Spears Zach, Paras Molly, Fitzsimmons Lauren, De Lacy Logan, Wawrzyn Peter, Conway Sam, Gopalan Srihari, Muckenhirn Kyle, Puccinelli John
Department of Biomedical Engineering, University of Wisconsin-Madison, Madison, USA.
Department of Orthopedics and Rehabilitation, University of Wisconsin Hospitals and Clinics, Madison, USA.
BMC Biomed Eng. 2024 Nov 1;6(1):10. doi: 10.1186/s42490-024-00085-x.
This study introduces a novel surgical instrument to reduce iatrogenic nerve injuries during procedures such as carpal tunnel and ulnar nerve decompression surgery. These injuries often result from direct damage to surrounding tissues by surgical instruments, whose designs have remained largely unchanged over the past decades. The novel device is a modified surgical forceps that has a deployable surgical scalpel that runs along a groove on the forceps. This design protects important anatomical structures while allowing fast dissection and cutting of fascial layers.
The process used to develop a novel instrument included computer-aided design (CAD) modeling, 3D printing for prototyping, and the fabrication of an aluminum prototype. Biomechanical testing was performed with the novel device, iris scissors, bandage scissors, and a scalpel on an MTS Static Materials Test System. The peak force to slide-cut, number of cut attempts, and percentage cut on first attempt were compared between the prototype and traditional surgical tools. The materials cut in testing were Ace™ bandage, stockinette, and gauze. Statistical analyses were performed using Welch's t-tests and Fisher's exact tests.
Compared to conventional bandage and iris scissors, the novel surgical instrument required significantly less force to cut through an Ace™ bandage, stockinette, and gauze (p < 0.01). The number of cuts required to transect those same materials with the novel device was comparable to that of the scalpel and bandage scissors. Additionally, while there were no differences between the novel device and the other devices for an Ace™ bandage and stockinette, the novel device tended to cut a greater percentage of gauze in one pass than did the iris scissors.
The novel surgical instrument designed in this study required less force compared to conventional scissors, demonstrated cutting efficiency similar to that of a scalpel blade, and had more safety features than either instrument. This study highlights the value of collaboration between biomedical engineering and orthopedic surgery departments on innovation in medical technology, through which new technologies with improved design and functionality demonstrate the potential to reduce iatrogenic injuries.
本研究引入了一种新型手术器械,以减少腕管减压术和尺神经减压术等手术过程中的医源性神经损伤。这些损伤通常是由手术器械对周围组织的直接损伤导致的,在过去几十年里,手术器械的设计基本没有变化。这种新型器械是一种改良的手术镊子,带有一个可展开的手术刀,该手术刀沿着镊子上的凹槽运行。这种设计在允许快速解剖和切割筋膜层的同时,保护了重要的解剖结构。
开发新型器械的过程包括计算机辅助设计(CAD)建模、3D打印原型以及制造铝制原型。在MTS静态材料测试系统上,使用新型器械、虹膜剪、绷带剪和手术刀进行生物力学测试。比较了原型器械与传统手术工具在滑切所需的峰值力、切割尝试次数以及首次尝试切割的成功率。测试中切割的材料为Ace™绷带(弹力绷带)、弹力网套和纱布。使用韦尔奇t检验和费舍尔精确检验进行统计分析。
与传统绷带剪和虹膜剪相比,新型手术器械切割Ace™绷带、弹力网套和纱布所需的力显著更小(p < 0.01)。用新型器械横断相同材料所需的切割次数与手术刀和绷带剪相当。此外,虽然新型器械与其他器械在切割Ace™绷带和弹力网套方面没有差异,但新型器械一次切割纱布的成功率往往高于虹膜剪。
本研究设计的新型手术器械与传统剪刀相比所需力更小,切割效率与手术刀相似,且比这两种器械都具有更多安全特性。本研究强调了生物医学工程与骨外科在医疗技术创新方面合作的价值,通过这种合作,具有改进设计和功能的新技术显示出减少医源性损伤的潜力。