A phantom study :|evaluation of a novel three-lumen balloon catheter for threatment of intractable limb ischemia

Abstract

Peripheral artery disease (PAD) is a serious health problem that includes occlusive arterial syndrome. Critical limb ischemia (CLI) which is the most severe form induces extremity gangrene or ulcers extremity rest pain which mostly can lead to limb loss. The most common CLI criteria: (a) 30 mmHg or less toe systolic pressure, (b) 0.4 or less ankle-brachial index (ABI), (c) 50 mmHg or less systolic ankle pressure. In this study, a custom made three lumen catheter (9 Fr) including a distal inflatable balloon in between the inflow and outflow lumen holes was constructed based on Hyper Perfusion Catheter patent (patent no: 2011/07038) owned by Emir Yusuf, MD. The aim of this catheter design is to elevate ankle and/or toe systolic pressures above 50-60 mmHg to promote healing and/or alleviating intractable pain due to intractable ischemia for patients with CLI. To simulate the blood circulation of related anatomy, in vitro CLI model phantom was designed and constructed by using a modified hemodialysis circuit; a hemodialysis pump and a tube set were used in bypass surgery procedures. 10% aqueous glycerol solution (by weight in water) was used to mimic human blood plasma. The data was collected by a custom-made circuit in real time and all measurements were verified with industrial certificated medical devices. In vitro CLI model phantom experiments have shown that it is feasible to elevate the pressure distal to the occlusion (representing ankle pressure) up to 80 mmHg without increasing the systemic pressure in certain conditions.|Keywords : Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI), Ankle Systolic Pressure, 9 Fr Three Lumen Catheter.