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.
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.
