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：每年在美国出生的400万婴儿中，有120,000（3％）患有复杂的先天缺陷。 一些缺陷，例如脊柱裂，在子宫干预措施中的保证，以改善胎儿结局。脊柱裂是一个 条件是脊髓周围的骨干和膜不完整的情况。德克萨斯州 儿童医院已经开创了一种胎儿镜方法来解决脊柱裂。虽然大部分手术可以 可以通过端口进行，目前需要外部对子宫进行外部才能放置胎儿 适当地放置成功，将绒毛膜膜固定在子宫壁上。缝合线是 放置膜（PPROM）的预成型过早破裂，该破裂导致母乳和胎儿 并发症。 PPROM是胎儿手术的常见并发症，大约30％的最小 侵入性病例。孕产妇和胎儿的PPR风险通常会抵消胎儿治疗的好处。 创新：子宫壁膜锚（UMA）是一种线性装置，可促进经皮 胎儿手术期间，将绒毛膜膜缝合到子宫壁。两个圆柱锚 部署在子宫壁的两侧，并通过打结的缝合线连接到 固定膜。该解决方案有助于将现有的开放胎儿程序转换为 经皮程序，并有可能发展新的胎儿干预措施。方法：在这个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 动物模型。 AIM 1专注于精炼和优化UMA原型并开发外科手术 部署设备的过程。这将加速我们在临床实施和 商业化。在AIM 2中，AIM 1中开发的优化原型将在怀孕的兔子中进行测试 慢性研究和怀孕的绵羊急性研究。我们认为，UMA设备将为患者带来价值， 医生和儿童医院通过提供减少母子和胎儿并发症的解决方案， 通过开发更安全的经皮手术来扩大患者群体，并导致更好 脊柱裂儿童的结果。