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  5. 多自由度腹腔镜手术器械腕部枢轴布置的人机工程学效应与设计权衡研究

多自由度腹腔镜手术器械腕部枢轴布置的人机工程学效应与设计权衡研究

深度研究匿名用户发表于 2026年07月21日 14:352阅读
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1. 研究背景与对象界定

1.1 腹腔镜手术器械人机工程设计的现实需求

腹腔镜手术（Laparoscopic Surgery）作为一种微创手术方式，尽管为患者带来了创伤小、恢复快等诸多益处，却也给外科医生带来了独特的职业挑战。由于手术器械操作的特殊性，外科医生在长时间手术过程中常被迫保持不自然、受限的姿态，这导致工作相关肌肉骨骼疾病（Work-Related Musculoskeletal Disorders, WMSDs）的发生率居高不下 12。据统计，高达70%-87%的外科医生在其职业生涯中经历过与工作相关的肌肉骨骼疼痛或损伤，这不仅影响其身体健康和生活质量，甚至可能导致休假、需要医疗或手术治疗、职业倦怠、专业变更乃至提前退休 13。

特别是在腹腔镜手术中，器械手柄设计不合理、力量传导效率低下等问题，常导致外科医生手部疲劳、不适甚至感觉异常 4。研究表明，与传统开放手术相比，腹腔镜手术要求医生付出更大的努力，并在更远离手术视野的情况下进行操作 4。长时间的静态肌肉活动和高强度体力负荷是微创手术的显著特点 5。例如，低经验（LE）外科医生在下背部肌肉的参考随意收缩百分比（%RVC）水平高于高经验（HE）外科医生，且在大多数肌肉群中的疲劳程度也更高 6。连续进行两台手术后，双臂的肱二头肌和肱三头肌等多个肌肉群的疲劳程度显著增加 6。

多自由度腹腔镜手术器械的腕部枢轴设计是影响操作体验和手术效果的核心因素之一。腕部枢轴的布置直接关系到器械末端的可操作性、灵活性以及操作时手腕和上肢的运动学姿态。传统腹腔镜器械的刚性结构限制了其在狭小空间内的运动自由度，而多自由度器械通过在末端引入额外的关节，显著提升了操作灵活性，使得在复杂解剖结构中进行精细操作成为可能 78。然而，不同的腕部枢轴布置方案会带来不同的人机工程学效应。例如，一些多自由度器械虽能提供更好的操作性，但可能会增加外科医生手腕的不适感，而背部不适感则可能相对降低 7。这种设计上的差异对外科医生的操作姿态、肌肉负荷、操作效率乃至远期职业健康都产生深远影响。鉴于外科医生WMSDs的普遍性和严重性，深入研究多自由度腹腔镜手术器械腕部枢轴布置的人机工程学效应，并在此基础上进行合理的设计权衡，对于提升外科医生工作舒适度、降低职业损伤风险、延长职业生涯具有重要的现实意义。

1.2 研究范围与评估维度设定

本研究旨在深入评估两种不同腕部枢轴布置方案的多自由度腹腔镜手术器械的人机工程学效应及其相关设计权衡。本次对比的核心方案包括：本团队正在探索的前置式腕部枢轴自研方案，以及市场上已有的LivsMed腕部枢轴方案（例如ArtiSential器械）。这两种方案在腕部/枢轴的布置方式上存在显著差异，理解这些设计决策背后的原理及其相关的权衡对于指导未来的器械开发至关重要。LivsMed的ArtiSential器械是一种柔性多关节器械，已被证实能够缩短腹腔镜直肠癌手术的手术时间，且不影响手术质量或肿瘤学结果，这表明其在临床应用中具有一定的优势9。

具体而言，前置式腕部枢轴方案通常指器械末端关节（即“腕部”）在器械轴线方向上更靠近操作端（手柄侧）或更靠近工作端（末端效应器侧）的设计。而LivsMed方案，通过其ArtiSential器械，可能采用了独特的腕部/枢轴布置，以提供更灵活的关节运动和更佳的操作体验。本次研究将不旨在判定哪种概念绝对“正确”或“错误”，而是通过基于证据的分析，全面理解不同解决方案的优势、劣势及可能的设计原因。

为确保评估的全面性和深入性，本研究将划定以下评估维度：

  • 人机工程学：这是研究的核心关注点，将重点分析不同枢轴位置对术者操作姿态、肌肉负荷、疲劳程度、认知负荷以及长期健康影响的差异。例如，机器人手术在姿势、可视化和操作方面提供了人机工程学优势，但可能因缺乏触觉反馈、视觉和精神疲劳以及工作流程中断而带来劣势，这提示我们需要全面考量人机工程学影响10。
  • 可用性 (Usability)：评估器械在实际手术环境中的易用性、学习曲线、操作直观性以及对不同经验水平术者的适配性。
  • 运动学 (Kinematics)：分析器械末端在不同枢轴布置下的运动自由度、操作范围、精度以及在狭窄空间内的可达性，理解其对不同术式和操作深度的影响11。
  • 可制造性 (Manufacturability)：考量两种方案在结构复杂度、零部件加工精度、材料选择以及批量生产和组装过程中的可行性和经济性。
  • 临床工作流 (Clinical Workflow)：评估器械在术前准备、术中更换、术后消毒维护等环节对整体手术流程效率的影响。
  • 知识产权 (Intellectual Property, IP) 考量：梳理现有专利布局，识别潜在的知识产权风险，并评估各自方案在专利保护方面的潜力和空间。

通过对上述维度的综合分析，本研究的目标是建立对不同腕部枢轴概念影响的循证理解，从而为多自由度腹腔镜手术器械的未来研发方向提供更为明智的决策依据。这有助于开发出既能提高手术效率和安全性，又能显著改善外科医生工作体验的创新型器械。

2. 两类腕部枢轴方案的人机工程学效应对比分析

2.1 操作姿态与肌肉负荷差异

腹腔镜手术器械腕部枢轴位置的设计对于外科医生的操作姿态和肌肉负荷具有决定性影响，直接关系到术者在长时间手术中的舒适度与疲劳风险。本研究将通过模拟操作实验和表面肌电（sEMG）采集等方法，对前置式腕部枢轴自研方案和LivsMed腕部枢轴方案进行对比分析，以量化评估它们在操作姿态、肌肉活动范围、肌肉疲劳程度以及肌肉劳损风险方面的差异。

传统腹腔镜手术中，由于器械的刚性限制，外科医生常需采用不自然的姿势操作，导致手腕、前臂、肩部和颈部肌肉的显著负荷。多自由度器械通过提供额外的运动自由度（如腕部关节的偏航和滚动 12），旨在改善这些不利的人机工程学状况。然而，不同的枢轴布置方式会对此产生不同的影响。

操作姿态与活动范围：

前置式腕部枢轴方案，其腕部关节更靠近器械工作端，理论上能使器械末端在较小的手腕动作下实现更大的操作角度和范围。这意味着外科医生在进行精细操作时，手腕可以保持更接近中立的姿势，从而减少手腕的过度偏离和扭转。通过动作捕捉系统记录术者手腕和上肢在不同操作任务（如缝合、打结、组织剥离）中的关节角度变化，可以量化比较两种方案下，手腕在屈伸、桡尺偏以及旋前旋后等方向上的活动范围，评估其是否能更好地引导术者保持符合人机工程学原则的“中立区”姿态。

相比之下，LivsMed方案（例如ArtiSential器械）通过其独特的枢轴布置，可能旨在提供类似手部自然运动的直观操作，但也可能在某些情况下对手腕产生特定的力学要求。对LivsMed方案的操作姿态分析将侧重于其是否能有效减少手腕的静态负荷，以及在复杂多角度操作中手腕需要作出的补偿性动作。

肌肉负荷与疲劳风险：

表面肌电图（sEMG）是评估肌肉活动和疲劳程度的常用客观方法 6。本研究将选择与腹腔镜操作密切相关的肌肉群进行sEMG数据采集，包括：

  • 前臂肌肉：如指浅屈肌（Flexor Digitorum Superficialis, FDS）、尺侧腕伸肌（Extensor Carpi Ulnaris, ECU）、桡侧腕长伸肌（Extensor Carpi Radialis Longus, ECR）和拇长伸肌（Extensor Pollicis Longus, EPL），这些肌肉直接参与器械的抓握和精细控制 13。
  • 上臂肌肉：肱二头肌和肱三头肌，反映手臂的弯曲和伸展负荷。
  • 肩部和颈部肌肉：如三角肌和斜方肌，反映肩部支撑和颈部姿态的负荷，因为肩部疲劳会降低认知注意力资源 14。

通过对sEMG信号的均方根值（RMS）进行分析，可以量化不同操作任务下各肌肉群的激活水平。将其标准化为最大自主收缩百分比（%MVC），可以更好地比较不同个体间的肌肉负荷。研究表明，高于15%MVC的持续肌肉活动会显著增加肌肉疲劳和损伤的风险 13。此外，通过分析sEMG信号中值频率（Median Frequency, MF）的下降趋势，可以客观评估不同时长操作下的肌肉疲劳发展情况 615。与高经验（HE）外科医生相比，低经验（LE）外科医生在大多数肌肉群中表现出更高的疲劳水平 6。

预期结果是，如果前置式腕部枢轴方案能够促进更中立的手腕姿态，则可能降低前臂肌肉（如FDS、ECR）的激活水平，特别对于小手型外科医生，其使用传统腹腔镜器械时前臂肌肉激活水平更高 13。而LivsMed方案如果能有效分散操作负荷，也可能在其他肌肉群（如肩部或上臂）表现出较低的疲劳积累。通过对比两种方案在模拟缝合、切割、抓持等任务中的肌肉负荷和疲劳曲线，可以更全面地理解它们对术者生理负荷的影响，从而评估各自的肌肉劳损风险。例如，与传统腹腔镜手术相比，机器人手术可显著降低肱二头肌和尺侧腕屈肌的累积肌肉负荷 16，这提示多自由度器械在正确设计下，有望实现类似的减负效果。

2.2 操作效率与认知负荷差异

腹腔镜手术的效率与安全性不仅取决于器械的物理性能，更与外科医生的操作效率和认知负荷密切相关。多自由度腹腔镜手术器械的腕部枢轴设计，通过影响器械的灵活性、控制精确度以及人机交互的直观性，进而显著影响术者的操作表现和心理状态。本节将对比前置式腕部枢轴自研方案和LivsMed腕部枢轴方案在精细缝合、深部组织操作等典型腹腔镜手术场景下的操作准确率、任务完成时长、认知负荷水平以及操作失误率差异。

操作准确率与任务完成时长：

在腹腔镜手术中，精细缝合、打结以及在深部狭窄空间内进行组织剥离和止血是衡量器械性能和术者技能的关键任务。研究将通过标准化模拟手术任务来评估两种方案。例如，可以采用类似于腹腔镜基础外科技能（FLS）项目中的穿钉、精确切割等任务，或者更高级的血管缝合、肠道吻合等模拟场景进行测试 17。

  • 任务完成时长 (Task Completion Time)：记录术者完成各项任务所需的时间。更高效的器械设计应能帮助术者更快地完成任务，而无需牺牲准确性。多自由度器械因其高灵活性和降低的操作难度，常能缩短手术时间 18。
  • 操作准确率 (Operational Accuracy)：通过评估缝合间距的均匀性、结扎的牢固度、切割边缘的平整度、对周围组织的损伤程度等指标来量化操作的精确性。例如，在穿钉任务中，记录成功抓取和放置钉子的数量以及误触的次数。对于精细缝合，则可评估缝合线的张力一致性和打结的规范性。有研究显示，具有灵活末端的器械在某些精细任务中能提供更高的精确度。

认知负荷与操作失误率：

认知负荷（Cognitive Load）是指个体在执行任务时所承受的心理努力程度。腹腔镜手术室中的噪音和干扰就已被证实会严重影响手术表现和患者结局，增加工作人员的认知负荷和错误率 19。此外，有研究指出，数字化手术清单和外科医生偏好卡的移动健康应用可以通过优化手术室工作流程，显著降低操作室护士的认知负荷 20。

  • 认知负荷水平 (Cognitive Load Level)：可以采用主观评估量表（如NASA-TLX问卷）让术者在完成任务后评估其心理需求、体力需求、时间压力、绩效表现、努力程度和挫败感。客观指标方面，眼动追踪技术可以分析注视点、瞳孔直径变化等，以反映认知努力程度；心率变异性（HRV）也可作为生理应激和认知负荷的间接指标。
  • 操作失误率 (Error Rate)：记录任务执行过程中发生的错误，例如误伤组织、器械滑脱、缝线断裂、未能正确完成指定步骤等。较高的失误率不仅影响手术效果，更可能导致严重的并发症。一项对比研究发现，使用控制关节（主从控制，MSC）的操纵器在处理时更为困难，导致在某些任务中出现更高的错误率，而使用控制轮（指尖控制，FTC）的操纵器则更受术者偏爱 21。

预期差异分析：

前置式腕部枢轴方案，如果设计得当，其末端关节的运动与术者手腕的自然运动映射关系更直观，可能减少术者的学习曲线，降低操作的认知负荷。由于其末端可达性可能更佳，术者在处理深部病灶或复杂角度时，无需过度扭转手腕或调整身体姿态，从而节省了认知资源，提高了操作效率和准确性。

LivsMed方案（如ArtiSential器械），若能提供类似手部自然关节的“主从控制”感，也可能在特定任务中展现出高效率。然而，一项比较研究显示，采用主从控制机制的操纵器可能比指尖控制机制的操纵器更难处理，并导致更高的错误率 21。

通过上述指标的量化对比，本研究将揭示两种腕部枢轴方案在实际操作中对术者效率和认知负荷的具体影响，为评估其综合性能提供关键数据支持。

2.3 不同术者群体的适配性差异

外科医生的个体差异，如身高、手部尺寸、操作习惯以及临床经验水平，对腹腔镜手术器械的实际使用体验和人机工程学表现具有显著影响。不同的腕部枢轴设计方案在适配这些个体差异方面可能存在差异，进而影响器械的普适性。本节将分析前置式腕部枢轴自研方案和LivsMed腕部枢轴方案对不同术者群体的适配度，评估其在普适性方面的表现。

手部尺寸与器械握持：

研究表明，现有市售腹腔镜器械的手柄尺寸往往偏大，主要针对男性外科医生设计，这导致女性外科医生在操作时面临更多的人机工程学问题，尤其是在手部和手指方面 2223。例如，女性外科医生报告称，使用环形手柄的腹腔镜钳时，其舒适度在所有评估类别中均低于男性同行，且对手部和手指造成不适，影响手术操作 22。手套尺寸较小的外科医生（例如小于6.5号）在使用常见的腹腔镜器械（如关闭式Babcock钳、旋转杯活检钳和操作内窥镜吻合器）时，会感到更大的困难 24。因此，腕部枢轴的设计不仅要考虑其机械性能，还要考虑手柄与手部尺寸的匹配性，以减少手部肌肉的过度使用和不适。如果前置式腕部枢轴方案能够结合更符合人体工程学的手柄设计，例如减少高压接触区域、促进手腕和前臂的中立姿势 25，则有望更好地适应不同手部尺寸的术者。

身高与操作姿态：

外科医生身高差异会影响其在手术台前的站立或坐姿，进而影响器械的持握角度和操作视野。如果器械的腕部枢轴设计能够提供更大的末端可达性或更灵活的角度调整能力，则不同身高的术者在保持舒适姿态的同时，也能有效操作器械，减少颈部、肩部和背部的劳损风险。例如，佩戴5.5-6.5号手术手套的女性外科医生比佩戴同尺寸手套的男性外科医生更容易出现肩部区域（颈部、肩部、上背部）的不适 23。优化器械设计，使其能适应不同身高术者的操作习惯，将有助于提升普适性。

操作习惯与经验水平：

术者的临床经验水平对器械的使用和适应性也有显著影响。经验丰富的外科医生可能更能适应器械的不足，而经验较少的医生则可能因器械的人机工程学缺陷而面临更大的挑战。直观、易于学习和操作的器械设计对于所有经验水平的术者都至关重要，特别是对于初学者。如果腕部枢轴设计能够提供更直观的力反馈或更自然的运动映射，可能会缩短学习曲线，使不同经验水平的术者都能更快掌握。

普适性评估：

LivsMed方案（例如ArtiSential器械）作为已上市产品，其设计可能已在一定程度上考虑了市场普适性。而前置式腕部枢轴自研方案，则需通过严格的临床前评估，确保其不仅在技术上优越，同时也能广泛适用于不同身形、不同操作习惯和经验水平的术者。评估其普适性，可以通过以下方式进行：

  • 用户体验调研：对不同身高、手部尺寸、性别和经验水平的术者进行问卷调查和访谈，收集他们对器械舒适度、易用性、操控性以及疲劳感的反馈。
  • 多中心模拟实验：在多个医疗中心组织模拟手术，邀请不同背景的术者参与，观察其操作行为，收集客观绩效数据和主观反馈。
  • 生物力学分析：评估器械握持时手部各区域的压力分布，确保器械手柄设计能够适应更广泛的用户群体，避免局部高压点导致不适。

综合来看，一个成功的腕部枢轴设计方案应尽可能地减少对特定术者群体的偏好，实现更广泛的普适性。这意味着器械设计应能提供足够的可调节性或自适应性，以适应外科医生个体的生理差异和操作偏好，从而最大程度地降低职业损伤风险，提升整体手术效率和质量。

3. 两类方案的关联影响因素对比评估

3.1 运动学性能与临床场景适配性

多自由度腹腔镜手术器械的腕部枢轴设计对其运动学性能具有根本性影响，这直接决定了器械末端在狭小腹腔内的操作灵活性、可达范围和精细控制能力，进而影响其对不同临床场景和手术术式的适配性。本节将分析前置式腕部枢轴自研方案和LivsMed腕部枢轴方案的运动学特征，包括运动自由度（DOF）、末端操作可达范围、操作盲区，并评估其在不同腹腔术式和操作深度场景下的适配能力。

运动自由度（Degrees of Freedom, DOF）

传统腹腔镜器械通常具有4个自由度（包括抓取功能），但这不足以实现器械末端的完全旋转，从而限制了在腹腔内难以触及器官的访问能力 12。多自由度器械通过在末端引入腕部关节，显著增加了运动自由度。

  • 前置式腕部枢轴自研方案：这种方案通常将腕部关节（如俯仰、偏航、滚动）设置在器械的远端，靠近末端效应器。这种设计的目标是最大化末端效应器的独立运动能力，使其在进入腹腔后能更灵活地调整角度和方向。例如，如果腕部提供两个额外的旋转自由度（如俯仰和偏航），再加上器械自身的插入、旋转和抓取，总自由度可达到7个或更多 12。这种设计在理论上能提供更精细的运动控制，使得器械末端能够模拟人手腕的灵巧性，在狭窄空间内实现多角度操作。
  • LivsMed腕部枢轴方案（如ArtiSential器械）：LivsMed的ArtiSential器械被描述为一种柔性多关节器械，其腕部枢轴的布置可能旨在提供更接近“主从控制”的直观运动映射。这种方案可能通过复杂的连杆或缆线驱动机制，将手柄处的运动精确地传递到器械末端。其运动自由度可能与前置式枢轴方案类似，但其运动学特性（如关节运动耦合、反向运动学解算复杂性）可能有所不同。研究表明，一些多自由度器械能够提供腕部关节的偏航和滚动自由度，从而改善末端操作的灵活性 12。

末端操作可达范围与操作盲区

器械的运动学设计直接影响其在给定切口位置下，末端效应器能够触及的手术区域大小（可达范围）以及无法触及的区域（操作盲区）。

  • 前置式腕部枢轴自研方案：由于腕部关节位于器械远端，其末端效应器可以在一个固定的穿刺点（端口）周围实现较大的锥形工作空间。这意味着在不改变穿刺点的情况下，医生可以触及腹腔内更广阔的区域，减少了额外穿刺点的需求，从而降低患者创伤。同时，在特定角度下，器械末端可以绕过障碍物，减少传统器械由于刚性直杆造成的“碰撞”问题。然而，如果腕部关节与末端效应器之间的距离过短，可能导致在某些极限角度下，器械轴杆与末端效应器之间形成夹角，限制某些运动方向的可达性。
  • LivsMed腕部枢轴方案：该方案可能通过其独特的关节设计，在保持器械轴线相对稳定的情况下，使末端具备较大的弯曲和旋转能力。这在理论上也能提供较大的可达范围。然而，如果其柔性关节段较长，可能在深部操作时出现“鞭梢效应”或控制精度下降的问题，从而增加操作盲区。此外，关节的物理约束（如最大弯曲角度）也会限制其可达范围。

临床场景适配性

  • 不同腹腔术式：
    • 胃肠道手术（如结直肠癌切除、胃大部切除）：这些手术常涉及深部狭窄区域的精细剥离、淋巴结清扫和吻合。具有高自由度和大可达范围的器械能够更好地应对这些挑战。前置式腕部枢轴方案可能因其末端灵活性在深部吻合中表现出色，而LivsMed方案如果能提供更自然的“手感”，则可能在组织牵拉和精细解剖中具有优势。
    • 妇科手术（如子宫切除、卵巢囊肿剥除）：这类手术对器械的精细操作和多角度可达性要求高。特别是在处理盆腔深部病灶时，器械需能够绕过骨盆结构进行操作。
    • 肝胆胰手术：涉及复杂的血管和胆管结构，要求器械具有极高的精度和稳定性，以避免损伤。
  • 不同操作深度场景：
    • 浅表操作：两种多自由度器械都能提供优于传统器械的灵活性。
    • 深部操作：器械的长度、刚性和控制精度变得尤为重要。过长的柔性段可能导致深部操作时控制困难。前置式腕部枢轴方案如果轴杆刚性好，且腕部关节反馈清晰，在深部操作中可能表现更稳定。LivsMed方案如果其柔性关节在深部仍能保持精确控制，则同样具有优势。

总的来说，运动学性能的优劣直接转化为临床应用中的效率和安全性。高自由度、大可达范围和低操作盲区是评估多自由度腹腔镜器械运动学性能的关键指标。通过精确的运动学分析和模拟，结合临床专家的反馈，可以全面评估两种枢轴方案在不同临床场景下的适配能力，从而为器械的选型和优化提供数据支持。一项关于新型7自由度腹腔镜器械的研究表明，这种器械能提供更好的操纵性、功能性和可达性，这进一步强调了高自由度器械在临床实践中的潜力 12。

3.2 可制造性与成本控制差异

多自由度腹腔镜手术器械的腕部枢轴设计不仅影响其人机工程学和运动学性能，更在很大程度上决定了其可制造性、生产成本以及全生命周期的维护成本。在器械概念验证阶段，对这些因素的评估至关重要，以确保最终产品在技术可行性的同时具备商业竞争力。本节将对比前置式腕部枢轴自研方案和LivsMed腕部枢轴方案在结构复杂度、零部件加工精度要求、装配良率，以及生产、维护全生命周期内的成本差异。

结构复杂度与零部件加工精度要求：

  • 前置式腕部枢轴自研方案：如果采用传统的机械连杆或齿轮传动机制，前置式腕部枢轴方案可能涉及多个小型精密机械部件，如微型齿轮、轴承、连杆和推杆等。这些部件为了实现紧凑的腕部结构和精确的运动，通常需要极高的加工精度。例如，微型关节的间隙控制、表面粗糙度以及材料选择（如生物相容性金属或工程塑料）都会显著影响其性能和制造成本。如果采用缆线驱动（tether-driven）机制，则需要精确的缆线布线、张力控制和导向机构，以实现解耦的自由度，缆线段长度在工作运动范围内变化很小，这会增加设计的复杂性和制造的挑战性 26。
  • LivsMed腕部枢轴方案（如ArtiSential器械）：LivsMed的柔性多关节器械可能采用更复杂的柔性连杆、弹簧元件或独特的传动设计。例如，其可能利用激光切割镍钛诺管（nitinol tube）制成的不对称切口腕部结构，这种结构通过单根肌腱驱动即可提供高远端曲率，且易于制造和扩展 27。这种设计在加工上可能对材料和工艺有特殊要求，例如激光切割的精度、热处理以及表面处理等。尽管某些柔性结构的零部件数量可能少于刚性连杆机构，但其集成度和材料特性可能导致更高的单件加工成本。

装配良率与生产效率：

  • 装配复杂度：结构越复杂、零部件数量越多、加工精度要求越高的方案，其装配过程通常也越复杂、耗时越长，对操作工人的技能要求也越高。例如，精密机械部件的组装可能需要专业的夹具和显微辅助设备。柔性结构的组装则可能涉及更精细的校准和预应力施加。
  • 装配良率：高复杂度和精度要求往往伴随着较低的首次通过良率。任何微小的尺寸偏差或装配失误都可能导致器械性能不达标，进而增加返工或报废成本。
  • 自动化潜力：两种方案在多大程度上能够实现自动化或半自动化装配，也是评估生产效率和成本的关键。结构标准化程度高、模块化设计强的方案，更易于引入自动化设备，从而降低人工成本并提高生产一致性。

生产、维护全生命周期成本差异：

  • 初始采购成本：多自由度器械因其技术含量和制造复杂性，初始采购成本普遍高于传统器械。具体到两种方案，需要评估其零部件成本、加工成本和组装成本。例如，采用先进材料（如镍钛诺）或精密加工工艺的部件，其成本会显著增加。
  • 重复使用与一次性使用：腹腔镜器械的成本效益与其重复使用性密切相关。一次性器械通常手术成本更高，而可重复使用的器械虽然初始成本高，但长期来看能显著节省费用 2829。如果两种腕部枢轴方案均设计为可重复使用，则需要考虑其消毒、维护和预期寿命。若其中一种方案由于结构过于复杂或材料限制导致无法有效消毒或易损，则可能偏向一次性使用，从而大幅增加每次手术的耗材成本 2830。
  • 维护与维修成本：可重复使用器械需要定期维护、校准和可能的维修。腕部枢轴作为器械的核心运动部件，其磨损、疲劳和损坏的可能性较高。设计更坚固、易于维护、模块化可更换部件的方案，能有效降低长期维护成本。例如，如果LivsMed的柔性结构在使用中容易疲劳或损坏，其维修或更换成本可能较高。
  • 供应链风险：零部件的来源、供应商的稳定性以及是否存在单一供应商，也会影响成本和生产的可持续性。

通过对上述因素的详细分析，可以在早期设计阶段识别潜在的成本驱动因素和制造成本风险，从而指导设计团队在性能、成本和可制造性之间进行权衡，最终选择一个具有最佳综合经济效益的腕部枢轴方案。

3.3 知识产权风险对比

在多自由度腹腔镜手术器械的研发过程中，知识产权（Intellectual Property, IP）考量是至关重要的环节，它不仅影响产品的市场准入和竞争格局，也决定了未来技术创新和商业化的自由度。本节将对前置式腕部枢轴自研方案和LivsMed腕部枢轴方案进行知识产权风险对比，梳理相关已公开专利布局，评估潜在的专利侵权风险，并探讨自有技术的专利布局空间。

已公开专利布局分析：

腹腔镜手术机器人和多自由度器械领域是专利竞争的焦点。例如，Swarup 机器人手臂（SWARM）是印度在腹腔镜机器人领域的第一项贡献，是一种完全由语音控制的持摄像机机械臂，这表明了在特定功能上实现专利保护的可能性 31。对于LivsMed的ArtiSential器械，其作为已上市的创新产品，必然拥有相应的专利保护，主要集中在以下几个方面：

  • 腕部关节结构与驱动机制：ArtiSential的独特之处在于其能够提供360°的腕关节自由度，这通常通过精密的机械结构、缆线驱动或柔性材料实现 32。其双关节施夹器具有90°的腕关节活动度，这表明其关节设计是其技术特点之一 33。
  • 控制系统与人机交互：虽然ArtiSential是一种手持式器械，但其多自由度操作的直观性可能也涉及特定的控制手柄设计或反馈机制的专利。
  • 可制造性与材料工艺：如前所述，一些柔性关节可能采用激光切割镍钛诺管等先进材料和工艺，这些也可能是其专利保护的重点。

对于前置式腕部枢轴自研方案，其专利布局分析将着眼于识别现有专利中可能对其核心技术构成障碍的范围。这包括：

  • 现有腹腔镜器械的通用机械结构专利：例如，关于器械杆、手柄、抓钳等基础部件的设计和功能专利。
  • 其他多自由度器械的腕部设计专利：特别是与前置式枢轴概念相似的关节结构、传动方式（如缆线驱动、连杆机构）以及实现运动自由度的方法。需要仔细比对关节数量、运动学实现方式、部件材料和组装方法等细节，以识别潜在的重叠。

专利侵权风险评估：

  • 对LivsMed方案的评估：LivsMed的ArtiSential器械已在市场销售并应用于临床，如腹腔镜胆囊切除术、胃切除术和泌尿外科手术，且效果良好 323334。这意味着其技术成熟且已通过市场验证。如果自研方案在腕部关节的结构、驱动方式或控制原理上与LivsMed的核心专利特征高度相似，则存在较高的侵权风险。特别需要关注LivsMed在韩国、美国等主要市场的专利布局。例如，一些关于关节式器械的专利可能涵盖了实现特定运动角度或增加自由度的一般方法。
  • 对前置式腕部枢轴自研方案的评估：侵权风险主要来源于现有公开的专利技术，特别是那些已形成“专利壁垒”的知名手术机器人和多自由度器械制造商。研发团队需要进行彻底的专利检索和分析（Freedom-to-Operate, FTO分析），确保自研方案的核心创新点未落入他人专利保护范围。如果自研方案的核心创新在于枢轴的精确位置、独特的传动路径、新型材料的应用或创新的组装方法，这些差异点可以作为规避现有专利的关键。

自有技术的专利布局空间：

  • 前置式腕部枢轴自研方案：如果经过FTO分析确认自研方案具有独创性且未侵犯现有专利，则应积极寻求专利保护。专利布局的重点可以放在：
    • 创新的枢轴几何结构：例如，实现特定运动学优势的关节形状、尺寸和排列方式。
    • 独特的传动机构：如果采用不同于现有技术的缆线布线、连杆设计或齿轮组合方式。
    • 集成化与小型化技术：在保持多自由度功能的同时，实现腕部结构的小型化和高集成度。
    • 特定的材料应用：如果使用了新型生物相容性材料或复合材料，以提升器械性能或延长使用寿命。
    • 与其他部件的协同设计：例如，腕部枢轴与手柄、末端效应器之间的创新接口设计，或整体工作流的优化。
  • 防御性与进攻性专利策略：除了保护核心技术，还可以考虑围绕核心技术布局外围专利，形成“专利网”，增加竞争对手的进入壁垒，同时为未来的技术升级和产品迭代预留空间。

综合来看，知识产权风险评估需要深入分析两种方案的技术细节与现有专利的对比。对于自研方案，关键在于如何在借鉴现有技术的基础上实现差异化创新，并通过有效的专利布局来保护这些创新，从而在激烈的市场竞争中占据有利地位。

3.4 临床工作流适配性差异

腹腔镜手术器械的腕部枢轴设计对临床工作流的影响不容忽视，这包括术前准备、术中器械更换、术后消毒维护等多个环节。不同的设计方案可能在操作便捷性、效率以及对医护人员的工作负荷方面存在显著差异。本节将分析前置式腕部枢轴自研方案和LivsMed腕部枢轴方案在临床全流程中的适配性差异。

术前安装调试：

  • 前置式腕部枢轴自研方案：如果该方案采用模块化设计，且腕部枢轴与器械杆、手柄之间的连接直观简便，那么术前安装调试时间将较短。例如，如果腕部关节是可拆卸的，或者其传动机构无需复杂的校准，就能快速与主机连接并进行功能测试。然而，如果其结构复杂，涉及多根缆线的精确连接或精密机械部件的对齐，则可能增加安装时间和难度，尤其是在紧急情况下。
  • LivsMed腕部枢轴方案（如ArtiSential器械）：作为已上市产品，ArtiSential可能已经针对快速安装和调试进行了优化。其设计可能更注重一体化和即插即用，减少了术前组装的复杂性。但如果其独特的柔性或多关节结构需要特定的附件或特殊的连接方式，也可能存在一些学习曲线或兼容性问题。

术中器械更换：

在长时间或复杂的手术中，器械更换是常见操作。器械更换的便捷性直接影响手术的连续性和效率。

  • 前置式腕部枢轴自研方案：如果腕部枢轴与器械杆集成度高，且更换时仅需整体替换器械，则更换流程相对简单。但如果其设计使得腕部枢轴需要与不同末端效应器（如抓钳、剪刀）进行多次拆装，则会显著增加术中操作的复杂度和耗时。此外，器械接口标准化是实现快速更换的关键。
  • LivsMed腕部枢轴方案：ArtiSential作为一种通用型器械，其更换流程可能已标准化。但其多关节或柔性结构在频繁插拔过程中是否容易受损，或者是否需要额外的保护措施，是需要考虑的因素。如果器械更换涉及复杂的手动操作或需要额外校准，将延长手术时间，增加术中风险。例如，与传统腹腔镜手术相比，机器人腹股沟疝修补术的手术时间可能更长 35。

术后消毒维护：

手术器械的消毒和维护是感染控制的关键环节 3637。设计不当的器械可能存在难以清洁的死角，增加感染风险并缩短器械寿命。

  • 前置式腕部枢轴自研方案：如果腕部枢轴包含多个微小机械部件或狭窄缝隙，则可能难以彻底清洁和消毒，从而增加生物膜形成和感染传播的风险。器械材料的选择也至关重要，需确保能够承受反复高温高压灭菌（如蒸汽灭菌）或化学消毒，而不会发生腐蚀或性能下降 37。模块化设计可以使得需要严格消毒的部件易于拆卸和分开处理。
  • LivsMed腕部枢轴方案：柔性多关节器械的消毒维护可能具有挑战性。其柔性部件或缆线驱动系统中的细小缝隙可能成为微生物滋生的温床。因此，LivsMed可能采用了特殊的设计或材料，以确保其可消毒性。成功的“6S”护理管理在消毒和供应中心的应用，能够显著提高手术器械质量和工作效率，降低处理错误率 38。对于多自由度器械，这种管理实践更为重要。

工作流效率与人员负担：

  • 手术室周转时间：器械的易用性、安装便捷性和消毒效率直接影响手术室的周转时间。更高效的器械设计有助于缩短两台手术之间的间隔，提高手术室的利用率。
  • 医护人员工作负荷：复杂的器械安装、频繁的故障排除或繁琐的消毒流程，都会增加护理人员和技术人员的工作负荷，从而影响其工作满意度和操作失误率。机器人手术平台在某些方面可以减轻外科医生的体力负荷，但可能增加其挫败感 35。在评估器械对整体工作流的影响时，需要全面考虑所有相关人员的体验。

通过对这些临床工作流环节的全面对比分析，可以评估两种腕部枢轴方案在实际手术环境中的整体适用性。一个优秀的设计方案不仅要关注手术操作本身，更要融入整个临床工作流，以实现效率、安全性和便捷性的最佳平衡。

4. 多源证据交叉验证

4.1 同类竞品设计规律总结

为全面评估前置式腕部枢轴自研方案和LivsMed腕部枢轴方案的潜在优势与局限性，有必要对当前市场上主流的多自由度腹腔镜器械和手术机器人器械的腕部枢轴设计特征进行梳理，总结其应用场景、优劣势及设计规律。这有助于从更广阔的行业视角，为本研究的方案选型提供循证支持。

多自由度（Multi-DOF）手术器械旨在克服传统腹腔镜器械在灵活性上的限制，通过在远端增加额外的关节，使器械末端能模拟人手腕的精细动作，从而提升手术操作的便利性和精度 18。根据驱动机制和结构特点，这些腕部枢轴设计大致可分为以下几类：

  1. 缆线驱动（Wire-driven）机制：

    • 设计特征：这是最常见的多自由度腕部机制之一，通过多根缆线（通常是镍钛诺合金线或其他高强度、低摩擦线）在器械杆内部布线，连接手柄端的操作机构和远端的关节。拉紧或放松不同的缆线，可以实现腕部关节的俯仰、偏航和滚动等运动。
    • 典型产品：许多机器人手术系统（如达芬奇手术系统）的器械腕部以及一些手持式多自由度器械都采用类似机制。LivsMed的ArtiSential器械也可能采用缆线驱动配合其柔性关节设计。
    • 优缺点：
      • 优势：结构相对紧凑，能够实现较高的自由度，末端操作灵活。理论上，缆线驱动可以实现较大的关节运动范围。
      • 劣势：缆线易受拉伸、磨损和疲劳，可能影响力反馈的精度和器械的寿命 39。缆线布线复杂，可能增加制造难度和成本。此外，缆线张力控制对于实现解耦运动和保持精度至关重要，过度张力可能导致机械变形 39。
    • 设计规律：通常需要精密的缆线导向结构和张力调节机构，以确保运动的顺畅性和精度。

  2. 连杆驱动（Link-driven）机制：

    • 设计特征：通过一系列微型刚性连杆和销轴组成复杂的机械结构，将手柄端的运动传递到远端腕部，实现多自由度运动。
    • 典型产品：一些早期或特定设计的腹腔镜多自由度器械采用连杆机制。
    • 优缺点：
      • 优势：机械刚性好，力传递效率高，不易变形，能提供更稳定的力反馈。
      • 劣势：结构复杂，零部件数量多，制造精度要求极高，难以实现小型化。连杆之间的间隙和摩擦可能影响运动的平滑性。
    • 设计规律：需要优化连杆机构的尺寸和几何形状，以在有限空间内实现所需运动范围，并减少传动误差。

  3. 板弹簧驱动（Plate-spring-driven）机制：

    • 设计特征：利用薄板弹簧的弹性变形来传递力和实现关节运动。这种机制可以提供高力传输和较大的工作空间。
    • 典型产品：有研究提出采用板弹簧驱动机制的单孔腹腔镜手术机器人，旨在克服传统缆线驱动力传输不足的问题 39。
    • 优缺点：
      • 优势：力传输能力强，不易受机械变形影响，可实现较高的末端输出力 39。结构可能比复杂连杆更简化，且能提供一定的柔性。
      • 劣势：弹簧的疲劳特性、材料选择和加工精度是关键。其运动学特性可能不如缆线或刚性连杆精确可控，尤其是在实现解耦的多自由度运动时。
    • 设计规律：主要应用于需要高力传输但对精细控制要求稍低的场景，或者通过组合驱动方式来弥补其在精细控制上的不足。

  4. 柔性体/连续体（Flexible/Continuum）机制：

    • 设计特征：器械远端腕部由连续的柔性材料（如镍钛诺合金或聚合物）构成，通过拉动嵌入其中的缆线或气动/液压方式，使其整体弯曲变形，从而实现末端的角度调整。
    • 典型产品：部分多关节器械和手术机器人导管式器械采用类似概念。LivsMed的ArtiSential器械在一定程度上借鉴了柔性体的设计理念。
    • 优缺点：
      • 优势：无离散关节，避免了传统关节的卡滞和摩擦问题。结构紧凑，易于小型化，对狭窄空间的适应性强。
      • 劣势：控制复杂，难以实现精确的位置和力控制。柔性体在负载下容易发生变形，可能影响操作精度和力反馈。消毒和维护可能也存在挑战。
    • 设计规律：通常需要先进的材料科学和复杂的控制算法，以克服柔性体的固有缺陷。

主流产品腕部设计趋势：

目前市场上的多自由度腹腔镜器械，包括机器人手术系统中的器械臂，普遍追求更高的自由度、更小的器械直径以及更直观的控制体验。例如，达芬奇手术系统以其高精度和灵活的腕部操作而闻名，其器械腕部通常采用缆线驱动的机械关节设计。新的模块化机器人系统也正致力于提升灵巧性和人机工程学，同时降低成本，很多也采用了小型化和多自由度器械 40。ArtiSential器械，作为一种创新的手持式多自由度器械，通过其独特的柔性关节设计，使得手持器械也能实现类似机器人器械的末端灵活性，已被证明在某些手术中能缩短手术时间，显示出良好的可行性和安全性 718。

综合来看，不同腕部枢轴设计方案各有侧重。缆线驱动和连杆驱动在精度和力反馈上表现较好，但可能在结构复杂度和小型化上受限；柔性体和板弹簧驱动则在紧凑性和力传递上有所优势，但控制精度和力反馈可能需要进一步优化。本研究的前置式腕部枢轴自研方案和LivsMed方案（ ArtiSential）的对比，正是聚焦于这些不同设计理念在人机工程学、运动学等方面的具体权衡。

4.2 研究结论与用户反馈佐证

为了确保对前置式腕部枢轴自研方案和LivsMed腕部枢轴方案优劣势判断的准确性和可靠性，本研究将结合已发表的外科器械人机工程学相关研究结论与一线外科医生的实际操作反馈进行交叉验证。这种多源证据的整合能够从理论和实践两个层面，全面审视两种设计方案的真实表现。

已发表研究结论的印证：

  1. 关于操作姿态与肌肉负荷：

    • 多自由度器械的普遍优势：现有研究普遍指出，相比传统刚性腹腔镜器械，多自由度器械能够显著改善外科医生的操作姿态，减少手腕、前臂和肩部的过度扭曲和静态负荷，从而降低肌肉骨骼疾病的风险。例如，机器人手术系统因其提供的腕关节功能，在人体工程学方面优于传统腹腔镜手术，可减轻外科医生的背部、肩部和腕部疼痛 41。本研究中两种多自由度腕部枢轴方案若能展现出类似的姿态改善和肌肉负荷降低，将与这些宏观结论相符。
    • 细节设计的影响：然而，即使是多自由度器械，其具体设计（如枢轴位置、手柄形状、力反馈机制）仍会产生差异。如果前置式腕部枢轴方案能提供更直观的运动映射和更好的力反馈，它可能在降低特定肌肉群（如前臂精细操作肌肉）的负荷方面表现更优。LivsMed的ArtiSential器械，其独特的双关节设计可能有助于分散手部负荷，但在某些精细操作中，其控制机制可能对术者的认知负荷提出更高的要求 33。

  2. 关于操作效率与认知负荷：

    • 灵活性与效率：具有腕部关节的器械通常能够提高操作效率和精度，尤其是在精细缝合和深部组织操作中。例如，ArtiSential夹持器械在机器人泌尿外科手术中，相较于标准夹持器械，提高了夹持应用的成功率和准确性 33。这支持了多关节器械在复杂任务中提升效率和准确性的观点。
    • 认知负荷的权衡：尽管多自由度器械提高了物理操作效率，但复杂的控制机制可能增加认知负荷。例如，外科医生的专业背景会显著影响其对手术器械手柄偏好，这表明复杂器械可能存在学习曲线，需要适应期 41。因此，若前置式腕部枢轴方案能提供更直观、易于学习的控制方式，可能在降低认知负荷方面优于某些需要适应期的复杂多自由度器械。

  3. 关于术者适配性：

    • 性别与手部尺寸差异：现有文献明确指出，现有市售手术器械普遍偏大，导致女性外科医生在使用环形手柄腹腔镜钳时面临显著的人机工程学问题，表现出较低的满意度和手部不适 22。因此，任何新的器械设计都必须充分考虑不同手部尺寸和性别的外科医生需求。如果两种腕部枢轴方案能够结合更具包容性的人机工程学设计，将显著提升其普适性。

一线外科医生用户反馈的佐证：

通过访谈、问卷调查和观察实验等方式，收集一线外科医生对两种方案的实际操作反馈至关重要。

  1. 对前置式腕部枢轴自研方案的反馈：

    • 积极反馈：如果医生反馈器械末端响应灵敏、运动轨迹预测性强、手腕姿态自然放松，且在深部操作中可达性良好，这将印证前置式枢轴在运动学和人机工程学方面的优势。例如，若医生报告在模拟缝合任务中，手腕不需要大幅度扭转即可完成复杂的角度调整，这支持了其改善操作姿态的潜力。
    • 潜在问题反馈：若医生反映器械力反馈不清晰、控制不够精确或在特定姿态下存在“僵硬感”，则需要进一步优化设计。例如，如果出现操作疲劳感主要集中在手指而非手腕，这可能提示手柄设计或驱动机制仍有改进空间。

  2. 对LivsMed腕部枢轴方案（ArtiSential器械）的反馈：

    • 积极反馈：鉴于ArtiSential已在临床使用，其用户反馈通常会强调其在复杂角度操作中的灵活性和便捷性。例如，若医生普遍认为其在狭小空间内“像手一样灵活”，或在需要弯曲操作时表现出色，这将证实其多关节设计的有效性。据报道，ArtiSential夹持器械在机器人泌尿外科手术中被证实可行，提高了夹持准确性，尽管可能增加了床旁助手的一些认知负荷 33。
    • 潜在问题反馈：医生也可能指出其在力反馈的直观性、学习曲线长度或特定复杂任务中的稳定性问题。例如，若有医生表示需要一定时间适应其独特的控制手感，或者在极端操作下感到器械有轻微颤动，这提示其在人机交互或机械稳定性方面仍有改进空间。对床旁助手认知负荷的增加也需要特别关注 33。

通过将这些主客观证据进行对比分析，本研究能够更全面、准确地评估两种腕部枢轴方案的优劣势。例如，如果研究发现前置式腕部枢轴方案在降低手腕肌肉负荷方面的表现与已发表的多自由度器械优势一致，同时用户反馈也证实其操作直观、疲劳感低，那么这一结论将得到强有力的支持。反之，如果LivsMed方案在提高操作效率的同时，部分用户反映存在认知负荷增加或学习曲线陡峭的问题，那么这一权衡点也需要被清晰地识别和阐明。这种多源交叉验证的方法，能够为最终的设计权衡决策提供坚实的证据基础。

5. 设计权衡框架与选型建议

5.1 多维度设计权衡决策框架

在对前置式腕部枢轴自研方案和LivsMed腕部枢轴方案进行全面评估之后，本节旨在汇总两种方案在人机工程学、运动学、可制造性、成本、知识产权和临床工作流等各评估维度的优劣势，并在此基础上构建一个多维度设计权衡决策框架。该框架将结合产品定位和目标场景需求，为不同应用背景下的器械选型提供优先级建议。

两种方案的优劣势汇总：

评估维度前置式腕部枢轴自研方案LivsMed腕部枢轴方案（如ArtiSential器械）
人机工程学优势：腕部关节靠近工作端，理论上可实现更自然的手腕姿态，减少过度扭转和肌肉负荷，降低手腕和前臂劳损风险。若结合良好手柄设计，普适性高。劣势：若传动机制复杂，可能增加手柄操作力。优势：独特的柔性或双关节设计可能提供直观的“手部感觉”，末端操作灵活。在复杂角度下可能操作更流畅。劣势：可能存在一定的学习曲线；某些报告显示可能增加床旁助手的认知负荷。手柄设计可能对部分用户手型不完全适配。
运动学优势：末端可达范围大，精细控制能力强，操作盲区小。易于实现高自由度且运动解耦。劣势：腕部关节与末端效应器距离过短时，可能在某些极限角度受限。优势：柔性或多关节设计在狭窄空间内具有极高的灵活性，可实现大范围弯曲。劣势：深部操作可能出现“鞭梢效应”，影响控制精度；柔性体在负载下易变形，可能影响力反馈稳定性。
可制造性优势：若采用成熟机械连杆或缆线驱动，可制造性相对明确，自动化潜力较大。劣势：小型化和高集成度要求高精密加工和复杂组装，可能增加成本和良率挑战。优势：若采用激光切割镍钛诺等创新工艺，可能实现结构简化和轻量化。劣势：特殊材料和工艺要求高，加工难度大，可能提高单件成本；柔性部件可能在装配、消毒中存在挑战。
成本控制优势：若能实现高良率和模块化设计，长期使用成本可能较低。劣势：初始研发和精密制造投入大；若设计为一次性，耗材成本高。优势：已量产，部分成本可能因规模效应摊薄。劣势：采用特殊材料和工艺可能导致初始采购成本较高。若柔性部件易损，维护或更换成本高。
知识产权优势：如能实现差异化创新，专利布局空间大，可建立自有技术壁垒。劣势：需进行严格FTO分析，规避现有广泛的专利，特别是机器人手术器械和多关节器械领域。优势：已上市产品，拥有成熟的专利保护体系，技术成熟度高。劣势：现有专利壁垒高，对后来者构成较高进入门槛。
临床工作流优势：若模块化设计，安装、更换便捷；若易于清洁消毒，维护成本低。劣势：结构复杂可能导致安装调试耗时，清洁消毒存在死角。优势：作为成熟产品，安装更换可能已标准化，无需复杂校准。劣势：柔性或多关节结构在消毒维护方面可能存在挑战，特定附件可能增加工作流复杂性。

多维度设计权衡决策框架：

为选择最适合的方案，我们需要根据产品的核心定位和目标临床场景，对上述维度进行加权评估。没有一个“最佳”的单一方案，只有最适合特定需求的方案。

决策框架要素：

  1. 产品核心定位 (Product Core Positioning)：

    • 高端机器人手术系统器械：强调高精度、高稳定性、长寿命，对成本敏感度相对较低。
    • 手持式高阶多自由度器械：注重人机交互直观性、操作舒适度、易用性和可负担性，要求成本效益。
    • 特定术式专用器械：针对某一特定复杂手术（如微创肿瘤切除、重建），强调在该术式中的极致性能和安全性。

  2. 目标临床场景需求 (Target Clinical Scenario Requirements)：

    • 对精细操作和力反馈要求极高的场景 (如神经外科、血管吻合)：此时人机工程学中的控制精度、力反馈直观性和运动学性能是主要考量。
    • 常规复杂腹腔镜手术 (如结直肠切除、妇科肿瘤)：平衡操作效率、人机工程学舒适度、器械寿命与成本。
    • 资源有限或发展中国家市场：成本、可制造性、耐用性及易维护性将成为关键考量。

决策评估流程：

  1. 设定权重：根据产品核心定位和目标临床场景，为“人机工程学”、“运动学”、“可制造性”、“成本控制”、“知识产权”和“临床工作流”六个维度分配不同的权重。例如，若定位为高端机器人手术器械，运动学和人机工程学（尤其是精度和疲劳降低）的权重会更高；若定位为普及型手持器械，则成本和易用性权重更高。
  2. 量化评估：基于前期实验数据、文献回顾和用户反馈，对两种方案在各维度下的表现进行评分（例如，1-5分制）。
  3. 加权得分：将每个维度得分乘以其对应权重，然后求和，得到两种方案的综合加权得分。
  4. 风险与机会评估：除了量化得分，还需定性评估两种方案的潜在知识产权风险、市场接受度、技术成熟度带来的不确定性，以及未来技术迭代的潜力。

不同应用场景下的优先选型方向：

  • 若追求极致精度与手术效率，且对成本敏感度不高（如高端机器人手术系统或特定高难度术式）：

    • 优先考虑：前置式腕部枢轴自研方案。如果其在运动学上能提供更精确、稳定的控制，且人机工程学优化能最大程度降低术者疲劳，同时确保足够的产品寿命，则其高研发和制造投入是值得的。知识产权上若能形成独有壁垒，则更具竞争力。
    • 次优选择：LivsMed方案。如果其已证明在某些高难度术式中具有显著效率优势且操作直观性高，且能够集成到现有工作流中，可作为快速推向市场的选项。

  • 若注重操作舒适度、易用性与成本效益（如普及型手持式多自由度器械）：

    • 优先考虑：需综合评估。如果前置式腕部枢轴自研方案能通过优化设计，显著降低制造成本并提高普适性，使其能被更广泛的术者接受，则可能具有优势。
    • 次优选择：LivsMed方案。鉴于其已上市的商业化成功经验，若其成本控制和可制造性能够进一步优化，并能适应不同术者群体，则具有较强的市场竞争力。

  • 若知识产权壁垒是首要考虑（如进入新市场或规避现有巨头专利）：

    • 优先考虑：前置式腕部枢轴自研方案。通过彻底的FTO分析和独特的创新，建立自有专利池，是规避风险、确保长期发展的关键。
    • 次优选择：LivsMed方案。若通过许可或合作方式获得其技术授权，可在一定程度上规避专利风险，但可能受制于授权方。

通过上述多维度设计权衡决策框架，本研究不仅对两种腕部枢轴方案进行了深入的技术分析，更提供了一个结构化的决策工具，以指导研发团队在复杂的设计权衡中做出明智、基于证据的选择，从而开发出最符合市场需求和临床期望的多自由度腹腔镜手术器械。

5.2 后续开发优化建议

基于对前置式腕部枢轴自研方案和LivsMed腕部枢轴方案的全面评估及多维度设计权衡框架，本节将针对性地提出后续开发优化建议，旨在提升所选方案的综合性能，并明确未来研究的验证路径。

针对选定方案的人机工程学及关联性能优化方向：

  1. 手柄构型与枢轴位置的联动优化：

    • 改善握持舒适度与操作力：无论选择哪种腕部枢轴方案，手柄构型都是人机工程学的核心。当前许多腹腔镜器械的手柄设计在人体工效学方面仍有提升空间，尤其在适配不同手部尺寸和握持习惯上。例如，研究表明电外科器械的人体工效学表现会受到术者手部尺寸等因素的影响 42。因此，后续开发应进行深入的人体测量学研究，开发可调节或多尺寸的手柄，以适应更广泛的术者群体。手柄应促进中立的腕部姿态，减少前臂肌肉的激活，并优化力矩传递，降低操作力。可以探索集成传感器，提供力反馈或触觉反馈，以增强操作直观性和安全性。例如，一些新型手柄设计通过铰链结构显著减少了极端腕部偏离的需求 43。
    • 枢轴位置的微调与刚性控制：对于前置式腕部枢轴方案，需要进一步优化腕部枢轴的精确位置，使其在提供最大末端可达性的同时，确保手腕能保持最自然姿态，减少上肢负荷。同时，应提高器械轴杆的整体刚性，尤其是在深部操作时，以避免“鞭梢效应”或末端控制不稳。对于柔性结构（如LivsMed方案），则需研究如何在保证灵活性的前提下，增强其在负载下的抗变形能力，提升力传递的精确性。

  2. 运动学补偿与精度提升：

    • 运动学去耦与直观映射：优化腕部关节的运动学设计，确保其运动与手柄操作之间建立更直观、更线性的映射关系，减少术者的认知负荷和学习曲线。特别是在多自由度器械中，关节间的运动解耦至关重要，以避免意外动作和提高操作精度。可以引入先进的控制算法，对器械末端的运动进行实时补偿，提高在复杂三维空间中的定位精度。
    • 减少操作盲区与提高可达性：通过优化腕部关节的最大弯曲角度、旋转范围和器械长度，进一步减少手术区域内的操作盲区。例如，研究表明新型直观手柄设计能够实现外科医生腕部与机器人关节的直接映射，同时避免过度劳损和疲劳，并在不影响机器人末端执行器工作空间的前提下，将操作力分散到外科医生的前臂 44。

  3. 针对临床特定术式的细分设计：

    • 模块化与可定制化：考虑到不同腹腔术式对器械功能和尺寸的特殊需求，建议开发模块化的腕部枢轴和末端效应器设计。例如，用于精细吻合的器械可能需要更小的末端尺寸和更高的力反馈灵敏度，而用于组织剥离的器械可能需要更大的力量输出和更坚固的结构。这种模块化设计不仅能满足不同术式的需求，还能简化生产和维护。
    • 集成辅助功能：考虑在腕部枢轴区域集成照明、冲洗、吸引或微型传感器等辅助功能，进一步提升器械的临床实用性。

针对不确定性问题的后续验证路径：

  1. 长期使用的耐用性与可靠性验证：

    • 加速老化测试：对选定方案进行加速老化实验，模拟数千次手术的使用强度，评估腕部枢轴关键部件（如缆线、齿轮、柔性材料）的磨损、疲劳和失效模式。这有助于预测器械的实际使用寿命和维护周期。
    • 材料疲劳与消毒兼容性测试：对于柔性材料或精密机械部件，需进行严格的材料疲劳测试和重复消毒（如高压蒸汽灭菌）兼容性测试，确保在长期临床使用和反复消毒下，器械性能不会显著下降，且无生物膜残留或腐蚀风险。

  2. 不同手径术者的精细触觉反馈差异：

    • 高精度肌电仿真与生物力学分析：利用高精度肌电仿真模型，预测不同手部尺寸和握持力度的术者在操作器械时，各肌肉群的负荷分布和疲劳积累情况。同时，进行手部生物力学分析，识别手柄与手部接触面的压力点，指导优化手柄形状和材质。
    • VR手术模拟测试与客观指标评估：结合虚拟现实（VR）手术模拟器 4546 进行大规模用户测试。VR环境可以提供标准化的任务和精确的性能指标（如任务完成时间、错误率、运动路径效率）。同时，可评估不同手径术者在精细操作任务中对力反馈、运动直观性的感知差异，以获得更客观、全面的评估数据。已有研究通过外科医生运动学、自我报告工作量和上半身不适来比较不同手术器械的性能 47。
    • 多中心临床先导试验：在完成实验室和模拟环境验证后，开展小规模的多中心临床先导试验。邀请不同背景（性别、经验、手部尺寸）的外科医生在真实手术环境中试用器械，收集其主观反馈（问卷、访谈）和客观数据（手术时间、并发症率、器械故障率）。这有助于发现实验室模拟中难以复现的问题，并为最终的产品定型提供最可靠的决策支撑。

通过上述优化建议和验证路径，可以系统性地推进多自由度腹腔镜手术器械的研发，确保最终产品在人机工程学、运动学性能、可制造性和临床适用性之间达到最佳平衡，最终改善外科医生的工作体验，提升手术效率和患者安全性。

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参考文献

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Andrew T Gabrielson, Marisa M Clifton, Christian P Pavlovich, et al.
Nat Rev Urol. 2021 Mar;18(3):160-169. doi: 10.1038/s41585-020-00414-4. Epub 2021 Jan 11.
Poor ergonomics in the operating room can have detrimental effects on a surgeon's physical, psychological and economic well-being. This problem is of particular importance to urologists who are trained in nearly all operative approaches (open, laparoscopic, robotic-assisted, microscopic and endoscopic surgery), each with their own ergonomic considerations. The vast majority of urologists have experienced work-related musculoskeletal pain or injury at some point in their career, which can result in leaves of absence, medical and/or surgical treatment, burnout, changes of specialty and even early retirement. Surgical ergonomics in urology has been understudied and underemphasized. In this Review, we characterize the burden of musculoskeletal injury in urologists and focus on various ergonomic considerations relevant to the urology surgeon. Although the strength of evidence remains limited in this space, we highlight several practical recommendations stratified by operative approach that can be incorporated into practice without interrupting workflow whilst minimizing injury to the surgeon. These recommendations might also serve as the foundation for ergonomics training curricula in residency and continuing medical education programmes. With improved awareness of ergonomic principles and the sequelae of injury related to urological surgery, urologists can be more mindful of their operating room environment and identify ways of reducing their own symptoms and risk of injury.

2A comparison of laparoscopic and robotic ergonomic risk.PubMed

Sara Monfared, Dimitrios I Athanasiadis, Luke Umana, et al.
Surg Endosc. 2022 Nov;36(11):8397-8402. doi: 10.1007/s00464-022-09105-0. Epub 2022 Feb 19.
INTRODUCTION: Work related injuries in minimally invasive surgery (MIS) are common because of the strains placed on the surgeon's or assistant's body. The objective of this study was to compare specific ergonomic risks among surgeons and surgical trainees performing robotic and laparoscopic procedures. MATERIALS AND METHODS: Ergonomic data and discomfort questionnaires were recorded from surgeons and trainees (fellows/residents) for both robotic and laparoscopic procedures. Perceived discomfort questionnaires were recorded pre/postoperatively. Intraoperatively, biomechanical loads were captured using motion tracking sensors and electromyography (EMG) sensors. Perceived discomfort, body position and muscle activity were compared between robotic and laparoscopic procedures using a linear regression model. RESULTS: Twenty surgeons and surgical trainees performed 29 robotic and 48 laparoscopic procedures. Postoperatively, increases in right finger numbness and right shoulder stiffness and surgeon irritability were noted after laparoscopy and increased back stiffness after robotic surgery. Further, the laparoscopic group saw increases in right hand/shoulder pain (OR 0.8; p = 0.032) and left hand/shoulder pain (0.22; p < 0.001) compared to robotic. Right deltoid and trapezius excessive muscle activity were significantly higher in laparoscopic operations compared to robotic. Demanding and static positioning was similar between the two groups except there was significantly more static neck position required for robotic operations. CONCLUSION: Robotic assisted surgeries led to lower postoperative discomfort and muscle strain in both upper extremities, particularly dominant side of the surgeon, but increased static neck positioning with subjective back stiffness compared with laparoscopy. These recognized ergonomic differences between the two platforms can be used to raise surgeon awareness of their intraoperative posture and to develop targeted physical and occupational therapy interventions to decrease surgeon WMSDs and increase surgeon longevity.

3Microbreaks in Laparoscopic Appendectomy have No Effect on Surgeons' Performance and Well-being.PubMed

Laurits Schou Kromberg, Niels Vinkel Kildebro, Laura Quitzau Mortensen, et al.
J Surg Res. 2020 Jul;251:1-5. doi: 10.1016/j.jss.2020.01.007. Epub 2020 Feb 21.
BACKGROUND: Musculoskeletal fatigue and pain as a consequence of performing surgery is found in 70%-87% of surgeons. The aim of this study was to examine the effect of microbreaks on surgeons' performance and well-being during laparoscopic appendectomy. MATERIALS AND METHODS: The study was a blinded randomized crossover trial. Twelve surgeons were tested at three time points: Before surgery (baseline), after surgery without intervention, and after surgery where microbreaks were used every 10 min for 10 s. The musculoskeletal endurance test was used as the primary outcome. Performance was assessed by procedure length and a manual precision test. The surgeons' well-being was measured by level of exhaustion rated on the Borg CR10 scale and visual analog scale ratings for musculoskeletal discomfort in the neck, shoulders, back, wrists, and legs. RESULTS: No significant differences were found in musculoskeletal endurance, procedure time, or the manual precision test. The level of exhaustion was significantly increased after both normal procedures (P = 0.01) and procedures with microbreaks (P = 0.03). However, no significant difference was found between the two (P = 0.25). There was a significant increase from baseline regarding self-reported musculoskeletal discomfort in the back, shoulders, and legs after surgery but no significant differences between procedures with and without microbreaks. CONCLUSIONS: This study did not find a positive effect of microbreaks on laparoscopic appendectomy. Exhaustion and discomfort were present after surgery, demonstrating that short surgical procedures (less than 60 min) can result in fatigue in surgeons.

4Surgical technology and the ergonomics of laparoscopic instruments.PubMed

R Berguer
Surg Endosc. 1998 May;12(5):458-62. doi: 10.1007/s004649900705.
Laparoscopic surgery provides patients with less painful surgery and a more rapid recovery, while requiring that surgeons work harder and in a more remote manner from the operating field. Cost-containment pressures on surgeons demand efficient surgery, whereas the increased technological complexity and sometimes poorly adapted equipment have led to increased complaints of surgeon fatigue and discomfort during laparoscopic surgery. There is, therefore, a need to evaluate the ergonomic integration and suitability of the laparoscopic operating room environment to address the issues of efficiency, safety, and comfort for the operating team. This approach is particularly important in the design of laparoscopic surgical instruments. A review of the literature on the biomechanics of laparoscopic surgical instrument use was combined with data from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Ergonomics Questionnaire and demonstration station. Laparoscopic instruments suffer from ergonomically inadequate handle designs and inefficient handle to tip force transmission, which lead to surgeon fatigue, discomfort, and hand paresthesias. Improvements in the design of laparoscopic instruments are needed to decrease the work and discomfort of tissue manipulation during video-endoscopic surgery.

5Surgeons' posture and muscle strain during laparoscopic and robotic surgery.PubMed

T Dalager, P T Jensen, J R Eriksen, et al.
Br J Surg. 2020 May;107(6):756-766. doi: 10.1002/bjs.11394. Epub 2020 Jan 10.
BACKGROUND: It is assumed that conventional laparoscopy (LAP) and robotic-assisted laparoscopic surgery (RALS) differ in terms of the surgeon's comfort. This study compared muscle workload, work posture and perceived physical exertion of surgeons performing LAP or RALS. METHODS: Colorectal surgeons with experience in advanced LAP and RALS performed one of each operation. Bipolar surface electromyography (EMG) recordings were made from forearm, shoulder and neck muscles, and expressed relative to EMG maximum (%EMG ). The static, median and peak levels of muscle activity were calculated, and an exposure variation analysis undertaken. Postural observations were carried out every 10 min, and ratings of perceived physical exertion before and after surgery were recorded. RESULTS: The study included 13 surgeons. Surgeons performing LAP showed higher static, median, and peak forearm muscle activity than those undertaking RALS. Muscle activity at peak level was higher during RALS than LAP. Exposure variation analysis demonstrated long-lasting periods of low-level intensity muscle activity in the shoulders for LAP, in the forearms for RALS, and in the neck for both procedures. Postural observations revealed a greater need for a change in work posture when performing LAP compared with RALS. Perceived physical exertion was no different between the surgical modalities. CONCLUSION: Minimally invasive surgery requires long-term static muscle activity with a high physical workload for surgeons. RALS is less demanding on posture.

6Assessment of muscle activity and fatigue during laparoscopic surgery.PubMed

Tegan Thurston, James P Dolan, Farah Husain, et al.
Surg Endosc. 2022 Sep;36(9):6672-6678. doi: 10.1007/s00464-021-08937-6. Epub 2022 Jan 16.
BACKGROUND: Cumulative musculoskeletal stress during operative procedures can contribute to the development of chronic musculoskeletal injury among surgeons. This is a concern in laparoscopic specialties where trainees may incur greater risk by learning poor operative posture or technique early in training. This study conducted an initial investigation of the physical stress encountered during the conduct of foregut laparoscopic surgery. METHODS: Subjects were divided into two groups based on their surgical experience level, high experience (HE), consisting of two attending surgeons, and low experience (LE), consisting of two fellow surgeons and a surgical chief resident. Nine distinct foregut laparoscopic procedures were observed for data collection within these groups. Electromyographic (EMG) activity was collected at the bilateral neck, shoulders, biceps, triceps, and lower back for each procedure. Physical workload was measured using percent reference voluntary contractions (%RVC) for each surgeon's muscle activities. Fatigue development was assessed using the median frequency of EMG data between two consecutive cases. Subjects completed a NASA-TLX survey when surgery concluded. RESULTS: LE surgeons experienced higher levels of %RVC in the lower back muscles compared to HE surgeons. LE fatigue level was also higher than HE surgeons across most muscle groups. A decrease in median frequency in six of the ten muscle groups after performing two consecutive cases, the largest decrements being in the biceps and triceps indicated fatigue development across consecutive cases for both surgeon groups. CONCLUSION: Surgeons developed fatigue in consecutive cases while performing minimally invasive surgery (MIS). HE surgeons demonstrated a lower overall physical workload while also demonstrating different patterns in muscle work. The findings from this study can be used to inform further ergonomic studies and the data from this study can be used to develop surgical training programs focused on the importance of surgeon ergonomics and minimizing occupational injury risk.

7Laparoscopic renal surgery using multi degree-of-freedom articulating laparoscopic instruments in a porcine model.PubMed

Jong Keun Kim, Bosik Kang, Yu Seon Kim, et al.
Investig Clin Urol. 2023 Jan;64(1):91-101. doi: 10.4111/icu.20220182.
PURPOSE: We evaluated the performance of a new multi-degree-of-freedom articulating laparoscopic instrument, ArtiSential, and compared it with that of a straight-shaped instrument and the da Vinci surgical system, in renal surgery using porcine model. MATERIALS AND METHODS: Nine female Yorkshire pigs were equally divided into three groups. The three groups were compared at each surgical step in terms of objective and subjective parameters. RESULTS: The median operative times for renal pedicle clamping and ureter dissection were significantly shorter in ArtiSential group than robotic group (1.3 min vs. 4.7 min, p=0.002; 8.1 min vs. 11.1 min, p=0.015). The median operative time for bladder repair was significantly longer in ArtiSential group than robotic and straight-shaped groups (17.9 min vs. 5.5 min, p=0.002; 17.9 min vs. 9.3 min, p=0.026). There were no significant differences among groups in terms of blood loss or intraoperative complications. ArtiSential device was less useable for renorrhaphy (p=0.009) and bladder repair (p=0.002) compared to the robotic system. ArtiSential group was less accurate than robotic group in terms of tumor resection, renorrhaphy, and bladder repair. During ureter dissection, bladder cuff excision, and bladder repair, the surgeon experienced greater wrist discomfort but lesser back discomfort in ArtiSential group than robotic group. CONCLUSIONS: For most steps, ArtiSential performed as well as robotic and straight-shaped instruments. The development of specialized surgical techniques for ArtiSential will maximize the advantages of these instruments.

8Portable manipulation system for commercial robotic surgery forceps.PubMed

Mustafa V Yazıcı, Mertcan Koçak, Mustafa O Oztan, et al.
Int J Med Robot. 2023 Oct;19(5):e2553. doi: 10.1002/rcs.2553. Epub 2023 Jul 19.
BACKGROUND: Transition from the utilisation of traditional instruments to new robotic methodologies in surgical operations occurs rapidly. Although the implementation of these methodologies to classical surgery operations is advantageous due to increased precisions and enhanced motion capabilities of robotic systems, overall worldwide accessibility and adaptation are still limited due to high equipment costs and special infrastructure requirements. METHODOLOGY: The design of four degrees of freedom low cost, compact and portable manipulation system was proposed to allow the utilisation of commercial robotic surgery forceps like a conventional laparoscopy instrument without the necessity of bulky manipulation systems. RESULTS: The structural design of the system was carried out along with necessary kinematic and coupled motion analysis. Prototypes were constructed. Hardware verification of the system was executed using implemented control methodology. CONCLUSIONS: The proposed design successfully demonstrated the advantages of multi degree of freedom robotic surgery forceps in a portable handheld system compared to classical laparoscopy instruments.

9Safety and efficacy of flexible articulated instrument (ArtiSential) in laparoscopic surgery for rectal cancer.PubMed

Jong-Sung Ahn, Jesung Park, Seung-Bum Ryoo, et al.
BMC Surg. 2025 May 2;25(1):192. doi: 10.1186/s12893-025-02841-9.
BACKGROUND: Laparoscopic surgery for rectal cancer remains challenging because of limited joint motion during dissection in the deep and narrow pelvis. Handheld multiarticulated instruments have been developed to address these limitations. This study aimed to assess the safety and efficacy of a flexible articulated instrument, the ArtiSential (Livsmed Co, Korea), at reducing the duration of laparoscopic rectal cancer surgery. STUDY DESIGN: We retrospectively reviewed patients who underwent laparoscopic low or ultralow anterior resection for primary mid to low rectal cancer (tumor distance from anal verge, ≤ 10 cm) performed by a single surgeon in 2012-2022. Patients were divided into groups based on the use of ArtiSential or straight device, and their clinical characteristics, surgical procedures, pathological findings, postoperative complications, and survival outcomes were analyzed. RESULTS: The study included 93 patients (articulating group, 32; straight group, 61). Low anterior resection was predominant in both groups, while operative time was significantly shorter in the articulating group (148.08 ± 49.72 vs. 188.13 ± 57.86; p = 0.003). Total mesorectal excision quality and resection margin status did not differ between groups. Postoperative complications, including anastomotic leakage, length of hospital stay, 3-year recurrence-free survival rate (90.6% vs. 88.5%, p = 0.760), and overall survival rate (100% vs. 85.2%, p = 0.092), did not differ between groups. CONCLUSION: Use of the flexible articulated instrument (ArtiSential) can reduce operative time without impairing surgical quality or oncologic outcomes. These results suggest that laparoscopic rectal cancer surgery can be performed safely and effectively using a flexible articulated instrument. CLINICAL TRIAL NUMBER: Not applicable.

10Robotic colorectal surgery and ergonomics.PubMed

Shing Wai Wong, Zhen Hao Ang, Phillip F Yang, et al.
J Robot Surg. 2022 Apr;16(2):241-246. doi: 10.1007/s11701-021-01240-5. Epub 2021 Apr 22.
Improved ergonomics for the operating surgeon may be an advantage of robotic colorectal surgery. Perceived robotic ergonomic advantages in visualisation include better exposure, three-dimensional vision, surgeon camera control, and line of sight screen location. Postural advantages include seated position and freedom from the constraints of the sterile operating field. Manipulation benefits include articulated instruments with seven degrees of freedom movement, elimination of fulcrum effect, tremor filtration, and scaling of movement. Potential ergonomic detriments of robotic surgery include lack of haptic feedback, visual, and mental strain from increased operating time and interruptions to workflow from crowding.

11Kinematic and experimental investigation of manual resection tools for transurethral bladder tumor resection.PubMed

Nima Sarli, Tracy Marien, Christopher R Mitchell, et al.
Int J Med Robot. 2017 Jun;13(2). doi: 10.1002/rcs.1757. Epub 2016 Oct 20.
BACKGROUND: Transurethral Resection of Bladder Tumors (TURBT) is a challenging procedure partly due to resectoscope limitations. To date, manual resection performance has not been fully characterized. This work characterizes manual resection performance in the bladder while analyzing the effect of resection location on accuracy. METHODS: Kinematic simulations are used to assess kinematic measures of resection dexterity. An experimental protocol for manual resection accuracy assessment is developed. Cross correlations between the theoretical performance measures and the observed experimental accuracy are investigated. RESULTS: Tangential accuracy correlates relatively strongly with normal singular value and moderately with tangential kinematic conditioning index and tangential minimum singular value. Simulations also clarified difficulties in resecting close to the bladder neck. CONCLUSIONS: Measures to evaluate accuracy and dexterity of TURBT from a kinematic viewpoint are presented to provide a currently missing quantified dexterity baseline in manual TURBT. Limitations in various bladder regions are illustrated. Copyright © 2016 John Wiley & Sons, Ltd.

12Design, Analysis and Experimental Validation of a Novel 7-Degrees of Freedom Instrument for Laparoscopic Surgeries.PubMed

Prabhat Kumar, Sagar Talele, Suresh Deshpande, et al.
Ann Biomed Eng. 2023 Apr;51(4):751-770. doi: 10.1007/s10439-022-03086-w. Epub 2022 Oct 4.
Laparoscopic surgery is widely used for treating intra-abdominal conditions involving the gallbladder, pancreas, liver, intestines and reproductive organs. Conventional laparoscopy instruments used in manual surgeries usually have straight shafts and four degrees of freedom (DOF) plus grasping. However, these are insufficient for the complete rotation of the instrument tip. This makes it challenging to access difficult-to-reach organs inside the abdomen during the surgeries. A few robotic instruments available in the market have higher maneuverability but are expensive. Instruments incorporating cable-based mechanisms require replacement after a few sterilization cycles. This paper describes a novel, reusable and affordable multi-DOF laparoscopy instrument that provides two additional DOF: (a) wrist articulation about one axis (wristed yaw) and (b) rotation of the jaw after articulation (jaw roll). The wrist can articulate up to 45° and also roll after articulation. The additional degrees of freedom enable better maneuverability, functionality and reach than conventional laparoscopy instruments. Further, the new instrument employs only rigid links, providing better strength and minimal loss of function after multiple sterilizations. The complete design of the novel instrument, followed by its kinematic analysis and force calculations are explained in this paper, concluding with its manufacture and experimental validation.

13Evaluation of the Effect of Hand Size on Forearm Muscle Activity While Using Laparoscopic Instruments.PubMed

Emily Olig, Matthew Buras, Sara Wilson, et al.
J Minim Invasive Gynecol. 2026 Mar;33(3):291-296. doi: 10.1016/j.jmig.2025.12.001. Epub 2025 Dec 5.
OBJECTIVE: Percent maximum voluntary contraction (%MVC) provides a normalized assessment of muscle exertion that can be compared between individuals. A higher %MVC during tasks can lead to more rapid muscle fatigue and increased risk of injury. This study evaluates the %MVC of forearm muscles while manipulating four laparoscopic energy devices and compares the differences in muscle activity between surgeons with different hand sizes. DESIGN: Nonexperimental correlational study. SETTING: Testing was performed in a simulation lab at Mayo Clinic Arizona. PARTICIPANTS: Surgeons and surgical trainees that regularly perform robotic/laparoscopic surgery. INTERVENTIONS: Demographic information, glove size, and grip strength were collected. Four advanced energy devices were assessed. Surface electromyography (sEMG) electrodes were applied to the flexor digitorum superficialis (FDS), extensor carpi ulnaris (ECU), extensor carpi radialis longus (ECR), and extensor pollicis longus (EPL) of the dominant hand. Isometric MVC was performed on each muscle. Participants performed opening, closing, and activation cycles for each instrument. EMG output was filtered and normalized to provide %MVC. MEASUREMENTS AND MAIN RESULTS: Twenty-four individuals participated. Fourteen were female. Glove sizes ranged from 5.5 to 8.5, with 6.5 being the most common (n = 8). Glove size analysis was split between small (≤ 6.5) and large (>6.5). When adjusting for training level and instrument used, FDS and ECR displayed statistically significantly higher levels of activation in the small-handed group (p = .0012 and 0.013, respectively). 15% MVC was selected as a cutoff for evaluation due to increased risk of muscle fatigue and injury with sustained use above this threshold. Of the 16 muscle/instrument combinations, 10 showed a mean %MVC of greater than 15% for small hands, with one combination over 15% for large hands. CONCLUSION: Smaller-handed surgeons demonstrate increased forearm muscle activation when using laparoscopic instruments. Industry partners should consider variations in surgeon hand size when developing instruments to prevent disproportionate risk of injury to surgeons with smaller hands.

14Shoulder Muscular Fatigue From Static Posture Concurrently Reduces Cognitive Attentional Resources.PubMed

Mitchell L Stephenson, Alec G Ostrander, Hamid Norasi, et al.
Hum Factors. 2020 Jun;62(4):589-602. doi: 10.1177/0018720819852509. Epub 2019 Jun 19.
OBJECTIVE: The goal of this work is to determine whether muscular fatigue concurrently reduces cognitive attentional resources in technical tasks for healthy adults. BACKGROUND: Muscular fatigue is common in the workplace but often dissociated with cognitive performance. A corpus of literature demonstrates a link between muscular fatigue and cognitive function, but few investigations demonstrate that the instigation of the former degrades the latter in a way that may affect technical task completion. For example, laparoscopic surgery increases muscular fatigue, which may risk attentional capacity reduction and undermine surgical outcomes. METHOD: A total of 26 healthy participants completed a dual-task cognitive assessment of attentional resources while concurrently statically fatiguing their shoulder musculature until volitional failure, in a similar loading pattern observed in laparoscopic procedures. Continuous and discrete monitoring task performance was recorded to reflect attentional resources. RESULTS: Electromyography of the anterior deltoid and descending trapezius, as well as self-assessment surveys indicated fatigue occurrence; continuous tracking error, tracking velocity, and response time significantly increased with muscular fatigue. CONCLUSION: Muscular fatigue concurrently degrades cognitive attentional resources. APPLICATION: Complex tasks that rely on muscular and cognitive performance should consider interventions to reduce muscular fatigue to also preserve cognitive performance.

15Physical and mental workload in single-incision laparoscopic surgery and conventional laparoscopy.PubMed

Dilek Koca, Sedat Yıldız, Feray Soyupek, et al.
Surg Innov. 2015 Jun;22(3):294-302. doi: 10.1177/1553350614556363. Epub 2014 Nov 6.
OBJECTIVES: The aim of the present study is to evaluate mental workload and fatigue in fingers, hand, arm, shoulder in single-incision laparoscopic surgery (SILS) and multiport laparoscopy. METHODS: Volunteers performed chosen tasks by standard laparoscopy and SILS. Time to complete tasks and finger and hand strength were evaluated. Lateral, tripod, and pulp pinch strengths were measured. Hand dexterity was determined by pegboard. Electromyography recordings were taken from biceps and deltoid muscles of both extremities. The main outcome measurement was median frequency (MF) slope. NASA-TLX was used for mental workload. RESULTS: Time to complete laparoscopic tasks were longer in the SILS group (P < .05). Decrease of strength in fingers and hand were similar in SILS and standard laparoscopy. Pegboard time was increased in both hands after SILS (P < .05). MF slope of biceps muscle and deltoid muscle in SILS was far away from the reference slope. MF slope of biceps muscle and deltoid muscle in standard laparoscopy was close to reference slope, indicating there was more fatigue in biceps and deltoid muscles of both upper extremities in SILS group. NASA-TLX score was 73 ± 13.3 and 42 ± 19.5 in SILS and multiport laparoscopy, respectively (P < .01). Mental demand, physical demand, temporal demand, performance, effort, and frustration were, respectively, scored 10.7 ± 3.8, 11.7 ± 3.5, 12.2 ± 2.7, 11 ± 3, 13.6 ± 2.7, and 13.5 ± 2.8 in SILS and 6.3 ± 3.1, 6.6 ± 3.3, 7.3 ± 3.3, 7.1 ± 4.1, 7.9 ± 3.9, and 6.6 ± 3.8 in standard laparoscopy (P < .01). CONCLUSIONS: SILS is mentally and physically demanding, particularly on arms and shoulders. Fatigue of big muscles, effort, and frustration were major challenges of SILS. Ergonomic intervention of instruments are needed to decrease mental and physical workload.

16Comparative assessment of physical and cognitive ergonomics associated with robotic and traditional laparoscopic surgeries.PubMed

Gyusung I Lee, Mija R Lee, Tameka Clanton, et al.
Surg Endosc. 2014 Feb;28(2):456-65. doi: 10.1007/s00464-013-3213-z. Epub 2013 Oct 3.
BACKGROUND: We conducted this study to investigate how physical and cognitive ergonomic workloads would differ between robotic and laparoscopic surgeries and whether any ergonomic differences would be related to surgeons' robotic surgery skill level. Our hypothesis is that the unique features in robotic surgery will demonstrate skill-related results both in substantially less physical and cognitive workload and uncompromised task performance. METHODS: Thirteen MIS surgeons were recruited for this institutional review board-approved study and divided into three groups based on their robotic surgery experiences: laparoscopy experts with no robotic experience, novices with no or little robotic experience, and robotic experts. Each participant performed six surgical training tasks using traditional laparoscopy and robotic surgery. Physical workload was assessed by using surface electromyography from eight muscles (biceps, triceps, deltoid, trapezius, flexor carpi ulnaris, extensor digitorum, thenar compartment, and erector spinae). Mental workload assessment was conducted using the NASA-TLX. RESULTS: The cumulative muscular workload (CMW) from the biceps and the flexor carpi ulnaris with robotic surgery was significantly lower than with laparoscopy (p < 0.05). Interestingly, the CMW from the trapezius was significantly higher with robotic surgery than with laparoscopy (p < 0.05), but this difference was only observed in laparoscopic experts (LEs) and robotic surgery novices. NASA-TLX analysis showed that both robotic surgery novices and experts expressed lower global workloads with robotic surgery than with laparoscopy, whereas LEs showed higher global workload with robotic surgery (p > 0.05). Robotic surgery experts and novices had significantly higher performance scores with robotic surgery than with laparoscopy (p < 0.05). CONCLUSIONS: This study demonstrated that the physical and cognitive ergonomics with robotic surgery were significantly less challenging. Additionally, several ergonomic components were skill-related. Robotic experts could benefit the most from the ergonomic advantages in robotic surgery. These results emphasize the need for well-structured training and well-defined ergonomics guidelines to maximize the benefits utilizing the robotic surgery.

17A cost-effective IoT learning environment for the training and assessment of surgical technical skills with visual learning analytics.PubMed

Pablo Castillo-Segura, Carmen Fernández-Panadero, Carlos Alario-Hoyos, et al.
J Biomed Inform. 2021 Dec;124:103952. doi: 10.1016/j.jbi.2021.103952. Epub 2021 Nov 16.
BACKGROUND: Surgeons need to train and certify their technical skills. This is usually done with the intervention of experts who monitor and assess trainees. Nevertheless, this is a time-consuming task that is subject to variations among evaluators. In recent decades, subjectivity has been significantly reduced through 1) the introduction of standard curricula, such as the Fundamentals of Laparoscopic Surgery (FLS) program, which measures students' performance in specific exercises, and 2) rubrics, which are widely accepted in the literature and serve to provide feedback about the overall technical skills of the trainees. Although these two elements reduce subjectivity, they do not, however, eliminate the figure of the expert evaluator, and so the process remains time consuming. OBJECTIVES: The objective of this work is to automate those parts of the work of the expert evaluator that the technology can measure objectively, using sensors to collect evidence, and visualizations to provide feedback. We designed and developed 1) a cost-effective IoT (Internet of Things) learning environment for the training and assessment of surgical technical skills and 2) visualizations supported by the literature on visual learning analytics (VLA) to provide feedback about the exercises (in real time) and overall performance (at the end of the training) of the trainee. METHODS: A hybrid approach was followed based on previous research for the design of the sensor based IoT learning environment. Previous studies were used as the basis for getting best practices on the tracking of surgical instruments and on the detection of the force applied to the tissue, with a focus on reducing the costs of data collection. The monitoring of the specific exercises required the design of sensors and collection mechanisms from scratch as there is little existing research on this subject. Moreover, it was necessary to design the overall architecture to collect, process, synchronize and communicate the data coming from the different sensors to provide high-level information relevant to the end user. The information to be presented was already validated by the literature and the focus was on how to visualize this information and the optimal time for its presentation to end users. The visualizations were validated with 18 VLA experts assessing the technical aspects of the visualizations and 4 medical experts assessing their functional aspects. RESULTS: This IoT learning environment amplifies the evaluation mechanisms already validated by the literature, allowing automatic data collection. First, it uses IoT sensors to automatically correct two of the exercises defined in the FLS (peg transfer and precision cutting), providing real-time visualizations. Second it monitors the movement of the surgical instruments and the force applied to the tissues during the exercise, computing 6 of the high-level indicators used by expert evaluators in their rubrics (efficiency, economy of movement, hand tremor, depth perception, bimanual dexterity, and respect for tissue), providing feedback about the technical skills of the trainee using a radar chart with these six indicators at the end of the training (summative visualizations). CONCLUSIONS: The proposed IoT learning environment is a promising and cost-effective alternative to help in the training and assessment of surgical technical skills. The system shows the trainees' progress and presents new indicators about the correctness of each specific exercise through real-time visualizations, as well as their general technical skills through summative visualizations, aligned with the 6 more frequent indicators in standardized scales. Early results suggest that although both types of visualizations are useful, it is necessary to reduce the cognitive load of the graphs presented in real time during training. Nevertheless, an additional evaluation is needed to confirm these results.

18A review of wrist mechanism design and the application in gastrointestinal minimally invasive surgery of multi-degree-of-freedom surgical laparoscopic instruments.PubMed

Yisi Tu, Jianhao Jiang, Jingyun Huang, et al.
Surg Endosc. 2025 Jan;39(1):99-121. doi: 10.1007/s00464-024-11406-5. Epub 2024 Dec 9.
BACKGROUND: This paper aims to comprehensively review current designs of Multi-degree-of-freedom (Multi-DOF) wrist mechanisms and the applications of Multi-DOF surgical instruments in gastrointestinal minimally invasive surgery (MIS). METHODS: By reviewing the advantages and limitations of traditional laparoscopic and robotic surgical instruments, we present the development of Multi-DOF surgical instruments. Then, we summarize the Multi-DOF wrist mechanisms, delineating their pros and cons. Finally, the surgical outcomes and efficiency of Multi-DOF surgical instruments are reviewed. RESULTS: The utilization of Multi-DOF surgical instruments for both benign and malignant gastrointestinal diseases demonstrates perioperative outcomes comparable to traditional laparoscopic and robotic surgeries. In certain aspects, it exhibits advantages such as shorter operative times and faster gastrointestinal function recovery. CONCLUSION: Further research is needed to effectively combine these driving mechanisms to achieve a new type of transmission mechanism with high rigidity and precision, ample working space, and decoupled degrees of freedom. Multi-DOF surgical instruments offer the advantages of high flexibility and lower costs, displaying good feasibility and safety in practical clinical applications within gastrointestinal surgery. Their promotion in primary care hospitals could benefit a larger patient population. However, more extensive sample-sized multicenter studies are still warranted to elucidate such surgical instruments' advantages further.

19Leading Through Noise: Operating Room Noise Challenges for Staff and Leadership Techniques to Ensure Optimal Operational Performance.PubMed

Mena Louis, Nathaniel Grabill, Priscilla Strom, et al.
Cureus. 2024 Sep 17;16(9):e69569. doi: 10.7759/cureus.69569. eCollection 2024 Sep.
Noise and distractions in the operating room (OR) critically impact surgical performance and patient outcomes, particularly in high-stakes environments such as trauma surgery. While historical hospital environments prioritized quiet to facilitate recovery and reduce stress, contemporary ORs, especially those handling trauma cases, face increasing noise challenges due to advanced surgical instruments, alarms, and staff conversations, often surpassing federal exposure limits. This review investigates OR noise sources, including staff activities and equipment, analyzing their effects on cognitive load, communication, and error rates among healthcare workers. It identifies high-risk scenarios and vulnerable groups, highlighting the necessity for targeted interventions. Key strategies include implementing strict noise control policies, using noise-reducing materials in OR design, and educating staff on noise impacts. Additionally, structured communication protocols and continuous monitoring systems are advocated to enhance operational efficiency and safety. Surgeon leadership is pivotal in balancing assertiveness and empathy to maintain a productive team dynamic. Furthermore, surgeons significantly boost OR efficiency and safety by adopting these protocols, promoting inclusive team dynamics, and applying noise-reduction strategies. These practices safeguard patient care and foster a more collaborative work atmosphere, aligning all team efforts toward optimal patient outcomes. This holistic approach emphasizes the need for continuous improvement and adaptability in surgical practices to meet modern healthcare demands, particularly in trauma surgery's fast-paced, unpredictable realm. Collectively, these measures can enhance patient safety and improve conditions for surgical teams, providing a framework for quieter, more focused OR environments that ultimately elevate surgical outcomes and healthcare quality.

20A Mobile Health Application for Operating Room Nurses: Optimizing Workflows with Surgical Checklists and Preference Cards.PubMed

Maria-Anna Katsiki, Joseph Liaskos, Emmanouil Zoulias, et al.
Stud Health Technol Inform. 2026 Jun 29;338:41-45. doi: 10.3233/SHTI260792.
Operating rooms (ORs) are high-risk environments where patient safety and efficiency depend on accurate preparation. Traditional paper-based preference cards and reliance on operative nurses' memory often result in workflow inefficiencies and increased cognitive stress. This study aims to design, develop, and evaluate a mobile health (mHealth) application that digitizes surgical checklists and surgeon preference cards to optimize OR preparation. A user-centered design approach was employed. Initial requirements were gathered through a focus group with six experienced OR nurses. Based on these insights, a web-based prototype was developed. Its usability and clinical applicability were evaluated by a panel of expert users through a structured questionnaire. The evaluation indicated high user acceptance. Participants reported that the application significantly reduced cognitive load, streamlined the preparation of surgical instruments and consumables, and served as a valuable educational tool for novice nurses. Digitizing OR workflows through targeted, user-informed mHealth applications can enhance team coordination, reduce preparation time, and improve patient safety.

21Comparison of two actuation systems for laparoscopic surgical manipulators using motion analysis.PubMed

Yogesh Vinod Kolwadkar, Stuart I Brown, Rami J Abboud, et al.
Surg Endosc. 2011 Mar;25(3):964-74. doi: 10.1007/s00464-010-1300-y. Epub 2010 Aug 24.
BACKGROUND: During surgery, all joints of the upper limbs, including shoulder, elbow, wrist, and finger, coordinate to complete a task. Hence, analysis of these joint movements during surgical manipulations is useful for the design of optimal hand-instrument interface. This study compared two types of surgical handheld manipulators with 6 degrees of freedom with different handle designs: one using a controlling wheel (fingertip control, FTC) and the other with a controlling joint (master slave control, MSC) in terms of ergonomics and movement efficiency. METHODS: Seventeen subjects consisting of surgeons and medical students participated in the experiment. Each performed two standardized surgical tasks in a surgical simulator. A set of reflective markers were attached on the subjects' upper limbs and the marker positions during the tasks were collected by a motion capture system for subsequent analysis of the trunk, shoulder, elbow, wrist, and fingers joint movements. The subjects also completed a Visual Analogue Scale-based questionnaire on their preference for the control mechanism and ease of handling. RESULTS: The data showed that the manipulator with the MSC was more difficult to handle and resulted in larger range of movements, higher velocities, and accelerations in some joints than the manipulator with FTC mechanism. Use of the MSC manipulator also was accompanied by a higher error rate. Additionally, the subjects preferred the finger actuated manipulator and gave it a higher Visual Analogue Score for maneuverability. CONCLUSIONS: The manipulator equipped with the MSC was ergonomically inferior; it was more difficult to handle and provided less precision, resulting in higher error rates than the FTC manipulator. This study also confirmed that motion analysis is useful for assessment of the design of handheld manipulators for endoscopic surgery.

22Gender equity in surgical instruments: ergonomics of ring-handled forceps.PubMed

Emiko Kono, Sachiyo Nomura, Takashi Sakamoto, et al.
Minim Invasive Ther Allied Technol. 2024 Feb;33(1):21-28. doi: 10.1080/13645706.2023.2261533. Epub 2024 Feb 2.
INTRODUCTION: Female surgeons have ergonomic issues with commercialized instruments tailored for male surgeons. The purpose of this study was to identify satisfaction levels and ergonomic problems of female surgeons while using laparoscopic forceps with ring-handles and suggest improvement measures. MATERIAL AND METHODS: A questionnaire was sent to 19,405 members of the Japanese Society of Gastroenterological Surgery email between 1 August 2022 and 30 September 2022. It included demographic information and specific questions regarding the use of laparoscopic forceps with ring- handles (ergonomic evaluation, influence of the negative aspects of laparoscopic forceps during surgery, physical discomfort in the hands and fingers, degree of satisfaction, and handle size). RESULTS: Valid responses were received from 1,030 respondents (131 female and 899 male surgeons). The ergonomics of the laparoscopic forceps with ring-handles were rated lower by female surgeons in all ten categories (all value < 0.05). They also reported a negative impact on surgical manipulation and discomfort to their hands and fingers. CONCLUSIONS: Female surgeons had a wide variety of ergonomic problems when using laparoscopic forceps with ring-handles, and showed lower levels of satisfaction. Developing a different model tailored to female surgeons with smaller hands and a weaker grip could be a viable solution.

23The ergonomics of women in surgery.PubMed

Erica Sutton, Myra Irvin, Craig Zeigler, et al.
Surg Endosc. 2014 Apr;28(4):1051-5. doi: 10.1007/s00464-013-3281-0.
BACKGROUND: Among surgeons who regularly perform minimally invasive surgery, as many as 87 % report injuries or symptoms related to job performance. Operating room and instrument design have traditionally favored surgeons who are taller and who possess hands that are, in general, large and strong. We hypothesize that women may be experiencing more ergonomic difficulties than men for whom the operating room and surgical instruments, although uniformly perilous, more traditionally have accommodated. METHODS: A 23-item web-based survey was offered via email to 2,000 laparoscopic surgeons and fellows currently practicing. The survey addressed four categories: demographics, physical symptoms, ergonomics, and environment/equipment. Key questions allowed us to identify which body part experienced which symptoms. RESULTS: There was a 15.7 % overall response rate. Among respondents, 17 % (54/314) were female. Women were significantly younger, shorter, had smaller glove size, and fewer years in practice than men surveyed (all p values < 0.0001). Of women reporting, 86.5 %—comparable to men—attribute physical discomfort to laparoscopic operating. Female surgeons are more likely to receive treatment for their hands, which includes the wrist, thumb, and fingers (odds ratio 3.5, p = 0.028). When men and women of the same glove size were compared, women with a larger glove size (7–8.5) reported more cases of treatment for their hands than men of the same glove size. (21 vs. 3 %, p = 0.016). Women who wore a size 5.5–6.5 surgical glove reported significantly more cases of discomfort in their shoulder area (neck, shoulder, upper back) than men who wore the same size surgical glove (77 vs. 27 %, p = 0.004). CONCLUSIONS: Women surgeons are experiencing more discomfort and treatment in their hands than male surgeons. Redesign of laparoscopic instrument handles and improvements to table height comprise the most promising solutions to these ergonomic challenges.

24Variables affecting surgeons' use of, and preferences for, instrumentation in veterinary laparoscopy.PubMed

Meghan R Smith, Nicole J Buote, Julia P Sumner, et al.
Vet Surg. 2024 Apr;53(3):513-523. doi: 10.1111/vsu.13995. Epub 2023 Jul 24.
OBJECTIVE: To investigate the impact of variables on use and preference of common laparoscopic instruments. STUDY DESIGN: Online survey. SAMPLE POPULATION: Surgeons (n = 140) with 3 years or more laparoscopic experience. METHODS: Electronic survey distributed via specialty group LISTSERVEs and Facebook groups. Responses collected included surgeon attributes, preferences, and surgical practice data. Statistical analysis was performed using Fishers exact, ANOVA, Tukey Kramer honestly significant difference (HSD) test, linear regression, and logistic regression. RESULTS: Ninety-eight of 140 respondents answered instrument-related questions and the completion rate of these questions was 76%: 48% of females and 49% of males responded to the survey. The median glove size of respondents was size 7 (range, 5.5 to 8.5). Closing laparoscopic Babcock forceps (p = .018), rotating cup biopsy forceps (p = .003), and manipulating endoscopic staplers (p < .001) were more difficult for surgeons with smaller glove sizes. The median difficulty score for the endoscopic stapler was 4/10 and the median percentage of time this was found difficult was 25%. Reusable instruments were preferred over disposable single-use instruments. The pistol grip was preferred for grasping and retracting (54/98, 55%) and fine dissection (46/96, 48%), while the axial grip was preferred for suturing and knot tying (61/98, 62%). CONCLUSION: Surgeons with smaller glove sizes (<6.5) experience more difficulty when using common laparoscopic instruments. The endoscopic stapler was the most difficult to use. CLINICAL SIGNIFICANCE: When purchasing laparoscopic instrumentation, surgeons should review all available options in handle size and design to improve ergonomics during minimally invasive procedures.

25Ergonomic assessment of a new hand tool design for laparoscopic surgery based on surgeons' muscular activity.PubMed

A G González, J Barrios-Muriel, F Romero-Sánchez, et al.
Appl Ergon. 2020 Oct;88:103161. doi: 10.1016/j.apergo.2020.103161. Epub 2020 May 22.
Laparoscopic surgery techniques are customarily used in non-invasive procedures. That said traditional surgical instruments and devices used by surgeons suffer from certain ergonomic deficiencies that may lead to physical complaints in upper limbs and back and general discomfort that may, in turn, affect the surgeon's skills during surgery. A novel design of the laparoscopic gripper handle is presented and compared with one of the most used instruments in this field in an attempt to overcome this problem. The assessment of the ergonomic feature of the novel design was performed by using time-frequency analysis of the surface electromyography (sEMG) signal during dynamic activities. Singular Spectrum Analysis (SSA) was used to decompose the sEMG signal and extract the median frequency of each muscle to assess muscle fatigue. The results reveal that using the proposed ergonomic grip reduces the mean values of the muscle activity during each of the proposed tasks. The novel design also improves the ease of use in laparoscopic surgery as it minimises high-pressure contact areas, reduces large amplitude movements and promotes a neutral position of the hand, wrist and forearm. Furthermore, the SSA method for time-frequency analysis provides a powerful tool to analyse a prescribed activity in ergonomic terms. The proposed methodology to assess muscle activity during surgery activities may be useful in the selection of surgical instruments when programming extended procedures, as it provides an additional selection criterion based on the surgeon's biomechanics and the proposed activity.

26Design of a tether-driven minimally invasive robotic surgical tool with decoupled degree-of-freedom wrist.PubMed

Karthik Chandrasekaran, Asokan Thondiyath
Int J Med Robot. 2020 Jun;16(3):e2084. doi: 10.1002/rcs.2084. Epub 2020 Mar 1.
BACKGROUND: Dexterous surgical tool wrists used in tele-operated robotic surgery typically have mechanically coupled pitch and yaw degree of freedom (DoF). This leads to complex control requirements. MATERIALS AND METHODS: The design of a robotic surgical tool with a mechanically decoupled dexterous wrist which uses stationary tether guides to guide drive tethers is presented. The tethers are routed through the plane of symmetry of the tool and follow law of belting to mechanically decouple the wrist. An optimization procedure for the placement of the stationary tether guides to minimize the change in tether length is presented. RESULTS: Experimental and analytical results confirm the decoupled motion capability of the wrist. Also, the change in length of tether segments over the operating range of motion was found to be very small. CONCLUSION: A prototype has been fabricated through metal 3D printing and integrated to a tele-operated robotic setup to demonstrate its utility in surgical application.

27Design, Fabrication, and Testing of a Needle-Sized Wrist for Surgical Instruments.PubMed

Philip J Swaney, Peter A York, Hunter B Gilbert, et al.
J Med Device. 2017 Mar;11(1):0145011-145019. doi: 10.1115/1.4034575. Epub 2016 Dec 21.
This paper presents a miniature wrist that can be integrated into needle-sized surgical instruments. The wrist consists of a nitinol tube with asymmetric cutouts that is actuated by a single tendon to provide high distal curvature. We derive and experimentally validate kinematic and static models for the wrist and describe several prototype wrists, illustrating the straightforward fabrication and scalability of the design. We experimentally investigate fatigue life, the concept of tip-first bending, and practical use of the wrist with a concentric tube robot in an endonasal surgical scenario.

28Cost-effective laparoscopic cholecystectomy.PubMed

M Slater, M I Booth, T C B Dehn
Ann R Coll Surg Engl. 2009 Nov;91(8):670-2. doi: 10.1308/003588409X12486167521154. Epub 2009 Sep 25.
INTRODUCTION: There is wide variation in costs, both theatre and ward, for the same operation performed in different hospitals. The aim of this study was to compare the true costs for a large number of consecutive laparoscopic cholecystectomy (LC) cases using re-usable equipment with those from an adjacent trust in which the policy was to use disposable LC equipment. PATIENTS AND METHODS: Data were collected prospectively between January 2001 and December 2007 inclusive for all consecutive patients undergoing LC by two upper gastrointestinal (UGI) consultants at the Royal Berkshire Hospital. Data were collected for all the instruments used, in particular any additional disposable instruments used at surgeons' preference. Sterilisation costs were calculated for all re-usable instruments. Costs were also obtained from an adjacent NHS trust which adopted a policy of using disposable ports and clip applicators. Disposable equipment such as drapes, insufflation tubing, and camera sheath were not considered as additional costs, since they are common to both trusts and not available in a re-usable form. RESULTS: Over 7 years, a total of 1803 LCs were performed consecutively by two UGI consultants at the Royal Berkshire Hospital. The grand total for 1803 LC cases for the re-usable group, including initial purchasing, was pound89,844.41 (an average of pound49.83 per LC case). The grand total for the disposable group, including sterilisation costs, was pound574,706.25 (an average of pound318.75 per LC case). Thus the saving for the trust using re-usable trocars, ports and clip applicators was pound268.92 per case, pound69,265.98 per annum and pound484,861.84 over 7 years. CONCLUSIONS: This study has demonstrated that considerable savings occur with a policy of minimal use of disposable equipment for LC. Using a disposable set, the instrument costs per procedure is 6.4 times greater than the cost of using re-usable LC sets. It behoves surgeons to be cost-effective and to reduce unnecessary expenditure and wastage. There is no evidence to support use of once-only laparoscopic instruments on grounds of patient safety, ease of use or transmission of infection. If the savings identified in this study of two surgeons' work (savings of pound484,861.84 in a 7-year period) was extended not only across the hospital but across the NHS, large savings could be made for laparoscopic cholecystectomy. Even greater savings would accrue if the results were extrapolated to cover all laparoscopic surgery of whatever discipline.

29Regional cost analysis for laparoscopic cholecystectomy.PubMed

Elizabeth M Pontarelli, Gary G Grinberg, Richard S Isaacs, et al.
Surg Endosc. 2019 Jul;33(7):2339-2344. doi: 10.1007/s00464-018-6526-0. Epub 2018 Nov 28.
BACKGROUND: Laparoscopic cholecystectomy is the most common procedure performed by general surgeons in the United States, with approximately 600,000 procedures performed annually. As the cost of care rises, there is increasing emphasis on utilization and quality. Our objective was to evaluate the cost of laparoscopic cholecystectomy in our health system and to compare the operative times and outcomes at high- and low-cost centers. METHODS: We evaluated all laparoscopic cholecystectomies performed in our system over a 1-year period. The operating room supply costs and procedure durations were obtained for each of the hospitals. The American College of Surgeons National Surgical Quality Improvement Program outcomes and demographics were compared to the costs for each hospital. RESULTS: During the study period, 7601 laparoscopic cholecystectomies were performed at 20 hospitals (170-759/hospital) by 227 surgeons. The average cost per case ranged from $296 at the lowest cost center to $658 at the highest cost center. The average operative time varied between sites from 46 to 95 min. There was no association between cost and operative time or case volume. There was a slight trend toward increased cost with higher number of emergency procedures, but this was not well correlated (R = 0.03). The patient demographics and comorbidities were similar between sites. There were no significant differences in postoperative complications between high- and low-cost centers. The items with the greatest increase in cost were disposable trocars, disposable hook cautery, disposable endoscissors, and disposable clip appliers. We estimate that a savings of over $300/case is possible by using reusable instruments, which would result in an annual savings of $1.3 million for our health system, and $285 million nationwide. CONCLUSION: Performing laparoscopic cholecystectomy with reusable instruments can significantly decrease costs and does not increase operative time or postoperative complications.

30Cost-effectiveness of minimally invasive pancreatic resection.PubMed

Katharina Joechle, Claudius Conrad
J Hepatobiliary Pancreat Sci. 2018 Jun;25(6):291-298. doi: 10.1002/jhbp.558.
While clinical outcomes of minimally invasive pancreatic resection (MIPR) compared to open surgery are well examined, only few studies focus on its associated cost. The aim of this study is to evaluate cost analyses comparing MIPR to open pancreatic resection (OPR). A systematic review of the literature using PubMed of all published studies between 2000 and 2017 was performed. Studies reporting on cost of laparoscopic distal pancreatectomy (LDP) and laparoscopic pancreatoduodenectomy (LPD) compared to open surgery were identified. Fourteen studies were included, eight that reported a cost comparison between LDP and open surgery and six that compared costs between LPD and open surgery. For both, LDP and LPD, operative costs were higher due to higher costs for surgical equipment. Reports suggest that lower postoperative costs for LDP and LPD could balance out the operative costs resulting in overall decreased costs for the laparoscopic compared to the open approach. Recent results show a positive trend towards cost savings for MIPR. To assess the overall benefit of MIPR compared to OPR comprehensive cost analyses and long-term quality outcomes need to be investigated.

31Innovation in robotic surgery: the Indian scenario.PubMed

Suresh V Deshpande
J Minim Access Surg. 2015 Jan-Mar;11(1):106-10. doi: 10.4103/0972-9941.147724.
Robotics is the science. In scientific words a "Robot" is an electromechanical arm device with a computer interface, a combination of electrical, mechanical, and computer engineering. It is a mechanical arm that performs tasks in Industries, space exploration, and science. One such idea was to make an automated arm - A robot - In laparoscopy to control the telescope-camera unit electromechanically and then with a computer interface using voice control. It took us 5 long years from 2004 to bring it to the level of obtaining a patent. That was the birth of the Swarup Robotic Arm (SWARM) which is the first and the only Indian contribution in the field of robotics in laparoscopy as a total voice controlled camera holding robotic arm developed without any support by industry or research institutes.

32Usefulness of articulating laparoscopic instruments during laparoscopic gastrectomy for gastric adenocarcinoma.PubMed

Eunju Lee, Kanghaeng Lee, So Hyun Kang, et al.
J Minim Invasive Surg. 2021 Mar 15;24(1):35-42. doi: 10.7602/jmis.2021.24.1.35.
PURPOSE: Conventional straight-shaped laparoscopic surgical instruments have limitations that, unlike robotic surgery, the wrist joint cannot be used. This study aimed to analyze the short-term safety and feasibility of ArtiSential (Livsmed), a new articulating laparoscopic instrument, which obviates the limitations of conventional laparoscopic surgery and allows the wrist joint to be used freely over 360° as in robotic surgery. METHODS: The study included patients who underwent conventional laparoscopy or laparoscopy with the ArtiSential instrument. Patients who underwent laparoscopic gastrectomy for primary gastric adenocarcinoma in our institution were retrospectively reviewed. The groups were propensity score matched in a 11 ratio. Primary endpoint was incidence of early postoperative complication (postoperative 30-day morbidity and mortality) and secondary endpoints were operative outcomes. RESULTS: A total of 327 patients (147 of the conventional group and 180 of the ArtiSential group) were propensity score matched. After propensity score matching was performed, each group comprised of 122 patients. Both groups were comparable with regard to operation time, estimated blood loss, number of retrieved lymph nodes, and length of hospital stay. The ArtiSential group had a faster time to a fluid diet (2.6 ± 1.3 days vs. 2.3 ± 0.6 days, = 0.015). There was no statistically significant difference in early postoperative complications between the two groups (the conventional group, 23.0%; the ArtiSential group, 26.2%; = 0.656). CONCLUSION: The current study showed that the use of ArtiSential is a safe and feasible option without increasing operation time, length of hospital stay, and intraoperative bleeding.

33ArtiSential® Clip Applier Use in Robotic Urologic Surgery: Initial Experience and Outcomes.PubMed

Shirin Razdan, Ali Fathollahi, Sanjay Razdan
J Endourol. 2025 Nov;39(11):1134-1138. doi: 10.1177/08927790251372155. Epub 2025 Aug 25.
The ArtiSential® clip applier (LivsMed®, San Diego, CA, USA) is a new double-jointed laparoscopic clip applier with 90° wrist articulation. We sought to explore the feasibility of the new clip applier in robotic urologic surgery and compare it with the standard Weck® laparoscopic Hem-o-lok® clip applier. A retrospective review of 100 consecutive robotic urologic surgeries completed using the new clip applier by two surgeons was conducted from August 2024 to January 2025. The surgeries performed were robotic radical prostatectomy (RALP), robotic radical nephrectomy (RARN), and robotic partial nephrectomy (RAPN). Clips were applied during pelvic lymph node dissection in RALP, during ureteral transection in RARN, and during renorrhaphy in RAPN. Both ArtiSential (Group 1) and Hem-o-lok (Group 2) clips were applied during similar portions of the cases, with the latter group acting as a control. The number of successfully deployed clips (no misfires) was recorded and compared between groups. Subjective surgeon and bedside assistant approval was assessed using a dichotomous scale of yes/no for correct clip application. Cognitive load for the bedside assistant using the ArtiSential clip applier was measured using the NASA task load index (TLX). A total of 340 clips in Group 1 and 360 clips in Group 2 were used. The percent of successful deployments of clips in Group 1 was 97.1% (330/340), while in Group 2 it was 94.4% (340/360) ( < 0.05). Subjective bedside assistant assessment of clip application was 91.2% accuracy in Group 1 (301/330 clips) and 87.6% accuracy in Group 2 (298/340 clips). Subjective surgeon assessment of clip application was 89.1% in Group 1 (294/330 clips) and 83.2% in Group 2 (283/340 clips). The mean NASA-TLX was significantly higher in Group 1 compared with Group 2. There was one reported lymphocele in Group 2. The ArtiSential clip applier is a double-jointed, multi-articulating laparoscopic clip applier that allows for improved accuracy of clip application when compared to standard Weck Hem-o-lok clip appliers in pelvic and retroperitoneal robotic urologic surgery.

34ArtiSential laparoscopic cholecystectomy: a comparative analysis with robotic single-port cholecystectomy.PubMed

Seoung Yoon Rho, Munseok Choi, Sung Hyun Kim, et al.
Ann Surg Treat Res. 2024 Dec;107(6):336-345. doi: 10.4174/astr.2024.107.6.336. Epub 2024 Dec 2.
PURPOSE: Laparoscopic cholecystectomy is the gold standard procedure for benign gallbladder disease. However, reducing ports still causes frustration when using various instruments. We investigated early perioperative outcomes of laparoscopic single site + 1 cholecystectomy using ArtiSential instruments (ArtiSential laparoscopic cholecystectomy [ALC], LIVSMED). METHODS: From July 2022 to December 2022, 116 patients underwent ALC in Severance Hospital and Yongin Severance Hospital. From May 2019 to December 2022, 210 patients underwent robotic single-port cholecystectomy (RSPC). We compared clinical characteristics, perioperative outcomes, and postoperative pain scores between the ALC and RSPC groups. RESULTS: Patients in the ALC group were significantly older than those in the RSPC group (51.9 years 43.9 years, P < 0.001), and the ALC group had a larger proportion of male patients (50.9% 24.8%, P < 0.001) and cases of acute cholecystitis with stones (21.6% 0.5%, P < 0.001) than the RSPC group. The groups did not differ in their estimated blood loss, postoperative complications, or hospital stays. The mean operation time of the ALC group was shorter than that of the RSPC group (56.5 minutes 94.8 minutes, P < 0.001). Although the pain scores reported on discharge day did not differ, the ALC group reported significantly lower immediate postoperative pain scores than the RSPC group (2.7 5.4, P < 0.001). CONCLUSION: ALC is a safe and feasible procedure. ALC patients reported markedly lower immediate postoperative pain scores than RSPC patients, with comparable operative outcomes for estimated blood loss, hospital stay, and postoperative complication rates.

35Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial.PubMed

Ajita S Prabhu, Alfredo Carbonell, William Hope, et al.
JAMA Surg. 2020 May 1;155(5):380-387. doi: 10.1001/jamasurg.2020.0034.
IMPORTANCE: Despite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair. OBJECTIVE: To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis. INTERVENTIONS: Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair. MAIN OUTCOMES AND MEASURES: Main outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection. RESULTS: A total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P < .001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P < .001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P = .004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument. CONCLUSIONS AND RELEVANCE: Results of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02816658.

36Effect of far-infrared radiation on inhibition of colonies on packaging during storage of sterilised surgical instruments.PubMed

Li-Yun Fann, Chih-Chien Cheng, Yung-Chen Chien, et al.
Sci Rep. 2023 May 25;13(1):8490. doi: 10.1038/s41598-023-35352-9.
The sterilisation of surgical instruments is a major factor in infection control in the operating room (OR). All items used in the OR must be sterile for patient safety. Therefore, the present study evaluated the effect of far-infrared radiation (FIR) on the inhibition of colonies on packaging surface during the long-term storage of sterilised surgical instruments. From September 2021 to July 2022, 68.2% of 85 packages without FIR treatment showed microbial growth after incubation at 35 °C for 30 days and at room temperature for 5 days. A total of 34 bacterial species were identified, with the number of colonies increasing over time. In total, 130 colony-forming units were observed. The main microorganisms detected were Staphylococcus spp. (35%) and Bacillus spp. (21%) , Kocuria marina and Lactobacillus spp. (14%), and mould (5%). No colonies were found in 72 packages treated with FIR in the OR. Even after sterilisation, microbial growth can occur due to movement of the packages by staff, sweeping of floors, lack of high-efficiency particulate air filtration, high humidity, and inadequate hand hygiene. Thus, safe and simple far-infrared devices that allow continuous disinfection for storage spaces, as well as temperature and humidity control, help to reduce microorganisms in the OR.

37Cleaning methods for dental instruments.PubMed

Martin R Fulford, Nikolai R Stankiewicz
Br Dent J. 2023 Jul;235(2):105-111. doi: 10.1038/s41415-023-6061-9.
It is essential to ensure that reusable dental instruments are scrupulously clean as a first step in the decontamination process. Any residual soil on the surface of equipment creates a risk that will prevent steam, generated during sterilisation, from condensing on the surface of the instrument and raising the temperature to that required to ensure sterilisation. Further, most microorganisms will struggle to attach to the surface of a clean instrument. Adherence of microorganisms to the surface of an instrument that is contaminated with organic soil or the irregular surface of residual dental materials is likely to be greatly enhanced. It is therefore important to ensure that residual dental materials are removed from the surface of instruments, at the point of use, before they are allowed to set.It is also important to ensure that the methods used to clean dental equipment do not damage the instrument. Any method that has the potential to scratch the surface of an instrument and therefore make it more difficult to clean should be avoided. Aggressive cleaning can lead to removal of the passivation layer, the chromium-rich layer that prevents corrosion occurring, formed on the surface of instruments made from stainless steel. If corrosion forms on the surface of an instrument, the surface becomes roughened and possibly stained. Surface staining can then be difficult to differentiate from other stains or marks caused by retained biological soil. Corrosion on the surface of an instrument will make the effective cleaning of the surface more difficult and therefore corroded or stained instruments should be discarded.

38Implementing '6S' Nursing Management in Sterilization and Supply Centers: Enhancing Surgical Instrument Quality and Work Efficiency.PubMed

Li Fang, Kaiping Xiao, Hongyu Zhu, et al.
Risk Manag Healthc Policy. 2025 Mar 30;18:1099-1108. doi: 10.2147/RMHP.S508701. eCollection 2025.
OBJECTIVE: This study examines the implementation of '6S' nursing management in sterilization and supply centers to evaluate its impact on improving surgical instrument management and overall operational quality. METHODS: The pre-management phase was from January to June 2019, during which the conventional management mode was applied in our hospital's sterilization and supply center, and 100 instrument packs were selected for quality inspection. The post-management phase was from July to December 2019, when the 6S management mode was implemented in the sterilization and supply center, with another 100 instrument packs selected for quality inspection. A total of 20 staff members were involved. The management quality (environmental management, packaging management, cleaning and sterilization, and instrument management), mastery of professional knowledge (theoretical knowledge, practical knowledge, and nursing skill knowledge), incidence of surgical instrument processing errors, quality of work (grooming, problem-solving, sense of responsibility, sense of initiative, and team communication), and work pass rate before and after 6S management were compared. RESULTS: After 6S management, the management quality scores were higher, the mastery of professional knowledge of personnel was raised, the quality of work was promoted, the overall incidence of errors in surgical instrument processing was reduced to 1%, and the qualification rates for cleaning, sterilization, and issuance were all increased to 100%, with significant differences compared to before the implementation of management measures (all < 0.05). CONCLUSION: The application of "6S" nursing management in the sterilization and supply center is an effective approach to addressing the current challenges of enhancing sterilization quality and management efficiency, significantly improving the quality of surgical instruments and work efficiency.

39A single port laparoscopic surgery robot with high force transmission and a large workspace.PubMed

Byungsik Cheon, Erkin Gezgin, Dae Keun Ji, et al.
Surg Endosc. 2014 Sep;28(9):2719-29. doi: 10.1007/s00464-014-3534-6. Epub 2014 May 2.
INTRODUCTION: This study presents the design of a novel single port laparoscopic surgery robot that is actuated by plate-spring-driven mechanisms with high force transmission and a larger workspace. Many ongoing studies aim to develop robotic single port laparoscopic surgery platforms due to the potential advantages in terms of a short recovery period and fewer postoperative scars. Most of these investigations of single port access have focused on resolving the inconvenient maneuverability of manual single port laparoscopic surgery. However, drive mechanism structures are another requirement. MATERIALS AND METHODS: Most of the existing robotic platforms cannot transmit sufficient force, as many of them use wire-driven mechanisms, which are prone to mechanical deformation that also negatively affects the accuracy of the end effector. In addition, even the best-known laparoscopic surgical robot system has instruments with a limited workspace for single port laparoscopic surgery. Therefore, the purpose of this study was to propose a novel robotic single port laparoscopic surgery platform that uses plate springs to transmit higher forces during tissue handling. RESULTS AND CONCLUSION: Compared to wire- or link-driven mechanisms, the plate-spring mechanism provided surpassing force transmission, with >14 N force transmission achieved, which enables most laparoscopic surgery with single port access. In addition, the high degree of freedom structure of the proposed design permitted an expanded workspace, which might be the most competitive characteristic among the single port systems reported to date.

40Hybrid robotic systems.PubMed

Ludovica Baldari, Luigi Boni, Elisa Cassinotti
Surgery. 2024 Nov;176(5):1538-1541. doi: 10.1016/j.surg.2024.07.049. Epub 2024 Aug 30.
Standard laparoscopic instruments have limited dexterity because of their few degrees of freedom, making some surgical tasks extremely challenging. Robotic surgery was developed to overcome these issues, but the da Vinci system is associated with high costs. During recent years, many companies developed new robotic systems to improve dexterity and ergonomics with less impact on cost-effectiveness. This work describes the main commercially available modular robotic platforms, focusing on the technology, architecture and features, and advantages and disadvantages of each system. One of the main advantages of modular systems is the possibility of performing the whole procedure robotically or performing part of the procedure laparoscopically and part robotically as a hybrid approach. Next-generation robotic systems mainly include a modular design, open or semiopen consoles, smaller instruments, decreased cost, and augmented reality. To date, there are still few data in the literature comparing the systems, as many of them are awaiting regulatory approval. Thus, future studies are necessary to answer these questions. Many other robotic platforms are currently under development and will be available on the market, with a potential to alter surgical practice.

41Survey on surgical instrument handle design: ergonomics and acceptance.PubMed

Laura Santos-Carreras, Monika Hagen, Roger Gassert, et al.
Surg Innov. 2012 Mar;19(1):50-9. doi: 10.1177/1553350611413611. Epub 2011 Aug 25.
Minimally invasive surgical approaches have revolutionized surgical care and considerably improved surgical outcomes. The instrumentation has changed significantly from open to laparoscopic and robotic surgery with various usability and ergonomics qualities. To establish guidelines for future designing of surgical instruments, this study assesses the effects of current surgical approaches and instruments on the surgeon. Furthermore, an analysis of surgeons' preferences with respect to instrument handles was performed to identify the main acceptance criteria. In all, 49 surgeons (24 with robotic surgery experience, 25 without) completed the survey about physical discomfort and working conditions. The respondents evaluated comfort, intuitiveness, precision, and stability of 7 instrument handles. Robotic surgery procedures generally take a longer time than conventional procedures but result in less back, shoulder, and wrist pain; 28% of surgeons complained about finger and neck pain during robotic surgery. Three handles (conventional needle holder, da Vinci wrist, and joystick-like handle) received significantly higher scores for most of the proposed criteria. The handle preference is best explained by a regression model related only to comfort and precision (R(2) = 0.91) and is significantly affected by the surgeon's background (P < .001). Although robotic surgery seems to alleviate physical discomfort during and after surgery, the results of this study show that there is room for improvement in the sitting posture and in the ergonomics of the handles. Comfort and precision have been found to be the most important aspects for the surgeon's choice of an instrument handle. Furthermore, surgeons' professional background should be considered when designing novel surgical instruments.

42Evidence-Based Guidelines for Instrument and Handle Selection for Ergonomic Optimization in Laparoscopic Surgery.PubMed

J Minim Invasive Gynecol. 2026 Jul;33(7):823-836. doi: 10.1016/j.jmig.2026.04.014. Epub 2026 Apr 24.
STUDY OBJECTIVE: To develop evidence-based practice guidelines for ergonomic optimization in laparoscopic surgery through the evaluation of various instrument handle designs. METHODS: A systematic review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Searches of Ovid MEDLINE, Embase, CINAHL, and the Cochrane Library were performed from database inception to February 2025. Studies evaluating laparoscopic instrument handle design-including needle drivers, graspers, and electrosurgical devices-and their impact on surgeon ergonomic outcomes were included. Outcomes were grouped into 4 domains: operative performance, muscle workload and fatigue, motion efficiency, and surgeon discomfort. Study quality was assessed using the Cochrane Risk of Bias tool for randomized trials and Risk of Bias in Non-randomized Studies of Interventions for nonrandomized studies. Evidence synthesis was performed narratively owing to heterogeneity of study designs and outcomes. RECOMMENDATIONS: Twenty-three studies met the inclusion criteria. Most were simulation-based randomized crossover trials with small sample sizes and heterogeneous outcome measures. Evidence comparing laparoscopic needle driver handle designs was limited and insufficient to support the superiority of any configuration. For graspers, in-line or intermediate handle configurations may promote more neutral wrist posture and reduce forearm muscle activation compared with the pistol-grip design, although findings were inconsistent. Studies evaluating electrosurgical devices suggest that ergonomic performance may be influenced by handle geometry, activation button placement, and surgeon-specific factors such as hand size; however, no device demonstrated consistent superiority. CONCLUSION: Current evidence supporting specific laparoscopic instrument handle designs for ergonomic optimization remains limited and heterogeneous. Conventional instruments remain appropriate for routine use, whereas alternative designs may be considered in select circumstances. Further prospective clinical studies using standardized ergonomic metrics are needed to guide evidence-based instrument development and reduce musculoskeletal strain for surgeons.

43Improved usability of a new handle design for laparoscopic dissection forceps.PubMed

M A Veelen, D W Meijer, R H M Goossens, et al.
Surg Endosc. 2002 Jan;16(1):201-7. doi: 10.1007/s004640090102. Epub 2001 Nov 12.
BACKGROUND: Recent studies have shown that the shape of most instrument handles causes user discomfort and that none of the handles currently available on the market satisfies all ergonomic criteria. Therefore, we designed a handle with improved usability; i.e., it is easier to manipulate and its use entails less risk of injury for the operator. The aim of this study was to demonstrate that the intended improvements of the new design were successful. METHODS: Six handles representative of the types that are currently available were compared with the new version. Eight surgeons used the seven handles during a precision task and a rough task in a pelvi-trainer. A questionnaire and video analyses were used to assess the usability of the handles. RESULTS: Based on the responses to the questionnaire, we determined that there were significant differences between the new handle and the Aesculap handle (means of rotation and angle between handle and shaft). No significant differences were found between the new handle and the five other handles. The video analyses (documenting extreme vs neutral wrist excursions) showed significant differences between the new handle and the six other handles. CONCLUSION: Compared to the six existing handles, the new handle has significantly improved usability; in particular, its hinged design obviates the need to make extreme wrist excursions.

44An intuitive surgical handle design for robotic neurosurgery.PubMed

Emmanouil Dimitrakakis, Lukas Lindenroth, George Dwyer, et al.
Int J Comput Assist Radiol Surg. 2021 Jul;16(7):1131-1139. doi: 10.1007/s11548-021-02402-4. Epub 2021 May 24.
PURPOSE: The expanded endoscopic endonasal approach, a representative example of keyhole brain surgery, allows access to the pituitary gland and surrounding areas through the nasal and sphenoid cavities. Manipulating rigid instruments through these constrained spaces makes this approach technically challenging, and thus, a handheld robotic instrument could expand the surgeon's capabilities. In this study, we present an intuitive handle prototype for such a robotic instrument. METHODS: We have designed and fabricated a surgical instrument handle prototype that maps the surgeon's wrist directly to the robot joints. To alleviate the surgeon's wrist of any excessive strain and fatigue, the tool is mounted on the surgeon's forearm, making it parallel with the instrument's shaft. To evaluate the handle's performance and limitations, we constructed a surgical task simulator and compared our novel handle with a standard neurosurgical tool, with the tasks being performed by a consultant neurosurgeon. RESULTS: While using the proposed handle, the surgeon's average success rate was [Formula: see text], compared to [Formula: see text] when using a conventional tool. Additionally, the surgeon's body posture while using the suggested prototype was deemed acceptable by the Rapid Upper Limb Assessment ergonomic survey, while early results indicate the absence of a learning curve. CONCLUSIONS: Based on these preliminary results, the proposed handle prototype could offer an improvement over current neurosurgical tools and procedural ergonomics. By redirecting forces applied during the procedure to the forearm of the surgeon, and allowing for intuitive surgeon wrist to robot-joints movement mapping without compromising the robotic end effector's expanded workspace, we believe that this handle could prove a substantial step toward improved neurosurgical instrumentation.

45An innovative virtual reality training tool for orthognathic surgery.PubMed

Y Pulijala, M Ma, M Pears, et al.
Int J Oral Maxillofac Surg. 2018 Sep;47(9):1199-1205. doi: 10.1016/j.ijom.2018.01.005. Epub 2018 Feb 15.
Virtual reality (VR) surgery using Oculus Rift and Leap Motion devices is a multi-sensory, holistic surgical training experience. A multimedia combination including 360° videos, three-dimensional interaction, and stereoscopic videos in VR has been developed to enable trainees to experience a realistic surgery environment. The innovation allows trainees to interact with the individual components of the maxillofacial anatomy and apply surgical instruments while watching close-up stereoscopic three-dimensional videos of the surgery. In this study, a novel training tool for Le Fort I osteotomy based on immersive virtual reality (iVR) was developed and validated. Seven consultant oral and maxillofacial surgeons evaluated the application for face and content validity. Using a structured assessment process, the surgeons commented on the content of the developed training tool, its realism and usability, and the applicability of VR surgery for orthognathic surgical training. The results confirmed the clinical applicability of VR for delivering training in orthognathic surgery. Modifications were suggested to improve the user experience and interactions with the surgical instruments. This training tool is ready for testing with surgical trainees.

46Validation of the ArthroS virtual reality simulator for arthroscopic skills.PubMed

J J Stunt, G M M J Kerkhoffs, C N van Dijk, et al.
Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3436-42. doi: 10.1007/s00167-014-3101-7. Epub 2014 Jun 11.
PURPOSE: Virtual reality simulator training has become important for acquiring arthroscopic skills. A new simulator for knee arthroscopy ArthroS™ has been developed. The purpose of this study was to demonstrate face and construct validity, executed according to a protocol used previously to validate arthroscopic simulators. METHODS: Twenty-seven participants were divided into three groups having different levels of arthroscopic experience. Participants answered questions regarding general information and the outer appearance of the simulator for face validity. Construct validity was assessed with one standardized navigation task. Face validity, educational value and user friendliness were further determined by giving participants three exercises and by asking them to fill out the questionnaire. RESULTS: Construct validity was demonstrated between experts and beginners. Median task times were not significantly different for all repetitions between novices and intermediates, and between intermediates and experts. Median face validity was 8.3 for the outer appearance, 6.5 for the intra-articular joint and 4.7 for surgical instruments. Educational value and user friendliness were perceived as nonsatisfactory, especially because of the lack of tactile feedback. CONCLUSION: The ArthroS™ demonstrated construct validity between novices and experts, but did not demonstrate full face validity. Future improvements should be mainly focused on the development of tactile feedback. It is necessary that a newly presented simulator is validated to prove it actually contributes to proficiency of skills.

47Kinematic and ergonomic assessment of laparoendoscopic single-site surgical instruments during simulator training tasks.PubMed

M Susan Hallbeck, Bethany R Lowndes, Bernadette McCrory, et al.
Appl Ergon. 2017 Jul;62:118-130. doi: 10.1016/j.apergo.2017.02.003. Epub 2017 Mar 1.
While laparoendoscopic single-site surgery (LESS) appears to be feasible and safe, instrument triangulation, tissue handling, and other bimanual tasks are difficult even for experienced surgeons. Novel technologies emerged to overcome LESS' procedural and ergonomic difficulties of "tunnel vision" and "instrument clashing." Surgeon kinematics, self-reported workload and upper body discomfort were used to compare straight, bent and two articulating instruments while performing two basic surgical tasks in a LESS simulator. All instruments resulted in bilateral elevation and rotation of the shoulders, excessive forearm motion and flexion and ulnar deviation of wrists. Surgeons' adopted non-neutral upper extremity postures and performed excessive joint excursions to compensate for reduced freedom of movement at the single insertion site and to operate the instrument mechanisms. LESS' cosmetic benefits continue to impact laparoscopic surgery and by enabling performance through improved instruments, ergonomic improvement for LESS can reduce negative impact on surgeon well-being and patient safety.