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1. 发明授权

US09599631B2 Automatic analyzer 有权
公开(公告)号：US09599631B2
公开(公告)日：2017-03-21
申请号：US14239379
申请日：2012-07-19
申请人： Isao Yamazaki , Masaharu Nishida , Kumiko Kamihara , Hideto Tamezane
发明人： Isao Yamazaki , Masaharu Nishida , Kumiko Kamihara , Hideto Tamezane
IPC分类号： G01N35/10 , G01N35/00
CPC分类号： G01N35/1002 , G01N35/1011 , G01N35/1016 , G01N2035/1018 , G01N2035/1062 , Y10T436/119163
摘要： A plunger is moved downwardly in predetermined distance while the tip of the sample probe is immersed in a sample to suck the sample into the probe. A pressure sensor detects the pressure fluctuation during the suction operation, an AD converter converting the signals into digital signals to send the signals for a signal processing unit. The signal processing unit extracts feature variables data of a suction waveform to calculate the Statistical distance from normal group data. The Statistical distance an a threshold value are compared with each other, it is judged that there is an abnormality in the suction operation when the Statistical distance is more than or equal to the threshold value. When the Statistical distance is smaller than the threshold value, an operation is proceeded to a discharge operation.

2. 发明授权

US09562917B2 Automatic analysis device and automatic analysis program 有权
标题翻译：自动分析装置和自动分析程序
公开(公告)号：US09562917B2
公开(公告)日：2017-02-07
申请号：US14117717
申请日：2012-04-17
申请人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
发明人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
IPC分类号： G01N31/00 , G01N35/00 , G01N35/04
CPC分类号： G01N35/00584 , G01N35/00693 , G01N2035/00673 , G01N2035/00702 , G01N2035/0453
摘要： Accuracy control of an automatic analysis device that mixes a sample and a reagent to measure temporal change of a mixed solution is realized. A plurality of measurement point data is acquired from a reaction process of the sample and the reagent. Parameters and test values of approximate equations for approximating the plurality of measurement point data are accumulated in a storage unit. A distribution map of reference data corresponding to the parameters or the test values is created based on predetermined numbers of the parameters or the test values accumulated in the storage unit. Next, a plurality of screens for individually superimposing, on the distribution map, curved lines corresponding to a plurality of regression function candidates obtained by applying a plurality of regression functions are arranged and presented on a display screen, so as to approximate the data to the distribution map of the reference data.
摘要翻译：实现了混合样品和试剂以测量混合溶液的时间变化的自动分析装置的精度控制。从样品和试剂的反应过程获取多个测量点数据。用于近似多个测量点数据的近似等式的参数和测试值被累积在存储单元中。基于在存储单元中累积的参数或测试值的预定数量来创建与参数或测试值相对应的参考数据的分布图。接下来，在分配图上单独叠加多个屏幕，将与通过应用多个回归函数获得的多个回归函数候选对应的曲线布置并呈现在显示屏上，以将数据近似为参考数据的分布图。

3. 发明授权

US09488667B2 Automatic analyzer 有权
标题翻译：自动分析仪
公开(公告)号：US09488667B2
公开(公告)日：2016-11-08
申请号：US13318819
申请日：2010-04-12
申请人： Kumiko Kamihara , Satoshi Mitsuyama , Tomonori Mimura , Chihiro Manri
发明人： Kumiko Kamihara , Satoshi Mitsuyama , Tomonori Mimura , Chihiro Manri
IPC分类号： G01C19/00 , G01N35/00
CPC分类号： G01N35/00613 , G01N2035/0097
摘要： To change a photometric time for each item or to change a measurement time for each specimen so that time required for biochemical measurement can be reduced, an index that indicates an end of a reaction is required. Unfortunately, however, no methods have been available for determining the end of the reaction. In measuring a substance to be measured contained in a sample, a parameter in an approximate expression is calculated using a measured value that changes with time, a degree of convergence of a reaction is determined according to a degree of convergence of the parameter, and a measured value at the end of the reaction is calculated using the parameter at a point in time at which it is determined that the reaction has converged.
摘要翻译：要更改每个项目的光度时间或更改每个样品的测量时间，以便可以减少生物化学测量所需的时间，则需要指示反应结束的指标。然而，不幸的是，没有方法可用于确定反应的结束。在测定样品中含有的待测物质时，使用随时间变化的测定值来计算近似表达式中的参数，根据参数的收敛程度确定反应的收敛程度，使用在确定反应已经收敛的时间点的参数来计算反应结束时的测量值。

4. 发明申请

US20140136123A1 AUTOMATIC ANALYSIS DEVICE AND AUTOMATIC ANALYSIS PROGRAM 有权
标题翻译：自动分析装置和自动分析程序
公开(公告)号：US20140136123A1
公开(公告)日：2014-05-15
申请号：US14117717
申请日：2012-04-17
申请人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
发明人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
IPC分类号： G01N35/00
CPC分类号： G01N35/00584 , G01N35/00693 , G01N2035/00673 , G01N2035/00702 , G01N2035/0453
摘要： Accuracy control of an automatic analysis device that mixes a sample and a reagent to measure temporal change of a mixed solution is realized. A plurality of measurement point data is acquired from a reaction process of the sample and the reagent. Parameters and test values of approximate equations for approximating the plurality of measurement point data are accumulated in a storage unit. A distribution map of reference data corresponding to the parameters or the test values is created based on predetermined numbers of the parameters or the test values accumulated in the storage unit. Next, a plurality of screens for individually superimposing, on the distribution map, curved lines corresponding to a plurality of regression function candidates obtained by applying a plurality of regression functions are arranged and presented on a display screen, so as to approximate the data to the distribution map of the reference data.
摘要翻译：实现了混合样品和试剂以测量混合溶液的时间变化的自动分析装置的精度控制。从样品和试剂的反应过程获取多个测量点数据。用于近似多个测量点数据的近似等式的参数和测试值被累积在存储单元中。基于在存储单元中累积的参数或测试值的预定数量来创建与参数或测试值相对应的参考数据的分布图。接下来，在分配图上单独叠加多个屏幕，将与通过应用多个回归函数获得的多个回归函数候选对应的曲线布置并呈现在显示屏上，以将数据近似为参考数据的分布图。

5. 发明授权

US09476893B2 Automatic analysis device and analysis method 有权
标题翻译：自动分析装置及分析方法
公开(公告)号：US09476893B2
公开(公告)日：2016-10-25
申请号：US13321072
申请日：2010-05-10
申请人： Satoshi Mitsuyama , Chihiro Manri , Tomonori Mimura , Kumiko Kamihara
发明人： Satoshi Mitsuyama , Chihiro Manri , Tomonori Mimura , Kumiko Kamihara
IPC分类号： G01N35/00
CPC分类号： G01N35/00663 , G01N35/00623 , G01N2035/00702 , G01N2035/0097
摘要： Provided are an automated analyzer and an automatic analysis method for highly accurately determining presence or absence of abnormality based on reaction process data obtained when concentration of a chemical component or an activity level of an enzyme is measured. The reaction process data is approximated by a function, and shape feature quantities indicating features of a shape of a curve section at an early stage of reaction are calculated. The obtained shape feature quantities are used to determine the presence or absence of abnormality.
摘要翻译：本发明提供一种自动分析装置和自动分析方法，用于根据测定化学成分浓度或酶活性水平时获得的反应过程数据，高精度地确定异常存在或不存在。反应过程数据由功能近似，并且计算表示在反应初期的曲线部分的形状的特征的形状特征量。获得的形状特征量用于确定是否存在异常。

6. 发明授权

US09383376B2 Automatic analyzer 有权
标题翻译：自动分析仪
公开(公告)号：US09383376B2
公开(公告)日：2016-07-05
申请号：US13133655
申请日：2009-11-11
申请人： Kumiko Kamihara , Tomonori Mimura
发明人： Kumiko Kamihara , Tomonori Mimura
IPC分类号： G06F17/18 , G01N35/00
CPC分类号： G01N35/00693 , G01N35/00603 , G06F17/18
摘要： Abnormality causes are automatically identified during daily quality control, based on the focused consideration of complex uncertainty factors and, especially, of the causes of device-side abnormalities, the latter of which are often difficult to identify. The analyzer performance that affects measurement results can be estimated from analysis parameters and calibration results. Thus, uncertainty estimates are automatically calculated for each analysis item during quality control, and the estimates are compared with uncertainties obtained during actual QC sample measurement, thereby monitoring and evaluating the analyzer performance. Also, measurements are performed on QC samples of multiple concentrations that contain substances known to subject to particular influences such as those of the optical system, sample dispenser, and reagent dispenser, so that the causes of abnormalities can be identified. Uncertainty estimates calculated from the parameters set for the analysis items are compared with uncertainties obtained from the QC sample measurements.
摘要翻译：基于对复杂不确定性因素的重点考虑，特别是器件方异常的原因，后者通常难以识别，在日常质量控制过程中自动识别异常原因。影响测量结果的分析仪性能可以通过分析参数和校准结果进行估算。因此，在质量控制期间，为每个分析项目自动计算不确定性估计，并将估计与实际QC样品测量期间获得的不确定性进行比较，从而监测和评估分析仪性能。此外，对含有已知会受到光学系统，样品分配器和试剂分配器的特定影响的物质的多种浓度的QC样品进行测量，从而可以识别出异常的原因。将从分析项目设置的参数中计算出的不确定度估计与从QC样本测量获得的不确定性进行比较。

7. 发明授权

US09310388B2 Automatic analyzer and analysis method 有权
标题翻译：自动分析仪和分析方法
公开(公告)号：US09310388B2
公开(公告)日：2016-04-12
申请号：US13318535
申请日：2010-04-12
申请人： Kumiko Kamihara , Satoshi Mitsuyama , Tomonori Mimura , Chihiro Manri
发明人： Kumiko Kamihara , Satoshi Mitsuyama , Tomonori Mimura , Chihiro Manri
IPC分类号： G01C19/00 , G01N35/00 , G01N21/27
CPC分类号： G01N35/00603 , G01N21/272
摘要： In known automatic analyzers for detecting an abnormality by approximating reaction process data using a function, accuracy of detecting a reaction abnormality is degraded because of poor approximation accuracy depending on test items. Data processing means stores the absorbance and time of day at which the absorbance is measured as time-series data. Letting x denote absorbance, t denote time, and * denote a symbol representing multiplication, we have a function x=a0+a1*exp(−k1*t)+a2*exp(−k2*t). Values of parameters a0, a1, a2, ai, k1, and k2 are calculated so that a difference between the absorbance at the measured time calculated using the above expression and the time-series data is minimal, and presence of an abnormality is determined based on the parameter values.
摘要翻译：在用于通过使用功能近似反应过程数据来检测异常的已知的自动分析器中，由于根据测试项目的近似精度不足，检测反应异常的精度降低。数据处理装置将吸光度和吸光度时间的时间存储为时间序列数据。令x表示吸光度，t表示时间，*表示表示乘法的符号，我们有函数x = a0 + a1 * exp（-k1 * t）+ a2 * exp（-k2 * t）。计算参数a0，a1，a2，ai，k1和k2的值，使得使用上述表达式计算的测量时间的吸光度与时间序列数据之间的差异最小，并且基于对参数值。

8. 发明申请

US20140220693A1 AUTOMATIC ANALYZER 有权
标题翻译：自动分析仪
公开(公告)号：US20140220693A1
公开(公告)日：2014-08-07
申请号：US14239379
申请日：2012-07-19
申请人： Isao Yamazaki , Masaharu Nishida , Kumiko Kamihara , Hideto Tamezane
发明人： Isao Yamazaki , Masaharu Nishida , Kumiko Kamihara , Hideto Tamezane
IPC分类号： G01N35/10
CPC分类号： G01N35/1002 , G01N35/1011 , G01N35/1016 , G01N2035/1018 , G01N2035/1062 , Y10T436/119163
摘要： A plunger 66 is moved downwardly in predetermined distance while the tip of the sample probe 15 is immersed in a sample to suck the sample into the probe. A pressure sensor 26 detects the pressure fluctuation during the suction operation, an AD converter converting the signals into digital signals to send the signals for a signal processing unit 76. The signal processing unit 76 extracts feature variables data of a suction waveform to calculate the Statistical distance D from normal group data. The Statistical distance D an a threshold value th are compared with each other, it is judged that there is an abnormality in the suction operation when the Statistical distance D is more than or equal to the threshold value th. When the Statistical distance D is smaller than the threshold value th, an operation is proceeded to a discharge operation.
摘要翻译：柱塞66以预定距离向下移动，同时将样品探针15的尖端浸入样品中以将样品吸入探针中。压力传感器26检测吸入操作期间的压力波动，AD转换器将信号转换成数字信号以发送信号处理单元76的信号。信号处理单元76提取抽吸波形的特征变量数据以计算统计距离D与正常组数据。统计距离D和阈值th彼此比较，当统计距离D大于或等于阈值th时，判断吸入操作中存在异常。当统计距离D小于阈值th时，进行放电操作。

9. 发明授权

US08150645B2 Automatic analzyer 有权
标题翻译：自动分析仪
公开(公告)号：US08150645B2
公开(公告)日：2012-04-03
申请号：US12362818
申请日：2009-01-30
申请人： Kumiko Kamihara , Tomonori Mimura , Shinichi Fukuzono
发明人： Kumiko Kamihara , Tomonori Mimura , Shinichi Fukuzono
IPC分类号： G06F17/18
CPC分类号： G01N35/00663 , Y10T436/101666
摘要： Measurement of the uncertainty used for quality control typically involves a plurality of factors. When the uncertainty exceeds a clinical permissible value, time is required for a medical technologist to investigate and to determine the factor causing the uncertainty. It is thus beneficial to automatically investigate factors in complicated uncertainty, particularly from the view point of reagents and samples which are subject to quality change and that are prone to affect the measurement quality. Quality control samples having a plurality of concentration levels are measured to calculate the average, coefficient of variation, standard deviation, and other numerical values. When quality control samples having n (n≧2) different concentration levels are measured, variation patterns determine the factor causing the uncertainty, the factor being specific to each of 3n different combinations of variation patterns.
摘要翻译：用于质量控制的不确定度的测量通常涉及多个因素。当不确定性超过临床允许值时，医疗技术人员需要时间调查并确定导致不确定性的因素。因此，自动调查复杂不确定因素的因素是有益的，特别是从质量变化的试剂和样品的角度出发，容易影响测量质量。测量具有多个浓度水平的质量控制样品以计算平均值，变异系数，标准偏差和其它数值。当测量具有n（n≥2）不同浓度水平的质量控制样品时，变化模式确定导致不确定性的因素，该因子特异于3n个不同组合的变化模式。

10. 发明授权

US10203277B2 Automatic analysis device and automatic analysis method 有权
公开(公告)号：US10203277B2
公开(公告)日：2019-02-12
申请号：US13641881
申请日：2011-04-05
申请人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
发明人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
IPC分类号： G01N21/27 , G01N35/00 , G01N21/78
摘要： There is provided a technique for automatically determining or predicting a line range specific to a sample that appears in a reaction curve in an automated analyzer for mixing a specimen and a reagent and measuring a change in a mixture of the specimen and the reagent with time. This invention approximates reaction curve data by a function and automatically determines a curve part at an early stage or a second stage of a reaction. The invention determines a line range not including a curve part for each sample and calculates a laboratory test value using absorbance data within the determined line range. This invention also automatically determines a start time of line at the early stage of the reaction on the basis of absorbance data obtained up to a point halfway through the reaction curve, predicts a line range on the basis of the end time of line and a planned end time of line, and calculates a predictive value on the basis of a result of the prediction.

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