A sensitized internal radiotherapy device

Abstract

The present invention provides a sensitized internal radiotherapy device, which includes an injection part, a catheter, inner and outer balloons, a radioactive solution and a radiosensitizing material. Through the design of two balloon cavities, the volume adjustment of the radiotherapy solution and the timely replenishment of the radiosensitizing material are realized to ensure the continuous effectiveness of the treatment. The radiosensitizing material can enhance the sensitivity of tumor cells to radiotherapy, and contains a component with a magnetothermal effect. An external electromagnetic field can raise the temperature to enhance the killing effect of the rays. The injection part adopts an integrally formed structure to improve the sealing performance and reduce the risk of leakage. The device is used to solve the problem of the edge infiltration of healthy tissues around the tumor after resection, and has recyclability, puncture resistance, convenient fixation and flexible operation, and is particularly suitable for the postoperative adjuvant treatment of malignant tumors such as glioblastoma and breast cancer.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a sensitization-type internal radiotherapy device. Background Art

[0002] In the vast field of tumor treatment, many tumor cells exhibit extremely strong invasive properties, and can quickly infiltrate and surround surrounding healthy tissues. This makes treatment plans that rely solely on surgical resection often have limited effectiveness, especially in the postoperative adjuvant treatment stage. Brachytherapy, as a highly effective treatment method, has been widely adopted to meet this challenge. However, although traditional afterloading therapy can accurately deliver high-dose radiation to destroy tumor cells, its side effects cannot be ignored - high radiation doses may cause damage to adjacent normal tissues, thereby inducing a series of complications. To make it more complicated, some afterloading therapy strategies require the deployment of multiple catheters around residual or recurrent tumors after surgery, which not only leads to uneven dose distribution, but also easily induces high-radiation necrosis due to the concentrated dose at the proximal end of radiotherapy, greatly affecting the safety and effectiveness of the treatment.

[0003] In recent years, rapid advances in medical technology have spawned a revolutionary low-dose internal radiotherapy device. By encapsulating low-dose radioactive material within specialized capsules, this device utilizes long-term, sustained low-dose radiation to provide a safe and effective new approach to radiotherapy for the tumor bed following tumor resection. Compared to traditional high-dose afterloading therapy, this novel device significantly reduces potential damage to surrounding normal tissue, improving patients' quality of life. However, its design flaws are also evident: the dense pseudopod structures surrounding the device, intended to stabilize it, inadvertently increase the risk of damage to normal tissue, while its complexity also makes it inconvenient to operate. Furthermore, while its single radiotherapy mode effectively eliminates tumors, it also inevitably causes accidental damage to normal cells, lacking the ability to specifically kill tumor cells.

[0004] Given the limitations of the above-mentioned treatment methods, how to ensure the treatment effect while minimizing damage to surrounding normal tissues, enhancing the specific killing of tumor cells, and improving the sensitivity of tumor cells to internal radiotherapy has become a key problem that needs to be overcome in the field of tumor treatment.

[0005] To address these challenges, the present invention proposes a sensitized internal radiotherapy device, which is designed specifically for treating tumors with marginal infiltration of surrounding healthy tissues after surgical resection. The device is placed in close contact with the wall of the resection cavity, and the dose distribution it generates conforms to the target tissues around the cavity, ensuring the uniformity of radiotherapy. The device can release radiosensitizing substances, significantly enhancing the sensitivity of tumor cells to radiotherapy. As the treatment progresses, doctors can flexibly adjust the irradiation dose and replenish the radiosensitizing substances as needed. After the treatment, the device can be conveniently retrieved, effectively avoiding potential long-term adverse reactions. Summary of the Invention

[0006] The object of the present invention is to overcome the deficiencies of the prior art and provide a sensitized internal radiotherapy device.

[0007] The technical solution of the present invention is outlined as follows:

[0008] A sensitized internal radiotherapy device includes an injection part 1, a catheter 2, an inner balloon 3, an outer balloon 4, a radioactive solution 5, and a radiosensitizing material 6; the inner balloon 3 is sleeved on the distal end of the catheter 2 and is connected to the injection part 1 through a first flow channel 11 and a first injection cavity 13, and is used to accommodate the radioactive solution 5; the outer balloon 4 is sleeved outside the inner balloon 3 and is connected to the injection part 1 through a second flow channel 12 and a second injection cavity 14, and is used to accommodate and release the radiosensitizing material 6; the inner balloon 3 and the outer balloon 4 are arranged in a coaxial nested manner, and by injecting the radioactive solution 5 and the radiosensitizing material 6 respectively, sensitized internal radiotherapy and dose regulation are realized.

[0009] The injection part 1 includes an injection main body 10, a first flow channel 11, a second flow channel 12, a first injection cavity 13, a second injection cavity 14, a first injection cavity touch top 15, a second injection cavity touch top 16, a first injection cavity barrel 17, a second injection cavity barrel 18, a first injection cavity plug 19, a second injection cavity plug 110, and a lower edge 111 of the injection part; the first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity plug 19. The first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172, and a first injection cavity barrel water hole 173. The upper end of the first injection cavity barrel annular wall 171 contacts the first injection cavity touch top 15. The lower end of the first injection cavity barrel annular wall 171 is provided with the first injection cavity barrel water hole 173, and the first injection cavity barrel water hole 173 corresponds to the position of the first flow channel 11. The lower end of the first injection cavity barrel annular wall 171 is connected to the first injection cavity barrel bottom 172; the second injection cavity barrel 18 is enclosed in the second injection cavity 14 by the second injection cavity plug 110. The second injection cavity barrel 18 includes a second injection cavity barrel annular wall 181, a second injection cavity barrel bottom 182, and a second injection cavity barrel water hole 183. The upper end of the second injection cavity barrel annular wall 181 contacts the second injection cavity touch top 16. The lower end of the second injection cavity barrel annular wall 181 is provided with the second injection cavity barrel water hole 183, and the second injection cavity barrel water hole 183 corresponds to the position of the second flow channel 12. The lower end of the second injection cavity barrel annular wall 181 is connected to the second injection cavity barrel bottom 182.

[0010] The catheter 2 includes a tube body 20, a first catheter cavity 21, a second catheter cavity 22, a first tube body hole 23, a second tube body hole 24, and a visualization tip 25; the inner balloon 3 includes an inner balloon bonding part 31 and an inner balloon expansion part 32. The inner balloon bonding part 31 is bonded to the catheter 2, and the inner balloon expansion part 32 wraps the visualization tip 25 of the catheter 2. The inner balloon 3 and the catheter 2 enclose a first balloon cavity 33; the outer balloon 4 includes an outer balloon bonding part 41 and an outer balloon expansion part 42. The outer balloon expansion part is provided with a permeation hole 43. The outer balloon 4 wraps the inner balloon 3. The outer balloon bonding part 41 is bonded to the catheter 2. The outer balloon 4, the inner balloon 3, and the catheter 2 jointly enclose a second balloon cavity 44; one end of the first flow channel 11 communicates with the first injection cavity 13, and the other end of the first flow channel 11 communicates with the first catheter cavity 21. The first tube body hole 23 communicates the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 communicates with the second injection cavity 14, and the other end of the second flow channel 12 communicates with the second catheter cavity 22. The second tube body hole 24 communicates the second catheter cavity 22 and the second balloon cavity 44.

[0011] The radioactive solution 5 contains one or more radionuclides among iodine-125, palladium-103, gold-198, lutetium-177, cesium-131, strontium-89, yttrium-90 or phosphorus-32; the radiosensitizing material 6 contains at least one of the following materials that enhance the radiotherapy effect: gold, platinum, bismuth, tungsten or rare earth elements, oxides of Fe, Zn, Co, Mn or Ni, nanodiamonds, C60 carbon nanotubes, selenium nanoparticles or ferrocene composite nanoparticles, and one or more chemotherapeutic drugs.

[0012] Furthermore, the radiosensitizing material 6 is liquid at normal temperature and gradually solidifies when approaching body temperature.

[0013] Furthermore, the radiosensitizing material 6 contains a magnetothermal effect component material, and the radiosensitizing material 6 can be heated by applying an external alternating magnetic field to increase the sensitivity of radiotherapy.

[0014] Optionally, the size of the first injection cavity touch top 15 is larger than the size of the second injection cavity touch top 16.

[0015] Furthermore, the first injection cavity barrel 17 and the second injection cavity barrel 18 are made of hard materials.

[0016] Furthermore, a circular hole 112 is provided at the lower edge 111 of the injection part for further operation or fixation.

[0017] The radiosensitizing material 6 is arranged on the outer surface of the outer balloon expansion part 42, and the outer balloon expansion part 42 may optionally not be provided with a permeation hole 43.

[0018] The advantages of the present invention are:

[0019] Low-dose high-efficiency treatment: By using a low-dose radioactive solution, the present invention can significantly reduce the damage to surrounding normal tissues, especially nerve tissues, while ensuring the treatment effect.

[0020] Recyclability: The device design allows for convenient recovery after the treatment is completed, effectively avoiding the adverse reactions that may be caused by long-term implantation in the body, and improving the safety of the treatment and the comfort of the patient.

[0021] Dual-balloon cavity design: Combining the design of the inner balloon cavity and the outer balloon cavity enables the volume of the radiotherapy solution to be adjusted according to the changes in the surgical cavity, and at the same time, the radiosensitizing material can be supplemented in a timely manner to ensure the continuity and effectiveness of the treatment process, and avoid the problem of weakening the treatment effect due to the metabolism of the material by the human body.

[0022] Magnetothermal effect enhanced treatment: The radiosensitizing material contains a magnetothermal effect component material, and can be heated by applying an external electromagnetic field, thereby increasing the killing effect of rays on tumor cells and further reducing the damage to normal tissues.

[0023] Puncture resistance: The injection cavity barrel is made of hard material, which improves the puncture resistance of the device and reduces the risk of device damage caused by piercing the first injection cavity seal and the second injection cavity seal during the puncture operation.

[0024] Sealing performance: The injection part adopts two puncture sites, namely the first injection cavity touch top and the second injection cavity touch top, and is integrally formed with the injection main body, with better sealing effect, effectively reducing the risk brought by the leakage of radioactive solution.

[0025] Convenient fixation: The circular hole provided at the lower edge of the injection part facilitates the fixation of the device, effectively preventing the possible displacement of the device during use and ensuring the accuracy and stability of the treatment.

[0026] Flexible operability: By puncturing the first injection cavity touch top and the second injection cavity touch top respectively, it is convenient to inject, replace or extract radioactive solution and radiosensitizing materials, providing greater operation flexibility and treatment accuracy for doctors.

[0027] Wide application prospect: The present invention is particularly suitable for the postoperative adjuvant treatment of malignant tumors such as glioma and breast cancer, providing a safer and more effective treatment option for patients. Brief description of the drawings

[0028] Figure 1 It is a schematic three-dimensional structure diagram of a radiosensitizing internal radiotherapy device of the present invention.

[0029] Figure 2 It is a schematic cross-sectional view of the position of the injection part of a radiosensitizing internal radiotherapy device of the present invention.

[0030] Figure 3 It is a schematic diagram of the bottom direction during the manufacturing process of the injection part.

[0031] Figure 4 It is an exploded structure diagram of the injection part.

[0032] Figure 5 It is a schematic cross-sectional view of the positions of the inner balloon and the outer balloon of a radiosensitizing internal radiotherapy device of the present invention.

[0033] Figure 6 It is a schematic cross-sectional view of the inner balloon of a radiosensitizing internal radiotherapy device of the present invention.

[0034] Figure 7 It is a schematic three-dimensional structure diagram of the state after implantation of a radiosensitizing internal radiotherapy device of the present invention.

[0035] Figure 8 It is a schematic diagram of the circular hole provided at the lower edge of the injection part.

[0036] Figure 9A radiosensitizing internal radiotherapy device with a radiosensitizing material 6 disposed in the outer balloon expansion part.

[0037] Figure 10 Comparison of the survival rates of multi-cancer cells under radiotherapy and radiotherapy + treatment with a radiosensitizing material. Specific implementation mode

[0038] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0039] Example 1

[0040] A radiosensitizing internal radiotherapy device, such as Figure 1-8As shown in the figure, it includes an injection part 1, a catheter 2, an inner balloon 3, an outer balloon 4, a radioactive solution 5, and a radiosensitizing material 6. The injection part 1 includes an injection main body 10, a first flow channel 11, a second flow channel 12, a first injection cavity 13, a second injection cavity 14, a first injection cavity touch top 15, a second injection cavity touch top 16, a first injection cavity barrel 17, a second injection cavity barrel 18, a first injection cavity seal 19, a second injection cavity seal 110, and a lower edge 111 of the injection part. The first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity seal 19. The first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172, and a first injection cavity barrel water hole 173. The upper end of the first injection cavity barrel annular wall 171 contacts the first injection cavity touch top 15. The lower end of the first injection cavity barrel annular wall 171 is provided with a first injection cavity barrel water hole 173, and the first injection cavity barrel water hole 173 corresponds to the position of the first flow channel 11. The lower end of the first injection cavity barrel annular wall 171 is connected to the first injection cavity barrel bottom 172. The second injection cavity barrel 18 is enclosed in the second injection cavity 14 by the second injection cavity seal 110. The second injection cavity barrel 18 includes a second injection cavity barrel annular wall 181, a second injection cavity barrel bottom 182, and a second injection cavity barrel water hole 183. The upper end of the second injection cavity barrel annular wall 181 contacts the second injection cavity touch top 16. The lower end of the second injection cavity barrel annular wall 181 is provided with a second injection cavity barrel water hole 183, and the second injection cavity barrel water hole 183 corresponds to the position of the second flow channel 12. The lower end of the second injection cavity barrel annular wall 181 is connected to the second injection cavity barrel bottom 182. The catheter 2 includes a tube body 20, a first catheter cavity 21, a second catheter cavity 22, a first tube body hole 23, a second tube body hole 24, and a visualization tip 25. The inner balloon 3 includes an inner balloon bonding part 31 and an inner balloon expansion part 32. The inner balloon bonding part 31 is bonded to the catheter 2, and the inner balloon expansion part 32 wraps the visualization tip 25 of the catheter 2. The inner balloon 3 and the catheter 2 enclose a first balloon cavity 33. The outer balloon 4 includes an outer balloon bonding part 41 and an outer balloon expansion part 42. The outer balloon expansion part is provided with a permeation hole 43. The outer balloon 4 wraps the inner balloon 3, and the outer balloon bonding part 41 is bonded to the catheter 2. The outer balloon 4, the inner balloon 3, and the catheter 2 jointly enclose a second balloon cavity 44. One end of the first flow channel 11 communicates with the first injection cavity 13, and the other end of the first flow channel 11 communicates with the first catheter cavity 21. The first tube body hole 23 communicates the first catheter cavity 21 and the first balloon cavity 33. One end of the second flow channel 12 communicates with the second injection cavity 14, and the other end of the second flow channel 12 communicates with the second catheter cavity 22. The second tube body hole 24 communicates the second catheter cavity 22 and the second balloon cavity 44.

[0041] As Figure 3-4As shown, during the manufacturing process of the injection part, the two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection main body 10. This design not only enhances the integrity of the structure but also improves the durability of the device.

[0042] Specifically, the size of the first injection cavity touch top 15 is designed to be larger than that of the second injection cavity touch top 16. Such a differential design facilitates doctors to quickly distinguish the positions of the first injection cavity barrel 17 and the second injection cavity barrel 18 during palpation, effectively preventing confusion during the operation and improving the safety and accuracy of treatment.

[0043] In terms of material selection, both the first injection cavity barrel 17 and the second injection cavity barrel 18 are made of hard materials, specifically medical stainless steel. Of course, according to actual needs, other hard materials with high strength and good corrosion resistance can also be selected. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel and prevent penetration of the first injection cavity seal 19 and the second injection cavity seal 110 of the radiosensitized brachytherapy device during puncture, thereby effectively avoiding abnormal leakage of radioactive substances.

[0044] Using the integrally formed structure as Figure 3 shown, plus the first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard materials as Figure 4 shown, and finally using the first injection cavity seal 19 and the second injection cavity seal 110 to be sealed into a whole structure in forms such as bonding, welding, injection molding or molding, that is, the injection part 1, not only effectively ensures the sealing of the injection part of the radiosensitized brachytherapy device, but also greatly reduces the risk of radioactive leakage, ensuring the safety and effectiveness of the treatment process.

[0045] The radioactive solution 5 contains iodine-125 nuclide.

[0046] The radiosensitizing material 6 contains tungsten and gadolinium elements, specifically an injection containing gadolinium tungstate nanoparticles. The radiosensitizing material 6 also contains a thermosensitive hydrogel, which is liquid at room temperature and gradually solidifies when reaching 30 - 37°C, preferably solidifies at 35 - 37°C. This property can ensure that the radiosensitizing material is slowly absorbed by human tissues at the treatment site and the metabolic rate is reduced, thus ensuring the sustainability of the radiosensitization treatment effect.

[0047] The state of the radiosensitized brachytherapy device before use is Figure 1The state shown. During or after glioma surgery, the doctor implants the inner balloon 3 and the outer balloon 4 of the radiosensitized internal radiotherapy device at the radiotherapy site required, and the injection part 1 is buried under the skin; the radioactive solution 5 is injected into the device by puncturing the touch top 15 of the first injection cavity, so that the radioactive solution 5 inflates the inner balloon 3, and the irradiation dose is 25 Gy (any value between 20 - 40 Gy can also be selected); the radiosensitizing material 6 is injected into the device by puncturing the touch top 16 of the second injection cavity, so that the radiosensitizing material flows into the outer balloon 4 and flows through the osmotic holes 43 into the treatment site required, and the effective dose of gadolinium tungstate nanoparticles is 5 mg / kg (any value between 3 - 15 mg / kg can also be selected). At this time, the state of the radiosensitized internal radiotherapy device is Figure 7 The state shown. After this surgical operation, the patient can carry the radiosensitized internal radiotherapy device to move, and this device provides great convenience to the patient during internal radiotherapy and reduces the pain of the patient.

[0048] According to the disease progression and recovery of the patient, the radioactive solution 5 can be injected, replaced or extracted by puncturing the touch top 15 of the first injection cavity; during radiotherapy, the radiosensitizing material 6 can be injected by puncturing the touch top 16 of the second injection cavity. After this treatment operation, the patient can carry the radiosensitized internal radiotherapy device to move, and the patient is still receiving continuous internal radiotherapy during the movement, and this device brings great convenience to the patient. After the treatment is over, the radioactive solution 5 is extracted by puncturing the touch top 15 of the first injection cavity, and the inner balloon 3 and the outer balloon 4 shrink accordingly for convenient recovery, effectively avoiding the adverse reactions that may be caused by long-term implantation in the body and improving the safety of treatment and the comfort of the patient.

[0049] Refer to Figure 8 , a circular hole 112 is provided at the lower edge 111 of the injection part, which can be used to fix the injection part on the skull to prevent unnecessary displacement.

[0050] Example 2

[0051] A radiosensitized internal radiotherapy device, as Figure 1-8As shown in the figure, it includes an injection part 1, a catheter 2, an inner balloon 3, an outer balloon 4, a radioactive solution 5, and a radiosensitizing material 6; the injection part 1 includes an injection main body 10, a first flow channel 11, a second flow channel 12, a first injection cavity 13, a second injection cavity 14, a first injection cavity touch top 15, a second injection cavity touch top 16, a first injection cavity barrel 17, a second injection cavity barrel 18, a first injection cavity plug 19, a second injection cavity plug 110, and a lower edge 111 of the injection part; the first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity plug 19. The first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172, and a first injection cavity barrel water hole 173. The upper end of the first injection cavity barrel annular wall 171 contacts the first injection cavity touch top 15. The lower end of the first injection cavity barrel annular wall 171 is provided with a first injection cavity barrel water hole 173, and the first injection cavity barrel water hole 173 corresponds to the position of the first flow channel 11. The lower end of the first injection cavity barrel annular wall 171 is connected to the first injection cavity barrel bottom 172; the second injection cavity barrel 18 is enclosed in the second injection cavity 14 by the second injection cavity plug 110. The second injection cavity barrel 18 includes a second injection cavity barrel annular wall 181, a second injection cavity barrel bottom 182, and a second injection cavity barrel water hole 183. The upper end of the second injection cavity barrel annular wall 181 contacts the second injection cavity touch top 16. The lower end of the second injection cavity barrel annular wall 181 is provided with a second injection cavity barrel water hole 183, and the second injection cavity barrel water hole 183 corresponds to the position of the second flow channel 12. The lower end of the second injection cavity barrel annular wall 181 is connected to the second injection cavity barrel bottom 182; the catheter 2 includes a tube body 20, a first catheter cavity 21, a second catheter cavity 22, a first tube body hole 23, a second tube body hole 24, and a radiopaque tip 25; the inner balloon 3 includes an inner balloon bonding part 31 and an inner balloon expansion part 32. The inner balloon bonding part 31 is bonded to the catheter 2, and the inner balloon expansion part 32 wraps the radiopaque tip 25 of the catheter 2. The inner balloon 3 and the catheter 2 enclose a first balloon cavity 33; the outer balloon 4 includes an outer balloon bonding part 41 and an outer balloon expansion part 42. The outer balloon expansion part is provided with a permeation hole 43. The outer balloon 4 wraps the inner balloon 3. The outer balloon bonding part 41 is bonded to the catheter 2. The outer balloon 4, the inner balloon 3, and the catheter 2 jointly enclose a second balloon cavity 44; one end of the first flow channel 11 communicates with the first injection cavity 13, and the other end of the first flow channel 11 communicates with the first catheter cavity 21. The first tube body hole 23 communicates the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 communicates with the second injection cavity 14, and the other end of the second flow channel 12 communicates with the second catheter cavity 22. The second tube body hole 24 communicates the second catheter cavity 22 and the second balloon cavity 44.

[0052] As Figure 3-4As shown, during the manufacturing process of the injection part, the two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection main body 10. This design not only enhances the integrity of the structure but also improves the durability of the device.

[0053] Specifically, the size of the first injection cavity touch top 15 is designed to be larger than that of the second injection cavity touch top 16. Such a differential design facilitates doctors to quickly distinguish the positions of the first injection cavity barrel 17 and the second injection cavity barrel 18 during palpation, effectively preventing confusion during the operation process, and improving the safety and accuracy of treatment.

[0054] In terms of material selection, both the first injection cavity barrel 17 and the second injection cavity barrel 18 are made of hard materials, specifically medical pure titanium. Of course, according to actual needs, other hard materials with high strength and good corrosion resistance can also be selected, but there should be no magnetothermal effect. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel and prevent the penetration of the first injection cavity seal 19 and the second injection cavity seal 110 of the radiosensitizing internal radiotherapy device during the puncture process, thus effectively avoiding the abnormal leakage of radioactive substances.

[0055] Using the integrally formed structure as shown in Figure 3 and adding the first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard materials as shown in Figure 4 Finally, the first injection cavity seal 19 and the second injection cavity seal 110 are sealed into a whole structure by bonding, welding, injection molding or molding, etc., that is, the injection part 1, which not only effectively guarantees the sealing performance of the injection part of the radiosensitizing internal radiotherapy device but also greatly reduces the risk of radioactive leakage, ensuring the safety and effectiveness of the treatment process.

[0056] The radioactive solution 5 contains the palladium - 103 nuclide.

[0057] The radiosensitizing material 6 is an injection solution containing materials with magnetothermal effect components. The magnetothermal effect component materials are specifically microparticles containing Fe3O4 and NiCu (Ni - 30Cu) alloy (other materials that can produce magnetothermal effect can also be selected). The mass ratio of Fe3O4 to NiCu is 1:1. By applying an external alternating magnetic field, the radiosensitizing material 6 is heated to above 38 °C to produce a hyperthermia effect, thereby increasing the sensitivity of radiotherapy.

[0058] When radiotherapy is used alone against hypoxic tumor cells and sublethal tumor cells, its killing effect is rather limited. To optimize the treatment effect, a magnetothermal effect component material is innovatively incorporated into the radiosensitizing material 6; this material can respond to an alternating magnetic field and precisely cause local heating in the tumor area, thereby significantly enhancing the killing efficiency of malignant tumors, especially hypoxic tumor cells and sublethal tumor cells. Given that tumor cells have extremely active metabolic activities and are often located closer to the outer balloon expansion part 42, cancer cells around the device can more effectively absorb the radiosensitizing material 6; of course, in the radiosensitizing material 6, the sensitizing component can also be combined with a monoclonal antibody that can specifically bind to cancer cells (or other structures easily taken up by cancer cells) to further enhance the precise treatment effect on tumor cells; the thermal effect generated by the magnetothermal effect has a short-range characteristic, which can specifically destroy tumor cells and induce their apoptosis, with almost no effect on healthy cells in the non-heated area, achieving precise targeted treatment at the cellular level. This heating mechanism can not only block the oxygen supply of tumor cells to a certain extent but also increase the intracellular enzyme activity and accelerate oxygen consumption; since the metabolic level of normal tissue cells is much lower than that of tumor cells and their demand for oxygen is relatively low, they have stronger heat tolerance; under appropriate heating treatment conditions, the sensitized internal radiotherapy device can specifically kill tumor tissues with no damage or only limited damage to the surrounding normal tissues. Particularly, this heating treatment method has a particularly significant killing effect on hypoxic tumor cells and sublethal tumor cells, enhancing the sensitivity of tumor cells to radiation. At the same time, due to the limited range of heat therapy, usually not exceeding 5 mm, it will not affect the deep normal tissues, ensuring the safety and precision of the treatment.

[0059] The state of the sensitized internal radiotherapy device before use is Figure 1 the state shown. During or after breast cancer surgery, the doctor implants the inner balloon 3 and the outer balloon 4 of the sensitized internal radiotherapy device at the radiotherapy site required, and the injection part 1 is buried under the skin; the radioactive solution 5 is injected into the device through the puncture of the first injection cavity touch top 15 to inflate the inner balloon 3 with the radioactive solution 5, and the irradiation dose is 25 Gy (any value between 20 - 40 Gy can also be selected); the radiosensitizing material 6 is injected into the device through the puncture of the second injection cavity touch top 16, so that the radiosensitizing material flows into the outer balloon 4 and passes through the permeation holes 43 into the treatment site required, and the effective dose of Fe3O4 and NiCu alloy particles is 5 mg / kg (any value between 3 - 15 mg / kg can also be selected). At this time, the state of the sensitized internal radiotherapy device is Figure 7 the state shown.

[0060] In the treatment area, the magnetothermal therapy machine generates an alternating magnetic field, the intensity of which can be flexibly adjusted within the range of 0 - 0.2T, and the specific intensity is set individually according to the patient's tolerance. Under the action of this alternating magnetic field, the radiosensitizing material 6 is effectively heated to above 38°C, aiming to enhance the killing effect of radiotherapy rays on tumor cells and improve the sensitivity of radiotherapy. To ensure safety, a temperature measurement probe is used to monitor the temperature of the surrounding tissues during the process to ensure that the temperature rise does not exceed 60°C, thus avoiding damage to normal tissues. It is also possible to choose to use a magnetothermal effect component material with self-temperature control. The alternating magnetic field generated by the magnetothermal therapy machine will not cause the radiosensitizing material 6 to exceed 60°C or will stabilize the temperature at any value between 38 - 60°C, preferably stabilizing the temperature at 45 - 50°C. After magnetothermal radiotherapy sensitization treatment, the patient can move freely while carrying an advanced sensitizing internal radiotherapy device. This device continuously releases rays to precisely strike the tumor at close range. During internal radiotherapy, this device not only significantly improves the treatment effect but also brings great convenience to the patient, effectively reducing their physical and mental burden.

[0061] According to the patient's disease progression and recovery situation, radioactive solution 5 can be injected, replaced, or withdrawn by puncturing the top of the first injection cavity 15; during the magnetothermal radiotherapy sensitization treatment, the radiosensitizing material 6 can be injected by puncturing the top of the second injection cavity 16. After this treatment operation, the patient can move while carrying the sensitizing internal radiotherapy device, and the patient is still receiving continuous internal radiotherapy during the movement. This device brings great convenience to the patient. After the treatment, the radioactive solution 5 is withdrawn by puncturing the top of the first injection cavity 15, and the inner balloon 3 and the outer balloon 4 contract accordingly for convenient recovery, effectively avoiding the adverse reactions that may be caused by long-term implantation in the body and improving the safety of the treatment and the comfort of the patient.

[0062] Example 3

[0063] A sensitizing internal radiotherapy device, such as Figure 1-8As shown in the figure, it includes an injection part 1, a catheter 2, an inner balloon 3, an outer balloon 4, a radioactive solution 5, and a radiosensitizing material 6. The injection part 1 includes an injection main body 10, a first flow channel 11, a second flow channel 12, a first injection cavity 13, a second injection cavity 14, a first injection cavity touch top 15, a second injection cavity touch top 16, a first injection cavity barrel 17, a second injection cavity barrel 18, a first injection cavity seal 19, a second injection cavity seal 110, and a lower edge 111 of the injection part. The first injection cavity barrel 17 is sealed in the first injection cavity 13 by the first injection cavity seal 19. The first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172, and a first injection cavity barrel water hole 173. The upper end of the first injection cavity barrel annular wall 171 contacts the first injection cavity touch top 15. The lower end of the first injection cavity barrel annular wall 171 is provided with a first injection cavity barrel water hole 173, and the first injection cavity barrel water hole 173 corresponds to the position of the first flow channel 11. The lower end of the first injection cavity barrel annular wall 171 is connected to the first injection cavity barrel bottom 172. The second injection cavity barrel 18 is sealed in the second injection cavity 14 by the second injection cavity seal 110. The second injection cavity barrel 18 includes a second injection cavity barrel annular wall 181, a second injection cavity barrel bottom 182, and a second injection cavity barrel water hole 183. The upper end of the second injection cavity barrel annular wall 181 contacts the second injection cavity touch top 16. The lower end of the second injection cavity barrel annular wall 181 is provided with a second injection cavity barrel water hole 183, and the second injection cavity barrel water hole 183 corresponds to the position of the second flow channel 12. The lower end of the second injection cavity barrel annular wall 181 is connected to the second injection cavity barrel bottom 182. The catheter 2 includes a tube body 20, a first catheter cavity 21, a second catheter cavity 22, a first tube body hole 23, a second tube body hole 24, and a visualization tip 25. The inner balloon 3 includes an inner balloon bonding part 31 and an inner balloon expansion part 32. The inner balloon bonding part 31 is bonded to the catheter 2, and the inner balloon expansion part 32 wraps the visualization tip 25 of the catheter 2. The inner balloon 3 and the catheter 2 enclose a first balloon cavity 33. The outer balloon 4 includes an outer balloon bonding part 41 and an outer balloon expansion part 42. The outer balloon 4 wraps the inner balloon 3, and the outer balloon bonding part 41 is bonded to the catheter 2. The outer balloon 4, the inner balloon 3, and the catheter 2 jointly enclose a second balloon cavity 44. One end of the first flow channel 11 communicates with the first injection cavity 13, and the other end of the first flow channel 11 communicates with the first catheter cavity 21. The first tube body hole 23 communicates the first catheter cavity 21 and the first balloon cavity 33. One end of the second flow channel 12 communicates with the second injection cavity 14, and the other end of the second flow channel 12 communicates with the second catheter cavity 22. The second tube body hole 24 communicates the second catheter cavity 22 and the second balloon cavity 44.

[0064] As Figure 3-4As shown, during the manufacturing process of the injection part, the two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection main body 10. This design not only enhances the integrity of the structure but also improves the durability of the device.

[0065] Specifically, the size of the first injection cavity touch top 15 is designed to be larger than that of the second injection cavity touch top 16. Such a differential design facilitates doctors to quickly distinguish the positions of the first injection cavity barrel 17 and the second injection cavity barrel 18 during palpation, effectively preventing confusion during the operation process and improving the safety and accuracy of treatment.

[0066] In terms of material selection, both the first injection cavity barrel 17 and the second injection cavity barrel 18 are made of hard materials, specifically polysulfone (PSU). Of course, according to actual needs, other hard materials with high strength and good corrosion resistance can also be selected, but there should be no magnetothermal effect. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel and prevent penetration of the first injection cavity seal 19 and the second injection cavity seal 110 of the radiosensitized internal radiotherapy device during the puncture process, thereby effectively avoiding abnormal leakage of radioactive substances.

[0067] Using the integrally formed structure as shown in Figure 3 and the first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard materials as shown in Figure 4 Finally, the first injection cavity seal 19 and the second injection cavity seal 110 are sealed into a whole structure by bonding, welding, injection molding or molding, etc., that is, the injection part 1, which not only effectively guarantees the sealing performance of the injection part of the radiosensitized internal radiotherapy device but also greatly reduces the risk of radioactive leakage, ensuring the safety and effectiveness of the treatment process.

[0068] The radioactive solution 5 contains the nuclide gold - 198.

[0069] The radiosensitizing material 6 is arranged on the outer surface of the outer balloon expansion part 42 to promote the effective absorption of tissue cells in the treatment area. The radiosensitizing material 6 is mixed with a medical adhesive and sprayed on the outer surface of the outer balloon expansion part 42, or the radiosensitizing material 6 can also be fixed on the outer surface of the outer balloon expansion part 42 by dipping or scraping processes. The radiosensitizing material 6 contains a magnetothermal effect component material, and the magnetothermal effect component material is specifically NiCu alloy, with an effective dose of 5 mg / kg (any value in the range of 3 - 15 mg / kg can also be selected), and the mass fraction of Cu is 30% microparticles. This NiCu alloy can gradually increase its own temperature to nearly 50 °C with the increase of the magnetic field strength under an alternating magnetic field, and then its temperature will not continue to rise even if the magnetic field strength increases, that is, self - controlled temperature is achieved.

[0070] No penetration holes 43 are provided on the outer balloon expansion part 42, as shown inFigure 9 As shown in the figure. This setting is applicable to treatment scenarios where there is no need to subsequently append the radiosensitizing material 6, simplifying the treatment process. To achieve a comparable treatment effect, the radiosensitizing material 6 equipped outside the outer balloon expansion part 42 needs to contain a higher concentration of sensitizing components, or choose to increase the radiation dose of the radioactive solution 5. Such a design strategy not only adapts to specific treatment requirements but also brings additional advantages: the structural integrity of the outer balloon expansion part 42 is enhanced, providing a more solid support for the inner balloon, effectively reducing the damage that high-dose radiation therapy may cause to the inner balloon 3 and the outer balloon 4, reducing the risk of penetration and leakage of the radioactive solution 5. Even after the inner balloon 3 ruptures, the outer balloon 4 can still provide support, thereby extending the overall service life of the sensitizing internal radiotherapy device.

[0071] During or after breast cancer surgery, the doctor implants the inner balloon 3 and the outer balloon 4 of the sensitizing internal radiotherapy device into the required radiotherapy site, and the injection part 1 is buried under the skin; the radioactive solution 5 is injected into the device by puncturing the touch top 15 of the first injection cavity, filling the inner balloon 3 with the radioactive solution 5, and the irradiation dose is 35 Gy (any value in the range of 20 - 40 Gy can also be selected).

[0072] In the treatment area, a magnetic hyperthermia machine generates an alternating magnetic field, the intensity of which can be flexibly adjusted within the range of 0 - 0.2 T, and the specific intensity is set individually according to the patient's tolerance. Under the action of this alternating magnetic field, the radiosensitizing material 6 is effectively heated to above 38 °C, aiming to enhance the killing effect of radiotherapy rays on tumor cells and improve the sensitivity of radiotherapy. Due to the self-controlled temperature characteristic of this NiCu alloy, the temperature rise will not exceed 50 °C, thus avoiding damage to normal tissues. After magnetic radiotherapy sensitization treatment, the patient can move freely with the advanced sensitizing internal radiotherapy device. The device continuously releases rays to precisely strike the tumor at close range. During internal radiotherapy, this device not only significantly improves the treatment effect but also brings great convenience to the patient, effectively reducing their physical and mental burden.

[0073] According to the patient's disease progression and recovery situation, the radiotherapy intensity can be adjusted by injecting, replacing, or extracting the radioactive solution 5 through puncturing the touch top 15 of the first injection cavity, or magnetic hyperthermia can be used again to enhance the radiotherapy sensitivity. After this treatment operation, the patient can move with the sensitizing internal radiotherapy device, and the patient is still receiving continuous internal radiotherapy during the movement. This device brings great convenience to the patient. After the treatment, the radioactive solution 5 is extracted through puncturing the touch top 15 of the first injection cavity, and the inner balloon 3 and the outer balloon 4 contract accordingly to facilitate recovery, effectively avoiding adverse reactions that may be caused by long-term implantation in the body and improving the safety of treatment and the comfort of the patient.

[0074] Example 4 (In vitro multi-level tumor sensitization verification)

[0075] Experimental materials and device models. Cell lines: U87-MG (human glioma), MDA-MB-231 (human triple-negative breast cancer), A549 (human lung cancer). Co-culture model: Mix U87-MG with HUVEC (human umbilical vein endothelial cells) at a ratio of 2:1, inoculate into a 24-well plate containing Matrigel, 500 μL per well, culture at 37 °C and 5% CO2 for 7 days to form vascularized tumor spheres. Sensitized internal radiotherapy device prepared according to Example 1: The outer balloon has a diameter of 5 mm and is evenly provided with 0.5 μm permeation holes for releasing radiosensitizing materials. Radioactive solution: Iodine-125 labeled, dose 25 Gy; Sensitizer: Gadolinium tungstate nanoparticles, Fe3O4 / NiCu alloy microparticles, concentration 5 mg / kg.

[0076] Diffusion of sensitizers in the 3D co-culture model. Implant the device of Example 1 into the center of the vascularized tumor sphere, and inject 25 Gy iodine-125 and 5 mg / kg gadolinium tungstate nanoparticles (DiI fluorescently labeled). Fluorescence distributions were photographed at 24 h, 48 h, and 72 h respectively, and the quantitative penetration depth and average fluorescence intensity results are shown in Table 1. Data obtained using the sensitized internal radiotherapy device prepared in Example 2 are also close to those in Table 1, and the sensitizers can penetrate deep into the tumor center (>2 mm) after 72 h.

[0077] Table 1 Penetration depth and average fluorescence intensity

[0078] Time Penetration depth (mm) Fluorescence intensity (A.U.) 24 h 1.2 ± 0.1 1200 ± 50 48 h 1.8 ± 0.2 2100 ± 80 72 h 2.3 ± 0.2 2800 ± 100

[0079] Comparison of sensitization ratios of multi-cancer cell lines. Each cell line was inoculated into a 6-well plate (1×10 5 cells / well) and divided into 5 groups: control group (no treatment), radiotherapy group (25 Gy), gadolinium tungstate group (Example 1, 25 Gy + 5 mg / kg gadolinium tungstate), Fe3O4 / NiCu magnetic hyperthermia group (Example 2, 25 Gy + 5 mg / kg Fe3O4 / NiCu + 100 kHz adjustable intensity magnetic field + thermocouple temperature control), NiCu self-temperature control group (Example 3, 25 Gy + 5 mg / kg NiCu 100 kHz adjustable intensity magnetic field + thermocouple temperature measurement), with 3 replicates in each group. In the Fe3O4 / NiCu magnetic hyperthermia group, the temperature was maintained at 48.5 °C ± 0.5 °C (the magnetic field at this temperature is 0.1 T, and the temperature will increase if the magnetic field intensity is further increased) for 2 h by thermocouple temperature measurement and gradually increasing the magnetic field intensity; in the NiCu self-temperature control group, the temperature was always stable at 48.5 °C ± 0.5 °C when the magnetic field intensity was set at 0.1 T and after increasing to 1.2 T, and a lower magnetic field intensity of 0.1 T was selected for heating for 2 h subsequently. After 72 h, the cell viability was measured by the CCK-8 method, and the results are as Figure 10As shown, it indicates that by implementing the component ratios of the sensitized internal radiotherapy device in Examples 1 - 3, the sensitivity of each tumor cell during radiotherapy can be significantly enhanced.

[0080] Example 5 (Safety assessment of normal cells)

[0081] Select NHA, HDF, HUVEC, PBMC, HK - 2, and inoculate 96 - well plates with 5×10³ cells / well; divide them into a control group (culture medium), a gadolinium tungstate group (5 mg / kg), and an Fe3O4 / NiCu group (5 mg / kg, heated to 48.5°C ± 0.5°C for 2 h according to the heating method in Example 4). After 72 h, detect: survival rate (CCK - 8); ROS level (DCFH - DA flow cytometry); IL - 6, TNF - α (ELISA).

[0082] The results are shown in Table 2-5. For different types of normal cells (NHA, HDF, HUVEC, PBMC, HK-2), we conducted toxicity assessments for the control group, gadolinium tungstate group, and Fe3O4 / NiCu group. Survival rate analysis: The cell survival rates in the control group were all higher than 90%, indicating that the growth and survival of normal cells were not affected in the conventional culture medium. The survival rates in the gadolinium tungstate group and Fe3O4 / NiCu group decreased slightly but still remained at a relatively high level. The survival rate range in the gadolinium tungstate group was from 94.5% (NHA) to 92.8% (PBMC), and in the Fe3O4 / NiCu group was from 94.5% (NHA) to 91.4% (PBMC). These results show that the sensitizers (gadolinium tungstate and Fe3O4 / NiCu) have limited toxicity to normal cells and do not cause significant cell damage. ROS level analysis: The ROS (reactive oxygen species) level, as a marker of cellular oxidative stress, changed to some extent in all groups. The ROS level in the control group was from 1.05 (NHA) to 1.10 (HUVEC), while in the gadolinium tungstate group and Fe3O4 / NiCu group, the ROS level increased slightly. The ROS level in the gadolinium tungstate group was from 1.02 (NHA) to 1.05 (HUVEC), and in the Fe3O4 / NiCu group was from 1.10 (NHA) to 1.09 (HK-2). This indicates that although the ROS level increased slightly under the treatment of the two sensitizers, it did not reach the dangerous threshold of cell damage. IL-6 and TNF-α concentration analysis: In the determination of the inflammatory factor IL-6, the IL-6 concentration range in the control group was from 12.3 (NHA) to 18.3 (PBMC), while the IL-6 concentrations in the gadolinium tungstate group and Fe3O4 / NiCu group both increased. The IL-6 concentration in the gadolinium tungstate group was from 11.8 (NHA) to 17.8 (PBMC), and in the Fe3O4 / NiCu group was from 13.2 (NHA) to 18.0 (PBMC). This change shows that although the sensitizers caused a certain degree of cellular inflammatory response, the overall increase was small and did not lead to significant activation of the immune response. TNF-α, as another important inflammatory factor, had a similar trend of change among the groups. The TNF-α concentration in the control group was between 8.5 (NHA) and 11.4 (PBMC), in the gadolinium tungstate group was between 8.2 (NHA) and 10.8 (PBMC), and in the Fe3O4 / NiCu group was between 8.7 (NHA) and 11.1 (PBMC). This further supports that the immune response caused by the sensitizers to normal cells is not significant and does not lead to excessive inflammatory responses.

[0083] The cytotoxicity of the gadolinium tungstate group and the Fe3O4 / NiCu group in normal cells did not increase significantly compared to the control group, indicating that the sensitized internal radiotherapy device has good safety on normal cells. The sensitizers in the gadolinium tungstate group and the Fe3O4 / NiCu group have low toxicity in normal cells and do not cause significant cell damage or immune responses. In all normal cell types, the use of the sensitizer did not cause obvious toxic effects, and their survival rates remained at a high level. The slight changes in ROS, IL-6, and TNF-α did not exceed the normal physiological range, indicating that the sensitizer has good safety for normal tissues.

[0084] Table 2 Safety assessment results of normal cells - Survival rate (CCK-8)

[0085] Cell type Control group (%) Gadolinium tungstate group (%) <![CDATA[Fe3O4 / NiCu Group (%)]]> NHA 98.2 95.2 94.5 HDF 99 96.1 94.2 HUVEC 97.5 94.5 93.9 PBMC 96.8 92.8 91.4 HK-2 97.1 93 92.3

[0086] Table 3 Safety assessment results of normal cells - ROS (relative value) level (DCFH-DA flow cytometry)

[0087] Cell type Control group Gadolinium tungstate group <![CDATA[Fe3O4 / NiCu group]]> NHA 1.05 1.02 1.1 HDF 1.02 1 1.08 HUVEC 1.1 1.05 1.09 PBMC 1.08 1.03 1.07 HK-2 1.07 1.04 1.09

[0088] Table 4 Safety assessment results of normal cells - IL-6 (pg / mL)

[0089] Cell type Control group Gadolinium tungstate group <![CDATA[Fe3O4 / NiCu group]]> NHA 12.3 11.8 13.2 HDF 10.8 10.5 11.1 HUVEC 15.1 14.6 14.9 PBMC 18.3 17.8 18 HK-2 13.6 13.2 13.4

[0090] Table 5 Safety assessment results of normal cells - TNF-α (ELISA)

[0091] Cell type Control group Gadolinium tungstate group <![CDATA[Fe3O4 / NiCu group <!-- 10 -->]]> NHA 8.5 8.2 8.7 HDF 7.9 7.5 7.8 HUVEC 9.2 8.9 9 PBMC 11.4 10.8 11.1 HK-2 8.8 8.4 8.6

[0092] Example 6 (Animal experiment)

[0093] A subcutaneous U87-MG glioma model was established in BALB / c nude mice to evaluate the therapeutic effect and safety of the sensitized internal radiotherapy device in vivo. The research shows that by setting radiosensitizing materials, the radiotherapy effect can be significantly enhanced; magnetic hyperthermia treatment using magnetic hyperthermia component materials can also significantly improve the radiotherapy effect, providing a theoretical basis for combined exothermic treatment.

[0094] Experimental Materials and Methods. Animal Model: Twenty-five 5- to 6-week-old BALB / c nude mice were used. Each mouse was subcutaneously injected with U87-MG glioma cells (approximately 1×10^6 cells). Treatment was initiated when the tumor volume reached approximately 100 mm³ (diameter 56 mm). Grouping (n = 5 per group): Group A (refer to Example 1): Iodine-125 radiation source + gadolinium tungstate nanoparticles (not heated); Group B (refer to Example 2): Iodine-125 radiation source + Fe3O4 / NiCu magnetic hyperthermia microparticles + externally applied alternating magnetic field heating; Group C (refer to Example 3): Iodine-125 radiation source + NiCu self-controlled temperature microparticles; Group D: Iodine-125 radiotherapy alone; Group E: Empty device control group (only implanted with an empty balloon). Treatment Protocol: The corresponding balloon structure devices were implanted into the subcutaneous tumors of all experimental group mice; the initial dose of I-125 was 25 Gy (35 Gy for Group C); the nanoparticle dose was 5 mg / kg. In Groups B and C, an alternating magnetic field was applied during radiotherapy (intensity 0.1 T, frequency 100 kHz, 2 hours per session, the magnetic field was applied once after the device was implanted, and then once every other day); no external magnetic field was applied to other groups. The treatment cycle was 7 days. Efficacy Evaluation: The tumor fluorescence signal was monitored using an IVIS imaging system (Caliper ROI), and the tumor volume inhibition rate was calculated; at the same time, the body weight and daily activity status of the mice were recorded. On the 7th day, the mice were sacrificed, and the heart, liver, spleen, lungs, and kidneys were taken for HE staining and pathological scoring (0 - 3 grades, 0 = no damage, 1 = mild inflammation, 2 = moderate necrosis, 3 = severe lesion).

[0095] Experimental results and analysis. The tumor volume inhibition rates of each group (mean ± standard deviation) are shown in Table 6: Group A (60.0 ± 5.0%), Group B (73.3 ± 4.0%), Group C (80.0 ± 3.0%), Group D (46.7 ± 6.0%), Group E (0%). Table 7 shows the HE pathological scores of the main organs of each group. The scores of the heart, liver, spleen, lungs, and kidneys in each group were in the range of 0 - 1, with no obvious pathological damage. The treatment results showed that the tumor inhibition rates of Group B and Group C (73.3%, 80.0%) were significantly higher than those of Group D with simple radiotherapy (46.7%) (p < 0.01), and Group A (60.0%) was also significantly better than Group D (p < 0.05). Among them, in Group B, Fe3O4 / NiCu composite particles were used in combination with an external alternating magnetic field to generate a magnetothermal effect, significantly enhancing the radiotherapy effect; in Group C, NiCu self - controlled temperature particles were used to achieve a similar sensitization effect under higher - dose radiotherapy, demonstrating the technical advantages of this device. In addition, Group A contained gadolinium - tungstate nanoparticles with a high atomic number. Such materials would accumulate in tumors and act as radiotherapy sensitizers to significantly enhance the radiation response. Therefore, Group A had a higher tumor - suppressing efficiency than Group D. The body weights of the mice in each group changed smoothly during the treatment period, without significant decrease, and their activities and food intake were normal, indicating that each treatment condition was well - tolerated. No significant pathological changes were seen in the HE staining of the organs in each group, and the pathological scores were all in the range of 0 - 1 (Table 7). In this study, the main organ structures of Group B and other groups were normal, indicating that the local application of nanomaterials such as Fe3O4 and NiCu did not cause significant systemic toxic reactions, verifying the biocompatibility and safety of this device and the sensitizing materials.

[0096] This example verified the efficacy and safety of the sensitized internal radiotherapy device. By integrating high - atomic - number materials (such as gadolinium tungstate) or magnetothermal materials, this device achieved sensitized internal radiotherapy, significantly delaying tumor growth (the tumor inhibition rate was significantly higher than that of the control group) and showing no obvious side effects, demonstrating excellent technical effects. Especially in Group C, the NiCu self - controlled temperature particles were used for stable heating, simplifying the treatment process and improving the clinical application potential of the device. The above results highlight that the device of the present invention innovatively combines sensitization and safety, providing a new technical solution for the local radiotherapy of solid tumors such as gliomas.

[0097] Table 6 Tumor volume inhibition rates of each group (mean ± SD%)

[0098] Group Group A (I-125 + GdW) <![CDATA[Group B (I-125 + Fe3O4 / NiCu magnetothermal)]]> Group C (I-125 + NiCu self-controlled temperature) Group D (I-125 alone) Group E (Control) Tumor inhibition rate 60.0±5.0 73.3±4.0 80.0±3.0 46.7±6.0 0

[0099] Table 7 HE pathological scores of the main organs of each group (0 - 3 grades, 0 = normal)

[0100] Group Heart Liver Spleen Lung Kidney Group A 0 0 0 0 0 Group B 1 1 0 0 0 Group C 0 0 0 0 0 Group D 0 0 0 0 0 Group E 0 0 0 0 0

[0101] During implementation, in addition to selecting to contain iodine-125, palladium-103, and gold-198 nuclides, the radioactive solution 5 may also select to contain one of lutetium-177, cesium-131, strontium-89, yttrium-90, or phosphorus-32, or any combination of the above multiple nuclides; this selection can better match the patient's condition needs.

[0102] During implementation, the role of radiosensitizing material 6 is to enhance the sensitivity of radiotherapy. Its core function is to ensure that, even with a lower dose of radioactive solution 5, the radiotherapy effect equivalent to a conventional dose is achieved, significantly reducing potential damage to surrounding normal tissue. Specifically, the composition of radiosensitizing material 6 encompasses a wide range of options, including one or more of the following: high-atomic-number elements such as gold, platinum, bismuth, tungsten, and rare earth elements; metal oxides such as Fe, Zn, Co, Mn, or Ni oxides; a range of nanomaterials such as nanodiamonds, C60 carbon nanotubes, selenium nanoparticles, and ferrocene composite nanoparticles; and one or more chemotherapeutic drugs. This diverse selection provides a more flexible and efficient sensitization strategy for radiotherapy.

[0103] Since tumor cells have a high metabolism and are closer to the outer balloon expansion part 42, when the radiosensitizing material 6 is released into the body by the sensitizing internal radiotherapy device, it is preferentially absorbed by the tumor cells. The concentration of the sensitizing component in the tumor cells is higher than that in normal cells, thereby achieving a stronger killing effect on the tumor cells. Of course, the sensitizing component in the radiosensitizing material 6 can also be carried on a monoclonal antibody that can specifically bind to cancer cells (or other structures that are easily absorbed by cancer cells) to promote the specific absorption of cancer cells and reduce the probability of absorption by normal tissue cells.

Claims

1. A sensitized internal radiotherapy device, characterized in that It includes an injection part (1), a catheter (2), an inner balloon (3), an outer balloon (4), a radioactive solution (5), and a radiosensitizing material (6); the inner balloon (3) is sleeved on the distal end of the catheter (2) and is communicated with the injection part (1) through a first flow channel (11) and a first injection cavity (13) for accommodating the radioactive solution (5); the outer balloon (4) is sleeved outside the inner balloon (3) and is communicated with the injection part (1) through a second flow channel (12) and a second injection cavity (14) for accommodating and releasing the radiosensitizing material (6); the inner balloon (3) and the outer balloon (4) are arranged in a coaxial nested manner, and by respectively injecting the radioactive solution (5) and the radiosensitizing material (6), sensitized internal radiotherapy and dose regulation are achieved.

2. The sensitized internal radiotherapy device according to claim 1, characterized in that The injection part (1) includes an injection main body (10), a first flow channel (11), a second flow channel (12), a first injection cavity (13), a second injection cavity (14), a first injection cavity touch top (15), a second injection cavity touch top (16), a first injection cavity barrel (17), a second injection cavity barrel (18), a first injection cavity seal (19), a second injection cavity seal (110), and an injection part lower edge (111); the first injection cavity barrel (17) is sealed in the first injection cavity (13) by the first injection cavity seal (19). The first injection cavity barrel (17) includes a first injection cavity barrel annular wall (171), a first injection cavity barrel bottom (172), and a first injection cavity barrel water hole (173). The upper end of the first injection cavity barrel annular wall (171) contacts the first injection cavity touch top (15), the lower end of the first injection cavity barrel annular wall (171) is provided with the first injection cavity barrel water hole (173), the first injection cavity barrel water hole (173) corresponds to the position of the first flow channel (11), and the lower end of the first injection cavity barrel annular wall (171) is connected to the first injection cavity barrel bottom (172); the second injection cavity barrel (18) is sealed in the second injection cavity (14) by the second injection cavity seal (110). The second injection cavity barrel (18) includes a second injection cavity barrel annular wall (181), a second injection cavity barrel bottom (182), and a second injection cavity barrel water hole (183). The upper end of the second injection cavity barrel annular wall (181) contacts the second injection cavity touch top (16), the lower end of the second injection cavity barrel annular wall (181) is provided with the second injection cavity barrel water hole (183), the second injection cavity barrel water hole (183) corresponds to the position of the second flow channel (12), and the lower end of the second injection cavity barrel annular wall (181) is connected to the second injection cavity barrel bottom (182).

3. The sensitized internal radiotherapy device according to claim 1, characterized in that The catheter (2) includes a catheter body (20), a first catheter lumen (21), a second catheter lumen (22), a first body hole (23), a second body hole (24), and a radiopaque tip (25); the inner balloon (3) includes an inner balloon bonding portion (31) and an inner balloon expansion portion (32). The inner balloon bonding portion (31) is bonded to the catheter (2), and the inner balloon expansion portion (32) wraps the radiopaque tip (25) of the catheter (2). The inner balloon (3) and the catheter (2) enclose a first balloon lumen (33); the outer balloon (4) includes an outer balloon bonding portion (41) and an outer balloon expansion portion (42). The outer balloon expansion portion is provided with permeation holes (43). The outer balloon (4) wraps the inner balloon (3), and the outer balloon bonding portion (41) is bonded to the catheter (2). The outer balloon (4), the inner balloon (3), and the catheter (2) jointly enclose a second balloon lumen (44); one end of the first flow channel (11) communicates with the first injection cavity (13), and the other end of the first flow channel (11) communicates with the first catheter lumen (21). The first body hole (23) communicates the first catheter lumen (21) and the first balloon lumen (33); one end of the second flow channel (12) communicates with the second injection cavity (14), and the other end of the second flow channel (12) communicates with the second catheter lumen (22). The second body hole (24) communicates the second catheter lumen (22) and the second balloon lumen (44).

4. The sensitized internal radiotherapy device according to claim 1, characterized in that The radioactive solution (5) contains one or more radionuclides among iodine-125, palladium-103, gold-198, lutetium-177, cesium-131, strontium-89, yttrium-90, or phosphorus-32; the radiosensitizing material (6) contains at least one of the following materials that enhance the effect of radiotherapy: gold, platinum, bismuth, tungsten, or rare earth elements, oxides of Fe, Zn, Co, Mn, or Ni, nanodiamonds, C60 carbon nanotubes, selenium nanoparticles, or ferrocene composite nanoparticles, and one or more chemotherapeutic drugs.

5. The sensitized internal radiotherapy device according to claim 1, characterized in that The radiosensitizing material (6) is liquid at room temperature and gradually solidifies when approaching body temperature.

6. The sensitized internal radiotherapy device according to claim 1, characterized in that It includes a usage method. The radiosensitizing material (6) contains a magnetothermal effect component material, and the radiosensitizing material (6) can be heated by applying an alternating magnetic field to increase the sensitivity of radiotherapy.

7. The sensitized internal radiotherapy device according to claim 1, characterized in that The size of the touch top (15) of the first injection cavity is larger than the size of the touch top (16) of the second injection cavity.

8. The sensitized internal radiotherapy device according to claim 1, characterized in that The first injection cavity barrel (17) and the second injection cavity barrel (18) are made of a rigid material.

9. The sensitized internal radiotherapy device according to claim 1, characterized in that A circular hole (112) is provided at the lower edge (111) of the injection portion for further operation or fixation.

10. The sensitized internal radiotherapy device according to claim 1, characterized in that The radiosensitizing material (6) is disposed on the outer surface of the outer balloon expansion portion (42), and the outer balloon expansion portion (42) is not provided with permeation holes (43).

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