Integrated preassembled amniotic membrane supporting device for ocular surface reconstruction in acute stage

Abstract

The invention discloses an integrated pre-assembled amniotic membrane support device for ocular surface reconstruction in an acute stage, which comprises an amniotic membrane body arranged at the inner side end of a conjunctival sac support ring, and a prefabricated through hole is formed in the middle of the inner side of the conjunctival sac support ring in a penetrating manner; the first silica gel cerclage belt is mounted in the first prefabricated groove, and a second prefabricated groove is formed in the upper end of the outer wall; the second silica gel cerclage band is arranged in the second prefabricated groove and located in the outer wall of the conjunctival sac supporting ring. The invention belongs to the technical field of ophthalmology medical consumables, and aims to solve the problems that in the prior art, surgical implantation is needed, the conjunctival sac supporting effect is poor, and the palpebral adhesion risk is large. The full-conjunctival sac support device has the advantages that the whole device can be comfortably placed on the ocular surface, the full-conjunctival sac is supported, the effect of repairing and reconstructing the whole ocular surface is conveniently achieved, and inflammation and pain possibly caused by the inflammation are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of ophthalmic medical consumables, and in particular to an integrated preassembled amniotic membrane support device for acute ocular surface reconstruction. Background Art

[0002] Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and chemical burns of the eye all carry the risk of serious ocular surface damage. The global incidence of SJS and TEN in children is about 2-2.5 cases per million people per year. Among them, the proportion of eye involvement in acute-stage SJS / TEN children is as high as 60%-100%. Such diseases are dangerous and can rapidly progress to complete corneal epithelial detachment in a short period of time, accompanied by severe pain. In severe cases, corneal dissolution and perforation may occur. If the acute stage is not properly handled, severe symblepharon, corneal conjunctivalization, severe dry eyes, and complete corneal opacity may occur in the late stage, causing irreversible vision loss. For the above diseases with a high risk of blindness, timely and reasonable treatment should be given in the acute stage, and the ocular surface should be actively reconstructed, otherwise the children will face lifelong vision defects and serious life troubles.

[0003] As a new type of biomaterial, amniotic membrane contains a variety of growth factors, anti-inflammatory factors, protease inhibitors, etc. It is avascular and has low immunogenicity. It can promote the repair of corneal and conjunctival epithelium, inhibit inflammation, scarring and neovascularization. In the acute stage, the amniotic membrane material is used to cover the affected area of ​​the ocular surface as early as possible, which can significantly reduce the patient's long-term complications. However, the current surgical method is to suture and fix the amniotic membrane to the corneal and conjunctival surface under local anesthesia within one week of onset. However, these patients often have severe systemic conditions in the early stage and have respiratory and pulmonary complications. They are unable to enter the operating room for surgery under a microscope and can only choose bedside surgery. This is especially true for pediatric patients, as local surgery is simply not possible. Suturing surgery is performed under anesthesia. The amniotic membrane is thin and soft. If you are not careful, it will be torn and broken during the operation, and it cannot effectively cover the ocular surface tissue. In addition, this type of disease often causes conjunctival pseudomembrane in the acute stage, and secondary adhesions and continuous conjunctival sac narrowing. Continuous adhesion separation is required, which is very painful for patients. Once adhesions are formed, subsequent treatment is very difficult. Therefore, it is necessary to implant a hard conjunctival sac support device in the early stage to avoid conjunctival sac narrowing and blepharobulbar adhesion. At the same time, the amniotic membrane coverage area is increased so that the amniotic membrane widely covers the cornea, bulbar conjunctiva, fornix conjunctiva, palpebral conjunctiva and eyelid margin, which can achieve full ocular surface repair and reconstruction, and inhibit the occurrence of blepharobulbar adhesion and conjunctival sac narrowing.

[0004] However, most of the current conjunctival sac support devices require surgical implantation, and the size of the amniotic membrane can only cover the cornea and bulbar conjunctiva. When in use, multiple pieces of amniotic membrane need to be sutured and fixed separately to achieve full ocular surface coverage. However, during bedside operations in the acute phase, the number of operating steps is increased, the surgical operation time is prolonged, and the fixation effect on the amniotic membrane itself is poor, and the amniotic membrane itself is prone to falling off after surgery. Summary of the invention

[0005] To this end, the present invention provides an integrated pre-assembled amniotic membrane support device for acute ocular surface reconstruction to solve the above-mentioned problems in the prior art.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] According to a first aspect of the present invention, an integrated preassembled amniotic membrane support device for acute ocular surface reconstruction comprises:

[0008] The amniotic membrane body is arranged at the inner end of the conjunctival sac support ring, and a prefabricated through hole is opened through the inner middle part of the conjunctival sac support ring, and a first prefabricated groove is opened at the lower end of the outer wall of the conjunctival sac support ring;

[0009] A first silicone ring tie is installed inside the first prefabricated groove, and a second prefabricated groove is formed at the upper end of the outer wall;

[0010] The second silicone ring ligature is arranged inside the second prefabricated groove and located in the outer wall of the conjunctival sac support ring.

[0011] Furthermore, the lower edge of the amniotic membrane body is folded and located at the outer end of the conjunctival sac support ring, and the wall thickness of the conjunctival sac support ring is 1.5 mm.

[0012] Furthermore, the conjunctival sac support ring is a single-piece arched ring structure made according to the conjunctival sac space and the curvature of the sclera there, and the conjunctival sac support ring is made of polymethyl methacrylate.

[0013] Furthermore, the conjunctival sac support ring is relatively narrow in width at the top, bottom and inside, and relatively long at the nasal side, with the top and bottom ring widths being 3mm, the inside ring width being 3mm, and the nasal ring width being 3mm.

[0014] Furthermore, the conjunctival sac support ring is longer in the direction parallel to the line connecting the inner and outer canthus, and shorter in the direction perpendicular to the line connecting the inner and outer canthus, with an inner diameter of 15 mm long and 13 mm wide, and an outer diameter of 25 mm long and 21 mm wide.

[0015] Furthermore, the amniotic membrane body is a wet biological amniotic membrane with a diamond design of 75mm*30mm, and the outer side of the amniotic membrane body is respectively connected to the first silicone cerclage band and the second silicone cerclage band.

[0016] Furthermore, a preset groove is formed on the inner side wall of the conjunctival sac support ring, and the lower end of the preset groove extends to the bottom of the conjunctival sac support ring.

[0017] The present invention has the following advantages:

[0018] 1. Through the conjunctival sac support ring and the amniotic membrane body, the treatment surface of the amniotic membrane body can be attached to the eyelid conjunctiva after being folded, so as to achieve the effect of repairing and reconstructing the entire ocular surface, reduce the occurrence of inflammation and the pain that may be caused by inflammation, inhibit scar formation, promote epithelial repair and tissue regeneration, and the conjunctival sac support ring can effectively support the fornix conjunctiva, avoid eyelid adhesion, reduce corneal epithelial detachment caused by blinking friction, and provide a protective environment;

[0019] 2. The conjunctival sac support ring is made of polymethyl methacrylate polymer material, and the conjunctival sac support ring is a single-piece arch ring structure made according to the conjunctival sac space and the curvature of the sclera here. The conjunctival sac support ring is used to support and fix the amniotic membrane body so that it can be comfortably placed on the ocular surface and support the entire conjunctival sac;

[0020] 3. Through the second silicone cerclage, the second silicone cerclage is tied and fixed to the outer side of the upper edge of the amniotic membrane body, and is engaged in the second prefabricated groove, so as to fix the amniotic membrane body again, further prevent the amniotic membrane body from falling off, and improve the overall wearing effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A front cross-sectional view of an integrated preassembled amniotic membrane support device for acute ocular surface reconstruction provided in some embodiments of the present invention.

[0022] Figure 2 A front cross-sectional view of the connection between the conjunctival sac support ring and the prefabricated through hole of an integrated preassembled amniotic membrane support device for acute ocular surface reconstruction provided in some embodiments of the present invention.

[0023] Figure 3 A front view of the connection between the conjunctival sac support ring and the first silicone cerclage band of the integrated preassembled amniotic membrane support device for acute ocular surface reconstruction provided in some embodiments of the present invention.

[0024] Figure 4 A top view of an integrated preassembled amniotic membrane support device for acute ocular surface reconstruction provided in some embodiments of the present invention.

[0025] Figure 5 An integrated preassembled amniotic membrane support device for acute ocular surface reconstruction provided by some embodiments of the present invention Figure 1 Enlarged view of point A in the middle.

[0026] In the figure: 1. conjunctival sac support ring; 2. amniotic membrane body; 3. prefabricated through hole; 4. first prefabricated groove; 5. second prefabricated groove; 6. first silicone cerclage; 7. preset groove; 8. second silicone cerclage. DETAILED DESCRIPTION

[0027] The following is a description of the implementation of the present invention by specific embodiments. People familiar with the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0028] Example 1

[0029] like Figures 1 to 5 As shown, the integrated preassembled amniotic membrane support device for acute ocular surface reconstruction in the embodiment of the first aspect of the present invention comprises: the amniotic membrane body 2 is arranged at the inner end of the conjunctival sac support ring 1, and a prefabricated through hole 3 is penetrated through the inner middle part of the conjunctival sac support ring 1, the conjunctival sac support ring 1 is made of polymethyl methacrylate PMMA polymer material, and the conjunctival sac support ring 1 is a single-piece arch ring structure made according to the conjunctival sac space and the curvature of the sclera there, the conjunctival sac support ring 1 is hollowed out in the middle under the action of the prefabricated through hole 3, which is convenient to wear, and the wall thickness of the conjunctival sac support ring 1 is 1.5 mm, It is relatively long in the direction parallel to the line connecting the inner and outer canthus, and relatively short in the direction perpendicular to the line connecting the inner and outer canthus. The inner diameter is 15mm long and 13mm wide, and the outer diameter is 25mm long and 21mm wide. The width of the conjunctival sac support ring 1 is relatively narrow at the upper, lower and temporal sides, and relatively long at the nasal side. The width of the upper and lower rings is 3mm, the width of the temporal rings is 3mm, and the width of the nasal rings is 3mm. The conjunctival sac support ring 1 is used to support and fix the amniotic membrane body 2 so that it can be comfortably placed on the ocular surface and support the entire conjunctival sac. The amniotic membrane body 2 is a frozen and preserved 75mm*30mm diamond-shaped wet biological amniotic membrane, which has the characteristics of anti-inflammatory, anti-scarring and promoting healing.

[0030] The lower edge of the amniotic membrane body 2 is folded and located at the outer end of the conjunctival sac support ring 1. During implantation, the clinician, under surface anesthesia, takes out the sterile product without suturing, places the amniotic membrane material against the patient's cornea with the surface facing upward, and places the conjunctival sac support ring 1 onto the patient's ocular surface. At this time, the amniotic membrane body 2 is tightly attached to the patient's ocular surface under the action of the conjunctival sac support ring 1, and the amniotic membrane body 2 is spread on the concave surface of the conjunctival sac support ring 1. The tail end of the amniotic membrane body 2 is lightly clamped to move the amniotic membrane body 2 located at the edges of the lower end of the conjunctival sac support ring 1 along The bottom edge of the conjunctival sac support ring 1 is folded to check whether there are wrinkles on the amniotic membrane body 2 and whether there are bubbles under the amniotic membrane body 2 that do not fully cover the eye surface. After the amniotic membrane body 2 is folded, the treatment surface can be attached to the eyelid conjunctiva, which is convenient for achieving the effect of repairing and reconstructing the entire eye surface, reducing the occurrence of inflammation and the pain that may be caused by inflammation, inhibiting scar formation, and promoting epithelial repair and tissue regeneration. The conjunctival sac support ring 1 can effectively support the descending conjunctiva, avoid eyelid adhesion, reduce corneal epithelial detachment caused by blinking friction, and provide a protective environment;

[0031] A first prefabricated groove 4 is provided in the middle of the outer side of the conjunctival sac support ring 1, and a first silicone ring ligature 6 is installed inside the first prefabricated groove 4. The height of the first prefabricated groove 4 is 2 mm, and the depth is 1 mm. The first silicone ring ligature 6 is made of a highly elastic silicone material with a thickness of 1 mm and a width of 2 mm. The folded amniotic membrane body 2 is fixed in a bundled manner and engaged in the first prefabricated groove 4 by the first silicone ring ligature 6. At this time, the first silicone ring ligature 6 has a good fixing effect on the amniotic membrane body 2, which can effectively prevent the amniotic membrane body 2 from falling off. At the same time, a second prefabricated groove 4 is provided on the upper end of the outer wall of the conjunctival sac support ring 1. Preformed groove 5, the second silicone cerclage 8 is arranged inside the second preformed groove 5 and is located in the outer wall of the conjunctival sac support ring 1, the second silicone cerclage 8 is adapted to the size of the second preformed groove 5, the folded amniotic membrane body 2 is in contact with the outer wall of the conjunctival sac support ring 1, and the amniotic membrane body 2 is located outside the second preformed groove 5, at this time, the second silicone cerclage 8 can be tied and fixed to the outside of the upper edge of the amniotic membrane body 2, and snapped into the second preformed groove 5, so as to fix the amniotic membrane body 2 again, further prevent the amniotic membrane body 2 from falling off, and improve the overall wearing effect;

[0032] A preset groove 7 is provided on the lower side of the rear end of the conjunctival sac support ring 1, and the lower end of the preset groove 7 extends to the bottom of the conjunctival sac support ring 1. The preset groove 7 can drain the fluid accumulated on the ocular surface, and the accumulated fluid can be discharged from the preset groove 7 by directly squeezing the amniotic membrane body 2.

Claims

1. An integrated preassembled amniotic membrane support device for acute ocular surface reconstruction, characterized in that: include: An amniotic membrane body (2) is arranged at the inner end of the conjunctival sac support ring (1), and a prefabricated through hole (3) is provided through the inner middle part of the conjunctival sac support ring (1), and a first prefabricated groove (4) is provided at the lower end of the outer wall of the conjunctival sac support ring (1); A first silicone ring band (6) is installed inside the first prefabricated groove (4), and a second prefabricated groove (5) is provided at the upper end of the outer wall of the (1); The second silicone ring band (8) is arranged inside the second prefabricated groove (5) and is located in the outer wall of the conjunctival sac support ring (1).

2. The integrated preassembled amniotic membrane support device for acute ocular surface reconstruction according to claim 1, characterized in that: The lower edge of the amniotic membrane body (2) is folded and located at the outer end of the conjunctival sac support ring (1), and the wall thickness of the conjunctival sac support ring (1) is 1.5 mm.

3. The integrated preassembled amniotic membrane support device for acute ocular surface reconstruction according to claim 2, characterized in that: The conjunctival sac support ring (1) is a single-piece arched ring structure made according to the conjunctival sac space and the curvature of the sclera there, and the conjunctival sac support ring (1) is made of polymethyl methacrylate.

4. The integrated preassembled amniotic membrane support device for acute ocular surface reconstruction according to claim 3, characterized in that: The conjunctival sac support ring (1) is relatively narrow in width at the top, bottom and inside, and relatively long at the nose side. The width of the ring at the top and bottom is 3 mm, the width of the ring at the inside is 3 mm, and the width of the ring at the nose side is 3 mm.

5. The integrated preassembled amniotic membrane support device for acute ocular surface reconstruction according to claim 4, characterized in that: The conjunctival sac support ring (1) is relatively long in the direction parallel to the line connecting the inner and outer canthus, and relatively short in the direction perpendicular to the line connecting the inner and outer canthus, with an inner diameter of 15 mm long and 13 mm wide, and an outer diameter of 25 mm long and 21 mm wide.

6. The integrated preassembled amniotic membrane support device for acute ocular surface reconstruction according to claim 1, characterized in that: The amniotic membrane body (2) is a wet biological amniotic membrane with a diamond-shaped design of 75 mm*30 mm, and the outer side of the amniotic membrane body (2) is respectively connected to the first silicone cerclage band (6) and the second silicone cerclage band (8).

7. The integrated preassembled amniotic membrane support for acute ocular surface reconstruction according to claim 5 The device is characterized in that The inner wall of the conjunctival sac support ring (1) is provided with a preset groove (7). Furthermore, the lower end of the preset groove (7) extends to the bottom of the conjunctival sac support ring (1).

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