JP2008531155A - 無菌カバーを持った動的統合切開テストストリップ - Google Patents
無菌カバーを持った動的統合切開テストストリップ Download PDFInfo
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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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- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
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- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150274—Manufacture or production processes or steps for blood sampling devices
- A61B5/150297—Manufacture or production processes or steps for blood sampling devices for piercing devices, i.e. devices ready to be used for lancing or piercing
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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
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- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
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- 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
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- 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
- A61B5/15117—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 biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
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- A—HUMAN NECESSITIES
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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
- A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
- A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
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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
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
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- A—HUMAN NECESSITIES
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- 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
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling devices
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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
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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
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
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Abstract
Description
Claims (24)
- 体液分析に適用されるテストストリップと該テストストリップに連結されたパケットからなる装置であって、
該パケットは、組織中に切り口を形成するための切り口形成部材と
切り口形成部材の無菌を維持しかつ該テストストリップと該切り口形成部材の間の二次汚染をふせぐためにパケットをカバーする無菌シートを含み、
該無菌シートにより、該切り口形成部材が、該テストストリップとは別個に滅菌が可能になることを特徴とする装置。 - 該切り口形成部材は、ランセットで切開する間に、該切り口形成部材を噛み合わせるための噛み合い開口部を定めることを特徴とする請求項1記載の装置。
- ランセットの噛み合せ開口部をかみ合わせるために該滅菌シートを突き刺すための刃を持ったカムアームと、該切り口形成部材を発射させるために、該カムアームに連結された発射メカニズムを含む計測器を、さらに含むことを特徴とする請求項2記載の装置。
- 該計測器は、切り口からの体液の流量圧縮を最小限にするために、サンプリングの間に組織に対して該テストストリップの位置を調節するための調節メカニズムを含んでいることを特徴とする請求項3記載の装置。
- 該刃が、該切り口形成部材中の噛み合せ開口部を完全に経由して、伸びることができるように、噛み合せ開口部と共に配列されているレリーフ開口部を、該テストストリップが定めることを特徴とする請求項3記載の装置。
- 該テストストリップは、該噛み合せ開口部と共に配列されている該レリーフ開口部を定めていることを特徴とする請求項2記載の装置。
- 該切り口形成部材が、摺動可能に配置されているガイドスロットを持ったガイド部材をさらに含む装置であって、該ガイドスロットは、該切り口形成部材が、ランセットで切開中に伸びるガイドスロット開口部を定めることを特徴としかつ滅菌シートが折りたたまれ、該ガイドスロット開口部を囲む折り目を持った2つのフラップを形成し、かつ該ガイド部材が、該該ガイドスロットを囲むための該フラップの間に挟まれていることを特徴とする請求項1記載の装置。
- 該テストストリップは、毛細管開口部を定め、その中に体液は、取り込まれて、該パケットに最近接して置かれているノッチが、該切り口形成部材から体液を直接流出させることを特徴とする請求項1記載の装置。
- 該切り口形成部材は、ランセットを含み、かつパケットとテストストリップの両方が、コンパクトな包装を可能にするために、一般的に平らであることを特徴とする請求項1記載の装置。
- 該無菌シートは、後退中に該切り口形成部材から体液をふき取るために、疏水性であることを特徴とする請求項1記載の装置。
- 該体液を分析するための手段であって、該体液分析用手段は、該テストストリップを含むことを特徴とする手段と、
切り口を形成するための手段であって、該切り口形成用手段は、該切り口形成部材を含むことを特徴とする手段と、
該切り口形成部材の無菌を維持するための手段であって、該切り口形成部材の無菌を維持するための手段は、該無菌シートを含むことを特徴とする手段とをさらに含むことを特徴とする請求項1記載の装置。 - 無菌包囲を形成するために、無菌シート中にランセットを囲い込むことにより、ランセットパケットを作り出し、
ランセットを殺菌し、かつランセットを消毒した後、ランセットパケットをテストストリップ付着させることにより、統合された切開テストストリップを組み立てることからなることを特徴とする方法。 - 該消毒が、該ランセットパケットを作り出した後に起きることを特徴とする請求項12記載の方法。
- 該消毒が、該ランセットパケットを作り出す前に起きることを特徴とする請求項12記載の方法。
- 該ランセットパケットの製作が、複数のランセットを含むベルトを提供し、かつ該無菌シートをベルトの周りに折りたたむことにより、該無菌シートの間にベルトを挟みこむことを包含することを特徴とする請求項12記載の方法。
- 該ベルトから統合された切開テストストリップを切り出すことをさらに含むことを特徴とする請求項15記載の方法。
- 該ランセット中における噛み合せ開口の作り出しと該テストストリップ中におけるレリーフノッチの作り出しとをさらに含む方法であって、該統合された切開テストストリップの組み立てが、該テストストリップのレリーフノッチと共にランセットの噛み合せ開口部と一列に並ばせることを特徴とする請求項12記載の方法。
- テストストリップを保持するために形成されたホルダーと、
体液がテストストリップを用いて採取されるに従い、切り口から体液の流出縮小を最小限にするために、組織に対して印加される圧力を減少させるため、該ホルダーと共同して切り口のある組織に対してテストストリップを位置付ける調節メカニズムとからなる測定器。 - 該テストストリップと、
該統合された切開テストストリップを形成するためのテストストリップに連結されたランセットと、
該ランセットを組織に向けて発射させるためのまた切り口からランセットを後退させるための該ホルダーに連結された発射メカニズムとをさらに含むことを特徴とする請求項18記載の測定器。 - 該発射メカニズムは、組織から遠いテストストリップの片端に連結されたコネクターであって、該コネクターは、該ホルダーに対して摺動可能に配置されたことを特徴とするコネクターと、
停止部材と該コネクターの間の距離を調節するために、該コネクターに対して移動可能な該停止部材であって、該停止部材は、該ランセットの後退中はコネクターの移動を制限するために位置付けられていることを特徴とする停止部材とを、さらに含むことを特徴とする請求項19記載の測定器。 - 該ランセットの無菌を維持するためにランセットを囲む無菌シートを含む該統合された切開テストストリップと、
噛み合い開口部を定める該ランセットと、
該テストストリップの片端に連結されたコネクターと、
該ホルダーに中枢となって連結されたカムアームであって、該カムアームは、カム部分と該無菌シートを突き刺すために形成された刃を含むことを特徴とするカムアームと、
該無菌シートを突き刺しかつ該統合された切開テストストリップを搭載する間、該ランセット中の該噛み合い開口部とかみ合わせるために、該カムアームの刃に対して、順にカム部を接触させかつ中枢軸を回転させるために、該ホルダーに対して摺動可能な該コネクターとを、さらに含むことを特徴とする請求項19記載の測定器。 - 該発射メカニズムと該ホルダーをコンパクトに詰めるために、隣り合った方向に該発射メカニズムを該ホルダーに接続させるコネクターを、さらに含むことを特徴とする請求項18記載の測定器。
- 該ホルダーが配置されたハウジングと、
該ハウジングに連結されたキャップと、
発現部材をはまり込むように、該キャップに対して移動させることが可能なるように、該キャップに対してねじ込むように連結されている発現部材であって、該発現部材は、テストストリップ体液を採取するサンプル開口を定めることを特徴とする発現部材とを、さらに含むことを特徴とする請求項18記載の測定器。 - 該テストストリップを保持するための手段と、
該組織に対して該テストストリップを位置付ける手段とを、さらに含むことを特徴とする請求項18記載の測定器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US11/070,502 | 2005-03-02 | ||
US11/070,502 US7815579B2 (en) | 2005-03-02 | 2005-03-02 | Dynamic integrated lancing test strip with sterility cover |
PCT/EP2006/001857 WO2006092281A2 (en) | 2005-03-02 | 2006-03-01 | Dynamic integrated lancing test strip with sterility cover |
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JP2008531155A true JP2008531155A (ja) | 2008-08-14 |
JP4712050B2 JP4712050B2 (ja) | 2011-06-29 |
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JP2007557412A Expired - Fee Related JP4712050B2 (ja) | 2005-03-02 | 2006-03-01 | 無菌カバーを持った動的統合切開テストストリップ |
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US (3) | US7815579B2 (ja) |
EP (1) | EP1865844B1 (ja) |
JP (1) | JP4712050B2 (ja) |
CN (1) | CN101132732B (ja) |
AT (1) | ATE546093T1 (ja) |
CA (1) | CA2598346C (ja) |
ES (1) | ES2380609T3 (ja) |
HK (1) | HK1118002A1 (ja) |
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WO (1) | WO2006092281A2 (ja) |
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JP2008206616A (ja) * | 2007-02-24 | 2008-09-11 | National Institute Of Advanced Industrial & Technology | 針一体型センサ |
JP2011501983A (ja) * | 2007-09-19 | 2011-01-20 | エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト | 無菌ランセット用のレーザによる箔の接合 |
US10258263B2 (en) | 2011-11-08 | 2019-04-16 | Phc Holdings Corporation | Biological information measurement cartridge and measurement device using same |
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US6036924A (en) | 1997-12-04 | 2000-03-14 | Hewlett-Packard Company | Cassette of lancet cartridges for sampling blood |
US6391005B1 (en) | 1998-03-30 | 2002-05-21 | Agilent Technologies, Inc. | Apparatus and method for penetration with shaft having a sensor for sensing penetration depth |
US8641644B2 (en) | 2000-11-21 | 2014-02-04 | Sanofi-Aventis Deutschland Gmbh | Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means |
AU2002315177A1 (en) | 2001-06-12 | 2002-12-23 | Pelikan Technologies, Inc. | Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties |
EP1404235A4 (en) | 2001-06-12 | 2008-08-20 | Pelikan Technologies Inc | METHOD AND DEVICE FOR A LANZETTING DEVICE INTEGRATED ON A BLOOD CARTRIDGE CARTRIDGE |
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- 2006-03-01 JP JP2007557412A patent/JP4712050B2/ja not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
---|---|
CA2598346C (en) | 2012-05-15 |
CN101132732A (zh) | 2008-02-27 |
CN101132732B (zh) | 2012-10-10 |
US9445756B2 (en) | 2016-09-20 |
ES2380609T3 (es) | 2012-05-16 |
ATE546093T1 (de) | 2012-03-15 |
PL1865844T3 (pl) | 2012-07-31 |
US7815579B2 (en) | 2010-10-19 |
CA2598346A1 (en) | 2006-09-08 |
EP1865844A2 (en) | 2007-12-19 |
HK1118002A1 (en) | 2009-01-30 |
WO2006092281A3 (en) | 2006-11-02 |
EP1865844B1 (en) | 2012-02-22 |
US9034250B2 (en) | 2015-05-19 |
JP4712050B2 (ja) | 2011-06-29 |
US20110000168A1 (en) | 2011-01-06 |
WO2006092281A2 (en) | 2006-09-08 |
US20060200045A1 (en) | 2006-09-07 |
US20110009775A1 (en) | 2011-01-13 |
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