一种新型冠状动脉粥样硬化切除系统，可用于两期手术

IF 2.3 4区医学 Q3 ENGINEERING, BIOMEDICAL

Medical Engineering & Physics Pub Date : 2025-06-02 DOI:10.1016/j.medengphy.2025.104374

Leilei Ma , Zhe Wang , Jiaqi Yang , Bin Shen , Yao Liu , Yihao Zheng , Yizhe Wu , Li Shen , Chenguang Li , Junbo Ge

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引用次数: 0

摘要

冠状动脉粥样硬化切除术系统（CAS）是一种新型的冠状动脉粥样硬化切除术系统，该系统采用了一种新型的毛刺，用于两阶段的动脉粥样硬化切除术：低速钻孔以穿过病变，高速旋转以获得腔隙增益，以去除动脉狭窄。目的探讨CAS的作用机制，验证其有效性和安全性。方法采用工程台架试验，对毛刺穿越时间、光增益、碎屑大小、温升和磨削力进行评价，并结合猪体内和离体研究。结果台架工程试验结果表明，CAS可将钙化管腔直径从0.4 mm扩大到1.7 mm，且碎屑尺寸、温升和磨削力相对较低且安全。在猪体内研究中，介质和内部弹性膜保持完整。在随访第0天切除动脉内膜，在随访第30天再生。数字减影血管造影、血检、心电图、解剖分析均未见异常。在离体研究中，通过在冠状动脉中插入斑块表面物（石墨），在管腔增益和安全性方面显示出类似的疗效。结论采用新型两相毛刺设计的CAS装置具有良好的安全性和有效性。

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A coronary atherectomy system with a novel burr design for two-phase operation

Backgrounds

A coronary atherectomy system (CAS) was developed with a novel burr designed for a two-phase atherectomy procedure: low-speed drilling for lesion crossing and high-speed orbiting to achieve luminal gain, to removal the stenosis in artery.

Aims

To investigate the CAS mechanism and validate its efficacy and safety.

Methods

Engineering bench-top testings were conducted to evaluate the burr crossing time, luminal gain, debris size, temperature rise, and grinding force together with in-vivo and ex-vivo swine studies.

Results

The bench-top engineering testing results showed that the CAS can expand the calcified lumen diameter from 0.4 to 1.7 mm and the debris size, temperature rise, and grinding force were relatively low and safe. In the in-vivo swine study, the media and internal elastic membrane remained intact. The intima of the artery was removed at the 0-day follow-up and re-growthed at the 30-day follow-up. No abnormal phenomenon in the digital subtraction angiography, blood testing, ECG, and anatomy analysis were found. The ex-vivo study, by inserting a plaque surragate (graphite) into the coronary artery, showed similar efficacy in luminal gain and safety.

Conclusions

This study demonstrated the efficacy and safety of CAS device with the novel two-phase burr design.

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来源期刊

Medical Engineering & Physics 工程技术-工程：生物医学

CiteScore

4.30

自引率

4.50%

发文量

172

审稿时长

3.0 months

期刊介绍： Medical Engineering & Physics provides a forum for the publication of the latest developments in biomedical engineering, and reflects the essential multidisciplinary nature of the subject. The journal publishes in-depth critical reviews, scientific papers and technical notes. Our focus encompasses the application of the basic principles of physics and engineering to the development of medical devices and technology, with the ultimate aim of producing improvements in the quality of health care.Topics covered include biomechanics, biomaterials, mechanobiology, rehabilitation engineering, biomedical signal processing and medical device development. Medical Engineering & Physics aims to keep both engineers and clinicians abreast of the latest applications of technology to health care.