Suture-free ocular surface repairing device and preparation method thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a suture-free ocular surface repair device and a preparation method thereof, the suture-free ocular surface repair device comprises a main body layer and a biological membrane; the main body layer is a structural body which is obtained by curing an invisible contact lens material and is consistent with the ocular surface curvature; the biological membrane is arranged on the inner side of the main body layer; before the main body layer is cured, the invisible contact lens material partially permeates into the biological membrane and then is cured to form a permeable layer, and the biological membrane is connected with the main body layer through the permeable layer. According to the technical scheme provided by the suture-free ocular surface repairing device and the preparation method thereof, the biological membrane and the main body layer can be stably combined and are not prone to falling off, meanwhile, it can be guaranteed that the side, close to the ocular surface, of the biological membrane is a flat face, foreign body sensation is reduced, the wearing comfort level is improved, the biological activity of the biological membrane can be kept, and the repairing effect is good. The medicine has a good treatment effect in clinical use.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a suture-free ocular surface repair device and a preparation method thereof. Background Art

[0002] Various ocular surface diseases such as chemical injuries, thermal burns, and keratitis can cause damage or loss of the cornea and conjunctiva, and are often accompanied by the formation of corneal neovascularization, which in turn affects visual function. Currently, the commonly used treatment for ocular surface and corneal damage or loss is to cover the ocular surface with an ocular dressing.

[0003] Corneal dressings are currently mainly fixed to the corneal limbus and the conjunctiva behind the corneal limbus through micro-sutures. However, this suturing method has many potential complications such as suture-related astigmatism, neovascularization, suture irritation and infection, which affect the long-term efficacy of the surgery.

[0004] In addition, due to a series of inherent defects such as the use of multiple needle double continuous or interrupted suture methods, the operation takes a relatively long time, the "sutures" stimulate the ocular surface, and the complications caused by the "sutures", there is an urgent clinical need for research on sutureless fixation method for the eye biological amniotic membrane.

[0005] At present, an ocular surface biomembrane fixing device made of polymethylmethacrylate (PMMA) has been used to fix the amniotic membrane. The full conjunctival sac amniotic membrane covering surgery completed by the ocular surface biomembrane fixing device covers the ocular surface for repair, overcoming the defects of the suture fixation method, but it is mainly used in the early treatment of chemical ocular surface burns. The disadvantage is that although the ocular surface biomembrane fixing device has the curvature of the ocular surface, it is difficult to match the conjunctival sac of different patients due to the hard texture and fixed size of PMMA, and the comfort is poor.

[0006] The invention patent "A method for manufacturing and storing a device for scarless repair of corneal damage", patent number: 201410256997.7, discloses a device for scarless repair of corneal (conjunctival) damage formed by depositing or bonding a specially prepared amniotic membrane component in or on the surface of various biological or synthetic attachment devices including invisible contact lenses through novel carrier controlled release technology and biological tissue engineering technology. The device bonds the amniotic membrane and the invisible contact lens by means of covalent bonds, attraction or adhesives. However, the attraction caused by hydrogen bonds, ionic bonds, van der Waals forces and similar forces may result in a low adhesion between the amniotic membrane and the invisible contact lens, which is easy to separate during use; while the covalent bonds or adhesives may easily lead to reduced activity of the amniotic membrane or deformation of the invisible contact lens.

[0007] Therefore, it is of great clinical significance to research and develop a suture-free ocular surface repair device that can stably bond the biofilm to the invisible contact lens. Summary of the invention

[0008] The purpose of the present invention is to provide an ocular surface repair device which is suture-free, can stably combine a biofilm with a main body layer and can maintain the activity of the biofilm.

[0009] The above-mentioned purpose is achieved by the following technical solutions.

[0010] A first aspect of the present invention provides a suture-free ocular surface repair device, the suture-free ocular surface repair device comprising a main body layer and a biofilm;

[0011] The main body layer is a structure obtained by curing the invisible contact lens material and having a curvature consistent with the ocular surface;

[0012] The biofilm is arranged on the inner side of the main body layer;

[0013] Before the main layer is solidified, the invisible contact lens material partially penetrates into the biological membrane and solidifies to form a permeation layer, and the biological membrane is connected to the main layer through the permeation layer.

[0014] In some embodiments, the thickness of the permeable layer is less than or equal to the thickness of the biofilm.

[0015] In some embodiments, the thickness of the permeable layer is 1 / 10 to 9 / 10 of the thickness of the biofilm.

[0016] In some of the embodiments, the invisible contact lens material is made of the following components, by weight: 98-99% copolymers of acrylic acid derivatives and their monomers and copolymers of hydrophilic vinyl derivatives and their monomers, 0.6-1.8% crosslinking agent and 0.2-0.5% photoinitiator.

[0017] In some of the embodiments, the mass ratio of the copolymer of the acrylic acid derivative and its monomer to the copolymer of the hydrophilic vinyl derivative and its monomer is 1:1.5 to 3:1.

[0018] In some of the embodiments, the acrylic acid derivative is at least one of methyl methacrylate, 2-hydroxybutyl methacrylate, tert-butyl methacrylate, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, ethoxyethyl methacrylamide, ethylene glycol methyl ether methacrylate, and isobornyl methacrylate.

[0019] In some of the embodiments, the hydrophilic vinyl derivative is at least one of N-vinyl-N-methylacetamide, N-vinyl pyrrolidone, N-vinyl formamide, N-vinyl acetamide, N-vinyl-N-ethylacetamide, N-vinyl isopropyl amide, N-vinyl caprolactam, N-vinyl-N-ethylformamide, 1,4-butanediol vinyl ether, ethylene glycol vinyl ether, and diethylene glycol vinyl ether.

[0020] In some embodiments, the crosslinking agent is at least one of polyethylene glycol diacrylate, ethylene glycol dimethacrylate, ethylene glycol diglycidyl ether, diethylene glycol dimethacrylate, 1,4-butanediol diacrylate, methylene bisacrylamide, N,N'-bisacrylamide, and dipropylene glycol diacrylate.

[0021] In some embodiments, the photoinitiator is at least one of benzoin ethyl ether, ammonium sulfate, tetramethylethylenediamine, diphenylethylenedione, benzophenone, and acetophenone derivatives.

[0022] In some embodiments, the biological membrane is one of amniotic membrane, umbilical cord membrane, and pericardial membrane; preferably, the biological membrane is amniotic membrane.

[0023] A second aspect of the present invention provides a method for preparing the suture-free ocular surface repair device as described above, the method comprising the following steps:

[0024] Loading the uncured contact lens material into a concave mold that conforms to the curvature of the ocular surface;

[0025] The biofilm is fitted into a convex mold that conforms to the curvature of the ocular surface;

[0026] The male mold with the biofilm fixed thereon is fitted into the female mold loaded with the invisible contact lens material and left to stand for 3 seconds to 10 minutes, so that the invisible contact lens material partially penetrates into the biofilm;

[0027] After standing still, the material is cured and demoulded to obtain the suture-free ocular surface repair device.

[0028] In some embodiments, the standing time is 3s to 5min.

[0029] In some embodiments, the standing time is 3s to 4min.

[0030] In some embodiments, the standing time is 3s to 1min.

[0031] In some embodiments, the standing time is 8s to 12s.

[0032] In some embodiments, the curing process is performed by using UV light; preferably, the UV light intensity is 20 μW / cm 2 ~100μW / cm 2 The curing time can be 3min to 5h; more preferably, the UV light intensity is 90μW / cm 2 ~100μW / cm 2 The curing time is 6min to 10min.

[0033] In the present invention, the main body layer of the suture-free ocular surface repair device is obtained by solidifying the invisible contact lens material, wherein the biofilm penetrates into the biofilm through the invisible contact lens material of the main body layer before solidification, and then solidifies to form a permeation layer to connect with the main body layer, that is, the unsolidified invisible contact lens material of the main body layer penetrates into the interior of the biofilm and then solidifies to combine the two into one, which has the characteristics of stable combination and not easy to fall off, and can also ensure that the side of the biofilm close to the ocular surface is a flat surface, reduce the foreign body sensation, improve the wearing comfort, and can maintain the biological activity of the biofilm, and has good therapeutic effect in clinical use. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 Schematic diagram of the structure of the suture-free ocular surface repair device according to an embodiment of the present invention.

[0035] Figure 2 This is the clinical application effect of the suture-free ocular surface repair device of Example 3.

[0036] Description of reference numerals:

[0037] 100. Suture-free ocular surface repair device;

[0038] 1. Main layer; 2. Biofilm; 3. Permeation layer. DETAILED DESCRIPTION

[0039] In order to facilitate the understanding of the present invention, the present invention will be described more fully below. The present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0040] The experimental methods in the following examples without specifying specific conditions are usually carried out under conventional conditions or conditions recommended by the manufacturers. The various commonly used chemical reagents used in the examples are all commercially available products.

[0041] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art to which the present invention belongs. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used in the present invention includes any and all combinations of one or more of the related listed items.

[0042] The embodiment of the present invention provides a suture-free ocular surface repair device 100, such as Figure 1 As shown, the suture-free ocular surface repair device 100 includes a main body layer 1 and a biological membrane 2.

[0043] The main body layer 1 is a structure obtained by curing the invisible contact lens material and having a curvature consistent with the ocular surface, so as to be able to adapt to the ocular surface morphology for wearing. The main body layer 1 can be adapted according to the ocular surface curvature of the actual wearer, so as to be able to fit the ocular surface curvature of different objects of application, and there is no special limitation here.

[0044] The biofilm 2 is arranged on the inner side of the main body layer 1. The inner side of the main body layer 1 corresponds to the side of the main body layer 1 close to the patient's eye surface when the main body layer 1 is worn.

[0045] Before the main layer 1 is solidified, the invisible contact lens material partially penetrates into the biofilm 2 and then solidifies to form a permeation layer 3, and the biofilm 2 is connected to the main layer 1 through the permeation layer 3; that is, the biofilm 2 partially penetrates into the interior of the biofilm 2 through the invisible contact lens material of the main layer 1 before solidification, and then solidifies to form a permeation layer 3 to connect with the main layer 1.

[0046] Specifically, the uncured invisible contact lens material is first loaded into a concave mold that is consistent with the curvature of the ocular surface, the biomembrane 2 is fitted into a convex mold that is consistent with the curvature of the ocular surface, the convex mold fixed with the biomembrane 2 is embedded in the concave mold loaded with the invisible contact lens material and allowed to stand. During the standing process, the invisible contact lens material can penetrate into the biomembrane 2. After the standing is completed, the invisible contact lens material is cured and demolded, so that a permeable layer 3 can be formed inside the biomembrane 2, thereby combining the biomembrane 2 and the main layer 1 into one.

[0047] In summary, the main body 1 of the suture-free ocular surface repair device 100 is obtained by solidifying the invisible contact lens material, wherein the biofilm 2 penetrates into the biofilm 2 through the invisible contact lens material of the main layer 1 before solidification, and then solidifies to form a penetration layer 3 to connect with the main layer 1, that is, the uncured invisible contact lens material of the main layer 1 penetrates into the interior of the biofilm 2 and then solidifies to combine the two into one, which has the characteristics of stable combination and not easy to fall off. At the same time, it can also ensure that the side of the biofilm 2 close to the ocular surface is a flat surface, reduce the foreign body sensation, improve the wearing comfort, and can maintain the biological activity of the biofilm 2, and has good therapeutic effect in clinical use.

[0048] In some embodiments, Figure 1 As shown, the thickness of the permeable layer 3 is less than or equal to the thickness of the biofilm 2. Specifically, when the patient's ocular surface is repaired, the biofilm 2 is in contact with the ocular surface, so the flatness of the side of the biofilm 2 close to the ocular surface will greatly affect the wearing comfort and the treatment effect of the ocular surface. Therefore, in this embodiment, by controlling the thickness of the permeable layer 3 to be less than or equal to the thickness of the biofilm 2, that is, the side in contact with the ocular surface is a flat biofilm 2, it can effectively avoid affecting the wearing comfort, and can effectively avoid the growth of new blood vessels into the wound area and the formation of obvious scars on the cornea during the treatment process. Preferably, the thickness of the permeable layer 3 accounts for 1 / 10 to 9 / 10 of the thickness of the biofilm 2.

[0049] In some embodiments, the invisible contact lens material is made of the following components, by weight: 98-99% copolymer of acrylic acid derivatives and their monomers and copolymer of hydrophilic vinyl derivatives and their monomers, 0.6-1.8% crosslinking agent and 0.2-0.5% photoinitiator.

[0050] In some embodiments, the mass ratio of the copolymer of the acrylic acid derivative and its monomer to the copolymer of the hydrophilic vinyl derivative and its monomer is 1:1.5 to 3:1.

[0051] In some embodiments, the acrylic acid derivative is at least one of methyl methacrylate, 2-hydroxybutyl methacrylate, tert-butyl methacrylate, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, ethoxyethyl methacrylamide, ethylene glycol methyl ether methacrylate, and isobornyl methacrylate.

[0052] In some embodiments, the hydrophilic vinyl derivative is at least one of N-vinyl-N-methylacetamide, N-vinyl pyrrolidone, N-vinyl formamide, N-vinyl acetamide, N-vinyl-N-ethylacetamide, N-vinyl isopropyl amide, N-vinyl caprolactam, N-vinyl-N-ethylformamide, 1,4-butanediol vinyl ether, ethylene glycol vinyl ether, and diethylene glycol vinyl ether.

[0053] In some embodiments, the crosslinking agent is at least one of polyethylene glycol diacrylate, ethylene glycol dimethacrylate, ethylene glycol diglycidyl ether, diethylene glycol dimethacrylate, 1,4-butanediol diacrylate, methylenebisacrylamide, N,N'-bisacrylcystamine, and dipropylene glycol diacrylate.

[0054] In some embodiments, the photoinitiator is at least one of benzoin ethyl ether, ammonium sulfate, tetramethylethylenediamine, diphenylethylenedione, benzophenone, and acetophenone derivatives.

[0055] In some embodiments, the biological membrane 2 is one of amniotic membrane, umbilical cord membrane, and pericardial membrane; preferably, the biological membrane is amniotic membrane.

[0056] In some embodiments, the biofilm 2 can be cut to have a surface area smaller than the inner surface area of ​​the main layer 1 , and its shape can be various, such as square, circular, with a hole in the middle, etc., without particular limitation.

[0057] The embodiment of the present invention further provides a method for preparing the suture-free ocular surface repair device 100 as described above, the method comprising the following steps:

[0058] Loading the uncured contact lens material into a concave mold that conforms to the curvature of the ocular surface;

[0059] The biofilm 2 is fitted into a convex mold that is consistent with the curvature of the eye surface;

[0060] The male mold with the biofilm 2 fixed thereon is fitted into the female mold loaded with the invisible contact lens material and left to stand for 3 seconds to 10 minutes, so that the invisible contact lens material partially penetrates into the biofilm 2;

[0061] After standing still, the material is cured and demoulded to obtain the suture-free ocular surface repair device 100.

[0062] Among them, in the above-mentioned preparation method, the control of the standing time affects the depth of the invisible contact lens material penetrating into the biomembrane 2. By controlling the specific standing time, the depth of the penetration layer 3 formed by the invisible contact lens material penetrating into the biomembrane 2 can be controlled to be less than or equal to the thickness of the biomembrane 2, which can effectively avoid affecting the wearing comfort and effectively avoid the growth of new blood vessels into the wound area and the formation of obvious scars on the cornea during the treatment process.

[0063] The curing method is UV light curing, and the UV light intensity is about 20 μW / cm 2 To about 100μW / cm 2 , curing time can be from 3 minutes to about 5 hours, depending on the intensity of the applied light.

[0064] Preferably, the UV light intensity is about 90 μW / cm 2 To about 100μW / cm 2 , curing time is 6 minutes to 10 minutes. Curing with high-intensity UV light can quickly initiate polymerization, which is beneficial to control the thickness of the permeation layer, that is, to reduce the impact of the curing process on the thickness of the permeation layer.

[0065] In some embodiments, the curing process is achieved by irradiating a photoinitiator in the contact lens material with ultraviolet light.

[0066] In some embodiments, the standing time is 3s to 5min.

[0067] In some embodiments, the standing time is 3s to 4min.

[0068] In some embodiments, the standing time is 3s to 1min.

[0069] In some embodiments, the standing time is 8s to 12s.

[0070] The following are specific embodiments of the present invention.

[0071] Example 1 Preparation of a suture-free ocular surface repair device

[0072] This embodiment provides a suture-free ocular surface repair device, and the preparation method thereof comprises the following steps:

[0073] 1. Cut the amniotic membrane into a circular shape so that its surface area is smaller than that of the invisible contact lens. In this embodiment, the amniotic membrane area is 3 / 4 of the surface area of ​​the invisible contact lens, and the amniotic membrane is attached to a convex mold that is consistent with the curvature of the eye surface and fixed.

[0074] 2. Loading the invisible contact lens material into a concave mold that is consistent with the curvature of the ocular surface; wherein the invisible contact lens material is composed of hydroxyethyl methacrylate (HEMA), methyl methacrylate (MMA), N-vinyl pyrrolidone (VP), a crosslinking agent (polyethylene glycol diacrylate), and a photoinitiator (ammonium sulfate), and the specific amount of each component is shown in Table 1;

[0075] 3. Fit the male mold with the amniotic membrane fixed in step 1 with the female mold loaded with the contact lens material in step 2; then let it stand for 6 seconds;

[0076] 4. UV light curing, the intensity of the UV light is about 90μW / cm 2 , curing time 8 minutes.

[0077] 5. Demoulding, you can get Figure 1 The suture-free ocular surface repair device is shown.

[0078] Table 1 Amount of each component of invisible contact lens material / g

[0079] HEMA MMA VP Crosslinking agent Photoinitiator Sample 1 45 3 50 1.8 0.2 Sample 2 50 3 45 1.5 0.5 Sample 3 55 4 40 0.8 0.2 Sample 4 60 5 34 0.7 0.3 Sample 5 65 6 28 0.6 0.4

[0080] The above formulations can all be used to successfully prepare suture-free ocular surface repair devices to obtain samples 1-5.

[0081] Example 2 Effect of the standing time after mold fitting on the bonding strength between the biofilm and the main body

[0082] This example uses the formula of sample 3 in example 1 and the preparation method of example 1 to prepare suture-free ocular surface repair device samples 6-9.

[0083] Preparation of sample 10: According to the preparation method of Example 1, the invisible contact lens material is first loaded into a concave mold consistent with the curvature of the ocular surface and solidified to obtain the main layer. Then, the amniotic membrane is attached to the convex mold and then fit into the concave mold again to make the amniotic membrane adhere to the main layer.

[0084] By setting different static time, the effect of biofilm and main body adhesion is observed, and the percentage of permeable layer (i.e. the ratio of permeable layer thickness to amniotic membrane thickness) and adhesion strength (i.e. maximum cleavage force (N)) between biofilm and main body are tested. The specific operation is as follows:

[0085] The sample 6-9 prepared in this example includes the main body and the biomembrane area slices, and the thickness of each layer in the main body and the biomembrane area is measured using a measuring microscope, and the percentage of the permeable layer between the biomembrane and the main body (i.e., the ratio of the permeable layer thickness to the amniotic membrane thickness) is calculated.

[0086] The areas including the main body and the biofilm of samples 6-10 prepared in this example were cut into 1 cm*1 cm squares, and the maximum cleavage force (N) between the main body and the biofilm of each group of samples was measured using an electronic universal testing machine (model: RGM-6002T). The specific results are as follows:

[0087] Table 2 Effect of standing time after mold fitting on the bonding strength between biofilm and main body

[0088]

[0089] As shown in Table 2, the maximum cleavage force (N) between the amniotic membrane and the main body of the suture-free ocular surface repair device increases with the increase of the reaction time. When the reaction time is 10 seconds, it reaches the highest value. After the reaction time exceeds 10 seconds, the bonding strength is basically the same as when the reaction time is 10 seconds. The bonding strength of sample 10 is significantly lower than that of sample groups 6-9. It can be seen that the present invention can make the bonding between the amniotic membrane and the main layer stronger by infiltrating the material of the main layer into the biomembrane and then solidifying to form a permeation layer to combine the biomembrane and the main layer into one structure.

[0090] Example 3 Application of the suture-free ocular surface repair device

[0091] In order to verify the clinical application effect of the suture-free ocular surface repair device of the present invention, an animal model with corneal epithelial and stromal layer damage was used to simulate the use of the suture-free ocular surface repair device product according to clinical requirements, and the performance of the suture-free ocular biological amniotic membrane product provided by the present invention and the effectiveness of repairing corneal wounds were tested.

[0092] 1. Establishing animal models

[0093] Fourteen New Zealand rabbits (2±0.5 kg) were anesthetized with intravenous sodium pentobarbital, placed in lateral position, and their heads were adjusted so that the ocular surface was facing upward. The periocular hair was shaved, and diluted iodine disinfectant and saline were used alternately to rinse and disinfect the periocular and ocular surface. Subsequently, local anesthetic was applied to the ocular surface, and the ocular surface anesthetic was applied to the operated eye 3 times before surgery. The ocular surface was exposed using an eyelid opener, and saline should be added at appropriate times during the operation to reduce the drying of the cornea due to long-term exposure during the operation. A corneal trephine with a diameter of 6 mm and an adjustable cutting depth was used, and the cutting area was 25-40 mm2. The lamellar corneal piece was removed using a corneal tunnel knife along the indentation to prepare an animal model of corneal epithelial and stroma damage.

[0094] The successfully established animal models were randomly divided into 7 groups, namely, sample group 6, sample group 7, sample group 8, sample group 9, sample group 10, suture group and control group.

[0095] 2. Surgical method

[0096] All surgical operations were performed using sterile surgical instruments and in strict accordance with clinical surgical requirements.

[0097] The animal model (2±0.5kg) was anesthetized by intravenous injection of sodium pentobarbital, and the front and rear limbs were fixed with ropes. The whole body of the experimental rabbit was wrapped with a surgical towel, and the hair around the right eye of the rabbit was removed with an electric shaver. It was disinfected with iodine to minimize the impact on the surgical process and subsequent corneal repair. The surgical site was the wound area of ​​the corneal epithelial and stroma layer injury model.

[0098] Suture-free groups (sample group 6, sample group 7, sample group 8, sample group 9, sample group 10): the suture-free ocular surface repair devices of sample group 6, sample group 7, sample group 8, sample group 9, and sample group 10 prepared in Example 2 were buckled on the right eyes of rabbits in each suture-free group. The suture-free ocular surface repair devices were removed 7 days after surgery.

[0099] Suture group: biological amniotic membrane (epithelial surface facing up) was used to cover the entire corneal surface, and 1 mm outside the wound surface, 10-0 nylon thread was used to suture 8 stitches in a "M" shape to fix the amniotic membrane to the ocular surface. The sutures were removed or the residual amniotic membrane was removed 7 days after surgery.

[0100] Control group: No treatment was performed on the operated eyes for model establishment.

[0101] 3. Postoperative evaluation

[0102] Observe and record the following evaluation items:

[0103] (1) Observe the mental state and activity of the experimental rabbits and observe the corneal repair status every day.

[0104] (2) Evaluation method: The corneal opacity and corneal neovascularization of rabbits in each group were observed 1 week, 4 weeks, and 8 weeks after surgery. The effectiveness of the suture-free ocular biological amniotic membrane provided by the present invention in repairing the ocular surface was comprehensively evaluated.

[0105] 4. Results

[0106] The results are as follows Figure 2 As shown, the experimental rabbits in the suture-free group (sample group 6, sample group 7, sample group 8, sample group 9, sample group 10), suture group and control group had all completed epithelialization 1 week after surgery. Among them, the corneas of the rabbits in the suture-free group (sample group 6, sample group 7, sample group 8, sample group 10) and suture group were clear and transparent, no new blood vessels grew into the wound area, and no obvious scars were observed directly; in the suture-free group, sample group 9, a small amount of new blood vessels were seen growing into the wound area, and the cornea had slight scars; in the control group, the corneas of the rabbits had a large number of new blood vessels growing into the wound area, and the cornea had severe scars.

[0107] It can be seen that the suture-free ocular surface repair device provided by the present invention has good anti-scarring and neovascularization inhibition effects when the percentage (%) of the permeable layer to the thickness of the amniotic membrane is less than 100%, that is, when the amniotic membrane is not completely covered by the invisible contact lens material, in clinical use, the effect is basically the same as that of the traditional suture of the amniotic membrane; when the percentage (%) of the permeable layer to the thickness of the amniotic membrane is equal to 100%, that is, when the amniotic membrane is completely permeated or covered by the invisible contact lens material, the anti-scarring and neovascularization inhibition effects of the suture-free ocular surface repair device are reduced. Compared with traditional suturing, the suture-free ocular surface repair device provided by the present invention is convenient for clinical use, avoids secondary damage to the eye caused by traditional sutures, and saves more surgical time.

[0108] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0109] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A suture-free ocular surface repair device, It is characterized in that The suture-free ocular surface repair device comprises a main body layer and a biological membrane; The main body layer is a structure obtained by curing the invisible contact lens material and having a curvature consistent with the ocular surface; The biofilm is arranged on the inner side of the main body layer; Before the main layer is solidified, the invisible contact lens material partially penetrates into the biological membrane and solidifies to form a permeation layer, and the biological membrane is connected to the main layer through the permeation layer.

2. The suture-free ocular surface repair device according to claim 1, It is characterized in that The thickness of the permeable layer is less than or equal to the thickness of the biofilm.

3. The suture-free ocular surface repair device according to claim 2, It is characterized in that The thickness of the permeable layer accounts for 1 / 10 to 9 / 10 of the thickness of the biofilm.

4. The suture-free ocular surface repair device according to any one of claims 1 to 3, It is characterized in that The invisible contact lens material is made of the following components by weight: 98-99% of copolymers of acrylic acid derivatives and monomers thereof and copolymers of hydrophilic vinyl derivatives and monomers thereof, 0.6-1.8% of crosslinking agent and 0.2-0.5% of photoinitiator.

5. The suture-free ocular surface repair device according to claim 4, It is characterized in that The mass ratio of the copolymer of the acrylic acid derivative and its monomer to the copolymer of the hydrophilic vinyl derivative and its monomer is 1:1.5 to 3:1; and / or, The acrylic acid derivative is at least one of methyl methacrylate, 2-hydroxybutyl methacrylate, tert-butyl methacrylate, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, ethoxyethyl methacrylamide, ethylene glycol methyl ether methacrylate, and isobornyl methacrylate; and / or, The hydrophilic vinyl derivative is at least one of N-vinyl-N-methylacetamide, N-vinyl pyrrolidone, N-vinyl formamide, N-vinyl acetamide, N-vinyl-N-ethylacetamide, N-vinyl isopropylamide, N-vinyl caprolactam, N-vinyl-N-ethylformamide, 1,4-butanediol vinyl ether, ethylene glycol vinyl ether and diethylene glycol vinyl ether; and / or, The cross-linking agent is at least one of polyethylene glycol diacrylate, ethylene glycol dimethacrylate, ethylene glycol diglycidyl ether, diethylene glycol dimethacrylate, 1,4-butanediol diacrylate, methylene bisacrylamide, N,N'-bisacrylcystamine, and dipropylene glycol diacrylate; and / or, The photoinitiator is at least one of benzoin ethyl ether, ammonium sulfate, tetramethylethylenediamine, diphenylethylenedione, benzophenone, and acetophenone derivatives.

6. The suture-free ocular surface repair device according to any one of claims 1 to 3, It is characterized in that The biological membrane is one of amniotic membrane, umbilical cord membrane and pericardial membrane; preferably, the biological membrane is amniotic membrane.

7. A method for preparing the suture-free ocular surface repair device according to any one of claims 1 to 6, It is characterized in that The preparation method comprises the following steps: Loading the uncured contact lens material into a concave mold that conforms to the curvature of the ocular surface; The biofilm is fitted into a convex mold that conforms to the curvature of the ocular surface; The male mold with the biofilm fixed thereon is fitted into the female mold loaded with the invisible contact lens material and left to stand for 3 seconds to 10 minutes, so that the invisible contact lens material partially penetrates into the biofilm; After standing still, the material is cured and demoulded to obtain the suture-free ocular surface repair device.

8. The preparation method according to claim 7, It is characterized in that The standing time is 3s to 5min.

9. The preparation method according to claim 8, It is characterized in that The standing time is 8s to 12s.

10. The preparation method according to claim 7, It is characterized in that In the curing process, UV light is used for curing; preferably, the intensity of UV light is ~100 μW / cm 2 The curing time can be 3min to 5h; more preferably, the UV light intensity is 90μW / cm 2 ~100μW / cm 2 The curing time is 6min to 10min.

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