Smart Seal Ostomy Appliance

描述(由申请人提供)：Korosensor.com，Inc.(KL)建议开发一种可穿戴的造口器械设备，该设备具有新型内置聚合物厚膜(PTF)传感器系统，可提醒造口用户由于密封破坏和熔化而可能出现的泄漏问题。能够识别由于密封无效造成的泄漏问题，可以减少口周皮肤破裂。每年有100多万例造口手术。接受造口手术的患者需要密集的身体和情感护理才能恢复正常生活。迫切需要为结肠造口、回肠造口和尿路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心理健康以及功能能力至关重要。皮肤问题、皮肤轮廓、造口问题和邮袋渗漏的关键因素导致用品使用量增加、成本增加、住院人数增加、医疗保健、家庭健康访问和手术修改。无效的封口会导致造口病人的痛苦循环。渗漏会导致皮肤破裂，从而导致进一步的渗漏，从而使循环永久化。拟议的第二阶段项目将专注于开发一种1000万微米的电化学传感器阵列，该阵列可以通过“带上传感器”制造来制造，提供一种具有轻型保形贴合的低成本一次性产品。该穿戴式造口器械能够适应身体轮廓的变化，促进患者的自我护理和健康。智能密封装置结合了创新的生物警报功能，以通知造口患者可能发生的渗漏，以采取纠正措施。

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.