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情况。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。虽然大部分手术可以通过端口进行，但目前需要对子宫进行外置，以便适当地定位胎儿，并放置缝线将绒毛羊膜固定在子宫壁上。放置缝线是为了防止早产胎膜早破(PPROM)，这会导致母婴并发症。胎膜早破是胎儿外科常见的并发症，约30%的微创病例会发生胎膜早破。PPROM的风险，无论是母亲还是胎儿，往往抵消了胎儿治疗的好处。创新：ChorioAnchor装置是一种线性装置，有助于在胎儿镜术中将绒毛羊膜经皮缝合到子宫壁。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起来，缝合线可以拧紧以固定膜。这一解决方案有助于将现有的开放式胎儿手术转变为经皮手术，并有可能开发新的胎儿干预措施。方法：在这个SBIR第二阶段项目中，Fannin Innovation Studio将开始制造扩大流程，收集数据以供监管部门提交，并在HDE提交之前继续商业化里程碑。目标1专注于将展开设备转移到我们的合同制造商Biotex，并与德克萨斯农工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式测试后，优化后的设备将达到设计冻结状态。聚合物精炼将在美国临床前服务公司进行的试点生物兼容性测试的基础上继续进行。最后，Aim 3将生成验证和确认测试数据，并将其包括在我们的设计历史文件中。这些数据将用于在进入HDE临床试验之前证明初步的安全性和有效性。我们相信，ChorioAnchor设备将为患者、医生和儿童医院带来价值，提供一种减少母婴并发症的解决方案，通过开发更安全的经皮手术扩大患者数量，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.