The ChorioAnchor: Design and Testing of a Novel Chorioamniotic Anchoring Device to Enable Percutaneous Fetoscopic Surgery.
The ChorioAnchor: Design and Testing of a Novel Chorioamniotic Anchoring Device to Enable Percutaneous Fetoscopic Surgery.
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DOI：
10.1159/000525768
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发表时间：
2022
影响因子：
2.2
通讯作者：
Espinoza, Jimmy
中科院分区：
文献类型：
--
作者：
Byju, Achu G.;Diemer, Ashley;Luk, Christine;Heffernan, Michael J.;Belfort, Michael A.;Simons, Brian W.;Koh, Chester J.;Haridas, Balakrishna;Espinoza, Jimmy
经皮胎儿镜手术是阻碍了早产儿胎膜破裂（PPROM）的风险增加。最近的手术技术表明，与经皮子宫内手术相比，剖腹手术和子宫外置术后剥离绒毛膜羊膜与PPROM的风险较低相关。本研究介绍了ChorioAnchor，这是一种新型可吸收器械，可将绒毛膜羊膜永久锚定在子宫壁上。人为因素试验和剥离试验用于模拟最差情况使用中负载条件，确定器械强度要求。拉伸试验用于测量器械的零时强度。猪尸体试验用于检查超声可见性和急性处理特征。通过在兔模型中进行的急性7天植入研究检查了短期宿主反应。由于零时拉伸强度为47 N，ChorioAnchor超过了既定的4 N强度要求。在超声成像下，ChorioAnchor和输送器械均清晰可见。宿主对器械的短期反应完全在此类器械的预期范围内。ChorioAnchor在植入的早期阶段符合其工程要求。未来的研究将检查器械在体外和体内的降解动力学。
Percutaneous fetoscopic surgery is hampered by an increased risk of preterm prelabor rupture of membranes (PPROM). Recent surgical techniques have shown that suturing the chorioamniotic membranes following laparotomy and uterine exteriorization is associated with a lower risk of PPROM compared to percutaneous in utero surgery. This study presents the ChorioAnchor, a novel resorbable device that percutaneously anchors the chorioamniotic membranes to the uterine wall. Human factors testing and peel tests were used to simulate the worst-case in-use loading conditions, establishing the device strength requirements. Tensile testing was used to measure the time-zero strength of the device. Porcine cadaver testing was used to examine ultrasound visibility and acute handling characteristics. Short-term host response was examined through an acute 7-day implantation study in a rabbit model. With a time-zero tensile strength of 47 N, the ChorioAnchor exceeded the established 4 N strength requirement. Both the ChorioAnchor and delivery device were seen to be clearly visible under ultrasound imaging. Short-term host response to the device was well within the range expected for this type of device. The ChorioAnchor meets its engineering requirements in the early stages of implantation. Future studies will examine the kinetics of degradation of the device in vitro and in vivo.
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影响因子：
5
作者：
Makadia HK;Siegel SJ
通讯作者：
Siegel SJ
影响因子：
9.8
作者：
Pedreira, Denise A. L.;Zanon, Nelci;Quintero, Ruben A.
通讯作者：
Quintero, Ruben A.
影响因子：
1.7
作者：
Williams, Simon F.;Rizk, Said;Martin, David P.
通讯作者：
Martin, David P.
影响因子：
2.2
作者：
Ochsenbein-Kolble, Nicole;Brandt, Simone;Zimmermann, Roland
通讯作者：
Zimmermann, Roland
影响因子：
7.2
作者：
Belfort, Michael A.;Whitehead, William E.;Cass, Darrell L.
通讯作者：
Cass, Darrell L.