Suture-free ocular surface repair device and preparation method thereof

Abstract

The present invention belongs to the field of medical device technology and discloses a suture-free ocular surface repair device and its preparation method. The suture-free ocular surface repair device comprises a main body layer and a biofilm; the main body layer is a structure obtained by solidifying invisible contact lens material and having a curvature consistent with the ocular surface; the biofilm is disposed on the inner side of the main body layer; before the main body layer solidifies, the invisible contact lens material partially penetrates into the biofilm and solidifies to form a permeable layer, which connects the biofilm to the main body layer via the permeable layer. The technical solution provided by the suture-free ocular surface repair device and its preparation method can ensure a stable and non-detachable bond between the biofilm and the main body layer, while also ensuring that the side of the biofilm closest to the ocular surface is flat, reducing foreign body sensation, improving wearing comfort, and maintaining the biological activity of the biofilm, resulting in good clinical therapeutic effects.

Description

Technical Field

[0001] The present 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, including chemical injuries, thermal burns, and keratitis, can cause damage or loss of the cornea and conjunctiva, often accompanied by corneal neovascularization, which can affect visual function. Currently, ocular surface dressings are the most common treatment for ocular surface and corneal damage or loss.

[0003] Corneal dressings are currently primarily fixed to the limbus and conjunctiva behind it using microsutures. However, this suturing method carries numerous potential complications, including suture-related astigmatism, neovascularization, and suture irritation and infection, which can affect the long-term efficacy of the procedure.

[0004] In addition, due to 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 there are complications caused by the "sutures". Therefore, there is an urgent need for clinical research on sutureless fixation of ocular biological amniotic membranes.

[0005] Currently, an ocular surface biomembrane fixation device made of polymethylmethacrylate (PMMA) is used to fix the amniotic membrane. This ocular surface biomembrane fixation device, used to perform a full conjunctival sac amniotic membrane repair procedure, overcomes the shortcomings of suture fixation, but is primarily used for the early treatment of chemical ocular surface burns. However, while this ocular surface biomembrane fixation device maintains the curvature of the ocular surface, due to the rigidity and fixed size of PMMA, it is difficult to adapt to the conjunctival sac of different patients, resulting in poor comfort.

[0006] The invention patent "A method for manufacturing and storing a device for scarless repair of corneal damage", patent number: 201410256997.7, discloses a specially prepared amniotic membrane component, which is deposited or bonded into or on the surface of various biological or synthetic attachment devices including invisible contact lenses through new carrier controlled release technology and biological tissue engineering technology to form a scarless repair device for corneal (conjunctival) damage. 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 weak 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 amniotic membrane activity 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 adhere 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 objectives are 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 solidifying 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 body 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 body 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 embodiments, the invisible contact lens material is made of the following components, by weight: 98-99% of a copolymer of acrylic acid derivatives and their monomers and a copolymer of hydrophilic vinyl derivatives and their monomers, 0.6-1.8% of a crosslinking agent, and 0.2-0.5% of a photoinitiator.

[0017] 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.

[0018] 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.

[0019] 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 isopropylamide, 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'-bisacryloylcystamine, 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 pericardium; 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 the mold is left to stand for 3 seconds to 10 minutes, so that the invisible contact lens material partially penetrates the biofilm;

[0027] After standing still, solidification and demoulding are completed 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 3 seconds to 1 minute.

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

[0032] In some embodiments, the curing process is performed 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 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 permeable layer to connect with the main body layer. That is, the uncured invisible contact lens material of the main body layer penetrates into the interior of the biofilm and then solidifies, thereby combining the two into one. The device has the characteristics of stable connection and is not easy to fall off. At the same time, it can also ensure that the side of the biofilm close to the ocular surface is a flat surface, reduce foreign body sensation, improve wearing comfort, and maintain the biological activity of the biofilm. Clinical use has good therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 This is a schematic structural diagram of a 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. Infiltration layer. DETAILED DESCRIPTION

[0039] To facilitate 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 present disclosure more thorough and comprehensive.

[0040] In the following examples, the experimental methods without specific conditions are generally 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 herein have the same meanings as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification are for the purpose of describing specific embodiments only and are not intended to limit the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated 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 shape consistent with the ocular surface curvature, so as to adapt to the ocular surface morphology during wear. The main body layer 1 can be configured to adapt to the ocular surface curvature of the wearer, without any particular limitation.

[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 that is close to the patient's ocular surface when the main body layer 1 is worn.

[0045] Before the main layer 1 solidifies, the invisible contact lens material partially penetrates into the biofilm 2 and 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 with the biomembrane 2 is fixed and the concave mold loaded with the invisible contact lens material are embedded 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 to form a permeation layer 3 inside the biomembrane 2, thereby combining the biomembrane 2 and the main layer 1 into one.

[0047] In summary, the main body layer 1 of the suture-free ocular surface repair device 100 is obtained by solidifying the invisible contact lens material, wherein the biomembrane 2 penetrates into the biomembrane 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 unsolidified invisible contact lens material of the main layer 1 penetrates into the interior of the biomembrane 2 and solidifies so that the two are combined into one, which has the characteristics of firm combination and not easy to fall off. At the same time, it can also ensure that the side of the biomembrane 2 close to the ocular surface is a flat surface, reducing the foreign body sensation, improving the wearing comfort, and maintaining the biological activity of the biomembrane 2, and has good therapeutic effect in clinical use.

[0048] In some embodiments, as 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. Therefore, 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, making the side in contact with the ocular surface a flat biofilm 2, it is possible to 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. 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 acrylic acid derivatives and monomers thereof to the copolymer of hydrophilic vinyl derivatives and monomers thereof 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 isopropylamide, 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'-bisacryloylcystamine, 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 pericardium; 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, round, 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] Fitting the biofilm 2 into a convex mold that is consistent with the curvature of the ocular 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 allowed to stand for 3 seconds to 10 minutes, so that the invisible contact lens material partially penetrates the biofilm 2;

[0061] After standing still, solidification and demoulding are completed, and the suture-free ocular surface repair device 100 is obtained.

[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 controlling the thickness of the permeation layer, that is, reducing 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 3 seconds to 1 minute.

[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, the preparation method of which includes the following steps:

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

[0074] 2. Loading the invisible contact lens material into a concave mold that conforms to the curvature of the ocular surface; the invisible contact lens material consists of hydroxyethyl methacrylate (HEMA), methyl methacrylate (MMA), N-vinyl pyrrolidone (VP), a crosslinker (polyethylene glycol diacrylate), and a photoinitiator (ammonium sulfate). The specific amounts of each component are shown in Table 1.

[0075] 3. Fit the male mold with the amniotic membrane fixed in step 1 to 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 sutureless 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 formulas were all able to successfully prepare suture-free ocular surface repair devices, and samples 1-5 were obtained.

[0081] Example 2 Effect of the Standing Time After Mold Fitting on the Adhesion Strength between the Biofilm and the Main Body

[0082] In this example, the formula of sample 3 in Example 1 was used and the preparation method of Example 1 was followed 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 prepare the main layer. Then, the amniotic membrane is attached to the convex mold and then fitted into the concave mold again to make the amniotic membrane adhere to the main layer.

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

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

[0086] The areas containing the main body and biofilm of samples 6-10 prepared in this example were cut into 1 cm*1 cm squares. The maximum cleavage force (N) between the main body and 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 reaction time, reaching its highest value at a reaction time of 10 seconds. After a reaction time exceeding 10 seconds, the bonding strength remains essentially the same as when the reaction time was 10 seconds. The bonding strength of sample 10 is significantly lower than that of samples 6-9. This indicates that the present invention achieves a stronger bond between the amniotic membrane and the main body by allowing the material of the main layer to penetrate into the biomembrane and then solidify to form a permeable layer, thereby integrating the biomembrane and the main body.

[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 an animal model

[0093] Fourteen New Zealand rabbits (2 ± 0.5 kg) were anesthetized with intravenous sodium pentobarbital and restrained in the lateral recumbent position. The head was adjusted to face the ocular surface upward, and the periocular hair was shaved. The periocular and ocular surface were irrigated and disinfected with alternating application of diluted iodine disinfectant and normal saline. Subsequently, a local anesthetic was applied to the ocular surface. The operative eye was then anesthetically applied three times preoperatively. An eyelid speculum was used to expose the ocular surface. During the procedure, normal saline was administered at appropriate times to minimize corneal drying caused by prolonged intraoperative exposure. A 6-mm diameter corneal trephine with an adjustable cutting depth was used to cut an area of ​​25 to 40 mm². A corneal tunnel knife was used to indent the lamellar cornea to create an animal model of corneal epithelial and stromal 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] Animal models (2 ± 0.5 kg) were anesthetized with intravenous sodium pentobarbital. Their forelimbs and hindlimbs were secured with ropes. A surgical drape was wrapped around the rabbit's entire body. The hair around the right eye was removed with an electric shaver and disinfected with iodine to minimize any impact on the surgical procedure and subsequent corneal repair. The surgical site was the wound area of ​​the corneal epithelial and stromal layers.

[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 prepared in Example 2 for Sample Groups 6, 7, 8, 9, and 10 were applied to the right eyes of the rabbits in each suture-free group. The suture-free ocular surface repair devices were removed 7 days after surgery.

[0099] In the suture group, the entire corneal surface was covered with biological amniotic membrane (epithelial surface facing up). Eight 10-0 nylon sutures in a "M" pattern were placed 1 mm outside the wound surface using traditional suture fixation to secure the amniotic membrane to the ocular surface. Sutures were removed or residual amniotic membrane was cleaned 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 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 one 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, with no new blood vessels growing into the wound area, and no obvious scars were observed directly; in sample group 9 of the suture-free group, a small amount of new blood vessels were seen growing into the wound area, and the cornea had slight scars; the corneas of the rabbits in the control group had a large number of new blood vessels growing into the wound area, and the cornea had severe scars.

[0107] Thus, the suture-free ocular surface repair device provided by the present invention has good anti-scarring and anti-neovascular effects when used clinically, 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. The effect is basically the same as that of traditional amniotic membrane suture. 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 anti-neovascular effects of the suture-free ocular surface repair device are reduced. Compared with traditional suture techniques, 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-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A method for preparing a suture-free ocular surface repair device, 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 solidifying 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 biofilm and solidifies to form a permeable layer, and the biofilm is connected to the main layer through the permeable layer; the thickness of the permeable layer is smaller than the thickness of the biofilm; 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 the mold is left to stand for 8 to 12 seconds to allow the invisible contact lens material to partially penetrate the biofilm; After standing still, solidification and demoulding are completed to obtain the suture-free ocular surface repair device.

2. The preparation method according to claim 1, wherein In the curing process, UV light is used for curing.

3. The preparation method according to claim 2, wherein UV light intensity is ~100 μW / cm 2 , the curing time is 3min~5h.

4. The preparation method according to claim 3, wherein The UV light intensity is 90 μW / cm 2 ~100μW / cm 2 , the curing time is 6min~10min.

5. The preparation method according to claim 1, wherein The thickness of the permeation layer accounts for 1 / 10 to 9 / 10 of the thickness of the biofilm.

6. The preparation method according to claim 1, wherein The invisible contact lens material comprises the following components by weight: 98-99% of a copolymer of acrylic acid derivatives and monomers thereof and a copolymer of hydrophilic vinyl derivatives and monomers thereof, 0.6-1.8% of a crosslinking agent and 0.2-0.5% of a photoinitiator.

7. The preparation method according to claim 6, wherein 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'-bisacryloyl cystamine, and dipropylene glycol diacrylate; and / or, The photoinitiator is at least one of benzoin ethyl ether, ammonium sulfate, tetramethylethylenediamine, diphenylethylenedione, benzophenone, and acetophenone derivatives.

8. The preparation method according to claim 1, wherein The biological membrane is one of amniotic membrane, umbilical cord membrane and pericardium.

Images