Prosthesis

Abstract

The utility model relates to the technical field of subcutaneous implants in medical cosmetic plastic surgery, in particular to a prosthesis. The utility model discloses a prosthesis, the prosthesis comprises at least one prosthesis main body, the prosthesis main body is made of at least one layer of sheet-shaped bulky material distributed with micropore structures for tissue cell growth, the prosthesis main body is provided with a first component and a second component which are integrally processed, and the first component and the second component are arranged on the first component and the second component. The first component and the second component are respectively provided with an outer end side of a square head structure, and an included angle between the central axis of the square head structure of the first component and the central axis of the square head structure of the second component is an obtuse angle. The prosthesis is high in shape universality, a doctor can conveniently design deviation of the supporting legs through the square head design, meanwhile, the abundant micropore structures can induce tissue cells to grow in, and fusion of the tissue cells and the prosthesis body is achieved.

Description

Technical Field

[0001] This application relates to the technical field of subcutaneous implants in medical aesthetic plastic surgery, and particularly relates to a prosthesis. Background Art

[0002] Medical Cosmetology refers to the repair and reshaping of a person's appearance and the morphology of various parts of the human body by using surgical methods, drugs, medical devices, and other medical technical methods with traumatic or invasive properties. With the progress of technology, new treatment methods and surgical techniques have emerged continuously, improving the safety and effectiveness of medical cosmetology. For example, the application of laser technology, minimally invasive surgery, and 3D printing technology has made medical cosmetology services more personalized and precise, further promoting the popularization of medical cosmetology.

[0003] The supraorbital ridge, also known as the "brow bone" or "supraorbital margin", is located below the frontal region. It is an arcuate elevation parallel to the supraorbital margin of the frontal tubercle and is the arcuate elevated bone above the supraorbital margin. The adjustment of the supraorbital ridge has a "weightlifting with a feather" effect on the three-dimensional sense of the eyebrows and eyes. The supraorbital ridge belongs to the bony structure and has a direct impact on the contour and three-dimensional sense. At the same time, it is located at the junction of the upper and middle facial thirds and affects the aesthetic forms of the eyebrows, upper eyelids, and nasal root. For example, the supraorbital ridge directly determines the height, trend, shape, and three-dimensionality of the eyebrows. The supraorbital ridge elevation surgery is a type of medical aesthetic plastic surgery. It buries a filler with a certain thickness in the supraorbital ridge tissue to make the supraorbital ridge change from low to high, thereby strengthening the relative drop between the eye socket and the eyebrows, deepening the eye socket, shaping a deep look in the eyes, making the eyebrows more coordinated with other facial features, and enhancing the three-dimensional sense and beauty of the face.

[0004] In the supraorbital ridge elevation surgery, when the supraorbital ridge changes from low to high, a filler with a certain thickness needs to be buried in the supraorbital ridge tissue. The doctor carves the prepared prosthesis main body to obtain a prosthesis for filling the supraorbital ridge that fits the customer. The most commonly used material for this prosthesis is silicone. However, the silicone material itself is a solid, and the immune mechanism of the human body's own tissues easily leads to the formation of a fibrous capsule. At the same time, the defects of the human orbital bones vary, and the supraorbital ridge branches may deviate to the left or right. When the prosthesis main body does not consider various possibilities, the carving space is insufficient to meet the current surgical needs. Summary of the Utility Model

[0005] In view of the above technical problems, this application provides a prosthesis, which includes at least one prosthesis main body made of at least one layer of sheet-shaped expanded polytetrafluoroethylene material distributed with microporous structures for tissue cell growth. Among them,

[0006] The prosthesis main body has a first component and a second component formed by integral processing. Both the first component and the second component have an outer end side with a square head structure. Among them,

[0007] The included angle between the central axis of the square head structure of the first component and the central axis of the square head structure of the second component is an obtuse angle.

[0008] Preferably, the prosthesis includes two prosthesis bodies that are mirror-symmetrical.

[0009] Each prosthesis body has a bottom surface and a top surface, and there is a smooth transition between the bottom surface and the top surface; within the contour line of the orthographic projection of the top surface on the bottom surface, the bottom surface gradually narrows towards the center until the top surface.

[0010] Preferably, the bottom surface is a curved surface that is concave towards the top surface, and the shape of the curved surface matches the shape of the bone at the human eyebrow arch.

[0011] Preferably, the orthographic projection of the bottom surface includes a first side, a second side, and a third side, as well as a first top side, a second top side, and a third top side; the first side, the first top side, the second side, the second top side, the third side, and the third top side are smoothly connected end to end in sequence to form a closed loop.

[0012] The third side is an arc that is concave towards the center point of the bottom surface.

[0013] Preferably, the length of the first component is equal to the horizontal distance between the endpoints of the first side, which is 25 mm to 80 mm, the length of the second component is equal to the horizontal distance between the endpoints of the second side, which is 20 mm to 60 mm, and the radius of curvature of the third side is 20 mm to 200 mm.

[0014] Preferably, the prosthesis body further has a third component integrally formed with the first component and the second component. The third component has an outer end side with a square head structure, and the third component and the second component are axisymmetric about the central axis of the square head structure of the first component.

[0015] Preferably, the orthographic projection of the bottom surface includes a first side, a second side, and a third side, as well as a first top side, a second top side, and a third top side; the first side, the first top side, the second side, the second top side, the third side, and the third top side are smoothly connected end to end in sequence to form a closed loop.

[0016] The first side, the second side, and the third side are arcs that are concave towards the center point of the bottom surface.

[0017] Preferably, the central axes of the square head structures of the first component, the second component, and the third component start from the intersection point of the central axes of the square head structures of the first component, the second component, and the third component, and are evenly distributed at an equal angular interval of 120°.

[0018] Preferably, the ratio of the length of the first member to the lengths of the second and third members is from 1.4:1 to 1.5:1.

[0019] Preferably, the vertical distance between the top surface and the point on the bottom surface closest to the top surface is from 1 mm to 6.5 mm.

[0020] Compared with the prior art, the beneficial effects of a prosthesis provided by the present application are as follows:

[0021] (1) The prosthesis provided by the present application has high shape versatility and can be adapted to facial filling surgeries in the vast majority of cases.

[0022] (2) The orbital bones of different people have different defects, and there is a possibility that the outermost ends of the brow arches (i.e., the first and second members) are left - deviated or right - deviated. The square - head design of the prosthesis shape provided by the present application can avoid the situation of insufficient carving space for the prosthesis main body, facilitating the doctor to design the deviation of the outermost ends.

[0023] (3) The prosthesis main body pressed from at least one layer of sheet - shaped expanded polytetrafluoroethylene material is distributed with a rich microporous structure, which can induce the growth of tissue cells into it, realize the fusion of tissue cells and the prosthesis main body, play a role in fixing the prosthesis, thereby preventing the prosthesis from sagging, and can effectively avoid the phenomenon of forming a fibrous capsule in the existing silicone prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present application will be further described below with reference to the drawings.

[0025] Figure 1 are multi - perspective views of a standard pre - formed prosthesis main body in an exemplary embodiment of the present application;

[0026] Figure 2 are multi - perspective views of a standard pre - formed prosthesis main body in another exemplary embodiment of the present application;

[0027] Figure 3 are multi - perspective views of the minimum - range setting of a prosthesis main body in another exemplary embodiment of the present application;

[0028] Figure 4 is a cross - sectional view of line A - A in a prosthesis main body with an adhesive layer in an exemplary embodiment of the present application;

[0029] Figure 5 is a cross - sectional view of line A - A in a prosthesis main body without an adhesive layer in an exemplary embodiment of the present application;

[0030] Figure 6 is a microscopic schematic view of a partial microporous structure of a prosthesis main body in an exemplary embodiment of the present application.

[0031] The description of the reference numerals is as follows:

[0032] In the figure: 1, prosthesis main body; 11, first component; 12, second component; 13, third component; 2, bottom surface; 21, first side edge; 22, second side edge; 23, third side edge; 24, first top edge; 25, second top edge; 26, third top edge; 3, top surface; 4, sheet-shaped expanded polytetrafluoroethylene material; 5, adhesive layer; 6, microporous structure. Specific embodiments

[0033] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0034] In the description of the present application, it should be understood that the orientation or positional relationships indicated by the terms "front", "rear", "left", "right", "upper", "lower", etc. are based on the orientation or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present 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 construed as a limitation to the present application.

[0035] In addition, the "first", "second", "outer end", "inner end" and similar terms used in the present application do not represent any order, quantity or importance, but are only used to distinguish different parts. "Vertical" is not strictly vertical, but within the allowable error range. "Parallel" is not strictly parallel, but within the allowable error range. The terms "comprising" or "including" and similar words mean that the elements before this word are covered by the elements listed after this word, and do not exclude the possibility of also covering other elements.

[0036] It should also be noted that in the description of the present application, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium. 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 situations. When it is described that a specific device is located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device.

[0037] All terms used in this application have the same meanings as those understood by those of ordinary skill in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in a general dictionary, for example, should be interpreted as having meanings consistent with their meanings in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense, unless specifically defined as such herein.

[0038] Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and devices should be regarded as part of the specification.

[0039] As Figures 1 - 6 shown, in one embodiment of the present application, a prosthesis is provided. The prosthesis includes at least one prosthesis body 1, and the prosthesis body 1 is made of at least one layer of sheet-shaped expanded polytetrafluoroethylene (ePTFE) material 4 distributed with microporous structures 6 for tissue cell growth. Among them, a first member 11 and a second member 12 are integrally formed, and both the first member 11 and the second member 12 have outer end sides with a square head structure. Among them,

[0040] the included angle between the central axis of the square head structure of the first member 11 and the central axis of the square head structure of the second member 12 is an obtuse angle.

[0041] It should be noted that the prosthesis body 1 is set to be made of at least one layer of sheet-shaped expanded polytetrafluoroethylene (ePTFE) material 4, and the sheet-shaped expanded polytetrafluoroethylene (ePTFE) material 4 is distributed with microporous structures 6 for tissue cell growth. The above structure can induce tissue cells to grow in, realize the fusion of tissue cells and the prosthesis body 1, play a role in fixing the prosthesis, thereby preventing the prosthesis from sagging, and no fibrous capsule will be formed.

[0042] As Figure 1 、 Figure 2 、 Figure 3 shown, the prosthesis provided in the present application has high shape versatility. In the prosthesis provided in the present application, its square head design can adapt to the problem of different orbital bone defects of different people. There is a possibility that the feet of the prosthesis (i.e., the outer ends of the first member 11 and the second member 12) are left-biased or right-biased. The prosthesis shape provided in the present application with a square head design can avoid the situation of insufficient carving space for the prosthesis body, facilitating the doctor to design the bias of the feet.

[0043] In one embodiment, the prosthesis includes two prosthesis bodies 1 that are mirror-symmetrical; each prosthesis body 1 has a bottom surface 2 and a top surface 3, and there is a smooth transition between the bottom surface 2 and the top surface 3; within the contour line of the orthographic projection of the top surface 3 on the bottom surface 2, the bottom surface 2 gradually narrows towards the center until the top surface 3. By adding the distinction between the top surface 3 and the bottom surface 2 to the prosthesis body, that is, the cross-sectional area of the top surface 3 is smaller than that of the bottom surface 2, it can help the doctor distinguish between the left and right prostheses. At the same time, because in the operation of filling the supraorbital ridge, the bottom surface 2 is located more medially relative to the top surface 3 in the human body, the bottom surface 2 needs to fit the bone at the supraorbital ridge of the human body, and the top surface 3 requires a smaller cross-sectional area. Therefore, limiting the top surface 3 within the contour line of the orthographic projection on the bottom surface 2 can reduce the workload of the doctor carving and cutting the prosthesis body 1, and can facilitate the doctor to improve the surgical efficiency. At the same time, the smooth transition between the top surface 3 and the bottom surface 2 can make the prosthesis more natural and beautiful after implantation.

[0044] In a specific embodiment, the bottom surface 2 is a curved surface concave towards the top surface, and the shape of the curved surface matches the shape of the bone at the supraorbital ridge of the human body. The outer contour of the curved surface includes three side edges, and the side edges are connected to each other by top edges. In another specific embodiment, the bottom surface 2 can be a flat surface, and the flat surface can be deformed into a curved surface matching the shape of the bone at the supraorbital ridge of the human body under the condition that an external force is applied to the prosthesis body 1. The outer contour of the curved surface includes three side edges, and the side edges are connected to each other by top edges.

[0045] In this application, the shape of the cooperation between the top edge and the side edge improves the fit between the prosthesis body 1 and the anatomical structure of the supraorbital ridge. The three top edges can limit the supraorbital ridge prosthesis from three directions, reducing the risk of displacement. The longer side edges are convenient for implantation and can achieve a natural appearance after implantation.

[0046] In one embodiment, as Figure 1 shown, the orthographic projection of the bottom surface 2 includes a first side edge 21, a second side edge 22, a third side edge 23, a first top edge 24, a second top edge 25, and a third top edge 26; the first side edge 21, the first top edge 24, the second side edge 22, the second top edge 25, the third side edge 23, and the third top edge 26 are smoothly connected end to end in sequence to form a closed loop; the third side edge 23 is an arc concave towards the center point of the bottom surface 2; the orthographic projection of the bottom surface 2 of the first component 11 includes the first side edge 21, the third top edge 26, and a part of the third side edge 23; the orthographic projection of the bottom surface 2 of the second component 12 includes the second side edge 22, the second top edge 25, and another part of the third side edge 23.

[0047] In one embodiment, the length a of the first member 11 is equal to the horizontal distance between the endpoints of the first side 21, which is 25 mm to 80 mm. The length b of the second member 12 is equal to the horizontal distance between the endpoints of the second side 22, which is 20 mm to 60 mm. The radius of curvature of the third side 23 is 20 mm to 200 mm. The first member 11 is used to fill the supraorbital ridge, and the second member 12 is used to support the supraorbital ridge prosthesis. The longer length of the first member 11 than the second member 12 can be used to help the doctor make a distinction.

[0048] In another embodiment, the length a of the first member 11 is equal to the horizontal distance between the endpoints of the first side 21, which is 20 mm to 60 mm. The length b of the second member 12 is equal to the horizontal distance between the endpoints of the second side 22, which is 25 mm to 80 mm. The radius of curvature of the third side 23 is 20 mm to 200 mm. The first member 11 is used to support the supraorbital ridge prosthesis, and the second member 12 is used to fill the supraorbital ridge. The shorter length of the first member 11 than the second member 12 can be used to help the doctor make a distinction.

[0049] In one embodiment, as Figure 2 、 3 shown, the prosthesis body 1 further has a third member 13 integrally formed with the first member 11 and the second member 12. The third member 13 has an outer end side with a square head structure. The third member 13 and the second member 12 are axisymmetric about the central axis of the square head structure of the first member 11. In the surgery of filling the supraorbital ridge, the temporal bone can be further filled to improve the postoperative visual effect and increase the three-dimensional degree of the facial features. The third member 13 can be used to fill the temporal bone. Among them, since the second member 12 and the third member 13 are axisymmetric about the central axis of the square head structure of the first member 11, their lengths and angles are exactly the same. When the prosthesis body 1 has an incompletely coincident bottom surface 2 and top surface 3, the prosthesis can still achieve a universal preformed design of the same model without distinguishing between left and right, so that the hospital does not need to distinguish between left and right when purchasing. As Figure 2 、 3 shown, the central axis of the square head structure of the first member 11 is the e-axis, the central axis of the square head structure of the second member 12 is the g-axis, and the central axis of the square head structure of the third member 13 is the f-axis. In a specific embodiment, the first member 11 is used to fill the supraorbital ridge, the second member 12 is used to support the supraorbital ridge, the third member 13 is used to fill the temporal bone, and the prosthesis body 1 is used for the left facial filling surgery. In another specific embodiment, the first member 11 is used to fill the supraorbital ridge, the second member 12 is used to fill the temporal bone, the third member 13 is used to support the supraorbital ridge, and the prosthesis body 1 is used for the right facial filling surgery.

[0050] In a specific embodiment, the orthographic projection of the bottom surface 2 includes a first side edge 21, a second side edge 22, and a third side edge 23, as well as a first top edge 24, a second top edge 25, and a third top edge 26; the first side edge 21, the first top edge 24, the second side edge 22, the second top edge 25, the third side edge 23, and the third top edge 26 are smoothly connected end to end in sequence to form a closed loop; the first side edge 21, the second side edge 22, and the third side edge 23 are arcs concave towards the center point of the bottom surface; the orthographic projection of the bottom surface 2 of the first member 11 includes a part of the first side edge 21, the third top edge 26, and a part of the third side edge 23; the orthographic projection of the bottom surface 2 of the second member 12 includes a part of the second side edge 22, the second top edge 25, and a part of the third side edge 23; the orthographic projection of the bottom surface 2 of the third member 13 includes a part of the third side edge 23, the first top edge 24, and a part of the second side edge 22.

[0051] In an embodiment, the central axis e-axis of the square head structure of the first member 11, the central axis g-axis of the square head structure of the second member 12, and the central axis f-axis of the square head structure of the third member 13 start from the intersection point of the central axis e-axis of the square head structure of the first member 11, the central axis g-axis of the square head structure of the second member 12, and the central axis f-axis of the square head structure of the third member 13, and are evenly distributed at an equal angular interval of 120°. As Figure 3 shown, Figure 3 is a multi-view drawing of the minimum range setting of the prosthesis main body in another exemplary embodiment of the present application; the first member 11, the second member 12, and the third member 13 are evenly distributed, and can provide the minimum form that conforms to the contour superposition of the prosthesis shape after being carved by multiple clinical surgeries.

[0052] In an embodiment, as Figure 2 shown, the ratio of the length of the first member 11 to the lengths of the second member 12 and the third member 13 is 1.4:1 to 1.5:1. By setting the length of the first member 11 to be greater than the lengths of the second member 12 and the third member 13, it can be used as an anti-mistake design to prevent doctors from being confused during surgical carving and facilitate the identification of the first member 11 and other members. In a specific embodiment, the ratio of the length of the first member 11 to the lengths of the second member 12 and the third member 13 is 1.48.

[0053] In an embodiment, the vertical distance h between the top surface 3 and the point on the bottom surface 2 closest to the top surface 3 is 1 mm to 6.5 mm. Specifically, the vertical distance h can be 6.5 mm, or 6 mm, or 5.5 mm, or 5 mm, or 4.5 mm, or 3 mm, or 2.5 mm, or 2 mm.

[0054] It should be noted that the longitudinal distance between the highest points of the top surface 3 and the bottom surface 2 can be adjusted according to the needs of people in different age groups for the supraorbital ridge prosthesis.

[0055] In one embodiment, the prosthesis main body 1 can be obtained in the following manner: mixing polytetrafluoroethylene dispersion resin and solvent oil in a preset ratio and preforming to obtain a solid mixture; extruding the solid mixture to obtain a polytetrafluoroethylene sheet; drying the polytetrafluoroethylene sheet to remove the solvent oil, stretching it at a temperature of 180°C to 300°C and sintering it at a temperature of 300°C to 370°C to obtain a sheet-shaped expanded material 4, stacking multiple layers of the sheet-shaped expanded material 4 and performing high-temperature pressing to obtain an original prosthesis; or, stacking multiple layers of the polytetrafluoroethylene sheets, drying to remove the solvent oil, stretching at a temperature of 180°C to 300°C and sintering at a temperature of 300°C to 370°C to obtain a sheet-shaped expanded material 4, pressing the sheet-shaped expanded material 4 to obtain an original prosthesis, pressing at least one layer of the sheet-shaped expanded material 4 to obtain an original prosthesis, and the sheet-shaped expanded material 4 is uniformly distributed with microporous structures 6 for tissue cell growth; carving the original prosthesis to obtain the prosthesis main body 1.

[0056] In one embodiment, the weight-average molecular weight value range of the polytetrafluoroethylene dispersion resin used in this application is 3,500,000 to 8,500,000. The weight-average molecular weight (Mw) is a way to describe the molar mass of a polymer, and the weight-average molecular weight value has a significant impact on the properties of polytetrafluoroethylene (PTFE) dispersion resin. The weight-average molecular weight of polytetrafluoroethylene dispersion resin is usually between 400,000 and 9,000,000, and sometimes can be as high as 10,000,000. This value range determines various physical and chemical properties of PTFE. This application selects a polytetrafluoroethylene dispersion resin with a relatively high molecular weight. A higher weight-average molecular weight means a longer molecular chain, which can improve its wear resistance and tensile strength. When the weight-average molecular weight value range is 3,500,000 to 8,500,000, the polytetrafluoroethylene dispersion resin has better mechanical strength, wear resistance and chemical corrosion resistance.

[0057] In one embodiment, the oil solvent is a chemical additive that can increase the solubility of oil substances. By reducing the interfacial tension between oil and other substances, it increases the dissolution range and ability of oil. De-aromaticized solvent oil refers to solvent oil from which aromatic hydrocarbon components are removed through a distillation process. Such oil has low toxicity and good chemical stability. In this application, de-aromaticized solvent oil can be preferably used as the solvent oil, and n-hexane, n-heptane, cyclohexane, etc. can also be selected as the solvent oil. These solvent oils have low chemical reactivity and can serve as a mixing medium for polytetrafluoroethylene dispersion resin, facilitating the processing and shaping of polytetrafluoroethylene dispersion resin while maintaining the chemical and physical properties of polytetrafluoroethylene dispersion resin. In a specific embodiment, the polytetrafluoroethylene dispersion resin and the solvent oil can be mixed in a weight ratio of (4:1 to 20:1), and after thorough mixing, the sieving method can be adopted to remove larger particles.

[0058] In one embodiment, the mixture of the polytetrafluoroethylene dispersion resin and the solvent oil is preformed to obtain a solid-state mixture, preparing for the next processing step. The solid-state mixture is one of a cuboid, cube, cone, cylinder, or can also be other irregular geometric shapes. In a specific embodiment, the polytetrafluoroethylene dispersion resin and the solvent oil can be preformed into a cylinder for subsequent processing.

[0059] In one embodiment, after being made into a solid-state mixture, the above solid-state mixture can be extruded at a temperature of 25°C to 38°C to form a film or sheet, obtaining a polytetrafluoroethylene sheet with a thickness of 0.8 mm to 2 mm.

[0060] In one embodiment, in step 204, the solvent oil in the polytetrafluoroethylene sheet is removed by drying, stretched at a temperature of 180°C to 300°C, and sintered at 300°C to 370°C to obtain a sheet-shaped expanded material 4. After stacking multiple layers of the sheet-shaped expanded material 4, high-temperature pressing is performed to obtain the original prosthesis.

[0061] The sheet-shaped expanded material 4 is sheet-shaped expanded polytetrafluoroethylene. Expanded polytetrafluoroethylene (ePTFE) has a network structure formed by the connection of fine fibers, and these fine fibers can form countless fine pores; in addition, expanded polytetrafluoroethylene has good biocompatibility, is not easily deformed or deteriorated, does not produce an inflammatory absorption reaction, and allows cell migration and tissue ingrowth.

[0062] In another embodiment, multiple layers of polytetrafluoroethylene sheets can be stacked first, and then the solvent oil can be removed by drying. Tensile is carried out at a temperature of 180 °C to 300 °C and sintered at 300 °C to 370 °C, and hot pressing is carried out at a high temperature according to the required thickness of the sheet-shaped expanded material 4 to obtain the sheet-shaped expanded material 4. In another specific embodiment, drying and tensile can be carried out synchronously. By means of a traction roller, deoiling and tensile are carried out synchronously, and the tensile sheet-shaped expanded material 4 is obtained.

[0063] In one embodiment, in step 204, as Figure 4 shown, Figure 4 is a cross-sectional view of the A-A line in the prosthesis main body shown in the present application Figure 3 with the binder 5. A binder layer 5 is contained between the multiple layers of polytetrafluoroethylene sheets or the sheet-shaped expanded material 4, and the binder layer 5 is a perfluoroethylenepropylene binder layer. Perfluoroethylenepropylene (abbreviation: FEP) is a high melting point fluoropolymer similar to polytetrafluoroethylene, which can play a binding effect and make the finished product of the prosthesis main body 1 more stable.

[0064] In another embodiment, Figure 5 is a cross-sectional view of the A-A line in the prosthesis main body shown in the present application Figure 3 without the binder layer 5. The multiple layers of polytetrafluoroethylene sheets or the sheet-shaped expanded material 4 do not contain a binder layer 5, and are directly hot pressed after being stacked to obtain the original prosthesis with the required thickness.

[0065] In one embodiment, in step 205, the original prosthesis is carved to obtain the prosthesis main body 1. The three-dimensional shaped expanded polytetrafluoroethylene prosthesis main body is obtained by carving the above-obtained original prosthesis. The prosthesis main body can be carved in advance according to the physiological structure and shape of the customer's eyebrow arch, so that the curved surface shape of the bottom surface 2 matches the shape of the bone at the human eyebrow arch, or the bottom surface 2 can be set as a plane, and the plane can be deformed into a curved surface that matches the shape of the bone at the human eyebrow arch under the condition that the prosthesis main body 1 is carved or other external forces are applied.

[0066] In one embodiment, the microporous structure 6 is as Figure 6 shown, and its pore diameter is 10 microns to 40 microns; preferably, it is 10 microns to 35 microns; more preferably, it is 10 microns to 30 microns; more preferably, it is 10 microns to 25 microns; more preferably, it is 10 microns to 20 microns; more preferably, it is 10 microns to 19 microns; more preferably, it is 10 microns to 18 microns; more preferably, it is 10 microns to 17 microns; more preferably, it is 10 microns to 16 microns; more preferably, it is 10 microns to 15 microns; more preferably, it is 10 microns to 14 microns.

[0067] It should be noted that by adaptively setting the pore size of the microporous structure 6 to match the size of tissue cells, it is possible to better induce tissue cells into the interior of the microporous structure 6, and thus better achieve the fusion of tissue cells and the prosthesis main body.

[0068] In one embodiment, the porosity of the prosthesis main body 1 is 40% to 80%; preferably, it is 40% to 75%; preferably, it is 60% to 75%; preferably, it is 65% to 75%; preferably, it is 65% to 70%. The prosthesis main body 1 with a pore structure is usually lighter than solid materials, reducing the burden on surrounding tissues. Tissue ingrowth into the pores can also increase the fixation of the prosthesis and reduce prosthesis displacement or rotation caused by daily activities.

[0069] The prosthesis of the present application is made of non-degradable material, implanted once and used for life; the material has excellent biocompatibility, and the prosthesis has a physiological structure simulating the human supraorbital margin, with better conformability. In addition, the prosthesis main body 1 has been pre-formed before the operation, and only partial adjustment and detailed carving are required, reducing the time for doctors to carve the prosthesis during the operation and reducing the risk of prosthesis contamination, thereby reducing the risk of postoperative infection.

[0070] So far, the embodiments of the present application have been described in detail. To avoid obscuring the concept of the present application, some details well known in the art have not been described. Those skilled in the art can fully understand how to implement the technical solutions disclosed herein based on the above description.

[0071] Although some specific embodiments of the present application have been described in detail by way of examples, those skilled in the art should understand that the above examples are only for illustration and not for limiting the scope of the present application. Those skilled in the art should understand that the above embodiments can be modified or partial technical features can be equivalently replaced without departing from the scope and spirit of the present application. In particular, as long as there is no structural conflict, the various technical features mentioned in each embodiment can be combined in any way. However, various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined in the present application can be implemented in other embodiments without departing from the spirit or scope of the present application.

Claims

1. A prosthesis, characterized in that: The prosthesis comprises at least one prosthesis body (1), wherein the prosthesis body (1) is made of at least one layer of sheet-like expanded material (4) having a microporous structure (6) for tissue cell growth, wherein: The prosthesis body (1) comprises a first component (11) and a second component (12) which are integrally formed, wherein the first component (11) and the second component (12) both have outer end sides in a square head structure, wherein: The angle between the central axis of the square head structure of the first component (11) and the central axis of the square head structure of the second component (12) is an obtuse angle.

2. The prosthesis according to claim 1, characterized in that The prosthesis comprises two prosthesis bodies (1) that are mirror-symmetrical; Each of the prosthesis bodies (1) has a bottom surface (2) and a top surface (3), and the bottom surface (2) and the top surface (3) have a smooth transition; the top surface (3) is within the contour line of the positive projection on the bottom surface (2), and the bottom surface (2) gradually narrows toward the center until it reaches the top surface (3).

3. The prosthesis according to claim 2, characterized in that The bottom surface (2) is a curved surface that is concave toward the top surface (3), and the shape of the curved surface matches the shape of the bone at the brow arch of the human body.

4. The prosthesis according to claim 3, characterized in that The orthographic projection of the bottom surface (2) comprises a first side edge (21), a second side edge (22), a third side edge (23), a first top edge (24), a second top edge (25), and a third top edge (26); the first side edge (21), the first top edge (24), the second side edge (22), the second top edge (25), the third side edge (23), and the third top edge (26) are connected in sequence end to end smoothly to form a closed loop; The third side edge (23) is a circular arc that is concave toward the center point of the bottom surface (2).

5. The prosthesis according to claim 4, characterized in that The length of the first member (11) is equal to the horizontal distance between the end points of the first side (21), which is 25 mm to 80 mm, the length of the second member (12) is equal to the horizontal distance between the end points of the second side (22), which is 20 mm to 60 mm, and the radius of curvature of the third side (23) is 20 mm to 200 mm.

6. The prosthesis according to claim 3, characterized in that The prosthesis body (1) also has a third component (13) formed integrally with the first component (11) and the second component (12); the third component (13) has an outer end side in a square head structure; the third component (13) and the second component (12) are axially symmetrical with respect to the central axis of the square head structure of the first component (11).

7. The prosthesis according to claim 6, characterized in that The orthographic projection of the bottom surface (2) comprises a first side edge (21), a second side edge (22), a third side edge (23), a first top edge (24), a second top edge (25), and a third top edge (26); the first side edge (21), the first top edge (24), the second side edge (22), the second top edge (25), the third side edge (23), and the third top edge (26) are connected in sequence end to end smoothly to form a closed loop; The first side edge (21), the second side edge (22) and the third side edge (23) are arcs that are concave toward the center point of the bottom surface (2).

8. The prosthesis according to claim 7, characterized in that The central axis of the square head structure of the first component (11), the central axis of the square head structure of the second component (12), and the central axis of the square head structure of the third component (13) are evenly distributed at equal angular intervals of 120° starting from the intersection of the central axis of the square head structure of the first component (11), the central axis of the square head structure of the second component (12), and the central axis of the square head structure of the third component (13).

9. The prosthesis according to claim 8, characterized in that The ratio of the length of the first component (11) to the length of the second component (12) and the third component (13) is 1.4:1 to 1.5:

1.

10. The prosthesis according to claim 2 or 6, characterized in that: The vertical distance between the top surface (3) and the point on the bottom surface (2) closest to the top surface (3) is 1 mm to 6.5 mm.

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