Tension-Free Bioabsorbable Scaffold for Pediatric Abdominal Wall Defect Closure

项目总结/摘要 意义：目前基于缝线的穿刺器端口闭合技术在易用性和支持方面受到限制， 伤口愈合接受腹腔镜手术的儿科患者面临穿刺器端口疝出的风险， 由于弯针手弯容易导致肠穿刺，增加了手术时间，并增加了伤口愈合 由于腹部筋膜层的缝合张力可变，这种新型设备的开发支持了 其他儿科腹部伤口闭合适应症，如女性，可能还有男性，儿科腹股沟 疝，脐疝，并协助修复复发性先天性腹股沟疝，腹裂， 以及单端口和机器人端口位置缺陷。该器械代表了一种上级筋膜缺损闭合技术 通过验证一种新的支架设计，有助于腹腔镜端口筋膜的手术修复和组织愈合， 缺陷与NICHD的使命一致，预期生物可吸收支架系统基本上 降低并发症的风险，减少儿科外科医生的手术时间， 支付者，并提高腹腔镜手术后儿科患者的生活质量。拟议项目将 显著提高小儿外科医生的技术能力，以改善腹腔镜临床实践。的 总体项目目标是验证生物可吸收支架器械概念， I期小儿腹腔镜下静脉筋膜缺损闭合术。假设：我们假设Fastlink 支架将能够更一致和快速地闭合儿科端口筋膜缺损，并提高安全性， 与基于针的穿刺技术相比。初步数据：在大型动物中使用初始FAStlink原型 尸检模型，我们成功地证明了10和12 mm套管针部位的输液港筋膜缺损边缘接合。 所有固定的筋膜缺损部位在观察或手拉伸时均未脱垂。具体目标：目标 是研究合适的支架几何形状和材料/机械性能，以实现安全和快速 关闭静脉筋膜缺损。器械系统的快速展开和接合将通过以下方式进行评价： 迭代3D工程原型。将通过拉伸强度试验评价牢固和安全的组织固定， 选择支架几何形状的缺损闭合，并通过组织学评价筋膜处的伤口愈合反应， 使用体内慢性动物模型的缺损部位。总体影响：这些研究将共同证明 生物可吸收FAStlink支架用于小儿腹腔镜套管针端口筋膜缺损闭合的可行性，以及 加速临床使用的上级儿科缺损闭合技术的商业化。

Project Summary/Abstract Significance: Current suture-based trocar port closure technologies are limited in their ease-of-use and support for wound healing. Pediatric patients undergoing laparoscopic surgery face the risk of trocar port herniation, increased operating time due to curved needle hand suturing being prone to bowel puncture, and increased wound healing time due to variable suture tension at the abdominal fascial layer. The development of this novel device supports additional pediatric abdominal wound closure indications such as female, and possibly male, pediatric inguinal hernias, umbilical hernias, and assists in the repair of recurrent congenital diaphragmatic hernias, gastroschisis, as well as single port and robotic port site defects. This device represents a superior fascial defect closure technology by validating a new scaffold design that facilitates surgical repair and tissue healing of laparoscopic port fascial defects. In alignment with the mission of NICHD, the bioabsorbable scaffold system is expected to substantially lower the risk of complications and reduce operating time for pediatric surgeons, decrease healthcare costs for payers, and improve quality of life for pediatric patients after laparoscopic procedures. The proposed project will significantly enhance the technical capability of pediatric surgeons for improved laparoscopy clinical practice. The overall project goal is to validate the bioabsorbable scaffold device concept for the rapid and safe tension-free closure of pediatric laparoscopic port fascial defects in Phase I. Hypothesis: We hypothesize that FAStlink scaffolds will enable more consistent and rapid closure of pediatric port fascial defects with improved safety as compared to needle-based suturing techniques. Preliminary Data: Using initial FAStlink prototypes in large animal necropsy models, we successfully demonstrated port fascial defect edge engagement in 10 and 12-mm trocar sites. All secured fascial defect sites did not prolapse while being observed or hand stretched. Specific Aims: The aims are to investigate suitable scaffold geometries and material/mechanical properties to enable secure and rapid closure of port fascial defects. Rapid deployment and engagement of the device system will be evaluated by iterating 3D engineering prototypes. Secure and safe tissue fixation will be evaluated by tensile strength testing of defect closures with select scaffold geometries, and by histological evaluation of wound healing response at fascial defect sites using in vivo chronic animal models. Overall Impact: Together, these studies will demonstrate the feasibility of bioabsorbable FAStlink scaffolds for pediatric laparoscopic trocar port fascial defect closures, and accelerate the commercialization of a superior pediatric defect closure technology for clinical use.