled part of the cervical dome at the deep position of the cervical canal and the dense scattering points, and the problem that the treatment effect is not ideal due to incomplete irradiation is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and specifically to a treatment head for cervical pre-cancerous lesions. Background Art

[0002] Cervical cancer is one of the malignant tumors that seriously threaten women's health globally and ranks among the top in the incidence rate of female malignant tumors. According to relevant data of the World Health Organization, the number of newly diagnosed cervical cancer cases is huge every year, and a considerable proportion of patients die due to failure to receive timely and effective treatment. If cervical pre-cancerous lesions can be detected and treated early, the risk of cervical cancer can be significantly reduced. Therefore, its treatment plays a key role in the prevention and control system of cervical cancer.

[0003] As a new treatment method, photodynamic therapy (PDT) shows unique advantages in the treatment of cervical pre-cancerous lesions. Existing photodynamic therapy devices for cervical pre-cancerous lesions have many limitations in clinical applications. From an anatomical perspective, the structure of the cervix is relatively complex. The cervical canal has a certain depth, and there are a large number of folds at the cervical fornix. During traditional treatment, when light is transmitted to the deep part of the cervical canal, due to the absorption and scattering of light by tissues, the energy will be severely attenuated. This results in insufficient light energy excitation of photosensitizers in the deep part of the cervical canal, and thus the number of reactive oxygen species generated is insufficient, making it impossible to completely eliminate cancer cells, greatly reducing the treatment effect and affecting the overall treatment effect and the prognosis of patients. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a treatment head for cervical pre-cancerous lesions, which solves the problem of unsatisfactory treatment effect caused by incomplete irradiation.

[0005] To achieve the above objectives, the present invention is realized through the following technical solutions: A treatment head for cervical pre-cancerous lesions, including a treatment head body. A high-pressure balloon is arranged in the middle of the outer wall of the treatment head body. A light-emitting body is arranged inside the treatment head body, and the light-emitting body is located inside the high-pressure balloon. The high-pressure balloon is made of high-elastic polyurethane, and the polyurethane can withstand the internal pressure without rupture, providing space for treatment operations. The treatment head body is made of a light-transmitting material with a high light transmittance. The light-transmitting material has light stability and can reduce the loss of light during transmission. The light-emitting body is composed of diffused optical fibers, and the diffused optical fibers continuously scatter during propagation and finally penetrate from the surface of the optical fibers.

[0006] Preferably, the overall shape of the high-pressure balloon is cylindrical, and the cylindrical shape can fit the vagina. One end of the high-pressure balloon is conical for inserting into the vagina.

[0007] Preferably, the treatment head body is provided with scattering points, which are in a dense state in the part close to the deep part of the cervical canal and in a gradually dispersed state in the part close to the cervical orifice, for scattering the bright light in different directions.

[0008] Preferably, the diffused optical fiber is in the visible light band, and the wavelength of the diffused optical fiber is between 400 - 700 nm.

[0009] A preparation method of a light-emitting body for a treatment head for precancerous lesions of the cervix, comprising the following steps: S1. Material preparation: Select high-purity quartz glass as the core material, fluoropolymer as the cladding material, and prepare titanium dioxide scattering particles; S2. Preparation of the optical fiber preform: The core material is made into a core rod through a specific process and mixed with scattering particles, and then a cladding is formed on the core rod; S3. Optical fiber drawing: Heat the preform on a drawing tower and draw it into a thin wire, control the parameters to ensure uniform diameter, and conduct real-time monitoring; S4. Post-treatment: Perform surface treatment and coating of a protective layer on the optical fiber; S5. Performance testing: Test the optical performance of the optical fiber, conduct optical transmission loss, scattering characteristics, and mechanical properties such as tensile strength and bending performance to ensure meeting the usage requirements.

[0010] Preferably, the material preparation in S1 includes the following steps: S101. Quartz glass has extremely low optical loss and high transparency, which is suitable for long-distance optical transmission; S102. Fluoropolymer has a refractive index lower than that of the core material, ensuring that light is transmitted through the principle of total internal reflection in the core material; S103. The size of the titanium dioxide scattering particles is between 0.1 - 1 μm, and they are doped in the core material for light diffusion.

[0011] Preferably, the preparation of the optical fiber preform in S2 includes the following steps: S201. Melt high-purity quartz raw materials into a liquid state at high temperature, and make a core rod with a certain shape through a mold; according to needs, mix a certain proportion of scattering particles into the core material raw materials, and the addition amount of the scattering particles is controlled between 0.1% - 5% of the core material mass; S202. On the basis of the core rod, sleeved a prefabricated cladding tube outside the core rod, and make the two closely combined through the processes of heating and stretching.

[0012] Preferably, the optical fiber drawing in S3 includes the following steps: S301. Install the prepared optical fiber preform on the optical fiber drawing tower, heat the fused silica optical fiber to 1900 - 2200 °C to soften the optical fiber preform and make the fused silica optical fiber in a stretchable state; S302. Use a traction device to stretch the softened preform into a filamentous shape at a speed of 1 - 10 m / s to form an optical fiber, and make the final diameter of the optical fiber between 50 - 500 μm.

[0013] Preferably, the post-treatment in S4 includes the following steps: S401. Perform surface treatment on the drawn fused silica optical fiber to improve the surface smoothness and corrosion resistance, and remove the microscopic defects and impurities on the surface through chemical etching treatment; S402. To protect the optical fiber, coat a layer of acrylate coating on the surface of the optical fiber. The thickness of the coating is between 10 - 100 μm, and the coating is used to prevent the optical fiber from being affected by the external environment.

[0014] Preferably, the performance test in S5 includes the following steps: S501. Use a spectral analyzer to test the loss of the optical fiber in the visible light band. Ensure that the fused silica optical fiber has a low loss in the working wavelength range of <1 dB / km; by inputting laser light at one end of the optical fiber and observing the light intensity distribution along the length of the optical fiber, evaluate whether its dispersion effect meets the design requirements; S502. Perform a tensile strength test on the optical fiber. Ensure that the fused silica optical fiber can withstand a tensile force of more than 500 N without breaking to meet the usage requirements in the treatment head body; by bending the optical fiber to a radius of 5 - 20 mm and observing the change in its light transmission performance, ensure that the optical fiber can still work normally in the bent state.

[0015] The present invention provides a treatment head for cervical pre-cancerous lesions. It has the following beneficial effects: 1. The present invention reduces the light transmission loss through the high light transmittance material of the treatment head body to ensure the light intensity and quality. Cooperating with the scattering points on the treatment head body, in the deep part of the cervical canal, the dense scattering points allow the light to penetrate deeply and evenly irradiate the folded parts of the cervical fornix, solving the problem of unsatisfactory treatment effect caused by incomplete irradiation.

[0016] 2. The present invention realizes the low light transmission loss and good scattering characteristics of the optical fiber through the materials and preparation processes. The low loss ensures that the light emitted by the light-emitting body can be transmitted to the treatment site with a relatively high intensity, improving the utilization efficiency of light energy and solving the problem of low light transmission efficiency.

[0017] 3. By mixing an appropriate amount of scattering particles during the production of the mandrel in the present invention, when the finally produced optical fiber emits light, the light can be scattered inside the optical fiber and when passing through the surface of the optical fiber. This scattering effect enables the light to be more evenly distributed within the treatment head body, avoiding the situation where light is concentrated in certain areas while causing insufficient illumination in other areas, providing more uniform illumination conditions for the treatment of precancerous cervical lesions, and solving the problem of poor light uniformity.

[0018] 4. By controlling the heating temperature and maintaining a stable drawing speed in the present invention, precise control of the optical fiber diameter is achieved, enabling the optical fiber to adapt to the internal structure of the treatment head, be stably installed and operate in the treatment head, ensuring that light can be effectively transmitted in the optical fiber, and solving the problem of inaccurate precise dimension control.

[0019] 5. Through surface treatment in the present invention, the smoothness of the optical fiber surface is improved, reducing the scattering and absorption of light on the optical fiber surface, thereby improving the light transmission efficiency. This enables the optical fiber to stably transmit light under various usage conditions, providing a reliable guarantee for the normal operation of the treatment head and solving the problem of poor transmission stability.

[0020] 6. Through loss testing and tensile strength testing, not only is it ensured that the optical fiber has low loss and good dispersion performance in the visible light band, but also it is ensured that the optical fiber has sufficient mechanical strength and flexibility, meeting the requirements for light uniformity in treatment, ensuring the stability and reliability of the treatment head, adapting to different clinical operation environments, improving the treatment effect, and solving the problem of easy damage to the optical fiber. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic plan view of the present invention; Figure 2 is an enlarged schematic view of the treatment head body of the present invention; Figure 3 is a schematic diagram of the scattering path of the present invention; Figure 4 is a flowchart architecture diagram of the preparation method of the light-emitting body of the present invention.

[0022] Among them, 1. High-pressure balloon; 2. Light-emitting body; 3. Treatment head body. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0023] The technical solutions of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0024] Please refer to the attachedFigure 1 - Attachment Figure 3 In an embodiment of the present invention, a treatment head for cervical precancerous lesions is provided, which includes a treatment head body 3. A high-pressure balloon 1 is provided in the middle of the outer wall of the treatment head body 3. A light-emitting body 2 is provided inside the treatment head body 3, and the light-emitting body 2 is located inside the high-pressure balloon 1. The high-pressure balloon 1 is made of highly elastic polyurethane, and the polyurethane can withstand the internal pressure without bursting, providing space for treatment operations. The treatment head body 3 is made of a light-transmitting material with a high light transmittance. The light-transmitting material has light stability and can reduce the loss of light during transmission. The light-emitting body 2 is composed of diffused optical fibers. The diffused optical fibers continuously scatter during propagation and finally emerge from the surface of the optical fiber. The overall shape of the high-pressure balloon 1 is cylindrical, and the cylindrical shape can fit the vagina. One end of the high-pressure balloon 1 is conical for inserting into the vagina. The treatment head body 3 is provided with scattering points. The scattering points are in a dense state in the part close to the deep part of the cervical canal and in a gradually dispersed state in the part close to the cervical orifice, for scattering the bright light in different directions. The diffused optical fibers are in the visible light band, and the wavelength of the diffused optical fibers is between 400 - 700 nm.

[0025] Specifically, before the treatment begins, gas is injected into the high-pressure balloon 1. Since the high-pressure balloon 1 is made of highly elastic polyurethane, this material has good elasticity and compressive resistance and can withstand the internal pressure without bursting. As the gas is injected, the high-pressure balloon 1 begins to expand, and its overall shape becomes cylindrical, which can closely fit the inner wall of the vagina, creating a stable spatial environment for subsequent treatment operations. At the same time, the conical design at one end of the high-pressure balloon 1 enables it to be inserted into the vagina more smoothly, reducing the resistance and discomfort during the insertion process. The treatment head body 3 is made of a light-transmitting material with a high light transmittance and light stability. When the light emitter 2 starts to work and emits light, the light enters the interior of the treatment head body 3. Due to the characteristics of the light-transmitting material, during the light transmission process, the absorption and scattering of light by the material itself are extremely small, thereby effectively reducing the energy loss of the light during transmission and ensuring that the light can be propagated with a high intensity and quality, providing a sufficient light energy basis for subsequent treatment. The light emerging from the surface of the diffused optical fiber will further pass through the scattering points on the treatment head body 3. These scattering points are not evenly distributed on the treatment head body 3, but are in a dense state in the part closer to the deep part of the cervical canal and in a gradually dispersed state in the part closer to the cervical orifice. When the light irradiates these scattering points, scattering occurs again. In the deep part of the cervical canal, the dense scattering points enable the light to irradiate more deeply into this area and make the light distribution more uniform, thereby providing sufficient and uniform light energy excitation for the photosensitizer applied in the deep part of the cervical canal; near the cervical orifice, the dispersed scattering points can radiate the light to the folded parts of the cervical fornix, enabling the photosensitizer in this area to be effectively excited. After absorbing the energy carried by the photons, the photosensitizer transitions from the ground state to the excited state, and through a chemical de-excitation process, a large amount of reactive oxygen species are generated, which interact with various biological macromolecules in cancer cells, destroying the cell structure and affecting cell function, ultimately achieving the purpose of killing cancer cells and treating cervical precancerous lesions.

[0026] The high light transmittance light-transmitting material of the treatment head body 3 reduces the light transmission loss, ensuring the light intensity and quality. The diffused optical fiber of the light emitter 2 operates in the visible light band, and the light is continuously scattered and transmitted during propagation. In cooperation with the scattering points on the treatment head body 3, in the deep part of the cervical canal, the dense scattering points allow the light to irradiate deeply and evenly; near the cervical orifice, the dispersed scattering points enable the light to irradiate the folded parts of the cervical fornix. It realizes a comprehensive and uniform light coverage of the lesion areas at different positions of the cervix, solving the problem of unsatisfactory treatment effect caused by incomplete irradiation.

[0027] Please refer to the appendix Figure 4 , a preparation method of a light emitter 2 for a treatment head for cervical precancerous lesions, comprising the following steps: S1. Material preparation: Select high-purity quartz glass as the core material, fluoropolymer as the cladding material, and prepare titanium dioxide scattering particles; S2. Preparation of optical fiber preform: The core material is made into a core rod through a specific process and mixed with scattering particles, and then a cladding is formed on the core rod. S3. Optical fiber drawing: The preform is heated on a drawing tower and drawn into a thin wire, and parameters are controlled to ensure uniform diameter while real-time monitoring is carried out. S4. Post-treatment: The optical fiber is subjected to surface treatment and coated with a protective layer. S5. Performance testing: The optical performance of the optical fiber is tested, including optical transmission loss, scattering characteristics, and mechanical properties such as tensile strength and bending performance, to ensure meeting the usage requirements.

[0028] The material preparation in S1 includes the following steps: S101. Quartz glass has extremely low optical loss and high transparency, being suitable for long-distance optical transmission. S102. Fluoropolymer has a refractive index lower than that of the core material, ensuring that light is transmitted through the principle of total internal reflection in the core material. S103. The size of titanium dioxide scattering particles is between 0.1 - 1 μm, and they are doped in the core material for light diffusion.

[0029] Specifically, high-purity quartz glass is selected as the core material because it has extremely low optical loss and high transparency, enabling efficient long-distance optical transmission and laying a foundation for the subsequent propagation of light in the optical fiber. Fluoropolymer is used as the cladding material, and its refractive index is lower than that of the core material. Based on the principle of total internal reflection of light, it can ensure the stable transmission of light in the core material and prevent light from leaking outside the optical fiber. Titanium dioxide scattering particles with a size between 0.1 - 1 μm are prepared, and these particles will be doped in the core material. During the subsequent light propagation process, they interact with light, triggering scattering phenomena, thereby achieving the light diffusion effect.

[0030] Through the materials and preparation process, low optical transmission loss and good scattering characteristics of the optical fiber are achieved. The low loss ensures that the light emitted by the light-emitting body 2 can be transmitted to the treatment site with a relatively high intensity, improving the utilization efficiency of light energy. The good scattering characteristics enable the light to uniformly penetrate from the surface of the optical fiber, forming a uniform illumination area in the treatment head body 3, providing a stable and reliable light source for the treatment of cervical precancerous lesions. The problem of low light transmission efficiency is solved.

[0031] The preparation of the optical fiber preform in S2 includes the following steps: S201. The high-purity quartz raw material is melted into a liquid state at high temperature and made into a core rod with a certain shape through a mold; according to needs, a certain proportion of scattering particles are mixed into the core material raw material, and the addition amount of the scattering particles is controlled between 0.1% - 5% of the core material mass. S202. On the basis of the core rod, a prefabricated cladding tube is sleeved outside the core rod, and the two are tightly combined through heating and stretching processes.

[0032] Specifically, high-purity quartz raw materials are placed in a high-temperature environment to reach the melting point and melt into a liquid state. Utilizing the specific shape of the mold, the liquid quartz is formed within the mold to create a core rod prototype with a certain shape and size. During this process, according to the requirements for the light scattering effect, scattering particles such as titanium dioxide are mixed into the core material raw materials. Since the refractive index of the scattering particles is different from that of the quartz core material, when light encounters these scattering particles during subsequent propagation, the propagation direction will change, thereby achieving light scattering. By precisely controlling the addition amount of the scattering particles between 0.1% and 5% of the core material mass, the degree of light scattering can be adjusted to meet the requirements of the light distribution for the treatment head. The prefabricated cladding tube has specific material properties, and its refractive index is lower than that of the quartz material of the core rod. After the cladding tube is sleeved outside the core rod, it is heated to soften the cladding tube, and at the same time, a certain external force is applied using the stretching process, so that the cladding tube closely adheres to the surface of the core rod. During this process, based on the principle of total internal reflection of light, when light propagates in the core rod to the interface with the cladding, if the incident angle is greater than the critical angle, the light will undergo total internal reflection at the interface, thereby being restricted to propagate within the core rod and preventing light from leaking outside the optical fiber, ensuring that the light can be stably transmitted along the axial direction of the core rod.

[0033] By mixing an appropriate amount of scattering particles during the production of the core rod, when the finally produced optical fiber emits light, the light can be scattered both inside the optical fiber and when it emerges from the surface of the optical fiber. This scattering effect enables the light to be more evenly distributed within the treatment head body 3, avoiding the situation where the light is concentrated in certain areas and resulting in insufficient illumination in other areas, providing a more uniform illumination condition for the treatment of precancerous lesions of the cervix. It solves the problem of poor light uniformity.

[0034] The optical fiber drawing in S3 includes the following steps: S301. Install the prepared optical fiber preform on the optical fiber drawing tower, heat the quartz glass optical fiber to 1900 - 2200 °C to soften the optical fiber preform and make the quartz glass optical fiber in a stretchable state; S302. Use the traction device to stretch the softened preform into a filamentous shape at a speed of 1 - 10 m / s to form an optical fiber, and make the final diameter of the optical fiber between 50 - 500 μm.

[0035] Specifically, the optical fiber drawing tower is equipped with an accurate heating system. After installing the prepared optical fiber preform on the drawing tower, the quartz glass optical fiber is heated. The temperature is controlled within the specific range of 1900 - 2200 °C because within this temperature range, the molecular structure of the quartz glass will change, the chemical bonds inside it become relatively active, and the rigidity of the material decreases, thus softening the optical fiber preform. This softened state enables the optical fiber preform to have stretchability, creating the necessary physical conditions for subsequent drawing into a filamentous optical fiber. A traction device is used to apply a certain pulling force to uniformly traction the softened preform at a speed of 1 - 10 m / s. During this process, since the preform is in a softened state, under the action of the pulling force, its material will gradually be stretched and thinned. By precisely controlling the traction speed and the magnitude of the pulling force, it can be ensured that the diameter of the optical fiber changes uniformly during the stretching process. At the same time, the diameter of the optical fiber is continuously monitored to make its final diameter stable between 50 - 500 μm to meet the requirements of the fiber size of the light-emitting body 2 in the treatment head, ensuring that the optical fiber can work properly in the treatment head and achieve the expected optical performance.

[0036] Through the control of the heating temperature and a stable traction speed, precise control of the optical fiber diameter is achieved. The obtained optical fiber diameter is between 50 - 500 μm, meeting the dimensional standards designed for the treatment head. This enables the optical fiber to adapt to the internal structure of the treatment head, be stably installed and work in the treatment head, ensuring that light can be effectively transmitted in the optical fiber and achieving the expected lighting effect within the treatment head body 3. The problem of inaccurate precise control of the size is solved.

[0037] The post-treatment in S4 includes the following steps: S401. The surface of the drawn quartz glass optical fiber is treated to improve the surface smoothness and corrosion resistance. Through chemical etching treatment, the tiny flaws and impurities on the surface are removed; S402. To protect the optical fiber, an acrylate coating is applied on the surface of the optical fiber. The thickness of the coating is between 10 - 100 μm, and the coating is used to prevent the optical fiber from being affected by the external environment.

[0038] Specifically, the chemical etching treatment utilizes specific chemical etching agents to react with the surface of the quartz glass optical fiber. These etching agents can selectively act on the minute defects and impurities on the fiber surface, dissolving them or converting them into substances that can be removed. For example, certain etching agents can react with the metal impurities or oxides on the fiber surface to form soluble salts, which are then removed from the fiber surface through the cleaning process. By precisely controlling parameters such as the etching time, temperature, and etching agent concentration, it is ensured that while removing impurities, the fiber body is not overly corroded, thereby improving the surface smoothness and corrosion resistance. The acrylate coating uniformly covers the fiber surface through a coating process. During the coating process, methods such as dip coating, spray coating, or spin coating can be used to apply the liquid acrylate material onto the fiber surface. By controlling the parameters of the coating equipment, such as the dip coating time, spray pressure, or spin coating speed, the coating thickness is stabilized between 10 - 100 μm. After curing, the acrylate material forms a protective film with a closely arranged molecular structure, which can block the erosion of moisture, chemical substances, and microorganisms in the external environment on the optical fiber.

[0039] Through surface treatment, the smoothness of the fiber surface is improved, reducing the scattering and absorption of light on the fiber surface, thereby enhancing the light transmission efficiency. At the same time, the enhanced corrosion resistance enables the optical fiber to maintain stable physical and optical properties in a complex chemical environment, extending the service life of the optical fiber. The acrylate coating effectively isolates the influence of the external environment on the optical fiber. Moisture cannot penetrate into the fiber interior, avoiding the degradation or damage of the fiber performance caused by moisture. Chemical substances also hardly react with the fiber body, protecting the material structure of the fiber. This enables the optical fiber to stably transmit light under various usage conditions, providing a reliable guarantee for the normal operation of the treatment head. The problem of poor transmission stability is solved.

[0040] The S5 performance test includes the following steps: S501. Use a spectral analyzer to test the loss of the optical fiber in the visible light band, ensuring that the quartz glass optical fiber has a low loss within the working wavelength range of <1 dB / km; by inputting a laser at one end of the optical fiber and observing the light intensity distribution along the length of the optical fiber, evaluate whether its dispersion effect meets the design requirements; S502. Conduct a tensile strength test on the optical fiber, ensuring that the quartz glass optical fiber can withstand a tensile force of more than 500 N without breaking, meeting the usage requirements in the treatment head body 3; by bending the optical fiber to a radius of 5 - 20 mm and observing the change in its light transmission performance, ensure that the optical fiber can still work normally in the bent state.

[0041] Specifically, the spectrum analyzer tests the optical fiber loss by emitting light of a specific wavelength and detecting the change in light intensity after passing through the optical fiber. In the visible light band, light of known intensity and wavelength is input from one end of the optical fiber, and the optical signal is received by a detector at the other end. According to the difference in light intensity before and after transmission and the transmission distance, the loss value is obtained according to the optical loss calculation formula to determine whether it meets the requirement of less than 1dB / km. For the evaluation of the dispersion effect, after inputting laser into one end of the optical fiber, light intensity detectors are set at different positions along the length of the optical fiber, and the light intensity data of each point is collected and recorded. The uniformity and change trend of the light intensity distribution are analyzed, and compared with the expected dispersion effect of the design to determine whether it meets the requirements. The tensile strength test uses a tensile testing machine to fix the two ends of the optical fiber on the fixture of the testing machine, and then gradually increase the tension at a certain rate while monitoring the state of the optical fiber. When the optical fiber breaks, the tension value at this time is recorded to determine whether it reaches more than 500n. In the bending performance test, a special bending device is used to bend the optical fiber to a radius of 5-20mm. During the bending process, the transmission of light in the optical fiber is maintained. By detecting changes in parameters such as power and wavelength of light transmission before and after bending, it is determined whether the optical transmission performance of the optical fiber in the bent state is normal.

[0042] Through precise loss testing and tensile strength testing, it is not only ensured that the optical fiber has low loss and good dispersion performance in the visible light band, but also ensured that the optical fiber has sufficient mechanical strength and flexibility to meet the treatment requirements for light uniformity, ensure the stability and reliability of the treatment head, adapt to different clinical operating environments, and improve the treatment effect. The problem of optical fiber being easily damaged is solved.

[0043] Working principle: The high-pressure balloon is made of highly elastic polyurethane. After inflation, it expands into a cylindrical shape to fit the vagina. The conical end is easy to insert, creating a stable space for treatment operations. The treatment head body is made of a material with high light transmittance and light stability to reduce light transmission loss. The illuminant is a diffuse optical fiber, and its preparation process includes several key steps. First, in terms of material preparation, high-purity quartz glass core material, fluoropolymer cladding material and titanium dioxide scattering particles are selected. In the preparation of the optical fiber preform, the quartz raw material is melted at high temperature to form a core rod and mixed with scattering particles, and then the cladding tube is put on and tightly combined by heating and stretching. The preform is then heated on the drawing tower and stretched into a filament, while the parameters are controlled to ensure uniform diameter and real-time monitoring. After drawing, the surface is treated and coated with an acrylic protective layer. The prepared diffuse optical fiber is in the visible light band. The light is continuously scattered and transmitted during propagation. Through the specially distributed scattering points on the treatment head body, the light is densely scattered deep in the cervical canal to radiate deeply and evenly, and the light is dispersed and scattered at the cervical canal opening to reach the cervical vault folds. Ultimately, the cervical lesions can be fully and evenly illuminated, stimulating the photosensitizer to produce reactive oxygen species to kill cancer cells.

[0044] Although embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A cervical precancerous lesion treatment head, comprising a treatment head body (3), characterized in that: A high-pressure balloon (1) is arranged in the middle of the outer wall of the treatment head body (3), and a light-emitting body (2) is arranged inside the treatment head body (3). The light-emitting body (2) is located inside the high-pressure balloon (1). The high-pressure balloon (1) is made of high-elasticity polyurethane. The polyurethane can withstand internal pressure without breaking, thereby providing space for treatment operations. The treatment head body (3) is made of a light-transmitting material with high light transmittance. The light-transmitting material has light stability and can reduce the loss of light during transmission. The light-emitting body (2) is made of a diffuse optical fiber. The diffuse optical fiber is continuously scattered during the transmission process and finally shines out from the surface of the optical fiber.

2. The cervical precancerous lesion treatment head according to claim 1, characterized in that: The high-pressure balloon (1) is cylindrical in shape as a whole, and the cylindrical shape can fit into the vagina; one end of the high-pressure balloon (1) is conical in shape for insertion into the vagina.

3. The cervical precancerous lesion treatment head according to claim 1, characterized in that: The treatment head body (3) is provided with scattering points, the scattering points are densely packed in the part close to the deep part of the cervical canal, and gradually dispersed in the part close to the opening of the cervical canal, so as to radiate the light from the scattering points in different directions.

4. The cervical precancerous lesion treatment head according to claim 1, characterized in that: The dispersed optical fiber is in the visible light band, and the wavelength of the dispersed optical fiber is between 400-700nm.

5. A cervical precancerous lesion treatment head according to any one of claims 1 to 4, characterized in that: The preparation method of the luminous body (2) comprises the following steps: S1. Material preparation: high-purity quartz glass is selected as the core material, fluoropolymer is used as the cladding material, and titanium dioxide scattering particles are prepared; S2, preparation of optical fiber preform rods, through a specific process, the core material is made into a core rod and mixed with scattering particles, and then a cladding is formed on the core rod; S3, optical fiber drawing, heating the preform on the drawing tower and stretching it into filaments, controlling parameters to ensure uniform diameter, and performing real-time monitoring; S4, post-processing, surface treatment of the optical fiber and coating of a protective layer; S5. Performance test: Test the optical performance of the optical fiber, including light transmission loss, scattering characteristics, and mechanical properties such as tensile strength and bending performance to ensure that they meet the requirements.

6. The cervical precancerous lesion treatment head according to claim 5, characterized in that: The material preparation in S1 includes the following steps: S101, quartz glass has extremely low light loss and high transparency, suitable for long-distance light transmission; S102, Fluoropolymer has a lower refractive index than the core material, which ensures that light is transmitted in the core material by the principle of total reflection; S103, titanium dioxide scattering particles with a size between 0.1-1μm, are doped into the core material for light diffusion.

7. The cervical precancerous lesion treatment head according to claim 5, characterized in that: The preparation of the optical fiber preform in S2 comprises the following steps: S201, melting high-purity quartz raw materials into liquid at high temperature, and making a core rod with a certain shape through a mold; mixing a certain proportion of scattering particles into the core material raw materials as needed, and the amount of scattering particles added is controlled between 0.1% and 5% of the core material weight; S202. On the basis of the core rod, a prefabricated cladding tube is put on the outside of the core rod, and the two are tightly combined through a heating and stretching process.

8. The cervical precancerous lesion treatment head according to claim 5, characterized in that: The optical fiber drawing in S3 comprises the following steps: S301, installing the prepared optical fiber preform on an optical fiber drawing tower, heating the quartz glass optical fiber to 1900-2200° C., softening the optical fiber preform, and making the quartz glass optical fiber in a stretchable state; S302, using a pulling device to stretch the softened preform rod into a filament at a speed of 1-10 m / s to form an optical fiber, so that the final diameter of the optical fiber is between 50-500 μm.

9. The cervical precancerous lesion treatment head according to claim 5, characterized in that: The post-processing in S4 comprises the following steps: S401, performing surface treatment on the drawn quartz glass optical fiber to improve the surface smoothness and corrosion resistance, and removing tiny surface flaws and impurities through chemical etching; S402. In order to protect the optical fiber, a layer of acrylic coating is applied on the surface of the optical fiber. The thickness of the coating is between 10-100 μm. The coating is used to prevent the optical fiber from being affected by the external environment.

10. The cervical precancerous lesion treatment head according to claim 5, characterized in that: The S5 performance test includes the following steps: S501. Use a spectrum analyzer to test the loss of the optical fiber in the visible light band. For quartz glass optical fiber, ensure that the loss is low within the working wavelength range of <1dB / km. Input laser into one end of the optical fiber, observe the light intensity distribution along the length of the optical fiber, and evaluate whether its dispersion effect meets the design requirements. S502, performing a tensile strength test on the optical fiber to ensure that the quartz glass optical fiber can withstand a tensile force of more than 500N without breaking, thereby meeting the use requirements in the treatment head body (3); by bending the optical fiber to a radius of 5-20mm, observing the change in its light transmission performance, ensuring that the optical fiber can still work normally in the bent state.

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