JP4272051B2 - 血液試料採取装置及び方法 - Google Patents
血液試料採取装置及び方法 Download PDFInfo
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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
- A61B5/15186—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
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- 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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- 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
- A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61B5/150167—Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
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- A61B5/15019—Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
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- A61B5/150229—Pumps for assisting the blood sampling
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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
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- A61B5/150381—Design of piercing elements
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- A61B5/150435—Specific design of proximal end
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- 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
- A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
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- 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
- A61B5/150007—Details
- A61B5/150885—Preventing re-use
- A61B5/150916—Preventing re-use by blocking components, e.g. piston, driving device or fluid passageway
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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
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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
- A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
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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
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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
- 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.
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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
- A61B5/15149—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
- A61B5/15174—Piercing elements stocked in the form of a stack or pile
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Description
使い捨ての試料収集モジュールの実施形態では、一体化した様式で試料を收集することができる。幾つかの実施形態を動作する際には、使用者の指を試料採取部位に載置し、一体化したランシング及び試料収集工程を通して指を置いたままとする。
本発明の特定の実施形態では、適切な試料の量の分析を容易にするために、3つの方法を記載するが、このうち1つの方法を用いることもでき、いずれか2つ又は3つ全ての方法を合わせて用いることもできる。第1の方法では、支持材料を表面処理して湿潤能力に差を生じさせることを記載している。第2の方法では、血液を試料リザーバに引き入れると共に、血液をリザーバから付加的な部位に分配するための毛管力に加えて、活性ポンプ装置を記載している。第3の方法は、第1の試料リザーバを隔離して第2のランシング及び収集段階を起動し、第2の「予備」試料リザーバを満たすことにより第1の試料リザーバ内の不適切な試料容量を補償する装置の利用を含む。
米国特許第3,030,059号明細書、第3,626,929号明細書、第4,360,016号明細書、第4,608,997号明細書、第4,622,974号明細書、第4,627,445号明細書、第4,637,403号明細書、第4,648,408号明細書、第4,653,513号明細書、第4,873,993号明細書、第4,883,068号明細書、第4,895,147号明細書、第4,920,977号明細書、第5,047,044号明細書、第5,871,494号明細書、第5,971,941号明細書、及び国際特許WO97/42882号明細書を、本明細書に援用する。
本発明の別の様態及び利点は、一部は以下の説明において示されるが、一部は、この説明から明らかになるか、本発明を実施することにより容易に明らかになると考える。前述の一般的な説明及び以下の詳細な説明は、いずれも単に例示的でかつ説明のためのものであり、請求の範囲に記載された本発明を制限するものでないことは当然理解される。
図1を参照すると、使い捨ての試料収集モジュール100、ランセットドライバ102、及び任意的な付属モジュール104を組み込んだ血液試料採取システムが示される。任意的な付属モジュールは、試料収集モジュール100を格納するための貯蔵キャビティ108を有するケース本体106を含む。このキャビティに対するカバーは、理解し易いように取り外している。付属モジュールは、更に、ランセットドライバ102を保持するためのチャンバ110を含む。ランセットドライバは、予荷重調節ノブ112を有し、これによってランセットドライバの起動ポイントを調節することができる。これにより、皮膚の表面に再現可能な張力が確実に生じ、穿通の深さ及び出血量の制御が良好になる。一実施形態では、図示するように、試料収集モジュール100は、取り外し自在にランセットドライバ102に取り付けられるため、試料収集モジュール100は使い捨てであり、ランセットドライバ102は再利用可能となる。別の実施形態では、試料収集モジュール及びランセットドライバは、単一の組み合わせハウジングに収容され、組み合わせ試料収集モジュール/ランセットドライバは使い捨てとなる。試料収集モジュール100は、試料採取部位114を含み、これは、くぼんだ凹部116即ちクレードルを有し、使用者の指又は他の解剖学的特徴部(図示せず)の形状に一致するようにすることが好ましい。試料採取部位は、更に、くぼんだ凹部内に配置された開口118を含む。ランセットドライバ102は、試料収集モジュール100内に収容され、該試料収集モジュールにより案内されるランセットを発射するのに用いられ、指が試料採取部位114に置かれると、使用者の指に切開を形成する。一実施形態では、皮膚が試料採取部位にしっかりと押し付けられると、試料採取部位は、開口において実質的に気密シールを形成し、試料採取部位は、付加的に、開口の周りに柔らかな圧縮可能な材料を有し、血液試料が周囲空気により汚染されるのを更に制限することもできる。「実質的に気密性」とは、この場合は、通常の作業条件では、無視することができる量の周囲空気しかシールを通過して漏れないことを意味し、実質的に気密シールにより、血液をシームレスに收集することができる。
102 ランセットドライバ
104 付属モジュール
106 ケース本体
108 貯蔵キャビティ
110 チャンバ
112 予荷重調節ノブ
114 試料採取部位
116 クレードル
118 開口
Claims (27)
- 患者の皮膚から血液を收集するための装置であって、
試料採取部位を有するハウジングを備え、前記試料採取部位は、使用者の指の外形に一致する凹状のくぼみすなわちクレードルと、該凹状のくぼみすなわちクレードルに位置する開口とを有し、
前記開口と流体的に連通する試料リザーバと、
前記ハウジング内に維持され、前記開口に隣接するランセット先端を有するランセットと、
前記ランセットに作動的に配置され、作動時に前記開口を通って前記ランセット先端を前進させて、皮膚をランシングするランセットドライバと、をさらに備え、前記装置は、前記ランセットドライバの作動、皮膚のランシング、血液の收集、及び血液の前記試料リザーバまでの移動を一体化することができるように構成されている装置において、
前記凹状のくぼみすなわちクレードルが、患者の皮膚が前記試料採取部位にしっかりと押し付けられたときに、前記開口に実質的に気密シールを形成するように患者の皮膚に一致し、
前記装置は、試料採取部位に設けられ、前記開口及び前記試料リザーバと流体的に連通する少なくとも2つの毛管チャネルをさらに含み、該毛管チャネルは、表面を有し、該毛管チャネルの表面の少なくとも一部が親水性であり、前記毛管チャネルの各々が断面積を有し、前記毛管チャネルの少なくとも1つが主毛管チャネルであり、前記毛管チャネルの少なくとも1つが補助毛管チャネルであり、前記少なくとも1つの主毛管チャネルの断面積が、前記少なくとも1つの補助毛管チャネルの断面積の少なくとも2倍である、
ことを特徴とする装置。 - 試料採取ポートと、
突き通し可能な膜と、
を更に備え、前記試料採取ポートが、前記開口に接触する第1の端部と、前記第1の端部と反対側にあり、該第1の端部よりも前記ランセット先端に比較的近接した第2の端部とを有し、前記突き通し可能な膜が、前記ランセット先端と前記開口との間の前記第2の端部に隣接する、
ことを特徴とする請求項1に記載の装置。 - 前記膜が、ランセットを突き刺すことによって生じた切れ目を自動的にシールする膜である、
ことを特徴とする請求項2に記載の装置。 - 前記試料採取ポートが表面を有し、該試料採取ポート表面の少なくとも一部が、親水性である、
ことを特徴とする請求項2に記載の装置。 - 前記膜が表面を有し、該膜表面の少なくとも一部が、疎水性である、
ことを特徴とする請求項2に記載の装置。 - 前記試料リザーバが、前記開口と流体的に連通するチャンバを備え、前記チャンバが、周囲と、該周囲に取り付けられた可撓性の隔膜とを有し、前記可撓性の隔膜が圧力源の作用により前記チャンバ内で動くことができ、前記隔膜の移動が、前記少なくとも1つの毛管チャネルを通る血液の輸送を容易にするのに役立つ、
ことを特徴とする請求項1に記載の装置。 - 前記装置が更に、前記開口と流体的に連通する検査手段を備える、
ことを特徴とする請求項1に記載の装置。 - 前記ランセットに関連して作動可能な深度選択装置と、前記ランセットドライバに関連して作動可能な予荷重調節手段とを更に備える、
ことを特徴とする請求項1に記載の装置。 - 前記装置の寸法が、約80mm×30mm×10mmより小さい、
ことを特徴とする請求項1に記載の装置。 - 前記試料採取部位に作動的に配置された予備ランセットを更に備える、
ことを特徴とする請求項1に記載の装置。 - 予備ランセット先端を有する予備ランセットを更に備え、該予備ランセットが前記ハウジング内に維持され、前記試料採取部位が前記予備ランセット先端に隣接する予備開口を定め、該予備開口が前記試料リザーバと流体的に連通する、
ことを特徴とする請求項1に記載の装置。 - 前記試料採取部位と流体的に連通する予備リザーバを更に備える、
ことを特徴とする請求項1に記載の装置。 - 予備ランセット先端を有する予備ランセットを更に備え、該予備ランセットが前記ハウジング内に維持され、前記試料部位が前記予備ランセット先端に隣接する予備開口を定め、前記試料収集モジュールが前記予備開口と流体的に連通する予備リザーバを更に含む、 ことを特徴とする請求項1に記載の装置。
- 患者の皮膚から血液を收集するのに用いる試料収集モジュールであって、
ハウジングと、
前記ハウジング上に開口を定め、前記皮膚の外形に一致すると共に、該皮膚と実質的に気密シールを形成する形状にされた試料採取部位と、
前記ハウジング内に維持され、前記開口に隣接するランセット先端を有し、前記開口を通して前記ランセット先端を送り出して前記患者の皮膚をランシングするように動作可能であるランセットと、
前記開口と流体的に連通する試料リザーバと
を備え、
前記試料収集モジュールが、
気密な仕方での前記血液の試料採取と、a)一体化された皮膚のランシング、前記開口を通る血液の収集、及び血液の前記試料リザーバへの移動とを可能とするように構成されており、
前記試料収集モジュールが、試料採取部位に設けられ、前記開口及び前記試料リザーバと流体的に連通する少なくとも2つの毛管チャネルをさらに含み、該毛管チャネルは、表面を有し、該毛管チャネルの表面の少なくとも一部が親水性であり、前記毛管チャネルの各々が断面積を有し、前記毛管チャネルの少なくとも1つが主毛管チャネルであり、前記毛管チャネルの少なくとも1つが補助毛管チャネルであり、前記少なくとも1つの主毛管チャネルの断面積が、前記少なくとも1つの補助毛管チャネルの断面積の少なくとも2倍である、
ことを特徴とする試料収集モジュール。 - 前記ハウジングが更に、ランセットドライバを取り付けるための取り付け部位を備える、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 前記試料収集モジュールが更に、前記ハウジング内に前記ランセットドライバを備え、該ランセットドライバが前記ランセットに作動的に配置されている、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 試料収集ポートと突き通し可能な膜とを更に含み、前記試料収集ポートが前記開口に接触する第1の端部と、該第1の端部と反対側にあり、前記第1の端部よりも前記ランセット先端に比較的近接した第2の端部とを有し、前記突き通し可能な膜が、前記ランセット先端と前記開口との間の前記第2の端部に隣接する、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 前記膜が、ランセットを突き刺すことによって生じた切れ目を自動的にシールする膜である、
ことを特徴とする請求項17に記載の試料収集モジュール。 - 前記試料採取ポートが表面を有し、該試料採取ポートの表面の少なくとも一部が、親水性である、
ことを特徴とする請求項17に記載の試料収集モジュール。 - 前記膜が表面を有し、該膜表面の少なくとも一部が、疎水性である、
ことを特徴とする請求項17に記載の試料収集モジュール。 - 前記試料リザーバが、前記開口と流体的に連通するチャンバを備え、該チャンバが、周囲と、該周囲に取り付けられた可撓性の隔膜とを有し、前記可撓性の隔膜が、圧力源の作用により前記チャンバ内で動くことができ、前記隔膜の移動が、前記少なくとも1つの毛管チャネルを通る血液の輸送を容易にするのに役立つ、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 前記開口と流体的に連通する検査手段を更に備える、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 前記試料収集モジュールの寸法が、長さ約15mm、幅約10mm、及び厚さ約10mmより小さい、
ことを特徴とする請求項14に記載の試料収集モジュール。 - 前記試料採取部位に作動的に配置された予備ランセットを更に備える、
ことを特徴とする請求項14に記載の装置。 - 予備ランセット先端を有する予備ランセットを更に備え、該予備ランセットが、前記ハウジング内に維持され、前記試料採取部位が前記予備ランセット先端に隣接する予備開口を定め、該予備開口が前記試料リザーバと流体的に連通する、
ことを特徴とする請求項14に記載の装置。 - 前記試料採取部位と流体的に連通する予備リザーバを更に備える、
ことを特徴とする請求項14に記載の装置。 - 予備ランセット先端を有する予備ランセットを更に備え、該予備ランセット先端が前記ハウジング内に維持され、前記試料部位が前記予備ランセット先端に隣接する予備開口を定め、前記試料収集モジュールが、前記予備試料開口と流体的に連通する予備リザーバを更に含む、
ことを特徴とする請求項14に記載の装置。
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-
2002
- 2002-06-12 AT AT02739900T patent/ATE450209T1/de not_active IP Right Cessation
- 2002-06-12 US US10/363,508 patent/US7682318B2/en active Active
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EP1404232A4 (en) | 2007-05-30 |
CA2448905A1 (en) | 2002-12-19 |
EP1404232A2 (en) | 2004-04-07 |
US7682318B2 (en) | 2010-03-23 |
JP2009106784A (ja) | 2009-05-21 |
JP2012223612A (ja) | 2012-11-15 |
JP5232664B2 (ja) | 2013-07-10 |
CA2448905C (en) | 2010-09-07 |
JP2004528936A (ja) | 2004-09-24 |
WO2002100252A2 (en) | 2002-12-19 |
WO2002100252A3 (en) | 2003-07-10 |
DE60234597D1 (de) | 2010-01-14 |
ES2335576T3 (es) | 2010-03-30 |
ATE450209T1 (de) | 2009-12-15 |
US20050101979A1 (en) | 2005-05-12 |
EP1404232B1 (en) | 2009-12-02 |
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