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

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。一些缺陷，如脊柱裂，需要在子宫内干预以改善胎儿结局。脊柱裂是脊柱和脊髓周围膜不完全闭合的一种情况。德克萨斯儿童医院开创了胎儿镜治疗脊柱裂的方法。虽然大部分手术可以通过港口进行，但目前需要将子宫移出，以便适当地定位胎儿并放置缝合线以将绒毛膜和羊膜固定在子宫壁上。缝合线的放置是为了防止导致母体和胎儿并发症的胎膜早破（PPROM）。PPROM是胎儿手术的常见并发症，约占微创手术病例的30%。母体和胎儿发生PPROM的风险往往抵消了胎儿治疗的益处。创新：ChorioAnchor装置是一种线性装置，可在胎儿镜手术中促进经皮将绒毛膜羊膜缝合到子宫壁。在子宫壁两侧放置两个圆柱形锚，通过打结的缝合线连接，可以收紧以固定膜。该解决方案促进了现有的开放式胎儿手术到经皮手术的转换，并有可能发展新的胎儿干预措施。方法：在SBIR二期项目中，Fannin创新工作室将开始生产放大流程，收集提交监管机构的数据，并在提交HDE之前继续商业化里程碑。目标1的重点是将部署设备移交给我们的合同制造商Biotex，并与德克萨斯A&M大学进行聚合物优化。我们将在设计历史文件中收集与未来监管文件相关的数据。在Aim 2中，经过优化的设备将在进一步修改和台式测试后达到设计冻结。基于美国临床前服务公司进行的中试生物相容性测试，聚合物将继续细化。最后，Aim 3将生成验证和验证测试数据，以包含在我们的设计历史文件中。在进入HDE临床试验之前，这些数据将用于证明初始安全性和有效性。我们相信，ChorioAnchor设备将为患者、医生和儿童医院带来价值，它提供了一种解决方案，可以减少母婴并发症，通过开发更安全的经皮手术扩大患者群体，并为患有胎儿疾病的儿童带来更好的结果。

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 risk of PPROM, both maternal and fetal, often offsets the benefits of fetal treatment. Innovation: The ChorioAnchor device is a linear device that facilitates the percutaneous suturing of chorioamniotic membranes to the uterine wall during fetoscopic surgery. Two cylindrical anchors are deployed on either side of the uterine wall and connected by a knotted suture that can be tightened to secure the membranes. This solution facilitates the conversion of existing open fetal procedures to percutaneous procedures and potentially the development of new fetal interventions. Approach: In this SBIR Phase II project, Fannin Innovation Studio will begin manufacturing scale-up processes, gather data for regulatory submission, and continue commercialization milestones prior to HDE submission. Aim 1 focuses on transferring the deployment device to Biotex, our contract manufacturer, and polymer optimization with Texas A&M University. We will gather data in our design history file relevant for future regulatory filing. In Aim 2, the optimized device will arrive at a design freeze after undergoing further modifications and benchtop testing. Polymer refinement will continue based off of pilot biocompatibility testing performed by American Preclinical Services, Inc. Finally, Aim 3 will generate verification and validation testing data to be included in our design history file. These data will be used to prove initial safety and efficacy prior to entering HDE clinical trials. We believe that the ChorioAnchor device will bring value to patients, doctors, and children’s hospitals by providing a solution that reduces maternal and fetal complications, expands patient populations through the development of a safer percutaneous procedure, and leads to better outcomes for children with fetal conditions.