title: A predictive model of minimally invasive bipolar fractional radiofrequency skin treatment.
abstract: BACKGROUND
  A novel bipolar fractional radiofrequency (FRF) system with temperature feedback was recently developed for facial laxity and rhytid treatment. The study objective was to develop a model based on published in vivo human skin data that could be extrapolated to aid physicians in making future dosimetry choices under clinically relevant conditions.
  
  
  METHODS
  A standard electrode pair designed for use with the FRF system was modeled using finite element analysis (FEA). The model incorporated temperature feedback from sensors within the electrodes, selectable target dermal temperatures, and an epidermal cooling plate. The model was validated using data obtained during clinical treatments. Thermal injury as a function of target temperatures and electrical conductivity was simulated and then validated using in vivo histology results.
  
  
  RESULTS
  Lesion size predicted by the model matched histology samples. Lesion width and height were 1.65 and 1.24 mm compared to 1.75 and 1.21 mm for the model versus in vivo, respectively. The thermal profile remained confined between the proximal and distal ends of the electrodes. Ninety-six percent of power was deposited in the dermis. Dose-response curves showed a nonlinear volume increase to 1.7 and 4.7 mm(3) at target temperatures of 65 and 75 degrees C, respectively, and a low sensitivity to electrical conductivity variation.
  
  
  CONCLUSIONS
  FEA of the Bipolar FRF system revealed that isotherms were mainly within the dermis. Lesion volume was found to be less sensitive to changes in electrical conductivity than to target temperature and duration. Simulation results matched well the in vivo lesion dimensions. To our knowledge, this is the first model of bipolar FRF treatment capable of accurately predicting the thermal response of human skin in vivo. The findings of this study allow for the development of accurate dose-response curves to aid physicians in parameter selection and achieving efficacy and safety profiles.
authors.affiliation: Primaeva Medical, 4160 Hacienda Drive, Pleasanton, CA 94588, USA. dberube@primaeva.com
authors.forename: Dany
authors.initials: D
authors.lastname: Berube
authors.forename: Bradley
authors.initials: B
authors.lastname: Renton
authors.forename: Basil M
authors.initials: BM
authors.lastname: Hantash
mesh_terms: D019583:Dose Fractionation, Radiation; D020342:Finite Element Analysis; D006801:Humans; D007150:Immunohistochemistry; D028022:Low-Level Light Therapy / Q000379:methods*; D008953:Models, Anatomic; D011237:Predictive Value of Tests; D011879:Radiotherapy Dosage; D012680:Sensitivity and Specificity; D012867:Skin / Q000473:pathology* / Q000528:radiation effects*; D013814:Thermal Conductivity