Valdastri P, Quaglia C, Susilo E, Menciassi A, Dario P, Ho C N, Anhoeck G, Schurr M O
CRIM (Center for Research in Microengineering) Lab, Scuola Superiore Sant'Anna, Pontedera, Pisa, Italy.
Endoscopy. 2008 Dec;40(12):979-82. doi: 10.1055/s-0028-1103424. Epub 2008 Dec 8.
Capsule endoscopy is becoming well established as a diagnostic technique for the gastrointestinal tract. Nevertheless swallowable capsule devices that can effectively perform surgical and therapeutic interventions have not yet been developed. Such devices would also be a valuable support for natural orifice transluminal endoscopic surgery (NOTES). The objective of this study was to assess the feasibility of using a swallowable wireless capsule to deploy a surgical clip under remote control.
A wireless endoscopic capsule, diameter 12.8 mm and length 33.5 mm, was developed. The device is equipped with four permanent magnets, thus enabling active external magnetic steering. A nitinol clip is loaded on the topside of the capsule, ready to be released when a control command is issued by an external operator. Repeated ex vivo trials were done to test the full functionality of the therapeutic capsule in terms of efficiency in releasing the clip and reliability of the remote control. An in vivo test was then carried out in a pig: the capsule was inserted transanally and steered by means of an external magnetic arm towards an iatrogenic bleeding lesion. The clip, mounted on the tip of the capsule, was released in response to a remote signal. The procedure was observed by means of a flexible endoscope.
A wireless capsule clip-releasing mechanism was developed and tested. During ex vivo trials, the capsule was inserted into the sigmoid section of a phantom model and steered by means of the external magnet to a specific target, identified by a surgical suture at a distance of 3 cm before the left flexure. The capsule took 3 to 4 minutes to reach the desired location moving under external magnetic guidance, while positioning of the capsule directly on the target took 2 to 3 minutes. Successful in vivo clipping of an iatrogenic bleed by means of a wireless capsule was demonstrated.
This study reports the first successful in vivo surgical experiment using a wireless endoscopic capsule, paving the way to a new generation of capsule devices able to perform both diagnostic and therapeutic tasks.
胶囊内镜作为一种胃肠道诊断技术已逐渐成熟。然而，能够有效实施手术和治疗干预的可吞咽胶囊装置尚未研发出来。此类装置对于自然腔道内镜手术（NOTES）也将是一项有价值的支持。本研究的目的是评估使用可吞咽无线胶囊在远程控制下部署手术夹的可行性。
研发了一种直径12.8毫米、长度33.5毫米的无线内镜胶囊。该装置配备有四个永久磁铁，从而实现外部主动磁控。一个镍钛合金夹装载在胶囊顶部，当外部操作人员发出控制指令时即可释放。进行了多次体外试验，以测试治疗性胶囊在释放夹子的效率和远程控制的可靠性方面的全部功能。然后在一头猪身上进行了体内试验：将胶囊经肛门插入，并通过外部磁臂将其导向医源性出血病变处。安装在胶囊尖端的夹子根据远程信号释放。通过柔性内镜观察该操作过程。
研发并测试了一种无线胶囊夹释放机制。在体外试验中，将胶囊插入模拟模型的乙状结肠段，并通过外部磁铁将其导向一个特定目标，该目标由左结肠曲前方3厘米处的手术缝线确定。在外部磁引导下，胶囊到达所需位置需要3至4分钟，而将胶囊直接定位在目标上需要2至3分钟。证明了通过无线胶囊成功地在体内夹闭医源性出血。
本研究报告了首次使用无线内镜胶囊成功进行的体内手术实验，为能够执行诊断和治疗任务的新一代胶囊装置铺平了道路。
