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

子宫壁膜锚定装置用于预防胎儿镜手术后子宫膜过早破裂

• 批准号: 10301644
• 负责人: MICHAEL JOHN HEFFERNAN
• 金额: $ 13.97万
• 依托单位: FANNIN PARTNERS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10301644
• 关键词: Address; Administrative Supplement; Advanced Development; Amnioscopic Surgical Procedures; Clinical; Complex; Complication; Congenital Abnormality; Data; Data Analyses; Defect; Development; Device Designs; Devices; Fetus; Flushing; Generations; Implant; Intervention; Membrane; Methods; Operative Surgical Procedures; Outcome; Patients; Pediatric Hospitals; Phase; Polymers; Positioning Attribute; Preparation; Prevention; Procedures; Provider; Risk Assessment; Role; Rupture; Safety; Small Business Innovation Research Grant; Spinal Cord; Spinal Dysraphism; Surgeon; Surgical sutures; System; Testing; Texas; Toxicology; Update; Uterus; Vertebral column; biomaterial compatibility; design; fetal; fetus surgery; improved; in utero; maternal outcome; meetings; minimally invasive; patient population; preterm premature rupture of membranes; prevent; prototype; repaired; risk mitigation; usability

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.

项目概要 美国每年出生的 400 万婴儿中，有 12 万（3%）患有复杂的出生缺陷，例如某些缺陷。 与脊柱裂一样，需要在子宫内进行干预以改善胎儿的结局。 德克萨斯儿童医院的脊柱和脊髓周围的膜不完全闭合。 首创了一种胎儿镜方法来解决脊柱裂，而大部分手术都可以通过该方法进行。 端口，目前需要将子宫取出，以便适当定位胎儿并放置缝合线 将绒毛膜羊膜固定在子宫壁上，以防止早产。 胎膜早破 (PPROM) 是一种导致母体和胎儿并发症的疾病。 胎儿手术常见并发症，约 30% 的微创病例发生。 ChorioAnchor 装置是一种线性装置，有助于经皮缝合绒毛膜羊膜 该解决方案在胎儿镜手术期间通过可吸收的锚定缝合线装置将膜固定在子宫壁上。 有助于将现有的开放式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、未预料到的额外活动是推动发展的必要条件 ChorioAnchor 正在向 FDA 提交上市前申请，其中包括开发基本安全性。 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。 通过扩大主题专家的作用并增加他们来协助数据分析和市场路径 SBIR 第二阶段行政补充活动包括： 1. 提交前会议和 HDE 提交的数据准备，并辅以添加主题 - 生物相容性、毒理学和可吸收聚合物植入物制造方面的专家加入到团队中。 2. 增加帐篷和冲水安全功能，包括概念生成、原型设计、 可用性和风险评估以及制造。 SBIR 第二阶段行政补充文件的预期结果将更新 ChorioAnchor 设备设计增加了安全机制和数据驱动的风险缓解措施，以呈现给 FDA 相信，ChorioAnchor 将为患者、医疗服务提供者和儿童医院带来价值。 提供减少母婴并发症的解决方案，通过以下方式扩大患者群体： 开发更安全的经皮手术，并为患有各种疾病的婴儿带来更好的结果 胎儿状况。

项目成果

The ChorioAnchor: Design and Testing of a Novel Chorioamniotic Anchoring Device to Enable Percutaneous Fetoscopic Surgery.

ChorioAnchor：新型绒毛膜羊膜锚定装置的设计和测试，以实现经皮胎儿镜手术。

• 发表时间: 2022
• 影响因子: 2.2
• 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
• 通讯作者: Espinoza, Jimmy