Precise individualized radiotherapy tissue compensator used after breast cancer plastic surgery

Abstract

The invention discloses a precise individualized radiotherapy tissue compensator used after breast cancer plastic surgery, and relates to the technical field of treatment instruments. Comprising a silica gel sheet body, a protruding breast positioning body is integrally connected to the middle of the silica gel sheet body, a nipple positioning hole is formed in the middle of the breast positioning body, and three conical position marking holes are formed in the edge of the silica gel sheet body; extra pressure cannot be generated on the prosthesis breast, and the risk of deformation or displacement of the prosthesis is effectively avoided; the position accuracy is ensured, meanwhile, the dose distribution can be accurately controlled, the radiotherapy effect is remarkably improved, complications are reduced, and safer and more effective treatment choices are brought to patients after breast cancer plastic surgery.

Description

Technical Field

[0001] The present invention belongs to the technical field of therapeutic appliances, and particularly relates to a precise individualized radiotherapy tissue compensator after breast cancer plastic surgery. Background Art

[0002] Breast cancer is a common malignant tumor clinically, and its incidence rate ranks first among female malignant tumors. Clinically, modified radical mastectomy is usually adopted for treatment. Although this surgical method can effectively remove the lesion and thus control the further development of the disease, due to its relatively large surgical incision, the aesthetic appearance of the breast after surgery is poor, which brings heavy physical image troubles and psychological traumas to patients, seriously affecting the quality of life of patients. In recent years, with the continuous improvement of the requirements for the quality of life and self-health care awareness of female breast cancer patients, breast reconstruction surgery has shown a significant growth trend in breast treatment centers across the country. This surgical method can significantly improve the aesthetic effect of the breast and enhance the overall quality of life on the premise of ensuring that the treatment effect is not affected.

[0003] Postoperative radiotherapy for breast cancer, as a key link in the comprehensive treatment system of breast cancer, plays an irreplaceable role in improving local control and enhancing survival prognosis. Clinical data show that about 70% of patients undergoing modified radical mastectomy for breast cancer need radiotherapy. However, when the high-energy X-rays used in radiotherapy enter the human body from the air, a dose build-up effect will occur, resulting in insufficient radiotherapy dose in the skin and superficial high-risk target areas, increasing the risk of tumor recurrence. Therefore, in clinical radiotherapy, tissue compensators are placed on the skin surface to increase the dose of the superficial target area. However, the current conventional tissue compensators are two-dimensional planar silicone materials with a certain hardness, and their rigid structures are only suitable for patients with a flat chest wall shape after modified radical mastectomy. For patients after modified radical mastectomy combined with breast reconstruction, due to the complex three-dimensional arc contour of the breast prosthesis, it is difficult for traditional two-dimensional tissue compensators to achieve full fitting of the dose compensation material to the skin surface, resulting in insufficient dose in the skin target area and seriously affecting the accuracy of radiotherapy. Therefore, there is an urgent need to develop three-dimensional individualized tissue compensators. An existing patent discloses a tissue compensation bag for breast cancer radiotherapy, with the application number 20222208455.1, which tightly adheres the tissue compensation glue to the chest wall surface by means of airbag pressurization, solving the problem of insufficient radiation dose received by the skin of patients with chest wall depression during radiotherapy. However, the pressure applied by the airbag easily causes deformation of the breast prosthesis and may even cause damage to the prosthesis. Once the prosthesis is deformed, it will directly cause deviation of the irradiation position, thereby affecting the accuracy and effectiveness of radiotherapy. Therefore, when this invention is applied to patients after modified radical mastectomy combined with breast reconstruction, there is obvious inapplicability and it is difficult to meet the clinical radiotherapy needs of such patients. An existing patent discloses a 3D-printed individualized tissue compensator for breast cancer radiotherapy, with the application number 202220148426.1, which uses 3D-printed rigid materials combined with fixed straps and exhaust hole designs to be able to make individualized tissue compensators for breast prostheses. However, the combination of its opaque rigid structure and fixed straps will cause deformation and displacement of the breast, affecting the accuracy of radiotherapy. Summary of the Invention

[0004] To solve the problems mentioned in the above background technology, the purpose of the present invention is to provide a precise individualized radiotherapy tissue compensator for patients after breast cancer plastic surgery.

[0005] A precise individualized radiotherapy tissue compensator for patients after breast cancer plastic surgery of the present invention includes a silicone sheet body. A protruding breast positioning body is integrally connected to the middle of the silicone sheet body. A nipple positioning hole is opened in the middle of the breast positioning body. Three position marking holes are opened at the edge of the silicone sheet body.

[0006] Preferably, three conical position marking holes are opened on the silicone sheet body.

[0007] Preferably, the silicone sheet body is a transparent silicone sheet body with a thickness of 0.5 - 2 cm.

[0008] Preferably, the silicone sheet is a slightly sticky flexible transparent silicone body.

[0009] A preparation method of a precise individualized radiotherapy tissue compensator after breast cancer plastic surgery, comprising the following steps:

[0010] (1) CT simulation positioning is performed on breast cancer radiotherapy patients after radical mastectomy combined with plastic surgery to obtain CT image data;

[0011] (2) Import the CT simulation positioning data into the radiotherapy planning system. The doctor delineates the lesion target area and the contour of normal human tissues, and the physicist designs the position, shape and thickness of the virtual tissue compensator in the planning system according to the requirements of the prescription dose;

[0012] (3) Based on the laser line of the radiotherapy simulation positioning CT, use a marker pen to mark three positions a, b and c on the patient's body surface, and use transparent tape to fix the lead points to the three corresponding positions on the patient's skin for accurate positioning in actual application;

[0013] (4) Import the CT simulation positioning data containing the target area delineation and tissue compensator information into the 3D printing design software. Accurately extract the three-dimensional contour model data of the tissue compensator through this software, and then create a mold opening model. During the process of constructing the mold opening model, the thickness of the compensator needs to be carefully set, and a, b, c conical positioning marks are designed to ensure that they are consistent with the virtual values in the planning system;

[0014] (5) Transmit the data of the mold opening model to the 3D printer and use a rigid photosensitive resin material for precise printing and production;

[0015] (6) Inject the prepared transparent silicone material into the mold cavity. After the silicone material is fully solidified and formed, the mold opening operation can be carried out, and the formed tissue compensation film can be taken out completely;

[0016] (7) Before the radiotherapy starts, fix the tissue compensator accurately at the corresponding position on the patient's body surface according to the previously made orientation markings.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] First, it will not generate additional pressure on the prosthetic breast, effectively avoiding the risk of deformation or displacement of the prosthesis.

[0019] Second, while ensuring accurate position, it can also achieve precise control of dose distribution, bringing significant advantages of double precision in position and dose to patients, improving the radiotherapy effect, reducing the occurrence of complications, and bringing a safer and more effective treatment option for patients after modified radical mastectomy combined with breast reconstruction. Brief Description of the Drawings

[0020] For ease of explanation, the present invention will be described in detail by the following specific embodiments and accompanying drawings.

[0021] Figure 1 is a structural schematic diagram of the present invention;

[0022] Figure 2 is a side view of the present invention;

[0023] Figure 3 is a schematic diagram of the lead point marking in this specific embodiment;

[0024] Figure 4 is a structural schematic diagram of the conical position marking hole in this specific embodiment.

[0025] In the figure: 1 - silicone sheet body; 2 - breast positioning body; 2-1 - nipple positioning hole; a(b, c) - position marking hole. Specific Embodiment

[0026] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be described by the specific embodiments shown in the accompanying drawings. However, it should be understood that these descriptions are merely exemplary and are not intended to limit the scope of the present invention. The structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those skilled in this technology to understand and read, and are not used to limit the limiting conditions under which the present invention can be implemented. Therefore, they do not have technical essence. Any modification of the structure, change of the ratio relationship or adjustment of the size, without affecting the effects that the present invention can produce and the objectives that can be achieved, should still fall within the scope covered by the technical content disclosed in the present invention. In addition, in the following description, the description of well-known structures and technologies is omitted to avoid unnecessarily confusing the concept of the present invention.

[0027] Here, it should also be noted that in order to avoid obscuring the present invention due to unnecessary details, only the structures and / or processing steps closely related to the solution of the present invention are shown in the drawings, and other details less related to the present invention are omitted.

[0028] As Figure 1 , Figure 2 , Figure 3 , Figure 4 shown, this specific embodiment adopts the following technical solutions: including a silicone sheet body 1, a protruding breast positioning body 2 is integrally connected to the middle of the silicone sheet body 1, a nipple positioning hole 2-1 is opened in the middle of the breast positioning body 2, and three conical position marking holes are opened at the edge of the silicone sheet body 1; the silicone sheet body 1 is a transparent silicone sheet body with a thickness of 0.5 - 2 cm; the silicone sheet body 1 is a slightly sticky flexible transparent silicone body.

[0029] As Figure 1 shown, three conical position marking holes, namely points a, b, and c, are provided on the silicone sheet body.

[0030] The preparation method of the precise individualized radiotherapy tissue compensator after breast cancer plastic surgery in this specific embodiment includes the following steps:

[0031] 1), Perform CT simulation positioning on breast cancer radiotherapy patients after radical mastectomy combined with plastic surgery to obtain CT image data.

[0032] 2), Import the CT simulation positioning data into the radiotherapy planning system. The doctor delineates the lesion target area and the contour of the normal human tissue. The physicist designs the position, shape, and thickness of the virtual tissue compensator in the planning system according to the requirements of the prescription dose.

[0033] 3), Based on the laser line of the radiotherapy simulation positioning CT as the benchmark, use a marker pen to mark three positions on the patient's body surface, namely a (12 o'clock position), b (6 o'clock position), and c (3 o'clock position), and use transparent tape to fix the lead points (such as Figure 3 ) to the three corresponding positions on the patient's skin for accurate positioning in actual application. In addition, the position of the nipple hole needs to be accurately determined to meet clinical requirements.

[0034] 4), Import the CT simulation positioning data containing the target area delineation and tissue compensator information into the 3D printing design software. Through this software, accurately extract the three-dimensional contour model data of the tissue compensator, and then create a mold opening model. During the process of constructing the mold opening model, the thickness of the compensator needs to be carefully set, and (a), (b), and (c) conical positioning marks are designed to ensure that they are consistent with the virtual values in the planning system.

[0035] 5), Transmit the data of the mold opening model to the 3D printer, and select a rigid photosensitive resin material for precise printing and production.

[0036] 6), Inject the prepared transparent silicone material into the mold cavity. After the silicone material is fully solidified and formed, the mold opening operation can be carried out, and the formed tissue compensation film can be taken out completely.

[0037] 7), Before the radiotherapy starts, fix the tissue compensator accurately at the corresponding position on the patient's body surface according to the previously made orientation markings.

[0038] The advantages of this specific embodiment are:

[0039] 1. Based on the patient's CT simulation positioning image data, the mold opening mold made by means of 3D printing technology has extremely high precision and shows distinct individualization and customization characteristics.

[0040] 2. The tissue compensator is made of a flexible transparent silicone material with slight adhesiveness through a mold - opening process. At the same time, orientation markings are provided on the compensator to enhance the accuracy of its placement position. This design enables the compensator to achieve precise and seamless fitting with the skin of the breast prosthesis. At the same time, due to the special nature of its material and structure, it will not exert additional pressure on the prosthetic breast, effectively avoiding the risk of deformation or displacement of the prosthetic breast. While ensuring precise positioning, it can also achieve precise control of dose distribution, bringing the dual advantages of precise position and dose to patients, significantly improving the radiotherapy effect, reducing the occurrence of complications, and bringing a safer and more effective treatment option for patients after modified radical mastectomy combined with breast reconstruction for breast cancer.

[0041] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above - mentioned exemplary embodiments, and without departing from the spirit or basic characteristics of the present invention, the present invention can be implemented in other specific forms. Therefore, from any point of view, the embodiments should be regarded as exemplary and non - restrictive. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention.

[0042] In addition, it should be understood that although this specification is described according to embodiments, not every embodiment only contains an independent technical solution. This narrative way of the specification is only for clarity. Those skilled in the art should regard the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A precise individualized radiotherapy tissue compensator after breast cancer plastic surgery, characterized in that: It includes a silicone sheet body (1). A protruding breast positioning body (2) is integrally connected to the middle of the silicone sheet body (1). A nipple positioning hole (2-1) is formed in the middle of the breast positioning body (2). Three conical position marking holes (a, b, c) are formed in the silicone sheet body (1).

2. The tissue compensator for precise individualized radiotherapy after breast cancer plastic surgery according to claim 1, wherein: The silicone sheet body (1) is a transparent silicone sheet body with a thickness of 0.5 - 2 cm.

3. The tissue compensator for precise individualized radiotherapy after breast cancer plastic surgery according to claim 2, wherein: The silicone sheet body (1) is a slightly sticky flexible transparent silicone body.

4. Preparation method of a precise individualized radiotherapy tissue compensator after breast cancer plastic surgery, characterized in that: It includes the following steps: (1) Perform CT simulation positioning on breast cancer radiotherapy patients after radical mastectomy combined with plastic surgery to obtain CT image data; (2) Import the CT simulation positioning data into the radiotherapy planning system. The doctor delineates the lesion target area and the contour of normal human tissues. The physicist designs the position, shape, and thickness of the virtual tissue compensator in the planning system according to the requirements of the prescribed dose; (3) Based on the laser lines of the radiotherapy simulation positioning CT as a reference, use a marker pen to mark three positions a, b, and c on the patient's body surface, and use transparent tape to fix the lead points to the three corresponding positions on the patient's skin for accurate positioning in actual application; (4) Import the CT simulation positioning data containing the target area delineation and tissue compensator information into 3D printing design software. Accurately extract the three-dimensional contour model data of the tissue compensator through this software, and then create a mold opening model. During the process of constructing the mold opening model, it is necessary to carefully set the thickness of the compensator and design three conical positioning marking holes a, b, and c to ensure that they are consistent with the virtual values in the planning system; (5) Transmit the data of the mold opening model to a 3D printer and use a rigid photosensitive resin material for accurate printing and production; (6) Inject the prepared transparent silicone material into the mold cavity. After waiting for the silicone material to fully solidify and form, the mold opening operation can be carried out, and the formed tissue compensation film can be taken out completely; (7) Before the start of radiotherapy, accurately fix the tissue compensator at the corresponding position on the patient's body surface according to the previously made position markings.

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