A manufacturing method of a one-time implantable artificial cornea

Abstract

The present invention discloses a manufacturing method of an artificial cornea for one-time implantation, belonging to the technical field of in-vivo prosthesis implantation. It solves at least the problems existing in the prior art, such as the need for donor corneas, multiple surgeries, large trauma and inapplicability to patients with severe eye diseases. The manufacturing method includes: manufacturing a lens column, which sequentially includes a first threaded section, a second threaded section, an optical axis section, a rear disc and a rear convex section from the front end to the rear end; manufacturing a stent, which includes a stent body and a connecting ring; the stent body is made of metal and is formed by stamping; manufacturing a cosmetic disc, the material of the cosmetic disc is the same as that of the lens column and is formed by injection molding, the cosmetic disc has a central connection hole, and the inner wall of the central connection hole has an internal thread that is screwed with the first threaded section; assembling the lens column, the stent and the cosmetic disc, specifically including: snapping the connecting ring into the central mounting hole of the stent body from top to bottom, and making the stent body snap into the annular limiting groove of the connecting ring to complete the assembly of the stent.

Description

Technical Field

[0001] The present invention belongs to the technical field of in-vivo prosthesis implantation, and particularly relates to a manufacturing method of an artificial cornea for single implantation. Background Art

[0002] An artificial cornea refers to a special refractive device made of biomedical materials, which is used to replace the cloudy cornea that hinders the optical path of the eyeball after the lesion, so that the patient can obtain a certain vision.

[0003] The prior art provides an artificial cornea with a blindness recovery rate of up to 79.9%, which is the most widely used artificial cornea in the world at present. During the treatment process of this artificial cornea, not only general anesthesia is required, but also a trephine is needed to remove the full-thickness cornea with a large diameter during the operation, and the risk of serious complications during the operation is high. In particular, a donor corneal graft is required as a carrier, but the severe shortage of donor corneas is a problem that is difficult to solve in China at present. Therefore, this artificial cornea cannot be used to carry out transplantation operations on a large scale. In addition, long-term local use of hormones or immunosuppressants is required after the operation, and the incidence of infection and glaucoma is high, and it is difficult to maintain long-term vision. In addition, due to the large-diameter posterior disc, the incidence of posterior membrane of the artificial cornea is high, which not only seriously threatens vision, but also has a high incidence of complications such as corneal graft dissolution. At the same time, it increases the risk of glaucoma. In addition, this artificial cornea has high requirements for the ocular surface conditions, that is, it requires good tear function and requires the eyelids and conjunctival sac to have good integrity, especially the prognosis of dry eye caused by autoimmune diseases is extremely poor. Moreover, in case of perforation and leakage, a new artificial cornea needs to be replaced urgently, and if there is no donor corneal graft, emergency rescue cannot be carried out.

[0004] The prior art also provides another artificial cornea with a blindness recovery rate of 86.6%. Moreover, it can be applied to binocular blind patients with severe ocular surface diseases, chemical burns, thermal burns, explosion injuries, eyelid atresia, and end-stage dry eye. However, two-stage surgeries are required, that is, a stent is implanted in the first-stage surgery, and a lens column is implanted in the second-stage surgery. The promotion of the surgical technique is difficult mainly because it is difficult to separate the corneal lamella, and it is easy to perforate the cornea during the operation, resulting in the failure of stent implantation. The surgical field is small during the second-stage operation, and it is extremely difficult to remove the lens, and the incidence of residual lens cortex is high, which can cause lens-derived inflammatory reactions and threaten visual function. To carry out such surgeries, the surgical learning curve is long, and the surgeon is required to have comprehensive surgical skills. Therefore, it is difficult to master and widely promote. In addition, the lens column is fixed in a screw-thread manner and is prone to fall off. Once it falls off, serious consequences will occur. The connecting piece between the stent and the lens column is inserted from the back to the front, and the second-stage lens column is implanted from the front to the back. During the implantation process, the force applied to the stent may cause the connecting piece to fall off, resulting in the dilemma of being unable to implant the lens column.

[0005] In view of this, there is an urgent need to propose a manufacturing method of an artificial cornea that can overcome the above technical problems and complete the treatment of corneal blindness restoration with a single implantation, as well as an artificial cornea manufactured by using the above manufacturing method. Summary of the Invention

[0006] The purpose of the present invention is to provide a manufacturing method of a single-implant artificial cornea, which can at least solve the problems existing in the prior art, such as the need for donor corneas, multiple surgeries for separately implanting the stent and the lens cylinder, large trauma, and inapplicability to patients with severe eye diseases.

[0007] In order to achieve the above purpose, the present invention provides the following technical solutions:

[0008] The present invention provides a manufacturing method of a single-implant artificial cornea, including the following steps:

[0009] Manufacture the lens cylinder, the lens cylinder sequentially includes a first threaded section, a second threaded section, an optical axis section, a rear disc, and a rear convex section from the front end to the rear end;

[0010] Manufacture the stent, the main body of the stent is made of metal, and the stent includes a stent main body and a connecting ring; the stent main body is formed by stamping; after stamping, the stent main body has a central mounting hole and fins, the fins have weight-reducing holes, the inner wall of the weight-reducing holes has a suture groove, and the non-weight-reducing hole positions of the fins have suture needle holes; the material of the connecting ring is the same as or similar to that of the lens cylinder body, and the connecting ring is manufactured by turning; after turning, the connecting ring is a hollow stepped shaft structure with a larger upper part and a smaller lower part, and the inner wall of the hollow part has an internal thread matching the second threaded section of the lens cylinder; an annular limiting groove for clamping with the stent main body is provided at the axial position of the hollow stepped shaft structure;

[0011] Manufacture the cosmetic disc, the material of the cosmetic disc is resin, and it is formed by injection molding. The cosmetic disc has a central opening, and the inner wall of the opening has an internal thread for screwing with the first threaded section; the cosmetic disc has an iris texture area and a scleral texture area; an iris texture layer is formed in the iris texture area, and an artificial conjunctival vascular texture layer is formed in the scleral texture area;

[0012] Assemble the lens cylinder, the stent, and the cosmetic disc, specifically including: snap the connecting ring into the central mounting hole of the stent main body from top to bottom, and make the stent main body snap into the annular limiting groove of the connecting ring to complete the assembly of the stent;

[0013] The front end of the lens cylinder penetrates through the threaded hole of the connecting ring to coaxially screw the second threaded section with the threaded hole;

[0014] Coaxially screw the central connection hole of the cosmetic disc with the first threaded section together.

[0015] As a possible implementation, the outer diameter of the first threaded section is smaller than that of the second threaded section to form a limiting step at the connection;

[0016] The outer diameter of the second threaded section, the diameter of the optical axis section, and the diameter of the rear convex section are equal.

[0017] As a possible implementation, a turning process is used to manufacture the lens barrel. Configure a turning tool, and the turning tool is any one of a cemented carbide tool or a diamond tool; configure the lens barrel body, and the diameter of the lens barrel body is larger than that of the rear disc; there are multiple turning cycles, and the manufacturing of the lens barrel is completed after all turning cycles are executed cyclically; specifically including:

[0018] Turn the lens barrel body according to the first set of turning process parameters to form a first threaded section with a preset length;

[0019] Turn the lens barrel body according to the second set of turning process parameters to form a second threaded section with a preset length;

[0020] Turn the lens barrel body according to the third set of turning process parameters to form an optical axis section with a preset length;

[0021] Turn the lens barrel body according to the fourth set of turning process parameters to form a rear disc with a preset thickness;

[0022] Turn the lens barrel body according to the fifth set of turning process parameters to form a rear convex section with a preset length;

[0023] Among them, the first set of turning process parameters, the second set of turning process parameters, the third set of turning process parameters, the fourth set of turning process parameters, and the fifth set of turning process parameters all at least include turning speed, feed rate, and turning depth. The turning speed, feed rate, and turning depth are determined based on the cutting temperature, and the cutting temperature is less than or equal to the glass transition temperature of the lens barrel body;

[0024] Configure a circulating coolant during turning, and the coolant covers the lens barrel body.

[0025] As a possible implementation, the material of the lens barrel is polymethyl methacrylate, and the glass transition temperature of polymethyl methacrylate is 104.5 °C;

[0026] The turning speed is 7000 - 9000 r / min; the feed rate is less than or equal to the minimum value of the pitch in the first threaded section and the second threaded section; the turning depth is calculated according to the following formula:

[0027] Turning depth = (nominal diameter - feed rate × cos60°) / 2;

[0028] The coolant type is selected from at least one of aqueous coolant, ester coolant, and silicone oil coolant.

[0029] As a possible implementation, when machining polymethyl methacrylate using a milling process, control the feed per tooth to be less than or equal to 0.005 mm / tooth.

[0030] As a possible implementation, after the stent is stamped and formed, apply a coating process to form a hydroxyapatite layer on the surface of the stent.

[0031] As a possible implementation, after manufacturing the beauty disc using an injection molding process, the manufacturing method further includes:

[0032] Apply image processing and 3D printing to form an iris texture layer and a conjunctiva-like vascular texture layer on the beauty disc; or,

[0033] The iris texture layer and the conjunctiva-like vascular texture layer are at least one of a contact lens, a soft lens, an iris cover plate, or colored contact lenses attached to the beauty disc.

[0034] As a possible implementation, the stent body is made of medical-grade titanium metal, and the stamping process is a hot stamping process. The hot stamping process parameters include forming temperature, deformation speed, and friction coefficient; wherein, the forming temperature is 650°C to 670°C, the deformation speed is 1 mm·min -1 ~4 mm·min -1 and the friction coefficient is 0.1 to 0.4.

[0035] In a second aspect, the present invention further provides another manufacturing method for a one-piece implanted artificial cornea. The materials of the lens cylinder and the stent are both polymethyl methacrylate, and the material of the beauty disc is silicone hydrogel, hydrogel ionic material, or non-ionic material; the manufacturing method includes the following steps:

[0036] Manufacture the lens cylinder, which sequentially includes a first optical axis section, a threaded section, a second optical axis section, a rear disc, and a rear convex section from the front end to the rear end;

[0037] Manufacture the stent, and form an internal threaded hole on the inner wall of the central mounting hole of the stent. The internal thread matches the threaded section;

[0038] Manufacture the beauty disc using an injection molding process. The beauty disc has a central opening, and the opening diameter is smaller than the diameter of the first optical axis section; the beauty disc has an iris texture area and a sclera texture area; an iris texture layer is formed in the iris texture area, and a conjunctiva-like vascular texture layer is formed in the sclera texture area;

[0039] Assemble the lens cylinder, the stent, and the beauty disc. The front end of the lens cylinder passes through the central mounting hole of the stent to coaxially screw the threaded section and the internal threaded hole;

[0040] Set the beauty disc on the first optical axis section in an interference fit manner.

[0041] Compared with the prior art, the present invention has the following effects:

[0042] 1. A cosmetic disc is added to the artificial cornea, and a hole is opened in the center of the cosmetic disc. The cosmetic disc has an iris texture area of the same size as the cornea. On the one hand, it will not affect the refractive function that the artificial cornea must possess. On the other hand, an iris texture layer is formed in the iris texture area, which can simulate the appearance of a real eye;

[0043] 2. The cosmetic disc of the present invention can prevent biological tissue from growing into the front end face of the lens column body, reducing the occurrence of complications such as posterior membranes;

[0044] 3. Reduce tear evaporation, reduce the degree of dry eye after surgery, and reduce medication;

[0045] 4. No donor cornea is required, and the treatment of corneal blindness can be completed by a single implantation surgery;

[0046] 5. The stent is located on the outer surface of the cornea, with small surgical difficulty, small trauma, short healing period and good healing effect;

[0047] 6. Use a connecting ring made of the same material as the lens column and having internal threads on the inner wall, or use a stent and a lens column made of the same material to avoid damaging the lens column body during rotation. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The drawings described herein are used to provide a further understanding of the present invention, and constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

[0049] Figure 1 Schematic diagram of the overall structure of the artificial cornea provided by the embodiment of the present invention;

[0050] Figure 2 Schematic diagram of the structure of the lens column provided by the embodiment of the present invention;

[0051] Figure 3 Schematic diagram of the structure of the stent provided by the embodiment of the present invention;

[0052] Figure 4 Schematic diagram of the structure of the connection for the stent provided by the embodiment of the present invention;

[0053] Figure 5 Schematic diagram of the structure of another stent provided by the embodiment of the present invention.

[0054] 1 - lens column, 10 - lens column body, 11 - rear disc;

[0055] 2 - Bracket, 20 - Bracket body, 21 - Connecting ring, 210 - Internal thread, 211 - Annular limit groove, 212 - Notch, 213 - Pinhole;

[0056] 3 - Beauty tray. Detailed implementation mode

[0057] For the convenience of clearly describing the technical solutions of the embodiments of the present invention, in the embodiments of the present invention, terms such as "first" and "second" are used to distinguish the same items or similar items with basically the same functions and effects. For example, the first threshold and the second threshold are only used to distinguish different thresholds, and do not limit their sequence. Those skilled in the art can understand that terms such as "first" and "second" do not limit the quantity and execution order, and "first", "second", etc. do not necessarily mean different.

[0058] It should be noted that in the present invention, words such as "exemplary" or "for example" are used to represent examples, illustrations or explanations. Any embodiment or design solution described as "exemplary" or "for example" in the present invention should not be construed as more preferred or more advantageous than other embodiments or design solutions. Exactly, using words such as "exemplary" or "for example" is intended to present related concepts in a specific manner.

[0059] In the present invention, "at least one" means one or more, and "a plurality" means two or more. "And / or" describes the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone, where A and B can be singular or plural. The character " / " generally represents an "or" relationship between the front and rear associated objects. "At least one (piece) of the following" or its similar expressions refer to any combination of these items, including any combination of single item (piece) or plural items (pieces). For example, at least one (piece) of a, b or c can represent: a, b, c, the combination of a and b, the combination of a and c, the combination of b and c, or the combination of a, b and c, where a, b and c can be single or multiple.

[0060] See Figures 1 to 4 , the embodiments of the present invention provide a manufacturing method for a one - time implant artificial cornea, including the following steps:

[0061] S10. Manufacture the lens column 1. The lens column 1 sequentially includes a first threaded section, a second threaded section, an optical axis section, a rear disc 11 and a rear convex section from the front end to the rear end. The first threaded section, the second threaded section, the optical axis section and the rear convex section together constitute the lens column body 10 of the lens column 1.

[0062] Among them, the outer diameter of the first threaded section is smaller than that of the second threaded section to form a limiting step at the connection. In practical applications, when the beauty disc 3 is screwed onto the first threaded section, the limiting step serves as a reminder of the proper position and restricts the beauty disc 3 from sliding further downwards.

[0063] The pitch of each position of the second threaded section is equal.

[0064] In specific implementation, the lens column 1 can be manufactured by turning process, that is, the lens column 1 is integrally formed through the turning process. Specifically, it includes the following steps:

[0065] Configure a turning tool. When the material of the lens column 1 is polymethyl methacrylate, the turning tool can be a cemented carbide tool or a diamond tool. At the same time, configure the lens column body 10, and the lens column body 10 can be a cylindrical structure with a diameter larger than that of the rear disc, so that the lens column body 10 has an appropriate cutting amount. It should be understood that there are multiple turning cycles. In the previous turning cycle, the basic contour of the lens column 1 is formed, and at this time, the turning speed, feed rate, and turning depth are relatively large. In the subsequent turning cycle, the lens column 1 is precisely trimmed to make each part reach the preset size. Specifically, it includes the following steps:

[0066] Turn the lens column body 10 according to the first set of turning process parameters to form a first threaded section with a preset length;

[0067] Turn the lens column body 10 according to the second set of turning process parameters to form a second threaded section with a preset length;

[0068] Turn the lens column body 10 according to the third set of turning process parameters to form a light axis section with a preset length;

[0069] Turn the lens column body 10 according to the fourth set of turning process parameters to form a rear disc 11 with a preset thickness;

[0070] Turn the lens column body 10 according to the fifth set of turning process parameters to form a rear convex section with a preset length;

[0071] Among them, the first set of turning process parameters, the second set of turning process parameters, the third set of turning process parameters, the fourth set of turning process parameters, and the fifth set of turning process parameters all at least include turning speed, feed rate, and turning depth. The turning speed, feed rate, and turning depth are determined based on the cutting temperature, and the cutting temperature is less than or equal to the glass transition temperature of the lens column body. The glass transition temperature can be measured and obtained by differential scanning calorimetry (DSC). By measurement, the glass transition temperature of polymethyl methacrylate is 104.5 °C.

[0072] During the turning process, a circulating coolant is configured, and the coolant covers the lens column body. As an example, the coolant type is selected from at least one of aqueous coolants, ester coolants, and silicone oil coolants. For example, ethylene glycol-based or propylene glycol-based coolants, coolants containing organic additives such as silicate from brands like BASF Glysantin, etc. can be selected.

[0073] In the subsequent turning process, in order to ensure the dimensional accuracy of turning, the feed rate of the turning tool can be adjusted to the nanometer level.

[0074] Based on the above embodiments, the turning speed can be 7000 - 9000 r / min. For example, 7000 r / min, 7500 r / min, 8000 r / min, 8500 r / min, or 9000 r / min.

[0075] The feed rate of each section can be equal. However, as mentioned above, the feed rate of the previous process can be larger than that of the subsequent process. For example, the feed rate is less than or equal to the minimum value of the pitch in the first thread section and the second thread section. Or, within the previous turning cycle, the feed rate is equal to the maximum value of the pitch in the first thread section and the second thread section, while within the subsequent turning cycle, the feed rate is less than or equal to the minimum value of the pitch in the first thread section and the second thread section.

[0076] The cutting depth is calculated according to the following formula:

[0077] Cutting depth = (nominal diameter - feed rate × cos60°) / 2.

[0078] When processing polymethyl methacrylate using the milling process, control the feed per tooth to be less than or equal to 0.005 mm / tooth. With such a setting, the generation of burrs during the milling process can be minimized to optimize the machining accuracy of the lens column.

[0079] The diameter of the lens column body 10 is smaller than the diameter of the rear disc 11. Specifically, the diameter of the lens column body 10 is 2.0 - 3.5 mm. The diameter of the rear disc 11 is 2 - 4 mm larger than the diameter of the lens column body 10, that is, the diameter of the rear disc 11 is 4 - 7.5 mm. For example, the diameter of the lens column body 10 is 2 mm and the diameter of the rear disc 11 is 4 mm; the diameter of the lens column body 10 is 3 mm and the diameter of the rear disc 11 is 5 mm; the diameter of the lens column body 10 is 3.5 mm and the diameter of the rear disc 11 is 7.5 mm.

[0080] In practical applications, the corneal diameter is 11 mm and the drilling diameter is 2.5 mm. The diameter of the rear disc 11 is less than or equal to the sum of the corneal radius and the radius of the lens column body 10.

[0081] The total length of the lens column body 10 is 4.5 to 8.5 mm. Among them, the distance from the rear disc 11 to the rear end face (rear convex section) is 1 to 2 mm, the optical axis section from the rear disc 11 to the end of the threaded section is 0.2 to 0.5 mm, the rear disc 11 is 0.3 to 0.5 mm, and the threaded section (the sum of the first threaded section and the second threaded section) is 3 to 5.5 mm.

[0082] The diopter of the lens column 1 is 42 to 62 D. For example, 42 D, 45 D, 50 D, 55 D, 60 D or 62 D.

[0083] The bottom end of the side surface of the lens column body 10 behind the rear disc 11 to the rear end face is a square edge. With such a setting, it is difficult for the biological tissue around the square edge to grow past the square edge towards the rear end face, that is, it can prevent the continuously growing biological tissue from covering the rear end face of the lens column 1, thereby effectively avoiding the problem that the lens column 1 cannot transmit light due to being covered by the continuously growing biological tissue.

[0084] The square edge is one of a right-angle edge, an obtuse-angle edge or an acute-angle edge. The lens column body 10 behind the rear disc 11 is one of an equal-diameter structure, a structure with a gradually decreasing diameter or a structure with a gradually increasing diameter.

[0085] The lens column body 10 behind the rear disc 11 is one of an equal-diameter structure, a structure with a gradually decreasing diameter or a structure with a gradually increasing diameter.

[0086] A hydroxyapatite film layer is coated on the non-threaded section of the lens column body 10. When using atmospheric plasma spraying, the coating thickness is 30 to 150 microns, and the adhesion strength is at least 10 Mpa.

[0087] The lens column body 10 constitutes an optical device for replacing the eye's optical path, that is, light forms an image on the retina after passing through the lens column body 10.

[0088] An annular outer edge is provided forward on the outer periphery of the rear disc 11 to seal the rear disc 11 and the posterior surface of the cornea to prevent water leakage and infection.

[0089] The material of the lens column 1 is at least one of hydroxyethyl polymethacrylate, polymethyl methacrylate, bioceramics or optical glass.

[0090] S11. Manufacture the stent 2. The stent body is made of metal. The stent 2 includes a stent body 20 and a connecting ring 21. The stent body 20 is formed by stamping. After stamping, the stent body 20 has a central mounting hole and fins. The fins have weight-reducing holes. The inner wall of the weight-reducing hole has a notch 212. The position of the fins where there is no weight-reducing hole has a suture needle hole 213. The material of the connecting ring 21 is the same as or similar to that of the lens column body 10. The connecting ring 21 is manufactured by turning. After turning, the connecting ring 21 is a hollow stepped shaft structure that is larger at the top and smaller at the bottom. The inner wall of the hollow part has an internal thread 210 that matches the second threaded section of the lens column. An annular limiting groove 211 that is clamped with the stent body is provided at the axial position of the hollow stepped shaft structure.

[0091] When the stent 2 and the lens column 1 are made of different materials but need to move relative to each other in a threaded connection manner, the metal stent 2 will damage the threads of the lens column 1. The internal and external threaded sections of the same material can minimize the damage to each other during rotational movement when the relative displacement changes between the two. Moreover, the connecting ring 21 is inserted into the central mounting hole of the stent from front to back. When the stent 2 is rotated towards the ocular surface during the operation, the connecting ring 21 will not fall off into the eye from the central mounting hole.

[0092] When the stent 2 is a metal stent, in order to shorten the healing cycle between the stent 2 and the cornea and improve the healing effect, a layer of hydroxyapatite can be plated on the surface of the stent 2.

[0093] In order to improve the healing efficiency and effect between the metal stent and the ocular surface, a hydroxyapatite film layer can be plated on the metal stent. During the atmospheric plasma spraying process, the coating thickness is 30 - 150 microns, and the adhesion strength is at least 10 Mpa.

[0094] Structurally, the stent 2 can be a butterfly stent, a single-ring stent, a double-ring stent (with grid connecting pieces between the outer ring and the inner ring), or a mesh stent. Among them, the mesh stent is convenient for nutritional exchange between the front and rear tissues.

[0095] Since the stent 2 needs to fit the anterior surface of the cornea, it needs to have a certain curvature to ensure that the stent 2 can completely fit on the anterior surface of the cornea. Moreover, the stent 2 needs to have a certain rigidity, that is, after the stent 2 is fitted to the anterior surface of the cornea, it is not easily deformed or warped by force. The stent 2 also needs to have a certain flexibility. Since the corneal curvatures of different patients are different, the stent 2 with a certain flexibility can have a certain deformation space to adapt to corneas with different curvatures.

[0096] The bracket 2 is provided with a notch 212 or a pinhole 213 for facilitating suture fixation. With such a setting, it is convenient to suture and fix the bracket 2 on the ocular surface. After the radial side incision of the cornea is sutured, the human cornea is fixed on the posterior surface of the cornea. After the bracket 2 moves to fit the anterior surface of the cornea, the bracket 2 is sutured to the cornea by using the notch 212 or the pinhole 213.

[0097] The outer peripheral dimension of the bracket 2 is 8.5 mm to 10 mm. For example, the outer peripheral dimension of the bracket 2 is 8.5 mm, 9.0 mm, 9.5 mm or 10 mm.

[0098] The radius of curvature of the bracket 2 is 7.8 mm ± 2.0 mm. For example, the radius of curvature of the bracket 2 is 5.8 mm, 6.8 mm, 7.8 mm, 8.8 mm or 9.8 mm.

[0099] The bracket body is made of medical titanium metal, and the stamping process is a hot stamping process. The hot stamping process parameters include the forming temperature, the deformation speed and the friction coefficient; among them, the forming temperature is 650 °C to 670 °C, the deformation speed is 1 mm·min-1 to 4 mm·min-1, and the friction coefficient is 0.1 to 0.4.

[0100] S12. Manufacture the beauty disc 3. The material of the beauty disc 3 is resin and is manufactured by an injection molding process. The center of the beauty disc 3 is provided with a hole, and the inner wall of the hole has an internal thread screwed with the first thread section; the beauty disc 3 has an iris texture area and a scleral texture area; an iris texture layer is formed in the iris texture area, and a layer imitating the conjunctival vascular texture is formed in the scleral texture area.

[0101] A beauty disc 3 is coaxially arranged at the front end of the lens column 1, and a texture imitating a human eye is formed on the beauty disc 3, so that the artificial cornea is closer to a real human eye and the aesthetics is improved. Moreover, it will not affect the refractive function that the artificial cornea must possess. The beauty disc 3 provided by the embodiment of the present invention can prevent biological tissue from growing into the front end surface of the lens column body 10, reduce the occurrence of complications such as posterior membranes, that is, reduce the adverse impact on the diopter of the lens column 1. The beauty disc 3 is equivalent to a barrier on the ocular surface and is placed outside the ocular surface, which can reduce the evaporation of tears, that is, can reduce the degree of dry eye after surgery and reduce the use of medicine.

[0102] The iris texture layer and the layer imitating the conjunctival vascular texture are formed by applying image processing and 3D printing. That is, image processing technology is applied for feature extraction to generate images of the iris texture layer and the layer imitating the conjunctival vascular texture. Then 3D printing is applied to form the iris texture layer and the texture layer of the conjunctival blood vessels in the corresponding areas of the beauty disc 3. For example, high molecular density resin can be formed on the front surface of the beauty disc 3 by spraying or printing processes.

[0103] The iris texture layer and the artificial conjunctival vascular texture layer are any one of a corneal contact lens, a soft contact lens, an iris prosthesis, or colored contact lenses attached to the beauty disc 3.

[0104] The size of the beauty disc 3 is adapted to the size of the conjunctival sac. The beauty disc 3 may be a sheet-like structure in the shape of an ellipse with a certain curvature. Its major axis is 11 mm to 26 mm, and its minor axis is 5.5 mm to 11 mm. For example, the major axis is 11 mm and the minor axis is 5.5 mm, or the major axis is 26 mm and the minor axis is 11 mm.

[0105] The radius of curvature of the beauty disc 3 is 12 mm ± 3.0 mm. For example, specifically 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm.

[0106] The beauty disc 3 has a structure that is thicker in the middle and thinner at both sides. The material is resin, and the thickness is 0.05 to 0.5 mm. For example, the beauty disc 3 is thickest near the central hole, and its thickness is 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, or 0.5 mm.

[0107] To facilitate the installation of the resin beauty disc and the lens post body 10, a notch (not shown in the figure) for easy clamping may be provided at the edge of the resin beauty disc. The notches may be spaced and evenly distributed along the circumference of the resin beauty disc.

[0108] The beauty disc 3 is a resin beauty disc. At the position where the lens post body 10 is used to install the resin beauty disc, an external thread is provided, and the diameter is smaller than the diameter of other positions to form a limiting step; the inner wall of the central hole of the beauty disc 3 is provided with an internal thread corresponding to it.

[0109] The pitch of the threaded section at the installation position of the resin beauty disc is different from the pitch of the threaded section at the position for installing the bracket, so that the resin beauty disc will not continue to rotate downward after being installed in place. That is, the threaded sections with different pitches can play a limiting role.

[0110] S13. Assemble the lens post, the bracket, and the beauty disc. Assembling the lens post, the bracket, and the beauty disc specifically includes: snapping the connecting ring into the central mounting hole of the bracket body from top to bottom, so that the bracket body is snapped into the annular limiting groove of the connecting ring to complete the assembly of the bracket;

[0111] The front end of the lens post penetrates through the threaded hole of the connecting ring to coaxially screw the second threaded section with the threaded hole;

[0112] Coaxially screw the central connection hole of the beauty disc with the first threaded section together.

[0113] See Figure 5, Second aspect, the present invention also provides another manufacturing method for a one-time implant artificial cornea. The materials of the lens cylinder 1 and the stent 2 are both polymethyl methacrylate, and the material of the cosmetic disc 3 is silicone hydrogel, hydrogel ionic material or non-ionic material; the manufacturing method includes the following steps:

[0114] Manufacture the lens cylinder 1, which sequentially includes a first optical axis section, a threaded section, a second optical axis section, a rear disc and a rear convex section from the front end to the rear end;

[0115] Manufacture the stent 2, and an internal threaded hole is formed on the inner wall of the central mounting hole of the stent, and the internal thread matches the threaded section;

[0116] Manufacture the cosmetic disc 3 by injection molding. The cosmetic disc has a central opening, and the opening diameter is smaller than the diameter of the first optical axis section; the cosmetic disc has an iris texture area and a scleral texture area; an iris texture layer is formed in the iris texture area, and a pseudo-conjunctival vascular texture layer is formed in the scleral texture area;

[0117] Assemble the lens cylinder, the stent and the cosmetic disc. The front end of the lens cylinder penetrates through the central mounting hole of the stent to coaxially screw the threaded section and the internal threaded hole;

[0118] The cosmetic disc is sleeved on the first optical axis section in an interference fit manner.

[0119] The first optical axis section, the threaded section, the second optical axis section and the rear convex section are of equal diameter structure.

[0120] Although the present invention has been described in conjunction with various embodiments herein, however, in the process of implementing the claimed invention, those skilled in the art can understand and achieve other variations of the disclosed embodiments by viewing the drawings, the disclosure content, and the like. In the specification, the word "comprising" does not exclude other components or steps, and "a" or "one" does not exclude a plurality of situations. A single processor or other unit can implement several functions listed in the specification. Certain measures are recited in different embodiments, but this does not mean that these measures cannot be combined to produce good results.

[0121] Although the present invention has been described in conjunction with specific features and their embodiments, it is obvious that various modifications and combinations can be made without departing from the spirit and scope of the present invention. Accordingly, this specification and the drawings are only exemplary descriptions of the present invention and are considered to have covered any and all modifications, variations, combinations or equivalents within the scope of the present invention. Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the present invention and its equivalent technologies, the present invention also intends to include these changes and modifications.

Claims

1. A method for manufacturing a one-time implantable artificial cornea, characterized in that: The steps include: Manufacturing a mirror column, wherein the mirror column includes, from the front end to the rear end, a first thread segment, a second thread segment, an optical axis segment, a rear disc and a rear convex segment; A bracket is manufactured, wherein the bracket comprises a bracket body and a connecting ring, wherein the bracket body is made of metal; the bracket body is formed by stamping; the bracket body after stamping has a central mounting hole and a fin, wherein the fin has a weight-reducing hole, the inner wall of the weight-reducing hole has a suture groove, and the position of the fin without the weight-reducing hole has a suture needle hole; the material of the connecting ring is the same as or similar to that of the mirror column body, and the connecting ring is manufactured by turning; the connecting ring after turning is a hollow stepped shaft-like structure with a larger upper portion and a smaller lower portion, and the inner wall of the hollow portion has an internal thread matching the second thread segment of the mirror column; the hollow stepped shaft-like structure has an annular limiting groove that is clamped with the bracket body at the axis; the bracket body is made of medical metal titanium, and the stamping process is a hot stamping process, and the hot stamping process parameters include forming temperature, deformation speed and friction factor; wherein the forming temperature is 650°C to 670°C, and the deformation speed is 1 mm·min -1 ~4mm·min -1 , the friction coefficient is 0.1~0.4; A cosmetic tray is manufactured, wherein the cosmetic tray is made of resin and is manufactured by an injection molding process, wherein a hole is opened in the center of the cosmetic tray, and an inner wall of the hole has an internal thread screwed to the first thread segment; the cosmetic tray has an iris texture area and a sclera texture area; an iris texture layer is formed in the iris texture area, and a bulbar conjunctival vascular texture layer is formed in the sclera texture area; Assembling the mirror column, the bracket and the beauty tray specifically includes: inserting the connecting ring into the central mounting hole of the bracket body from top to bottom, so that the bracket body is inserted into the annular limiting groove of the connecting ring to complete the assembly of the bracket; The front end of the mirror column passes through the threaded hole of the connecting ring so that the second threaded section is coaxially screwed to the threaded hole; The central connecting hole of the beauty tray is coaxially screwed together with the first threaded section.

2. The method for manufacturing a one-time implantable artificial cornea according to claim 1, characterized in that: The outer diameter of the first thread segment is smaller than the outer diameter of the second thread segment, so as to form a limiting step at the connection; The outer diameter of the second threaded section, the diameter of the optical axis section and the diameter of the rear convex section are equal.

3. The method for manufacturing a one-time implantable artificial cornea according to claim 2, characterized in that: The mirror column is manufactured by a turning process, and a turning tool is provided, wherein the turning tool is any one of a carbide tool and a diamond tool; a mirror column body is provided, wherein the diameter of the mirror column body is larger than the diameter of the rear disc; a plurality of turning cycles are provided, and the manufacturing of the mirror column is completed after all turning cycles are cyclically executed; specifically, the process includes: Turning the mirror column body according to a first set of turning process parameters to form a first thread segment of a preset length; Turning the mirror column body according to a second set of turning process parameters to form a second thread segment of a preset length; Turning the mirror column body according to a third set of turning process parameters to form an optical axis segment of a preset length; Turning the mirror column body according to the fourth group of turning process parameters to form a rear plate of a preset thickness; Turning the mirror column body according to the fifth group of turning process parameters to form a rear convex section of a preset length; The first group of turning process parameters, the second group of turning process parameters, the third group of turning process parameters, the fourth group of turning process parameters and the fifth group of turning process parameters all include at least a turning speed, a feed rate and a turning depth, and the turning speed, the feed rate and the turning depth are determined based on a cutting temperature, and the cutting temperature is less than or equal to a glass transition temperature of the mirror column body; During the turning process, a circulating coolant is provided, which covers the mirror column body.

4. The method for manufacturing a one-time implantable artificial cornea according to claim 3, characterized in that: The mirror column is made of polymethyl methacrylate, and the glass transition temperature of polymethyl methacrylate is 104.5°C; The turning speed is 7000-9000 r / min; the feed rate is less than or equal to the minimum value of the pitch in the first thread segment and the second thread segment; the turning depth is calculated according to the following formula: Turning depth = (nominal diameter - feed rate × cos60°) / 2; The coolant type is selected from at least one of aqueous coolant, ester coolant, and silicone oil coolant.

5. The method for manufacturing a one-time implantable artificial cornea according to claim 3, characterized in that: When the milling process is used to process polymethyl methacrylate, the feed amount per tooth is controlled to be less than or equal to 0.005 mm / tooth.

6. The method for manufacturing a one-time implantable artificial cornea according to claim 1, characterized in that: After the stent is stamped and formed, a coating process is applied to form a hydroxyapatite layer on the surface of the stent.

7. The method for manufacturing a one-time implantable artificial cornea according to claim 1, characterized in that: After the beauty tray is formed by injection molding, the manufacturing method further comprises: Applying image processing and 3D printing to form an iris texture layer and a bulbar conjunctival vascular texture layer on the beauty tray; or, The iris texture layer and the imitation bulbar conjunctiva blood vessel texture layer are at least one of a corneal contact lens, a contact lens, an iris cover lens or a cosmetic contact lens attached to the cosmetic tray.

8. A method for manufacturing a one-time implantable artificial cornea, characterized in that: The mirror column and the bracket are made of polymethyl methacrylate, and the material of the beauty tray is silicone hydrogel, hydrogel ionic material or non-ionic material; the manufacturing method comprises the following steps: Manufacturing a mirror column, wherein the mirror column includes, from the front end to the rear end, a first optical axis section, a threaded section, a second optical axis section, a rear disk, and a rear convex section; A bracket is manufactured, wherein the bracket has a central mounting hole and a fin, wherein the inner wall of the central mounting hole of the bracket is manufactured to form an internal threaded hole, wherein the internal thread matches the threaded section; the fin has a weight-reducing hole, wherein the inner wall of the weight-reducing hole has a suture groove, and the position of the fin other than the weight-reducing hole has a suture needle hole; The cosmetic tray is manufactured by injection molding, wherein the cosmetic tray has a central opening, and the opening diameter is smaller than the diameter of the first optical axis segment; the cosmetic tray has an iris texture area and a sclera texture area; the iris texture area is formed with an iris texture layer, and the sclera texture area is formed with a bulbar conjunctival vascular texture layer; Assembling the mirror column, the bracket and the beauty tray, wherein the front end of the mirror column passes through the central mounting hole of the bracket so that the threaded section is coaxially screwed with the internal threaded hole; The beauty tray is sleeved on the first optical axis segment in an interference fit manner.

9. According to the method for manufacturing a one-time implantable artificial cornea as described in claim 8, the first optical axis segment, the threaded segment, the second optical axis segment and the posterior convex segment are of equal diameter structures.

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