Tension-Free Bioabsorbable Scaffold for Pediatric Abdominal Wall Defect Closure

用于儿童腹壁缺损闭合的无张力生物可吸收支架

• 批准号: 9201427
• 负责人: Michael Fourkas
• 金额: $ 24.53万
• 依托单位: LAP IQ, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-05 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9201427
• 关键词: Abdomen; Adolescent; Adoption; Age; Anatomy; Animal Model; Animals; Autopsy; Biological; Blood Vessels; Childhood; Chronic; Clinical; Congenital diaphragmatic hernia; Congenital exomphalos; Data; Defect; Development; Devices; Engineering; Ensure; Evaluation; Face; Family suidae; Female; Foreign-Body Reaction; Gastroschisis; Geometry; Goals; Growth; Hand; Harvest; Healed; Health Care Costs; Hernia; Histopathology; Image; Imprisonment; Incidence; Infection; Inflammation; Inguinal Hernia; Injection of therapeutic agent; Injury; Intestinal Obstruction; Intestines; Laparoscopic Surgical Procedures; Laparoscopy; Lead; Learning; Maintenance; Mechanics; Mission; Modeling; Molds; National Institute of Child Health and Human Development; Necrosis; Needles; Obesity; Omentum; Operative Surgical Procedures; Outcome; Patients; Perforation; Phase; Physiological; Polymers; Postoperative Period; Procedures; Property; Ptosis; Puncture procedure; Quality of life; Recurrence; Residual state; Retrieval; Risk; Robotics; Safety; Secure; Site; Stretching; Surgeon; Surgical sutures; Suture Techniques; System; Technology; Tensile Strength; Testing; Thick; Time; Tissue Fixation; Tissue Model; Tissue Sample; Tissues; Trocars; Visual; Weight; Wound Healing; abdominal wall; abstracting; base; blind; chronic wound; clinical practice; commercialization; copolymer; design; healing; improved; in vivo; juvenile animal; male; materials science; novel; pediatric patients; poly(D,L-lactide-co-glycolide); polycaprolactone; pre-clinical; prototype; repaired; response; scaffold; tissue repair; tissue support frame; wound

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.

项目摘要/摘要 意义：当前基于缝合的套管针封闭技术的易用性和支持受到限制 伤口愈合。接受腹腔镜手术的儿科患者面临to肌疝的风险，增加 由于弯曲的针手缝合而导致的工作时间，容易刺穿，并增加了伤口愈合 由于腹部筋膜层的缝合张力变化而引起的时间。这个新型设备的开发支持 额外的小儿腹部伤口闭合指示，例如雌性，可能是雄性小儿腹股沟 疝气，脐疝，并有助于修复经常性先天性diaphragmaragmatic疝气，胃肠道 以及单端口和机器人端口站点缺陷。该设备代表了一种优越的筋膜缺陷闭合技术 通过验证新的脚手架设计，该设计有助于腹腔镜端口筋膜的手术修复和组织愈合 缺陷。为了与NICHD的任务保持一致，可生物吸附的脚手架系统有望实质上 降低并发症的风险并减少小儿外科医生的工作时间，降低医疗保健成本 腹腔镜手术后，付款人，改善儿科患者的生活质量。拟议的项目将 显着增强了儿科外科医生在改善腹腔镜临床实践方面的技术能力。这 总体项目目标是验证可生物吸附的脚手架设备概念，以无张力 小儿腹腔镜端口筋膜缺陷的关闭。假设：我们假设FastLink 脚手架将使小儿港口束缚缺陷更加一致，快速闭合，并改善安全性 与基于针头的缝合技术相比。初步数据：使用大型动物的初始快速链接原型 尸检模型，我们成功地展示了10毫米和12毫米套管卡部位的港口束缚边缘互动。 在观察或伸展时，所有有固定的筋膜缺陷部位均未脱垂。具体目的：目的 要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 关闭港口筋膜缺陷。设备系统的快速部署和参与度将由 迭代3D工程原型。安全且安全的组织固定将通过拉伸强度测试评估 缺陷封闭，具有精选的支架几何形状，并通过对筋膜的伤口愈合反应进行组织学评估 使用体内慢性动物模型的缺陷部位。总体影响：这些研究将共同​​证明 可生物吸收的快速链接支架可用于小儿腹腔镜套管针孔筋膜缺陷闭合和 加速了临床使用的高级小儿缺陷闭合技术的商业化。