Department of BioMechanical Engineering, Faculty of Biomedical Engineering, University of Technology Delft, Mekelweg 2, 2628 CD, Delft, The Netherlands.
Department of Surgery, University Medical Centers Amsterdam, Location VUMC, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Surg Endosc. 2021 Oct;35(10):5857-5866. doi: 10.1007/s00464-021-08603-x. Epub 2021 Jun 22.
Complications that occur in laparoscopic surgery are often associated with the initial entry into the peritoneal cavity. The literature reported incidences of Veress needle (VN) injuries of e.g. 0.31% and 0.23%. In a 2010 national survey of laparoscopic entry techniques in the Canadian General Surgical practice, 57.3% of respondents had either experienced or witnessed a serious laparoscopic entry complication like bowel perforation and vascular injury. As those complications are potentially life threatening and should be avoided at all costs, improving safety of this initial action is paramount.
Based on a bare minimum design approach with focus on function expansion of existing components, a new Safety mechanism was developed for the VN that decreases the risks of VN overshooting. The mechanism works by preventing the puncturing acceleration of the tip of the VN by decoupling the surgeon's hand from the VN immediately after entering the abdomen.
Based on a set of requirements, a first prototype of the VN+ with force decoupling safety mechanism is presented and evaluated on an ex vivo porcine abdominal wall tissue model in a custom setup. The experiments conducted by two novices and one experienced surgeon indicated a significant difference between the attempts with a standard, conventional working VN (41.4 mm [37.5-45 mm]) and VN+ with decoupling mechanism (20.8 mm [17.5-22.5 mm]) of p < 0.001.
A new decoupling safety mechanism was integrated successfully in a standard VN resulting in a VN+ . The results from the pilot study indicate that this new VN+ reduces overshooting with a minimum of 50% in a standardised ex vivo setting on fresh porcine abdominal wall specimens.
腹腔镜手术中的并发症通常与初次进入腹腔有关。文献报道 Veress 针(VN)损伤的发生率为 0.31%和 0.23%。在 2010 年加拿大普通外科实践中腹腔镜进入技术的全国调查中,57.3%的受访者经历过或目睹过严重的腹腔镜进入并发症,如肠穿孔和血管损伤。由于这些并发症具有潜在的生命威胁,应不惜一切代价避免,因此提高这一初始操作的安全性至关重要。
基于以功能扩展为重点的最低限度设计方法,为 VN 开发了一种新的安全机制,可降低 VN 过冲的风险。该机制通过在进入腹部后立即将医生的手与 VN 分离,防止 VN 尖端的穿刺加速来工作。
根据一组要求,提出了具有力解耦安全机制的 VN+的第一个原型,并在定制设置的离体猪腹壁组织模型上进行了评估。两名新手和一名经验丰富的外科医生进行的实验表明,标准常规工作 VN(41.4mm [37.5-45mm])和具有解耦机制的 VN+(20.8mm [17.5-22.5mm])之间的尝试存在显著差异,p<0.001。
成功地将一种新的解耦安全机制集成到标准 VN 中,得到了 VN+。初步研究结果表明,这种新的 VN+在新鲜猪腹壁标本的标准离体环境中,以最小的 50%减少了过冲。