Development of an ABO Incompatibility Stop Device (AISD)

描述（由申请人提供）：这是一项标题为“ABO血型不合终止装置的开发”（以下简称AISD）的1期STTR申请，旨在防止错误输血。错误输血是一个术语，通常用于描述“错误的患者接受错误的血液”的情况，发生错误输血的原因有多种，包括在最初的血型样本采集过程中对预期受血者的识别不当，血库中血液成分或受血者的血型或输血前检测不当，或者在开始输血时对患者受体和/或血液单元的错误识别。错误输血被大多数权威机构认为是输血相关死亡的主要原因，据报道，在美国，估计发生率接近1/14，000单位。存在许多被认为能够减少错误输血的技术，包括患者和血液单元标识符的条形码、射频识别（RFID）、需要特殊床边代码的组合锁定袋，以及允许操作员重新确定患者血型并将患者血型与血液单元标签匹配的床边ABO测试。到目前为止，这些方法中没有一种得到了适度的实施，并且这些方法中的每一种都涉及人类的行为，解释或决策，因此允许人为错误。因此，人为错误是导致输血相关死亡的首要原因。在本申请中，我们描述了新型全自动床边医疗设备AISD，其能够：1）执行床边兼容性测试，以及2）防止误输血事件。该第1阶段申请以概念验证格式提供，并提供初步数据，以支持此类器械的概念和申报的AISD设计都是可行的。第一阶段的总体目标体现在一个具体目标中：设计、测试和设计一个由4个元件组成的台式原型AISD：红细胞排除过滤器（REF）、相容性反应室（CRC）、不相容性检测器（ID）和停止元件（SE）。将对构成AISD基本单元的这4个元件中的每一个进行设计、制造、测试和优化。随后将建立一个工作台原型，可以在各种临床相关情况下进行测试（即，相容的输血组合[O至A]和不相容的[A至O]组合），以验证功能和原理证明。公共卫生相关性：虽然输血是挽救生命的干预措施，但有时不相容的血液被错误地输入，这可能导致死亡。事实上，这是输血的1号并发症。已经尝试了许多方法来改善这个问题，包括更好地培训人员和条形码识别病人，但没有一个奏效。在此应用中，我们提出了一种全自动设备，该设备将对患者/受体和供体血液单元进行采样，并在没有人工帮助的情况下证明兼容性。如果装置不兼容，则不允许进行输血。这应该可以阻止所有的输血错误和相关的死亡。

DESCRIPTION (provided by applicant): This is a Phase 1 STTR application entitled "Development of an ABO Incompatibility Stop Device" (hereafter AISD) to prevent mistransfusion. Mistransfusion, a term generally used to describe an episode where "the wrong patient receives the wrong blood", occurs for a variety of reasons including improper identification of the intended recipient during initial sample collection for blood typing, improper typing or pretransfusion testing of the blood component or recipient in the blood bank, or misidentification of the patient recipient and/or the blood unit at the time of initiation of the blood transfusion. Mistransfusion, considered by most authorities to be the leading cause of transfusion-related mortality, has a reported estimated incidence approaching 1 in 14,000 units in the United States. A number of technologies exist that are thought to be able to reduce mistransfusion including bar-coding of patient and blood unit identifiers, radio frequency identification (RFID), combination locked pouches that require a special bedside code, and bedside ABO tests that would allow an operator to retype the patient and match the patient blood type with the blood unit label. None of these methods has enjoyed even modest implementation to date, and each of these methods involves human actions, interpretation, or decision, thus allowing human error. It is human error, then, that leads to the #1 cause of transfusion-associated death. In this application, we describe novel fully automated, bedside medical device, the AISD, capable of: 1) performing a bedside compatibility test, and 2) preventing a mistransfusion event. This Phase 1 application is offered in a proof of concept format with preliminary data to support that both the concept of such a device and the proposed AISD design are feasible. The overall goal of Phase I is represented in a single Specific Aim: To design, test, and engineer a bench top prototype AISD consisting of 4 elements: the Red cell Exclusion Filter (REF), Compatibility Reaction Chamber (CRC), Incompatibility Detector (ID), and Stop Element (SE). Each of these 4 elements which constitute the AISD base unit will be designed, fabricated, tested, and optimized. This will be followed by building a working, bench top prototype that can be tested in a variety of clinically relevant circumstances (i.e., compatible transfusion combinations [O to A] and incompatible [A to O] combinations) in order to validate function and proof of principle. PUBLIC HEALTH RELEVANCE: While blood transfusions are life-saving interventions, sometimes incompatible blood is transfused in error and this can lead to death. In fact, this is the #1 complication of blood transfusion. A number of methods have been tried to improve this problem including better training of personnel and barcode identification of patients, but none has worked. In this application, we present a fully automated device that will sample the patient/recipient and the donor blood unit and prove compatibility without human assistance. If the unit is not compatible, the transfusion is not allowed to proceed. This should stop all mistransfusion and the related deaths.