Degradation and Fatigue Behavior of 3D Printed Bioresorbable Tracheal Splints

3D 打印生物可吸收气管夹板的降解和疲劳行为

• 批准号: 9751354
• 负责人: Scott J Hollister
• 金额: $ 58.2万
• 依托单位: GEORGIA INSTITUTE OF TECHNOLOGY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-19 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9751354
• 关键词: 3-Dimensional; 3D Print; Acute; Address; Affect; Anatomy; Animal Model; Animals; Behavior; Blood Vessels; Caliber; Cartilage; Cessation of life; Child; Clinical; Clinical Trials; Custom; Data; Development; Devices; Elements; Emergency Situation; Engineering; Environmental air flow; Event; Failure; Family suidae; Fatigue; Finite Element Analysis; Future; Geometry; Growth; Height; Implant; In Vitro; Legal patent; Length; Life; Liquid substance; Measures; Mechanical Stimulation; Mechanics; Modeling; Molecular Weight; NR4A1 gene; New England; Operative Surgical Procedures; Pathway interactions; Patients; Phase I Clinical Trials; Pre-Clinical Model; Prevalence; Printing; Probability; Process; Property; Publishing; Reporting; Resistance; Risk; Safety; Splint Device; Spottings; Stress; Structure; Surgical sutures; TNFRSF11B gene; TR-2 mycotoxin; Testing; Thick; Thinness; Time; Tracheobronchial; Tracheobronchomalacia; Tracheostomy procedure; United States; airway remodeling; base; cartilage development; clinical application; design; follow-up; improved; in vitro testing; in vivo; insight; mechanical properties; meetings; off-patent; polycaprolactone; pre-clinical; pressure; respiratory; success

Abstract Tracheobonchomalacia (TBM) is a congenital or acquired deficiency of tracheal and/or bronchial cartilages that presents with dynamic airway collapse, respiratory difficulties, and, in severe cases, acute life-threatening events. TBM prevalence is estimated at 1 in 2,200 children1, and severe cases can result in death or require tracheostomy with ventilation for 2-3 years, a significant burden on the child and family2,3. We recently developed a bioresorbable, patient specific 3D printed polycaprolactone (PCL) splint to treat TBM, reporting the first case in the New England J. of Medicine4. Three subsequent children with life threatening TBM were saved with the splint and the first child continues to be asymptomatic 30 months post-surgery. However, long term clinical application of the splint requires further engineering to reduce the risk of fatigue failure in addition to understanding how resorption of the splint affects mechanical deformation and remodeling of the airway to improve safety and efficacy of the splint. In addition, the FDA also requires such data for regulatory approval based on our August 22, 2014 meeting with the FDA to initiate a phase I clinical trial for Humanitarian Device Exempt (HDE) approval. We will address these questions in two specific aims using both in vitro and in vivo preclinical model, the Yorkshire pig. The first aim will characterize splint degradation both in vitro and in vivo for up to 2 years. The second aim will use this data to characterize how the splint affects airway mechanics.

抽象的 气管结构（TBM）是气管和/或支气管的先天性或可靠性的缺陷 呈现动态气道崩溃，呼吸困难以及严重的软骨 案例，急性威胁生命的事件。 TBM患病率估计为2,200名儿童中的1个，1 严重的病例可能导致死亡或需要气管切开术并进行通风2 - 3年，a 儿童和家庭重大负担2，3。我们最近开发了可生物吸收的患者 特定的3D印刷多丙酮酸（PCL）夹板以治疗TBM，报告了第一种情况 新英格兰医学J.4。随后的三个有生命威胁性TBM的儿童得救了 夹板和第一个孩子在手术后30个月继续进行。 但是，夹板的长期临床应用需要进一步的工程以减少 除了了解夹板的吸收如何影响机械外，疲劳失败的风险 气道的变形和重塑，以提高夹板的安全性和功效。在 此外，FDA还需要根据我们2014年8月22日的此类数据进行监管批准 与FDA会面，启动I阶段临床试验人道主义设备豁免（HDE） 赞同。我们将使用体外和体内的两个具体目标中解决这些问题 临床前模型，约克郡猪。第一个目的将表征夹板降解都在 体内和体内长达2年。第二个目标将使用此数据来表征 夹板影响气道力学。