Bouquet Jean M, Naji Rayyan, Armas Carlos A, Roldan Valentina, Selkhi Shadi, Bentley Camille Z, Zapata Isain, Fisher Jensen
Department of Family Medicine, Rocky Vista University College of Osteopathic Medicine, Englewood, CO, 80112, USA.
Department of Biomedical Engineering, College of Engineering and Computing, Florida International University, Miami, FL, 33174, USA.
Med Devices (Auckl). 2023 Sep 25;16:211-218. doi: 10.2147/MDER.S415558. eCollection 2023.
The main objective of this study is to evaluate the effectiveness of a newly designed vaginal speculum, the , in-vitro. The setting of this study was at Florida International University and involved four senior students in the Department of Biomedical Engineering.
A phantom vaginal model was used to test three variables of the (Visibility, Pressure and Gynecologic Tools tests). As this was bench-lab testing with simulated models, no human participants were involved in this study.
The results of this in-vitro study are as follows: The demonstrated statistically better visualization of the cervix and the cervical os (sampling area for pap tests) with the over the existing 2-bladed speculum at all intrapelvic pressures; The demonstrated an equal radial distribution of force, without breakage, across the ; The demonstrated that the 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.
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.
本研究的主要目的是在体外评估一种新设计的阴道窥器的有效性。本研究在佛罗里达国际大学进行，涉及生物医学工程系的四名高年级学生。
使用一个模拟阴道模型来测试该阴道窥器的三个变量（可视性、压力和妇科工具测试）。由于这是使用模拟模型进行的实验室台架测试，本研究未涉及人类参与者。
这项体外研究的结果如下：在所有盆腔内压力下，与现有的两叶窥器相比，该阴道窥器在子宫颈和子宫颈外口（巴氏试验采样区域）的可视化方面在统计学上表现更好；该阴道窥器在整个窥器上显示出均匀的径向力分布，且无破损；该阴道窥器表明，在妇科检查和筛查过程中获取样本以及进入子宫颈外口和整个子宫颈方面，它与现有的窥器和标准妇科工具兼容。
阴道窥器设计的这一创新变革在妇科筛查和操作方面的价值每年可挽救数十万人的生命，为患者提供更舒适的检查，并为医疗服务提供者带来更高效、更便捷的体验。
