PATIENT INTERFACE FOR CONTINUOUS POSITIVE AIRWAY PRESSUR

描述：（申请人摘要中的逐字记录）阻塞性睡眠呼吸暂停 (OSA)影响了1200万人它是由频繁关闭鞋面造成的 呼吸道阻塞夜间呼吸。鼻持续 气道正压通气（N-CPAP）是最有效的OSA治疗方法;它打开 通过在鼻罩中产生正压来控制呼吸道。虽然治疗 是有效的，相对简单的诊断研究， 开它（CPAP滴定）仍然不方便和昂贵。CPAP滴定 研究在医院过夜进行，费用昂贵。医院 也过于拥挤，不熟悉的环境导致许多患者失去 睡眠，从而防止准确的压力滴定。这种方法不鼓励 这是一个很大的问题，也是造成不成比例的低人数的部分原因。 接受治疗的OSA患者（估计1200万人中的100万人）。的 家庭是一个更自然的环境，在解决 现有患者需求。这是更方便和成本效益，但目前 移动式装置不适合于家庭内CPAP滴定。他们依靠 传统的患者接口不可靠，并产生信号质量 这通常会受到患者移动的影响。这使患者不愿 使用和医生从处方在家里的研究。第一阶段将展示 利用小型化无线通信的新型患者接口的可行性 压力和气流传感器嵌入在面罩中， 生物电位数据（EEG，EKG，.）一个小型生物放大器了建设一 一个原型的建议接口，并比较它与传统的 接近。第二阶段将开发商业化的患者界面和 具有调制解调器功能的记录单元，用于在线远程监控 家和诊所。 拟定商业应用： 这种设备有巨大的潜在市场。 在估计的1200万人中， 只有100万患者患有OSA，这使得巨大的需求得不到满足。的 拟议的设备将通过允许患者在家中进行诊断来扩展治疗;因此， 帮助提高呼吸系统产品的总销售额，如口罩、监测器等。等睡眠 呼吸设备市场的呼吸暂停产品部分收入为122美元 1996年，亿。 拟议设备的商业潜力不仅限于家庭使用 但新的患者界面也可以使传统的实验室研究受益， 患者移动性，而不会影响数据完整性。

DESCRIPTION: (Verbatim from the Applicant's Abstract) Obstructive Sleep Apnea (OSA) affects 12 million people. It is caused by frequent closure of the upper respiratory airway obstructing breathing during the night. Nasal Continuous Positive Airway Pressure (N-CPAP) is the most effective OSA treatment; it opens the airways by creating positive pressure in a nasal mask. Although treatment is efficacious and relatively straight-forward the diagnostic study to prescribe it (CPAP titration) remains inconvenient and costly. CPAP titration studies are conducted overnight in the hospital, which is expensive. Hospitals are also overcrowded, and the unfamiliar setting causes many patients to lose sleep thus preventing accurate pressure titration. This approach discourages enlisting, and is partly responsible for the disproportionately low numbers of OSA patients who are treated (1 million out of the estimated 12 million). The home is a more natural setting and holds great potential in addressing the existing patient demand. It is more convenient and cost effective but current ambulatory devices are unsuited for in-home CPAP titration. They rely on traditional patient interfaces that are unreliable and generate signal quality that is often compromized by patient movement. This discourages patients from using and physicians from prescribing in-home studies. Phase I will demonstrate feasibility of a novel patient interface that utilizes miniaturized wireless pressure and airflow sensors embedded in the mask, and wireless transmission of biopotential data (EEG, EKG,.) with a compact Bio-amplifier. We will construct a prototype of the proposed interface and compare it with conventional approaches. Phase II will develop the commercial patient interface and a recording unit with modem capability for on-line remote monitoring between the home and the clinic. PROPOSED COMMERCIAL APPLICATION: There is a huge potential market for this device. Out of the estimated 12 million people who suffer from OSA only 1 million patients are treated leaving a huge demand that is unmet. The proposed device will expand treatment by allowing patients to be diagnosed at home; thus help raise total sales of respiratory products such as masks, monitors, .. etc. The sleep apnea products segment of the respiratory devices market posted revenues of $122 million in 1996. The commercial potential for the proposed device is not only for home use but the new patient interface can also benefit traditional in-lab studies because it improves patient mobility without compromising data integrity.