技术领域Technical Field
本发明属于人体植入医疗器械技术领域，主要是一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体及制作方法。The present invention belongs to the technical field of human body implant medical devices, and mainly relates to a breast prosthesis with the functions of treating and preventing breast cancer recurrence and breast reconstruction, and a manufacturing method thereof.
背景技术Background Art
乳腺癌是威胁全球女性健康的最恶性疾病之一，目前已有许多女性因乳腺癌而手术切除了整个或部分乳房，这不但破坏了她们外观，同时也给她们心灵造成创伤。为修复其外观，临床上主要通过乳房假体、皮瓣移植和自体脂肪移植等技术来帮助患者重建乳房，其中乳房假体植入是最为常见的一种方法，它可同时重建乳房大小及形态，但目前商品化乳房假体形态多呈半球体，故无法满足部分乳房切除患者的需求。3D打印是一种增材制造技术，可将生物安全材料打印成特定的三维结构。利用3D打印技术打印不同形态的乳房假体，以满足部分乳房切除的患者的特定需求，显得尤为重要，但目前此方面应用尚未起步。另外，临床上传统的硅胶假体并不具治疗或响应肿瘤的作用。Breast cancer is one of the most malignant diseases that threaten the health of women worldwide. Currently, many women have undergone surgery to remove all or part of their breasts due to breast cancer, which not only destroys their appearance, but also causes trauma to their hearts. In order to repair their appearance, breast prostheses, flap transplantation, and autologous fat transplantation are mainly used clinically to help patients reconstruct their breasts. Among them, breast prosthesis implantation is the most common method, which can simultaneously reconstruct the size and shape of the breast. However, the current commercial breast prostheses are mostly hemispherical, so they cannot meet the needs of some patients who have undergone mastectomy. 3D printing is an additive manufacturing technology that can print biosafe materials into specific three-dimensional structures. It is particularly important to use 3D printing technology to print breast prostheses of different shapes to meet the specific needs of some patients who have undergone mastectomy, but this application has not yet started. In addition, traditional silicone prostheses do not have the effect of treating or responding to tumors in clinical practice.
发明内容Summary of the invention
本发明的目的在于克服现有技术存在的不足，而提供一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体及制作方法。The purpose of the present invention is to overcome the deficiencies of the prior art and to provide a breast prosthesis and a manufacturing method thereof that has the functions of treating and preventing breast cancer recurrence and breast reconstruction.
本发明的目的是通过如下技术方案来完成的。一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体，所述乳房假体由底板和支架组成的半球体结构，支架的顶部和底板之间设有圆柱体，所述底板和支架上开有多个孔洞形成镂空孔状结构；所述镂空结构内填充有脂肪或生长因子类物质或特异响应肿瘤的载药水凝胶。The purpose of the present invention is achieved through the following technical solutions: A breast prosthesis with the function of treating breast cancer recurrence and preventing breast reconstruction, the breast prosthesis is a hemispherical structure composed of a base plate and a bracket, a cylinder is arranged between the top of the bracket and the base plate, and a plurality of holes are opened on the base plate and the bracket to form a hollow hole structure; the hollow structure is filled with fat or growth factor substances or drug-loaded hydrogel that specifically responds to tumors.
更进一步的，所述乳房假体的组成材料为：将3wt％聚乙二醇二丙烯酸酯和15wt％聚醚F127二丙烯酸酯溶于含光引发剂和光吸收剂的溶液中配制而成。Furthermore, the breast prosthesis is made of a material prepared by dissolving 3 wt % polyethylene glycol diacrylate and 15 wt % polyether F127 diacrylate in a solution containing a photoinitiator and a light absorber.
更进一步的，所述孔洞为圆形或三角形或正方形或其他形状。Furthermore, the holes are circular, triangular, square or other shapes.
本发明同时公开了一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体的制作方法，其特征在于：包括步骤如下：The present invention also discloses a method for manufacturing a breast prosthesis with the functions of treating breast cancer recurrence and preventing breast reconstruction, which is characterized by comprising the following steps:
步骤一、建立乳房假体三维模型：根据所需的乳房隆起程度来设计半球体结构的高度，将半球体结构上设计多个孔洞形成镂空孔状结构，在乳房假体中间设置圆柱体，通过改变该圆柱体的大小及空心程度来调节乳房假体的弹性模量；Step 1: Establish a 3D model of a breast prosthesis: design the height of the hemispherical structure according to the required degree of breast bulge, design multiple holes on the hemispherical structure to form a hollow hole structure, set a cylinder in the middle of the breast prosthesis, and adjust the elastic modulus of the breast prosthesis by changing the size and hollowness of the cylinder;
步骤二、乳房假体的制造：将设计好的乳房假体三维模型导入电脑中，将配制好的乳房假体材料加入3D打印机的料槽中，将uv光强调整为16mW/cm2，曝光时间调为4s，底层曝光时间调增为6s，此后即将特定的乳房假体模型打印出来；Step 2: Manufacturing of breast prosthesis: Import the designed 3D model of breast prosthesis into the computer, add the prepared breast prosthesis material into the material tank of the 3D printer, adjust the UV light intensity to 16mW/cm2 , the exposure time to 4s, and the bottom layer exposure time to 6s, and then print out the specific breast prosthesis model;
步骤三、填充乳房假体：依据乳房假体的应用场景来决定乳房假体的填充物，若是用于肿瘤复发的治疗中则将特异响应肿瘤的载药水凝胶填充于乳房假体空隙中，若是用于单纯乳房填充、重建中则将脂肪或生长因子类物质填充于乳房假体空隙中。Step 3. Filling the breast prosthesis: The filler of the breast prosthesis is determined based on the application scenario of the breast prosthesis. If it is used for the treatment of tumor recurrence, the drug-loaded hydrogel that specifically responds to the tumor will be filled into the breast prosthesis gap. If it is used for simple breast filling and reconstruction, fat or growth factor substances will be filled into the breast prosthesis gap.
本发明的有益效果为：本发明将肿瘤特异性响应的功能与假体相结合，3D打印技术可赋予乳房假体孔隙及通道结构，使乳房假体有富余空间装载特异性响应肿瘤的治疗性水凝胶。为实现肿瘤特异性响应，肿瘤微环境是肿瘤的一大特点，在肿瘤微环境中ROS水平会显著高于正常组织中的ROS，因而ROS可作为特异性响应肿瘤的一个物质。将此类ROS响应性水凝胶作为药物载体来抑制肿瘤的发生与进展，该水凝胶可将药物特异性递送到肿瘤部位，并有效降低TME中ROS的水平。因此将此类装载药物的ROS响应性水凝胶与3D打印的乳房假体相结合，是解决肿瘤治疗兼并美观的好方案。The beneficial effects of the present invention are as follows: the present invention combines the function of tumor-specific response with the prosthesis, and the 3D printing technology can give the breast prosthesis pores and channel structures, so that the breast prosthesis has spare space to load therapeutic hydrogels that specifically respond to tumors. In order to achieve tumor-specific response, the tumor microenvironment is a major feature of the tumor. The ROS level in the tumor microenvironment is significantly higher than the ROS in normal tissues, so ROS can be used as a substance that specifically responds to tumors. Such ROS-responsive hydrogels are used as drug carriers to inhibit the occurrence and progression of tumors. The hydrogel can specifically deliver drugs to the tumor site and effectively reduce the level of ROS in the TME. Therefore, combining such drug-loaded ROS-responsive hydrogels with 3D-printed breast prostheses is a good solution to the problem of tumor treatment and aesthetics.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为本发明的立体结构示意图。FIG1 is a schematic diagram of the three-dimensional structure of the present invention.
图2为本发明的主视结构示意图。FIG. 2 is a schematic diagram of the front structural view of the present invention.
图3为本发明乳房假体材料的性能示意图。FIG. 3 is a schematic diagram showing the performance of the breast prosthesis material of the present invention.
具体实施方式DETAILED DESCRIPTION
为了使本领域的技术人员更好地理解本发明的技术方案，下面结合附图和具体实施例对本发明的优选实施方案进行描述，但是应当理解，附图仅用于示例性说明，不能理解为对本发明的限制；为了更好说明本实施例，附图某些部件会有省略、放大或缩小，并不代表实际产品的尺寸；对于本领域技术人员来说，附图中某些公知结构及其说明可能省略是可以理解的。附图中描述位置关系仅用于示例性说明，不能理解为对本发明的限制。In order to enable those skilled in the art to better understand the technical solution of the present invention, the preferred implementation scheme of the present invention is described below in conjunction with the accompanying drawings and specific embodiments. However, it should be understood that the accompanying drawings are only used for exemplary description and cannot be understood as limiting the present invention; in order to better illustrate the present embodiment, some parts of the accompanying drawings may be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the accompanying drawings may be omitted. The positional relationship described in the accompanying drawings is only used for exemplary description and cannot be understood as limiting the present invention.
如图1和2所示，一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体，所述乳房假体1由底板1-1和支架1-2组成的半球体结构，支架1-2的顶部和底板1-1之间设有圆柱体1-3，所述底板1-1和支架1-2上开有多个孔洞2形成镂空孔状结构，所述镂空结构内填充有脂肪或生长因子类物质或特异响应肿瘤的载药水凝胶。即该多孔结构在不妨碍乳房假体支撑性的同时又可赋予其功能性，例如填充脂肪来重建乳房或是填充治疗性水凝胶来抑制乳腺癌术后的复发及乳房重建。As shown in Figures 1 and 2, a breast prosthesis with the function of treating breast cancer recurrence and preventing and reconstructing breasts, the breast prosthesis 1 is a hemispherical structure composed of a base plate 1-1 and a bracket 1-2, a cylinder 1-3 is provided between the top of the bracket 1-2 and the base plate 1-1, and a plurality of holes 2 are opened on the base plate 1-1 and the bracket 1-2 to form a hollow hole structure, and the hollow structure is filled with fat or growth factor substances or drug-loaded hydrogels that specifically respond to tumors. That is, the porous structure can give the breast prosthesis functionality while not hindering its support, such as filling fat to reconstruct the breast or filling therapeutic hydrogels to inhibit the recurrence of breast cancer after surgery and reconstruct the breast.
所述乳房假体的组成材料为：3wt％聚乙二醇二丙烯酸酯(PEGDA)-15wt％聚醚F127二丙烯酸酯(F127DA)，将3wt％聚乙二醇二丙烯酸酯和15wt％聚醚F127二丙烯酸酯溶于含光引发剂和光吸收剂的溶液中配制而成。该材料具有较好生物相容性、韧性及稳定性，以光固化3D生物打印技术可将该材料打印成特定的结构。如图3所示，PEGDA提升了溶液的凝胶点，降低了外界温度对F127DA材料的影响，从而提升了打印精度，同时PEGDA的加入亦提升了该材料的机械力，使得打印出的模型有更好的支撑性。The composition material of the breast prosthesis is: 3wt% polyethylene glycol diacrylate (PEGDA)-15wt% polyether F127 diacrylate (F127DA), which is prepared by dissolving 3wt% polyethylene glycol diacrylate and 15wt% polyether F127 diacrylate in a solution containing a photoinitiator and a light absorber. The material has good biocompatibility, toughness and stability, and can be printed into a specific structure using photocuring 3D bioprinting technology. As shown in Figure 3, PEGDA increases the gel point of the solution and reduces the effect of external temperature on the F127DA material, thereby improving the printing accuracy. At the same time, the addition of PEGDA also increases the mechanical strength of the material, making the printed model have better support.
尽管上述乳房假体设计方案优化了现有乳房假体的形状，但于本领域的技术人员而言，本发明可有各种的更改和优化，例如：将乳房假体上的孔洞设计为圆形、三角形、正方形或其他形状；将假体的半球体形设计为半椭圆的形态；将镂空假体中填入脂肪用于乳房重建或是填充治疗性水凝胶用于乳腺癌复发的防治及乳房重建，此类型修改和变化、等同替换和改进等，均应包含在本发明的保护范围之内。Although the above-mentioned breast prosthesis design optimizes the shape of the existing breast prosthesis, it is known to those skilled in the art that the present invention may be modified and optimized in various ways, for example: the holes on the breast prosthesis may be designed to be circular, triangular, square or other shapes; the hemispherical shape of the prosthesis may be designed to be semi-elliptical; fat may be filled into the hollow prosthesis for breast reconstruction or therapeutic hydrogel may be filled for the prevention and treatment of breast cancer recurrence and breast reconstruction. Such modifications and changes, equivalent substitutions and improvements, etc., should all be included in the scope of protection of the present invention.
本发明同时公开了一种具治疗乳腺癌复发防治及乳房重建功能的乳房假体的制作方法，包括步骤如下：The present invention also discloses a method for manufacturing a breast prosthesis with the functions of treating breast cancer recurrence and preventing breast reconstruction, comprising the following steps:
步骤一、建立乳房假体三维模型：根据所需的乳房隆起程度来设计半球体结构的高度，将半球体结构上设计多个孔洞形成镂空孔状结构，在乳房假体中间设置圆柱体或空心圆柱体，通过改变该圆柱体的大小及空心程度来调节乳房假体的弹性模量；Step 1: Establish a three-dimensional model of a breast prosthesis: design the height of the hemispherical structure according to the required degree of breast bulge, design multiple holes on the hemispherical structure to form a hollow hole structure, set a cylinder or a hollow cylinder in the middle of the breast prosthesis, and adjust the elastic modulus of the breast prosthesis by changing the size and hollowness of the cylinder;
步骤二、乳房假体的制造：将设计好的乳房假体三维模型导入电脑中，将材料PEGDA及F127DA溶于含0.25％光引发剂和0.05％光吸收剂的溶液中配制成3wt％PEGDA-15wt％F127DA，此后将配制好的乳房假体材料加入3D打印机的料槽中，将uv光强调整为16mW/cm2，曝光时间调为4s，底层曝光时间调增为6s，此后即将特定的乳房假体模型打印出来；Step 2, manufacturing of breast prosthesis: import the designed breast prosthesis 3D model into the computer, dissolve the materials PEGDA and F127DA in a solution containing 0.25% photoinitiator and 0.05% light absorber to prepare 3wt% PEGDA-15wt% F127DA, then add the prepared breast prosthesis material into the material tank of the 3D printer, adjust the UV light intensity to 16mW/cm2 , the exposure time to 4s, and the bottom layer exposure time to 6s, then print out the specific breast prosthesis model;
步骤三、填充乳房假体：依据乳房假体的应用场景来决定乳房假体的填充物，若是用于肿瘤复发的治疗中则将特异响应肿瘤的载药水凝胶填充于乳房假体空隙中，若是用于单纯乳房填充、重建中则将脂肪或生长因子类物质填充于乳房假体空隙中。对于有乳房重建需求的人群，植入含有脂肪的乳房假体会使重建后的乳房更贴近人体自然乳房的弹性及柔软性。Step 3: Filling the breast prosthesis: The filler of the breast prosthesis is determined based on the application scenario of the breast prosthesis. If it is used for the treatment of tumor recurrence, a drug-loaded hydrogel that specifically responds to the tumor is filled into the breast prosthesis gap. If it is used for simple breast filling and reconstruction, fat or growth factor substances are filled into the breast prosthesis gap. For people who need breast reconstruction, implanting a breast prosthesis containing fat will make the reconstructed breast closer to the elasticity and softness of the natural breast of the human body.
本发明中的乳房假体支架是一种生物相容性、稳定性、韧性较好的支架，其弹性模量与商业化硅胶假体相似。其较高的精密度和可打印性，能为术后患者提供个性化定制的乳房假体，同时合并特异性响应肿瘤的载药水凝胶使得具备抑制肿瘤复发的功能。其为病人修复外观的基础上抑制了肿瘤的复发，是一个具有临床应用前景的乳房假体支架。The breast prosthesis scaffold of the present invention is a scaffold with good biocompatibility, stability and toughness, and its elastic modulus is similar to that of commercial silicone prostheses. Its high precision and printability can provide personalized breast prostheses for postoperative patients, and at the same time, it combines a drug-loaded hydrogel that specifically responds to tumors to have the function of inhibiting tumor recurrence. It inhibits tumor recurrence on the basis of restoring the patient's appearance, and is a breast prosthesis scaffold with clinical application prospects.
本发明的另一方面，提供了个性化乳房假体的用途，其可用于负载特异性响应肿瘤的含药水凝胶、脂肪或生长因子；或单纯用于乳房填充及修复重建中。Another aspect of the present invention provides the use of a personalized breast prosthesis, which can be used to load drug-containing hydrogels, fats or growth factors that specifically respond to tumors; or simply used for breast augmentation and repair and reconstruction.
应用场景如下：The application scenarios are as follows:
1、乳腺肿瘤切除术后，活检确定肿瘤类型，选出最合适的治疗药物，并以水凝胶来装载该药物，CT检测肿瘤形态，设计出合适的假体形状，并以3D打印方式将其打印出；1. After breast tumor resection, biopsy is performed to determine the tumor type, the most appropriate therapeutic drug is selected, and the drug is loaded into hydrogel. CT scans the tumor morphology, and the appropriate prosthesis shape is designed and printed out by 3D printing;
2、植入具有治疗效果的乳房假体；2. Implantation of therapeutic breast prostheses;
3、水凝胶响应到肿瘤的复发，释放药物并抑制肿瘤生成；3. The hydrogel responds to tumor recurrence, releases drugs and inhibits tumor formation;
4、肿瘤治愈，载药水凝胶降解，余下乳房假体。4. The tumor is cured, the drug-loaded hydrogel degrades, and the breast prosthesis remains.
可以理解的是，对本领域技术人员来说，对本发明的技术方案及发明构思加以等同替换或改变都应属于本发明所附的权利要求的保护范围。It is understandable that, for those skilled in the art, any equivalent replacement or change to the technical solution and inventive concept of the present invention should fall within the protection scope of the claims attached to the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310822150.XACN118662275A (en) | 2023-07-06 | 2023-07-06 | Breast prosthesis with functions of treating breast cancer recurrence, preventing and treating breast cancer, and breast reconstruction, and its manufacturing method |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310822150.XACN118662275A (en) | 2023-07-06 | 2023-07-06 | Breast prosthesis with functions of treating breast cancer recurrence, preventing and treating breast cancer, and breast reconstruction, and its manufacturing method |
| Publication Number | Publication Date |
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| CN118662275Atrue CN118662275A (en) | 2024-09-20 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310822150.XAPendingCN118662275A (en) | 2023-07-06 | 2023-07-06 | Breast prosthesis with functions of treating breast cancer recurrence, preventing and treating breast cancer, and breast reconstruction, and its manufacturing method |
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| CN (1) | CN118662275A (en) |
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| WO2020242694A1 (en)* | 2019-05-31 | 2020-12-03 | Tepha, Inc. | Implants assembled from skeletal polyhedron unit cells, coiled unit cells or mesh unit cells |
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