Blood Oxygenation
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.

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

