artificial cornea

Abstract

This invention belongs to the field of medical device technology and discloses an artificial cornea, including a lens column and a support. The support has a mounting hole in its center, and the lens column is installed within the mounting hole. Both the front and rear surfaces of the lens column protrude outwards from the mounting hole. The front surface of the lens column is convex, and the rear surface is concave. The rear surface of the lens column is closer to the retina, while the front surface is further away from the retina. The rear surface of the support has an annular guide groove that surrounds the lens column. The annular guide groove guides the movement trajectory of surgical instruments and maintains a preset distance from the lens column. The support also has multiple fixing holes that penetrate the support from front to back, surrounding the annular guide groove. This artificial cornea can be transplanted into patients with mild to moderate corneal blindness, replacing the diseased cornea in mild to moderate cases. It effectively fills the treatment gap in the field of mild to moderate corneal blindness, reduces the risk of iatrogenic injury and complications, and solves the problem of severe donor shortage.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an artificial cornea. Background Technology

[0002] Patients with mild to moderate corneal blindness often have focal, layer-limited corneal lesions in the early stages of the disease (such as recurrent epithelial erosion, superficial scars, early keratoconus, or mild endothelial dysfunction). The ocular surface microenvironment is relatively stable (the tear film, eyelid margin, and conjunctival structure are basically intact). Therefore, layered surgery can often restore transparency and image quality in a short period of time.

[0003] However, these diseases exhibit clear or potential natural progression: in a few cases, keratoconus continues to protrude outwards and involve deeper stroma; stromal dystrophy and post-infectious scarring can gradually deepen and form irregular astigmatism; Fuchs endothelial corneal dystrophy (FECD) can evolve from focal detachment to diffuse pump dysfunction. Meanwhile, stratified treatment itself has indications and technical limitations, and any failure increases the likelihood of further intervention. Multiple surgeries and long-term medication can also exacerbate the risks of iatrogenic injury and complications. Therefore, a significant number of patients initially classified as mild to moderate but experiencing natural progression and accumulated treatment failures eventually progress to full-thickness opacity or full-thickness lesions, with PKP (penetrating keratoplasty, a one-time replacement of full-thickness corneal tissue) as the final treatment pathway.

[0004] The quality of donor corneas is the cornerstone of surgical success. However, donor corneas currently face the following challenges: there is a severe shortage of human donors, while the applicability of combining animal donors with artificial products is limited. Summary of the Invention

[0005] This invention innovatively provides an artificial cornea that can solve at least some of the above-mentioned problems.

[0006] To achieve the above-mentioned technical objectives, this invention discloses an artificial cornea, comprising a lens column and a support structure.

[0007] The bracket has a mounting hole in the middle, and the mirror post is installed in the mounting hole. Both the front and rear surfaces of the mirror post protrude outward from the mounting hole.

[0008] The front surface of the lens pillar is convex, the rear surface is concave, the rear surface is closer to the retina, and the front surface is farther from the retina.

[0009] The rear surface of the support is provided with an annular guide groove, which surrounds the endoscope column and guides the movement trajectory of the surgical instrument. The annular guide groove maintains a preset distance from the endoscope column.

[0010] The bracket is also provided with a plurality of fixing holes that pass through the front and back of the bracket, and the plurality of fixing holes are arranged around the annular guide groove.

[0011] Furthermore, the lens post includes an inlet section and an outlet section arranged sequentially from front to back along the axial direction of the lens post. The inlet section includes an outwardly protruding portion and a neck arranged sequentially from front to back along the axial direction of the lens post. The surface of the outwardly protruding portion facing away from the neck is the front surface of the lens post. The front end of the neck is connected to the outwardly protruding portion, and the rear end of the neck is connected to the outlet section. The outlet section passes through the mounting hole and is connected to the bracket. The surface of the outlet section facing away from the neck is the rear surface of the lens post.

[0012] The outer diameter of the protruding portion is greater than the outer diameter of the leading section, the outer diameter of the front end of the neck is not greater than the outer diameter of the protruding portion, and the outer diameter of the rear end of the neck is the same as the outer diameter of the front end of the leading section.

[0013] Furthermore, the export section includes a first export section, a fixing section, and a second export section arranged sequentially from front to back along the axial direction of the mirror column. The outer diameter of the fixing section is larger than the outer diameters of the first export section and the second export section. The fixing section is located inside the mounting hole and connected to the bracket. The first export section is connected to the neck and is located at the front end of the bracket, and the second export section is located at the rear end of the bracket.

[0014] Furthermore, the circumferential surface of the neck is either a sloped surface or an arc-shaped surface protruding away from the central axis of the mirror column;

[0015] And / or, the outer edge of the protrusion is provided with a rounded chamfer;

[0016] And / or, the outer edge of the rear end of the derived segment is provided with a rounded chamfer.

[0017] Furthermore, the bracket and the mirror column are integrally formed.

[0018] Furthermore, the outer diameter of the bracket is 4~8mm, the outer diameter of the annular guide groove is 3.5~5mm, the inner diameter of the annular guide groove is 1.8~3.8mm, the diameter of the mounting hole is 1.5~3.5mm, and the outer diameter of the protrusion is 2~4mm;

[0019] And / or, the axial length of the bracket is 0.5~1mm, the groove depth of the annular guide groove is 0.1~0.5mm, and the axial length of the mirror column is 1~1.5mm.

[0020] Furthermore, the axial length of the lead-out section is 0.7~1.2mm, and the sum of the axial lengths of the lead-out section and the neck is 0.8~1.3mm.

[0021] Furthermore, a perforated hole is provided between the annular guide groove and the mounting hole on the bracket.

[0022] Furthermore, the front surface of the mirror pillar is provided with an anti-glare layer, which includes a nano-micropillar array or a hydrophilic coating.

[0023] The nanopillar array includes multiple nanopillars arranged in an array. The axial cross-section of each nanopillar is trapezoidal. The diameter of the front end of each nanopillar is smaller than the diameter of its rear end. The rear end of each nanopillar is connected to the front surface of the mirror pillar.

[0024] Furthermore, UV-protective particles are uniformly dispersed within the mirror column.

[0025] The beneficial effects of this invention are as follows:

[0026] The artificial cornea of ​​this invention can be transplanted into patients with mild to moderate corneal blindness to replace the diseased cornea in mild to moderate cases, effectively filling the treatment gap in the field of mild to moderate corneal blindness, reducing the risk of iatrogenic damage and complications, and solving the problem of severe donor shortage. Attached Figure Description

[0027] Figure 1 This is a three-dimensional structural diagram of the artificial cornea according to an embodiment of the present invention, viewed from the front surface of the lens column.

[0028] Figure 2 This is a three-dimensional structural diagram of the artificial cornea according to an embodiment of the present invention, viewed from the rear surface of the lens column.

[0029] Figure 3 This is a front view of the artificial cornea according to an embodiment of the present invention.

[0030] Figure 4 This is a rear view of the artificial cornea according to an embodiment of the present invention.

[0031] Figure 5 This is a three-dimensional structural diagram of an artificial cornea as seen from the anterior surface of the lens column, according to another embodiment of the present invention.

[0032] Figure 6 This is a rear view of an artificial cornea according to another embodiment of the present invention.

[0033] Figure 7 This is a schematic diagram of the structure of the mirror column according to an embodiment of the present invention.

[0034] Figure 8 This is a side view of the mirror column according to an embodiment of the present invention.

[0035] Figure 9 yes Figure 8 A sectional view along line AA.

[0036] Figure 10 This is a schematic diagram of the structure of a nanopillar array according to an embodiment of the present invention.

[0037] Figure 11 This is a side view of the nanopillar array according to an embodiment of the present invention.

[0038] In the figure, 1 is the mirror column; 11 is the inlet section; 111 is the outward protrusion; 112 is the neck; 12 is the outlet section; 121 is the first outlet section; 122 is the fixing section; 123 is the second outlet section; 2 is the bracket; 21 is the mounting hole; 22 is the annular guide groove; 23 is the fixing hole; 24 is the hollow hole; 3 is the anti-glare layer; and 31 is the nano-microcolumn. Detailed Implementation

[0039] The artificial cornea, artificial cornea and its application method provided by the present invention will be explained and described in detail below with reference to the accompanying drawings.

[0040] Currently, the following are the methods for layered surgery for patients with mild to moderate corneal blindness: For epithelial / anterior superficial stromal lesions, PTK (Phototherapeutic Keratectomy) or surface polishing can be used; for keratoconus, CXL (Corneal Collagen Cross-Linking) is used as a stable foundation and can be combined with ICRS (Intrastromal Corneal Ring Segments) / morphological aberration correction; for deep stromal lesions that preserve the endothelium, DALK (Deep Anterior Lamellar Keratoplasty) can be performed; for simple endothelial lesions, DMEK (Descemet Membrane Endothelial Keratoplasty) or ultra-thin DSAEK (Descemet Stripping Automated Endothelial Keratoplasty) can be performed. Layered surgery can often restore transparency and image quality in a short period of time.

[0041] However, these diseases have a clear or potential natural progression: in a few cases, keratoconus continues to protrude outwards and involve deeper stroma; stromal dystrophy and post-infectious scarring can gradually deepen and form irregular astigmatism; Fuchs' corneal endothelial dystrophy can evolve from focal detachment to diffuse pump function decompensation; at the same time, stratified treatment itself also has indications and technical limitations, such as repeated ablation of PTK leading to progressive corneal thinning and hyperopia drift; DALK may produce persistent scattering due to Descemet's membrane perforation or interface roughness, requiring reoperation; DMEK / DSAEK may relapse due to failure of attachment within the initial learning curve, graft decompensation, or insufficient endothelial reserve, and any failure will increase the chance of re-intervention. Multiple surgeries and long-term medication can exacerbate iatrogenic damage and complications: repeated epithelial defects, recurring infections, intensified inflammatory microenvironment, imbalance between corneal neovascularization and nerve remodeling, suture-related astigmatism, and structural weakness, gradually transforming a previously healthy ocular surface into a high-risk phenotype. Once the lesion crosses the epithelium-stroma-Descemet-endothelium layers, the cornea exhibits a "full-thickness damage landscape" characterized by diffuse opacity, structural and mechanical imbalance, and endothelial pump failure. Any single-layer replacement cannot simultaneously restore transparency, refractive function, and biomechanical stability. In this situation, layered strategies can no longer provide predictable visual reconstruction and long-term homeostasis. Only penetrating keratoplasty (PKP), which replaces the entire thickness of the cornea, can restore optical continuity and tissue integrity. Therefore, a significant number of patients initially classified as having mild cases but experiencing natural progression and accumulated treatment failures will eventually progress to full-thickness opacity or full-thickness lesions, with PKP becoming the final treatment pathway.

[0042] Currently, the applicability of combining animal donors with artificial products is limited: animal donors (such as decellularized porcine corneas) and synthetic artificial corneal products are mainly used in partial lamellar keratoplasty (e.g., repairing the superficial corneal stroma), and are not suitable for penetrating keratoplasty (PKP), which requires replacement of the entire cornea. PKP requires the transplanted corneal tissue to have an intact and viable endothelial cell layer, a core requirement that current artificial materials and treated animal corneas cannot meet.

[0043] In view of this, this embodiment discloses an artificial cornea that can be transplanted into patients with mild to moderate corneal blindness to replace the diseased cornea in mild to moderate cases, effectively filling the treatment gap in the field of mild to moderate corneal blindness, reducing the risk of iatrogenic damage and complications, and solving the problem of severe donor shortage.

[0044] This embodiment specifically discloses an artificial cornea, such as... Figures 1-6As shown, the device includes a lens pillar 1 and a support 2. The support 2 has a mounting hole 21 in its center. Preferably, the mounting hole 21 is located in the center of the support 2. The lens pillar 1 is installed within the mounting hole 21, and both the front and rear surfaces of the lens pillar 1 protrude outwards from the mounting hole 21. The support 2 does not affect the optical performance of the lens pillar 1. The lens pillar 1 is made of a transparent material with excellent optical properties and stable physicochemical properties, used to replace a cloudy cornea that obstructs the optical pathway of the eye after a lesion. The support 2 serves as a bridge connecting the lens pillar 1 and surrounding tissues.

[0045] The anterior surface of pillar 1 is convex, and the posterior surface is concave. The posterior surface of pillar 1 is closer to the retina, while the anterior surface is farther from the retina. In patients with mild to moderate corneal blindness, the imaging function of the lens (or previously implanted artificial lens) is basically intact. Therefore, if the artificial cornea implanted via PKP closely matches the curvature, aspherical characteristics, and effective refractive power of the human eye's native cornea, it can restore the eye's focusing and image quality to the maximum extent without altering the lens and vitreous humor. The anterior surface of the artificial cornea is a "prolate" aspherical surface, steep in the center and flat at the periphery, with a negative cone constant k, approximately -0.2 to -0.8. The posterior surface is mostly slightly concave, but closer to a sphere than the anterior surface, with a k value of approximately -0.1 to -0.4. Its core optical function lies in effectively reducing spherical aberration. When parallel light rays pass through a spherical lens, peripheral rays are refracted more intensely than central rays, causing them to fail to converge at a single point and forming a blurred image. The prolate morphology of the cornea (steep centrally, flat peripherally) acts as a "negative spherical aberration element," compensating for the "positive spherical aberration" inherent in the lens itself. This allows light to focus more precisely on the fovea of ​​the retina, significantly improving visual quality (especially contrast sensitivity in low light). Biomechanically, this morphology helps maintain the structural stability of the artificial cornea, resisting intraocular pressure and evenly distributing mechanical stress. The asphericity of the artificial cornea varies from person to person and may change with myopia degree (high myopia often results in a more prolate cornea), age (tending towards oblate shift), and pathological conditions (such as the asymmetric steepness of keratoconus). Therefore, it is necessary to accurately measure the k-value of the patient receiving the implanted artificial cornea to design the optimal artificial corneal model for patients with corneal blindness.

[0046] In this embodiment, the cone constant k value of the anterior surface of the lens column 1 ranges from -0.2 to -0.8, and the cone constant k value of the posterior surface of the lens column 1 ranges from -0.1 to -0.4. The specific values ​​of the cone constants of the anterior and posterior surfaces of the lens column 1 are set according to the measured cone constant of the cornea of ​​the implanted patient in order to improve visual quality.

[0047] like Figure 2 , 4As shown in Figure 6, the rear surface of the support 2 is provided with an annular guide groove 22, which surrounds the lens column 1 and is coaxial with the lens column 1. The annular guide groove 22 is used to guide the movement trajectory of the surgical instrument. The annular guide groove 22 maintains a preset distance from the lens column 1. The surgical instrument can be a scalpel or a micro-robot. The annular guide groove 22 guides the surgical instrument so that the surgical instrument moving on the corneal surface or interface always maintains a fixed movement trajectory and will not scratch the lens column 1 or other tissues.

[0048] The annular guide groove 22 maintains a preset distance from the endoscope column 1 to avoid direct, unisolated contact between the endoscope column 1 and the annular guide groove 22, thus preventing light leakage at the edge of the endoscope column 1 and the reduction in stability caused by the reduced contact area. It also prevents surgical instruments from scratching the endoscope column 1 during the operation.

[0049] like Figures 1-6 As shown, the support 2 is also provided with multiple fixing holes 23 that pass through the front and rear of the support 2. The multiple fixing holes 23 are arranged around the annular guide groove 22. The fixing holes 23 are used to position and fix the support 2, for example, by fixing the support 2 with sutures. At the same time, it facilitates the growth of human tissue and further fixes the support 2.

[0050] The shape and number of fixation holes 23 can be determined based on the implantation stability of the artificial cornea and the structural strength of the stent 2. The number of fixation holes 23 is at least two. Preferably, the fixation holes 23 are evenly distributed around the annular guide groove 22. The shape of the fixation holes 23 can be circular, elliptical, square, rectangular, or fan-shaped; this application does not impose any special limitation on the specific shape of the fixation holes 23.

[0051] The method of using the artificial cornea in this embodiment is as follows:

[0052] During the surgery, the host corneal opening is first prepared according to conventional PKP, and the artificial cornea of ​​this embodiment is placed into the incision. Initial fixation is achieved by suturing through the fixation hole 23, so that the annular guide groove 22 faces into the eye and is concentric with the corneal bed. Then, the micro-surgical robot is sent into the anterior chamber through a small auxiliary incision in the cornea or clear cornea, allowing it to automatically engage with the annular guide groove 22 facing inward and run on the circumferential path defined by the annular guide groove 22. When the micro-robot moves in a uniform circle along the annular guide groove 22, its front end blade or micro-abrasive head removes or cleans the intraocular tissue corresponding to the inner edge of the artificial cornea (such as residual host corneal posterior elastic layer, fibrotic tissue or neovascularization) at a preset depth. The cutting debris is removed by synchronous perfusion / suction. After completing one or more circles, the micro-robot is withdrawn from the original incision. Finally, the artificial cornea is fixed by fixing each fixation hole 23 or by circumferential suturing, so that it fits tightly with the cleaned host edge and restores the closure and optical center of the anterior segment.

[0053] The artificial cornea of ​​this application embodiment can be transplanted into patients with mild to moderate corneal blindness to replace the diseased cornea in mild to moderate cases, effectively filling the treatment gap in the field of mild to moderate corneal blindness, reducing the risk of iatrogenic damage and complications, and solving the problem of severe donor shortage. The scaffold 2 of this application can adopt a biomimetic structural design, which has good mechanical stability and can fit closely with ocular tissues, promoting tissue growth and fixation.

[0054] Optionally, the mirror pillar 1 can be made of polymethyl methacrylate, allyl diethylene glycol carbonate, polycarbonate, acrylic resin, modified acrylate, optical glass, or low-scatter copolymer, and is responsible for imaging. The support 2 can be made of titanium alloy to ensure mechanical stability and durability.

[0055] The lens column 1 and the support frame 2 are molded as a single unit. During the manufacture of the artificial cornea, the support frame 2 is manufactured first, then placed in a mold, and the raw material for the lens column 1 is poured in, forming the lens column 1 through injection molding. This enhances the structural strength of the artificial cornea. While ensuring good optical performance, it prevents the lens column 1 from detaching due to increased intraocular pressure, improving the patient's rate and effectiveness of vision restoration, and reducing surgical risks.

[0056] In some alternative embodiments, such as Figures 7-9 As shown, the endoscope column 1 includes an inlet section 11 and an outlet section 12 arranged sequentially from front to back along the axial direction of the endoscope column 1. The inlet section 11 and the outlet section 12 are integrally formed. The inlet section 11 includes an outwardly protruding portion 111 and a neck 112 arranged sequentially from front to back along the axial direction of the endoscope column 1. The surface of the outwardly protruding portion 111 facing away from the neck 112 is the front surface of the endoscope column 1 and is convex. The front end of the neck 112 is connected to the outwardly protruding portion 111, and the rear end of the neck 112 is connected to the outlet section 12. The outlet section 12 passes through the mounting hole 21 and is connected to the bracket 2. The surface of the outlet section 12 facing away from the neck 112 is the rear surface of the endoscope column 1. The outer diameter of the outwardly protruding portion 111 is larger than the outer diameter of the outlet section 12. The outer diameter of the front end of the neck 112 is not larger than the outer diameter of the outwardly protruding portion 111, and the outer diameter of the rear end of the neck 112 is the same as the outer diameter of the front end of the outlet section 12. The inlet section 11 is mushroom-shaped, and the neck 112 is designed to prevent human tissue from growing onto the front surface of the endoscope column 1.

[0057] In some alternative embodiments, the derived segment 12 is cylindrical.

[0058] In some alternative embodiments, such as Figures 7-9As shown, the guide section 12 includes a first guide section 121, a fixing section 122, and a second guide section 123 arranged sequentially from front to back along the axial direction of the endoscope column 1. The outer diameter of the fixing section 122 is larger than the outer diameter of the first guide section 121 and the second guide section 123. The outer diameter of the first guide section 121 is the same as the outer diameter of the second guide section 123. The fixing section 122 is located inside the mounting hole 21 and connected to the support 2. The first guide section 121 is connected to the neck 112 and is located at the front end of the support 2. The second guide section 123 is located at the rear end of the support 2. The axial length of the fixing section 122 can be the same as the axial length of the mounting hole 21, or the axial length of the fixing section 122 can be greater than the axial length of the mounting hole 21. The fixing section 122 is used to connect the endoscope column 1 and the support 2. The setting of the fixing section 122 further increases the distance between the annular guide groove 22 and the first guide section 121 and the second guide section 123, avoiding damage to the first guide section 121 and the second guide section 123 by surgical instruments.

[0059] The first guide segment 121 is located at the front end of the guide segment 12, with one end directly connected to the neck 112 and the other end connected to the fixing segment 122. This allows for a smooth transition from the neck to the fixing segment, avoiding structural stress concentration caused by abrupt diameter changes. It also ensures the compatibility between the front end of the lens column and the front end of the support frame, without interfering with the overall mechanical stability of the support frame. The first guide segment 121 is located at the front end of the support frame 2, and its outer diameter is smaller than the outer diameter of the protruding part of the lens column. Combined with the design of the lens column's neck, the first guide segment can further prevent eye tissues (such as epithelial cells and fibrous tissue) from growing onto the front surface of the lens column 1, avoiding optical obstruction caused by tissue coverage and ensuring the light transmittance and imaging quality of the artificial cornea.

[0060] The second guide segment 123 allows the posterior surface of the lens pillar to protrude outward from the posterior surface of the stent 2, ensuring optical compatibility between the posterior surface of the lens pillar and the aqueous humor and retina, and preventing the light path from being obstructed by the stent thickness. Located at the posterior end of the stent 2, the second guide segment 123 has an outer diameter smaller than the fixed segment 122, creating a small gap between the posterior end of the lens pillar and the posterior surface of the stent. This facilitates the removal of residual tissue by surgical instruments and prevents tissue residue from accumulating between the posterior surface of the lens pillar and the retina, reducing postoperative complications (such as tissue fibrosis and increased intraocular pressure).

[0061] The first and second guide sections extend from both sides of the support, forming a "thin at both ends and thick in the middle" guide section structure together with the middle fixing section. This makes the force on the lens column more uniform in the mounting hole of the support, resists the axial stress caused by changes in intraocular pressure, maintains the alignment of the optical center of the lens column with the fovea of ​​the retina, and ensures imaging accuracy.

[0062] In some alternative embodiments, the circumferential surface of the neck 112 is a sloped surface or an arc-shaped surface protruding away from the central axis of the endoscope column 1 to achieve a smooth transition and maintain patient comfort.

[0063] In some alternative embodiments, the outer edge of the protrusion 111 is provided with a rounded chamfer, which has a smooth edge to avoid sharp edges irritating intraocular tissues, improve postoperative patient comfort, and reduce tissue inflammation.

[0064] In some alternative embodiments, the outer rear edge of the exported segment 12 is provided with a rounded chamfer, which has a smooth edge to avoid sharp edges irritating intraocular tissues, improve postoperative patient comfort, and reduce tissue inflammation.

[0065] In some optional embodiments, the outer diameter d3 of the bracket 2 is 4~8mm, the outer diameter d6 of the annular guide groove 22 is 3.5~5mm, the inner diameter d5 of the annular guide groove 22 is 1.8~3.8mm, the diameter d4 of the mounting hole 21 is 1.5~3.5mm, and the outer diameter d2 of the protrusion 111 is 2~4mm, so as to match the patient's eye condition and ensure good visual effect.

[0066] The diameter d4 of the mounting hole 21 is also the outer diameter of the outlet section 12. If the outlet section 12 is a cylindrical shape with a constant diameter, the diameter of the outlet section 12 is the same as the diameter of the mounting hole 21, which is 1.5~3.5mm. If the outlet section 12 includes a first outlet section 121, a fixed section 122, and a second outlet section 123, the outer diameter of the fixed section 122 is the same as the diameter of the mounting hole 21, which is 1.5~3.5mm. The outer diameters of the first outlet section 121 and the second outlet section 123 are smaller than the diameter of the mounting hole 21. The difference between the diameter of the mounting hole 21 and the outer diameters of the first outlet section 121 and the second outlet section 123 can be set according to actual needs. For example, the outer diameters of the first outlet section 121 and the second outlet section 123 are 0.1~0.3mm smaller than the diameter of the mounting hole 21. The difference between the inner diameter d5 of the annular guide groove 22 and the diameter d4 of the mounting hole 21 is the distance between the annular guide groove 22 and the mirror post 1. This distance can be set according to the actual structural strength and the size of the surgical instrument, for example, 0.3~0.6mm.

[0067] The size of the fixing hole 23 is set according to the distance between the outer edge of the bracket 2 and the outer groove wall of the annular guide groove 22, so as to ensure structural strength while achieving positioning. For example, the diameter d1 of the fixing hole 23 is 0.2~2.2mm.

[0068] In some optional embodiments, the axial length h1 of the support 2 is 0.5~1mm, the groove depth h5 of the annular guide groove 22 is 0.1~0.5mm, and the axial length h4 of the endoscope 1 is 1~1.5mm, so as to match the patient's eye environment, so that the anterior and posterior surfaces of the endoscope 1 protrude outward from the support 2, ensuring visual effect, and during surgery, ensuring the guiding effect of the surgical instruments while avoiding contact with or scratching of the endoscope 1 by the surgical instruments.

[0069] In some optional embodiments, the axial length h2 of the lead-out segment 12 is 0.7~1.2mm, so that the front end and rear end of the lead-out segment 12 protrude outward from the mounting hole 21. The difference between the axial length h4 of the mirror column 1 and the axial length h2 of the lead-out segment 12 is the axial length of the lead-in segment 11, for example, 0.3mm. The sum h3 of the axial lengths of the lead-out segment 12 and the neck 112 is 0.8~1.3mm. The difference between the sum h3 of the axial lengths of the lead-out segment 12 and the neck 112 and the axial length h2 of the lead-out segment 12 is the length of the neck 112, for example, 0.1mm, so that the neck 112 plays a transition role and prevents human tissue from growing onto the front surface of the protrusion 111.

[0070] In some alternative embodiments, such as Figure 5 and Figure 6 As shown, a perforated hole 24 is provided between the annular guide groove 22 and the mounting hole 21 on the support 2, allowing human tissue to grow through the perforated hole 24 and further fixing the support 2. The shape, number, and size of the perforated hole 24 are set according to the actual structural strength and the fixation stability of the artificial cornea. The perforated hole 24 is kept at a distance from both the annular guide groove 22 and the mounting hole 21. The shape of the perforated hole 24 can be circular, elliptical, square, rectangular, or fan-shaped. The number of perforated holes 24 is at least two. Preferably, the perforated holes 24 are evenly distributed around the mounting hole 21.

[0071] The specific method for designing the size of the artificial cornea in this embodiment is as follows:

[0072] Using individual patient corneal parameters as a reference, the anterior corneal surface radius R1 ≈ 7.6–7.9 mm, and the posterior corneal surface radius R2 ≈ 6.2–6.8 mm. The anterior corneal surface is an outwardly convex aspherical surface (typical cone constant k = -0.2 to -0.8), while the posterior corneal surface is a slightly outwardly convex aspherical surface, closer to a sphere than the anterior surface, with k often ranging from near 0 to slightly negative, approximately k ≈ -0.1 to -0.4. To avoid overcorrection leading to contrast loss in low-light conditions, artificial corneal materials (using PMMA (polymethyl methacrylate) or highly transparent copolymers) often have a higher refractive index than the corneal stroma (1.376). Therefore, equivalent power design is needed rather than "directly replicating the radius," specifically using the thick lens formula:

[0073]

[0074] For the front surface of mirror pillar 1, n2 represents the refractive index of mirror pillar 1 material, n1 represents the refractive index of air, F1 represents the optical power of the front surface, and R1 represents the radius of curvature of the front surface.

[0075] For the posterior surface of an artificial cornea, n2 represents the refractive index of the lens column 1 material, n3 represents the refractive index of the aqueous humor, F2 represents the optical power of the posterior surface, and R2 represents the radius of curvature of the posterior surface.

[0076] For mirror pillar 1 as a whole, F total The total equivalent power of the artificial cornea is represented by t, which is similar to the refractive power of the natural cornea (approximately 43D). t represents the center thickness of the lens 1, and n represents the refractive index of the lens 1 material.

[0077] Given the refractive index of the material of pillar 1 and the center thickness t of pillar 1, substitute these values ​​into the above thick lens formula to solve for R1, R2, and k, such that F total ≈ Patient's original corneal power.

[0078] The specific method uses the thick lens formula to calculate R1 and R2 to an equivalent power close to 43D. However, at this point, aberrations and the MTF (Modulation Transfer Function) of the light rays may still need further adjustment. By using optical software to treat k as an optimizable variable, the value of k can be kept within a reasonable range to meet both power and aberration requirements. This allows the refractive power of the artificial cornea to be similar to that of the natural cornea, resulting in good visual effects.

[0079] The artificial cornea in this application embodiment is designed with the following aspects in terms of interface reflection and scattering control:

[0080] The front surface of the lens pillar 1 exhibits Fresnel reflection. The theoretical reflectivity of the interface between air and the PMMA (n≈1.49) material of the lens pillar 1 is approximately ~3-4%, which is higher than that of the natural cornea (~2.5%). To avoid glare and reduced contrast, an anti-glare layer 3 is provided on the front surface of the lens pillar 1. The anti-glare layer 3 includes a nano-micropillar array or a hydrophilic coating, making the effective refractive index of the surface close to 1.376, specifically 1.376±0.1.

[0081] The refractive index of air is n1=1, the refractive index of PMMA is n2≈1.49, and the refractive index of normal corneal stroma is n2≈1.376.

[0082] The Fresnel formula for a planar interface is:

[0083]

[0084] Air-PMMA: R≈((1.49−1) / (1.49+1)) 2 ≈3.8%

[0085] Air-cornea: R≈((1.376−1) / (1.376+1)) 2 ≈2.5%

[0086] The hydrophilic coating is used to ensure the stable spread of the liquid film. This makes the outermost layer of the front surface of the mirror pillar 1 become a layer close to water (n≈1.33), which is equivalent to less reflection than air. However, it does not necessarily "change the refractive index of the material to 1.376". Instead, it reduces reflection by forming an intermediate layer and stabilizing the liquid film.

[0087] By mimicking the subwavelength micromorphology of a moth's eye, the nanopillar array suppresses Fresnel reflection and improves light transmittance, allowing the effective refractive index of the outermost layer of the front surface of the mirror pillar 1 to approach 1.376 from 1.49.

[0088] like Figure 10 and Figure 11 As shown, the nanopillar array includes multiple nanopillars 31 arranged in an array. The array can be rectangular or polygonal (e.g., hexagonal). The axial cross section of the nanopillars 31 is trapezoidal. The nanopillars 31 can be frustum-shaped. The front diameter of the nanopillars 31 is smaller than the rear diameter of the nanopillars 31. The rear end of the nanopillars 31 is connected to the front surface of the mirror pillar 1.

[0089] For example, using the front surface of the convex portion 111 as the substrate, the rear diameter d7 of the nanopillar 31 is ≤200 nm, and the front diameter d8 of the nanopillar 31 is in the range of 50 ≤ d8 < 200 nm. The front surface of the nanopillar 31 is convex, and the rear surface of the nanopillar 31 is concave, matching the substrate. The cone constants of the front surface, rear surface, and front surface of the convex portion 111 are consistent, ensuring the consistency of the light path. The axial length of the nanopillar 31 is 300-500 nm, and the spacing between adjacent nanopillars 31 is 0 or has a small spacing, allowing the equivalent refractive index to gradually transition from air to the substrate, with a refractive index step Δn < 0.1 between adjacent layers. This subwavelength effective dielectric layer can significantly suppress Fresnel reflection within the 400-700 nm range, reducing the average reflectivity of the normal single interface to ≤1-2%, corresponding to a transmittance ≥98%, reducing glare and improving contrast.

[0090] By setting up a nano-micropillar array, it is equivalent to designing the entire surface as a lattice structure, without affecting other shape parameters, in order to reduce glare and improve contrast.

[0091] The aberration and refractive quality design of the artificial cornea in this application embodiment is as follows: A normal lens typically exhibits negative spherical aberration to partially offset the positive spherical aberration of the cornea; when the lens function is normal, the artificial cornea does not aim for a completely aberration-free surface, but rather retains physiological-level positive spherical aberration to ensure a higher modulation transfer function at a moderate pupil diameter (~4 mm). In other words, the artificial cornea is not designed as a "perfect lens with zero aberration," but rather intentionally retains a slight positive spherical aberration similar to that of a normal cornea, allowing the positive spherical aberration of the artificial cornea to pair with the negative spherical aberration of the patient's existing lens, resulting in a total aberration of the entire eye approaching that of a normal eye.

[0092] The specific method is as follows: In this application, the artificial cornea uses an aspherical surface on the anterior surface of the lens pillar 1 to quantitatively control spherical aberration. The anterior surface of the artificial cornea is designed to be convex, gradually flattening at the periphery. As a result, the entire surface still provides a small amount of positive spherical aberration, consistent with the direction of the natural cornea, but the value can be controlled. If k is not precise enough, higher-order aspherical terms can be added to allow the artificial cornea to meet the spherical aberration requirement at a pupil diameter of 4 mm. During the optical design stage, the aspherical front surface (negative k and necessary higher-order terms) is used for image quality optimization with a pupil diameter of 4 mm, locking the spherical aberration within the physiological range. Then, through small adjustments to the posterior surface, this positive spherical aberration is preserved and cancels out the negative spherical aberration of the patient's normal lens, thereby achieving a higher MTF at a medium pupil diameter.

[0093] In some optional embodiments, UV-protective particles are uniformly dispersed within the lens column 1, providing UV protection and effectively blocking UV damage to the fundus, thus increasing fundus protection for patients and avoiding the risk of lifelong blindness caused by fundus lesions.

[0094] For example, the UV-protective particles can be surface-modified CeO2 / ZnO / TiO2 nanoparticles with a particle size of 20-30 nm, which mainly absorb ultraviolet light in the 280-400 nm range. The volume fraction φ of the UV-protective particles in the lens column 1 is 0.2%-0.5%. Under the conditions of a particle size of 25 nm and a volume fraction of 0.5%, the UV-protective particles are uniformly dispersed in three dimensions in the lens column 1, with an average center-to-center distance of approximately 95 nm and an average surface spacing of 70 nm, which is sufficient to avoid significant scattering in the visible light region and achieve fundus protection.

[0095] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0096] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0097] In the description of this specification, the references to terms such as "this embodiment," "an embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in a suitable manner in any at least one embodiment or example. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0098] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0099] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and simple improvements made on the substantive content of the present invention should be included within the protection scope of the present invention.

Claims

1. An artificial cornea, characterized by, The mirror column and the support, The middle part of the support is provided with a mounting hole, the mirror column is mounted in the mounting hole, the front and rear surfaces of the mirror column are both outwardly protruding from the mounting hole, The front surface of the mirror column is a convex surface, the rear surface of the mirror column is a concave surface, the rear surface of the mirror column is the surface close to the retina, the front surface of the mirror column is the surface away from the retina, the mirror column comprises a leading-in section and a leading-out section arranged in sequence along the axial direction of the mirror column, the leading-in section comprises an outer convex part and a neck part arranged in sequence along the axial direction of the mirror column, the surface of the outer convex part away from the neck part is the front surface of the mirror column, the front end of the neck part is connected with the outer convex part, the rear end of the neck part is connected with the leading-out section, the surface of the leading-out section away from the neck part is the rear surface of the mirror column, the leading-out section comprises a first leading-out section, a fixed section and a second leading-out section arranged in sequence along the axial direction of the mirror column, the outer diameter of the fixed section is greater than the outer diameters of the first leading-out section and the second leading-out section, the fixed section is located in the mounting hole and connected with the support, the first leading-out section is connected with the neck part and located at the front end of the support, the second leading-out section is located at the rear end of the support, The rear surface of the support is provided with an annular guide groove, the annular guide groove surrounds the mirror column, the annular guide groove is used for guiding the movement track of the surgical instrument, and the annular guide groove maintains a preset distance from the mirror column, The support is further provided with a plurality of fixing holes penetrating through the support, and the plurality of fixing holes are arranged around the annular guide groove.

2. The artificial cornea of claim 1, wherein, The outer diameter of the outer convex part is greater than the outer diameter of the leading-out section, the outer diameter of the front end of the neck part is not greater than the outer diameter of the outer convex part, and the outer diameter of the rear end of the neck part is the same as the outer diameter of the front end of the leading-out section.

3. The artificial cornea of claim 1, wherein, The circumferential surface of the neck part is a bevel or an arc surface protruding away from the central axis of the mirror column; And / or, the outer edge of the outer convex part is provided with a round chamfer; And / or, the rear end of the leading-out section is provided with a round chamfer.

4. The keratoprosthesis according to any of claims 1-3, wherein, The support and the mirror column are integrally formed.

5. The artificial cornea of claim 1, wherein, The outer diameter of the support is 4-8 mm, the outer diameter of the annular guide groove is 3.5-5 mm, the inner diameter of the annular guide groove is 1.8-3.8 mm, the diameter of the mounting hole is 1.5-3.5 mm, and the outer diameter of the outer convex part is 2-4 mm; And / or, the axial length of the support is 0.5-1 mm, the groove depth of the annular guide groove is 0.1-0.5 mm, and the axial length of the mirror column is 1-1.5 mm.

6. The artificial cornea according to claim 1 or 5, characterized in that, The axial length of the leading-out section is 0.7-1.2 mm, and the sum of the axial lengths of the leading-out section and the neck part is 0.8-1.3 mm.

7. The artificial cornea of claim 1, wherein, The annular guide groove and the mounting hole on the support are provided with a hollow hole.

8. The artificial cornea of claim 1, wherein, The front surface of the mirror column is provided with an anti-glare layer, and the anti-glare layer comprises a nano micro-column array or a hydrophilic coating, The nano-micro pillar array comprises a plurality of nano-micro pillars arranged in an array, an axial section of the nano-micro pillar is trapezoidal, a front end diameter of the nano-micro pillar is smaller than a rear end diameter of the nano-micro pillar, and the rear end of the nano-micro pillar is connected with the front surface of the mirror column.

9. The artificial cornea of claim 1, wherein, The mirror column is uniformly dispersed with anti-ultraviolet particles.

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