School of Mechanical Engineering, Pusan National University, Busan, South Korea.
Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University College of Medicine, Busan, South Korea.
PLoS One. 2024 May 2;19(5):e0302737. doi: 10.1371/journal.pone.0302737. eCollection 2024.
As advancements in surgical instruments and techniques continue to evolve, minimally invasive surgery has become increasingly preferred as a means of reducing patient pain and recovery time. However, one major challenge in performing minimally invasive surgery for early gastrointestinal cancer is accurately identifying the location of the lesion. This is particularly difficult when the lesion is confined to the lumen of the intestine and cannot be visually confirmed from the outside during surgery. In such cases, surgeons must rely on CT or endoscopic imaging to locate the lesion. However, if the lesion is difficult to identify with these images or if the surgeon has less experience, it can be challenging to determine its precise location. This can result in an excessive resection margin, deviating from the goal of minimally invasive surgery. To address this challenge, researchers have been studying the development of a marker for identifying the lesion using a radio-frequency identification (RFID) system. One proposed method for clinical application of this detection system is to attach an RFID tag to an endoscopic hemostatic clip and fix it to the intended position, providing a stable marker for the inner wall of the organ. This approach has the potential to improve the accuracy and effectiveness of minimally invasive surgery for early gastrointestinal cancer.
In the development of a marker for identifying gastrointestinal lesions using a radio-frequency identification (RFID) system, the shape of the clip and suitable materials for attaching the RFID tag were determined through finite element method (FEM) analysis. A prototype of the clip was then fabricated and ex-vivo experiments were conducted using porcine intestine to evaluate the stability of the clip in relation to its position. To further evaluate the performance of the RFID-integrated clip in vivo, the clip was placed in the gastric wall of the stomach of anesthetized porcine using an endoscopic instrument. The clip was then detected using a RFID detector designed for laparoscopic approach. And later, the accuracy of detection was confirmed by incising the lesion.
The design and fabrication of a clip with varying thicknesses using STS316 and STS304 stainless steel were accomplished using the results of finite element method analysis. The stability of the clip was evaluated through ex-vivo experiments, showing it to be a viable option. In-vivo experiments were performed on anesthetized porcine, in which the RFID-integrated clip was placed in the gastric wall and detected using a custom-made RFID detector. The resection margin, measured at about 30 mm from the detector position, was accomplished with low error. These findings indicate the feasibility and efficacy of using an RFID-integrated clip as a marker in minimally invasive surgery for the identification of gastrointestinal lesions.
The study evaluated the feasibility of using stainless steel clips for lesion detection in endoscopic surgery using computer-aided engineering analysis and ex-vivo experimentation. Results showed that STS304 was suitable for use while STS316L was not. The ex-vivo experiments revealed that the clip holding force and tissue retention length varied depending on the location of attachment. In-vivo experiments confirmed the accuracy and usefulness of the RFID lesion detection system. However, challenges remain for its use in clinical field, such as ensuring the stability of the clip and the safe attachment of the RFID tag, which requires further research for commercialization.
随着手术器械和技术的不断进步，微创手术已成为减少患者疼痛和康复时间的首选方法。然而，对于早期胃肠道癌症的微创手术来说，一个主要挑战是准确识别病变部位。当病变局限于肠腔且在手术过程中无法从外部直观确认时，这尤其困难。在这种情况下，外科医生必须依靠 CT 或内镜成像来定位病变。然而，如果这些图像难以识别病变，或者外科医生经验不足，确定其确切位置可能具有挑战性。这可能导致切除边缘过大，偏离微创手术的目标。为了解决这个挑战，研究人员一直在研究使用射频识别（RFID）系统识别病变的标记物的开发。该检测系统的一种临床应用方法是将 RFID 标签附加到内镜止血夹上，并将其固定在预期位置，为器官内壁提供稳定的标记物。这种方法有可能提高早期胃肠道癌症微创手术的准确性和有效性。
在使用射频识别（RFID）系统识别胃肠道病变的标记物的开发中，通过有限元方法（FEM）分析确定了夹的形状和适合粘贴 RFID 标签的材料。然后制造了夹的原型，并使用猪肠进行了离体实验，以评估夹相对于其位置的稳定性。为了进一步评估体内带有 RFID 的夹的性能，使用内镜器械将夹放置在麻醉猪的胃壁中。然后使用专为腹腔镜方法设计的 RFID 探测器检测夹。然后通过切开病变来确认检测的准确性。
使用 STS316 和 STS304 不锈钢通过有限元法分析的结果设计和制造了具有不同厚度的夹。通过离体实验评估了夹的稳定性，结果表明这是一种可行的选择。在麻醉猪身上进行了体内实验，其中将带有 RFID 的夹放置在胃壁中，并使用定制的 RFID 探测器进行检测。从探测器位置测量的切除边缘误差约为 30 毫米。这些发现表明，在胃肠道病变的微创手术中，使用带有 RFID 的夹作为标记物具有可行性和有效性。
本研究通过计算机辅助工程分析和离体实验评估了使用不锈钢夹进行内镜手术中病变检测的可行性。结果表明，STS304 适合使用，而 STS316L 则不适合。离体实验表明，夹的夹持力和组织保留长度取决于附着位置。体内实验证实了 RFID 病变检测系统的准确性和实用性。然而，在临床领域使用它仍面临挑战，例如确保夹的稳定性和 RFID 标签的安全附着，这需要进一步研究以实现商业化。
