A Hybrid Venous Cardiotomy Reservoir

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,524,326.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
2R44HL066810-04A1
Award Id:
n/a
Agency Tracking Number:
R44HL066810
Solicitation Year:
2011
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA10-050
Small Business Information
21 SINGWORTH ST, OYSTER BAY, NY, 11771-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
786778944
Principal Investigator:
YEHUDA TAMARI
(516) 624-2424
ytamari@cirtec.com
Business Contact:
YEHUDA TAMARI
(516) 624-2424
ytamari@cirtec.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): 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 forthe clinician.

* information listed above is at the time of submission.

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