Modernising trans-radial prosthetic socket creation with digital methods

据估计，全球20-25%的截肢是上肢，每2500名儿童中约有1名出生时患有上肢缺陷。尽管如此，上肢假肢，特别是接受腔的进步一直很缓慢，目前患者往往留下不满意和不可靠的设备。接受腔是假肢的重要组成部分--它必须是独特的、舒适的，并且适合截肢者的生活方式。安装插座很耗时，需要多次去专业诊所，而且往往离家很远。目前，制造插座是非常费力的，并占用了大量的临床医生的时间。肌电（电子操作）设备是上肢假肢的一个子类型，目前没有在NHS资助。为了使用肌电手，假肢接受腔必须有电极，可以检测皮肤下的神经冲动。来自神经的信号是对假手的“指令”。短期疾病和水潴留可能会导致肢体体积发生显着变化，从而导致接受腔不合适;这会导致假手的信号质量低下和不可预测的反应，从而导致截肢者完全放弃他们的设备。修复领域的多项系统综述强调了对新型接受腔设计进行更多临床验证研究的必要性。几种新颖的上肢插座设计存在，但往往只测试了他们的影响因素，他们的目的是改善，或没有测试临床上的所有.Research Objective：本研究的目的是采取一个整体的方法来创建和测试一个新的设计上肢插座。该项目的研究目标可以分为：I。使用现代制造方法来创建一个新的上肢插座，包括可调节性，肌电控制和解剖轮廓。二.与志愿者一起测试插座，以观察其对电极-主体和插座-主体界面的影响。三.使用传感器技术将反馈机制纳入接受腔，以评估和量化可调节和优化的接受腔设计对剩余肢体的影响。目标：将利用3D扫描、3D打印和现代材料设计出一种数字化的接受腔制作方法，以减少使用传统工艺（如铸造和层压）制作接受腔所需的时间和成本。将通过一系列原型设计和测试装置评估不同插座修改对控制、舒适度和患者满意度的影响。将基于各种现有的关节窝设计创建原型可调节关节窝，并在经历经桡侧肢体缺失/缺陷的志愿者中进行测试。利用志愿者的反馈，设计将被完善和调整，包括肌电控制电极。志愿者将被招募进行一项研究，将新型插座与传统插座进行比较，以显示新型设计是否改善了肌电控制的可靠性，舒适性和其他因素。在改进肌电插座后，各种传感器将作为反馈机制包括在设计中，以帮助量化新型插座对肢体的影响。

It is estimated that globally 20-25% of all amputations are upper-limb, and approximately 1 in every 2500 children are born with upper-limb deficiency. Despite this, advances in upper-limb prosthetics, in particular the socket, have been slow and currently patients are often left with unsatisfactory and unreliable devices. The socket is a crucial part of the prostheses - it must be unique, comfortable and appropriate for the amputee's lifestyle. Socket-fitting is time-consuming and requires several visits to specialised clinics, often far from home. Currently, manufacturing sockets is extremely laborious and takes up lots of clinician time.Myoelectric (electronically operated) devices are a sub-type of upper limb prostheses that are not currently funded on the NHS. To use a myoelectric hand, the prosthetic socket must have electrodes which detect nerve impulses under the skin. The signals from the nerves are the 'instructions' to the prosthetic hand. Short term illnesses and water retention can cause significant changes in limb volume and therefore poor-fitting sockets; this contributes to low-quality signals and unpredictable reactions from the prosthetic hand, which can cause amputees to abandon their devices entirely. Multiple systematic reviews of the prosthetics field have highlighted a need for more clinically validated studies into novel socket designs. Several novel upper-limb socket designs exist, but often have only been tested for their effect on the factor they were designed to improve, or not tested clinically at all.Research Aim: The aim of this research is to take a holistic approach to creating and testing a novel design of upper limb socket. The research goals of the project can be categorised to:I. Use modern manufacturing methods to create a novel upper-limb socket that includes adjustability, myoelectric control and anatomical contouring. II. Test the socket with volunteers to see its effect on the electrode-body and socket-body interfaces. III. Incorporate a feedback mechanism into the socket using sensor technology, to assess and quantify the effects on the remaining limb of having an adjustable and optimised socket design.Objectives: A digital method of creating sockets will be devised utilising 3D scanning, 3D printing and modern materials to reduce the time and cost it takes to create a socket using traditional processes such as casting and lamination. The effects of different socket modifications will be assessed for their impact on control, comfort and patient satisfaction through a series of prototype designs and test rigs. A prototype adjustable socket will be created based on various existing socket designs and tested with volunteers experiencing trans-radial limb loss/deficiency. Using the feedback from the volunteers, the design will be refined and adapted to include electrodes for myoelectric control. Volunteers will be recruited for a study to compare the novel socket against a traditional socket to show whether myoelectric control reliability, comfort and other factors are improved with the novel design. After refining the myoelectric socket, various sensors will be included in the design as a feedback mechanism to help quantify the effect the novel socket has on the limb.