Non-invasive total fornix amniotic membrane fixation device and non-invasive amniotic membrane treatment device

Abstract

The utility model discloses a non -invasive full dome amnion fixing device contains first fixed establishment, second fixed establishment and connecting fixed establishment. Amnion is placed between first fixed establishment and second fixed establishment, and amnion is fixed between first fixed establishment, second fixed establishment through connecting fixed establishment. The utility model discloses a non -invasive full dome amnion fixing device has the shape of adapting with dome structure or can be self -adapted dome structure, realizes full dome adaptation. The utility model discloses a non -invasive amnion treatment device contains the utility model discloses a non -invasive full dome amnion fixing device and amnion, and is placed in the treatment site non -invasively, and amnion is pasted in the treatment site through the treatment window and carries out repair, treatment. Avoid the harm that suture brings in amnion repair, especially for the patient who needs to carry out the amnion of regular replacement and carries out treatment, the utility model discloses a non -invasive amnion treatment device can effectively reduce the repeated suture trauma in long -term treatment process.

Description

Technical Field

[0001] This utility model relates to an ophthalmic surgical instrument, and in particular to a non-invasive full-fornix amniotic membrane fixation device and a non-invasive amniotic membrane treatment device used in amniotic membrane repair surgery. Background Technology

[0002] Amniotic membrane is frequently used clinically to repair skin and mucous membrane wounds due to its excellent abilities in promoting epithelial healing, inhibiting inflammatory responses, antimicrobial activity, and preventing adhesions. It has the advantage of promoting epithelial cell differentiation and proliferation, and accelerating the healing of epithelial injuries. It is also widely used in the treatment of corneal ulcers, chemical eye burns, bullous keratopathy, and corneal perforation in ophthalmology.

[0003] The amniotic membrane has the following problems in current clinical use:

[0004] 1. Suturing and fixing the amniotic membrane is an invasive procedure: Existing amniotic membrane covering or transplantation surgeries all require suturing and are therefore invasive procedures. Because the amniotic membrane is thin and easily melts, especially in cases with long disease courses, slow recovery, and high recurrence rates, such as corneal erosion and chemical burns, repeated amniotic membrane covering treatments are required. The surgical trauma caused by this type of suturing and repeated suturing is unavoidable.

[0005] 2. Limited exposure of transplantation site, leaving treatment blind spots: Many ocular surface diseases often involve the entire ocular surface structure, including the palpebral conjunctiva, fornix conjunctiva, and bulbar conjunctiva. Because the physiological structure of the eye is characterized by a small palpebral fissure and a deep fornix, like a jar with a small mouth and a large belly, the above-mentioned areas cannot be exposed during surgery. Only the amniotic membrane covering or transplantation within a 3-5 mm range around the cornea can be completed.

[0006] 3. Uneven amniotic membrane fixed by sutures affects efficacy: The amniotic membrane is thin and easily rolled up. In addition, the shape of the diseased conjunctival sac is irregular. Traditional surgery makes it difficult to flatten the amniotic membrane. The amniotic membrane cannot form a tight attachment with the implantation bed, which not only affects the efficacy, but also causes tearing of the transplanted amniotic membrane due to friction from eye movement, leading to surgical failure.

[0007] 4. Confusion between the front and back of the amniotic membrane affects the treatment effect: Clinical amniotic membrane procedures include two main categories: amniotic membrane transplantation and amniotic membrane covering. The former requires the basal surface of the amniotic membrane to be attached to the implantation bed, while the latter requires the epithelial surface of the amniotic membrane to contact the implantation bed. However, fresh or wet-preserved amniotic membranes are very thin, only 0.02 to 0.05 mm. Moreover, because the amniotic membrane is semi-transparent, it is very difficult to distinguish the epithelial surface from the basal surface if the amniotic membrane is rolled up during the operation.

[0008] 5. There is no effective way to avoid or reduce constriction of the fornix and symblepharon: In many inflammatory and traumatic ocular surface diseases, the palpebral conjunctiva, fornix conjunctiva and bulbar conjunctiva are in close contact, which can easily lead to constriction of the fornix and symblepharon, and even adhesion and fusion of the upper and lower eyelid margins, burying the eyeball. Current methods cannot effectively prevent its occurrence and development.

[0009] To address the aforementioned clinical problems, this invention presents a non-invasive, suture-free, fully fornix-adaptive amniotic membrane fixation device, aiming to overcome these clinical issues. Summary of the Invention

[0010] The non-invasive full fornix amniotic membrane fixation device of this utility model can be directly fixed to the site requiring treatment by means of a shape that adapts to the fornix, without the need for additional sutures, so as to realize non-invasive insertion and replacement of the full fornix, while providing support for the palpebral conjunctiva and effectively preventing adhesions.

[0011] The non-invasive full-fornix amniotic membrane fixation device of this utility model includes a first fixation mechanism 1, a second fixation mechanism 2, a connecting fixation mechanism 3, and a treatment window 10, characterized in that:

[0012] A. The first fixing mechanism 1 is provided with a first amniotic membrane bonding surface 11, and the second fixing mechanism 2 is provided with a second amniotic membrane bonding surface 21;

[0013] B. The connecting and fixing mechanism 3 is disposed on the first fixing mechanism 1 and / or the second fixing mechanism 2; the treatment window 10 is disposed on the first fixing mechanism 1 and / or the second fixing mechanism 2;

[0014] C. The amniotic membrane 200 is placed between the first fixing mechanism 1 and the second fixing mechanism 2. When the connecting fixing mechanism 3 connects and fixes the first fixing mechanism 1 and the second fixing mechanism 2 into a whole, the first amniotic membrane contact surface 11 and the second amniotic membrane contact surface 21 form a surface contact with the amniotic membrane 200. The amniotic membrane 200 is fixed between the first fixing mechanism 1 and the second fixing mechanism 2. The amniotic membrane 200 is fixed by the connecting fixing mechanism 3 and covers the treatment window 10.

[0015] D. The non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure or can adapt to the fornix structure and can be fixed at the treatment site. The amniotic membrane 200 is attached to the treatment site through the treatment window 10 for repair and treatment. Since the non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure, it can be directly and non-invasively fixed at the treatment site to achieve full fornix adaptation.

[0016] Typically, the second fixation mechanism 2 is a lower annular structure with a bottom shape adapted to or capable of adapting to the dome structure. The center of the annular structure is the treatment window 10. The shapes of the first fixation mechanism 1 and the second fixation mechanism 2 are adapted to fix the amniotic membrane 200 between the first fixation mechanism 1 and the second fixation mechanism 2. The treatment window 10 provides space for the amniotic membrane 200, allowing it to adhere to the treatment site. Because the non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the dome structure, its vertical position can be easily distinguished after the amniotic membrane 200 is fixed, and its front and back sides can be clearly identified. Therefore, it is easy to distinguish the epithelial surface and the basal surface of the amniotic membrane 200, making it very convenient and safe for clinical use. When the first fixation mechanism 1 is a lower annular structure, the treatment window 10 is located on the first fixation mechanism 1.

[0017] Because the amniotic membrane 200 is a very thin amniotic membrane-like material, to ensure good fixation without causing accidental damage such as cutting, the first fixation mechanism 1 and the second fixation mechanism 2 form surface contact with the amniotic membrane 200. Since the bottom of the second fixation mechanism 2 has a shape adapted to the dome or can adapt to the dome structure, in clinical use, the non-invasive full-dome amniotic membrane fixation device 100, with the amniotic membrane 200 fixed, can be directly placed on the treatment site. Because the bottom of the second fixation mechanism 2 has a shape adapted to the dome or can adapt to the dome structure, and the dome shape is asymmetrical, the non-invasive full-dome amniotic membrane fixation device 100 will not shift.

[0018] Furthermore, the non-invasive full-fornix amniotic membrane fixation device 100 is typically made of a medical elastic material with a certain supporting force. Therefore, for parts that cannot be exposed, the non-invasive full-fornix amniotic membrane fixation device 100, with the amniotic membrane 200 fixed, can be moved to a position on the inner side of the eyelid that cannot be exposed, achieving positioning through shape adaptation at the bottom of the second fixation mechanism 2. Since the non-invasive full-fornix amniotic membrane fixation device 100 with the amniotic membrane 200 fixed can be placed at any position inside the eye as needed, thus achieving full fornix adaptation. At the same time, due to the supporting effect and continuous elastic expansion force of the non-invasive full-fornix amniotic membrane fixation device 100, it can provide good support and expansion for many inflammatory and traumatic ocular surface diseases, such as fornix narrowing and symblepharon caused by close adhesion of the palpebral conjunctiva, fornix conjunctiva, and bulbar conjunctiva, and even adhesion and fusion of the upper and lower eyelid margins, effectively avoiding or reducing fornix narrowing and symblepharon.

[0019] The parts of the first fixation mechanism 1 and the second fixation mechanism 2 that come into contact with human tissue are both made of medical materials. Since the non-invasive total fornix amniotic membrane fixation device 100 requires continuous intraocular treatment, to ensure clinical safety during the treatment process, the parts of the first fixation mechanism 1 and the second fixation mechanism 2 that come into contact with human tissue are both made of medical materials.

[0020] The contact portions of the first fixation mechanism 1 or the second fixation mechanism 2 that come into contact with the moving tissue all have a smooth surface structure. Since there are multiple movable parts in the eyeball structure, such as the eyelids and the eyeball itself, the contact portions of the first fixation mechanism 1 or the second fixation mechanism 2 that come into contact with the moving tissue all have a smooth surface structure to avoid accidental injury during movement.

[0021] The non-invasive full-fornix amniotic membrane fixation device 100 further includes an amniotic membrane tensioning mechanism 4. This mechanism applies a radially outward stretching force to the amniotic membrane 200, causing it to stretch and flatten outward along the first amniotic membrane bonding surface 11 and the second amniotic membrane bonding surface 21, and then be flatly and securely embedded between them. Since wrinkles during the application of the amniotic membrane 200 can cause visual distortion and affect epithelial healing, the non-invasive full-fornix amniotic membrane fixation device 100 also includes the amniotic membrane tensioning mechanism 4. This mechanism stretches, tightens, and flattens the amniotic membrane 200 outward, providing a better clinical treatment outcome.

[0022] The connecting and fixing mechanism 3 is either a mechanical connecting and fixing mechanism 31 or a magnetic connecting and fixing mechanism 32. The applicant has only specifically illustrated the above two connection methods here. In practical applications, those skilled in the art can design different connection methods as needed. The applicant will not provide examples of each of these methods here, but none of them will depart from the protection scope of this application.

[0023] The mechanical connection fixing mechanism 31 adopts a concave-convex snap-fit ​​connection method; the first fixing mechanism 1 is provided with an annular slot 13, and the second fixing mechanism 2 is provided with an annular positioning protrusion 22. The annular positioning protrusion 22 and the annular slot 13 constitute the mechanical connection fixing mechanism 31. When pressed down, the annular positioning protrusion 22 is embedded in the annular slot 13. During the pressing process, the amnion 200 is stretched outward. The amnion 200 is subjected to an outward radial stretching force. The amnion 200 is stretched and flattened outward along the first amnion bonding surface 11 and the second amnion bonding surface 21, and is embedded and fixed between the first amnion bonding surface 11 and the second amnion bonding surface 21. The mechanical connection fixing mechanism 31 also constitutes the amnion tensioning mechanism 4.

[0024] The mechanical connection method using the convex and concave clips is simple to operate. The connection can be achieved with just a simple press. At the same time, during the pressing process, the amnion 200 can be stretched outward, tightened and flattened, so that the connection and tightening functions can be achieved in one action, which is very convenient for clinical use.

[0025] The connecting and fixing mechanism 3 is a magnetic connecting and fixing mechanism 32; the first fixing mechanism 1 is made of magnetic material, and the second fixing mechanism 2 is made of magnetic stainless steel material. When the amnion 200 is placed on the second fixing mechanism 2, and the first fixing mechanism 1 is brought close to the second fixing mechanism 2, the first fixing mechanism 1 and the second fixing mechanism 2 adhere to each other under magnetic attraction, and the amnion 200 is fixed between the first fixing mechanism 1 and the second fixing mechanism 2.

[0026] The magnetic connection method allows for automatic adhesion simply by bringing the first fixing mechanism 1 close to the second fixing mechanism 2, making the installation process very simple. Furthermore, the mutual attraction of the magnetic forces facilitates the alignment of the first fixing mechanism 1 and the second fixing mechanism 2. Simultaneously, because the first fixing mechanism 1 and the second fixing mechanism 2 are in a ring-shaped contact, the amnion 200 is stretched and flattened outwards. The magnetic connection fixing mechanism 32 also simultaneously forms the amnion tensioning mechanism 4, making the fixation process of the amnion 200 very simple and convenient.

[0027] The magnetic material of the first fixation mechanism 1 is coated with medical material. To ensure the safety of the magnetic material in clinical use, the magnetic material of the fixation mechanism 1 is coated with medical material to ensure its biocompatibility during clinical use.

[0028] The medical material is medical-grade titanium, medical-grade titanium alloy, or medical-grade elastic material. The applicant has only listed these three types of medical materials here; those skilled in the art can select other medical materials to coat the magnetic material as needed.

[0029] The medical elastic material is medical-grade silicone rubber or thermoplastic polyurethane (TPU). Due to its flexibility, the medical elastic material can not only effectively encapsulate magnetic materials during use, but also provide better comfort, especially during eye movements.

[0030] The magnetic material of the first fixing mechanism 1 is neodymium iron boron (NdFeB) sheet material, filament material, and / or NdFeB powder material. The magnetic material can be a thin sheet of magnetic material, a magnetic wire, or a magnetic powder. Thin sheet magnetic materials have the best magnetic adsorption capacity; wires can be wound into different shapes as needed, possessing both good magnetic adsorption capacity and better flexibility; and magnetic powder materials can be encapsulated in medical elastic materials, providing excellent comfort.

[0031] The second fixing mechanism 2 is a ring-shaped sheet structure made of magnetic stainless steel material, or a ring-shaped sheet structure made of magnetic stainless steel wire. The ring-shaped sheet magnetic material has excellent magnetic adsorption capacity, and the wire can be wound into different shapes as needed, providing both good magnetic adsorption capacity and better flexibility.

[0032] The magnetic stainless steel material of the second fixing mechanism 2 is covered with a medical elastic material; the medical elastic material is medical silicone rubber or thermoplastic polyurethane (TPU).

[0033] The second fixing mechanism 2 is made of an elastic material and can deform under external force, thereby enabling it to adapt to the contour of the treatment site and accommodate different treatment site shapes. This adaptive structure can freely adapt to different dome contours, making it more adaptable in clinical use.

[0034] The non-invasive full-fornix amniotic membrane fixation device 100 also includes a positioning mechanism 5. The positioning mechanism 5 can play a good guiding role in the fitting process of the first fixation mechanism 1 and the second fixation mechanism 2.

[0035] The positioning mechanism 5 is an annular positioning ring 51 disposed on the first fixing mechanism 1 and / or the second fixing mechanism 2.

[0036] The first fixing mechanism 1 and / or the second fixing mechanism 2 are provided with an annular positioning ring 51, and the corresponding second fixing mechanism 2 or the first fixing mechanism 1 is usually provided with a positioning protrusion 52, which constitutes the positioning mechanism 5. The first fixing mechanism 1 and the second fixing mechanism 2 are in annular contact, and the annular positioning ring 51 is pressed on the positioning protrusion 52, so that the amnion 200 is stretched and flattened outward. The positioning mechanism 5 can also constitute the amnion tensioning mechanism 4.

[0037] The second fixing mechanism 2 is equipped with an adaptive mechanism 6, which enables the second fixing mechanism 2 to automatically adapt to the dome. This adaptive structure can freely adapt to different dome contours, making it more adaptable in clinical use.

[0038] The adaptive mechanism 6 is a spiral spring 61 made of shape memory alloy. The spiral spring 61 is wound from a shape memory alloy with good elasticity, has excellent shape conformability, and can be customized into various spatial shapes and the shape of the treatment window 10 according to different dome structures, achieving excellent personalized customization.

[0039] The non-invasive amniotic membrane treatment device of this utility model includes the non-invasive full-fornix amniotic membrane fixation device 100 and the amniotic membrane 200.

[0040] The amniotic membrane 200 is fixed between the first fixation mechanism 1 and the second fixation mechanism 2. The non-invasive amniotic membrane treatment device 900 is placed on the treatment site via non-invasive insertion. The amniotic membrane 200 is adhered to the treatment site through the treatment window 10 for repair and treatment. Because the bottom of the second fixation mechanism 2 has a shape adapted to the dome or can adapt to the dome structure, and the dome shape is asymmetrical, the non-invasive full-dome amniotic membrane fixation device 100 will not shift. Therefore, the non-invasive amniotic membrane treatment device 900 can be placed on the treatment site via non-invasive insertion, and the amniotic membrane 200 can be directly adhered to the area requiring treatment through the treatment window 10 for repair and treatment. This avoids the damage caused by sutures in existing amniotic membrane repair methods. Especially for patients who need regular amniotic membrane replacements, the non-invasive amniotic membrane treatment device 900 can effectively reduce repeated suture trauma during long-term treatment.

[0041] During production, the second fixing mechanism 2 of the whole plate is first placed horizontally on the table and positioned. Then, the amnion 200 is laid flat on the second fixing mechanism 2. The first fixing mechanism 1 of the whole plate is pressed down on the second fixing mechanism 2 to fix the amnion 200. Then, the non-invasive full fornix amnion fixation device 100 is divided and packaged one by one.

[0042] In clinical use, select the appropriate size of the non-invasive total fornix amniotic membrane fixation device 100 according to the size of the area to be repaired, and place the non-invasive total fornix amniotic membrane fixation device 100 on the area of ​​the eye requiring treatment with the second fixation mechanism 2 facing downwards. For unexposed treatment areas, adjust the position by grasping the edge of the non-invasive total fornix amniotic membrane fixation device 100 with medical forceps.

[0043] This utility model discloses a non-invasive full-fornix amniotic membrane fixation device comprising a first fixation mechanism 1, a second fixation mechanism 2, and a connecting fixation mechanism 3. The connecting fixation mechanism 3 is disposed on the first fixation mechanism 1 and / or the second fixation mechanism 2. The amniotic membrane 200 is placed between the first fixation mechanism 1 and the second fixation mechanism 2. When the connecting fixation mechanism 3 connects and fixes the first fixation mechanism 1 and the second fixation mechanism 2 into a whole, the first amniotic membrane contact surface 11 and the second amniotic membrane contact surface 21 form surface contact with the amniotic membrane 200, and the amniotic membrane 200 is embedded and fixed between the first amniotic membrane contact surface 11 and the second amniotic membrane contact surface 21. The non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure or can adapt to the fornix structure, and can be fixed at the treatment site. The amniotic membrane 200 is attached to the treatment site through the treatment window 10 for repair and treatment. Because the non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure, it can be directly and non-invasively fixed at the treatment site, achieving full fornix adaptation. This utility model discloses a non-invasive amniotic membrane treatment device comprising a non-invasive full-fornix amniotic membrane fixation device and the amniotic membrane 200. It can be placed on the treatment site non-invasively. The amniotic membrane 200 can be directly attached to the area requiring treatment through the treatment window 10 for repair and treatment. This avoids the damage caused by sutures in existing amniotic membrane repair methods. Especially for patients who require regular amniotic membrane replacement, the non-invasive amniotic membrane treatment device 900 can effectively reduce the trauma of repeated sutures during long-term treatment. Attached Figure Description

[0044] Figure 1 This is a perspective view of the non-invasive full-fornix amniotic membrane fixation device of this utility model with a mechanical connection structure.

[0045] Figure 1-1 yes Figure 1 Top view.

[0046] Figure 1-2 yes Figure 1-1 AA sectional view.

[0047] Figure 1-3 yes Figure 1-2 Enlarged view of point B.

[0048] Figure 2 This is a cross-sectional view of the non-invasive full-fornix amniotic membrane fixation device of this utility model, which features a sheet-like magnetic connection mechanism.

[0049] Figure 2-1 yes Figure 2 Enlarged view of point C.

[0050] Figure 3It is made of a linear magnetic material. This is a cross-sectional view of the non-invasive full-fornix amniotic membrane fixation device of this utility model.

[0051] Figure 3-1 yes Figure 3 Enlarged view of point D.

[0052] Figure 4 This is a three-dimensional structural diagram of the non-invasive full-fornix amniotic membrane fixation device of this utility model, which includes an adaptive mechanism.

[0053] Figure 4-1 yes Figure 4 Top view.

[0054] Figure 4-2 yes Figure 4-1 EE sectional view.

[0055] Figure 4-3 yes Figure 4-2 Enlarged view of point F.

[0056] Figure 5 This is a perspective view of the non-invasive amniotic membrane treatment device of this utility model with mechanical connection.

[0057] Figure 5-1 yes Figure 5 Top view.

[0058] Figure 5-2 yes Figure 5-1 GG cross-sectional view.

[0059] Figure 5-3 yes Figure 5-2 Enlarged view of point H.

[0060] Figure 6 This is a cross-sectional view of the non-invasive amniotic membrane treatment device of this utility model with a sheet-like magnetic connection mechanism.

[0061] Figure 6-1 yes Figure 6 Enlarged view of point I.

[0062] Figure 7 This is a cross-sectional view of the non-invasive amniotic membrane treatment device of this utility model, which is made of linear magnetic material.

[0063] Figure 7-1 yes Figure 7 Enlarged view of point J.

[0064] Figure 8 This is a schematic diagram illustrating the working principle of the non-invasive amniotic membrane treatment device of this utility model, which includes an adaptive mechanism.

[0065] In the above figure:

[0066] 100 represents the non-invasive full-fornix amniotic membrane fixation device of this utility model, 200 represents the amniotic membrane, and 900 represents the non-invasive amniotic membrane treatment device of this utility model.

[0067] 1 is the first fixing mechanism, 2 is the second fixing mechanism, 3 is the connecting fixing mechanism, 4 is the amniotic membrane tightening mechanism, 5 is the positioning mechanism, 6 is the self-adaptive mechanism, and 10 is the treatment window.

[0068] 11 is the first amniotic membrane bonding surface, 12 is magnetic powder, 13 is an annular groove, and 14 is a positioning wire / ring; 21 is the second amniotic membrane bonding surface, 22 is an annular positioning step, and 23 is an annular fixing groove; 31 is a mechanical connection fixing mechanism, 32 is a magnetic connection fixing mechanism, 51 is an annular positioning ring, 52 is a positioning step, and 61 is a spiral spring.

[0069] 32-1 is neodymium iron boron (NdFeB) powder material, 32-2 is magnetic stainless steel sheet, and 32-3 is magnetic stainless steel ring. Detailed Implementation

[0070] Example 1: The non-invasive full-fornix amniotic membrane fixation device of this utility model with mechanical connection

[0071] refer to Figures 1 to 1-3 The non-invasive full-fornix amniotic membrane fixation device of this embodiment includes a first fixation mechanism 1, a second fixation mechanism 2, and a connecting fixation mechanism 3.

[0072] refer to Figure 1-2 , Figure 1-3 , Figure 5-2 and Figure 5-3 The first fixing mechanism 1 has a first amniotic membrane bonding surface 11 on its lower side and a second amniotic membrane bonding surface 21 on its upper side. The connecting fixing mechanism 3 is disposed on the first fixing mechanism 1 and / or the second fixing mechanism 2. The amniotic membrane 200 is placed between the first fixing mechanism 1 and the second fixing mechanism 2. When the connecting fixing mechanism 3 connects and fixes the first fixing mechanism 1 and the second fixing mechanism 2 into a whole, the first amniotic membrane bonding surface 11 and the second amniotic membrane bonding surface 21 form a surface contact with the amniotic membrane 200, and the amniotic membrane 200 is embedded and fixed between the first amniotic membrane bonding surface 11 and the second amniotic membrane bonding surface 21.

[0073] refer to Figure 1-2 and Figure 5-2Typically, the second fixation mechanism 2 is a ring-shaped structure with a bottom shape adapted to or capable of adapting to the dome structure. The center of the ring is the treatment window 10. The shapes of the first fixation mechanism 1 and the second fixation mechanism 2 are adapted to fix the amniotic membrane 200 between the first fixation mechanism 1 and the second fixation mechanism 2. The treatment window 10 provides space for the amniotic membrane 200, allowing it to adhere to the treatment site. Since the amniotic membrane 200 is a very thin amniotic membrane-like material, to ensure good fixation without causing accidental damage such as cutting, the first fixation mechanism 1 and the second fixation mechanism 2 form surface contact with the amniotic membrane 200. Because the bottom of the second fixation mechanism 2 has a shape adapted to the fornix or can adapt to the fornix structure, the non-invasive full fornix amniotic membrane fixation device 100, with the amniotic membrane 200 fixed, can be directly placed on the treatment site during clinical use. Since the bottom of the second fixation mechanism 2 has a shape adapted to the fornix or can adapt to the fornix structure, and the fornix is ​​an asymmetrical structure, the non-invasive full fornix amniotic membrane fixation device 100 will not shift. Furthermore, the non-invasive full fornix amniotic membrane fixation device 100 is typically made of a medical elastic material with a certain supporting force. Therefore, for areas that cannot be exposed, the non-invasive full fornix amniotic membrane fixation device 100 with the amniotic membrane 200 fixed can be moved to a location on the inner side of the eyelid that cannot be exposed, achieving positioning through the shape adaptation of the bottom of the second fixation mechanism 2. Because the non-invasive full fornix amniotic membrane fixation device 100 with the amniotic membrane 200 fixed can be placed at any position inside the eye as needed, a full fornix adaptation is achieved. Moreover, due to the supporting effect of the non-invasive full fornix amniotic membrane fixation device 100, adhesions between overlapping areas, such as the palpebral conjunctiva and the bulbar conjunctiva, can be effectively avoided.

[0074] The parts of the first fixation mechanism 1 and the second fixation mechanism 2 that come into contact with human tissue are both made of medical materials. Since the non-invasive total fornix amniotic membrane fixation device 100 requires continuous intraocular treatment, to ensure clinical safety during the treatment process, the parts of the first fixation mechanism 1 and the second fixation mechanism 2 that come into contact with human tissue are both made of medical materials.

[0075] The contact portions of the first fixation mechanism 1 or the second fixation mechanism 2 that come into contact with the moving tissue all have a smooth surface structure. Since there are multiple movable parts in the eyeball structure, such as the eyelids and the eyeball itself, the contact portions of the first fixation mechanism 1 or the second fixation mechanism 2 that come into contact with the moving tissue all have a smooth surface structure to avoid accidental injury during movement.

[0076] The connecting and fixing mechanism 3 is either a mechanical connecting and fixing mechanism 31 or a magnetic connecting and fixing mechanism 32. The applicant has only specifically illustrated the above two connection methods here. In practical applications, those skilled in the art can design different connection methods as needed. The applicant will not provide examples of each of these methods here, but none of them will depart from the protection scope of this application.

[0077] In this embodiment, the connecting and fixing mechanism 3 is a mechanical connecting and fixing mechanism 31, which adopts a concave-convex locking connection method. The first fixing mechanism 1 is provided with an annular groove 13, and the second fixing mechanism 2 is provided with an annular positioning protrusion 22. The annular positioning protrusion 22 and the annular groove 13 constitute the mechanical connecting and fixing mechanism 31. When pressed down, the annular positioning protrusion 22 is embedded in the annular groove 13. During the pressing process, the amnion 200 is stretched outward, and the amnion 200 is subjected to an outward radial stretching force. The amnion 200 is stretched and flattened outward along the first amnion bonding surface 11 and the second amnion bonding surface 21, and is embedded and fixed between the first amnion bonding surface 11 and the second amnion bonding surface 21. The mechanical connecting and fixing mechanism 31 also constitutes the amnion tensioning mechanism 4.

[0078] Simultaneously, the annular groove 13 forms an annular positioning ring 51, and the annular positioning protrusion 22 provided on the corresponding second fixing mechanism 2 forms a positioning protrusion 52. The two work together to form the positioning mechanism 5. The first fixing mechanism 1 and the second fixing mechanism 2 are in annular contact, and the annular positioning ring 51 presses on the positioning protrusion 52, thereby stretching and flattening the amnion 200 outward. The positioning mechanism 5 can also form the amnion tensioning mechanism 4.

[0079] The mechanical connection method using the convex and concave clips is simple to operate. The connection can be achieved with just a simple press. At the same time, during the pressing process, the amnion 200 can be stretched outward, tightened and flattened, so that the connection and tightening functions can be achieved in one action, which is very convenient for clinical use.

[0080] The non-invasive full-fornix amniotic membrane fixation device 100 further includes an amniotic membrane tensioning mechanism 4. This mechanism applies a radially outward stretching force to the amniotic membrane 200, causing it to stretch and flatten outward along the first amniotic membrane bonding surface 11 and the second amniotic membrane bonding surface 21, and then be flatly and securely embedded between them. Since wrinkles during the application of the amniotic membrane 200 can cause visual distortion and affect epithelial healing, the non-invasive full-fornix amniotic membrane fixation device 100 also includes the amniotic membrane tensioning mechanism 4. This mechanism stretches, tightens, and flattens the amniotic membrane 200 outward, providing a better clinical treatment outcome.

[0081] In this embodiment, the non-invasive full-fornix amniotic membrane fixation device 100 further includes a positioning mechanism 5. The positioning mechanism 5 can provide good guidance for the fitting process of the first fixation mechanism 1 and the second fixation mechanism 2.

[0082] The positioning mechanism 5 is an annular positioning ring 51 disposed on the first fixing mechanism 1 and / or the second fixing mechanism 2.

[0083] refer to Figure 1-2 and Figure 1-3 The first fixing mechanism 1 is provided with an annular positioning ring 51, and the corresponding second fixing mechanism 2 is provided with a positioning protrusion 52, thus forming the positioning mechanism 5. The first fixing mechanism 1 and the second fixing mechanism 2 are in annular contact, and the annular positioning ring 51 is pressed on the positioning protrusion 52, thereby stretching and flattening the amnion 200 outward. The positioning mechanism 5 can also form the amnion tensioning mechanism 4.

[0084] During production, the second fixing mechanism 2 of the whole plate is first placed horizontally on the table and positioned. Then, the amnion 200 is laid flat on the second fixing mechanism 2. The first fixing mechanism 1 of the whole plate is pressed down on the second fixing mechanism 2 to fix the amnion 200. Then, the non-invasive full fornix amnion fixation device 100 is divided and packaged one by one.

[0085] In clinical use, select the appropriate size of the non-invasive total fornix amniotic membrane fixation device 100 according to the size of the area to be repaired, and place the non-invasive total fornix amniotic membrane fixation device 100 on the area of ​​the eye requiring treatment with the second fixation mechanism 2 facing downwards. For unexposed treatment areas, adjust the position by grasping the edge of the non-invasive total fornix amniotic membrane fixation device 100 with medical forceps.

[0086] In this embodiment, the non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure and can be fixed at the treatment site. The amniotic membrane 200 is attached to the treatment site through the treatment window 10 for repair and treatment. Since the non-invasive full-fornix amniotic membrane fixation device 100 has a shape adapted to the fornix structure, it can be directly and non-invasively fixed at the treatment site to achieve full fornix adaptation.

[0087] Example 2: The non-invasive full-fornix amniotic membrane fixation device of this utility model with magnetic connection

[0088] refer to Figures 2 to 3-1 The difference between this embodiment and embodiment 1 is that in this embodiment, the connecting and fixing mechanism 3 is a magnetic connecting and fixing mechanism 32.

[0089] In this embodiment, the first fixing mechanism 1 is made of magnetic material, and the second fixing mechanism 2 is made of magnetic stainless steel. The amnion 200 is placed on the second fixing mechanism 2, and the first fixing mechanism 1 is brought close to the second fixing mechanism 2. Under magnetic attraction, the first fixing mechanism 1 and the second fixing mechanism 2 adhere to each other, and the amnion 200 is fixed between the first fixing mechanism 1 and the second fixing mechanism 2.

[0090] The magnetic material of the first fixation mechanism 1 is coated with medical material. To ensure the safety of the magnetic material in clinical use, the magnetic material of the fixation mechanism 1 is coated with medical material to ensure its biocompatibility during clinical use.

[0091] The medical material is medical-grade titanium, medical-grade titanium alloy, or medical-grade elastic material. The applicant has only listed these three types of medical materials here; those skilled in the art can select other medical materials to coat the magnetic material as needed.

[0092] The medical elastic material is medical-grade silicone rubber or thermoplastic polyurethane (TPU). Due to its flexibility, the medical elastic material can not only effectively encapsulate magnetic materials during use, but also provide better comfort, especially during eye movements.

[0093] refer to Figure 2 and Figure 3 In this embodiment, the magnetic material of the first fixing mechanism 1 is neodymium iron boron (NdFeB) powder material 32-1. In practical applications, the magnetic material of the first fixing mechanism 1 can also be neodymium iron boron (NdFeB) sheet material or filament material.

[0094] The second fixing mechanism 2 is a ring-shaped sheet structure made of magnetic stainless steel material or a ring-shaped sheet structure made of magnetic stainless steel wire.

[0095] refer to Figure 2 and Figure 2-1 The second fixing mechanism 2 is made of a ring-shaped thin-film magnetic stainless steel sheet 32-2, with the outer layer coated with a medical elastic material. The medical elastic material is medical silicone rubber or thermoplastic polyurethane (TPU). The ring-shaped thin-film magnetic material has excellent magnetic adsorption capabilities.

[0096] refer to Figure 3 and Figure 3-1 The second fixing mechanism 2 is made of a magnetic stainless steel ring 32-3 with an annular sheet structure made of magnetic stainless steel wire, and the outer layer is covered with medical elastic material. The wire can be wound into different shapes as needed, and it has good magnetic adsorption ability while also having better flexibility.

[0097] refer to Figures 2 to 3-1 An annular positioning ring 51 is provided on the first fixing mechanism 1. During the process of the first fixing mechanism 1 and the second fixing mechanism 2 being fitted together, the annular positioning ring 51 surrounds the second fixing mechanism 2 to achieve positioning.

[0098] The magnetic connection method allows for automatic bonding simply by bringing the first fixing mechanism 1 close to the second fixing mechanism 2, making the installation process very simple. Furthermore, the mutual attraction of the magnetic forces facilitates the alignment of the first fixing mechanism 1 and the second fixing mechanism 2. Simultaneously, since the first fixing mechanism 1 and the second fixing mechanism 2 are bonded in a ring shape, the amnion 200 is stretched and flattened outwards under the guidance of the positioning mechanism 5. The magnetic connection fixing mechanism 32 also simultaneously forms the amnion tensioning mechanism 4, making the fixing process of the amnion 200 very simple and convenient.

[0099] Example 3: Adaptive Non-invasive Full Fornix Amniotic Membrane Fixation Device of this Utility Model

[0100] refer to Figures 4 to 4-3 The difference between this embodiment and embodiment 1 is that in this embodiment, the second fixing mechanism 2 includes an adaptive mechanism 6.

[0101] In this embodiment, the adaptive mechanism 6 is a spiral spring 61 made of shape memory alloy. The spiral spring 61 is wound from a shape memory alloy with good elasticity, has excellent shape conformability, and can be customized into various spatial shapes and the shape of the treatment window 10 according to different dome structures, achieving excellent personalized customization.

[0102] refer to Figure 4-2 and Figure 4-3 The outer layer of the spiral spring 6 is wrapped with a soft, elastic medical material, such as medical silicone or medical TPU film, to increase comfort.

[0103] The upper part of the second fixing mechanism 2 is provided with an annular fixing groove 23. The first fixing mechanism 1 is a positioning wire / ring 14. The positioning wire / ring 14 is embedded in the annular fixing groove 23 to fix the amnion 200 and extend and flatten it outward.

[0104] This adaptive structure can be freely adapted to different dome contours, making it more adaptable in clinical use.

[0105] Example 4: Non-invasive amniotic membrane treatment device of this utility model

[0106] refer to Figures 5 to 8 The non-invasive amniotic membrane treatment device of this embodiment includes the non-invasive full fornix amniotic membrane fixation device 100 and the amniotic membrane 200.

[0107] The amnion 200 is fixed between the first fixing mechanism 1 and the second fixing mechanism 2.

[0108] refer to Figures 5 to 5-3 The first fixing mechanism 1 and the second fixing mechanism 2 are connected by mechanical fixing.

[0109] refer to Figures 6 to 7-1 The first fixing mechanism 1 and the second fixing mechanism 2 are connected by a magnetic connection.

[0110] refer to Figure 8 The second fixing mechanism 2 is provided with an adaptive mechanism 6.

[0111] Because the bottom of the second fixation mechanism 2 has a shape adapted to the dome or can adapt to the dome structure, and the dome shape is an asymmetrical structure, the non-invasive full-dome amniotic membrane fixation device 100 will not shift. Therefore, the non-invasive amniotic membrane treatment device 900 can be placed on the treatment site non-invasively, and the amniotic membrane 200 can be directly attached to the area requiring treatment through the treatment window 10 for repair and treatment. This avoids the damage caused by sutures in existing amniotic membrane repair, especially for patients who need to have their amniotic membrane replaced regularly for treatment. The non-invasive amniotic membrane treatment device 900 can effectively reduce the repeated suture trauma during long-term treatment.

[0112] It should be noted that the structures disclosed and described herein can be replaced by other structures with the same effect, and the embodiments described herein are not the only structures for implementing this utility model. Although preferred embodiments of this utility model have been described and illustrated herein, those skilled in the art will understand that these embodiments are merely illustrative, and those skilled in the art can make numerous variations, improvements, and substitutions without departing from this utility model. Therefore, the scope of protection of this utility model should be defined in accordance with the spirit and scope of the appended claims.

Claims

1. A non-invasive total fornix amniotic membrane fixation device, wherein the non-invasive total fornix amniotic membrane fixation device (100) comprises a first fixation mechanism (1), a second fixation mechanism (2), a connecting fixation mechanism (3), and a treatment window (10), characterized in that: A. The first fixing mechanism (1) is provided with a first amniotic membrane bonding surface (11), and the second fixing mechanism (2) is provided with a second amniotic membrane bonding surface (21); B. The connecting and fixing mechanism (3) is disposed on the first fixing mechanism (1) and / or the second fixing mechanism (2); the treatment window (10) is disposed on the first fixing mechanism (1) and / or the second fixing mechanism (2); C. The amniotic membrane (200) is placed between the first fixing mechanism (1) and the second fixing mechanism (2). When the connecting fixing mechanism (3) connects and fixes the first fixing mechanism (1) and the second fixing mechanism (2) into a whole, the first amniotic membrane contact surface (11) and the second amniotic membrane contact surface (21) form a surface contact with the amniotic membrane (200). The amniotic membrane (200) is fixed between the first fixing mechanism (1) and the second fixing mechanism (2). The amniotic membrane (200) is fixed by the connecting fixing mechanism (3) and covers the treatment window (10). D. The non-invasive full-fornix amniotic membrane fixation device (100) has a shape adapted to the fornix structure or can adapt to the fornix structure and can be fixed at the treatment site. The amniotic membrane (200) is attached to the treatment site through the treatment window (10) for repair and treatment. Since the non-invasive full-fornix amniotic membrane fixation device (100) has a shape adapted to the fornix structure, it can be directly and non-invasively fixed at the treatment site to achieve full fornix adaptation.

2. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The parts of the first fixation mechanism (1) and the second fixation mechanism (2) that come into contact with human tissue are made of medical materials.

3. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The contact portion of the first fixing mechanism (1) or the second fixing mechanism (2) that contacts the moving tissue adopts a smooth surface structure.

4. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The non-invasive full-fornix amniotic membrane fixation device (100) also includes an amniotic membrane tensioning mechanism (4), which can apply a radial stretching force outward from the plane to the amniotic membrane (200), so that the amniotic membrane (200) is stretched and flattened outward along the first amniotic membrane bonding surface (11) and the second amniotic membrane bonding surface (21), and is flatly embedded and fixed between the first amniotic membrane bonding surface (11) and the second amniotic membrane bonding surface (21).

5. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The connecting and fixing mechanism (3) is a mechanical connecting and fixing mechanism (31) or a magnetic connecting and fixing mechanism (32).

6. The non-invasive full-fornix amniotic membrane fixation device according to claim 5, characterized in that: The mechanical connection fixing mechanism (31) adopts a concave-convex snap-fit ​​connection method; the first fixing mechanism (1) is provided with an annular slot (13), and the second fixing mechanism (2) is provided with an annular positioning protrusion (22). The annular positioning protrusion (22) and the annular slot (13) constitute the mechanical connection fixing mechanism (31). When pressed down, the annular positioning protrusion (22) is embedded in the annular slot (13). During the pressing process, the amnion (200) is stretched outward. The amnion (200) is subjected to an outward radial stretching force. The amnion (200) is stretched and flattened outward along the first amnion bonding surface (11) and the second amnion bonding surface (21), and is embedded and fixed between the first amnion bonding surface (11) and the second amnion bonding surface (21). The mechanical connection fixing mechanism (31) also constitutes the amnion tensioning mechanism (4).

7. The non-invasive full-fornix amniotic membrane fixation device according to claim 5, characterized in that: The connecting and fixing mechanism (3) is a magnetic connecting and fixing mechanism (32); the first fixing mechanism (1) is made of magnetic material, and the second fixing mechanism (2) is made of magnetic stainless steel material. The amnion (200) is placed on the second fixing mechanism (2), and the first fixing mechanism (1) is brought close to the second fixing mechanism (2). Under the magnetic attraction, the first fixing mechanism (1) and the second fixing mechanism (2) are attached together, and the amnion (200) is fixed between the first fixing mechanism (1) and the second fixing mechanism (2).

8. The non-invasive full-fornix amniotic membrane fixation device according to claim 7, characterized in that: The magnetic material of the first fixing mechanism (1) is covered with medical material.

9. The non-invasive full-fornix amniotic membrane fixation device according to claim 8, characterized in that: The medical material is medical titanium, medical titanium alloy, or medical elastic material.

10. The non-invasive full-fornix amniotic membrane fixation device according to claim 9, characterized in that: The medical elastic material is medical silicone rubber or thermoplastic polyurethane (TPU).

11. The non-invasive full-fornix amniotic membrane fixation device according to claim 7, characterized in that: The magnetic material of the first fixing mechanism (1) is neodymium iron boron (NdFeB) sheet material, filament material and / or neodymium iron boron (NdFeB) powder material.

12. The non-invasive full-fornix amniotic membrane fixation device according to claim 7, characterized in that: The second fixing mechanism (2) is a ring-shaped sheet structure made of magnetic stainless steel material or a ring-shaped sheet structure made of magnetic stainless steel wire.

13. The non-invasive full-fornix amniotic membrane fixation device according to claim 7, characterized in that: The magnetic stainless steel material of the second fixing mechanism (2) is covered with a medical elastic material; the medical elastic material is medical silicone rubber or thermoplastic polyurethane (TPU).

14. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The second fixing mechanism (2) is made of elastic material and can deform under external force, thereby enabling it to adapt to the contour of the treatment site and to accommodate different treatment site shapes.

15. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The non-invasive full-fornix amniotic membrane fixation device (100) also includes a positioning mechanism (5).

16. The non-invasive full-fornix amniotic membrane fixation device according to claim 15, characterized in that: The positioning mechanism (5) is an annular positioning ring (51) disposed on the first fixing mechanism (1) and / or the second fixing mechanism (2).

17. The non-invasive full-fornix amniotic membrane fixation device according to claim 1, characterized in that: The second fixing mechanism (2) is provided with an adaptive mechanism (6), which enables the second fixing mechanism (2) to automatically adapt to the dome.

18. The non-invasive full-fornix amniotic membrane fixation device according to claim 17, characterized in that: The adaptive mechanism (6) is a spiral spring (61) made of shape memory alloy.

19. A non-invasive amniotic membrane treatment device, characterized in that: The non-invasive amniotic membrane treatment device (900) includes the non-invasive full fornix amniotic membrane fixation device (100) and amniotic membrane (200) as described in claim 1.

20. The non-invasive amniotic membrane treatment device according to claim 19, characterized in that: The amniotic membrane (200) is fixed between the first fixing mechanism (1) and the second fixing mechanism (2). The non-invasive amniotic membrane treatment device (900) is placed on the treatment site by non-invasive insertion. The amniotic membrane (200) is attached to the treatment site through the treatment window (10) for repair and treatment.

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