Low-Cost, Single-Use Trans-Nasal Cryotherapy Device for Low-Resource Settings

项目摘要/摘要 食道癌是一种侵袭性疾病，五年存活率低于20%。的发病率。 这种癌症在过去的50年里急剧增加，预计至少在 2030年。慢性酸反流导致食道衬里改变和Barrett病的发生 一些患者的食道。患有巴雷特食道(BE)的患者患食管炎的风险增加50倍 与普通人群相比，罹患癌症的人数更多。 在过去的二十年里，出现了几种内窥镜消融方法来治疗或预防食道 癌症。目前所有的消融技术仅限于在医院环境中使用。病人必须服用镇静剂 同时内窥镜在消融装置交付之前通过口腔。经济负担 除了最晚期的癌前疾病和癌症，大多数治疗方法都是令人望而却步的。不便之处， 缺乏当地提供者和痛苦也是更广泛接受的障碍，特别是在低收入和中等收入国家 国家(LMIC)。与非洲黑人相比，非洲黑人的食道癌发病率高出两到三倍 给他们的白人同行。 最近，已经开发了多种新的诊断模式。这些选项中有几个未服用镇静剂 和办公室，这可能会识别更多的患者，因为大多数人的身份都是不明的。 因此，至关重要的是开发新的疗法，消除诸如需要镇静等障碍， 医院通道，昂贵的内窥镜和消融系统，以及需要重新处理和维修设备。 CryoScope Medical的专利一次性消融设备是第一个也是唯一一个允许医生 经鼻腔进入食道，实现未经镇静的冷冻消融。冷冻消融的独特之处在于 与无线电相比，治疗对组织具有止痛作用，并减少了对术后麻醉药物的依赖 射频消融(RFA)。冷冻消融术是FDA批准的食道消融术。将循环消融与 经鼻内窥镜将在一种低成本、紧凑的设备中提供先进的治疗方法，从而使这种疗法 数以百万计的人在资源匮乏的情况下可以获得。 在这个项目中，将使用初步的设备开发来开发我们的完整功能原型 新型鼻腔冷冻治疗仪。我们的方法包括利用经过验证的计算模型和 3D打印可在关键竞争约束内快速迭代和收敛至最佳设计。该项目 包括通过台式测试和医生评估研究进行验证。具体地说，行业领先 内窥镜医生将收到该设备的原型，以进行模拟程序来评估设备的性能。 基于医生评估研究的迭代开发将指导对原型的进一步改进。 最终，作为这一项目的结果，第一个用于低资源环境的冷冻消融设备将是 针对稳健的成功标准进行设计和验证，以降低全球食道癌发病率。

PROJECT SUMMARY/ABSTRACT Esophageal cancer is an aggressive disease with a five-year survival rate below 20 percent. The incidence of this cancer has increased dramatically over the last 50 years and is projected to continue increasing at least until 2030. Chronic acid reflux leads to changes in the lining of the esophagus and the development of Barrett’s Esophagus in some patients. Patients with Barrett’s esophagus (BE) have a 50-fold increase in their risk of developing cancer compared to the general population. Over the last two decades, several endoscopic ablation methods have emerged to treat or prevent esophageal cancer. All current ablation technologies are limited to use in the hospital setting. Patients must be sedated while an endoscope is passed through the mouth before the ablation device is delivered. The economic burden of therapy can be prohibitive for all but the most advanced pre-cancerous conditions and cancer. Inconvenience, lack of local providers, and pain are also barriers to wider acceptance, especially in low- and middle-income countries (LMICs). The incidence of esophageal cancer is two to three times higher in black Africans compared to their white counterparts. More recently, multiple new diagnostic modalities have been developed. Several of these options are unsedated and office-based, which will likely identify many more patients since most people with BE go unidentified. Accordingly, it is critical to develop new therapies which would eliminate barriers such as the need for sedation, hospital access, costly endoscopy and ablation systems, and the need to reprocess and repair equipment. CryoScope Medical’s patented single-use ablation device is the first and only device that allows the physician to trans-nasally pass into the esophagus, enabling unsedated cryoablation. Cryoablation is unique in that the therapy has an analgesic effect on tissues and reduces reliance on narcotics post-procedure, compared to Radio Frequency Ablation (RFA). Cryoablation is FDA-approved for esophageal ablation. Combining cyroablation with trans-nasal endoscopy will provide advanced treatment in a low-cost, compact device that will make this therapy accessible to millions of people in low-resource settings. In this project, preliminary device development will be used to develop a complete functional prototype of our novel trans-nasal cryotherapy device. Our approach includes leveraging a validated computational model and 3D printing to rapidly iterate and converge on an optimal design within the key competing constraints. The project involves verification by benchtop testing as well as a physician evaluation study. Specifically, industry-leading endoscopists will receive a prototype of the device to conduct a mock procedure to assess device performance. Iterative development based on the physician evaluation study will guide further improvements to the prototype. Ultimately, as a result of this project, a first-of-its-kind cryoablation device for low-resource settings will be designed and validated against robust success criteria to mitigate the global incidence of esophageal cancer.