JP2004202256A - 診断テスト用血液の採取方法及び装置 - Google Patents
診断テスト用血液の採取方法及び装置 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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- A61B5/1486—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 enzyme electrodes, e.g. with immobilised oxidase
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- 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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Abstract
【解決手段】(a)血液サンプルを抜き取る皮膚面に非閉塞開口を形成するステップ及び(b)皮膚の非閉塞開口から血液サンプルを真空及び皮膚伸張の補助により抜き取るステップを含む。(a)サンプルを抜き取る皮膚面に非閉塞開口を形成するためのデバイス、好ましくは切開アセンブリ及び(b)真空ポンプを含む。好ましくはこの装置はハウジングをも含む。更に空気圧切開アセンブリを含み、この空気圧切開アセンブリはランセットを皮膚組織に押出すために差ガス圧を用いる。更に血液を回収し、血液中のアナライトを検出し得る物品を含み、この物品の検出素子により発生する信号を測定するメータと組み合わせて使用され得る。
【選択図】図2
Description
本発明は、その後の診断テスト、例えばグルコース監視用に患者から血液サンプルを抜き取るための方法及び装置を提供する。本発明の方法は、
(a)前記血液サンプルを抜き取る皮膚面に非閉塞開口を形成するステップ、及び
(b)前記皮膚の非閉塞開口から前記血液サンプルを真空及び皮膚伸張(stretching)の補助により抜き取るステップ
を含む。
(a)ハウジング、
(b)サンプルを抜き取る皮膚面に非閉塞開口を形成するためのデバイス、好ましくは切開アセンブリ、及び
(c)真空ポンプ
を含む。
(a)ランセットアセンブリを保持するためのホルダー、
(b)ホルダー内のランセットアセンブリが患者の皮膚から離れて配置されるような位置にホルダーを保持するのに十分な力を与えるための手段、及び
(c)ガスによりホルダー内のランセットが患者の皮膚を穿刺し得るような位置にホルダーが移動するように、ホルダー保持手段により与えられた力に打ち勝つに十分な力をガスにより与えるための手段
を含む。
(a)血液を受容し、受容した血液を化学的ウィッキングにより輸送し得る層、
(b)血液中のアナライトの存在を検出またはアナライトの量を測定し得る層、及び
(c)血液輸送層の上の、メータに接して配置され得る層
を含み、前記層(a)が血液を前記層(b)に輸送し得る多層素子である。
(a)開口部を有する保護層、
(b)前記保護層の上の、血液を該保護層の開口部を介して受容し、血液を化学的ウィッキングにより輸送し得る層、
(c)前記血液輸送層の上の、メータに接して配置され得る層、及び
(d)前記保護層と前記メータ接触層との間に配置され、血液輸送層からの血液を受容し得る層であって、血液中のアナライトの存在を検出するかまたはアナライトの量を測定し得る層
を含む多層素子である。
本発明の実施態様は、診断テスト、例えばグルコース監視を実施するために血液サンプルを採取する方法を実施するために以下のステップを必要とする。
(a)シール可能なチャンバと、該シール可能なチャンバと流体連通しているシール可能な開口部とを有するハウジング、
(b)パワー源、
(c)前記パワー源に作動可能に連結し、前記シール可能なチャンバに連通している真空ポンプ、
(d)前記シール可能なチャンバ内に配置された、ランセットをシール可能な開口部に対して移動させ得る切開アセンブリ、及び
(e)前記シール可能なチャンバ中に配置され、前記シール可能な開口部と流体連通している流体コレクタ。
70は、ランセットホルダ66が移動できる通路88を有する。
キャップ70はまた、ピストン64を標的皮膚組織に対して案内するのを助けるように機能する。
M×a(t)=A×[Pc(t)−Pv(t)]−Ks×[x(t)+Xs]−Ff(t)
上記式中、
t=経過時間
M=総慣性質量(ピストン+切開アセンブリ)
a(t)=時間tにおけるランセットの並進加速度
Pc(t)=時間tにおいてピストンの上面に作用する空気圧
Pv(t)=時間tにおいてピストンの作用に対抗する空気圧
A=Pc(t)及びPv(t)による作用を受けるピストンの投影表面積
Ks=戻りばねのばね定数
x(t)=時間tにおけるランセットの並進変位
Xs=戻りばねの初期変位
Ff(t)=時間tにおけるピストンシールの摩擦力
Pc(t)−Pv(t)=時間tにおいてピストンを加速させる差圧力レベル
ランセット変位(X)対時間(t)に関する上記数式から経時的ランセットスピードが求められ得るが、上記数式の解決には本発明の設計の詳細及び三方弁を含む熱力学及び圧縮流の分野における多くの補助方程式を必要とする。一般的に、皮膚に衝突時のランセットスピード(Up)は下記の変数で表され得る。
Up=F[A,M,S,Xp,Ks,Xs,Cv,Dtv,Vc,Vv,Pa,Pv,Ta,Ff]
上記式中、
A=空気圧が作用するピストンの有効表面積
M=総慣性質量(ピストン+ランセットアセンブリ)
S=ピストンのストローク距離
Xp=皮膚と衝突が起きたときのランセット変位(Xp<S)
Ks=戻りばねのばね定数
Xs=戻りばねの初期変位
Cv=動作状態にした三方弁の流量係数
Dtv=三方弁の切換時間(完全に動作状態にするための時間)
Vc=ピストンと三方弁間の初期空気容積
Vv=装置の初期キャビティ容積(すなわち、ランセットを作動させる前に測定したキャビティの容積)
Pa=高圧空気源の圧力レベル
Pv=装置のキャビティの初期圧力レベル(すなわち、ランセットを作動させる前に測定した低圧空気源の圧力)
Ta=空気温度レベル
Ff=ピストンシールの摩擦力プロフィール(通常、ピストンの変位に応じて変化する)
ピストンの特定ストローク距離(S)内のランセットスピードの最大化は、高流量係数(Cv)及び迅速切換時間(Dtv)を有する三方弁を選択することにより、ピストンの表面積(A)及びピストンと三方弁間の初期空気容積(Vc)を最適化することにより、総慣性質量(M)、ばね力(Ks,Xs)及びピストンシールの摩擦力プロフィール(Ff)を最小化することにより、十分な初期キャビティ容積(Vv)を確保することにより、また装置が許す限り大きい差圧(Pa−Pv)を適用することにより達成される。
(a)血液を受容し、受容した血液を化学的ウィッキング(chemically aided wicking)により輸送し得る層、
(b)アナライトの存在を検出または血液中のアナライトの量を測定し得る層、及び
(c)血液輸送層の上にあり、メータに接して配置され得る層
を含む多層素子を含み、前記層(a)により血液は層(b)に輸送され得る。
(a)開口部を有する保護層、
(b)前記保護層の上にあり、血液を該保護層の開口部を介して受容し、血液を化学的ウィッキングにより輸送し得る層、
(c)前記血液輸送層の上にあり、メータに接して配置され得る層、及び
(d)前記保護層と前記メータ接触層との間に配置され、血液輸送層からの血液を受容し得る層であって、アナライトの存在を検出するかまたは血液中のアナライトの量を測定し得る層
を含む多層素子を含む。
1110は、1つもしくは複数の、生物学的流体中のアナライト
と反応して測定可能な電気的応答または測定可能な光学的応答を生ずることができる化学物質、例えば酵素を含む層からなる。血液中のグルコースに応答して測定可能な電気信号を生じ得る検出層は、援用により本明細書に含まれるとする米国特許第4,545,382号明細書、同第4,711,245号明細書及び同第5,682,884号明細書に記載されている。血液中のグルコースに応答して測定可能な反射率変化を生じ得る検出層は、援用により本明細書に含まれるとする米国特許第4,935,346号明細書及び同第4,929,545号明細書に記載されている。検出層の例は米国特許第5,682,884号明細書に記載されている。米国特許第5,682,884号明細書に記載されている検出層は、支持体に沿って広がる第1コンダクタ及び第2コンダクタを含み、更にリードアウト回路に接続するための手段をも含む。液体血液サンプル及び第1コンダクタに接して配置される活性電極には、液体血液サンプル中のアナライト化合物、例えばグルコースが関与する反応を触媒し得る酵素が付着されている。電子が酵素触媒反応と第1コンダクタの間を移動して電流が発生する。参照電極は液体血液サンプルと第2コンダクタと接するように配置されている。
(a)疎水性を有する材料、例えばセルロースに沿った流体の流れ;
(b)その表面に少なくとも1つの化学物質が適用されている材料、例えば界面活性剤をコートしたナイロンに沿った流体の流れ;
(c)化学的または物理的方法により疎水性にした材料、例えばコロナ放電処理、プラズマ処理、火炎処理等により処理されたポリエステルに沿った流体の流れ。
1114の開口部と整列した小さな開口部を有し、これにより切
開作業中にランセットがメッシュのストランドにぶつかる恐れがなくなる。
(1)その上に検出層1110を印刷する表面を提供する;
(2)多層素子の1つ以上の開口部とランセットを整列させる;
(3)多層素子の検出部分からの信号を読みとるために多層素子とメータとを接触させる;
(4)多層素子が容易に持ち上げられ、メータと接し得るように堅い層を提供し、光学的応答を測定する検出器の場合には光源及び検出層からのグルコース信号を読みとる手段を含むメータに接する表面を提供する。
多層素子が大量生産されることが好ましいが、1つの多層素子を製造するためには以下の方法を使用することができる。
多層素子の構成成分を詳細に例示する図21A及び21B、並びに血液サンプル中のアナライトの存在または量を検出するために本発明の装置を使用するために多層素子をどのように操作するかを示す図29A、29B、29C及び29Dを参照すると、多層素子1100は血液採取装置のランセットストップ1124とノーズピースアセンブリ1126との間に配置されている。ノーズピースアセンブリ1126はノーズピース1127及びシール1128からなる。保護層1102の開口部1104とメータ接触層1114の開口部1116は切開アセンブリ1131のランセット1130と整列している。血液採取装置のノーズピースアセンブリ1126のシール1128を皮膚“S”に対して置く。図29Aは真空を適用する前の装置を示す。図29Bは真空の適用後、皮膚を伸張して多層素子の保護層1102に接触するまで引き込んだ後の装置を示す。真空を、血液をノーズピース1127に引き込まれた皮膚内に貯留させるに十分な時間適用する。次いで、切開アセンブリを始動させ、ランセット1130をランセットストップ1124の開口部1132及び多層素子の開口部(図29A、29B、29C及び29Dにファントム画法で示し、図21A及び21Bに図番1104、1116で示す)を通過させる。その後、ランセットは皮膚を穿通し、皮膚に開口を形成する。図29Cを参照されたい。その後、ランセットを引込めると、皮膚に非閉塞開口が形成される。血液“B”は真空の補助で皮膚の開口から流れ出、血液輸送層1108と接し、血液輸送層に沿って流れ、検出層1110に達する。図29D参照。検出層の表面で化学反応が起こる。化学反応の結果は検出層1110の電気接触子1110aで読みとることができる。多層素子が満たされると、真空を解放し、皮膚はノーズピースから離れて行く。
1.血液抜き取りのための部位として指以外の身体部分を使用することができる;
2.指を切開しなくて済むので痛みを軽減できる;
3.皮膚の伸張と熱及び/または真空とを組み合わせる予備処理により血液サンプルの回収速度が上昇する;
4.血液サンプルを抜き取るための装置にグルコース検出器を組み込める。
痛み2=ちくりとしたが、標準の指ランセットで指を穿刺したときほど痛くなかった。
痛み3=標準の指ランセットで指を穿刺したときとほぼ同程度のはっきりした痛みを感じた。
痛み1=81%
痛み2=17%
痛み3=2%
対照ラン(真空適用せず)では、真空を適用したランに比して非常に少ない容量の血液しか回収されなかった。真空レベルを高くするとより多くの血液が抜き取られた。痛みは最低限で、指の穿刺と同等の痛みを感じたのは穿刺の2%にすぎなかった。
痛み1=58%
痛み2=31%
痛み3=11%
真空レベルと回収血液量との間にほぼ直線的な関係が認められた。穿刺前及び穿刺後真空を適用して回収した血液の平均容量は、穿刺後のみ真空を適用し穿刺前に真空を適用せずに回収した血液の平均容量の約2倍であった。この比較について実施例1の結果を参照されたい(7.8μl対3.1μl)。−2.5psigを除くすべての真空レベルで、回収血液容量は常に1μlを越えた。
痛み1=91%
痛み2=9%
痛み3=0%
15秒間予備加熱して回収した血液の平均容量は、予備加熱なしで穿刺後−5.0psigの真空レベルで回収した血液の平均容量の2倍以上であった。この比較について実施例1の結果を参照されたい(6.91μl対3.1μl)。60秒間予備加熱して回収した血液の平均容量は、予備加熱なしで穿刺後−5.0psigの真空レベルで回収した血液の平均容量の約4倍であった。この比較について実施例1の結果を参照されたい(11.6μl対3.1μl)。
痛み1=94%
痛み2=6%
痛み3=0%
回収される血液の容量及び成功率(すなわち、回収血液が>1μlのサンプルの%)の、皮膚伸張と真空を組み合わせた条件と皮膚伸張なしと真空を組み合わせた条件との間の差異は予想以上であった。痛みスコアは低かった。この実施例は、皮膚伸張と真空との組み合わせにより抜き取られる血液容量が大きく増加することが立証する。
痛み1=89%
痛み2=10%
痛み3=1%
回収される血液容量及び成功率(すなわち、回収血液が>1μlのサンプルの%)は真空によりデバイスに持ち上げられる皮膚の面積に応じて直接変動することが判明した。より小さな直径のピペットチップに比してより大きな直径のピペットチップの方がより多くの皮膚を持ち上げた。
痛み1=100%
痛み2=0%
痛み3=0%
本実施例は、多点プラスチックランセット、穿刺前加熱、皮膚伸張及び穿刺後真空を用いる血液抜き取り方法は少なくとも50%の時間で少なくとも1μlの血液を抜き取ることができることを立証する。
A=30.7mm2(直径=6.25mm)
M=1.2g
S=10mm
Xp=n/a
Ks=19.5N/m
Xs=8.7mm
Cv=0.015
Dtv=0.7msec
Vc=0.01cc
Vv=5cc
Pa=14.7psia(=0psig)
Pv=6.7psia(=−8.0psig)
Ta=25℃
Ff=0.13N−0.18N
この試作品をヒトに対してテストしたところ良好な切開結果が得られた。ストロークの末端で測定したランセット速度は2.7m/secであった。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子を製造した。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子を製造した。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子を製造した。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子の形態のグルコース検出器を製造した。
に置いた。検出器1302を、開口部1309(ファントム画法で示す)含むランセットストップ1308とノーズピースアセンブリ1310の間に置いた。ノーズピースアセンブリには、ノーズピース1311及び皮膚“S”と接するシール1312が含まれた。真空適用前の切開アセンブリ1304を図34Aに示す。ノーズピースアセンブリをボランティアの前腕に対して置いた。真空(−7.5psig)の適用後、皮膚を図34Bに示す検出器の近くまでまたは接触するまで伸張させた。ノーズピース内の皮膚に血液が貯留されるに十分な時間(5秒間)真空を適用した。次いで、ランセットを図34Cに示すようにランセットの開口部及び検出器の開口部を通って発射させた。ランセットが皮膚を穿通した。その後、図34Dに示すようにランセットを引込めた。真空及び皮膚の伸張の補助で皮膚に形成された開口から血液が流れ出た。血液の抜き取り中、血液が血液輸送層に達するまで真空を適用した。その後、血液“B”は、多層素子の検出層に達するまで血液輸送層に沿って輸送された。血液が多層素子の検出層に達したら、電流が発生した。この電流を真空を解放する時を決定するために使用し、皮膚をノーズピースから離した。検出層を使用してグルコースのようなアナライトについて血液を分析した。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子の形態のグルコース検出器を製造した。
Squared Manufacturing Companyから販売されている部品番号T2−03.08.004のような市販の小形真空ポンプを装置と使用することができる。テストしたシール材料で漏出率が低いという結果が得られたことは、良好にシールするために皮膚にノーズピースを取り付ける面倒な方法が不要となることを意味する。真空シールを形成するための皮膚にノーズピースを取り付ける他の方法は好ましくない。接着剤は、ノーズピースアセンブリを簡単に取り外せず、シールを剥がすときに使用者に痛みを与える恐れがあるので好ましくない。グリースは、テスト終了後かすが残るので好ましくない。
(1)メータ接触層、
(2)検出層、
(3)オーバーコート層、
(4)血液輸送層、
(5)保護層
を含む多層素子の形態のグルコース検出器を製造した。
Claims (11)
- ランセットを用いて患者の皮膚に開口を形成し得るアセンブリであって、
(a)ランセットアセンブリを保持するためのホルダー、
(b)ホルダー内のランセットが患者の皮膚から離れて配置されるような位置にホルダーを保持するのに十分な力を与えるための手段、及び
(c)ガスによりホルダー内のランセットが患者の皮膚を穿刺し得るような位置にホルダーが移動するように、ホルダー保持手段により与えられた力に打ち勝つに十分な力をガスにより与えるための手段
を含むことを特徴とする前記アセンブリ。 - ホルダー内のランセットアセンブリを更に含むことを特徴とする請求の範囲第1項に記載のアセンブリ。
- ホルダーに取付けたピストンに作用するガスによりホルダーが移動することを特徴とする請求の範囲第1項に記載のアセンブリ。
- ホルダー保持手段(b)がピストンバイアス手段であることを特徴とする請求の範囲第1項に記載のアセンブリ。
- 手段(c)がホルダーに取付けられたピストンを含み、前記ピストンはボア内に配置されており、前記ボアは、ホルダー内のランセットが患者の皮膚を穿刺し得るような位置にホルダーを移動させるべく前記ピストンを移動させるために十分な圧力のガスが進入できるように開放され得ることを特徴とする請求の範囲第1項に記載のアセンブリ。
- 手段(c)は第1ポート、第2ポート及び第3ポートを有する弁を含み、前記第1ポートは第1圧力下のガス源と連通し得、前記第2ポートはボアと連通し得、前記第3ポートは第1圧力よりも低い第2圧力下のガス源と連通し得ることを特徴とする請求の範囲第1項に記載のアセンブリ。
- ボアのシール手段を更に含むことを特徴とする請求の範囲第5項に記載のアセンブリ。
- ホルダーに取付けたピストンを更に含み、前記ピストンは(1)第1圧力下のガスが進入する前のボア内の圧力を越える第1圧力下のガスがボアに進入するときにはボア内の第1方向に進み、(2)ホルダー保持手段(b)がボア内のピストンに対して作用するガスの力に打ち勝つときにはボア内の第2方向に進むことを特徴とする請求の範囲第1項に記載のアセンブリ。
- 患者の皮膚に開口を形成するためのランセットアセンブリを保持し得るアセンブリであって、
(a)軸を有するボアと、弁マニホールドに嵌合される弁と、前記弁マニホールド内の第1ポートであって、該第1ポートを介して第1圧力下のガスが弁マニホールドを通過し得る前記第1ポートと、前記弁マニホールド内の第2ポートであって、該第2ポートを介して第1圧力下のガスが弁マニホールドを通過してボアに進入し得る前記第2ポートと、前記弁マニホールド内の第3ポートであって、該第3ポートを介してボアからのガスが第1圧力よりも低い第2圧力下のガスを有する位置に弁マニホールドを通過し得る前記第3ポートとを有するハウジング、
(b)前記ボア内に配置された、該ボアの軸に沿って移動し得るピストンであって、第2ポートに隣接する近位端部とランセットを保持するためのホルダーを含む遠位端部とを有する前記ピストン、及び
(c)第1ポートが閉じたときにピストンの近位端部が患者の皮膚から離れた別の位置にあるようにピストンをバイアスする手段
を含むことを特徴とする前記アセンブリ。 - 弁がソレノイドにより作動することを特徴とする請求の範囲第9項に記載のアセンブリ。
- ボアのシール手段を更に含むことを特徴とする請求の範囲第9項に記載のアセンブリ。
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