Sensitization type internal radiotherapy device

Abstract

The invention provides a sensitization type internal radiotherapy device which comprises an injection part, a catheter, an internal balloon, an external balloon, a radioactive solution and a radiosensitization material. Through the design of the two balloon cavities, volume adjustment of a radiotherapy solution and timely supplement of radiosensitization materials are realized, and continuous and effective treatment is ensured. The radiosensitization material can enhance the sensitivity of tumor cells to radiotherapy and contains magnetocaloric effect components, and an external electromagnetic field can increase the temperature and enhance the ray killing effect; the injection part is of an integrally-formed structure, the sealing performance is improved, and the leakage risk is reduced; the device is used for solving the problem that the edge infiltrates surrounding healthy tissues after tumor excision, has recoverability, puncture resistance, convenience in fixation and flexible operability, and is particularly suitable for postoperative adjuvant therapy of malignant tumors such as brain glioma 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 show extremely strong invasiveness and can quickly penetrate and surround the surrounding healthy tissues, which makes the treatment plan that relies solely on surgical resection often have limited effectiveness, especially in the postoperative adjuvant treatment stage. Brachytherapy, as an efficient 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. What is more complicated is that 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 concentrated doses at the proximal end of radiotherapy, which greatly affects the safety and effectiveness of treatment.

[0003] In recent years, the rapid development of medical technology has spawned a revolutionary low-dose internal radiotherapy device. This device encapsulates low-dose radioactive materials in special pharmaceutical capsules and uses long-term, continuous low-dose radiation to provide a new, safe and efficient way of radiotherapy for the tumor bed area after tumor resection. Compared with traditional high-dose afterloading therapy, this new device significantly reduces the potential damage to surrounding normal tissues and improves the quality of life of patients. However, its design deficiencies are also obvious: the dense pseudopodia structure around the device is intended to stabilize the device, but it invisibly increases the risk of damage to normal tissues, and the complexity of the device also brings inconvenience to operation. In addition, while its single radiotherapy mode effectively eliminates tumors, it is also difficult to avoid accidental injury to normal cells and lacks 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 meet these challenges, the present invention proposes a sensitizing internal radiotherapy device, which is specially designed for treating tumors that infiltrate surrounding healthy tissues at the margins after surgical resection. The device is placed in close contact with the resection cavity wall, and the dose distribution it produces fits the target tissue around the cavity, ensuring the uniformity of radiotherapy irradiation. 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 supplement radiosensitizing substances as needed. After the treatment, the device can also be easily recovered, effectively avoiding potential long-term adverse reactions. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a sensitization-enhanced internal radiotherapy device.

[0007] The technical solution of the present invention is summarized as follows: A sensitization-type internal radiotherapy device comprises 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 contain 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 contain and release the radiosensitizing material 6; the inner balloon 3 and the outer balloon 4 are arranged in a coaxial nested manner, and the radioactive solution 5 and the radiosensitizing material 6 are injected respectively to achieve sensitization-type internal radiotherapy and dose regulation.

[0008] The injection part 1 includes an injection 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 an injection part lower edge 111; 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 flow hole 173, the upper end of the first injection cavity barrel annular wall 171 contacts the first injection cavity touch top 15, and the lower end of the first injection cavity barrel annular wall 171 is provided with a first injection cavity barrel flow hole 173. Water hole 173, the first injection chamber barrel water hole 173 corresponds to the position of the first flow channel 11, and the lower end of the first injection chamber barrel annular wall 171 is connected to the first injection chamber barrel bottom 172; the second injection chamber barrel 18 is enclosed in the second injection chamber 14 by the second injection chamber plug 110, and the second injection chamber barrel 18 includes a second injection chamber barrel annular wall 181, a second injection chamber barrel bottom 182 and a second injection chamber barrel water hole 183, the upper end of the second injection chamber barrel annular wall 181 contacts the second injection chamber touch top 16, and the lower end of the second injection chamber barrel annular wall 181 is provided with a second injection chamber barrel water hole 183, the second injection chamber barrel water hole 183 corresponds to the position of the second flow channel 12, and the lower end of the second injection chamber barrel annular wall 181 is connected to the second injection chamber barrel bottom 182.

[0009] 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 developing 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, the inner balloon expansion portion 32 wraps the developing tip 25 of the catheter 2, and the inner balloon 3 and the catheter 2 surround a first balloon cavity 33; the outer balloon 4 includes an outer balloon bonding portion 41, an outer balloon expansion portion 42, the outer balloon expansion portion is provided with a penetration hole 43, and the outer balloon 4 wraps the inner balloon 3 The outer balloon bonding part 41 is bonded to the catheter 2, and the outer balloon 4, the inner balloon 3 and the catheter 2 together form a second balloon cavity 44; one end of the first flow channel 11 is connected to the first injection cavity 13, and the other end of the first flow channel 11 is connected to the first catheter cavity 21, and the first tube body hole 23 is connected to the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 is connected to the second injection cavity 14, and the other end of the second flow channel 12 is connected to the second catheter cavity 22, and the second tube body hole 24 is connected to the second catheter cavity 22 and the second balloon cavity 44.

[0010] The radioactive solution 5 contains one or more nuclides selected from 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 for increasing 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 chemotherapy drugs.

[0011] Furthermore, the radiosensitizing material 6 is liquid at room temperature and gradually solidifies when it approaches body temperature.

[0012] Furthermore, the radiosensitizing material 6 contains a material with a magnetocaloric effect component, and the radiosensitizing material 6 can be heated up by applying an alternating magnetic field to increase the sensitivity of radiotherapy.

[0013] Optionally, the size of the first injection cavity touching the top 15 is larger than the size of the second injection cavity touching the top 16 .

[0014] Furthermore, the first injection cavity barrel 17 and the second injection cavity barrel 18 are made of hard material.

[0015] Furthermore, a circular hole 112 is provided on the lower edge 111 of the injection portion for further operation or fixation.

[0016] The radiosensitizing material 6 is disposed on the outer surface of the outer balloon expansion portion 42 , and the outer balloon expansion portion 42 may be optionally provided with no penetration hole 43 .

[0017] The advantages of the present invention are: Low-dose and high-efficiency treatment: By adopting 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.

[0018] Recyclability: The device design allows for easy recycling after treatment, effectively avoiding possible adverse reactions caused by long-term implantation in the body, and improving the safety of treatment and patient comfort.

[0019] Double balloon cavity design: Combining the design of the inner balloon cavity and the outer balloon cavity, the volume of the radiotherapy solution can be adjusted according to the changes in the surgical cavity. At the same time, the radiosensitizing material can be replenished in time to ensure the continuity and effectiveness of the treatment process, avoiding the problem of weakening the treatment effect due to the metabolism of the material by the human body.

[0020] Magnetothermal effect enhanced therapy: Radiosensitizing materials contain magnetothermal effect components, which can be heated up by applying an external electromagnetic field, thereby increasing the killing effect of radiation on tumor cells and further reducing damage to normal tissues.

[0021] Puncture resistance: The injection chamber barrel is made of hard material, which improves the puncture resistance of the device and reduces the risk of device damage caused by puncturing the first injection chamber blockage and the second injection chamber blockage during the puncture operation.

[0022] Sealing: The injection part adopts two puncture sites, namely the first injection cavity touch top and the second injection cavity touch top, which is an integrally molded structure with the injection body, with better sealing effect, effectively reducing the risk of leakage of radioactive solution.

[0023] Convenient fixation: The circular hole set on the lower edge of the injection part facilitates the fixation of the device, effectively preventing the device from shifting during use and ensuring the accuracy and stability of the treatment.

[0024] Flexible operability: By puncturing the touch top of the first injection cavity and the touch top of the second injection cavity respectively, the radioactive solution and radiosensitizing material can be easily injected, replaced or extracted, providing doctors with greater operational flexibility and treatment accuracy.

[0025] Broad application prospects: The present invention is particularly suitable for postoperative adjuvant treatment of malignant tumors such as brain glioma and breast cancer, providing patients with a safer and more effective treatment option. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a schematic diagram of the three-dimensional structure of a sensitization-type internal radiotherapy device of the present invention.

[0027] Figure 2 The figure is a cross-sectional schematic diagram of the injection portion of a sensitization-type internal radiotherapy device of the present invention.

[0028] Figure 3 This is a schematic diagram of the bottom direction during the injection part production process.

[0029] Figure 4 This is a schematic diagram of the structural explosion of the injection part.

[0030] Figure 5 This is a cross-sectional schematic diagram of the positions of the inner balloon and the outer balloon of a sensitization-type internal radiotherapy device of the present invention.

[0031] Figure 6 This is a schematic cross-sectional view of an inner balloon of a sensitization-type internal radiotherapy device of the present invention.

[0032] Figure 7 It is a schematic diagram of the three-dimensional structure of a sensitization-type internal radiotherapy device of the present invention after implantation.

[0033] Figure 8 This is a schematic diagram showing that a circular hole is provided on the lower edge of the injection portion.

[0034] Fig. 9The invention is a sensitization type internal radiotherapy device in which a radiosensitizing material 6 is arranged in the outer balloon expansion part.

[0035] Fig.10 This is a comparison of the survival rates of multiple cancer cells under radiotherapy and radiotherapy + radiosensitizing material treatment. DETAILED DESCRIPTION

[0036] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] Example 1

[0038] A sensitization type internal radiotherapy device, such as Figure 1-8As shown, 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 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 an injection part lower edge 111; the first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity plug 19, and the first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172 and The first injection chamber barrel has a water hole 173, the upper end of the first injection chamber barrel annular wall 171 contacts the first injection chamber touch top 15, the lower end of the first injection chamber barrel annular wall 171 is provided with a first injection chamber barrel water hole 173, the first injection chamber barrel water hole 173 corresponds to the position of the first flow channel 11, and the lower end of the first injection chamber barrel annular wall 171 is connected to the first injection chamber barrel bottom 172; the second injection chamber barrel 18 is enclosed in the second injection chamber 14 by the second injection chamber plug 110, the second injection chamber barrel 18 includes a second injection chamber barrel annular wall 181, a second injection chamber barrel bottom 182 and a second injection chamber barrel water hole 183, the upper end of the second injection chamber barrel annular wall 181 contacts the second injection chamber touch Touch the 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, 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; 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 developing 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, the inner balloon expansion portion 32 wraps the developing tip 25 of the catheter 2, and the inner balloon 3 and the catheter 2 surround the first balloon cavity 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 a penetration hole 43, the outer balloon 4 wraps the inner balloon 3, the outer balloon bonding portion 41 is bonded to the catheter 2, and the outer balloon 4, the inner balloon 3 and the catheter 2 together form a second balloon cavity 44; one end of the first flow channel 11 is connected to the first injection cavity 13, the other end of the first flow channel 11 is connected to the first catheter cavity 21, and the first tube body hole 23 is connected to the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 is connected to the second injection cavity 14, the other end of the second flow channel 12 is connected to the second catheter cavity 22, and the second tube body hole 24 is connected to the second catheter cavity 22 and the second balloon cavity 44.

[0039] like Figure 3-4As shown, during the manufacturing process of the injection part, two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection body 10. This design not only enhances the integrity of the structure, but also improves the durability of the device.

[0040] In particular, the size of the first injection cavity touch top 15 is designed to be larger than the size of the second injection cavity touch top 16. Such a differentiated design facilitates the doctor 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 operation and improving the safety and accuracy of treatment.

[0041] In terms of material selection, the first injection cavity barrel 17 and the second injection cavity barrel 18 are both made of hard materials, specifically medical stainless steel. Of course, other hard materials with high strength and good corrosion resistance can also be selected according to actual needs. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel, to prevent the first injection cavity plug 19 and the second injection cavity plug 110 of the sensitization type internal radiotherapy device from penetrating during the puncture process, thereby effectively avoiding abnormal leakage of radioactive substances.

[0042] Use Figure 3 The one-piece structure shown in the figure, plus Figure 4 The first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard material as shown are finally sealed into an integral structure, i.e., the injection part 1, by bonding, welding, injection molding or molding with the first injection cavity plug 19 and the second injection cavity plug 110. This not only effectively ensures the sealing of the injection part of the sensitization internal radiotherapy device, but also greatly reduces the risk of radioactive leakage, thereby ensuring the safety and effectiveness of the treatment process.

[0043] The radioactive solution 5 contains iodine-125 nuclide.

[0044] 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 it reaches 30-37°C, preferably solidifies at 35-37°C. This property can ensure that the radiosensitizing material is slowly absorbed by human tissue at the treatment site, reduce the metabolic rate, and thus ensure the sustainability of the radiosensitization treatment effect.

[0045] The status of the sensitization internal radiotherapy device before use is Figure 1The state shown. During or after the brain glioma surgery, the doctor implants the inner balloon 3 and the outer balloon 4 of the sensitization-type internal radiotherapy device into the desired radiotherapy site, with the injection part 1 buried under the skin; the radioactive solution 5 is injected into the device by puncturing the first injection cavity touch top 15, so that the radioactive solution 5 fills the inner balloon 3, and the irradiation dose is 25Gy (any value between 20-40Gy can also be selected); the radiosensitizing material 6 is injected into the device by puncturing the second injection cavity touch top 16, so that the radiosensitizing material flows into the outer balloon 4 and flows into the desired treatment site through the penetration hole 43, and the effective dose of gadolinium tungstate nanoparticles is 5mg / kg (any value between 3-15mg / kg can also be selected). At this time, the state of the sensitization-type internal radiotherapy device is Figure 7 After this operation, the patient can carry the sensitization internal radiotherapy device to move around. This device provides great convenience to the patient during internal radiotherapy and reduces the patient's pain.

[0046] According to the progress of the patient's disease and recovery, the radioactive solution 5 can be injected, replaced or extracted by puncturing the first injection cavity touch top 15; during the radiotherapy process, the radiosensitizing material 6 can be injected by puncturing the second injection cavity touch top 16. After this treatment operation, the patient can carry the sensitizing internal radiotherapy device and continue to receive internal radiotherapy during the activity. This device brings great convenience to the patient. After the treatment, the radioactive solution 5 is extracted by puncturing the first injection cavity touch top 15, and the inner balloon 3 and the outer balloon 4 shrink accordingly to facilitate 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.

[0047] Reference 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.

[0048] Example 2

[0049] A sensitization type internal radiotherapy device, such as Figure 1-8As shown, 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 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 an injection part lower edge 111; the first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity plug 19, and the first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 172 and The first injection chamber barrel has a water hole 173, the upper end of the first injection chamber barrel annular wall 171 contacts the first injection chamber touch top 15, the lower end of the first injection chamber barrel annular wall 171 is provided with a first injection chamber barrel water hole 173, the first injection chamber barrel water hole 173 corresponds to the position of the first flow channel 11, and the lower end of the first injection chamber barrel annular wall 171 is connected to the first injection chamber barrel bottom 172; the second injection chamber barrel 18 is enclosed in the second injection chamber 14 by the second injection chamber plug 110, the second injection chamber barrel 18 includes a second injection chamber barrel annular wall 181, a second injection chamber barrel bottom 182 and a second injection chamber barrel water hole 183, the upper end of the second injection chamber barrel annular wall 181 contacts the second injection chamber touch Touch the 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, 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; 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 developing 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, the inner balloon expansion portion 32 wraps the developing tip 25 of the catheter 2, and the inner balloon 3 and the catheter 2 surround the first balloon cavity 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 a penetration hole 43, the outer balloon 4 wraps the inner balloon 3, the outer balloon bonding portion 41 is bonded to the catheter 2, and the outer balloon 4, the inner balloon 3 and the catheter 2 together form a second balloon cavity 44; one end of the first flow channel 11 is connected to the first injection cavity 13, the other end of the first flow channel 11 is connected to the first catheter cavity 21, and the first tube body hole 23 is connected to the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 is connected to the second injection cavity 14, the other end of the second flow channel 12 is connected to the second catheter cavity 22, and the second tube body hole 24 is connected to the second catheter cavity 22 and the second balloon cavity 44.

[0050] like Figure 3-4As shown, during the manufacturing process of the injection part, two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection body 10. This design not only enhances the integrity of the structure, but also improves the durability of the device.

[0051] In particular, the size of the first injection cavity touch top 15 is designed to be larger than the size of the second injection cavity touch top 16. Such a differentiated design facilitates the doctor 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 operation and improving the safety and accuracy of treatment.

[0052] In terms of material selection, the first injection cavity barrel 17 and the second injection cavity barrel 18 are both 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 they cannot have magnetocaloric effect. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel, to prevent the first injection cavity plug 19 and the second injection cavity plug 110 of the sensitization type internal radiotherapy device from penetrating during the puncture process, thereby effectively avoiding abnormal leakage of radioactive substances.

[0053] Use Figure 3 The one-piece structure shown in the figure, plus Figure 4 The first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard material as shown are finally sealed into an integral structure, i.e., the injection part 1, by bonding, welding, injection molding or molding with the first injection cavity plug 19 and the second injection cavity plug 110. This not only effectively ensures the sealing of the injection part of the sensitization internal radiotherapy device, but also greatly reduces the risk of radioactive leakage, thereby ensuring the safety and effectiveness of the treatment process.

[0054] The radioactive solution 5 contains palladium-103 nuclide.

[0055] The radiosensitizing material 6 is an injection solution containing a magnetocaloric effect component material, and the magnetocaloric effect component material specifically contains Fe 3 O 4 , NiCu (Ni-30Cu) alloy particles (other materials that can produce magnetocaloric effect can also be selected), Fe 3 O 4 , NiCu mass ratio is 1:1, and the radiosensitizing material 6 is heated to above 38°C by applying an alternating magnetic field to produce a thermal effect, thereby increasing the sensitivity of radiotherapy.

[0056] When radiotherapy is used alone, its killing effect is relatively limited when targeting hypoxic tumor cells and sublethal tumor cells. In order to optimize the treatment effect, a magnetothermal effect component material is innovatively incorporated into the radiosensitizing material 6; the material can respond to the alternating magnetic field and accurately induce local temperature rise in the tumor area, thereby significantly improving the killing efficiency of malignant tumors, especially hypoxic tumor cells and sublethal tumor cells. Given that tumor cells have extremely vigorous metabolic activities and are often located closer to the outer balloon expansion portion 42, cancer cells around the device can more effectively absorb the radiosensitizing material 6; of course, the sensitizing component can also be combined with a monoclonal antibody that can specifically bind to cancer cells (or other structures that are easily taken up by cancer cells) in the radiosensitizing material 6, so as 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, while having almost no effect on healthy cells in the non-thermal zone, thus achieving precise targeted treatment at the cellular level. This heating mechanism can not only block the oxygen supply to tumor cells to a certain extent, but also increase the activity of intracellular enzymes and accelerate oxygen consumption; because the metabolic level of normal tissue cells is much lower than that of tumor cells, and the demand for oxygen is relatively low, they have stronger heat resistance; under appropriate heating treatment conditions, the sensitized internal radiotherapy device can specifically kill tumor tissue, while causing no damage or only limited damage to surrounding normal tissue. In particular, this heating treatment method has a particularly significant killing effect on hypoxic tumor cells and sublethal tumor cells, and enhances the sensitivity of radiation to tumor cells. At the same time, due to the limited range of thermal therapy, which usually does not exceed 5mm, it will not affect deep normal tissues, ensuring the safety and accuracy of treatment.

[0057] The status of the sensitization internal radiotherapy device before use is Figure 1 During or after breast cancer surgery, the doctor implants the inner balloon 3 and outer balloon 4 of the sensitization type internal radiotherapy device into the desired radiotherapy site, with the injection part 1 buried under the skin; the radioactive solution 5 is injected into the device by puncturing the first injection cavity touch top 15, so that the radioactive solution 5 fills the inner balloon 3, and the irradiation dose is 25Gy (any value between 20-40Gy can also be selected); the radiosensitization material 6 is injected into the device by puncturing the second injection cavity touch top 16, so that the radiosensitization material flows into the outer balloon 4 and flows into the desired treatment site through the penetration hole 43, Fe 3 O 4 The effective dose of NiCu alloy particles is 5 mg / kg (any value between 3 and 15 mg / kg can also be selected). At this time, the state of the sensitization type internal radiotherapy device is Figure 7 Status shown.

[0058] In the treatment area, the magnetic hyperthermia machine generates an alternating magnetic field, the intensity of which is flexibly adjusted within the range of 0-0.2T, and the specific intensity is set 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, which is intended to enhance the killing effect of radiotherapy rays on tumor cells and improve the sensitivity of radiotherapy. To ensure safety, a temperature probe is used to monitor the temperature of the surrounding tissue during the process to ensure that the temperature rise does not exceed 60°C, thereby avoiding damage to normal tissue. It is also possible to choose to use a magnetic thermal effect component material that can self-control the temperature. The alternating magnetic field generated by the magnetic hyperthermia machine will not cause the radiosensitizing material 6 to exceed 60°C or stabilize the temperature at any value between 38-60°C, preferably stabilizing the temperature at 45-50°C. After magnetic thermal radiation sensitization treatment, patients can move freely with advanced sensitization internal radiotherapy devices. The device continuously releases radiation to carry out close and precise attacks on tumors. During internal radiotherapy, this device not only significantly improves the treatment effect, but also brings great convenience to patients, effectively reducing their physical and mental burden.

[0059] According to the progress of the patient's disease and recovery, the radioactive solution 5 can be injected, replaced or extracted by puncturing the first injection cavity touch top 15; during the magnetic thermal radiation sensitization treatment, the radiosensitizing material 6 can be injected by puncturing the second injection cavity touch top 16. After this treatment operation, the patient can carry the sensitization type internal radiotherapy device and continue to receive internal radiotherapy during the activity. This device brings great convenience to the patient. After the treatment, the radioactive solution 5 is extracted by puncturing the first injection cavity touch top 15, and the inner balloon 3 and the outer balloon 4 shrink accordingly to facilitate 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.

[0060] Example 3

[0061] A sensitization type internal radiotherapy device, such as Figure 1-8As shown, 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 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 an injection part lower edge 111; the first injection cavity barrel 17 is enclosed in the first injection cavity 13 by the first injection cavity plug 19, and the first injection cavity barrel 17 includes a first injection cavity barrel annular wall 171, a first injection cavity barrel bottom 1 72 and the first injection chamber barrel water hole 173, the upper end of the first injection chamber barrel annular wall 171 contacts the first injection chamber touch top 15, the lower end of the first injection chamber barrel annular wall 171 is provided with the first injection chamber barrel water hole 173, the first injection chamber barrel water hole 173 corresponds to the position of the first flow channel 11, and the lower end of the first injection chamber barrel annular wall 171 is connected to the first injection chamber barrel bottom 172; the second injection chamber barrel 18 is enclosed in the second injection chamber 14 by the second injection chamber plug 110, the second injection chamber barrel 18 includes a second injection chamber barrel annular wall 181, a second injection chamber barrel bottom 182 and a second injection chamber barrel water hole 183, and the upper end of the second injection chamber barrel annular wall 181 is connected to the first injection chamber barrel bottom 172; The second injection cavity touches the top 16, and 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, and 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 developing 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, the inner balloon expansion portion 32 wraps the developing tip 25 of the catheter 2, and the inner balloon 3 and the catheter 2 form 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, the outer balloon bonding part 41 is bonded to the catheter 2, and the outer balloon 4, the inner balloon 3 and the catheter 2 together form a second balloon cavity 44; one end of the first flow channel 11 is connected to the first injection cavity 13, the other end of the first flow channel 11 is connected to the first catheter cavity 21, and the first tube body hole 23 is connected to the first catheter cavity 21 and the first balloon cavity 33; one end of the second flow channel 12 is connected to the second injection cavity 14, the other end of the second flow channel 12 is connected to the second catheter cavity 22, and the second tube body hole 24 is connected to the second catheter cavity 22 and the second balloon cavity 44.

[0062] like Figure 3-4As shown, during the manufacturing process of the injection part, two puncture sites, the first injection cavity touch top 15 and the second injection cavity touch top 16, are integrally formed with the injection body 10. This design not only enhances the integrity of the structure, but also improves the durability of the device.

[0063] In particular, the size of the first injection cavity touch top 15 is designed to be larger than the size of the second injection cavity touch top 16. Such a differentiated design facilitates the doctor 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 operation and improving the safety and accuracy of treatment.

[0064] In terms of material selection, the first injection cavity barrel 17 and the second injection cavity barrel 18 are both 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 they cannot have magnetocaloric effect. The selection of these materials is mainly to enhance the puncture resistance of the injection cavity barrel, to prevent the first injection cavity plug 19 and the second injection cavity plug 110 of the sensitization type internal radiotherapy device from penetrating during the puncture process, thereby effectively avoiding abnormal leakage of radioactive substances.

[0065] Use Figure 3 The one-piece structure shown in the figure, plus Figure 4 The first injection cavity barrel 17 and the second injection cavity barrel 18 made of hard material as shown are finally sealed into an integral structure, i.e., the injection part 1, by bonding, welding, injection molding or molding with the first injection cavity plug 19 and the second injection cavity plug 110. This not only effectively ensures the sealing of the injection part of the sensitization internal radiotherapy device, but also greatly reduces the risk of radioactive leakage, thereby ensuring the safety and effectiveness of the treatment process.

[0066] The radioactive solution 5 contains gold-198 nuclide.

[0067] The radiosensitizing material 6 is arranged on the outer surface of the outer balloon expansion part 42 to promote the effective absorption of the 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. The radiosensitizing material 6 can also be fixed on the outer surface of the outer balloon expansion part 42 by processes such as dipping or scraping. The radiosensitizing material 6 contains a magnetocaloric effect component material, which is specifically a NiCu alloy with an effective dose of 5 mg / kg (any value between 3 and 15 mg / kg can also be selected), wherein the mass fraction of Cu is 30% of the particles. This NiCu alloy can gradually increase its own temperature to nearly 50°C under an alternating magnetic field as the magnetic field strength increases, and then its temperature will not continue to rise even if the magnetic field strength increases, that is, self-temperature control is achieved.

[0068] No penetration hole 43 is provided on the outer balloon expansion portion 42. Fig. 9 As shown. This setting is suitable for treatment scenarios where no subsequent additional radiosensitizing material 6 is required, which simplifies the treatment process. In order to achieve a comparable treatment effect, the radiosensitizing material 6 provided on the outside of the outer balloon expansion portion 42 needs to contain a higher concentration of sensitizing components, or the radiation dose of the radioactive solution 5 can be increased. This design strategy not only meets specific treatment needs, but also brings additional advantages: the structural integrity of the outer balloon expansion portion 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, and reducing the risk of penetration and leakage of the radioactive solution 5. Even if the inner balloon 3 ruptures, the outer balloon 4 can still provide support, thereby extending the overall service life of the sensitized internal radiotherapy device.

[0069] During or after breast cancer surgery, the doctor implants the inner balloon 3 and outer balloon 4 of the sensitization internal radiotherapy device into the desired radiotherapy site, with the injection part 1 buried under the skin; the radioactive solution 5 is injected into the device by puncturing the first injection cavity touch top 15, so that the radioactive solution 5 fills the inner balloon 3, and the irradiation dose is 35Gy (any value between 20-40Gy can also be selected).

[0070] In the treatment area, the magnetic hyperthermia machine generates an alternating magnetic field, the intensity of which is flexibly adjusted within the range of 0-0.2T, and the specific intensity is set 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, which is intended to enhance the killing effect of radiotherapy rays on tumor cells and improve the sensitivity of radiotherapy. Due to the self-controlling temperature characteristics of this NiCu alloy, the temperature rise will not exceed 50°C, thereby avoiding damage to normal tissues. After magnetic thermal radiation sensitization treatment, patients can move freely with advanced sensitization internal radiotherapy devices. The device continuously releases rays to carry out close and precise strikes on tumors. During internal radiotherapy, this device not only significantly improves the treatment effect, but also brings great convenience to patients, effectively reducing their physical and mental burden.

[0071] According to the progress of the patient's disease and recovery, the radioactive solution 5 can be injected, replaced or extracted by puncturing the first injection cavity and touching the top 15 to adjust the intensity of radiotherapy, or the magnetic hyperthermia machine can be used again for hyperthermia to enhance radiotherapy sensitivity. After this treatment operation, the patient can carry the sensitization-enhanced internal radiotherapy device and continue to receive internal radiotherapy during the activity. This device brings great convenience to the patient. After the treatment, the radioactive solution 5 is extracted by puncturing the first injection cavity and touching the top 15, and the inner balloon 3 and the outer balloon 4 shrink accordingly to facilitate 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.

[0072] Example 4 (In vitro multi-level tumor sensitization verification) 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: U87-MG and HUVEC (human umbilical vein endothelial cells) were mixed at a ratio of 2:1 and inoculated into a 24-well plate containing Matrigel, 500 μL per well, at 37 °C, 5% CO 2 After 7 days of culture, vascularized tumor spheroids were formed. The sensitized internal radiotherapy device prepared according to Example 1: the outer balloon has a diameter of 5 mm and is evenly permeated with 0.5 μm holes for releasing radiosensitizing materials. Radioactive solution: iodine-125 labeled, dose 25 Gy; sensitizer: gadolinium tungstate nanoparticles, Fe 3 O 4 / NiCu alloy particles, concentration 5 mg / kg.

[0073] Diffusion of sensitizer in 3D co-culture model. The device of Example 1 was implanted in the center of the vascularized tumor spheroid, and 25Gy of iodine-125 and 5 mg / kg of gadolinium tungstate nanoparticles (DiI fluorescent labeling) were injected. Fluorescence distribution was photographed at 24 h, 48 h, and 72 h, and the results of quantitative penetration depth and average fluorescence intensity are shown in Table 1. The data obtained by the sensitizing internal radiotherapy device prepared in Example 2 were similar to those in Table 1, and the sensitizer was able to penetrate deep into the center of the tumor (>2 mm) after 72 h.

[0074] Table 1 Penetration depth and average fluorescence intensity time Penetration depth (mm) Fluorescence intensity (AU) 24 h 1.2 ± 0.1 1200 ± 50 48 h 1.8 ± 0.2 2100 ± 80 72 h 2.3 ± 0.2 2800 ± 100 Comparison of sensitization ratios of multiple cancer cell lines. Each cell line was seeded in a 6-well plate (1×10 5 cells / well), and were divided into a control group (no treatment), a radiotherapy group (25 Gy), a gadolinium tungstate group (Example 1, 25 Gy + 5 mg / kg gadolinium tungstate), and a Fe 3 O 4 / NiCu magnetocaloric group (Example 2, 25 Gy + 5 mg / kgFe 3 O 4 / NiCu+100 kHz adjustable magnetic field+thermocouple temperature control), NiCu self-temperature control group (Example 3, 25 Gy+5 mg / kgNiCu 100 kHz adjustable magnetic field+thermocouple temperature measurement), a total of 5 groups, each with 3 replicates. 3 O 4The temperature of the NiCu magnetic heating group was maintained at 48.5°C±0.5°C (the magnetic field at this temperature was 0.1 T, and the temperature would rise if the magnetic field strength was further increased) for 2 h by measuring the temperature with thermocouples and gradually increasing the magnetic field strength. The temperature of the NiCu self-controlled temperature group was always stable at 48.5°C±0.5°C when the magnetic field strength was set to 0.1 T and increased to 1.2 T. Subsequently, a lower magnetic field strength of 0.1 T was selected for heating for 2 h. The survival rate was measured by CCK-8 method after 72 h. The results are as follows Fig.10 As shown, it is shown that the sensitivity of each tumor cell during radiotherapy can be significantly enhanced by the composition ratio of the sensitization internal radiotherapy device of Examples 1-3.

[0075] Example 5 (Safety Assessment of Normal Cells) NHA, HDF, HUVEC, PBMC, and HK-2 were selected and inoculated into 96-well plates at 5×10³ cells / well. The plates were divided into control group (culture medium), gadolinium tungstate group (5 mg / kg), Fe 3 O 4 / NiCu group (5 mg / kg, heated to 48.5°C±0.5°C for 2 h according to the heating method of Example 4). Detection after 72 h: survival rate (CCK-8); ROS level (DCFH-DA flow cytometry); IL-6, TNF-α (ELISA).

[0076] The results are shown in Tables 2-5. For different types of normal cells (NHA, HDF, HUVEC, PBMC, HK-2), we conducted control group, gadolinium tungstate group and Fe 3 O 4 Toxicity evaluation of the Gd-tungstate group and Fe-TiO2 group. Survival rate analysis: The cell survival rates of the control group were all above 90%, which indicated that the growth and survival of normal cells were not affected in the conventional culture medium. 3 O 4 The survival rate of the Gd2O3 group was 94.5% (NHA) to 92.8% (PBMC), while the survival rate of the Fe2O3 group was 94.5% (NHA) to 92.8% (PBMC). 3 O 4 The survival rates of the NiCu group were 94.5% (NHA) and 91.4% (PBMC). These results suggest that the sensitizers (Gd2O3 and Fe 3 O 4 / NiCu) had limited toxicity to normal cells and did not cause significant cell damage. ROS level analysis: ROS (reactive oxygen species) levels, as a marker of cellular oxidative stress, varied to a certain extent in all groups. The ROS levels in the control group ranged from 1.05 (NHA) to 1.10 (HUVEC), while in the Gd-tungstate group and Fe-tungstate group, the ROS levels in the control group ranged from 1.05 (NHA) to 1.10 (HUVEC). 3 O 4In the NiCu / Ga2O3 group, the ROS level increased slightly. The ROS levels in the Gd2O3 group were 1.02 (NHA) to 1.05 (HUVEC), Fe 3 O 4 / NiCu group: 1.10 (NHA) to 1.09 (HK-2). This shows that although the ROS level increased slightly under the treatment of the two sensitizers, it did not reach the dangerous threshold of cell damage. Analysis of IL-6 and TNF-α concentrations: In the determination of inflammatory factor IL-6, the IL-6 concentration of the control group ranged from 12.3 (NHA) to 18.3 (PBMC), while the gadolinium tungstate group and Fe tungstate group did not reach the dangerous threshold of cell damage. 3 O 4 The IL-6 concentrations in the Gd-tungstate group were 11.8 (NHA) to 17.8 (PBMC), and the IL-6 concentrations in the Fe-tungstate group were 11.8 (NHA) to 17.8 (PBMC). 3 O 4 / NiCu group: 13.2 (NHA) to 18.0 (PBMC). This change shows that although the sensitizer caused cellular inflammatory response to a certain extent, the overall increase was small and did not lead to significant immune response activation. TNF-α, another important inflammatory factor, had a similar trend in concentration among the groups. The TNF-α concentration in the control group was between 8.5 (NHA) and 11.4 (PBMC), the concentration in the gadolinium tungstate group was between 8.2 (NHA) and 10.8 (PBMC), and the concentration in the Fe 3 O 4 The concentrations of the / NiCu group ranged from 8.7 (NHA) to 11.1 (PBMC). This further supports that the immune response induced by the sensitizer to normal cells is not significant and does not lead to excessive inflammatory response.

[0077] Gd-tungstate group and Fe 3 O 4 The cytotoxicity of normal cells in the Gd2O3 / NiCu group was not significantly increased compared with that in the control group, indicating that the sensitized internal radiotherapy device has good safety on normal cells. 3 O 4 The sensitizers in the NiCu / NiCu group were less toxic in normal cells and did not cause significant cell damage or immune response. In all normal cell types, the use of the sensitizers 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 sensitizers were safe for normal tissues.

[0078] Table 2 Safety assessment results of normal cells - survival rate (CCK-8) Cell Type Control group (%) Gadolinium tungstate group (%) <![CDATA[Fe 3 O 4 / 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 Table 3 Safety assessment results of normal cells - ROS (relative value) level (DCFH-DA flow cytometry) Cell Type Control group Gadolinium Tungstate Group <![CDATA[Fe 3 O 4 / 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 Table 4 Safety evaluation results of normal cells - IL-6 (pg / mL) Cell Type Control group Gadolinium Tungstate Group <![CDATA[Fe 3 O 4 / 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 Table 5 Safety evaluation results of normal cells - TNF-α (ELISA) Cell Type Control group Gadolinium Tungstate Group <![CDATA[Fe 3 O 4 / NiCu Group]]> 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 Example 6 (Animal Experiment) The U87-MG glioma model was transplanted subcutaneously in BALB / c nude mice to evaluate the therapeutic effect and safety of the sensitized internal radiotherapy device in vivo. The study showed that the radiotherapy effect can be significantly enhanced by setting up radiosensitizing materials; magnetic heat therapy based on magnetic heat effect component materials can also significantly improve the radiotherapy effect, providing a theoretical basis for combined radiothermal therapy.

[0079] Experimental materials and methods. Animal model: 25 5-6 week old BALB / c nude mice were subcutaneously injected with U87-MG glioma cells (about 1×10^6 cells) and the treatment was started when the tumor volume was about 100 mm³ (diameter 56 mm). Groups (n=5 per group): Group A (refer to Example 1): iodine-125 radioactive source + gadolinium tungstate nanoparticles (without heating); Group B (refer to Example 2): iodine-125 radioactive source + Fe 3 O 4 / NiCu magnetothermal particles + external alternating magnetic field heating; Group C (refer to Example 3): iodine-125 radiation source + NiCu self-controlled temperature particles; Group D: iodine-125 radiotherapy alone; Group E: empty device control group (only empty balloon implanted). Treatment plan: The corresponding balloon structure device was implanted in the subcutaneous tumor of mice in all experimental groups; the initial dose of I-125 was 25 Gy (35 Gy in Group C); the nanoparticle dose was 5 mg / kg. Groups B and C were given an alternating magnetic field at the same time as radiotherapy (intensity 0.1 T, frequency 100 kHz, 2 hours / time, the magnetic field was applied once after the device was implanted, and then once every 1 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 the IVIS imaging system (Caliper ROI) to calculate the tumor volume inhibition rate; the weight and daily activity status of the mice were recorded at the same time. On the 7th day, the mice were killed, and the heart, liver, spleen, lung, and kidney tissues were obtained for HE staining and pathological scoring (grade 0-3, 0 = no damage, 1 = mild inflammation, 2 = moderate necrosis, 3 = severe lesions).

[0080] Experimental results and analysis. The tumor volume inhibition rate of each group (mean ± standard deviation) is 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 in each group. The scores of the heart, liver, spleen, lung, and kidney in each group were all in the range of 0-1, and there was no obvious pathological damage. The treatment results showed that the tumor inhibition rates of Groups B and C (73.3%, 80.0%) were significantly higher than those of Group D (46.7%) treated with radiotherapy alone (p<0.01), and Group A (60.0%) was also significantly better than Group D (p<0.05). Among them, Group B used Fe 3 O 4 / NiCu combined particles cooperate with an external alternating magnetic field to produce a magnetothermal effect, which significantly enhances the radiotherapy effect; Group C uses NiCu self-controlled temperature particles to achieve a similar sensitization effect under higher doses of radiotherapy, reflecting the technical advantages of this device. In addition, Group A contains high atomic number gadolinium-tungstate nanoparticles. This type of material will be enriched in tumors and significantly enhance the radiation response as a radiotherapy sensitizer. Therefore, Group A has a higher tumor inhibition efficiency than Group D. The body weight of mice in each group changed steadily during the treatment period, without a significant decrease, and their activities and eating were normal, indicating that all treatment conditions were well tolerated. No significant pathological changes were found in the HE staining of organs in each group, and the pathological scores were all 0-1 (Table 7). In this study, the main organ structures of Group B and other groups were normal, indicating that Fe 3 O 4 The local application of nanomaterials such as NiCu did not cause significant systemic toxicity, verifying the biocompatibility and safety of the device and sensitizing materials.

[0081] This example verifies the efficacy and safety of the sensitization-type internal radiotherapy device. The device achieves sensitization-type internal radiotherapy by integrating high atomic number materials (such as gadolinium tungstate) or magnetocaloric materials, significantly delaying tumor growth (the tumor inhibition rate is significantly higher than that of the control group) without obvious side effects, reflecting excellent technical effects. In particular, Group C uses NiCu self-temperature-controlled particles for stable heating, which simplifies the treatment process and improves the clinical application potential of the device. The above results highlight that the device of the present invention innovatively takes into account both sensitization and safety, and provides a new technical solution for local radiotherapy of solid tumors such as gliomas.

[0082] Table 6 Tumor volume inhibition rate of each group (mean ± SD%) Group Group A(I-125+GdW) <![CDATA[Group B (I-125 + Fe 3 O 4 / NiCu magnetothermal)]]> Group C (I-125+NiCu self-temperature control) Group D (I-125 simple) Group E (control) Tumor inhibition rate 60.0±5.0 73.3±4.0 80.0±3.0 46.7±6.0 0 Table 7 HE pathological scores of major organs in each group (0-3 grades, 0=normal) 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 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 medical needs.

[0083] During implementation, the role of the radiosensitizing material 6 is to enhance the sensitivity of radiotherapy. Its core function is that, by introducing this material, it can ensure that when a lower dose of radioactive solution 5 is used, the radiotherapy effect equivalent to the conventional dose is still achieved, thereby greatly reducing the potential damage to surrounding normal tissues. Specifically, the composition of the radiosensitizing material 6 covers a wide range of options, including one or more of the following materials: 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 series of nanoscale materials, such as nanodiamonds, C60 carbon nanotubes, selenium nanoparticles and ferrocene composite nanoparticles; one or more chemotherapy drugs. These diverse options provide a more flexible and efficient sensitization strategy for radiotherapy.

[0084] Since tumor cells have vigorous metabolism and are closer to the outer balloon expansion portion 42, when the radiosensitizing material 6 is released into the body by the sensitizing internal radiotherapy device, it is preferentially absorbed by tumor cells, and the concentration of the sensitizing component in tumor cells is higher than that in normal cells, thereby achieving a stronger killing effect on 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 sensitization type internal radiotherapy device, characterized in that The invention comprises 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 contain 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 contain and release 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), sensitization-type internal radiotherapy and dose regulation are achieved.

2. A sensitization type internal radiotherapy device according to claim 1, characterized in that The injection part (1) comprises an injection 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) comprises a first injection cavity barrel annular wall (171), a first injection cavity barrel bottom (172), and a first injection cavity barrel water flow 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 The injection chamber barrel has a water flow hole (173), the first injection chamber barrel water flow hole (173) corresponds to the position of the first flow channel (11), and the lower end of the first injection chamber barrel annular wall (171) is connected to the first injection chamber barrel bottom (172); the second injection chamber barrel (18) is enclosed in the second injection chamber (14) by the second injection chamber plug (110), the second injection chamber barrel (18) comprises a second injection chamber barrel annular wall (181), a second injection chamber barrel bottom (182) and a second injection chamber barrel water flow hole (183), the upper end of the second injection chamber barrel annular wall (181) contacts the second injection chamber touch top (16), the lower end of the second injection chamber barrel annular wall (181) is provided with a second injection chamber barrel water flow hole (183), the second injection chamber barrel water flow hole (183) corresponds to the position of the second flow channel (12), and the lower end of the second injection chamber barrel annular wall (181) is connected to the second injection chamber barrel bottom (182).

3. The sensitization type internal radiotherapy device according to claim 1, characterized in that The catheter (2) comprises 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 developing tip (25); the inner balloon (3) comprises 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); the inner balloon expansion portion (32) wraps around the developing tip (25) of the catheter (2); the inner balloon (3) and the catheter (2) form a first balloon cavity (33); the outer balloon (4) comprises an outer balloon bonding portion (41) and an outer balloon expansion portion (42); the outer balloon expansion portion is provided with a permeation hole (43); the outer balloon (4) wraps around the developing tip (25) of the catheter (2); The inner balloon (3) is wrapped, the outer balloon bonding portion (41) is bonded to the catheter (2), and the outer balloon (4), the inner balloon (3) and the catheter (2) together form a second balloon cavity (44); one end of the first flow channel (11) is connected to the first injection cavity (13), the other end of the first flow channel (11) is connected to the first catheter cavity (21), and the first tube body hole (23) is connected to the first catheter cavity (21) and the first balloon cavity (33); one end of the second flow channel (12) is connected to the second injection cavity (14), the other end of the second flow channel (12) is connected to the second catheter cavity (22), and the second tube body hole (24) is connected to the second catheter cavity (22) and the second balloon cavity (44).

4. The sensitization type internal radiotherapy device according to claim 1, characterized in that The radioactive solution (5) contains one or more nuclides selected from the group consisting of iodine-125, palladium-103, gold-198, lutetium-177, cesium-131, strontium-89, yttrium-90, and phosphorus-32; the radiosensitizing material (6) contains at least one of the following materials for increasing 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, or one or more chemotherapy drugs.

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

6. The sensitization type internal radiotherapy device according to claim 1, characterized in that The invention comprises a method of use. The radiosensitizing material (6) contains a material with a magnetothermal effect component, and the radiosensitizing material (6) can be heated by applying an alternating magnetic field to increase the sensitivity of radiotherapy.

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

8. The sensitization type 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 hard material.

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

10. The sensitization type 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 a permeable hole (43).

Images