SBIR-STTR Award

Microdialysis is an innovative approach to managing compartment syndrome, which will result in reduced healthcare costs and improved patient function and outcomes. Compartment syndrome is a serious potential complication of trauma to the extremities. Prolonged elevated compartment pressure can result in irreversible nerve and muscle damage, amputation and death. The outcome of compartment syndrome is highly dependent on accurate and timely diagnosis. Compartment syndrome is considered a surgical emergency requiring prompt treatment by fasciotomy. Controversy over threshold pressure measurements and subjective clinical indications often render the diagnosis of compartment syndrome difficult and/or untimely. In North America, failure to correctly diagnose and treat compartment syndrome is one of the most common causes of litigation against the medical profession. In this proposal, the applicant's encouraging preliminary studies will be continued in an established animal model, to demonstrate the feasibility of microdialysis technology to manage compartment syndrome. Three Specific Aims separately demonstrate feasibility of microdialysis to (1) monitor, (2) prevent an impending compartment syndrome, and (3) treat a developed compartment syndrome, using this innovative microdialysis methodology. In Phase II, human clinical trials, and further optimization of catheters and manufacturing of microdialysis systems are planned.Proposed Commercial Applications:Therapeutic MicroDialysis plans to manufacture and market a microdialysis system for the treatment of compartment syndrome patients. The contemplated product is a self-contained unit with a disposable grouping of microdialysis fibers (with disposable insertion needles), attached to a manifold which optionally attaches to wall suction, and which drains and contains the interstitial edema (with the additional benefit of protecting staff from exposure to body fluids, and aiding in hospital infection control). The market potential is estimated at $80 million.

Thesaurus Terms:
There are no thesaurus terms on file for this project.NAT INST OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

Compartment Syndrome (CS) is a condition of high tissue pressure causing ischemia damaging muscles and nerves. It is known that in highly non-compliant tissues a small fluid volume decrease can produce a large pressure drop, and thereby increase perfusion and improve circulation and oxygenation. During Phase I, we demonstrated feasibility of an innovative use of tissue ultrafiltration (UF) to reduce tissue pressure by removing interstitial and/or intracellular fluid volume, and to use the increased fluid levels of metabolites to improve diagnosis. 77'e central hypothesis is that UF catheters in muscle compartments can be used to improve functional outcome in CS, by improving diagnosis and reducing intramuscular pressure. In Phase II, bench, animal and human studies have been designed to further develop UF as a clinical tool. Patients will not be placed at higher risk of CS sequelae since UF has limited invasiveness, a history of safety as an assay tool, and does not pre-empt eventual fasciotomy should clinical signs and symptoms warrant. Our expectation is that clinical application of CSUF will provide earlier diagnosis, less morbid treatment, and will prevent sequelae of untreated CS. Expected US healthcare cost savings from the use of CSUF are $200 million per year.