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

意义：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，如脊柱裂，需要在子宫内进行干预，以改善胎儿结局。脊柱裂是一种 脊椎和脊髓周围的膜不完全闭合的状态。德克萨斯州 儿童医院首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 要通过端口进行手术，目前需要对子宫进行外置以定位胎儿 并适当放置缝线将绒毛羊膜固定在子宫壁上。缝合线是 放置以防止早产胎膜早破(PPROM)，导致母体和胎儿 并发症。胎膜早破是胎儿外科手术的常见并发症，约30%的胎膜早破发生在 侵入性病例。胎膜早破的风险，无论是母体还是胎儿，往往抵消了胎儿治疗的好处。 创新：子宫壁-膜锚(UMA)是一种线性装置，有助于经皮 胎儿镜术中绒毛羊膜与子宫壁的缝合。两个圆柱形锚 部署在子宫壁的两侧，并通过打结的缝合线连接，可以收紧到 把膜固定好。这一解决方案有助于将现有的开放胎儿手术转换为 经皮手术和潜在的新的胎儿干预措施的开发。方法：在本SBIR中 第一阶段项目，范宁创新工作室将优化原型设备设计，并在台式和 动物模型。目标1专注于提炼和优化UMA原型并开发外科手术 部署设备的步骤。这将加快我们的临床实施进度，并 商业化。在目标2中，目标1中开发的优化样机将在怀孕的兔子身上进行测试 慢性研究和怀孕绵羊急性研究。我们相信UMA设备将为患者带来价值， 医生和儿童医院通过提供减少孕产妇和胎儿并发症的解决方案， 通过开发更安全的经皮穿刺术扩大患者人数，并导致更好的 脊柱裂儿童的预后。

Significance: 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 Uterine wall-Membrane Anchor (UMA) 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 I project, Fannin Innovation Studio will optimize the prototype device design and test it in benchtop and animal models. Aim 1 is focused on refining and optimizing the UMA prototype and developing the surgical procedure to deploy the device. This will accelerate our progress towards clinical implementation and commercialization. In Aim 2, the optimized prototype developed in Aim 1 will be tested in pregnant rabbit chronic studies and pregnant sheep acute studies. We believe that the UMA device will bring value to patients, doctors, and children’s hospitals by providing a solution that reduces maternal and fetal complications, expands patient population through the development of a safer percutaneous procedure, and leads to better outcomes for children with spina bifida.