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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL066810-04A1
Application #
8057578
Study Section
Special Emphasis Panel (ZRG1-SBTS-E (10))
Program Officer
Baldwin, Tim
Project Start
2001-02-01
Project End
2013-01-31
Budget Start
2011-02-15
Budget End
2012-01-31
Support Year
4
Fiscal Year
2011
Total Cost
$634,135
Indirect Cost
Name
Circulatory Technology, Inc.
Department
Type
DUNS #
786778944
City
Oyster Bay
State
NY
Country
United States
Zip Code
11771