High-Resolution Ultrasonic Micro-Transducer for In Utero Procedures

项目摘要 20世纪80年代预示着胎儿手术的到来，带来了一种新的治疗胎儿的范例， 严重的先天性缺陷，包括脊柱裂、先天性腹股沟疝和并发症 例如双胞胎输血综合征。在子宫内的早期治疗允许自然和持续的 在子宫的安全范围内发育，甚至在这些人出生之前就改善了他们的结局。 出生临床研究表明，产前脊柱裂治疗改善的结果相比， 通过降低潜在的破坏性神经影响的发生率或严重程度来减少产后手术。 然而，这些程序和许多其他胎儿干预一直受到“阿喀琉斯之踵”的困扰 称为早产胎膜早破（PPROM）。为了实现胎儿的全部承诺， 通过干预和降低与胎儿手术相关的风险，PPROM的问题必须得到缓解。 目前的研究集中在进一步完善手术技术，以减少风险， 由于医疗干预导致的PPROM发生率。有无数种潜在的解决方案来治疗 PPROM破裂后，已发生，但没有一个已被证明是临床有效的。 具体而言，研究集中于通过使用某些粘合剂或组织密封剂来修复破裂。 尽管有过多的方法，但没有任何方法能够可靠地降低PPROM的发生率 跨程序，并且没有预防性护理标准，只有PPROM后的管理， 发生了。一种新的技术和独特的方法，包括预先密封绒毛膜羊膜， 在膜破裂之前，最近已经证明。在这项工作中，我们的目标是 展示了一种高分辨率的超声波微传感器，可以准确地定位薄绒毛膜羊膜， 膜，从而使预密封方法在临床上可行。 对于第一阶段项目，我们提出以下具体目标以表明可行性：（1）展示高- 分辨率，超声波微型传感器，适合在一个高规格的针;（2）展示精确的指导 使用超声波微传感器进行密封胶分配。

PROJECT SUMMARY The 1980s heralded the advent of fetal surgery, bringing forth a new paradigm of treatment for fetuses with significant congenital defects including spina bifida, congenital diaphragmatic hernia, and complications such as twin-twin transfusion syndrome. Earlier treatment in the womb allows for natural and continued development within the safety of the uterus, improving outcomes for these individuals even before they are born. Clinical studies demonstrated that prenatal spina bifida treatment improved outcomes as compared to postnatal surgery by reducing the incidence or severity of potentially devastating neurologic effects. However, these procedures and many other fetal interventions have been plagued by an “Achilles heel” known as preterm premature rupture of membranes (PPROM). In order to realize the full promise of fetal intervention and lower the risks associated with fetal procedures, the problem of PPROM must be mitigated. Current research has focused on further refinement of surgical techniques that diminish the risks or incidences of PPROM due to medical interventions. There have been a myriad of potential solutions to treat PPROM after the rupture has occurred, yet none of them have been shown to be clinically effective. Specifically, research has concentrated on repairing ruptures by using certain adhesives or tissue sealants. Despite the plethora of approaches, nothing has been able to reliably lower the occurrence of PPROM across procedures, and there exists no prophylactic standard of care, only management after PPROM has occurred. A new technique and unique approach that consists of presealing the chorioamniotic membrane prior to membrane disruption has recently been demonstrated. In this proposed work we aim to demonstrate a high-resolution, ultrasonic micro-transducer that can accurately locate the thin chorioamniotic membrane, thereby making the presealing approach clinically viable. For the Phase I project we propose the following Specific Aims to show feasibility: (1) Demonstrate a high- resolution, ultrasonic micro-transducer that fits in a high-gauge needle; (2) Demonstrate precision guidance of sealant dispensing using an ultrasound micro-transducer.