Development of a mechanical skin flap therapy device is proposed for the removal of stagnated blood and generation of blood flow within congested skin flaps to promote survival. Venous congestion is defined as a patent arterial inflow with compromised venous outflow in skin flaps, and has a 10 percent occurrence rate. Preliminary data shows multiple mechanically made outlets are as effective as leeches in alleviating venous congestion. With this data and an understanding of the beneficial mechanisms of leech therapy, a micro-mechanical, disposable device was designed to mimic these mechanisms while eliminating the drawbacks. The device design comprises a self-contained vacuum pump, based upon an innovative lightweight actuator, sharp outlets to puncture the skin and draw fluid from the flap, and an on-board battery power supply. Optimizing the actuator to maximize displacement while minimizing power is important to a successful design. Such a device would be utilized clinically like a leech to alleviate venous congestion and prophylactic treatments averting potential congestion. Leeches are currently not applied for prophylaxis. the long-term goal is to increase the success rate of skin flaps through commercial availability of this micro-device for interventional fluid transport from congested flaps.
There are approximately 1,000,000 procedures performed in the United States that potentially require the use of skin flaps. For treatment of venous congested flaps, over 70,000 leeches are currently sold to plastic surgery clinics annually, but they are only utilized upon serious, advanced indications of venous congestion. With the development of a small device that mimics the leech available off the shelf, that market could easily grow to three times that amount (see pages MARKET RESEARCH discussion), while also enhancing the overall success rate of skin flap transfer procedures. With the proposed device, the existing drawbacks to leech therapy would be eliminated thus making the mechanical leech a viable alternative in this market for patients, health care providers, and insurance companies.
