Keratoprosthesis

Abstract

A keratoprosthesis (100), comprising a support (10) and a lens column (30), the lens column (30) comprising a body (31) and a collar (32). A middle part of the support (10) is provided with a mounting hole (10A), a hole wall of which being provided with an internal thread (111), and the outer peripheral wall of the collar (32) being provided with an external thread (321) fitting with the internal thread (111), so as to detachably assemble the support (10) and the collar (32). The material of the body (31) is polymethyl methacrylate, so as to provide a reliable light path structure, and the collar (32) is titanium metal. The body (31) and the collar (32) are integrally formed, such that the collar (32) is sleeved on the body (31) so as to form a lens column (30), and the outer peripheral wall of the body (31) is provided with a limiting slot (31D) for limiting the collar (32). The support (10) is titanium metal, such that the internal thread (111) and the external thread (321) are metal threads of the same material, and the heat shrinkage ratios of structures of the same material undergoing a temperature change are the same, so that a joint has a high assembly reliability and does not separate or fall off unless an external force is applied thereto. The service life of the artificial cornea is increased, surgical risks are reduced, a patient is protected from secondary injury or being blinded again, and use satisfaction is increased.

Description

artificial cornea

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on September 18, 2023, with application number 202311199721.5 and application name “Artificial Cornea”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to an artificial cornea. Background Art

[0003] The human eye is an extremely complex and delicate organ. The transparent anterior sixth of the outermost layer of the eyeball, known as the cornea, plays a crucial role in visual imaging. The World Health Organization released the first global report on vision, stating that over 2.2 billion people worldwide suffer from visual impairment or blindness, with approximately 60 million people suffering from corneal blindness. For patients with vision impairment caused by corneal opacity due to various reasons, corneal transplantation is often the most effective rehabilitation option, and most corneal blind patients can regain their sight through conventional donor cornea transplantation.

[0004] However, due to factors such as the limited number of donor corneas, inaccessible corneal databases, and the inadequate utilization of limited corneas, corneal donors remain in severe short supply. Developing artificial corneas has long been a pursuit for scientists. Furthermore, corneal blindness patients who have suffered severe corneal thermal burns or chemical injuries that have resulted in neovascularization are more likely to experience post-operative rejection of a donor cornea transplant, potentially leading to the failure of vision restoration surgery.

[0005] An artificial cornea is a product made of medical polymer materials that resembles the human cornea. In related technologies, an artificial cornea consists of two parts: an optical column and a support. The optical column is made of a transparent material with excellent optical properties and stable physical and chemical properties, and is used to replace the cloudy cornea that blocks the eye's optical pathway after disease. The support serves as a bridge connecting the optical column and surrounding tissue. Currently, most artificial corneas on the market consist of a support made of titanium plates or titanium foil and a PMMA column. Long-term wear can cause the connection between the two to separate and fall off, not only failing the optical restoration function but also potentially causing secondary eye injury.

[0006] Summary of the Invention

[0007] The main purpose of the present invention is to provide an artificial cornea, aiming to solve the technical problem that the existing titanium bracket and PMMA lens column are easy to fall off after long-term wear, causing damage to human eye tissue or blindness again.

[0008] To achieve the above-mentioned purpose, the artificial cornea proposed in the present invention includes a bracket and a lens column;

[0009] The bracket is made of titanium metal, a mounting hole is provided in the middle of the bracket, the hole wall of the mounting hole is provided with an internal thread, and the mirror column is detachably arranged in the mounting hole;

[0010] The mirror column includes a body and a ring, the body is made of polymethyl methacrylate, and the ring is made of titanium metal;

[0011] The body is in-situ synthesized into one piece in the collar by photopolymerization or the body is formed into one piece with the collar by melt casting, and a limiting groove is provided on the outer peripheral wall of the body;

[0012] The collar is sleeved on the body to form the mirror column. The collar is limited in the limiting groove. The outer peripheral wall of the collar is provided with an external thread adapted to the internal thread.

[0013] In one embodiment of the present invention, the diameter of the collar is 1.5 mm to 5 mm, and the axial length of the collar is 0.5 mm to 4 mm;

[0014] The middle part of the collar is provided with a fixing hole, the hole wall of the fixing hole is provided with a first limiting portion, the outer peripheral wall of the body corresponding to the position of the fixing hole is provided with a second limiting portion, and the second limiting portion is snap-fitted with the first limiting portion.

[0015] In one embodiment of the present invention, a plurality of first limiting portions are provided at intervals, and the plurality of first limiting portions correspond to the second limiting portions one by one;

[0016] And / or, a plurality of first limiting portions are provided, and the plurality of first limiting portions are spaced apart along the circumferential direction or axial direction of the collar;

[0017] And / or, the first limiting portions are distributed in a ring shape along the circumferential direction;

[0018] And / or, one of the first limiting portion and the second limiting portion is a groove, and the other is a protrusion, and the protrusion is limited in the groove.

[0019] In one embodiment of the present invention, the main body includes an introduction section, a fixed section, an outlet section, and an exposure section sequentially connected along the axial direction;

[0020] The end of the introduction section away from the fixed section is provided with an inner concave surface;

[0021] The introduction section and the outlet section cooperate with the outer periphery of the fixed section to form the limiting groove;

[0022] An outer convex surface is provided on a side of the exposure section facing away from the lead-out section, corresponding to the inner concave surface.

[0023] In one embodiment of the present invention, the inner concave surface is a spherical surface, and the spherical radius of the inner concave surface is 5 mm to 40 mm;

[0024] And / or, the outer convex surface is a spherical surface, and the spherical radius of the outer convex surface is 5 mm to 9 mm;

[0025] And / or, the diameter of the introduction section is 1.5 mm to 5 mm, and the axial length of the introduction section is 1 mm to 3 mm;

[0026] And / or, the diameter of the lead-out section is 1.5 mm to 5 mm, and the axial length of the lead-out section is 1 mm to 4 mm;

[0027] And / or, the diameter of the exposed section is 1.5 mm to 11 mm, and the axial length of the exposed section is 0.2 mm to 3 mm.

[0028] In one embodiment of the present invention, the bracket comprises:

[0029] A connecting piece, wherein the mounting hole is provided in the middle of the connecting piece;

[0030] A support member, wherein the support member is provided with a support cavity, and the connecting member is provided in the support cavity; and

[0031] At least two transition pieces are provided at intervals in the support cavity, and two ends of each transition piece are respectively connected to the connecting piece and the support piece.

[0032] In one embodiment of the present invention, the surface on which the support member is located is an arc-shaped curved surface, the connecting member is arranged corresponding to the arc-shaped curved surface, and the curvature radius of the arc-shaped curved surface is infinitely close to the curvature radius of the human cornea.

[0033] In one embodiment of the present invention, the support member is annular;

[0034] Alternatively, the support member is circular or elliptical.

[0035] In one embodiment of the present invention, the artificial cornea further comprises a plug, and the peripheral wall of the plug is provided with a threaded section;

[0036] The artificial cornea has a first state and a second state, and in the first state, the threaded section of the plug and the internal thread of the bracket are detachably assembled;

[0037] In the second state, the external thread of the mirror column and the internal thread of the bracket are detachably assembled.

[0038] The artificial cornea of ​​the present invention comprises a support and a lens post. The lens post comprises a body for forming an optical path and a collar for connecting to the support. A mounting hole is provided in the center of the support, and the wall of the mounting hole is provided with an internal thread. The outer wall of the collar is provided with an external thread that matches the internal thread. The support and collar are detachably assembled by the internal and external threads. The body is made of polymethyl methacrylate to provide a reliable optical path, and the collar is made of titanium. The body is synthesized in situ within the collar by photopolymerization or formed integrally with the collar by melt casting, so that the collar is sleeved onto the body to form the lens post. A retaining groove is provided on the outer wall of the body, and the collar is retained within the retaining groove. Both the collar and the support are made of titanium, ensuring that the internal and external threads are made of the same metal. Structures made of the same material have the same thermal shrinkage ratio under temperature changes, resulting in a highly reliable connection and preventing separation or disengagement without external forces. This extends the lifespan of the artificial cornea, prevents secondary injury or blindness, and improves patient satisfaction. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0040] FIG1 is a schematic diagram of the three-dimensional structure of an artificial cornea according to an embodiment of the present invention;

[0041] FIG2 is a schematic side view of the structure of an artificial cornea according to an embodiment of the present invention;

[0042] FIG3 is a schematic diagram of the three-dimensional structure of the mirror column of an artificial cornea according to an embodiment of the present invention;

[0043] FIG4 is a schematic front cross-sectional view of a lens column of an artificial cornea according to an embodiment of the present invention;

[0044] FIG5 is a schematic diagram of the three-dimensional structure of the ring of an artificial cornea according to an embodiment of the present invention;

[0045] FIG6 is a schematic diagram of a top cross-sectional structure of a ring of an artificial cornea according to an embodiment of the present invention;

[0046] FIG7 is a schematic diagram of the three-dimensional structure of the main body of an artificial cornea according to an embodiment of the present invention;

[0047] FIG8 is a schematic frontal cross-sectional view of the main body of an artificial cornea according to an embodiment of the present invention;

[0048] FIG9 is a schematic top view of the structure of a bracket of an artificial cornea according to an embodiment of the present invention;

[0049] FIG10 is a schematic diagram of the three-dimensional structure of the embolization of another embodiment of the artificial cornea of ​​the present invention.

[0050] Description of Figure Numbers:

[0051] The purpose, features and advantages of the present invention will be further described with reference to the accompanying drawings and in conjunction with the embodiments. DETAILED DESCRIPTION

[0052] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0053] It should be noted that all directional indications in the embodiments of the present invention (such as up, down, left, right, front, back, etc.) are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0054] In the present invention, unless otherwise specified or limited, the terms "connected" and "fixed" should be understood in a broad sense. For example, "fixed" can mean fixed connection, detachable connection, or integration; it can mean direct connection or indirect connection through an intermediate medium; it can mean internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0055] In addition, in the present invention, descriptions such as "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the meaning of "and / or" appearing throughout the text is to include three parallel solutions. Taking "A and / or B as an example", it includes solution A, or solution B, or solutions that meet both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in this field to implement them. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0056] The human eye is an extremely complex and delicate organ. The transparent anterior sixth of the outermost layer of the eyeball, known as the cornea, plays a crucial role in visual imaging. The World Health Organization released the first global report on vision, stating that over 2.2 billion people worldwide suffer from visual impairment or blindness, with approximately 60 million people suffering from corneal blindness. For patients with vision impairment caused by corneal opacity due to various reasons, corneal transplantation is often the most effective rehabilitation option, and most corneal blind patients can regain their sight through conventional donor cornea transplantation.

[0057] However, due to factors such as the limited number of donor corneas, inaccessible corneal databases, and the inadequate utilization of limited corneas, corneal donors remain in severe short supply. Developing artificial corneas has long been a pursuit for scientists. Furthermore, corneal blindness patients who have suffered severe corneal thermal burns or chemical injuries that have resulted in neovascularization are more likely to experience post-operative rejection of a donor cornea transplant, potentially leading to the failure of vision restoration surgery.

[0058] An artificial cornea is a product made of medical polymer materials that resembles the human cornea. In related technologies, an artificial cornea consists of two parts: an optical column and a support. The optical column is made of a transparent material with excellent optical properties and stable physical and chemical properties, and is used to replace the cloudy cornea that blocks the eye's optical pathway after disease. The support serves as a bridge connecting the optical column and surrounding tissue. Currently, most artificial corneas on the market consist of a support made of titanium plates or titanium foil and a PMMA column. Long-term wear can cause the connection between the two to separate and fall off, not only failing the optical restoration function but also potentially causing secondary eye injury.

[0059] The present invention proposes an artificial cornea 100. It should be noted that the human eye is an extremely complex and delicate organ. The transparent anterior 1 / 6 of the outermost layer of the eyeball wall is the cornea, which we are familiar with. Composed primarily of avascular connective tissue, it is approximately 1 mm thick and resembles a convex-concave lens, refracting light and playing a vital role in visual imaging. The artificial cornea 100's support 10 and lens column 30 are both safe biological implant materials, reducing postoperative rejection and facilitating the attachment and growth of human eye tissue to the support 10 and lens column 30.

[0060] In existing clinical surgical applications, the artificial cornea 100 comprises a support 10 made of titanium or a titanium alloy, and a lens post 30 made of PMMA (polymethyl methacrylate). Internal threads 111 and external threads 321 are provided on the titanium support 10 and PMMA lens post 30, respectively, to facilitate detachable connection between the support 10 and lens post 30. Due to the differences in the materials, the toughness, brittleness, and thermal contraction ratios of the two materials differ. The artificial cornea 100 needs to remain in the patient's eye for several years or even decades after surgery. The connection between the PMMA lens post 30 and the titanium support 10 exhibits different mechanical structures, and the thermal contraction ratios generated by heat also vary with temperature. In other words, the different expansion coefficients of the different materials result in uneven stress at the connection between the two components, leading to misalignment and compression at the connection. This can, in mild cases, partially affect the patient's vision, while in severe cases, it can cause the support 10 and lens post 30 to detach and fall into the ocular tissue, ultimately resulting in secondary eye injury and the need for further surgery. In severe cases, it can damage the ocular tissue and prevent vision restoration.

[0061] Referring to Figures 1 to 10, Figure 1 is a schematic diagram of the three-dimensional structure of an embodiment of an artificial cornea 100 of the present invention; Figure 2 is a schematic diagram of the side structure of an embodiment of an artificial cornea 100 of the present invention; Figure 3 is a schematic diagram of the three-dimensional structure of the mirror column 30 of an embodiment of an artificial cornea 100 of the present invention; Figure 4 is a schematic diagram of the front sectional structure of the mirror column 30 of an embodiment of an artificial cornea 100 of the present invention; Figure 5 is a schematic diagram of the three-dimensional structure of the ring 32 of an embodiment of an artificial cornea 100 of the present invention; Figure 6 is a schematic diagram of the top sectional structure of the ring 32 of an embodiment of an artificial cornea 100 of the present invention; Figure 7 is a schematic diagram of the three-dimensional structure of the main body of an embodiment of an artificial cornea 100 of the present invention; Figure 8 is a schematic diagram of the front sectional structure of the main body of an embodiment of an artificial cornea 100 of the present invention; Figure 9 is a schematic diagram of the top structure of the bracket 10 of an embodiment of an artificial cornea 100 of the present invention; Figure 10 is a schematic diagram of the three-dimensional structure of the embolism 50 of another embodiment of an artificial cornea 100 of the present invention.

[0062] In an embodiment of the present invention, the artificial cornea 100 includes a support 10 and a lens post 30. The support 10 is made of titanium. As shown in Figures 1 to 4 and 9, a mounting hole 10A is provided in the center of the support 10, and the wall of the mounting hole 10A is provided with an internal thread 111. The lens post 30 is removably mounted in the mounting hole 10A and comprises a body 31 and a collar 32. The body 31 is made of polymethyl methacrylate, and the collar 32 is made of titanium. The body 31 is in-situ synthesized within the collar 32 by photopolymerization or integrally formed with the collar 32 by melt casting, so that the collar 32 is sleeved onto the body 31 to form the lens post 30. The collar 32 is sleeved onto the body 31. The outer peripheral wall of the body 31 is provided with a retaining groove 31D, within which the collar 32 is retained. The outer peripheral wall of the collar 32 is provided with external threads 321 that mate with the internal threads 111.

[0063] The artificial cornea 100 of the present invention comprises a support 10 and a lens column 30. The lens column 30 comprises a body 31 for forming an optical path and a collar 32 for connecting to the support 10. A mounting hole 10A is defined in the center of the support 10, with an internal thread 111 formed in the wall of the mounting hole 10A. The outer wall of the collar 32 is provided with an external thread 321 that mates with the internal thread 111. The support 10 and the collar 32 are detachably assembled by the internal and external threads 111 and 321. The body 31 is in-situ synthesized within the collar 32 by photopolymerization or integrally molded with the collar 32 by melt casting. The collar 32 is sleeved onto the body 31 to form the lens column 30. Along the axial direction of the lens column 30, the ends of the body 31 protrude beyond the ends of the collar 32. A retaining groove 31D is defined on the outer wall of the molded body 31, and the collar 32 is retained within the retaining groove 31D. The body 31 of the artificial cornea 100 of the present invention is made of polymethyl methacrylate to provide a reliable optical path. The collar 32 and bracket 10 are both made of titanium, ensuring that both the internal thread 111 and the external thread 321 are made of the same metal. Structures made of the same material have the same thermal shrinkage ratio under temperature fluctuations, resulting in highly reliable assembly at the joint and preventing unintentional separation or dislodgement. This extends the lifespan of the artificial cornea 100, prevents secondary injury or blindness, and improves user satisfaction.

[0064] Compared to existing technologies, the assembleable fixed-wing artificial cornea 100 designed in this invention is essentially a specialized refractive device based on artificial assembly. It can replace the cloudy cornea that affects the eye's optical pathways after disease, and by leveraging its transparent refractive matrix, it can restore vision to patients. Due to the excellent biocompatibility of the materials used, it easily heals with surrounding tissues and is less susceptible to post-transplant rejection. It is suitable for patients with bilateral turbid blindness who have failed conventional corneal transplants, including those suffering from severe chemical burns, severe corneal vascularization caused by various etiologies, and severe dry eye.

[0065] Furthermore, the external thread 321 of the ring 32 cooperates with the internal thread 111 of the bracket 10 to fix the entire mirror column 30, which has stronger structural stability and can also be effectively sealed to prevent leakage of intraocular fluid. The use of a medical titanium metal ring 32 and the inner ring of the bracket 10 will be tighter and not easy to fall off during the actual assembly process, effectively reducing various accidental risks during the surgical implantation process, improving the success rate of postoperative recovery, and the relative position of the mirror column 30 can be adjusted within a certain range.

[0066] Furthermore, the material used for the main body 31 of the lens column 30 is polymethyl methacrylate, abbreviated as PMMA. Polymethyl methacrylate is a transparent carbon-containing high-molecular inert organic substance. The corneal tissue has good tolerance to it, has high light transmittance and refractive index, stable performance, high resistance to aging and environmental changes, is non-biodegradable, resistant to acids, alkalis and organic solvents, is light and not easy to break, has strong plasticity, and is easy to process.

[0067] In one embodiment of the present invention, the main body 31 is synthesized in situ in the ring 32 by photopolymerization and is molded into one piece with the ring 32 to form the mirror column 30; or, the main body 31 is molded into one piece with the ring 32 by melt casting to form the mirror column 30.

[0068] Furthermore, in the artificial cornea 100 structure of the present invention, the lens post 30 is cylindrical, and the radial cross-section of the lens post 30 is circular. The collar 32 and body 31 that constitute the lens post 30 are integrally formed and can be prefabricated to form a single piece. The external threads 321 on the outer periphery of the collar 32 of the lens post 30 are then threadedly assembled with the internal threads 111 of the support 10 to achieve detachable assembly of the lens post 30 and the support 10.

[0069] During the manufacturing process, the ring 32 is an annular structure made of titanium metal, and a fixing hole 32A may be provided in the middle of the annular structure. The prefabricated ring 32 is placed in a photopolymerization mold or a casting mold, so that the main body 31 is synthesized in situ in the ring 32 by photopolymerization and formed into an integral mirror column 30 with the ring 32, or the main body 31 is formed into an integral body with the ring 32 by melt casting to form the mirror column 30.

[0070] The raw material for making the main body 31 is placed in a mold with a ring 32 pre-placed therein. Through photopolymerization and curing, the main body 31 is formed in the fixing hole 32A of the ring 32, and continues to be synthesized along the axial extension direction from the fixing hole 32A, so that the two ends of the main body 31 protrude from the two ends of the ring 32 along the axial direction.

[0071] In the molten casting mold, the collar 32 is placed in the mold in advance, and then the main body 31 raw material is melted into a liquid state and then injected into the mold. The liquid main body 31 raw material fills the molding cavity of the mold to form a main body 31 that is partially penetrated into the fixing hole 32A of the collar 32 and extends in opposite directions at both ends, so that the collar 32 and the main body 31 of different materials are integrally formed, which facilitates the detachable assembly of the external thread 321 of the collar 32 made of titanium metal and the internal thread 111 of the bracket 10 made of the same material.

[0072] The collar 32 and body 31 are preformed integrally through photopolymerization or melt casting, where the light can be ultraviolet light. This improves the structural stability of the mirror column 30, preventing relative displacement between the collar 32 and body 31, which are made of different materials. This improves the structural stability of the mirror column 30. Since threads made of the same material have the same coefficient of expansion due to temperature fluctuations, uneven force at the joint due to thermal expansion is avoided, thus improving the structural stability of the assembly of the mirror column 30 and the bracket 10.

[0073] The axial extension of the lens column 30 and the support 10 is defined as the length direction, and the radial extension is defined as the thickness direction. In clinical medical applications, the artificial cornea 100, corresponding to the human cornea region, requires relatively precise structural accuracy and a compact size. To facilitate clinical surgery and post-operative wound suturing, the radial cross-sectional area of ​​the support 10 of the artificial cornea 100 is smaller than the area of ​​the human iris region.

[0074] It should be noted that the collar 32 and body 31 are integrally formed. A fixing hole 32A is formed in the center of the collar 32. The portion of the body 31 formed within the fixing hole 32A not only enhances the reliability of the integral molding, but also provides the collar 32 with a certain radial thickness. Furthermore, the thickness of the portion of the stent 10 connecting to the collar 32, excluding the mounting hole 10A, is also limited. Therefore, creating the internal thread 111 or external thread 321 on the small, high-precision artificial cornea 100 component is a highly challenging operation, difficult to achieve with the precision of existing equipment.

[0075] In one embodiment of the present invention, the diameter of the collar 32 is 1.5 mm to 5 mm, and the axial length of the collar 32 is 0.5 mm to 4 mm.

[0076] In a specific embodiment of the present invention, the external threads 321 and internal threads 111 on the collar 32 and stent 10 are formed separately by milling. The collar 32 is made of titanium, has an axial length of 0.8 mm to 4 mm, a diameter of 1.5 mm to 5 mm, and a thickness of 0.3 mm to 0.8 mm. The dimensions of the collar 32 are customized based on the patient's condition and are not intended to be exclusive.

[0077] For example, taking the maximum diameter of the collar 32 as 5 mm, assuming that a fixing hole 32A with a diameter of 3.5 mm is opened in the collar 32, the annular wall thickness of the collar 32 is about 0.8 mm, and the collar 32 is subjected to a milling process on the outer wall of the hole with a thickness of 0.8 mm to form an external thread 321. The milling process has relatively high precision and difficulty, and the equipment used is also high-precision and high-cost equipment.

[0078] The thickness of the portion of the stent 10 connected to the collar 32, excluding the mounting hole 10A, can be set to 0.1mm to 2mm. The diameter of the mounting hole 10A can be set to correspond to the outer diameter of the collar 32, that is, the diameter of the mounting hole 10A can be 1.5 to 5mm. For example, in a stent 10 with a collar 32 having a maximum thickness of 2mm, the stent 10 uses a milling process to form internal threads 111 on the inner wall of the 2mm-thick hole within the mounting hole 10A with a diameter of 5mm. The threads are formed on the outer periphery of the collar 32 of the same material while ensuring the structural stability of the collar 32 and the mechanical balance of the connection between the two, thereby extending the post-operative service life of the artificial cornea 100.

[0079] The preparation of the accessories of the above-mentioned artificial cornea 100 has higher requirements on the processing head, processing accuracy, processing control and operation technology of the milling equipment for processing the internal thread 111 or the external thread 321 than the existing artificial cornea 100, and the production cost is high. Equipment that meets the requirements can improve the production yield of accessories and extend the service life of the artificial cornea 100 after the accessories are assembled.

[0080] As shown in Figures 4 to 6, in one embodiment of the present invention, a fixing hole 32A is provided in the middle of the ring 32, and a first limiting portion 322 is provided on the hole wall of the fixing hole 32A. A second limiting portion 315 is provided on the outer peripheral wall of the main body 31 corresponding to the position of the fixing hole 32A, and the second limiting portion 315 is snap-fitted with the first limiting portion 322.

[0081] In this embodiment, the collar 32 includes a ring body 323 with a fixing hole 32A defined in the middle. The middle portion of the body 31 is positioned within the fixing hole 32A, and the ends of the body 31 extend beyond the axial ends of the collar 32. A first stopper 322 is provided on the contact surface of the collar 32 corresponding to the body 31. The first stopper 322 is formed on the wall of the fixing hole 32A in the middle portion of the ring body 323. A second stopper 315 is provided on the outer circumferential wall of the body 31 corresponding to the connection with the collar 32. The second stopper 315 engages with the first stopper 322, enhancing the connection reliability between the collar 32 and the body 31. It also serves to limit relative displacement between the body 31 and the collar 32 in the axial or radial directions. This ensures that the integrally formed mirror column 30 has a high structural stability, is resistant to external forces such as knobs or pulls, and has a long service life.

[0082] It can be understood that the radial cross-section of the lens column 30 is circular. In the respective cross-sections of the main body 31 and the ring 32, the radial cross-sections of the main body 31 extending in the axial direction are multiple circles of different diameters, and the cross-section of the ring 32 is annular. Since the overall structural volume of the artificial cornea 100 is relatively small, the influence of the first limiting portion 322 and the second limiting portion 315 on the cross-sectional shapes of the two can be considered negligible.

[0083] In one embodiment of the present invention, a plurality of first limiting portions 322 are provided and distributed at intervals, and the plurality of first limiting portions 322 correspond one-to-one to the second limiting portions 315 ;

[0084] And / or, a plurality of first limiting portions 322 are provided, and the plurality of first limiting portions 322 are spaced apart along the circumferential direction or axial direction of the collar 32;

[0085] And / or, the first limiting portion 322 is distributed in a ring shape along the circumferential direction;

[0086] And / or, one of the first limiting portion 322 and the second limiting portion 315 is a groove, and the other is a protrusion, and the protrusion is limited in the groove.

[0087] In this embodiment, the first limiting portions 322 correspond to the second limiting portions 315 in a one-to-one manner, wherein the correspondence includes the correspondence in number, shape, and arrangement position between the first limiting portions 322 and the second limiting portions 315 .

[0088] Based on the above correspondence, in one embodiment, one of the first limiting portion 322 and the second limiting portion 315 is a groove, and the other is a protrusion. The protrusion is retained in the groove to strengthen the connection between the collar 32 and the body 31. For example, a groove is provided inside the fixing hole 32A of the collar 32 as the first limiting portion 322, and a protrusion is provided on the outer periphery of the body 31 as the second limiting portion 315. The groove can be a dot-shaped groove, a straight groove, a curved groove, or an annular groove connected end to end, and the protrusion is adapted to fit the groove.

[0089] Based on the structural arrangement of the protrusions and grooves in the above embodiment, the first limiting portion 322 in another embodiment can be provided as one or more. When there is one groove, the groove can be a point-shaped groove, a straight groove, a curved groove, or an annular groove connected end to end; when there are multiple grooves, the grooves can be multiple single point-shaped grooves, straight grooves, curved grooves, or annular grooves connected end to end, or a free combination of the above groove types. Multiple protrusions can be adapted to multiple grooves, and no exhaustive list is provided here.

[0090] In another embodiment, the first limiting portion 322 and the second limiting portion 315 are respectively provided in plurality, and the grooves of the plurality of first limiting portions 322 are distributed in a point shape or an annular shape, and can be distributed regularly or irregularly, as long as the connection stability between the lifting ring 32 and the main body 31 is satisfied.

[0091] Furthermore, one end of the body 31 extends into the eye and has an inner concave surface 31A, while the other end, exposed at the iris, has an outer convex surface 31B. These inner concave surface 31A and outer convex surface 31B are curved on the same side of the body 31 to form a curved surface. The combination of inner concave surface 31A and outer convex surface 31B allows the body 31 of the lens column 30 to have a certain diopter, increasing the light-collecting angle, broadening the patient's viewing angle, and also providing vision correction.

[0092] 3 , 4 , 7 and 8 , in one embodiment of the present invention, the main body 31 includes an inlet section 312, a fixed section 311, an outlet section 313 and an exposed section 314 connected in sequence along the axial direction; an inner concave surface 31A is provided at the end of the inlet section 312 away from the fixed section 311; the inlet section 312 and the outlet section 313 cooperate with the outer periphery of the fixed section 311 to form a limiting groove 31D; an outer convex surface 31B is provided on the side of the exposed section 314 facing away from the outlet section 313 corresponding to the inner concave surface 31A.

[0093] In this embodiment, the main body 31 includes an introduction section 312, a fixed section 311, an outlet section 313 and an exposure section 314 connected in sequence along the axial direction. The fixed section 311 is used to be connected to the ring 32. The end of the introduction section 312 is provided with an inner concave surface 31A, and the end of the exposure section 314 is provided with an outer convex surface 31B. The inner concave surface 31A and the outer convex surface 31B are located at both ends of the main body in the radial direction. The setting of the two curved surfaces enables the mirror column 30 to have a certain refractive power, increase the lighting angle, improve the patient's viewing angle range, and also play a role in correcting vision.

[0094] The outer wall of the body 31 is provided with a retaining groove 31D, and the collar 32 is retained within the retaining groove 31D. Specifically, the outer wall of the body 31 is provided with a retaining groove 31D for retaining the collar 32. The retaining groove 31D is formed by the inlet section 312 and the outlet section 313 cooperating with the outer periphery of the fixed section 311. The retaining groove 31D is an annular groove that is recessed inward along the radial direction of the body 31. The collar 32 is embedded in the annular retaining groove 31D, and the outer wall of the collar 32 is provided with an external thread 321. After the ring 32 is integrally arranged with the body 31, the outer diameter of the ring 32 is greater than or equal to the outer diameter of the introduction section 312, and the outer diameter of the outlet section 313 is greater than the outer diameter of the ring 32, so that the connection between the ring 32 and the outlet section 313 presents a step, which is used to limit the threaded locking stroke of the ring 32 and the bracket 10, preventing the threaded connection between the mirror column 30 and the bracket 10 from slipping off, thereby improving the connection reliability between the mirror column 30 and the bracket 10.

[0095] It is understandable that a locking portion 31C matching an external assembly tool is provided on the side of the exposed section 314 facing the outside, and the locking portion 31C is located at the edge of the exposed section 314 to facilitate disassembly and assembly.

[0096] In one embodiment of the present invention, the inner concave surface 31A is a spherical surface, and the spherical radius of the inner concave surface 31A is 5 mm to 40 mm;

[0097] And / or, the outer convex surface 31B is a spherical surface, and the spherical radius of the outer convex surface 31B is 5 mm to 9 mm.

[0098] And / or, the diameter of the introduction section 312 is 1.5 mm to 5 mm, and the axial length of the introduction section 312 is 1 mm to 3 mm;

[0099] And / or, the diameter of the lead-out section 313 is 1.5 mm to 5 mm, and the axial length of the lead-out section 313 is 1 mm to 4 mm;

[0100] And / or, the diameter of the exposed section 314 is 1.5 mm to 11 mm, and the axial length of the exposed section 314 is 0.2 mm to 3 mm.

[0101] In this embodiment, the concave surface 31A is generally spherical, while the convex surface 31B is also spherical. These two surfaces determine the lens column 30's refractive power and, consequently, the patient's postoperative visual field. Concave surface 31A and convex surface 31B are located at either end of the lens column 30's main body along the radial direction, ensuring a certain refractive power. This increases the light-collecting angle, broadens the patient's visual field, and also provides vision correction.

[0102] In this embodiment, the present invention designs the main body of the mirror column 30 to include a fixed section 311 , an introduction section 312 , an exit section 313 and an exposure section 314 .

[0103] The medical titanium metal or titanium alloy ring 32 can fit more tightly with the bracket 10 and is not easy to fall off during the actual assembly process. The relative position of the mirror column 30 can be adjusted within a certain range.

[0104] The outer diameter of the introduction section 312 is smaller than or equal to the diameter of the mounting hole 10A of the bracket 10 , so that the mirror column 30 can quickly enter the mounting hole 10A of the bracket 10 .

[0105] The external thread 321 of the collar 32 combined with the lens column 30 cooperates with the internal thread 111 of the bracket 10 to fix the lens column 30 and the bracket 10, and can also effectively seal to prevent leakage of eye fluid.

[0106] The lead-out section 313 forms a part of the optical path of the mirror column 30, thereby realizing effective regulation of the external collected light.

[0107] The exposed section 314 is umbrella-shaped, and the outer diameter of the exposed section 314 is larger than the lead-out section 313, which can effectively collect external light and prevent human eye tissue from gathering around the lead-out section 313 to affect the transmittance, thereby improving the transmittance and avoiding secondary damage during the adjustment and replacement of the mirror column 30.

[0108] In a specific implementation, the spherical radius of the inner concave surface 31A is 9.5 mm to 40 mm.

[0109] Based on the inner concave surface 31A, the outer convex surface 31B is a spherical surface, and the spherical radius of the outer convex surface 31B is 5 mm to 9 mm.

[0110] Based on the outer convex surface 31B and the inner concave surface 31A, the diameter of the introduction section 312 is 1.5 mm to 5 mm, and the axial length of the introduction section 312 is 1 mm to 3 mm;

[0111] Based on the outer convex surface 31B, the inner concave surface 31A and the lead-in section 312 , the diameter of the lead-out section 313 is 1.5 mm to 5 mm, and the axial length of the lead-out section 313 is 1 mm to 4 mm;

[0112] Based on the outer convex surface 31B, the inner concave surface 31A, the introduction section 312 and the outlet section 313 , the diameter of the exposed section 314 is 1.5 mm to 11 mm, and the axial length of the exposed section 314 is 0.2 mm to 3 mm.

[0113] It is understandable that the sizes of the above-mentioned accessory parts are set accordingly based on the patient's needs. The sizes of each part can be set independently or in combination with each other to improve the scope of application of the artificial cornea 100.

[0114] In one embodiment of the present invention, the bracket 10 includes a connecting member 11, a supporting member 12 and at least two transition members 13. The middle portion of the connecting member 11 is provided with a mounting hole 10A, the supporting member 12 is provided with a supporting cavity 12A, the connecting member 11 is disposed in the supporting cavity 12A, and at least two transition members 13 are spaced apart in the supporting cavity 12A. The two ends of each transition member 13 are respectively connected to the supporting member 12 and the connecting member 11.

[0115] In this embodiment, the stent 10 of the artificial cornea 100 can be hollow or can be arranged in parallel with side teeth. Taking the hollow stent 10 as an example, the connector 11 can serve as the inner ring segment of the stent 10, which is used to connect to the collar 32. The support member 12 serves as the outer ring segment of the stent 10. The outer ring segment and the inner ring segment are connected by at least two connectors 11. The at least two connectors 11 are transition bridges. The provision of the transition bridge allows the inner and outer rings to be hollowed out, which not only reduces the weight of the stent 10, but also provides a hollow outer support ring for the attachment and growth of the stent 10 and the eye tissue, thereby improving the structural stability of the stent 10 when placed in the human eye and facilitating postoperative growth.

[0116] Furthermore, the stent 10 is composed of two inner and outer ring structures connected by two or more transition bridges, and the maximum transverse diameter can be 8.4 mm. The outer ring segment of the stent 10 is conducive to fixation in the cornea, and the separated corneal pocket is reduced when making a lamellar incision, thereby reducing damage.

[0117] Stent 10 utilizes medical-grade titanium or titanium alloy as a safe bioimplant material, offering high biosafety. The titanium surface is modified with hydroxyapatite or bioactive glass. When stent 10 is implanted in the human body, biomacromolecules in the tissue fluid initially adsorb onto the implant surface, guiding cell attachment and influencing cell growth, differentiation, and functional expression, ultimately achieving tissue healing.

[0118] In one embodiment of the present invention, the surface where the support member 12 is located is an arc-shaped curved surface, and the connecting member 11 is arranged corresponding to the arc-shaped curved surface. The curvature radius of the arc-shaped curved surface is infinitely close to the curvature radius of the human cornea.

[0119] In this embodiment, the structural design of the overall stent 10 is conducive to the adhesion of corneal cells and matrix. When the human eye tissue grows, the tissue around the stent 10 can grow together, thereby fixing the stent 10 more firmly and enhancing its position stability; and the curvature radius of the support 12 of the outer ring of the stent 10 is close to the curvature radius of the human cornea. This curvature reduces the surgical difficulty during implantation and the mechanical pressure of the peripheral part of the titanium stent 10 on the surrounding corneal tissue. The thinner thickness of the stent 10 does not affect the nutrient metabolism and transportation between the corneal layers.

[0120] In one embodiment of the present invention, the support member 12 is annular; or, the support member 12 is circular or elliptical.

[0121] In this embodiment, the support member 12 is circular, that is, the support cavity 12A is circular, and the connecting member 11 is located at the center of the support member 12, which facilitates the placement of the artificial cornea 100 in the human eye without the need for subsequent adjustment of the circumferential position, thereby improving the convenience of the operation.

[0122] In another embodiment, the support member 12 is elliptical, which is shaped like a playground and has a long side and a short side. In specific clinical operations, the short side is opposite to the wound position, reducing the support force of the bracket 10 on the human eye iris tissue, facilitating postoperative suturing, and accelerating postoperative recovery.

[0123] With reference to Figure 10, in one embodiment of the present invention, the artificial cornea 100 also includes a plug 50, and the outer peripheral wall of the plug 50 is provided with a threaded segment 51; the artificial cornea 100 has a first state and a second state. In the first state, the threaded segment 51 of the plug 50 and the internal thread 111 of the bracket 10 can be detachably assembled; in the second state, the external thread 321 of the lens column 30 and the internal thread 111 of the bracket 10 can be detachably assembled.

[0124] In this embodiment, the artificial cornea 100 proposed by the present invention is an assembleable fixed-wing artificial cornea 100. Either the lens post 30 or the plug 50 is assembled with the stent 10. The implantation of the artificial cornea 100 into the human body is performed in two phases. In the first phase, the fixed-wing stent 10 is implanted between the corneal layers and sealed with the plug 50. In the second phase, after a period of time (for the stent 10 and the human eye tissue to recover after surgery), the plug 50 is removed and the threaded lens post 30 is implanted into the mounting hole 10A of the inner ring section of the stent 10. The two-phase procedure allows for observation of the first-phase stent 10 implantation to determine any complications. If there is infection or corneal dissolution and thinning, anti-inflammatory treatment and various corneal reinforcement measures can be performed, allowing the tissue to heal firmly over a relatively long period of time.

[0125] Furthermore, the plug 50 can be made of PMMA, titanium, or a combination of PMMA and titanium, as described for the mirror post 30. The plug 50 has a joint 52 on its exterior surface that mates with external assembly tools, facilitating assembly and disassembly.

[0126] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made by using the contents of the present invention description and drawings under the inventive concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. An artificial cornea, characterized in that: The artificial cornea comprises a support and a lens column; The bracket is made of metal, a mounting hole is provided in the middle of the bracket, an internal thread is provided on the hole wall of the mounting hole, and the mirror column is detachably arranged in the mounting hole; The mirror column comprises a body and a ring, the body is made of a transparent polymer material, and the ring is made of a metal; The body and the collar are formed as one body, and the outer peripheral wall of the body is provided with a limiting groove; The collar is sleeved on the body to form the mirror column, the collar is limited in the limiting groove, and the outer peripheral wall of the collar is provided with an external thread matched with the internal thread.

2. The artificial cornea according to claim 1, characterized in that: The support material is titanium metal or titanium alloy, the body material is polymethyl methacrylate, and the ring material is titanium metal or titanium alloy.

3. The artificial cornea according to claim 1, characterized in that: The main body is synthesized in situ in the ring by photopolymerization and is formed as a whole with the ring, or the main body is formed as a whole with the ring by melt casting.

4. The artificial cornea according to claim 1, characterized in that: The diameter of the collar is 1.5 mm to 5 mm, and the axial length of the collar is 0.5 mm to 4 mm; And / or, the middle part of the ring has a fixing hole, the hole wall of the fixing hole is provided with a first limiting portion, the outer peripheral wall of the body corresponding to the position of the fixing hole is provided with a second limiting portion, and the second limiting portion is snap-fitted with the first limiting portion.

5. The artificial cornea according to claim 4, characterized in that: The first limiting parts are provided with a plurality of spaced apart portions, and the plurality of the first limiting parts correspond to the second limiting parts one by one; And / or, a plurality of first limiting portions are provided, and the plurality of first limiting portions are arranged at intervals along the circumferential direction or axial direction of the collar; And / or, the first limiting portions are distributed in a ring shape along the circumferential direction; And / or, one of the first limiting portion and the second limiting portion is a groove, and the other is a protrusion, and the protrusion is limited in the groove.

6. The artificial cornea according to claim 1, characterized in that: The body comprises an introduction section, a fixed section, an outlet section and an exposure section which are sequentially connected along the axial direction; The end of the introduction section away from the fixing section is provided with an inner concave surface; The introduction section and the outlet section cooperate with the outer periphery of the fixed section to form the limiting groove; The side of the exposure section facing away from the lead-out section is provided with an outer convex surface corresponding to the inner concave surface.

7. The artificial cornea according to claim 6, characterized in that: The inner concave surface is a spherical surface, and the spherical radius of the inner concave surface is 5 mm to 40 mm; And / or, the outer convex surface is a spherical surface, and the spherical radius of the outer convex surface is 5 mm to 9 mm; And / or, the diameter of the introduction section is 1.5 mm to 5 mm, and the axial length of the introduction section is 1 mm to 3 mm; And / or, the diameter of the lead-out section is 1.5 mm to 5 mm, and the axial length of the lead-out section is 1 mm to 4 mm; And / or, the diameter of the exposed section is 1.5 mm to 11 mm, and the axial length of the exposed section is 0.2 mm to 3 mm.

8. The artificial cornea according to any one of claims 1 to 7, characterized in that: The support comprises: A connecting piece, wherein the mounting hole is provided in the middle of the connecting piece; A support member, wherein the support member is provided with a support cavity, and the connecting member is arranged in the support cavity; and At least two transition pieces are provided in the support cavity at intervals, and two ends of each transition piece are respectively connected to the connection piece and the support piece.

9. The artificial cornea according to claim 8, characterized in that: The surface where the support member is located is an arc-shaped curved surface, the connecting member is arranged corresponding to the arc-shaped curved surface, and the curvature radius of the arc-shaped curved surface is infinitely close to the curvature radius of the human cornea.

10. The artificial cornea according to claim 8, characterized in that: The support member is ring-shaped; Alternatively, the support member is circular or elliptical.

11. The artificial cornea according to any one of claims 1 to 7, characterized in that: The artificial cornea further comprises a plug, and the peripheral wall of the plug is provided with a threaded section; The artificial cornea has a first state and a second state, and in the first state, the threaded section of the plug and the internal thread of the bracket are detachably assembled; In the second state, the external thread of the mirror column and the internal thread of the bracket are detachably assembled.

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