Division of Thoracic and Cardiovascular Surgery, Department of Surgery, Chang Gung University, Chang Gung Memorial Hospital, Linkou, Taiwan.
Division of Chest, Department of Internal Medicine, Chang Gung University, Chang Gung Memorial Hospital, Linkou, Taiwan.
J Biomed Mater Res B Appl Biomater. 2018 Apr;106(3):1017-1027. doi: 10.1002/jbm.b.33911. Epub 2017 May 8.
All available conventional ports share a common design, including catheter, locking nut, and port body, and all share two sites of structural weakness. One site is the junction between the locking nut and the proximal end of the catheter. The other site is the catheter fixation site between the locking nut and the protruding stud of the connecting tube. To overcome these shortcomings, we designed a new type of intravenous port which combines the connecting tube into one piece. The aims of this study were to test the mechanical characteristics of the new design and assess its safety in animal study. The prototype of the preattached port was manufactured from biocompatible materials, including PEEK, silicone and polyurethane. All components were assembled with biocompatible glue and mechanical and safety tests were performed to determine the mechanical strength, and tissue reaction of surrounding soft tissue and entry vessels. The mechanical tests showed the new design would not lead to catheter fracture in the oscillation test. The traction test showed significant peak load (18.75 ± 3.29 vs. 26.61 ± 1.75 N; p = 0.036) because of the difference in catheter extension capacity (26.57 ± 4.28 vs. 47.93 ± 2.45 mm; p = 0.012). Significantly smaller endurable injection pressure was identified in the prototype. (90 ± 20 vs. 177.5± 9.48 psi; p = 0.01) The safety test showed good tolerance in beagle dogs and led to no intravascular thrombus and minimal reaction in surrounding tissues. The new prototype preattached port showed good mechanical strength and overcame two potential structural weakness points. The integrated fixation design not only reduced the dimensions of the port device but also provided a greater injection area compared to current designs. It did not cause intravascular thrombosis and produced minimal tissue reaction in surrounding soft tissue, as identified by autopsy. The new design of the fixation device could serve as the basis for the next generation of intravenous ports. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1017-1027, 2018.
所有可用的常规端口都具有共同的设计，包括导管、锁定螺母和端口体，并且都具有两个结构薄弱部位。一个部位是锁定螺母和导管近端之间的连接处。另一个部位是锁定螺母和连接管突出螺柱之间的导管固定部位。为了克服这些缺点，我们设计了一种新型的静脉端口，将连接管组合成一个整体。本研究的目的是测试新设计的机械特性，并在动物研究中评估其安全性。预装端口的原型由生物相容性材料制成，包括聚醚醚酮、硅酮和聚氨酯。所有组件均用生物相容性胶组装，并进行机械和安全测试，以确定机械强度以及周围软组织和进入血管的组织反应。机械测试表明，新设计不会导致振荡测试中的导管断裂。牵引测试显示，由于导管延伸能力的差异，显著的峰值负载（18.75±3.29 与 26.61±1.75 N；p=0.036）。（26.57±4.28 与 47.93±2.45 mm；p=0.012）。原型中可承受的注射压力明显较小。（90±20 与 177.5±9.48 psi；p=0.01）安全测试表明在比格犬中具有良好的耐受性，不会导致血管内血栓形成，周围组织反应最小。新型预装端口具有良好的机械强度，克服了两个潜在的结构弱点。集成固定设计不仅减小了端口设备的尺寸，而且与现有设计相比提供了更大的注射区域。尸检显示，它不会引起血管内血栓形成，也不会引起周围软组织的明显反应。固定装置的新设计可以作为下一代静脉端口的基础。2017 年 Wiley 期刊公司。J 生物医学材料研究 B：应用生物材料，106B：1017-1027，2018 年。
