Ocular surface biofilm fixation device and ocular surface repair device

Abstract

The present invention belongs to the field of biomedical technology, and discloses a biomembrane fixing device for the ocular surface and an ocular surface repair device. The biomembrane fixing device for the ocular surface includes a fixing body; the fixing body has an inner surface and an outer surface, the outer surface of the fixing body is a smooth surface, the inner surface of the fixing body has a curvature adapted to the morphology of the ocular surface, and the inner surface of the fixing body has a fixing area for fixing the biomembrane, and a plurality of protruding structures are dispersedly arranged at the fixing area. When the biomembrane is placed on the inner surface of the fixing body and the biomembrane is buckled on the patient's ocular surface, the biomembrane fixing device for the ocular surface can limit the relative displacement of the relative contact and fitting position of the biomembrane relative to the patient's ocular surface, so that the contact and fitting position of the biomembrane and the patient's ocular surface is kept stable, the biomembrane can be fixed on the moist ocular surface and is not easily displaced, which is beneficial to the repair of superficial ocular surface injuries, and has the characteristics of simple structure, convenient wearing and small foreign body sensation.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedicine, and particularly relates to a biomembrane fixing device for the ocular surface and an ocular surface repair device. Background Art

[0002] Various ocular surface diseases such as chemical burns of the ocular surface, thermal burns, and keratitis can cause damage or loss of the cornea and conjunctiva, and are often accompanied by the formation of corneal neovascularization, thereby affecting visual function. Currently, for damage or loss of the ocular surface and cornea, the commonly used treatment method is to cover the cornea and ocular surface with dressings. For severe corneal damage or loss, corneal transplantation may also be required.

[0003] For corneal dressing coverage, it is currently mainly fixed to the conjunctiva behind the corneal limbus and corneal limbus through microsutures. However, this suture method has many potential complications such as suture-related astigmatism, neovascularization, and suture irritation and infection, which affect the long-term efficacy of the surgery.

[0004] In addition, due to this method of using multi-needle double continuous or interrupted sutures (more than 20 needles), there are a series of inherent defects such as relatively long surgical time, "suture" irritation of the ocular surface, and complications caused by "sutures". Therefore, there is an urgent need for research on a sutureless fixation method for ophthalmic biological amniotic membranes in clinical practice.

[0005] Currently, there has been an ocular surface biomembrane fixing device made of polymethylmethacrylate (PMMA) to fix the amniotic membrane. The total conjunctival sac amniotic membrane coverage surgery completed using this ocular surface biomembrane fixing device covers the ocular surface for repair, overcoming the defects of the suture fixation method. However, it is mainly applied to the early treatment of chemical ocular surface burns. The drawback is that although this ocular surface biomembrane fixing device has the curvature of the ocular surface, due to the hard texture and fixed size of PMMA, it is difficult to match the conjunctival sacs of different patients, and the comfort is poor.

[0006] Bio-Tissue company has also developed a product called CAM360 AG, which is a non-ring cryopreserved amniotic membrane (CAM). This product can adhere to and stay under a collagen shield or bandage contact lens (BCL), and then the BCL with CAM360 AG is placed on the corneal surface according to the method of wearing a contact lens. However, directly adhering the amniotic membrane under a collagen shield or bandage contact lens (BCL) is prone to displacement and shedding of the amniotic membrane and the bandage contact lens (BCL) under a moist ocular surface and blinking, thereby affecting the ocular surface repair effect.

[0007] Therefore, it is of great clinical significance to research and develop an ocular surface biomembrane fixing device that can fix the biomembrane on a moist ocular surface and is not easily displaced. Summary of the Invention

[0008] The object of the present invention is to provide an ocular surface biofilm fixing device that can fix the biofilm on a moist ocular surface and is not easily displaced.

[0009] Achieving the above object includes the following technical solutions.

[0010] In a first aspect of the present invention, there is provided an ocular surface biofilm fixing device, which includes a fixing body;

[0011] The fixing body has an inner surface and an outer surface. The outer surface of the fixing body is a smooth surface. The inner surface of the fixing body has a curvature adapted to the morphology of the ocular surface, and the inner surface of the fixing body has a fixing area for fixing the biofilm. A plurality of protruding structures are dispersedly arranged at the fixing area.

[0012] In some embodiments, the fixing area of the fixing body is formed by inwardly recessing on the side corresponding to the inner surface to form a recessed groove structure. The protruding area at the edge of the fixing area is the edge area, and the edge area is a smooth surface.

[0013] In some embodiments, the height of the protruding structure is lower than or equal to the recessed depth of the fixing area; preferably, the recessed depth of the fixing area is 0.01 mm to 0.05 mm, and the height of the protruding structure is 0.01 mm to 0.05 mm.

[0014] In some embodiments, the fixing area and the inner surface of the fixing body are concentrically arranged, and the radius of the fixing area is 1 / 2 to 3 / 4 of the radius of the inner surface of the fixing body.

[0015] In some embodiments, the protruding structure is annular, and the radial lengths of the protruding structures increase in sequence and are arranged in a concentric ring structure in the fixing area. The longitudinal section of the protruding structure is arc-shaped, triangular or square.

[0016] In some embodiments, the protruding structure is columnar, and the cross-sectional shape of the protruding structure is at least one of linear, arc-shaped, circular and square; each of the protruding structures is arranged in an array in the fixing area.

[0017] In some embodiments, the distance between two adjacent protruding structures is 0.4 to 1.5 times the projected width of the protruding structure in the fixing area; and / or,

[0018] The width of the protruding structure in the positive projection direction of the fixing area is 2 to 5 times the height; and / or,

[0019] The thickness of the fixed body corresponding to the fixed area is 0.05 mm to 0.3 mm.

[0020] The second aspect of the present invention provides an ocular surface repair device, which includes a biological membrane and the above-mentioned biological membrane fixing device for the ocular surface, and the biological membrane is disposed at the fixed area.

[0021] In some embodiments, the biological membrane is an amniotic membrane or a pericardial membrane; preferably, the biological membrane is a human-derived biological amniotic membrane.

[0022] The technical solution provided by the present invention has the following advantages and effects:

[0023] The fixed body of the biological membrane fixing device for the ocular surface is provided with an inner surface adapted to the curvature of the ocular surface, and a plurality of convex structures are arranged on the inner surface to increase the friction force. When the biological membrane is placed on the inner surface of the fixed body and the biological membrane is buckled on the ocular surface of the patient, the relative displacement of the relative contact and fitting position of the biological membrane relative to the ocular surface of the patient can be restricted, so that the position where the biological membrane contacts and fits with the ocular surface of the patient remains stable, the biological membrane can be fixed on the moist ocular surface and is not easy to shift, which is beneficial to the repair of superficial ocular surface injuries, and has the characteristics of simple structure, convenient wearing and small foreign body sensation. Description of the Drawings

[0024] Figure 1 is a schematic structural diagram of the biological membrane fixing device for the ocular surface according to Embodiment 1 of the present invention;

[0025] Figure 2 is Figure 1 the longitudinal sectional structural diagram of the biological membrane fixing device for the ocular surface;

[0026] Figure 3 is Figure 2 the longitudinal sectional structural diagram of the biological membrane fixing device for the ocular surface after being assembled with the biological membrane;

[0027] Figure 4 is a schematic structural diagram of the biological membrane fixing device for the ocular surface according to Embodiment 2 of the present invention;

[0028] Figure 5 is Figure 4 the longitudinal sectional structural diagram of the biological membrane fixing device for the ocular surface;

[0029] Figure 6 is a schematic structural diagram of the biological membrane fixing device for the ocular surface according to Embodiment 3 of the present invention;

[0030] Figure 7 is Figure 6 the longitudinal sectional structural diagram of the biological membrane fixing device for the ocular surface;

[0031] Figure 8 It is a schematic structural diagram of the biofilm fixing device for the ocular surface in Embodiment 4 of the present invention;

[0032] Figure 9 is Figure 4 an enlarged schematic diagram of the structure at Location A of the biofilm fixing device for the ocular surface;

[0033] Figure 10 It is a schematic diagram of the clinical application effect in Embodiment 5.

[0034] Explanation of the reference numerals:

[0035] 100, ocular surface repair device;

[0036] 10, biofilm fixing device for the ocular surface;

[0037] 1, fixing body; 11, inner surface; 111, fixing area; 112, edge area; 113, partition; 12, outer surface; 13, convex structure;

[0038] 20, biofilm. Detailed implementation manners

[0039] For the convenience of understanding the present invention, the specific embodiments of the present invention will be described in more detail below with reference to the accompanying drawings of the specification.

[0040] Unless otherwise specified or defined, the "first, second..." used herein is only for differentiating names and does not represent a specific quantity or order.

[0041] Unless otherwise specified or defined, the term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0042] It should be noted that the "fixed to" and "connected to" herein can be directly fixed or connected to an element, or indirectly fixed or connected to an element.

[0043] An embodiment of the present invention provides a biofilm fixing device 10 for the ocular surface. As Figures 1 to 9 shown, the biofilm fixing device 10 for the ocular surface can be used to fix the biofilm 20 to assemble the ocular surface repair device 100. When the ocular surface repair device 100 is used for repairing the ocular surface defect of a patient, the side close to the biofilm 20 contacts the ocular surface of the patient, such as the cornea.

[0044] The biofilm fixing device 10 for the ocular surface includes a fixing body 1; the fixing body 1 has an inner surface 11 and an outer surface 12. The outer surface 12 of the fixing body 1 is a smooth surface. The inner surface 11 of the fixing body 1 has a curvature adapted to the morphology of the ocular surface, and the inner surface 11 of the fixing body 1 has a fixing area 111 for fixing the biofilm 20. A plurality of protruding structures 13 are dispersedly arranged at the fixing area 111. Specifically, the number of the protruding structures 13 can be set to a plurality according to actual needs, and no special limitation is made here. Specifically, it can be the number evenly dispersed at each position of the fixing area 111. In addition, the protruding structures 13 do not need to be evenly dispersed, and can be arranged according to specific needs, and no special limitation is made here. Among them, by setting the inner surface 11 of the fixing body 1 with a curvature adapted to the morphology of the ocular surface and arranging the protruding structures 13 at the fixing area 111 of the inner surface 11, when the biofilm 20 is placed at the fixing area 111, the protruding structures 13 can increase the friction force and can limit the displacement of the biofilm 20 when the biofilm 20 is buckled on the ocular surface of the patient, so that the position where the biofilm 20 contacts and fits with the ocular surface of the patient remains stable, and the biofilm 20 can be fixed on the moist ocular surface and is not easily displaced. In addition, it should be noted that in this embodiment, the whole of the fixing body 1 has a curvature adapted to the morphology of the ocular surface.

[0045] In summary, the fixing body 1 of the biofilm fixing device 10 for the ocular surface is provided with an inner surface 11 adapted to the curvature of the ocular surface and a plurality of protruding structures 13 on the inner surface 11 to increase the friction force, which can limit the relative displacement of the biofilm 20 relative to the contact and fitting position of the ocular surface of the patient when the biofilm 20 is placed on the inner surface 11 of the fixing body 1 and the biofilm 20 is buckled on the ocular surface of the patient, so that the position where the biofilm 20 contacts and fits with the ocular surface of the patient remains stable, and the biofilm 20 can be fixed on the moist ocular surface and is not easily displaced, which is beneficial to the repair of superficial ocular surface injuries, and has the characteristics of simple structure, convenient wearing and small foreign body sensation.

[0046] In some embodiments, such as Figure 2 and Figure 3As shown, on one side of the fixed body 1 corresponding to the inner surface 11, a fixed area 111 with a sunken groove structure is formed by inward depression. The protruding area at the edge of the fixed area 111 is the edge area 112, and the edge area 112 is a smooth surface. Among them, by inwardly depressing the inner surface 11 of the fixed body 1 to form the fixed area 111 with a sunken groove structure, specifically, the inner surface 11 of the fixed body 1 is inwardly depressed along its own thickness direction to form the fixed area 111. The sunken groove of the fixed area 111 is used to form a placement space for placing the biofilm 20. By arranging a convex structure 13 in the fixed area 111 in the shape of a sunken groove, while increasing the friction force, it can also quickly and accurately place the biofilm 20 at the position of the fixed area 111. Combining with the smooth surface formed by the edge area 112 around the fixed area 111 can effectively reduce the sense of foreign body.

[0047] In some embodiments, as Figure 2 shown, the height H of the convex structure 13 is lower than or equal to the sunken depth of the fixed area 111, so that the convex structure 13 does not protrude from the inner surface 11 of the fixed body 1, and enough space can be formed to place the biofilm 20 while increasing the friction force, so that the inner surface 11 of the fixed body 1 equipped with the biofilm 20 forms a smooth surface, further reducing the sense of foreign body during the treatment process. Specifically, in this embodiment, the sunken depth of the fixed area 111 is 0.01 mm to 0.05 mm, and the height of the convex structure 13 is 0.01 mm to 0.05 mm. The height within this preferred range can form a large friction force, is convenient for assembling the biofilm 20, and has better comfort.

[0048] In some embodiments, as Figure 2 shown, the fixed area 111 and the inner surface 11 of the fixed body 1 are concentrically arranged, and the radius of the fixed area 111 is 1 / 2 to 3 / 4 of the radius of the inner surface 11 of the fixed body 1. Among them, a convex structure 13 is arranged at the fixed area 111 to increase the friction force. By optimizing the position of the fixed area 111 on the fixed body 1 and the size of the fixed area 111 relative to the fixed body 1, a larger friction force can be formed within a limited space to limit the displacement of the biofilm 20, and it will not affect the wearing effect and cause a sense of foreign body during wearing.

[0049] In some embodiments, as Figures 2 to 7As shown, the convex structure 13 is annular, and the radial lengths of the convex structure 13 increase successively and are arranged in a concentric ring structure in the fixed area 111; the longitudinal section of the convex structure 13 is arc-shaped, triangular or square. Among them, the annulus of the convex structure 13 includes but is not limited to circular annulus, triangular annulus, square annulus, etc., and the annulus of the convex structure 13 can be a closed annulus or a non-closed annulus, etc. For example, it can be a concentric ring structure and the convex structure 13 with an arc-shaped longitudinal section. No special limitation is made here. Through the convex structure 13 of the concentric ring structure, the convex structure 13 can be evenly arranged at various positions in the fixed area 111, so as to form a uniform frictional force to limit the displacement of the biofilm 20. Preferably, in this embodiment, the convex structure 13 is circular, and the radial lengths of the convex structures 13 increase successively and are arranged in a concentric circular ring structure in the fixed area 111.

[0050] In some embodiments, as Figure 8 shown, the convex structure 13 is columnar, and the cross-sectional shape of the convex structure 13 is at least one of linear, arc-shaped, circular and square; the convex structures 13 are arranged in an array in the fixed area 111. Among them, the linear shape can be a straight line shape, a broken line shape or a wavy line shape, etc. No special limitation is made here, and the array layout can be arranged in a circular, triangular, square layout, etc. for permutation and combination. Among them, any one of the above-shaped convex structures 13 or an orderly permutation and combination of multiple convex structures 13 can be in the fixed area 111. For example, the fixed area 111 can be divided into multiple partitions 113, and each partition 113 is provided with a convex structure 13 of one shape, which can be specifically designed according to actual needs. No special limitation is made here.

[0051] In some embodiments, as Figure 9 shown, the distance (W2) between two adjacent convex structures 13 is 0.4 to 1.5 times the projection width (W1) of the convex structure 13 in the fixed area 111. Among them, by limiting the ratio of the distance between the convex structures 13 to the width of the convex structure 13, the biofilm 20 can be well supported and the displacement of the biofilm 20 can be limited.

[0052] In some embodiments, the width (W1) of the convex structure 13 in the positive projection direction of the fixed area 111 is 3 to 5 times the height (H), so that the convex structures 13 can cooperate with each other to better support the biofilm 20 in the fixed area 111.

[0053] In some embodiments, the thickness of the fixed body 1 corresponding to the fixed area 111 is 0.05 mm to 0.3 mm. The thickness within this range can enable the fixed body 1 to have corresponding support strength at the position corresponding to the fixed area 111, so that the fixed body 1 can still maintain good support strength after forming the sunken fixed area 111 to realize the limitation of the position of the biofilm 20 and the support of the shape.

[0054] In some embodiments, the fixed body 1 and the convex structure 13 are integrally formed structures, which can be specifically prepared from hydrogel or silica gel. Since its overall structure is small, the integrally formed structure is convenient to prepare and can be obtained by curing and demolding the hydrogel or silica gel put into a mold adapted to the structure of the fixed body 1. Since the preparation method is a conventional method, no special description is made here. Of course, in other embodiments, the fixed body 1 and the convex structure 13 can also be a split assembly structure, and no special limitation is made here.

[0055] An embodiment of the present invention further provides an ocular surface repair device 100, as Figure 3 shown. The ocular surface repair device 100 includes a biofilm 20 and the ocular surface biofilm fixing device 10 as described above, and the biofilm 20 is disposed at the fixed area 111.

[0056] Among them, the ocular surface repair device 100 arranges the biofilm 20 at the fixed area 111 on the inner surface 11 of the fixed body 1. By arranging a plurality of convex structures 13 on the inner surface 11 of the fixed body 1 to increase the friction force, the relative displacement of the biofilm 20 relative to the contact and fitting position of the patient's ocular surface can be restricted when the biofilm 20 fits on the inner surface 11 of the fixed body 1 and buckles the biofilm 20 on the patient's ocular surface. Thus, the position where the biofilm 20 contacts and fits with the patient's ocular surface is kept stable, and the biofilm 20 can be fixed on the moist ocular surface and is not easily displaced, which is beneficial to the repair of superficial ocular surface injuries, and has the characteristics of simple structure, convenient wearing and small foreign body sensation.

[0057] In some embodiments, the biofilm 20 is amniotic membrane or pericardium. Specifically, it can be amniotic membrane, pericardium, etc. derived from humans or mammals such as bovines, equines, porcines, canines, felines, rodents or primates. Preferably, the biofilm 20 is human-derived biological amniotic membrane.

[0058] The following takes specific embodiments to illustrate the ocular surface biofilm fixing device 10 of the present invention.

[0059] Embodiment 1

[0060] As Figure 1 and Figure 2As shown in the figure, this embodiment provides a biofilm fixing device 10 for the ocular surface. The biofilm fixing device 10 for the ocular surface includes a fixing body 1, which has an outer surface 12 and an inner surface 11; the inner surface 11 has a curvature adapted to the morphology of the ocular surface. On one side corresponding to the inner surface 11 of the fixing body 1, a fixing area 111 with a concave groove structure is formed by inward depression. The protruding area at the edge of the fixing area 111 is an edge area 112, and the edge area 112 is a smooth surface.

[0061] The fixing area 111 and the inner surface 11 of the fixing body 1 are concentrically arranged, and the radius of the fixing area 111 is 3 / 4 of the radius of the inner surface 11 of the fixing body 1.

[0062] Among them, the depression depth of the fixing area 111 is 0.01 mm, and its function is to form a concave area. During clinical use, the biofilm 20 can be limited within the fixing area 111.

[0063] A plurality of convex structures 13 are uniformly arranged on the fixing area 111. The convex structures 13 are circular rings, and the radial lengths of the convex structures 13 increase in sequence and are arranged in a concentric ring structure within the fixing area 111. The longitudinal section of the convex structure 13 is arc-shaped. The height of the convex structure 13 is 0.01 mm, the projected width of the convex structure 13 on the inner surface 11 of the fixing body 1 is 0.03 mm, the interval length between two adjacent convex structures 13 is 0.03 mm, and the thickness of the fixing body 1 corresponding to the fixing area 111 is 0.05 mm.

[0064] Embodiment 2

[0065] As Figure 4 and Figure 5 shown in the figure, this embodiment provides a biofilm fixing device 10 for the ocular surface. The biofilm fixing device 10 for the ocular surface includes a fixing body 1, which has an outer surface 12 and an inner surface 11; the inner surface 11 has a curvature adapted to the morphology of the ocular surface. On one side corresponding to the inner surface 11 of the fixing body 1, a fixing area 111 with a concave groove structure is formed by inward depression. The protruding area at the edge of the fixing area 111 is an edge area 112, and the edge area 112 is a smooth surface.

[0066] The fixing area 111 and the inner surface 11 of the fixing body 1 are concentrically arranged, and the radius of the fixing area 111 is 3 / 4 of the radius of the inner surface 11 of the fixing body 1.

[0067] Among them, the depression depth of the fixing area 111 is 0.05 mm. Its function is to form a concave area. During clinical use, the biofilm 20 can be limited within the fixing area 111.

[0068] A plurality of convex structures 13 are uniformly arranged on the fixed area 111. The convex structures 13 are in an annular shape, and the radial lengths of the convex structures 13 increase in sequence and are arranged in a concentric ring structure within the fixed area 111. The longitudinal section of the convex structure 13 is rectangular, the height of the convex structure 13 is 0.02 mm, the projected width of the convex structure 13 on the inner surface 11 of the fixed body 1 is 0.05 mm, the interval length between two adjacent convex structures 13 is 0.02 mm, and the thickness of the fixed body 1 corresponding to the fixed area 111 is 0.2 mm.

[0069] Example 3

[0070] As Figure 6 and Figure 7 As shown, this embodiment provides a biofilm fixing device 10 for the ocular surface. The biofilm fixing device 10 for the ocular surface includes a fixed body 1, and the fixed body 1 has an outer surface 12 and an inner surface 11; the inner surface 11 has a curvature adapted to the morphology of the ocular surface. A fixed area 111 with a concave groove structure is formed by inward depression on one side of the fixed body 1 corresponding to the inner surface 11. The protruding area at the edge of the fixed area 111 is the edge area 112, and the edge area 112 is a smooth surface.

[0071] The fixed area 111 and the inner surface 11 of the fixed body 1 are arranged in concentric circles, and the radius of the fixed area 111 is 3 / 4 of the radius of the inner surface 11 of the fixed body 1.

[0072] Among them, the depression depth of the fixed area 111 is 0.05 mm. Its function is to form a concave area, and during clinical use, the biofilm 20 can be limited within the fixed area 111.

[0073] A plurality of convex structures 13 are uniformly arranged on the fixed area 111. The convex structures 13 are in an annular shape, and the radial lengths of the convex structures 13 increase in sequence and are arranged in a concentric ring structure within the fixed area 111. The longitudinal section of the convex structure 13 is triangular, the height of the convex structure 13 is 0.02 mm, the projected width of the convex structure 13 on the inner surface 11 of the fixed body 1 is 0.05 mm, the interval length between two adjacent convex structures 13 is 0.02 mm, and the thickness of the fixed body 1 corresponding to the fixed area 111 is 0.2 mm.

[0074] Example 4

[0075] As Figure 8As shown in the figure, this embodiment provides a biomembrane fixing device 10 for the ocular surface. The biomembrane fixing device 10 for the ocular surface includes a fixing body 1, and the fixing body 1 has an outer surface 12 and an inner surface 11; the inner surface 11 has a curvature adapted to the morphology of the ocular surface. On one side of the fixing body 1 corresponding to the inner surface 11, a fixing area 111 with a concave groove structure is formed by inward depression. The protruding area at the edge of the fixing area 111 is the edge area 112, and the edge area 112 is a smooth surface.

[0076] The fixing area 111 is arranged concentrically with the inner surface 11 of the fixing body 1, and the radius of the fixing area 111 is 1 / 2 of the radius of the inner surface 11 of the fixing body 1.

[0077] Among them, the depression depth of the fixing area 111 is 0.05 mm. Its function is to form a concave area, and during clinical use, the biomembrane 20 can be limited within the fixing area 111.

[0078] The fixing area 111 is evenly divided into four partitions 113 with its own center as the center. The cross-sectional shapes of the protruding structures 13 corresponding to each partition 113 are different, namely circular, triangular, rectangular, and polygonal. The height of the protruding structure 13 is 0.05 mm, the width of its projection on the inner surface 11 is 0.1 mm, and the interval length between two adjacent protruding structures 13 is 0.05 mm. The thickness of the fixing body 1 corresponding to the fixing area 111 is 0.3 mm.

[0079] Example 5

[0080] In order to verify the clinical application effect of the biomembrane fixing device 10 for the ocular surface of the present invention, an animal model with corneal epithelial layer and stromal layer injuries is used. According to clinical requirements, the biomembrane fixing device 10 for the ocular surface is simulated for use, and the product performance of the biomembrane fixing device 10 provided by the present invention and the effectiveness of repairing corneal wounds are tested.

[0081] 1. Establish an animal model

[0082] After taking 8 New Zealand rabbits (2 ± 0.5 kg) and anesthetizing them by intravenous injection of sodium pentobarbital, place them in a lateral position for fixation, adjust the head position so that the ocular surface faces directly upward, shave the hair around the eyes, alternately rinse and disinfect the periocular area and the ocular surface with diluted iodophor disinfectant and normal saline, then instill local anesthetic drops on the ocular surface, and instill the preoperative ocular surface anesthetic into the operative eye 3 times. Use an eyelid retractor to expose the ocular surface, and during the operation, instill normal saline in a timely manner to reduce corneal dryness due to long-term exposure during the operation. Use a corneal trephine with an adjustable cutting depth and a diameter of 6 mm to cut an area of 25 - 40 mm2, and use a corneal tunnel knife to excise the lamellar corneal piece along the indentation to prepare an animal model with corneal epithelial layer and stromal layer injuries.

[0083] Randomly divide the successfully established animal models mentioned above.

[0084] 2. Surgical methods

[0085] Sterile surgical instruments are used for all surgical operations, which are carried out strictly in accordance with clinical surgical requirements.

[0086] Sterile surgical instruments are used for all surgical operations, which are carried out strictly in accordance with clinical surgical requirements.

[0087] After anesthetizing the animal model (2 ± 0.5 kg) by intravenous injection of sodium pentobarbital, fix the front and hind limbs with ropes, wrap the whole body of the experimental rabbit with a surgical drape, remove the hair around the right eye of the rabbit cleanly with an electric shaver, and disinfect it with iodophor to minimize the impact on the surgical process and subsequent corneal repair. The surgical site is the wound area of the corneal epithelium and stroma injury model.

[0088] Experimental group: Cut the biological amniotic membrane into a size corresponding to the fixed area of the biomembrane fixation device for the ocular surface, apply it to the fixed area on the inner surface of the biomembrane fixation device for the ocular surface prepared in Example 1, and then buckle it on the right eye of the rabbit in the experimental group;

[0089] Control group 1: Cut the biological amniotic membrane directly into a 10-mm circle, apply it to the inner surface of a commercially available contact lens (manufacturer: coopervision lnc, name: soft hydrophilic contact lens, specification: Biomedics 55), and then buckle it on the right eye of the rabbit in the experimental group;

[0090] Control group 2: Spread and cover the entire corneal surface with the biological amniotic membrane (epithelial side up), and use a traditional suture fixation method to suture 8 stitches in a "cross" shape with 10-0 nylon thread to fix the amniotic membrane to the ocular surface.

[0091] Control group 3: Do not perform any treatment on the operated eye.

[0092] 3. Postoperative evaluation

[0093] Observe and record the following evaluation items:

[0094] (1) Observe the position change of the biomembrane on the ocular surface every day; the position change of the biomembrane and the biomembrane fixation device for the ocular surface.

[0095] (2) Observe the mental state and activity of the experimental rabbits every day, and observe the corneal repair situation.

[0096] (3) Evaluation method: Observe the corneal turbidity and corneal neovascularization of each group of rabbits 1 week after surgery. Comprehensively evaluate the effectiveness of using the biomembrane fixation device for the ocular surface to repair the ocular surface.

[0097] 4. Results

[0098] Regarding the positional changes of the biofilm on the ocular surface, the position of the biofilm on the ocular surface and the position of the biofilm and the ocular surface with the biofilm fixation device in the experimental group did not change. However, in control group 1, the position of the biofilm on the ocular surface and the position of the biofilm and the ocular surface with the biofilm fixation device both showed displacement. This shows that the biofilm fixation device for the ocular surface provided by the embodiments of the present invention can stably fix the biofilm on the corneal surface.

[0099] As Figure 10 shown, all the experimental rabbits in the experimental group and control groups 1-3 had completed epithelialization 1 week after the operation. Among them, the corneas of the rabbits in the experimental group and control group 2 were clear and transparent, without new blood vessels growing into the wound area, and no obvious scars were observed directly. A small amount of new blood vessels grew into the wound area of the cornea of the rabbits in control group 1, and there were slight scars on the cornea. A large number of new blood vessels grew into the wound area of the cornea of the rabbits in control group 3, and there were severe scars on the cornea. Thus, it can be seen that when using the biofilm fixation device for the ocular surface provided by the present invention in clinical use, it has a good effect on fixing the biofilm on the ocular surface, and its effect is basically the same as that of traditional sutured amniotic membrane. At the same time, it can also be found that during the clinical application process, if the biofilm cannot be stably fixed on the cornea, that is, when displacement is likely to occur, it will affect its clinical treatment effect. In addition, compared with the traditional suture technique, the biofilm fixation device for the ocular surface provided by the present invention is convenient for clinical use. In addition to avoiding the secondary injury to the eye caused by traditional sutures, it also saves more surgical time.

[0100] Thus, it can be seen that when using the biofilm fixation device for the ocular surface provided by the present invention in clinical use, it can stably fix the biofilm on the ocular surface, which is beneficial for the biofilm to play the role of anti-scarring and inhibiting new blood vessels. Its effect is basically the same as that of traditional sutured amniotic membrane. However, the biofilm fixation device for the ocular surface provided by the present invention is convenient for clinical use. In addition to avoiding the secondary injury to the eye caused by traditional sutures, it also saves more surgical time.

[0101] The above embodiments are not exhaustive listings based on the present invention. In addition, there may be multiple other embodiments not listed. Any substitution and improvement made without violating the concept of the present invention fall within the protection scope of the present invention.

Claims

1. An ocular surface biofilm fixing device, characterized in that The biomembrane fixing device for the ocular surface includes a fixing body; The fixing body has an inner surface and an outer surface. The outer surface of the fixing body is a smooth surface. The inner surface of the fixing body has a curvature adapted to the morphology of the ocular surface, and the inner surface of the fixing body has a fixing area for fixing the biomembrane. A plurality of dispersedly arranged convex structures are provided at the fixing area; The fixing area of the fixing body is formed by inward depression on the side corresponding to the inner surface to form a concave groove structure. The protruding area at the edge of the fixing area is the edge area, and the edge area is a smooth surface; The height of the convex structure is lower than or equal to the depression depth of the fixing area; The depression depth of the fixing area is 0.01 mm to 0.05 mm, and the height of the convex structure is 0.01 mm to 0.05 mm; The distance between two adjacent convex structures is 0.4 to 1.5 times the projected width of the convex structure in the fixing area; The width of the convex structure in the positive projection direction of the fixing area is 2 to 5 times the height.

2. The biofilm fixing device for ocular surface according to claim 1, characterized in that, The fixing area and the inner surface of the fixing body are concentrically arranged, and the radius of the fixing area is 1 / 2 to 3 / 4 of the radius of the inner surface of the fixing body.

3. The biomembrane fixing device for ocular surface according to any one of claims 1-2, characterized in that, The convex structure is annular, and the radial lengths of the convex structures increase in sequence and are arranged in a concentric ring structure in the fixing area. The longitudinal section of the convex structure is arc-shaped, triangular or square.

4. The biofilm fixing device for ocular surface according to any one of claims 1-2, characterized in that, The convex structure is columnar, and the cross-sectional shape of the convex structure is at least one of linear, arc-shaped, circular and square; each convex structure is arranged in an array in the fixing area.

5. The biofilm fixing device for ocular surface according to any one of claims 1-2, characterized in that, The thickness of the fixing body corresponding to the fixing area is 0.05 mm to 0.3 mm.

6. An ocular surface repair device, characterized in that, The ocular surface repair device includes a biomembrane and the biomembrane fixing device for the ocular surface according to any one of claims 1-5, and the biomembrane is arranged at the fixing area.

7. The ocular surface repair device according to claim 6, wherein, The biomembrane is amniotic membrane or pericardium.

8. The ocular surface repair device according to claim 7, wherein, The biomembrane is human-derived biological amniotic membrane.

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