JP6076313B2 - 体液中の検体の検出のためのシステム - Google Patents
体液中の検体の検出のためのシステム Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value 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
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
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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
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
- A61B5/150152—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by an adequate mechanical impact on the puncturing location
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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
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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
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
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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
- A61B5/150503—Single-ended needles
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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
- A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
- A61B5/150816—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by tactile feedback, e.g. vibration
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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
- A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
- A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
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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
- A61B5/150954—Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
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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
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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
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15109—Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
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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
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
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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
- A61B5/15—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
- A61B5/15123—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 comprising magnets or solenoids
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- Pain & Pain Management (AREA)
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- Optics & Photonics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
Description
112 ハウジング
114 内部
116 開口部
118 指
120 ランセット
122 皮膚部分
124 駆動装置
126 搬送装置
128 テストエレメント
129 テストパネル
130 試料
132 キャピラリー
134 測定装置
136 制御部
138 光学センサ
140 湿度計
142 さらなるパラメータのためのセンサ
Claims (24)
- 体液中の少なくとも1つの検体の検出のためのシステム(110)であって、
前記システム(110)が、前記体液の試料(130)を生成するための少なくとも1つのランセット(120)と、該試料(130)を受承し、前記少なくとも1つの検体を検出する少なくとも1つのテストエレメント(128)と、生成した前記試料(130)を前記少なくとも1つのテストエレメント(128)に搬送する少なくとも1つの搬送機構とを備え、
前記少なくとも1つのランセットによる前記試料(130)の生成と、前記少なくとも1つの搬送機構による前記試料(130)の前記テストエレメント(128)への適用との間の搬送時間が、1秒未満となるように設計され、
前記システム(110)が、前記試料(130)の生成中および/または前記テストエレメント(128)への前記試料(130)の搬送中に、少なくとも1つの湿度計により湿度を検出するように設計され、
さらに、制御部(136)によって、前記検体の検出の結果として生じた測定値を、前記湿度に応じて補正可能なように設計され、
前記湿度に依存する蒸発効果および結果として生じる濃度変化が補償され、
前記システム(110)が、前記システム(110)によって取り込まれた前記試料(130)および/または前記テストエレメント(128)に搬送された前記試料(130)の実際の試料体積を少なくとも1つの光学センサ(138)によって検出するように設計されてなり、
前記システム(110)が、さらに、制御部(136)によって、前記検体の検出の結果として生じた測定値を、前記実際の試料体積に応じて補正可能なように設計されてなり、試料体積に依存する蒸発効果および結果として生じる濃度変化が補償されるシステム(110)。 - 前記検体が血糖である請求項1記載のシステム(110)。
- 前記テストエレメント(128)が、テストパネル(129)である請求項1または2記載のシステム(110)。
- 前記搬送時間が、500ミリ秒未満となるように設計されてなる請求項1〜3のいずれか1項に記載のシステム(110)。
- 前記搬送機構が、
前記システム(110)に備えられた少なくとも1つのキャピラリー(132)によって、前記試料(130)を前記テストエレメント(128)に搬送する機構、
少なくとも部分的にキャピラリー(132)として設計された少なくとも1つのランセット(120)によって、前記試料(130)を前記テストエレメント(128)に搬送する機構、および、
前記試料(130)が、まず皮膚部分上に生成され、その後、前記皮膚部分および/または前記試料(130)に対する前記テストエレメント(128)の移動により、前記テストエレメント(128)に搬送される少なくとも1つの機構により、前記試料(130)を前記テストエレメント(128)に搬送する機構、
のうち、1つまたは2つ以上の機構を含む請求項1〜4のいずれか1項に記載のシステム(110)。 - 前記ランセット(120)が、少なくとも部分的に、前記ランセット(120)の長手方向に沿って部分的に開口したキャピラリー(132)として設計されてなる請求項5記載のシステム(110)。
- 前記ランセット(120)が、一体化されたテストエレメント(128)を有してなる請求項1〜6のいずれか1項に記載のシステム(110)。
- 皮膚部分を穿刺するための少なくとも1つのランセット(120)を含むシステムであって、前記試料(130)が、前記システム(110)に備えられた少なくとも1つのキャピラリー(132)を介して搬送され、前記テストエレメント(128)が前記ランセット(120)に一体化されてなる請求項1〜7のいずれか1項に記載のシステム(110)。
- 前記キャピラリー(132)が、前記ランセット(120)に一体化されてなる請求項8記載のシステム(110)。
- 少なくとも1つのキャピラリー(132)が前記試料(130)の搬送のために設けられ、該キャピラリー(132)が、少なくとも1回の親水化処理がなされる請求項1〜9のいずれか1項に記載のシステム(110)。
- 少なくとも1つのキャピラリー(132)が前記試料(130)の搬送のために設けられ、該キャピラリー(132)が、少なくとも1回の親水化処理により形成される少なくとも1種類の親水性被膜を有してなる請求項1〜9のいずれか1項に記載のシステム(110)。
- 少なくとも1つのキャピラリー(132)が前記試料(130)の搬送のために設けられ、キャピラリーの径に対する、キャピラリーのうちの試料を充填可能な長さの割合が100未満である請求項1〜11のいずれか1項に記載のシステム(110)。
- 前記システム(110)によって取り込まれ、前記テストエレメント(128)に搬送される前記試料(130)の試料体積が10nlを超えるように設計されてなり、試料体積が500nl未満である請求項1〜12のいずれか1項に記載のシステム(110)。
- 前記試料体積が、300nl未満である請求項13記載のシステム(110)。
- 前記試料体積が、200nl未満である請求項13記載のシステム(110)。
- 前記試料体積が、100nl未満である請求項13記載のシステム(110)。
- 前記システム(110)が、少なくとも1つの開口部(116)を有しており、皮膚部分を該開口部(116)に全体的または部分的に置くことが可能であり、該皮膚部分が少なくとも部分的に前記開口部(116)を閉鎖し、前記試料(130)が前記開口部(116)に置かれた前記皮膚部分において生成される請求項1〜16のいずれか1項に記載のシステム(110)。
- 前記開口部(116)が、閉鎖可能である請求項17記載のシステム。
- 前記皮膚部分が、指の皮膚部分である請求項17または18記載のシステム。
- 前記システム(110)が、前記試料(130)の生成と、閉鎖したハウジング(112)内における前記テストエレメント(128)への搬送とをもたらすように設計されてなり、前記システム(110)が前記ハウジング(112)内の湿度を検出するように設計されてなる請求項17〜19のいずれか1項に記載のシステム(110)。
- 前記システム(110)が、さらに、所定の最低湿度に達しない場合、前記検体の検出を少なくとも一時的に中断し、および/または警告を発生するように設計されてなる請求項17〜20のいずれか1項に記載のシステム(110)。
- 前記システム(110)が、さらに、前記試料(130)の生成中および/または前記テストエレメント(128)への前記試料(130)の搬送中に、前記試料(130)および/または前記試料(130)の成分の蒸発または蒸発率に対して影響を有する少なくとも1つのさらなるパラメータを検出するように設計されてなる請求項17〜21のいずれか1項に記載のシステム(110)。
- 前記パラメータが、前記ハウジング(112)内において検出される請求項22記載のシステム(110)。
- 前記試料(130)中の前記検体の検出において、制御部(136)によって、前記検体の検出の結果として生じた測定値を、前記少なくとも1つのさらなるパラメータに応じて補正可能なように設計されてなる請求項22または23記載のシステム(110)。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/020,766 | 2008-01-28 | ||
US12/020,766 US7766846B2 (en) | 2008-01-28 | 2008-01-28 | Rapid blood expression and sampling |
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JP2010543481A Division JP2011510699A (ja) | 2008-01-28 | 2009-01-21 | 体液中の検体の検出のためのシステム |
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JP2015042289A JP2015042289A (ja) | 2015-03-05 |
JP6076313B2 true JP6076313B2 (ja) | 2017-02-08 |
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Application Number | Title | Priority Date | Filing Date |
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JP2010543481A Pending JP2011510699A (ja) | 2008-01-28 | 2009-01-21 | 体液中の検体の検出のためのシステム |
JP2010543431A Expired - Fee Related JP5509096B2 (ja) | 2008-01-28 | 2009-01-23 | 迅速な血液の圧出およびサンプリング |
JP2014216554A Expired - Fee Related JP6076313B2 (ja) | 2008-01-28 | 2014-10-23 | 体液中の検体の検出のためのシステム |
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JP2010543481A Pending JP2011510699A (ja) | 2008-01-28 | 2009-01-21 | 体液中の検体の検出のためのシステム |
JP2010543431A Expired - Fee Related JP5509096B2 (ja) | 2008-01-28 | 2009-01-23 | 迅速な血液の圧出およびサンプリング |
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Country | Link |
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US (2) | US7766846B2 (ja) |
EP (2) | EP2234536B1 (ja) |
JP (3) | JP2011510699A (ja) |
KR (3) | KR101635663B1 (ja) |
CN (2) | CN102088897B (ja) |
AU (1) | AU2009210195B2 (ja) |
BR (1) | BRPI0906665B8 (ja) |
CA (2) | CA2713211C (ja) |
HK (1) | HK1152633A1 (ja) |
MX (1) | MX2010007680A (ja) |
RU (1) | RU2496406C2 (ja) |
SG (1) | SG187527A1 (ja) |
WO (2) | WO2009095343A1 (ja) |
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CA2558086C (en) | 2004-03-06 | 2013-02-26 | F. Hoffmann-La Roche Ag | Body fluid sampling device |
US7819822B2 (en) * | 2004-03-06 | 2010-10-26 | Roche Diagnostics Operations, Inc. | Body fluid sampling device |
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