Biological membrane fixing device for ocular surface and ocular surface repairing device

Abstract

The invention belongs to the technical field of biomedicine, and discloses a biological membrane fixing device for the ocular surface and an ocular surface repairing device.The biological membrane fixing device for the ocular surface comprises a fixing body; the fixing body is provided with 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 radian matched with the shape of an ocular surface, the inner surface of the fixing body is provided with a fixing area for fixing a biological membrane, and the fixing area is provided with a plurality of convex structures which are dispersedly arranged. According to the biological membrane fixing device for the ocular surface, when a biological membrane is placed on the inner surface of the fixing body and buckled on the ocular surface of a patient, the relative displacement of the biological membrane relative to the contact and attachment position of the ocular surface of the patient is limited, so that the contact and attachment position of the biological membrane and the ocular surface of the patient is kept stable; the biofilm can be fixed on the moist ocular surface and is not prone to displacement, repairing of ocular surface superficial layer damage is facilitated, and the biofilm fixing device has the advantages of being simple in structure, convenient to wear and small in foreign body sensation.

Description

Technical Field

[0001] The invention belongs to the field of biomedical technology, and in particular relates to an ocular surface biofilm fixing device and an ocular surface repairing device. Background Art

[0002] Chemical injuries, thermal burns, keratitis and other ocular surface diseases 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 corneal and ocular surface dressing coverage. For severe corneal damage or loss, corneal transplantation may also be required.

[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 the use of multiple needle double continuous or interrupted sutures (more than 20 stitches), 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 clinical need for research on sutureless fixation of ocular biological amniotic membranes.

[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] Bio-Tissue has also developed a product called CAM360 AG, which is a ring-free cryopreserved amniotic membrane (CAM) that 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 in the same way as wearing a contact lens. However, when the amniotic membrane is directly adhered to a collagen shield or bandage contact lens (BCL), the amniotic membrane and bandage contact lens (BCL) are prone to displacement and detachment when the ocular surface is moist or when blinking, which affects the ocular surface repair effect.

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

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

[0010] A first aspect of the present invention provides a biofilm fixing device for an ocular surface, the biofilm fixing device for an ocular surface comprising a fixing body;

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

[0012] In some embodiments, the fixing body corresponds to a fixing area of ​​the inner surface which is recessed inward to form a recessed groove structure, and a protruding area at the edge of the fixing area is an edge area, and the edge area is a smooth surface.

[0013] In some embodiments, the height of the protruding structure is less than or equal to the depth of the recessed area of ​​the fixing area; preferably, the depth of the recessed area 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 arranged concentrically, 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 length of the protruding structure increases successively and is arranged in the fixing area in a concentric ring structure, and 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 fixed area.

[0017] In some embodiments, the distance between two adjacent protrusion structures is 0.4 to 1.5 times the projection width of the protrusion structure on the fixed area; and / or,

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

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

[0020] A second aspect of the present invention provides an ocular surface repair device, which includes a biofilm and the ocular surface biofilm fixing device as described above, wherein the biofilm is arranged at the fixing area.

[0021] In some embodiments, the biological membrane is amnion or pericardium; preferably, the biological membrane is human amnion.

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

[0023] The fixed body of the ocular surface biofilm fixing device is provided with an inner surface adapted to the curvature of the ocular surface, and a plurality of raised structures are provided on the inner surface to increase friction. When the biofilm is placed on the inner surface of the fixed body and the biofilm is buckled on the patient's ocular surface, the relative displacement of the biofilm in contact with the patient's ocular surface can be limited, so that the contact and fitting position of the biofilm with the patient's ocular surface remains stable. The biofilm can be fixed on a moist ocular surface and is not easily displaced, which is beneficial to the repair of superficial ocular surface injuries. The device has the characteristics of simple structure, easy wearing, and little foreign body sensation. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a schematic structural diagram of a biofilm fixing device for an ocular surface according to Example 1 of the present invention;

[0025] Figure 2 yes Figure 1 Schematic diagram of the longitudinal cross-sectional structure of the ocular surface biofilm fixing device;

[0026] Figure 3 yes Figure 2 Schematic diagram of the longitudinal cross-sectional structure of the ocular surface biofilm fixing device and the biofilm after assembly;

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

[0028] Figure 5 yes Figure 4 Schematic diagram of the longitudinal cross-sectional structure of the ocular surface biofilm fixing device;

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

[0030] Figure 7 yes Figure 6 Schematic diagram of the longitudinal cross-sectional structure of the ocular surface biofilm fixing device;

[0031] Figure 8 is a schematic structural diagram of an ocular surface biofilm fixing device according to Embodiment 4 of the present invention;

[0032] Fig. 9 yes Figure 4 An enlarged schematic diagram of the structure at A of the ocular surface biofilm fixation device;

[0033] Fig.10 It is a schematic diagram of the clinical application effect of Example 5.

[0034] Description of reference numerals:

[0035] 100. Ocular surface repair device;

[0036] 10. Biofilm fixation device for ocular surface;

[0037] 1. fixed body; 11. inner surface; 111. fixed area; 112. edge area; 113. partition; 12. outer surface; 13. raised structure;

[0038] 20. Biofilm. DETAILED DESCRIPTION

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

[0040] Unless otherwise specified or defined, the "first, second..." used in this article is merely used to distinguish names and does not represent a specific quantity or order.

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

[0042] It should be noted that, in this document, “fixed to” or “connected to” may mean directly fixing or connecting to an element, or indirectly fixing or connecting to an element.

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

[0044] The ocular surface biofilm fixing device 10 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 an arc adapted to the ocular surface morphology, and the inner surface 11 of the fixing body 1 has a fixing area 111 for fixing the biofilm 20, and a plurality of dispersed convex structures 13 are arranged at the fixing area 111. Specifically, the number of the convex structures 13 can be set in multiples according to actual needs, and no special restrictions are made here. Specifically, it can be the number of evenly dispersed at various positions of the fixing area 111. In addition, the convex structures 13 do not need to be evenly dispersed, and can be arranged according to specific needs, and no special restrictions are made here. Among them, by setting the fixed body 1 to have an inner surface 11 with a curvature adapted to the ocular surface morphology, and setting the protruding structure 13 in the fixed area 111 of the inner surface 11, when the biofilm 20 is placed in the fixed area 111, the protruding structure 13 can increase the friction force, and can limit the displacement of the biofilm 20 when the biofilm 20 is buckled on the patient's ocular surface, so that the position where the biofilm 20 contacts and fits with the patient's ocular surface 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 entire fixed body 1 has a curvature adapted to the ocular surface morphology.

[0045] In summary, the fixed body 1 of the ocular surface biofilm fixing device 10 is provided with an inner surface 11 adapted to the curvature of the ocular surface, and a plurality of protrusion structures 13 are provided on the inner surface 11 to increase friction. When the biofilm 20 is placed on the inner surface 11 of the fixed body 1 and the biofilm 20 is buckled on the patient's ocular surface, the relative displacement of the biofilm 20 relative to the contact and fitting position of the patient's ocular surface can be limited, thereby keeping the contact and fitting position of the biofilm 20 with the patient's ocular surface stable. The biofilm 20 can be fixed on a 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, easy wearing, and little foreign body sensation.

[0046] In some embodiments, Figure 2 and Figure 3As shown, the fixed body 1 is concave inwardly corresponding to one side of the inner surface 11 to form the fixed area 111 of the concave groove structure, and 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, the fixed area 111 of the concave groove structure is formed by concave inwardly on the inner surface 11 of the fixed body 1, specifically, one side of the inner surface 11 of the fixed body 1 is concave inwardly along its own thickness direction to form the fixed area 111, and the concave groove of the fixed area 111 is used to form a placement space for placing the biofilm 20. By setting the protruding structure 13 in the fixed area 111 of the concave groove shape, it is possible to increase the friction force while also realizing the rapid and accurate placement of the biofilm 20 at the position of the fixed area 111. The smooth surface formed by the edge area 112 around the fixed area 111 can effectively reduce the foreign body sensation.

[0047] In some embodiments, Figure 2 As shown, the height H of the protruding structure 13 is lower than or equal to the recessed depth of the fixed area 111, so that the protruding structure 13 does not protrude from the inner surface 11 of the fixed body 1, and can form enough space for placing 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 foreign body sensation during treatment. Specifically in this embodiment, the recessed depth of the fixed area 111 is 0.01mm to 0.05mm, and the height of the protruding structure 13 is 0.01mm to 0.05mm. The height in this preferred range can form a larger friction force, and it is also convenient to assemble the biofilm 20, and it has better comfort.

[0048] In some embodiments, Figure 2 As shown, the fixing area 111 and the inner surface 11 of the fixing body 1 are arranged in a concentric circle, and the radius of the fixing area 111 is 1 / 2 to 3 / 4 of the radius of the inner surface 11 of the fixing body 1. The fixing area 111 is provided with the protruding structure 13 to increase the friction force. By optimizing the position of the fixing area 111 on the fixing body 1 and optimizing the size of the fixing area 111 relative to the fixing body 1, a greater friction force can be formed in a limited space to limit the displacement of the biofilm 20, without affecting the wearing effect and causing a foreign body sensation when wearing.

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

[0050] In some embodiments, Figure 8 As shown, the protruding structure 13 is columnar, and the cross-sectional shape of the protruding structure 13 is at least one of linear, arc, circular and square; each of the protruding structures 13 is arranged in an array in the fixed area 111. The linear shape can be a straight line, a broken line, a wavy line, etc., and there is no special restriction here. The array layout can be arranged and combined in a circular, triangular, square layout, etc. Among them, the fixed area 111 can be any protruding structure 13 of the above shape or an orderly arrangement and combination of multiple protruding structures 13. For example, the fixed area 111 can be divided into a plurality of partitions 113, and each partition 113 is provided with a protruding structure 13 of a certain shape. The specific design can be based on actual needs, and there is no special restriction here.

[0051] In some embodiments, Fig. 9 As shown, the distance (W2) between two adjacent protrusion structures 13 is 0.4 to 1.5 times the projection width (W1) of the protrusion structure 13 in the fixed area 111. By limiting the ratio of the distance between the protrusion structures 13 and the width of the protrusion 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 protrusion structure 13 in the orthographic projection direction of the fixing area 111 is 3 to 5 times the height (H), so that the protrusion structures 13 cooperate with each other to better support the biofilm 20 in the fixing 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 ensure that the position of the fixed body 1 corresponding to the fixed area 111 has corresponding support strength, so that the fixed body 1 can still maintain good support strength after forming a recessed fixed area 111 to achieve the limitation of the position of the biofilm 20 and the support of its shape.

[0054] In some embodiments, the fixed body 1 and the protruding structure 13 are an integrally formed structure, which can be made of hydrogel or silicone. Since the overall structure is small, the integrally formed structure is easy to prepare and can be obtained by putting the hydrogel or silicone into a mold that is compatible with the structure of the fixed body 1 and curing and demolding. Since the preparation method is a conventional method, no special description is given here. Of course, in other embodiments, the fixed body 1 and the protruding structure 13 can also be a separate assembly structure, which is not particularly limited here.

[0055] The embodiment of the present invention further provides an ocular surface repair device 100, such as Figure 3 As 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 arranged at the fixing area 111 .

[0056] Among them, the ocular surface repair device 100 sets the biofilm 20 in the fixed area 111 of the inner surface 11 of the fixed body 1, and sets a plurality of protrusion structures 13 on the inner surface 11 of the fixed body 1 to increase the friction force. When the biofilm 20 is attached to the inner surface 11 of the fixed body 1 and the biofilm 20 is buckled on the patient's ocular surface, the relative displacement of the biofilm 20 relative to the patient's ocular surface can be limited, so that the contact and fitting position of the biofilm 20 with the patient's ocular surface remains stable, the biofilm 20 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, easy wearing, and little foreign body sensation.

[0057] In some embodiments, the biological membrane 20 is amnion or pericardium, and can be amnion, pericardium, etc. from humans or mammals such as bovines, equines, swine, canines, felines, rodents, or primates. Preferably, the biological membrane 20 is human amnion.

[0058] The ocular surface biofilm fixing device 10 of the present invention is described below with reference to specific embodiments.

[0059] Example 1

[0060] like Figure 1 and Figure 2As shown, this embodiment provides a biofilm fixing device 10 for an ocular surface, and the biofilm fixing device 10 for an 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, and the fixing body 1 is concave inwardly corresponding to one side of the inner surface 11 to form a fixing area 111 with a concave groove structure, and 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 arranged in a concentric circle, 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] The depth of the depression of the fixing area 111 is 0.01 mm, and its function is to form a concave area. When used clinically, the biofilm 20 can be confined within the fixing area 111 .

[0063] A plurality of raised structures 13 are evenly arranged on the fixing area 111, the raised structures 13 are in a circular ring shape, and the radial lengths of the raised structures 13 increase successively and are arranged in a concentric ring structure in the fixing area 111, the longitudinal section of the raised structure 13 is in an arc shape, the height of the raised structure 13 is 0.01 mm, the projection width of the raised structure 13 on the inner surface 11 of the fixing body 1 is 0.03 mm, the interval length between two adjacent raised 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] Example 2

[0065] like Figure 4 and Figure 5 As shown, this embodiment provides a biofilm fixing device 10 for an ocular surface, and the biofilm fixing device 10 for an 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, and the fixing body 1 is concave inwardly corresponding to one side of the inner surface 11 to form a fixing area 111 with a concave groove structure, and 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 arranged in a concentric circle, 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] The depth of the depression of the fixing area 111 is 0.05 mm, which is used to form a concave area, and the biofilm 20 can be confined in the fixing area 111 during clinical use.

[0068] A plurality of raised structures 13 are evenly arranged on the fixing area 111, the raised structures 13 are in a circular ring shape, and the radial lengths of the raised structures 13 increase successively and are arranged in the fixing area 111 in a concentric ring structure, the longitudinal section of the raised structure 13 is rectangular, the height of the raised structure 13 is 0.02 mm, the projection width of the raised structure 13 on the inner surface 11 of the fixing body 1 is 0.05 mm, the interval length between two adjacent raised structures 13 is 0.02 mm, and the thickness of the fixing body 1 corresponding to the fixing area 111 is 0.2 mm.

[0069] Example 3

[0070] like Figure 6 and Figure 7 As shown, this embodiment provides a biofilm fixing device 10 for an ocular surface, and the biofilm fixing device 10 for an 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, and the fixing body 1 is concave inwardly corresponding to one side of the inner surface 11 to form a fixing area 111 with a concave groove structure, and 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.

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

[0072] The depth of the depression of the fixing area 111 is 0.05 mm, which is used to form a concave area, and the biofilm 20 can be confined in the fixing area 111 during clinical use.

[0073] A plurality of raised structures 13 are evenly arranged on the fixing area 111, the raised structures 13 are in a circular ring shape, and the radial lengths of the raised structures 13 increase successively and are arranged in the fixing area 111 in a concentric ring structure, the longitudinal section of the raised structure 13 is triangular, the height of the raised structure 13 is 0.02 mm, the projection width of the raised structure 13 on the inner surface 11 of the fixing body 1 is 0.05 mm, the interval length between two adjacent raised structures 13 is 0.02 mm, and the thickness of the fixing body 1 corresponding to the fixing area 111 is 0.2 mm.

[0074] Example 4

[0075] like Figure 8As shown, this embodiment provides a biofilm fixing device 10 for an ocular surface, and the biofilm fixing device 10 for an 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, and the fixing body 1 is concave inwardly corresponding to one side of the inner surface 11 to form a fixing area 111 with a concave groove structure, and 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.

[0076] The fixing area 111 and the inner surface 11 of the fixing body 1 are arranged in a concentric circle shape, 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] The depth of the depression of the fixing area 111 is 0.05 mm, which is used to form a concave area, and the biofilm 20 can be confined in the fixing area 111 during clinical use.

[0078] The fixing area 111 is 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 folded line. The height of the protruding structures 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 ocular surface biofilm fixation device 10 of the present invention, an animal model with corneal epithelial and stromal layer damage was used to simulate the use of the ocular surface biofilm fixation device 10 product according to clinical requirements, and the product performance of the ocular surface biofilm fixation device 10 provided by the present invention and the effectiveness of repairing corneal wounds were tested.

[0081] 1. Establishing animal models

[0082] Eight New Zealand rabbits (2±0.5 kg) were anesthetized with intravenous injection of sodium pentobarbital, and then placed in lateral recumbency. The head position was adjusted so that the ocular surface was facing upwards, and the periocular hair was shaved. The periocular and ocular surface were rinsed and disinfected with diluted iodine disinfectant and saline alternately. 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 with an eyelid opener, and saline should be added in time 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 by indentation along the corneal tunnel knife to prepare an animal model of corneal epithelial and stroma damage.

[0083] The animal models successfully established above were randomly divided into groups.

[0084] 2. Surgical method

[0085] All surgical operations were performed using sterile surgical instruments and in strict accordance with clinical surgical requirements.

[0086] All surgical operations were performed using sterile surgical instruments and in strict accordance with clinical surgical requirements.

[0087] 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.

[0088] Experimental group: the biological amniotic membrane was cut into a size corresponding to the fixing area of ​​the ocular surface biological membrane fixing device, and applied to the fixing area of ​​the inner surface of the ocular surface biological membrane fixing device prepared in Example 1, and then buckled on the right eye of the rabbit in the experimental group;

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

[0090] Control group 2: biological amniotic membrane (epithelial surface upward) was spread to cover the entire corneal surface, and the amniotic membrane was fixed to the sample using the traditional suturing method with 10-0 nylon thread in a "M" shape with 8 stitches.

[0091] Control group 3: No treatment was given to the operated eye.

[0092] 3. Postoperative evaluation

[0093] Observe and record the following evaluation items:

[0094] (1) Observe the changes in the position of the biofilm on the ocular surface and the biofilm fixation device on the ocular surface every day.

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

[0096] (3) Evaluation method: The corneal opacity and corneal neovascularization of rabbits in each group were observed 1 week after surgery. The effectiveness of the ocular surface biofilm fixation device for repairing the ocular surface was comprehensively evaluated.

[0097] 4. Results

[0098] Regarding the change in the position 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 biofilm fixing device in the experimental group did not change, while in the control group 1, the position of the biofilm on the ocular surface and the position of the biofilm and the ocular surface biofilm fixing device both shifted. This indicates that the ocular surface biofilm fixing device provided by the embodiment of the present invention can stably fix the biofilm on the corneal surface.

[0099] like Fig.10 As shown, the experimental rabbits in the experimental group and the control group 1 to 3 had all completed epithelialization one week after surgery. Among them, the corneas of the rabbits in the experimental group and the control group 2 were clear and transparent, with no new blood vessels growing into the wound area, and no obvious scars were observed directly; a small amount of new blood vessels can be seen growing into the wound area of ​​the cornea of ​​the rabbit in the control group 1, and the cornea has slight scars; the cornea of ​​the rabbit in the control group 3 has a large number of new blood vessels growing into the wound area, and the cornea has severe scars. It can be seen that the use of the ocular surface biofilm fixing device provided by the present invention has a good effect on the fixation of the biofilm to the ocular surface during clinical use, and its effect is basically the same as that of the traditional suture of the amniotic membrane. At the same time, it can also be found that in the process of clinical application, if the biofilm cannot be stably fixed to the cornea, that is, it is easy to displace, it will affect its clinical treatment effect. In addition, compared with traditional suturing, the ocular surface biofilm fixing device provided by the present invention is convenient for clinical use, avoids secondary damage to the eye by traditional suture, and saves more surgical time.

[0100] It can be seen that the ocular surface biomembrane fixing device provided by the present invention can stably fix the biomembrane on the ocular surface during clinical use, which is beneficial for the biomembrane to play an anti-scarring and anti-angiogenesis role. The effect is basically the same as that of traditional suture of amniotic membrane. However, the ocular surface biomembrane fixing device provided by the present invention is easy to use clinically, avoids secondary damage to the eye caused by traditional sutures, and saves more surgical time.

[0101] The above embodiments are not exhaustive enumerations of the present invention, and there may be multiple other implementations not listed. Any replacement and improvement made without violating the concept of the present invention shall fall within the protection scope of the present invention.

Claims

1. A biofilm fixing device for ocular surface, characterized in that: The ocular surface biofilm fixing device comprises a fixing body; The fixed body has an inner surface and an outer surface, the outer surface of the fixed body is a smooth surface, the inner surface of the fixed body has a curvature adapted to the ocular surface morphology, and the inner surface of the fixed body has a fixed area for fixing the biofilm, and a plurality of dispersed protrusion structures are arranged at the fixed area.

2. The ocular surface biofilm fixing device according to claim 1, characterized in that: The fixing body corresponds to a fixing area of ​​the inner surface which is recessed inwardly to form a recessed groove structure. The protruding area at the edge of the fixing area is an edge area, and the edge area is a smooth surface.

3. The ocular surface biofilm fixing device according to claim 2, characterized in that: The height of the protruding structure is less than or equal to the depth of the recessed area of ​​the fixing area; preferably, the depth of the recessed area 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.

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

5. The ocular surface biofilm fixing device according to any one of claims 1 to 4, characterized in that: The protruding structure is annular, and the radial length of the protruding structure increases successively and is arranged in the fixing area in a concentric ring structure. The longitudinal section of the protruding structure is arc-shaped, triangular or square.

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

7. The ocular surface biofilm fixing device according to any one of claims 1 to 4, characterized in that: The distance between two adjacent protruding structures is 0.4 to 1.5 times the projection width of the protruding structures on the fixed area.

8. The ocular surface biofilm fixing device according to any one of claims 1 to 4, characterized in that: The width of the protruding structure in the orthographic projection direction of the fixed area is 2 to 5 times the height; and / or, The thickness of the fixing body corresponding to the fixing area is 0.05 mm to 0.3 mm.

9. An ocular surface repair device, characterized in that: The ocular surface repair device comprises a biofilm and the ocular surface biofilm fixing device according to any one of claims 1 to 8, wherein the biofilm is arranged at the fixing area.

10. The ocular surface repair device according to claim 9, characterized in that: The biological membrane is amnion or pericardium; preferably, the biological membrane is human amnion.

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