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

doi:10.1177/11297298221127760

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 journal › Article › peer-review

1 Citation (Web of Science)

Abstract

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 language	English
Pages (from-to)	790-799
Number of pages	10
Journal	Journal of Vascular Access
Volume	25
Issue number	3
Early online date	24 Oct 2022
DOIs	https://doi.org/10.1177/11297298221127760
Publication status	Published - May 2024

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Doyle, B. J., Kelsey, L. J., Shelverton, C., Abbate, G., Ainola, C., Sato, N., Livingstone, S., Bouquet, M., Passmore, M. R., Wilson, E. S., Colombo, S., Sato, K., Liu, K., Heinsar, S., Wildi, K., Carr, P. J., Suen, J., Fraser, J., Li Bassi, G., & Keogh, S. (2024). Design, development and preliminary assessment in a porcine model of a novel peripheral intravenous catheter aimed at reducing early failure rates. Journal of Vascular Access, 25(3), 790-799. https://doi.org/10.1177/11297298221127760

@article{c0a030210622441a927d3434f4ddd5b0,

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

abstract = "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.",

keywords = "Catheters, dialysis access, new devices, biomaterials, intensive care, nursing, SHEAR-STRESS, ADULTS",

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

year = "2024",

month = may,

doi = "10.1177/11297298221127760",

language = "English",

volume = "25",

pages = "790--799",

journal = "Journal of Vascular Access",

issn = "1129-7298",

publisher = "SAGE Publications Ltd",

number = "3",

}

Doyle, BJ , Kelsey, LJ, Shelverton, C, Abbate, G, Ainola, C, Sato, N, Livingstone, S, Bouquet, M, Passmore, MR, Wilson, ES, Colombo, S, Sato, K, Liu, K, Heinsar, S, Wildi, K, Carr, PJ, Suen, J, Fraser, J, Li Bassi, G & Keogh, S 2024, 'Design, development and preliminary assessment in a porcine model of a novel peripheral intravenous catheter aimed at reducing early failure rates', Journal of Vascular Access, vol. 25, no. 3, pp. 790-799. https://doi.org/10.1177/11297298221127760

TY - JOUR

T1 - Design, development and preliminary assessment in a porcine model of a novel peripheral intravenous catheter aimed at reducing early failure rates

AU - Doyle, Barry J.

AU - Kelsey, Lachlan J.

AU - Shelverton, Caroline

AU - Abbate, Gabriella

AU - Ainola, Carmen

AU - Sato, Noriko

AU - Livingstone, Samantha

AU - Bouquet, Mahe

AU - Passmore, Margaret R.

AU - Wilson, Emily S.

AU - Colombo, Sebastiano

AU - Sato, Kei

AU - Liu, Keibun

AU - Heinsar, Silver

AU - Wildi, Karin

AU - Carr, Peter J.

AU - Suen, Jacky

AU - Fraser, John

AU - Li Bassi, Gianluigi

AU - Keogh, Samantha

PY - 2024/5

Y1 - 2024/5

N2 - 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.

AB - 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.

KW - Catheters

KW - dialysis access

KW - new devices

KW - biomaterials

KW - intensive care

KW - nursing

KW - SHEAR-STRESS

KW - ADULTS

U2 - 10.1177/11297298221127760

DO - 10.1177/11297298221127760

M3 - Article

C2 - 36281219

SN - 1129-7298

VL - 25

SP - 790

EP - 799

JO - Journal of Vascular Access

JF - Journal of Vascular Access

IS - 3

ER -

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

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