Artificial biological valve and processing method thereof

Abstract

The invention provides an artificial biological valve and a processing method thereof. The processing method comprises the steps that the temperature of a cavity bearing the artificial biological valve is reduced to a second preset temperature from a first preset temperature at a first cooling rate, wherein the second preset temperature is higher than the crystallization temperature of the artificial biological valve, and the second preset temperature is a critical crystallization temperature; the temperature of the cavity bearing the artificial biological valve is reduced from the second preset temperature to a third preset temperature at a second cooling rate, wherein the third preset temperature is lower than the crystallization temperature of the artificial biological valve, and the second cooling rate is higher than the first cooling rate; and drying of the artificial biological valve is carried out. In this way, the artificial biological valve capable of being dried and stored can be provided.

Description

technical field [0001] The present application relates to the field of medical technology, in particular to an artificial biological valve and a processing method thereof. Background technique [0002] Heart valve disease is a kind of disease that endangers human health and life, seriously affecting the work and quality of life of patients. The traditional treatment plan is mainly surgical valve replacement in addition to conservative drug treatment. Although surgery can significantly improve the prognosis, elderly patients often have multiple diseases and poor cardiopulmonary function and cannot tolerate surgery that requires thoracotomy. Compared with surgery, the emerging transcatheter valve interventional therapy has less trauma to the human body, faster postoperative recovery, and has benefited many patients. [0003] Currently limited by the treatment methods, the bioprosthetic valve used in the transcatheter valve intervention system needs to be stored in a preserva...

AI Technical Summary

Problems solved by technology

[0006] 1. Some existing freeze-drying methods cannot uniformly and simultaneously freeze the entire biological tissue to be treated or various parts of the artificial biological valve, and will generate thermal stress inside the artificial biological valve during freezing, causing damage to the biological tissue;

[0007] 2. When some existing freeze-drying methods freeze the entire biological tissue or artificial biological valve to be treated, the crystallization rate of each part is different, resulting in different crystal sizes. On the one hand, large crystals are easy to damage the internal structure of the biological tissue, and on the other hand On the one hand, it will cause different sublimation rates of water in different parts during drying, and different degrees of drying. Insufficiently dried parts will have too much water remaining and are difficult to preserve, and excessively dried parts will affect the performance of biological tissues;

[0008] 3. Some existing freeze-drying methods do not have a good plan for the control of the sublimation drying process. They often rewarm to room temperature after a period of low-temperature drying. On the one hand, the residual free water content is not controlled when rewarming from low temperature , which will often cause damage to the tissue, and on the other hand, it will also cause excessive residual moisture after drying (for example, the residual moisture content in some programs is as high as 15% to 30%). Since water is the main participant in biochemical reactions, The higher the moisture content, the more unfavorable the long-term preservation of the artificial biological valve;

High concentrations of lyoprotectants are very toxic and will cause certain toxic damage to biological tissues; and in the subsequent drying process, a large amount of lyoprotectants will not be removed, and will concentrate and remain on biological tissues, reducing the Biocompatibility of biological tissue

[0010] In addition, for the postoperative thrombosis problem of interventional valves, oral anticoagulant therapy is currently the main treatment, and there is no suitable commercial product with a corresponding solution

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