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1. 发明申请

WO1997044672A1 PORTABLE MODULAR BLOOD ANALYZER WITH SIMPLIFIED FLUID HANDLING SEQUENCE 审中-公开
标题翻译：便携式模块化血液分析仪，具有简化的流体处理顺序
公开(公告)号：WO1997044672A1
公开(公告)日：1997-11-27
申请号：PCT/US1997008737
申请日：1997-05-20
申请人： SENDX MEDICAL, INC.
发明人： SENDX MEDICAL, INC. , SAVAGE, Douglas, R. , LAWRENCE, Ronald, L.
IPC分类号： G01N35/10
CPC分类号： G01N33/4925 , G01N2035/00326 , Y10T436/11 , Y10T436/2575
摘要： A portable, modular blood analyzer capable of analyzing multiple blood values in an inexpensive, relatively simple, easy-to-use and easy-to-maintain instrument. The invention comprises a three-part system including an analyzer body (10), calibrant cartridge (14), and sensor cartridge (12). A modular calibrant cartridge (14) is insertable into the analyzer body (10), and contains all necessary calibrant fluids as well as a waste container. A modular sensor cartridge (12) having integral pump tubing (16) plugs into the analyzer body (10) for easy removal and replacement of the sensor elements. The analyzer body (10) internally has modular units including an electronics module, a display module, and a fluidics/printer module. The analyzer uses a single pump head (18) to aspirate blood only to a sensor array within the sensor cartridge (12). This action is accomplished by aspirating blood by rotationg a peristaltic pump (18) in one direction during a first portion of an analysis cycle, and by reversing the pump (18) and flushing the blood from the sensor cartridge (12) with fluid pumped from the opposite direction during a second portion of an analysis cycle. Accordingly, blood contacts only a small portion of the analyzer mechanism, most of which is disposable. Because all valves are "downstream" from the single pump, no blood products pass through any valves. The analyzer fluid handling section is easily cleaned by removal of the sensor cartridge (12), yielding a single tube pathway. A short path length for blood travel permits using blood samples as small as 200 mu l. The analyzer is light and modular in design and is fully automatic.
摘要翻译：便携式，模块化的血液分析仪，能够在廉价，相对简单，易于使用和易于维护的仪器中分析多种血液值。本发明包括三部分系统，包括分析器体（10），校准器盒（14）和传感器盒（12）。模块化的校准盒（14）可插入分析器主体（10）中，并且包含所有必需的校准液和废物容器。具有整体泵管（16）的模块化传感器盒（12）插入分析器主体（10）中，以便于移除和更换传感器元件。分析器主体（10）内部具有包括电子模块，显示模块和流体/打印机模块的模块化单元。分析仪使用单个泵头（18）仅将血液吸入传感器盒（12）内的传感器阵列。该作用是通过在分析循环的第一部分期间沿一个方向旋转蠕动泵（18）来抽吸血液而实现的，并且通过使泵（18）反向并且从所述传感器盒（12）中泵送的液体在分析周期的第二部分期间的相反方向。因此，血液仅接触分析器机构的一小部分，其大部分是一次性的。因为所有的阀都是从单个泵的“下游”，所以没有血液制品通过任何阀门。分析器流体处理部分通过移除传感器盒（12）容易地清洁，产生单个管道。血液行程短路径允许使用少于200微升的血液样本。分析仪设计轻巧，模块化，全自动。

2. 发明申请

WO1997043639A1 LOCKING SENSOR CARTRIDGE WITH INTEGRAL FLUID PORTS, ELECTRICAL CONNECTIONS, AND PUMP TUBE 审中-公开
标题翻译：带有整体流体管道，电气连接和泵管的锁定传感器盒
公开(公告)号：WO1997043639A1
公开(公告)日：1997-11-20
申请号：PCT/US1997007731
申请日：1997-05-06
申请人： SENDX MEDICAL, INC. , SAVAGE, Douglas, R. , BARKER, John, M.
发明人： SENDX MEDICAL, INC.
IPC分类号： G01N33/483
CPC分类号： G01N33/4915
摘要： The present invention is a sensor cartridge (100) into which sensors are installed. The sensor cartridge (100) allows the sensors to be easily and reliably installed into a blood analyzer. The sensor assembly (400) has an electrical connector (1205) mounted on the rear side of the assembly (400). A plurality of inner walls (122) within the housing locate a pump tube assembly (106) and right angle fluid coupling (108) within the housing. An opening in the housing receives a first boss (208) which extends from the blood analyzer. A capture/release arm has an opening through which the first boss protrudes. The arm is resiliently held in place such than an inner edge of the opening is captured within a ring-like groove (210) in the boss that extends from the blood analyzer when the cartridge is installed in the blood analyzer. A portion of the arm extends beyond the housing to allow an operator to press the arm and thus release the edge of the arm from the groove in the boss. Electrical contacts of the connector on the rear side of the sensor assembly are aligned to mating electrical contacts of the blood analyzer as the sensor assembly is being installed by alignment of the boss which extends from the blood analyzer to mate with the boss which extends from the housing, and alignment of two male fluid connectors. Accordingly, the electrical contacts of the sensor assembly will be in close alignment with the electrical contacts of the blood analyzer as the contacts approach one another.
摘要翻译：本发明是安装传感器的传感器盒（100）。传感器盒（100）允许将传感器容易且可靠地安装到血液分析器中。传感器组件（400）具有安装在组件（400）的后侧上的电连接器（1205）。壳体内的多个内壁（122）将壳体内的泵管组件（106）和直角流体联接器（108）定位。壳体中的开口接收从血液分析仪延伸的第一凸台（208）。捕获/释放臂具有第一凸起凸出的开口。臂被弹性地保持在适当位置，例如，当将盒安装在血液分析器中时，开口的内边缘被捕获在凸起部中的环形凹槽（210）中，该凹槽从血液分析器延伸。臂的一部分延伸超过壳体，以允许操作者按压臂，从而将臂的边缘从凸台中的凹槽释放。传感器组件后侧的连接器的电触点与血液分析仪的配合电触点对准，因为传感器组件通过从血液分析仪延伸的凸起的对准被安装，从而与从凸起延伸的凸起相配合外壳和两个公头流体连接器对齐。因此，当触头彼此接近时，传感器组件的电触点将与血液分析仪的电触点紧密对准。

3. 发明申请

WO1997043634A1 SENSORS WITH SUBMINIATURE THROUGH HOLES, AND METHOD FOR FABRICATING SUCH SENSORS 审中-公开
标题翻译：具有通过孔的底座的传感器以及用于制造这种传感器的方法
公开(公告)号：WO1997043634A1
公开(公告)日：1997-11-20
申请号：PCT/US1997007602
申请日：1997-05-06
申请人： SENDX MEDICAL, INC. , LEADER, Matthew, J. , GRAVES, Jeffrey , SAVAGE, Douglas, R.
发明人： SENDX MEDICAL, INC.
IPC分类号： G01N27/403
CPC分类号： G01N33/4925
摘要： The present invention is a sensor having an electrode formed in electrical contact with a subminiature through hole. Because of the small diameter of the through hole, the material that fills the through hole and the through hole itself have an essentially negligible effect on the sensor. A relatively large number of sensors can be formed on the surface of the substrate within a relatively small fluid flowcell. Thus, more information can be attained using less analyte. The sensors of the present invention are preferably disposed on an alumina substrate which is essentially impervious to aqueous electrolytes and blood over long periods of storage in potentially corrosive environments. Since the substrate on which the sensors are deposited, and the encapsulants which insulate the conductive elements of the sensor do not break down or become unstable when exposed over time to such corrosive environments, the isolation that is provided remains very high between each sensor and each other sensor, between each sensor and each conduction path, and between each conduction path and each other conduction path. The superior isolation provides for a high level of accuracy in the sensor of the present invention. Furthermore, the use of the through holes allows the conduction paths between the electrodes of the sensors and any external devices to be exclusively on the opposite side of the substrate from the sample. This physical isolation of the sample from the conduction paths between the sensor electrodes and external devices ensures very high electrical isolation between each of the sensors is maintained over an extended period of time during which reactive fluids (such as electrolytes and/or blood) are present in the flowcell.
摘要翻译：本发明是具有与微型通孔电接触形成的电极的传感器。由于通孔的直径很小，填充通孔的材料和通孔本身对传感器具有基本上可以忽略的影响。可以在相对较小的流体流通池内的基板的表面上形成相对大量的传感器。因此，可以使用较少的分析物获得更多的信息。本发明的传感器优选地设置在氧化铝基底上，该氧化铝基底在潜在的腐蚀性环境中长期储存时基本上不透水性电解质和血液。由于传感器沉积在其上的基板和绝缘传感器的导电元件的密封剂在随时间暴露于这种腐蚀性环境中时不会分解或变得不稳定，所以提供的隔离在每个传感器和每个传感器之间保持非常高的每个传感器和每个传导路径之间以及每个传导路径和每个传导路径之间的传感器。优越的隔离在本发明的传感器中提供了高水平的精度。此外，通孔的使用允许传感器的电极和任何外部装置之间的传导路径完全在与样品相反的基底上。样品与传感器电极和外部设备之间的传导路径的这种物理隔离确保了每个传感器之间的非常高的电隔离保持在反应流体（例如电解质和/或血液）存在的延长的时间段内在流通池中。

4. 发明申请

WO1997044660A1 METHOD AND APPARATUS FOR RATIOMETRIC MEASUREMENT OF HEMATOCRIT 审中-公开
标题翻译： HEMATOCRIT的比例测量方法与装置
公开(公告)号：WO1997044660A1
公开(公告)日：1997-11-27
申请号：PCT/US1997007826
申请日：1997-05-06
申请人： SENDX MEDICAL, INC. , SHERMAN, Marshall, Lee
发明人： SENDX MEDICAL, INC.
IPC分类号： G01N33/487
CPC分类号： G01N33/49
摘要： A method and apparatus for measuring resistance of a blood sample in order to determine the hematocrit of that blood sample. The present invention makes a direct ratiometric measurement. That is, the alternating current that flows through the sample is directly measured by applying that alternating current to an integrator which converts the current to a D.C. voltage which is directly proportional to the applied current.
摘要翻译：一种用于测量血液样本的电阻以便确定该血液样本的血细胞比容的方法和装置。本发明进行直接比例测量。也就是说，通过将该交流电流施加到将电流转换成与施加的电流成正比的直流电压的积分器来直接测量流过样品的交流电流。

5. 发明申请

WO1997044657A1 BLOOD GAS/ELECTROLYTE CALIBRATOR AND METHOD FOR USE 审中-公开
标题翻译：血液/电解质校准器和使用方法
公开(公告)号：WO1997044657A1
公开(公告)日：1997-11-27
申请号：PCT/US1997008581
申请日：1997-05-19
申请人： SENDX MEDICAL, INC.
发明人： SENDX MEDICAL, INC. , BETTS, Ronald, E.
IPC分类号： G01N31/00
CPC分类号： G01N33/96 , G01N33/492 , G01N33/84 , G01N2496/70
摘要： Free calcium ion is maintained in an aqueous calibration solution for maintaining quality control in a blood gas/electrolyte analyzer, which solution contains calcium and sodium bicarbonate, by addition of sufficient of a protecting species, preferably acetate ion, to prevent formation of calcium carbonate in the solution.
摘要翻译：游离钙离子保持在水性校准溶液中，以通过加入足够的保护物质，优选乙酸根离子来保持血液/电解质分析仪中的质量控制，该溶液含有碳酸氢钙和碳酸氢钠，以防止碳酸钙形成解决方案。

6. 发明申请

WO1997044662A1 INTEGRAL FLUID AND WASTE CONTAINER FOR BLOOD ANALYZER 审中-公开
标题翻译：用于血液分析仪的综合液体和废物容器
公开(公告)号：WO1997044662A1
公开(公告)日：1997-11-27
申请号：PCT/US1997008259
申请日：1997-05-20
申请人： SENDX MEDICAL, INC.
发明人： SENDX MEDICAL, INC. , SAVAGE, Douglas, R. , WEINZIERL, Michael, C.
IPC分类号： G01N33/50
CPC分类号： G01N35/00594 , B01L3/0293 , B01L3/505 , G01N35/00693 , G01N35/1002 , G01N2001/2893 , Y10T137/87949 , Y10T137/87965 , Y10T436/11 , Y10T436/2575
摘要： A calibration fluid cartridge (120) for a medical device, such as a blood analyzer. The cartridge (120) includes at least one calibrant bag (302) that is filled with a flexible calibration fluid and a flexible waste bag (306) for holding fluid waste from the blood analyzer. The calibrant bags (302, 304) contract as calibration fluid exits the bags, leaving a void in the cartridge (120) that is filled by the waste bag (306), which expands with waste fluids as the calibrant bags (302, 304) contract. Thus, the cartridge (120) can be made compact and lightweight, making it particularly suited for use in a portable blood analyzer. The calibrant bags (302, 304) have fluid ports (310) with self-sealing valves and a flange to secure them within the cartridge (120), as well as a compliant member for facilitating a secure, fluid-tight seal between fluid fitting on the blood analyzer and the calibrant and waste bags. The calibrant bags (302, 304) can be directly coupled to the blood analyzer to reduce diffusion of gases from the calibrant bags (302, 304).
摘要翻译：一种用于医疗装置的校准液体盒（120），例如血液分析仪。盒（120）包括填充有柔性校准流体的至少一个校准袋（302）和用于保持来自血液分析器的流体废物的柔性废物袋（306）。当校准流体离开袋子时，校准物袋（302,304）收缩，在由废气袋（306）填充的料盒（120）中留下空隙，废物袋（306）随着校准气袋（302,304）的废液膨胀，合同。因此，盒（120）可以制造得紧凑和重量轻，使其特别适用于便携式血液分析仪。校准袋（302,304）具有带有自密封阀的流体端口（310）和用于将它们固定在盒（120）内的凸缘，以及柔性构件，用于促进流体配件在血液分析仪和校准物和废物袋上。校准袋（302,304）可以直接耦合到血液分析器以减少来自校准袋（302,304）的气体的扩散。

7. 发明申请

WO1997044249A2 REFERENCE SOLUTION CONTAINER HAVING IMPROVED GAS RETENTION 审中-公开
标题翻译：具有改进气体保持性的参考解决方案容器
公开(公告)号：WO1997044249A2
公开(公告)日：1997-11-27
申请号：PCT/US1997008736
申请日：1997-05-20
申请人： SENDX MEDICAL, INC.
发明人： SENDX MEDICAL, INC. , BETTS, Ronald, E. , SAVAGE, Douglas, R. , WEINZIERL, Michael, C.
IPC分类号： B65D00/00
CPC分类号： B01L3/505 , B01L2200/148 , G01N27/4163 , G01N33/4925 , G01N35/1002 , G01N2001/2893 , G01N2035/00326
摘要： A reference solution container for an analyzer for measuring gas and/or electrolyte levels in a fluid. The vessel includes a fluid container for holding a reference solution and a self-sealing fluid port for repeatedly accessing the reference solution in the fluid vessel by a fluid carrying device that is external to the reference solution container. The partial pressure of each gas in the reference solution within the fluid vessel is maintained at a substantially constant level.
摘要翻译：用于测量流体中气体和/或电解质水平的分析仪的参考溶液容器。容器包括用于保持参考溶液的流体容器和用于通过在参考溶液容器外部的流体输送装置反复进入流体容器中的参考溶液的自密封流体端口。流体容器内的参考溶液中的每种气体的分压保持在基本恒定的水平。

8. 发明申请

WO1997043988A1 WASTE CONTAINER FOR PORTABLE BLOOD ANALYZER 审中-公开
标题翻译：用于便携式血液分析仪的废物容器
公开(公告)号：WO1997043988A1
公开(公告)日：1997-11-27
申请号：PCT/US1997008582
申请日：1997-05-19
申请人： SENDX MEDICAL, INC.
发明人： SENDX MEDICAL, INC. , WEINZIERL, Michael, C. , GRAVES, Jeffrey
IPC分类号： A61F05/44
CPC分类号： B01L1/50 , A61F5/44 , G01N2035/00277
摘要： A waste container for a blood analyzer or other fluid analysis medical device. The waste container (100) includes a flexible waste bag (102) having a gas vent (104) that may include a gas permeable, but substantially fluid impermeable, material or fabric (106). The fabric (106) allows gases to escape the waste bag (102), but substantially prevents fluids from escaping. The waste container (100) also includes a moisture absorbent material (108), such as a polyacrylamide polymer, that converts waste fluid, such as blood, from the blood analyzer (202) into a substantially solid material, such as a gel, as waste fluids (204) enter the waste bag (102). As waste fluids enter (204) the waste bag (102) and are converted into a substantially solid material, expelled gases that form in the waste bag (102) as well as gases entering the waste bag (102) from the blood analyzer (202) pass through the gas vent (104). The waste container (100) can be used with a blood analyzer (202) that analyzes blood gases and electrolytes.
摘要翻译：用于血液分析仪或其他流体分析医疗装置的废物容器。废物容器（100）包括具有气体通气口（104）的柔性废物袋（102），该排气口可包括气体可渗透但基本上不透流体的材料或织物（106）。织物（106）允许气体逸出废物袋（102），但是基本上防止流体逸出。废物容器（100）还包括将诸如血液的废液从血液分析器（202）转化为基本上固体的材料如凝胶的诸如聚丙烯酰胺聚合物的吸湿材料（108），如废液（204）进入废物袋（102）。当废液进入（204）废物袋（102）并被转化成基本上固体的物质时，在废物袋（102）中形成的排出的气体以及从血液分析器（202）进入废物袋（102）的气体）通过排气口（104）。废物容器（100）可以与分析血液气体和电解质的血液分析仪（202）一起使用。

9. 发明申请

WO1997043077A1 METHOD FOR DRILLING MICRO-MINIATURE THROUGH HOLES IN A SENSOR SUBSTRATE 审中-公开
标题翻译：用于在传感器基板中钻孔通过孔进行微小的方法
公开(公告)号：WO1997043077A1
公开(公告)日：1997-11-20
申请号：PCT/US1997007825
申请日：1997-05-06
申请人： SENDX MEDICAL, INC. , LEADER, Matthew, J. , GRAVES, Jeffrey , MOORMAN, John
发明人： SENDX MEDICAL, INC.
IPC分类号： B23K26/00
CPC分类号： B23K26/0624 , B23K26/382 , B23K26/40 , B23K2103/172 , B23K2103/42 , B23K2103/50 , B23K2103/52 , G01N33/4925
摘要： The present invention is a sensor formed over a subminiature through hole. Because of the small diameter of the through hole, the material that fills the through hole and the through hole itself have an essentially negligible effect on the sensor. Only a small amount of conductive material which fills each through hole is in contact with each associated electrode. Therefore, the purity of the electrode is not significantly altered by the conductive material coupled to the electrode. A relatively large number of sensors can be formed on the surface of the substrate within a relatively small fluid flowcell. Thus, more information can be attained using less blood. The sensors of the present invention are preferably disposed on an alumina substrate which is essentially impervious to aqueous electrolytes and blood over long periods of storage in potentially reactive environments. Since the substrate on which the sensors are deposited does not break down or become unstable when exposed over time to such reactive environments, the isolation that is provided by the substrate remains very high between each sensor and each other sensor, between each sensor and each conduction path, and between each conduction path and each other conduction path. The superior isolation provided by the substrate provides for a high level of accuracy in the sensor of the present invention. Furthermore, the use of the through holes allows the conduction paths between the electrodes of the sensors and any external devices to be exclusively on the opposite side of the substrate from the sample. This physical isolation of the sample from the conduction paths between the sensor electrodes and external devices ensures very high electrical isolation between each of the sensors is maintained over an extended period of time during which reactive fluids (such as electrolytes and/or blood) are present in the flowcell.
摘要翻译：本发明是形成在超小型通孔上的传感器。由于通孔的直径很小，填充通孔的材料和通孔本身对传感器具有基本上可以忽略的影响。只有少量的填充每个通孔的导电材料与每个相关电极接触。因此，电极的纯度没有被耦合到电极的导电材料显着改变。可以在相对较小的流体流通池内的基板的表面上形成相对大量的传感器。因此，可以使用较少的血液获得更多的信息。本发明的传感器优选设置在氧化铝基底上，氧化铝基底在潜在的反应性环境中长时间储存时基本上不渗透水性电解质和血液。由于传感器沉积在其上的基板在随时间暴露于这种反应性环境中时不会分解或变得不稳定，所以基板提供的隔离在每个传感器和每个传感器之间在每个传感器和每个传导之间保持非常高路径，并且在每个传导路径和彼此传导路径之间。由衬底提供的优越的隔离在本发明的传感器中提供高水平的精度。此外，通孔的使用允许传感器的电极和任何外部装置之间的传导路径完全在与样品相反的基底上。样品与传感器电极和外部设备之间的传导路径的这种物理隔离确保了每个传感器之间的非常高的电气隔离保持在反应流体（例如电解质和/或血液）存在的延长的时间段内在流通池中。

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