Institute of Micro Technology and Medical Device Technology, Technical University of Munich, Boltzmannstr. 15, 85748, Garching, Germany.
IRDC GmbH International Reference and Development Centre for Surgical Technology, Käthe-Kollwitz-Straße 64, 04109, Leipzig, Germany.
Int J Comput Assist Radiol Surg. 2020 Sep;15(9):1549-1559. doi: 10.1007/s11548-020-02220-0. Epub 2020 Jul 1.
Draf drainage is the standard treatment procedure for frontal sinus diseases. In this procedure, rigid angled endoscopes and rigid curved instruments are used. However, laterally located pathologies in the frontal sinus cannot be reached with rigid instrumentation. In order to assist surgeons with such complicated cases, we propose a novel handheld flexible manipulator system.
A cross section of 3 mm × 4.6 mm enables transnasal guiding of a flexible endoscope with 1.4 mm diameter and a standard flexible surgical instrument with up to 1.8 mm diameter into the frontal sinus with increased reachability. The developed system consists of an electrical discharge-machined flexure hinge-based nitinol manipulator arm and a purely mechanical handheld control unit. The corresponding control unit enables upward and left-right bending of the manipulator arm, translation, rolling, actuation and also quick exchange of the surgical instrument. In order to verify the fulfillment of performance requirements, tests regarding reachability and payload capacity were conducted.
Reachability tests showed that the manipulator arm can be inserted into the frontal sinus and reach its lateral regions following a Draf IIa procedure. The system can exert forces of at least 2 N in the vertical direction and 1 N in the lateral direction which is sufficient for manipulation of frontal sinus pathologies.
Considering the fact that the anatomical requirements of the frontal sinus are not addressed satisfactorily in the development of prospective flexible instruments, the proposed system shows great potential in terms of therapeutic use owing to its small cross section and dexterity.
额窦疾病的标准治疗程序是引流。在此过程中，使用刚性角度内窥镜和刚性弯曲器械。然而，额窦内的侧向病变无法用刚性器械到达。为了帮助外科医生处理此类复杂病例，我们提出了一种新型手持式柔性操作器系统。
横截面为 3mm×4.6mm，可通过经鼻引导直径为 1.4mm 的柔性内窥镜和直径达 1.8mm 的标准柔性手术器械进入额窦，从而增加可达性。所开发的系统由基于放电加工的镍钛诺挠曲铰链的柔性操纵臂和纯机械手持式控制单元组成。相应的控制单元可使操纵臂向上和左右弯曲、平移、滚动、驱动，并且还可以快速更换手术器械。为了验证性能要求的满足情况，进行了可达性和承载能力测试。
可达性测试表明，操纵臂可以插入额窦，并按照 Draf IIa 程序到达其侧区。该系统可以在垂直方向上施加至少 2N 的力，在侧向方向上施加至少 1N 的力，足以操纵额窦病变。
考虑到前瞻性柔性器械的开发未能充分满足额窦的解剖要求，由于其较小的横截面和灵活性，所提出的系统在治疗用途方面具有很大的潜力。
