From Simulation to Reality: A Comprehensive Study on the Efficacy of a Rotating Monopolar and Bipolar Radiofrequency System through In-Silico Modeling and Pre-Clinical and Clinical Validation

Abstract

Background: Skin aging is an unavoidable process aggravated by environmental agents. Among other energy devices, non-invasive radiofrequency (RF) technology is widely used for skin tightening and body contouring as it is simpler and more affordable than other technologies that also minimize pain and side-effects. However, most of the current RF devices do not provide automatic skin temperature control and it is difficult to achieve controlled, deep, and harmless thermal increase, so treatment performance and safety is dependent on the operator’s movements and expertise. Objective: To show the potential of numerical simulations for optimizing the design of monopolar and bipolar RF electrodes that are capable of providing homogeneous, deep and controlled heating. Materials and methods: In-silico models were developed and analyzed using Comsol Multiphysics software to simulate the RF effect produced in tissue by rotating monopolar and bipolar electrodes with different geometries from the Sculpt & Shape RF device (Sinclair, Spain), operating at frequencies of 0.5 and 1 MHz. Ex-vivo and in-vivo proof-of-concept tests were carried out to validate the simulations. Finally, treatments were performed on 16 subjects and a total of 78 body areas to assess the clinical results generated by the RF electrodes for skin tightening and body contouring. Results: In- silico studies emulated the superficial and deep dispersion of heat due to the release of RF energy into human skin tissue. The rotating electrodes (monopolar and bipolar) and the selected RF frequency (0.5 and 1 MHz) determined the homogeneity of the thermal distribution, the penetration depth (between 4.37 mm and 25.0 mm) and the heating dynamics (between 30 and 100 seconds to reach the target skin temperature), which were confirmed by ex-vivo and in-vivo tests. In addition, real treatments on facial and body areas using skin temperatures of between 43˚C and 44˚C showed consistent results with good clinical efficacy for skin tightening, circumference reduction and cellulite reduction, with no adverse effects and high subject satisfaction. Conclusions: New monopolar and bipolar RF electrodes with rotating technology have been designed and optimized using numerical simulations. The use of in-silico studies and accurate models that reproduce the thermal behavior of human biological tissues can be used to better understand RF devices and to develop superior, efficient, and safer products more quickly.