A low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope and preparation method thereof

Abstract

The present invention discloses a low-foreign-body-sense liquid-absorbable split-type biological amniotic membrane bandage mirror and a preparation method thereof, comprising an amniotic membrane support frame, an amniotic membrane fixing ring and amniotic membrane, the amniotic membrane fixing ring is made of a soft material, the amniotic membrane support frame comprises an amniotic membrane support area, a landing area, a downward pressure attachment area and a liquid-absorption fixing ring, the amniotic membrane support area is made of a hard material, the landing area and the downward pressure attachment area are both made of soft materials, the amniotic membrane support area is used to support the landing area and the downward pressure attachment area, the lower end of the downward pressure attachment area is fixedly connected to the upper end of the amniotic membrane support area, the upper end of the landing area is fixedly connected to the lower end of the amniotic membrane support area, the amniotic membrane is attached to the inner and outer surfaces of the amniotic membrane support frame, and is fixed by the amniotic membrane fixing ring. The present invention can reduce contact with the cornea, prevent corneal injury, reduce oppression, reduce foreign body sensation, improve comfort, prevent pus from flowing back to infect the cornea, is beneficial to the treatment and recovery of the cornea, is simple to operate, can be directly removed from the eye, does not require excessive instrument assistance, and greatly reduces the chance of infection.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to a low-foreign-body-sense liquid-absorbable split biological amniotic membrane bandage endoscope and a preparation method thereof. Background Art

[0002] At present, biological amniotic membrane has been widely used in the treatment of ophthalmic diseases such as pterygium, corneal ulcer, chemical burn, symblepharon and so on. Amniotic membrane has the function of inhibiting fibrosis and reducing scar formation, which is very beneficial for symblepharon and conjunctival fornix narrowing caused by severe ocular surface diseases. Amniotic membrane cells can secrete a variety of antibodies, a variety of lysozymes, lysates and complements, and have antiviral and bactericidal effects; compared with lip mucosa and nasal mucosa transplantation, the risk of infection after transplantation is lower, so amniotic membrane transplantation can be used for the repair of a variety of wounds, such as as a graft to cover the wound of skin burns, and as a substitute for artificial sheath. Amniotic membrane contains neural analgesic factors and has analgesic effect. Traditional amniotic membrane transplantation and covering surgery requires the use of sutures, which is an invasive operation with high requirements for equipment. It is prone to complications such as intraoperative pain, bleeding and amniotic membrane slippage, as well as suture reactions, iatrogenic injuries and other problems. Surgical treatment is traumatic, expensive, and has poor patient tolerance. Therefore, the biological amniotic membrane is fixed by a certain fixing device and made into a corneal contact lens style, commonly known as "amniotic lens", which can be worn directly on the defective area of ​​the ocular surface, thereby avoiding additional surgical operations such as suturing and bonding, and greatly reducing the operation time. However, the "amniotic lens" in the prior art still has many defects, such as: 1. The contact position with the cornea or sclera is designed to be a hard material, and the patient has a strong foreign body sensation after wearing it. The landing area made of hard material is tightly buckled on the sclera, which will compress the capillaries on the sclera, causing fundus congestion and even complications such as conjunctival staining. 2. The pus is drained to the outside of the amniotic membrane bandage lens through the through hole, and the pus will flow back through the through hole, which is not conducive to corneal treatment. 3. The design is hollow on the upper side, and the amniotic membrane and the cornea cannot be better attached, which is not conducive to corneal treatment. 4. The contact position with the sclera is designed as a curved surface that does not match the sclera, which makes the patient uncomfortable to wear and may also crush the sclera; or the product does not use the sclera as the support area, but uses the cornea to support the entire amniotic membrane bandage lens, which makes the patient uncomfortable to wear and may also crush the cornea. 5. The contact position with the cornea is designed as a curved surface that does not match the cornea, which makes the patient uncomfortable to wear and may also crush the cornea. 6. When removing the amniotic membrane bandage lens, it is extremely inconvenient to remove it by opening the eyelids, which makes the patient uncomfortable to remove it. It requires the assistance of more surgical instruments, increases the chance of infection, and is not conducive to the patient's recovery. 7. The drainage groove is only on the inside of the amniotic membrane bandage lens, and there is no drainage groove on the outside of the amniotic membrane bandage lens. The pus on the outside of the amniotic membrane bandage lens cannot be discharged, which increases the chance of infection and is not conducive to the patient's recovery. Therefore, it is urgent to develop a low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage lens and its preparation method to solve the above technical problems.

[0003] In view of this, the present invention is proposed. Summary of the invention

[0004] The purpose of the present invention is to provide a low foreign body sensation, liquid-absorbent, split biological amniotic membrane bandage lens, which can reduce contact with the cornea, prevent corneal injury, reduce the sense of oppression, reduce the foreign body sensation, improve comfort, prevent pus from flowing back and infecting the cornea, and is beneficial to the treatment and recovery of the cornea. It is simple to operate and can be directly removed from the eye without the need for excessive instrument assistance, which greatly reduces the chance of infection. It has broad application prospects and is conducive to popularization and application.

[0005] In order to achieve the above-mentioned purpose, the present invention provides a low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage mirror, comprising an amniotic membrane support frame, an amniotic membrane fixing ring and amniotic membrane, the amniotic membrane fixing ring is made of a soft material, the amniotic membrane support frame comprises an amniotic membrane support area, a landing area, a downward pressure attachment area and a liquid-absorbent fixing ring, the amniotic membrane support area is made of a hard material, the landing area and the downward pressure attachment area are both made of soft materials, the amniotic membrane support area is used to support the landing area and the downward pressure attachment area, the lower end of the downward pressure attachment area is fixedly connected to the upper end of the amniotic membrane support area, the upper end of the landing area is fixedly connected to the lower end of the amniotic membrane support area, the amniotic membrane is attached to the inner and outer surfaces of the amniotic membrane support frame, and is fixed by the amniotic membrane fixing ring.

[0006] Preferably, the liquid absorption fixing ring includes a liquid absorption fixing ring body, the liquid absorption fixing ring body is made of a soft material, six outer liquid absorption cottons are evenly distributed on the circumference of the inner side of the liquid absorption fixing ring body, and six inner liquid absorption cottons are evenly distributed on the circumference between the six outer liquid absorption cottons on the inner side of the liquid absorption fixing ring body. The outer liquid absorption cotton and the inner liquid absorption cotton are bonded to the liquid absorption fixing ring body, and the angle between the inner liquid absorption cotton and the outer liquid absorption cotton is 30°. The outer liquid absorption cotton and the inner liquid absorption cotton are made of hard material when they are not in contact with liquid, and become soft material after absorbing liquid after contacting liquid.

[0007] Preferably, a landing curved surface is provided on the inner side of the landing area, the landing curved surface is consistent with the curvature of the sclera, and is in tangential contact with the sclera, and the landing area forms an angle with the cornea.

[0008] Preferably, a transition smooth curved surface 5 is provided inside the downward pressure attachment area, and the transition smooth curved surface 5 is located at the edge of the cornea and is divided into two areas: an edge adaptation area and a corneal edge area. The corneal edge area is located at the edge of the cornea and maintains a gap with the corneal edge.

[0009] Preferably, a downward pressing attachment support strip is provided on the upper side of the downward pressing attachment area, and the downward pressing attachment support strip is cross-shaped, six-petal-shaped or eight-petal-shaped, and air windows are provided between the petals of the downward pressing attachment support strip, and a picking groove is provided on the inner side of the downward pressing attachment support strip.

[0010] Preferably, the amniotic membrane fixation ring, the suction fixation ring body, the landing area and the downward pressure attachment area are all polymerized from ethoxyethyl methacrylate, hydroxyethyl acrylate, lauryl methacrylate and 2-methyl-2-acrylic acid-2,3-dihydroxypropyl ester.

[0011] Preferably, the outer liquid-absorbing cotton, the inner liquid-absorbing cotton and the liquid-absorbing fixing ring body are bonded with medical glue.

[0012] Preferably, the amniotic membrane support area is made of a hard fluorosilicone acrylate material with an oxygen permeability coefficient DK of 60-150 and a Shore hardness of 80, and the radius of curvature of the outer surface of the amniotic membrane support area is 6.4-9.2 mm.

[0013] Preferably, the inner surface curvature radius of the landing area is 10-20 mm, and the outer surface curvature radius of the landing area is 6.4-9.2 mm; the inner surface curvature radius of the downward pressure attachment area is 6.8-8.4 mm, and the outer surface curvature radius of the downward pressure attachment area is 6.4-9.2 mm.

[0014] The present invention also provides a method for preparing the above-mentioned low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope, comprising the following steps:

[0015] S1: The amniotic membrane support area, the landing area, the downward pressure attachment area, the amniotic membrane fixing ring and the main body of the suction fixing ring are manufactured by molding and injection molding;

[0016] S2: Finishing by turning and milling method;

[0017] S3: The main body of the liquid absorbing fixed ring and the external liquid absorbing cotton are bonded with medical glue to form a liquid absorbing fixed ring;

[0018] S4: Install the liquid absorption fixing ring on the liquid absorption fixing ring placement groove on the landing area, and install all the external liquid absorption cotton installation grooves and the internal liquid absorption cotton installation grooves on the external liquid absorption cotton installation grooves and the internal liquid absorption cotton installation grooves on the landing area respectively;

[0019] S5: installing the landing area to the amniotic membrane support area, and installing the downward pressure attachment area to the amniotic membrane support area to form an amniotic membrane support frame;

[0020] S6: Use a tool to install the amniotic membrane on the amniotic membrane support frame;

[0021] S7: Install the amniotic membrane fixing ring onto the amniotic membrane support frame on which the amniotic membrane has been installed.

[0022] The present invention provides a low-foreign-body-sense, liquid-absorbable, split-type biological amniotic membrane bandage endoscope and a preparation method thereof, which have the following beneficial effects.

[0023] 1. The support frame of the present invention is made of hard material, which is conducive to supporting the entire product. The inner side in contact with the cornea is made of soft material, which will not crush the sclera, can reduce the foreign body sensation and improve comfort.

[0024] 2. The present invention has drainage grooves on both the inner and outer sides, and the pus on both sides can be directly absorbed and stored by the absorbent cotton, preventing the pus from flowing back and infecting the wound again, which is beneficial to the treatment and recovery of the cornea.

[0025] 3. The present invention is provided with a downward pressure attachment support strip, which can increase the contact area between the amniotic membrane and the cornea, make the amniotic membrane and the cornea adhere better, and more effectively exert the therapeutic effect of the amniotic membrane, which is beneficial to corneal treatment and recovery.

[0026] 4. The landing surface of the present invention is consistent with the curvature of the sclera and contacts the sclera in a tangential direction, so that the scleral contact lens can be well fixed on the sclera. The landing area forms an angle with the cornea, which is conducive to the exchange of tears, pus and oxygen, making the patient more comfortable to wear, and can also reduce contact with the cornea, reduce corneal injury and reduce the sense of oppression.

[0027] 5. The transition smooth curved surface 5 of the present invention is located at the edge of the cornea and is divided into two areas: the edge adaptation area and the corneal limbus area. The corneal limbus area is located at the edge of the cornea and keeps a gap with the corneal edge. The edge adaptation area is used to adjust the sagittal height of the scleral lens and the compensation of the sagittal height, so that the amniotic membrane fits the cornea better, which is conducive to the absorption of the corneal wound and obtains more effective recovery.

[0028] 6. The present invention is provided with a removal groove, and can be directly removed from the eye using a special surgical forceps, without the need for excessive instrument assistance, and is simple to operate, greatly reducing the chance of infection and facilitating patient recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A top view of a low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope provided by the present invention;

[0030] Figure 2 for Figure 1 AA section view;

[0031] Figure 3 for Figure 2 A local enlarged schematic diagram of location I;

[0032] Figure 4 A three-dimensional schematic diagram of a low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope provided by the present invention;

[0033] Figure 5 It is a top view of the amniotic membrane support area;

[0034] Figure 6 for Figure 5 BB cross-section diagram;

[0035] Figure 7 for Figure 6 A partial enlarged view of location II;

[0036] Figure 8 This is a bottom view of the amniotic membrane support area;

[0037] Fig. 9 It is a three-dimensional schematic diagram of the amniotic membrane support area;

[0038] Fig.10 for Fig. 9 A partial enlarged view of location III;

[0039] Fig.11 for Fig. 9 A local enlarged view of IV;

[0040] Fig.12 It is a top view of the downward pressure attachment area;

[0041] Fig.13 for Fig.12 CC profile of ;

[0042] Fig.14 for Fig.13 A local enlarged view of the V part;

[0043] Fig.15 It is a bottom view of the downward pressure attachment area;

[0044] Fig.16 Three-dimensional schematic diagram of the downward pressure attachment area;

[0045] Fig.17 for Fig.16 A partial enlarged view of the VI;

[0046] Fig.18 for Fig.16 A partial enlarged view of VII

[0047] Fig.19 This is a bird's-eye view of the landing area;

[0048] Fig. 20 for Fig.19 DD profile diagram;

[0049] Fig.21 for Fig. 20 A partial enlarged view of position VIII;

[0050] Fig. 22 This is a bottom view of the landing area;

[0051] Fig.23 A three-dimensional map of the landing area;

[0052] Fig.24 for Fig.23 A partial enlarged view of position IX;

[0053] Fig.25 for Fig.23 A local enlarged view of point X;

[0054] Fig.26 This is a top view of the amniotic membrane fixation ring;

[0055] Fig. 27 for Fig.26 EE profile diagram;

[0056] Fig.28 for Fig. 27 A partial enlarged view of position XI;

[0057] Fig.29 Three-dimensional schematic diagram of the amniotic membrane fixation ring;

[0058] Fig.30 It is a three-dimensional schematic diagram of the liquid suction fixing ring;

[0059] Fig.31 Top view of the amniotic membrane support frame;

[0060] Fig.32 for Fig.31 FF cross-section diagram;

[0061] Fig.33 for Fig.32 A partial enlarged view of XII;

[0062] Fig.34 It is a three-dimensional schematic diagram of the amniotic membrane support frame;

[0063] Fig.35 It is a schematic diagram of the assembly tooling;

[0064] Fig.36 A schematic diagram of the adaptation of a low foreign body sensation, liquid-absorbable, split biological amniotic membrane bandage mirror and an assembly tool provided by the present invention.

[0065] In the figure:

[0066] 1. Amniotic membrane support frame 1A. Amniotic membrane support area 1A01. Amniotic membrane fixation ring slot 1A02. Amniotic membrane fixation ring anti-drop buckle 1A03. Amniotic membrane fixation ring slide into the inclined surface 1A04. Ventilation hole 1A05. Amniotic membrane fixation ring anti-rotation limit column 1A06. External liquid introduction groove 1A07. Connection area 1 1A08. Connection area 2 1A09. Transition smooth curved surface 1 1A10. Transition smooth curved surface 2 1A11. Connection slot 1A12. Connecting slot 2 1A13. Anti-rotation buckle 2 1A14. Connecting column 1 1A15. Connecting column 2 1A16. Anti-rotation buckle 1 B. Landing area 1B01. Liquid absorption fixed ring placement groove 1B02. External liquid absorption cotton installation groove 1B03. Internal liquid absorption cotton installation groove 1B04. Liquid absorption fixed ring anti-drop buckle 1B05. Connecting column 3 1B06. Ventilation hole 2 1B07. Internal liquid introduction groove 1 B0 8. External liquid tank 2 1B09. Connection area 3 1B10. Transition smooth curved surface 3 1B11. Landing curved surface 1B12. Connection slot 4 1B13. Anti-rotation slot 1 1B14. Connection area 4 1B15. Transition smooth curved surface 4 1C. Downward pressure attachment area 1C01. Ventilation window 1C02. Downward pressure attachment support bar 1C03. Connection area 5 1C04. Transition smooth curved surface 5 1C05. Connection card column 4 1C0 6. Internal liquid introduction groove two 1C07. Ventilation hole three 1C08. Removal groove 1C09. External liquid introduction groove three 1C10. Connection card groove three 1C11. Anti-rotation groove two 1C12. Transition smooth curved surface six 1C13. Connection area six 2. Amniotic membrane fixing ring 201. External liquid introduction groove four 202. Anti-rotation limiting groove one 3. Liquid absorption fixing ring 301. External liquid absorption cotton 302. Internal liquid absorption cotton 303. Liquid absorption fixing ring body 4. Amniotic membrane. DETAILED DESCRIPTION

[0067] The present invention is further described below in conjunction with specific embodiments and drawings to help understand the content of the present invention.

[0068] like Figure 1-Figure 4 The figures are respectively a top view, an AA cross-sectional view, a local enlarged view at position I and a three-dimensional schematic diagram of a low foreign body sensation and liquid-absorbable split biological amnion bandage endoscope provided by the present invention. The low foreign body sensation and liquid-absorbable split biological amnion bandage endoscope comprises an amnion support frame 1, an amnion fixing ring 2 and an amnion 4.

[0069] like Figure 26-Figure 29 As shown, there are respectively a top view of the amniotic membrane fixing ring, a cross-sectional view of EE, a partial enlarged view at XI and a three-dimensional schematic diagram. The amniotic membrane fixing ring 2 is made of a soft material, and six external liquid introduction grooves 201 are evenly distributed on the outside of the amniotic membrane fixing ring 2, and six anti-rotation limit grooves 202 are evenly distributed on the inside of the amniotic membrane fixing ring 2;

[0070] like Figure 31-Figure 34 As shown, they are respectively a top view of the amniotic membrane support frame, a FF cross-sectional view, a local enlarged view at XII and a three-dimensional schematic diagram. The amniotic membrane support frame 1 includes an amniotic membrane support area 1A, a landing area 1B, a downward pressure attachment area 1C and a liquid suction fixing ring 3. The amniotic membrane support area 1A is made of a hard material, and the landing area 1B and the downward pressure attachment area 1C are both made of soft materials. The amniotic membrane support area 1A is used to support the landing area 1B and the downward pressure attachment area 1C. The lower end of the downward pressure attachment area 1C is fixedly connected to the upper end of the amniotic membrane support area 1A, and the upper end of the landing area 1B is fixedly connected to the lower end of the amniotic membrane support area 1A. The amniotic membrane 4 is attached to the inner and outer surfaces of the amniotic membrane support frame 1 and fixed by the amniotic membrane fixing ring 2;

[0071] like Fig.30 The figure shows a three-dimensional schematic diagram of a liquid absorbing fixed ring. The liquid absorbing fixed ring 3 comprises a liquid absorbing fixed ring body 303, the liquid absorbing fixed ring body 303 is made of a soft material, six outer liquid absorbing cottons 301 are evenly distributed on the inner circumference of the liquid absorbing fixed ring body 303, and six inner liquid absorbing cottons 302 are evenly distributed on the inner circumference of the six outer liquid absorbing cottons 301 on the inner side of the liquid absorbing fixed ring body 303, the outer liquid absorbing cottons 301 and the inner liquid absorbing cottons 302 are bonded to the liquid absorbing fixed ring body 303, and the angle between the inner liquid absorbing cottons 302 and the outer liquid absorbing cottons 301 is 30°, and the outer liquid absorbing cottons 301 and the inner liquid absorbing cottons 302 are hard materials when not in contact with liquid, which is convenient for installation, and absorb liquid and become soft materials after contacting liquid.

[0072] like Figure 5-Figure 11As shown, there are respectively a top view of the amniotic support area, a BB cross-sectional view, a partial enlarged view at II, a bottom view, a three-dimensional schematic diagram, a partial enlarged view at III and a partial enlarged view at IV. Six anti-rotation buckles 1A16 are evenly distributed on the inner circumference of the upper end of the amniotic support area 1A, a connecting area 1A07 is provided on the outer circumference of the upper end, and a connecting column 1A14 is provided between the anti-rotation buckle 1A16 and the connecting area 1A07. Six anti-rotation buckles 1A13 are evenly distributed on the inner circumference of the lower end of the amniotic support area 1A, a connecting area 1A08 is provided on the outer circumference of the lower end of the amniotic support area 1A, and a connecting column 1A15 is provided between the connecting area 1A08 and the anti-rotation buckle 1A13. The outer side of the amniotic support area 1A, the connecting area 1A07 and the connecting column 1A14 are provided between the anti-rotation buckle 1A16 and the connecting area 1A07. A transition smooth curved surface 1A09 is provided on the lower side, a transition smooth curved surface 1A10 is provided on the upper side of the second connection area 1A08 outside the amniotic membrane support area 1A, an amniotic membrane fixing ring groove 1A01 is provided between the transition smooth curved surface 1A09 and the transition smooth curved surface 1A10, six amniotic membrane fixing ring anti-rotation limit posts 1A05 are evenly distributed on the circumference of the amniotic membrane fixing ring groove 1A01, an amniotic membrane fixing ring anti-dropping buckle 1A02 is provided on the upper end of the amniotic membrane fixing ring groove 1A01, an amniotic membrane fixing ring sliding inclined surface 1A03 is provided on the lower end of the amniotic membrane fixing ring groove 1A01, and the amniotic membrane fixing ring is provided with a fixed surface 1A03. The fixed ring 2 is fixed in the amniotic membrane fixing ring groove 1A01. After assembly, the amniotic membrane fixing ring 2 does not protrude from the amniotic membrane fixing ring groove 1A01. The transition smooth curved surface 1A09 and the transition smooth curved surface 2 1A10 are smoothly transitioned with the outer side of the amniotic membrane fixing ring 2, so that the wearing comfort is improved. The inner arc surface of the amniotic membrane fixing ring 2 is consistent with the arc surface of the amniotic membrane fixing ring groove 1A01 to ensure the matching accuracy. The amniotic membrane fixing ring anti-rotation limit column 1A05 is engaged with the anti-rotation limit groove 1 202 to prevent the amniotic membrane fixing ring 2 from rotating and affecting the assembly accuracy. The amniotic membrane fixing ring anti-drop buckle 1A02 prevents the amniotic membrane fixing ring 2 from falling off When the amniotic membrane fixing ring 2 is installed, the amniotic membrane fixing ring slides into the inclined surface 1A03, which facilitates the amniotic membrane fixing ring 2 to slide into the amniotic membrane fixing ring groove 1A01, and facilitates installation. On the inner and outer sides of the amniotic membrane support area 1A, six external liquid inlet grooves 1A06 are evenly distributed on the circumference between the connecting area 1A07 and the connecting area 2 1A08, and twelve air holes 1A04 are evenly distributed on the lower side of the anti-rotation buckle 1A16. On the inner side of the amniotic membrane support area 1A, a connecting groove 1A11 is provided on the lower side of the air hole 1A04, and a connecting groove 2 1A12 is provided on the lower side of the connecting groove 1A11.

[0073] like Figure 19-Figure 25As shown, they are respectively a top view of the landing area, a DD cross-sectional view, a partial enlarged view at position VIII, a bottom view, a three-dimensional view, a partial enlarged view at position IX, and a partial enlarged view at position X. The landing area 1B serves as the load-bearing area of ​​the entire amniotic membrane bandage lens. A connection area 3 1B09 is provided on the upper side of the landing area 1B. A transition smooth curved surface 3 1B10 is provided on the inner side of the landing area 1B and the lower side of the connection area 3 1B09. Twelve air holes 2 1B06 are evenly distributed on the circumference of the lower side of the transition smooth curved surface 3 1B10. Oxygen passes through the air holes 2 1B06 for gas exchange, providing oxygen for the recovery and growth of the corneal wound. Six inner liquid guide grooves 1B07 are evenly distributed on the inner circumference of the landing area 1B. A landing curved surface 1B11 is provided on the inner side of the landing area 1B. The landing curved surface 1B11 is consistent with the curvature of the sclera and is in tangential contact with the sclera, so that the scleral contact lens can be well fixed on the sclera. On the amniotic membrane, the landing area 1B forms an angle with the cornea, which is beneficial to the exchange of tears, pus and oxygen, making it more comfortable for patients to wear, and may also reduce the contact between the landing area 1B and the cornea, reduce corneal injury, and reduce the sense of oppression. On the outside of the landing area 1B, a connecting clamping column 3 1B05 is provided on the lower side of the excessively smooth curved surface 3 1B10. The connecting clamping column 3 1B05 is engaged with the connecting clamping groove 2 1A12 to prevent the landing area 1B from moving up and down in the amniotic membrane support area 1A to ensure the matching accuracy. Six anti-rotation grooves 1B13 are evenly distributed on the circumference of the lower side of the connecting clamping column 3 1B05. The six anti-rotation grooves 1B13 are engaged with the six anti-rotation buckles 2 1A13 in a one-to-one correspondence to prevent the landing area 1B from rotating in the amniotic membrane support area 1A , to ensure the matching accuracy, the outer side of the anti-rotation groove 1B13 is provided with a connecting card slot 4 1B12, and the connecting card slot 4 1B12 is engaged with the connecting card column 2 1A15 to prevent the landing area 1B from moving left and right in the amniotic membrane support area 1A, to ensure the matching accuracy, the outer circumference of the connecting card slot 4 1B12 is provided with a connecting area 4 1B14, and the connecting area 4 1B14 is clearance-matched with the connecting area 2 1A08 to prevent the interference fit from causing the landing area 1B to deform and wrinkle, affecting the wearing comfort, and preventing the clearance from being too large, so that the patient feels a pressure mark when wearing it, and the lower circumference of the connecting area 4 1B14 is provided with an oversmooth curved surface 4 1B15, and the oversmooth curved surface 4 1B15 is designed with an arc surface with the oversmooth curved surface 1A09 The transition smooth curved surface 4 1B15 is concentrically matched with the transition smooth curved surface 1A09, so that the transition smooth curved surface 4 1B15 and the transition smooth curved surface 1A09 are smoothly transitioned at the intersection, without edges or protruding curved surfaces, so that patients are more comfortable when wearing. The transition smooth curved surface 4 1B15 is evenly distributed on the circumference with six external liquid introduction grooves 2 1B08, and the lower side of the external liquid introduction groove 2 1B08 is provided with a liquid suction fixing ring placement groove 1B01, and the liquid suction fixing ring 3 is fixed in the liquid suction fixing ring placement groove 1B01. After assembly, the liquid suction fixing ring 3 does not protrude from the liquid suction fixing ring placement groove 1B01. The transition smooth curved surface 4 1B15 and the outer side of the liquid suction fixing ring body 303 are smoothly transitioned, so that the wearing comfort is improved.The inner arc surface of the liquid absorption fixing ring 3 is consistent with the arc surface of the liquid absorption fixing ring placement groove 1B01 to ensure the matching accuracy. On the upper side of the liquid absorption fixing ring placement groove 1B01, six outer liquid absorption cotton installation grooves 1B02 are evenly distributed on the circumference just below the outer liquid introduction groove 1B08. Between the six outer liquid absorption cotton installation grooves 1B02, six inner liquid absorption cotton installation grooves 1B03 are evenly distributed on the circumference just below the inner liquid introduction groove 1B07. The inner liquid absorption cotton installation groove 1B03 is an inner and outer through hole, which can be conveniently installed from the outside and can be connected to the inner liquid absorption cotton installation groove 1B03. The outer side of the liquid absorption fixing ring placement groove 1B01 A liquid absorbing fixed ring anti-drop buckle 1B04 is provided, the liquid absorbing fixed ring placement groove 1B01 cooperates with the liquid absorbing fixed ring body 303 to fix the liquid absorbing fixed ring body 303, the six external liquid absorbing cotton installation grooves 1B02 cooperate with the six external liquid absorbing cottons 301, and the six internal liquid absorbing cotton installation grooves 1B03 cooperate with the internal liquid absorbing cotton 302, which can prevent the liquid absorbing fixed ring 3 from rotating on the landing area 1B to ensure the matching accuracy. The angle between the external liquid absorbing cotton installation groove 1B02 and the internal liquid absorbing cotton installation groove 1B03 is 30°. The liquid absorbing fixed ring anti-drop buckle 1B04 prevents the liquid absorbing fixed ring 3 from falling out to ensure product stability.

[0074] like Figure 12-Figure 18As shown, respectively, are a top view of the downward pressure attachment area, a CC cross-sectional view, a local enlarged view at V, a bottom view, a three-dimensional schematic diagram, a local enlarged view at VI and a local enlarged view at VII. A connection area 6 1C13 is provided on the lower side of the downward pressure attachment area 1C. The connection area 6 1C13 is clearance-matched with the connection area 3 1B09 to prevent interference fit from causing deformation and wrinkling of the landing area 1B and the downward pressure attachment area 1C, which affects the wearing comfort, and to prevent excessive clearance from causing the patient to feel an indentation when wearing the product. An oversmooth curved surface 5 1C04 is provided on the inner side of the downward pressure attachment area 1C. The oversmooth curved surface 5 1C04 is located at the edge of the cornea and is divided into two areas, an edge adaptation area and a limbal area. The limbal area is located at the edge of the cornea and maintains a gap with the edge of the cornea. The edge adaptation area is used to adjust the sagittal height of the scleral lens and compensate for the sagittal height, so that the amniotic membrane 4 can better fit the cornea, which is beneficial to the absorption of the corneal wound and more The invention can effectively restore the cornea without changing the shape of the cornea, making it more comfortable for patients to wear. The over-smooth curved surface 5 1C04 is consistent with the over-smooth curved surface 3 1B10 in arc surface design. The over-smooth curved surface 5 1C04 is concentrically matched with the over-smooth curved surface 3 1B10, so that the intersection of the over-smooth curved surface 5 1C04 and the over-smooth curved surface 3 1B10 is smooth and has no edges or protruding curved surfaces, making it more comfortable for patients to wear. The over-smooth curved surface 5 1C04 is evenly distributed with twelve air holes 3 1C07 on the circumference. The diameters of the twelve air holes 3 1C07 and the twelve air holes 1A04 are equal. The twelve air holes 3 1C07 and the twelve air holes 1A04 are matched one by one, and oxygen is discharged according to the over-smooth curved surface 5 1C04. The gas exchange is carried out through the air vent 1A04 and the air vent 3 1C07 for the second time to provide oxygen for the recovery and growth of the corneal wound. The circumference of the transition smooth curved surface 5 1C04 is evenly distributed with six inner liquid guide grooves 2 1C06. The inner liquid guide grooves 2 1C06 and the inner liquid guide grooves 1 1B07 form a liquid guide groove. The pus flows downward through the inner liquid guide grooves 2 1C06 and the inner liquid guide grooves 1 1B07 in turn and flows directly to the inner liquid absorbent cotton 302 at the bottom. The inner liquid absorbent cotton 302 continuously absorbs and stores pus to prevent the pus from flowing back and infecting the wound again. The outer side of the downward pressure attachment area 1C and the upper side of the connection area 6 1C13 are provided with connecting card columns 4 1C05. The connecting card columns 4 1C05 are connected to the connecting card grooves 1A1 1 is engaged to prevent the downward pressure attachment area 1C from moving up and down in the amniotic membrane support area 1A to ensure the matching accuracy. A connection area 5 1C03 is provided on the upper side of the connection clamp column 4 1C05. The connection area 5 1C03 is clearance-matched with the connection area 1A07 to prevent the downward pressure attachment area 1C from being deformed and wrinkled due to interference fit, affecting the wearing comfort, and to prevent the clearance from being too large so that the patient feels a pressure mark when wearing it. A connection slot 3 1C10 is provided on the connection area 5 1C03. The connection slot 3 1C10 is engaged with the connection clamp column 1A14 to prevent the downward pressure attachment area 1C from moving left and right in the amniotic membrane support area 1A to ensure the matching accuracy. Six anti-rotation grooves 2 1C11 are evenly distributed on the inner circumference of the connection slot 3 1C10.The six connecting card slots 3 1C10 are engaged with the six anti-rotation buckles 1A16 in a one-to-one correspondence to prevent the downward pressure attachment area 1C from rotating on the amniotic membrane support area 1A to ensure the matching accuracy. The upper side of the connecting area 5 1C03 is provided with a transition smooth curved surface 6 1C12. The transition smooth curved surface 6 1C12 is consistent with the arc surface design of the transition smooth curved surface 2 1A10. The transition smooth curved surface 6 1C12 is concentrically matched with the transition smooth curved surface 2 1A10 to make the transition smooth curved surface 6 1C1 2 and the transition smooth curved surface 2 1A10 are smoothly transitioned at the intersection, without edges or protruding curved surfaces, so that patients are more comfortable when wearing. Six external liquid guide grooves 3 1C09 are evenly distributed on the circumference of the transition smooth curved surface 6 1C12. The external liquid guide groove 3 1C09, the external liquid guide groove 1 1A06, the external liquid guide groove 4 201, and the external liquid guide groove 2 1B08 form a liquid guide groove. The pus passes through the external liquid guide groove 3 1C09, the external liquid guide groove 1 1A06, the external liquid guide groove 4 201, the external liquid guide groove 2 1B08 in sequence. The second liquid guide groove 1B08 flows downward and directly flows to the outer liquid absorbent cotton 301 at the bottom. The outer liquid absorbent cotton 301 continuously absorbs the stored pus to prevent the pus from flowing back and infecting the wound again. The upper side of the downward pressure attachment area 1C is provided with a downward pressure attachment support strip 1C02. The downward pressure attachment support strip 1C02 is a cross-shaped, six-petal-shaped or eight-petal-shaped, which can increase the contact area between the amniotic membrane 4 and the cornea, make the membrane and the cornea better attached, and more effectively exert the therapeutic effect of the amniotic membrane 4, which is beneficial to corneal treatment and recovery. The downward pressure attachment support strip 1C02 is provided with a ventilation window 1C01 between the petals. Oxygen passes through the ventilation window 1C01. The ventilation window 1C01 can exchange gases over a larger area and provide oxygen for the recovery and growth of the corneal wound. The inner side of the downward pressure attachment support strip 1C02 is provided with a removal groove 1C08, which can be directly removed from the eye using special surgical forceps. It does not require too much instrument assistance, is simple to operate, greatly reduces the chance of infection, and is beneficial to patient recovery.

[0075] The amniotic membrane fixing ring 2, the liquid-absorbing fixing ring body 303, the landing area 1B and the downward pressure attachment area 1C are all polymerized by ethoxyethyl methacrylate, hydroxyethyl acrylate, lauryl methacrylate, and 2-methyl-2-acrylic acid-2,3-dihydroxypropyl. The outer liquid-absorbing cotton 301, the inner liquid-absorbing cotton 302 and the liquid-absorbing fixing ring body 303 are bonded by medical glue. The amniotic membrane support area 1A is made of hard fluorosilicone acrylate material, with an oxygen permeability coefficient DK of 60-150 and a Shore hardness of 80, which can increase the oxygen permeability of the amniotic membrane bandage mirror and facilitate oxygen exchange. The outer surface curvature radius of the amniotic membrane support area 1A is 6.4-9.2mm. The total diameter of the low foreign body sensation liquid-absorbing split biological amniotic membrane bandage mirror is 12.5-14.5mm. The inner surface curvature radius of the landing area 1B is 10-20mm, and the outer surface curvature radius of the landing area 1B is 6.4-9.2mm. The inner surface curvature radius of the pressed attachment area 1C is 6.8-8.4mm, and the outer surface curvature radius of the pressed attachment area 1C is 6.4-9.2mm. The matching clearances of the connection area 4 1B14 and the connection area 2 1A08, the connection area 6 1C13 and the connection area 3 1B09, and the connection area 5 1C03 and the connection area 1 1A07 are all 0-0.05mm. The intersection diameter of the transition smooth surface 5 1C04 and the transition smooth surface 3 1B10 is 10.0-11.5mm.

[0076] The present invention also provides a method for preparing the above-mentioned low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope, comprising the following steps:

[0077] S1: using molding and injection molding methods to manufacture the amniotic membrane support area 1A, the landing area 1B, the downward pressure attachment area 1C, the amniotic membrane fixing ring 2 and the liquid suction fixing ring body 303;

[0078] S2: Finishing by turning and milling method;

[0079] S3: The liquid absorbing fixing ring body 303 and the outer liquid absorbing cotton 301 are bonded together using medical glue, and the liquid absorbing fixing ring body 303 and the outer liquid absorbing cotton 301 are bonded together using medical glue to form a liquid absorbing fixing ring 3;

[0080] S4: Install the liquid absorbing fixing ring 3 on the liquid absorbing fixing ring placement groove 1B01 on the landing area 1B, and install all the external liquid absorbing cotton installation grooves 1B02 and the internal liquid absorbing cotton installation grooves 1B03 on the landing area 1B respectively;

[0081] S5: installing the landing area 1B to the amniotic membrane support area 1A, and installing the downward pressure attachment area 1C to the amniotic membrane support area 1A to form an amniotic membrane support frame 1;

[0082] S6: Use a tool to install the amniotic membrane 4 onto the amniotic membrane support frame 1; Fig.35 The figure shows a schematic diagram of assembly tooling.

[0083] S7: Install the amniotic membrane fixing ring 2 onto the amniotic membrane support frame 1 on which the amniotic membrane 4 has been installed. Fig.36 As shown, it is a schematic diagram of the adaptation of a low foreign body sensation, liquid-absorbable, split-type biological amniotic membrane bandage mirror and an assembly tool provided by the present invention.

[0084] The present invention can reduce contact with the cornea, prevent corneal injury, reduce pressure, reduce foreign body sensation, improve comfort, prevent pus from flowing back and infecting the cornea, is beneficial to the treatment and recovery of the cornea, is simple to operate, can be directly removed from the eye, does not require excessive instrument assistance, and greatly reduces the chance of infection.

[0085] The invention concept is described in detail using specific examples herein, and the description of the above embodiments is only used to help understand the core idea of ​​the invention. It should be pointed out that any obvious modification, equivalent substitution or other improvement made by a person of ordinary skill in the art without departing from the invention concept should be included in the protection scope of the present invention.

Claims

1. A low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope, characterized in that: The invention comprises an amniotic membrane support frame, an amniotic membrane fixing ring and amniotic membrane, wherein the amniotic membrane fixing ring is made of a soft material, the amniotic membrane support frame comprises an amniotic membrane support area, a landing area, a downward pressure attachment area and a liquid suction fixing ring, the amniotic membrane support area is made of a hard material, the landing area and the downward pressure attachment area are both made of a soft material, the amniotic membrane support area is used to support the landing area and the downward pressure attachment area, the lower end of the downward pressure attachment area is fixedly connected to the upper end of the amniotic membrane support area, the upper end of the landing area is fixedly connected to the lower end of the amniotic membrane support area, the amniotic membrane is attached to the inner and outer surfaces of the amniotic membrane support frame, and is fixed by the amniotic membrane The liquid absorbing fixing ring is fixed by a ring, the liquid absorbing fixing ring comprises a liquid absorbing fixing ring body, the liquid absorbing fixing ring body is made of soft material, six outer liquid absorbing cottons are evenly distributed on the inner circumference of the liquid absorbing fixing ring body, six inner liquid absorbing cottons are evenly distributed on the inner side of the liquid absorbing fixing ring body between the six outer liquid absorbing cottons, the outer liquid absorbing cottons and the inner liquid absorbing cottons are bonded to the liquid absorbing fixing ring body, the angle between the inner liquid absorbing cotton and the outer liquid absorbing cotton is 30°, the outer liquid absorbing cottons and the inner liquid absorbing cottons are made of hard material when not in contact with liquid, and become soft material after absorbing liquid after contacting liquid.

2. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 1, characterized in that: A landing curved surface is provided on the inner side of the landing area. The landing curved surface is consistent with the curvature of the sclera and contacts the sclera in a tangential direction. The landing area forms an angle with the cornea.

3. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 2, characterized in that: A transition smooth curved surface 5 is provided inside the downward pressure attachment area. The transition smooth curved surface 5 is located at the edge of the cornea and is divided into two areas: an edge adaptation area and a corneal edge area. The corneal edge area is located at the edge of the cornea and maintains a gap with the corneal edge.

4. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 3, characterized in that: A downward pressing attachment support strip is provided on the upper side of the downward pressing attachment area. The downward pressing attachment support strip is cross-shaped, six-petal-shaped or eight-petal-shaped. Air windows are provided between the petals of the downward pressing attachment support strip. A picking groove is provided on the inner side of the downward pressing attachment support strip.

5. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 4, characterized in that: The amniotic membrane fixing ring, the liquid suction fixing ring body, the landing area and the downward pressure attachment area are all polymerized from ethoxyethyl methacrylate, hydroxyethyl acrylate, lauryl methacrylate and 2-methyl-2-acrylic acid-2,3-dihydroxypropyl.

6. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 5, characterized in that: The outer liquid-absorbing cotton, the inner liquid-absorbing cotton and the liquid-absorbing fixing ring body are bonded with medical glue.

7. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 6, characterized in that: The amniotic membrane support area is made of hard fluorosilicone acrylate material, with an oxygen permeability coefficient DK of 60-150 and a Shore hardness of 80. The radius of curvature of the outer surface of the amniotic membrane support area is 6.4-9.2 mm.

8. The low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to claim 7, characterized in that: The inner surface curvature radius of the landing area is 10-20 mm, and the outer surface curvature radius of the landing area is 6.4-9.2 mm; the inner surface curvature radius of the downward pressure attachment area is 6.8-8.4 mm, and the outer surface curvature radius of the downward pressure attachment area is 6.4-9.2 mm.

9. A method for preparing the low foreign body sensation and liquid-absorbable split biological amniotic membrane bandage endoscope according to any one of claims 1 to 8, characterized in that: The steps include: S1: The amniotic membrane support area, the landing area, the downward pressure attachment area, the amniotic membrane fixing ring and the main body of the suction fixing ring are manufactured by molding and injection molding; S2: Finishing by turning and milling method; S3: The main body of the liquid absorbing fixed ring and the external liquid absorbing cotton are bonded with medical glue to form a liquid absorbing fixed ring; S4: Install the liquid absorption fixing ring on the liquid absorption fixing ring placement groove on the landing area, and install all the external liquid absorption cotton installation grooves and the internal liquid absorption cotton installation grooves on the external liquid absorption cotton installation grooves and the internal liquid absorption cotton installation grooves on the landing area respectively; S5: installing the landing area to the amniotic membrane support area, and installing the downward pressure attachment area to the amniotic membrane support area to form an amniotic membrane support frame; S6: Use a tool to install the amniotic membrane on the amniotic membrane support frame; S7: Install the amniotic membrane fixing ring onto the amniotic membrane support frame on which the amniotic membrane has been installed.

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