The cardiopulmonary bypass circuit (i.e. the Heart Lung Machine) that supports patients undergoing cardiac surgery, is constantly being refined. Both the venous reservoir and the cardiotomy reservoir, prominent in the cardiopulmonary bypass circuit have weakness. Phase II SBIR funding allowed us to develop a Hybrid venous reservoir that (1) is superior in air handling, (2) provides the safety of a venous reservoir bag with the ease of setup and use of a hard shell (open) venous reservoir (3), delivers clinically useful features (e.g. two chamber cardiotomy reservoir that separates dirty and clean blood) and (4) eliminates shortfalls of current systems (e.g. large blood-air interface, early mixing of venous blood and sucker blood filtrate). The reservoir would allow CPB using minicircuits that provide low priming/operating volume and low surface area without the drawbacks of current minicircuits. If clinical conditions require, the circuit can be converted to standard bypass having the volume capacity of the venous reservoir chamber by moving a single tubing clamp., and the data collected will be used to apply for a 510k submission to the FDAThe funding requested will be used to optimize manufacture of the Hybrid reservoir. Tools and manufacturing processes that meet FDA requirements for a Class II device will be procured and employed to assemble clinical units. The units will be tested under conditions that imitate clinical bypass using calves.
The relevance of the proposed research to public health is to provide a device that would make the cardiopulmonary bypass circuit (i.e. the Heart Lung Machine) that supports patients undergoing cardiac surgery, safer for the patient and easier to use for the clinician.