JP2007503958A - 個人診断装置と関連手法 - Google Patents
個人診断装置と関連手法 Download PDFInfo
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- JP2007503958A JP2007503958A JP2006526215A JP2006526215A JP2007503958A JP 2007503958 A JP2007503958 A JP 2007503958A JP 2006526215 A JP2006526215 A JP 2006526215A JP 2006526215 A JP2006526215 A JP 2006526215A JP 2007503958 A JP2007503958 A JP 2007503958A
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Abstract
Description
この発明以前は、典型的な皮膚パッチと言えば主に人間の身体における積極的な薬物投与装置として使用されてきた。そのような装置の例としては、禁煙用のニコチンパッチや、船酔いを軽減するために既定の量のドラマミンを投与するための船酔いパッチなどが挙げられる。
まず、図1に関し、ここにはバイオブレスレット(図8A)、あるいはバイオパッチ(図8B)の形状において使用可能な個人診断装置104を装着している使用者102が示されている。図1の使用者102は、パーソナルコンピュータ108、キーボード110、ディスプレーモニター112を含むワークステーション106に座っている。個人診断装置104の1つの主要な実施形態により、本装置は個人診断装置104からの電気信号を適切な無線周波数受信機114が装備されているパーソナルコンピュータ108に伝えるために使用される無線送信器223(図8A、B)を含んでいる。このように、装置104内で処理され保存された診断テスト結果は、ワイヤレスでパーソナルコンピュータ108に伝えられ、そこで適宜ディスプレーモニター112に表示することができる。
光エミッター228と光検出器230は例えば電化結合素子(CCD)、光ファイバー、ナノワイヤー、マイクロワイヤー、半導体発光、また/あるいは検出器具、あるいはその他の適切な発光、検出の器具や装置を含み、様々な異なる光学装置あるいは形式において実施することが可能である。なお、これにより本発明が限定されるものではない。
核酸プローブ結合形成法を使用して、特定の核酸配列の標的核酸検体を検出する能力を適用できる状況は多い。適用例の中には、感染性疾患、遺伝性疾患の診断、人間や動物の癌感受性の判断、化粧品、食糧、水中のウイルスもしくは微生物汚染の特定、人間の法医学的鑑定、又は父子鑑定、動植物における増殖分析や品種改良のような遺伝子レベルでの個人個人の識別及び特性付け、などがある。核酸プローブ結合形成法の応用の基礎となるのは、オリゴヌクレオチドや核酸断片プローブの混成能力、つまり、安定した二本鎖結合を形成する能力である。この形成は、相補的塩基対合、具体的には特定の配列を持ち、特定の種、株、個体や有機体から採集した細胞の中でしか起こらない相補的塩基対合を通して行われる。
免疫システムとは、バクテリア、ウイルス、菌類、寄生虫(細菌)など、感染症、疾患、そして死さえも引き起こしうる体外からの侵略者から人体を守る細胞や器官でできている。正しく機能しているとき、免疫システムは感染症を寄せ付けず、人体を健康に保つ。しかし正常に機能しないとき、人体に進入した細菌はより容易に疾患や死を引き起こす。免疫システムにおいて非常に重要な役割を果たす二つの細胞の種類は、ヘルパーT細胞(CD4細胞としても知られる)と サプレッサT細胞(CD8細胞としても知られる)である。免疫不全症候群(AIDS)に罹った人はヘルパーT細胞(CD4ベアリング細胞、CD4+細胞とも呼ばれる)が減少するのが特徴である。HIVに感染したとき、CD4+T−ヘルパー細胞は機能しなくなり、減少する。これらのCD4+リンパ球の減少は免疫を抑制し、患者は広範囲にわたる日和見性の感染症や悪性腫瘍にかかりやすくなる。
着色液体内、特に全血や尿及び、血清や血漿を例とする生体液体誘導体のような着色生体流体内の化学的、生化学的構成要素の数量化は、かつてないほど重要になってきている。医療診断と治療、そして治療薬剤、麻薬、有害化学物質、及び同様のものへの暴露の数量化において重要な適用例がある。例えば、決定された物質の量は、非常に少ない(ミクログラムかデシリットル未満の範囲)か、簡単に決定するのは困難であるかであり、使用される器具は複雑で検査技師にしか有用ではない。この場合、検査結果は通常サンプルを採取後数時間か数日後に判明する。他の例では、非専門家の技師がその検査を定期的に素早く、そして再生可能な方法で、研究室の外で迅速に素早く情報を表示する能力が強調される。
ブドウ糖分析
ブドウ糖酸化酵素
ブドウ糖+H2O2+O2 → クロマジェン酸+H2O2
ペルオキシターゼ
H2O2+減数クロマジェン → 酸化クロマジェン+ H2O
(無色) (有色)
検出方法が視覚的なものの場合は、図19Bに示されるように、マイクロワイヤーエミッタ320が稼動して、検出可能な反応生成物391に向かって入射照明を発する。入射エネルギーと検出可能な反応生成物391間の光/物質相互反応の後、変性された電磁気はマイクロワイヤー検出器322へ移動させられる。光及び/もしくは映像分析は上記で説明したように、結果を数量化するために稼動する。検出方法が電気化学である代替実施形態である場合、酵素ペルオキターゼとクロマジェン基質が省かれる。この場合、生成されたH2O2は白金電極で酸化し、サンプルブドウ糖濃度に比例して電子電流を作り出す。
日々の生活において、人々は多くの種類のストレスにさらされている。ストレスが健康全般にあたえる悪影響はよく報告されている。心臓病、うつ病、エネルギー不足、不眠症、そして 高血圧のような健康上の問題はみな、ストレスと関係している。したがって、発明者はここで1日を通じた使用者のストレスレベルを記録する個人診断装置を提案する。1日の終わり、使用者は1日のストレスに関する分析をダウンロードし、1日のどの時間帯に使用者がもっとも高いストレスレベルにさらされるかを見る。
脱水症状、熱中症、低体温症の適時診断は、これらの状態が運動に関連した怪我や病気を引き起こす可能性があることから、スポーツ活動に参加している選手にとって重要であり、運動に関連した怪我や病気は極度の身体活動による罹患率と死亡率に関連している。運動に関連した怪我や病気の二大原因は、不整脈、心停止、心筋虚血として現れる運動誘発性低ナトリウム血症と心疾患である。
図23Eとの関連で上記に説明されているように、全ての血液サンプルは5つの分析チェンバー(平行の形状に位置している)に移動する。乳酸の数量化に使用される分析チェンバーには、下記の乳酸反応に必要な全ての酵素が事前に装填される。乳酸分析のため、分析チェンバーは乳酸オキシダーゼ、ペルオキシダーゼ、H2O2の存在下でペルオキシダーゼによって検出可能な反応生成物に変えられる基質試薬を含むことが可能である。このパッチにおいては電気化学的方法が検出に最適な方法であることから、酵素ペルオキシダーゼとクロマジェン基質は除外される。この場合、サンプル乳酸濃度に比例した電流を作り出すために生成されたH2O2は白金電極で酸化している。以下に示されているのは、本スポーツパッチに関連する乳酸分析反応である。
乳酸オキシダーゼ
L-乳酸 + O2 → ピルビン酸塩 + H2O2
ペルオキシダーゼ
H2O2+還元クロマジェン → 酸化クロマジェン + H2O
(無色) (有色)
酸素は電流測定法で測定される。酸素隔膜は酸素を内部の電解質溶液に浸透させ、そこでは陰極で酸素が減少する。酸素還元電流は溶存酸素濃度に比例する。
今日世界が直面している大きな課題の1は、ますます増加する高齢者人口への医療の提供である。定年年齢の65歳に達する人口が増えるだけでなく、その寿命も延びている。長寿とともに、心臓病、腎臓病、糖尿病などの慢性疾患が現れ、その全ては人の自立性を侵害する。そのため、高齢者への経済的な医療の提供に対するニーズはますます急を要するものとなっている。
A.心疾患マーカーCK−MB 、TnI、ミオグロビンの数量化
標識帯あるいは接合放出パッドに浸透しているのは、関心のある心疾患マーカーに対する特定の信号標識が付いた第一抗体(着色ラテックス粒子あるいは蛍光標識あるいは酵素標識)である。分析パッドの捕捉抗体は生体内あるいは体外で生成することが可能である。抗体の生成方法は当技術分野の専門家には周知である。例えば、ピーター・デルブス(Ed)、ジョン ワイリー アンド サンズ社「抗体生成:不可欠なテクニック」ISBN:0471970107(1997)を参照されたい。代替的に、抗体は商業的供給源から入手することも可能である。抗体は当技術分野で周知の共有結合、直接吸着、物理的捕捉、タンパク質でコーティングされた表面への結合など、様々な方法により固相で固定化することが可能である。
B.クレアチニンの数量化
以下のセクションは、本発明の高齢者ケアパッチで使用されているクレアチニンの数量化とクレアチニン分析を説明している。
クレアチニナーゼ
クレアチニン+H2O → クレアチン
クレアチナーゼ
クレアチニン+H2O → サルコシン + 尿素
サルコシン・オキシダーゼ
サルコシン+O2+H2O → ホルムアルデヒド + グリシン + H2O2
ペルオキシダーゼ
H2O2+ 還元クロマジェン → 酸化クロマジェン + H2O
(無色) (有色)
反応帯:上記のクレアチニン反応に必要な全ての酵素が細胞膜に浸透している。クレアチニン分析のため、反応パッドはクレアチニナーゼ、クレアチナーゼ、サルコシン・オキシダーゼ、ペルオキシダーゼ、H2O2の存在下でペルオキシダーゼによって検出可能な反応生成物に変えられる基質試薬を含んでいる。反応パッドは多孔性の、流体が完全に浸透した後の厚みが約125μm、直径が約1mmの融解ポリマー基質細胞膜であることが望ましい。各パッドの吸収量は5−10μmの範囲であることが望ましい。
C.総ヘモグロビンの数量化
ヘモグロビン分析は貧血の検出に使用される。貧血は60−80%の腎機能障害の患者の生活の質と早期死亡に影響があることが知られている。
本発明の特定の態様が、関連の精神衛生、脳、認知科学の分野に使用される個人診断装置においても使用され得ることが、発明者により現在意図されている。本発明のこの適用においては、発明者は脳の活動、使用者の神経システムの機能また/あるいは関連の信号をモニターできるバイオパッチあるいはブレスレットを意図している。
Claims (20)
- 使用者から流体サンプルを採取するためのサンプル採取層と、
前記使用者から得られた前記流体サンプルを処理するための流体サンプル層で、前記サンプル採取層と流体連通している前記流体サンプル層と、
前記流体サンプルの前記処理から生じた診断結果を検出するための手段と、
前記診断結果を表示するための手段を含む個人診断装置。 - さらに少なくとも1つの加圧ガスを含有する空洞を含む請求項1の装置。
- さらに少なくとも1つの真空の空洞を含む請求項1の装置。
- さらに流体の流れを遅延させるための疎水性表面を含む請求項1の装置。
- さらに流体の流れを促進するための親水性表面を含む請求項1の装置。
- さらに前記使用者にフィードバックを提供するためのサウンドエミッターを含む請求項1の装置。
- さらに論理処理システムを含む請求項1の装置。
- さらに前記論理処理装置内にIPアドレスを含む請求項7の装置。
- 使用者の周囲環境からのエアサンプルを採取するためのエアサンプル採取部と、
少なくとも1つの特定の空気汚染物質のために前記エアサンプルをテストするための手段と、
使用者から流体サンプルを採取するための流体サンプル採取層と、
前記使用者から得られた前記流体サンプルを処理するための流体サンプル層で、前記サンプル採取層と流体連通している前記流体サンプル層と、
前記流体サンプルの前記処理から生じた診断結果を検出するために使用される検出器と、
前記診断結果を表示する表示する表示部を含む個人診断装置。 - さらにTCP/IPを有する論理処理システムを含む請求項9の装置。
- さらに前記使用者の位置に関する遠隔情報を提供するための受信機と送信機を含む請求項9の装置。
- さらに前記検出器により検出された前記診断結果処理のための処理装置を含む請求項9の装置。
- 前記処理装置は、前記使用者の医学的状態に関する出力情報を発生する請求項12の装置。
- さらに前記出力情報を保存するためのメモリを含む請求項13の装置。
- 個人診断装置を使用する方法であって、次のステップを含む方法。
使用者に各個人診断装置を装着、
前記個人診断装置で前記使用者から生体サンプルを採取、
前記使用者に関する医学的あるいは健康情報を得るため前記個人診断装置内の前記生体サンプルを処理、
前記情報を受信装置に送信、及び
前記医学的状態に関する出力結果を表示。 - さらに前記送信ステップが実行される前に前記個人診断装置内の前記情報を保存するためのステップを含む請求項15の方法。
- 前記受信装置は、前記個人診断装置内にある請求項15の方法。
- 前記受信装置は、パーソナルコンピュータである請求項15の方法。
- 前記受信装置は、連絡ネットワークと結ばれている請求項15の方法。
- 前記生体サンプルは、血液である請求項15の方法。
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US9993189B2 (en) | 2018-06-12 |
HK1100761A1 (en) | 2007-09-28 |
WO2005084534A1 (en) | 2005-09-15 |
CN1874720A (zh) | 2006-12-06 |
KR101165102B1 (ko) | 2012-07-12 |
US20180344230A1 (en) | 2018-12-06 |
US20160058354A1 (en) | 2016-03-03 |
US20050106713A1 (en) | 2005-05-19 |
CA2537796A1 (en) | 2005-09-15 |
CN1874720B (zh) | 2010-11-17 |
EP1670356A1 (en) | 2006-06-21 |
CN102018496A (zh) | 2011-04-20 |
SG146630A1 (en) | 2008-10-30 |
CA2537796C (en) | 2013-12-03 |
US20240090804A1 (en) | 2024-03-21 |
AU2004317007A2 (en) | 2005-09-15 |
US20160066828A1 (en) | 2016-03-10 |
WO2005084534A8 (en) | 2005-10-20 |
US9133024B2 (en) | 2015-09-15 |
US11737694B2 (en) | 2023-08-29 |
BRPI0414067A (pt) | 2006-10-24 |
KR20060123103A (ko) | 2006-12-01 |
AU2004317007A1 (en) | 2005-09-15 |
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