阅读说明：本技术 眶下区可植入复合假体及制作方法 (Infraorbital implantable composite prosthesis and manufacturing method thereof ) 是由 王忠堂 于 2019-05-14 设计创作，主要内容包括：眶下区可植入复合假体包括软组织加固部件和软组织填充部件,软组织加固部件和软组织填充部件联结为一体,或相互独立,其中,软组织加固部件由不降解立体网状支架结合可降解材料制作的贴面组成,用于加强眶隔,实现回纳眶隔脂肪并预防其再次膨出,改善上睑凹陷,软组织填充部件由多层不降解材料制作,可裁剪、折叠,用于矫正眶下区凹陷畸形。(The infraorbital implantable composite prosthesis comprises a soft tissue reinforcing part and a soft tissue filling part, wherein the soft tissue reinforcing part and the soft tissue filling part are connected into a whole or are mutually independent, the soft tissue reinforcing part is composed of an undegraded three-dimensional reticular bracket combined with a veneering made of degradable materials and used for reinforcing the infraorbital septum, the fat of the infraorbital septum is returned and prevented from bulging again, the upper eyelid depression is improved, the soft tissue filling part is made of multiple layers of undegraded materials and can be cut and folded for correcting the infraorbital depression deformity.)

1. The compound prosthesis implantable in the infraorbital region is used for being implanted between the orbital septum and the orbicular muscle layer of the eye, strengthening the orbital septum, eliminating fat swelling, improving upper eyelid depression and correcting lacrimal groove depression deformity, and is characterized by comprising a soft tissue reinforcing part and a soft tissue filling part, wherein the soft tissue reinforcing part comprises a three-dimensional reticular stent and a veneer, and the soft tissue filling part is of a porous sponge membranous structure;

the three-dimensional net-shaped bracket comprises a main body part and an edge part, and is of an approximate semicircular structure formed by interconnected grids made of non-degradable materials, and the diameter of the three-dimensional net-shaped bracket is 20-25 mm; the grid is of a hexagonal prism structure, the side length of a hexagon of the grid is 1.0-2.0 mm, the width of a hexagonal prism column is 0.25-0.5 mm, and the depth of the grid is 0.25-5.0 mm, preferably 0.5-2.0 mm; the non-degradable material is preferably a high-strength medical high polymer material;

the main body part is in a narrow crescent honeycomb-like structure, the major diameter is 15-22 mm, the minor diameter is 3-8 mm, the core area gradually bulges and thickens towards the lateral side of the orbital septum, the thickness is 0.5-3.0 mm, preferably 1.0-2.0 mm, and the core area corresponds to the fat bulge area of the orbital septum under the orbital region of a human body;

the edge part is arranged on the periphery of the main body part and comprises an inner side part, an outer side part, an upper edge part and a lower edge part, the thickness of the edge part is 0.25-0.5 mm, the inner side part is close to the infraorbital region nasal side corresponding to the human body, the outer side part is close to the infraorbital region temporal side corresponding to the human body, the upper edge part is close to the lower eyelid margin corresponding to the human body, the lower edge part is close to the infraorbital region lower edge corresponding to the human body, and the corresponding finger is an implanted anatomical part when the finger is used for the;

the veneers cover the deep surface and the shallow surface of the three-dimensional reticular bracket, are in porous sponge membrane structures, and have the thickness of 0.1 mm-0.2 mm; the deep face is close to the orbit septal side, and tiny barbs are arranged on the surface of the facing face; the superficial surface is proximate to the orbicularis oculi muscle side, where the overlay is provided as a smooth surface; the facing is made of degradable materials;

the soft tissue filling part is arranged at the lower end of the soft tissue reinforcing part, is in a strip shape, has the length of 20-25 mm, the width of 10-20 mm and the thickness of 0.25-1.0 mm, is made of one or more layers of soft, light and thin porous non-degradable materials, and can be trimmed, folded and sutured according to the depression range and depth of the lacrimal duct of the infraorbital region of a user.

2. The infraorbital implantable composite prosthesis of claim 1, wherein the three-dimensional mesh scaffold is made of a porous sponge-like material with a pore size of 100-500 um, preferably 150-300 um, and a porosity of 85-95%.

3. The infraorbital implantable composite prosthesis of claim 1, wherein the three-dimensional mesh stent types include a thin section, a thick section, and a reinforced section, the thin section having the mesh depth of less than 1mm, the thick section having the mesh depth of 1mm to 2.5mm, and the reinforced section having the mesh depth of greater than 2.5 mm.

4. The infraorbital implantable composite prosthesis of claim 1, wherein the degradable material comprises one or a mixture of poly 4-hydroxybutyrate, polylactic acid, polyglycolic acid, polytrimethylene carbonate, silk fibroin.

5. The infraorbital implantable composite prosthesis of claim 1, wherein the non-degradable material comprises one or a mixture of polypropylene, polyester, polytetrafluoroethylene, silicone.

6. The infraorbital implantable composite prosthesis of claim 1, wherein the soft tissue augmentation component and the soft tissue augmentation component bind stem cells, tissue cells, growth factors, polypeptides via physical adsorption, embedding, or chemical coupling fixation.

7. The infraorbital implantable composite prosthesis of claim 1, wherein the three-dimensional mesh scaffold may be further provided without the overlay or with only a single layer of the overlay, the single layer may be provided at the deep portion of the three-dimensional mesh scaffold or at the shallow portion of the three-dimensional mesh scaffold, and the overlay may also be made of the non-degradable material.

8. The intraorbital implantable composite prosthesis of claim 1, wherein the intraorbital implantable composite prosthesis is provided as a left prosthesis for implantation of a left orbital soft tissue of a human body and a right prosthesis for implantation of a right orbital soft tissue of a human body, respectively.

9. The method of making an infraorbital implantable composite prosthesis of claim 1, wherein the fabrication protocol includes batch fabrication and personalized fabrication.

10. The method of manufacturing of claim 9, wherein the batch manufacturing process comprises: obtaining orbital area anatomical average data according to the human body measurement big data; designing the soft tissue reinforcing component and the soft tissue filling component which are implanted into a left infraorbital region and a right infraorbital region respectively, wherein the three-dimensional reticular stent of the soft tissue reinforcing component is provided with three models of the thin model, the thick model and the reinforcing model respectively; 3D modeling; opening a mould; manufacturing the soft tissue reinforcing part and the soft tissue filling part; coupling the soft tissue augmentation component and the soft tissue augmentation component; sterilizing, removing pyrogen, and packaging under aseptic condition.

11. The method of claim 9, wherein the personalized production process comprises: acquiring facial scanning data of a user, skin soft tissue sagging degree evaluation data, upper eyelid depression, infraorbital region fat swelling and lacrimal duct depression deformity degree evaluation data; constructing a 3D model of the implantable prosthesis in the orbital inferior region of the user according to the selected properties of the three-dimensional reticular stent material; implanting the prosthesis 3D model into the orbit inferior region of the user in a simulated manner, virtually simulating an implantation effect, and if the user is not satisfied with the implantation effect, adjusting the prosthesis 3D model until the user is satisfied with the implantation effect; then, opening a mold and carrying out production or 3D printing to manufacture the soft tissue reinforcing part and the soft tissue filling part; coupling the soft tissue augmentation component and the soft tissue augmentation component; sterilizing, removing pyrogen, and packaging under aseptic condition.

Technical Field

Relates to an implantable material for a human body, in particular to an infraorbital region implantable composite prosthesis and a manufacturing method thereof.

Background

The facial aging begins around the eyes, including upper eyelid concavity, laxity, pouch formation, and lacrimal depression deformity. Removal of bags is a common service item in orthopedics, including orbital septal release, transfer of orbital fat to the lacrimal depression, removal of sagging skin, and acquisition of a youthful appearance of the infraorbital area.

However, the infraorbital fat and the supraorbital fat are communicated through the back of the eyeball, and when the infraorbital fat is removed, the infraorbital fat is accelerated to move downwards, the depression of the upper eyelid is aggravated, and the upper eyelid is more aged.

If the swelling fat of the infraorbital region is reset, not only the pouch is removed, but also the upper eyelid depression and lacrimal duct depression deformity are improved, and the youthful eye circumference is realized. According to the structural characteristics of infraorbital bony tissues and soft tissues, the composite prosthesis is made of soft, light and thin biocompatible materials, and is probably a better choice for realizing the youthfulness of the eye periphery.

However, patents CN203736350U, CN204016556U, CN106420111B, CN205198213U, US6277150B1, US10052186B2 provide facial implant prostheses that, while strong enough, are not soft, light and thin enough, moreover present a significant foreign body sensation, and are not suitable for implantation in the infraorbital superficial soft tissue.

In view of this, the intraorbital area implantable composite prosthesis comprising the tissue reinforcing and reinforcing component and the soft tissue filling component is designed and manufactured to reinforce the orbital septum, dispel the pouch and prevent the pouch from bulging again, improve the upper eyelid depression, and correct the orbital area lacrimal duct depression deformity by cutting and folding.

Disclosure of Invention

Based on the above background, the present invention is directed to an intraorbital implantable composite prosthesis and a method for manufacturing the same.

In order to achieve the purpose, the solution of the invention is as follows:

the infraorbital implantable composite prosthesis comprises two parts, namely a soft tissue reinforcing part and a soft tissue filling part, wherein the soft tissue reinforcing part comprises a three-dimensional reticular stent and a veneer, the orbital septal strength is enhanced by implanting the infraorbital septal prosthesis into a human body, and the soft tissue filling part is of a porous sponge membranous structure and is placed in a lacrimal groove sunken area to correct lacrimal groove sunken deformity;

the three-dimensional net-shaped support comprises a main body part and an edge part, an approximate semicircular structure is formed by interconnected grids made of non-degradable materials, the approximate semicircular structure is matched with the orbital fossa structure of the infraorbital region of a human body, and the diameter of the approximate semicircular structure is 20-25 mm; the grid is a hexagonal prism, the side length of the hexagon is 1.0 mm-2.0 mm, the width of the hexagonal prism is 0.25 mm-0.5 mm, and the depth of the grid is 0.25 mm-5.0 mm, preferably 0.5 mm-2.0 mm;

the nondegradable material is preferably a high-strength medical high polymer material, such as 10-degree-hardness silica gel and porous polytetrafluoroethylene;

the main body part is in a narrow crescent honeycomb-like structure, the long diameter is 15-22 mm, the short diameter is 3-8 mm, the core area gradually bulges and thickens towards the orbit septal direction, and the thickness is 0.5-3.0 mm, preferably 1.0-2.0 mm; the core area is an area corresponding to the expansion of infraorbital septal fat;

the edge part is arranged on the periphery of the main body part and comprises an inner side part, an outer side part, an upper edge part and a lower edge part, the thickness of the edge part is 0.25-0.5 mm, the inner side part is close to the corresponding orbital inferior area nasal side of the human body, the outer side part is close to the corresponding orbital inferior area temporal side of the human body, the upper edge part is close to the corresponding inferior eyelid margin of the human body, the lower edge part is close to the corresponding orbital inferior edge of the human body, and the corresponding finger is an implanted anatomical part when the finger is used for the human body; the inner side part, the outer side part, the upper edge part and the lower edge part can be cut according to requirements, and are fixed to periosteum and fascia of the orbit part in a sewing mode, so that an orbit septal tightening effect is achieved;

the veneers cover the deep surface and the shallow surface of the three-dimensional reticular bracket, are in porous sponge membrane structures, and have the thickness of 0.1 mm-0.2 mm; the deep surface refers to one side close to the orbital septum when the prosthesis is implanted into a human body, wherein the surface of the veneering is provided with tiny barbs for increasing the friction force between the prosthesis and the surface of the orbital septum and improving the reinforcing effect; the superficial surface refers to the side close to the orbicularis oculi when the prosthesis is implanted into a human body, and the veneering is arranged to be a smooth surface so as to promote the skin of the infraorbital region to present a mellow appearance; the facing is made of degradable materials;

the soft tissue filling part is arranged at the lower end of the soft tissue reinforcing part, is in a strip shape, has the length of 15 mm-20 mm, the width of 10 mm-20 mm, preferably the width of 5 mm-10 mm and the thickness of 0.25 mm-1.0 mm, is made of one or more layers of soft, light and thin porous non-degradable materials, and can be used for trimming, folding and sewing and correcting the depression according to the depression range and depth of the lacrimal duct of the infraorbital region of a user.

Furthermore, the three-dimensional net-shaped bracket is made of a porous spongy material, the aperture of the micropores of the three-dimensional net-shaped bracket is 100um to 500nm, preferably 150um to 300um, and the porosity of the three-dimensional net-shaped bracket is 85 percent to 95 percent.

Furthermore, the three-dimensional mesh-shaped support comprises a thin mesh, a thick mesh and a reinforced mesh, the depth of the thin mesh is smaller than 1mm, the depth of the thick mesh is 1 mm-2.5 mm, and the depth of the reinforced mesh is larger than 2.5 mm.

Furthermore, the degradable material comprises one or a mixture of a plurality of poly 4-hydroxybutyric acid, polylactic acid, polyglycolic acid, polytrimethylene carbonate and silk protein.

Further, the non-degradable material comprises one or a mixture of polypropylene, polyester, polytetrafluoroethylene and silica gel.

Furthermore, the soft tissue reinforcing part and the soft tissue filling part can be combined with stem cells, tissue cells, growth factors and polypeptides in a physical adsorption, embedding and chemical coupling fixing mode.

Furthermore, the three-dimensional reticular stent can be not provided with the facing, or only provided with a single layer of the facing, the single layer can be arranged at the deep part of the three-dimensional reticular stent, or arranged at the shallow part of the three-dimensional reticular stent, and the facing can also be made of the non-degradable material.

Further, the intraorbital implantable composite prosthesis is set as a left side prosthesis and a right side prosthesis, the left side prosthesis is used for implanting soft tissues of the left intraorbital region of the human body, and the right side prosthesis is used for implanting soft tissues of the right intraorbital region of the human body.

The manufacturing method of the infraorbital region implantable composite prosthesis comprises batch manufacturing and personalized manufacturing.

Further, the batch manufacturing process includes: acquiring orbital area anatomical average data according to anthropometric big data, wherein the anthropometric big data comprises measurement data of groups of adults of different ethnicities, different facial shapes and different ages, and the measurement data comprises body surface measurement data and imaging detection data; designing the soft tissue reinforcing component and the soft tissue filling component suitable for being implanted into the left infraorbital region and the right infraorbital region of different groups respectively, wherein the three-dimensional reticular stent of the soft tissue reinforcing component is provided with three models of the thin model, the thick model and the reinforcing model respectively; 3D modeling; opening a mould; manufacturing the soft tissue reinforcing part and the soft tissue filling part; connecting the soft tissue reinforcing component and the soft tissue filling component, wherein the connecting comprises a hot pressing mode, a biological glue bonding mode and a suturing mode; sterilizing, removing pyrogen, and packaging under aseptic condition.

Further, the personalized production process includes: acquiring facial scanning data, imaging detection data, skin soft tissue sagging degree evaluation data, upper eyelid depression, infraorbital region fat swelling and lacrimal duct depression deformity degree evaluation data of a user; constructing the 3D model of the implantable prosthesis in the orbital inferior region of the user according to the selected properties of the three-dimensional mesh-shaped support material; then the prosthesis 3D model is implanted into the orbit inferior region of the user in a simulated mode to achieve a virtual implantation effect, and if the user is not satisfied with the implantation effect, the prosthesis 3D model is adjusted until the user is satisfied with the implantation effect; then, opening a mold and carrying out production or 3D printing to manufacture the soft tissue reinforcing part and the soft tissue filling part which are suitable for the user; coupling the soft tissue augmentation component and the soft tissue augmentation component; sterilizing, removing pyrogen, and packaging under aseptic condition.

Drawings

FIG. 1 is a schematic diagram of the orbital bony structure of a human body;

FIG. 2 is an illustration of an eye pouch body surface structure of a human body;

FIG. 3 is a schematic view of the structure of an intraorbital implantable composite prosthesis;

FIG. 4 is a schematic representation of corresponding bony landmarks of the intraorbital implantable composite prosthesis implanted in a human body;

FIG. 5 is a schematic view of a corresponding body surface landmark of an intraorbital implantable composite prosthesis implanted in a human body;

FIG. 6 is a schematic view of a soft tissue augmentation component;

FIG. 7 is a schematic view of a three-dimensional mesh stent structure;

FIG. 8 is a schematic view of a three-dimensional mesh stent structure composed of interconnected mesh cells;

FIG. 9A is a sagittal cross-sectional view of a soft tissue augmentation component;

figure 9B is a coronal cross-sectional view of a soft tissue augmentation component.

Detailed Description

In order to make the technical content, structural features, objectives and functions of the present invention exhaustive, the following embodiments are described in detail with reference to the accompanying drawings.

As shown in fig. 1-9, the intraorbital implantable composite prosthesis disclosed by the present invention is provided in pairs as a left-side prosthesis for implantation of a left-side intraorbital soft tissue of a human body and a right-side prosthesis for implantation of a right-side intraorbital soft tissue of a human body.

The infraorbital implantable composite prosthesis structure comprises a soft tissue reinforcing part 1 and a soft tissue filling part 3 which are combined through a connecting part 2, wherein the soft tissue reinforcing part 1 comprises a three-dimensional reticular bracket 11 and a facing 12 and is implanted into a human body to strengthen the strength of an infraorbital space, and the soft tissue filling part 3 is of a porous sponge membranous structure and is placed into a lacrimal groove depressed area to correct the lacrimal groove depressed deformity.

The three-dimensional mesh support 11 comprises a main body part 111 and an edge part 112, wherein interconnected grids 113 made of non-degradable materials form an approximate semicircular structure, are matched with the orbital fossa structure of the infraorbital region of a human body, and have the diameter of 20-25 mm; the grid 113 is a hexagonal prism, the length of a hexagonal edge 1131 of the grid is 1.0 mm-2.0 mm, the width of a hexagonal prism column 1132 is 0.25 mm-0.5 mm, and the depth of a space 1133 of the grid 113 is 0.25 mm-5.0 mm, preferably 0.5 mm-2.0 mm; the three-dimensional reticular bracket 11 is made of a porous spongy material, the aperture of the micropores is 100-500 um, preferably 150-300 nm, and the porosity is 85-95%; the non-degradable material is preferably a high-strength medical polymer material, such as 10-degree-of-hardness silica gel and porous polytetrafluoroethylene. In addition, the non-degradable material can also be selected from polypropylene and polyester.

The three-dimensional mesh-shaped support 11 comprises a thin mesh support, a thick mesh support and a reinforced mesh support, wherein the depth of the thin mesh support 113 is smaller than 1mm, the depth of the thick mesh support 113 is 1 mm-2.5 mm, and the depth of the reinforced mesh support 113 is larger than 2.5 mm.

The main body 111 has a narrow crescent honeycomb-like structure, a long diameter of 15mm to 22mm and a short diameter of 3mm to 8mm, and a core region 1111 gradually bulges and thickens in the orbital septal direction, and has a thickness of 0.5mm to 3.0mm, preferably 1.0mm to 2.0 mm; the core region 1111 is the region corresponding to the most distended fat of the infraorbital pouch.

The edge portion 112 is disposed on the periphery of the main body portion 111, and includes an inner side portion 1122, an outer side portion 1124, an upper edge portion 1121, and a lower edge portion 1123, and the thickness of the edge portion is 0.25mm to 0.5mm, the inner side portion 1122 is close to the corresponding orbital inferior nasal side of the human body, the outer side portion 1124 is close to the corresponding orbital inferior temporal side of the human body, the upper edge portion 1121 is close to the corresponding lower eyelid margin of the human body, the lower edge portion 1123 is close to the corresponding orbital inferior edge of the human body, and the correspondence refers to the anatomical region implanted when the anatomical region is used for; the inner side 1122, the outer side 1124, the upper edge 1121, and the lower edge 1123 may be cut as required, and fixed to the periosteum and fascia of the orbit by suturing, so as to tighten the orbital septum.

The overlay 12 comprises a deep part 121 and a shallow part 122 which cover the three-dimensional reticular bracket 11, is of a porous sponge membrane structure and has a thickness of 0.1 mm-0.2 mm; the deep part is the side close to the orbital septum when the prosthesis is implanted into a human body, and the surface of the facing 12 is provided with micro barbs 1211 for increasing the friction force between the prosthesis and the surface of the orbital septum and improving the reinforcing effect; the superficial portion 122 is the side of the orbicularis oculi that is proximate to the prosthesis when implanted in the body, where the facing 12 is configured as a smooth surface to promote a rounded appearance of the infraorbital skin; the overlay 12 is made of degradable material, and the degradable material can be one or a mixture of poly 4-hydroxybutyric acid, polylactic acid, polyglycolic acid, polytrimethylene carbonate and silk protein.

Based on the consideration of reducing the design difficulty and simplifying the manufacturing procedure, the three-dimensional mesh-shaped support 11 may not be provided with the overlay 12, and correspondingly, the length of the hexagonal edge 1131 of the mesh 113 is set to be 0.5mm to 1.0mm, and the width of the hexagonal prism column 1132 is set to be 0.2mm to 0.4mm, so that the meshes of the three-dimensional mesh-shaped support 11 are reduced, and the appearance profile of the prosthesis is prevented from appearing in the infraorbital region of the user after application; in addition, the three-dimensional mesh-like stent 11 even eliminates the mesh 113 and changes the mesh into a solid structure.

In addition, the three-dimensional reticulated framework 11 may be provided with only a single layer of the facing 12, and the single layer of the facing 12 may be provided on the deep-surface portion 121 of the three-dimensional reticulated framework 11 or may be provided on the shallow-surface portion 122 of the three-dimensional reticulated framework 11; also, the overlay 12 may be made of the non-degradable material.

The soft tissue filling part 3 is arranged at the lower end of the soft tissue reinforcing part 1, is in a belt shape, has the length of 15 mm-20 mm, the width of 10 mm-20 mm, the preferred width of 5 mm-10 mm and the thickness of 0.25 mm-1.0 mm, is made of one or more layers of soft, light, thin and porous non-degradable materials, and can be used for trimming, folding and sewing according to the depression range and depth of the lacrimal duct under the orbit of a user to correct the depression deformity of the lacrimal duct.

The infraorbital condition of a user has individual difference, fat bulge of the infraorbital region is mainly caused, and lacrimal depression deformity is not obvious; some people have predominantly depressed lacrimal malformations, while the infraorbital fat puffiness is not obvious. The soft tissue reinforcing part 1 and the soft tissue filling part 3 are independently designed, manufactured and packaged and are respectively used for users with orbital region fat bulging as a main part or users with lacrimal duct depression deformity as a main part. The soft tissue reinforcing member 1 and the soft tissue filling member 3 may be combined by the joint 2, and the soft tissue filling member 3 of the composite prosthesis may be trimmed for intraorbital region fat swelling as a primary user, and the soft tissue reinforcing member 1 of the composite prosthesis may be trimmed for intraorbital region lacrimal groove depression deformity as a primary user.

In addition to the use of such prostheses, bioactive materials such as stem cells, tissue cells, growth factors, polypeptides are also widely used in the treatment of eye rejuvenation. Therefore, the soft tissue reinforcing member 1 and the soft tissue filling member 3 are adsorbed or embedded by the physical adsorption characteristic of the porous spongy material, and are fixed by chemical coupling, and stem cells, tissue cells, growth factors and polypeptides are combined, so that the treatment effect of the rejuvenation around the eyes is enhanced.

The manufacturing method of the infraorbital region implantable composite prosthesis comprises batch manufacturing and personalized manufacturing.

The batch manufacturing process 100 includes:

s101: acquiring orbital inferior anatomy average data according to anthropometric big data, wherein the anthropometric big data comprises measurement data which is divided into groups according to different ethnicities, different face shapes and different age groups, and the measurement data comprises body surface measurement data and imaging detection data;

s102: the soft tissue reinforcing part and the soft tissue filling part implanted into the left infraorbital region and the right infraorbital region of the human body in different groups are respectively designed and matched, wherein the three-dimensional reticular bracket of the soft tissue reinforcing part is respectively provided with three models of the thin model, the thick model and the reinforcing model;

s103: 3D modeling;

s104: opening a mould;

s105: manufacturing the soft tissue reinforcing part and the soft tissue filling part;

s106: connecting the soft tissue reinforcing component and the soft tissue filling component, wherein the connecting comprises a hot pressing mode, a biological glue bonding mode and a suturing mode;

s107: sterilizing, removing pyrogen, and packaging under aseptic condition.

The personalization process 200 includes:

s201: acquiring facial scanning data, imaging detection data, skin soft tissue sagging degree evaluation data, upper eyelid depression, infraorbital region fat swelling and lacrimal duct depression deformity degree evaluation data of a user;

s202: constructing the 3D model of the implantable prosthesis in the orbital inferior region of the user according to the selected properties of the three-dimensional mesh-shaped support material;

s203: then the prosthesis 3D model is implanted into the orbit inferior region of the user in a simulated mode to achieve a virtual implantation effect, and if the user is not satisfied with the implantation effect, the prosthesis 3D model is adjusted until the user is satisfied with the implantation effect;

s2041: opening a mold, and manufacturing the soft tissue reinforcing part and the soft tissue filling part which are suitable for the user;

s2042: 3D printing, namely manufacturing the soft tissue reinforcing part and the soft tissue filling part which are suitable for the user;

s205: coupling the soft tissue augmentation component and the soft tissue augmentation component;

s206: sterilizing, removing pyrogen, and packaging under aseptic condition.

The above description is only exemplary of the present invention and is not intended to limit the technical scope of the present invention, so that any minor modifications, equivalent changes and modifications made to the above exemplary embodiments according to the technical spirit of the present invention are within the technical scope of the present invention.