The pumping oxygenator: design criteria and first in vitro results

A new project is presented, the pumping oxygenator, functionally integrating pulsatile pumping and blood oxygenation in a single device. Solid, semipermeable silicone membranes allow gas exchange and simultaneously transfer energy from pressurized gas to blood thanks to their distensibility and to inlet and outlet 1-way valves. Two small-sized (1 m2 exchange surface area) prototypes were designed, constructed, hydraulically characterized, and subjected to gas transfer evaluation tests. Blood flow rates (Q(b)) up to 1,250 ml/min were obtained with 30 mm Hg static preload and 130 mm Hg afterload with 0.7 m upstream and 2.1 m downstream 3/8 inch pipes. Physiological oxygen transfer (VO2 = 5 ml/dl, ml of transferred O2/dl of treated blood) was delivered at Q(b) < 900 ml/min, about 4 ml/dl at Q(b) = 1,250 ml/min. VO2 also was significantly increased by increasing percent systolic time. CO2 transfer decreased regularly with increasing Q(b) from VCO2 = 4.8 ml/dl at Q(b) = 400 ml/min to VCO 2 = 2.1 ml/dl at Q(b) = 1,250 ml/min. The results confirm the possibility of integrating oxygenation and pulsatile pumping. The pumping oxygenator represents a promising project deserving further improvements.     

Laboratory evaluation of a new membrane oxygenator with a built-in hemoconcentrator

In order to facilitate the handling of cardiopulmonary bypass (CPB) and simplify the circuit, we have developed a new membrane oxygenator with a hemofiltration function. The hollow fiber units for gas exchange and hemofiltration were combined in concentric circles in a cylindrical housing. The total priming volume was 190 ml. Because we used a silicon-coated hollow fiber membrane for gas exchange, this oxygenator was completely resistant to serum leakage. The gas exchange and hemofiltration sections both have a blood-outside flow configuration. All blood flows in a radial direction from around the central core to the surrounding hollow fiber units, first to the hemofiltration portion and then to the gas exchange section. Filtered fluid was easily collected through a stopcock mechanism. The oxygen transfer rate was 312 ml/min at a blood flow rate of 6 L/min, and the ultrafiltration rate was 3.5 L/hour at a blood flow rate of 4 L/min with 25% hematocrit and 200 mmHg transmembrane pressure in an in vitro study. The pressure drop was 62 mmHg at a blood flow rate of 4 L/min. We found no adverse effects in an in vivo study using a mongrel dog. In conclusion, this durable combined device could achieve excellent and simplified hemoconcentration by having all the blood in the unit flow through the hemofiltration portion, and may be useful not only in CPB during open heart surgery, but also in extracorporeal membrane oxygenation.     

Gas Transfer Performance of a Hollow Fiber Silicone Membrane Oxygenator: Ex Vivo Study

Based on the results of in vitro studies of many experimental models, a silicone hollow fiber membrane oxygenator for pediatric cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) was developed using an ultrathin silicone hollow fiber with a 300 microm outer diameter and a wall thickness of 50 microm. In this study, we evaluated the gas transfer performance of this oxygenator simulating pediatric CPB and ECMO conditions. Two ex vivo studies in a pediatric CPB condition for 6 h and 5 ex vivo studies in an ECMO condition for 1 week were performed with venoarterial bypass using healthy calves. At a blood flow rate of 2 L/min and V/Q = 4 (V = gas flow rate, Q = blood flow rate) (pediatric CPB condition), the O2 and CO2 gas transfer rates were maintained at 97.44 +/- 8.88 (mean +/- SD) and 43.59 +/- 15.75 ml/min/m2, respectively. At a blood flow rate of 1 L/min and V/Q = 4 (ECMO condition), the O2 and CO2 gas transfer rates were maintained at 56.15 +/- 8.49 and 42.47 +/- 9.22 ml/min/m2, respectively. These data suggest that this preclinical silicone membrane hollow fiber oxygenator may be acceptable for both pediatric CPB and long-term ECMO use.     

Oxygenator with Built-in Hemoconcentrator: A New Concept

Abstract: A hemoconcentrator is an instrument essential for open heart surgery without blood transfusion. In order to simplify the extracorporeal blood circuit and to facilitate handling of cardiopulmonary bypass, we have combined a hollow fiber unit for gas exchange and that for hemofiltration into one component and developed a new membrane oxygenator with the function of a hemoconcentrator. The cylindrical device consists of a hollow fiber for hemofiltration with another fiber for gas exchange provided outside. Both of them adopt the blood outside perfusion system. Blood enters and flows through the central hole for hemofiltration and then flows into the oxygenator. By applying the flow mode to the device, blood is allowed to flow from the center of the core toward the hollow fiber around it. Therefore, even distribution of blood flow to the entire fiber is realized, and the performance of the device is improved. The oxygen transfer rate was 317 ml/min at a flow rate of 6 L/min, and the ultrafiltration rate was 7 L/h at a flow rate of 4 L/tnin with a hematocrit of 25%. The combined structure of the two units has not caused any adverse effects. In conclusion, by combining an oxygenator and a hemoconcentrator, excellent and simplified hemoconcentration is made available as the blood outside flow mode is adopted, which is one of the unique aspects of this device.     

Development of a New Hollow Fiber Silicone Membrane Oxygenator: In Vitro Study

An experimental silicone hollow fiber membrane oxygenator for long-term extracorporeal membrane oxygenation (ECMO) was developed in our laboratory using an ultrathin silicone hollow fiber. However, the marginal gas transfer performances and a high-pressure drop in some cases were demonstrated in the initial models. In order to improve performance the following features were incorporated in the most recent oxygenator model: increasing the fiber length and total surface area, decreasing the packing density, and modifying the flow distributor. The aim of this study was to evaluate the gas transfer performances and biocompatibility of this newly improved model with in vitro experiments. According to the established method in our laboratory, in vitro studies were performed using fresh bovine blood. Gas transfer performance tests were performed at a blood flow rate of 0.5 to 6 L/min and a V/Q ratio (V = gas flow rate, Q = blood flow rate) of 2 and 3. Hemolysis tests were performed at a blood flow rate of 1 and 5 L/min. Blood pressure drop was also measured. At a blood flow rate of 1 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 72.45 +/- 1.24 and 39.87 +/- 2.92 ml/min, respectively. At a blood flow rate of 2 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 128.83 +/- 1.09 and 47.49 +/- 5.11 ml/min. Clearly, these data were superior to those obtained with previous models. As for the pressure drop and hemolytic performance, remarkable improvements were also demonstrated. These data indicate that this newly improved oxygenator is superior to the previous model and may be clinically acceptable for long-term ECMO application.     

Development of a new silicone membrane oxygenator for ECMO.

Two types small and efficient ECMO oxygenators were developed utilizing the most up to date hollow fiber technology. Newly silicone hollow fibers possess sufficient mechanical strength while maintaining ultra thin walls of 50 micro meter. Two types of oxygenators were made with this fiber. The fiber length for the type 1 module is 150mm with a priming volume 194 cc (surface area 1.3 m(2)) and type 2 has a fiber length of 100 mm with a 144 cc priming volume (the surface area 0.8 m(2)). The studies were performed at 0.5, 1.0 and 2.0 L/min of blood flow and these oxygenators demonstrated. O(2) gas transfer rate of 69+/-4 ml/min/L for type 1 and 68+/-6 ml/min/L for type 2. The CO(2) gas transfer rate was 25+/-2 ml/min/L for type 1 and 32+/-2 ml/min/L for type 2. These results demonstrate type 2 oxygenator has similar gas exchange capabilities to those of Kolobows' oxygenator which has about 2.0 times larger surface area. Additionally, comparative hemolysis tests were preformed with this new oxygenator and the Kolbow. The NIH value was 0.006 (g/100 L) for the type 1 oxygenator and 0.01 (g/100 L) for the Kolbow oxygenator. These results suggested that this ECMO oxygenator had sufficient gas exchange performance in spite of being smaller and induced minimal blood damage.     

Gas-exchange function of a preprimed pediatric oxygenator stored for one year for emergency cardiopulmonary bypass

To save priming time and perform more rapid initiation of emergency cardiopulmonary bypass for acute cardiopulmonary failure, an extracorporeal circuit with a hollow-fiber oxygenator (EL-2000 for pediatric use; Kurary Co. Ltd., Osaka, Japan) was preprimed, and the gas-exchange function was evaluated after 1 year of storage. EL-2000 has a dense polyolefin membrane with a surface area of 0.3 m2. When the bypass flow rates were 250, 500, 1,000, and 1,500 ml/min with 100% oxygen at the same flow rate as the bypass blood flow (namely, V/Q = 1) to the oxygenator, oxygen transport rates of the stored oxygenator were 19.6 +/- 0.3, 38.3 +/- 0.41, 64.4 +/- 0.9, and 76.4 +/- 2.7 ml/min (n = 5, mean +/- SD), respectively. PCO2 differences between pre- and postoxygenator blood (delta PCO2) were 18.6 +/- 1.4, 12.0 +/- 1.6, and 4.4 +/- 1.2 mm Hg at V/Q = 1 and the same bypass blood flow rates, respectively, excluding 1,500 ml/min, the data for which were excluded because of preparatory failure. PCO2 removal indices (defined as the ratio of delta PCO2 to PCO2 in preoxygenator blood) were 0.45 +/- 0.03, 0.29 +/- 0.12, and 0.10 +/- 0.03, respectively. Though the evaluation was done using only a single oxygenator, we feel strongly that the gas-exchange function of the preprimed dense-membrane hollow fiber oxygenator will be preserved even after 1 year of storage.     

Initial clinical experience with a more efficient hollow fiber oxygenator of unique design

The first 90 cardiac surgery cases perfused with a new hollow fiber membrane oxygenator in which the gas flows through the fibers and blood flows around the fibers are reported. The fibers are microporous polypropylene with a pore size of 0.03 microns. Membrane surface area is 2.0 M2 and priming volume is 480 ml, including heat exchanger PaO2 is controlled by FIO2 and PaCO2 by gas flow rate. Patients as large as 2.36 M2 were perfused up to 348 min using hemodilution and hypothermia. The mean PaO2 was 200 mmHg and the mean PaCO2 39.5 mmHg. Oxygen transfer was as high as 230 ml/min. This low prime device transfers large volumes of gas, an efficiency which results from a crossed arrangement of the fibers to break up laminar flow of the blood around them. The low priming volume makes it appropriate for use in all but the smallest patients.     

Preclinical evaluation of a new hollow fiber silicone membrane oxygenator for pediatric cardiopulmonary bypass: ex-vivo study.

Based on the results of many experimental models, a hollow fiber silicone membrane oxygenator applicable for long-term extracorporeal membrane oxygenation (ECMO) was developed. For further high performance and antithrombogenicity, this preclinical model was modified, and a new improved oxygenator was successfully developed. In addition to ECMO application, the superior biocompatibility of silicone must be advantageous for pediatric cardiopulmonary bypass (CPB). An ex vivo short-term durability test for pediatric CPB was performed using a healthy miniature calf for six hours. Venous blood was drained from the left jugular vein of a calf, passed through the oxygenator and infused into the left carotid artery using a Gyro C1E3 centrifugal pump. For six hours, the O2 and CO2 gas transfer rates were maintained around 90 and 80 ml/min at a blood flow rate of 2 L/min and V/Q=3, respectively. The plasma free hemoglobin was maintained around 5 mg/dl. These data suggest that this newly improved oxygenator has superior efficiency, less blood trauma, and may be suitable for not only long-term ECMO but also pediatric CPB usage.     

Extracorporeal membrane oxygenator compatible with centrifugal blood pumps

Coil-type silicone membrane oxygenators can only be used with roller blood pumps due to the resistance from the high blood flow. Therefore, during extracorporeal membrane oxygenation (ECMO) treatment, the combination of a roller pump and an oxygenator with a high blood flow resistance will induce severe hemolysis, which is a serious problem. A silicone rubber, hollow fiber membrane oxygenator that has a low blood flow resistance was developed and evaluated with centrifugal pumps. During in vitro tests, sufficient gas transfer was demonstrated with a blood flow less than 3 L/min. Blood flow resistance was 18 mm Hg at 1 L/min blood flow. This oxygenator module was combined with the Gyro C1E3 (Kyocera, Japan), and veno-arterial ECMO was established on a Dexter strain calf. An ex vivo experiment was performed for 3 days with stable gas performance and low blood flow resistance. The combination of this oxygenator and centrifugal pump may be advantageous to enhance biocompatibility and have less blood trauma characteristics.     

Considerations and Problems in the Development of the Mini-Spindle Pump

Abstract: The premise for the development of the mini-spindle pump, planned as an implantable device for assisted circulation, was to transport 4 L of water/min in mock circulation with a speed of 12–15,000 rpm against an afterload of 90 mm Hg. After calculations, the resulting first prototype had a spindle rotor with 3 threads (outer diameter, 18 mm; inner diameter, 6.2 mm; length, 45 mm) in a U-shaped housing, driven by an electric motor with a cooling system. In mock circulation, this pump moved 7.8 L of water/min at 18,000 rpm. To avoid animal experiments, its influence on the blood was tested in a Maxima oxygenator. The device circulated 4.2 L of blood/min with the same speed. Because of its high traumatic he-molysis rate (>250 mg% of free hemoglobin after 7 h of pumping), the rotor was modified, first without effect at 2.5 threads and then at 4 threads. In addition, in this third prototype, the flow direction was reversed. This prototype was more effective (4.3 L of blood/min at 12,000 rpm in the oxygenator) and the hemolysis rate, after a pumping duration of 8 h, could only be reduced to 180 mg% of free hemoglobin. As a result, a fourth prototype was developed (i.e., the U-shape of the housing was abandoned). This device functioned better than the third prototype (4.5 L of blood/min at 12,000 rpm in the oxygenator), but the blood trauma increased (220 mg% of free hemoglobin after 7 h of pumping). To find out if the oxygenator may be responsible for the hemolysis problem, the 16th prototype of the large spindle pump was tested in the oxygenator. The result was expected, the level of free plasma hemoglobin was high again (190 mg%). To verify the function of the third and the fourth prototype of the mini-spindle pump, 4 animal experiments were performed. Under normal cardiac conditions, the devices emptied the left ventricle up to 70% with a speed between 10,500 and 11,200 rpm, moving about 6 L of blood/min (afterload between 65 and 90 mm Hg). The hemolysis rates were between 32 and 90 mg% of free hemoglobin in the plasma.     

Initial In Vitro Evaluation of a Pediatric Vortex-Mixing Membrane Lung

Abstract: A new design for a pediatric membrane lung is described in this paper. The lung consists of eight blood compartments, each having six U-shaped blood channels, with microporous PTFE membranes supported on rigid plates in such a way that the membranes form furrowed blood channels. Two rolling diaphragm pumps are attached to the open ends of the U-shaped blood channels; these pumps are operated in antiphase. Mean flow is provided by a roller pump placed at the inlet end of the membrane lung. Pulsatile blood flow within the blood channels produces successive vortex formation and ejection, leading to good blood mixing and high efficiency in gas transport. The design of the rolling diaphragm piston pumps ensures that the blood prime volume is low (280 ml), and the grouping of the pumps at one end of the oxygenator allows the driving mechanism to be simple and compact. The relatively wide blood channels (minimum width 0.5 mm) and vortex mixing make priming the membrane lung particularly easy. The membrane area is 0.39 m². Preliminary performance testing of the pediatric membrane lung was undertaken by pumping blood around a circuit containing a roller pump, the membrane lung, and a bubble oxygenator (to adjust the blood gases at the inlet to the membrane lung). In five such experiments it was shown that the membrane lung transferred 80 ml O₂/min and 120 ml CO₂/min at a blood flow rate of 1.5 L/min.     

From the spinning disc to the membrane oxygenator for open-heart surgery

Gibbon's rotating cylinder could not be enlarged to oxygenate an animal larger than a cat. The spinning disc oxygenator, introduced in 1947, had the capacity to perfuse a dog and the potential to increase oxygenation capacity by addition of more discs. When centers began to do three to four open-heart operations per day, the disposable bubble oxygenator was more practical. Bubble size was optimized to decrease the flow of oxygen relative to the blood flow and reduce trauma to blood. The bubble oxygenator is the type most commonly used today. Use of deep hypothermia with whole blood at an esophageal temperature of 10 degrees C was initially complicated by brain damage due to aggregation of white blood corpuscles and platelets. The introduction of hemodilution permitted safe utilization of hypothermic perfusion. Perfusion of infants should not be carried out at hematocrit below 25 ml/100 m. Early membrane oxygenators used nonporous silicone, or modified silicone membranes. High priming volumes, high pressure drop and marginal gas transfer efficiency characterized these devices. Recent advances in membrane technology have spawned a new generation of membrane oxygenators utilizing microporous polypropylene. In these new oxygenators, with either microporous hollow fibers or sheet membrane, the gas transfer characteristics are far superior to those of types produced in the past. The hollow-fiber devices typically have larger surface areas and higher pressure drop than in the new state-of-the-art flat plate models. An evaluation of one of these new-generation membrane oxygenators gave optimal oxygen and carbon dioxide exchange at a gas flow of 1 l/min of 60% oxygen in air at 30 degrees C and 2 l/min of 80% oxygen in air at normal temperature and rewarming for an adult. Today, after almost 40 years of oxygenator development, these new membrane device can offer better platelet preservation and reduced blood trauma as compared with types developed in the past. The new membrane oxygenators are fast becoming the preferred choice for use in infants and in protracted perfusion.     

Effects of Ultrathin Silicone Coating of Porous Membrane on Gas Transfer and Hemolytic Performance

Abstract: To assess the effect of an ultrathin (0.2 μm) silicone-coated microporous membrane oxygenator on gas transfer and hemolytic performance, a silicone-coated capillary membrane oxygenator (Mera HP Excelung-prime, HPO-20H-C, Senko Medical Instrument Mfg. Co., Ltd. Tokyo, Japan) was compared with a noncoated polypropylene microporous membrane oxygenator of the same model and manufacturer using an in vitro test circuit. The 2 oxygenators showed little difference in the oxygen (O₂) transfer rate over a wide range of blood flow rates (1 L/min to 8 L/min). The carbon dioxide (CO₂) transfer rate was almost the same in both devices at low blood flow rates. but the silicone-coated oxygenator showed a decrease of more than 20% in the CO₂ transfer rate at higher blood flow rates. This loss in performance could be partly attenuated by increasing the gas/blood flow ratio from 0.5 or 1.0 to 2.0. In the hemolysis study, the silicone-coated membrane oxygenator showed a smaller increase in plasma free hemoglobin than the noncoated oxygenator. The pressure drop across both oxygenators was the same. These results suggest that the ultrathin silicone-coated porous membrane oxygenator may be a useful tool for long-term extracorporeal lung support while maintaining a sufficient gas transfer rate and causing less blood component damage.     

Initial clinical experience with a low pressire drop membrane oxygenator for cardiopulmonary bypass in adult patients

The new Travenol oxygenator is composed of 80 parallel blood pathways. Microporous membrane separates the blood and gas compartments. The membrane surface area is 3 m², with a pore size of 0.01 microns. Venous blood drains directly from the patient through the oxygenator, then through an integral heat exchanger and into a reservoir, from which a single arterial pump returns the blood to the patient. The advantage of this configuration of membrane oxygenator is simplicity of setup and operation. A disadvantage that we have observed is an apparent variation in resistance to blood flow through the oxygenator during clinical perfusion. Construction changes in a later version of the oxygenator have reduced the resistance to flow through the blood pathway.This device has been used for 20 perfusions at moderate hypothermia (mean 31.8 °C) in patients up to 2.1 m² body surface area for up to 313 minutes. Blood flow was 2.1 to 5.6 liters/min, partial arterial oxygen pressure 100 to 394 torr, partial arterial carbon dioxide pressure 19 to 57 torr (mean 37 torr) and, arterial pH 7.29 to 7.56 (mean 7.41). Oxygen transfer was as high as 230 ml/min.This integral oxygenator-heat exchanger-reservoir is operated like a bubble oxygenator, with direct venous drainage through the device and a single pump, but it uses a membrane oxygenator for gas exchange to eliminate the detrimental effects of bubbles.     

Partial cardiopulmonary bypass in rats using a hollow fibre oxygenator

Despite new minimally invasive techniques, cardiopulmonary bypass (CPB) is still necessary for many major operations in the field of cardiac surgery. Unwanted side effects of CPB are well known but poorly understood. We therefore developed a rodent model to study the pathophysiology of these potential complications. Male Fischer rats were anaesthetized, intubated and ventilated. The carotid artery and jugular vein were cannulated. The blood was actively drained from the venous circulation and further transferred by a miniaturized roller pump to a hollow fibre oxygenator and back to the animal via the carotid artery. The roller pump produces a pulsatile blood flow between 5 and 40 ml/min. The surface of the hollow fibre oxygenator is 0.025 m2. The priming volume (Ringer solution) of the whole system is 12 ml. Animals were catheterized and brought in partial bypass for a mean of 50+/-15 min. Normal cardiac function after successful weaning was confirmed by electrocardiography and blood pressure measurements. This technical study demonstrates the feasibility of a small animal model of CPB. The main improvement over existing techniques is the use of a highly effective hollow fibre oxygenator with a minimized priming volume. Therefore, no additional animals are needed as blood donors.     

Studies on ECMO. (III)--Study on pumpless A-V ECMO

Silicon hollow fiber membrane oxygenator is considered to be useful for long term extracorporeal membrane oxygenation (ECMO) and blood usually flows inside of the fiber (inside flow type). But if it flows outside of the fiber (outside flow type), the pressure drop is supposed to be less than that of inside flow type. In this study the oxygenator of an outside flow type was used. At first, the pilot study was done to evaluate the capability of this oxygenator as an outside flow type. The pressure drop was 50 mmHg at the blood flow of 400 ml.min-1. At this blood flow and same gas flow, CO2 transfer rate was 22.3 ml.min-1. In the second study, the effects of pumpless arterio-venous ECMO (pumpless A-V ECMO) were studied in 8 dogs under mechanical hypoventilation. During ECMO, there were no significant changes in hemodynamics when the blood flow rate was 15% of cardiac output. PaO2 and PaCO2 recovered considerably. In conclusion, pumpless A-V ECMO using this membrane oxygenator of outside flow type is effective for CO2 removal and considered to be clinically useful.     

Description of a flow optimized oxygenator with integrated pulsatile pump

Extracorporeal membrane oxygenation (ECMO) is a well-established therapy for several lung and heart diseases in the field of neonatal and pediatric medicine (e.g., acute respiratory distress syndrome, congenital heart failure, cardiomyopathy). Current ECMO systems are typically composed of an oxygenator and a separate nonpulsatile blood pump. An oxygenator with an integrated pulsatile blood pump for small infant ECMO was developed, and this novel concept was tested regarding functionality and gas exchange rate. Pulsating silicone tubes (STs) were driven by air pressure and placed inside the cylindrical fiber bundle of an oxygenator to be used as a pump module. The findings of this study confirm that pumping blood with STs is a viable option for the future. The maximum gas exchange rate for oxygen is 48mL/min/L(blood) at a medium blood flow rate of about 300mL/min. Future design steps were identified to optimize the flow field through the fiber bundle to achieve a higher gas exchange rate. First, the packing density of the hollow-fiber bundle was lower than commercial oxygenators due to the manual manufacturing. By increasing this packing density, the gas exchange rate would increase accordingly. Second, distribution plates for a more uniform blood flow can be placed at the inlet and outlet of the oxygenator. Third, the hollow-fiber membranes can be individually placed to ensure equal distances between the surrounding hollow fibers.     

Development of an Intravenous Membrane Oxygenator: Enhanced Intravenous Gas Exchange Through Convective Mixing of Blood around Hollow Fiber Membranes

Abstract: In vitro testing of a new prototype intravenous membrane oxygenator (IMO) is reported. The new IMO design consists of matted hollow fiber membranes arranged around a centrally positioned tripartite balloon. Short gas flow paths and consistent, reproducible fiber geometry after insertion of the device result in an augmented oxygen flux of up to 800% with balloon activation compared with the static mode (balloon off). Operation of the new IMO device with the balloon on versus the balloon off results in a 400% increase in carbon dioxide flux. Gas flow rates of up to 9. 5 L/min through the 14–cm–long hollow fibers have been achieved with vacuum pressures of 250 mm Hg. Gas exchange efficiency for intravenous membrane oxygenators can be increased by emphasizing the following design features: short gas flow paths, consistent and reproducible fiber geometry, and most importantly, an active means of enhancing convective mixing of blood around the hollow fiber membranes     

Experimental evaluation of the Medtronic Maxima Forté hollow fiber membrane oxygenator.

A new hollow fiber membrane oxygenator, the Medtronic Maxima Forté, was tested for gas transfer, blood path resistance and blood handling characteristics in a standardized setting with surviving animals. Three calves (mean body weight: 71 +/- 9.6 kg) were placed on cardiopulmonary bypass at a mean flow rate of 50 ml/kg/min for six hours. The circuit included the Maxima Forté oxygenator. The animals were weaned from cardiopulmonary bypass and then from the ventilator. After seven days, the animals were sacrificed electively. Physiologic blood gas values could be maintained throughout perfusion in all animals. Mean pressure drop through the oxygenator varied between 49 mmHg and 66 mmHg. The respective baseline values for red blood cell count, white blood cell count and platelets were 8.90 +/- 1.26 10(6)/mm3, 7.46 +/- 3.17 10(3)/mm3. and 680 +/- 216 10(3)/mm3. Red blood cell and platelet counts dropped slightly to 7.26 +/- 1.61 10(6)/mm3 and 400 +/- 126 10(3)/mm3 at the end of the bypass, whereas the white blood cell count increased up to 9.13 +/- 5.25 10(3)/mm3. All three cell lines returned to near their baseline values after seven days. Blood trauma evaluated as a function of plasma hemoglobin (plasma Hb) and lactate dehydrogenase (LDH) showed stable values during all the perfusion time. Both peaked at 24 hours before returning to their baseline values at seven days. LDH showed a statistically significant variation: 3255 +/- 693 IU at 24 hours versus 2029 +/- 287 IU at baseline (p = 0.04). The variation of plasma Hb was not statistically significant (93.5 +/- 7.7 mumol/l at 24 hours versus 77.3 +/- 52.3 mumol/l at baseline) indicating a weak effect of the perfusion on blood trauma. The Medtronic Maxima Forté hollow fiber membrane oxygenator offered good gas exchange capabilities, a low pressure drop, and low blood trauma over a prolonged perfusion time of six hours in this evaluation.