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.

项目摘要 在美国每年出生的400万婴儿中，有12万（3%）患有复杂的出生缺陷。等缺陷 如脊柱裂，保证子宫内干预，以改善胎儿的结果。脊柱裂是一种条件， 是脊柱和脊髓周围的膜的不完全闭合。德州儿童医院 开创了一种胎儿镜治疗脊柱裂的方法。虽然大部分手术可以通过 端口，子宫目前需要外置，以便适当地定位胎儿并放置缝线 将绒毛膜羊膜锚在子宫壁上。缝合是为了防止早产 胎膜早破（PPROM），导致母亲和胎儿并发症。PPROM是一种 胎儿手术的常见并发症，发生在约30%的微创病例中。 ChorioAnchor器械是一种线性器械，可促进绒毛膜羊膜的经皮穿刺 在胎儿镜手术过程中，通过可吸收锚定缝线套件将胎膜固定到子宫壁。该溶液 促进了现有的开放式胎儿手术向经皮手术的转变， 开发新的胎儿干预措施。 有两个重大的未预料到的额外活动是必要的，以推动发展， ChorioAnchor向FDA提交上市前申请。这包括制定一个基本的安全 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主题专家，以协助数据分析和市场路径 决策SBIR第二阶段行政补充活动包括： 1.通过添加受试者帮助准备预提交会议和HDE提交的数据- 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。 2.增加帐篷和冲洗安全功能，包括概念生成、原型设计， 可用性和风险评估以及制造。 SBIR第二阶段行政补充的预期成果将是一份更新的 ChorioAnchor器械设计增加了安全机制和数据驱动的风险缓解措施，以提供给 FDA.我们相信ChorioAnchor将通过以下方式为患者、供应商和儿童医院带来价值： 提供了一种解决方案，减少产妇和胎儿并发症，扩大患者人数，通过 开发一种更安全的经皮手术，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.

• DOI: 10.1159/000525768
• 发表时间: 2022
• 期刊: FETAL DIAGNOSIS AND THERAPY
• 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