JP5612607B2 - 体液を分析するシステム及び方法 - Google Patents
体液を分析するシステム及び方法 Download PDFInfo
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- JP5612607B2 JP5612607B2 JP2011545730A JP2011545730A JP5612607B2 JP 5612607 B2 JP5612607 B2 JP 5612607B2 JP 2011545730 A JP2011545730 A JP 2011545730A JP 2011545730 A JP2011545730 A JP 2011545730A JP 5612607 B2 JP5612607 B2 JP 5612607B2
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00009—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones
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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
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
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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
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
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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
- A61B5/145—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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- 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
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
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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
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
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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
- A61B5/150007—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
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
-
- 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
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
- A61B5/150511—Details of construction of shaft
-
- 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.
-
- 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
- G01N21/84—Systems specially adapted for particular applications
- G01N21/8483—Investigating reagent band
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1065—Multiple transfer devices
- G01N35/1067—Multiple transfer devices for transfer to or from containers having different spacing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- 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
- A61B5/1455—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
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- Life Sciences & Earth Sciences (AREA)
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- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Emergency Medicine (AREA)
- Optics & Photonics (AREA)
- Dermatology (AREA)
- Urology & Nephrology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Sampling And Sample Adjustment (AREA)
Description
リザーバ内に体液を収容している採取要素と、上記体液中の分析対象物を検出すべく設計された検査要素との間に流体的接続が確立され、
測定期間の間においては上記検査要素上で分析対象物固有の測定信号が検出され、
上記検査要素は、該検査要素の検出領域上に液体柱が維持される様に、測定期間の間において、上記リザーバ内に配置された上記体液に対して持続的に接触され、
上記測定期間の後、上記検査要素及び上記採取要素は相互から分離される。
Claims (14)
- 体液(32)をリザーバ(28)内に受容する採取要素(14)と、
前記体液(32)中の分析対象物を検出すべく構成された検査要素(18)と、
前記採取要素(14)と前記検査要素(18)との間の流体的接続を確立するための移送デバイス(20)と、
測定期間の間においては前記検査要素(18)上で分析対象物固有の測定信号を検出する検出ユニット(22)とを具備する体液を分析するシステムにおいて、
前記移送デバイス(20)が、前記検査要素(18)の検出領域(38)上に液体柱(44)が維持される様に、前記測定期間の間において、前記リザーバ(28)内に配置された前記体液(32)に対して前記検査要素(18)を持続的に接触させ、
前記リザーバ(28)の液体容積は、前記検出領域(38)に亙る前記液体柱(44)が、前記測定期間の持続時間に亙り最小高さを下回らない様に定められ、且つ、
前記移送デバイス(20)が、前記測定期間の後、前記検査要素(18)及び前記採取要素(14)を相互から物理的に分離させるべく構成され、
前記液体柱(44)の前記最小高さは、10μmより大きいことを特徴とするシステム。 - 前記液体柱(44)の前記最小高さは、50μmより大きいことを特徴とする請求項1に記載のシステム。
- 前記検査要素(18)が、前記測定期間の間において前記体液(32)を展開領域(46)に亙り2次元的に分布させるべく構成され、且つ、
前記展開領域(46)のサイズ及び前記リザーバ(28)の容積が、前記測定期間の間において前記検出領域(38)に亙り液体柱(44)が維持されるように整合されることを特徴とする請求項1又は2に記載のシステム。 - 前記リザーバ(28)が、50〜150μmの深さと、50〜150μmの幅と、1mmより大きく、好適には約2mmの長さとを有することを特徴とする請求項1乃至3のいずれか一項に記載のシステム。
- 前記検出領域(38)は0.1mm2〜1mm2の範囲内のサイズを有することを特徴とする請求項1乃至4のいずれか一項に記載のシステム。
- 前記分析対象物固有の測定信号が、前記採取要素及び検査要素(14、18)の間における前記流体的接続を確立した後で、0〜15秒の時間間隔内に検出されることを特徴とする請求項1乃至5のいずれか一項に記載のシステム。
- 前記測定期間の終了が、単位時間当たりの測定信号の変化が予め定められた値に到達したときであると定められることを特徴とする請求項1乃至6のいずれか一項に記載のシステム。
- 前記採取要素(14)及び検査要素(18)が、初期状態においては別体的な構成要素として離間され、且つ、
前記流体的接続が、前記採取要素(14)及び/又は前記検査要素(18)を能動的に移動させ乍ら確立され得ることを特徴とする請求項1乃至7のいずれか一項に記載のシステム。 - 前記体液が穿刺プロセスにより取り込まれ、且つ、
前記検査要素(18)に対する前記採取要素(14)の前記流体的接続が、前記穿刺プロセスの後まで確立されないことを特徴とする請求項1乃至8のいずれか一項に記載のシステム。 - 前記リザーバ(28)が、好適には片面にて開放される毛細管状構造、特に直線状の毛細管状チャネル又は毛細管状間隙により形成されることを特徴とする請求項1乃至9のいずれか一項に記載のシステム。
- 前記検出領域(38)が、特に測光式検出のための酵素に基づく乾燥化学層(30)により形成されることを特徴とする請求項1乃至10のいずれか一項に記載のシステム。
- 前記採取要素(14)が、少なくとも前記リザーバ(28)の領域において親水性被覆(34)を備えることを特徴とする請求項1乃至11のいずれか一項に記載のシステム。
- 前記採取要素(14)及び前記検査要素(18)が、前記測定期間の後、好適には前記移送デバイス(20)によって相互から再び離間され得ることを特徴とする請求項1乃至12のいずれか一項に記載のシステム。
- a)体液(32)をリザーバ(28)内に受容している採取要素(14)と、前記体液(32)中の分析対象物を検出すべく構成された検査要素(18)との間に流体的接続が確立され、
b)測定期間の間においては前記検査要素(18)上で分析対象物固有の測定信号が検出される、
体液を分析する方法において、
c)前記検査要素(18)が、該検査要素(18)の検出領域(38)上に液体柱(44)が維持される様に、前記測定期間の間において、前記リザーバ(28)内に配置された前記体液(32)に対して持続的に接触され、
d)前記リザーバ(28)の液体容積は、前記検出領域(38)に亙る前記液体柱(44)が、前記測定期間の持続時間に亙り最小高さを下回らない様に定められ、且つ、
e)前記測定期間の後、前記検査要素(18)及び前記採取要素(14)は相互から分離され、
前記液体柱(44)の前記最小高さは、10μmより大きいことを特徴とする方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20090150807 EP2208459A1 (de) | 2009-01-16 | 2009-01-16 | System und Verfahren zur Analyse einer Körperflüssigkeit |
EP09150807.7 | 2009-01-16 | ||
PCT/EP2010/050395 WO2010081848A1 (de) | 2009-01-16 | 2010-01-14 | System und verfahren zur analyse einer körperflüssigkeit |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2012515028A JP2012515028A (ja) | 2012-07-05 |
JP5612607B2 true JP5612607B2 (ja) | 2014-10-22 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2011545730A Expired - Fee Related JP5612607B2 (ja) | 2009-01-16 | 2010-01-14 | 体液を分析するシステム及び方法 |
Country Status (13)
Country | Link |
---|---|
US (1) | US9128066B2 (ja) |
EP (2) | EP2208459A1 (ja) |
JP (1) | JP5612607B2 (ja) |
KR (1) | KR101717794B1 (ja) |
CN (1) | CN102281814B (ja) |
AU (1) | AU2010205619B2 (ja) |
BR (1) | BRPI1006854B8 (ja) |
CA (1) | CA2749052C (ja) |
HK (1) | HK1164670A1 (ja) |
MX (1) | MX2011007453A (ja) |
RU (1) | RU2545790C2 (ja) |
SG (2) | SG173024A1 (ja) |
WO (1) | WO2010081848A1 (ja) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
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RU2663732C1 (ru) * | 2017-05-04 | 2018-08-09 | Игорь Михайлович Рулев | Способ автоматического отбора и упаковки микробиологических объектов |
CN110891485A (zh) * | 2017-08-02 | 2020-03-17 | 豪夫迈·罗氏有限公司 | 葡萄糖测试装置和方法 |
EP3477287A1 (en) * | 2017-10-26 | 2019-05-01 | Roche Diabetes Care GmbH | Analyte measuring system and method |
WO2021134014A1 (en) * | 2019-12-27 | 2021-07-01 | Sean Kelly | Analysis of a biological sample using tape-to-tape fluidic transfer |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5801057A (en) * | 1996-03-22 | 1998-09-01 | Smart; Wilson H. | Microsampling device and method of construction |
ATE335435T1 (de) * | 2001-06-08 | 2006-09-15 | Hoffmann La Roche | Entnahmevorrichtung für körperflüssigkeiten und testmedienskassette |
US7303726B2 (en) | 2002-05-09 | 2007-12-04 | Lifescan, Inc. | Minimal procedure analyte test system |
DE10332488A1 (de) | 2003-07-16 | 2005-02-24 | Roche Diagnostics Gmbh | Analysegerät und Analyseverfahren für Körperflüssigkeiten |
US20050137471A1 (en) * | 2003-12-18 | 2005-06-23 | Hans-Peter Haar | Continuous glucose monitoring device |
PT1722670E (pt) * | 2004-03-06 | 2013-11-27 | Hoffmann La Roche | Dispositivo de amostragem de fluido corporal |
EP1627684A1 (de) * | 2004-08-20 | 2006-02-22 | F. Hoffmann-La Roche Ag | Mikrofluidiksystem und Verfahren zu dessen Herstellung |
EP1760469A1 (de) | 2005-09-01 | 2007-03-07 | F.Hoffmann-La Roche Ag | Testsystem zur Untersuchung von Körperflüssigkeiten mit einem drehbaren Optikelement |
EP1759633A1 (de) * | 2005-09-01 | 2007-03-07 | F.Hoffmann-La Roche Ag | Anordnung zum Aufnehmen von Körperflüssigkeiten sowie Herstellungsverfahren hierfür |
-
2009
- 2009-01-16 EP EP20090150807 patent/EP2208459A1/de not_active Withdrawn
-
2010
- 2010-01-14 JP JP2011545730A patent/JP5612607B2/ja not_active Expired - Fee Related
- 2010-01-14 EP EP10700410.3A patent/EP2389097B1/de not_active Not-in-force
- 2010-01-14 KR KR1020117016595A patent/KR101717794B1/ko active IP Right Grant
- 2010-01-14 CA CA2749052A patent/CA2749052C/en not_active Expired - Fee Related
- 2010-01-14 BR BRPI1006854A patent/BRPI1006854B8/pt not_active IP Right Cessation
- 2010-01-14 AU AU2010205619A patent/AU2010205619B2/en not_active Ceased
- 2010-01-14 WO PCT/EP2010/050395 patent/WO2010081848A1/de active Application Filing
- 2010-01-14 SG SG2011051588A patent/SG173024A1/en unknown
- 2010-01-14 CN CN201080004955.4A patent/CN102281814B/zh not_active Expired - Fee Related
- 2010-01-14 RU RU2011134297/15A patent/RU2545790C2/ru active
- 2010-01-14 MX MX2011007453A patent/MX2011007453A/es active IP Right Grant
- 2010-01-14 SG SG2014003255A patent/SG196822A1/en unknown
-
2011
- 2011-07-15 US US13/183,976 patent/US9128066B2/en not_active Expired - Fee Related
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2012
- 2012-06-05 HK HK12105460.6A patent/HK1164670A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
CN102281814B (zh) | 2014-10-29 |
RU2011134297A (ru) | 2013-02-27 |
BRPI1006854B8 (pt) | 2021-06-22 |
CN102281814A (zh) | 2011-12-14 |
KR20110110191A (ko) | 2011-10-06 |
EP2389097A1 (de) | 2011-11-30 |
EP2389097B1 (de) | 2014-11-26 |
SG196822A1 (en) | 2014-02-13 |
EP2208459A1 (de) | 2010-07-21 |
BRPI1006854B1 (pt) | 2021-02-09 |
BRPI1006854A2 (pt) | 2020-09-15 |
JP2012515028A (ja) | 2012-07-05 |
CA2749052A1 (en) | 2010-07-22 |
RU2545790C2 (ru) | 2015-04-10 |
HK1164670A1 (en) | 2012-09-28 |
AU2010205619A1 (en) | 2011-08-04 |
US20120006105A1 (en) | 2012-01-12 |
SG173024A1 (en) | 2011-08-29 |
KR101717794B1 (ko) | 2017-03-17 |
US9128066B2 (en) | 2015-09-08 |
CA2749052C (en) | 2017-07-11 |
WO2010081848A1 (de) | 2010-07-22 |
AU2010205619B2 (en) | 2014-11-20 |
MX2011007453A (es) | 2011-07-21 |
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