Cerebral edema subsequent to stroke and traumatic brain injury (TBI) is a life-threatening complication that is refractory to conventional treatments in many patients. The proposed research will develop a novel tissue ultrafiltration (TUF) therapy for use in humans with brain edema. Bench studies will identify materials (ultrafiltration fibers, bonding agents, supports) and operational parameters (extraction methods, pressure magnitudes) providing optimal fluid flux via TUF probes during in vitro and ex vivo brain tissue testing. Large-scale, single- or multiple-fiber TUF probes will be tested for ability to acutely (6h) or chronically (24h) extract edematous fluid, reduce intracranial pressure (ICP), and/or reduce tissue water content in a feline model of cyrogenic cortical injury. Larger scale TUF probes will be tested for fluid extraction and ability to reduce edema and ICP in a nonhuman primate model of stroke, using comuted tomography and magnetic resonance imaging to measure cerebral blood flow and tissue water distributions. Successful development and marketing of this proprietary methodology could significantly reduce morbidity and mortality after human stroke or TBI.

Proposed Commercial Applications

The Company plans to manufacture and market ultrafiltration systems to treat cerebral edema in patients with severe TBI, stroke and other neurological disorders. The contemplated product is a self contained unit with tissue ultrafiltration catheters, fluid collection lines and collection chambers for containment of ultrafiltrate.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44NS038015-03
Application #
6394024
Study Section
Special Emphasis Panel (ZRG1-BDCN-1 (03))
Program Officer
Michel, Mary E
Project Start
2000-07-15
Project End
2002-07-31
Budget Start
2001-08-01
Budget End
2002-07-31
Support Year
3
Fiscal Year
2001
Total Cost
$403,144
Indirect Cost
Name
Twin Star Medical
Department
Type
DUNS #
076324156
City
St Paul
State
MN
Country
United States
Zip Code
55114