Adsorption fixing device for cornea crosslinking and use method

Abstract

The invention relates to the technical field of eye medical instruments, in particular to an adsorption fixing device for corneal cross-linking and a using method.The adsorption fixing device comprises an adsorption fixing device body, a cross-linking cavity is formed in the center of the adsorption fixing device body, a transparent cover plate is arranged at the top of the cross-linking cavity, and a negative pressure adsorption cavity is coaxially formed outside the cross-linking cavity; the adsorption fixing device is provided with an adsorption skirt outside the negative pressure adsorption cavity, a cross-linking through hole of the cross-linking cavity is communicated with a cross-linking agent pipeline, a pressure applying through hole of the cross-linking cavity is communicated with a pressure applying pipeline, a cleaning through hole of the cross-linking cavity is communicated with a cleaning pipeline, and a negative pressure through hole of the negative pressure adsorption cavity is communicated with an air exhaust pipeline. According to the adsorption fixing device for cornea cross-linking and the use method, the tensile strain of the cornea which is in a tensile state under the action of intraocular pressure originally is reduced or even inverted into compressive strain, so that the non-deformability of the cornea is improved through cross-linking, and the curvature of the cornea can be reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of ocular medical devices, and in particular to an adsorption and fixing device for corneal cross-linking and a method of using the device. Background Art

[0002] The refraction of light by the cornea accounts for 70% of the refractive power of the eyeball. Changing the corneal curvature to make it flatter can reduce the refraction of light by the cornea, thereby achieving the purpose of correcting myopia. For example, the existing excimer laser in situ keratomileusis (LASIK), femtosecond laser flap-making excimer laser in situ keratomileusis (FS-LASIK), all-femtosecond laser micro-incision corneal stromal lens extraction (SMILE), orthokeratology, and implantation of lenses in the corneal layer. However, these surgeries are invasive surgeries, among which laser corneal refractive surgery requires the removal of a part of the stromal layer from the cornea, which will weaken the cornea's ability to resist deformation and has the risk of keratoconus.

[0003] Cross-linking the cornea can improve the spatial structure of corneal collagen fibers and thus increase the mechanical strength and hardness of the cornea, which has become an important way to treat keratoconus. Currently, there are two methods of corneal cross-linking: riboflavin plus ultraviolet light cross-linking and chemical cross-linking. Chemical cross-linking is to directly apply the cross-linking agent to the corneal surface or inject it into the corneal stroma to complete the cross-linking. This is a type of non-invasive surgery that strengthens the mechanical properties of the cornea from the outer surface by chemical methods. However, the current method can only improve the cornea's ability to resist deformation, but it is not enough to reduce the curvature of the cornea to correct myopia. Therefore, research on correcting myopia through corneal cross-linking has important theoretical and clinical significance. Summary of the invention

[0004] The purpose of the present invention is to provide an adsorption and fixation device for corneal cross-linking and a method of use, which can reduce the tensile strain of the cornea that is originally in a stretched state under the action of intraocular pressure or even convert it into a compressive strain, thereby achieving not only improving the cornea's anti-deformation ability but also reducing its curvature through cross-linking.

[0005] To achieve the above-mentioned purpose, the present invention provides an adsorption and fixing device for corneal cross-linking, including an adsorption and fixing device, a cross-linking chamber is provided in the center of the adsorption and fixing device, a transparent cover is provided on the top of the cross-linking chamber, a negative pressure adsorption chamber is coaxially provided outside the cross-linking chamber, the adsorption and fixing device is provided with an adsorption skirt outside the negative pressure adsorption chamber, the cross-linking through hole of the cross-linking chamber is connected to the cross-linking agent pipeline, the pressure through hole of the cross-linking chamber is connected to the pressure pipeline, the cleaning through hole of the cross-linking chamber is connected to the cleaning pipeline, and the negative pressure through hole of the negative pressure adsorption chamber is connected to the exhaust pipeline.

[0006] Preferably, a transparent capsule membrane is provided in the center of the cross-linking chamber, the pressure through hole is located between the transparent cover plate and the transparent capsule membrane, and the cross-linking through hole and the cleaning through hole are located below the transparent capsule membrane.

[0007] Preferably, the cross-linking agent pipeline, the pressure pipeline and the cleaning pipeline all penetrate the side wall of the negative pressure adsorption chamber and are connected with the cross-linking chamber.

[0008] Preferably, the cross-section of the negative pressure adsorption chamber is a circular ring or an elliptical ring.

[0009] Preferably, the cross-section of the cross-linking chamber is circular or elliptical.

[0010] Preferably, the inner and outer walls of the negative pressure adsorption chamber include: the negative pressure adsorption chamber and the outer wall of the adsorption fixing device form the outer wall of the negative pressure adsorption chamber, the negative pressure adsorption chamber and the outer wall of the cross-linking chamber form the inner wall of the negative pressure adsorption chamber, the inner and outer walls of the negative pressure adsorption chamber are both 0.5~2.5 mm thick, the outer wall height of the negative pressure adsorption chamber is 0~2.5 mm higher than the inner wall height, and the outer wall height is not limited.

[0011] Preferably, the absorbent skirt is coated with hydrogel.

[0012] The method for using the above-mentioned adsorption fixation device for corneal cross-linking comprises the following steps: S1. The adsorption skirt of the adsorption fixing device is brought into contact with the outer edge of the part of the cornea to be cross-linked, and air is pumped outward through the air pumping pipe. After negative pressure is formed in the negative pressure adsorption chamber, the adsorption fixing device is adsorbed and connected to the cornea; S2, adding a cross-linking agent to the corneal surface in the cross-linking chamber through a cross-linking agent pipeline; S3, injecting gas / liquid into the cross-linking chamber through a pressure pipe, so that the transparent capsule membrane expands downward to press the cornea, causing the corneal surface to become flat or concave inward; S4, selecting whether to use ultraviolet light or blue light, wherein the ultraviolet light or blue light passes through the optical path formed by the transparent cover plate, the gas / liquid and the transparent capsule membrane to irradiate the corneal surface infiltrated with the crosslinking agent; S5. After the cross-linking is completed, the cross-linking agent remaining in the cross-linking chamber is sucked out through the cleaning pipeline, and then cleaned with physiological saline or clean water.

[0013] Preferably, in S2, the cross-linking agent includes one of genipin and riboflavin.

[0014] Preferably, in S4, the irradiation time of ultraviolet light or blue light is 30 sec to 30 min.

[0015] Preferably, in S4, oxygen may be introduced into the cross-linking chamber through a cross-linking agent pipeline.

[0016] Therefore, the present invention adopts the above-mentioned adsorption and fixation device for corneal cross-linking and the use method, and its beneficial effects are: 1. The negative pressure adsorption chamber structure is adopted. The negative pressure state can be formed in the negative pressure adsorption chamber by vacuuming through the vacuum pipe. Due to the existence of negative pressure and the design of the adsorption skirt, the surface of the negative pressure adsorption chamber can fit closely with the cornea to form a closed chamber, thus avoiding the overflow of the cross-linking agent to the non-cross-linking area of ​​the eyeball; 2. Due to the negative pressure adsorption, the adsorption and fixing device can be fixed on the part of the cornea to be cross-linked. This can make the cornea in the cross-linking chamber become flat or inward from the original spherical surface when subjected to the external pressure generated by the pressure bag expanded by gas (liquid) injection, and its fixed periphery can still remain unchanged relative to the adsorption and fixing device. In this way, the tensile strain of the cornea, which is originally in a stretched state under the action of intraocular pressure, can be reduced or even converted into compressive strain, thereby achieving the purpose of not only improving the cornea's deformation resistance but also reducing its curvature through cross-linking, thereby achieving the purpose of correcting the degree of myopia.

[0017] The technical solution of the present invention is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic diagram of an adsorption fixation device for corneal cross-linking of the present invention; Figure 2 is a side cross-sectional view of an adsorption fixation device for corneal cross-linking of the present invention; Figure 3 is a schematic flow chart of the method for using the adsorption fixing device in the present invention, in, Figure 3 (A) is the state diagram at step S1. Figure 3 (B) is the state diagram for steps S3 and S4. Figure 3 (C) is a comparison of the corneal status before and after cross-linking.

[0019] Reference numerals: 1. Cross-linking chamber; 2. Transparent cover; 3. Negative pressure adsorption chamber; 4. Adsorption skirt; 5. Cross-linking agent pipeline; 6. Pressure pipeline; 7. Cleaning pipeline; 8. Vacuum pipeline; 9. Transparent capsule membrane. DETAILED DESCRIPTION

[0020] The present invention is further described below in conjunction with the accompanying drawings and embodiments. Unless otherwise defined, the technical terms or scientific terms used in the present invention should be the common meanings understood by people with ordinary skills in the field to which the present invention belongs. The above-mentioned features or features mentioned in the specific examples mentioned in the present invention can be combined arbitrarily, and these specific embodiments are only used to illustrate the present invention and are not used to limit the scope of the present invention.

[0021] Example 1 like Figure 1-Figure 2As shown, the present invention provides an adsorption and fixing device for corneal cross-linking, including the adsorption and fixing device, a cross-linking chamber 1 is provided in the center of the adsorption and fixing device, a transparent cover plate 2 is provided on the top of the cross-linking chamber 1, a negative pressure adsorption chamber 3 is coaxially provided outside the cross-linking chamber 1, and the adsorption and fixing device is provided with an adsorption skirt 4 outside the negative pressure adsorption chamber 3; the cross-linking through hole of the cross-linking chamber 1 is connected with the cross-linking agent pipeline 5, the pressure through hole of the cross-linking chamber 1 is connected with the pressure pipeline 6, the cleaning through hole of the cross-linking chamber 1 is connected with the cleaning pipeline 7, the negative pressure through hole of the negative pressure adsorption chamber 3 is connected with the exhaust pipeline 8, and the transparent capsule membrane 9 separates the cross-linking chamber 1 into two pressure capsule chambers and a cross-linking agent chamber that are not connected to each other.

[0022] The adsorption fixing device can be integrally formed or assembled after being formed separately. The adsorption fixing device is brought into contact with the edge of the corneal region to be cross-linked, and the gas in the negative pressure adsorption chamber 3 is extracted through the gas channel. With the assistance of the adsorption skirt 4, a negative pressure environment relative to the atmospheric pressure is formed in the negative pressure adsorption chamber 3, so that the adsorption fixing device fits tightly with the edge of the corneal region to be cross-linked. The adsorption fixing device is coated with a coating at the contact point with the cornea. The coating uses a hydrogel material with good hydrophilicity, good biocompatibility, and no biotoxicity. The material of the adsorption fixing device itself is selected from glass materials, other hard inorganic or organic materials.

[0023] The negative pressure adsorption chamber 3 is provided to ensure that the adsorption fixing device is always fixed at a fixed position on the cornea when subjected to external force. At this time, the cornea area to be cross-linked is completely located inside the cross-linking chamber 1, and the open part of the cross-linking chamber 1 contacts the cornea to form a closed environment, thereby preventing the cross-linking agent from entering the negative pressure adsorption chamber 3 or leaking to the cornea surface outside the adsorption fixing device during the cross-linking process.

[0024] During the cross-linking process between the cross-linking agent and the cornea to be cross-linked in the cross-linking chamber 1, the cross-linking agent enters the cross-linking chamber 1 through the cross-linking pipe, contacts the cornea to be cross-linked and penetrates into the cornea, and ultraviolet light or blue light is irradiated into the cross-linking chamber 1 through the transparent cover plate 2 to cross-link the cornea infiltrated by the cross-linking agent.

[0025] A transparent capsule 9 is provided in the center of the cross-linking chamber 1, a pressure through hole is located between the transparent cover plate 2 and the transparent capsule 9, and a cross-linking through hole and a cleaning through hole are located below the transparent capsule 9. The transparent capsule 9 is made of a transparent material with a large deformation range and good biocompatibility, ensuring that the transparent capsule 9 can contact the cornea under the action of pressurized gas / liquid, and ultraviolet light or blue light can also pass through the transparent capsule 9 to irradiate the corneal surface.

[0026] The pressure through hole is set so that the gas / liquid applies pressure above the transparent capsule 9, and the pressurized liquid does not directly contact the cornea. When the transparent capsule 9 is not provided, only pressurized gas is selected to apply pressure. After the pressure is applied, the cornea to be cross-linked becomes flat or inward under the pressure.

[0027] The crosslinking agent pipeline 5, the pressure pipeline 6 and the cleaning pipeline 7 all penetrate the side wall of the negative pressure adsorption chamber 3 and are connected to the crosslinking chamber 1. After the crosslinking agent remaining after crosslinking is sucked out through the cleaning pipeline 7, the crosslinking agent remaining on the cornea is cleaned with physiological saline or clean water through the cleaning pipeline 7 to prevent other parts of the cornea from being affected by the residual crosslinking agent.

[0028] The cross section of the negative pressure adsorption chamber 3 is a circular ring or an elliptical ring. When the cross section of the negative pressure adsorption chamber 3 is an elliptical ring, the inner radius of the major axis is 2.5-10 mm, and the ellipticity is 0-0.5.

[0029] The cross-section of the cross-linking chamber 1 is circular or elliptical. When the cross-section of the cross-linking chamber is elliptical, the inner major axis radius is 1.5-7 mm and the ellipticity is 0-0.5.

[0030] The inner diameters of the exhaust pipe 8, the crosslinking agent pipe 5, the pressure pipe 6 and the cleaning pipe 7 can be varied within 0.2 to 3 mm as required, and the wall thickness of the above pipes is 0.6 mm ± 0.4 mm. The lengths of these pipes and their positions on the adsorption fixture are not restricted.

[0031] The adsorption skirt 4 is coated with hydrogel, and the width of the adsorption skirt 4 is 0.2-1.8 mm, and the thickness is 0.2-1 mm. The adsorption skirt 4 is a trumpet-shaped structure, which ensures that the adsorption skirt 4 can fit closely with the cornea.

[0032] The adsorption fixation device is used to treat keratoconus or correct myopia.

[0033] Example 2 A method for using a corneal cross-linking adsorption fixation device in Example 1 comprises the following steps: S1. The adsorption skirt 4 of the adsorption fixing device is brought into close contact with the outer edge of the part of the cornea to be cross-linked, and air is pumped outwards through the air pumping pipe 8. After negative pressure is formed in the negative pressure adsorption chamber 3, the adsorption fixing device is adsorbed and connected to the cornea.

[0034] S2. When chemical cross-linking is performed using genipin, a cross-linking agent is dripped onto the corneal surface in the cross-linking chamber 1 through the cross-linking agent pipeline 5 .

[0035] S3. Inject gas / liquid into the cross-linking chamber 1 through the pressure pipe 6 to make the transparent capsule 9 expand downward to press the cornea, so that the corneal surface becomes flat or inward.

[0036] S4. Do not use ultraviolet light or blue light.

[0037] S5. After the cross-linking is completed, the residual cross-linking agent in the cross-linking chamber 1 is sucked out through the cleaning pipe 7, and then cleaned with physiological saline or clean water.

[0038] Example 3 like Figure 3 As shown, a method for using an adsorption fixation device for corneal cross-linking in Example 1 comprises the following steps: S1. The adsorption skirt 4 of the adsorption fixing device is brought into contact with the outer edge of the part of the cornea to be cross-linked, and air is pumped outwards through the air pumping pipe 8. After negative pressure is formed in the negative pressure adsorption chamber 3, the adsorption fixing device is adsorbed and connected to the cornea.

[0039] S2. Add a cross-linking agent to the corneal surface in the cross-linking chamber 1 through the cross-linking agent pipeline 5.

[0040] In S2, the crosslinking agent is riboflavin. When riboflavin is used for photochemical crosslinking, the corneal area to be crosslinked is first infiltrated with riboflavin solution. The infiltration time can be determined according to the infiltration method (such as using ion introduction, or adding materials that promote riboflavin penetration into the tissue will shorten the time required for infiltration), which generally takes 10-30 minutes.

[0041] S3. Inject gas / liquid into the cross-linking chamber 1 through the pressure pipe 6 to make the transparent capsule 9 expand downward to press the cornea, so that the corneal surface becomes flat or inward.

[0042] S4. Use ultraviolet light to irradiate the corneal surface soaked by the crosslinking agent through the light path formed by the transparent cover plate 2, the gas / liquid and the transparent capsule 9. At the same time, oxygen can be filled into the crosslinking chamber 1 through the crosslinking agent pipeline 5 to accelerate the crosslinking process, increase the crosslinking effect, and shorten the ultraviolet light irradiation time.

[0043] In S4, 3 mW / cm 2 The UV irradiation time was 30 min.

[0044] S5. After the cross-linking of the cross-linking agent by ultraviolet light irradiation is completed, the residual cross-linking agent in the cross-linking chamber 1 is sucked out through the cleaning pipe 7, and then the cleaning is performed.

[0045] Therefore, the present invention adopts the above-mentioned adsorption and fixing device and method of use for corneal cross-linking to reduce the tensile strain of the cornea that is originally in a stretched state under the action of intraocular pressure or even convert it into compressive strain, thereby achieving not only improving the cornea's anti-deformation ability but also reducing its curvature through cross-linking.

[0046] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that they can still modify or replace the technical solution of the present invention with equivalents, and these modifications or equivalent replacements cannot cause the modified technical solution to deviate from the spirit and scope of the technical solution of the present invention.

Claims

1. An adsorption and fixation device for corneal cross-linking, characterized in that: The invention comprises an adsorption fixing device, wherein a cross-linking chamber is provided in the center of the adsorption fixing device, a transparent cover is provided on the top of the cross-linking chamber, a negative pressure adsorption chamber is coaxially provided outside the cross-linking chamber, an adsorption skirt is provided outside the negative pressure adsorption chamber, the cross-linking through hole of the cross-linking chamber is connected with a cross-linking agent pipeline, the pressure through hole of the cross-linking chamber is connected with a pressure pipeline, the cleaning through hole of the cross-linking chamber is connected with a cleaning pipeline, and the negative pressure through hole of the negative pressure adsorption chamber is connected with an exhaust pipeline.

2. The adsorption and fixing device for corneal cross-linking according to claim 1, characterized in that: A transparent capsule membrane is arranged in the center of the cross-linking chamber, a pressure through hole is located between the transparent cover plate and the transparent capsule membrane, and a cross-linking through hole and a cleaning through hole are located below the transparent capsule membrane.

3. The adsorption and fixing device for corneal cross-linking according to claim 1, characterized in that: The cross-linking agent pipeline, the pressure pipeline and the cleaning pipeline all penetrate the side wall of the negative pressure adsorption chamber and are connected with the cross-linking chamber.

4. The adsorption and fixation device for corneal cross-linking according to claim 1, characterized in that: The cross section of the negative pressure adsorption chamber is a circular ring or an elliptical ring.

5. The adsorption and fixation device for corneal cross-linking according to claim 1, characterized in that: The cross-section of the cross-linking chamber is circular or elliptical.

6. The adsorption and fixation device for corneal cross-linking according to claim 1, characterized in that: The absorbent skirt is coated with hydrogel.

7. A method for using the adsorption and fixation device for corneal cross-linking according to any one of claims 2 to 6, characterized in that: The following steps are included: S1. The adsorption skirt of the adsorption fixing device is brought into contact with the outer edge of the part of the cornea to be cross-linked, and air is pumped outward through the air pumping pipe. After negative pressure is formed in the negative pressure adsorption chamber, the adsorption fixing device is adsorbed and connected to the cornea; S2, adding a cross-linking agent to the corneal surface in the cross-linking chamber through a cross-linking agent pipeline; S3, injecting gas / liquid into the cross-linking chamber through a pressure pipe, so that the transparent capsule membrane expands downward to press the cornea, causing the corneal surface to become flat or concave inward; S4, selecting whether to use ultraviolet light or blue light, wherein the ultraviolet light or blue light passes through the optical path formed by the transparent cover plate, the gas / liquid and the transparent capsule membrane to irradiate the corneal surface infiltrated with the crosslinking agent; S5. After the cross-linking is completed, the cross-linking agent remaining in the cross-linking chamber is sucked out through the cleaning pipeline, and then cleaned with physiological saline or clean water.

8. The method for using the adsorption and fixation device for corneal cross-linking according to claim 7, characterized in that: In S2, the cross-linking agent includes one of genipin and riboflavin.

9. The method for using the adsorption and fixation device for corneal cross-linking according to claim 7, characterized in that: In S4, the irradiation time of ultraviolet light or blue light is 30 seconds to 30 minutes.

10. The method for using the adsorption and fixation device for corneal cross-linking according to claim 7, characterized in that: In S4, oxygen may be introduced into the cross-linking chamber through the cross-linking agent pipeline.

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