Device and method for preparing skirt of composite keratoprosthesis

Abstract

The application discloses a composite artificial cornea skirt preparation device and method, which comprises a turnover plate and driving units installed on both sides of the turnover plate, eye ball fixing cups are arranged on the upper end face of the turnover plate in a matrix mode, the upper end of the eye ball fixing cup is open and used for fixing an eye ball, a decellularization liquid tank is arranged below the turnover plate, the driving units are used for driving the turnover plate to overturn by 180 DEG and sink downwards until the cornea of the eye ball is completely immersed below the liquid level of the decellularization liquid tank, and the device further comprises a stroma plate layer cutting knife, a central stroma ring cutter, a stroma bulking device, a stroma plate layer tunnel knife and a peripheral stroma ring cutter. The application has the beneficial effects that the cleaning, material taking, decellularization, bulking and fixing of the corneal stroma are completed at one time, and the whole process is automatically, standardly and normatively produced, so that the decellularized corneal stroma skirt or a biological cornea is obtained.

Description

Technical Field

[0001] The present invention relates to the technical field of biological corneal skirt preparation, and in particular to a device and method for preparing a composite artificial corneal skirt. Background Art

[0002] There are currently two types of artificial corneas: biological corneas and artificial corneas. Both have their own shortcomings, but the advantages of each can well compensate for the shortcomings of the other: ① Biological corneas: have good tissue compatibility and can heal with tissues, but postoperative vision is not ideal and is only suitable for lamellar corneal transplantation; ② Artificial corneas: can achieve good postoperative vision, but cannot heal with tissues, have many complications, and a three-year exfoliation rate of 42-82%. In view of this, Chinese invention patent CN109157305A discloses a composite artificial cornea and its preparation method, including a central optical column made of polyhydroxyethyl methacrylate (PHEMA), a corneal skirt structure made of acellular matrix hydrogel, and an intermediate interlayer grid support connecting the central optical column and the corneal skirt structure, integrating the advantages of existing biological corneas and artificial corneas, and presenting a "mirror-skirt" structure. However, the above-mentioned composite artificial cornea skirt is prepared by a casting method and needs to be manually cut later, which cannot achieve SOP management and cannot meet mass production requirements.

[0003] In addition, xenogeneic eyeballs are also commonly used corneal raw materials and can be fully applied to the above-mentioned "mirror-skirt" structure, thus serving as a substitute for the corneal skirt structure. However, the xenogeneic cornea also needs to be manually cut later, which cannot be managed by SOP and cannot meet mass production requirements. Summary of the Invention

[0004] In response to the above problems, the present invention proposes a composite artificial corneal skirt preparation device and method, which mainly solves the problem that the existing technology lacks a device for preparing corneal skirts for xenogeneic eyes.

[0005] To solve the above technical problems, the first aspect of the present invention provides a composite artificial cornea skirt preparation device, comprising a flip plate and drive units mounted on both sides of the flip plate. Eyeball fixation cups are distributed in a matrix on the upper end surface of the flip plate. The upper ends of the eyeball fixation cups are open and used to fix the eyeball. A decellularization tank is provided below the flip plate. The drive unit is used to drive the flip plate to flip 180 degrees and sink downward until the eyeball is completely immersed below the liquid level of the decellularization tank.

[0006] It also includes a stromal lamellar cutting knife or laser knife channel for transversely penetrating the cornea of ​​the eyeball, a central stromal ring cutter for longitudinally removing the cornea to form a central hole, a stromal expander for expanding the cornea to form a porous structure, a stromal lamellar tunnel knife for transversely penetrating the porous structure along the edge of the central hole, and a peripheral stromal ring cutter fixture for longitudinally removing the cornea to form a ring-shaped corneal skirt.

[0007] In some embodiments, the eyeball fixing cup is removable.

[0008] In some embodiments, the eyeball fixing cup includes a cup seat with an open upper end and a cup cap that penetrates axially. The outer wall diameter of the open end of the cup seat is retracted to form a limiting portion. The open end of the limiting portion is used to fix the eyeball, and the lower end of the cup cap is nested on the outside of the limiting portion. The sides of the cup seat and the cup cap are respectively provided with a first through hole and a second through hole that penetrate radially. The first through hole and the second through hole overlap with each other and are used to allow the matrix plate layer cutting knife to enter.

[0009] In some embodiments, the outer wall of the cup cap expands radially outward to form a supporting portion.

[0010] In some embodiments, a pressure sensor is disposed inside the limiting portion.

[0011] In some embodiments, an ultrasonic oscillator and / or a microbubble generator is installed on the wall of the decellularization tank.

[0012] In some embodiments, a dehydration dryer is further included.

[0013] In some embodiments, a refrigerator is also included.

[0014] In some embodiments, a robotic arm is further included, wherein the robotic arm is configured to drive the matrix slab cutting knife, the central matrix ring cutter, the matrix expander, the matrix slab tunnel knife, and the peripheral matrix ring cutter fixture.

[0015] A second aspect of the present invention provides a method for preparing a composite artificial cornea skirt, using the composite artificial cornea skirt preparation device described above, comprising the following steps:

[0016] Place the eyeball on the open end of the limiting portion with the cornea facing upward, and nest the cup cap on the outside of the limiting portion, and rotate the cup cap until the first through hole and the second through hole completely overlap;

[0017] Injecting clean water into the interior of the eyeball, determining whether the real-time pressure value received by the pressure sensor reaches a preset pressure, and if so, terminating the injection of clean water;

[0018] The cooling energy released by the refrigerator fills the entire operating room until the temperature of the operating room reaches a preset value;

[0019] The stromal plate cutting knife is inserted through the first through hole and the second through hole to separate the stromal plate of the cornea. After the stromal plate of the cornea is separated, the stromal plate cutting knife is retracted.

[0020] The central stroma circular cutter enters from the upper end of the cup cap and performs vertical rotary cutting on the center of the cornea to form a central hole;

[0021] The matrix expander enters from the upper end of the cup cap and penetrates the matrix skirt to perform gas injection operation, thereby forming a porous structure inside the cornea;

[0022] The stroma lamellar tunnel knife enters from the upper end of the cup cap and pierces the cornea along the edge of the central hole to create a radial puncture tunnel;

[0023] The driving unit drives the flip plate to flip 180 degrees and sink downward until the cornea is completely immersed below the liquid level of the decellularization tank, activates the ultrasonic oscillator and / or the microbubble generator to accelerate the removal of cellular components in the cornea, and the driving unit drives the flip plate to return to its original position, and uses the dehydration dryer to remove water from the cornea;

[0024] The peripheral matrix ring cutting fixer enters from the upper end of the cup cap, ring cutting and fixing the decellularized cornea to form a ring-shaped corneal skirt.

[0025] The beneficial effects of the present invention are: eyeball cleaning, matrix sampling, decellularization, expansion, and fixation are completed in one step, and the whole process is automated, normalized, and standardized to obtain the decellularized corneal matrix skirt. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic structural diagram of a composite artificial cornea skirt preparation device disclosed in Example 1 of the present invention;

[0027] Figure 2 This is an exploded view of the eyeball fixation cup disclosed in Example 1 of the present invention;

[0028] Figure 3 Schematic diagram of the coordination between the eyeball, the eyeball fixation cup and the matrix lamella cutting knife;

[0029] Figure 4 Schematic diagram of the coordination between the eyeball and the central matrix circumcision device;

[0030] Figure 5 This is a schematic diagram of the coordination between the eyeball and the matrix expander;

[0031] Figure 6Schematic diagram of the cooperation between the eyeball and the matrix lamella tunnel knife;

[0032] Figure 7 Schematic diagram of the coordination between the eyeball and the peripheral matrix ring cutting fixator;

[0033] Figure 8 Schematic diagram of the structure of the corneal skirt. DETAILED DESCRIPTION

[0034] To make the objectives, technical solutions, and advantages of the present invention more clear and distinct, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely for the purpose of explaining the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all of the present invention.

[0035] Example 1

[0036] like Figure 1-8 As shown, this embodiment proposes a composite artificial corneal skirt preparation device, which completes eyeball cleaning, corneal stroma sampling, decellularization, expansion, and fixation in one step, and the entire process is automated, normalized, and standardized to obtain a decellularized corneal stroma skirt.

[0037] It mainly includes a flip plate 1 and drive units 2 installed on both sides of the flip plate 1. The upper end surface of the flip plate 1 is distributed with eyeball fixation cups 3 in a matrix. A decellularization tank 4 is set below the flip plate 1. The drive unit 2 is used to drive the flip plate 1 to flip 180 degrees and sink downward until the cornea b of the eyeball a is completely immersed below the liquid level of the decellularization tank 4.

[0038] It also includes a stromal lamellar cutting knife 5 or a laser knife channel for transversely penetrating the cornea b of the eyeball a, a central stromal ring cutter 6 for longitudinally removing the cornea b to form a central hole c, a stromal expander 7 for expanding the cornea b to form a porous structure d, a stromal lamellar tunnel knife 8 for transversely penetrating the porous structure d along the edge of the central hole c, and a peripheral stromal ring cutting fixture 9 for longitudinally removing the cornea b to form a ring-shaped corneal skirt f.

[0039] More preferably, the eyeball fixing cup 3 is detachable.

[0040] In one embodiment, the eyeball fixing cup 3 includes a cup seat 301 with an open upper end and a cup cap 302 that penetrates axially. The outer wall diameter of the open end of the cup seat 301 is retracted to form a limiting portion 303. The open end of the limiting portion 303 is used to fix the eyeball a. The lower end of the cup cap 302 is nested on the outside of the limiting portion 303. The sides of the cup seat 301 and the cup cap 302 are respectively provided with a first through hole 305 and a second through hole 306 that penetrate radially. The first through hole 305 and the second through hole 306 overlap with each other and are used to allow the matrix plate layer cutting knife 5 to enter the eyeball. The fixing cup 3 has a cap with an open upper end and a built-in pressure measuring and pressure regulating device for regulating the intraocular pressure, which is used to fix the eyeball a.

[0041] In an optional embodiment, the outer wall of the cup cap 302 expands radially outward to form a supporting portion 304, and the supporting portion 304 is used to allow the robot to lift the cup cap 302 vertically upward.

[0042] In an optional embodiment, a pressure sensor is provided inside the limiting portion 303, which is used to indirectly obtain the pressure of the eyeball a. Obviously, a booster device should also be provided for the eyeball to maintain the pressure of the eyeball a at a fixed value. The booster device can provide positive pressure from the inside to the outside for the eyeball a.

[0043] An ultrasonic oscillator and / or a microbubble generator is installed on the wall of the decellularization liquid tank 4 to accelerate the decellularization process of the cornea b.

[0044] The invention also comprises a dehydration drying device for dehydrating the cornea b.

[0045] It also includes a refrigerator to provide cooling capacity throughout the preparation process.

[0046] The apparatus further includes a robotic arm for driving the matrix slab cutter 5, the central matrix ring cutter 6, the matrix expander 7, the matrix slab tunnel cutter 8, and the peripheral matrix ring cutter fixture 9. It should be noted that the positions and structures of the components (such as the matrix slab cutter 5) not specifically described above can be varied, and this embodiment only utilizes their functions without modifying their structures.

[0047] Example 2

[0048] This embodiment provides a method for preparing a composite artificial corneal skirt. Figure 1-8 The composite artificial cornea skirt preparation device described in Example 1 is used, comprising the following steps:

[0049] Place the eyeball a on the open end of the limiting portion 303 with the cornea b of the eyeball a facing upwards, and nest the cup cap 302 on the outside of the limiting portion 303. Rotate the cup cap 302 until the first through hole 305 and the second through hole 306 completely overlap.

[0050] Inject clean water into the eyeball a and determine whether the real-time pressure value received by the pressure sensor reaches the preset pressure. If so, terminate the injection of clean water. In this step, the clean water injection device is used as a pressurizing device for the eyeball a, and the pressure of the eyeball a can be maintained at a fixed value in conjunction with the pressure sensor. In addition, a stress spring can be set inside the cup holder 301 as a pressurizing device for the eyeball a.

[0051] The cooling capacity released by the refrigerator fills the entire operating room until the temperature of the operating room reaches the preset value;

[0052] The stroma layer cutting knife 5 is inserted from the first through hole 305 and the second through hole 306 to separate the stroma layer of the cornea b. After the stroma layer of the cornea b is separated, the stroma layer cutting knife 5 is retracted.

[0053] The central stroma circular cutter 6 enters from the upper end of the cup cap 302 and performs vertical rotary cutting on the center of the cornea b to form a central hole c;

[0054] The matrix expander 7 enters from the upper end of the cup cap 302 and penetrates the matrix skirt to perform gas injection operation, forming a porous structure d inside the cornea b;

[0055] The stroma tunnel knife 8 enters from the upper end of the cup cap 302 and pierces the cornea b along the edge of the central hole c to create a radial puncture tunnel e;

[0056] The driving unit 2 drives the flip plate 1 to flip 180 degrees and sink downward until the cornea b of the eyeball a is completely immersed below the liquid level of the decellularization tank 4. The ultrasonic oscillator and / or microbubble generator are activated to accelerate the removal of cellular components in the cornea b. The driving unit 2 drives the flip plate 1 back to its original position, and the dehydration dryer is used to remove water from the cornea b.

[0057] The peripheral stroma ring cutting fixture 9 enters from the upper end of the cup cap 302, ring cutting and fixing the decellularized cornea b to form a ring-shaped corneal skirt f.

[0058] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made based on the essence of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. A composite artificial corneal skirt preparation device, characterized in that: The device comprises a flip plate and drive units mounted on both sides of the flip plate. Eyeball fixation cups are distributed in a matrix on the upper end surface of the flip plate. The upper ends of the eyeball fixation cups are open and used to fix the eyeball. A decellularization tank is provided below the flip plate. The drive units are used to drive the flip plate to flip 180 degrees and sink downward until the cornea of ​​the eyeball is completely immersed below the liquid level of the decellularization tank. The device further comprises a corneal stroma cutting knife for transversely penetrating the eyeball, a central stroma ring cutter for longitudinally cutting the corneal stroma to form a central hole, a stroma expander for expanding the corneal stroma to form a porous structure, a stroma tunnel knife for radially penetrating the porous structure along the edge of the central hole, and a peripheral stroma ring cutter fixture for longitudinally cutting the corneal stroma to form a ring-shaped corneal skirt. The eyeball fixing cup includes a cup seat with an open upper end and a cup cap extending axially therethrough. The outer wall of the open end of the cup seat is radially inwardly contracted to form a limiting portion. The open end of the limiting portion is used to fix the eyeball. The lower end of the cup cap is nested outside the limiting portion. The sides of the cup seat and the cup cap are respectively provided with a first through hole and a second through hole extending radially therethrough. The first through hole and the second through hole overlap with each other and are used to allow the matrix plate cutting knife to enter. Also included is a robotic arm for driving the matrix slab cutting knife, the central matrix ring cutter, the matrix expander, the matrix slab tunnel knife, and the peripheral matrix ring cutter fixture.

2. The composite artificial cornea skirt preparation device according to claim 1, characterized in that: The eyeball fixing cup is detachable.

3. The composite artificial cornea skirt preparation device according to claim 1, characterized in that: The outer wall of the cup cap expands radially outward to form a supporting portion.

4. The composite artificial cornea skirt preparation device according to claim 3, characterized in that: A pressure sensor is arranged inside the limiting portion.

5. The composite artificial cornea skirt preparation device according to claim 4, characterized in that: An ultrasonic oscillator and / or a microbubble generator is installed on the wall of the decellularization liquid tank.

6. The composite artificial cornea skirt preparation device according to claim 5, characterized in that: Also includes a dehydrating dryer.

7. The composite artificial cornea skirt preparation device according to claim 6, characterized in that: Also includes a refrigerator.

8. A method for preparing a composite artificial corneal skirt, characterized in that: The composite artificial cornea skirt preparation device according to claim 7 comprises the following steps: Place the eyeball on the open end of the limiting portion with the cornea facing upward, and nest the cup cap on the outside of the limiting portion, and rotate the cup cap until the first through hole and the second through hole completely overlap; Determining whether the real-time pressure value of the eyeball received by the pressure sensor in the eyeball fixing cup reaches a preset pressure, wherein a pressure boosting device is provided in the eyeball fixing cup to maintain the pressure of the eyeball at a fixed value, and the pressure boosting device provides positive pressure from the inside to the outside of the eyeball; The cooling energy released by the refrigerator fills the entire operating room until the temperature of the operating room reaches a preset value; The stromal plate cutting knife is inserted through the first through hole and the second through hole to separate the stromal plate of the cornea. After the stromal plate of the cornea is separated, the stromal plate cutting knife is retracted. The central stroma circular cutter enters from the upper end of the cup cap and performs vertical rotary cutting on the center of the cornea to form a central hole; The matrix expander enters from the upper end of the cup cap and penetrates the matrix skirt from the side wall of the central hole and then performs gas injection operation to form a porous structure inside the cornea; The stroma lamellar tunnel knife enters from the upper end of the cup cap and pierces the cornea along the cutting edge of the central hole to create a radial puncture tunnel; The driving unit drives the flip plate to flip 180 degrees and sink downward until the corneal stroma is completely immersed below the liquid level of the decellularization tank, activates the ultrasonic oscillator and / or the microbubble generator to accelerate the removal of cellular components in the cornea, and the driving unit drives the flip plate to return to its original position, and uses the dehydration dryer to remove water from the cornea; The peripheral stroma ring cutting fixer enters from the upper end of the cup cap, ring cutting and fixing the decellularized cornea to form a ring-shaped corneal stroma skirt.

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