A method for manufacturing a 3D bionic structure artificial eye and the artificial eye

Abstract

The present invention belongs to the field of medical device technology and discloses a method for manufacturing a 3D bionic structure prosthetic eye and the prosthetic eye, which solves the problems of long production cycle, complex process, non-reproducibility, large deviation in authenticity, morphological mismatch, and insufficient personalized demand in the prosthetic eye manufacturing process in the prior art. The present invention first obtains the fundus OCT scanning data of the patient's healthy eye and the three-dimensional data of the corneal model obtained by taking a liquid mold of the patient's affected eye as the basic data for the prosthetic eye design. These basic data are used in modeling software to perform reverse three-dimensional modeling, design the appearance structure, and perform texture design and color mapping design. Finally, a three-dimensional model of the prosthetic eye that is a 1:1 replica of the healthy eye is obtained. Finally, the prosthetic eye is manufactured using the three-dimensional model of the prosthetic eye with the help of 3D printing technology.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a method for manufacturing a 3D bionic structure artificial eye and the artificial eye. Background Art

[0002] A prosthetic eye is used to fill, support, and enhance the appearance of the eye after enucleation surgery. It consists of a prosthetic eyepiece and a base. The base is a spherical structure that replaces the eyeball, while the prosthetic eyepiece sits outside the base to maintain the appearance of the eye. Currently, prosthetic eyepieces are often made of materials such as coral, hydroxyapatite, and acrylic, and are handcrafted layer by layer by technicians.

[0003] The production process mainly includes the following steps:

[0004] (1) Take an eye socket impression from the patient:

[0005] First, alginate material is injected into the eye socket to fill the entire eye socket, and the filling level is roughly equivalent to that of a healthy eye. After the material solidifies, the impression is removed and placed in a special mold. Next, the mold is filled with plaster and then pressed and fixed. After the plaster solidifies, the mold and tray are removed. After obtaining the mold, acrylic resin is filled into the mold and the mold is clamped and fixed and placed in a high-pressure curing device and left to stand until it solidifies to obtain an acrylic resin model.

[0006] (2) Use acrylic resin model to debug and mark the iris and pupil positions:

[0007] Acrylic resin is placed in the patient's affected eye, and the pupil area is drawn with a marker.

[0008] (3) Manual drawing of iris:

[0009] Take an acrylic resin molding model the size of a healthy eye's iris, use oil paint to realistically draw the iris texture according to the healthy eye, draw the pupil in the appropriate position, and then stick the drawn sclera on the resin cornea. After it is completely cured and bonded, use a grinder to polish and trim it.

[0010] (4) Re-molding of the artificial eye model:

[0011] A small pillar is fixed with a candle at the marked acrylic resin eye piece, placed in the mold, and then injected with plaster to compact and reinforce it to obtain a plaster mold for the artificial eye piece; the polished and trimmed iris is placed in the plaster mold, compacted and then injected with white resin, and then a high-pressure curing process is performed to obtain a rough mold of the artificial eye piece.

[0012] (5) Post-processing of the rough mold of the artificial eye:

[0013] Use grinding and cutting tools to grind and cut the rough mold of the artificial eye to remove excess parts, and use a grinding stone to grind the surface to expose the iris and measure it simultaneously.

[0014] (6) Color texture drawing of artificial eye sclera:

[0015] Use hard colored pencils to modify the iris and draw blood vessels, then apply a layer of transparent resin on the surface of the eye to seal the texture drawn with the colored pencils, then stick some fine silk threads on the surface of the resin layer to increase the realism of the artificial eye, and finally seal it with another layer of transparent resin. After the resin solidifies, polish it.

[0016] (7) Try on artificial eye:

[0017] If you feel any discomfort during the trial wearing process, please promptly report it to the prosthetic eye technician or doctor, and then repeat the above steps for polishing and trimming.

[0018] In the above scheme, the production cycle of artificial eyes is long, the process is complicated, it is non-replicable and expensive, and the specifications are fixed. It can only roughly match the patient's eye socket and often cannot be fully adapted. In addition, the choice of artificial eyes has disadvantages such as mismatching the color and shape of the fellow eye, which affects the postoperative effect and aesthetics. Therefore, the existing artificial eye production process can no longer meet the personalized needs of patients. Summary of the Invention

[0019] The technical problem to be solved by the present invention is to propose a method for manufacturing a 3D bionic structure artificial eye and an artificial eye, so as to solve the problems existing in the prior art of artificial eye manufacturing process, such as long production cycle, complex process, non-replicability, large deviation in authenticity, mismatch in shape, and insufficient personalized needs.

[0020] The technical solution adopted by the present invention to solve the above technical problems is:

[0021] In one aspect, the present invention provides a method for manufacturing a 3D bionic structure artificial eye, comprising the following steps:

[0022] S1. Obtain fundus OCT scan data of the patient's healthy eye;

[0023] S2. Taking a liquid mold of the patient's affected eye to obtain a corneal model, and extracting three-dimensional data of the corneal model;

[0024] S3. Designing a three-dimensional model of the artificial eye with reference to the fundus OCT scan data of the healthy eye and the three-dimensional data of the corneal model;

[0025] S4, making an artificial eye according to the three-dimensional model of the artificial eye;

[0026] S5. Post-process the artificial eye.

[0027] Furthermore, in step S1, the method of obtaining the fundus OCT scan data of the patient's healthy eye includes:

[0028] The ocular surface of the patient's healthy eye was scanned using an optical coherence scanner to obtain multi-angle views.

[0029] Furthermore, in step S2, the method of taking a liquid mold of the affected eye of the patient to obtain a corneal model and extracting three-dimensional data of the corneal model includes:

[0030] Place the mold-taking accessories on the patient's affected eye socket, and use a dental silicone impression gun to inject the impression material into the affected area until the fullness of the affected eye socket is consistent with that of the patient's healthy eye. Then let it stand and wait for the model to harden. After the model hardens, use a 3D scanner to extract the 3D data of the corneal model.

[0031] Furthermore, in step S3, the three-dimensional model of the artificial eye is designed with reference to the fundus OCT scan data of the healthy eye and the three-dimensional data of the corneal model, which specifically includes:

[0032] Appearance and structural design of artificial eye:

[0033] Import the 3D data of the corneal model into the modeling software and extract the part that fits the affected part of the eye, which is the lower surface model of the artificial eye to be designed;

[0034] The extracted lower surface model of the prosthetic eye is aligned with the multi-angle views of the OCT scan. The ocular surface curvature curve is drawn based on the multi-angle views of the OCT scan. The upper surface model of the prosthetic eye is designed with reference to the ocular surface curvature curve, completing the appearance and structural design of the prosthetic eye.

[0035] Pupil sclera texture design:

[0036] Reconstruct the pupil spherical cavity, draw the scleral texture on the modeling software based on the scleral texture of the patient's healthy eye and the physiological shape, and perform three-dimensional restoration of the bloodshot on the ocular surface;

[0037] Color map design:

[0038] The pupil, sclera, bloodshot eyes and white of the eye in the artificial eye structure are designed with reference to the color of the patient's healthy eye.

[0039] Furthermore, when reconstructing the pupil spherical cavity, an arched cavity with a diameter of 12 mm is designed, and a lower platform concave with a diameter of 4-5 mm is designed inside the arched cavity.

[0040] Furthermore, when designing the mapping for the pupil, sclera, bloodshot eyes and white of the eye in the artificial eye structure, ensure that the mapping thickness is above 1 mm.

[0041] Furthermore, in step S4, the method of making the prosthetic eye according to the three-dimensional model of the prosthetic eye includes:

[0042] The artificial eye piece three-dimensional model is imported into a color 3D printer for slicing and printing to obtain the artificial eye piece.

[0043] Furthermore, in step S5, the post-processing of the artificial eye comprises:

[0044] Support removal, grinding and surface varnish spraying.

[0045] On the other hand, the present invention also provides a prosthetic eye, which is manufactured using the manufacturing method of the 3D bionic structure prosthetic eye as described above.

[0046] Furthermore, the prosthetic eye includes a transparent layer, a sclera-iris layer and a pupil part, the transparent layer is located in the upper layer, the sclera-iris layer and the pupil part are in the same layer, and together constitute the color part of the prosthetic eye, which is located in the lower layer of the transparent layer, and the pupil part is located in the middle of the sclera-iris layer; the center thickness of the transparent layer is 3-4mm, the pupil diameter is 4-5mm, and the iris diameter is 11-12mm.

[0047] The beneficial effects of the present invention are:

[0048] (1) Compared with traditional artificial eyes, 3D printed bionic artificial eyes eliminate the steps of repeated molding, polishing and modification, and painting and drying during the production process. The design process is optimized and the production cycle is greatly shortened;

[0049] (2) The design refers to the real human eye map, basically restoring the color and texture of the healthy eye side, with higher aesthetics and realism;

[0050] (3) Three-dimensional data collection is performed based on the eye structure of each patient, which is highly personalized and can meet the needs of different patients. It can also meet the morphological matching and is more comfortable to wear;

[0051] (4) The artificial eye is formed in one piece using 3D printing. Hundreds of artificial eyes can be printed in the same batch. The labor cost in the production process is low and the production cycle is shorter. Therefore, the overall production cost is lower than that of traditional production processes.

[0052] (5) The data of 3D bionic structure artificial eye can be saved, copied and iterated, which is convenient for patients to replace the eye next time. If it is damaged or lost, it can be directly produced and printed, eliminating the need for redesign. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 This is a flow chart of a method for manufacturing a 3D bionic structure artificial eye in an embodiment of the present invention;

[0054] Figure 2 Schematic diagram of the reconstruction of the pupil spherical cavity;

[0055] Markings in the figure: 1 is the arched cavity, 2 is the concave platform of the lower platform. DETAILED DESCRIPTION

[0056] The present invention aims to provide a method for manufacturing a 3D bionic structure prosthetic eye and a prosthetic eye, thereby resolving the problems of the prior art prosthetic eye manufacturing process, such as long production cycles, complex processes, non-reproducibility, large deviations in authenticity, morphological mismatches, and insufficient individualization requirements. The core concept is to first obtain fundus OCT scan data of the patient's healthy eye and three-dimensional data of a corneal model obtained by liquid molding of the patient's affected eye as the basic data for prosthetic eye design. This basic data is then used in modeling software for reverse three-dimensional modeling to design the appearance structure, perform texture design, and perform color mapping design. Ultimately, a three-dimensional model of the prosthetic eye that is a 1:1 replica of the healthy eye is obtained. Finally, the prosthetic eye is manufactured using the three-dimensional model using 3D printing technology.

[0057] The solution of the present invention is further described below with reference to the accompanying drawings and embodiments.

[0058] Example:

[0059] like Figure 1 As shown, the method for manufacturing the 3D bionic structure artificial eye in this embodiment includes the following steps:

[0060] S101. Obtain fundus OCT scan data of the patient's healthy eye:

[0061] As a specific example, this step can use an eye scanning device - an optical coherence optical scanner to scan the ocular surface of the patient's healthy eye to obtain multi-angle views such as the front view, left view, right view, and back view, which will serve as part of the basic data for modeling the subsequent artificial eye three-dimensional model.

[0062] S102: Take a liquid model of the patient's affected eye to obtain a corneal model, and extract three-dimensional data of the corneal model:

[0063] As a specific example, the liquid molding process in this step is: place the molding accessories on the affected part, use a dental silicone impression gun to inject the impression material into the affected part of the eye, so that the affected eye socket is fully filled. After the filling degree reaches the same as the contralateral healthy eye, let it stand and wait for hardening. The model obtained after hardening is the corneal model; then, the three-dimensional data of the corneal model is extracted through a three-dimensional scanner as another part of the basic data for modeling the subsequent artificial eye three-dimensional model.

[0064] S103, designing a three-dimensional model of the artificial eye with reference to the fundus OCT scan data of the healthy eye and the three-dimensional data of the corneal model:

[0065] As a specific example, the design process of the prosthetic eye 3D model in this step mainly includes the design of the prosthetic eye appearance structure, pupil and sclera texture design, and color map design, as follows:

[0066] Appearance and structural design of artificial eye:

[0067] Import the 3D data of the corneal model into the modeling software and extract the part that fits the affected part of the eye, which is the lower surface model of the artificial eye to be designed;

[0068] The extracted lower surface model of the prosthetic eye is aligned with the multi-angle views of the OCT scan. The ocular surface curvature curve is drawn based on the multi-angle views of the OCT scan. The upper surface model of the prosthetic eye is designed with reference to the ocular surface curvature curve, completing the appearance and structural design of the prosthetic eye.

[0069] Pupil sclera texture design: Reconstruct the pupil spherical cavity. When reconstructing the pupil spherical cavity, design an arched cavity 1 with a diameter of 12mm, and design a lower platform concave platform 2 with a diameter of 4-5mm inside the arched cavity. Figure 2 As shown; the sclera texture of the patient's healthy eye is drawn on the modeling software in combination with the physiological shape, and the pupil texture concave-convex value is about 0.5-1mm. Then the bloodshot on the eye surface is three-dimensionally restored, and the bloodshot diameter is controlled at about 0.5mm.

[0070] Color map design: After the pupil and sclera texture design is completed, adjust the UV corresponding to the model to ensure that its pixel size is not distorted in the map. Therefore, it is preferred to export a UV reference map with a pixel size of 4096*4096 on a graphic design software (such as Photoshop, AI) according to the four parts of the eyeball structure (pupil, sclera, bloodshot eyes, and white eyes). Make a one-to-one correspondence. Each part corresponds to a different color map layer. The map color refers to the color of the patient's healthy eye and can also be adjusted at any time according to the patient's needs. For Asians, the pupil is mostly black, the sclera is mostly black and brown, and the bloodshot eyes and white eyes are designed according to the patient's specific situation.

[0071] The three-dimensional model of the artificial eye based on the above design has a three-part structure of a transparent layer, a sclera iris layer, and a pupil part; the three-part structure is divided into two layers;

[0072] The transparent layer is located on the upper layer, and the sclera, iris, and pupil layers are on the same layer, together forming the color portion of the prosthetic eye. The center thickness of the upper transparent layer is controlled to be approximately 3-4mm, ensuring it has the visual magnification effect of a convex lens. The bottom surface of the upper layer is identical in shape to the contact area of the pupil, sclera, and iris, ensuring that there is no excess support during the printing process, which would affect the molding effect. The pupil diameter is typically 4-5mm, and the iris diameter is 11-12mm. The specific design will be adjusted according to the patient's actual size.

[0073] The raised curvature of the prosthetic eye surface is consistent with that of the healthy eye, ensuring that the prosthetic eye is in a natural state after being worn; the curvature of the bottom of the prosthetic eye fits the affected part to ensure comfortable wearing and reduce friction with the eye. It not only improves the aesthetics and realism of the prosthetic eye after installation, but also optimizes the mold design, processing, trial mold and other design and production processes of traditional prosthetic eyes, greatly shortening the production cycle of prosthetic eyes.

[0074] S104, making an artificial eye according to the three-dimensional model of the artificial eye;

[0075] As a specific example, this step relies on 3D printing technology, and the three-dimensional model of the artificial eye is imported into a color 3D printer for slicing and printing to obtain the artificial eye.

[0076] S105, post-processing the artificial eye:

[0077] As a specific example, in order to make the artificial eye more comfortable and beautiful to wear, the artificial eye can be subjected to post-processing such as grinding and surface varnish spraying in this step.

[0078] Based on the above scheme of the embodiment, by optimizing the design process, the production cycle can be greatly shortened, manual participation can be reduced, and thus the production cost is reduced; since the design refers to the real human eye map design, the color texture of the healthy eye side is basically restored, the aesthetics and realism are higher, and three-dimensional data collection is performed according to the eye structure of each patient, which has a high degree of personalization, can meet the needs of different patients, and can meet the morphological matching, and is more comfortable to wear; in addition, the 3D bionic structure artificial eye data can be saved, copied and iterated, which is convenient for the patient to replace the eye next time. If it is damaged or lost, it can be directly produced and printed, eliminating the need for redesign.

[0079] Finally, it should be noted that the above embodiments are merely preferred implementations and are not intended to limit the present invention. It should be noted that those skilled in the art will be able to make modifications, equivalent substitutions, and improvements without departing from the spirit and scope of the present invention and the claims, all of which should be included within the scope of protection of the present invention.

Claims

1. A method for manufacturing a 3D bionic structure artificial eye, characterized in that: The following steps are involved: S1. Obtain fundus OCT scan data of the patient's healthy eye; S2. Taking a liquid mold of the patient's affected eye to obtain a corneal model, and extracting three-dimensional data of the corneal model; S3. Designing a three-dimensional model of the artificial eye with reference to the fundus OCT scan data of the healthy eye and the three-dimensional data of the corneal model; S4, making an artificial eye according to the three-dimensional model of the artificial eye; S5. post-processing the artificial eye; In step S3, the three-dimensional model of the artificial eye is designed with reference to the fundus OCT scan data of the healthy eye and the three-dimensional data of the corneal model, which specifically includes: Appearance and structural design of artificial eye: Import the 3D data of the corneal model into the modeling software and extract the part that fits the affected part of the eye, which is the lower surface model of the artificial eye to be designed; The extracted lower surface model of the prosthetic eye is aligned with the multi-angle views of the OCT scan. The ocular surface curvature curve is drawn based on the multi-angle views of the OCT scan. The upper surface model of the prosthetic eye is designed with reference to the ocular surface curvature curve, completing the appearance and structural design of the prosthetic eye. Pupil sclera texture design: Reconstruct the pupil spherical cavity, draw the scleral texture on the modeling software based on the scleral texture of the patient's healthy eye and the physiological shape, and perform three-dimensional restoration of the bloodshot on the ocular surface; Color map design: The pupil, sclera, bloodshot eyes and white of the eye in the artificial eye structure are designed with reference to the color of the patient's healthy eye.

2. The method for manufacturing a 3D bionic structure artificial eye according to claim 1, wherein: In step S1, the method of obtaining fundus OCT scan data of the patient's healthy eye includes: The ocular surface of the patient's healthy eye was scanned using an optical coherence scanner to obtain multi-angle views.

3. The method for manufacturing a 3D bionic structure artificial eye according to claim 1, wherein: In step S2, the method of taking a liquid mold of the affected eye of the patient to obtain a corneal model and extracting three-dimensional data of the corneal model includes: Place the mold-taking accessories on the patient's affected eye socket, and use a dental silicone impression gun to inject the impression material into the affected area until the fullness of the affected eye socket is consistent with that of the patient's healthy eye. Then let it stand and wait for the model to harden. After the model hardens, use a 3D scanner to extract the 3D data of the corneal model.

4. The method for manufacturing a 3D bionic structure artificial eye according to claim 1, wherein: When reconstructing the pupil spherical cavity, an arched cavity with a diameter of 12 mm is designed, and a lower platform concave with a diameter of 4-5 mm is designed inside the arched cavity.

5. The method for manufacturing a 3D bionic structure artificial eye according to claim 1, wherein: When designing the textures for the pupil, sclera, bloodshot eyes, and white of the eye in the artificial eye structure, ensure that the texture thickness is above 1mm.

6. The method for manufacturing a 3D bionic structure artificial eye according to any one of claims 1 to 3, characterized in that: In step S4, the method of making the prosthetic eye according to the three-dimensional model of the prosthetic eye includes: The artificial eye piece three-dimensional model is imported into a color 3D printer for slicing and printing to obtain the artificial eye piece.

7. The method for manufacturing a 3D bionic structure artificial eye according to any one of claims 1 to 3, characterized in that: In step S5, the post-processing method of the artificial eye comprises: Support removal, grinding and surface varnish spraying.

8. A prosthetic eye, characterized in that: The artificial eye is manufactured using the method for manufacturing a 3D bionic structure artificial eye as described in any one of claims 1 to 7.

9. The artificial eye according to claim 8, characterized in that: The artificial eye includes a transparent layer, a sclera-iris layer and a pupil part. The transparent layer is located in the upper layer, the sclera-iris layer and the pupil part are in the same layer, and together constitute the color part of the artificial eye, which is located in the lower layer of the transparent layer, and the pupil part is located in the middle of the sclera-iris layer; the center thickness of the transparent layer is 3-4mm, the pupil diameter is 4-5mm, and the iris diameter is 11-12mm.

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