Daniel Atai, Coronel Matan, Peer Segev, Grinshpan Ben, Duru Soner, Peiro Jose L, Leach James L, Abellán Elena, Doerning Carolyn M, Zarrouk David, Mangano Francesco T
Department of Mechanical Engineering, Ben-Gurion University of the Negev, Be'er Sheva, Israel.
Division of Neurosurgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Patient Saf Surg. 2024 Dec 18;18(1):36. doi: 10.1186/s13037-024-00420-0.
External ventricular drain (EVD) insertion is one of the most commonly performed neurosurgical procedures. Herein, we introduce a new concept of a cranial fixation device for insertion of EVDs, that reduces reliance on freehand placement and drilling techniques and provides a simple, minimally invasive approach that provides strong fixation to minimal thickness skulls.
An experimental device for catheter insertion and fixation was designed and tested in both ex-vivo and in-vivo conditions to assess accurate cannulation of the ventricle and to test the strength of fixation to the skull. The ex-vivo experiments were conducted at Ben-Gurion University of the Negev (BGU) in Be'er Sheva, Israel. These experiments included functionality bench testing and pullout force measurements for the ball mechanism and catheter fixation. For the in-vivo experiments the fixation device was initially tested at the Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, Ohio on one day of life 1 (DOL 1) male control lamb. Additional experiments were conducted on 3 hydrocephalic DOL 0 lambs (1 male 2 female) at the Jesús Usón Minimally Invasive Surgery Centre (JUMISC) in Caceres, Spain. The hydrocephalic animal model used for this study was created with in utero intracisternal injection of BioGlue in fetal lambs. The catheter insertion trajectory was determined using MR imaging to assess the device's impact on the placement accuracy. The fixation device was evaluated on reaching the ventricle and enabling extraction of CSF for all 7 fixations placed. For 5 of the fixation devices, post-mortem pullout force was measured. The general functionality of the device was also evaluated.
In the experiments, 7/7 (100%) catheter trajectories successfully reached the ventricle without any apparent complications related to the device or the procedure. The cranial fixation device base demonstrated significant strength in withstanding an average pull-out force of 4.18kgf (STD[Formula: see text]0.72, N = 5) without detachment from the subject's skull for all 5 devices included in this test. Additionally, the EVD catheter pull test was conducted with the addition of a safety loop which did not allow movement of the EVD to a force of 3.6kgf. At this force the catheter tore but did not release from its fixation point.
The newly designed experimental device demonstrates initial proof of concept from ex vivo and in vivo testing. It appears suitable for accurate ventricular catheter placement and cranial fixation.
外置脑室引流管（EVD）置入是最常开展的神经外科手术之一。在此，我们介绍一种用于EVD置入的颅骨固定装置的新概念，该装置减少了对徒手放置和钻孔技术的依赖，并提供了一种简单、微创的方法，可对最薄的颅骨提供牢固固定。
设计了一种用于导管插入和固定的实验装置，并在体外和体内条件下进行测试，以评估脑室的准确插管情况，并测试对颅骨的固定强度。体外实验在以色列贝尔谢巴的内盖夫本-古里安大学（BGU）进行。这些实验包括对球机制和导管固定的功能台架测试和拔出力测量。对于体内实验，固定装置最初在俄亥俄州辛辛那提市的辛辛那提儿童医院医疗中心（CCHMC）对1日龄（DOL 1）雄性对照羔羊进行测试。另外在西班牙卡塞雷斯的赫苏斯·乌松微创外科中心（JUMISC）对3只0日龄脑积水羔羊（1只雄性，2只雌性）进行了实验。本研究使用的脑积水动物模型是通过在子宫内对胎羊脑池内注射生物胶创建的。使用磁共振成像确定导管插入轨迹，以评估该装置对放置准确性的影响。对所有7次放置的固定装置，评估其到达脑室并抽取脑脊液的能力。对其中5个固定装置，测量了死后拔出力。还评估了该装置的一般功能。
在实验中，7/7（100%）的导管轨迹成功到达脑室，未出现与该装置或手术相关的明显并发症。颅骨固定装置底座在承受平均拔出力4.18千克力（标准差[公式：见正文]0.72，N = 5）时表现出显著强度，本次测试中的所有5个装置均未从受试者颅骨上脱离。此外，在进行EVD导管拉力测试时增加了一个安全环，在3.6千克力的力作用下EVD无法移动。在此力作用下，导管撕裂但未从其固定点松开。
新设计的实验装置通过体外和体内测试初步证明了概念。它似乎适用于准确的脑室导管放置和颅骨固定。
