PDF(Pubmed)
Abstract：
UNASSIGNED: Leakage of orogastric secretions past the cuff of a tracheal tube is a contributory factor in ventilator-associated pneumonia. Current bench test methods specified in the International Standard for Anaesthetic and Respiratory Equipment (EN ISO 5361:2023) to test cuff leakage involve using a glass or plastic rigid cylinder model of the trachea. There is a need for more realistic models to inform cuff leakage.
UNASSIGNED: We used human computerised tomography data and additive manufacturing (3D printing), combined with casting techniques to fabricate a bio-inspired synthetic tracheal model with analogous tissue characteristics. We conducted cuff leakage tests according to EN ISO 5361:2023 and compared results for high-volume low-pressure polyvinyl chloride and polyurethane cuffs between the rigid cylinder trachea with our bio-inspired model.
UNASSIGNED: The tracheal model demonstrated close agreement with published tracheal tissue hardness for cartilaginous and membranous soft tissues. For high-volume low-pressure polyvinyl chloride cuffs the leakage rate was >50% lower in the bio-inspired tracheal model compared with the rigid cylinder model (151 [8] vs 261 [11] ml h-1). For high-volume low-pressure polyurethane cuffs, much lower leakage rates were observed than polyvinyl chloride cuffs in both models with leakage rates higher for the bio-inspired trachea model (0.1 [0.2] vs 0 [0] ml h-1).
UNASSIGNED: A reproducible tracheal model that incorporates the mechanical properties of the human trachea can be manufactured from segmented CT images and additive manufactured moulds, providing a useful tool to inform future cuff development, leakage testing for industrial applications, and clinical decision-making. There are differences between cuff leakage rates between the bio-inspired model and the rigid cylinder recommended in EN ISO 5361:2023. The bio-inspired model could lead to more accurate and realistic cuff leakage rate testing which would support manufacturers in refining their designs. Clinicians would then be able to choose better tracheal tubes based on the outcomes of this testing.
UNASSIGNED: We used human computerised tomography data and additive manufacturing (3D printing), combined with casting techniques to fabricate a bio-inspired synthetic tracheal model with analogous tissue characteristics. We conducted cuff leakage tests according to EN ISO 5361:2023 and compared results for high-volume low-pressure polyvinyl chloride and polyurethane cuffs between the rigid cylinder trachea with our bio-inspired model.
UNASSIGNED: The tracheal model demonstrated close agreement with published tracheal tissue hardness for cartilaginous and membranous soft tissues. For high-volume low-pressure polyvinyl chloride cuffs the leakage rate was >50% lower in the bio-inspired tracheal model compared with the rigid cylinder model (151 [8] vs 261 [11] ml h-1). For high-volume low-pressure polyurethane cuffs, much lower leakage rates were observed than polyvinyl chloride cuffs in both models with leakage rates higher for the bio-inspired trachea model (0.1 [0.2] vs 0 [0] ml h-1).
UNASSIGNED: A reproducible tracheal model that incorporates the mechanical properties of the human trachea can be manufactured from segmented CT images and additive manufactured moulds, providing a useful tool to inform future cuff development, leakage testing for industrial applications, and clinical decision-making. There are differences between cuff leakage rates between the bio-inspired model and the rigid cylinder recommended in EN ISO 5361:2023. The bio-inspired model could lead to more accurate and realistic cuff leakage rate testing which would support manufacturers in refining their designs. Clinicians would then be able to choose better tracheal tubes based on the outcomes of this testing.
摘要：
■口胃分泌物通过气管导管袖带的泄漏是呼吸机相关性肺炎的一个促成因素。在麻醉和呼吸设备国际标准(ENISO5361:2023)中规定的用于测试袖带渗漏的现有台架测试方法涉及使用气管的玻璃或塑料刚性圆筒模型。需要更现实的模型来告知袖带泄漏。
■我们使用了人类计算机断层扫描数据和增材制造（3D打印），结合铸造技术，制造出具有类似组织特征的生物启发合成气管模型。我们根据ENISO5361：2023进行了袖带泄漏测试，并将刚性圆柱气管与我们的生物启发模型之间的高容量低压聚氯乙烯和聚氨酯袖带的结果进行了比较。
■气管模型证明与已发表的软骨和膜状软组织的气管组织硬度非常吻合。对于高容量低压聚氯乙烯套管，与刚性圆筒模型相比，生物吸气气管模型的渗漏率低50%以上（151[8]对261[11]mlh-1）。对于高容量低压聚氨酯袖口，两种模型的渗漏率都比聚氯乙烯袖口低得多,生物吸气气管模型的渗漏率更高(0.1[0.2]vs0[0]mlh-1).
■可以从分割的CT图像和增材制造的模具中制造出一种可重现的气管模型，该模型结合了人体气管的机械性能，提供了一个有用的工具来告知未来的袖带发展，工业应用的泄漏测试，和临床决策。生物启发模型和ENISO5361：2023中推荐的刚性圆柱体之间的袖带泄漏率存在差异。生物启发模型可以导致更准确和现实的袖带泄漏率测试，这将支持制造商改进他们的设计。然后，临床医生将能够根据该测试的结果选择更好的气管导管。
■我们使用了人类计算机断层扫描数据和增材制造（3D打印），结合铸造技术，制造出具有类似组织特征的生物启发合成气管模型。我们根据ENISO5361：2023进行了袖带泄漏测试，并将刚性圆柱气管与我们的生物启发模型之间的高容量低压聚氯乙烯和聚氨酯袖带的结果进行了比较。
■气管模型证明与已发表的软骨和膜状软组织的气管组织硬度非常吻合。对于高容量低压聚氯乙烯套管，与刚性圆筒模型相比，生物吸气气管模型的渗漏率低50%以上（151[8]对261[11]mlh-1）。对于高容量低压聚氨酯袖口，两种模型的渗漏率都比聚氯乙烯袖口低得多,生物吸气气管模型的渗漏率更高(0.1[0.2]vs0[0]mlh-1).
■可以从分割的CT图像和增材制造的模具中制造出一种可重现的气管模型，该模型结合了人体气管的机械性能，提供了一个有用的工具来告知未来的袖带发展，工业应用的泄漏测试，和临床决策。生物启发模型和ENISO5361：2023中推荐的刚性圆柱体之间的袖带泄漏率存在差异。生物启发模型可以导致更准确和现实的袖带泄漏率测试，这将支持制造商改进他们的设计。然后，临床医生将能够根据该测试的结果选择更好的气管导管。
