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: 9466780
• 负责人: ATUL VARADHACHARY
• 金额: $ 22.46万
• 依托单位: FANNIN PARTNERS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-21 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9466780
• 关键词: Acute; Address; Affect; Amnioscopic Surgical Procedures; Animal Model; Animals; Area; Blood Vessels; Child; Chronic; Clinical; Complex; Complication; Congenital Abnormality; Congenital diaphragmatic hernia; Defect; Development; Device Designs; Devices; Documentation; Evaluation Reports; Fetus; Intervention; Lead; Membrane; Meningomyelocele; Methods; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Patients; Pediatric Hospitals; Performance; Phase; Placenta; Positioning Attribute; Pregnancy; Pregnant Uterus; Premature Birth; Premature Labor; Prevention; Procedures; Provider; Risk; Rupture; Safety; Secure; Sepsis; Sheep; Side; Small Business Innovation Research Grant; Spinal; Spinal Cord; Spinal Dysraphism; Surgical sutures; System; Testing; Texas; Tissues; Ultrasonography; United States; Uterus; Vertebral column; base; commercialization; design; fetal; fetus surgery; human tissue; improved; in utero; innovation; intraamniotic infection; minimally invasive; patient population; preclinical study; pregnant; preterm premature rupture of membranes; prevent; prototype; standard care; standard of care

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.

意义：在美国每年出生的 400 万婴儿中，有 120,000 名 (3%) 患有复杂的出生缺陷。 一些缺陷，例如脊柱裂，需要在子宫内进行干预以改善胎儿的结局。 德克萨斯州脊髓周围的脊柱和膜不完全闭合的情况。 儿童医院首创了一种胎儿镜方法来治疗脊柱裂，而大部分手术都可以治疗。 通过端口进行，目前需要将子宫取出以定位胎儿 适当缝合，将绒毛膜羊膜固定在子宫壁上。 放置以防止胎膜早破（pPROM），这会导致母体和胎儿 并发症 PPROM 是胎儿手术的常见并发症，发生率约为 30%。 母体和胎儿的侵袭性病例的风险常常抵消胎儿治疗的益处。 创新：子宫壁膜锚定器 (UMA) 是一种线性装置，有助于经皮 在胎儿镜手术期间将绒毛膜羊膜缝合到子宫壁。 部署在子宫壁的两侧，并通过可拉紧的打结缝合线连接 该解决方案有助于将现有的开放式胎儿手术转换为 经皮手术和潜在的新胎儿干预方法的开发：在本 SBIR 中。 第一阶段项目，Fannin Innovation Studio 将优化原型设备设计并在台式和 目标 1 专注于完善和优化 UMA 原型并开发手术方法。 部署该设备的程序将加速我们的临床实施和进展。 在目标 2 中，目标 1 中开发的优化原型将在怀孕兔子中进行测试。 我们相信UMA装置将为患者带来价值， 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手术扩大患者群体，并带来更好的效果 脊柱裂儿童的结果。