Initial experiences with a new design for a preattached intravenous port device

Abstract

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.

Long-Term Results of a Standard Algorithm for Intravenous Port Implantation

“…This strategy not only preserved the whole layer of subcutaneous tissue but also avoided catheter impingement. By adhering to the algorithm, hematoma, port erosion, impingement-related fracture [ 25 ], and malfunction were markedly decreased [ 6 ]. Intra-operative fluoroscopy not only allowed real-time monitoring of port implantation, it also helped to standardize the catheter-nut angle and to optimize the tip location [ 5 , 6 ].…”

Does catheter material affect functional performance of intravenous ports via the superior vena cava?

“…The former avoids the pinch-off syndrome caused by repetitive compression generated by the 1st rib and clavicle ( Fig 3C and 3D ) [ 18 , 19 ], and the latter avoids catheter impingement caused by persistent external forces generated by the surrounding tissue ( Fig 3C and 3E ) [ 19 ]. From the literature review, another potential fracture site is the mounting of the catheter at the protruding stud of the connecting tube [ 19 , 25 ]. At the protruding stud, the catheter material is stretched and the locking nut with its conjugate inner structure is locked onto the protruding stud of the connecting tube.…”

“…At the protruding stud, the catheter material is stretched and the locking nut with its conjugate inner structure is locked onto the protruding stud of the connecting tube. The shear forces generated by the locking nut and protruding stud of the connecting tube are focused on the reduced wall thickness which may lead to broken integrity ( Fig 3C and 3F ) [ 19 , 25 ]. This is frequently seen after longer periods of implantation [ 26 ], however, we did not observe it in this study.…”