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首页> 美国卫生研究院文献>European Spine Journal >In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study
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In vivo biostability of polymeric spine implants: retrieval analyses from a United States investigational device exemption study

机译：聚合物脊柱植入物的体内生物稳定性：来自美国研究器械豁免研究的检索分析

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The Dynesys System for stabilizing the lumbar spine was first surgically implanted in Europe in 1994. In 2003, a prospective, randomized, investigational device exemption clinical trial of the system for non-fusion dynamic stabilization began. Polycarbonate urethane (PCU) and polyethylene terephthalate (PET) components explanted from four patients who had participated in the study were analyzed for biostability. Components had been implanted 9–19 months. The explanted components were visually inspected and digitally photographed. Scanning electron microscopy was used to analyze the surface of the spacers. The chemical and molecular properties of the retrieved spacers and cords were quantitatively compared with lot-matched, shelf-aged, components that had not been implanted using attenuated total reflection Fourier transform infrared (FTIR) and gel permeation chromatography (GPC). FTIR analyses suggested that the explanted spacers exhibited slight surface chemical changes but were chemically unchanged below the surface and in the center. New peaks that could be attributed to biodegradation of PCU were not observed. The spectral analyses for the cords revealed that the PET cords were chemically unchanged at both the surface and the interior. Peaks associated with the PET biodegradation were not detected. GPC results did not identify changes to the distributions of molecular weights that might be attributed to biodegradation of either PCU spacers or PET cords. The explanted condition of the retrieved components demonstrated the biostability of both PCU spacers and PET cords that had been in vivo for up to 19 months.
机译：用于稳定腰椎的Dynesys系统于1994年在欧洲首次通过外科手术植入。2003年，一项针对非融合动态稳定系统的前瞻性，随机，研究性装置豁免临床试验开始。从参加研究的四名患者中移植出的聚碳酸酯尿烷（PCU）和聚对苯二甲酸乙二酯（PET）成分进行了生物稳定性分析。组件已植入9-19个月。目测检查外植成分并进行数码照相。使用扫描电子显微镜分析间隔物的表面。将回收的间隔物和帘线的化学和分子性质与未使用衰减全反射傅里叶变换红外光谱（FTIR）和凝胶渗透色谱法（GPC）植入的大量匹配，货架期的组件进行了定量比较。 FTIR分析表明，外植的垫片显示出轻微的表面化学变化，但在表面下方和中央化学不变。没有观察到可能归因于PCU生物降解的新峰。帘线的光谱分析表明，PET帘线的表面和内部在化学上均未改变。未检测到与PET生物降解相关的峰。 GPC结果未能确定分子量分布的变化，这可能归因于PCU垫片或PET帘线的生物降解。取出的组件的外植情况证明了在体内长达19个月的PCU垫片和PET帘线的生物稳定性。

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