Double-cavity radiotherapy and chemotherapy integrated treatment bag for brain glioma

Abstract

The invention relates to a double-cavity radiotherapy and chemotherapy integrated treatment capsule for brain glioma, which aims to solve the problems that the existing radioactive seed source or chemotherapy carrier cannot give consideration to radiotherapy and chemotherapy, the dosage is difficult to regulate and control, the medicine distribution is non-uniform and the like. The brain glioma double-cavity radiotherapy and chemotherapy integrated treatment bag is composed of a radiotherapy pipeline and a chemotherapy pipeline, the whole integrated treatment bag is a spiral pipe body, the radiotherapy pipeline is located in an inner ring, the chemotherapy pipeline is located in an outer ring, the radiotherapy pipeline is a closed cavity, a liquid radioactive source is contained in the closed cavity, and the liquid radioactive source is located in an outer ring. The chemotherapy medicine is released from the head end of the chemotherapy pipeline, the chemotherapy medicine is injected from the tail end of the chemotherapy pipeline, and the surface of the integrated treatment bag is coated with a composite antibacterial layer. According to the integrated treatment capsule, radiopharmaceuticals and chemical drugs are placed in the inner cavity and the outer cavity respectively, synergistic treatment of radiotherapy and chemotherapy is achieved through the synchronous effect of the two channels, and long-term low-dose release of the radiopharmaceuticals and the chemotherapy drugs is achieved and toxic and side effects are reduced by adjusting the screw pitch and the thickness of the tube wall.

Description

Technical Field

[0001] This invention belongs to the field of comprehensive tumor treatment technology, specifically relating to a dual-cavity radiotherapy and chemotherapy treatment capsule device for individualized treatment of glioma. Background Technology

[0002] Research on the treatment of gliomas has always been a key focus in the fields of medicine and bioengineering. Due to the complexity of the human brain and its close relationship with various physiological functions, surgical resection alone is often insufficient to completely eliminate lesions, resulting in a high recurrence rate and failing to meet the comprehensive needs of clinical treatment. Therefore, radiotherapy and chemotherapy have gradually become crucial components of comprehensive glioma treatment systems. Their combined application has been proven to synergistically enhance treatment efficacy, delay tumor recurrence, and improve the overall prognosis of patients to some extent.

[0003] In this process, the structural design of radiotherapy and chemotherapy devices has a significant impact on treatment efficacy. Current radiotherapy capsules primarily achieve localized high-dose radiation by precisely guiding the spatial distribution of the radiation source, thereby effectively killing tumor cells. Chemotherapy capsules, on the other hand, rely on sustained-release and targeted delivery technologies to directly deliver drugs to the lesion area, reducing systemic toxicity. However, current radiotherapy and chemotherapy carriers used in the treatment of gliomas still face several technical bottlenecks.

[0004] Existing radiotherapy capsules or seed-based devices mostly adopt a cylindrical structure, primarily using titanium as the encapsulation material. These devices present the following problems in clinical use: (1) The activity of radionuclides decays over time, making it difficult to maintain a stable therapeutic dose; (2) Insufficient uniformity of dose distribution makes it difficult to accurately control the intensity of local irradiation; (3) The radiation source dose is not adjustable and cannot be dynamically adjusted according to changes in the patient's condition during treatment; (4) Replacing or removing the seed source requires craniotomy, which carries a high risk and the treatment cannot be repeated; (5) This type of structure can only achieve the function of radiotherapy and cannot take into account the local release and control of chemotherapy drugs.

[0005] On the other hand, existing chemotherapy carrier structures also have significant shortcomings. Most drug carriers are difficult to control precisely during drug release, resulting in uneven drug concentration distribution; and they generally lack the ability to be re-injected and dose-adjusted. Once the drug release is completed or the patient's condition changes, a second surgery is required to replace or replenish the drug, increasing treatment risks and the burden on patients.

[0006] In summary, most existing radiotherapy and chemotherapy devices for gliomas are single-function structures, making it difficult to achieve simultaneous and synergistic effects of radiotherapy and chemotherapy. These issues result in long treatment cycles, difficulties in dosage control, uneven drug distribution, and poor patient compliance. These problems have become key technical bottlenecks restricting the further development of comprehensive treatment for gliomas. Summary of the Invention

[0007] The purpose of this invention is to solve the problems of existing radioactive seed sources or chemotherapy carriers that cannot simultaneously perform radiotherapy and chemotherapy, are difficult to control dosage, have uneven drug distribution, and cannot achieve individualized treatment, and to provide a dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma.

[0008] This invention relates to a dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma, which consists of a radiotherapy conduit and a chemotherapy conduit. The radiotherapy conduit and the chemotherapy conduit are not interconnected. The integrated treatment capsule is shaped like a spiral tube, with the radiotherapy conduit located in the inner circle and the chemotherapy conduit located in the outer circle. The radiotherapy conduit is a closed cavity containing a liquid radiation source. Chemotherapy drugs are released from the head end of the chemotherapy conduit and injected from the tail end of the chemotherapy conduit. The surface of the integrated treatment capsule is coated with a nano-silver-chitosan composite antibacterial layer.

[0009] This invention relates to a dual-cavity integrated radiotherapy and chemotherapy treatment capsule for gliomas, comprising a radiotherapy conduit and a chemotherapy conduit, wherein the inner cavity is the radiotherapy conduit and the outer cavity is the chemotherapy conduit. The radiotherapy conduit forms a closed cavity to contain a liquid radiation source (such as ¹²). 5 I, ¹³¹I); The chemotherapy conduit forms an open channel at its tip for the continuous release of chemotherapy drugs (such as doxorubicin, temozolomide, etc.). The two lumens are separated by independent septa, and the tube body adopts a spiral flat structure, highly conforming to the postoperative tumor residual cavity. The overall structure is made of medical-grade polymer materials (such as PTFE or PEEK), and an antibacterial composite coating is applied to the outer surface of both the radiotherapy and chemotherapy conduits to enhance anti-infection properties and biocompatibility.

[0010] Compared with existing radiotherapy and chemotherapy methods for gliomas, which suffer from problems such as separation of radiotherapy and chemotherapy, imprecise dosage control, and uneven drug distribution, the dual-cavity integrated radiotherapy and chemotherapy treatment capsule for gliomas of this invention has the following significant advantages and technical effects:

[0011] 1. Achieving integrated and precise radiotherapy and chemotherapy: This invention places radiopharmaceuticals and chemotherapy drugs in separate inner and outer cavities. Through the synchronous action of the two channels, radiotherapy and chemotherapy can be synergistically treated in the same implantation procedure, avoiding the clinical risks of multiple surgeries and multiple localizations, and improving overall treatment efficiency and patient compliance.

[0012] 2. Uniform dose distribution and strong targeting: The spiral dual-cavity structure design, with optimized spacing between the inner and outer cavities, pitch and drug release aperture, makes the radiation dose distribution more uniform, local dose deviation controlled within ±10%, and chemotherapy drug concentration gradient stable, effectively reducing the risk of radiation exposure to adjacent normal brain tissue.

[0013] 3. Personalized and adjustable design: Through three-dimensional reconstruction of the patient's MRI images, the pitch, inner diameter and outer diameter of the treatment cyst can be modeled individually, so that the cyst shape can be precisely matched with the spatial shape of the patient's glioma, thereby maximizing the coverage of the lesion area and reducing the drug efficacy attenuation in the gap area.

[0014] 4. Controlled release and long-term efficacy: By adjusting the pitch and wall thickness, long-term low-dose release of radiopharmaceuticals and chemotherapeutic drugs can be achieved, maintaining local high drug concentration and reducing systemic toxic side effects.

[0015] 5. Simple manufacturing and low cost: This invention uses 3D printing technology to quickly realize the manufacturing of individualized structures with high printing accuracy and material utilization rate of over 90%. The overall preparation cycle is shortened to less than 24 hours, which is about 70% shorter than the production cycle of traditional customized implants, significantly reducing the cost of clinical use.

[0016] 6. A nano-silver-chitosan composite antibacterial layer was introduced onto the inner and outer surfaces of the radiotherapy and chemotherapy conduits. This coating is composed of nano-silver particles with excellent broad-spectrum antibacterial properties and highly biocompatible natural polymer chitosan, forming a dense and stable functional layer. This composite antibacterial layer can continuously release low concentrations of silver ions after microcavity capsule implantation, inhibiting bacterial adhesion and biofilm formation, thereby significantly reducing the risk of postoperative infection. Simultaneously, the chitosan substrate improves the release rate and distribution uniformity of silver ions, avoiding cytotoxicity problems caused by excessively high local concentrations. Furthermore, this composite antibacterial layer also acts as a physical barrier layer, preventing chemotherapy drugs from penetrating into the radiotherapy channel during transport, further ensuring the independence of drug efficacy and radiation dose.

[0017] 7. High structural safety and implant compatibility: The capsule material is made of biocompatible polymer material with high mechanical strength and good flexibility. After implantation, it can fit well into brain tissue, avoid displacement and deformation, and ensure the simultaneous and stable administration of radiotherapy and chemotherapy. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the implantation of the dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma according to the present invention;

[0019] Figure 2 This is a schematic diagram of the integrated treatment capsule in the sixth specific implementation method;

[0020] Figure 3This is a schematic diagram of the integrated treatment capsule in the seventh specific implementation method;

[0021] Figure 4 This is a comparative test diagram of radial absorbed dose rate of three different types of radioactive sources in the embodiment;

[0022] Figure 5 This is a physical image of the dual-cavity radiotherapy and chemotherapy integrated treatment capsule for gliomas, which was prepared using 3D printing technology in this embodiment. Detailed Implementation

[0023] Specific Implementation Method 1: In this implementation method, the dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma consists of a radiotherapy conduit and a chemotherapy conduit, which are not interconnected. The integrated treatment capsule is shaped like a spiral tube, with the radiotherapy conduit located in the inner circle and the chemotherapy conduit in the outer circle. The radiotherapy conduit is a closed cavity containing a liquid radiation source. Chemotherapy drugs are released from the head end of the chemotherapy conduit and injected from the tail end of the chemotherapy conduit. The surface of the integrated treatment capsule is coated with a nano-silver-chitosan composite antibacterial layer.

[0024] This embodiment of the dual-cavity chemoradiotherapy treatment capsule for glioma integrates radiotherapy and chemotherapy functions. It employs a parallel dual-cavity structure design, with the inner cavity for radiopharmaceutical delivery and the outer cavity for chemotherapeutic drug release, achieving synergistic effects of local radiotherapy and chemotherapy and significantly improving the local control rate of glioma lesions. Based on preoperative or postoperative brain MRI data, the capsule can automatically segment and reconstruct the three-dimensional morphology of the glioma. According to the shape, volume, and location of the lesion, key geometric parameters such as the pitch, microcavity diameter, and overall capsule diameter of the treatment capsule are individually designed to ensure a high degree of fit between the treatment capsule structure and the lesion cavity, thereby optimizing dose distribution and reducing radiation damage to surrounding tissues.

[0025] This implementation integrates radiotherapy and chemotherapy functions through a dual-cavity helical structure, enabling precise radiotherapy and synergistic local chemotherapy treatment of the glioma lesion area, thereby significantly improving treatment efficiency and safety. Through geometric optimization of the helical structure and spatial synergistic design of the radiotherapy and chemotherapy conduits, a gradient irradiation distribution with a high central dose and a low peripheral dose can be achieved. Simultaneously, combined with external cavity sustained-release chemotherapy, continuous drug action and a synergistic effect of radiotherapy are achieved, improving tumor killing efficiency and reducing recurrence rates.

[0026] Specific Implementation Method Two: This implementation method differs from Specific Implementation Method One in that the dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma is made using 3D printing technology.

[0027] In this embodiment, the dual-cavity integrated radiotherapy and chemotherapy treatment capsule for glioma is fabricated using 3D printing technology. First, the patient's brain MRI image data is imported into 3D modeling software. Then, image segmentation and 3D reconstruction algorithms are used to obtain the 3D contour of the tumor. Based on the tumor's spatial morphology, an individualized dual-cavity spiral model is designed. After optimization, the model is input into a medical 3D printing device, and medical-grade materials are used for printing. The printing accuracy can reach ±0.1 mm, and the printing time is approximately 3 hours. After printing, the surface is smoothed and sterilized. After implantation, the radiotherapy conduit slowly releases radiopharmaceuticals, achieving localized low-dose continuous irradiation, while the chemotherapy conduit simultaneously releases chemotherapeutic drugs, achieving a synergistic anti-tumor effect. The implantation path can be optimized by shortening the tube length and increasing the spiral angle.

[0028] Specific Implementation Method 3: This implementation method differs from Specific Implementation Method 2 in that it uses polytetrafluoroethylene (PTFE) slurry or polyetheretherketone (PEEK) slurry through a 3D printing photocuring molding process.

[0029] In this embodiment, polytetrafluoroethylene (PTFE) or polyetheretherketone (PEEK) is selected as the capsule material, addressing the requirements of high biocompatibility and high radiation resistance, respectively. Both materials can be precisely processed during 3D printing, ensuring that the capsule maintains stable performance under high-dose radiotherapy conditions.

[0030] Polytetrafluoroethylene (PTFE): PTFE has good biocompatibility, inertness, and ease of processing, and can be used to create individualized capsule structures through 3D printing templates. It also exhibits excellent radiation resistance, withstanding a maximum gamma radiation dose of approximately 60 kGy, making it suitable for carrying liquid radioactive sources.

[0031] Polyetheretherketone (PEEK): PEEK has high mechanical strength, radiation resistance and chemical stability. It can maintain structural integrity and mechanical properties under irradiation environment, making it an ideal medical implant material, especially suitable for radiotherapy scenarios that require high irradiation doses.

[0032] Specific Implementation Method Four: This implementation method differs from Specific Implementation Method Three in that the printed layer thickness is controlled to be 10–25 μm, the exposure time to be 1.2–1.8 s, and the light intensity to be controlled to be 3–6 mW / cm² during the 3D printing photopolymerization process. 2 3D printing is performed, followed by immersion in an ethanol solution and then a secondary UV light-enhanced curing process.

[0033] This implementation method utilizes the geometric characteristics of the spiral structure and employs a variable density support strategy: high-density supports are configured in the spiral corner areas, while low-density supports are configured in the straight sections, to prevent the hollow cavity from collapsing, shifting, or locally warping during printing. After printing, residual photosensitive resin is removed by a rotary immersion process, and the internal cavity undergoes secondary UV-curing to ensure sufficient mechanical strength and chemical stability of the cavity walls. The final product then undergoes surface smoothing treatment to ensure unobstructed cavity flow, uniform wall thickness, and that the pitch and cavity diameter meet individual design requirements.

[0034] Compared to traditional homogeneous microcavity implants, the 3D printing process described in this embodiment offers significant advantages in terms of forming precision, cavity patency, and structural stability of the helical dual-cavity microstructure. First, MRI data-driven individualized 3D modeling allows for precise adjustment of the pitch, cavity diameter, and outer diameter of the treatment capsule according to the patient's tumor morphology, achieving a high degree of conformity with the tumor residual cavity and thus improving the uniformity of radiotherapy and chemotherapy doses in the target area. Second, the ultra-thin layer thickness of 10–25 μm and optimized exposure parameters control the wall thickness error of the microcavity structure to the micrometer level, significantly reducing the risk of cavity blockage or deformation. Third, the variable density support strategy effectively solves the problem of self-weight collapse of the dual-cavity helical structure during printing, ensuring stable forming of the long-range helical cavity. Furthermore, the rotary immersion and secondary UV curing processes further improve the smoothness, radiation resistance, and chemical corrosion resistance of the cavity walls, providing reliable assurance for subsequent continuous injection of radiation sources and chemotherapy drugs. Overall, the above manufacturing process ensures high-precision forming of the treatment capsule at low cost and short cycle time, giving it good clinical implantation stability and safety.

[0035] Specific Implementation Method 5: This implementation method differs from Specific Implementation Methods 1 to 4 in that the inner diameter of the radiotherapy conduit is 0.1 to 2.0 mm, and the thickness of the conduit wall is 0.1 to 1.0 mm.

[0036] The pitch range of this embodiment is 1 to 10 mm, which can be adjusted according to the size and spatial morphology of the patient's brain tumor; the wall thickness has a certain degree of flexibility and compressive strength to ensure morphological stability after implantation.

[0037] Specific Implementation Method Six: This implementation method differs from Specific Implementation Methods One to Five in that the inner diameter of the chemotherapy conduit is 0.1 to 2.0 mm, and the wall thickness of the chemotherapy conduit is 0.1 to 1.0 mm.

[0038] Specific Implementation Method Seven: This implementation method differs from Specific Implementation Methods One to Six in that the integrated treatment capsule is a single-tube capsule A, with the radiotherapy conduit 2 and the chemotherapy conduit 1 set in separate cavities.

[0039] This embodiment uses a single-capsule, dual-lumen model as follows: Figure 2 As shown, the surface of the single-tube capsule A is the capsule wall 4. Two unconnected microcavities are established within the same capsule A, serving as the radiotherapy conduit and the chemotherapy conduit, respectively, separated by a thin wall 3. This model has a compact structure and a thin capsule wall, which facilitates the transmission of radioactive energy and improves irradiation efficiency.

[0040] Specific Implementation Method Eight: This implementation method differs from Specific Implementation Methods One to Seven in that the integrated treatment capsule is a double-tube capsule B, with the radiotherapy channel 2 and the chemotherapy channel 1 set separately.

[0041] The double-capsule, double-lumen model in this embodiment is as follows: Figure 3 As shown, the double-capsule, double-cavity structure consists of two single-capsule, single-cavity units connected side-by-side, with the surface of the double-capsule, double-cavity structure being the capsule wall 4. Each single-capsule, single-cavity model contains only one type of channel, and a multi-cavity structure can be achieved by combining multiple capsule modules. This design features a simple fabrication process, moderate capsule wall thickness, and a large inter-cavity spacing, which facilitates implantation and radiation source replacement. The double-capsule, double-cavity structure is suitable for the treatment of complex intracranial gliomas, and the number and distribution of microcavities can be flexibly configured according to the lesion morphology.

[0042] Specific Implementation Method Nine: This implementation method differs from Specific Implementation Methods One through Eight in that the preparation process of the nano-silver-chitosan composite antibacterial layer is as follows:

[0043] 1. Dissolve chitosan in a 1%–2% acetic acid solution and stir to form a chitosan solution;

[0044] 2. Add nano-silver sol to the chitosan solution and stir to obtain a composite solution;

[0045] 3. The composite liquid is coated onto the surface of the integrated treatment capsule by spraying or spin coating, and after drying and curing, a nano-silver-chitosan composite antibacterial layer is formed.

[0046] This embodiment adds a nano-silver-chitosan composite antibacterial layer to the outer wall of the double-cavity capsule, which has antibacterial, anti-inflammatory and anti-biofilm functions; the coating is compatible with the radiation environment and maintains stable structure and antibacterial properties under gamma ray conditions, significantly reducing the implantation infection rate.

[0047] Specific Implementation Method 10: This implementation method differs from Specific Implementation Methods 1 to 9 in that when the diameter of the glioma is less than 2 cm, the diameter of the integrated treatment capsule spiral structure is 8-10 mm.

[0048] Specific Implementation Method Eleven: This implementation method differs from Specific Implementation Methods One to Nine in that when the diameter of the glioma is greater than 3 cm, the diameter of the integrated treatment capsule spiral structure is 10-20 mm.

[0049] Example: In this example, the dual-cavity integrated radiotherapy and chemotherapy treatment capsule for glioma consists of a radiotherapy conduit and a chemotherapy conduit. The integrated treatment capsule is either a single-tube capsule A or a double-tube capsule B. The radiotherapy conduit and the chemotherapy conduit are not interconnected. The integrated treatment capsule is a spiral tube in shape, with the radiotherapy conduit 2 located in the inner circle and the chemotherapy conduit 1 located in the outer circle. The radiotherapy conduit is a closed cavity, with both ends sealed by gel. The closed cavity contains a liquid radiation source. Chemotherapy drugs are released from the head end of the chemotherapy conduit and injected from the tail end of the chemotherapy conduit. The surface of the integrated treatment capsule is coated with a nano-silver-chitosan composite antibacterial layer.

[0050] In this embodiment, the integrated therapeutic capsule is reconstructed three-dimensionally based on the patient's brain MRI image data, and an individualized spiral structure design is generated according to the geometric characteristics of the tumor remnant cavity. After the structural model is completed, it is manufactured using a high-precision stereolithography 3D printing machine. During the 3D printing process, the layer thickness is set to 15 μm, the exposure time is 1.5 s, and the light intensity is controlled at 4 mW / cm². 2 To ensure the complete molding of the microscale helical cavity, a variable density support strategy is employed, taking into account the geometric characteristics of the helical structure: high-density supports are configured in the helical corner areas, while low-density supports are configured in the straight sections, to prevent the hollow cavity from collapsing, shifting, or locally warping during printing. After printing, residual photosensitive resin is removed using an ethanol solution through a rotary immersion process, and the internal cavity undergoes a secondary UV-curing treatment to ensure sufficient mechanical strength and chemical stability of the cavity walls. The final product then undergoes surface smoothing treatment to ensure unobstructed cavity flow, uniform wall thickness, and that the pitch and cavity diameter meet individual design requirements.

[0051] This embodiment of a dual-cavity integrated radiotherapy and chemotherapy treatment capsule for gliomas utilizes a dual-cavity design, allowing for multiple injections or replacements of the radioactive liquid source after capsule implantation. This embodiment employs a "two-stage gel sealing" structure at the end of the radiotherapy conduit: first, a first-stage gel with punctureability and short-term self-healing sealing properties is injected, followed by a second-stage gel with long-term stability, forming a double liquid-tight barrier. Both gels possess good biocompatibility and can be injected and solidified in situ under image guidance. The stability time of the second-stage gel is designed to be significantly longer than the decay period of the radioactive liquid source used, ensuring continuous lumen sealing and preventing leakage during the natural decay of radioactivity. When changing the radioactive liquid source, the first-stage gel can be punctured under image guidance to aspirate and re-inject the radioactive liquid, thus achieving flexible and replaceable radiotherapy doses while maintaining a safe seal. This allows for dynamic dose control of chemotherapy drugs, enabling adjustments to the treatment plan based on changes in the patient's condition without the need for a second craniotomy. Conformal fit and leak-proof design: The treatment capsule adopts a flat spiral and loop-shaped cavity structure, which is highly compatible with the geometry of the residual cavity after surgery. This ensures that the radiation dose is concentrated on the lesion while significantly reducing the impact on healthy tissue. The double-layered capsule wall and independent access structure effectively prevent the leakage of radiopharmaceuticals and chemotherapy drugs from the puncture site, improving treatment safety.

[0052] like Figure 1 As shown in the figure, in this embodiment, the tail end of the dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma is implanted subcutaneously at the patient's treatment site for puncture drug administration and radiation source injection; the head end is implanted at the tumor site in the body, adjacent to the lesion tissue, to achieve precise irradiation and release of chemotherapy drugs.

[0053] The radiotherapy drugs in this embodiment can be selected according to needs. 125 I, 131 Low-energy gamma radiation sources such as Class I; chemotherapy drugs such as doxorubicin, doxorubicin, temozolomide, and cisplatin can be used alone or in combination to achieve a synergistic effect of radiotherapy and chemotherapy.

[0054] The treatment capsule is designed with a flattened spiral shape, highly conforming to the postoperative cavity shape of glioma surgery, allowing it to fit the tumor edge as closely as possible and minimizing radiation damage to surrounding healthy tissues. The internal spiral design effectively counteracts the effects of gravity, ensuring uniform distribution of the liquid radiation source and chemical agents within the capsule.

[0055] The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for gliomas in this embodiment allows for multiple injections of radioactive solutions and chemotherapy drugs, enabling treatment regimen updates without the need for a second craniotomy. Individualized treatment dosage control can be achieved by replacing radiopharmaceuticals with different activity levels. Simultaneously, the dual-chamber design effectively prevents leakage of radioactive materials and chemotherapy drugs from the puncture site, ensuring treatment safety.

[0056] like Figure 4As shown, the radial absorbed dose rate distribution results comparing the traditional radioactive source (Type 6711 seed source) with the single-capsule dual-cavity model and the dual-capsule dual-cavity model of this invention show that the dose rate of all three structures decreases rapidly with increasing radial distance; the central dose rate of the traditional seed source is low, making it difficult to reach the lethal dose for gliomas (approximately 73–80 Gy); the central dose rate of the structure of this invention is significantly improved, achieving efficient tumor cell killing while maintaining a safe threshold (≤160 Gy); simultaneously, due to the sustained-release effect of the outer chemotherapy channel, it can continuously inhibit the growth of residual tumor cells during radiotherapy intervals, achieving a synergistic effect of radiotherapy and chemotherapy. The therapeutic capsule can be implanted in the body for a long time, and drugs and radioactive sources can be repeatedly injected or replaced through the tail end interface without the need for re-opening the skull. Antibacterial and anti-contamination: The antibacterial coating on the outer surface can effectively inhibit bacterial growth.

Claims

1. A dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma, characterized in that... The dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma consists of a radiotherapy conduit and a chemotherapy conduit, which are not interconnected. The integrated treatment capsule is shaped like a spiral tube, with the radiotherapy conduit located in the inner circle and the chemotherapy conduit in the outer circle. The radiotherapy conduit is a closed cavity containing a liquid radiation source. Chemotherapy drugs are released from the head end of the chemotherapy conduit and injected from the tail end of the chemotherapy conduit. The surface of the integrated treatment capsule is coated with a nano-silver-chitosan composite antibacterial layer.

2. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... The dual-chamber chemoradiotherapy capsule for gliomas is manufactured using 3D printing technology.

3. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 2, characterized in that... It is made by using polytetrafluoroethylene slurry or polyetheretherketone slurry through 3D printing photocuring molding process.

4. The dual-cavity radiotherapy and chemotherapy integrated treatment capsule for glioma according to claim 3, characterized in that... During the 3D printing photopolymerization process, the printed layer thickness was controlled to be 10–25 μm, the exposure time to be 1.2–1.8 s, and the light intensity to be controlled to be 3–6 mW / cm². 2 3D printing is performed, followed by immersion in an ethanol solution and then a secondary UV light-enhanced curing process.

5. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... The inner diameter of the radiotherapy conduit is 0.1–2.0 mm, and the thickness of the conduit wall is 0.1–1.0 mm.

6. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... The integrated treatment capsule is a single-tube capsule A, with separate cavities for the radiotherapy conduit (2) and the chemotherapy conduit (1).

7. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... The integrated treatment capsule is a double-tube capsule B, with separate tubes for radiotherapy (2) and chemotherapy (1).

8. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... The preparation process of the nano-silver-chitosan composite antibacterial layer is as follows:

1. Dissolve chitosan in a 1%–2% acetic acid solution and stir to form a chitosan solution; 2. Add nano-silver sol to the chitosan solution and stir to obtain a composite solution; 3. The composite liquid is coated onto the surface of the integrated treatment capsule by spraying or spin coating, and after drying and curing, a nano-silver-chitosan composite antibacterial layer is formed.

9. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... When the diameter of a glioma is less than 2 cm, the diameter of the integrated therapeutic spiral structure is 8-10 mm.

10. The dual-chamber integrated radiotherapy and chemotherapy treatment capsule for glioma according to claim 1, characterized in that... When the diameter of a glioma is greater than 3 cm, the diameter of the integrated treatment capsule spiral structure is 10-20 mm.

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