DEBI:一种更安全针头插入的新型机械装置

Ayhan Aktas, Enrico Franco
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摘要

仅在美国,每年就有超过100万例芯针乳腺活检[1],而胃肠道和前列腺活检估计也有类似的数量。核心针乳腺活组织检查的费用从人工程序的500美元到图像引导程序的6000美元不等[2]。一项回顾性研究表明,约2.5%的乳腺活检失败[3]。针头弯曲已被确定为活检错误的一个重要原因,尤其可能发生在插入阶段[2]。相关风险包括:i)错误部位活检导致误诊;Ii)穿刺插入路径附近的敏感区域;3)反复插入,延长手术周期,增加患者不适。活检针也容易屈曲,这可能永久损坏针。临床上纠正针弯的常用技术包括重复插入(这可能很耗时)或使用导针器(这减少了最大插入深度)。在研究中,斜尖针的转向通常采用轴向旋转,但对于轴对称针尖的针来说,轴向旋转效果较差[4]。此外,直插需要连续的轴向旋转,这可能会由于斜尖的旋转而损伤软组织[5]。另一种方法是使用可操纵的针头,但目前尚未成为临床实践的一部分[6]。我们已经开发了一种机械装置,可以在针头发生弯曲时立即检测到,并立即减少插入力,从而有助于避免因针头偏转而深度插入和相关风险。与现有的解决方案不同,我们的设计不需要执行器或传感器,因此它可以使MRI安全,可消毒或一次性使用。最后,我们的设备可以与各种标准针一起使用,包括多斜角针(例如钻石尖或锥形尖)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DEBI: a new mechanical device for safer needle insertions
Over 1 million core-needle breast biopsies are performed every year in the US alone [1], while gastrointestinal and prostate biopsies are estimated in similar numbers. The cost of core-needle breast biopsies ranges between $500 for manual procedures to $6,000 for image-guided procedures [2]. A retrospective study indicated that approximately 2.5% of breast biopsies fail [3]. Needle bending has been identified as a significant cause of error in biopsies and is particularly likely to occur at the insertion stage [2]. The associated risks include: i) biopsy of the wrong site leading to misdiagnosis; ii) puncture of sensitive areas in proximity of the insertion path; iii) repeated insertions, thus longer procedure du- ration and increased patient discomfort. Biopsy needles are also prone to buckling, which can damage the needle permanently. Common techniques for correcting needle bending in clinical settings include repeating the inser- tion (which can be time-consuming) or using a needle guide (which reduces the maximum insertion depth). In research, axial rotation is typically employed for steering bevel-tip needles, but it is less effective for needles with an axial-symmetric tip [4]. Additionally, straight insertions require continuous axial rotation, which can damage soft tissue due to the spinning of the bevel tip [5]. Alternative approaches employ steerable needles, which are not yet part of clinical practice [6]. We have developed a mechanical device that detects needle bending as soon as it occurs and that immediately reduces the insertion force thus helping to avoid deep insertions with deflected needles and the associated risks. Unlike existing solutions, our design does not require actuators or sensors hence it can be made MRI- safe, sterilisable or disposable. Finally, our device can be used with a variety of standard needles, including multi-bevel needles (e.g. diamond tip or conical tip).
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