# Development of higher efficiency and safer Oxygenators for Critical Respiratory Failure Treatment and Heart/Lung Surgery Assist

> **NIH NIH R43** · CVD EQUIPMENT CORPORATION · 2022 · $259,613

## Abstract

Project Summary/Abstract
Essential life-maintaining O2 and CO2 gas exchanges for over 700,000 patients worldwide with critical
respiratory failure or undergoing heart/lung surgery are provided by flowing blood through an circuit containing
an extracorporeal oxygenator. Commercially available oxygenators use hollow fibers (HF) as gas exchange
components. Blood flows turbulently around the outside of these HFs while a sweep gas flows through their
hollow channels. Through the microporous HF walls, O2 diffuses into the blood, and CO2 diffuses out,
converting venous blood into arterial blood. However, key hemostatic complication risk factors, like blood-
contact area, priming volume, turbulent and high-pressure flow conditions, and accumulated shear stress, pose
continuous health risks that affect treatment and recovery (i.e., temporary cognitive impairment, etc.) and
contribute to significant morbidity and mortality (i.e., multiple organ failures, etc.), which are further aggravated
with prolonged use. HF oxygenator technology has only incrementally improved over the last decade and
alternative technologies that could significantly improve performance and/or safety are still in their infant (low
flow capacity) stage. The goal of this SBIR proposal is to develop first a pediatric and then an adult safer FAB-
Oxygenator. FAB-Oxygenators incorporate novel gas exchange components (Fluid channel Array Bricks,
herein called “FABs”) having a straight and laminar blood flow path, low-pressure drop, and a higher O2 and
CO2 gas transfer efficiency. These FAB-Oxygenators provide the required O2 and CO2 gas transfer rates with
lower levels of multiple key hemostatic complication risk factors, i.e. (i) blood contact surface area, (ii) priming
volume, (iii) pressure drop, and (iv) accumulated stress, thereby improving patient safety. These risk factors
affect blood damage and loss, platelet activation, coagulation risk, demand for blood products, and gas transfer
rate stability. The long-term goal of this SBIR proposal is to develop a family of safer oxygenators, optimally
configured for each patient class (neonatal, pediatric, small, and large adults). FAB-Oxygenator scale-up to
adult patient class, together with fully optimized FABs, under a future development, could lead to an
extracorporeal artificial lung. In Phase I, we will develop a safer pediatric FAB-Oxygenator. Feasibility will be
established by comparison to commercially available pediatric HF oxygenators through in vitro evaluation
under the FDA-recommended AAMI 7199 test protocol, and with modeling and a safety merit function value
comparison. Phase II, if granted, will be sufficient to complete extended in vitro verification/validation of up to
adult size FAB-Oxygenators, perform the first in vivo tests, begin the transfer to volume manufacturing, and
prepare for FDA submission. We plan to establish FAB-Oxygenator design licensing/technology transfer and
FABs/FAB-SubAssembly supply partnerships wit...

## Key facts

- **NIH application ID:** 10484485
- **Project number:** 1R43HL160306-01A1
- **Recipient organization:** CVD EQUIPMENT CORPORATION
- **Principal Investigator:** Karlheinz Strobl
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $259,613
- **Award type:** 1
- **Project period:** 2022-06-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484485

## Citation

> US National Institutes of Health, RePORTER application 10484485, Development of higher efficiency and safer Oxygenators for Critical Respiratory Failure Treatment and Heart/Lung Surgery Assist (1R43HL160306-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10484485. Licensed CC0.

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