Design, development, and preliminary assessment of a novel peripheral intravenous catheter aimed at reducing early failure rates

Doyle, B.; Kelsey, L.; Shelverton, C.; Abbate, G.; Ainola, C.; Carr, P.; Livingstone, S.; Bouquet, M.; Passmore, M.; Wilson, E.; Colombo, S. M.; Sato, K.; Liu, K.; Heinsar, S.; Sato, N.; Wildi, K.; Suen, J.; Fraser, J.; Li Bassi, G.; Keogh, S.

doi:10.1101/2022.06.20.496233

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bioRxiv · 10.1101/2022.06.20.496233

Design, development, and preliminary assessment of a novel peripheral intravenous catheter aimed at reducing early failure rates

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Abstract

BackgroundPeripheral intravenous catheters (PIVCs) are the most commonly used invasive medical device, yet despite best efforts by end-users, PIVCs experience unacceptably high early failure rates. We aimed to design a new PIVC that reduces the early failure rate of in-dwelling PIVCs and we conducted preliminary tests to assess its efficacy and safety in a large animal model of intravenous access. MethodsWe used computer-aided design and simulation to create a PIVC with a ramped tip geometry, which directs the infused fluid away from the vein wall; we called the design the FloRamp. We created FloRamp prototypes (test device) and tested them against a market-leading device (BD Insyte; control device) in a highly-controlled setting with five insertion sites per device in four pigs. We measured resistance to infusion and visual infusion phlebitis (VIP) every six hours and terminated the experiment at 48 hours. Veins were harvested for histology and seven pathological markers were assessed. ResultsComputer simulations showed that the optimum FloRamp tip reduced maximum endothelial shear stress by 60%, from 12.7Pa to 5.1Pa, compared to a typical PIVC tip, and improved the infusion dynamics of saline in the blood stream. In the animal study, we found that 2/5 of the control devices were occluded after 24 hours, whereas all test devices remained patent and functional. The FloRamp created less resistance to infusion (0.73{+/-}0.81 vs 0.47{+/-}0.50, p=0.06) and lower VIP scores (0.60{+/-}0.93 vs 0.31{+/-}0.70, p=0.09) that the control device, although neither findings were significantly different. Histopathology revealed that 5/7 of the assessed markers were lower in veins with the FloRamp. ConclusionsAs PIVCs are used in almost every hospitalized patient, there is an urgent need to reduce failure rates. Herein we report preliminary assessment of a novel PIVC design, which could be advantageous in clinical settings through decreased device occlusion.

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Doyle, B., Kelsey, L., Shelverton, C., Abbate, G., Ainola, C., Carr, P., Livingstone, S., Bouquet, M., Passmore, M., Wilson, E., Colombo, S. M., Sato, K., Liu, K., Heinsar, S., Sato, N., Wildi, K., Suen, J., Fraser, J., Li Bassi, G., Keogh, S.. 2022-06-21. Design, development, and preliminary assessment of a novel peripheral intravenous catheter aimed at reducing early failure rates. https://doi.org/10.1101/2022.06.20.496233

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