Amnionoscope and fitting method thereof

Abstract

The present invention relates to an amnionoscope and a fitting method thereof, wherein the amnionoscope comprises an amnion area, a transition area and a landing area; the transition area is connected to the landing area, and in a top-down perspective, the landing area surrounds the transition area; a connection path is provided on the top of the transition area around its circumference, and the amnion area is installed on the transition area through the connection path; the connection path comprises a plurality of fluid channels and a plurality of connection components; the plurality of fluid channels are cross-arranged to form a grid-shaped path body, and the plurality of connection components are located one by one in a plurality of grid areas of the path body; the fluid channel is filled with a biocompatible adhesive, the transition area is connected to the amnion area through the biocompatible adhesive, and the amnion area abuts against the plurality of connection components, and the plurality of connection components form physical adsorption on the amnion area, and the beneficial effect is that the transition area forms a main connection and an auxiliary connection with the amnion area through the connection channel, and a stable connection between the amnion and the transition area is achieved without affecting the biological characteristics of the amnion, thereby ensuring the subsequent use effect of the amnionoscope.

Description

Technical Field

[0001] The present invention relates to the technical field of contact lenses, and in particular to an amniotic lens and a fitting method thereof. Background Art

[0002] The amniotic membrane is the innermost layer of the placenta, including substances required for the growth of conjunctival cells and corneal epithelial cells. It has a smooth surface, no blood vessels, nerves or lymph inside, has a certain elasticity, is about 0.02 to 0.5 mm thick, and is composed of an epithelial layer, a basement membrane, a dense layer, a fibroblast layer and a spongy layer. The amniotic membrane is similar in structure to the human conjunctiva, contains substances required for the growth of ocular surface epithelial cells, including conjunctival cells and corneal epithelial cells, and has the functions of promoting epithelial repair, inhibiting scar formation, inhibiting corneal neovascularization, and inhibiting immune response. Therefore, the amniotic membrane has been widely used in the treatment of ocular surface diseases.

[0003] At present, the publication number CN112155845A discloses a fitted amnionoscope, including an annular fitting part, the amnion is fixed on the fitting part, the lower surface of the fitting part is in contact with the ocular surface, and the fitting part moves with the eyeball when in contact with the ocular surface. The amnionoscope can be worn for a long time to be close to the ocular surface and move with the movement of the eyeball, so that the amnion on the amnionoscope is always in the treatment position, solving the problem of the amnionoscope being offset due to the inability of the amnionoscope to move with the eyeball in the past. It only discloses that the amnion is fixedly connected to the fitting part, but the current conventional connection method is likely to affect the biological characteristics of the amnion, resulting in poor subsequent use of the amnionoscope. Summary of the invention

[0004] 1. Technical issues to be resolved

[0005] In view of the above-mentioned shortcomings and deficiencies of the prior art, the present invention provides an amnioscopic scope and a fitting method thereof, which solves the technical problem that the conventional connection method of the prior art easily affects the biological properties of the amnion, resulting in poor subsequent use effect of the amnioscopic scope.

[0006] (II) Technical solution

[0007] In order to achieve the above object, the main technical solutions adopted by the present invention include:

[0008] On the one hand, the present invention provides an amnioscope, comprising an amniotic membrane region, a transition zone and a landing zone; the transition zone is connected to the landing zone, and in a top-down perspective, the landing zone surrounds the transition zone; a connection path is provided on the top of the transition zone around its circumference, and the amniotic membrane region is installed on the transition zone through the connection path; the connection path comprises a plurality of fluid channels and a plurality of connection components; a plurality of the fluid channels are cross-arranged to form a grid-shaped path body, and a plurality of connection components are located one by one in a plurality of grid areas of the path body; the fluid channel is filled with a biocompatible adhesive, the transition zone is connected to the amniotic membrane region through the biocompatible adhesive, and the amniotic membrane region abuts against a plurality of the connection components, and the plurality of the connection components form physical adsorption on the amniotic membrane region.

[0009] Furthermore, the connection component includes a plurality of nanostructures; the plurality of nanostructures are evenly arranged in the grid area, and the top ends of the plurality of nanostructures are embedded in the bottom of the amniotic membrane area to achieve physical adsorption.

[0010] Furthermore, the shape of the nanostructure is one of hook, strip or column.

[0011] Furthermore, the width of the path body is 1.5 to 3.5 mm; the width of the fluid channel is 200 to 400 μm.

[0012] Furthermore, the amniotic membrane area is spherical and its vertical projection is circular, the transition area is aspherical and its vertical projection is annular, and the landing area is spherical and its vertical projection is annular.

[0013] Furthermore, the biocompatible adhesive is a biohydrogel.

[0014] On the other hand, the present invention also provides a method for fitting the above-mentioned amnioscopic device, comprising the steps of:

[0015] S1. Perform a pre-fitting examination on the patient's eyes to determine the patient's eye condition; then select trial lenses based on the patient's eye condition.

[0016] S2. Fill the trial piece with sterile saline, dye it, and then put it into the patient's eyes. After 5 minutes, check whether there are bubbles between the trial piece and the eye. If there are bubbles, put it on again.

[0017] S3. Perform adaptation evaluation on the gap between the amniotic membrane area and the patient's cornea, and the gap between the transition zone and the patient's corneoscleral limbus. The evaluation standard is that the gap between the amniotic membrane area and the cornea needs to be 0 to 50 μm, and the gap between the transition zone and the corneoscleral limbus needs to be 100 to 250 μm. Perform adaptation evaluation on whether the landing area of ​​the trial wear lens fits the sclera.

[0018] S4. After the evaluation is qualified, the settlement amounts of the amniotic membrane area and the transition zone are recorded respectively when the patient wears the trial lens for 1 hour, 2 hours, 4 hours and 8 hours, and the final settlement amount is determined according to the settlement amounts in the four stages; then the gap between the amniotic membrane area and the patient's cornea after settlement and the gap between the transition zone and the patient's corneoscleral limbus are confirmed to obtain two gap parameters after settlement; the vector height compensation is performed on the amniotic membrane area and the transition zone according to the final settlement amount and the two gap parameters.

[0019] S5. Remove the trial lens and check the health of the patient's ocular surface; determine the parameters of the amniotic membrane area, transition area and landing area suitable for the patient.

[0020] Furthermore, the diameter of the trial lens selected in step S1 is 14.5 mm, 15.5 mm or 16.5 mm; the lens type of the trial lens is conventional or toric; the lens sagitta of the trial lens is the effective sagitta of the patient's eye plus 50 to 150 μm.

[0021] Furthermore, the calculation formula for determining the diameter of the trial lens is: D1 = d H +3mm, D1 is the first diameter, d H is the patient's visible iris diameter; or, D2 = d W +2.5mm, D2 is the second diameter, d W The diameter of the patient's cornea; compare D1 or D2 with 14.5mm, 15.5mm and 16.5mm, and select the size that is closer in value.

[0022] Furthermore, the trial fitting lens in step S3 and step S4 is positioned and centered throughout the entire process.

[0023] (III) Beneficial effects

[0024] The beneficial effects of the present invention are:

[0025] The present invention provides an amniotic mirror, wherein the amniotic region and the transition region can form a cavity with the cornea of ​​the patient, so that the amniotic mirror as a whole can better fit the patient's eyeball, improving the patient's wearing experience. The transition region is connected to the amniotic region through a connection path set on its top, and a plurality of fluid channels are cross-set to form a grid-shaped path body. The biocompatible adhesive filled in the fluid channel is used as the main connection between the amniotic region and the transition region, which does not affect the biological characteristics of the amniotic region, and does not cause allergies or irritation in the eye environment. The plurality of connection components located in the plurality of grid regions of the path body form physical adsorption on the amniotic membrane as an auxiliary connection. Compared with the prior art, the transition region forms a main connection and an auxiliary connection with the amniotic region through the connection channel, and the amniotic membrane is firmly connected to the transition region without affecting the biological characteristics of the amniotic membrane, thereby ensuring the subsequent use effect of the amniotic mirror. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a schematic diagram of the overall structure of the amnioscopic device in Example 1 of the present invention;

[0027] Figure 2 is a schematic top view of the transition zone and the landing zone in Example 1 of the present invention;

[0028] Figure 3 yes Figure 2 The enlarged view of point A in the middle;

[0029] Figure 4 is a schematic structural diagram of the connection between the amniotic region and the transition region in Example 1 of the present invention;

[0030] Figure 5 It is a schematic diagram of the structure of the amnioscopic device when being worn in Example 1 of the present invention.

[0031] [Description of Reference Numerals]

[0032] 1: amniotic region; 2: transition zone; 3: landing zone; 4: connection path; 41: fluid channel; 42: nanostructure. DETAILED DESCRIPTION

[0033] In order to better understand the above technical solution, exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a clearer and more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0034] Embodiment 1:

[0035] like Figure 1As shown, a specific embodiment of the present invention provides an amnioscope, including an amniotic membrane region 1, a transition region 2 and a landing region 3; the transition region 2 is connected to the landing region 3, and the landing region 3 surrounds the transition region 2 in a top view; a connection path 4 is provided on the top of the transition region 2 around its circumference, and the amniotic membrane region 1 is installed on the transition region 2 through the connection path 4; the connection path 4 includes a plurality of fluid channels 41 and a plurality of connection components; the plurality of fluid channels 41 are cross-arranged to form a grid-shaped path body, and the plurality of connection components are located one by one in the plurality of grid regions of the path body; the fluid channel 41 is filled with a biocompatible adhesive, and in this embodiment, the biocompatible adhesive is a biohydrogel. The transition region 2 is connected to the amniotic membrane region 1 through a biocompatible adhesive, and the amniotic membrane region 1 abuts against the plurality of connection components, and the plurality of connection components form physical adsorption on the amniotic membrane region 1. In this embodiment, the amniotic membrane region 1 is spherical and its vertical projection is circular, the transition region 2 is aspherical and its vertical projection is annular, and the landing region 3 is spherical and its vertical projection is annular. The transition zone 2 can form a cavity with the patient's corneoscleral limbus.

[0036] Specifically, the cavity formed between the transition zone 2 and the patient's corneoscleral limbus can make the amnioscope fit the patient's eyeball better as a whole, improving the patient's wearing experience. The transition zone 2 is connected to the amniotic membrane area 1 through the connection path 4 set on its top, and a plurality of fluid channels 41 are cross-set to form a grid-shaped path body. The biocompatible adhesive filled in the fluid channel 41 is used as the main connection between the amniotic membrane area 1 and the transition zone 2, which does not affect the biological properties of the amniotic membrane area 1, and does not cause allergies or irritation in the eye environment. The multiple connection components located in the multiple grid areas of the path body form physical adsorption on the amniotic membrane as an auxiliary connection. Compared with the prior art, the transition zone 2 forms a main connection and an auxiliary connection with the amniotic membrane area 1 through the connection channel, and the amniotic membrane is firmly connected to the transition zone 2 without affecting the biological properties of the amniotic membrane, thereby ensuring the subsequent use effect of the amniotic membrane.

[0037] Further, as shown in the figure, the connection component includes a plurality of nanostructures 42. The plurality of nanostructures 42 are evenly arranged in the grid area, and the tops of the plurality of nanostructures 42 are embedded in the bottom of the amniotic region 1 to achieve physical adsorption. Specifically, the shape of the nanostructure 42 is one of hook, strip or column. The principle of physical adsorption is mainly based on the van der Waals force between molecules, which is a weak interaction force between molecules. Unlike the formation of chemical bonds in chemical adsorption, physical adsorption does not change the chemical properties of the adsorbate, nor does it produce new chemical bonds, so the adsorption process is usually reversible and has low energy requirements. The van der Waals force is the attraction generated by the instantaneous polarization and induced polarization caused by the uneven charge distribution between molecules. Although this attraction between each molecule is very small, when large-scale molecules come into contact, these weak forces will accumulate to form a sufficiently strong adsorption effect. In this embodiment, physical adsorption is achieved by the intermolecular van der Waals force on the surface of the nanostructure 42. The nanostructure 42 can provide a large surface area, so that the contact points between the amniotic region 1 and the transition region 2 are increased, and the force of physical adsorption will also be stronger. The van der Waals attraction between the molecules on the surface of the amniotic membrane and the nanostructure 42 is strong enough to stabilize the amniotic membrane without affecting its biocompatibility and optical properties. Since no chemical reaction is involved, physical adsorption will not cause chemical damage to the adsorbate (such as the amniotic membrane area 1), so it is very suitable for biological materials such as amniotic membrane, which reduces damage to the surface of the amniotic membrane while maintaining its biological properties. In this embodiment, the width of the path body is 1.5 to 3.5 mm; the width of the fluid channel 41 is 200 to 400 μm. Thus, the biocompatible adhesive on the grid line of the path body is used as the main connection, and the physical adsorption of the grid area is used as an auxiliary connection to minimize the surface damage to the amniotic membrane.

[0038] Embodiment 2:

[0039] This embodiment provides a method for fitting the amnioscopic device in Embodiment 1, comprising the steps of:

[0040] S1. Perform a pre-fitting examination on the patient's eyes to determine the patient's eye condition; then select the trial lens of the amnioscope according to the patient's eye condition. The diameter of the trial lens is 14.5mm, 15.5mm or 16.5mm; the lens type of the trial lens is conventional or toric; the lens sagitta of the trial lens is the effective sagitta of the patient's eye plus 50-150μm.

[0041] S2. Fill the trial lens with sterile saline, dye it, and then put it into the patient's eyes. After 5 minutes, check whether there are bubbles between the trial lens and the eye. If there are bubbles, put it back on.

[0042] S3. Based on the centering of the trial lens, the gap between the transition zone 2 of the trial lens and the patient's corneoscleral limbus is evaluated for fit; the evaluation standard is that the gap between the amniotic membrane zone 1 and the cornea needs to be 0-50μm, and the gap between the transition zone 2 and the corneoscleral limbus needs to be 100-250μm; the landing zone 3 of the trial lens is evaluated for fit to the sclera.

[0043] S4. After the evaluation is qualified, the settlement amount of the amniotic membrane area 1 and the transition zone 2 is recorded when the patient wears the trial lens for 1 hour, 2 hours, 4 hours and 8 hours respectively, and the final settlement amount is determined according to the settlement amount of the four stages; then the gap between the amniotic membrane area 1 and the patient's cornea and the gap between the transition zone 2 and the patient's corneoscleral limbus after settlement are confirmed to obtain two gap parameters after settlement; the transition zone 2 is compensated for the vector height according to the final settlement amount and the two gap parameters. The settlement amount of the four stages is compared with the settlement amount after wearing for 8 hours as the reference, for example, by recording the settlement amount after wearing for 1 hour, the corresponding estimated settlement amount after wearing for 8 hours is calculated; by recording the settlement amount after wearing for 2 hours, the corresponding estimated settlement amount after wearing for 8 hours is calculated; by recording the settlement amount after wearing for 4 hours, the corresponding estimated settlement amount after wearing for 8 hours is calculated; then the settlement amount after wearing for 8 hours is compared with the 8-hour settlement standard in the settlement table, and the final settlement amount is the closest to the settlement standard.

[0044] S5. Remove the trial lens, check the health of the patient's ocular surface, and examine the patient's cornea and conjunctiva; determine the parameters of the amniotic zone 1, transition zone 2, and landing zone 3 that are suitable for the patient.

[0045] Specifically, the calculation formula for determining the diameter of the trial lens is:

[0046] D1=d H +3mm, D1 is the first diameter, d H is the patient's visible iris diameter.

[0047] Or, D2 = d W +2.5mm, D2 is the second diameter, d W is the patient's corneal diameter.

[0048] When comparing D1 or D2 with 14.5mm, 15.5mm, and 16.5mm, choose the size that is closer in value. If D1 or D2 is between 14.5mm and 16.5mm, choose 16.5mm.

[0049] Then determine the lens sagitta according to the diameter of the selected trial lens. If you choose a diameter of 14.5mm, you need to measure the sagitta on a 13.5mm chord (the two ends of this chord are approximately parallel to the iris plane, and the two ends of the chord need to fall on the iris surface) as the effective sagitta. If you choose a trial lens with a diameter of 15.5mm, you need to measure the sagitta on a 14.5mm chord as the effective sagitta. If you choose a trial lens with a diameter of 16.5mm, you need to measure the sagitta on a 15.5mm chord as the effective sagitta. The sagitta of the trial lens is the effective sagitta plus 50 to 150μm.

[0050] In the description of the present invention, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0051] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0052] In the present invention, unless otherwise clearly specified and limited, when a first feature is “on” or “below” a second feature, it may be that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, when a first feature is “above”, “above” or “above” a second feature, it may be that the first feature is directly above or obliquely above the second feature, or it may simply mean that the first feature is higher in level than the second feature. When a first feature is “below”, “below” or “below” a second feature, it may be that the first feature is directly below or obliquely below the second feature, or it may simply mean that the first feature is lower in level than the second feature.

[0053] In the description of this specification, the description of the terms "one embodiment", "some embodiments", "embodiment", "example", "specific example" or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, unless they are contradictory.

[0054] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may alter, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. An amnioscopic device, characterized in that: Includes the amniotic zone (1), transition zone (2), and landing zone (3); The transition zone (2) is connected to the landing zone (3), and in a top view, the landing zone (3) surrounds the transition zone (2); a connection path (4) is provided on the top of the transition zone (2) around the circumference thereof, and the amniotic membrane zone (1) is mounted on the transition zone (2) via the connection path (4); The connection path (4) comprises a plurality of fluid channels (41) and a plurality of connection components; A plurality of the fluid channels (41) are arranged crosswise to form a grid-shaped path body, and a plurality of connection components are located in a plurality of grid areas of the path body in a one-to-one correspondence; The fluid channel (41) is filled with a biocompatible adhesive, the transition zone (2) is connected to the amniotic membrane region (1) via the biocompatible adhesive, and the amniotic membrane region (1) abuts against a plurality of the connecting components, and the plurality of the connecting components form physical adsorption on the amniotic membrane region (1); The connection assembly includes a plurality of nanostructures (42); The plurality of nanostructures (42) are evenly arranged in the grid area, and the top ends of the plurality of nanostructures (42) are embedded in the bottom of the amniotic membrane area (1) to achieve physical adsorption.

2. The amnioscopic device according to claim 1, wherein: The shape of the nanostructure (42) is one of a hook shape, a strip shape or a column shape.

3. The amnioscopic device according to claim 1, wherein: The width of the path body is 1.5-3.5 mm; The width of the fluid channel (41) is 200-400 μm.

4. The amnioscopic device according to claim 1, wherein: The amniotic membrane area (1) is spherical and its vertical projection is circular, the transition area (2) is aspherical and its vertical projection is annular, and the landing area (3) is spherical and its vertical projection is annular.

5. The amnioscopic device according to claim 1, wherein: The biocompatible adhesive is a biohydrogel.

6. A method for fitting an amnioscopic device according to any one of claims 1 to 5, characterized in that: Includes steps: S1. Perform a pre-matching examination on the patient's eyes to determine the patient's eye condition; then select a trial lens for the amnioscope based on the patient's eye condition; S2, fill the trial lens with sterile saline, dye it and put it into the patient's eyes. After 5 minutes, check whether there are bubbles between the trial lens and the eye. If there are bubbles, put it back on; S3, performing a fitting evaluation on the gap between the transition zone (2) of the trial lens and the limbus of the patient's cornea and sclera; evaluating whether the gap between the amniotic membrane zone (1) and the cornea needs to be 0-50 μm, and evaluating whether the gap between the transition zone (2) and the limbus of the cornea and sclera needs to be 100-250 μm; and performing a fitting evaluation on whether the landing zone (3) of the trial lens fits the sclera; S4. After the evaluation is qualified, the settlement amounts of the amniotic membrane area (1) and the transition area (2) are recorded respectively when the patient wears the trial lens for 1 hour, 2 hours, 4 hours and 8 hours, and the final settlement amount is determined according to the settlement amounts at the four stages; then, the gap between the amniotic membrane area (1) and the patient's cornea and the gap between the transition area (2) and the patient's corneal scleral limbus after the settlement are confirmed to obtain two gap parameters after the settlement; and the transition area (2) is subjected to vector height compensation according to the final settlement amount and the two gap parameters; S5. Remove the trial lens and check the health of the patient's ocular surface; determine the parameters of the amniotic membrane area (1), transition area (2) and landing area (3) suitable for the patient.

7. The method for fitting an amnioscopic device according to claim 6, wherein: The diameter of the trial lens selected in step S1 is 14.5 mm, 15.5 mm or 16.5 mm; The lens type of the trial lens is conventional or toric; The lens sagitta of the trial lens is the effective sagitta of the patient's eye plus 50-150 μm.

8. The method for fitting an amnioscopic device according to claim 7, wherein: The calculation formula for determining the diameter of the trial piece is: D1=d H +3mm, D1 is the first diameter, d H is the patient’s visible iris diameter; Or, D2 = d W +2.5mm, D2 is the second diameter, d W is the patient's corneal diameter; Calculate the absolute difference between the calculated result of D1 and the three values ​​of 14.5mm, 15.5mm and 16.5mm respectively, and select the value with the smallest absolute difference among the three values ​​as the final value of D1; The absolute differences between the calculated result of D2 and the three values ​​of 14.5 mm, 15.5 mm and 16.5 mm are calculated respectively, and the value with the smallest absolute difference among the three values ​​is selected as the final value of D2.

9. The method for fitting an amnioscopic device according to claim 6, wherein: The trial fitting lens described in step S3 and step S4 is positioned and centered throughout the entire process.

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