经皮器械件软组织固定罩材料制备及组织学评价

目的针对植入性经皮器件生物密封，采用在皮下安装软组织固定罩设计，对周围组织起固定作用，降低经皮密封部位软组织在界面处的应力，为生物密封提供条件。软组织固定罩材料及结构几何特征对于其周围软组织生长的影响与固定作用是应首先进行研究重要问题。方法本文选取了5种不同表面结构以及不同几何结构特征的样品植入动物皮下软组织，对植入后三个时间段的软组织的生长和表面结合情况进行观察和评价。结果纯钛表面等离子涂层处理明显较好．其次为阳极氧化处理、酸碱处理，及纯钛，较差的是超高分子量聚乙烯。孔间距对软组织在孔中的生长无明显影响。样品植入60d之内，孔径和孔深度对软组织的生长有一定的影响，但90d时，这种差别已明显减小。结论选取表面喷涂羟磷灰石涂层的钛为制作材料，90d为植入愈合期，作为用于经皮组织固定罩设计的重要参数。

Preparation and histologcal evaluation for soft tissue fixation flange applied to percutaneuos device

Objection A new design of soft tissue fixation flange was introduced to reduce the interfacial stress near seal,and provide favorable condition to biological sealing between the percutaneuos device(PD)and the soft tissue of body.It is an important problem to understand the tissue regeneration affected by the materials properties and dimension of fixation flange.Methods Five types of samples with different materials,different surface modifications,and construction dimension were implanted in the dorsal of animal.For three interesting period after implantation,relative histological evaluations of the tissue for samples were given.Results A more stable junction with soft tissue was formed for hydroxyapatite(HA) coating sprayed titanium,next to it were titanium treated by anodic oxidation,titanium by two-step chemical treatment and smoothed pure titanium.The unfavorable one was sample prepared by Ultra-high Molecular Weoght Polyethylene(UHMWPE).Distance between holes had little effect on the growth of connective tissue.Hole diameter and thickness functioned clearly only in 60 days after implanted,and the distinctive tissue.Hole diameter and thickness functioned clearly only in 60 days after implanted,and the distinction produced by them decreased dramatically after 90 day implanted.Condusion The parameter as the design of subcutaneous soft tissue fixation flange is as follows:pure titanium with HA coating as produce material,90 days as suitable for clinic cure.