A NEW APPROACH TO BODY CONTOURING USING CONTROLLED RF HEATING AND HIGH VOLTAGE ULTRA-SHORT ELECTRICAL PULSES

R. Stephen Mulholland, MD, FRCS(C), Michael Kreindel . Ph.D

 

The TiteFX device (Invasix Ltd.) combines, in a synergistic fashion, the following therapeutic energy sources:

• Uniform RF heating of the skin and subcutaneous fat with real time monitoring of skin temperature using an infrared thermometer built into the hand piece.
• High-voltage (HV) short RF pulses applied to the subcutaneous fat to deliver irreversible electroporation to the adipocyte leading to delayed apoptosis of the fat cell and secondary minor muscle stimulation.

The TiteFX applicator has a large suction cavity on the undersurface of the hand piece with RF electrodes on each side.  The hand piece applies suction pressure to the soft tissue of the convex contour irregularity, drawing the skin and subcutaneous tissue up in the cavity.  Bipolar RF is passed between the two electrodes and through the adipose tissue and skin (Figure 1).

As the RF heats the tissue, the surface temperature rises.  The TiteFX hand piece displays this measured skin surface temperature on the hand piece.  When the temperature gets to an endpoint that is established by the physician (the “trigger temperature”) the device will emit a train of High Voltage Pulses (HVPs) directly into the adipose tissue.

The TiteFX allows for very uniform skin heating to a depth of 15mm due to the vacuum suction and electrode placement.  Figure 2 shows a thermal image of the skin with uniform temperature distribution.  The uniformity of the skin temperature means a target “trigger temperature” of 42°C can be reached with minimal patient discomfort.

Irreversible electroporation is the process of creating pores in cell membranes under an external electrical field, leading to apoptotic death of cells in certain conditions.  Preheating of the skin with RF current allows for a significant reduction in the electroporation threshold and target selectively, as the preheated large adipocytes are more sensitive to electrical fields.  With the HVP adipocyte apoptosis, the fat cells die and adipose tissue deflates and loses volume, thereby improving contour.  Another benefit of the RF energy and HVP is that the controlled RF energy heats the skin resulting in dermal tightening which enhances the contour as the adipose tissue becomes reduced.

In the current study 20 female and male patients were enrolled.  The age range of the patients was 28 to 58 years old, with an average age of 36.5.  Patient BMI varied from 18 to 28 and all of patients were interested in focal shape correction, without anticipating any weight reduction.  The patients were treated in the abdominal and flanks regions once a week over a period of 6 weeks.  Patients were observed for 3 months to determine the long-term adipose tissue effects and body contour changes.  Standard photography and circumferential measurements were taken prior to treatment and at 3 months following the last treatment.

The protocol during the treatment involved moving the TiteFX applicator on half of the target zone, heating the soft tissue every three seconds and then moving to the next area, overlapping 10-20% with the previous treatment, rapidly rising the tissue temperature to 41-43°C.  Once the trigger temperature of 42°C was achieved, HVP energy was delivered in a pulse of 5-7 seconds with-5 passes of High Voltage pulses completed in each zone.  RF power of 40-50W was used and the treatment s were completed at an average of 30mins per zone.