JP2005521452A - 一体型試料検査器 - Google Patents
一体型試料検査器 Download PDFInfo
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Abstract
Description
本発明の目的は、上記問題を少なくとも部分的に解決することにある。
穿刺手段、
穿刺手段を突出位置と引込位置の間で駆動する駆動列、
試料受け領域をそれぞれ有する複数の検査片を収容した検査片カートリッジ、
検査片に受けた液体試料を分析するセンサ、及び
検査片を個々に検査片カートリッジから、検査片がセンサに接続する試料受け位置に移動させる検査片分配装置
を収容した単一モジュール式ハウジングを備えている一体型試料検査器であって、
使用に際して利用者の皮膚の第1の位置に位置させて作動させたときに、穿刺手段が突出位置に移動し、利用者の皮膚に穴を形成して引っ込み、検査片がカートリッジから試料受け位置に移動するように設計してある検査器を提供する。
好ましくは、回路はデータを検査器に入力するために、指などに感応するディスプレイ、制御ボタン、又はマイクロフォン及びボイス作動式ソフトウェアなどの手段を含んでいる。
好ましくは、検査器は孔の周りに液滴を容易に形成するように設計した圧力装置を備えている。
便宜的に、圧力リングは、引込位置に在る穿刺手段を覆うキャップの一部としてある。好ましくは、キャップは例えば側壁などの手段を備えている。この側壁は駆動列と協働し、駆動列の作動毎に穿刺手段がほぼ同じ経路に沿って移動することを確実にする。
望む場合に、検査器は少なくとも2つの交換可能なキャップ、例えば前腕に使用するためのキャップ及び指に使用するためのキャップを備えることができる。
好ましくは、駆動列は、利用者に穿刺手段の突出位置を設定させる調整ねじを備えている。これにより、利用者は、必要以上の痛みを生じさせることなく、男性又は女性の皮膚を十分に穿刺して十分な大きさの液滴を生じさせるように、検査器の動作を校正することができる。
便宜的に、調整ねじの動作は、穿刺手段の移動距離が一定のままであるが、穿刺手段の突出位置が大いに変化するように設計してある。このことは、利用者が感じる痛みの量が穿刺深さと不釣り合いに増加しないことを確かにする。
しかし、カートリッジ上のデータは、例えばバーコード、抵抗ブリッジ回路、又は電子メモリ・モジュール内に格納したものとして機械可読な形式で存在するのが好ましい。
データが電子メモリ・モジュール内に存在する場合には、それを読出し専用メモリ(ROM)、又はEPROM又はEEPROMなどの書換え可能なメモリで構成することができる。
便宜的に、検査器は検査片をカートリッジから受け入れて試料受け位置に案内する送り溝を備えている。
好ましくは、送り溝は段部を備えている。段部は、検査片がその段部を通過したときに、検査片が段部に落ちるか押し込まれ、それによって検査片がカートリッジ側に戻らないように設計してある。
検査片は、検査器に配置したばねによって段部に押し込むのが好ましい。便宜的に、ばねは電気的に導電性でもあって、検査片上の電極又は導電性バーと電気的に接触するように設計してある(以下を参照)。
便宜的に、検査器は、使用した検査片を検査がいったん終了したら検査器から放出する放出手段を備えている。カートリッジがカートリッジ・キャップを備えている場合には、放出手段はカートリッジ・キャップが閉じたときに作動するのが好ましい。
アセンブリの移動により、検査器の回路全体をも導通状態にすることができる。駆動列は、レバーの更なる移動によって、又は好ましくはトリガの駆動によって発射することができる。
十分な液体が穴の周りに集まったならば、利用者は検査器を第2の位置に移動させる。この第2の位置では、検査片が液滴内に位置し、検査片の試料受け領域が液体の試料を吸収する。
好ましくは、検査器は血液又は間質液の試料を生じさせて分析するよう、特にグルコース濃度を求めて血液試料を分析するように適合させてある。このような測定を行うように適合させた検査片は、その技術が周知となっている。これらは電気化学的又は測光学的な検査片とすることができる。
好ましくは、検査片は電気化学的な分析を行うように適合させ、検査器内の回路はその検査片内の電極と接触するように設計してある。
以下、本発明を血液試料採取に関連して説明する。しかし、当業者であれば他の種類の液体も取り扱うことができることを理解するであろう。
何れの方法でも、検査片が試料受け位置から離れて戻ることはない。
一実施例によれば、カートリッジの材料自体に乾燥性を持たせるか、小型ハウジングの内部に乾燥剤を配置することができる。検査片の小型ハウジングに入り込む恐れのあるどんな湿気も、これらの材料によって吸収し、無力化することができる。
その代りに、カートリッジには、例えば視覚的表現の文字、バーコード、又は抵抗器のブリッジ回路などの他の形態のデータも含めることができる。
Claims (33)
- 穿刺手段、
穿刺手段を突出位置と引込位置の間で駆動する駆動列、
試料受け領域をそれぞれ有する複数の検査片を収容した検査片カートリッジ、
検査片に受けた液体試料を分析するセンサ、及び
検査片を個々に検査片カートリッジから、検査片がセンサに接続する試料受け位置に移動させる検査片分配装置
を収容した単一モジュール式ハウジングを備えている一体型試料検査器であって、
使用に際して利用者の皮膚の第1の位置に位置させて作動させたときに、穿刺手段が突出位置に移動し、利用者の皮膚に穴を形成して引っ込み、検査片が検査片カートリッジから試料受け位置に移動するように設計してある検査器。 - 動作を制御する電気的又は電子的な回路を備えている請求項1記載の検査器。
- 回路は、利用者が個々の検査の全ての結果を読み出し得る表示装置を備えている請求項2記載の検査器。
- 回路は、データを検査器に入力する手段を備えている請求項2又は請求項3記載の検査器。
- 孔の周りに液滴を容易に形成するように設計した圧力装置を備えている請求項1から請求項4のいずれか1つに記載の検査器。
- 圧力装置は、利用者の皮膚の上に置かれる開口を持った検査器の容積に負圧を加えるように適合させたポンプを備えている請求項5記載の検査器。
- 穿刺手段が貫通する開口は、滑らない材料で作ってある請求項6記載の検査器。
- 圧力装置は、使用に際して利用者の皮膚の上に置かれるように設計した圧力リングを備え、この圧力リングは縁を押し付けて中央で利用し得る液体の量を増加させるようになっている請求項5記載の検査器。
- 圧力リングは、滑らない材料で作ってある請求項8記載の検査器。
- 圧力リングは、適用する皮膚の領域の形状に順応するように形作ってある請求項8又は請求項9記載の検査器。
- 圧力リングは、その外側から内側へ圧力傾度を増加させるための多数の等高線に沿って形成した面を有している請求項8から請求項10のいずれか1つに記載の検査器。
- 圧力リングは、引込位置に在る穿刺手段を覆うキャップの一部としてある請求項8から請求項11のいずれか1つに記載の検査器。
- 引込位置に在る穿刺手段を覆うキャップを備えている請求項1から請求項11のいずれか1つに記載の検査器。
- キャップはハウジングに取外し可能に取り付けてある請求項12又は請求項13記載の検査器。
- 駆動列はばね仕掛けとしてある請求項1から請求項14のいずれか1つに記載の検査器。
- 駆動列は、利用者に穿刺手段の突出位置を設定させる調整ねじを備えている請求項1から請求項15のいずれか1つに記載の検査器。
- 調整ねじの動作は、穿刺手段の移動距離が一定のままであるが、穿刺手段の突出位置が大いに変化するように設計してある請求項16記載の検査器。
- キャップは、駆動列の作動毎に穿刺手段が皮膚をほぼ同じ位置で穿刺するように駆動列を案内する手段を備えている請求項12若しくは請求項13又はそれらに従属するいずれかの請求項に記載の検査器。
- 検査片カートリッジは、積み重ねた検査片、部分的に取外し可能なカートリッジ・キャップ、及び積み重ねた検査片をカートリッジ・キャップの方へ移動させる手段を受け入れる設計の空所を画定したカートリッジ・ハウジングを備えている請求項1から請求項18のいずれか1つに記載の検査器。
- 検査片カートリッジは、検査片カートリッジ内の検査片用の校正コードに関するデータを有している請求項19記載の検査器。
- 検査片カートリッジ上のデータは、機械可読の形式で存在している請求項20記載の検査器。
- データは電子的メモリ・モジュール内に存在している請求項21記載の検査器。
- データは、個別の検査片カートリッジを識別する固有の番号、検査片カートリッジ内に元来存在している検査片の数、検査片カートリッジの失効日、及び/又は異なった液体源に関する異なった校正係数も含んでいる請求項20から請求項23のいずれか1つに記載の検査器。
- 検査片カートリッジのメモリ・モジュールは書換え可能であり、検査器はその動作に関する情報をメモリ・モジュールに書き込むように設計してある請求項22又は請求項22に従属するときの請求項23記載の検査器。
- 検査器は、検査片を検査片カートリッジから受け入れて試料受け位置に案内する送り溝を備えている請求項1から請求項24のいずれか1つに記載の検査器。
- 使用した検査片を検査がいったん終了したら検査器から放出する放出手段を備えている請求項1から請求項25のいずれか1つに記載の検査器。
- 最初の検査片が所定位置に未だ存在している間に検査片分配装置が更なる検査片を試料受け位置に移動させないようにする偏向器を備えている請求項1から請求項26のいずれか1つに記載の検査器。
- 検査片が試料受け位置に存在していることを確認する手段を備えている請求項1から請求項27のいずれか1つに記載の検査器。
- 確認する手段は、検査器内の回路を完全に作動させるためにも利用している請求項28記載の検査器。
- ハウジングに保持した多機能アセンブリの1回だけの動きを利用して手で作動させる請求項1から請求項29のいずれか1つに記載の検査器。
- 検査片は電気化学的な分析を行うように適合させ、検査器内の回路は前記検査片の電極に接触するように設計してある請求項1から請求項30のいずれか1つに記載の検査器。
- 血糖検査を行うように適合させてある請求項1から請求項31のいずれか1つに記載の検査器。
- 請求項1から請求項32のいずれか1つに記載のの一体型検査器に検査片カートリッジを搭載すること、検査器のアセンブリを作動させて穿刺装置の発射準備をすると共に検査片を試料受け位置に移動させること、一体型検査器を利用者の皮膚に押し付けて穿刺手段を作動させ皮膚の表面に血液の滴又はその他の液体を発生させること、試料を一体型検査器によって自動分析するために検査片が血液又はその他の液体の必要量を吸収し得るように検査器を移動させることを含んでいる、血糖濃度又は体液内のその他の被検体を試料採取して検査する統合された方法。
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