Development and Validation of a Physiological Testing Method for Sternal Closure Systems

IF 0.8 4区医学 Q4 ENGINEERING, BIOMEDICAL

Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-01-26 DOI:10.1115/1.4053687

Annette Kienle, Nadine Renner, Constanze Bischoff

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引用次数: 0

Abstract

After a median sternotomy, the sternal bone has to be refixated using implants such as wires, plates or clamps. However, there is still a lack of specifically applicable test methods to investigate the mechanical safety and effectiveness of such implant systems. The aim of this study was to develop a new test method that replicates the in vivo loads acting on the sternum and that is applicable to all types of sternal closure systems. Based on the scientific literature a setup was developed that incorporates the physiological loads acting on the sternum during breathing (91 N) and coughing (328 N). These loads are applied to a sternum replicate at 5 Hz for approximately 1.8 million cycles. This cycle number is assumed to represent the healing period. For validation, the new method was applied to two different sternal closure systems: a PEEK clamp system and wires. The new test method proved to be easily applicable. The validation tests with the two sternal closure systems showed reasonable and reproducible results regarding all outcome parameters. The pre-tension exerted by the implants significantly differed between the two implant groups and decreased after the first coughing cycles. The fracture gap separation during breathing also significantly different between the two test groups but it was similar during coughing. No implant failed. Using this new test method it is possible to compare sternal closure systems under reproducible conditions and interpret their mechanical characteristics regarding their in vivo safety and effectiveness.

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胸骨闭合系统生理测试方法的开发与验证

胸骨正中切开术后，胸骨必须用金属丝、钢板或夹子等植入物进行再固定。然而，仍然缺乏专门适用的测试方法来研究这种植入系统的机械安全性和有效性。本研究的目的是开发一种新的测试方法，该方法可以复制作用在胸骨上的体内负荷，并适用于所有类型的胸骨闭合系统。在科学文献的基础上，开发了一种装置，该装置结合了呼吸(91牛)和咳嗽(328牛)时作用于胸骨的生理负荷。这些负荷以5赫兹的频率在胸骨上重复约180万次。这个周期数被假定为表示治疗周期。为了验证，新方法应用于两种不同的胸骨闭合系统:PEEK夹紧系统和钢丝。新的测试方法被证明是易于应用的。两种胸骨闭合系统的验证试验在所有结局参数方面显示出合理和可重复的结果。两组患者的预张力差异显著，且在第一次咳嗽后降低。呼吸时骨折间隙分离在两组之间也有显著差异，但在咳嗽时相似。没有植入失败。使用这种新的测试方法，可以在可重复的条件下比较胸骨闭合系统，并解释其体内安全性和有效性的机械特性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Medical Devices-Transactions of the Asme ENGINEERING, BIOMEDICAL-

CiteScore

1.80

自引率

11.10%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.