CN-122005204-A - Frameless amniotic mirror device, manufacturing method and using method

Abstract

The invention relates to the technical field of medical equipment, in particular to a borderless amniotic mirror device, a manufacturing method and a using method thereof, wherein the device comprises an amniotic tissue layer and a biocompatible film layer formed by spraying a mixed solution of polymethyl acrylate and polyvinyl alcohol, the overall diameter of the device is 14mm, the sagittal height is 6.2+/-0.1 mm, and the device can be directly implanted into an ocular surface to cover a cornea without frame support. The preparation method comprises the steps of amniotic membrane treatment, model eye forming, mixed solution preparation, spray coating to form a membrane, trimming and sterilization. The application method relates to implantation, fitting observation and subsequent removal after surface anesthesia. The invention solves the problems of displacement of the prior framed amniotic mirror, strong foreign body sensation and incapability of wearing by patients with shallow conjunctiva sac through a frame-free conformal fitting design, and simultaneously avoids secondary wounds of suture operation. The residual membrane after the amniotic membrane is dissolved can continuously provide protection, and has the advantages of good fit, high comfort level for patients, simple and convenient operation and good safety.

Inventors

• ZHANG CHENMING

Assignees

• 济南市第二人民医院(济南市眼科医院、济南市眼视光医院)

Dates

Publication Date

20260512

Application Date

20260327

Claims (7)

1. 1. The frameless amniotic mirror device is characterized by comprising an amniotic tissue layer and a film layer; an amniotic tissue layer covering the surface of the model eye for shaping; The membrane layer formed by the mixed solution of polymethyl acrylate and polyvinyl alcohol is sprayed on the surface of the amniotic membrane tissue layer; The amniotic membrane device can be directly implanted into conjunctival sac to cover cornea without frame support, and residual biocompatible film layer after amniotic membrane dissolution still has a protective effect.
2. 2. The borderless amniotic mirror device of claim 1 wherein the device has an overall diameter of 14mm and a sagittal height of 6.2+ -0.1 mm and the amniotic tissue layer is fresh amniotic membrane or bioengineered amniotic membrane treated within 6 hours of separation.
3. 3. A method for manufacturing a borderless amniotic mirror device as defined in any one of claims 1 to 2, comprising the steps of: firstly, obtaining fresh amniotic membrane tissue, and cleaning chorion and asepsis in an environment of 4 ℃ within 6 hours from the body; Step two, covering the treated amniotic membrane tissue on the surface of the model eye; step three, preparing a mixed solution containing polymethyl acrylate and polyvinyl alcohol, Spraying the mixed solution on the surface of the amniotic membrane tissue to form a composite layer with tension; trimming the periphery of the amniotic tissue to form a circular arc-shaped frameless amniotic mirror with the diameter of 14mm and the sagittal height of 6.2+/-0.1 mm; and step six, the obtained amnioscope is stored in a preservation solution at the temperature of-20 ℃ for freezing and is sterilized by cobalt 60 radiation.
4. 4. The method of manufacturing a polymer electrolyte according to claim 3, wherein the low molecular weight polymethyl acrylate is added to the physiological saline at a ratio of 30% by weight to form an emulsion, the polyvinyl alcohol is dissolved in the physiological saline at a ratio of 4% by weight, and the two solutions are mixed to obtain a final concentration of 1% by weight of polymethyl acrylate in the mixture.
5. 5. A method of using the rimless amniotic mirror device according to any one of claims 1 to 2, comprising the steps of: step one, carrying out surface anesthesia on the ocular surface of a patient; step two, an eyelid opener is used for opening the eyelid, and the surface of the amniotic membrane is washed by sterile normal saline; Step three, clamping the edge of the amniotic membrane mirror by using ophthalmic forceps, and implanting a conjunctival sac to cover the cornea; Step four, lightly closing eyes and rotating eyeballs to enable the amniotic membrane mirror to be attached to the ocular surface; step five, observing the fitting condition through a slit lamp; And step six, directly taking out the residual film after the cornea epithelium is repaired or the amniotic membrane is dissolved.
6. 6. The method of claim 5, wherein the topical anesthetic is oxybuprocaine hydrochloride eye drops.
7. 7. The method of claim 5, wherein the amniotic mirror is removed after the corneal epithelium has been completely repaired or the amniotic membrane has been dissolved.

Description

Frameless amniotic mirror device, manufacturing method and using method Technical Field The invention relates to the technical field of ophthalmic medical equipment, in particular to a borderless amniotic mirror device, a manufacturing method and a using method. Background Corneal damage is a common ophthalmic disease, and amniotic membrane transplantation is an effective means for promoting corneal epithelial repair and anti-scarring. The form of amniotic membrane currently in clinical use mainly comprises self-contained fresh amniotic membrane, monolithic biological amniotic membrane (dry/wet state) and biological amniotic membrane with frame support device (such as PROKERA in U.S.). However, the prior art has obvious defects: 1. The self-contained fresh amniotic membrane has the problems of limited sources, cross infection risks and legal ethics; 2. The single biological amniotic membrane needs to be sutured and fixed, so that secondary operation wound, strong foreign body sensation and inflammatory reaction of a patient are caused, and the in-situ time of the amniotic membrane is shortened; 3. although the operation is simplified by the biological amniotic membrane (suture-free) with the frame support device, the hard frame of the biological amniotic membrane can cause displacement and poor following performance of the device, is not applicable to patients with shallow conjunctiva sac, and has the risks of foreign body sensation and cornea scratch during taking out. Accordingly, there is a strong need in the art for an ocular surface repair device that retains the biological activity of the amniotic membrane while avoiding the drawbacks of suturing and frames. Disclosure of Invention Aiming at the defects of the prior art, the invention provides a frameless amniotic mirror device, a manufacturing method and a using method thereof, the device does not need to be sewed and has no hard frame, can be closely adhered to an ocular surface, and can still provide continuous protection after the amniotic membrane is dissolved, thereby improving the comfort level of patients, simplifying clinical operation and improving the treatment effect. The invention is realized by the following technical scheme: a borderless amniotic mirror device comprises an amniotic tissue layer and a membrane layer; an amniotic tissue layer covering the surface of the model eye for shaping; The membrane layer formed by the mixed solution of polymethyl acrylate and polyvinyl alcohol is sprayed on the surface of the amniotic membrane tissue layer; the amniotic membrane device can be directly implanted into conjunctival sac to cover cornea without frame support, and residual biocompatible film layer after amniotic membrane dissolution still has a protective effect. Preferably, the whole diameter of the device is 14mm, the sagittal height is 6.2+/-0.1 mm, and the amniotic tissue layer is fresh amniotic membrane or bioengineered amniotic membrane treated in 6 hours from the body. A method of manufacturing a borderless amniotic mirror device comprising the steps of: firstly, obtaining fresh amniotic membrane tissue, and cleaning chorion and asepsis in an environment of 4 ℃ within 6 hours from the body; Step two, covering the treated amniotic membrane tissue on the surface of the model eye; step three, preparing a mixed solution containing polymethyl acrylate and polyvinyl alcohol, Spraying the mixed solution on the surface of the amniotic membrane tissue to form a composite layer with tension; trimming the periphery of the amniotic tissue to form a circular arc-shaped frameless amniotic mirror with the diameter of 14mm and the sagittal height of 6.2+/-0.1 mm; and step six, storing the obtained amnioscope in a preservation solution at-20 ℃ and performing cobalt 60 radiation sterilization. Further preferably, the method for preparing the mixed solution comprises adding 30% by weight of low molecular weight polymethyl acrylate into physiological saline to form emulsion, adding 4% by weight of polyvinyl alcohol into physiological saline to dissolve, and mixing the two solutions to make the final concentration of polymethyl acrylate in the mixed solution be 1% by weight. The application method of the frameless amniotic mirror device comprises the following steps: step one, carrying out surface anesthesia on the ocular surface of a patient; step two, an eyelid opener is used for opening the eyelid, and the surface of the amniotic membrane is washed by sterile normal saline; Step three, clamping the edge of the amniotic membrane mirror by using ophthalmic forceps, and implanting a conjunctival sac to cover the cornea; Step four, lightly closing eyes and rotating eyeballs to enable the amniotic membrane mirror to be attached to the ocular surface; step five, observing the fitting condition through a slit lamp; And step six, directly taking out the residual film after the cornea epithelium is repaired or the amniotic membrane is dissolved. Further pre