Low Cost Modular Tissue Microarray Instrument

描述(申请人提供：第一阶段研究的目标是设计和制造一种低成本的组织微阵列(TMA)设备，以满足市场对高质量、快速TMA构建的需求。为此，Micatu Inc.成功开发了可用于生产的TMA设备和套件(MicaArray)，该设备成功地展示了H&E染色TMA，其特点是90%的样品芯与接收块对齐，95%的样品芯垂直放置，以及100%符合要求的TMA切片计数。Micatu的第二阶段开发计划将在这些成功和快速进展的基础上继续下去，以提供负担得起的交钥匙仪器套件，进一步扩大调查人员构建其 拥有TMA而无需求助于昂贵的核心实验室设施，并允许高效、可靠和低成本地建造TMA，以便在研究和临床环境中验证和使用。这将促进病理学、组织学、免疫组织化学控制和癌症诊断等领域的应用激增，具有重大的医学影响。MicaArray的愿景代表了一个简单但强大的概念，它基于无缝集成、精密制造和构建TMA的工具的优化。第二阶段的研究计划将改进以高精度间隔登记和引导取芯针的新型对准模板，设计和制造一种新颖、符合人体工程学和多功能的取心和注射针，带有螺纹针系统，允许单个手柄同时提取供体块芯和注入受体块，通过设计验证测试证明使用可加工或注塑塑料的MicaArray器件的低成本坚固结构，用于批量生产和制造，提供用于铸造TMA块的定制低成本模具，设计、建造和安装集成热电冷却器(TEC)/加热器，可以直接加热和冷却供体和受体块，从而提供一种新的、强大的、并且到目前为止，还没有能力以电子方式控制和设计对石蜡和冷冻(冷冻)嵌入TMA结构都是最佳的热循环序列，并以比任何商业可获得的仪器低30倍的销售价格将MicaArray试剂盒商业化。识别研究或技术的关键词：组织、微阵列、染色、石蜡、冷冻、受体块、供体块、模板、取心针、TMA研究的潜在商业应用概述：Micatu，Inc.研究计划为学术、临床和研究市场提供商业化潜力

DESCRIPTION (provided by applicant: The objective for the Phase I study was to design and build a low cost Tissue Microarray (TMA) device that would meet market demands for high quality, fast TMA construction. To that end Micatu Inc. has successfully developed a production ready TMA device and kit (MicaArray) that has successfully demonstrated H&E stained TMAs featuring 90% alignment of sample cores to the recipient block, 95% sample core perpendicular placement, and 100% compliance to required TMA sectioning count. Micatu's Phase II development program will continue on these successes and rapid progress to provide an affordable, turnkey instrument suite that further expands investigators' ability to construct their own TMAs without resorting to expensive core laboratory facilities as well as allow for the efficient, reliable, and low cost construction of TMAs for validation and use in research and clinical settings. This will foster a proliferation of applications in fields such as pathology, histology, IHC controls, and cancer diagnosis, having major medical impact. The MicaArray vision represents a simple, yet powerful concept based on seamless integration, precision fabrication, and optimization of tools for constructing TMAs. The Phase II research plan will refine the novel alignment template that registers and guides the coring needle at highly precise intervals, design and build a novel, ergonomic, and versatile coring and injection needle with a threaded needle system that allows for a single handle for both extraction of the donor block cores and injection into recipient block, prove out with design verification testing a low cost rugged construction of the MicaArray device using machinable or injection molded plastic for volume production and manufacturability, provide a custom low cost mold for casting TMA blocks, design build and install an integrated Thermoelectric Cooler (TEC)/Heater that can directly heat and cool donor and recipient blocks thereby providing a new, powerful, and heretofore unavailable capability to electronically control and devise thermal cycling sequences that are optimum for both paraffin and cryo (frozen) embedded TMA construction, and commercialize the MicaArray kit at a sales price that is 30x less than any commercially available instrument. Key words to identify the research or technology: Tissue, microarray, staining, paraffin, cryo, recipient block, donor block, template, Coring Needle, TMA Brief summary of the potential commercial applications of the research: Micatu, Inc. research plan provides commercialization potential to the academic, clinical and research markets