Smart Seal Ostomy Appliance

描述（由申请人提供）：Korosensor.com, Inc. （Kl）提出开发一种可穿戴式造口器械设备，该设备具有新颖的内置聚合物厚膜（PTF）传感器系统，该系统可提醒造口用户由于密封破坏和熔化而产生的潜在泄漏问题。识别由于无效密封导致的泄漏问题的能力可以减少口周皮肤破裂。每年进行的造口手术超过100万例。接受造口手术的患者需要密集的身体和精神护理才能恢复正常生活。迫切需要为结肠造口、回肠造口和泌尿造口患者提供有效的皮肤屏障，实现有效的器械密封对造口患者的身体和情感健康以及功能能力至关重要。皮肤问题、皮肤轮廓、造口结构问题和眼袋泄漏等关键因素导致供应品使用量增加、成本增加、住院、医疗护理、家庭健康就诊和手术翻修率增加。无效的密封会给造口病人带来痛苦的循环。渗漏会导致皮肤破裂，皮肤破裂又会导致更多的渗漏，如此循环往复。拟议的第二阶段项目将专注于开发一个10.0 mil的电化学传感器阵列，该传感器阵列可以通过“传感器-磁带”制造制造，提供一种低成本的一次性产品，具有轻质保形贴合的特点。身体佩戴的造口器适应身体轮廓的变化，促进患者的自我保健和健康。智能密封装置结合了创新的生物报警功能，通知造口患者潜在的泄漏，采取纠正措施。

DESCRIPTION (provided by applicant): Korosensor.com, Inc. (Kl) proposes to develop a wearable ostomy appliance device with a novel built-in polymer-thick-film (PTF) sensor system that alerts the ostomy user of potential leakage problems due to seal undermining and meltdown. The ability to identify leakage problems due to an ineffective seal could reduce peristomal skin breakdown. Over 1 million ostomy surgeries are performed each year. Patients undergoing ostomy surgery need intensive physical and emotional care to return to a normal life. The pressing need to provide effective skin barriers for colostomy, ileostomy and urostomy patients, achieving an effective appliance seal is critical to physical and emotional well-being as well as functional abilities of an individual with ostomies. Key factors of skin problems, skin contour, stoma construction problems and pouch leakage lead to increased supply usage, increased costs, increased hospitalizations, medical care, home health visits, and surgery revision. An ineffective seal leads to a cycle of misery for the ostomy patient. Leakage causes skin breakdown, which causes further leakage, thus perpetuating the cycle. The proposed Phase II project will focus on the development of a 10.0 mil electrochemical sensor array that can be fabricated with "sensor-on-tape" manufacturing, offering a low-cost disposable product that features a lightweight conformal fit. The body-worn ostomy appliance adapts to body contour changes, which promotes patient self-care and wellness. The smart seal device incorporates an innovative bio-alerting function to inform the ostomy patient of potential leakage to take corrective action.