Minimally Invasive Beaded Electrosurgical Dissectors, Basic Science, and Pilot Studies

Abstract

Abstract Background Minimally invasive beaded electrosurgical dissectors (“BEED devices”) provide simultaneous sharp dissection, blunt dissection, and electrosurgical coagulation while performing 100 sqcm porcine tissue plane dissections in 0.8 to 3 minutes with minimal bleeding and no perforations. Objectives To report the basic science and potential clinical applications plus to video document the speed and quality of planar dissections in in vivo and ex vivo porcine models with thermal damage quantified by thermal and histopathologic measurements. Additionally, in vivo porcine specimens were followed for 90 days to show whether adverse events occurred on a gross or macroscopic basis as evidenced by photography, videography, physical examination, and dual ultrasonography. Methods Ex vivo porcine models were subject to 20, 30, and 50 Watts in single-stroke passages with BEED dissectors (granted FDA 510(k) clearance (K233002)) with multi-channel thermocouple, 3-second delay recordation combined with matching H&E histopathology. In vivo porcine models were subjected to eight 10 × 10 cm dissections in each of 2 subjects at 20, 30, and 50 Watts and evaluated periodically until 90 days wherein histopathology for H&E, collagen and elastin was taken plus standard and doppler ultrasounds prior to euthanasia. Results 5-8 mm-width dissectors were passed at 1-2 cm/sec in ex vivo models (1-10 cm/sec in vivo models) with an average temperature rise of 5°C at 50W. Clinically evidenced seromas occurred in the undressed, unprotected wounds, and resolved well prior to 90-days as documented by ultrasounds and histopathology. Conclusions In vivo/ex-vivo models demonstrated thermal values that were below levels known to damage subcutaneous adipose tissue or skin. Tissue histopathology confirmed healing parameters while doppler ultrasound demonstrated normal blood flow in post-treatment tissues.