JP5420246B2 - 体液の検査をするためのテストエレメントおよびテストシステム - Google Patents
体液の検査をするためのテストエレメントおよびテストシステム Download PDFInfo
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- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
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- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
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- A61B5/15—Devices for taking samples of blood
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- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
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- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150435—Specific design of proximal end
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- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15149—Arrangement of piercing elements relative to each other
- A61B5/15151—Each piercing element being stocked in a separate isolated compartment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
- A61B5/15159—Piercing elements stocked in or on a disc
- A61B5/15163—Characterized by propelling the piercing element in an axial direction relative to the disc
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- A—HUMAN NECESSITIES
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- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
- A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
- A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
- A61B5/15174—Piercing elements stocked in the form of a stack or pile
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6848—Needles
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N21/7703—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator using reagent-clad optical fibres or optical waveguides
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
- G01N2021/7769—Measurement method of reaction-produced change in sensor
- G01N2021/7773—Reflection
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Description
Claims (20)
- 身体部位へ穿刺可能な穿刺部分(14)と、
前記穿刺部分(14)上に構成された、穿刺により得られた体液の採取領域(16)と、
前記採取領域(16)で光学測定をするための少なくとも1つの光導波路(18)とを備える、体液の検査をするための使い捨て用品としてのテストエレメントにおいて、
前記採取領域は穿刺方向に延びている前記穿刺部分(14)の採取凹所(16)によって形成されており、前記光導波路(18)は前記穿刺部分(14)へ統合されているとともに、前記光導波路(18)の遠位端(36)が前記採取凹所(16)内に突出し、
前記採取凹所(16)が、毛管作用のある通路として、前記穿刺部分(14)の片側の側面または両側側面において開いたスリットであり、前記スリットが、前記採取凹所(16)の長さ全体にわたって延びていることを特徴とするテストエレメント。 - 前記光導波路(18)はその遠位端(36)で、前記採取凹所(16)を充填する体液を検出するためのプローブを形成していることを特徴とする請求項1記載のテストエレメント。
- 前記光導波路(18)および/または前記電極は検出された体液との接触に依存して前記穿刺部分(14)の運動制御をするための測定信号を供給することを特徴とする請求項1または2記載のテストエレメント。
- 前記光導波路(18)の遠位端(36)の領域に、体液中の分析物に対して反応するテスト区画(38)が配置されていることを特徴とする請求項1〜3のいずれか1項に記載のテストエレメント。
- 前記テスト区画(38)が不可逆的に反応をする請求項4記載のテストエレメント。
- 少なくとも2つまたは3つの別個の光導波路(18)が並行測定のために前記穿刺部分(14)へ統合されており、それぞれの前記光導波路(18)の遠位端(36)は互いに側方の間隔をおいて配置されていることを特徴とする請求項1〜5のいずれか1項に記載のテストエレメント。
- 前記光導波路(18)の前記遠位端は支持フィルム(62)を介して1つの共通のテスト区画(38)へ光学的に結合されており、該テスト区画(38)は、前記光導波路(18)と反対を向いているほうの前記支持フィルム(62)の自由な前面に塗布された試薬層によって形成されていることを特徴とする請求項6記載のテストエレメント。
- 前記支持フィルム(62)の厚みは隣接する前記光導波路(18)の中心線の相互間隔の0.5〜1.5倍であることを特徴とする請求項7記載のテストエレメント。
- 前記光導波路、前記支持フィルム(62)、および前記試薬層は互いに適合化された実質的に一致する屈折率を有していることを特徴とする請求項7または8記載のテストエレメント。
- 前記テスト区画(38)は前記試薬層に、体液の溶液中で前記試薬層の屈折率を少なくとも1つの前記光導波路の屈折率に合わせて適合化する反応中立的な補助物質を含んでいることを特徴とする請求項4〜8のいずれか1項に記載のテストエレメント。
- 前記反応中立的な補助物質が塩化ナトリウムであることを特徴とする請求項10記載のテストエレメント。
- 前記光導波路(18)は好ましくは光学コネクタを介して前記測定装置(12)の光学的な送信ユニット(54)および/または受信ユニット(58)と取り外し可能に接続可能であることを特徴とする請求項1〜6のいずれか1項に記載のテストエレメント。
- 前記採取凹所(16)の長さは、穿刺方向で見て、前記採取凹所(16)の近位の端部区域が穿刺時に身体部位の外部にとどまるように設定されていることを特徴とする請求項1〜8のいずれか1項に記載のテストエレメント。
- 前記採取凹所(16)は1〜100nlの容積を有していることを特徴とする請求項1〜9のいずれか1項に記載のテストエレメント。
- 前記採取凹所(16)が5〜50nlの容積を有していることを特徴とする請求項1〜9のいずれか1項に記載のテストエレメント。
- 前記採取凹所(16)は断面が拡張した近位の端部区域を測定ゾーン(34)として有していることを特徴とする請求項1〜11のいずれか1項に記載のテストエレメント。
- 身体部位へ穿刺可能な穿刺部分(14)と、
前記穿刺部分(14)上に構成された、穿刺により得られた体液の採取領域(16)と、
前記採取領域(16)で光学測定または電気化学測定をするための、光導波路または電気的な条導体として構成された少なくとも1つの信号導体(18)とを備える、体液を検査するための使い捨て用品としてのテストエレメントにおいて、
前記採取領域は穿刺方向に長く延びる毛管として作用する前記穿刺部分(14)の採取凹所(16)によって形成されており、前記信号導体(18)は前記穿刺部分(14)に統合されているとともに、体液中の分析物に対して反応する試薬を含んだテスト区画(38)に連結されており、該テスト区画は前記採取凹所(16)の近位の測定ゾーン(34)で、流れ込んでくる体液に対して毛管断面を前面で少なくとも部分的に区切り、
前記信号導体(18)の遠位端が前記採取凹所(16)内に突出し、
前記採取凹所(16)が、毛管作用のある通路として、前記穿刺部分(14)の片側の側面または両側側面において開いたスリットであり、前記スリットが、前記採取凹所(16)の長さ全体にわたって延びていることを特徴とするテストエレメント。 - 請求項1〜17のいずれか1項に記載の少なくとも1つのテストエレメント(10)のための収容部を備えている、体液を検査するためのテストシステム。
- 多数の前記テストエレメント(10)を備蓄しておくためのマガジンを有していることを特徴とする請求項18記載のテストシステム。
- 前記マガジンが、円盤型マガジンまたはドラム型マガジンであることを特徴とする請求項19記載のテストシステム。
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Application Number | Priority Date | Filing Date | Title |
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EP05022535.8 | 2005-10-15 | ||
EP05022535 | 2005-10-15 | ||
PCT/EP2006/009945 WO2007045412A1 (de) | 2005-10-15 | 2006-10-15 | Testelement und testsystem zur untersuchung einer körperflüssigkeit |
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JP2009511141A JP2009511141A (ja) | 2009-03-19 |
JP2009511141A5 JP2009511141A5 (ja) | 2009-12-03 |
JP5420246B2 true JP5420246B2 (ja) | 2014-02-19 |
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JP2008534947A Expired - Fee Related JP5420246B2 (ja) | 2005-10-15 | 2006-10-15 | 体液の検査をするためのテストエレメントおよびテストシステム |
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Country | Link |
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US (1) | US9883828B2 (ja) |
EP (1) | EP1933695B1 (ja) |
JP (1) | JP5420246B2 (ja) |
CN (1) | CN101287406B (ja) |
CA (1) | CA2625857C (ja) |
HK (1) | HK1125017A1 (ja) |
WO (1) | WO2007045412A1 (ja) |
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CN101287406B (zh) | 2013-04-10 |
WO2007045412A1 (de) | 2007-04-26 |
CA2625857A1 (en) | 2007-04-26 |
EP1933695A1 (de) | 2008-06-25 |
JP2009511141A (ja) | 2009-03-19 |
CN101287406A (zh) | 2008-10-15 |
US9883828B2 (en) | 2018-02-06 |
EP1933695B1 (de) | 2015-05-27 |
CA2625857C (en) | 2013-05-28 |
HK1125017A1 (en) | 2009-07-31 |
US20080249435A1 (en) | 2008-10-09 |
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