3D-printed customized tissue compensator and method of making the same

Abstract

The application discloses a 3D printing customized tissue compensation and a manufacturing method thereof, and relates to the technical field of radiotherapy. The application comprises the following steps: a model is prepared by using 3D printing technology according to a radiotherapy plan formulated by a doctor, and a tissue compensation is prepared by pouring, wherein the tissue compensation comprises an inner surface consistent with the body surface topography. The application provides a manufacturing method of a personalized and non-uniform thickness tissue compensation. The thickness of the radiotherapy compensation pad is determined according to the radiotherapy plan formulated by the doctor, and the manufacturing process does not require basic medical knowledge. The obtained tissue compensation pad is consistent with the thickness, shape and size required by the radiotherapy plan formulated by the doctor. The tissue compensation pad can better adhere to the skin of a patient, meet the requirements of the radiotherapy plan, and guarantee the accuracy and stability of the radiotherapy dose, so that the purpose of precise treatment is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of radiotherapy, in particular to a 3D printing customized tissue compensator and a manufacturing method thereof. BACKGROUND

[0002] In recent years, radiotherapy as one of the main means for treating tumor diseases has been widely used in clinical practice. Precise control of the radiotherapy dose is one of the core contents of precision medicine. However, both high-energy X (gamma) rays and electron beams have dose building-up effects, which cause the problem of insufficient dose in the target area in the treatment of superficial lesions (such as breast cancer, skin cancer, perineal Paget's disease, etc.). At this time, a radiotherapy tissue compensator is usually used to increase the dose of the superficial target area.

[0003] The most commonly used tissue compensator in clinical practice is a square silicone equivalent tissue compensator with a certain thickness. However, due to its fixed shape, there are many shortcomings in the use process. Firstly, the body surface is often irregular. Therefore, there must be an air gap between the tissue compensator and the body surface. The existence of the air gap can significantly reduce the surface dose. Reducing the air gap can improve the uniformity of the target dose and improve the accuracy of radiotherapy. For irregular body surfaces, small millet bags, paraffin, wet gauze, and vaseline (gauze) are usually used to fill the gap in clinical practice. However, these methods have the defects of rough process, poor conformability, poor tissue uniformity, poor repeatability, and other defects, which greatly affect the actual radiotherapy dose of superficial lesions and the treatment effect. Secondly, the commercially available tissue compensator cannot change its thickness, making it difficult to meet the clinical requirements. For example, breast cancer patients who need postoperative adjuvant radiotherapy may need tissue compensators with different thicknesses ranging from 3mm to 10mm. Thirdly, some special cases of breast cancer patients, such as patients who need breast skin irradiation after breast-conserving surgery, also need special devices that combine positioning and compensation functions to assist.

[0004] Therefore, a 3D printing customized tissue compensator and a manufacturing method thereof are proposed. SUMMARY

[0005] The purpose of the present application is to solve the above problems, and the present application provides a 3D printing customized tissue compensator and a manufacturing method thereof.

[0006] In order to achieve the above purpose, the present application specifically adopts the following technical solutions:

[0007] The manufacturing method of the 3D printing customized tissue compensator comprises manufacturing a tissue compensator according to the radiotherapy plan requirements made by a doctor, and the tissue compensator comprises an inner surface consistent with the body surface topography, characterized by comprising the following steps:

[0008] S1, extract the shape of the simulated tissue compensator in the radiotherapy plan, obtain its three-dimensional model, when the compensator is two layers, a protrusion is constructed at the center of one side of the three-dimensional model;

[0009] S2, according to the above three-dimensional model, obtain the inverse mold model wrapped around the tissue compensator, specifically, according to the shape data of the tissue compensator derived from the radiotherapy planning system, generate the casting model wrapped around the model by using three-dimensional image processing technology; when the compensator is two layers, a gap will be generated on one side of the inner cavity of the inverse mold model due to the establishment of the protrusion, a partition plate model is established, one side of the partition plate model is provided with a connected protrusion model, and at least one guide rail model is provided on the outer layer of the partition plate model;

[0010] S3, use a 3D printer to print the inverse mold model; when the compensator is two layers, the printed inverse mold model is divided into two layers, the mold cavity is formed by the fitting of the cavity surface, and the partition plate model is printed out;

[0011] S4, pour silicone into the inverse mold model, remove the printed object after curing, and obtain a tissue compensator consistent with the radiotherapy plan; when the compensator is two layers, the partition plate is inserted into one layer of the inverse mold model by the protrusion inserting into the gap and is fixed by external force, the resin is poured in the layer, the partition plate is taken out after the resin is cured, a groove consistent with the guide rail is formed on the inner surface of the resin, and then the two layers of inverse mold models are combined, the silicone is poured on the base layer, the silicone fills into the groove and forms the guide rail after curing, the inverse mold model is separated through the connection of the guide rail and the groove of the resin, and the tissue compensator with the silicone layer and the resin layer spliced is prepared.

[0012] Further, the S1 further comprises the following steps:

[0013] S1.1, the patient is positioned, the patient lies in a special posture fixing bed, and the CT scan determines the lesion position;

[0014] S1.2, import the CT data into the radiotherapy treatment planning system, the doctor formulates a radiotherapy plan in the planning system according to the disease condition, determines the required irradiation dose, depth and other parameters, and specifies the position, size and thickness of the required tissue compensator;

[0015] S1.3, import the CT data and the data generated by the radiotherapy plan into a special 3D design software, and obtain the three-dimensional data of the tissue compensator customized in the radiotherapy plan.

[0016] Further, the thickness of the protrusion is 0.5-5mm, the width is consistent with the three-dimensional model, and the length is 0.2-0.5cm.

[0017] Further, the partition plate model is the same as the three-dimensional model and has a thickness of 0.5-5mm.

[0018] 3D printing customized tissue compensation material, characterized in that, according to the above steps.

[0019] Further, the resin is one of polycarbonate, polystyrene, polypropylene, polyimide or polymethyl methacrylate, and one or more of antioxidants, plasticizers, plasticizers, light stabilizers, antibacterial agents or lubricants are added.

[0020] Further, the silica gel is added with one or more of crosslinking agents, plasticizers, anti-sticking agents or antibacterial agents.

[0021] Further, the Shore hardness of the silica gel layer is 5°-10°.

[0022] The beneficial effects of the present application are as follows:

[0023] 1. The present application provides a method for making personalized, non-uniform thickness tissue compensation material. The method determines the thickness of the radiotherapy compensation pad according to the radiotherapy plan prepared by the doctor, and does not require basic medical knowledge during the production process. The obtained tissue compensation pad is consistent with the thickness, shape and size required by the radiotherapy plan prepared by the doctor. It can not only better fit the patient's skin and meet the requirements of the radiotherapy plan, but also can ensure the accuracy and stability of the radiotherapy dose, and achieve the purpose of precise treatment.

[0024] 2. In the preparation of the double-layer tissue compensation material, the 3D printing technology is fully utilized, the connecting groove is established in the resin layer in advance, and the silica gel layer with the connecting structure of the resin layer is poured out. After the preparation of the double-layer tissue compensation material, the resin layer provides support effect while ensuring that the overall shape, thickness, etc. are consistent with the measured three-dimensional data, which is beneficial to improve the target area dose uniformity, and in the subsequent processing process, the silica gel layer and the resin layer can be separated quickly for processing by moving the guide rail on the silica gel layer and the groove on the resin layer. It improves convenience and efficiency, and compared with the bonding method, it can avoid misplacement and other problems.

[0025] 3. The present application can replace the tissue compensation material with the separating plate to test the size of the air gap by fitting the skin, if the test result does not meet the requirements, the adjusting can be performed in time before the preparation of the tissue compensation material, and the treatment delay, the reduction of efficiency and the waste of materials are avoided. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 is a structural schematic diagram of the double-layer tissue compensation material of the present application;

[0027] Fig. 1 is a structural schematic diagram of the double-layer tissue compensation material of the present application. DETAILED DESCRIPTION

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0029] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0030] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0031] In the description of the embodiments of the present invention, it should be noted that the terms "inner", "outer", "upper", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0032] Example 1

[0033] like Figure 1 As shown, the method for fabricating a customized 3D-printed tissue compensator involves creating a tissue compensator according to the radiotherapy plan prescribed by the doctor. This tissue compensator includes an inner surface that conforms to the body surface morphology. The specific steps include:

[0034] S1. Extract the morphology of the simulated tissue compensator in the radiotherapy plan and obtain its three-dimensional model. When the compensator is two-layered, construct a protrusion with a thickness of 0.5 mm, a width consistent with the three-dimensional model, and a length of 0.2 cm at the center of one side of the three-dimensional model.

[0035] S2, according to the three-dimensional model, obtain the inverse mold model of the wrapping tissue compensator, specifically, according to the appearance data of the tissue compensator derived from the radiotherapy planning system, generate the pouring model wrapping the model by using three-dimensional image processing technology; when the compensator is two layers, the inner cavity of the inverse mold model will produce a gap due to the establishment of the protrusion, and a separation plate model with the same thickness of 0.5mm as the three-dimensional model is established, one side of the separation plate model is provided with a connected protrusion model, and at least one T-shaped guide rail model is arranged on the outer layer of the separation plate model.

[0036] S3, use a 3D printer to print the inverse mold model; when the compensator is two layers, the printed inverse mold model is divided into two layers, and the mold cavity is formed by the fitting of the cavity surface, and the separation plate model is printed out.

[0037] S4, pour silica gel into the inverse mold model, and remove the printed object after curing to obtain a tissue compensator consistent with the radiotherapy plan;

[0038] The tissue compensator can be uniform or non-uniform in thickness, and according to the treatment requirements, the corresponding tissue compensator is generated according to the data in the radiotherapy plan, and the inverse mold model is printed by using a Fused Deposition Modeling or StereoLithography 3D printer, and it should be noted that thin wall mode hollow printing is not used in this technology, because the shape of the tissue compensator pad is different, and the thickness is also not uniform, when the thickness changes sharply, the thin wall mode will produce a gap on the surface of the model, which will lead to the failure of pouring, therefore, the inverse mold model produced by the present technology is a model with certain thickness and hardness, which can ensure that the shape is not deformed during pouring, and also avoids the generation of gaps on the surface of the model;

[0039] When the compensator is two layers, the separation plate is inserted into one layer of the inverse mold model by the protrusion inserted into the gap and is fixed by external force, and the resin is poured in this layer, and after the resin is cured, the separation plate is taken out, and a groove consistent with the T-shaped guide rail is formed on the inner surface of the resin, and then the two layers of inverse mold models are combined, and the silica gel is poured on the base layer, and the silica gel is filled into the groove and forms a T-shaped guide rail after curing, it should be noted that the T-shaped guide rail does not correspond to the bottom of the separation plate, and after the silica gel is cured, the inverse mold model is separated through the connection of the T-shaped guide rail and the groove of the resin, and a double-layer spliced tissue compensator is prepared;

[0040] In the preparation of the double-layer tissue compensator, the 3D printing technology is fully utilized, the connecting groove is established in the resin layer in advance, and then the silica gel layer with the connecting structure of the resin layer is poured out, so that the double-layer tissue compensator can be prepared to ensure that the resin layer provides support effect while the overall shape, thickness and other parameters are consistent with the measured three-dimensional data, which is beneficial to improve the target dose uniformity and save cost and avoid waste.

[0041] In addition, since the partition plate is consistent with the shape of the tissue compensator, the partition plate can be used to replace the tissue compensator to test the size of the air gap, and if the test result does not meet the requirements, the tissue compensator can be prepared in time before the preparation of the tissue compensator, and the above steps can be repeated to adjust, so as to avoid delay of treatment, reduction of efficiency and waste of materials.

[0042] In addition, a release agent is applied on the mold cavity or the partition plate before injection molding, and the release agent is silicone oil.

[0043] S5, the patient lies in the fixed bed in the same posture during radiotherapy, and adjusts the position according to the marked positioning line, places the above-mentioned tissue compensator according to the body shape characteristics, and tightly adheres to the skin, finally performs radiotherapy according to the pre-customized radiotherapy plan, meets the various conditions required in the radiotherapy plan, and when the tissue compensator is double-layer, the silica gel layer is adhered to the skin.

[0044] S1 further comprises the following steps:

[0045] S1.1, the patient performs simulation positioning, and lies in a special posture fixing bed, and the CT scan determines the lesion position.

[0046] S1.2, import the CT data into the radiotherapy treatment planning system, and the doctor formulates the radiotherapy plan in the planning system according to the disease condition, determines the required irradiation dose, depth and other parameters, and specifies the position, size and thickness of the required tissue compensator.

[0047] S1.3, import the CT data and the data generated by the radiotherapy plan into the special 3D design software, and obtain the three-dimensional data of the customized tissue compensator in the radiotherapy plan.

[0048] 3D printing customized tissue compensator, prepared according to the above steps, wherein the resin is polycarbonate, and antioxidant, plasticizer, plasticizer, light stabilizer and antibacterial agent are added.

[0049] Further, the silica gel is added with crosslinking agent, plasticizer, anti-sticking agent and antibacterial agent.

[0050] The Shore hardness of the silica gel layer is 5°.

[0051] Example Two

[0052] As shown in the figure, the method for making a 3D-printed customized tissue compensator, according to the requirements of the radiotherapy plan made by the doctor, makes a tissue compensator, which includes an inner surface consistent with the body surface topography, and specifically includes the following steps: Figure 1 S1, extract the topography of the simulated tissue compensator in the radiotherapy plan, obtain its three-dimensional model, and when the compensator is two layers, build a protrusion with a thickness of 5mm, a width consistent with the three-dimensional model and a length of 0.5cm at the center of one side of the three-dimensional model.

[0053] S2, according to the above three-dimensional model, obtain the inverse mold model of the tissue compensator, specifically, according to the topography data of the tissue compensator derived from the radiotherapy planning system, generate a casting model wrapping the model using three-dimensional image processing technology; when the compensator is two layers, the inner cavity of the inverse mold model will have a gap due to the establishment of the protrusion, and a partition plate model with the same thickness as the three-dimensional model and a thickness of 5mm is established, one side of the partition plate model is provided with a connected protrusion model, and at least one T-shaped guide rail model is provided on the outer layer of the partition plate model.

[0054] S3, use a 3D printer to print the inverse mold model; when the compensator is two layers, the printed inverse mold model is divided into two layers, a mold cavity is formed by the fit of the cavity surface, and the partition plate model is printed out.

[0055] S4, pour silicone into the inverse mold model, and after curing, remove the printed object to obtain a tissue compensator consistent with the radiotherapy plan;

[0056] The tissue compensator can be uniform or non-uniform in thickness, and according to the treatment requirements, the corresponding tissue compensator is generated according to the data in the radiotherapy plan, and the inverse mold model is printed using a Fused Deposition Modeling or StereoLithography 3D printer. Note that thin-walled hollow printing is not used in this technology, because the shape of the tissue compensator varies and the thickness is not uniform. When the thickness changes sharply, the thin-walled method will produce holes on the surface of the model, resulting in the inability to cast. Therefore, the inverse mold model produced by this technology is a model with a certain thickness and hardness, which can ensure that the shape is not deformed during casting, and also avoids the generation of holes on the surface of the model.

[0057]

[0058] ​When the compensator is two layers, the partition plate is inserted into one layer of the inverse mold model by inserting the protrusion into the gap and is fixed by external force, the resin is poured in this layer, and after the resin is cured, the partition plate is taken out, the inner surface of the resin forms a groove consistent with the T-shaped guide rail, and then the two layers of the inverse mold model are combined, the base layer is poured with silica gel, the silica gel fills into the groove and forms a T-shaped guide rail after curing, it is noted that the T-shaped guide rail does not correspond to the bottom of the partition plate, and after the silica gel is cured, the T-shaped guide rail is connected with the groove of the resin, and the inverse mold model is separated, thereby obtaining a double-layer spliced tissue compensator;

[0059] In the preparation of the double-layer tissue compensator, the 3D printing technology is fully utilized to pre-establish a connecting groove in the resin layer, and then a silica gel layer with a connecting structure with the resin layer is poured, so that after the preparation of the double-layer tissue compensator, the resin layer can provide support effect, and the overall shape, thickness and other parameters are consistent with the measured three-dimensional data, which is beneficial to improve the target dose uniformity, save cost, avoid waste, and separate the silica gel layer and the resin layer for processing, thereby improving the convenience and efficiency, and avoiding the problems such as misalignment compared with the bonding method;

[0060] In addition, since the partition plate is consistent with the shape of the tissue compensator, the partition plate can be used to replace the tissue compensator to test the size of the air gap, and if the test result does not meet the requirements, the problem can be found in time before the tissue compensator is prepared, and the above steps can be repeated for adjustment, thereby avoiding the delay of treatment, the reduction of efficiency and the waste of materials;

[0061] In addition, a release agent is applied on the mold cavity or the partition plate before injection molding, and the release agent is an emulsified release agent.

[0062] S5, the patient lies in the fixed bed in the same posture during radiotherapy, adjusts the position according to the marked positioning line, places the above-mentioned tissue compensator according to the body features, and tightly adheres to the skin, finally performs radiotherapy according to the pre-customized radiotherapy plan, meets various conditions required in the radiotherapy plan, and the silica gel layer adheres to the skin when the tissue compensator is double-layer.

[0063] S1 further comprises the following steps:

[0064] S1.1, the patient is positioned, the patient lies in a special posture fixing bed, and the CT scan determines the lesion position.

[0065] S1.2, the CT data is imported into the radiotherapy treatment planning system, the doctor formulates a radiotherapy plan in the planning system according to the disease condition, determines the required irradiation dose, depth and other parameters, and specifies the position, size and thickness of the required tissue compensator.

[0066] S1.3. Import the CT data and the data generated by the radiotherapy plan into the dedicated 3D design software to obtain the three-dimensional data of the customized tissue compensator in the radiotherapy plan.

[0067] 3D printed customized tissue compensators are prepared according to the above steps, wherein the resin is one of polymethyl methacrylate and plasticizers, light stabilizers, antibacterial agents and lubricants are added.

[0068] Furthermore, the silicone contains plasticizers, anti-sticking agents, and antibacterial agents.

[0069] The Shore hardness of the silicone layer is 10°.

[0070] Example 3

[0071] like Figure 1 As shown, the method for fabricating a customized 3D-printed tissue compensator involves creating a tissue compensator according to the radiotherapy plan prescribed by the doctor. This tissue compensator includes an inner surface that conforms to the body surface morphology. The specific steps include:

[0072] S1. Extract the morphology of the simulated tissue compensator in the radiotherapy plan and obtain its three-dimensional model. When the compensator is two-layered, construct a protrusion with a thickness of 2.5 mm, a width consistent with the three-dimensional model, and a length of 0.35 cm at the center of one side of the three-dimensional model.

[0073] S2. Based on the above three-dimensional model, a casting model of the tissue compensator is obtained. Specifically, based on the morphological data of the tissue compensator exported from the radiotherapy planning system, a casting model encapsulating the model is generated using three-dimensional image processing technology. When the compensator has two layers, a gap will be generated on one side of the inner cavity of the casting model due to the establishment of the protrusion. A partition plate model with the same thickness as the three-dimensional model and 2.5mm is established. One side of the partition plate model is provided with a connected protrusion model, and the outer layer of the partition plate model is provided with at least one T-shaped guide rail model.

[0074] S3. Use a 3D printer to print a mold model; when the compensation material is two layers, the printed mold model is divided into two layers, and the cavity is formed by the bonding of the cavity surfaces, and the partition plate model is printed out.

[0075] S4. Silicone is poured into the mold, cured, and then the printed material is removed to obtain tissue compensator consistent with the radiotherapy plan.

[0076] The tissue compensator can be uniform or non-uniform in thickness, and according to the treatment requirements, the corresponding tissue compensator is generated according to the data in the radiotherapy plan, a negative mold model is printed by using a fused deposition modeling (Fused Deposition Modeling) or a stereo lithography (StereoLithography) 3D printer, and it is noted that a thin-wall hollow printing method is not used in the present technology, because the shapes of the tissue compensation pads are different, and the thickness is also non-uniform, when the thickness changes sharply, the thin-wall method will produce holes on the surface of the model, which will cause the model to be unable to be poured, therefore, the negative mold model generated by the present technology is a model with a certain thickness and hardness, which can ensure that the shape is not deformed during pouring, and also avoids the generation of holes on the surface of the model;

[0077] When the compensator is two layers, the separation plate is inserted into one layer of the negative mold model by inserting the protrusion into the gap and fixed by external force, and the resin is poured in this layer, after the resin is cured, the separation plate is taken out, and the inner surface of the resin forms a groove consistent with the T-shaped guide rail, and then the two layers of negative mold models are combined, and the base layer is poured with silica gel, the silica gel is filled into the groove and forms a T-shaped guide rail after curing, it should be noted that the T-shaped guide rail does not correspond to the bottom of the separation plate, after the silica gel is cured, the T-shaped guide rail is connected with the groove of the resin, and the negative mold model is separated, and a double-layer spliced tissue compensator is prepared;

[0078] In the preparation of the double-layer tissue compensator, the 3D printing technology is fully utilized to pre-establish a connecting groove in the resin layer, and then a silica gel layer with a connecting structure with the resin layer is poured, so that after the preparation of the double-layer tissue compensator, the resin layer can provide support effect, and at the same time, the overall shape, thickness, etc. are consistent with the measured three-dimensional data, which is beneficial to improve the target area dose uniformity, save cost, avoid waste, and in the subsequent processing process, the silica gel layer and the resin layer can be quickly separated for processing by moving the guide rail on the silica gel layer and the groove on the resin layer, improving convenience and efficiency, and compared with the bonding method, the misalignment problem can be avoided;

[0079] In addition, because the shape of the separation plate is consistent with that of the tissue compensator, the separation plate can be used to replace the tissue compensator to test the size of the air gap, if the test result does not meet the requirements, the preparation of the tissue compensator can be adjusted in time, and the above steps can be repeated to adjust, so as to avoid the delay of treatment, the reduction of efficiency and the waste of materials;

[0080] In addition, a release agent is applied on the injection mold cavity or the separation plate before injection, and the release agent is a silicone type release agent.

[0081] S5, the patient lies in the fixed bed in the same posture during radiotherapy, and the position is fine-tuned according to the marked positioning line, the above-mentioned tissue compensation is placed according to the body shape characteristics, and is closely attached to the skin, and finally radiotherapy is carried out according to the pre-customized radiotherapy plan, various conditions required in the radiotherapy plan are met, and when the tissue compensation is double-layered, the silica gel layer is attached to the skin.

[0082] S1 further comprises the following steps:

[0083] S1.1, the patient is positioned, the patient lies in a special posture fixing bed, and CT scanning determines the lesion position.

[0084] S1.2, the CT data is imported into a radiotherapy treatment planning system, a doctor formulates a radiotherapy plan in the planning system according to the condition, determines the required irradiation dose, depth and other parameters, and specifies the required position, size and thickness of the tissue compensation.

[0085] S1.3, the CT data and the data generated by the radiotherapy plan are imported into special 3D design software to obtain the three-dimensional data of the customized tissue compensation in the radiotherapy plan.

[0086] 3D printing of customized tissue compensation is prepared according to the above steps, wherein the resin is polypropylene, and antioxidants, plasticizers, light stabilizers, antibacterial agents and lubricants are added.

[0087] Further, the silica gel is added with a crosslinking agent, a plasticizer and an antibacterial agent.

[0088] The Shore hardness of the silica gel layer is 7.5°.

[0089] The basic principles, main features and advantages of the present application are shown and described above. It should be understood by those skilled in the art that the present application is not limited by the above embodiments, and the above embodiments and descriptions in the specification are only the principles of the present application. Without departing from the spirit and scope of the present application, various changes and improvements can be made to the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection claimed by the present application is defined by the appended claims and their equivalents.

Claims

1. A method for making a customized 3D printed tissue compensator, comprising making a tissue compensator according to a radiation therapy plan prescribed by a physician, the tissue compensator comprising an inner surface conforming to a body surface topography, characterized in that, The method comprises the following steps: S1, extracting the shape of the simulated tissue compensator in the radiotherapy plan to obtain a three-dimensional model thereof; S2, obtaining a reverse mold model wrapped around the tissue compensator according to the three-dimensional model, specifically, generating a casting model wrapped around the model by using three-dimensional image processing technology according to the shape data of the tissue compensator derived from the radiotherapy planning system; S3, printing the reverse mold model using a 3D printer; S4, pouring silicone into the reverse mold model, removing the printed object after solidification, and obtaining a tissue compensator consistent with the radiotherapy plan; When the compensator is two layers, the method further comprises the following steps: S5, when the compensator is two layers, a protrusion is constructed at the center of one side of the three-dimensional model; S6, a gap is generated on one side of the inner cavity of the reverse mold model due to the establishment of the protrusion, a partition plate model is established, one side of the partition plate model is provided with a connected protrusion model, and at least one guide rail (3) model is provided on the outer layer of the partition plate model; S7, the printed reverse mold model is divided into two layers, a mold cavity is formed by fitting the cavity surfaces, and the partition plate model is printed out; S8, before casting, the partition plate is used to replace the tissue compensator to fit the skin to test the size of the air gap, and if the requirement is not met, the step S6 is repeated; S9, when the compensator is two layers, the partition plate is inserted into one layer of the reverse mold model by the protrusion insertion gap and is fixed by external force, the resin is cast in this layer, the partition plate is taken out after the resin is solidified, a groove consistent with the guide rail (3) is formed on the inner surface of the resin, and then the two layers of the reverse mold model are combined, the silicone is cast on the base layer, the silicone is filled into the groove and forms the guide rail (3) after solidification, and the reverse mold model is separated through the connection of the guide rail (3) and the groove of the resin after the silicone is solidified, thereby obtaining the tissue compensator with the silicone layer (1) and the resin layer (2) spliced.

2. The method of claim 1, wherein the 3D printed customized tissue compensator is made of a material selected from the group consisting of: a biocompatible polymer, a biocompatible ceramic, a biocompatible metal, a biocompatible composite, and a biocompatible hydrogel. The S1 further comprises the following steps: S1.1, the patient is positioned, the patient lies on a special posture fixing bed, and the CT scan determines the lesion position; S1.2, the CT data is imported into the radiotherapy treatment planning system, the doctor formulates a radiotherapy plan in the planning system according to the disease condition, determines the required irradiation dose and depth parameter, and specifies the position, size and thickness of the required tissue compensator; S1.3, the CT data and the data generated by the radiotherapy plan are imported into a special 3D design software to obtain the three-dimensional data of the tissue compensator customized in the radiotherapy plan.

3. The method of claim 1, wherein the 3D printed customized tissue compensator is made of a material selected from the group consisting of: a biocompatible polymer, a biocompatible ceramic, a biocompatible metal, a biocompatible composite, and a biocompatible hydrogel. The thickness of the protrusion is 0.5-5 mm, the width is consistent with the three-dimensional model, and the length is 0.2-0.5 cm.

4. The method of claim 1, wherein the 3D printed customized tissue compensator is made of a material selected from the group consisting of: a biocompatible polymer, a biocompatible ceramic, a biocompatible metal, a biocompatible composite, and a biocompatible hydrogel. The partition plate model is the same as the three-dimensional model and has a thickness of 0.5-5 mm.

5. The method of claim 1, wherein the 3D printed customized tissue compensator is made of a material selected from the group consisting of: a biocompatible polymer, a biocompatible ceramic, a biocompatible metal, a biocompatible composite, and a biocompatible hydrogel. A release agent is applied on the mold cavity or the partition plate before injection molding, and the release agent is one of silicone oil, silicone type release agent, polytetrafluoroethylene spray or emulsified release agent.

6. A 3D printed customized tissue compensator, characterized in that, Prepared by the method of claim 1.

7. The 3D-printed customized tissue compensator of claim 6, wherein, The resin is one of polycarbonate, polystyrene, polypropylene, polyimide or polymethyl methacrylate, and one or more of antioxidants, plasticizers, plasticizers, light stabilizers, antibacterial agents or lubricants are added.

8. The 3D-printed customized tissue compensator of claim 6, wherein, The silicone is added with one or more of crosslinking agents, plasticizers, anti-adhesion agents or antibacterial agents.

9. The 3D-printed customized tissue compensator of claim 6, wherein, The Shore hardness of the silicone layer is 5°-10°.

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