Improved Performance of Neonatal Vascular Access Catheters via 3D Magnetic Printing

 描述（由申请人提供）：新生儿重症监护室（NICU）中婴儿的临床治疗特别具有挑战性，因为他们的解剖结构小，医疗不稳定， 未成熟的生理过程由于缺乏专门设计用于适应这一独特患者人群的治疗器械和仪器，治疗往往变得复杂。例如，目前的血管通路导管不是专门为新生儿患者的非常小的脉管系统设计和定制的，这加剧了常见的并发症，包括血管穿孔、血栓性闭塞、导管断裂和感染。制造复杂的、针对患者的新生儿导管将大大减少这些并发症，并更好地为这一人群服务。3D打印提供了生成复杂和患者特定3D架构的能力。我们在东北大学的合作者正在开创3D磁性打印，这是一种新技术，在打印过程中，增强陶瓷纤维与磁场对齐，以创建具有高度可调增强结构的复合材料。我们将使用3D磁性打印来生产坚固、灵活、针对患者的新生儿血管通路导管。具体而言，我们将生产可定制的复合导管管路，其具有增强的壁刚度和强度，同时保持柔韧性、爆破强度和抗扭结性。这种新颖的设计方法将允许生产具有更薄壁的下一代新生儿血管通路导管，从而允许减小导管直径和/或更高的流体输送速率。新生儿导管的3D磁性打印提供了以下优点：改善了对导管侧壁塌陷和扭结的抵抗力，这些塌陷和扭结通常会导致导管阻塞，以及更高的流体输送速率， 将血栓和纤维蛋白鞘形成的可能性降至最低。此外，3D打印技术与传统的导管材料（例如聚氨酯和硅树脂）兼容，并且允许利用生物相容性纤维（如羟基磷灰石），从而促进调节。 批准途径。该印刷方法是稳健的、低成本的和可扩展的。在第一阶段，我们将打印各种定制的纤维结构，包括纵向，横向和径向加强使用聚氨酯和硅胶的导管管材。样品表征将用于微调材料的有限元分析模型。该模型将用于设计改进的管材，以与传统挤压管材进行比较。我们的主要目标是展示具有减小的壁厚、优化的机械性能和增强的流动特性的管材的生产。在第II阶段，该模型将用于设计具有复杂增强结构的功能导管。

 DESCRIPTION (provided by applicant): Clinical treatment of infants in the neonatal intensive care unit (NICU) is particularly challenging due to their small anatomies, medical instability, and immature physiological processes. Treatment is often complicated by the lack of therapeutic devices and instrumentation designed specifically to accommodate this unique patient population. For instance, current vascular access catheters are not specifically designed and customized for the very small vasculature of neonatal patients, which exacerbates common complications including vessel perforation, thrombotic occlusions, catheter breakage, and infection. Creating sophisticated, patient-specific neonatal catheters would dramatically reduce these complications and work to better serve this population. 3D printing offers the ability to generate complex and patient-specific 3D architectures. Our collaborators at Northeastern University are pioneering 3D Magnetic Printing, a new technique in which reinforcing ceramic fibers are aligned with magnetic fields during the printing process to create composites with highly tunable reinforcement architectures. We will use 3D Magnetic Printing to produce strong, flexible, patient-specific neonatal vascular access catheters. Specifically, we will generate customizable composite catheter tubing with enhanced wall stiffness and strength while maintaining flexibility, burst strength and kink resistance. Such a novel design approach will allow production of next generation neonatal vascular access catheters with thinner walls, permitting reduction of catheter diameters and/or higher fluid transport rates. 3D Magnetic Printing of neonatal catheters offers the advantages of improved resistance to catheter sidewall collapse and kinking that often leads to catheter occlusion, and higher fluid transport rates which will minimize the probability of thrombus and fibrin sheath formation. Furthermore, the 3D printing technique is compatible with conventional catheter materials such as polyurethane and silicone and allows utilization of biocompatible fibers like hydroxyapatite facilitating regulatory approval pathways. The printing method is robust, low cost, and scalable. In Phase I we will print a variety of catheter tubing with customized fiber architectures including longitudinal, lateral, and radial reinforcement using both polyurethane and silicone. Sample characterization will be used to fine tune a finite element analysis model of the material. This model will be used to design improved tubing for comparison to conventionally extruded tubing. Our primary objective is to demonstrate the production of tubing with reduced wall thickness, optimized mechanical properties, and enhanced flow characteristics. In Phase II this model will be used to design functional catheters having complex reinforcement architecture.