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Blood Oxygenation

Warning: The oxygenators described on this page and elsewhere on this site are not approved by the FDA for use in humans. Membrane modules should not be used for blood oxygenation in humans under any circumstances.

Under the auspices of the National Institutes of Health, MedArray has further built upon it's proprietary membrane forming techniques and membrane device designs to improve long term blood oxygenating technology for extracorporeal membrane oxygenation (ECMO) oxygenators. Because MedArray's membrane hollow fibers are made from dense silicone, they are not susceptible to plasma leakage when used for extended periods, unlike microporous membranes which wet-out and leak  plasma when used in long term applications. Under NIH SBIR grant, we optimized membrane utilization and flow patterns in three ECMO oxygenator designs suitable for neonatal, pediatric, and adult patients requiring long term extracorporeal support. We used computational fluid dynamics (CFD), gas exchange models,  flow visualization, in-vitro, and in-vivo testing to enable the development of greatly improved ECMO oxygenators, suitable for replacing current FDA approved ECMO oxygenators with designs which date back to the early sixties.

ECMO prototypes


CFD simulations of the blood pressure field in the fiber bundle at rated flow. Note that the isobars are concentric indicating uniform radial flow.
CFD SIMULATIONS_ISOBARS

    Our results have shown that our three ECMO oxygenators designs can provide the necessary gas exchange and replace six currently commercially available ECMO oxygenators (Medtronic models) with significantly less membrane surface area, blood priming volume, hemodynamic pressure drop, and platelet consumption.  The tables below summarize results obtained in Phase II. Our goal is to further improve our designs and to conduct the necessary pre-clinical testing required for an eventual FDA submission for clinical use.

Table 1. Gas exchange performance comparison for MedArray's ECMO oxygenator designs.

Oxygenator
Size
Membrane Surface Area
(m2)
VO2 per m2 (cc/min/m2) VCO2 (cc/min)
Medtronic MedArray Medtronic MedArray Medtronic MedArray

Neonatal

0600 0.6

0.6

0600 78.3

116

0600 27

46

0800 0.8 0800 87.5 0800 37
Pediatric 1500 1.5 1.1 1500 76.7 92 1500 65 79

Adult

I-2500 2.5

2.8

I-2500 N/A

129

I-2500 N/A

221

I-3500 3.5 I-3500 N/A I-3500 N/A
I-4500 4.5 I-4500 88.9 I-4500 208

 


Table 2. ECMO oxygenator performance specifications.
Oxygenator
Size
    Rated Flow (L/min)        Priming Volume (cc)     Pressure Drop at Rated
Flow (mmHg)
Medtronic MedArray Medtronic MedArray Medtronic MedArray

Neonatal

0600 1.0

1.2

0600 90

53

0600 150

24

0800 1.2 0800 100 0800 312
Pediatric 1500 1.8 1.8 1500 175 98 1500 185 50

Adult

I-2500 4.5

6.5

I-2500 455

202

I-2500 N/A

211

I-3500 5.5 I-3500 575 I-3500 N/A
I-4500 6.5 I-4500 665 I-4500 300