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

Barry J. Doyle, Lachlan J. Kelsey, Caroline Shelverton, Gabriella Abbate, Carmen Ainola, Noriko Sato, Samantha Livingstone, Mahe Bouquet, Margaret R. Passmore, Emily S. Wilson, Sebastiano Colombo, Kei Sato, Keibun Liu, Silver Heinsar, Karin Wildi, Peter J. Carr, Jacky Suen, John Fraser, Gianluigi Li Bassi, Samantha Keogh

Research output: Contribution to journalArticlepeer-review

1 Citation (Web of Science)


Background: Peripheral 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 porcine model of intravenous access. Methods: We 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 (TM). We created FloRamp prototypes (test device) and tested them against a market-leading device (BD Insyte (TM); 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 6 h and terminated the experiment at 48 h. Veins were harvested for histology and seven pathological markers were assessed. Results: Computer simulations showed that the optimum FloRamp tip reduced maximum endothelial shear stress by 60%, from 12.7 Pa to 5.1 Pa, 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 h, 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) than 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. Conclusions: Herein we report preliminary assessment of a novel PIVC design, which could be advantageous in clinical settings through decreased device occlusion and reduced early failure rates.

Original languageEnglish
Pages (from-to)790-799
Number of pages10
JournalJournal of Vascular Access
Issue number3
Early online date24 Oct 2022
Publication statusPublished - May 2024


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