Background: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. Objective: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. Methods: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for ‘surgical device design in low resource settings’ and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. Results: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. Conclusions: Using a context-specif...

中文翻译：

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一种对负载和输入功率不敏感的微波功率传输谐波抑制能量收集超表面


背景：全世界有超过 50 亿人无法接受手术，尤其是在资源匮乏的环境中，尽管手术是主要的挽救生命的治疗方法。无注气腹腔镜手术 (GILLS) 可以通过将现有的 GILLS 仪器改进至现代手术标准来解决这种不平等问题。目的：开发一种新型腹部无注气手术牵开器 (RAIS) 并将其投入临床使用，从而为推进 GILLS 手术提供一个适合环境的系统。方法：成立了来自英国和印度的多学科协作团队，让当地临床利益相关者和行业合作伙伴参与定义用户和背景需求。系统开发基于“资源匮乏环境下的手术设备设计”的分阶段路线图，以及在传统医疗设备设计方法支持的迭代过程中嵌入的参与性和节俭的设计原则。利益相关者团队通过使用尸体手术​​模拟的互动研讨会对每个开发阶段进行了评估。商业化阶段进行了从设计到制造和监管审批活动。然后，乡村外科医生使用 RAIS 系统执行 GILLS 手术进行了临床验证。使用半结构化问卷和访谈来评估设备性能。结果：定义并形式化了一组用户需求和上下文要求。系统开发经历了五次迭代。利益相关者的参与有助于达成满足用户需求的设计。随后，行业合作伙伴在印度监管机构的批准下生产了商业 RAIS 系统。 该技术已成功用于临床验证，在印度农村的两个地点进行了 12 次外科手术。手术反馈表明，RAIS 系统提供了一种有价值且可用的手术器械，适合在资源匮乏的情况下使用。结论：使用特定于上下文的...