Degradable breast implant

Abstract

The invention provides a degradable breast implant which is of a three-dimensional network structure and comprises a surface part and a filling part, the surface part is a first three-dimensional virtual boundary and is located on the periphery of the breast implant, the appearance of the first three-dimensional virtual boundary is of a preset shape, the size of the first three-dimensional virtual boundary is of a preset size, and the center position of the surface part is a base point; the surface part is filled with the filling part, the filling part is of a dot matrix structure formed by a plurality of lattice units, the fiber thickness of the lattice units is the line diameter, the dot matrix structure comprises a plurality of dot matrix layers which are connected and communicated with one another, the shape of the dot matrix layers is the same as a preset shape, and the size of the dot matrix layers is scaled down relative to the preset size. The line diameters of the same dot matrix layer are the same, and the line diameters of different dot matrix layers are gradually reduced from the base point to the surface part. The line diameters of the different dot matrix layers are designed to be gradually reduced in the direction from the base point to the surface part, so that the problem of non-uniform breast tissue regeneration and growth caused by no difference of the degradation speed of the breast implant is successfully solved.

Description

Technical Field

[0001] This application relates to the technical field of tissue engineering and biomanufacturing, and particularly relates to a degradable breast implant. Background Art

[0002] Breast reconstruction surgery includes implant reconstruction and autologous tissue reconstruction. Most of the implant reconstructions are non-degradable implant prostheses made of materials such as silicone. After the non-degradable materials such as silicone are implanted into the human body, they may cause rejection reactions of the body; while autologous tissue transplantation also has problems such as lack of blood supply leading to fat resorption and low transplantation efficiency. To solve these problems, there is currently a technical means of degradable breast implants, which not only provides good support through a three-dimensional network structure, but also is conducive to the repair and regeneration of breast tissue. Since the regeneration of breast tissue develops from the outside to the inside of the implant, however, there is no obvious difference in the degradation rate of existing breast implants from the outside to the inside, resulting in uneven regeneration and growth of breast tissue and prone to scar problems. Summary of the Invention

[0003] This application provides a degradable breast implant to solve the problem of uneven regeneration and growth of breast tissue caused by the lack of difference in the degradation rate of breast implants.

[0004] To solve the above technical problems, this application provides a degradable breast implant. The degradable breast implant is a three-dimensional network structure, including: A surface part, the surface part is a first three-dimensional virtual boundary and is located on the 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 central position of the surface part is a base point; A filling part, the filling part is filled inside the surface part. The filling part is a lattice structure formed by a number of lattice units. The fiber thickness of the lattice unit is a wire diameter. The lattice structure includes a plurality of interconnected and penetrating 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, and the wire diameter of different lattice layers gradually decreases from the base point towards the direction of the surface part.

[0005] Among them, the wire diameter connected to the base point is the maximum wire diameter, and the reduction ratio of the wire diameter smaller than the maximum wire diameter relative to the maximum wire diameter is 0.1 to 1.

[0006] Among them, the range of the wire diameter is between 0.02 mm and 2 mm.

[0007] Among them, when the number of dot matrix layers in each dot matrix space is 1, the wire diameters of different dot matrix layers gradually decrease in the direction from the base point towards the surface part.

[0008] Among them, the dot matrix structure includes a number of dot matrix spaces, and the wire diameters of different dot matrix spaces gradually decrease in a gradient manner in the direction from the base point towards the surface part.

[0009] Among them, when the number of dot matrix layers in each dot matrix space is 1, the wire diameters of different dot matrix layers gradually decrease in a gradient manner in the direction from the base point towards the surface part.

[0010] Among them, the structure of the lattice unit includes a cubic lattice structure, a dodecahedral lattice structure, a tetrahedral lattice structure, an octahedral lattice structure, a hexagonal lattice structure, a cylindrical lattice structure, and a spring-type lattice structure.

[0011] Among them, the lattice unit in the dot matrix structure is of a single structure.

[0012] Among them, the range of the equivalent spherical diameter of the lattice unit is between 0.2 mm and 10 mm.

[0013] Among them, the lattice unit structures within the same dot matrix space are the same, and the structures of the lattice units in different dot matrix spaces are the same and / or different.

[0014] Among them, the acquisition methods of the preset shape and the preset size include acquisition through medical image data and acquisition through calculation.

[0015] Among them, the material of the degradable breast implant is a biodegradable polymer material, including polyhydroxyalkanoates (PHA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (PBS) and their copolymers, as well as polyvinyl alcohol (PVA), polylactic acid (PLA), and poly(lactic acid - glycolic acid) copolymer (PLGA) Among them, the manufacturing methods of the degradable breast implant include 3D printing technology and mold perfusion technology.

[0016] Distinct from the prior art, the beneficial effects of the embodiments of the present application are as follows: The present application provides a degradable breast implant. The degradable breast implant has a three-dimensional network structure, including a surface part and a filling part. The surface part is a first three-dimensional virtual boundary and is located on the outer periphery of the breast implant. The outer 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 central position of the surface part is the base point. The filling part is filled inside the surface part. The filling part is a lattice structure formed by a number of lattice units. The fiber thickness of the lattice unit is the wire diameter. The lattice structure includes a plurality of interconnected and penetrating 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, and the wire diameters of different lattice layers gradually decrease from the base point towards the surface part. By designing the wire diameters of different lattice layers to gradually decrease from the base point towards the surface part, the outermost layer of fibers is the thinnest part of the entire implant. After being implanted into the human body, it degrades successively from the outermost layer of the implant towards its interior, successfully solving the problem of uneven regeneration and growth of breast tissue caused by the lack of difference in the degradation rate of breast implants. On the other hand, the thinner fibers on the outside can reduce the foreign body sensation during implantation and facilitate the operation of the implantation surgery. The thicker fiber structure inside has better support force and can prevent structural deformation caused by the initial tissue not growing in, meeting the requirements of breast implants for internal support force and external elasticity. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for the description of the embodiments. Obviously, the following described drawings are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings, where: Figure 1 FIG. is a solid structure diagram of the first embodiment of the degradable breast implant provided by the present application; Figure 2 is Figure 1 a schematic cross-sectional structure diagram of the degradable breast implant shown; Figure 3 is Figure 1 a schematic model diagram of the preset shape of the degradable breast implant shown; Figure 4 is Figure 1 a schematic structure diagram of the lattice unit of the degradable breast implant shown; Figure 5 FIG. is a schematic cross-sectional structure diagram of the second embodiment of the degradable breast implant provided by the present application; Figure 6 isFigure 5 Schematic diagram of the conceptual structure of the degradable breast implant shown; Figure 7 Schematic diagram of the conceptual structure of the third embodiment of the degradable breast implant provided by this application; Figure 8 Schematic diagram of the conceptual structure of the fourth embodiment of the degradable breast implant provided by this application; Figure 9 Schematic diagram of the equivalent sphere structure of the lattice unit of the degradable breast implant provided by this application; Figure 10 Schematic diagram of the cross-sectional structure of the fifth embodiment of the degradable breast implant provided by this application. Detailed implementation manners

[0018] Next, the technical solutions in the embodiments of this application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of this application. It can be understood that the specific embodiments described herein are only used to explain this application, rather than limiting this application. Additionally, it should be noted that for the sake of description, only parts related to this application rather than all structures are shown in the accompanying drawings. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of this application.

[0019] In the description of this application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be understood as a limitation to this application. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the described features. In the description of this application, "a plurality" means two or more, unless otherwise specifically defined.

[0020] In the description of the present application, it should be noted that, unless otherwise clearly specified and defined, the terms "installed", "connected", and "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection, an electrical connection, or a connection that allows mutual communication; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the internal communication of two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0021] In the present application, unless otherwise clearly specified and defined, the first feature being "on" or "under" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through additional features therebetween. Moreover, the first feature being "above", "over" and "on top of" the second feature includes that the first feature is directly above and obliquely above the second feature, or merely means that the horizontal height of the first feature is higher than that of the second feature. The first feature being "under", "below" and "beneath" the second feature includes that the first feature is directly below and obliquely below the second feature, or merely means that the horizontal height of the first feature is lower than that of the second feature.

[0022] Reference to "an embodiment" in this context means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present application. The phrase appearing in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art will explicitly and implicitly understand that the embodiments described herein can be combined with other embodiments.

[0023] Common breast reconstruction surgeries on the market currently include implant reconstruction and autologous tissue reconstruction. Most of the implant reconstructions use non-degradable implant prostheses made of materials such as silicone. When non-degradable materials such as silicone are implanted into the human body, they may cause rejection reactions in the body; while autologous tissue transplantation also has problems such as fat resorption due to lack of blood supply and low transplantation efficiency. To solve these problems, there is currently a technical means of degradable breast implants, which not only provides good support through a three-dimensional network structure, but also is beneficial to the repair and regeneration of breast tissue. Since the regeneration of breast tissue develops from the outside to the inside of the implant, however, there is no significant difference in the degradation rate of existing breast implants from the outside to the inside, resulting in uneven growth of breast tissue regeneration and prone to scar problems.

[0024] In view of the above problems, the present application provides a degradable breast implant for solving the problem of uneven growth of breast tissue regeneration caused by the lack of difference in the degradation rate of breast implants. As Figures 1 to 10Specific embodiments of the degradable breast implant provided by the present application.

[0025] Figure 1 Entity structure diagram of the first embodiment of the degradable breast implant provided by the present application; Figure 2 For Figure 1 Schematic cross-sectional structure diagram of the degradable breast implant shown; Figure 3 For Figure 1 Schematic model diagram of the preset shape of the degradable breast implant shown; Figure 4 For Figure 1 Schematic structure diagram of the lattice unit of the degradable breast implant shown; Figure 5 Schematic cross-sectional structure diagram of the second embodiment of the degradable breast implant provided by the present application; Figure 6 For Figure 5 Schematic conceptual structure diagram of the degradable breast implant shown; Figure 7 Schematic conceptual structure diagram of the third embodiment of the degradable breast implant provided by the present application; Figure 8 Schematic conceptual structure diagram of the fourth embodiment of the degradable breast implant provided by the present application; Figure 9 Schematic structure diagram of the equivalent sphere of the lattice unit of the degradable breast implant provided by the present application; Figure 10 Schematic cross-sectional structure diagram of the fifth embodiment of the degradable breast implant provided by the present application.

[0026] As Figures 1 to 4 shown, the present application provides a degradable breast implant 100. As Figure 1 shown, the degradable breast implant 100 is a three-dimensional network structure. The three-dimensional network structure has excellent mechanical support performance, can simulate the elastic characteristics of real breast tissue, and at the same time, the three-dimensional network structure is suitable for the ingrowth of mammary tissue cells. As the implant degrades continuously, breast repair is completed at the implantation site.

[0027] As Figure 2 shown, the degradable breast implant 100 includes a surface part 110. The surface part 110 is located on the outer periphery of the breast implant 100. The surface part 110 is actually a virtual structure, and this virtual structure is defined as the first three-dimensional virtual boundary 11. The shape of the first three-dimensional virtual boundary 11 is the preset shape 210, and the size of the first three-dimensional virtual boundary 11 is the preset size. The shape and size of the outer contour of the degradable breast implant 100 are determined by the shape and size of the first three-dimensional virtual boundary 11. As Figure 3As shown, it is a schematic model diagram of the preset shape 210 corresponding to this embodiment. In actual production, the preset shape 210 can be various shapes without specific limitations, and is determined by the required position of the transplanted breast. In some specific embodiments, the preset shape 210 and the preset size can be obtained from medical image data. The degradable breast implant is used to be implanted into the vacant position after tumor tissue resection in the patient's breast. Then, by extracting the patient's medical image data, the preset shape and preset size of the first three-dimensional virtual boundary 11 are determined to match the vacant position. In some other specific embodiments, the degradable breast implant is used to be implanted into the patient's breast to achieve a cosmetic lifting effect. Then, the preset shape and preset size can be obtained through the combination and calculation of the doctor's treatment plan for the patient.

[0028] As Figure 2 shown, the central position of the surface part 110 is the base point 111, and the specific orientation of the base point 111 is determined according to the preset shape 210 and the preset size through calculation.

[0029] As Figure 2 shown, the degradable breast implant 100 further includes a filling part 120, and the filling part 120 fills inward with the surface part 110 as the boundary. The filling part 120 is a lattice structure formed by a number of lattice units 123. As Figure 4 shown, it is the specific structure of the lattice unit 123 in this example. The lattice structure includes a plurality of interconnected and penetrating 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 wire diameter d, and the wire diameter d of the same lattice layer 122 is the same. The wire diameter d of different lattice layers 122 gradually decreases from the base point 111 towards the surface part 110. That is, the wire diameter d of different lattice layers 122 shows a decreasing trend in the direction from the base point 111 towards the surface part 110.

[0030] By designing the wire diameter d of the lattice units of different dot matrix layers 122 to gradually decrease in the direction from the base point 111 towards the surface part 110, the outermost layer of the degradable breast implant 100 is the thinnest, and the wire diameter d of the degradable breast implant 100 gradually increases from the outermost layer to the inner layer. The degradation rate at the thinnest part of the fiber is the fastest, that is, the degradable breast implant 100 degrades gradually from the outer layer to the inner layer, synchronizing the repair and regeneration direction of breast tissue cells, thereby achieving uniform regeneration of breast tissue cells at the implantation position. When the breast implant 100 is completely degraded, the breast tissue has also completed the repair. On the other hand, due to the need for better support force at the central position of the degradable breast implant 100 to prevent deformation problems that are likely to occur in the early stage of implantation because no cells grow into the inner layer, and the outer layer needs to have better deformation performance to facilitate the operation of the implantation surgery and improve the postoperative comfort, reducing the foreign body sensation of implantation. Through this structural design, the outer layer fibers are thinner, with a smaller elastic modulus and are prone to deformation; the inner layer fibers are thicker, with a larger elastic modulus and greater stiffness, and are less likely to deform, meeting the requirements of the breast implant for internal support force and external flexibility.

[0031] The wire diameter d connected to the base point 111 is the maximum wire diameter d, that is, the fibers of the innermost dot matrix layer are the thickest. For the convenience of product production, in some embodiments, the wire diameter d smaller than the maximum wire diameter d, that is, the wire diameter d of the remaining dot matrix layers, has a reduction ratio relative to the maximum wire diameter d of 0.1 - 1, and the range of the wire diameter d is between 0.02 mm and 2 mm. The determination of the size range and reduction ratio of the wire diameter d can, on the one hand, ensure the overall structural stability of the degradable implant, and on the other hand, be suitable for the actual production of the product.

[0032] Since the tissue growth rates in different regions of the breast are different, and the breast conditions among different individuals are also different, considering various situations in specific implementations, we have proposed multiple embodiments.

[0033] Such as Figure 5 、 Figure 6 As shown, this is the second specific embodiment of the degradable breast implant proposed in this application. The filling part 120 is a dot matrix structure including a number of dot matrix spaces 121, and the dot matrix spaces 121 are formed by performing a Boolean difference operation on the first three-dimensional virtual boundary 11 scaled proportionally with the base point 111 as the center. The number of dot matrix layers 122 in any dot matrix space 121 is greater than or equal to 1. The wire diameter d within the same dot matrix space 121 is of the same size, and the wire diameter d of different dot matrix spaces 121 gradually decreases in the direction from the base point 111 towards the surface part 110. In this embodiment, as Figure 5As shown, the first three-dimensional virtual boundary 11 is centered on the base point 111 and scaled twice to form the second three-dimensional virtual boundary 12 and the third three-dimensional virtual boundary 13, and then a Boolean difference operation is performed to form three lattice spaces, which are the first lattice space A, the second lattice space B, and the third lattice space C from the inside to the outside. The fibers at the nodes of adjacent lattice spaces are connected and transitioned to each other. As Figure 6 shown, the wire diameter d of the fibers filled in the first lattice space A is 2 mm, the wire diameter d in the second lattice space B is 1.3 mm, and the wire diameter d in the third lattice space C is 0.8 mm, gradually decreasing in the direction from the base point towards the surface part. This embodiment is one of the embodiments where the wire diameter d of different lattice spaces gradually decreases in the direction from the base point towards the surface part, and any embodiment belonging to this technical means is within its protection scope.

[0034] As Figure 7 shown, this is the third specific embodiment of the degradable breast implant proposed in this application. The filling part 120 is a lattice structure including several lattice spaces 121. Similarly, the lattice space 121 is formed by performing a Boolean difference operation after scaling the first three-dimensional virtual boundary 11 centered on the base point 111. The number of lattice layers 122 in any lattice space 121 is greater than or equal to 1. The wire diameter d within the same lattice space 121 is the same. However, the wire diameter d of different lattice spaces 121 gradually decreases in a gradient manner in the direction from the base point 111 towards the surface part 110. In this embodiment, as Figure 7 shown, the first three-dimensional virtual boundary 11 is centered on the base point 111 and scaled three times to form the second three-dimensional virtual boundary, the third three-dimensional virtual boundary, and the fourth three-dimensional virtual boundary, and then a Boolean difference operation is performed to form four lattice spaces, which are the first lattice space A, the second lattice space B, the third lattice space C, and the fourth lattice space D from the inside to the outside. The fibers at the nodes of adjacent lattice spaces are connected and transitioned to each other. As Figure 6 shown, the wire diameter d of the fibers filled in the first lattice space A is 1.5 mm, the wire diameter d of the second lattice space B is 1.1 mm, the wire diameter d in the third lattice space C is 0.7 mm, and the wire diameter d in the fourth lattice space D is 0.3 mm, gradually decreasing in a gradient manner in the direction from the base point towards the surface part. In this embodiment, the next lattice space decreases step by step according to the rule of reducing 0.4 mm compared with the previous lattice space. This embodiment is one of the embodiments where the wire diameter d of different lattice spaces gradually decreases in a gradient manner in the direction from the base point towards the surface part, and any embodiment belonging to this technical means is within its protection scope.

[0035] When the number of lattice layers in the lattice space is 1, the wire diameter d of different lattice layers gradually decreases in the direction from the base point towards the surface part. The division of the lattice layers can be carried out according to specific requirements. It can be divided based on the entire lattice unit or based on a partial structure of the lattice unit. In this embodiment, an example is given where the lattice layers are divided based on the entire lattice unit. As Figure 8 shown, the fourth specific embodiment of the biodegradable breast implant proposed in this application. The filling part 120 is a lattice structure. The first three-dimensional virtual boundary 11 is scaled 5 times with the base point 111 as the center and then a Boolean difference operation is performed to form 5 lattice spaces. From the inside to the outside, 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. There is only one lattice layer in each lattice space. That is, the first lattice layer is in the first lattice space A, the second lattice layer is in the second lattice space B, the third lattice layer is in the third lattice space C, the fourth lattice layer is in the fourth lattice space D, and the fifth lattice layer is in the fifth lattice space E. The nodes between adjacent lattice layers are connected to each other. Figure 8 It is a conceptual schematic diagram showing the wire diameter d of the five lattice layers. The connection relationship diagram of the five lattice layers is not shown in the figure. The wire diameter d of the first lattice layer is 1 mm, the wire diameter d of the second lattice layer is 0.9 mm, the wire diameter d of the third lattice layer is 0.7 mm, the wire diameter d of the fourth lattice layer is 0.4 mm, and the wire diameter d of the fifth lattice layer is 0.2 mm. Each layer gradually decreases. In this embodiment, the way of gradual decrease in each layer does not show a gradient gradual decrease. This embodiment is one of the embodiments where the wire diameter d of the lattice units of different lattice layers gradually decreases in the direction from the base point towards the surface part. The number of lattice layers is not specifically limited, and any embodiment belonging to this technical means is within its protection scope. In other embodiments, the wire diameter d of different lattice layers can also gradually decrease in a gradient manner in the direction from the base point towards the surface part. For example, the first lattice layer is 1 mm, the wire diameter d of the second lattice layer is 0.8 mm, the wire diameter d of the third lattice layer is 0.6 mm, the wire diameter d of the fourth lattice layer is 0.4 mm, and the wire diameter d of the fifth lattice layer is 0.2 mm. Each layer shows a gradient gradual decrease. This embodiment is one of the embodiments where the wire diameter d of the lattice units of different lattice layers gradually decreases in a gradient manner in the direction from the base point towards the surface part, and any embodiment belonging to this technical means is within its protection scope.

[0036] A biodegradable breast implant proposed in this application, the structure of the lattice unit includes a cubic lattice structure, a dodecahedral lattice structure, a tetrahedral lattice structure, an octahedral lattice structure, a hexagonal lattice structure, a cylindrical lattice structure, a spring-type lattice structure. As Figures 1 to 6 、 Figure 9As shown, this is a specific implementation of the degradable breast implant proposed in this application. The structure of all lattice units 123 in this degradable breast implant is an octahedral lattice structure. The degradable breast implant formed by octahedral lattice units can provide a large growth space for cell growth, and its structure is stable, so it has strong support as an implant. As Figure 9 Shown is a schematic diagram of the structure of the equivalent sphere of the lattice unit in this embodiment. The range of the diameter L1 of the equivalent sphere is between 0.2 mm and 10 mm, which not only adapts to the growth of breast tissue but also conforms to the actual manufacturing process.

[0037] To conform to the diversity of breast implant situations, this application provides another specific implementation. The lattice unit structures within the same lattice space are the same, and the lattice unit structures in different lattice spaces are the same and / or different. As Figure 10 Shown is a specific implementation provided by this application. In this embodiment, the filling part 120 of the degradable breast implant is a lattice structure. The first three-dimensional virtual boundary 11 is centered on the base point 111 and scaled twice to form the second three-dimensional virtual boundary 12 and the third three-dimensional virtual boundary 13, and then a Boolean difference operation is performed to form 3 lattice spaces, which are the first lattice space A, the second lattice space B, and the third lattice space C from the inside to the outside. 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 three-dimensional network structure formed thereby has mechanical properties of small internal elasticity and strong support force, and large elasticity on the outer layer. In other embodiments, it can also be that the lattice unit structures in some lattice spaces are the same, and the lattice unit structures in the remaining lattice spaces are different, and corresponding adjustments can be made according to specific implementation scenarios. Any implementation belonging to this technical means is within its protection scope.

[0038] In order to achieve the biocompatibility of the degradable breast implant in the human body, in some specific implementations, the degradable breast implant is made of a biodegradable polymer material. The biodegradable polymer materials include polyhydroxyalkanoates (PHA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (PBS) and their copolymers, as well as polyvinyl alcohol (PVA), polylactic acid (PLA), and poly(lactic acid - glycolic acid) copolymer (PLGA). Other materials that can be degraded in the human body and have good performance also belong to the protection scope of this application.

[0039] For the production and manufacturing of degradable breast implants to quickly adapt to market demands, the degradable breast implants can be made by 3D printing technology or mold perfusion. However, the manufacturing method is not limited thereto, and all other methods that can achieve rapid production are within the scope of protection of this application.

[0040] This application provides a degradable breast implant. The breast implant has a three-dimensional network structure, including a surface part and a filling part. The surface part is a first three-dimensional virtual boundary and is located on the outer periphery of the breast implant. The outer 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 part is a base point; the filling part is filled inside the surface part. The filling part is a lattice structure formed by a number of lattice units. The fiber thickness of the lattice unit is a wire diameter. The lattice structure includes a plurality of interconnected and penetrating 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, and the wire diameter of different lattice layers gradually decreases from the base point towards the surface part. By designing the wire diameters of different lattice layers to gradually decrease from the base point towards the surface part, the outermost layer of fibers is the thinnest part of the entire implant. After being implanted into the human body, it degrades sequentially from the outermost layer of the implant towards its interior, successfully solving the problem of uneven growth of mammary tissue regeneration caused by the lack of difference in the degradation rate of breast implants. On the other hand, the thinner outer fibers can reduce the foreign body sensation during implantation and facilitate the operation of the implantation surgery. The thicker inner fiber structure has better supporting force and can prevent structural deformation caused by the initial tissue not growing in, meeting the requirements of the breast implant for internal supporting force and external elasticity.

[0041] The above is only the implementation mode of this application and does not limit the patent scope of this application. Any equivalent structural or equivalent process transformation made using the content of the specification and drawings of this application, or directly or indirectly applied in other related technical fields, shall be included in the patent protection scope of this application by the same token.

Claims

1. A degradable breast implant, characterized in that The degradable breast implant is a three-dimensional mesh structure, comprising: a surface portion, the surface portion being a first three-dimensional virtual boundary and being located at the periphery of the breast implant, the first three-dimensional virtual boundary having an outer shape being a preset shape, the first three-dimensional virtual boundary having a preset size, and the center position of the surface portion being a base point; A filling portion, wherein the filling portion is filled inside the surface portion, the filling portion is a lattice structure formed by a plurality of lattice units, the fiber thickness of the lattice unit is the wire diameter, the lattice structure comprises a plurality of interconnected and interpenetrating 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 diameters of the same lattice layer are the same, and the wire diameters of different lattice layers gradually decrease from the base point toward the surface portion.

2. The degradable breast implant according to claim 1, characterized in that The wire diameter connected to the base point is the maximum wire diameter, and the wire diameter smaller than the maximum wire diameter has a reduction ratio of 0.1 to 1 relative to the maximum wire diameter.

3. The degradable breast implant according to claim 2, characterized in that The wire diameter ranges from 0.02 mm to 2 mm.

4. The degradable breast implant according to claim 3, characterized in that The lattice structure includes a plurality of lattice spaces, wherein the lattice space is formed by scaling the first three-dimensional virtual boundary with the base point as the center 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, and the line diameters in different lattice spaces decrease step by step from the base point toward the surface portion.

5. The degradable breast implant according to claim 4, characterized in that When the number of the dot matrix layer in each of the dot matrix spaces is 1, the line diameters of different dot matrix layers decrease step by step from the base point toward the surface portion.

6. The degradable breast implant according to claim 4, characterized in that The line diameters of different lattice spaces decrease gradually from the base point toward the surface portion.

7. The degradable breast implant according to claim 6, characterized in that When the number of the dot matrix layer in each of the dot matrix spaces is 1, the line diameters of different dot matrix layers decrease gradually from the base point toward the surface portion.

8. The degradable breast implant according to any one of claims 1 to 7, characterized in that The structure of the lattice unit includes a cubic lattice structure, a dodecahedral lattice structure, a tetrahedral lattice structure, an octahedral lattice structure, a hexagonal lattice structure, a cylindrical lattice structure, and a spring-type lattice structure.

9. The degradable breast implant according to claim 8, characterized in that The lattice unit in the lattice structure is a single structure.

10. The degradable breast implant according to claim 9, characterized in that The equivalent spherical diameter of the lattice unit ranges from 0.2 mm to 10 mm.

11. The degradable breast implant according to any one of claims 4 to 7, characterized in that: The lattice units in the same lattice space have the same structure, and the lattice units in different lattice spaces have the same and / or different structures.

12. The degradable breast implant according to any one of claims 1 to 7, characterized in that The preset shape and the preset size are obtained by obtaining through medical imaging data or by calculation.

13. The degradable breast implant according to any one of claims 1 to 7, characterized in that: The material of the degradable breast implant is a biodegradable polymer material, including polyhydroxyalkanoate (PHA), polycaprolactone (PCL), polyglycolide (PGA), polybutylene succinate (PBS) and copolymers thereof, as well as polyvinyl alcohol (PVA), polylactic acid (PLA) and polylactic-glycolic acid copolymer (PLGA).

14. The degradable breast implant according to any one of claims 1 to 7, characterized in that The manufacturing method of the degradable breast implant includes 3D printing technology and mold infusion technology.

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