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Research Highlights

Accurately Evaluating Safety of Ultrasound Therapeutic Devices

  • Writerkrissadmin
  • Date2022-01-21 00:00
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Accurately Evaluating Safety of Ultrasound Therapeutic Devices


- A technology for precisely measuring the internal temperature distribution of 

a material included in a focused ultrasound therapeutic device. -


▲ Yong Tae Kim, a principal research scientist of the Ultrasound Standard Team (left), 

and Il Doh, a principal research scientist of the Medical Data Precision Measurement Team at KRISS (right) 

are evaluating the performance of an ultrasound therapeutic device.


KRISS successfully developed a technology for precisely measuring the internal temperature distribution of a material included in an ultrasound therapeutic device to evaluate the device performance. The developed technology, which allows for more accurate evaluation of the safety of focused ultrasound therapeutic devices, will increase the therapeutic effects and significantly contribute to the reduction of the side effects.

A focused ultrasound therapeutic device is a medical device that focuses ultrasound into the human body to locally generate heat and mechanical energy in order to acquire therapeutic effects. The device is often applied to a surgical therapy to cause necrosis of tumors by heat or to the stimulation of tissues to perform full facelift, reduce the abdominal fat and deliver a drug.

For increasing the therapeutic effects and minimizing the side effects, the ultrasound should be focused only on the desired target in the body to increase the temperature at the target and avoid any damage by minimizing the temperature increase at the surrounding tissues. The evaluation of the performance and safety of the ultrasound therapeutic devices requires the measurement of the temperature variation at different positions by the focused ultrasound.

However, the test method provided by the current guideline from the Korean Food and Drug Safety is to measure the local temperature by inserting a temperature probe (thermometer) into the material. However, a temperature probe cannot measure the temperature accurately because of the ultrasound reflection. In addition, the temperature distribution measured by the method is often distorted, as the heat generated by ultrasound is transferred along the thermometer, which has high thermal conductivity.

The core of the present study was a film type temperature sensor array technology, which allows for the accurate measurement of the temperature distribution in a material without affecting the progress of ultrasound. The technology was developed by the collaboration of the Medical Data Precision Measurement Team, the Ultrasound Standard Team, and the Thermodynamic Temperature Team at KRISS.

▲ A phantom for evaluating the performance of a focused ultrasound therapeutic device 

by using a film-type temperature sensor array.


The research group integrated a total of 100 temperature sensor arrays in an interval of 1 mm on a film having a thickness of 3 μm, which is 30 times thinners than the hair. Using the arrays, the research group addressed the ultrasound reflection issue by the temperature probe and developed a technology for accurately measure the temperature distribution at the focused area and the surrounding areas.

The new technology for precisely measuring and controlling the temperature distribution is expected to extend the scope of the diseases to which the therapeutic device can be applied, and strengthen the international competitiveness of the manufacturers of the ultrasound-based medical devices in Korea.

Yong Tae Kim, a principal research scientist of the Ultrasound Standard Team at KRISS, commented, “As the ultrasound power is increased, the precise temperature measurement technology will gain more importance to minimize the side effects on human body.” He added, “We will make efforts through the collaboration with the ultrasound therapeutic device manufacturers in Korea so that the newly developed technology can be applied to not only the medical device manufacturers but also clinical sites.”

Il Doh, a principal research scientist of the Medical Data Precision Measurement Team, explained, “The citizens’ satisfaction with the medical services will be improved through the use of the safe and effective devices.” He also added, “We will continuously focus on the research for developing technologies for evaluating the performance and safety of medical devices in pursuit of the citizens’ health and safety.”

The results of the present study, supported by the Key Research Program of KRISS and the Korea Medical Device Development Fund, were published in IEEE Sensors Journal in November 2021.

 

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