An Innovative Design for the Vaginal Speculum.

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2023-09-25 eCollection Date: 2023-01-01 DOI:10.2147/MDER.S415558
Jean M Bouquet, Rayyan Naji, Carlos A Armas, Valentina Roldan, Shadi Selkhi, Camille Z Bentley, Isain Zapata, Jensen Fisher
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Abstract

Introduction: The main objective of this study is to evaluate the effectiveness of a newly designed vaginal speculum, the Bouquet Speculum, in-vitro. The setting of this study was at Florida International University and involved four senior students in the Department of Biomedical Engineering.

Methods: A phantom vaginal model was used to test three variables of the Bouquet Speculum (Visibility, Pressure and Gynecologic Tools tests). As this was bench-lab testing with simulated models, no human participants were involved in this study.

Results: The results of this in-vitro study are as follows: The visibility test demonstrated statistically better visualization of the cervix and the cervical os (sampling area for pap tests) with the Bouquet Speculum over the existing 2-bladed speculum at all intrapelvic pressures; The pressure test demonstrated an equal radial distribution of force, without breakage, across the Bouquet Speculum; The gynecologic tools test demonstrated that the Bouquet Speculum is compatible with the existing speculum and standard gynecologic tools in terms of retrieving samples and accessing the cervical os and entire cervix during gynecologic procedures and screening.

Conclusion: The gynecologic screening and procedural value of this innovative change in the design of the vaginal speculum could save hundreds of thousands of lives every year, provide a more comfortable exam for the patient, and result in a more efficient and user-friendly provider experience.

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阴道镜的创新设计。
引言:本研究的主要目的是评估新设计的阴道窥器Bouquet speculum在体外的有效性。这项研究的背景是佛罗里达国际大学,涉及生物医学工程系的四名大四学生。方法:使用阴道模型测试Bouquet Speculum的三个变量(能见度、压力和妇科工具测试)。由于这是用模拟模型进行的实验室试验,因此没有人类参与者参与这项研究。结果:这项体外研究的结果如下:能见度测试显示,在所有骨盆内压力下,Bouquet Speculum对宫颈和宫颈口(pap测试的采样区域)的可视化在统计学上优于现有的双瓣窥器;压力测试表明,力在Bouquet Speculum上的径向分布相等,没有断裂;妇科工具测试表明,Bouquet Speculum与现有的窥器和标准妇科工具在妇科手术和筛查过程中检索样本、进入宫颈口和整个宫颈方面是兼容的。结论:阴道窥器设计的这一创新变化的妇科筛查和程序价值每年可以挽救数十万人的生命,为患者提供更舒适的检查,并带来更高效和用户友好的提供者体验。
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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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