Degradable breast implant
By designing a biodegradable breast implant with a three-dimensional mesh structure, the problem of uneven breast tissue regeneration was solved, achieving uniform regeneration of breast tissue and meeting the support requirements, while reducing scarring.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SHENZHEN BIOREGENERATION TECHNOLOGY CO LTD
- Filing Date
- 2025-05-29
- Publication Date
- 2026-07-30
AI Technical Summary
The fact that existing breast implants degrade at a uniform rate leads to uneven regeneration of breast tissue, which can easily cause scarring.
Design a biodegradable breast implant with a three-dimensional mesh structure. The surface part is a first three-dimensional virtual boundary, and the filling part is a lattice structure formed by several crystal units. The wire diameter gradually decreases and gradually degrades from the outer layer to the inner layer. The outer layer fibers are finer to reduce the foreign body sensation, while the inner layer fibers are coarser to provide support.
It achieves uniform regeneration of breast tissue, reduces scarring, and meets the needs of breast implants for internal support and external elasticity.
Smart Images
Figure CN2025098137_30072026_PF_FP_ABST
Abstract
Description
Biodegradable breast implants
[0001] Cross-references to related applications
[0002] This application claims priority to Chinese patent application 202510112611.3 entitled “Degradable Breast Implant”, filed on January 24, 2025, the entire contents of which are incorporated herein by reference. Technical Field
[0003] This application relates to the fields of tissue engineering and biomanufacturing technology, and in particular to a biodegradable breast implant. Background Technology
[0004] Breast reconstruction surgery includes implant reconstruction and autologous tissue reconstruction. Implant reconstruction mostly uses non-degradable implants made of materials like silicone, which can cause rejection reactions in the body. Autologous tissue transplantation also faces challenges such as insufficient blood supply leading to fat reabsorption and low transplantation efficiency. To address these issues, a biodegradable breast implant technology has been developed. Its three-dimensional mesh structure provides excellent support and promotes breast tissue repair and regeneration. Since breast tissue regeneration progresses from the outer side of the implant to the inner side, existing breast implants exhibit no significant difference in degradation rate from the outer to the inner side, resulting in uneven breast tissue regeneration and a higher risk of scarring. Summary of the Invention
[0005] This application provides a biodegradable breast implant to address the problem of uneven breast tissue regeneration and growth caused by the uniform degradation rate of breast implants.
[0006] To address the aforementioned technical problems, this application provides a biodegradable breast implant, wherein the biodegradable breast implant has a three-dimensional mesh structure, comprising:
[0007] The surface portion is a first three-dimensional virtual boundary located on the outer periphery of the breast implant. The shape of the first three-dimensional virtual boundary is a preset shape, the size of the first three-dimensional virtual boundary is a preset size, and the center position of the surface portion is a base point.
[0008] A filling portion, which fills the interior of the surface portion, is a lattice structure formed by several lattice units. The fiber thickness of the lattice unit is the wire diameter. The lattice structure includes multiple interconnected and continuous lattice layers. The shape of the lattice layer is the same as the preset shape. The size of the lattice layer is proportionally reduced relative to the preset size. The wire diameter of the same lattice layer is the same. The wire diameter of different lattice layers gradually decreases from the base point toward the surface portion.
[0009] Wherein, the wire diameter connected to the base point is the maximum wire diameter, and the wire diameter smaller than the maximum wire diameter is reduced by a ratio of 0.1 to 1 relative to the maximum wire diameter.
[0010] The wire diameter is in the range of 0.02mm to 2mm.
[0011] The dot matrix structure includes several dot matrix spaces. Each dot matrix space is formed by scaling the first three-dimensional virtual boundary proportionally around the base point and performing a Boolean difference operation. The number of dot matrix layers in any dot matrix space is greater than or equal to 1. The line diameters in the same dot matrix space are the same. The line diameters in different dot matrix spaces decrease progressively from the base point toward the surface.
[0012] Wherein, when the number of lattice layers in each lattice space is 1, the line diameter of different lattice layers decreases gradually from the base point toward the surface portion.
[0013] In this process, the line diameter of different lattice spaces decreases gradually from the base point toward the surface portion in a gradient manner.
[0014] Wherein, when the number of lattice layers in each lattice space is 1, the line diameter of different lattice layers decreases gradually from the base point toward the surface portion.
[0015] The structure of the lattice unit includes one or more of the following: cubic lattice structure, dodecahedral lattice structure, tetrahedral lattice structure, octahedral lattice structure, hexagonal lattice structure, cylindrical lattice structure, and spring-type lattice structure.
[0016] The lattice unit within the lattice structure is a single structure.
[0017] The lattice unit has an octahedral crystal structure.
[0018] The equivalent sphere diameter of the lattice unit ranges from 0.2 mm to 10 mm.
[0019] Wherein, the lattice unit structures within the same lattice space are the same, and the lattice unit structures in different lattice spaces are the same or different.
[0020] The lattice structure consists of a first lattice space, a second lattice space, and a third lattice space from the inside out. The lattice units in the first lattice space are dodecahedral lattices, the lattice units in the second lattice space are face-centered cubic lattices, and the lattice units in the third lattice space are octahedral lattices.
[0021] The preset shape and preset size are obtained through methods including obtaining them through medical imaging data and / or through calculation.
[0022] The biodegradable breast implant is made of a biodegradable polymer material, including at least one of polyhydroxyalkanoate (PHA) and its copolymers, polycaprolactone (PCL) and its copolymers, polyglycolic acid (PGA) and its copolymers, polybutylene succinate (PBS) and its copolymers, polyvinyl alcohol (PVA) and its copolymers, polylactic acid (PLA) and its copolymers, and polylactic acid-glycolic acid copolymer (PLGA).
[0023] The biodegradable breast implants are manufactured using 3D printing technology and / or mold injection technology.
[0024] The beneficial effects of this application embodiment, which differs from the prior art, are as follows: This application provides a biodegradable breast implant, which is a three-dimensional mesh structure including a surface portion and a filling portion. The surface portion is a first three-dimensional virtual boundary located on the outer periphery of the breast implant. The shape of the first three-dimensional virtual boundary is a preset shape, and the size of the first three-dimensional virtual boundary is a preset size. The center position of the surface portion is a base point. The filling portion fills the interior of the surface portion and is a lattice structure formed by several lattice units. The fiber thickness of the lattice unit is the line diameter. The lattice structure includes multiple interconnected and continuous lattice layers. The shape of the lattice layer is the same as the preset shape, and the size of the lattice layer is proportionally reduced relative to the preset size. The line diameter of the same lattice layer is the same, and the line diameter of different lattice layers gradually decreases from the base point toward the surface portion. By designing the diameter of different lattice layers to gradually decrease from the base point towards the surface, the outermost fiber layer is the thinnest part of the implant. After implantation, the implant degrades sequentially from the outermost layer inwards, successfully solving the problem of uneven breast tissue regeneration caused by the uniform degradation rate of breast implants. On the other hand, the finer outer fibers reduce the feeling of a foreign body and facilitate the implantation procedure, while the coarser inner fiber structure provides better support and prevents structural deformation caused by the initial lack of tissue ingrowth, thus meeting the needs of breast implants for both internal support and external elasticity. Attached Figure Description
[0025] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort, wherein:
[0026] Figure 1 is a structural diagram of the first embodiment of the biodegradable breast implant provided in this application;
[0027] Figure 2 is a schematic cross-sectional view of the biodegradable breast implant shown in Figure 1.
[0028] Figure 3 is a schematic diagram of the pre-designed shape of the biodegradable breast implant shown in Figure 1;
[0029] Figure 4 is a schematic diagram of the lattice unit structure of the biodegradable breast implant shown in Figure 1;
[0030] Figure 5 is a cross-sectional structural diagram of a second embodiment of the biodegradable breast implant provided in this application;
[0031] Figure 6 is a schematic diagram of the conceptual structure of the biodegradable breast implant shown in Figure 5;
[0032] Figure 7 is a conceptual structural diagram of a third embodiment of the biodegradable breast implant provided in this application;
[0033] Figure 8 is a conceptual structural diagram of the fourth embodiment of the biodegradable breast implant provided in this application;
[0034] Figure 9 is a schematic diagram of the equivalent sphere structure of the lattice unit of the biodegradable breast implant provided in this application;
[0035] Figure 10 is a cross-sectional structural schematic diagram of the fifth embodiment of the biodegradable breast implant provided in this application;
[0036] Figure 11 is a schematic cross-sectional view of a lattice layer in a biodegradable breast implant provided in one embodiment of this application. Detailed Implementation
[0037] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. It is understood that the specific embodiments described herein are only for explaining this application and not for limiting it. Furthermore, it should be noted that, for ease of description, only the parts related to this application are shown in the accompanying drawings, not all structures. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.
[0038] In the description of this application, it should be understood that the terms "center," "thickness," "upper," "lower," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are used only for the convenience of describing this application and for 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, and therefore should not be construed as a limitation of this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.
[0039] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication between two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.
[0040] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a mutually exclusive, independent, or alternative embodiment. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.
[0041] Currently, common breast reconstruction surgeries include implant reconstruction and autologous tissue reconstruction. Implant reconstruction mostly uses non-degradable implants made of materials like silicone, which can cause rejection reactions in the body. Autologous tissue transplantation also suffers from problems such as insufficient blood supply leading to fat reabsorption and low transplantation efficiency. To address these issues, a biodegradable breast implant technology has emerged. Its three-dimensional mesh structure provides excellent support and promotes breast tissue repair and regeneration. Since breast tissue regeneration progresses from the outside of the implant to the inside, existing breast implants exhibit no significant difference in degradation rate from the outside to the inside, resulting in uneven breast tissue regeneration and a higher risk of scarring.
[0042] In view of the above problems, this application provides a biodegradable breast implant to solve the problem of uneven breast tissue regeneration and growth caused by the uniform degradation rate of breast implants. Figures 1 to 11 show specific embodiments of the biodegradable breast implant provided in this application.
[0043] Figure 1 is a physical structural diagram of a first embodiment of the biodegradable breast implant provided in this application; Figure 2 is a cross-sectional structural diagram of the biodegradable breast implant shown in Figure 1; Figure 3 is a model schematic diagram of the preset shape of the biodegradable breast implant shown in Figure 1; Figure 4 is a structural schematic diagram of the lattice unit of the biodegradable breast implant shown in Figure 1; Figure 5 is a cross-sectional structural diagram of a second embodiment of the biodegradable breast implant provided in this application; Figure 6 is a conceptual structural diagram of the biodegradable breast implant shown in Figure 5; Figure 7 is a conceptual structural diagram of a third embodiment of the biodegradable breast implant provided in this application; Figure 8 is a conceptual structural diagram of a fourth embodiment of the biodegradable breast implant provided in this application; Figure 9 is a structural schematic diagram of the equivalent sphere of the lattice unit of the biodegradable breast implant provided in this application; Figure 10 is a cross-sectional structural diagram of a fifth embodiment of the biodegradable breast implant provided in this application; Figure 11 is a cross-sectional conceptual structural diagram of a certain lattice layer in a biodegradable breast implant provided in an embodiment of this application.
[0044] As shown in Figures 1 to 4, this application provides a biodegradable breast implant 100. As shown in Figure 1, the biodegradable breast implant 100 has a three-dimensional mesh structure. The three-dimensional mesh structure has excellent mechanical support performance and can simulate the elastic characteristics of real breast tissue. At the same time, the three-dimensional mesh structure can be adapted to the ingrowth of breast tissue cells. As the implant degrades, the breast is repaired at the implantation site.
[0045] As shown in Figure 2, the biodegradable breast implant 100 includes a surface portion 110 located on the outer periphery of the breast implant 100. The surface portion 110 is actually a virtual structure, defined as a first three-dimensional virtual boundary 11. The shape of the first three-dimensional virtual boundary 11 is a preset shape 210, and its size is a preset size. The shape and size of the outer contour of the biodegradable breast implant 100 are determined by the shape and size of the first three-dimensional virtual boundary 11. Figure 3 shows a schematic diagram of the preset shape 210 corresponding to this embodiment. In actual production, the preset shape 210 can be of various shapes and is not specifically limited, determined by the required location of the transplanted breast. In some specific embodiments, the preset shape 210 and preset size can be obtained through medical imaging data. The biodegradable breast implant is used to implant into the vacancy location after tumor tissue removal in a patient's breast. Therefore, the preset shape and preset size of the first three-dimensional virtual boundary 11 are determined by extracting the patient's medical imaging data to match the vacancy location. In other specific embodiments, biodegradable breast implants are used to be implanted into a patient's breast to achieve a cosmetic lifting effect. In this case, the preset shape and preset size can be obtained by the doctor in combination with the patient's treatment plan.
[0046] As shown in Figure 2, the center position of the surface part 110 is the base point 111. The specific orientation of the base point 111 is determined by calculation based on the preset shape 210 and preset size.
[0047] As shown in Figure 2, the biodegradable breast implant 100 also includes a filling portion 120, which fills the interior of the surface portion 110. The filling portion 120 is a lattice structure formed by a plurality of lattice units 123, and Figure 4 shows the specific structure of the lattice unit 123 in this example. Referring to Figure 11, Figure 11 shows a schematic diagram of the structure of a certain lattice layer 122 in the biodegradable breast implant 100 according to an embodiment of this application. The lattice structure includes a plurality of interconnected and through lattice layers 122, the shape of the lattice layer 122 is the same as the preset shape 210, and the size of the lattice layer 122 is proportionally reduced relative to the preset size. The fiber thickness of the lattice unit 123 is the line diameter d, the line diameter d of the same lattice layer 122 is the same, and the line diameter d of different lattice layers 122 gradually decreases from the base point 111 toward the surface portion 110. That is, the line diameter d of different lattice layers 122 tends to decrease in the direction from the base point 111 toward the surface portion 110.
[0048] By designing the line diameter d of the lattice units in different lattice layers 122 to gradually decrease from the base point 111 towards the surface portion 110, the outermost layer of the biodegradable breast implant 100 is the thinnest, while the line diameter d of the biodegradable breast implant 100 gradually increases from the outermost layer to the inner layer. The degradation rate is fastest at the thinnest fiber layer, meaning the biodegradable breast implant 100 degrades gradually from the outer layer to the inner layer. This synchronizes with the repair and regeneration direction of breast tissue cells, thereby achieving uniform regeneration of breast tissue cells at the implantation site. When the breast implant 100 is completely degraded, the breast tissue has also completed its repair. On the other hand, the center of the biodegradable breast implant 100 needs to have good support to prevent deformation problems that may occur in the early stages of implantation due to the lack of cell ingrowth in the inner layer. The outer layer needs to have good deformability to facilitate the implantation surgery and improve postoperative comfort, reducing the feeling of a foreign body. This structural design features a thinner outer fiber layer with a lower elastic modulus, making it more prone to deformation; and a thicker inner fiber layer with a higher elastic modulus and greater stiffness, making it less prone to deformation. This satisfies the requirements of breast implants for both internal support and external flexibility.
[0049] The wire diameter d connected to base point 111 is the maximum wire diameter d. max In other words, the fibers in the innermost lattice layer are the thickest. To facilitate product manufacturing, in some implementations, the fibers are smaller than the maximum wire diameter d. max The wire diameter d, which is the wire diameter d of the other lattice layers relative to the maximum wire diameter d max The reduction ratio is 0.1 to 1, and the wire diameter d ranges from 0.02 mm to 2 mm. Determining the range of wire diameter d and the reduction ratio ensures the overall structural stability of the biodegradable implant and is suitable for actual product manufacturing.
[0050] Because the tissue growth rate varies in different areas of the breast, and the breast conditions differ between individuals, we have proposed several implementation methods to consider various specific implementation scenarios.
[0051] Figures 5 and 6 show a second specific embodiment of the biodegradable breast implant proposed in this application. The filling part 120 has a lattice structure, which includes several lattice spaces 121. Each lattice space 121 is formed by scaling the first three-dimensional virtual boundary 11 proportionally around the base point 111 and performing a Boolean difference operation. The number of lattice layers 122 in any lattice space 121 is greater than or equal to 1. The line diameter d in the same lattice space 121 is the same, and the line diameter d in different lattice spaces 121 decreases progressively from the base point 111 toward the surface part 110. In this embodiment, as shown in Figures 5 and 6, the first three-dimensional virtual boundary 11 is scaled twice around the base point 111 to form a second three-dimensional virtual boundary 12 and a third three-dimensional virtual boundary 13. Then, a Boolean difference operation is performed to form three lattice spaces 121, which are, from the inside out, the first lattice space A, the second lattice space B, and the third lattice space C. The fibers at the nodes of adjacent lattice spaces are interconnected and transitioned. As shown in Figure 6, the fiber diameter d in the first lattice space A is 2 mm, the fiber diameter d in the second lattice space B is 1.3 mm, and the fiber diameter d in the third lattice space C is 0.8 mm, decreasing progressively from the base point towards the surface. This embodiment is one implementation where the fiber diameter d in different lattice spaces gradually decreases from the base point towards the surface. Any implementation method falling under this technical means is within its protection scope.
[0052] Figure 7 illustrates a third specific embodiment of the biodegradable breast implant proposed in this application. The filling portion 120 has a lattice structure comprising several lattice spaces 121. Similarly, each lattice space 121 is formed by scaling the first three-dimensional virtual boundary 11 proportionally around the base point 111 and performing a Boolean difference operation. The number of lattice layers 122 within any lattice space 121 is greater than or equal to 1. The line diameter d within the same lattice space 121 is the same. However, the line diameter d of different lattice spaces 121 decreases gradually from the base point 111 toward the surface portion 110. In this embodiment, as shown in Figure 7, the first three-dimensional virtual boundary 11 is scaled three times around the base point 111 to form a second, third, and fourth three-dimensional virtual boundary. Then, a Boolean difference operation is performed to form four lattice spaces 121, which are, from the inside out, the first lattice space A, the second lattice space B, the third lattice space C, and the fourth lattice space D. The fibers at the nodes of adjacent lattice spaces are interconnected and transitioned. As shown in Figure 6, the fiber diameter d in the first lattice space A is 1.5 mm, the fiber diameter d in the second lattice space B is 1.1 mm, the fiber diameter d in the third lattice space C is 0.7 mm, and the fiber diameter d in the fourth lattice space D is 0.3 mm. The diameter decreases gradually from the base point towards the surface. In this embodiment, the next lattice space 121 decreases gradually by 0.4 mm compared to the previous lattice space 121. This embodiment is one implementation where the fiber diameter d of different lattice spaces decreases gradually from the base point towards the surface. Any implementation using this technique is within its protection scope.
[0053] When the number of lattice layers in the lattice space is 1, the line diameter d of different lattice layers decreases progressively from the base point towards the surface. The division of lattice layers can be based on specific needs; it can be based on the entire crystal unit or on a portion of the crystal unit's structure. As shown in Figure 11, in this embodiment, lattice layer 122 is divided based on the entire crystal unit 123. Figure 8 shows the fourth specific embodiment of the biodegradable breast implant proposed in this application. The filling part 120 is a lattice structure. It is formed by scaling the first three-dimensional virtual boundary 11 five times around the base point 111 and performing Boolean difference operations to create five lattice spaces. From the inside out, they are the first lattice space A, the second lattice space B, the third lattice space C, the fourth lattice space D, and the fifth lattice space E. Each lattice space contains only one lattice layer. That is, the first lattice space A contains the first lattice layer, the second lattice space B contains the second lattice layer, the third lattice space C contains the third lattice layer, the fourth lattice space D contains the fourth lattice layer, and the fifth lattice space E contains the fifth lattice layer. The nodes between adjacent lattice layers are interconnected. Figure 8 is a schematic diagram representing the concept of the line diameter d of the five lattice layers. The connection relationship of the five lattice layers is not shown in the diagram. The diameter d of the first lattice layer is 1 mm, the diameter d of the second lattice layer is 0.9 mm, the diameter d of the third lattice layer is 0.7 mm, the diameter d of the fourth lattice layer is 0.4 mm, and the diameter d of the fifth lattice layer is 0.2 mm, decreasing progressively with each layer. In this embodiment, the progressive decrease in diameter of each layer does not exhibit a gradient. This embodiment is one implementation where the diameter d of the lattice units of different lattice layers decreases progressively from the base point towards the surface. The number of lattice layers is not specifically limited, and any implementation method falling under this technical means is within its protection scope. In other embodiments, the diameter d of different lattice layers can also decrease progressively with a gradient from the base point towards the surface. For example, the diameter d of the first lattice layer is 1 mm, the diameter d of the second lattice layer is 0.8 mm, the diameter d of the third lattice layer is 0.6 mm, the diameter d of the fourth lattice layer is 0.4 mm, and the diameter d of the fifth lattice layer is 0.2 mm, decreasing progressively with each layer. This embodiment is one of the implementations in which the line diameter d of the lattice unit of different lattice layers decreases gradually from the base point toward the surface. Any implementation that falls under this technical means is within its protection scope.
[0054] This application proposes a biodegradable breast implant whose lattice unit structure includes one or more of the following: cubic lattice structure, dodecahedral lattice structure, tetrahedral lattice structure, octahedral lattice structure, hexagonal lattice structure, cylindrical lattice structure, and spring-type lattice structure. This application provides a specific embodiment where the lattice unit within the lattice structure is a single structure. As shown in Figures 1 to 6 and Figure 9, this is a specific embodiment of the biodegradable breast implant proposed in this application. All lattice units 123 in this biodegradable breast implant have an octahedral lattice structure. The biodegradable breast implant formed by octahedral lattice units can provide a larger growth space for cell growth, and its stable structure provides strong implant support. Figure 9 shows a schematic diagram of the equivalent sphere structure of the lattice unit in this embodiment. The diameter L1 of the equivalent sphere ranges from 0.2 mm to 10 mm, which not only adapts to the growth of breast tissue but also conforms to actual manufacturing processes. As shown in Figure 5, in this embodiment, the equivalent sphere diameter L1 is 6mm. The size of 6mm provides sufficient growth space for mammary gland cells and vascular endothelial cells, which is conducive to cell adhesion, proliferation and differentiation, thereby improving the overall efficiency of the implant and autologous tissue.
[0055] To accommodate the diversity of breast implantation cases, this application provides another specific implementation method. The lattice unit structures within the same lattice space are identical, while the lattice unit structures in different lattice spaces are identical and / or different. Figure 10 shows one specific implementation method provided by this application. In this embodiment, the biodegradable breast implant filling portion 120 has a lattice structure. The first three-dimensional virtual boundary 11 is scaled twice around a base point 111 to form a second three-dimensional virtual boundary 12 and a third three-dimensional virtual boundary 13. Then, Boolean difference operations are performed to form three lattice spaces, from the inside out: the first lattice space A, the second lattice space B, and the third lattice space C. In this embodiment, the lattice unit structures within each lattice space are different. The lattice units in the first lattice space A are dodecahedral lattices, the lattice units in the second lattice space B are face-centered cubic lattices, and the lattice units in the third lattice space C are octahedral lattices. The resulting three-dimensional mesh structure has the mechanical properties of low internal elasticity and strong support, and high external elasticity. In other embodiments, some lattice units in the lattice space may have the same structure, while the lattice units in the remaining lattice spaces may have different structures. Adjustments can be made according to the specific implementation scenario. Any implementation method falling under this technical approach is within its protection scope.
[0056] To achieve biocompatibility of biodegradable breast implants in the human body, in some specific embodiments, the biodegradable breast implants are made of biodegradable polymer materials. Biodegradable polymer materials include at least one of polyhydroxyalkanoates (PHA) and their copolymers, polycaprolactone (PCL) and their copolymers, polyglycolic acid (PGA) and its copolymers, polybutylene succinate (PBS) and its copolymers, polyvinyl alcohol (PVA) and its copolymers, polylactic acid (PLA) and its copolymers, and polylactic-glycolic acid copolymer (PLGA). Other materials that can degrade in the human body and have good performance are also within the scope of protection of this application.
[0057] To facilitate the production and manufacturing of biodegradable breast implants and quickly adapt to market demands, biodegradable breast implants can be manufactured using 3D printing technology, mold casting technology, or a combination of both. However, no restrictions are placed on the manufacturing method; all other methods enabling rapid production are within the scope of this application.
[0058] This application provides a biodegradable breast implant, which is a three-dimensional mesh structure including a surface portion and a filling portion. The surface portion is a first three-dimensional virtual boundary located on the outer periphery of the breast implant. The first three-dimensional virtual boundary has a preset shape and size, and the center of the surface portion is a base point. The filling portion fills the interior of the surface portion and is a lattice structure formed by several lattice units. The fiber thickness of each lattice unit is the line diameter. The lattice structure includes multiple interconnected and continuous lattice layers. The shape of each lattice layer is the same as the preset shape, and the size of each lattice layer is proportionally reduced relative to the preset size. The line diameter of the same lattice layer is the same, while the line diameter of different lattice layers gradually decreases from the base point toward the surface portion. By designing the line diameter of different lattice layers to gradually decrease from the base point toward the surface portion, the outermost fiber layer is the thinnest part of the implant as a whole. After implantation into the human body, the implant degrades sequentially from the outermost layer inwards, successfully solving the problem of uneven breast tissue regeneration and growth caused by the uniform degradation rate of breast implants. On the other hand, the finer external fibers can reduce the feeling of a foreign body and facilitate the implantation surgery, while the coarser internal fiber structure has better support and can prevent structural deformation caused by the initial lack of tissue ingrowth, thus meeting the needs of breast implants for internal support and external elasticity.
[0059] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.
Claims
1. A biodegradable breast implant, wherein, The biodegradable breast implant has a three-dimensional mesh structure, comprising: The surface portion is a first three-dimensional virtual boundary located on the outer periphery of the breast implant. The shape of the first three-dimensional virtual boundary is a preset shape, the size of the first three-dimensional virtual boundary is a preset size, and the center position of the surface portion is a base point. A filling portion, which fills the interior of the surface portion, is a lattice structure formed by several lattice units. The fiber thickness of the lattice unit is the wire diameter. The lattice structure includes multiple interconnected and continuous lattice layers. The shape of the lattice layer is the same as the preset shape. The size of the lattice layer is proportionally reduced relative to the preset size. The wire diameter of the same lattice layer is the same. The wire diameter of different lattice layers gradually decreases from the base point toward the surface portion.
2. The biodegradable breast implant as claimed in claim 1, wherein, The wire diameter connected to the base point is the maximum wire diameter, and the wire diameter smaller than the maximum wire diameter is reduced by a ratio of 0.1 to 1 relative to the maximum wire diameter.
3. The biodegradable breast implant as described in claim 1 or 2, wherein, The wire diameter ranges from 0.02 mm to 2 mm.
4. The biodegradable breast implant as described in claim 3, wherein, The lattice structure includes several lattice spaces. Each lattice space is formed by scaling the first three-dimensional virtual boundary proportionally around the base point and performing a Boolean difference operation. The number of lattice layers in any lattice space is greater than or equal to 1. The line diameters in the same lattice space are the same. The line diameters in different lattice spaces decrease progressively from the base point toward the surface.
5. The biodegradable breast implant of claim 4, wherein, When the number of lattice layers in each lattice space is 1, the line diameter of different lattice layers decreases gradually from the base point toward the surface portion.
6. The biodegradable breast implant of claim 4, wherein, The line diameter in different lattice spaces decreases gradually from the base point toward the surface portion in a gradient manner.
7. The biodegradable breast implant of claim 6, wherein, When the number of lattice layers in each lattice space is 1, the line diameter of different lattice layers decreases gradually from the base point toward the surface portion.
8. The biodegradable breast implant as described in any one of claims 1 to 7, wherein, The structure of the lattice unit includes one or more of the following: cubic lattice structure, dodecahedral lattice structure, tetrahedral lattice structure, octahedral lattice structure, hexagonal lattice structure, cylindrical lattice structure, and spring-type lattice structure.
9. The biodegradable breast implant of claim 8, wherein, The lattice unit within the lattice structure is a single structure.
10. The biodegradable breast implant of claim 9, wherein, The structure of the lattice unit is the octahedral lattice structure.
11. The biodegradable breast implant as described in any one of claims 8 to 10, wherein, The equivalent sphere diameter of the lattice unit ranges from 0.2 mm to 10 mm.
12. The biodegradable breast implant as described in any one of claims 4 to 7, wherein, The lattice units within the same lattice space have the same structure, and the lattice units in different lattice spaces may have the same or different structures.
13. The biodegradable breast implant of claim 12, wherein, The lattice structure consists of a first lattice space, a second lattice space, and a third lattice space from the inside out. The lattice units in the first lattice space are dodecahedral lattices, the lattice units in the second lattice space are face-centered cubic lattices, and the lattice units in the third lattice space are octahedral lattices.
14. The biodegradable breast implant as described in any one of claims 1 to 13, wherein, The preset shape and preset size are obtained through medical image data and / or through calculation.
15. The biodegradable breast implant as described in any one of claims 1 to 14, wherein, The biodegradable breast implant is made of a biodegradable polymer material, including at least one of polyhydroxyalkanoate (PHA) and its copolymers, polycaprolactone (PCL) and its copolymers, polyglycolic acid (PGA) and its copolymers, polybutylene succinate (PBS) and its copolymers, polyvinyl alcohol (PVA) and its copolymers, polylactic acid (PLA) and its copolymers, and polylactic acid-glycolic acid copolymer (PLGA).
16. The biodegradable breast implant as described in any one of claims 1 to 15, wherein, The biodegradable breast implants are manufactured using methods including 3D printing and / or mold injection techniques.