IEEE Trans Biomed Eng. 2024 Feb;71(2):574-582. doi: 10.1109/TBME.2023.3309540. Epub 2024 Jan 19.
Recently, MRI-guided focused ultrasound (FUS) has shown great promise in treating various conditions non-invasively.
The focus of this article is to introduce an MRI-guided FUS device, which can provide full electronic steering range without mechanical movement and with low near-field heating. A pilot study was conducted in order to investigate the feasibility, and safety of the device in a large animal model and a pilot clinical trial.
A flat, fully steerable FUS phased array with 4096 elements was designed and manufactured to be compatible with an MR scanner. Pre-clinical experiments were carried out for testing the accuracy of the focus at different steering angles as well as evaluating the ablation efficiency using MR thermometry. Eleven patients with uterine fibroids were treated in the pilot clinical trial.
Pre-clinical results showed successful ablation at various steering angles with reasonable targeting accuracy and no off-target heating. During the pilot clinical study, effective fibroid ablation was achieved with significant symptom reduction observed over time. In general, the treatment results showed the system to be effective in ablating deep tissue volumes. The device was successful at efficiently ablating large volumes with minimal near-field heating and eliminating the need for mechanical translation.
Being capable of providing high acoustic power, full electronic steering range in 3D for large volume ablations, this device can provide a safe and efficient treatment option as an outpatient procedure for uterine fibroids and other pelvic and abdominal tumors.
最近，磁共振引导聚焦超声（FUS）在无创治疗各种疾病方面显示出巨大的潜力。
本文的重点是介绍一种磁共振引导 FUS 设备，该设备可以在不进行机械运动的情况下提供全电子转向范围，并且近场加热低。进行了一项初步研究，以调查该设备在大型动物模型和初步临床试验中的可行性和安全性。
设计并制造了一种具有 4096 个元件的平坦、完全可转向的 FUS 相控阵，以与磁共振扫描仪兼容。进行了临床前实验，以测试在不同转向角度下焦点的准确性，并使用磁共振测温法评估消融效率。11 名患有子宫肌瘤的患者在初步临床试验中接受了治疗。
临床前结果表明，在各种转向角度下都能成功消融，具有合理的靶向准确性，没有非目标加热。在初步临床研究中，随着时间的推移，观察到症状明显减轻，实现了有效的肌瘤消融。总的来说，治疗结果表明该系统能够有效地消融深部组织体积。该设备能够高效地消融大体积组织，同时近场加热最小，并消除了机械平移的需要。
作为一种门诊程序，该设备能够为子宫肌瘤和其他盆腔和腹部肿瘤提供一种安全有效的治疗选择，因为它能够提供高声功率、3D 全电子转向范围用于大体积消融。
