Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery

项目总结 在美国每年出生的400万名婴儿中，有12万名(3%)患有复杂的出生缺陷。一些缺陷，比如 作为脊柱裂，宫内干预有必要改善胎儿结局。脊柱裂是一种情况，有 脊椎和脊髓周围的膜不完全闭合。德克萨斯儿童医院已经 开创了一种治疗脊柱裂的胎儿镜方法。虽然大部分手术都可以通过 宫口，子宫目前需要外置，以便适当地定位胎儿并缝合。 把绒毛羊膜固定在子宫壁上。放置缝合线是为了防止早产 胎膜早破(PPROM)会导致母婴并发症。PPROM是一种 胎儿手术的常见并发症，约30%发生在微创病例中。 绒毛膜锚定装置是一种便于经皮缝合绒毛膜羊膜的线性装置 在胎儿镜手术中，通过可吸收的锚线装置将胎膜连接到子宫壁。此解决方案 促进将现有的开放胎儿手术转换为经皮手术，并有可能 开发新的胎儿干预措施。 有两项主要的、意想不到的额外活动是推动 ChorioAnchor向FDA提交上市前申请。这包括开发一种基本安全 由临床利益相关者在可用性测试期间确定的功能。此外，这将有利于加强我们的团队 通过扩展主题专家的角色和增加主题专家来协助数据分析和市场路径 决定。SBIR第二阶段行政补充活动如下： 1.为提交前会议和人类发展评估报告编写数据，并增加主题-- 生物兼容性、毒理学和可吸收聚合物植入物制造方面的专家加入该团队。 2.增加帐篷和法拉盛安全功能，包括概念生成、原型设计、 可用性和风险评估，以及制造。 SBIR第二阶段行政补编的预期成果将是最新的 ChorioAnchor设备设计，增加了安全机制和数据驱动的风险缓解，以提供给 美国食品和药物管理局。我们相信，ChorioAnchor将通过以下方式为患者、提供者和儿童医院带来价值 提供一种解决方案，减少母婴并发症，通过 开发一种更安全的经皮穿刺术，并通过各种方式为婴儿带来更好的结局 胎儿状况。

PROJECT SUMMARY Of the 4 million babies born in the US each year, 120,000 (3%) have a complex birth defect. Some defects, such as spina bifida, warrant in utero interventions to improve fetal outcomes. Spina bifida is a condition where there is incomplete closing of the backbone and membranes around the spinal cord. Texas Children’s Hospital has pioneered a fetoscopic method to address spina bifida. While much of the surgery can be performed through ports, the uterus currently needs to be exteriorized in order to position the fetus appropriately and place sutures to anchor the chorioamniotic membranes to the uterine wall. The sutures are placed to prevent preterm premature rupture of membranes (PPROM) which leads to both maternal and fetal complications. PPROM is a common complication of fetal surgery, occurring in about 30% of minimally invasive cases. The ChorioAnchor device is a linear device that facilitates the percutaneous suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery via a resorbable anchor-suture set. This solution facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the development of new fetal interventions. There are two major unanticipated additional activities that are necessary to advance the development of ChorioAnchor towards an FDA premarket submission. This includes the development of an essential safety feature identified by clinical stakeholders during usability tests. In addition, it will be beneficial to bolster our team by expanding upon the roles of and adding subject-matter experts to assist in data analysis and path-to-market decisions. The SBIR Phase II Administrative Supplement Activities are: 1. Data Preparation for Presubmission Meeting and HDE Submission, aided by the addition of subject- matter experts in biocompatibility, toxicology, and resorbable polymer implant manufacturing to the team. 2. Addition of Tenting and Flushing Safety Features, including concept generation, prototype design, usability and risk assessment, and manufacturing. The expected outcome of the SBIR Phase II Administrative Supplement will be an updated ChorioAnchor device design with added safety mechanisms and data-driven risk mitigations to present to the FDA. We believe that the ChorioAnchor will bring value to patients, providers, and children’s hospitals by providing a solution that reduces maternal and fetal complications, expands the patient population through the development of a safer percutaneous procedure, and leads to better outcomes for babies with all manners of fetal conditions.