[go: up one dir, main page]

WO2012006778A1 - 流体检测试片 - Google Patents

流体检测试片 Download PDF

Info

Publication number
WO2012006778A1
WO2012006778A1 PCT/CN2010/075153 CN2010075153W WO2012006778A1 WO 2012006778 A1 WO2012006778 A1 WO 2012006778A1 CN 2010075153 W CN2010075153 W CN 2010075153W WO 2012006778 A1 WO2012006778 A1 WO 2012006778A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
detecting test
fluid detecting
test piece
test strip
Prior art date
Application number
PCT/CN2010/075153
Other languages
English (en)
French (fr)
Inventor
谢文彬
王正贤
Original Assignee
红电医学科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 红电医学科技股份有限公司 filed Critical 红电医学科技股份有限公司
Priority to JP2013518927A priority Critical patent/JP2013530409A/ja
Priority to PCT/CN2010/075153 priority patent/WO2012006778A1/zh
Publication of WO2012006778A1 publication Critical patent/WO2012006778A1/zh

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels

Definitions

  • the invention relates to a fluid detecting test piece, in particular to a fluid detecting test piece having a special design in a sampling area of a biological sample.
  • a sheet is designed with a flow path or a micro-channel structure on a substrate or a substrate and is subjected to surface hydrophobic treatment, and the fluid to be tested is not soaked with a material such as protein or sugar.
  • a composition with a high hysteresis so when the fluid to be tested flows, it will remain on the flow path, so that the fluid to be tested cannot be completely reacted, which not only causes waste of the fluid to be tested, but also may cause errors in the final test results.
  • the problem of fluid transfer in the conventional fluid detecting test piece is that the originally existing air in the flow channel causes the fluid to be tested to be injected into the flow channel to be generated or entangled in bubbles of different sizes, thereby causing the flow channel to be blocked, resulting in actual The measurement error even caused the test to fail.
  • an electrochemical test strip 9 used in the conventional art includes a substrate 91 which is sequentially stacked, a plurality of electrodes 921, an insulating layer 93, and an upper cap layer 94. Further, a lateral groove 931 parallel to the short axis of the electrochemical test strip 9 is provided in the insulating layer 93. Therefore, after the assembly is completed, the lateral grooves 931, the substrate 91 and the upper cover together constitute a flow path 95 parallel to the short axis of the fluid detecting test piece 9, in which the reaction area 950 is provided.
  • the electrochemical test strip 9 of this design has an opening 951 and 952 on each side of the flow path 95, and both openings 951 and 952 can serve as sample inlets for sampling.
  • the opening 951 When the opening 951 is used as a sample inlet, the opening 952 becomes an exhaust port and vice versa. That is, after the sample to be tested (e.g., blood) enters the flow channel 95 from the opening 951, the sample to be tested flows through the reaction zone 950 by capillary action, and the reaction zone 950 is coated with the reaction material.
  • the analyte such as blood glucose
  • the electrode 921 can conduct the current signal generated by the electrochemical reaction to the rear detection instrument for judgment.
  • the width of the flow path 95 is limited, so that the sizes of the openings 951 and 952 are not too large.
  • the user needs to carefully align the sample to allow the sample to be tested (such as fingertip blood) to flow smoothly into the reaction area 95.
  • users of the electrochemical test strip 9 include patients suffering from chronic chronic diseases (for example, diabetic patients) who often develop complications due to long-term chronic diseases (for example, macular degeneration or peripheral nerve atrophy).
  • chronic chronic diseases for example, diabetic patients
  • long-term chronic diseases for example, macular degeneration or peripheral nerve atrophy.
  • the phenomenon of impaired vision or insufficient coordination of movements can not perform the above-mentioned fine operations requiring hand-eye coordination, and it is also likely to cause measurement errors and user frustration.
  • the flow path 95 of the electrochemical test strip 9 extends rearward from the front end thereof into an approximately U-shaped structure, and the flow path 95 of the U-shaped structure has only one opening 951.
  • the sample to be tested is injected into the flow path 95 from the opening 951 of the flow path 95.
  • the air resistance is blocked by the air resistance, and bubbles are generated in the flow channel 95, and the capillary action and the siphon phenomenon are promoted, so that the sample to be tested can smoothly flow into the reaction region 950, in the flow channel.
  • the upper cover layer 94 is provided with an exhaust opening 94 ⁇ so that the air originally present in the flow path 95 can be discharged by the exhaust opening 941.
  • the present invention provides a fluid detecting test piece for detecting a fluid sample, comprising a substrate stacked in sequence, a plurality of electrodes, a support layer, and an upper cover.
  • the fluid detecting test piece has a longitudinal long axis and a lateral short axis, the longitudinal long axis and the transverse short axis are perpendicular to each other, and the fluid detecting test piece has a first end and a second end opposite to the first end along the longitudinal long axis direction, the electrode
  • the layer has a plurality of electrodes.
  • the fluid detecting test piece has a sensing area at the end of the first end, the sensing area is disposed parallel to the lateral short axis and is jointly defined by the upper cover, the supporting layer and the substrate, and the electrode extends into the sensing area.
  • the sensing region has a maximum depth along the longitudinal long axis direction, and the sensing region has a maximum width along the lateral short axis direction, and the maximum width is greater than the maximum depth.
  • the fluid sample flows within the sensing region after entering and has the longest flow path, and the sensing region has a ⁇ -shaped configuration along a section perpendicular to the longest flow path.
  • the upper cover faces the sensing area and is coated with a hydrophilic material.
  • the main object of the present invention is to provide a fluid detecting test piece whose sensing region is extended In the long-axis direction, the three-sided closed area, when the sample to be tested enters the sensing area, the air originally present in the sensing area can be directly discharged from other directions and positions where the sample to be tested enters. There is no need to provide a venting hole. Therefore, it is not necessary to provide an venting hole in the upper cover or in the support layer or on the electrode layer during the test piece production process, so there is no need to accurately align with the lower flow path (sensing area). Fits with, thus reducing manufacturing costs and increasing manufacturing yield.
  • Another object of the present invention is to provide a fluid detecting test piece whose sensing area is located at the foremost end of the fluid detecting test piece and whose width is greater than the depth, and the sample to be tested can be accepted as long as the opening of the sensing area is acceptable. Injecting, when injecting the sample to be tested, the air originally present in the sensing area is used, which is convenient for long-term chronic patients and elderly people.
  • Another object of the present invention is to provide a fluid detecting test piece, wherein a lead angle structure can be further disposed at the first end and on both sides of the longitudinal long axis, and the user only needs to bring the lead angle structure close to the sampling point, the sample to be tested
  • the capillary enters into the sensing area, and the air originally present in the sensing area is discharged from the front end of the test piece and the other end of the lead, which is convenient for sampling.
  • FIG. 1A is a schematic view showing the combination of fluid detecting test pieces according to a first preferred embodiment of the present invention.
  • Figure 1B is an exploded perspective view of a fluid detecting test strip according to a first preferred embodiment of the present invention.
  • Fig. 1C is an enlarged schematic view showing a first end portion of a fluid detecting test piece according to a first preferred embodiment of the present invention.
  • Fig. 1D is a plan view of a fluid detecting test piece according to the first preferred embodiment.
  • Fig. 1E is a plan view of a fluid detecting test piece according to the first preferred embodiment.
  • Fig. 1 F is a schematic cross-sectional view showing a fluid detecting test piece according to a first preferred embodiment of the present invention.
  • 2A is a schematic view showing the combination of fluid detecting test pieces according to a second preferred embodiment of the present invention.
  • Fig. 2B is an exploded perspective view showing a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • Fig. 2C is an enlarged schematic view showing the first end portion of the fluid detecting test piece according to the second preferred embodiment of the present invention.
  • FIG. 2D is a schematic cross-sectional view of a fluid detecting test strip according to a second preferred embodiment of the present invention.
  • Fig. 3A is a schematic view of an electrochemical test strip according to the conventional art.
  • Figure 3B is a schematic illustration of an electrochemical test strip disclosed in U.S. Patent No. 6,258,229.
  • the upper cover faces one side of the groove 141, 241
  • the present invention discloses a fluid detecting test piece in which the biological sample detecting principle and the solution coating technique are utilized, which are known to those skilled in the relevant art, and therefore will not be fully described in the following description.
  • the corresponding drawings in the following drawings are schematic diagrams relating to the features of the present invention, and are not required to be completely drawn according to the actual situation, and are previously stated.
  • FIG. 1A is a schematic diagram of a fluid detecting test strip assembly according to a first preferred embodiment of the present invention.
  • the fluid detecting test piece 1 includes a substrate 1 1 , a plurality of electrodes 121, a support layer 13 and an upper cover 14.
  • the substrate 1 1 is preferably made of a bio-inert material.
  • the fluid detecting test piece 1 has a longitudinal long axis X and a lateral short axis Y, and the longitudinal long axis X and the lateral short axis Y are perpendicular to each other.
  • the fluid detecting test strip 1 has a first end 101 and a second end 102 opposite the first end 101 in the longitudinal direction of the longitudinal axis X.
  • the length L2 of the support layer 13 along the longitudinal long axis X direction is smaller than the length L1 of the upper cover 14 along the longitudinal long axis X direction, and the upper cover 14 is disposed on the support layer 13, and the fluid detecting test piece 1 has a feeling at the end of the first end 101
  • the sensing area 15 is defined by the support layer 13 together with the upper cover 14 and the substrate 11, and the upper cover 14 completely covers the sensing area 15.
  • the sensing area 15 is set parallel to the lateral short axis Y. In use, the user only needs to bring the first end 101 of the fluid detecting test piece 1 close to the sampling position (for example, at the skin pin), and the sample to be tested enters the sensing area 15 due to capillary phenomenon, which is convenient for sampling.
  • FIG. 1B is an exploded perspective view of a fluid detecting test piece according to a preferred embodiment of the present invention.
  • Base The board 11, the plurality of electrodes 121, the support layer 13, and the upper cover 14 are sequentially stacked from bottom to top.
  • the electrode 121 is coated on the substrate 11, for example, by printing, coating, or deposition.
  • FIG. 1C an enlarged view of a first end portion of a fluid detecting test piece according to a preferred embodiment of the present invention is shown.
  • the maximum width W of the sensing region 15 along the lateral minor axis in the Y direction is greater than the maximum depth Dmax of the longitudinal long axis in the X direction.
  • the volume of the sensing region 15 is preferably at most 5 microliters, more preferably 1 microliter.
  • the maximum depth Dmax is greater than the maximum width W.
  • the ratio of the maximum depth Dmax to the maximum width W is preferably 1:2 or less, and most preferably 1:
  • the purpose of the above design is to Capillary action can be utilized to enable the sample to be tested to enter from any one of the sensing regions 15, and then fill the entire sensing region 15, and the air originally left in the sensing region 15 is pushed by the sample to be tested. And discharging to the other non-test sample entering region of the sensing region 15.
  • the upper cover 14 does not need to be additionally designed with vent holes, thereby reducing manufacturing costs and improving manufacturing yield.
  • the sample inlet (sensing area 15) of the fluid detecting test piece 1 is located at the end of the front end (first end 101), and the maximum width W of the sensing area 15 along the lateral short axis Y is larger than the edge
  • the maximum depth Dmax of the longitudinal long axis X as long as the opening of the sensing region 15 can accept the injection of the sample to be tested, even if the sample to be tested is injected from the center of the sensing region 15, it is originally left in the sensing region 15.
  • the air will also be discharged from the center to both sides due to the pushing of the sample to be tested.
  • the user does not need to accurately align the fluid test strip 1 with the sampling point, which is convenient for long-term chronic patients and elderly people.
  • FIG. 1D is a top view of the fluid detecting test piece 1 of the first preferred embodiment.
  • the fluid sample seeks the shortest path due to capillary action to enter the sensing region 15 in the entering direction E (parallel to the longitudinal long axis X). Then, after contacting the fluid sample against a side 133 of the support layer 13 toward the first end 101, the fluid sample will follow along due to the interaction between the cohesive force of the fluid sample itself and the contact force between the fluid sample and the side surface 133.
  • the path P (parallel to the lateral minor axis Y) flows.
  • the maximum width W of the sensing region 15 along the transverse short axis Y direction (fluid sample)
  • the maximum flow distance in the direction P is greater than the maximum depth Dmax along the longitudinal axis X (the maximum flow distance of the fluid sample in the direction E), so the longest flow path of the fluid sample in the sensing region 15 is the path P. . Therefore, while the fluid sample flows along the direction E and the path P, an interface as shown by the broken line curve in FIG. 1D is formed, and the air originally present in the sensing region 15 is pushed by the fluid sample. Other non-fluid samples of the measurement zone 15 are discharged into the direction of the zone (as indicated by the dashed straight arrow in Figure 1D).
  • Fig. 1E is a plan view of the fluid detecting test piece 1 of the first preferred embodiment.
  • the fluid sample seeks the shortest path along the entry direction E due to capillary action (with The longitudinal long axis X is parallel) into the sensing region 15.
  • the fluid sample will then follow along the interaction between the cohesive force of the fluid sample itself and the contact force between the fluid sample and the side surface 133, respectively.
  • the path P1 and the path P2 both parallel to the lateral minor axis Y) flow.
  • the longest flow path in the sensing region 15 is the path P1 plus the path P2.
  • an interface as shown by the dashed curve in Fig. 1E is formed, and the air originally present in the sensing region 15 is pushed through the fluid sample.
  • the squeezing is discharged to the direction in which the other non-fluid sample of the sensing region 15 enters the region (as indicated by the dashed straight arrow in FIG. 1E).
  • FIG. 1F is a cross-sectional view of the fluid detecting test strip 1 along the line AA of FIG. 1A according to the first preferred embodiment of the present invention.
  • the AA line is perpendicular to the longest flow path P of the fluid sample described in the previous paragraph (or P1 plus P2).
  • the upper cover 14 is disposed on the support layer 13 to completely cover the sensing region 15, and therefore, the upper cover 14 is formed with a cantilever structure at the first end 101 (shown in FIG. 1A) of the fluid detecting test strip 1.
  • the electrode 121 extends into the sensing region 15.
  • the sensing region 15 is defined by the support layer 13 together with the upper cover 14 and the substrate 11, and as shown, has a ⁇ -shaped configuration.
  • the ratio Z: Dmax of the two needs to be at least 1: 20, preferably 1 : 10 , that is, when the height Z of the sensing region 15 is ⁇ (micrometer ), the maximum of the sensing region 15 along the lateral minor axis Y
  • the depth Dmax is preferably 1 mm (millmeter).
  • the one side 141 of the upper cover 14 facing the sensing region 15 is coated with a hydrophilic material to facilitate the smooth flow of the sample to be tested into the sensing region 15.
  • the upper cover 14 is preferably a transparent material near the first end 101.
  • the present invention provides a second preferred embodiment, which is also a fluid detecting test piece, please refer to Figs. 2A to 2D.
  • the fluid detecting test piece disclosed in the present embodiment is substantially the same as that described in the first preferred embodiment, and only the differences between the two will be described below.
  • the fluid detecting test piece 2 has a longitudinal long axis X and a lateral short axis Y, and the longitudinal long axis X and the transverse short axis Y are perpendicular to each other.
  • the fluid detecting test strip 2 has a first end 201 and a second end 202 opposite the first end 201 in the longitudinal long axis X direction.
  • the first end 201 of the fluid detecting test piece 2 is provided with a lead angle structure 203 with respect to both sides of the longitudinal long axis X, and the lead angle structure 203 extends from the first end 201 to the second end 202. Further, the lead angle structure 203 shown in Fig.
  • the lead angle structure 203 may also be designed in an arc shape for special needs. Therefore, when in use, the user only needs to bring the lead structure 203 close to the sampling point (for example, at the skin pin), and the sample to be tested enters the sensing area 25 due to capillary phenomenon, which is convenient for sampling.
  • FIG. 2B there is shown an exploded perspective view of a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • the substrate 21, the plurality of electrodes 221, the support layer 23, and the upper cover 24 are sequentially stacked from bottom to top.
  • the support layer 23 has a recess 231 corresponding to the first end 201. Electrode 221 extends into sensing region 25 (shown in Figure 2A).
  • FIG. 2C is an enlarged schematic view showing a first end portion of a fluid detecting test piece according to a second preferred embodiment of the present invention.
  • the groove 231 is not a complete rectangular structure but has an approximately trapezoidal structure, so the adjacent lead angle is along the longitudinal long axis X direction.
  • Structure 203 further has a minimum depth Dmin.
  • the ratio of the minimum depth Dmin of the groove 231 to the maximum depth Dmax of the sensing region 25 is preferably 3:5 or less, more preferably 2:5 or less.
  • the recess 231 has a rounded configuration 232 toward the second end 202 (shown in FIG.
  • the reason for adopting the above design is that when the sample to be tested flows into the groove 231, the rounded configuration 232 of the groove 231 facing the second end 202 has an R value of at least 0.5 mm, thereby reducing eddy current or turbulence. Avoid creating bubbles here without disturbing the detection or quantification of the sample to be tested.
  • the maximum width W of the sensing region 25 is greater than the maximum depth Dmax, and in the design of the size ratio, the ratio of the maximum depth Dmax to the maximum width W is preferably 1:2 or less, and most preferably 1:5. .
  • the purpose of the above design is to enable the sample to be tested to enter the sensing region 25 by the groove 231 adjacent to any of the two corner structures 203 by capillary action, and the air originally left in the sensing region 25 is caused by the capillary action. The pushing of the sample to be tested is discharged toward the first end 201 and the other corner guide structure 203.
  • the upper cover 24 does not need to be additionally designed with a vent hole, and the upper cover 24 does not need to be accurately aligned with the groove 231 during the manufacturing process, thereby reducing the manufacturing cost and improving the manufacturing yield.
  • the sample inlet of the fluid detecting test piece 2 is located at the front end (first end 201), and the maximum width W and the opening width W of the sensing region 25 along the lateral minor axis Y are larger than The maximum depth Dmax along the longitudinal long axis X, when the sample to be tested is injected, the air originally left in the sensing region 25 is discharged from the center toward the two guiding structures 203 due to the pushing of the sample to be tested, and the user does not need to The fluid test strip 2 is accurately aligned with the sampling site, which is convenient for long-term chronic patients and elderly people.
  • FIG. 2D a cross-sectional view of the fluid detecting test piece 2 of the second preferred embodiment of the present invention taken along line AA of FIG. 2A.
  • the upper cover 24 is disposed on the support layer 23 to completely cover the sensing area 25.
  • the sensing region 25 is defined by the support layer 23 together with the upper cover 24 and the substrate 11.
  • the one side 241 of the upper cover 24 facing the sensing area 25 is coated with a hydrophilic material to facilitate the smooth flow of the sample to be tested into the sensing area 25 along the groove 231.
  • the detection error is caused, and the upper cover 24 is preferably transparent near the first end 201.
  • the proportional relationship between the height of the sensing region 25 and the maximum width Dmax of the sensing region 25 along the lateral minor axis is the same as that described in the first preferred embodiment, and the details are not repeated herein.

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Electrochemistry (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

一种流体检测试片（1）包括依序堆叠一基板（11，21）、多个电极（121，221）、一支撑层（13，23）以及一上盖（14，24）。该流体检测试片（1）具有互相垂直的一纵向长轴（X）以及一横向短轴（Y），且具有一第一端（101，201）以及沿该纵向长轴方向与该第一端相对的第二端（102，202）。该流体检测试片在该第一端（101，201）端末处具有一感测区域（15，25），该感测区域（15，25）平行于该横向短轴（Υ）设置且由该上盖（14，24）、该支撑层（13，23）及该基板（11，21）共同限定出。该感测区域（15，25）沿该纵向长轴方向（X）具有一最大深度，沿该横向短轴方向（Υ）具有一最大宽度，该最大宽度大于该最大深度。该流体样本进入后在该感测区域（15，25）内流动并具有一最长流动路径，且该感测区域沿垂直于该最长流动路径的剖面具有匚型构型。

Description

流体检测试片
技术领域
本发明涉及一种流体检测试片， 特别涉及一种生物检体采样区域具有 特殊设计的流体检测试片。 背景技术 片在其基板或底材上设计有流道或微流道结构并经过表面亲疏水性处理， 而因流道周围并非吸水材质， 且待测流体多为含有如蛋白质或是醣类等黏 滞度高的组成物， 所以当待测流体流过后， 会在流道上残留， 使得待测流 体无法完全反应， 如此一来， 不仅造成待测流体的浪费， 而且可能造成最 终测试结果存在误差。
此外， 传统技术的流体检测试片在流体传送方面的问题在于， 流道中 原本存在的空气会使得待测流体注入流道后产生或卷入大小不一的气泡， 进而造成流道阻塞， 导致实际测量的误差， 甚至致使测试失败。
例如， 第 3A图所示， 为传统技术采用的一种电化学检测试片 9 , 包含 有依序迭置的基板 91、 多个电极 921、 绝缘层 93 以及上盖层 94。 而在绝 缘层 93中设置有与电化学检测试片 9的短轴平行的横向沟槽 931。 因此， 在组装完成之后， 横向沟槽 931、 基板 91与上盖共同组成一个平行于流体 检测试片 9的短轴的流道 95 , 其中段设置有反应区域 950。
此种设计的电化学检测试片 9由于在流道 95两侧各具有一个开口 951 及 952 , 两个开口 951及 952均可以作为采样的样品入口。 当开口 951作 为样品入口时， 开口 952就成为排气口， 反之亦然。 即， 当待测样本（如 血液 ) 自开口 951进入流道 95之后， 待测样本利用毛细作用流经反应区域 950 , 反应区域 950中涂布有反应材料。 待测样本中的待测物（如血糖）会 与反应材料进行电化学反应， 电极 921 即可将电化学反应所产生的电流信 号传导至后方的检测仪器中加以判断。 此外， 要维持流道 95具有毛细作用， 流道 95的宽度会受到限制， 导 致开口 951与 952的大小不能太大。 在使用时， 使用者需要仔细对位才能 使待测样本 (如指尖血液)顺利流到反应区域 95之中。 然而， 电化学检测试 片 9的使用者包括患有长期慢性疾病的患者 （例如， 糖尿病患者） ， 这些 患者往往由于长期慢性疾病而衍生并发症 （例如， 眼球黄斑部病变或末梢 神经萎缩等） ， 产生视力受损或是动作协调力不足的现象， 无法进行上述 需要手眼协调能力的精细操作， 也容易造成测量上的误差与使用者的挫折 感。
此外， 美国专利 US6,258,229 中揭露了另一种设计的传统技术的电化 学检测试片。 如图 3B所示， 电化学检测试片 9，的流道 95，自其前端向后延 伸成为一近似 U型的结构， U型结构的流道 95，仅具有一个开口 951，。 在 使用时， 待测样品是从流道 95，的开口 951，注入流道 95，。 为了要避免待测 样品进入流道 95，后受到空气阻力的阻挡在流道 95，中产生气泡， 以及增进 其毛细作用和虹吸现象， 使得待测样品能够顺利流入反应区域 950，， 在流 道 95，的末端 954，上方， 在上盖层 94，上设置有排气开孔 94Γ , 使得原本存 在流道 95，之中的空气， 可以由排气开孔 941，排出。 发明内容
为克服上述缺点， 本发明提供一种流体检测试片， 用于检测一流体样 本， 包括依序堆叠的基板、 多个电极、 支撑层以及上盖。 流体检测试片具 有纵向长轴以及横向短轴， 纵向长轴与横向短轴互相垂直， 且流体检测试 片具有第一端以及沿该纵向长轴方向与第一端相对的第二端， 电极层具有 多个电极。 流体检测试片在第一端端末处具有感测区域， 感测区域平行于 横向短轴设置且由上盖、 支撑层及基板共同限定出， 电极延伸至该感测区 域内。 感测区域沿纵向长轴方向具有最大深度， 感测区域沿横向短轴方向 具有最大宽度， 最大宽度大于最大深度。 流体样本进入后在感测区域内流 动并具有最长流动路径， 且感测区域沿垂直于最长流动路径的剖面具有匸 型构型。 上盖朝向感测区域的一面， 涂布有亲水性材质。
因此， 本发明的主要目的是提供一种流体检测试片， 其感测区域从延 长轴方向的剖面来看， 为三面封闭型的区域， 当待测样品进入感测区域的 同时， 原本存在于感测区域中的空气可直接由待测样品进入处的其它方向 及位置直接排出， 不需另设排气孔道， 因此在检测试片制作过程中无须在 上盖或在支撑层或在电极层设置排气孔道， 因此也不需要与下方流道 (感测 区域 )精准对位与贴合， 因此降低了制造成本并提高了制造良率。
本发明的另一目的是提供一种流体检测试片， 其感测区域位于流体检 测试片的最前方的末端， 且其宽度大于深度， 只要是感测区域的开放处皆 可接受待测样本的注入， 注入待测样本时， 原本存在于感测区域中的空气 使用， 便于长期慢性病患及年长者使用。
本发明的另一目的是提供一种流体检测试片， 在第一端且相对于纵向 长轴的两侧可进一步设置导角结构， 使用者仅需将导角结构靠近采样处， 待测样本就会因毛细现象进入感测区域， 原本存在于感测区域中的空气便 由试片前端及另一端导角处排出， 便于采样。 附图说明
图 1 A为根据本发明第一较佳实施例的流体检测试片的组合示意图。 图 1 B为根据本发明第一较佳实施例的流体检测试片的分解示意图。 图 1C 为根据本发明第一较佳实施例的流体检测试片的第一端部份的 放大示意图。
图 1D为根据第一较佳实施例的流体检测试片的俯视图。
图 1E为根据第一较佳实施例的流体检测试片的俯视图。
图 1 F为根据本发明第一较佳实施例的流体检测试片的剖面示意图。 图 2 A为根据本发明第二较佳实施例的流体检测试片的组合示意图。 图 2B为根据本发明第二较佳实施例的流体检测试片的分解示意图。 图 2C 为根据本发明第二较佳实施例的流体检测试片的第一端部份的 放大示意图。
图 2D为根据本发明第二较佳实施例的流体检测试片的剖面示意图。 图 3 A为根据传统技术的一种电化学检测试片的示意图。 图 3B为美国专利 US6,258,229中揭露的电化学检测试片的示意图。
【主要组件符号说明】
流体检测试片 1、 2
第一端 101、 201
第二端 102、 202
导角结构 203
基板 11、 21
电极 121、 221
支撑层 13、 23
凹槽 231
圆角构型 232
支撑层朝向第一端的一侧面 133
上盖 14、 24
上盖朝向凹槽之一面 141、 241
感测区域 15、 25
感测区域的侧边处 151
感测区域的中间处 152
纵向长轴 X
横向短轴 γ
感测区域沿纵向长轴的最大深度 Dmax
凹槽沿纵向长轴的最小深度 Dmin
感测区域沿横向短轴的最大宽度 W
感测区域的开口宽度 W
感测区域的高度 Z
进入方向 E
路径 P、 Pl、 P2
长度 Ll、 L2
电化学检测试片 9、 9，
基板 91 电极 921
绝缘层 93
横向沟槽 931
— t 94、 94，
排气开孔 941 '
流道 95、 95，
反应区域 950、 950，
开口 951，
流道的末端 954， 具体实施方式
本发明揭露了一种流体检测试片， 其中利用生物样品检测原理及溶液 涂布技术， 这对于相关技术领域的普通技术人员是已知的， 因此在以下说 明中， 不再作完整描述。 同时， 以下文中的相应附图是表示与本发明特征 有关的示意图， 并未也不需要依据实际情形完整绘制， 在先声明。
首先， 请参照图 1A, 为本发明提供的第一较佳实施例的一种流体检测 试片组合的示意图。 流体检测试片 1 包括基板 1 1、 多个电极 121、 支撑层 13以及上盖 14。 基板 1 1优选用生物惰性 (bio-inert)的材料制成。
流体检测试片 1具有纵向长轴 X以及横向短轴 Y , 纵向长轴 X与横向 短轴 Y互相垂直。 流体检测试片 1具有第一端 101 , 以及沿纵向长轴 X方 向与第一端 101相对的第二端 102。
支撑层 13沿纵向长轴 X方向的长度 L2小于上盖 14沿纵向长轴 X方 向的长度 L1 , 上盖 14设置在支撑层 13上， 流体检测试片 1在第一端 101 端末处具有感测区域 15 , 并且由支撑层 13与上盖 14及基板 11共同限定 出感测区域 15 , 上盖 14完整覆盖感测区域 15。 感测区域 15平行于横向短 轴 Y设置。 在使用时， 使用者仅需将流体检测试片 1的第一端 101靠近采 样处 （例如， 皮肤扎针处） ， 待测样本就会因毛细现象进入感测区域 15 , 便于采样。
请参考图 1B , 为本发明较佳实施例的流体检测试片的分解示意图。 基 板 11、 多个电极 121、 支撑层 13以及上盖 14由下而上依序堆叠。 电极 121 覆盖在基板 11 上， 例如， 利用印刷 （printing ) 、 涂布 （coating ) 或沉积 ( deposition ) 等方法。
请参考图 1C , 为本发明较佳实施例的流体检测试片的第一端部份的放 大示意图。 感测区域 15沿横向短轴 Y方向的最大宽度 W大于纵向长轴 X 方向的最大深度 Dmax。 感测区域 15的体积优选至多 5微升（ microliter ) , 更优选为 1微升。
再次， 同前所述， 最大深度 Dmax大于最大宽度 W, 在尺寸比例的设 计上，最大深度 Dmax与最大宽度 W的比例优选为 1 : 2以下，最优选为 1 : 采用上述设计的目的在于， 能够利用毛细作用， 使待测样品能够由感 测区域 15 中的任何一个地方进入， 并且进而填满整个感测区域 15 , 原本 留存在感测区域 15中的空气则因待测样品的推挤， 向感测区域 15的其它 非待测样本进入区域的方向排出。
因此， 上盖 14无须再额外设计排气孔， 从而降低了制造成本并提高了 制造良率。 此外， 由于在使用上， 流体检测试片 1 的待测样品入口 （感测 区域 15 )位于前端 （第一端 101 ) 端末处， 且感测区域 15 沿横向短轴 Y 的最大宽度 W大于沿纵向长轴 X的最大深度 Dmax, 只要是感测区域 15 的开放处皆可接受待测样本的注入， 即使将待测样本由感测区域 15的中央 注入，原本留存在感测区域 15中的空气也会因待测样品的推挤而由中央向 两侧方向排出， 使用者无须将流体检测试片 1 与采样处精准对位， 这样便 于长期慢性病患者及年长者使用。
例如， 请参考图 1D , 为第一较佳实施例的流体检测试片 1的俯视图。 当使用者使流体样本经由感测区域的侧边处 151接触流体检测试片 1时， 流体样本由于毛细作用寻求最短路径沿进入方向 E (与纵向长轴 X平行） 进入感测区域 15。 接着， 流体样本在接触到支撑层 13 的朝向第一端 101 的一侧面 133之后， 由于流体样本本身的内聚力与流体样本与侧面 133之 间的接触力两者的交互作用， 流体样本接着会沿着路径 P (与横向短轴 Y 平行） 流动。 由于感测区域 15沿横向短轴 Y方向的最大宽度 W (流体样 本沿方向 P的最大流动距离）大于沿纵向长轴 X方向的最大深度 Dmax(流 体样本沿方向 E的最大流动距离 ) , 所以流体样本在感测区域 15中的最长 流动路径即为路径 P。 因此， 在流体样本沿着方向 E与路径 P流动的同时， 形成如图 1D中虚线曲线所示的接口， 原本存在于感测区域 15之中的空气 就会经由流体样本的推挤， 向感测区域 15的其它非流体样本进入区域的方 向 （如图 1D中虚线直线箭头的方向）排出。
另外， 请参考图 1E, 为第一较佳实施例的流体检测试片 1的俯视图。 当使用者使流体样本由感测区域 15的中间处 152 (不一定是正中央）接触 流体检测试片 1 时， 与前述的情形类似， 流体样本会由于毛细作用寻求最 短路径沿进入方向 E (与纵向长轴 X平行 )进入感测区域 15。 接着流体样 本在接触到支撑层 13的朝向第一端 101的一侧面 133之后， 由于流体样本 本身的内聚力与流体样本与侧面 133之间的接触力两者的交互作用， 流体 样本接着会分别沿着路径 P1与路径 P2 (均与横向短轴 Y平行 ) 流动。 流 体样本在此种状况下， 在感测区域 15中的最长流动路径为路径 P1加上路 径 P2。 同样地， 在流体样本沿着方向 E与路径 P 1或路径 P2流动的同时， 形成如图 1E中虚线曲线所示的接口， 原本存在于感测区域 15中的空气就 会经由流体样本的推挤，向感测区域 15的其它非流体样本进入区域的方向 (如图 1E中虚线直线箭头的方向）排出。
请继续参考图 1F,为本发明第一较佳实施例的流体检测试片 1沿图 1A 中 AA连线的剖面示意图。 AA连线垂直于之前段落所描述的流体样本的最 长流动路径 P (或是 P1加上 P2 )。 上盖 14设置在支撑层 13上， 完整覆盖 感测区域 15 , 因此， 上盖 14在流体检测试片 1的第一端 101 (如图 1A所 示） 处形成有悬臂结构。 电极 121延伸至感测区域 15 内。 感测区域 15由 支撑层 13与上盖 14及基板 11共同限定出， 且如图所示， 具有匸型构型。 此外， 当待测样本的表面张力大于其与感测区域 15之间产生的毛细作用力 时， 待测样本的进入则会变得緩慢。 因此， 为了维持感测区域 15具有较佳 的毛细作用力， 感测区域 15的高度 Z与最大深度 Dmax (如图 1C所示） ， 两者的比例 Z: Dmax需至少为 1 : 20 , 优选为 1 : 10 , 即， 当感测区域 15 的高度 Z为 ΙΟΟμηι ( micrometer )时， 感测区域 15的沿横向短轴 Y的最大 深度 Dmax优选为 lmm ( millimeter ) 。
再次， 上盖 14朝向感测区域 15的一面 141涂布有亲水性材质， 以利 于待测样品能够顺利地流入感测区域 15之中。为了能够方便观察待测样品 流入感测区域 15的状况， 以防止发生待测样品不足以填满待测区域 15而 导致检测误差， 上盖 14靠近第一端 101处优选为透明材质。
此外， 本发明还提供第二较佳实施例， 也为一种流体检测试片， 请参 考图 2A至图 2D。 本实施例中所揭露的流体检测试片与第一较佳实施例中 所述大致相同， 以下仅就两者不同之处进行说明。
请先参考图 2A, 流体检测试片 2具有纵向长轴 X以及横向短轴 Y , 纵 向长轴 X与横向短轴 Y互相垂直。 流体检测试片 2具有第一端 201 , 以及 沿纵向长轴 X方向与第一端 201相对的第二端 202。 流体检测试片 2的第 一端 201相对于纵向长轴 X的两侧，各设置有导角结构 203 ,导角结构 203 自第一端 201向第二端 202处延伸。此外， 图 2A所示的导角结构 203为直 线； 但是针对特殊需求， 导角结构 203也可设计为圆弧状。 因此， 在使用 时， 使用者仅需将导角结构 203靠近采样处 （例如， 皮肤扎针处） ， 待测 样本就会因毛细现象进入感测区域 25 , 便于采样。
请参考图 2B , 为本发明第二较佳实施例的流体检测试片的分解示意 图。 基板 21、 多个电极 221、 支撑层 23以及上盖 24由下而上依序堆叠。 支撑层 23对应于第一端 201处具有凹槽 231。 电极 221延伸至感测区域 25 (如图 2A所示 ) 内。
请参考图 2C , 为本发明第二较佳实施例的流体检测试片的第一端部份 的放大示意图。由于流体检测试片 2的第一端 201的两侧具有导角结构 203 , 所以凹槽 231 并非一个完整的矩形结构， 而是具有近似梯形的结构， 所以 在沿纵向长轴 X方向邻近导角结构 203处进一步具有最小深度 Dmin。 而 且， 凹槽 231的最小深度 Dmin与感测区域 25的最大深度 Dmax的比例优 选为 3 : 5以下， 更优选为 2: 5以下。 此外， 凹槽 231朝向第二端 202 (如 图 2A所示）处且相对于纵向长轴 X的两侧各具有圆角构型 232。采用上述 设计的原因在于， 当待测样品流入凹槽 231时， 位于凹槽 231朝向第二端 202的圆角构型 232 ,其 R值至少为 0.5mm,因此可以降低涡流或紊流现象， 避免在此处产生气泡， 而不致妨碍待测样品的检测或定量。
再次， 同前所述， 感测区域 25的最大宽度 W大于最大深度 Dmax, 而 在尺寸比例的设计上， 最大深度 Dmax与最大宽度 W的比例优选为 1 : 2 以下， 最优选为 1 : 5。 采用上述设计的目的在于， 能够利用毛细作用， 使 待测样品能够由凹槽 231邻近两导角结构 203中的任何一个地方进入感测 区域 25 , 原本留存在感测区域 25 中的空气则因待测样品的推挤， 向第一 端 201以及另一处的导角结构 203方向排出。 因此， 上盖 24无须再额外设 计排气孔， 在制作过程中， 上盖 24无须与凹槽 231进行精准对位， 因此降 低了制造成本并提高了制造良率。 此外， 由于在使用上， 流体检测试片 2 的待测样品入口位于前方的末端 （第一端 201 ) , 且感测区域 25的沿横向 短轴 Y的最大宽度 W以及开口宽度 W，均大于沿纵向长轴 X的最大深度 Dmax, 在注入待测样本时， 原本留存在感测区域 25 中的空气则因待测样 品的推挤而由中央向两导角结构 203方向排出， 使用者无须将流体检测试 片 2与采样处精准对位， 这样便于长期慢性病患与年长者使用。
请参考图 2D , 为本发明第二较佳实施例的流体检测试片 2沿第 2A图 中 AA连线的剖面示意图。 上盖 24设置于支撑层 23上， 完整覆盖感测区 域 25。 感测区域 25由支撑层 23与上盖 24及基板 11共同限定。 而且， 上 盖 24朝向感测区域 25的一面 241涂布有亲水性材质， 以利于待测样品能 够顺利地沿凹槽 231流入感测区域 25之中。为了能够方便观察待测样品流 入感测区域 25的状况， 以防止发生待测样品不足以填满感测区域 25而导 致检测误差， 上盖 24靠近第一端 201处优选为透明材质。 感测区域 25的 高度与感测区域 25沿横向短轴的最大宽度 Dmax两者之间的比例关系与第 一较佳实施例中所述相同， 在此不再重复赘述。
以上所述仅为本发明较佳实施例而已， 并非用来限定本发明申请专利 权利； 同时以上的描述对于本领域技术人员来说应该可以明白与实施， 因 此在不脱离本发明所揭示的精神下所完成的等效改变或修改， 均应包含在 本申请的范围内。

Claims

权利要求书
1、 一种流体检测试片， 用于检测一流体样本， 包括依序堆叠一基板、 多个电极、 一支撑层以及一上盖， 该流体检测试片具有一纵向长轴以及一 横向短轴， 该纵向长轴与横向短轴互相垂直， 且该流体检测试片具有一第 一端以及沿该纵向长轴方向与该第一端相对的第二端， 其特征在于：
该流体检测试片在该第一端端末处具有一感测区域， 该感测区域平行 于该横向短轴设置且由该上盖、 该支撑层及该基板共同限定出， 该等电极 延伸至该感测区 i或内；
该感测区域沿该纵向长轴方向具有一最大深度， 该感测区域沿该横向 短轴方向具有一最大宽度， 该最大宽度大于该最大深度；
该流体样本进入后在该感测区域内流动并具有一最长流动路径， 且该 感测区域沿垂直于该最长流动路径的剖面具有匸型构型； 以及
该上盖朝向该感测区域的一面涂布有亲水性材质。
2、 根据权利要求 1所述的流体检测试片， 其中， 该最大深度与该最 大宽度的比例为 1 : 2以下。
3、 根据权利要求 1所述的流体检测试片， 其中， 该流体检测试片在 该第一端相对于该纵向长轴的两侧， 各设置有一导角结构， 该导角结构自 该第一端向该第二端处延伸。
4、 根据权利要求 3所述的流体检测试片， 其中， 该支撑层在对应该 第一端处形成有一凹槽， 且该凹槽沿该纵向长轴方向进一步具有一最小深 度， 且该最小深度与该感测区域的该最大深度的比例为 3: 5以下。
5、 根据权利要求 4所述的流体检测试片， 其中， 该最小深度与该最 大深度的比例优选为 1 : 5以下。
6、 根据权利要求 4所述的流体检测试片， 其中， 该凹槽朝向该第二 端处且相对于该纵向长轴的两侧各具有一圆角构型， 其中该圆角构型的曲 率半径 （R )值系至少为 0.5毫米。
7、 根据权利要求 3所述的流体检测试片， 其中， 该两导角结构为圆 孤状或直线。
8、 根据权利要求 1 所述的流体检测试片， 该感测区域的体积至少 5 微升。
9、 根据权利要求 1所述的流体检测试片， 其中， 该基板为生物惰性 材料。
10、 根据权利要求 1所述的流体检测试片， 该上盖靠近该第一端处为 透明材质。
PCT/CN2010/075153 2010-07-14 2010-07-14 流体检测试片 WO2012006778A1 (zh)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2013518927A JP2013530409A (ja) 2010-07-14 2010-07-14 体液サンプル検出用試験ストリップ
PCT/CN2010/075153 WO2012006778A1 (zh) 2010-07-14 2010-07-14 流体检测试片

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2010/075153 WO2012006778A1 (zh) 2010-07-14 2010-07-14 流体检测试片

Publications (1)

Publication Number Publication Date
WO2012006778A1 true WO2012006778A1 (zh) 2012-01-19

Family

ID=45468877

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2010/075153 WO2012006778A1 (zh) 2010-07-14 2010-07-14 流体检测试片

Country Status (2)

Country Link
JP (1) JP2013530409A (zh)
WO (1) WO2012006778A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2501870A (en) * 2012-04-13 2013-11-13 Smartcare Technologies Ltd Sample plate for electrical measurements

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6258229B1 (en) * 1999-06-02 2001-07-10 Handani Winarta Disposable sub-microliter volume sensor and method of making
CA2481425A1 (en) * 2002-04-19 2003-10-30 Nova Biomedical Corporation Disposable sensor with enhanced sample port inlet
WO2004093784A2 (en) * 2003-04-21 2004-11-04 Home Diagnostics, Inc. Systems and methods for blood glucose sensing
CN1675537A (zh) * 2002-08-13 2005-09-28 郡是株式会社 生物传感器及其制造方法
CN201145695Y (zh) * 2008-01-24 2008-11-05 五鼎生物技术股份有限公司 生化感测试片
CN201355357Y (zh) * 2009-02-18 2009-12-02 五鼎生物技术股份有限公司 生化感测试片、生化感测系统及测量装置

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11125618A (ja) * 1997-08-22 1999-05-11 Nok Corp バイオセンサ
JPH11304748A (ja) * 1998-04-23 1999-11-05 Omron Corp バイオセンサ
JP4345885B2 (ja) * 2003-07-24 2009-10-14 グンゼ株式会社 バイオセンサ
US7846311B2 (en) * 2005-09-27 2010-12-07 Abbott Diabetes Care Inc. In vitro analyte sensor and methods of use

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6258229B1 (en) * 1999-06-02 2001-07-10 Handani Winarta Disposable sub-microliter volume sensor and method of making
CA2481425A1 (en) * 2002-04-19 2003-10-30 Nova Biomedical Corporation Disposable sensor with enhanced sample port inlet
CN1675537A (zh) * 2002-08-13 2005-09-28 郡是株式会社 生物传感器及其制造方法
WO2004093784A2 (en) * 2003-04-21 2004-11-04 Home Diagnostics, Inc. Systems and methods for blood glucose sensing
CN201145695Y (zh) * 2008-01-24 2008-11-05 五鼎生物技术股份有限公司 生化感测试片
CN201355357Y (zh) * 2009-02-18 2009-12-02 五鼎生物技术股份有限公司 生化感测试片、生化感测系统及测量装置

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2501870A (en) * 2012-04-13 2013-11-13 Smartcare Technologies Ltd Sample plate for electrical measurements
GB2501870B (en) * 2012-04-13 2018-07-18 Smartcare Tech Limited Improvements in and relating to sample measurement
US10641724B2 (en) 2012-04-13 2020-05-05 Smartcase Technologies Limited Electrical impedance hematocrit and HBA1C biosensor comprising sample plate and sample apparatus
US11415541B2 (en) 2012-04-13 2022-08-16 Smartcare Technologies Ltd Electrical impedance hematocrit and HbA1c biosensor comprising sample plate and sample apparatus

Also Published As

Publication number Publication date
JP2013530409A (ja) 2013-07-25

Similar Documents

Publication Publication Date Title
KR100951741B1 (ko) 바이오센서
EP2275820B1 (en) Diagnostic test strip having fluid transport features
US10571425B2 (en) Disposable test sensor with improved sampling entrance
WO2009044088A1 (en) Assay device and method
JPWO2007026683A1 (ja) 試料供給状態の検出方法および分析用具
KR20150048702A (ko) 교차하는 샘플 수용 챔버들을 가진 전기화학-기반 분석 검사 스트립
WO2022100617A1 (zh) 生物传感器
US10088444B2 (en) Disposable test sensor with improved sampling entrance
WO2012006778A1 (zh) 流体检测试片
CN110146568A (zh) 一种多参数电化学检测电极片
KR101875417B1 (ko) 바이오센서
US10386323B2 (en) Test sensor with multiple sampling routes
CN209559811U (zh) 一种多参数电化学检测电极片
CN102135523A (zh) 连接器及包含该连接器的生物传感器装置
US20110315549A1 (en) Testing strip for detecting a fluidic sample
CN102297885A (zh) 具有微通道的生物感测试片结构
WO2011161926A1 (ja) バイオセンサ、同バイオセンサを収納するカートリッジ、同バイオセンサを用いた測定装置
TW201403063A (zh) 具有被擋止連結處分開的毛細吸附樣本接收室之分析測試條
JP5487466B2 (ja) 分析用デバイス
TWI589875B (zh) 多參數型之生物感測試片
WO2008007702A1 (en) Biosensor chip and process for manufacturing the same
TW201501694A (zh) 具有經實體障壁島分隔之毛細管試樣接受室的分析測試條

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 10854571

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2013518927

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 10854571

Country of ref document: EP

Kind code of ref document: A1