A type of eyelid implant

Abstract

A type of under-eye implant includes two mirror-symmetrical implant units. Each implant unit is arc-shaped, tapering at both ends and thickening in the middle along its length. All edges and surfaces are smoothly transitioned through rounded surfaces. The arc trajectory of the implant unit matches the natural contour of the lower eyelid from the inner corner to the outer corner, with the radius of curvature of the inner segment near the inner corner being larger than that of the outer segment near the outer corner. Each implant unit has a through-hole at each end. The implant is made of expanded polytetrafluoroethylene (ePTFE), whose microporous structure induces tissue cell ingrowth after implantation, preventing implant displacement and light transmission, and demonstrating good biocompatibility.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a crescent-shaped prosthesis that matches the shape below the eye. Background Technology

[0002] In the field of oculoplastic surgery and repair, implants are often used to improve the appearance of the eyes or repair damage to eye tissues. For example, in blepharoplasty (eyelid surgery), some patients may experience hollowing under their eyes due to excessive fat removal or relaxation of the orbicularis oculi muscle, affecting their appearance. In such cases, a suitable implant is needed to fill the hollow and restore the natural shape of the area under the eyes.

[0003] Currently, various types of eye implants are available on the market. Some implants have relatively simple shapes, typically round, oval, or rectangular. When applied to the lower eyelid, these shapes are difficult to precisely conform to the complex anatomical structure of the area. The lower eyelid exhibits a unique arc-shaped contour from the inner corner to the outer corner, and this varies between individuals. Conventional-shaped implants cannot adequately adapt to this shape, easily leading to problems such as noticeable implant edges and displacement. This not only affects the surgical outcome but may also cause discomfort to the patient.

[0004] There are also customizable prostheses, which, in theory, can be designed according to individual patient needs. However, in practice, the customization process is often complex and costly. It typically requires obtaining detailed data about the patient's eyes using high-precision 3D scanning equipment, followed by specialized software design and complex manufacturing processes to produce the prosthesis. This process is not only time-consuming, increasing patient waiting time and financial burden, but also demands extremely high levels of technology and equipment, limiting its widespread clinical application.

[0005] Patent application CN118178038A discloses a subcutaneous implant for lower eyelid enhancement. This implant is prismatic in shape with a triangular cross-section, or a triangular prism of uniform thickness, or a combination of several segments that increase in thickness from one end to the other. The implant is made of silicone. Problems with this implant include: firstly, silicone itself is a solid material, which easily leads to capsular contracture after implantation, resulting in poor long-term outcomes and clinical problems such as implant translucency, displacement, and sagging; secondly, the prismatic structure is not aesthetically pleasing.

[0006] Therefore, developing an eye prosthesis that can accurately match the shape below the eye, is easy to manufacture, and is cost-effective has significant clinical implications and market demand. Utility Model Content

[0007] The purpose of this application is to provide an eye prosthesis with a crescent shape that can precisely match the shape below the eye, effectively solving the shortcomings of existing eye prostheses in fitting the structure below the eye, improving the effect of eye plastic and reconstructive surgery, reducing complications caused by prosthesis mismatch, simplifying the manufacturing process, reducing costs, and facilitating clinical application.

[0008] A type of aegyo sal (eye bags) implant includes two mirror-symmetrical implant units. Each implant unit is arc-shaped and has tapered ends and a thick middle section along its length. All edges and surfaces are smoothly transitioned by rounded surfaces. The arc trajectory of the implant unit matches the natural contour of the lower eyelid from the inner corner to the outer corner, wherein the radius of curvature of the inner segment near the inner corner is greater than the radius of curvature of the outer segment near the outer corner. Each implant unit has a through guide hole at each end.

[0009] Furthermore, the total length of the prosthetic unit is 15-25mm, the maximum width of the middle section is 4-7mm, and the maximum thickness of the middle section is 1-3mm.

[0010] Furthermore, the radius of curvature of the inner segment is 8-12 mm, the radius of curvature of the outer segment is 5-8 mm, and the radius of curvature of the middle segment of the prosthesis unit is 10-15 mm.

[0011] Furthermore, the diameter of the guide hole is 0.1-0.5 mm, and the distance from the center of the hole to the end of the prosthesis unit is 1-2 mm.

[0012] Furthermore, the width and thickness of the two ends of the prosthetic unit are both less than 1 mm.

[0013] Furthermore, the width and thickness of the prosthetic unit gradually increase from both ends to the middle section, forming a continuous gradient shape.

[0014] Furthermore, the prosthetic unit is made of expanded polytetrafluoroethylene.

[0015] Furthermore, the prosthesis unit is provided with micropores, the pore diameter of which is 15-40 μm.

[0016] After adopting the above technical solution, this application has the following technical effects:

[0017] 1. Compared with existing eye implants of uniform shape, the crescent-shaped implant of this application can more precisely conform to the shape below the eye. Because its unique shape design is based on in-depth research into the anatomy of the eye, it can better follow the natural curve from the inner corner of the eye to below the outer corner. Therefore, after implantation, it can significantly reduce the problem of obvious implant edges, making the repaired eye appearance more natural and improving the aesthetic effect of the surgery.

[0018] 2. This prosthesis mimics the structure of the human eyelid, providing excellent fit after implantation. It is made of a porous structure using polymer materials, with polytetrafluoroethylene (PTFE) being the preferred choice due to its inertness and ability to be permanently implanted. The porous structure of the prosthesis makes it lightweight, and the microporous structure guides tissue cells to expand in, achieving fusion between the prosthesis and the body's own tissues. Attached Figure Description

[0019] Figure 1 This is a three-dimensional view of a single prosthesis in this utility model.

[0020] Figure 2 This is a front view of a single prosthesis of this utility model.

[0021] Figure 3 This is a rear view of a single prosthesis of this utility model.

[0022] Figure 4 This is a bottom view of a single prosthesis of this utility model. Detailed Implementation

[0023] The technical solution of this utility model will be further described below with reference to the accompanying drawings and embodiments.

[0024] like Figure 1-4 As shown, the under-eye fitting prosthesis in this embodiment consists of two mirror-symmetrical prosthesis units 1, corresponding to the under-eye areas of the left and right eyes, respectively. Each prosthesis unit 1 presents a smooth arc shape. When viewed along the length direction, its shape is an irregular contour that gradually tapers at both ends and is thick in the middle. All edges (including the two sides in the length direction and the top and bottom edges in the width direction) and surfaces are smoothly transitioned by rounded surfaces, without any sharp corners or transitions. The overall visual presentation presents a natural and soft curve, which is highly coordinated with the natural contour of the under-eye area from the inner corner to the outer corner.

[0025] Specifically, the structural features of each prosthetic unit 1 are as follows:

[0026] Main arc-shaped structure: The whole structure has an arc-shaped trajectory. The arc extends from the side near the inner corner of the eye (inner segment 11) to the side near the outer corner of the eye (outer segment 13). The radius of arc of the inner segment 11 is greater than that of the outer segment 13. The radius of arc of the middle segment 12 (the part between the inner segment 11 and the outer segment 13) is between the two, forming a gradual arc that matches the anatomical contour below the eye.

[0027] End guide hole 14: A through guide hole 14 is provided at each end of the prosthesis unit 1 (near the tip). The guide hole 14 extends through the thickness direction of the prosthesis unit 1 and the hole wall is smooth and burr-free.

[0028] The width and thickness of the prosthesis unit 1 gradually change from both ends to the middle section 12. That is, the width and thickness are the smallest at both ends, gradually increasing towards the middle section 12, reaching the maximum width and thickness in the middle section 12, and then gradually decreasing towards the other end, forming a symmetrical gradient structure that is "wide in the middle and narrow at both ends" and "thick in the middle and thin at both ends".

[0029] Based on the analysis of the eye's location, the soft tissue distribution below the eye, from the inner corner to the outer corner, exhibits a characteristic of "a raised middle section and gentler ends." In this embodiment, the middle section 12 corresponds to the main raised area of ​​the lower eyelid ("aegyo sal"), with a thicker tissue thickness, while the tissue at both ends (near the inner and outer corners) is thinner and narrower. This structure allows the implant to precisely fill the anatomical area below the eye. The thick middle section 12 corresponds to the need for a raised lower eyelid, while the tapered ends accommodate thinner soft tissue areas, avoiding localized overfilling. The fully curved edges and surfaces reduce friction with surrounding tissues, lowering the risk of tissue damage, and resulting in a more natural appearance after implantation with no obvious implant edge traces.

[0030] Furthermore, from a conventional understanding of ocular anatomy, the natural contour of the area below the eye, from the inner corner to the outer corner, exhibits a difference in curvature: the skin and subcutaneous tissue in the inner corner region (closer to the nose) are relatively flat, resulting in a gentler contour (larger radius); while the contour in the outer corner region (closer to the temple) is relatively steeper (smaller radius). The prosthesis in this embodiment employs a design where the radius of curvature of the inner segment 11 is greater than that of the outer segment 13. Its core purpose is to simulate this natural anatomical difference, allowing the prosthesis to better conform to the physiological curve below the eye, thereby improving the naturalness and stability after implantation.

[0031] During surgical implantation, the prosthesis needs to be placed into the tissue space below the eye through a tiny incision. Without a positioning structure, it is prone to curling or displacement. In this embodiment, the guide hole 14 can be threaded with sutures, which facilitates the pulling of the prosthesis during surgery, ensuring that it remains stretched during implantation and is accurately placed in the preset position. At the same time, the prosthesis can be temporarily fixed to the surrounding tissues by sutures to prevent early postoperative displacement.

[0032] Normally, the thickness and width of the tissue below the eye change continuously from the center to both ends without obvious breaks. This embodiment uses a continuously gradual size design to make the transition between the prosthesis and the tissue smoother, avoiding unnatural local shapes caused by abrupt size changes, while reducing pressure on surrounding tissues and lowering the risk of postoperative discomfort or tissue deformation.

[0033] Furthermore, the specific dimensions of each implant unit 1 are as follows: Total length (measured when bent): 15-25mm, with the appropriate size selected according to different palpebral fissure lengths to ensure coverage of the target area below the eye from the inner corner to the outer corner. Mid-section 12 maximum width: 4-7mm, corresponding to the filling needs at the widest point of the lower eyelid, adapting to the eye proportions of most people.

[0034] The maximum thickness of the middle section 12 is 1-3mm, which can be adjusted according to the degree of depression under the eyes to meet the needs of different filling volumes.

[0035] Dimensions of both ends of the tip: The width and thickness of both ends of the tip are less than 1mm, which is suitable for the thin soft tissue area below the inner and outer corners of the eyes and avoids the tip protruding. The diameter of the guide hole 14 is 0.1-0.5mm, and the distance between the center of the hole and the end of the prosthesis unit 1 is 1-2mm, which facilitates the passage of sutures and avoids the reduction of structural strength caused by being too close to the end.

[0036] The radius of curvature of the inner segment 11 is 8-12mm (e.g.) Figure 2 As shown at point a), the radius of curvature of the outer segment 13 is 5-8 mm (as shown at point a). Figure 2 As shown at point c), the radius of curvature of the middle section 12 is 10-15mm (as shown at point c). Figure 2 As shown at point b), the gradient curvature matches the natural contour below the eyes.

[0037] The eyelid implant uses polytetrafluoroethylene dispersion resin as raw material and dearomatic solvent as extrusion aid. Through processes such as mixing, preforming, extrusion, stretching and sintering, expanded polytetrafluoroethylene sheet is obtained. Then, the expanded polytetrafluoroethylene molded eyelid implant is made by carving process. The implant has a shape that is pointed at both ends, thick in the middle and has an overall arc transition.

[0038] The prosthesis in this embodiment has a porous structure, making it lightweight. The microporous structure guides tissue cells to expand, achieving fusion between the prosthesis and the surrounding tissue. The pore size is 15–40 micrometers, and the porosity of the polytetrafluoroethylene prosthesis is 50%–80%. The pinholes at both ends of the prosthesis serve as guide holes during implantation and also allow for traction, keeping the prosthesis in an extended state and preventing "coiling." If necessary, the prosthesis can also be simply fixed through the pinholes.

[0039] Production steps:

[0040] (1) Mixing: Polytetrafluoroethylene dispersion resin is used as raw material and mixed with solvent oil in a weight ratio of (10:2 to 10:4). The molecular weight of the selected polytetrafluoroethylene resin is preferably 3.5 million to 8.5 million, and the solvent oil is preferably dearomatic solvent oil. After thorough mixing, if necessary, a 10-40 mesh sieve is used to remove larger particles.

[0041] (2) Preforming: The above mixture is formed from a fluid state into a solid form, which can be a cuboid, cube, cone or other geometric shape. Preforming into a cylinder is preferred.

[0042] (3) Extrusion: The above preformed mixture is extruded at a certain temperature (25-40℃) to form a film or sheet, resulting in a film or sheet with a thickness of 0.5-1.5 mm.

[0043] (4) Drying, stretching, sintering and shaping: The obtained film or sheet is dried to remove solvent oil, and then stretched at 180-300℃ to obtain expanded polytetrafluoroethylene. According to the required thickness, it is laminated at high temperature to obtain expanded polytetrafluoroethylene sheet of the required thickness. If necessary, drying and stretching can also be carried out simultaneously. The oil removal and stretching can be carried out simultaneously by using traction rollers to obtain stretched sheets. These sheets are then stacked. During the stacking process, one or more compounds can be used as binders. High-melting-point fluoropolymers similar to polytetrafluoroethylene, such as perfluoroethylene propylene (FEP), are preferred.

[0044] (5) Cutting and carving: The expanded polytetrafluoroethylene sheet obtained above is carved to obtain a three-dimensional shaped eyelid prosthesis. The prosthesis is pointed at both ends, thick in the middle and has an overall arc transition.

[0045] The procedure in this embodiment is as follows: Based on the shape of the patient's lower eyelid (such as palpebral fissure length, degree of concavity, and natural contour curvature), select a prosthesis unit 1 with a suitable size and curvature (the left and right eyes are mirror-symmetrical); make small incisions near the inner and outer corners of the lower eyelid, with the incision length slightly larger than the diameter of the prosthesis end to facilitate prosthesis implantation; use a guide to separate a tissue gap that matches the shape of the prosthesis in the target layer below the eyelid, ensuring that the size of the gap matches the size of the prosthesis; pass sutures through the guide holes 14 at both ends of the prosthesis unit 1, and implant the prosthesis into the tissue gap through the inner or outer incision; pull the sutures to stretch the prosthesis and adjust it to the correct position, ensuring that the arc trajectory of the prosthesis fits the natural contour below the eyelid; after confirming that the position of the prosthesis is correct, suture the incision.

[0046] Although the present invention has been described in detail through the above preferred embodiments, it should be understood that the above description should not be considered as a limitation of the present invention. Various modifications and substitutions to the present invention will be apparent to those skilled in the art after reading the above content. Therefore, the scope of protection of the present invention should be defined by the appended claims.

Claims

1. A type of aegyo sal (eye bags) implant, characterized in that, It includes two mirror-symmetrical prosthetic units (1), each of which is arc-shaped and has tapered ends and a thick middle section (12) along its length. All edges and surfaces are smoothly transitioned by arc surfaces. The arc trajectory of the prosthetic unit (1) matches the natural contour of the lower eyelid from the inner corner to the outer corner. The radius of curvature of the inner section (11) near the inner corner is greater than that of the outer section (13) near the outer corner. Each of the prosthetic units (1) has a through guide hole (14) at each end.

2. The under-eye bag prosthesis according to claim 1, characterized in that, The total length of the prosthetic unit (1) is 15-25mm, the maximum width of the middle section (12) is 4-7mm, and the maximum thickness of the middle section (12) is 1-3mm.

3. The under-eye bag prosthesis according to claim 1, characterized in that, The radius of curvature of the inner segment (11) is 8-12 mm, the radius of curvature of the outer segment (13) is 5-8 mm, and the radius of curvature of the middle segment (12) of the prosthesis unit (1) is 10-15 mm.

4. The under-eye bag prosthesis according to claim 1, characterized in that, The diameter of the guide hole (14) is 0.1-0.5 mm, and the distance between the center of the hole and the end of the prosthesis unit (1) is 1-2 mm.

5. The under-eye bag prosthesis according to claim 1, characterized in that, The width and thickness of the two ends of the prosthetic unit (1) are both less than 1 mm.

6. The under-eye bag prosthesis according to claim 5, characterized in that, The width and thickness of the prosthetic unit (1) gradually increase from both ends to the middle section (12), forming a continuous gradient shape.

7. The under-eye bag prosthesis according to claim 6, characterized in that, The prosthetic unit (1) is made of expanded polytetrafluoroethylene.

8. The under-eye bag prosthesis according to claim 6, characterized in that, The prosthesis unit (1) is provided with micropores, the pore diameter of which is 15-40μm.

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