A method for manufacturing an amnionoscope

Abstract

The present invention relates to a method for manufacturing an amnionoscope, comprising the steps of S1, transparentizing and solidifying the amnion to obtain an amnion area with a spherical shape; S2, casting a super-permeable material to obtain an integrated transition zone and landing zone, wherein the landing zone surrounds the transition zone; wherein the transition zone is aspherical and its vertical projection is a ring, and the landing zone is spherical and its vertical projection is a ring; S3, etching a plurality of cross-arranged fluid channels on the top of the transition zone, wherein the plurality of fluid channels form a grid-like path body extending circumferentially along the transition zone; S4, forming a plurality of uniformly arranged nanostructures in each grid area of ​​the path body to form a connection path; S5, filling the fluid channel with a biocompatible adhesive, placing the amnion area on the transition area, and the bottom edge of the amnion area abutting the connection path; and then curing the biocompatible adhesive, which has the beneficial effect of achieving a stable connection between the amnion area and the transition zone while ensuring the biological characteristics of the amnion area.

Description

Technical Field

[0001] The invention relates to the technical field of medical contact lenses, and in particular to a method for manufacturing an amniotic lens. 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, there is already an amniotic mirror that combines the amniotic membrane with invisible glasses to treat ocular surface diseases. For example, the patent with publication number CN112155845A discloses a fitted amniotic mirror, including an annular fitting portion, the amniotic membrane is fixed on the fitting portion, the lower surface of the fitting portion is in contact with the ocular surface, and the fitting portion moves with the eyeball when in contact with the ocular surface. The amniotic mirror 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 amniotic membrane on the amniotic mirror is always in the treatment position, solving the problem of amniotic mirror deviation caused by the inability of the amniotic mirror to move with the eyeball. However, the manufacturing process of this invisible amniotic mirror is not mature, and the connection between the amniotic membrane and the fitting portion cannot be ensured on the basis of the biological properties of the amniotic membrane during the manufacturing process, resulting in poor subsequent use of the amniotic mirror. 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 a method for manufacturing an amnionoscope, which solves the technical problem that the prior art cannot ensure the connection between the amnion and the fitting part on the basis of the biological properties of the amnion during the manufacturing process, resulting in poor subsequent use of the amnionoscope.

[0006] (II) Technical solution

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

[0008] The present invention provides a method for manufacturing an amnionoscope, comprising the steps of:

[0009] S1. The amniotic membrane is transparentized and solidified to obtain an amniotic membrane region which is spherical in shape and circular in vertical projection.

[0010] S2. Casting the super oxygen permeable material to obtain an integrated transition zone and landing zone, wherein the landing zone surrounds the transition zone; wherein the transition zone is aspherical and its vertical projection is a ring, and the landing zone is spherical and its vertical projection is a ring.

[0011] S3. Etching a plurality of cross-arranged fluid channels on the top of the transition zone, wherein the plurality of fluid channels form a grid-like path body extending circumferentially along the transition zone.

[0012] S4. Forming a plurality of uniformly arranged nanostructures in each grid region of the path body to form a connection path.

[0013] S5. Fill the fluid channel with a biocompatible adhesive, place the amniotic membrane area on the transition zone and apply pressure to the edge of the amniotic membrane area so that the bottom edge of the amniotic membrane area abuts the connection path; and then cure the biocompatible adhesive.

[0014] Further, step S1 includes:

[0015] S11, removing the epithelial layer located on the top of the amniotic membrane and pollutants on the surface of the amniotic membrane to form the amniotic membrane body.

[0016] S12, dehydrating the amniotic membrane body by freeze drying; and then cross-linking the amniotic membrane body.

[0017] S13, polishing the surface of the amniotic membrane body to be smooth, and then covering the surface of the amniotic membrane body with a transparent polymer coating; wherein the thickness of the transparent polymer coating is 5 to 10 μm.

[0018] S14, immersing the amniotic membrane body in a hyaluronic acid solution to form a basic refractive index, then covering the surface of the amniotic membrane body with a refractive index coating, and then drying the surface; wherein the concentration of the hyaluronic acid solution is 0.1%-0.5%; and the thickness of the refractive index coating is 50-100nm.

[0019] S15, sterilizing the amniotic membrane area, and then covering the amniotic membrane body with a spherical transparent protective layer that is vertically projected as a circle to form the amniotic membrane area.

[0020] Furthermore, in step S12, the cross-linking treatment method is to irradiate the amniotic membrane body with ultraviolet rays for 10 to 20 minutes, and the wavelength of the ultraviolet rays is 320 to 400 nm.

[0021] Furthermore, in step S14, after the surface of the amniotic membrane body is covered with the refractive index coating, it is dried by mild heating.

[0022] Furthermore, after step S14, the biological performance test of the amniotic membrane body is performed, and then step S15 is performed.

[0023] Furthermore, in step S1, the diameter of the vertical projection of the amniotic membrane area is 4 to 11 mm; in step S2, the outer diameter of the vertical projection of the transition area is 10 to 13 mm; and the outer diameter of the vertical projection of the landing area is 13 to 17 mm.

[0024] Furthermore, in step S3, the width of the path body is 1.5-3.5 mm; the width of the fluid channel is 200-400 μm.

[0025] Furthermore, in step S4, the shape of the nanostructure is one of hook, strip or column.

[0026] Furthermore, the biocompatible adhesive in step S5 is a biohydrogel, which is cured by light.

[0027] (III) Beneficial effects

[0028] The beneficial effects of the present invention are:

[0029] The present invention provides a method for manufacturing an amnionoscope, which forms a transparent amnion area, the shape of the amnion area is spherical and the vertical projection is circular. An integrated transition zone and landing zone are formed, the shape of the transition zone is non-spherical and the vertical projection is annular, the shape of the landing zone is spherical and the vertical projection is annular, and then a connection path is formed on the top of the transition zone. Step S1 and steps S2-S4 do not interfere with each other and can be performed simultaneously, thereby increasing production efficiency. A biocompatible adhesive is filled in the fluid channel of the connection path, and then the amnion area is covered above the transition zone, the bottom edge of the amnion area is abutted against the connection path, and then the biocompatible adhesive is cured, thereby achieving the connection between the amnion area and the transition zone. 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 the auxiliary connection to minimize the surface damage to the amnion area, ensure the biological characteristics of the amnion area, and then ensure the use effect of the amnionoscope. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 is a schematic flow chart of a method for manufacturing an amnioscopic membrane in a specific embodiment of the present invention;

[0031] Figure 2 It is a flow chart of step S1 in a specific implementation manner of the present invention. DETAILED DESCRIPTION

[0032] 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.

[0033] like Figure 1 As shown, a specific embodiment of the present invention provides a method for manufacturing an amnioscopic membrane, comprising the steps of:

[0034] S1. The amniotic membrane is transparentized and solidified to obtain an amniotic membrane region with a spherical shape and a circular vertical projection, wherein the diameter of the vertical projection of the amniotic membrane region is 4 to 11 mm.

[0035] S2. Cast the super oxygen permeable material to obtain an integrated transition zone and landing zone, wherein the landing zone surrounds the transition zone; wherein the transition zone is aspherical and its vertical projection is annular, and the landing zone is spherical and its vertical projection is annular. wherein the outer diameter of the vertical projection of the transition zone is 10 to 13 mm; and the outer diameter of the vertical projection of the landing zone is 13 to 17 mm.

[0036] S3. Etching a plurality of cross-arranged fluid channels on the top of the transition zone, wherein the plurality of fluid channels form a grid-like path body extending along the circumference of the transition zone, wherein the width of the path body is 1.5 to 3.5 mm, and the width of the fluid channel is 200 to 400 μm.

[0037] S4. Form multiple uniformly arranged nanostructures in each grid area of ​​the path body to form a connection path. The shape of the nanostructure is one of hook, strip or column. This can increase the contact area with the amniotic membrane area and ensure physical adsorption capacity.

[0038] S5, filling the fluid channel with a biocompatible adhesive, placing the amniotic membrane area on the transition area and applying pressure to the edge of the amniotic membrane area so that the bottom edge of the amniotic membrane area abuts the connection path; and then curing the biocompatible adhesive. The biocompatible adhesive is a biohydrogel, which is cured by light.

[0039] Specifically, a transparent amniotic membrane area is formed, the shape of the amniotic membrane area is spherical and the vertical projection is circular. An integrated transition zone and landing zone are formed, the shape of the transition zone is non-spherical and the vertical projection is annular, the shape of the landing zone is spherical and the vertical projection is annular, and then a connection path is formed on the top of the transition zone. Step S1 and steps S2-S4 do not interfere with each other and can be performed simultaneously, thereby increasing production efficiency. A biocompatible adhesive is filled in the fluid channel of the connection path, and then the amniotic membrane area is covered above the transition zone, the bottom edge of the amniotic membrane area is abutted against the connection path, and then the biocompatible adhesive is cured, thereby achieving the connection between the amniotic membrane area and the transition zone. 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 the auxiliary connection to minimize the surface damage to the amniotic membrane area, ensure the biological characteristics of the amniotic membrane area, and then ensure the use effect of the amnionoscope.

[0040] Furthermore, if Figure 2 As shown, step S1 includes:

[0041] S11, removing the epithelial layer at the top of the amnion and the contaminants on the surface of the amnion to form the main body of the amnion. In this specific embodiment, the method for removing the epithelial layer at the top of the amnion is to use mechanical stripping to strip the epithelial layer from the surface of the amnion under sterile conditions. The stripping process needs to be precisely controlled to ensure that the basement membrane below is not damaged.

[0042] S12. Dehydrate the amniotic membrane by freeze drying. The amniotic membrane after freeze drying is dry and transparent. Its collagen fibers still maintain a good arrangement order, which helps to retain biological functions. The amniotic membrane body is then cross-linked. In this specific embodiment, the cross-linking method is to irradiate the amniotic membrane body with ultraviolet rays for 10 to 20 minutes, and the wavelength of the ultraviolet rays is 320 to 400nm, ensuring that the light energy only acts on the surface and does not damage its deep structure. The transparency of the amniotic membrane body after cross-linking treatment is improved, and the fiber structure is more stable.

[0043] S13. Polish the surface of the amniotic membrane body to make it smooth, and then cover the surface of the amniotic membrane body with a transparent polymer coating; wherein the thickness of the transparent polymer coating is 5 to 10 μm, ensuring transparency while providing certain mechanical protection. Specifically, the surface of the amniotic membrane body is polished by high-precision polishing equipment. The purpose of this step is to ensure that the surface of the amniotic membrane body is flat and has no significant bumps, thereby reducing light scattering and distortion. The amniotic membrane body needs to be kept moist during polishing to prevent its surface from being damaged. The transparent polymer coating further enhances the surface properties and reduces optical distortion.

[0044] S14, the amniotic membrane body is immersed in a hyaluronic acid solution to form a basic refractive index, and then a refractive index coating is covered on the surface of the amniotic membrane body, and then a drying treatment is performed. In this specific embodiment, the drying is performed by mild heating to evaporate the solvent, leaving a uniform functional coating; wherein the concentration of the hyaluronic acid solution is 0.1%-0.5%, and its refractive index is 1.34-1.36; the thickness of the refractive index coating is 50-100nm. The refractive index of the cornea is 1.376. The basic refractive index of the amniotic membrane body is adjusted to 1.34-1.36 by immersion in a hyaluronic acid solution. The surface coating rule can be further accurately adjusted by a coating material with a higher refractive index, and finally the refractive index of the amniotic membrane body is close to or reaches the standard of the cornea. Hyaluronic acid can provide biocompatibility while maintaining the transparency of the amniotic membrane, avoiding possible biological reactions after coating treatment. The refractive index coating can fill the tiny unevenness that may exist on the surface of the amniotic membrane body, improve its optical properties, and reduce astigmatism and aberrations.

[0045] S15, sterilizing the amniotic membrane area, and then covering the amniotic membrane main body with a spherical transparent protective layer that is vertically projected as a circle to form the amniotic membrane area. The transparent protective layer can protect the amniotic membrane main body and form a solid effect.

[0046] Furthermore, before step S15, the amniotic membrane body can be subjected to biological performance tests, including cell adhesion experiments: using corneal epithelial cells to be cultured on the surface of the treated amniotic membrane to observe their adhesion and growth. Ideally, the basement membrane of the amniotic membrane can still support the growth and migration of epithelial cells; anti-inflammatory and anti-scar experiments: testing the inhibitory effect of the amniotic membrane on pro-inflammatory factors to ensure that its anti-inflammatory properties are not damaged; transparency test: using a spectrophotometer to test the transmittance of the treated amniotic membrane to ensure that its optical properties meet clinical requirements.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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. A method for manufacturing an amnionoscope, characterized in that: Includes steps: S1. Transparentizing and solidifying the amniotic membrane to obtain an amniotic membrane region that is spherical in shape and circular in vertical projection; S2. Casting the super oxygen permeable material to obtain an integrated transition zone and landing zone, wherein the landing zone surrounds the transition zone; wherein the transition zone is aspherical and its vertical projection is a ring, and the landing zone is spherical and its vertical projection is a ring; S3, etching a plurality of cross-arranged fluid channels on the top of the transition zone, wherein the plurality of fluid channels form a grid-like path body extending circumferentially along the transition zone; S4, forming a plurality of uniformly arranged nanostructures in each grid area of ​​the path body to form a connection path; S5. Fill the fluid channel with a biocompatible adhesive, place the amniotic membrane area on the transition zone and apply pressure to the edge of the amniotic membrane area so that the bottom edge of the amniotic membrane area abuts the connection path; and then cure the biocompatible adhesive.

2. The method for manufacturing an amnioscopic device according to claim 1, wherein: Step S1 includes: S11, removing the epithelial layer located on the top of the amniotic membrane and pollutants on the surface of the amniotic membrane to form an amniotic membrane body; S12, dehydrating the amniotic membrane body by freeze drying; and then cross-linking the amniotic membrane body; S13, polishing the surface of the amniotic membrane body to be smooth, and then covering the surface of the amniotic membrane body with a transparent polymer coating; wherein the thickness of the transparent polymer coating is 5 to 10 μm; S14, the amniotic membrane body is immersed in a hyaluronic acid solution to form a basic refractive index, and then a refractive index coating is covered on the surface of the amniotic membrane body, and then a drying process is performed; wherein the concentration of the hyaluronic acid solution is 0.1%-0.5%; and the thickness of the refractive index coating is 50-100nm; S15, sterilizing the amniotic membrane area, and then covering the amniotic membrane body with a spherical transparent protective layer that is vertically projected as a circle to form the amniotic membrane area.

3. The method for manufacturing an amnioscopic device according to claim 2, wherein: In step S12, the cross-linking treatment method is to irradiate the amniotic membrane body with ultraviolet rays for 10 to 20 minutes, and the wavelength of the ultraviolet rays is 320 to 400 nm.

4. The method for manufacturing an amnioscopic device according to claim 2, wherein: In step S14, after the surface of the amniotic membrane body is covered with the refractive index coating, it is dried by light heating.

5. The method for manufacturing an amnioscopic device according to claim 2, wherein: After step S14, the biological performance test of the amniotic membrane body is performed, and then step S15 is performed.

6. The method for manufacturing an amnioscopic device according to claim 1, wherein: In step S1, the diameter of the vertical projection of the amniotic membrane region is 4 to 11 mm; In step S2, the outer diameter of the vertical projection of the transition zone is 10-13 mm; the outer diameter of the vertical projection of the landing zone is 13-17 mm.

7. The method for manufacturing an amnioscopic device according to claim 1, wherein: In step S3, the width of the path body is 1.5-3.5 mm; the width of the fluid channel is 200-400 μm.

8. The method for manufacturing an amnioscopic device according to claim 1, wherein: In step S4, the shape of the nanostructure is one of hook, strip or column.

9. The method for manufacturing an amnioscopic device according to claim 1, wherein: The biocompatible adhesive in step S5 is a biohydrogel, which is cured by light irradiation.

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