OrthoAdjust - Shoulder Balancer

**未满足的需求**：与膝关节和髋关节置换术相比，肩关节置换术（SA）在优化植入物坐位和软组织平衡方面是一项具有挑战性的手术。关节盂内不良的假体坐位使假体容易变形，微运动增加了松动的风险。因此，在肩部肌肉中预先设定正确的被动张力与实现最佳定位和固定肩关节部件同样重要。目前，关节盂试验期间的软组织张力和被动活动范围（ROM）是通过使用可互换的垫片来调整试验的高度来手动评估的，这是一项劳动密集型的工作，并且依赖于外科医生的经验。**我们的解决方案：**OrthoAdjust使用微型电磁螺杆式螺丝可调机构（<4mm高），自动调整关节盂试验表面的高度，俯角和滚动，证明比手动垫片更好地控制植入物位置。OrthoAdjust同时测量肩关节力，使用传感器连接到嵌入外帽的悬臂，帮助患者实现无限制的无痛活动。**方法：**OrthoAdjust是基于一个微型“带扳手”的原理，使用一对通电的微型螺线管，棘轮在来回振荡动作中旋转，以拧紧或松开螺纹螺钉。反过来，轮子驱动丝杠“腿”通过一个孔转换成线性驱动。三对执行器创建一个稳定的三脚架，用于调整表面的俯仰和滚动。**项目团队：**汇集了一家大公司（Smith+Nephew）和一家小公司（Marturion-Electronics），他们在医疗设备、低功耗电路和微致动器方面具有综合专业知识。**主要目标/重点**：将OrthoAdjust从有线实验室演示器（TRL-4）发展为在肩部尸体上测试的无线设备（TRL-6/7），该设备可以作为独立的术中软组织平衡器或更复杂的机器人辅助手术的辅助设备销售。**针对性改进：***微螺线管（绕组/直径/电流）*棘轮（直径）*丝杆（尺寸/节距）*最佳摩擦力；“拉”和“复位”模式，*试用规模/可扩展性；超小型，小型，中型，大型，*车载电源/数据管理。

**Unmet Need**:Shoulder arthroplasty (SA) is a challenging procedure to perform, compared to knee and hip arthroplasties, in terms of optimizing implant seating and soft tissue balancing. Poor implant component seating in the glenoid predisposes the implant to deformation, and micromotion increasing the risk of loosening. Consequently, pre-setting the correct passive tension in the shoulder muscles is as important as achieving optimum orientation and fixation of the glenoid components. Currently, soft tissue tension and passive range-of-motion (ROM) during glenoid trialing are assessed manually using interchangeable shims to adjust the height of the trial, which is labour-intensive, and dependent upon surgeon experience.**Our Solution:**OrthoAdjust uses a micro-solenoid ratcheting screw adjustable mechanism (<4mm high) that automatically adjusts the height, pitch and roll of the glenoid trial surface proving finer control of implant position than manual shims. OrthoAdjust simultaneously measures glenohumeral forces using sensors attached to cantilevers embedded in the outer cap, which help patient achieve unrestricted pain-free mobility.**Approach:**OrthoAdjust is based upon the principle of a miniature "strap-wrench" using a pair of energized micro-solenoids that ratchet a wheel to rotate in a back-and-forth oscillatory action to either tighten or loosen a threaded screw. In turn, the wheel drives a leadscrew "leg" through a hole converting rotary into linear actuation. Three pairs of actuators create a stable tripod for adjusting the pitch and roll of the surface.**Project team:**brings together a large (Smith+Nephew) and a small company (Marturion-Electronics) with combined expertise in medical devices, low-powered circuits and micro-actuators.**Key Objectives/Focus**:Development of OrthoAdjust from a wired lab-demonstrator(TRL-4) to a wireless device tested on shoulder cadavers(TRL-6/7), which can be marketed as either a standalone intra-operative soft-tissue balancer or an adjunct for more complex robot-assisted procedures.**Targeted Improvements:*** Micro-solenoid (windings/diameter/current)* Ratchet wheel (diameter)* Lead screw (size/pitch)* Optimum frictional forces;"pull" and "reset" mode,* Trial size/scalability;extra-small,small,medium,large,* On-board power/data management.