An endovascular stent and associated system and method

Abstract

The application discloses an internal radioactive source bone prosthesis and a manufacturing method thereof. The internal radioactive source bone prosthesis comprises a prosthesis body and radioactive particles, the prosthesis body is arranged with a plurality of reserved holes for the radioactive particles, and the radioactive particles are arranged in the reserved holes for the radioactive particles. The shape of the prosthesis body is the same as that of the healthy bone of a resected section, and the arrangement mode of the radioactive particles is determined according to the size, shape and distribution of residual tumor tissues after the resection of the tumor section. The application designs and manufactures a personalized prosthesis for replacing the bone of the tumor section by means of machining or 3D printing technology, the prosthesis is arranged with corresponding reserved holes according to the position of the tumor, the radioactive particles are accurately embedded in the reserved positions during the operation, so that the problem of insufficient implantation position accuracy of the radioactive particles is solved, the size of the reserved holes is consistent with that of the selected radioactive sealed seed source, and the fixing problem of the particle implantation is solved. The process is completed at one time and does not need to be taken out subsequently, so that the operation process is greatly simplified.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of in-vivo bone prosthesis, in particular to an internal radioactive source bone prosthesis and a manufacturing method thereof. BACKGROUND

[0002] Malignant bone tumor is a tumor occurring in bone or its accessory tissue, which can cause serious symptoms such as bone swelling and deformity, surrounding muscle paralysis and necrosis. The current commonly used method generally adopts a comprehensive treatment mainly by tumor segment resection surgery, the diseased bone and surrounding tissue are all removed, an artificial prosthesis is replaced, and finally radiotherapy and chemotherapy are assisted to avoid recurrence of residual tumor cells.

[0003] The most commonly used tumor resection radiotherapy method at present is external beam radiotherapy, but this method has a large range of killing, and for the pelvic bone, rib and other parts, the important organs around them will be located on the irradiation path and difficult to avoid, thus easily causing secondary damage. Since 1905, in-vivo radiotherapy in the form of brachytherapy has been born. Brachytherapy is a general term for a class of radiotherapy means that the encapsulated radioactive nuclide is placed near the tumor body, implanted in the tumor body, or placed on the surface of the tumor body for irradiation. The most prominent feature of brachytherapy is that the dose is very high near the source, and then the dose drops sharply. By using this feature, the radioactive source is placed near the tumor or implanted in the lesion, and the action process is that the radiation "from inside to outside" first causes a large dose of irradiation to the lesion, and the dose drops sharply in normal tissues, thereby protecting normal tissues well.

[0004] The in-vivo implant used in the current brachytherapy mainly depends on the judgment of the residual tumor tissue amount and distribution of the lesion area by the doctor during the operation, and lacks accurate source distribution and estimation of particle arrangement. The traditional brachytherapy is realized by coating of radioactive elements, and the fixation of radioactive substances or particles cannot be guaranteed. The existing post-tumor resection radiotherapy is realized in the form of external radiotherapy, which cannot avoid healthy organs and does not meet the requirements of targeted and precise treatment. SUMMARY

[0005] The purpose of the present application is to provide an internal radioactive source bone prosthesis and a manufacturing method thereof, so as to solve the problem that the radiotherapy process in the existing treatment method cannot avoid healthy organs and does not meet the requirements of precise treatment, and in comparison with the existing in-vivo radiotherapy form, the fixation of radioactive particles can be guaranteed.

[0006] To achieve the above purpose, the technical scheme adopted by the present application is as follows:

[0007] The internal radioactive source bone prosthesis comprises a prosthesis body (1) and radioactive particles (3), the prosthesis body (1) is provided with a plurality of radioactive particle reserved holes (2), and the radioactive particles (3) are arranged in the radioactive particle reserved holes (2); the shape of the prosthesis body (1) is the same as that of the healthy bone of the resected segment, and the arrangement mode of the radioactive particles (3) is determined according to the shape of the resected segment.

[0008] Further, the material of the prosthesis body (1) is an implantable medical high-performance polymer material.

[0009] Further, the implantable medical high-performance polymer material is specifically polyether ketone, polysulfone or polyethylene.

[0010] Further, the radioactive particle (3) is a radioactive sealed seed source.

[0011] Further, the radioactive sealed seed source is specifically iodine-125, gold-198 or palladium-103.

[0012] Further, the depth of the radioactive particle reserved hole 2 ranges from 3 to 6 mm, and the diameter ranges from 0.5 to 1.6 mm.

[0013] Further, a manufacturing method of the internal radioactive source bone prosthesis comprises the following steps:

[0014] S1, according to the CT data of the operation area, a three-dimensional bone model of the resected segment is generated by using a model reconstruction algorithm, and the model of the main part of the bone prosthesis is completed;

[0015] S2, test the activity of the radioactive sealed seed source, determine the irradiation intensity and effective radiation radius of the radioactive sealed seed source;

[0016] S3, according to the CT data of the operation area, determine the residual contour and distribution range after the resection of the dangerous area, according to the irradiation radius of the radioactive sealed seed source, use the equidistant source distribution algorithm to arrange the position of the radioactive sealed seed source in the residual distribution area, use the dynamic programming algorithm to optimize the arrangement of the radioactive sealed seed source, so that the radioactive sealed seed source can meet the requirement of forming an irradiation area completely surrounding the tumor tissue, and generate a complete CAD model of the bone prosthesis;

[0017] S4, according to the activity and effective radiation radius of the particles, determine the boundary conditions in the particle radiation process, and simulate the irradiation range and intensity of the bone prosthesis;

[0018] S5, after the product is manufactured, the bone prosthesis is subjected to high-temperature steam sterilization and sealed packaging;

[0019] S6, use the bone prosthesis to replace the resected bone tissue and fix, according to the calculation result, determine the amount of radioactive particles, and embed the radioactive particles into the prosthesis.

[0020] Further, in step S1, the prosthesis body part is manufactured by machining or 3D printing according to the designed model, and the finished product manufacturing is completed.

[0021] Further, step S3 is specifically:

[0022] S301, the shape, size and distribution of the target region are outlined in the software of the editable CT model according to the CT data, and the target region is bounded by the outer expansion of 4-6mm of the tumor in CT scanning;

[0023] S302, the dose of the required radioactive sealed seed is calculated according to the shape, size and distribution of the outlined target region by selecting the particle accurate algorithm in the TPS system;

[0024] S303, the irradiation area formed by the radioactive sealed seed is simplified as a hemispherical structure according to the irradiation radius of the selected radioactive sealed seed, the particles are arranged at equal intervals in the target region according to the size, shape and distribution of the target region, and the particle arrangement is optimized by using the dynamic programming algorithm to adjust the particle position, so that the particle arrangement can meet the requirement of forming an irradiation area completely surrounding the tumor tissue;

[0025] S304, the particle placement position and effect are verified, the action intensity and range of the particles in the target region and the adjacent area are simulated by means of finite element, the particle arrangement is continuously optimized, and a model with minimum damage to the critical healthy tissue is generated.

[0026] Compared with the prior art, the present application has the following technical effects:

[0027] The present application designs and manufactures a personalized prosthesis for replacing the tumor segment bone by means of machining or 3D printing technology, the corresponding holes are reserved on the prosthesis according to the position of the tumor, and the radioactive particles are accurately embedded in the reserved positions, so as to solve the problem of insufficient accuracy of radioactive particle implantation position, the size of the reserved hole is consistent with the size of the selected radioactive sealed seed, and the problem of fixation after radioactive particle implantation is solved. This process is completed at one time and does not need to be taken out subsequently, greatly simplifying the process of operation.

[0028] The radioactive particles are not determined by experience, but are accurately placed in the specific position of the prosthesis according to the digital model, so that the killing area just contains the tumor area and minimally affects the surrounding tissue, and the target removal of residual tumor tissue is realized. The radioactive particles are wrapped by a shell and embedded in the tissue engineering scaffold, which can eliminate the risk of leakage and diffusion of radioactive substances with blood, and is safer than the doping method in the material. BRIEF DESCRIPTION OF DRAWINGS

[0029] Figure 1 The schematic diagram of the precise radiotherapy bone prosthesis;

[0030] Figure 2 A two-dimensional diagram of forming an irradiation area for a radioactive prosthesis;

[0031] Figure 3 A flow chart for manufacturing a prosthesis;

[0032] Figure 4 A flow chart for using a prosthesis.

[0033] 1. The main part of the precise radiotherapy prosthesis; 2. The reserved hole of the radioactive particle; 3. The radioactive particle; 4. The irradiation area of the radioactive prosthesis. DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0035] The present application provides a precise radiotherapy bone prosthesis with an embedded radioactive source, which is used for bone repair after bone tumor resection and precise radiotherapy of residual tumor tissue. Figure 1 As shown in the figure, the precise radiotherapy bone prosthesis includes a bone prosthesis body and embedded radioactive particles. The prosthesis body part is the same as the ideal healthy bone shape of the tumor resection segment; the radioactive particles are radioactive particles for interstitial brachytherapy of in-vivo tissue, which are embedded in the prosthesis body material, and the specific arrangement is determined by a computer-aided design algorithm according to the tumor shape.

[0036] Figure 2 A two-dimensional diagram of forming an irradiation area for a radioactive prosthesis, as shown in the figure, the prosthesis forms an irradiation range area for radiotherapy according to the arrangement of the particles.

[0037] Please refer to Figure 3 The present application also provides a manufacturing method of the precise radiotherapy bone prosthesis, which includes the following steps:

[0038] S1, CT model reconstruction

[0039] According to the CT data of the operation area, a three-dimensional bone model of the resection segment is generated by using a model reconstruction algorithm, and a CAD model of the main part of the precise radiotherapy bone prosthesis is completed;

[0040] S2, radioactive particle activity test

[0041] The activity of the radioactive particle is tested to determine the irradiation intensity and effective radiation radius of the radioactive particle;

[0042] S3, automatic arrangement of radioactive particles and construction of composite model

[0043] After determining the outline and distribution range of the residual tumor in the patient's body according to the CT data of the tumor resection danger zone in the operation area, the particle positions are arranged using the equidistant source arrangement algorithm in the tumor distribution area according to the irradiation radius of the radioactive particle, and the particle arrangement is optimized using the dynamic programming algorithm, so that the particle source arrangement can meet the requirement of forming an irradiation area completely surrounding the tumor tissue, and a complete CAD model of the precision radiotherapy bone prosthesis is generated.

[0044] S4, analysis and verification of the rationality of radioactive particle arrangement

[0045] According to the activity and effective radiation radius of the particle, the boundary condition in the particle radiation process is determined, the irradiation range and intensity of the precision radiotherapy bone prosthesis are simulated, and the rationality of the particle arrangement is verified.

[0046] S5, manufacturing product

[0047] According to the completed CAD model, the prosthesis body part is manufactured by machining or 3D printing, and appropriate post-processing is performed.

[0048] S6, sterilization and storage

[0049] The precision radiotherapy bone prosthesis is subjected to high-temperature steam sterilization and sealed packaging and storage, and secondary disinfection and sterilization is performed before the operation.

[0050] S7, particle embedding

[0051] The precision radiotherapy bone prosthesis is used to replace and fix the resected bone tissue, the amount of radioactive sealed seed source is determined according to the calculation result, and the selected radioactive sealed seed source is embedded in the reserved hole of the prosthesis.

[0052] Further, the prosthesis body material is an implantable medical high-performance polymer material; the model reconstruction algorithm is an image space iterative reconstruction algorithm (IRIS); the initial source arrangement method of the computer-aided design is an equidistant source arrangement method, and the optimization algorithm is a dynamic programming algorithm.

[0053] Please refer to Figure 4 , the use method of the present application comprises the following steps:

[0054] 1) CT scanning and pre-planning:

[0055] The position and outline of the bone tumor are confirmed by CT scanning, and the resection area is planned.

[0056] 2) Customized precision radiotherapy bone prosthesis:

[0057] According to the customization method of the precision radiotherapy bone prosthesis, the precision radiotherapy bone prosthesis is customized.

[0058] 3) replacement operation:

[0059] The bone tumor resection operation is performed, and the implantation operation of the bone prosthesis is performed.

[0060] 4) Observation and review.

[0061] To sum up, the bone prosthesis capable of realizing precision radiotherapy is designed, the arrangement of radioactive particles is designed according to the position of the postoperative tumor by means of computer-aided algorithm, and the radioactive particles are embedded in the reserved hole of the prosthesis in the operation according to the use requirements of the radioactive sealed seed source, so that the problem of insufficient implantation position precision of the radioactive particles is solved, and the precision and targeting of postoperative radiotherapy are improved.

Claims

1. An endocurie bone prosthesis, characterized in that The application discloses a built-in radioactive source bone prosthesis, which comprises a prosthesis body (1) and radioactive particles (3), wherein the prosthesis body (1) is provided with a plurality of radioactive particle reserved holes (2), and the radioactive particles (3) are arranged in the radioactive particle reserved holes (2); the shape of the prosthesis body (1) is the same as that of healthy bone of a resected section, and the arrangement mode of the radioactive particles (3) is determined according to the shape of the resected section; and the radioactive particles (3) are radioactive sealed seeds. The manufacturing method of the built-in radioactive source bone prosthesis comprises the following steps: S1, generating a three-dimensional bone model of a resected section by using a model reconstruction algorithm according to CT data of a surgical area, and completing a model of a main body part of a bone prosthesis; S2, testing the activity of the radioactive sealed seeds, and determining the irradiation intensity and effective radiation radius of the radioactive sealed seeds; S3, determining a residual contour and a distribution range after a dangerous area of a resection is removed according to the CT data of the surgical area, arranging the radioactive sealed seeds in the residual distribution area according to the effective radiation radius of the radioactive sealed seeds by using an equidistant source arrangement algorithm, and optimizing the arrangement of the radioactive sealed seeds by using a dynamic programming algorithm, so that the arrangement of the radioactive sealed seeds can meet the requirement of forming an irradiation area completely surrounding tumor tissue, and a complete CAD model of the bone prosthesis is generated; S4, determining boundary conditions in the radiation process of the radioactive sealed seeds according to the activity and the effective radiation radius of the radioactive sealed seeds, and simulating the irradiation range and intensity of the bone prosthesis; S5, after the product is manufactured, the bone prosthesis is subjected to high-temperature steam sterilization and is sealed and stored; S6, the bone prosthesis is used to replace and fix resected bone tissue, the amount of the radioactive sealed seeds is determined according to the calculation result, and the radioactive sealed seeds are embedded into the prosthesis.

2. The internal radioactive source bone prosthesis of claim 1, wherein, In step S1, the prosthesis body part is manufactured by using machining or 3D printing according to the completed model, and the product manufacturing is completed.

3. The internal radioactive source bone prosthesis of claim 1, wherein, Step S3 is specifically as follows: S301, the shape, size and distribution of a target area are outlined in software of an editable CT model according to the CT data, and the target area takes the boundary of CT scanning tumor expansion of 4-6 mm as the boundary; S302, the dose of the required radioactive sealed seeds is calculated according to the shape, size and distribution of the outlined target area by selecting the radioactive sealed seed precise algorithm in a TPS system; S303, the irradiation area formed by the radioactive sealed seeds is simplified as a hemispherical structure according to the effective radiation radius of the selected radioactive sealed seeds, the radioactive sealed seeds are arranged equidistantly in the target area, the arrangement of the radioactive sealed seeds is optimized by using a dynamic programming algorithm, and the position of the radioactive sealed seeds is adjusted, so that the arrangement of the radioactive sealed seeds can meet the requirement of forming an irradiation area completely surrounding tumor tissue; S304, the position and effect of the radioactive sealed seeds are verified, the action intensity and range of the radioactive sealed seeds in the target area and adjacent areas are simulated by using a finite element method, the arrangement of the radioactive sealed seeds is continuously optimized, and a model with strong action on the target area and minimum damage to critical healthy tissue is generated.

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