Biological amnion cornea surface transplantation device

Abstract

The utility model provides a biological amnion cornea surface transplantation device which comprises a fixing body which is a circular ring and is matched with the corneal limbus of a human body. The fixing support piece at least comprises a fixing loop, and the fixing loop is a metal wire made of shape memory metal; one end of the fixing loop is fixedly connected with the fixing main body, and the other end of the fixing loop is far away from the diameter direction of the fixing main body passing through the connection point of the fixing loop and the fixing main body; and at least two fixing support pieces are arranged on the periphery of the fixing main body. Deformation and recovery of the memory metal and structural characteristics of human eyeballs are ingeniously utilized, the fixing loops are clamped to penetrate through the amniotic membrane and the corneal limbus conjunctiva and then are loosened, the memory metal recovers deformation in the gap between the conjunctiva and the sclera, the at least two fixing loops form a clamping jaw in the gap between the conjunctiva and the sclera along the corneal limbus radian, and the clamping jaw is clamped by the memory metal. Therefore, the amniotic membrane is pressed on the surface of the cornea by the fixing main body. The device is simple in structure, low in cost and easy to operate, trauma in an operation is small, and postoperative recovery is fast.

Description

Technical Field

[0001] The utility model relates to an ophthalmic medical device, in particular to a device used in ophthalmic surgery for applying biological amniotic membrane to perform corneal surface transplantation to treat corneal ulcers, keratitis, corneal perforation and other diseases. Background Art

[0002] Keratitis, corneal ulcers, and corneal perforations are common ophthalmic diseases in ophthalmology. Treatment options include medication, iontophoresis, corneal cross-linking, and surgery. Surgery is the most commonly used treatment in clinical practice. Surgical procedures include amniotic membrane transplantation, conjunctival flap coverage, partial corneal transplantation, lamellar keratoplasty, and penetrating keratoplasty. Full corneal surface transplantation using biological amniotic membrane is a cost-effective and safe option due to its commercial availability, absorbability, reproducibility, and proven efficacy.

[0003] There are two main fixation methods for existing bio-amniotic membrane corneal surface transplantation surgeries, including traditional suture fixation and bio-protein glue fixation. Among them, the disadvantages of traditional suture fixation include: (1) Suture suturing is cumbersome, and generally requires more than 8 stitches to suture the corneal limbus, which is very traumatic and prone to bleeding during the operation. (2) Because the suture method only uses point fixation, the bio-amniotic membrane and the cornea and conjunctiva will always be poorly attached, thus affecting the therapeutic effect of the bio-amniotic membrane. (3) Suture suturing causes local bio-amniotic membrane wrinkles due to the span of the knot, resulting in poor attachment, causing a foreign body sensation after surgery and rapid melting of the amniotic membrane, affecting the therapeutic effect. (4) The foreign body sensation in the eye caused by suture suturing cannot be avoided (5) Suture suturing needs to be removed after surgery, which increases the treatment burden on patients. The disadvantages of bio-protein glue fixation include: (1) The reliability of bio-protein glue fixation is poor, and the bio-amniotic membrane is prone to fall off and shift after surgery, resulting in surgical failure. (2) The toxicity of bioprotein glue itself affects the repair of corneal and conjunctival tissue after bioamniotic membrane transplantation. Therefore, bioprotein glue is not recommended for fixation in bioamniotic membrane transplantation for diseases such as keratitis and corneal ulcers. (3) After solidification, bioprotein glue forms a thin layer of solid tissue, which blocks the amniotic membrane and the cornea and conjunctiva, affecting the scaffolding effect of amniotic membrane transplantation and the migration of corneal and conjunctival cells. Utility Model Content

[0004] In order to solve the above problems, the purpose of the utility model is to provide a biological amniotic membrane corneal surface transplant device, which cleverly utilizes the annular anatomical feature of the space between the limbal conjunctiva and the sclera of the human eyeball, punctures the amniotic membrane and the limbal conjunctiva respectively and extends into the space between the conjunctiva and the sclera. After the annular structure is restored by the memory metal deformation, the amniotic membrane is fixed to the corneal periphery and pressed against the corneal surface.

[0005] The utility model is achieved through the following technical solutions:

[0006] A biological amniotic membrane corneal surface transplantation device, comprising:

[0007] A fixing body, wherein the fixing body is a ring adapted to fit the human corneal limbus;

[0008] A fixing support, the fixing support comprising at least one fixing loop, the fixing loop being a metal wire made of shape memory metal; one end of the fixing loop being fixedly connected to the fixing body, the other end of the fixing loop being a free end, the free end of the fixing loop being away from the fixing body in a diametrical direction passing through the connection point between the fixing loop and the fixing body;

[0009] Wherein, fixed supports are provided at least at two locations on the periphery of the fixed body.

[0010] Furthermore, each of the fixing supports includes two fixing loops, and the free ends of the two fixing loops face away from each other.

[0011] Furthermore, the free end of the fixing loop away from the fixing body is conical.

[0012] Furthermore, the fixing support is centrally symmetrical on the fixing body.

[0013] Furthermore, three, four or more fixing supports are provided.

[0014] Furthermore, there is no intersection between adjacent fixing loops.

[0015] Furthermore, the fixing body and the fixing support are integrally formed.

[0016] Compared with the prior art, the technical solution of the present utility model and its beneficial effects are as follows:

[0017] (1) The amniotic membrane corneal surface transplantation device of the present invention cleverly utilizes the deformation and recovery properties of memory metal and the structural characteristics of the human eyeball. After the clamping fixation loop passes through the amniotic membrane and the limbal conjunctiva and is released, the memory metal recovers its deformation in the space between the conjunctiva and the sclera. At least two fixation loops form a "claw" along the curvature of the limbus in the space between the conjunctiva and the sclera, thereby allowing the fixation body to press the amniotic membrane against the corneal surface. The device has a simple structure, low cost, and is easy to operate, resulting in minimal intraoperative trauma and rapid postoperative recovery.

[0018] (2) The number of the fixing supports of the present invention is three or four, and the fixing supports are centrally symmetrical, so that the fixing body is evenly stressed, thereby improving the stability of the fixation and the comfort of the eyeball. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a front view of a biological amniotic membrane corneal surface transplantation device provided by an embodiment of the utility model;

[0020] Figure 2 This is a schematic diagram of the transplant device provided by an embodiment of the present invention combined with the amniotic membrane;

[0021] Figure 3 This is a cross-sectional view of a human eyeball provided by an embodiment of the present utility model;

[0022] Figure 4 This is a schematic diagram of the transplantation device provided in an embodiment of the present invention pressing the amniotic membrane onto the cornea.

[0023] Illustration:

[0024] Fixed body - 100;

[0025] Fixed support 200; fixed loop 210; fixed end 211; free end 212;

[0026] Amniotic membrane - 300;

[0027] Eyeball - 400; pupil - 410. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described are part of the embodiments of the present invention, rather than all the embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention and are not used to limit the present invention. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0029] See Figures 1 to 4 A biological amniotic membrane corneal surface transplant device includes a fixing body 100 and a fixing support 200. The fixing body 100 is a circular ring adapted to fit the human corneal limbus. Specifically, the inner diameter of the fixing body 100 can be sized to accommodate corneas of varying diameters across age groups and individual patient differences. The fixing support 200 is disposed on the periphery of the fixing body 100. In this embodiment, the fixing supports 200 are provided in at least two locations, each including at least one fixing haptic 210. The fixing haptic 210 is a metal wire made of shape-memory metal. One end of the fixing haptic 210 is fixedly connected to the fixing body 100, which is the fixing end 211 of the fixing haptic. The other end of the fixing haptic 210 is a free end 212, which is diametrically spaced from the fixing end 211 of the fixing body 100.

[0030] When using this device, the amniotic membrane (including dry amniotic membrane, wet amniotic membrane, or any membranous implant) is rehydrated and trimmed into a circular shape of appropriate size. The diameter of the circular amniotic membrane is generally greater than 13 mm. A device with a suitable diameter for the fixing body 100 is selected. The fixing loop is gripped with microtweezers or a microneedle holder and penetrates the entire thickness of the amniotic membrane at the corresponding location, with the penetration point approximately radially past the fixing end 211. After penetrating the amniotic membrane, the fixing loop 210 recovers its deformation to a curved configuration toward the fixing body (i.e., the free end is radially away from the fixing end). The fixing body is provided with fixing supports at least two locations around its periphery, i.e., at least two penetration points. The fixing body is located on the front of the amniotic membrane, and at least two fixing loops 210 are located on the back of the amniotic membrane, thereby clamping the amniotic membrane and securing the fixing body and the amniotic membrane together. To ensure a good unfolding effect of the amniotic membrane and facilitate subsequent conjunctival puncture, in this embodiment, at least four fixing supports are provided. The subsequent descriptions and illustrations will use the example of four fixing supports.

[0031] Following conventional amniotic membrane corneal transplantation procedures, after disinfection and draping, the eyeball is anesthetized with 400°C of topical anesthesia. After opening the eyelids with an eyelid speculum, a 1-2 mm wide microconjunctival incision is made in the limbus and bulbar conjunctiva at the locations corresponding to the connection between the fixation haptic 210 and the fixation body. Four locations, typically 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock, are used. The fixation haptic of the device, which is secured to the amniotic membrane, is clamped with microtweezers or a microneedle holder and passed through the prefabricated 1-2 mm wide limbus and conjunctival incision. The clamped fixation haptic is released. Due to the properties of shape memory metal and the structure of the eye, the fixation haptic moves in the gap between the conjunctiva and sclera until its shape is restored. At this point, the fixation body is located on the front of the amniotic membrane, while the back of the amniotic membrane adheres to the front of the cornea and conjunctiva. The majority of the fixation haptic is located in the gap between the conjunctiva and sclera, meaning the fixation haptic is located on the back of the conjunctiva. The fixation body and fixation haptic are then used to press the amniotic membrane into a circular shape against the surface of the limbus and conjunctiva.

[0032] Generally, the amniotic membrane will melt on its own 5-7 days after the operation, but the device can still be fixed on the corneal surface. The method of removing the device is as follows: open the eyelid under the slit lamp, use micro forceps or micro needle holder to directly clamp the ring-shaped fixed body of the device, and remove the device directly perpendicular to the cornea without removing stitches or contact fixation. The 1-2mm corneal limbal conjunctival incision during the operation can heal on its own without suturing the incision.

[0033] This device cleverly utilizes the properties of memory metal and the specific location of the space between the limbus, conjunctiva, and sclera of the human eyeball. It relies on the elasticity of the memory metal to secure the biological amniotic membrane, without damaging the ocular surface. Furthermore, because the fixed body adheres closely to the limbus, the postoperative foreign body sensation is minimal. After the amniotic membrane melts, the device is easily removed, eliminating the need for suture removal, reducing the cost and burden of postoperative suture removal for the patient. Using this device, surgery requires only a small 1mm incision on the conjunctival surface, or a fixed loop can be used to directly penetrate the conjunctiva without requiring an incision. This minimally invasive procedure minimizes damage and can be performed under topical anesthesia, eliminating the need for local infiltration anesthesia. The device utilizes titanium memory alloy, allowing for repeated disinfection and reuse, resulting in low cost, energy conservation, and environmental protection.

[0034] In this embodiment, each fixing support 200 includes two fixing loops 210, the free ends of which face away from each other, thereby enhancing the fixing effect of the fixing support 200. The number of fixing supports 200 is at least two, and may also be three, four, or more. The fixing supports 200 are centrally symmetrical to ensure uniform force on the fixing body 100.

[0035] As will be appreciated, the free end 212 of the fixation haptic 210, distal from the fixation body 100, is conical, facilitating puncture of the amniotic membrane and cornea. Adjacent fixation haptics 210 do not intersect, thereby preventing interference between them. The inclination of the fixation haptics is tailored to the anatomy of the eyeball, enabling the fixation haptics to move within the space between the conjunctiva and sclera after penetrating the cornea.

[0036] In this embodiment, the fixing body and the fixing support are integrally formed, and the structure is simple and durable. The fixing body can be applied to biological amniotic membranes of various shapes and sizes on the market, including dry and wet amniotic membranes, and has wide applicability.

[0037] The foregoing description shows and describes preferred embodiments of the present invention. It should be understood that the present invention is not limited to the form disclosed herein and should not be construed as excluding other embodiments. Rather, the present invention can be used in various other combinations, modifications, and environments and can be modified within the scope of the present invention through the above teachings or techniques or knowledge in the relevant field. Modifications and variations made by those skilled in the art that do not depart from the spirit and scope of the present invention are intended to be protected by the claims appended hereto.

Claims

1. A biological amniotic membrane corneal surface transplantation device, characterized in that: include: A fixing body, the fixing body being a circular ring adapted to fit the limbus of the human eyeball; A fixing support, the fixing support comprising at least one fixing loop, the fixing loop being a metal wire made of shape memory metal; one end of the fixing loop being fixedly connected to the fixing body, the other end of the fixing loop being a free end, the free end of the fixing loop being away from the fixing body in a diametrical direction passing through the connection point between the fixing loop and the fixing body; Wherein, fixed supports are provided at least at two locations on the periphery of the fixed body.

2. The biological amniotic membrane corneal surface transplantation device according to claim 1, characterized in that: Each of the fixing supports includes two fixing loops, and the free ends of the two fixing loops are away from each other.

3. The biological amniotic membrane corneal surface transplantation device according to claim 1, characterized in that: The free end of the fixing loop away from the fixing body is conical.

4. The biological amniotic membrane corneal surface transplantation device according to claim 1, characterized in that: The fixing support is centrally symmetrical on the fixing body.

5. The biological amniotic membrane corneal surface transplantation device according to claim 4, characterized in that: The number of the fixing supports is three, four or more.

6. The biological amniotic membrane corneal surface transplantation device according to claim 1, characterized in that: There is no intersection between adjacent fixing loops.

7. The biological amniotic membrane corneal surface transplantation device according to claim 1, characterized in that: The fixing body and the fixing support are integrally formed.

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