Initial evaluation of an intracorporeal oxygenation device

Abstract

SummaryWe describe a recently developed intracorporeal gas transfer device, its potential applications and hazards. To date, patients with potentially reversible respiratory failure have been treated with controlled oxygen therapy and positive pressure ventilation. but this treatment may itself contribute to lung parenchymal damage from barotrauma and oxygen toxicity. Total or partial extracorporeal gas exchange can be used to reduce these risks, but this treatment is complex and has SigniJicant morbidity and mortaIity. This gas exchange device has been designed to provide partial gas transfer with simplicity of insertion and use. The oxygenator lies in the vena cava to provide prepulmonary gas exchange. In preliminary studies with three calves we have shown that the device increases both mean mixed venous and arterial oxygen content and reduces mean arterial carbon dioxide tension.

Intravascular Gas Exchange: Physiology, Literature Review, and Current Efforts

“…43 Various sizes were tested clinically ranging from 38-48 Fr (1.26-1.6 cm) in diameter in the furled insertional configuration and 30-40 cm in length. 32 These devices had a surface area ranging from 0.2-0.5 m 2 . 43 The IVOX device was tested in a clinical trial from 1990-1993 in 160 subjects with acute hypoxic and/or hypercapnic respiratory failure receiving positive-pressure ventilation.…”

Development of a novel intravascular oxygenator catheter: Oxygen mass transfer properties across nonporous hollow fiber membranes

“…The first and only such intravascular device to reach human clinical trials was the intravascular oxygenator (IVOX) catheter, which was composed of over 1,000 microporous polypropylene hollow fibers coated in siloxane furled together to fit in the vena cava with subatmospheric oxygen flowing within. While this device delivered a measurable oxygen amount, its large size (12.6–16 mm diameter in furled insertion configuration, containing 0.21–0.51 m 2 of diffusing surface area) was cumbersome and led to a 24.5% clinically recognized complication rate, including bleeding during insertion, thrombophlebitis, and hemodynamic instability (Cockroft et al, 1992; Conrad et al, 1994). IVOX did not gain FDA approval and device development was halted (Federspiel & Henchir, 2004).…”