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，保证在子宫内干预，以改善胎儿的结果。脊柱裂是一种脊柱和脊髓周围膜不完全闭合的疾病。得克萨斯州儿童医院开创了一种胎儿镜检查方法来治疗脊柱裂。虽然大部分手术可以通过输液港进行，但目前需要将子宫外置，以便适当地定位胎儿，并将缝线将绒毛膜羊膜锚在子宫壁上。放置缝线是为了防止导致母体和胎儿并发症的早产胎膜早破（PPROM）。PPROM是胎儿手术的常见并发症，约30%的微创病例发生。产妇和胎儿PPROM的风险通常会抵消胎儿治疗的益处。创新：ChorioAnchor器械是一种线性器械，可在胎儿镜手术期间促进绒毛膜羊膜经皮固定到子宫壁。两个圆柱形锚钉部署在子宫壁的两侧，并通过打结的缝线连接，可以收紧以固定膜。该解决方案有助于将现有的开放式胎儿手术转换为经皮手术，并可能开发新的胎儿干预措施。方法：在此SBIR第二阶段项目中，Fannin Innovation Studio将开始生产规模扩大过程，收集监管提交数据，并在HDE提交之前继续商业化里程碑。目标1的重点是将部署设备转移到我们的合同制造商Biotex，并与德克萨斯A&M大学进行聚合物优化。我们将在我们的设计历史文件中收集与未来监管备案相关的数据。在目标2中，经过进一步修改和台架测试后，优化的设备将达到设计冻结。将根据American Preclinical Services，Inc.进行的中试生物相容性试验继续进行聚合物精制。最后，Aim 3将生成验证和确认测试数据，以纳入我们的设计历史文件。这些数据将用于在进入HDE临床试验之前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，可减少孕产妇和胎儿并发症，通过开发更安全的经皮手术扩大患者人群，并为患有胎儿疾病的儿童带来更好的结局。

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.