Biological amnion cornea surface transplantation device

Abstract

The invention 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 invention relates to ophthalmic medical instruments, in particular to an ophthalmic medical instrument for use in corneal surface transplantation using biological amniotic membrane 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 clinics. Treatment methods mainly include drug therapy, drug ion introduction therapy, corneal cross-linking therapy, and surgical treatment. Among them, surgical treatment is a commonly used clinical treatment method. Surgical methods include: amniotic membrane transplantation, conjunctival flap coverage, partial corneal transplantation, lamellar keratoplasty, and penetrating keratoplasty. Among them, the use of biological amniotic membrane for full corneal surface transplantation is a cost-effective and safe solution due to its commercialization and absorbability, good repeatability and definite treatment effect.

[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 traditional suture fixation has the following disadvantages: (1) Suture suturing surgery is cumbersome, and generally requires more than 8 stitches to suture the corneal limbus, which is 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 have poor adhesion, 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, which causes poor adhesion, resulting in a foreign body sensation after surgery and rapid melting of the amniotic membrane, affecting the therapeutic effect. (4) The postoperative foreign body sensation in the eye caused by suture suturing cannot be avoided (5) Suture suturing needs to be removed after surgery, increasing the patient's treatment burden. 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 bio-amniotic membrane transplantation. Therefore, bioprotein glue fixation is not recommended for bio-amniotic 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, affecting the scaffolding effect of amniotic membrane transplantation and the migration of corneal and conjunctival cells. Summary of the invention

[0004] In order to solve the above problems, the purpose of the present invention is to provide a biological amniotic membrane corneal surface transplantation 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, and after the annular structure is restored by the memory metal deformation, the amniotic membrane is fixed to the periphery of the cornea and pressed against the corneal surface.

[0005] The present invention 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 circular ring adapted to fit the human corneal limbus;

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

[0009] Wherein, fixed supports are arranged 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, the number of the fixed supports is three, four or more than four.

[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 invention 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 of memory metal and the structural characteristics of the human eyeball. The clamping and fixing loops are loosened after passing through the amniotic membrane and the limbal conjunctiva. The memory metal recovers its deformation in the gap between the conjunctiva and the sclera. At least two fixing loops form a "claw" along the limbal curvature in the gap between the conjunctiva and the sclera, so that the fixing body presses the amniotic membrane against the corneal surface. The device has a simple structure, low cost, and is easy to operate, resulting in less trauma during surgery and faster recovery after surgery.

[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 is a front view of a biological amniotic membrane corneal surface transplantation device provided by an embodiment of the present invention;

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

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

[0022] Figure 4 It 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 Description:

[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 scheme and advantages of the embodiments of the present invention clearer, the technical scheme 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 described embodiments are part of the embodiments of the present invention, rather than all the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention. Based on the embodiments of 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 also Figures 1 to 4 A biological amniotic membrane corneal surface transplantation device includes a fixed body 100 and a fixed support 200. The fixed body 100 is a circular ring adapted to the edge of the human cornea, that is, the inner diameter of the fixed body 100 can be 10mm, 11mm, 12mm, 13mm, 14mm, 15mm and other different diameters to adapt to corneas of different age groups and individual differences of various patients. The fixed support 200 is arranged on the periphery of the fixed body 100. In this embodiment, the fixed support 200 is arranged at least at two locations, and each fixed support 200 includes at least one fixed haptic 210, which is a metal wire made of shape memory metal. One end of the fixed haptic 210 is connected to the fixed body 100, which is the fixed end 211 of the fixed haptic, and the other end of the fixed haptic 210 is a free end 212, and the free end 212 is away from the diameter direction of the fixed body 100 passing through the fixed end 211.

[0030] When the device is used, 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. The device with a suitable diameter of the fixing body 100 is selected, and the fixing loop is clamped by using micro forceps or micro needle holders to penetrate the entire layer of the amniotic membrane at the corresponding part, and the penetration point is roughly in the radial direction of the fixing end 211. After the fixing loop 210 penetrates the amniotic membrane, the fixing loop 210 recovers its deformation to a shape bent toward the fixing body (that is, the free end is away from the radial direction of the fixing end). At least two fixing supports are provided on the periphery of the fixing body, that is, 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 fixing the fixing body and the amniotic membrane together. In order to have a good unfolding effect of the amniotic membrane and facilitate the subsequent operation of puncturing the conjunctiva, in this embodiment, at least four fixing supports are provided. In the subsequent scheme description and illustrations, the fixing supports are provided at four times as an example.

[0031] According to the conventional amniotic membrane full corneal transplantation operation steps, after disinfection and draping, the eyeball is anesthetized at 400°. After the eyelid is opened with an eyelid opener, a 1-2mm wide conjunctival micro-incision is made at the limbus bulbar conjunctiva at the position corresponding to the connection between the fixing loop 210 and the fixing body, generally at the limbus 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock. The fixing loop of the device fixed to the amniotic membrane is clamped by a micro forceps or a micro needle holder and passed through a prefabricated 1-2 mm wide limbal conjunctival incision. The clamped fixing loop is released, and through the characteristics of the shape memory metal and the structure of the eyeball, the fixing loop will move in the gap between the conjunctiva and the sclera until the deformation is restored. At this time, the fixing body is located on the front of the amniotic membrane, and the back of the amniotic membrane fits the cornea and the front of the conjunctiva. Most of the structure of the fixing loop is located in the gap between the conjunctiva and the sclera, that is, the fixing loop is located on the back of the conjunctiva. The amniotic membrane is pressed in a ring shape onto the surface of the limbal conjunctiva through the fixing body 100 and the fixing loop 210.

[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: 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 the device can be directly removed vertically to the cornea without removing stitches or contact fixation. During the operation, the 1-2mm corneal limbal conjunctival incision can heal on its own without suturing the incision.

[0033] This device cleverly utilizes the characteristics of memory metal and the gap between the limbal conjunctiva and sclera of the human eyeball, and relies on the elastic force of memory metal to fix the biological amniotic membrane without damaging the ocular surface. And because the fixed body is close to the limbus, the foreign body sensation after surgery is small; after the amniotic membrane melts, the device is easy to remove, and there is no need to remove the stitches, which reduces the cost and burden of stitch removal after surgery for patients. With this device, surgery only requires a small 1mm incision on the conjunctival surface, or the fixed loop can be used to directly pass through without an incision, with minimal invasive damage, and the surgery can be performed under surface anesthesia without the need for local infiltration anesthesia, which is convenient and safe; titanium metal memory alloy is used, which can be repeatedly disinfected and reused, with low cost, energy saving and environmental protection.

[0034] In this embodiment, each fixing support 200 includes two fixing loops 210, and the free ends of the two fixing loops 210 are separated from each other, thereby enhancing the fixing effect of the fixing support 200. The number of the fixing supports 200 is at least two, and of course it can also be three, four or more than four. The fixing supports 200 are centrally symmetrical so that the fixing body 100 is evenly stressed.

[0035] It is understandable that the free end 212 of the fixing haptic 210 away from the fixing body 100 is conical, which facilitates the fixing haptic 210 to puncture the amniotic membrane and the cornea. There is no intersection between adjacent fixing haptics 210, thereby avoiding mutual influence between the fixing haptics. The inclination of the fixing haptic is adapted to the structure of the eyeball, so that the fixing haptic can move in the gap between the conjunctiva and the 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 the fixing support has wide applicability.

[0037] The above description shows and describes the 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 regarded as excluding other embodiments, but can be used in various other combinations, modifications and environments, and can be modified within the scope of the invention, through the above teachings or the technology or knowledge of the relevant field. The changes and modifications made by those skilled in the art shall not depart from the spirit and scope of the present invention, and shall be within the scope of protection of the claims attached to the present invention.

Claims

1. A biological amniotic membrane corneal surface transplantation device, characterized in that: include: A fixing body, wherein the fixing body is a circular ring adapted to fit the corneal limbus of a human eyeball; A fixed support, the fixed support comprising at least one fixed loop, the fixed loop being a metal wire made of shape memory metal; one end of the fixed loop is fixedly connected to the fixed body, the other end of the fixed loop is a free end, and the free end of the fixed loop is away from the diameter direction of the fixed body passing through the connection point between the fixed loop and the fixed body; Wherein, fixed supports are arranged 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 comprises 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 fixed supports is three, four or more than four.

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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