聚丙烯外科补片体外加速氧化降解试验

IF 3.2 4区 医学 Q2 ENGINEERING, BIOMEDICAL Journal of biomedical materials research. Part B, Applied biomaterials Pub Date : 2023-08-19 DOI:10.1002/jbm.b.35308
Tanmay Jain, Chinnapatch Tantisuwanno, Arindam Paul, Pavel Takmakov, Abraham Joy, Irada Isayeva, David D. Simon
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引用次数: 0

摘要

聚丙烯(PP)手术补片在修补疝和治疗应激性尿失禁(SUI)方面取得了一定的成功;然而,它们用于盆腔器官脱垂(POP)的修复导致了高度可变的结果,并在一些患者中导致终身并发症。与补片相关的POP并发症相关的几个因素之一是由于PP在体内氧化降解而导致植入手术补片性能的改变。目前,还没有标准化的体外台架测试方法可用于评估手术补片对氧化降解的易感性和评估手术补片的长期体内稳定性。在这项工作中,我们采用了先前报道的自动反应性加速老化(aRAA)系统,该系统使用高温和高浓度过氧化氢(H2O2)来加速PP手术网的台架氧化降解测试。由于H2O2在高温下和长时间内非常不稳定,因此aRAA系统包含一个基于电化学检测方法的反馈回路,以保持测试溶液中H2O2浓度的一致性。选取4个不同网状编织设计、长丝直径、重量和孔隙率的PP网样进行为期4周的aRAA测试,并使用热分析、傅里叶变换红外光谱-衰减全反射(FTIR-ATR)和扫描电子显微镜(SEM)对其进行表征。此外,根据FTIR-ATR光谱计算氧化指数(OI)值,以估计PP手术网的氧化降解和氧化反应动力学。随着aRAA时效时间的延长,OI值和表面损伤(表面剥落、剥落和横向裂纹的形成)均有所增加。本文介绍的aRAA测试方法可用于外科补片长期稳定性的标准化评估,也可用于其他聚合物基医疗器械的加速氧化降解测试。
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Accelerated in vitro oxidative degradation testing of polypropylene surgical mesh

Polypropylene (PP) surgical mesh had reasonable success in repair of hernia and treatment of stress urinary incontinence (SUI); however, their use for the repair of pelvic organ prolapse (POP) resulted in highly variable results with lifelong complications in some patients. One of several factors that could be associated with mesh-related POP complications is changes in the properties of the implanted surgical mesh due to oxidative degradation of PP in vivo. Currently, there are no standardized in vitro bench testing methods available for assessing the susceptibility to oxidative degradation and estimating long-term in vivo stability of surgical mesh. In this work, we adapted a previously reported automated reactive accelerated aging (aRAA) system, which uses elevated temperatures and high concentrations of hydrogen peroxide (H2O2), for accelerated bench-top oxidative degradation testing of PP surgical mesh. Since H2O2 is highly unstable at elevated temperatures and for prolonged periods, the aRAA system involves a feedback loop based on electrochemical detection methods to maintain consistent H2O2 concentration in test solutions. Four PP mesh samples with varying mesh knit designs, filament diameter, weight, and % porosity, were selected for testing using aRAA up to 4 weeks and characterized using thermal analysis, Fourier-transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR) and scanning electron microscopy (SEM). Additionally, the oxidation index (OI) values were calculated based on the FTIR-ATR spectra to estimate the oxidative degradation and oxidation reaction kinetics of PP surgical mesh. The OI values and surface damage in the form of surface flaking, peeling, and formation of transverse cracks increased with aRAA aging time. The aRAA test method introduced here could be used to standardize the assessment of long-term stability of surgical mesh and may also be adopted for accelerated oxidative degradation testing of other polymer-based 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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Additively Manufactured 3D Clamp-Culture System for the Investigation of Material-Cell Interactions in Multi-Material Hybrid Scaffolds for Musculoskeletal Tissue Defects Mimicking the Architecture and Dissolution Chemistry of Cancellous Bone Tissue to Optimize the Biocompatibility of Bioactive Scaffolds Issue Information Issue Information Accelerated in vitro oxidative degradation testing of polypropylene surgical mesh
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