Miniaturized electrochemical sensor for the minimally invasive control of post-operative tissue ischemia of free flaps. Free flaps are pieces of a patient’s tissue commonly used in reparative surgeries for the reconstruction of a damaged area.
Up to 25% of free flaps require re-operation due to circulatory compromises. Early detection of ischemia is crucial for successful reconstruction of a damaged tissue, otherwise tissue loss can occur with serious consequences, including increased morbidity and mortality.
- The scope of the current project is centered on miniaturizing the prototype to reach the market requirements, as well as validating its performance on a animal flap model.
Problem to Solve
Free flap reconstruction surgery is very common, and requires microsurgical anastomosis to ensure microvascular blood perfusion throughout the insert. Therefore, post-operative monitoring of microsurgical reconstruction is central to identify early vascular complications in flaps. Deep tissue flap monitoring relies on general patient symptomology, so microcirculatory complications are generally detected 5 to 8 days post-surgery, when the flap recovery rate is very low. The standard monitoring method currently used is based on subjective clinical observations, which greatly depends on the experience of the caregiver. In addition, early flap compromise is often asymptomatic, further increasing ischemic times and reducing successful recovery rates.
ISCHEMSURG permits the continuous control of deep flap conditions with a wireless device. The device measures physiological changes directly in the tissue, instead of blood flow perturbations on arteries, making the device more reliable and with fewer risks. More importantly, ISCHEMSURG is a cost-effective technology that can be implemented in the majority of clinical settings.
Level of Innovation
The available options on the market are more expensive and have proven to give a high rate of false positives, therefore it exists a clear unmmet medical need that needs to be addressed. In addition, ISCHEMSURG could effectively monitor deep tissue flaps, giving caregivers early actionable information in the event of ischemia, reducing the rates of re-operation.