• Title/Summary/Keyword: Low-intensity focused ultrasound

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A Study on the Safety and Performance Test Guideline of Low Intensity Therapeutic Ultrasound Device (저강도 초음파 치료기기의 안전성 및 성능평가 가이드라인 수립을 위한 연구)

  • Kim, Ju-Young;Kim, Jae-Young;Noh, Si-Cheol;Choi, Heung-Ho
    • Journal of Biomedical Engineering Research
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    • v.36 no.5
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    • pp.162-168
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    • 2015
  • In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

Magnetic Resonance-Guided Focused Ultrasound : Current Status and Future Perspectives in Thermal Ablation and Blood-Brain Barrier Opening

  • Lee, Eun Jung;Fomenko, Anton;Lozano, Andres M.
    • Journal of Korean Neurosurgical Society
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    • v.62 no.1
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    • pp.10-26
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    • 2019
  • Magnetic resonance-guided focused ultrasound (MRgFUS) is an emerging new technology with considerable potential to treat various neurological diseases. With refinement of ultrasound transducer technology and integration with magnetic resonance imaging guidance, transcranial sonication of precise cerebral targets has become a therapeutic option. Intensity is a key determinant of ultrasound effects. High-intensity focused ultrasound can produce targeted lesions via thermal ablation of tissue. MRgFUS-mediated stereotactic ablation is non-invasive, incision-free, and confers immediate therapeutic effects. Since the US Food and Drug Administration approval of MRgFUS in 2016 for unilateral thalamotomy in medication-refractory essential tremor, studies on novel indications such as Parkinson's disease, psychiatric disease, and brain tumors are underway. MRgFUS is also used in the context of blood-brain barrier (BBB) opening at low intensities, in combination with intravenously-administered microbubbles. Preclinical studies show that MRgFUS-mediated BBB opening safely enhances the delivery of targeted chemotherapeutic agents to the brain and improves tumor control as well as survival. In addition, BBB opening has been shown to activate the innate immune system in animal models of Alzheimer's disease. Amyloid plaque clearance and promotion of neurogenesis in these studies suggest that MRgFUS-mediated BBB opening may be a new paradigm for neurodegenerative disease treatment in the future. Here, we review the current status of preclinical and clinical trials of MRgFUS-mediated thermal ablation and BBB opening, described their mechanisms of action, and discuss future prospects.

High-intensity focused ultrasound beam path visualization using ultrasound imaging (초음파 영상을 이용한 고강도 집중 초음파 빔 시각화)

  • Song, Jae Hee;Chang, Jin Ho;Yoo, Yang Mo
    • The Journal of the Acoustical Society of Korea
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    • v.39 no.1
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    • pp.16-23
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    • 2020
  • In High-Intensity Focused Ultrasound (HIFU) treatment, effective localization of HIFU focus is important for developing a safe treatment plan. While Magnetic Resonance Imaging guided HIFU (MRIgHIFU) can visualize the ultrasound path during the treatment for localizing HIFU focus, it is challenging in ultrasound imaging guided HIFU (USIgHIFU). In the present study, a real-time ultrasound beam visualization technique capable of localizing HIFU focus is presented for USIgHIFU. In the proposed method, a short pulse, with the same center frequency of an imaging ultrasound transducer below the regulated acoustic intensity (i.e., Ispta < 720 mW/㎠), was transmitted through a HIFU transducer whereupon backscattered signals were received by the imaging transducer. To visualize the HIFU beam path, the backscattered signals underwent dynamic receive focusing and subsequent echo processing. From in vitro experiments with bovine serum albumin gel phantoms, the HIFU beam path was clearly depicted with low acoustic intensity (i.e., Ispta of 94.8 mW/㎠) and the HIFU focus was successfully localized before any damages were produced. This result indicates that the proposed ultrasound beam path visualization method can be used for localizing the HIFU focus in real time while minimizing unwanted tissue damage in USIgHIFU treatment.

Characteristics of Focused Ultrasound Mediated Blood-Brain Barrier Opening in Magnetic Resonance Images

  • Kyung Won Chang;Seung Woo Hong;Won Seok Chang;Hyun Ho Jung;Jin Woo Chang
    • Journal of Korean Neurosurgical Society
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    • v.66 no.2
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    • pp.172-182
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    • 2023
  • Objective : The blood-brain barrier (BBB) is an obstacle for molecules to pass through from blood to the brain. Focused ultrasound is a new method which temporarily opens the BBB, which makes pharmaceutical delivery or removal of neurodegenerative proteins possible. This study was demonstrated to review our BBB opening procedure with magnetic resonance guided images and find specific patterns in the BBB opening. Methods : In this study, we reviewed the procedures and results of two clinical studies on BBB opening using focused ultrasound regarding its safety and clinical efficacy. Magnetic resonance images were also reviewed to discover any specific findings. Results : Two clinical trials showed clinical benefits. All clinical trials demonstrated safe BBB opening, with no specific side effects. Magnetic resonance imaging showed temporary T1 contrast enhancement in the sonication area, verifying the BBB opening. Several low-signal intensity spots were observed in the T2 susceptibility-weighted angiography images, which were also reversible and temporary. Although these spots can be considered as microbleeding, evidence suggests these are not ordinary microbleeding but an indicator for adequate BBB opening. Conclusion : Magnetic resonance images proved safe and efficient BBB opening in humans, using focused ultrasound.

The Effect of Osteoblast like Cell on Low Intensity Pulsed Ultrasound Used in Current Clinical Practice (임상에서 쓰이는 저 출력 초음파(Low Intensity Pulsed Ultrasound)가 조골세포에 미치는 영향)

  • Park, Sang-Rye;Kim, Ji-Young;Choi, Byul Bo-Ra
    • Journal of dental hygiene science
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    • v.14 no.2
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    • pp.101-106
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    • 2014
  • In this study, we investigated the proliferative and adhesional effect of human osteoblast like MG-63 cell treated with low intensity pulsed ultrasound (LIPUS). We tested the effectiveness of LIPUS in human osteoblast like MG-63 cells. Cell proliferation was measured using a water soluble tetrazolium salts-1 assay. The mRNA expression of alkaline phosphate, vascular endothelial growth factor (VEGF), integrin alpha 2, colla 1A1 were performed by reverse transcription-polymerase chain reaction. LIPUS was no cytotoxicity in human osteoblast like MG-63 cells. In addition, the data show that treatment with 1 MHz and 3 MHz LIPUS on increased proliferation 7 days after. There were significant increased in mRNA expression of alkaline phosphatase, osteocalcin, VEGF, integrin alpha 2 and colla 1A1 (p<0.05). Therefore, the LIPUS significantly increased differential expression of mRNA levels in osteoblast like MG-63 cell and new possibilities in dental clinical practice.

Effects of Anticancer Drug Delivery based on Microbubble and Microbubble-Nanoparticle Complex using Low-Intensity Focused Ultrasound in Breast Cancer Animal Model (유방암 동물모델에서의 저강도 집속초음파를 이용한 마이크로버블 및 마이크로버블-나노물질 복합체 기반 항암제 전달 효율 검증)

  • Baek, Hee Gyu;Ha, Shin-Woo;Huh, Hyungkyu;Jung, Byeongjin;Han, Mun;Moon, Hyungwon;Kim, Sangkyun;Lee, Hak Jong;Park, Juyoung
    • Journal of Biomedical Engineering Research
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    • v.40 no.2
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    • pp.39-47
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    • 2019
  • Ultrasound sonication along with microbubble (MB) could enhance drug delivery to promote the absorption of anticancer drugs into cancers in a noninvasive and targeted manners. In this study, we verify the acute drug delivery enhancement (within an hour) of two representative focused ultrasound driven drug delivery enhancement methods (MB and Doxorubicin-coated Nanoparticle complex (MB-NP) based). Experiments were conducted using in vivo mouse model with MDA-MB-231 breast cancer cell line. Ultrasound generated by single-element 1 MHz focused ultrasound transducer was delivered in pulsed sonication consisted of 0.125 msec bursts at a pulse repetition frequency of 2 Hz for 20 seconds without a significant increase in local temperature (less than $0.1^{\circ}C$) or hemorrhage. Doxorubicin concentrations in tumors were improved by 1.97 times in the case of MB-NP, and 1.98 times by using Doxorubicin and MB separately. These results indicate anticancer drug delivery based on MB and MB-NP can significantly improve the effect of anticancer drugs delivered to tumors in a short time period by using low-intensity focused ultrasound.

Drug Release from Thermosensitive Liposomes by High-Intensity Focused Ultrasound (고강도 집속 초음파에 의한 온도민감성 리포솜으로부터 약물 방출)

  • Jeon, Ye Won;Cho, Sun Hang;Han, Hee Dong;Shin, Byung Cheol
    • Journal of the Korean Chemical Society
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    • v.58 no.6
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    • pp.575-579
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    • 2014
  • Development of liposomes has been actively studied for effective delivery of drug at tumor site. However, despite their preferential accumulation at tumor site, the therapeutic efficacy of such liposomal drug has been limited because of low drug release. Therefore, we developed a temperature-sensitive liposome (TSL), which can be made to maximize release of drug by external stimulation such as ultrasound. Doxorubicin (DOX) as a model drug was encapsulated into TSL by a pH gradient method. The particle size of the TSL was $142.0{\pm}6.24nm$. Surface charge was $-10.55{\pm}1.12mV$. Release of drug from TSLs was up to 80% within 15 min at over $42^{\circ}C$ measured by fluorescence intensity. Cytotoxicity of released DOX from TSLs with ultrasound was highly increased compared to TSLs without ultrasound. Taken together, we demonstrate that temperature sensitive drug release from TSLs with ultrasound, which may be useful for cancer therapy to increase drug concentration at tumor site by external stimulation.

Developed an output device for high-frequency cosmetic medical equipment using micro multi-needle (마이크로 멀티니들을 이용한 고주파 피부미용 의료기기를 위한 출력 장치 개발)

  • Kim, Jun-tae;Joo, Kyu-tai;Cha, Eun Jong;Kim, Myung-mi;Jeong, Jin-hyoung
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.14 no.5
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    • pp.394-402
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    • 2021
  • The entry of an aging society and the extension of human life expectancy, the increasing interest in women's social advancement and men's appearance, and the natural interest in K-culture through media media, while receiving worldwide attention, Focus on K-Bueaty. Recently, looking at the occupation of the medical tourism field, in the case of aesthetic medicine tourism such as molding and dermatology, it has gained popularity not only in Asia such as China and Japan, but also in North America and Europe. The first external confirmation of human aging is the wrinkles on the skin of the face. Clean, wrinkle-free, elastic and healthy skin is a desire of most people. Skin condition and condition such as focused ultrasonic stimulation (HIFU: High Intensity Focused Utrasound) and low frequency, high frequency (RF: Radio Frequency), galvanic therapy using microcurrent, cryotherapy using rapid cooling, etc. Depending on the method of management, the effect of the treatment differs depending on the output and the stimulation site, etc., even in the treatment of medical equipment and beauty equipment using the same mechanism. In this research, in order to develop invasive high-frequency dermatological devices using a large number of beauty medical devices and microneedles of beauty devices, the international standards IEC 60601-2 (standards for individual medical devices) and MFDS (Ministry of) We designed and developed a high-frequency output device in compliance with the high-frequency stimulation standard announced in the Food and Drug Safety (Ministry of Food and Drug Safety). The circuit design consists of an amplifier (AMP: Amplifier) using Class-A Topology and a power supply device using Half-Bridge Topology. As a result of measuring the developed high-frequency output device, an average efficiency of 63.86% was obtained, and the maximum output was measured at 116.7W and 50.67dBm.