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Novel Dense Hollow Fiber for Blood Gas Exchange

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60242
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
HL068375
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MEDARRAY, INC.
2875 WALTERS WAY ANN ARBOR, MI -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2008
Title: Novel Dense Hollow Fiber for Blood Gas Exchange
Agency: HHS
Contract: 2R44HL068375-05A2
Award Amount: $3,000,000.00
 

Abstract:

DESCRIPTION (provided by applicant): MedArray has successfully developed under SBIR Phase I and II, a novel silicone membrane hollow fiber for use in blood oxygenators. Our patented silicone hollow fiber has great commercial potential for use in long term extracorporeal membrane oxygenation (ECMO) as well as routine cardiopulmonary bypass. Because ECMO can last more than 1 day, dense rather than microporous membranes are typically used to prevent plasma leakage. The membrane of choice for ECMO is silicone b ecause of its excellent blood compatibility, and because it has no pores for plasma leakage. In the US, the only oxygenator currently FDA approved for use in long term applications is Medtronic's ECMO oxygenator. However, this spiral wound, flat sheet sili cone oxygenator's design dates back to 1963, and has many disadvantages including areas of blood stagnation, minimal convective mixing, large blood contact surface areas, and high hemodynamic resistance. The lack of a suitable dense membrane hollow fiber f or long term use in the US has prevented US manufacturers from developing a more efficient hollow fiber based long term oxygenator. Our studies in Phase I and II have shown that our silicone hollow fibers' performance is superior to the spiral wound silico ne membranes, and comparable to microporous membranes in gas transfer and platelet trends. However, our silicone membrane cannot leak plasma or grossly embolize gas into the blood side like microporous membranes. Moreover, we have shown in an 11-day in-viv o study that our membrane can perform and sustain the rigors of long- term cardiorespiratory support. MedArray's silicone membrane hollow fiber will enable a strong ECMO oxygenator market contender in the US and abroad. This proposal is aimed at continuing the development of our proprietary dense membrane hollow fiber while focusing on all aspects relevant to implementing our membrane in clinical oxygenators. Specifically, we will investigate the effects of membrane materials on safety, effectiveness, and b iocompatibility following FDA guidelines to ultimately meet their requirements and expectations prior to clinical use. We will also rigorously test our membrane in oxygenators for gas transfers performance, and thrombogenicity in long-term in-vivo studies. Finally, we will continue refining our membrane fabrication processes by assessing the parameters pertinent to quality control and cost reduction to ultimately establish a robust and controlled process compliant with good manufacturing practices (GMP).Thi s research and development work will result in a membrane for long-term blood-gas transfer that can replace current membrane technology dating back to 1963. The proposed membrane will enable the manufacture of highly efficient blood oxygenators with superi or gas transfer, and reduced risk of deadly complications compared to currently used long term membranes.

Principal Investigator:

Jean P. Montoya
7347613889
MONTOYA@MEDARRAY.COM

Business Contact:

Patrick Montoya
7347613889
MONTOYA@MEDARRAY.COM
Small Business Information at Submission:

MEDARRAY, INC.
2875 WALTERS WAY 1610 HARBAL DR ANN ARBOR, MI 48103

EIN/Tax ID: 383537892
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No