公开(公告)号：US08765482B2

公开(公告)日：2014-07-01

申请号：US13795227

申请日：2013-03-12

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Abner D. Joseph ,  Brian A. Heald

IPC: G01N33/66 ,  G01N33/49 ,  G01N33/52 ,  C12Q1/00 ,  A61B5/1455

CPC classification number: G01N33/49 ,  A61B5/1455 ,  A61B10/0045 ,  C12Q1/006 ,  F21V33/0068 ,  G01N1/10 ,  G01N33/48785 ,  G01N33/52 ,  G01N33/66 ,  Y10T436/144444

Abstract: A test strip with a sample chamber is secured to a meter. The sample chamber in the portion of the test strip that extends out of the meter is illuminated by transmitting light from a light source inside the meter internally through the test strip towards the sample chamber. By way of analogy, the test strip acts in a fashion similar to a fiber optic cable or optical wave guide by transmitting the light from the meter to the remotely located sample chamber that extends outside the meter. The user is then able to easily see the sample chamber of the test strip in dark conditions so that the user is able to readily align the sample chamber with the drop of fluid on the skin as well as view the sample chamber in order to ensure proper filling. The light also illuminates a test strip slot into which the test strip is inserted.

Abstract translation: 带有样品室的测试条固定在仪表上。 通过将来自仪器内部的光源的光透过测试条朝向样品室传送来自测量仪器外延的测试条部分中的样品室。 通过类推，测试条以与光纤电缆或光波导相似的方式通过将来自仪表的光传输到延伸到仪表外部的位于远处的样品室。 使用者然后能够在黑暗的条件下容易地看到测试条的样品室，使得用户能够容易地将样品室与皮肤上的一滴液体对准，并且观察样品室以确保适当 填充。 灯也照亮测试条插入的测试条槽。

公开(公告)号：US08759081B2

公开(公告)日：2014-06-24

申请号：US13629905

申请日：2012-09-28

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Christoph Klaunick ,  Romi Roedl ,  Daniel Rohleder ,  Valerie Winckler-Desprez

IPC: C12M1/34 ,  B01L3/00

CPC classification number: B01L3/5027 ,  B01L3/502715 ,  B01L2300/0654 ,  B01L2300/0851

Abstract: A test element, analytical system and method for optical analysis of fluid samples is provided. The test element has a substrate and a microfluidic channel structure, which is enclosed by the substrate and a cover layer. The channel structure has a measuring chamber with an inlet opening. The test element has a first level, which faces the cover layer, and a second level, which interconnects with the first level such that the first level is positioned between the cover layer and the second level. A part of the measuring chamber extending through the first level forms a measuring zone connecting with a part of the measuring chamber that extends partially into the second level, forming a mixing zone. Optical analysis of fluid samples is carried out by light guided through the first level parallel to the cover layer, such that the light traverses the measuring zone along an optical axis.

Abstract translation: 提供了一种用于流体样品的光学分析的测试元件，分析系统和方法。 测试元件具有衬底和微流体通道结构，其被衬底和覆盖层包围。 通道结构具有具有入口开口的测量室。 测试元件具有面向覆盖层的第一层和与第一层互连的第二层，使得第一层位于覆盖层和第二层之间。 延伸穿过第一级的测量室的一部分形成与部分地延伸到第二级中的测量室的一部分连接的测量区，形成混合区。 流体样品的光学分析通过平行于覆盖层的第一级引导的光进行，使得光沿着光轴穿过测量区。

公开(公告)号：US20140166482A1

公开(公告)日：2014-06-19

申请号：US14183986

申请日：2014-02-19

Applicant: Roche Diagnostics Operations, Inc.

Inventor： James R. Hanson ,  Derek C. Lotarski ,  Matthew C. Sauers ,  Anthony J. Uberta, III

IPC: G01N27/416 ,  A61B5/145

CPC classification number: G01N27/416 ,  A61B5/145 ,  G01N33/4875 ,  G01N33/49 ,  Y10T436/11 ,  Y10T436/112499

Abstract: A system and method for receiving and ejecting a test strip of a fluid testing device. The system includes parallel first and second guide rails defining a rail cavity between the guide rails. A sled includes a sled post and opposed first and second side leg sets each having at least one deflectable leg. Each of the deflectable legs is externally slidably engaged to one of the guide rails limiting the sled to only sliding motion in either a loading direction or an opposite ejection direction. An actuator arm is rotatably connected to a mechanism assembly. The sled post is received in an actuator arm slot. Actuator arm rotation in a loading rotational direction displaces the sled in the loading direction in a sliding motion. Subsequent opposite rotation of the actuator arm in an ejection rotational direction displaces the sled in the ejection direction and ejects the test strip.

公开(公告)号：US08730779B2

公开(公告)日：2014-05-20

申请号：US13904071

申请日：2013-05-29

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Markus Serr ,  Dirk Voelkel ,  Mandiaye Ndao

IPC: G11B7/00

CPC classification number: G11B7/0065 ,  G01N21/8483 ,  G01N33/4875 ,  G01N2021/8494 ,  G03H1/16 ,  G03H1/30 ,  G03H2001/0288 ,  G03H2001/2244 ,  G11B7/24044

Abstract: A test element is disclosed for analyzing a human or animal body fluid sample. The test element includes a substrate carrying a test field with a reagent for effecting a detection reaction when exposed to the body fluid sample, and an optical data storage in which data regarding the test element, preferably calibration data, is stored. Accordingly, the data storage is a holographic data storage. A hologram reader also is disclosed for reading the data storage of such a test element. Moreover, a hologram label and a method for manufacturing a hologram label are disclosed, as is a medical product including a holographic data storage in which data regarding the product is stored.

Abstract translation: 公开了用于分析人或动物体液样品的测试元件。 测试元件包括：当暴露于体液样品时，携带具有用于进行检测反应的试剂的测试场地的基底;以及光学数据存储器，其中存储关于测试元件，优选校准数据的数据。 因此，数据存储是全息数据存储。 公开了一种用于读取这种测试元件的数据存储的全息读取器。 此外，公开了全息图标签和制造全息图标签的方法，以及包括存储关于产品的数据的全息数据存储的医疗产品。

公开(公告)号：US20140128804A1

公开(公告)日：2014-05-08

申请号：US14151162

申请日：2014-01-09

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Raymond Strickland ,  Kurt Klem ,  Mark Nierzwick

IPC: A61M5/172 ,  H04W76/02

CPC classification number: A61M5/1723 ,  G06F19/00 ,  G16H40/63 ,  H04W76/14

Abstract: A private extension of the IEEE 11073 standard for enabling pass-thru communication between a external computing device and a medical device via a diabetes management device is disclosed herein. Within this context, a diabetes management system for configured to allow pass thru communication is described. The system includes a diabetes management device in communication with a external computing device and the first medical device. A pass-thru module of the diabetes management device uses a set of pass-thru commands for establishing a pass-thru communication path and enabling communication between the external computing device and the first medical device, and wherein the set of pass-through commands is defined in compliance with a communication protocol defined in accordance with IEEE standard 11073-20601.

Abstract translation: 本文公开了用于通过糖尿病管理设备实现外部计算设备和医疗设备之间的通过通信的IEEE 11073标准的私人扩展。 在这种情况下，描述了用于配置为允许通过通信的糖尿病管理系统。 该系统包括与外部计算设备和第一医疗设备通信的糖尿病管理设备。 糖尿病管理装置的通过模块使用一组直通命令来建立通过通路的通路，并实现外部计算装置与第一医疗装置之间的通信，其中，所述一组通过命令是 根据IEEE标准11073-20601定义的通信协议来定义。

公开(公告)号：US20140110480A1

公开(公告)日：2014-04-24

申请号：US14055266

申请日：2013-10-16

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Martin Burri ,  Andreas Eberhart ,  Akihiro Tanji

IPC: G06Q10/08

CPC classification number: G01N35/00732 ,  B01L9/06 ,  B01L99/00 ,  B01L2300/024 ,  G01N2035/00782 ,  G01N2035/00801 ,  G01N2035/00831 ,  G01N2035/00851 ,  G06Q10/087

Abstract: A system and method for locating sample vessels are presented. The system comprises a holder having an array of positions for holding sample vessels. An information tag is attached to the holder for storing and/or retrieving machine-readable information related to the positions of sample vessels with respect to the array of positions. The system further comprises a handheld device capable of reading information on the information tag. The handheld device has an input for inputting information related to a to-be-located sample vessel and an output for outputting a position of the to-be-located sample vessel with respect to the array of positions based on information stored in the information tag. The method comprises inputting information related to a to-be-located sample vessel into the handheld device, reading information stored in the holder's information tag with the handheld device; and outputting a position of the to-be-located sample vessel.

Abstract translation: 提出了一种用于定位样品容器的系统和方法。 该系统包括具有用于保持样品容器的位置阵列的保持器。 一个信息标签连接到保持器，用于存储和/或检索与样品容器相对于位置阵列相关的位置的机器可读信息。 该系统还包括能够读取关于信息标签的信息的手持设备。 手持装置具有用于输入与要定位的取样容器相关的信息的输入端和用于基于存储在信息标签中的信息输出相对于位置阵列的待定位样品容器的位置的输出 。 该方法包括将与待定位的采样容器相关的信息输入到手持设备中，用手持设备读取存储在保持器的信息标签中的信息; 并输出待定位的样品容器的位置。

公开(公告)号：US20140106383A1

公开(公告)日：2014-04-17

申请号：US14136769

申请日：2013-12-20

Applicant: Roche Diagnostics Operations Inc.

Inventor： Liesel Doerge ,  Margarete Galm ,  Carina Horn

IPC: G01N27/26

CPC classification number: G01N27/26 ,  C12Q1/005 ,  C12Q1/56 ,  G01N33/86

Abstract: Methods and devices for determining factor Xa inhibitors, in particular heparins and fractionated or low-molecular-weight heparins, as well as direct factor Xa inhibitors in blood samples. The methods include contacting a blood sample with a detection reagent that contains at least one thrombin substrate having a peptide residue that can be cleaved by thrombin and is amidically bound via the carboxyl end to an electrogenic substance, and with a known amount of factor X reagent and an activator reagent which induces the conversion of factor X into factor Xa. Subsequently, in a second step, the amount or activity of the electrogenic substance that is cleaved from the thrombin substrate by the factor Xa-mediated thrombin activation and/or the time course thereof is determined as the measurement signal using electrochemical methods. In a third step, the amount of the factor Xa inhibitor in the sample of the blood to be analyzed or a measured quantity that correlates therewith, in particular a clotting time that correlates therewith, is determined on the basis of this measurement signal.

Abstract translation: 用于确定因子Xa抑制剂，特别是肝素和分级或低分子量肝素的方法和装置，以及血液样品中的直接因子Xa抑制剂。 所述方法包括使血液样品与含有至少一个凝血酶底物的检测试剂接触，所述凝血酶底物具有可被凝血酶切割的肽残基，并且经由羧基末端与电生物质酰胺结合，并且使用已知量的因子X试剂 和诱导因子X转化成因子Xa的活化剂。 随后，在第二步骤中，通过因子Xa介导的凝血酶活化和/或其时间过程将从凝血酶底物切割的电生物质的量或活性确定为使用电化学方法的测量信号。 在第三步骤中，基于该测量信号确定要分析的血液样品中的因子Xa抑制剂的量或与其相关的测量量，特别是与其相关的凝血时间。

公开(公告)号：US20140080693A1

公开(公告)日：2014-03-20

申请号：US14087342

申请日：2013-11-22

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Joerg Haechler

IPC: B04B13/00

CPC classification number: B04B13/00 ,  B04B2011/046 ,  G01N35/0092 ,  G01N35/0095 ,  G01N2035/0094 ,  Y10T436/111666

Abstract: Illustrative embodiments of automated sample workcells and methods of operation are disclosed. The methods may include receiving a first plurality of samples, each of the first plurality of samples being linked to a requested analysis selected from among a plurality of analysis types; assigning at least one centrifugation parameter to each of the first plurality of samples in response to the requested analysis linked to that sample; loading a second plurality of samples into a centrifuge, the second plurality of samples being selected from among the first plurality of samples and comprising samples that have been assigned at least two different centrifugation parameters; determining a centrifugation parameter of highest centrifugation intensity from among the at least two different centrifugation parameters assigned to samples in the second plurality of samples; and centrifuging the second plurality of samples according to a centrifugation protocol comprising the centrifugation parameter of highest centrifugation intensity.

Abstract translation: 公开了自动样品工作单元的说明性实施例和操作方法。 所述方法可以包括：接收第一多个样本，所述第一多个样本中的每一个被链接到从多个分析类型中选择的请求分析; 响应于与所述样品相关联的所请求的分析，将至少一个离心参数分配给所述第一多个样品中的每一个; 将第二多个样品加载到离心机中，所述第二多个样品选自所述第一多个样品中并且包括已经分配了至少两个不同离心参数的样品; 从分配给第二多个样品中的样品的至少两个不同离心参数中确定最高离心强度的离心参数; 以及根据包含最高离心强度的离心参数的离心方案离心所述第二多个样品。

公开(公告)号：US20140066737A1

公开(公告)日：2014-03-06

申请号：US13739189

申请日：2013-01-11

Applicant: ROCHE DIAGNOSTICS OPERATIONS, INC.

Inventor： Joachim Kasielke ,  Ulrich Haueter ,  Ulrike Kamecke ,  Christian Hof ,  Matthew Reynolds ,  Timon Kasielke ,  Steven Gray ,  Harvey B. Buck ,  Michael David Church Loukine ,  Fritz Hindelang

IPC: A61B5/05 ,  A61B5/00

CPC classification number: A61B5/04 ,  A61B5/0002 ,  A61B5/05 ,  A61B5/1473 ,  A61B5/14865 ,  A61B5/6846 ,  A61B5/7405 ,  A61B5/742 ,  A61B5/7455 ,  A61B5/746 ,  H05K1/028 ,  H05K1/144 ,  H05K1/147 ,  H05K1/189 ,  H05K3/323 ,  H05K3/361 ,  H05K2201/042 ,  H05K2201/10098 ,  H05K2201/10151

Abstract: A sensor may include a substrate having a sensing portion defining a sensor thereon and a circuit mounting portion defining at least one electrically conductive pad that is electrically connected to the sensor. The sensor may be configured to produce a signal indicative of a condition of the patient. An anisotropic medium may be disposed on the circuit mounting portion and may be electrically conductive in a direction through the medium and electrically insulating in directions along the medium. An electrical circuit may be mechanically mounted to the circuit mounting portion of the first substrate via the anisotropic medium with at least one electrically conductive terminal juxtaposed over the at least one electrically conductive pad. The anisotropic medium may establish local electrical contact between the at least one electrically conductive terminal and the at least one electrically conductive pad.

Abstract translation: 传感器可以包括具有在其上限定传感器的感测部分的基板和限定电连接到传感器的至少一个导电焊盘的电路安装部分。 传感器可以被配置为产生指示患者状况的信号。 各向异性介质可以设置在电路安装部分上，并且可以在通过介质的方向上导电并且沿着介质的方向电绝缘。 电路可以经由各向异性介质机械地安装到第一基板的电路安装部分，其中至少一个导电端子并置在至少一个导电焊盘上。 各向异性介质可以在至少一个导电端子和至少一个导电焊盘之间建立局部电接触。

公开(公告)号：US20140065648A1

公开(公告)日：2014-03-06

申请号：US13776314

申请日：2013-02-25

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Ursula-Henrike Wienhues-Thelen ,  Dirk Block ,  Hendrik Heudig ,  Sabine Vogel-Ziebolz ,  Christine Boehm ,  Georg Hess ,  Andrea Horsch ,  Dietmar Zdunek

IPC: G01N33/68

CPC classification number: G01N33/54306 ,  G01N33/6887 ,  G01N33/6893 ,  G01N2333/4712 ,  G01N2333/495 ,  G01N2333/58 ,  G01N2800/325 ,  G01N2800/50 ,  G01N2800/52

Abstract: Methods and systems for diagnosing functional and/or structural abnormalities of the heart preceding heart failure, and for predicting the risk of developing heart failure, in a subject comprising measuring a cardiac troponin in a sample and comparing the measurement to a reference value. Other markers, including GDF15 and IGFBP7 are also measured in some embodiments.

Abstract translation: 用于诊断心脏衰竭前的心脏的功能和/或结构异常以及用于预测心脏衰竭发展的风险的方法和系统，包括测量样品中的心肌肌钙蛋白并将测量值与参考值进行比较。 在一些实施方案中也测量了其它标志物，包括GDF15和IGFBP7。