Extracorporeal blood handling system with automatic flow control and methods of use

Abstract

Apparatus for processing blood in an extracorporeal circuit with automatic flow control is provided in which error conditions are sensed and system operation is modulated responsive to the error conditions. The apparatus includes an extracorporeal blood processing system, at least one sensor that senses the presence or absence of gas or monitors venous pressure, and a controller operably coupled to the blood processing system to selectively reduce pump speed or to reconfigure flow paths within the blood processing system responsive to the sensor output.

Description

FIELD OF THE INVENTION [0001] The present invention relates to an extracorporeal blood handling system with automatic flow control and methods for use for monitoring and detecting error conditions, and modulating flow through the extracorporeal blood handling system in response to the detected error conditions. BACKGROUND OF THE INVENTION [0002] For more than thirty years, vascular diseases have been treated using open surgical procedures. In 1999 alone, 753,000 open-heart procedures, including coronary artery bypass grafting (CABG), valve replacements, and heart transplants, were performed. During a typical CABG procedure, a sternotomy is performed to gain access to the pericardial sac, the patient is put on cardiopulmonary bypass (CPB), and the heart is stopped using a cardioplegia solution. [0003] Generally, previously-known CPB is accomplished by constructing an extracorporeal blood handling system including, inter alia, a venous line, a venous reservoir, a centrifugal or roller...

AI Technical Summary

Benefits of technology

[0016] In view of the foregoing, it is an object of the present invention to provide an extracorporeal blood handling system that monitors and automatically modulates system operation in response to trigger conditions, thereby increasing the time available for an operator, e.g., the perfusionist, to correct trigger conditions.

[0017] It is another object of the present invention to provide an extracorporeal blood handling system that monitors and automatically modulates pump speed in response to the detection of gas in the system, to enhance the ability of an air evacuation line to remove the air and avoid depriming of the pump.

[0023] In a first mode, the automatic flow control system of the present invention comprises a controller coupled to at least one sensor disposed to sense air. Upon sensing a bolus of air, the microprocessor reduces the pump speed to a predetermined lower limit. The predetermined lower limit preferably is determined such that forward blood flow is maintained through the extracorporeal circuit to the patient.

Problems solved by technology

Previously-known methods of CPB are susceptible to several error or trigger conditions.

This may occur in a number of ways, including inadvertent opening of a vent line, improper priming of the circuit, or by turning the heart during surgery.

In addition, differences between blood inflow to a venous reservoir and outflow from the venous reservoir due to the pump head can lead to depletion of the reservoir and the entrainment of large amounts of air.

If returned to the patient, air can cause significant patient injury such as brain damage, cardiac dysfunction, and myocardial damage.

Further, an air-blood mixture may cause turbulence and high shear stresses within the circuit, resulting in hemolysis and humoral and / or cellular activation.

Unfortunately, this strategy leads to no forward flow to the patient, with potentially serious consequences if flow is not restored promptly.

Low venous pressure is a known risk factor for air entrainment and may result in depletion of the venous reservoir as previously discussed, thus requiring blood delivery to the patient to be suspended while the condition is corrected or the CPB system is re-primed.

Yet another problem with previously-known extracorporeal blood handling systems is the substantial suction force required for proper air evacuation due to an open air source.

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