15 Comparative Thermal Impact of A New Liposuction Device Utilizing Tissue Liquefaction Technology
Evaluate the thermal effects of three lipoplasty systems on subcutaneous adipose tissue. The systems evaluated were SAL, UAL, and a new FDA-cleared lipoplasty device using Tissue Liquefaction Technology (TLT).
Methods/Technique:
For this study, resected human abdominoplasty tissues were chosen as they are identical to the tissue targeted by these devices. The resected human abdominoplasty tissues were immediately frozen after resection and transported to the test facility. The tissues were kept in a frozen condition from the time of receipt until one day before testing. The tissues were then defrosted and brought to 37⁰C prior to testing. During the test, tissues were contained in a heated enclosure to maintain them at 37⁰C uniformly throughout the test. For the SAL analysis, 5 tissue samples were aspirated for 4:00 minutes with a 15cm x 4mm Byron single aperture cannula with a HK Surgical Aspiration system set to 75% vacuum control. For the UAL analysis, 6 tissue samples were exposed to ultrasound energy for 90 seconds and then aspirated for 4:00 minutes with a 15cm x 4mm Byron single aperture cannula with a HK Surgical Aspiration system set to 75% vacuum control. For the TLT analysis, 6 tissue samples were aspirated for 4:00 minutes with a 15cm x 4mm dual aperture cannula with the TLT aspiration system set to 75% vacuum control. Tissue temperature was monitored at several locations and at specific points during the procedures; and histological analyses were later conducted to assess evidence of necrosis, fibrosis, or inflammation.
Results/Complications:
With the SAL system there is no thermal energy used, and the test tissues never increased above the starting tissue temperature. The small increase in tissue temperature noted as part of fat aspiration can be attributed to any heat generated by friction and the 37⁰C environment where the tissues were contained. As evident from this temperature data set, there is no thermal impact on adipose tissue during SAL.
The UAL system produced a noticeable amount of thermal and ultrasound energy transmitted to the subcutaneous adipose tissue bed. The test tissue temperature increased on average about 8⁰C above the starting tissue temperature. The test tissue temperature increase seen during the ultrasound portion of the procedure diminished during the aspiration step. The aspiration test tissue temperatures were in-line with those of SAL and TLT. The average contact temperature of the probe during the ultrasound emulsification step demonstrates that the probe generates significant thermal energy, about 60⁰C, with individual test readings as high as 78⁰C. As evident from this temperature data set, there is a noticeable thermal impact on the adipose tissue bed during UAL lipoplasty. However, the tissue temperature increase appeared to be clinically insignificant and does not cause any significant thermal injury to non-target tissue in the subcutaneous adipose tissue bed.
The TLT system results in very little thermal energy transmitted to the subcutaneous adipose tissue bed. The average test tissue temperature did not increase above the starting tissue temperature. Only two individual samples had test site temperature readings that were higher than the starting tissue, and the higher of those two had a temperature elevation of only 2⁰C. The small increase in tissue temperatures noted as part of the fat aspiration phase is insignificant and does not cause thermal injury to the remaining tissues in the tissue bed that are not aspirated.
Conclusion:
There is no thermal impact on the human subcutaneous adipose tissue bed as a result of using SAL or TLT lipoplasty system. This is evident in both the contact thermal data and the histological analysis. The contact thermal data showed no significant temperature elevations above body temperature that would result in thermal injuries.