KeyScope: The Key to Sustainable Cancer Diagnosis and Treatment in Uganda

摘要 腹腔镜手术是高收入国家许多胸部癌症手术的标准治疗方法 和腹部腹腔镜手术通过使用微型摄像机和精密仪器避免了大切口 通过钥匙孔切口进行操作，但在低收入和中等收入国家通常无法获得 （中低收入国家）由于安装费用高、缺乏合格的维修人员、电力不可靠 以及消耗品短缺。LMIC患者将受益于腹腔镜手术，因为 优点包括：减少疼痛，改善恢复时间，减少伤口感染，缩短住院时间 留下来腹腔镜手术将减少恢复时间，使患者能够返回家中并更多地工作 快速，从而减少了浪费的医疗支出。 KeyScope和KeyLoop（统称为KeySuite）是我们拥有的腹腔镜原型， 为中低收入国家的资源、需求和挑战而设计。KeyScope是一种腹腔镜， 制造成本为150美元（商品成本），插入笔记本电脑，在手术过程中显示图像， 无需复杂的组装，可通过浸入Cidex进行灭菌。它连接到一个远程指导 在能力建设伙伴关系中，经验丰富的外科医生可以指导外科医生。KeyLoop是一个 一种腹腔镜牵开器，在手术过程中提升腹壁，避免了对恒定功率的需求 供应和医用级二氧化碳。这将使腹腔镜手术能够在农村地区进行， 医院，大多数患者居住在LMIC，并增加三级中心的使用， 设备稀少且昂贵。我们描述了外科医生之间的多学科合作， 工程师、肿瘤学家、律师、全球健康专家和企业高管， 进入下一阶段 我们将在乌干达癌症研究所进行临床首次人体研究。乌干达外科医生将使用 KeySuite设备用于对腹腔内肿瘤进行活检。主要结果将是执行 腹腔镜下活检，无需转为开放手术。次要结局包括：1）器械 可行性和安全性数据以及2）患者满意度。 我们将证明，KeySuite设备可以在乌干达建造，通过公爵MUK航运 容器制造商空间。我们将创建物料清单、制造工艺说明、培训视频， 和质量控制措施。一旦我们达到了卓越的施工质量，我们将把这个 乌干达工业研究所（UIRI）将把KeySuite转变为一种产品， 商业化使用世界卫生组织良好生产规范（GMP），我们将建立质量保证 KeyScope和KeyLoop的可持续本地制造和监管批准协议， 乌干达国家药品管理局和CE标志。

Abstract Laparoscopic surgery is the standard of care in high-income countries for many cancer operations in the chest and abdomen. Laparoscopic surgery avoids large incisions by using a tiny camera and fine instruments manipulated through keyhole incisions, but it is generally unavailable in low- and middle-income countries (LMICs) due to high cost of installment, lack of qualified maintenance personnel, unreliable electricity and shortage of consumable items. Patients in LMICs would benefit from laparoscopic surgery, as advantages include: decreased pain, improved recovery time, fewer wound infections, and shorter hospital stays. Laparoscopic surgery would reduce recovery time, enabling patients to return to home and work more quickly, thereby mitigating impoverishing health expenditure. KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that we have designed for the resources, needs and challenges of LMICs. KeyScope is a laparoscope that can be made for $150 (cost of goods), plugs into a laptop computer to display images during surgery, exists as a single unit without complicated assembly and is sterilizable by immersion in Cidex. It links to a tele-mentoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide. This would enable laparoscopic surgery to be performed in rural hospitals, where most patients live in LMICs, and increase access in tertiary centers where laparoscopic equipment is rare and expensive. We describe a multi-disciplinary collaboration between surgeons, engineers, oncologists, attorneys, global health experts and business executives to take this technology to the next stage. We will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors. Primary outcome will be the ability to perform biopsies laparoscopically without conversion to open surgery. Secondary outcomes include: 1) device feasibility and safety data and 2) patient satisfaction. We will demonstrate that KeySuite devices can be constructed in Uganda, through the Duke-MUK Shipping Container Makerspace. We will create a bill of materials, manufacturing process instructions, training videos, and measures of quality control. Once we have achieved exceptional construction quality, we will transfer this work to the Uganda Industrial Research Institute (UIRI) which will move the KeySuite to a product for commercialization. Using the WHO Good Manufacturing Practices (GMP) we will establish quality assurance protocols for sustainable local manufacturing and regulatory approval of the KeyScope and KeyLoop through the Uganda National Drug Authority and CE mark.