超高分子量聚乙烯 (UHMWPE) 的加速体外氧化降解测试。

IF 3.2 4区 医学 Q2 ENGINEERING, BIOMEDICAL Journal of biomedical materials research. Part B, Applied biomaterials Pub Date : 2024-10-21 DOI:10.1002/jbm.b.35495
Tanmay Jain, Hunter Danesi, Anne Lucas, Benita Dair, Katherine Vorvolakos
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引用次数: 0

摘要

根据短期测试,生物医学应用中使用的不可吸收聚合物被认为是永久稳定的,但有些聚合物在植入数年后可能会发生氧化降解。传统的体外氧化降解筛选采用过氧化氢(H2O2)溶液。然而,H2O2 本身的不稳定性会影响氧化条件的一致性,尤其是在加速测试所使用的较长时间和较高温度下。在本研究中,我们使用了一种集成了电化学检测方法和反馈回路的自动反应加速老化(araA)系统,以确保在聚合物氧化降解测试过程中精确控制 H2O2 的浓度。通过比较四个相同的设置,对 aRAA 系统的可重复性进行了评估。在 (i) 医用级维生素 E (VE) 混合超高分子量聚乙烯 (UHMWPE) 和 (ii) 高交联 (HXL) UHMWPE 模型材料上证明了其作为氧化挑战的功效。经过 aRAA 老化的 VE-UHMWPE 和 HXL-UHMWPE 样品还与经过现有加速老化标准 ASTM F2003-02(2022)老化的样品进行了比较。使用衰减全反射傅立叶变换红外(ATR-FTIR)光谱对样品进行分析,以根据 ASTM F2102-17 标准计算其氧化指数。我们发现,与传统的 ASTM F2003-02(2022)方法相比,aRAA 系统对 VE-UHMWPE 和 HXL-UHMWPE 的氧化更有效。通过提供评估聚合物氧化降解的标准化可靠方法,aRAA 系统可提高医疗器械中不可吸收聚合物长期稳定性预测的准确性。
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Accelerated In Vitro Oxidative Degradation Testing of Ultra-High Molecular Weight Polyethylene (UHMWPE)

Nonabsorbable polymers used in biomedical applications are assumed to be permanently stable based on short-term testing, but some may be susceptible to oxidative degradation over several years of implantation. Traditional in vitro oxidative degradation screenings employ hydrogen peroxide (H2O2) solutions. However, the inherent instability of H2O2 can compromise the consistency of oxidative conditions, especially over extended periods and at elevated temperatures used for accelerated testing. In this study, an automated reactive accelerated aging (aRAA) system, which integrates an electrochemical detection method and a feedback loop, was utilized to ensure precise control of H2O2 concentrations during polymer oxidative degradation testing. The reproducibility of the aRAA system was evaluated by comparing four identical setups. Its efficacy as an oxidation challenge was demonstrated on (i) medical-grade vitamin E (VE) blended ultra-high molecular weight polyethylene (UHMWPE) and (ii) highly crosslinked (HXL) UHMWPE as model materials. The aRAA-aged VE-UHMWPE and HXL-UHMWPE samples were also compared against samples aged via an existing accelerated aging standard, ASTM F2003-02(2022). Samples were analyzed using attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy to calculate their oxidation index per ASTM F2102-17. We observed that the aRAA system was more effective in oxidizing VE-UHMWPE and HXL-UHMWPE than the traditional ASTM F2003-02(2022) method. By providing a standardized and reliable approach to assess polymer oxidative degradation, the aRAA system could enhance the accuracy of long-term stability predictions for nonresorbable polymers in medical devices.

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来源期刊
CiteScore
7.50
自引率
2.90%
发文量
199
审稿时长
12 months
期刊介绍: Journal of Biomedical Materials Research – Part B: Applied Biomaterials is a highly interdisciplinary peer-reviewed journal serving the needs of biomaterials professionals who design, develop, produce and apply biomaterials and medical devices. It has the common focus of biomaterials applied to the human body and covers all disciplines where medical devices are used. Papers are published on biomaterials related to medical device development and manufacture, degradation in the body, nano- and biomimetic- biomaterials interactions, mechanics of biomaterials, implant retrieval and analysis, tissue-biomaterial surface interactions, wound healing, infection, drug delivery, standards and regulation of devices, animal and pre-clinical studies of biomaterials and medical devices, and tissue-biopolymer-material combination products. Manuscripts are published in one of six formats: • original research reports • short research and development reports • scientific reviews • current concepts articles • special reports • editorials Journal of Biomedical Materials Research – Part B: Applied Biomaterials is an official journal of the Society for Biomaterials, Japanese Society for Biomaterials, the Australasian Society for Biomaterials, and the Korean Society for Biomaterials. Manuscripts from all countries are invited but must be in English. Authors are not required to be members of the affiliated Societies, but members of these societies are encouraged to submit their work to the journal for consideration.
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