Self-unfolding RV-PA 3D Printed Conduits

自展开 RV-PA 3D 打印导管

• 批准号: 9245197
• 负责人: David H Gracias
• 金额: $ 23.72万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-19 至 2018-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9245197
• 关键词: 3D Print; Adult; Anatomy; Animal Model; Autopsy; Biological Models; Blood; Blood flow; Cardiac Surgery procedures; Cardiopulmonary; Cardiopulmonary Bypass; Cell physiology; Characteristics; Child; Childhood; Coupled; Custom; Devices; Dimensions; Endothelial Cells; Erythrocytes; Evaluation; Extracellular Matrix; FDA approved; Goretex; Growth; Heart; Histologic; Immunohistochemistry; Implant; In Vitro; Infant; Inflammation; Ink; Left; Leukocytes; Lung; Measures; Medicine; Modeling; Modification; Obstruction; One-Step dentin bonding system; Operative Surgical Procedures; Organ; Palliative Care; Patients; Pediatric Surgical Procedures; Performance; Phase; Platelet Activation; Printing; Process; Pulmonary artery structure; Quality of life; Repeat Surgery; Resolution; Right ventricular structure; Sampling; Series; Shapes; Sheep; Structure; Surface; System; Testing; Thoracotomy; Thrombosis; Time; Tissue Harvesting; Tube; Validation; Vascular blood supply; base; biomaterial compatibility; congenital heart disorder; design; follow-up; hemodynamics; implantable device; improved; in vitro testing; in vivo; infancy; mechanical properties; model design; novel; operation; prototype; simulation

Project Summary/Abstract Right ventricle–to–pulmonary artery (RV-PA) conduits are frequently used as a surgical palliative treatment for a variety of congenital heart diseases in infants and children. Due to the growth of the infant or child, or complications like kinking or thrombosis of the device, these conduits require replacement which may involve several major open heart surgery before adulthood. We propose to utilize 3D printing to design and develop a novel RV-PA conduit that increases its size via tailored self-unfolding triggered by flow and time so that fewer complications as well as surgeries are required to maintain and develop normal pulmonary blood flow from infancy to adulthood. It is envisioned that 3D printing will also allow for improved precision in patient customization and on-demand design changes to enable better functionality. We anticipate that self- unfolding mechanisms and associated shape changes will result in operation of the conduits over longer periods of infant and child growth into adulthood. In the R21 phase, we will design, fabrication, surface modification, and in-vitro testing of self-unfolding RV- PA conduits. We will first conduct printing parameter studies for 3D printing of FDA-approved materials for fabrication of RV-PA conduits with variable dimensions. Simultaneously, we will utilize numerical simulations to determine design parameters that allow size changes and validate these using in-vitro tests for functionality and biocompatibility. In the R33 phase, we will upgrade our 3D printer and refine the RV-PA conduits to enable printing with better resolution and with fluoropolymer inks to eliminate the need for surface modification. Finally, we will validate in- vivo operation using comprehensive hemodynamic evaluations and post-mortem gross-histological evaluation in a sheep model. We will analyze extracellular matrix formation, characterize endothelial cell function and white blood cell activation, and quantify immunohistochemistry for inflammation analysis. We anticipate that these studies will enable a new class of RV-PA conduits as well as serve as a model for designing patient-specific shape changing biomedical implants for infants that are capable of growing at the same rate to reduce the number of follow up operations.

项目摘要/摘要 右通气至肺动脉（RV-PA）导管经常用作手术姑息治疗 用于婴儿和儿童的各种先天性心脏病。由于婴儿或儿童的成长，或 诸如扭结或设备血栓形成之类的并发症，这些导管需要更换，这可能涉及 成年前进行了几项主要的心脏手术。我们建议利用3D打印来设计和开发 一种新型的RV-PA导管，通过量身定制的自我折叠增加了流动和时间触发的尺寸，因此 维持和发展正常的肺部需要较少的并发症和手术 从婴儿期到成年的血流。可以预见的是，3D打印还可以提高精度 患者定制和按需设计更改以实现更好的功能。我们预计这是自我的 展开的机制和相关的形状变化将导致导管在更长的时间内运行 婴儿和儿童成长的成长。 在R21阶段，我们将设计，制造，表面修饰和自我折叠RV-的体外测试 PA导管。我们将首先进行印刷参数研究，以用于3D打印FDA批准的材料 具有可变尺寸的RV-PA导管的制造。同时，我们将使用数值模拟 确定允许大小更改并使用视频内测试的功能和功能和 生物相容性。 在R33阶段，我们将升级3D打印机，并完善RV-PA导管以更好地启用打印 分辨率和氟聚合物墨水以消除对表面修饰的需求。最后，我们将验证 使用全面的血流动力学评估和验尸后的体内操作 在绵羊模型中。我们将分析细胞外基质形成，表征内皮细胞功能和白色 血细胞激活并量化免疫组织化学以进行感染分析。 我们预计这些研究将使一类新的RV-PA导管以及作为模型 设计特定于患者的形状，以改变能够在 减少随访操作数量的相同速率。