Bruce and Ruth Rappaport Faculty of Medicine (Dr. Nathan), Technion-Israel Institute of Technology, Haifa, Israel.
Division of Urogynecology (Dr. Goldberg), NorthShore University Healthsystem, University of Chicago Pritzker School of Medicine, Skokie, Illinois.
J Minim Invasive Gynecol. 2020 May-Jun;27(4):959-965. doi: 10.1016/j.jmig.2019.07.005. Epub 2019 Jul 10.
The purpose of this study was to present the feasibility and potential clinical advantages of Apyx (Escala Medical, Israel), a minimally invasive incision-free anchoring device, for apical prolapse repair.
An experimental prospective animal and cadaver study.
Animal facility and a cadaver laboratory of a tertiary care teaching hospital.
Included in this study were 7 ovine models, 2 porcine specimens, and 3 fresh unembalmed female human cadavers.
The Apyx device for sacrospinous ligament (SSL) suspension was tested on ovine and porcine models. The pullout force needed to detach the Apyx anchor from the SSL was measured. Safety, reliability, and feasibility of this new incision-free procedure were also tested on an ovine model and human cadavers. The precision in deployment of the Apyx device to the SSL was tested via palpation by the surgeon, tissue dissection, and x-ray imaging. The efficacy was tested both by pullout forces and histologic analysis of the vaginal attachment to the SSL.
Forty-two anchors were inserted into the SSLs on ovine and porcine models and on cadaver SSLs. No abnormalities or malfunctions were noted in the functional performance of the anchors or the retrieval device. Mean pullout force for the ovine animal model was 38.64 ± 2.80 N. Pullout force in the porcine model was found to be in correlation with the values observed in the ovine model. None of the measured forces was below 20 N. Accuracy and safety tests showed good consistency when deploying the Apyx device to the SSL with no damage to surrounding organs in the ovine or the human cadaver model. Histology demonstrated biologic adhesion characterized by a gross assessment of a newly formed, firm fibrotic tissue 12 weeks after anchor deployment.
The Apyx anchoring system, a novel incision-free minimally invasive prolapse repair device, demonstrated an anatomically feasible, easy-to-use procedure for suspending the vaginal apex to the SSLs. Its clinical safety, efficacy, and impact on patient symptoms and quality of life should be further studied.
本研究旨在介绍 Apyx（Escala Medical，以色列）作为一种微创无切口锚固装置，用于治疗 apical prolapse 的可行性和潜在临床优势。
一项实验性前瞻性动物和尸体研究。
动物设施和三级教学医院的尸体实验室。
本研究纳入了 7 只绵羊模型、2 只猪标本和 3 具新鲜未防腐的女性人体尸体。
在绵羊和猪模型上测试了用于骶棘韧带（SSL）悬吊的 Apyx 装置。测量了将 Apyx 锚从 SSL 上分离所需的拔出力。还在绵羊模型和人体尸体上测试了这种新的无切口手术的安全性、可靠性和可行性。通过外科医生触诊、组织解剖和 X 射线成像测试了 Apyx 装置在 SSL 上的精确部署。通过拔出力和阴道与 SSL 附着的组织学分析测试了该装置的疗效。
在绵羊和猪模型以及尸体 SSL 上共插入了 42 个锚。在锚或回收装置的功能性能方面未发现异常或故障。绵羊动物模型的平均拔出力为 38.64±2.80N。在猪模型中观察到的拔出力与绵羊模型中观察到的拔出力相关。测量的力均未低于 20N。在绵羊或人体尸体模型中，部署 Apyx 装置至 SSL 时的准确性和安全性测试显示出良好的一致性，且不会对周围器官造成损伤。组织学显示出生物附着，12 周后锚定器部署后，形成了新的、坚固的纤维组织。
Apyx 锚固系统是一种新颖的微创无切口脱垂修复装置，为悬吊阴道顶点至 SSL 提供了一种具有解剖学可行性、易于使用的方法。其临床安全性、疗效以及对患者症状和生活质量的影响应进一步研究。
