A deformable memory amnioscope device

Abstract

The deformable amniotic membrane endoscope device of the present invention includes an amniotic membrane and a deformable amniotic membrane support device. The deformable amniotic membrane support device includes a C-shaped open ring and a solid annular cylinder nested together. The C-shaped open ring is a ring with a C-shaped cross-section, and the opening of the C-shaped structure faces inward. The solid annular cylinder is also an annular structure. The amniotic membrane, after being stripped of its chorionic villi and flattened, is inserted into the C-shaped open ring. The annular cylinder supports the amniotic membrane, pressing it into the groove of the C-shaped open ring. The periphery of the amniotic membrane is trimmed, leaving a certain width of free amniotic membrane tissue around the opening of the C-shaped open ring, thus forming the amniotic membrane endoscope. The beneficial effect of this invention is that the nickel-titanium shape memory alloy has a 37% [unclear meaning - possibly referring to a specific feature or characteristic] in the human body. 0 The amniotic membrane does not deform, allowing it to completely cover the entire conjunctival and corneal surface according to the anatomy of the conjunctival sac. This achieves full coverage of the entire ocular surface without any blind spots, preventing or reducing further adhesion between the eyelid and the eyeball.

Description

Technical Field

[0001] This invention relates to the field of ophthalmic medical device technology, specifically a deformable memory amniotic membrane lens device. Background Technology

[0002] Amniotic membrane, as a biological tissue transplant material, has been proven to have anti-inflammatory and anti-fibrotic effects and has been widely used in the treatment of ocular surface diseases in recent years, playing an important role in ocular surface reconstruction. Because of its active amniotic epithelial cells, the amniotic membrane can secrete a large amount of bioactive factors, playing an anti-inflammatory and repair-promoting role, allowing the amniotic membrane to perform greater physiological functions. Therefore, amniotic membrane, especially fresh amniotic membrane, has been widely used in ocular surface diseases, such as ocular surface chemical burns, corneal diseases, and some patients with dry eye syndrome. A common surgical procedure is amniotic membrane coverage. However, conventional amniotic membrane coverage surgery uses sutures to fix the amniotic membrane to the ocular surface, resulting in significant surgical trauma. Furthermore, due to difficulties in exposure, in most cases, only the amniotic membrane can cover the cornea, limbus, and part of the bulbar conjunctiva near the limbus. For patients with ocular surface damage such as chemical or thermal injuries, the entire ocular surface needs to be covered with the amniotic membrane. Because there is no support structure, this procedure still cannot prevent symblepharon caused by the injury. Moreover, conventional suture amniotic membrane coverage surgery has limitations such as being time-consuming and leaving treatment blind spots. Especially for more severe ocular surface diseases, a single surgery is often insufficient, requiring multiple amniotic membrane coverages. The sutured amniotic membrane is prone to melting and falling off, leading to secondary or even multiple surgical traumas. In addition, traditional surgical methods require hospitalization, wasting significant medical resources. Therefore, it is imperative to find a new, easy-to-operate, sutureless conjunctival sac amniotic membrane coverage technique.

[0003] Currently, the amniotic membranes used in ophthalmology include self-prepared fresh amniotic membranes, bioengineered corneas (dry amniotic membranes and wet amniotic membranes), and bio-amniotic membranes with frame support devices (ophthalmic bio-amniotic membranes from PROKERA in the United States and Nanjing Titanium Shield Company).

[0004] Following ocular surface or corneal injury, such as severe chemical or thermal burns or severe immune-mediated ocular surface diseases, symblepharon and conjunctival sac stenosis are common, leading to abnormalities in the anatomical structure of the conjunctival sac. These abnormalities vary widely and are highly individualized. Furthermore, early-stage ocular surface injury necessitates timely amniotic membrane coverage to alleviate symblepharon. Current amniotic membrane support devices are all of a standardized shape and fixed curvature, unable to adapt to different conjunctival sac shapes and corneal curvatures for personalized coverage. This results in some patients, such as those with shallow symblepharon or abnormal corneal curvature, being unable to use framed amniotic membrane support devices, or experiencing poor adhesion between the amniotic membrane and the ocular surface / cornea—either too loose or too tight—failing to achieve adequate coverage. In some cases, this can even lead to corneal epithelial damage or increased intraocular pressure due to pressure on the eyeball, requiring traditional amniotic membrane suturing. Simultaneously, because framed amniotic membrane support devices have a fixed shape, they cannot achieve complete coverage of the entire injured ocular surface in the early stages and cannot prevent the progression of symblepharon. To address the current problems with framed amniotic membranes, we have developed a deformable memory amniotic membrane support device (amnioscopy).

[0005] The three types of amniotic membrane currently used in ophthalmology have certain shortcomings.

[0006] 1. The source of fresh amniotic membrane is limited and there is a risk of cross-infection. It has a short shelf life and is inconvenient to transport. There are currently legal and ethical issues and risks. With the market availability of biological amniotic membrane, fresh amniotic membrane is rarely used in clinical practice.

[0007] 2. Single-piece biological amniotic membranes overcome the cumbersome procedures involved in obtaining, preparing, and preserving fresh amniotic membranes. They are readily available and can be used immediately, facilitating timely surgery and demonstrating strong practicality, making them worthy of widespread clinical application. A retrospective cohort study by Miao Jianbo et al. showed that biological amniotic membranes have essentially the same tissue structure as fresh amniotic membranes. While they are comparable in improving postoperative visual acuity in treating ocular burns, they can reduce the time required for ocular surface epithelialization and offer greater safety. However, like fresh amniotic membranes, single-piece biological amniotic membranes require sutures to be attached to the ocular surface, subjecting patients to secondary or even multiple surgical traumas and making it difficult to prevent eyelid-ball adhesions. Furthermore, the sutures cause intense foreign body sensation and can lead to aseptic inflammatory reactions on the ocular surface. These factors significantly shorten the time the amniotic membrane remains in place on the ocular surface, potentially leading to repeated amniotic membrane suturing surgeries for patients.

[0008] 3. A framed amniotic membrane is a wet, transparent, thin, and flexible biological amniotic membrane, less prone to curling or damage due to improper surgical technique during surgery. Compared to single-piece biological amniotic membranes, such as the wet biological amniotic membrane produced by Jiangxi Ruiji, the framed amniotic membrane avoids contact and friction between the eyelid and corneal wound, providing a good mechanical barrier. It is also a sutureless amniotic membrane, making it easier to use in clinical settings, shortening surgical time, reducing costs, and offering the additional benefits of eliminating postoperative discomfort and suture-related complications, such as eliminating suture irritation. Numerous studies have demonstrated this advantage. [3] Studies have also shown that this type of bio-amniotic membrane with a framed support device has a longer dissolution time and a longer in-situ time compared to the traditionally sutured single-piece bio-amniotic membrane. For patients who refuse traditional amniotic membrane suturing due to fear of surgery and pain, the bio-amniotic membrane with a framed support device offers a simpler alternative treatment, and is well-tolerated by patients undergoing repeat surgeries. However, the current bio-amniotic membrane with a framed support device has a fixed shape, making it unsuitable for some patients with superficial conjunctival sacs, and causing poor adhesion between the amniotic membrane and cornea in patients with abnormal ocular surface or corneal curvature, thus losing its covering function. Furthermore, the current bio-amniotic membrane with a framed support device cannot cover the entire ocular surface tissue and cannot deform to cover according to the ocular surface anatomy or curvature. Additionally, due to the relatively rigid framed support device, the amniotic membrane has poor following ability during eye movement, which may lead to displacement. Moreover, the presence of the relatively rigid and large framed support device causes some patients to experience a foreign body sensation, and the removal of the support device may scratch the corneal tissue. Early-stage ocular surface chemical and thermal burns can be treated with traditional full amniotic membrane coverage as quickly as possible. However, due to the lack of a support device, it is still difficult to prevent eyelid-ball adhesion. Current amniotic membranes with support devices have a fixed shape but cannot fully cover the damaged ocular surface. Summary of the Invention

[0009] To overcome the shortcomings of the prior art, the present invention provides a deformable memory amniotic membrane endoscope device.

[0010] This invention is achieved through the following technical solution: A deformable memory amniotic membrane endoscope device, characterized in that: it includes an amniotic membrane and a deformable amniotic membrane support device, the deformable amniotic membrane support device includes a C-shaped open ring and a solid annular cylinder nested together, the C-shaped open ring is a ring with a C-shaped cross-section and a groove inside, the opening of the groove facing the inside of the ring, and the solid annular cylinder is also a ring. The amnion, after being stripped of its chorionic villi and flattened, is inserted into a C-shaped open ring. A ring-shaped cylinder is used to support the amnion as it is inserted into the groove of the C-shaped open ring and pressed down. The surrounding amnion is trimmed so that a certain width of free amnion tissue is left around the opening of the C-shaped open ring, thus forming an amnioscope.

[0011] Further preferably, the C-shaped open ring and the solid annular cylinder are made of nickel-titanium shape memory alloy.

[0012] Further preferred are the C-shaped open rings, which have an outer circumference diameter of 25mm, a longitudinal diameter (i.e., the cross-sectional diameter of the C-shaped structure) of 2.5mm, and an opening height (i.e., the groove height) of 1.5mm; and the solid annular cylinders, which have a transverse diameter (i.e., the outer circumference diameter) of 23mm and a longitudinal diameter (i.e., the cross-sectional cylinder diameter) of 1mm.

[0013] In a further preferred embodiment, the outer periphery of the opening of the C-shaped opening ring retains 9-11 mm of free amniotic membrane tissue.

[0014] The method for manufacturing the deformable memory amniotic membrane endoscope device of the present invention includes the following steps: (1) A nickel-titanium shape memory alloy is made into a C-shaped open ring with a diameter of 25 mm, a longitudinal diameter of 2.5 mm, and an opening of 1.5 mm. At the same time, a nickel-titanium shape memory alloy solid ring cylinder with a transverse diameter of 23 mm and a longitudinal diameter of 1 mm is also made. (2) Fresh amniotic membrane tissue obtained clinically is subjected to sterilization within 6 hours of ex vivo and 4 hours after ex vivo. 0 The lint is removed and sterile cleaning is performed in a C environment; (3) 4 0 Under C conditions, the amniotic membrane tissue is flattened and implanted into a C-shaped open ring. A ring-shaped cylinder is then implanted into the C-shaped open ring. The surrounding amniotic membrane is trimmed so that 10 mm of free amniotic membrane tissue is left outside the opening of the C-shaped open ring, thus forming an amniotic endoscope. (4) Implant this amnioscope into the preservation solution -20 0 Stored in C and sterilized by cobalt-60 radiation.

[0015] In a further preferred embodiment, in step (4): the preservation solution is a sterile preservation solution containing DMEM culture medium, glycerol and antibiotics; the absorption dose of the cobalt-60 source is 25 kGy.

[0016] The beneficial effects of this invention are that using nickel-titanium shape memory alloy as an amnion support device have the following advantages: (1) Nickel-titanium shape memory alloy at 40 0 Temperatures above 42°C can be adjusted according to the anatomical structure of the conjunctival sac, and this adjustment temperature can be controlled by the 42°C temperature currently used in clinical practice. 0 C-type atomized eye patches achieve deformation of the amniotic lens in the fornix of the ocular surface, while at 40 0 Below C, such as 37 in the human body 0 C then ceases to deform, allowing the amnion to completely cover the entire conjunctival and corneal surface according to the anatomy of the conjunctival sac.

[0017] (2) A C-shaped ring device made of nickel-titanium shape memory alloy and a solid nickel-titanium shape memory alloy ring cylinder are combined to form an amniotic membrane tissue fixation device. A 10mm free amniotic membrane tissue is retained around the device. Depending on the curvature of the ocular surface or cornea and the different anatomical structures of the conjunctival sac, the fixation device can be adjusted within a 40° radius. 0 In environments above C, the amniotic membrane slides to cover the entire ocular surface, resulting in better adhesion between the amniotic membrane and the ocular surface. Compared to traditional biological amniotic membranes with fixed-size framed support devices, it provides a better fit and achieves personalized coverage.

[0018] (3) The deformation temperature node of nickel-titanium shape memory alloy is 40°C. 0 C, while the temperature for clinically used eye nebulization fumigation is 42.5°C. 0 Therefore, this provides favorable and safe conditions for the application of nickel-titanium shape memory alloys as deformable support materials for amnioscopes.

[0019] (4) Nickel-titanium shape memory alloy deformable amniotic lens has a smooth surface and a small diameter, so it will not cause tissue damage to the eye when it is removed.

[0020] (5) While achieving personalized coverage, the deformation device also achieves full coverage of the entire ocular surface without any blind spots, which can prevent or reduce further adhesion of the eyelid and eyeball.

[0021] (6) This deformable device enables the amniotic membrane to fit perfectly with the entire ocular surface regardless of the curvature of the ocular surface or cornea.

[0022] (7) Nickel-titanium shape memory alloy deformable amnioscope, with a small diameter support device, utilizes the gap in the conjunctival sac fornix. After the support device is deformed, it is implanted into the conjunctival sac fornix, so that the patient has almost no foreign body sensation.

[0023] (8) Nickel-titanium shape memory alloy has good compatibility, mild properties, and is non-toxic and non-irritating to the human body.

[0024] (9) Wide clinical applicability: Applicable to a variety of ocular surface diseases such as non-infectious corneal ulcers, chemical burns, and persistent epithelial defects. Attached Figure Description

[0025] Figure 1 , Figure 2 The following are, in order, the overall structure of the present invention and a partially enlarged schematic diagram. Figure 3 , Figure 4 The images show the overall structure and cross-sectional diagram of the C-shaped open ring, in sequence. Figure 5 This is a schematic diagram of the overall structure of a solid annular cylinder. Figure 6 This is the overall structure after deformation. Figure 7 A deformable memory amniotic membrane device is inserted into the eye in a deformed state. Figure 8This refers to a deformable memory amniotic membrane device placed in the eye in another deformed state. Figure 9 Images of two groups of rabbit corneal fluorescence staining.

[0026] In the diagram: 1. C-shaped open ring (i.e., outer ring), 2. Solid annular cylinder (i.e., inner ring), 3. Amnion, 4. Free amnion tissue, 5. Groove. Detailed Implementation

[0027] The attached figure shows a specific embodiment of the present invention.

[0028] The deformable memory amniotic membrane device of the present invention includes an amniotic membrane 3 and a deformable amniotic membrane support device. The deformable amniotic membrane support device includes a C-shaped open ring 1 and a solid annular cylinder 2 nested together. The C-shaped open ring is a ring with a C-shaped cross-section and a groove 5 inside. The opening of the groove faces the inside of the ring. The solid annular cylinder is also a ring. The amnion, after being stripped of its chorionic villi and flattened, is inserted into a C-shaped open ring. A ring-shaped cylinder is used to support the amnion, which is then inserted into the groove 5 of the C-shaped open ring and pressed down. The surrounding amnion is trimmed so that a certain width of free amnion tissue 4 is retained around the opening of the C-shaped open ring, thus forming an amnion endoscope.

[0029] The C-shaped open ring and the solid annular cylinder are made of nickel-titanium shape memory alloy.

[0030] The C-shaped open ring has an outer circumference diameter of 25mm, a longitudinal diameter (the cross-sectional diameter of the C-shaped structure) of 2.5mm, and an opening height (the height of the groove) of 1.5mm; the solid annular cylinder has a transverse diameter (the outer circumference diameter) of 23mm and a longitudinal diameter (the cross-sectional diameter of the cylinder) of 1mm.

[0031] The outer periphery of the C-shaped opening ring retains 9-11 mm of free amniotic membrane tissue.

[0032] Nickel-titanium shape memory alloys, which undergo stress-induced deformation and recover at room temperature, commonly have a weight percentage of Ni ≈ 50.5-51% and Ti ≈ 49.5-49%.

[0033] The method for manufacturing the deformable memory amniotic membrane endoscope device of the present invention includes the following steps: (1) A nickel-titanium shape memory alloy is made into a C-shaped open ring with a diameter of 25mm, a longitudinal diameter of 2.5mm, and an opening of 1.5mm. At the same time, a nickel-titanium shape memory alloy solid ring cylinder with a transverse diameter of 23mm and a longitudinal diameter of 1mm is also made. (2) Fresh amniotic membrane tissue obtained clinically is subjected to sterilization within 6 hours of ex vivo and 4 hours after ex vivo. 0 The lint is removed and sterile cleaning is performed in a C environment; (3), 40 Under C conditions, the amniotic membrane tissue is flattened and implanted into a C-shaped open ring. A ring-shaped cylinder is then implanted into the C-shaped open ring. The surrounding amniotic membrane is trimmed so that 10 mm of free amniotic membrane tissue is left outside the opening of the C-shaped open ring, thus forming an amniotic endoscope. (4) Implant this amnioscope into the preservation solution -20 0 Stored in C and sterilized by cobalt-60 radiation.

[0034] In step (4), the preservation solution is a sterile preservation solution containing DMEM medium, glycerol and antibiotics; the absorption dose of the cobalt-60 source is 25 kGy.

[0035] The preservation solution was prepared with the following formulation: 49.9% glycerol, 35% RPMI-1640 medium, 10% fetal bovine serum, 5% DMSO, and 0.1% penicillin-drug combination (0.0375% streptomycin at 10 mg / ml and 0.0625% penicillin at 80,000 U / ml). Alternatively, it could be 49.9% glycerol, 22.5% DMEM, 2.5% fetal bovine serum, 25% albumin, and 0.1% penicillin-drug combination (0.0375% streptomycin at 10 mg / ml and 0.0625% penicillin at 80,000 U / ml).

[0036] How to use: (1) Instruct the patient to sit or lie down; (2) Instill one drop of ophthalmic topical anesthetic such as oxybuprocaine hydrochloride into the conjunctival sac; (3) Instruct the patient to close their eyes for 1 minute; (4) Use an eyelid opener to open the upper and lower eyelids; (5) Use ophthalmic forceps to grasp the edge of the nickel-titanium shape memory alloy deformable amniotic lens, and rinse the surface preservation solution of the amniotic lens with 10ml of sterile physiological saline. (6) Insert the nickel-titanium shape memory alloy deformable amniotic lens into the conjunctival sac, remove the eyelid opener, and gently close the eyes; (7) Wearing a device commonly used in clinical practice that has heating (42.5) 0 C) Functional nebulized fumigation eye mask: Turn on the nebulizer and instruct the patient to open their eyes slightly for 15 minutes; (8) Observe the fit between the amniotic lens and the ocular surface under a slit lamp, and ask the patient about their comfort level at the same time; (9) Use ophthalmic eye drops according to the condition; (10) After the corneal epithelium has been well repaired, or the amniotic membrane has dissolved, the nickel-titanium memory alloy support of the amniotic lens can be removed. When removing it, under the slit lamp, use ophthalmic forceps to grasp the edge of the nickel-titanium memory alloy support and remove it directly to observe the condition of the cornea and conjunctiva.

[0037] Ophthalmic eye drops mainly include: 1. Antibiotic eye drops, used to prevent ocular surface infections, such as levofloxacin eye drops; 2. Drugs that promote corneal epithelial repair, such as recombinant human epidermal growth factor eye drops.

[0038] The maximum wearing time is generally 4 weeks. Whether to replace the amniotic lens depends on the repair progress of the patient's ocular surface or corneal damage: if the damage has been repaired, the amniotic lens can be removed at any time; if it has not been repaired and the amniotic membrane has not dissolved, it can be worn continuously for 4 weeks, after which the amniotic lens can be removed and replaced with a new one; if the damage has not been repaired within four weeks but the amniotic membrane has dissolved, a new amniotic lens can be replaced.

[0039] After wearing an amniotic lens, its coverage extends completely to the entire conjunctiva and corneal surface, providing comprehensive protection for the ocular surface. The lens boundary precisely matches the edge of the conjunctival sac, forming a seamless, sealed structure that ensures no fluid leakage or intrusion of external contaminants. This design achieves full coverage of the entire ocular surface, eliminating any visual or physical blind spots and providing an ideal microenvironment for corneal repair. The amniotic membrane remains stable under the lens's support, with even and moderate tension distribution. This avoids localized pressure caused by excessive tightness and prevents wrinkles or displacement caused by looseness. The uniform tension allows the amniotic membrane to adhere tightly to the corneal surface, eliminating gaps and promoting epithelial cell migration and adhesion, accelerating wound healing. Simultaneously, the excellent fit ensures even tear distribution under the lens, maintaining ocular surface moisture, reducing friction and irritation, and significantly improving patient comfort and treatment outcomes.

[0040] After eight patients wore the deformable memory amniotic membrane lens device for a period of time (1h, 2h, 4h, 8h, 12h, 24h, 36h, and 48h), no allergies or irritation were caused in the ocular environment, and no symptoms such as redness, swelling, inflammation, or ulceration were observed. Animal experiments.

[0041] Fourteen healthy adult New Zealand white rabbits were selected, and a rabbit corneal epithelial injury model was established using the ethanol method. They were randomly divided into two groups of seven rabbits (seven eyes) each. Group A (amniotic lens group): The deformable memory amniotic lens device prepared according to this invention was worn in the left eye, and a 42℃ atomized eye mask was used for 15 minutes to allow the amniotic lens to deform in the fornix of the ocular surface. Group B (control group): The left eye received no special treatment. Corneal epithelial healing was observed at 0H, 12H, 24H, 36H, and 48H postoperatively. Corneal fluorescence staining was performed under a slit lamp, and photographs were taken. The area of ​​unhealed corneal epithelium was measured using Image-J software and compared. Conjunctival hyperemia score, amniotic membrane adhesion, and amniotic lens dislocation rate were recorded at 0H and 48H postoperatively, and the mechanical damage to the cornea was observed.

[0042] The experimental results showed that, firstly, the corneal epithelial healing time in group A was significantly faster than that in group B. Figure 9 As shown in Table 1, the unhealed area of ​​the corneal epithelium in group A was statistically analyzed using ImageJ software. The results showed that the corneal epithelial healing speed in group A was significantly faster than that in group B, with a statistically significant difference. Secondly, the conjunctival hyperemia scores in group A and group B were similar, as shown in Table 2, indicating that the amniotic membrane lens caused minimal irritation to the ocular surface. Thirdly, at the end of the experiment, no significant mechanical damage, hemorrhage, exudation, or granulation tissue proliferation occurred in group A. The amniotic membrane fit was 100%, and the amniotic membrane lens dislocation rate was 0%. These results indicate that the amniotic membrane can effectively promote corneal epithelial healing, has anti-inflammatory, antibacterial, and repair-promoting effects, and offers good wearing safety. It can also completely cover the cornea and the entire conjunctival surface, achieving 360° full coverage of the ocular surface without any blind spots.

[0043] Table 1 ; Table 2 .

Claims

1. A deformable amniotic membrane speculum device, characterized by: It includes an amnion and a deformable amnion support device. The deformable amnion support device includes a C-shaped open ring and a solid annular cylinder nested together. The C-shaped open ring is a ring with a C-shaped cross-section and a groove inside. The opening of the groove faces the inside of the ring. The solid annular cylinder is also a ring. The amnion, after being stripped of its chorionic villi and flattened, is inserted into a C-shaped open ring. A ring-shaped cylinder is used to support the amnion as it is inserted into the groove of the C-shaped open ring and pressed down. The surrounding amnion is trimmed so that a certain width of free amnion tissue is left around the opening of the C-shaped open ring, thus forming an amnioscope.

2. The deformable memory amniotic membrane endoscope device according to claim 1, characterized in that: The C-shaped open ring and the solid annular cylinder are made of nickel-titanium shape memory alloy.

3. The deformable memory amniotic membrane endoscope device according to claim 1, characterized in that: The C-shaped open ring has an outer circumference diameter of 25mm, a longitudinal diameter (the cross-sectional diameter of the C-shaped structure) of 2.5mm, and an opening height (the height of the groove) of 1.5mm; the solid annular cylinder has a transverse diameter (the outer circumference diameter) of 23mm and a longitudinal diameter (the cross-sectional diameter of the cylinder) of 1mm.

4. The deformable memory amniotic membrane endoscope device according to claim 1, characterized in that: The outer periphery of the C-shaped opening ring retains 9-11 mm of free amniotic membrane tissue.

5. A method for manufacturing the deformable memory amniotic membrane endoscope device according to claim 1, characterized in that: Includes the following steps: (1) A nickel-titanium shape memory alloy is made into a C-shaped open ring with a diameter of 25mm, a longitudinal diameter of 2.5mm, and an opening of 1.5mm. At the same time, a nickel-titanium shape memory alloy solid ring cylinder with a transverse diameter of 23mm and a longitudinal diameter of 1mm is also made. (2), the fresh amniotic membrane tissue obtained in the clinic is removed chorion and sterilized within 6 hours, 4 0 under C environment (3), 4 0 Under C environment, the amniotic membrane tissue is pulled flat, the amniotic membrane is implanted into the C-shaped open ring, the annular cylinder is implanted into the C-shaped open ring, the peripheral amniotic membrane is trimmed, 10mm of free amniotic membrane tissue is reserved on the periphery of the C-shaped open ring, and an amniotic membrane mirror is formed. (4) The amniotic membrane mirror is implanted into the preservation solution at -20 0 C and is sterilized by cobalt 60 radiation.

6. The method for manufacturing the deformable memory amniotic membrane endoscope device according to claim 5, characterized in that: In step (4): the preservation solution is a sterile preservation solution containing DMEM medium, glycerol and antibiotics; the absorption dose of cobalt-60 source is 25 kGy.

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