Biological patch for posterior scleral reinforcement surgery and preparation method thereof

Abstract

The invention relates to a biological patch for a posterior scleral reinforcement surgery and a preparation method thereof. According to the invention, the pericardium meridian of the heterogeneous animal cattle, horses and pigs is subjected to impurity removal, and then steps of degreasing, decellularization, fibers combing, thinning, thickening, cross-linking, forming, packaging and sterilization are carried out, the pericardial thickness tends to be consistent at a maximum degree, the material tensile elongation is controlled, its biomechanics is improved, the biocompatibility is improved,the anti-degradation ability of the material is enhanced, and the biological patch for the posterior scleral reinforcement surgery is obtained. The method can greatly provide the available area of a pericardial material, improves the qualified rate of the patch, and reduces the production cost. The biological patch is purple-blue, and spherical fusiform-shaped, the spherical surface radius is greater than 12.0 mm, a fixed tensile rate is less than or equal to 3%, a water content is greater than 300%, a thickness is 0.10 to 0.65 mm, a length is 28 to 55 mm, and a width is 8 to 18 mm. The biological patch is reliable and effective for treating high myopia and retinal detachment and macular retinoschisis due to high myopia, ending its development, and restoring vision.

Description

technical field [0001] The invention relates to an ophthalmic medical device, in particular to a biological patch for posterior sclera reinforcement for treating pathological high myopia and a production method thereof. Background technique [0002] Due to genetic and microenvironmental infection factors, the thickness of the posterior sclera is thinned and the strength is weakened, resulting in continuous expansion. The continuous extension of the eye axis is manifested by the continuous increase of negative diopters and the progressive aggravation of high myopia; the continuous expansion of the posterior sclera can also It leads to retinal detachment, and as the course of the disease progresses, most patients become blind due to fundus lesions in adulthood. According to statistics, the incidence of myopia among Chinese students at different stages of elementary school, middle school, and university is 30%, 50%, and 70%, respectively, and 3-5% of them have pathological high...

AI Technical Summary

Problems solved by technology

It shows that the unsatisfactory long-term curative effect of posterior scleral reinforcement in clinical practice is probably caused by the increase of tensile elongation rate caused by the degradation of the patch.

[0008] Chinese patent CN 102525729 B discloses a technical scheme for preparing a biological patch for scleral reinforcement of the human eye from the pericardium or dura mater of cattle, horses, and pigs. The dura mater of the animal is uneven and uneven in thickness like walnut skin , the blood vessels are distributed like veins, it is difficult to find a suitable surface area for surgery, and the success rate of the patch is extremely low;

The toughness, mechanical strength and degradation resistance of the cross-linked biofilm material are related to the degree of cross-linking. With the increase of the degree of cross-linking, the toughness, mechanical strength and degradation resistance increase, but as the hardness of the material increases decreased compliance

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