A new top-loading venous bag provides vacuum-assisted venous drainage.

A new venous bag has been developed, prototyped, and tested. The new bag has its inlet, outlet purge, and infusion tubes extending upward from the top of the bag, and are threaded through, bonded to, and sealed within a flat rigid top plate. This design allows the bag to be hung from its top plate by its tubes. It also allows the bag to be: 1) dropped into or removed from its holder, as is done with existing hard-shell reservoirs so that its weight pulls it into the holder without the need for eyelets and hooks and 2) placed closer to the floor so that gravity drainage is facilitated. The V-Bag (VB) is easily sealed within an accompanying rigid housing. Once sealed, vacuum applied to the housing is transmitted across the flexible walls of the bag to the venous blood. Thus, vacuum-assisted venous drainage (VAVD) is obtained as it is with a hard-shell reservoir, but without any contact of air with the blood. Bench tests, using a circuit that simulated the venous side of the cardiopulmonary bypass (CPB) circuit, showed that applying suction to the housing increased venous flow, and the fractional increase in flow was not a function of the venous cannula, but of the level of vacuum applied. In the gravity drainage mode, the bubble counts at the outlet of the V-Bag compared to two other bags were lower at any pumping condition. When used in the VAVD mode, bubble counts were two orders of magnitude lower than when using kinetically assisted venous drainage (KAVD) with a centrifugal pump. Results obtained with the VB suggest its clinical usefulness.

A new bladder allows kinetic venous augmentation with a roller pump.

Augmented venous drainage improves venous return during minimally invasive cardiac surgery. Two systems to augment drainage are common: in one, a centrifugal pump draws blood from the venous site and pumps it into a venous reservoir. In the other, suction is applied directly to a hard-shell venous reservoir. Both systems overcome the high resistance of the venous cannula when gravity alone is insufficient to provide adequate drainage. Both systems also have shortcomings: in the first approach, the centrifugal pump head can entrap large bubbles, reducing flow and requiring pump stoppage to remove them. Air from the venous line also can be broken up by the centrifugal pump into small bubbles that can pass through the pump head. The direct suction system in the second approach cannot use a closed-bag reservoir, and has the potential to introduce air into the arterial line. We have developed a new venous augmentation system for a closed venous reservoir that provides excellent suction control without the potential to introduce air into the arterial line. Our system replaces the centrifugal pump of the first approach with a roller pump controlled by the Better-Bladder, a new device with FDA 510(k) clearance for long-term pumping. The Better-Bladder is a length of medical tubing, processed to form a thin-walled, enlarged bladder that is sealed within a clear rigid housing. It acts as an in-line reservoir that provides compliance in the venous line and a noninvasive means to measure blood pressure at the pump inlet. The bladder housing can maintain a negative pressure set by the user that controls the degree of gravity drainage. Tests have shown that the Better-Bladder allows for safe, smooth pump control using a roller pump in the venous line.

An improved bladder for pump control during ECMO procedures.

A new inline reservoir called the Better-Bladder, now FDA-cleared for long term use, overcomes some disadvantages of the silicone bladder and bladder box used in extracorporeal membrane oxygenation circuits. The Better-Bladder provides compliance in the venous line and allows for noninvasive pressure measurements. Both features are useful for controlling pump speed as a function of venous line pressure. Bench tests showed that the Better-Bladder measures pressure noninvasively within +/- 4% of invasive (i.e., liquid contacting) pressure measurements in a range from -200 to +500 mmHg and at temperatures from 10 degrees C to 37 degrees C. After 60 days, the error in noninvasive pressure measurement with the Better-Bladder was less than +/- 3%. The Better-Bladder withstood pressurization to 1700 mmHg for ten days without leaking or failing in other ways. The advantages of the Better Bladder, along with its accuracy and durability, suggest its use for short and long term pumping applications.

Clinical evaluation of setting pump occlusion by the dynamic method: effect on flow.

Pump manufacturers recommend setting roller pump occlusion such that the level of a 100 cm column of crystalloid drops 2.5 cm/min (Sarns, 8000 Modular Perfusion System, operator's manual, roller pump software version 2.3L. May 1993; 2.1-2.14). Though this almost occlusive setting ensures accurate pump flow, it has been shown to cause more hemolysis than nonocclusive pumps (Noon GP, Kane LE, Feldman L et al. Reduction of blood trauma in roller pumps for long-term perfusion. World J Surg 1985; 9: 65-71). We conducted a clinical study (n = 19) to compare the standard occlusion method with the dynamic method and to determine the accuracy of flow for the nonocclusive pump. Standard occlusion was set by clamping the pump tubing distal to the arterial line filter and timing the drop in pump outlet pressure as indicated by a pressure transducer connected to the filter. The occlusion setting, expressed in mmHg/s, was recorded for each roller at two specific points along the raceway. The pump was then set nonocclusively with the dynamic method using the Better Header (BH) (Circulatory Technology, Oyster Bay, NY, USA). Readings of the change in pressure in the same two selected points on the raceway were taken. The latter was repeated after discontinuation of bypass. Flow was recorded throughout the procedure from both roller pump output display and a flow meter (Model #109 Transonic, Ithaca, NY, USA). The average drop in pump outlet pressure for the standard method was 1.3 +/- 4.0 (range 0-18 mmHg/s), and for the dynamic method was 38 +/- 28 (range 1.2-89 mmHg/s). Off bypass, the average reading was 44 +/- 38 (range 2.0-103 mmHg/s). Regression analysis indicates that patient flow, when corrected for retrograde flow by the dynamic method, equals 1.003 x revolutions per minute + 40 ml/min (r2 = 0.964). The average error between indicated pump flow, corrected for retrograde flow, was -1% (range from -6.7 to 6.6%). We conclude that the BH allows nonocclusive setting (30 times less than our standard method) without sacrificing pump flow accuracy.

Errors in flow and pressure related to the arterial filter purge line.

The purge line is a necessary component on arterial filters, although its presence may affect the amount of flow reaching the patient as well as the pump outlet pressure in the extracorporeal circuit. In-vitro and clinical studies conducted to investigate these effects with a commonly used purge line showed that at flows less than 1.5 L/min, rates for pediatric or infant patients, the purge line diverts as much as 40% of the intended pump flow away from the patient. A small diameter resistance tube connected in series with the purge line reduced purge flow such that over 80% of the pump flow reached the patient. Pressure monitored at the arterial filter port with the purge line open could be as much as 45 mmHg lower than the pressure measured with the purge line closed to the filter. Studies should be done to determine if the arterial filter purge line compromises flow to the patient, and if an additional resistance to the purge line is appropriate to reduce the flow through it.

New roller pump disposable provides safety and simplifies occlusion setting.

A new disposable insert for the arterial roller pump, the Better-Header, provides safety and functionality beyond what standard tubing provides. It automatically limits pump outlet pressure to a level determined by the user and provides a self-contained, simple means to set pump occlusion. The Better-Header consists of a Starling-like pressure relief valve connected across standard header tubing. As long as arterial line pressure at the pump outlet remains below a set limit, the valve is closed. If line pressure approaches the pressure limit, the valve opens, preventing overpressurization by shunting blood from pump outlet to inlet. The Better-Header can also be used to set occlusion by the "dynamic method" to obtain nonocclusive settings. The Better-Header was evaluated in the lab for its pressure-flow characteristics. Even when the arterial line was completely clamped at a pump flow of 7 L/min, line pressure was limited to a safe level and all circuit connections were preserved. The Better-Header has been used successfully at North Shore University Hospital in over 500 clinical cases covering a wide range of patients and procedures. In several instances, the user was alerted to high pressure situations by fluid flow through the valve and by an audible alarm, allowing rapid correction of the source of pressure. Compared to the standard setup, the Better-Header maintains outlet pressure within safe, user-settable limits, and permits consistent, nonocclusive settings with predictable retrograde flow.

A dynamic method for setting roller pumps nonocclusively reduces hemolysis and predicts retrograde flow.

In general, roller pumps are set almost occlusively despite evidence that nonocclusive settings cause less hemolysis. Almost-occlusive settings are used because of the concern that forward flow would not be accurately known if retrograde flow were allowed to occur through a nonocclusive gap. This article presents a dynamic method for setting roller pumps nonocclusively that overcomes the many difficulties of the "drop method" for setting occlusion. Studies were conducted to determine the effect of nonocclusive settings on pump flow and hemolysis generated; the results suggest that roller pumps can and should be set more nonocclusively than is the currently accepted standard to reduce pump related hemolysis without greatly affecting pump performance. The dynamic method allows retrograde flow to be easily predicted and corrected with an increase in pump speed.

The effects of pressure and flow on hemolysis caused by Bio-Medicus centrifugal pumps and roller pumps. Guidelines for choosing a blood pump.

Two Bio-Medicus BP-50 centrifugal pumps and two roller pumps were tested simultaneously with porcine blood at 21 degrees +/- 1 degree C in four in vitro circuits to determine the effect of four combinations of flow and pressure conditions on blood damage. Flows of 300 ml/min (1/4-inch inner-diameter tubing in the roller pump) and 1775 ml/min (1/2-inch inner-diameter tubing in the roller pump) and pressure differences across the pump (delta P = outlet pressure--inlet pressure) of 215 mm Hg (n = 6) and 345 mm Hg (n = 5) were examined. The index of hemolysis (milligrams plasma hemoglobin per 100 L blood pumped) for the BP-50 pump was higher at a flow of 300 ml/min than at a flow of 1775 ml/min (p < 0.0002). At 300 ml/min, the index of hemolysis for the BP-50 pump tended to be higher at 345 mm Hg than at 215 mm Hg (mean +/- standard error of the mean, 135 +/- 22 versus 88 +/- 9, p = 0.059). At 1775 ml/min, there was no difference in the index of hemolysis for the BP-50 pump between 215 and 345 mm Hg (37 +/- 7 versus 29 +/- 5, p = 0.32). With the roller pump, the index of hemolysis was higher at a flow of 300 ml/min than at a flow of 1775 ml/min (p < 0.036), but there was no difference in the indexes of hemolysis between 215 and 345 mm Hg at 300 ml/min (60 +/- 9 versus 61 +/- 11, p = 0.93) or at 1775 ml/min (40 +/- 6 versus 36 +/- 6, p = 0.61). Comparison between the two types of pumps showed that the index of hemolysis was significantly higher for the BP-50 than for the roller pump at a flow of 300 ml/min and a delta P of 215 mm Hg (88 +/- 9 versus 60 +/- 9, p = 0.009), as well as at a flow of 300 ml/min and a delta P of 345 mm Hg (135 +/- 22 versus 61 +/- 11, p = 0.001). At a flow of 1775 ml/min, there was no difference in the index of hemolysis between the two pumps at either pressure condition.(ABSTRACT TRUNCATED AT 250 WORDS)

Bloodless testing for microporous membrane oxygenator failure: a preliminary study.

The use of a bloodless solution and high pressure to accelerate microporous membrane oxygenator (MMO) failure was investigated. It was hypothesized that albumin acts as a wetting agent, contributing to plasma leakage through the membrane, and that high MMO outlet pressure accelerates the process. Three MMO, B-Bentley BCM-40 (n = 7), M-Medtronic Maxima (n = 4), and S-Sarns 16310 (n = 7) were tested at 37 +/- 2 degrees C using three identical closed recirculating circuits and four conditions: 1) Lactated Ringer solution (LR) with MMO outlet pressure (Pmo) 750 mmHg; 2) LR + albumin (4 g/100 ml), Pmo 150 mmHg; 3) LR + albumin, Pmo 300 mmHg; and 4) LR + albumin, Pmo 750 mmHg. "Blood" flow and gas flow were maintained at 2 l/min. Failure was indicated when Na+ was detected in the effluent of the MMO exhaust gas. There were no failures without albumin in the solution. B and M showed no signs of failure under any of the test conditions at 78 hours. S failed at (mean +/- SEM) 4.9 +/- 1.0, 12.1 +/- 0.2, and 19 hours for conditions 4, 3, and 2 respectively. Preceding failure, inlet gas pressure increased more than eightfold (27 +/- 1 to 224 +/- 34 mmH2O). These preliminary results are similar to previous findings with blood and suggest that high MMO outlet pressure and the presence of albumin may promote plasma breakthrough for S. The combination may provide a basis for an accelerated bloodless test for MMO compatibility with long-term respiratory support.

The effect of high pressure on microporous membrane oxygenator failure.

A retrospective study to determine the relationship between early microporous membrane oxygenator (MMO) failure and blood pressure at the MMO outlet (Pmo) was conducted using data collected with 19 dogs (22 +/- 1 kg, mean +/- SEM) undergoing routine normothermic cardiopulmonary bypass. Because gas flow was maintained at a high level, it could not be used to control CO2 exchange. Instead, blood PCO2 was controlled by adding CO2 to the sweep gas. Blood PO2 was controlled as suggested by the manufacturer, by adjusting the %O2 in the gas phase (g). Blood flow was 2575 +/- 54 ml/min; Pmo ranged from 173 to 790 mm Hg; and hematocrit was 33 +/- 1%. O2 exchange was calculated from blood gas parameters. Changes in the diffusion potential of O2 (delta PO2) and CO2 (delta PCO2) and MMO performance (P, taken as oxygen exchange normalized to a diffusion potential of 100 mm Hg) indicated MMO failure. Initial values, taken within 60 min of bypass initiation, were compared to final values taken at 226 +/- 9 min of bypass. Despite higher final delta PO2 (411 +/- 9 vs. 538 +/- 19 mm Hg, p less than 0.0001 paired t-test) and delta PCO2 (18.6 +/- 2.4 vs. 30.5 +/- 4.7 mm Hg, p less than 0.0017), arterial blood PO2 decreased (159 +/- 15 to 89 +/- 6 mm Hg, p less than 0.0005) and PCO2 increased (36.4 +/- 1.5 to 46.1 +/- 3.0 mm Hg, p less than 0.0039), and the performance decreased [24.5 +/- 1.1 to 20.1 +/- 0.7 (ml/min)/(100 mm Hg), p less than 0.0001].(ABSTRACT TRUNCATED AT 250 WORDS)