Stent with radioactivity, conveying device and mounting equipment
By designing radioactive scaffolds and using elastic materials or wire braided mesh carriers combined with radioactive substances, the limitations of single high-dose radiotherapy in the treatment of cervical and endometrial cancer are solved, and low-dose, long-term, Treatment with good conformality reduces the cost of treatment and the needs of hospital treatment, and improves the comfort and safety of treatment.
Patent Information
- Application Number
- CN202310761488.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-06-26
- Publication Date
- 2024-12-27
AI Technical Summary
There are problems such as local damage, long treatment time, long cycle, high cost and inconvenience in the existing radiation therapy for cervical and endometrial cancer, especially the inability to achieve conformity and sustainability of post-installation treatment. Sexual radiotherapy.
A radioactive scaffold is designed, the carrier is made of elastic material or wire braided mesh, combined with radioactive substances, used to implant into the cervix or uterine cavity, achieving low-dose, long-term radiotherapy, including carriers and delivery devices. and install the equipment, the stent can be placed continuously and removed after the treatment cycle is over.
Low-dose, long-term radiation therapy is achieved, which reduces damage to normal tissues, simplifies the treatment process, reduces the cost of treatment, avoids multiple hospital treatments, improves the conformity of treatment and the comfort of patients, and Controllable recovery of radioactive sources to avoid safety hazards.
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Figure CN119185799A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a radioactive stent, a conveying device and an installation equipment. Background Art
[0002] Endometrial cancer and cervical cancer are the two most common uterine malignancies. According to statistics, the incidence of cervical cancer ranks first among female cancers. Women of all ages may develop cervical cancer, and it is most common in women aged 25 to 45. The incidence of endometrial cancer is second only to cervical cancer, accounting for 7% of the total number of female cancers and 20% to 30% of female reproductive tract malignancies. The average age of onset is around 60 years old. In recent years, its incidence has tended to be younger, and the incidence rate is on the rise.
[0003] At present, the treatment of cervical cancer or endometrial cancer includes external beam irradiation (long-distance external beam irradiation) and afterloading therapy (close-range intracavitary irradiation). External beam irradiation mainly targets the primary lesion and the pelvic spread and lymphatic metastasis areas, while afterloading therapy mainly irradiates the primary lesion area. Afterloading therapy is a radiotherapy that first places the applicator at the tumor treatment site, and then sends the radiation source to the applicator installed in the body through a control device. It is mainly carried out in a single large-dose manner. It uses the natural cavity of the human body to bring the radiation source directly close to the tumor surface, directly killing tumor cells, while causing little damage to normal tissues, that is, it protects normal tissues to the greatest extent and reduces the side effects of radiotherapy. However, the problems with afterloading therapy are also very significant: 1) A single large dose of radiotherapy can cause local mucosal damage or local acute reactions, which can cause tissue damage and lead to cervical bleeding and perforation; 2) Due to the special location of the uterine cavity and cervix, it is impossible to cover all areas during treatment, and imaging guidance is required. A single treatment time is long and conformal treatment cannot be achieved; 3) After treatment, radiotherapy is required again according to the patient's treatment situation. The treatment process is cumbersome and the treatment cycle is long; 4) During treatment, it is necessary to go to the hospital to use an afterloading device for treatment. The treatment cost is high, and the hospital has limited equipment. The treatment process is inconvenient and time-consuming for both doctors and patients.
[0004] Therefore, it is very necessary to develop a radioactive stent that can be applicable to cervical cancer and endometrial cancer, can achieve continuous small-dose radiotherapy, and has convenient treatment, good conformity, and low treatment cost. Summary of the invention
[0005] The purpose of the present invention is to provide a radioactive stent, a conveying device and an installation device to solve the technical problems that a single large-dose radiotherapy causes great damage, a single treatment time and cycle of afterloading therapy is long, contour-matching cannot be achieved, the treatment cost is high, and the treatment is time-consuming and labor-intensive.
[0006] In order to solve the above technical problems, the present invention provides a radioactive stent for treating cervical cancer or endometrial cancer, wherein the radioactive stent comprises: a carrier and a radioactive substance; the carrier is made of an elastic material, or the carrier is a mesh formed by weaving silk threads; the radioactive substance comprises a radioactive interlayer, a radioactive coating or radioactive particles; the carrier is used to carry the radioactive substance, and the radioactive stent is used to be implanted in the cervix or uterine cavity.
[0007] Optionally, the radioactive material is a radioactive particle, and the carrier has a particle capsule, and the particle capsule holds the radioactive particle; preferably, the radioactive material includes at least one of iodine-125, palladium-103, iridium-192, californium, gold-198, cesium-131, ytterbium-169, yttrium-90 and phosphorus-32; preferably, the elastic material of the carrier includes at least one of thermoplastic elastomer, silicone, polyester or rubber material; the mesh body formed by silk thread weaving is made of metal wire.
[0008] Optionally, the carrier is in a circular ring structure, the inner diameter of the circular ring structure is 28 to 48 mm, and the outer diameter is 50 to 75 mm, so that it can be stuck in the cervix and posterior fornix; the concave holes on the carrier form the particle capsule, and the particle capsule is designed to imitate the shape of radioactive particles, and the dimensions of the particle capsule in all directions match the dimensions of the radioactive particles.
[0009] Optionally, the radioactive particles are cylindrical, the length of the cylinder is 0.2 to 20 mm, and the outer diameter is 0.2 to 2.0 mm; the effective irradiation distance of the radioactive particles is 10 to 30 mm; and the initial dose rate of radioactivity is not less than 7.7 cGY / h.
[0010] Optionally, the particle capsules are evenly arranged along the circumferential direction of the carrier, the particle capsules are used for placing radioactive particles, and the particle capsules are also used to calculate the spacing between each radioactive particle for even or uneven placement of the radioactive particles; preferably, the spacing between each radioactive particle is 10 to 30 mm; preferably, the opening of the particle capsule is in the same direction as the axial direction of the carrier; preferably, the therapeutic time of the radioactive stent is the half-life of the radioactive particle, preferably, the treatment time is 20 to 60 days; preferably, the calculation formula for the number of radioactive particles is: the required number of radioactive particles = Da*5 / ionizing radiation of each radioactive particle, Da is the average value of the sum of the length, width and height of the target tissue, Da is in cm, and the unit of ionizing radiation of each radioactive particle is mCi.
[0011] Optionally, the carrier includes a sheet structure, a pocket-shaped structure is arranged on the sheet structure to form the particle capsule, the carrier is arranged in a trapezoidal shape, with an upper base size of 11 to 25 mm, a lower base size of 5 to 11 mm, a height of 25 to 33 mm, and a thickness of 0.4 to 1 mm, for being spread flat in the uterine cavity; the spatial size of the particle capsule can accommodate the loading of the radioactive particles; preferably, the opening of the particle capsule faces one side of the long side of the carrier; the particle capsules are arranged in an array on the carrier.
[0012] Optionally, the carrier further comprises a cervical rod, and the cervical rod is connected to the sheet structure. Preferably, the length of the cervical rod is 3 to 5 cm; preferably, the cervical rod is a hollow rod.
[0013] Optionally, the carrier includes a cervical inner diameter clamping portion and a cervical os clamping portion, the cervical os clamping portion is connected to the cervical inner diameter clamping portion, the cervical inner diameter clamping portion is used to clamp into the cervix, and the cervical inner diameter clamping portion or the cervical os clamping portion is provided with a hole or a pocket to form a particle capsule; preferably, the cervical inner diameter clamping portion is a hollow rod or a ring; preferably, the cervical os clamping portion includes at least two claws, and the at least two claws are used to clamp to the anterior and posterior vaults; preferably, the cervical os clamping portion includes an umbrella-like structure for supporting the cervical os.
[0014] In order to solve the above technical problems, the present invention also provides a delivery device for delivering the radioactive stent as described above, the delivery device comprising: a delivery cavity rod and a delivery push rod, the radioactive stent is compressed and placed in the delivery cavity rod, the delivery cavity rod is delivered to the uterine cavity opening, and the delivery push rod is used to push the radioactive stent to the target position.
[0015] In order to solve the above technical problems, the present invention also provides an installation device for installing a radioactive stent, the installation device comprising: the installation device is used to install or coat the radioactive material of the radioactive stent as described above on the carrier; preferably, the radioactive material of the radioactive stent is radioactive particles, and the carrier is made of elastic material; the installation device comprises a base, a cover plate and a contour mold, the contour mold is arranged on the base, the cover plate is connected to the base and wraps the contour mold, the contour mold is used to place the radioactive stent, the cover plate has a through hole, the position of the through hole is adapted to the position of the contour mold for implanting radioactive particles; preferably, the installation device also comprises a spray gun, the spray gun is used to spray the radioactive particles from the through hole into the contour mold.
[0016] In a radioactive stent, a delivery device and an installation device provided by the present invention, the radioactive stent is used to treat cervical cancer or endometrial cancer, and the radioactive stent includes: a carrier and a radioactive substance; the carrier is made of an elastic material, or the carrier is a mesh body woven by silk threads; the radioactive substance includes a radioactive interlayer, a radioactive coating or radioactive particles; the carrier is used to carry the radioactive substance, and the radioactive stent is used to be implanted in the cervix or uterine cavity. In this way, under the support of the carrier, the radioactive substance can be implanted into the cervix or uterine cavity, and the radioactive substance is combined with the carrier to realize the characteristics of the stent, thereby realizing low-dose and long-term treatment, avoiding the adverse effects caused by a single short-term high-dose radiotherapy, and causing little damage to normal tissues, and the stent is simple in composition and easy to use. The carrier is made of an elastic material, or a mesh body woven by silk threads, and has good conformability and is suitable for contoured setting, which is convenient for conformal treatment in special positions of the uterine cavity and cervix. After the radioactive stent is implanted into the uterine cavity or cervix, it can be placed continuously for a treatment cycle. After the treatment cycle, the stent is removed. The treatment is simple and the patient's experience of treatment is greatly improved. In this process, no device treatment is used, and there is no need to go to the hospital for multiple treatments. The treatment cost is low and the process of going to the hospital repeatedly and queuing for treatment is saved. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.
[0018] Figure 1 This is a schematic diagram of a radioactive stent provided in Example 1 of the present invention.
[0019] Figure 2 This is a schematic diagram of a radioactive stent provided in Example 2 of the present invention.
[0020] Figure 3a This is a front view of the radioactive stent provided in Example 3 of the present invention.
[0021] Figure 3b FIG. 3 is a top view of the radioactive stent.
[0022] Figure 4 This is a schematic diagram of a radioactive stent provided in Example 4 of the present invention.
[0023] Figure 5 This is a schematic diagram of a radioactive stent provided in Example 5 of the present invention.
[0024] In the attached figure:
[0025] 1-carrier, 11-particle capsule, 12-annular structure, 13-sheet structure, 14-cervical rod, 15-cervical inner diameter clamping part, 151-hole, 16-cervical mouth clamping part, 161-claw, 17-umbrella structure. DETAILED DESCRIPTION
[0026] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.
[0027] As used in this specification, the singular forms "a", "an", and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise. In addition, in the description below, a large number of specific details are given in order to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. It should be noted that the following detailed descriptions are illustrative and are intended to provide further explanation of the present application. Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those commonly understood by those of ordinary skill in the art to which the present application belongs.
[0028] The term "target site" refers to a location where radiation can be delivered to a cancerous area in need of treatment.
[0029] The term "target tissue" refers to the site of cancer that requires treatment.
[0030] The present invention provides a radioactive stent, a delivery device, and an installation device. The radioactive stent is used to treat cervical cancer or endometrial cancer. The radioactive stent includes: a carrier and a radioactive substance; the carrier is made of an elastic material, or the carrier is a mesh formed by weaving silk threads; the radioactive substance includes a radioactive interlayer, a radioactive coating, or radioactive particles; the carrier is used to carry the radioactive substance, and the radioactive stent is used to be implanted in the cervix or uterine cavity. In this way, under the support of the carrier, the radioactive substance can be implanted into the cervix or uterine cavity, and the radioactive substance is combined with the carrier to realize the characteristics of the stent, thereby realizing low-dose, long-term treatment. The stent has good conformability and profiling, simple composition, easy use, simple treatment, low treatment cost, and improves the patient's treatment experience.
[0031] The technical solutions of Embodiments 1 to 5 are described in detail below.
[0032] [Example 1]
[0033] Please refer to Figure 1 , Figure 1 This is a schematic diagram of a radioactive stent provided in Example 1 of the present invention.
[0034] like Figure 1 As shown, a radioactive stent is used to treat cervical cancer. The radioactive stent comprises: a carrier 1 and a radioactive substance (not shown). It should be understood that for the convenience of description, the stent hereinafter refers to the radioactive stent.
[0035] The carrier 1 is made of an elastic material, and the elastic material of the carrier 1 includes at least one of thermoplastic elastomer (TPE), silicone, polyester or rubber materials. In the first embodiment, the carrier 1 preferably adopts a thermoplastic elastomer, so that the carrier 1 has good flexibility and is easy to manufacture. Of course, in other preferred embodiments, the carrier 1 can also adopt a mesh structure that realizes weaving molding, and the mesh structure has good contractility, so that the carrier 1 has good flexibility, and thus the conformability of the carrier 1 is good, and it can match the special and complex structures in the cervix and uterine cavity. And it is suitable for profiling settings, which is convenient for conformal treatment of special positions of the uterine cavity and cervix. In addition, stents of different models and sizes can be manufactured according to clinical needs, and stents of different models and sizes can be customized according to individual sizes. The manufacturing is flexible and simple, the cost is low, and the conformability is further improved, the pain of patients during treatment is reduced, and the comfort after implantation and wearing is improved.
[0036] The radioactive material includes a radioactive interlayer, a radioactive coating or radioactive particles (not shown), the carrier 1 is used to carry the radioactive material, and the radioactive stent is used to be implanted in the cervix or uterine cavity, so that the radioactive material can be implanted into the target position together with the carrier 1. In this way, under the support of the carrier 1, the radioactive material can be implanted into the cervix or uterine cavity, and the stent formed by combining the radioactive material with the carrier has the characteristics of an implantable stent, thereby achieving low-dose, long-term treatment, avoiding the adverse effects of bleeding or perforation on the tissue caused by a single short-term high-dose radiotherapy, and causing less damage to normal tissue. The stent is simple in composition, easy to use, and has low manufacturing and treatment costs. After the stent is implanted into the uterine cavity or cervix, it can be placed continuously for a treatment cycle. After the treatment cycle ends, the stent is removed, and the treatment is simple. In this process, no device treatment is used, and there is no need to go to the hospital for multiple treatments. The treatment cost is low, and the process of going to the hospital repeatedly and queuing for treatment is omitted. In addition, in the prior art, there is another treatment that directly implants radioactive particles into the cancerous part. This implantation treatment can cause bleeding, infection, pain and other symptoms at the perforated part. After implantation, as the tumor shrinks, the radioactive particles will be detached and free, so that the radioactive particles cannot be recovered in the body, causing continuous radioactive radiation to the patient, so that the patient always has a radioactive source in the body, and the treatment cycle and process are uncontrollable, thereby affecting the patient's normal life and the patient's physical and mental health. Especially for patients whose cancer has been cured, if the radioactive source is not removed, this sequelae adds a great psychological burden to the patient. In addition, if the radioactive source is not detached from the body, it will also cause radiation to the environment, posing a safety hazard. The stent in this embodiment, on the one hand, can be implanted in the uterine cavity and cervical part without perforation for weak and complex parts such as endometrial cancer and cervical cancer. The implantation process is safe and non-damaging, and there will be no symptoms such as infection caused by bleeding. On the other hand, the stent can be recycled. After completing a treatment cycle, the carrier and the radioactive substance are recycled together, avoiding the problem that the radioactive source cannot be recycled in the body, and the treatment cycle and process are controllable. At the same time, the recovery of radioactive sources avoids safety hazards.
[0037] In the first embodiment, the radioactive material is preferably a radioactive particle, and the radioactive material 1 is preferably at least one of iodine-125, palladium-103, iridium-192, californium, gold-198, cesium-131, ytterbium-169, yttrium-90 and phosphorus-32. For example, the radioactive particle is iodine-125. The carrier 1 has a particle capsule 111, and the particle capsule 111 holds the radioactive particle, thereby realizing the combination of the radioactive particle and the carrier 1. In other embodiments, the radioactive material can also be a radioactive interlayer, for example, the radioactive interlayer is arranged using a radioactive particle array. The radioactive interlayer is sandwiched in the carrier 1, for example, the radioactive interlayer is arranged in the middle layer, and the carrier 1 is arranged in the outer two layers; or, the radioactive interlayer is wrapped in the carrier 1. The radioactive material can also be a radioactive coating, and the radioactive coating is formed, for example, using californium material. The thickness of the coating can be set according to the radioactivity requirements, and the coating can be, for example, a mixture of radioactive substances or a pure radioactive substance.
[0038] Please continue to refer to Figure 1 Preferably, the carrier 1 is in the form of a circular ring structure 12, and the circular ring structure 12 is used to be stuck in the cervix and posterior fornix. The inner diameter of the circular ring structure 12 is preferably 28-48 mm, and the outer diameter is 50-75 mm. Of course, in other embodiments, the inner and outer diameters of the circular ring structure 12 can also be changed according to specific needs. For example, different sizes are designed according to different countries, and they are not limited to the range of inner diameter 28-48 mm and outer diameter 50-75 mm. The outer diameter is, for example, 64 mm, and the inner diameter is, for example, 40 mm. The concave holes on the carrier 1 form the particle capsule 111, and the particle capsule 111 is designed to imitate the shape of radioactive particles. The dimensions of the particle capsule 111 in all directions match the dimensions of the radioactive particles 2, so that the radioactive particles 2 can be accommodated in the particle capsule 111. Preferably, the opening of the particle capsule 111 is in a constricted shape, so that the radioactive particles 2 are not easy to escape from the particle capsule 111. The constriction can ensure that the radioactive particles 2 can be installed smoothly. Of course, those skilled in the art can set the structure of the particle capsule 111 according to actual needs, and other structures that can accommodate radioactive particles are not described in detail herein. The design of the particle capsule 111 can realize the rapid loading of radioactive particles, save the doctor's operation time, and reduce the doctor's exposure to radiation; and can also use specific tooling for safe and radiation-free drug loading.
[0039] Preferably, the radioactive particle 2 is cylindrical, and the length of the cylinder is 0.2 to 20 mm, and the outer diameter is 0.2 to 2.0 mm. In this way, the shape of the radioactive particle 2 can be ensured to be uniform. At the same time, the cylindrical structure has a larger surface area than the square structure, which can increase the radiation area of the radioactivity. Compared with the spherical structure, the cylindrical structure is convenient to install, not easy to slip, and easy to match with the installation equipment. The setting of the size of the radioactive example 2 combined with the carrier 1 of the annular structure 12 can achieve effective radiation therapy to treat lesions and cancer tissues.
[0040] Preferably, the effective irradiation distance of the radioactive particles 2 is 10 to 30 mm, so that the irradiation distance can be within the range of cancer lesions. More preferably, the selection of the irradiation distance will not form a large-scale irradiation, will not affect healthy tissues, and thus greatly reduce the side effects of irradiation. Preferably, the initial dose rate of the radioactivity is not less than 7.7 cGY / h, so that the radioactive stent can have an effective therapeutic radiation dose.
[0041] Preferably, the particle capsules 11 are evenly arranged for placement of radioactive particles 2; and the particle capsules 11 are also used to calculate the spacing between each radioactive particle 2. For example, the distance between each particle capsule 11 is 5 mm. When the radioactive particles 2 need to be placed at intervals of 10 mm, one particle capsule 11 is spaced between two radioactive particles 2. The particle capsules 2 can also be used for uniform or uneven placement of the radioactive particles 2. For example, when the cancerous site is annular, the annular setting of the radioactive particles 2 can better provide annular treatment, and the particle capsules 11 provide annular uniform placement of the radioactive particles 2. When the cancerous site is locally non-annular, the radioactive particles 2 can be set on one side of the annular structure 12, thereby achieving targeted treatment of local lesions, and the particle capsules 11 provide uneven placement of the radioactive particles 2. Preferably, the opening of the particle capsule 11 is in the same direction as the axial direction of the carrier 1. In this way, after the stent is implanted, it is not easy to fall out under the action of gravity. Of course, in other embodiments, the opening of the particle capsule 11 can also be oriented toward the inside or outside of the annular structure 12. For example, when the opening of the particle capsule 11 is oriented toward the outside, the opening toward the outside is not wrapped by the carrier 1, so that the radiation dose of the carrier 1 toward the outside is greater than the radiation dose toward other parts. In this way, the opening toward the outside can be targeted toward the cancerous part, thereby achieving precise treatment.
[0042] Preferably, the spacing between each of the radioactive particles 2 is 10 to 30 mm, and the spacing between the radioactive particles 2 can be adaptively selected according to the irradiation distance.
[0043] Preferably, the therapeutic effect of the radioactive stent is 20 to 60 days. Thus, compared with short-distance treatment and afterloading treatment, continuous small-dose treatment can be achieved during the treatment period, which improves the treatment effect, reduces the pain of the patient, and achieves a qualitative change in the treatment of cervical cancer.
[0044] Preferably, the formula for calculating the number of radioactive particles is: the required number of radioactive particles = Da*5 / ionizing radiation of each radioactive particle, Da is the average value of the sum of the length, width and height of the target tissue, the unit of Da is cm, and the unit of ionizing radiation of each radioactive particle is mCi.
[0045] Preferably, the inner diameter of the annular structure 12 has a concave notch 121, so that when the notch is placed in a mold of an installation device, the position can be ensured to be stable without twisting or deflection. At the same time, when the annular structure 12 is installed in a conveying device, the concave structure can be used as a folding point to facilitate folding and installation.
[0046] This embodiment 1 also provides a delivery device, which is used to deliver the radioactive stent as described above, and includes: a delivery cavity rod and a delivery push rod, the radioactive stent is compressed and placed in the delivery cavity rod, the delivery cavity rod is delivered to the uterine cavity, and the delivery push rod is used to push the radioactive stent to the target position. The beneficial effects of the delivery device have the beneficial effects of the stent, which will not be repeated here.
[0047] This embodiment also provides a mounting device, which is used to mount a radioactive bracket, and the mounting device includes: the mounting device is used to mount or coat the radioactive material of the above-mentioned radioactive bracket on the carrier 1. The beneficial effects of the mounting device have the beneficial effects of the bracket, which will not be repeated here.
[0048] Preferably, the radioactive material of the radioactive stent is a radioactive particle, and the carrier is made of an elastic material; the installation device includes a base, a cover plate, and a profiling mold, the profiling mold is arranged on the base, the cover plate is connected to the base and wraps the profiling mold, the profiling mold is used to place the radioactive stent, the cover plate has a through hole, and the position of the through hole is adapted to the position of the profiling mold for implanting radioactive particles. In this way, radiation during the installation process can be avoided.
[0049] Preferably, the installation device further comprises a spray gun, and the spray gun is used to spray the radioactive particles from the through hole into the contoured mold. The provision of the spray gun can achieve rapid installation of the reflective particles.
[0050] [Example 2]
[0051] Please refer to Figure 2 , Figure 2 This is a schematic diagram of a radioactive stent provided in Example 2 of the present invention.
[0052] The difference between the second embodiment and the first embodiment is that the structure of the carrier of the radioactive stent is different. The same parts of the radioactive stent in the second embodiment and the first embodiment will not be described again, and only the differences will be described below.
[0053] like Figure 2 As shown, the carrier 1 with a radioactive stent includes a sheet structure 13, which is used to treat endometrial cancer. A pocket-shaped structure is arranged on the sheet structure 13 to form the particle capsule 11, and the carrier 1 is arranged in a trapezoidal shape so that the trapezoidal structure matches the size of the uterine cavity. Preferably, the trapezoidal structure has a long bottom side size of 11 to 25 mm, a short bottom side size of 5 to 11 mm, a height of 25 to 33 mm, and a thickness of 0.4 to 1 mm, and is used to be laid flat in the uterine cavity. The spatial size of the particle capsule 11 can accommodate the loading of the radioactive particles 2. Preferably, the opening of the particle capsule 11 faces one side of the long bottom side of the carrier 1; the particle capsule 11 is arranged in an array on the carrier 1. This arrangement is because when the carrier 1 is placed in the uterine cavity, one side of the long bottom side is located at the upper part of the uterine cavity, and the opening of the particle capsule 11 faces, so that the particle capsule 11 is not easy to fall out under the action of gravity.
[0054] It should be understood that the sheet structure 13 may also be provided with a radioactive coating or radioactive interlayer as described in the first embodiment. The material of the sheet structure 13 and the content of the radioactive particles may refer to the description in the first embodiment.
[0055] Preferably, the particle capsules 11 are arranged in an array on the carrier, thereby ensuring that the radioactive particles 2 can be arranged in an array and ensuring uniform distribution or uneven targeted distribution of the radiation dose.
[0056] [Example 3]
[0057] Please refer to FIG. 3 , which is a schematic diagram of a radioactive stent provided in Embodiment 3 of the present invention.
[0058] The difference between the third embodiment and the first and second embodiments is that the structure of the carrier of the radioactive stent is different. The same parts of the radioactive stent in the third embodiment and the first embodiment will not be described again, and only the differences will be described below.
[0059] As shown in FIG3 , the difference between the third embodiment and the second embodiment is that the carrier 1 further includes a cervical rod 13, and the cervical rod 13 is connected to the sheet structure 12. Preferably, the length of the cervical rod 13 is 3 to 5 cm. The cervical rod 13 is used to match the size of the cervix. The cervical rod 13 is, for example, a cylindrical hollow rod, and the outer diameter of the hollow rod can be set according to the requirements. The wall thickness of the hollow rod can be selectively set according to the required support force. The setting of the cervical rod 13 can support the sheet structure 12 to prevent it from falling out. On the other hand, a plurality of particle capsules 11 can be arranged on the outside of the cervical rod 13, thereby achieving the joint treatment of cervical cancer and endometrial cancer. It should be understood that the size of the cervical rod 13 can be an elastic material or a mesh woven by silk thread. The material of the cervical rod 13 and the sheet structure 12 can be the same or different. For example, the sheet structure 12 and the cervical rod 13 are both mesh structures woven by silk thread, or are both elastic materials. Alternatively, the sheet structure 12 may be made of elastic material, and the cervical rod 13 may be a mesh structure formed by weaving silk threads. Preferably, the material of the weaving silk threads is a metal material, and the metal material may be nickel titanium.
[0060] [Example 4]
[0061] Please refer to Figure 4 , Figure 4 This is a schematic diagram of a radioactive stent provided in Example 4 of the present invention.
[0062] The difference between the fourth embodiment and the first, second and third embodiments is that the structure of the carrier of the radioactive stent is different. The same parts of the radioactive stent in the fourth embodiment as those in the other embodiments will not be described again, and only the differences will be described below.
[0063] like Figure 4 As shown, the carrier 1 includes a cervical inner diameter clamping portion 15 and a cervical os clamping portion 16. The cervical os clamping portion 16 is connected to the cervical inner diameter clamping portion 15. The cervical inner diameter clamping portion 15 is used to clamp into the cervix, thereby achieving cancer treatment in the cervix.
[0064] The cervical inner diameter clamping portion 15 or the cervical mouth clamping portion 16 is provided with a hole or a pocket shape to form a particle capsule 11. Preferably, the cervical inner diameter clamping portion 15 is a hollow rod or a ring.
[0065] Preferably, the inner diameter of the cervical inner diameter clamping portion 15 may be 2-5 mm, and the outer diameter may be 5-8 mm. The length of the cervical inner diameter clamping portion 15 may be 5-40 mm. Of course, in other embodiments, the size is not limited thereto.
[0066] Preferably, the hollow rod of the cervical inner diameter clamping portion 15 is also provided with a plurality of holes 151 to facilitate the drainage of bleeding and discharge of secretions during the treatment of the lesion, thereby reducing the risk of infection in the uterine cavity.
[0067] Preferably, the cervical opening clamping part 16 includes at least two clamping claws 161, and the at least two clamping claws 161 are used to clamp the front and rear fornixes. The clamping claws 161 are everted and upturned, and the everted width of the clamping claws 161 can be the wall thickness of the cervical opening, for example, 3 to 7 mm, and the upturned height of the clamping claws 161 can be 10 to 30 mm, etc., to ensure that the bracket can be stable at the target position.
[0068] [Example 5]
[0069] Please refer to Figure 5 , Figure 5 This is a schematic diagram of a radioactive stent provided in Example 5 of the present invention.
[0070] The difference between the fifth embodiment and the first, second, third and fourth embodiments is that the structure of the carrier of the radioactive stent is different. The same parts of the radioactive stent in the fifth embodiment and the other embodiments are not described again, and only the differences are described below.
[0071] like Figure 5 As shown, the difference between the fifth embodiment and the fourth embodiment is that the cervical os clamping portion 16 includes an umbrella-shaped structure 17, and the width of the umbrella-shaped structure 17 can be, for example, 25 to 40 mm, for supporting the cervical os to prevent the stent from prolapse. The size of the cervical clamping portion 15 can refer to the content of the fourth embodiment.
[0072] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.
Claims
1. A radioactive stent, characterized in that: Used for treating cervical cancer or endometrial cancer, the radioactive stent comprises: a carrier and a radioactive substance; The carrier is made of elastic material, or the carrier is a mesh formed by weaving silk threads; The radioactive material includes a radioactive interlayer, a radioactive coating or radioactive particles; The carrier is used for carrying radioactive substances, and the radioactive stent is used for implantation into the cervix or uterine cavity.
2. The radioactive stent according to claim 1, characterized in that: The radioactive material is a radioactive particle, and the carrier has a particle capsule, and the particle capsule contains the radioactive particle; Preferably, the radioactive material includes at least one of iodine-125, palladium-103, iridium-192, californium, gold-198, cesium-131, ytterbium-169, yttrium-90 and phosphorus-32; Preferably, the elastic material of the carrier includes at least one of thermoplastic elastomer, silicone, polyester or rubber materials; the mesh body formed by weaving wires is made of metal wires.
3. The radioactive stent according to claim 2, characterized in that: The carrier is in a circular ring structure with an inner diameter of 28 to 48 mm and an outer diameter of 50 to 75 mm, so as to be stuck in the cervix and posterior fornix. The concave holes on the carrier form the particle capsule, which is designed to imitate the shape of radioactive particles, and the dimensions of the particle capsule in all directions match the dimensions of the radioactive particles.
4. The radioactive stent according to claim 3, characterized in that: The radioactive particles are cylindrical, with a length of 0.2 to 20 mm and an outer diameter of 0.2 to 2.0 mm; the effective irradiation distance of the radioactive particles is 10 to 30 mm; and the initial dose rate of the radioactivity is not less than 7.7 cGY / h.
5. The radioactive stent according to claim 3, characterized in that: The particle capsules are evenly arranged along the circumferential direction of the carrier, and are used to place radioactive particles. The particle capsules are also used to calculate the spacing between each radioactive particle, so as to place the radioactive particles evenly or unevenly. Preferably, the spacing between each of the radioactive particles is 10 to 30 mm; Preferably, the opening of the particle capsule is in the same direction as the axial direction of the carrier; Preferably, the therapeutic time of the radioactive stent is the half-life of the radioactive particles, and preferably, the treatment time is 20 to 60 days; Preferably, the formula for calculating the number of radioactive particles is: the required number of radioactive particles = Da*5 / ionizing radiation of each radioactive particle, Da is the average value of the sum of the length, width and height of the target tissue, the unit of Da is cm, and the unit of ionizing radiation of each radioactive particle is mCi.
6. The radioactive stent according to claim 2, characterized in that: The carrier includes a sheet structure, a pocket-shaped structure is arranged on the sheet structure to form the particle capsule, the carrier is arranged in a trapezoidal shape, the upper base size is 11-25 mm, the lower base size is 5-11 mm, the height is 25-33 mm, and the thickness is 0.4-1 mm, and is used for being spread flat in the uterine cavity; the spatial size of the particle capsule can accommodate the loading of the radioactive particles; preferably, the opening of the particle capsule faces one side of the long side of the carrier; the particle capsules are arranged in an array on the carrier.
7. The radioactive stent according to claim 6, characterized in that: The carrier also includes a cervical rod, which is connected to the sheet structure. Preferably, the length of the cervical rod is 3 to 5 cm; preferably, the cervical rod is a hollow rod.
8. The radioactive stent according to claim 2, characterized in that: The carrier includes a cervical inner diameter clamping portion and a cervical os clamping portion, the cervical os clamping portion is connected to the cervical inner diameter clamping portion, the cervical inner diameter clamping portion is used to clamp into the cervix, the cervical inner diameter clamping portion or the cervical os clamping portion is provided with a hole or a pocket to form a particle capsule; preferably, the cervical inner diameter clamping portion is a hollow rod or a ring; preferably, the cervical os clamping portion includes at least two claws, and the at least two claws are used to clamp to the anterior and posterior vaults; preferably, the cervical os clamping portion includes an umbrella-like structure for supporting the cervical os.
9. A conveying device, characterized in that: Used to deliver a radioactive stent according to any one of claims 1-8, the delivery device includes: a delivery cavity rod and a delivery push rod, the radioactive stent is compressed and placed in the delivery cavity rod, the delivery cavity rod is delivered to the uterine cavity, and the delivery push rod is used to push the radioactive stent to the target position.
10. A mounting device, characterized in that: Used for installing a radioactive stent, the installation equipment comprises: the installation equipment is used to install or coat the radioactive material of the radioactive stent according to claim 1 on the carrier; preferably, the radioactive material of the radioactive stent is radioactive particles, and the carrier is made of elastic material; the installation equipment comprises a base, a cover plate and a contour mold, the contour mold is arranged on the base, the cover plate is connected to the base and wraps the contour mold, the contour mold is used for placing the radioactive stent, the cover plate has a through hole, the position of the through hole is adapted to the position of the contour mold for implanting radioactive particles; preferably, the installation equipment also comprises a spray gun, the spray gun is used to spray the radioactive particles from the through hole into the contour mold.
