Biological membrane for treating glaucoma and preparation method thereof

Abstract

The invention discloses a biological membrane for treating glaucoma and a preparation method thereof. The biological membrane is prepared by the following steps: soaking a sheep membrane in a high molecular polysaccharide water solution to thicken the sheep membrane, and then sterilizing the sheep membrane by radiation at a temperature of -16 to -4 DEG C; wherein the thickness of the biological membrane is 0.2 to 0.5 mm. In the preparation method, the thick sheep membrane around the umbilical cord is taken as the raw material, and the biological membrane is prepared through steps of rapid material obtaining, punching and cutting, composite thickening, and radiation sterilization. The provided biological membrane and preparation method have the following advantages: (1) various natural active components such as collagen, growth factors, anti-inflammation factors, and the like, in sheep membrane can be effectively preserved; (2) the bioactivity of the biological membrane is the same as that of fresh sheep membrane; (3) the clinical safety is greatly improved; (4) the thickness and degrading property of the biological membrane can meet the requirements on materials used for sclera subvalvular filling in glaucoma treatment, and the biological membrane can prevent synechia in the early stage after the operation and inhibit the formation of scars in the later period.

Description

【Technical field】 [0001] The invention relates to the field of medical appliances, in particular to the technical field of tissue engineering Chinese medical biomaterials, in particular to a biofilm for glaucoma treatment and a preparation method thereof. 【Background technique】 [0002] Glaucoma is currently the second leading cause of blindness in the world, and the most commonly used surgical treatment is filtering surgery, but postoperative scarring of the filtering tract is often the main reason for surgical failure. There is no stable and good solution to this international problem. At present, there are glaucoma drainage devices with holes in sheet shape prepared by polymer materials such as polyethylene, polypropylene, polytetrafluoroethylene, or metal magnetic materials (such as the publication number is Chinese patent CN1337212A Chinese patent application, and the Chinese patent publication number is The Chinese patent application of CN103732182A, Chinese patent pu...

AI Technical Summary

Problems solved by technology

However, these two amniotic membranes have not been terminally sterilized and virus inactivated, so they cannot meet the sterility standard of implantable medical devices and may have hidden dangers of viruses

Therefore, in recent years, a variety of terminally sterilized amniotic membrane products have been successfully developed at home and abroad, but the content of amnion factor after more process steps is greatly lost, the biological activity of amnion is reduced, and it cannot play the equivalent role of fresh amnion or refrigerated amnion; and The current amniotic membrane product type is single-layer amniotic membrane, and the thickness of the product is relatively thin (0.005-0.05mm). When used in glaucoma filtration surgery, it cannot play a suitable supporting space role, degrades quickly, and has a limited maintenance time.

[0005] The amniotic membrane products disclosed in the U.S. patent applications with publication numbers US006152142A and US006326019B1 are cesarean section placenta bluntly separated to remove the chorion after cleaning, and the epithelium is spread upwards on nitrocellulose filter paper, and then stored in DMEM:glycerol at a ratio of 1:1 , stored in a -80°C refrigerator, the prepared amnion has not been decellularized, dried and sterilized, so the integrity of the composition and structure of the amnion is preserved to the greatest extent; but the existing problems are: ①The preservation cost is too high , and it is inconvenient to transport; ②It has been frozen at low temperature during storage, and needs to be thawed at room temperature when it is used. These two processes will cause damage to the structure of amnion collagen and become brittle; At the bottom, the amnion needs to be torn off during use, which makes the already fragile amnion more likely to tear or curl, which brings a lot of inconvenience to clinical operations;

The disadvantage of this technology is that the storage condition of glue-linked amniotic membrane is 0-6°C, and it is difficult to maintain the activity of amniotic membrane for a long time. The storage time of foreign refrigerated amniotic membrane product AmnioGraft at this temperature is only 3 months.

In addition, the gel-linked amniotic membrane prepared by this technology has not been terminally sterilized, which cannot ensure the sterility level of the product and the virus inactivation effect, which has potential safety hazards.

[0008] The Chinese patent application with the publication number CN1088118A discloses a preparation method of a medical wound protection film. After the amniotic membrane is processed in multiple steps, the multi-layer amniotic membrane is compounded and dried to prepare a multi-layer amniotic membrane. The technical disadvantages are many The step-by-step treatment causes the active components of the amnion to be greatly reduced, and the drying step also further reduces the activity of the amnion factor, which cannot guarantee that the final product can still exert the natural biological activity of the amnion

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