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...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.展开更多
Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that mak...Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that make the results highly dependent on the user’s experience or clinical limitations that compromise safety, efficacy and comfort. Objective: To evaluate the efficacy and safety of a novel semi-automatic non-ablative RF device for skin tightening, body shaping and cellulite reduction. Materials and methods: A retrospective multicenter study was performed using a novel rotative RF device with temperature and impedance control (Sculpt&Shape<sup>®</sup>, Sinclair, Spain). 58 subjects underwent a minimum of 4 treatments every 1-2 weeks. A total of 120 treatments (56.7% body and 43.3% facial) and 1034 sessions were performed. Efficacy was evaluated by 3 researchers using the Global Aesthetic Improvement Scale (GAIS) and anthropometric measurements were collected. Subject and practitioner satisfaction were recorded. Safety was evaluated by analyzing the perception of pain during the treatment and the side and adverse effects immediately after treatment and over the next 48 hours. Results: Between 25% and 50% improvement was achieved according to the GAIS. Statistically significant (p < 0.01) abdominal fold reduction of 5.1 mm and circumference reduction of 32.0 mm, 16.4 mm and 13.9 mm were recorded for the abdomen, legs and arms, respectively. 77.5% of subjects and 94.9% of practitioners were either satisfied or very satisfied. Minor adverse effects were found in 0.97% of the sessions. Conclusion: This novel semi-automatic rotative RF device has been found to provide treatments that are effective, safe and comfortable for both practitioners and subjects. .展开更多
文摘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.
文摘Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that make the results highly dependent on the user’s experience or clinical limitations that compromise safety, efficacy and comfort. Objective: To evaluate the efficacy and safety of a novel semi-automatic non-ablative RF device for skin tightening, body shaping and cellulite reduction. Materials and methods: A retrospective multicenter study was performed using a novel rotative RF device with temperature and impedance control (Sculpt&Shape<sup>®</sup>, Sinclair, Spain). 58 subjects underwent a minimum of 4 treatments every 1-2 weeks. A total of 120 treatments (56.7% body and 43.3% facial) and 1034 sessions were performed. Efficacy was evaluated by 3 researchers using the Global Aesthetic Improvement Scale (GAIS) and anthropometric measurements were collected. Subject and practitioner satisfaction were recorded. Safety was evaluated by analyzing the perception of pain during the treatment and the side and adverse effects immediately after treatment and over the next 48 hours. Results: Between 25% and 50% improvement was achieved according to the GAIS. Statistically significant (p < 0.01) abdominal fold reduction of 5.1 mm and circumference reduction of 32.0 mm, 16.4 mm and 13.9 mm were recorded for the abdomen, legs and arms, respectively. 77.5% of subjects and 94.9% of practitioners were either satisfied or very satisfied. Minor adverse effects were found in 0.97% of the sessions. Conclusion: This novel semi-automatic rotative RF device has been found to provide treatments that are effective, safe and comfortable for both practitioners and subjects. .
