JP4754770B2 - 非侵襲性測定用機器 - Google Patents
非侵襲性測定用機器 Download PDFInfo
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- JP4754770B2 JP4754770B2 JP2002567070A JP2002567070A JP4754770B2 JP 4754770 B2 JP4754770 B2 JP 4754770B2 JP 2002567070 A JP2002567070 A JP 2002567070A JP 2002567070 A JP2002567070 A JP 2002567070A JP 4754770 B2 JP4754770 B2 JP 4754770B2
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- eye
- conjunctiva
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- 0 CCCC1*CCC1 Chemical compound CCCC1*CCC1 0.000 description 6
- HFHJBWYDQAWSIA-UHFFFAOYSA-N CCCC1CC(C)CCC1 Chemical compound CCCC1CC(C)CCC1 HFHJBWYDQAWSIA-UHFFFAOYSA-N 0.000 description 1
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Description
涙液中及び/又は目の表面上の血液成分及び化学物質の測定を行う機器及び方法は、電流を供給する酵素反応と結合する電極に基づいている。それは、距離を置いた受信装置にラジオ波送信し、継続的に涙液中あるいは目の表面の物質の濃度のデータを与える。このICLシステムは、好ましくは接触装置で試薬や機械的/動作部分を全く必要としない拡散制限センサ方式に基づく。ICLを用いるブドウ糖検出器の好ましい方法と機器は、ブドウ糖酸化酵素を用いる。その酵素は、接触装置に装着された電気化学的センサに結びつけられているブドウ糖と酸素の反応を触媒する。センサは、接触装置の膜で覆われた触媒金属電極でのブドウ糖の直接電気化学反応と同様に、反応の生成物で、内因的な共反応剤あるいは、フェロセン-ブドウ糖センサのような結合電子担体分子のどちらかに感知する。
H2O2 → 1/2O2+H2O
カタラーゼ酵素によって、全体の反応は:ブドウ糖+1/2O2 → グルコン酸:と表せる。
コレステロールエステル→(コレステロールエステラーゼ)→フリーコレステロール+脂肪酸
フリーコレステロール+O2→(コレステロール酸化酵素)→ コレステノン+H2O2
さらに実施例としては、接触装置に収容され、目の涙液と表面からpH及び他の化学物質を検出することに用いられるアンチモン電極を利用する。またpH−内部ラジオゾンデのようなpH等を測定できるトランジスタ回路を持つガラス電極が用いられ、接触装置に設置されて、涙液や目の表面での測定に用いられ、信号は好ましくは遠隔ステーションにラジオ波で送られる。
・様々な組織層をもつ試料
・散乱組織をもつ試料
・ランダムな厚さをもつ試料
・未知の厚さをもつ試料
・個人間で異なる厚さをもつ試料
・老化とともに厚さが変化する試料
・老化とともに組織の中で変化する試料
・ケラチンをもつ試料
・さらされている環境によって変わる試料
・放射線の透過の障壁をもつ試料
・住んでいる環境によって変わる試料
・脂肪をもつ試料
・軟骨をもつ試料
・骨をもつ試料
・筋肉をもつ試料
・高含水の試料
・血管壁をもつ試料
・信号の原因である、不可視の媒体をもつ試料
・不透明な接触面をもつ試料
・接触面が死細胞から作られた試料。
・傷跡がある接触面を備えた試料
・痛みと接触に非常に敏感な試料。
・メラニンをもつ試料
・異なる色相をもつ接触面のある試料
・ヘモグロビンをもつ試料
・動いている試料媒体
・細胞の成分をもつ試料媒体
・赤血球をもつ試料
・測定されている物質が不均等分布をもつ試料
・測定されている物質が不安定な供給をされる試料
・均質でない試料
・測定されている物質が低濃度である試料
・高水含量を持つ構造物に囲まれた試料
・不規則な構造物に囲まれた試料
・振動する試料媒体
・様々な未知の厚さの血管壁をもつ試料
・不安定な圧力をもつ試料
・位置が変わる試料
・堆積物で満たされた試料
・身体深くに位置する試料
・不安定な温度をもつ試料
・熱勾配をもつ試料
・熱エネルギーと直接接触がない試料
・活発な伝熱のない試料
・熱損失をもつ試料
・外部温度によって影響を受ける試料
・不等温線の状態をもつ試料
・熱エネルギーの自己吸収をもつ試料
本発明によって減じられるか除去される、放射線を照射される試料の中にある妨害成分のうちのいくつかの模範になる説明
a)標的組織に向けられた放射線は、皮膚のいくつかの層、様々な血液細胞成分、脂質、骨、血管等を含む様々な成分に吸収されることができる。これは強力に信号を減じる。また、処理はこれら干渉する要素をすべて減じることを要求する。放射線を照射される試料中の列挙された妨害成分はすべて、本発明で除去される。
b)皮膚自身が付加された散乱組織であるので、標的組織として皮膚単独で、信号対雑音を減少させる。本発明は、放射線を照射される試料中にある干渉し散乱させる構造を除去する。
c)皮膚(それは舌の表面を含む)の厚さは、位置によって厚さが変化し、非常に小さなエリアでさえ同じ個体内でもランダムである。組織学の(組織除去)研究がされていないポイント毎に皮膚の正確な厚さを知るのは非常に難しい。皮膚の厚さにより信号は非常に可変性になる。放射線を照射される試料中の構造のランダムな厚さ及び未知の厚さのような、誤差及び可変性のそれらの原因がすべて除去される。
d)皮膚において正確に同じ位置でも、皮膚の厚さもまた個体間で変わる。また、このように、個々に各生物によって信号を考慮しなければならない。放射線を照射される試料中の構造の厚さにおける個体の可変性も除去される。
e)老化で生じる皮膚の厚さと組織の変化は、正確な測定を得る際に劇的効果を持つ。放射線を照射された試料中の構造の老化による、組織及び厚さの変化も除去される。
f)様々な代謝・環境要因に生じる皮膚及び舌裏におけるケラチンの量の変化も、正確な信号の獲得を防ぐ。放射線を照射される試料中のケラチン及び可変性は両方とも除去される。
g)エラスチンの量のような皮膚構造は、日光曝露の量、汚染、オゾン層の変化及び他の環境要因により、人によって非常に変わる。それらは信号獲得において大きな可変性に至らしめる。前述の環境要因から自然に保護されることにより、ほとんどの環境要因に侵されやすい、放射線を照射される試料が除去される。
h)皮膚の構造及び厚さにより、放射線は、重要な物質が存在する位置に透過し達することができる。放射線への障壁として働く放射線を照射される試料中の構造が除去される。
i)前述の個体の周囲条件及び代謝の状態による、同じ個体の水和及び皮膚表面温度における日々の変化によって、測定もまた影響される。周囲の状態による水和と温度の変化に侵されやすい放射線を照射される試料中の構造が除去される。
j)反射されたあるいは伝搬された信号の強度は、脂肪の量のような個々の物理的特性に依存して、患者により劇的に変わりうる。痩身及び肥満の人は、脂肪の量において非常に変わる。従って同じ濃度の重要な物質に対する放射線信号において非常に変わるであろう。放射線を照射されている試料エリアの脂肪が除去される。
k)筋肉の固まりのようなタンパク質量も、人により非常に変わる。放射線を照射する試料エリアの筋肉の固まりの可変性が除去される。
l)組織の周囲及び皮膚の水分及び水和のレベルは、個体間及び、同じ個体中でも蒸発により時間で変わる。放射線を照射される試料エリアの水蒸発の変化のためにおこる、人及び時間による可変性が除去される。
m)血管の壁の厚さ及び組織も、老化とともに実質上変化し、位置により非常に変わる。位置及び老化とともに実質上変化する壁のためにおこる、放射線を照射される試料中の信号の可変性が除去される。
n)同じ年齢集団内で深い血管位置及び構造は、さらに人により非常に変わる。また、組織の変化量は、各個体において血管の異なる深さ及び位置でかなり一定である。それらの血管が深く位置され、皮膚のような不透明な組織によって覆われるので、前述の血管の位置を精密に測定するのは不可能である。試料に放射線照射される間、見ることのできない信号の原因媒体が除去される。
・バックグラウンド干渉が少ないことにより、血しょう/結膜接触面で高い信号が得られる。
・熱源が感知手段と直接付着しているので、信号が妨げられない。
・まぶたのポケットが熱を封じ込めていることにより、温度が安定する。
・まぶたのポケットが空隙として働く。まぶたの端は、眼球表面のしっかり反対側にあり、目の中で容易に観察されるからである。まぶたポケットの内部を見るために、能動的にまぶたを引くことが必要である。
・空隙の内部に熱損失はない。
・センタに直接接触する局所的な血流によって起こる血管からの能動的に伝熱される。
・目の温度は、中枢神経系循環から直接供給されることによって、中心温度と直接の平衡状態にある。
本発明は、結膜の表面に好ましくは近赤外線を向ける手段、後方散乱スペクトルあるいは反射を重要な物質の濃度に変換する及び分析を行う手段、及び目の表面に隣接した検出手段と光源の位置決めの手段を含む。本発明はまた、前述の方法で重要な物質の濃度を確定するための方法を与える。前述の方法は、結膜の上、中、あるいは下に存在する血しょうを含む目の流体を用い、血しょう接触面に近赤外のような電磁放射を向け、生じたスペクトルをとりあげ検出上の電気信号を与え、信号を処理し前述の信号によって重要な物質の濃度を報告するというステップを含む。その発明は、安定した圧力及び温度をもち安定した位置に、光源及び検出器の位置を決めるための手段と方法も含む。それは放射線が向けられる及び受け取られる表面に関連している。結膜の真下に集められた血しょうは、線源媒体として、重要な物質の濃度の測定に好ましく用いられる。
本発明の好ましい実施例をここで図面を参照しながら説明する。図1に示した好ましい実施例により、圧平式により眼圧を測定するシステムを与える。このシステムは、角膜4と接触して置かれる接触装置2と、接触装置の一部を角膜4に向って突出させ、予め定義した圧平量を与えるように、接触装置2を作動させるための駆動手段6とを含む。
更に、システムは、角膜4の圧平量が予め定義した値に達した時を検出する検出配列8、及び計算ユニット10とを含む。その計算ユニットは、力の量に基づく眼圧の確定のために検出配列8に応答する。この力の量は、予め定義した圧平量に達するために、角膜4に対して接触装置2が加えなければならない力の量である。
各光学フィルタ92は異なる割合の光を除き、検出器86の予め定義された部分は光学フィルタ92の特定の一つと、それに関連するフィルタする割合とで決められている。
・圧入式(Indentation)
図1から図5までで示した接触装置2と関連するシステムとは圧入により眼圧を測定するためにも使用される。圧入技術は眼圧測定に用いられ、予め定義された力が、圧入装置により角膜に加えられる。この力により圧入装置が角膜方向に移動し、この移動に伴ない角膜を押し込む。圧入装置により、予め定義された力に応じて角膜方向に移動した距離は眼圧に逆比例することが知られている。従って、基準となる圧入装置の大きさ及び力と、移動距離及び眼圧との相関を示す種々のテーブルがある。
・目の流体力学測定
本発明の圧入装置は、房水流出率を含む目の流体力学を非侵襲的に計測することにも利用できる。
本発明の方法は以下に述べるいくつかの段階から成立っている。
・その他の接触装置の詳細
前述した説明は接触装置2の内側の面に可撓性の膜14を持つような接触装置2の実施例について利用したが、本発明がそのような構成に限定されないことはすぐに分かることである。実際に、本発明の範囲に含まれる接触装置の変形が沢山ある。
こうすると、光は接触装置2を完全に通過し、接触装置2によってゆがみを被ることなく、角膜に直接当たる。その他にも、透明な中心部には透明な固体物質を満すこともできる。そのような透明な固体物質としては、ポリメチルメタクリレート、ガラス、固いアクリル、可塑性ポリマー等が例示できる。望ましい構成としては、角膜よりも本質的に大きな反射率を持つガラスは、光が接触装置2を通過する際、角膜の反射率を増す働きをする。望ましくは、ガラスの反射率は角膜の反射率1.37に比べて、1.7より大きい方が良い。
同様に、可動中央部片16の環状の型は、透明な底を持つ板状構造(示されない)を加えることで修正される。この板状構造は可動中央部片16の平らで透明な底表面を明確にする。このように変形が為されると、可動中央部片16はカップ状の外観を持つようになる。平らな透明の底の面は、可動中央部片16の平面化効果を高めるために、角膜近傍に位置させることが好ましい。なお、望むならば、透明板は、可動中央部片16の外側の面に配列することも可能であることは言うまでもない。
圧平化による眼圧を測定する他の実施例
図16を参照しながら、圧平化により眼圧を測定するシステムの他の実施例について説明する。本実施例は透明な中央部分をもつ接触装置2を変形して用いることが好ましい。
可動中央部片16の磁場変化した際の磁気双極子モーメントmは次の式によって決定できる。
(ここで、Bは可動中央部片16の一つの極の表面における磁気誘導ベクトルである。Vはその体積で、u0は自由空間の透磁率で、12.57×10-7H/mである。)
アルニコ磁石で磁化された可動中央部片16のBの典型的な値は0.5テスラである。もしこの可動中央部片16が厚さ1mm、直径5mm、その全体積の50%が機械加工で除去されているとすれば、その体積Vは9.8立方mm(9.8×10-9m3)となる。この値を式(2)に代入すると、可動中央部片の磁気双極子モーメントは、m=0.00390Am2になる。
(ここで、xは鉄心の磁化率、Nはコイルの巻き数、Iは電線を流れる電流、Lはコイル30の長さ、RADはコイル30の半径である。)
本実施例においての推奨される値は、x=500,N=200,I=1.0A、L=0.05m、RAD=0.025mである。しかしながら、本発明においてはこの値に限定されない。u0は、通常、12.57×10-7H/mである。
ゴルドマン(Goldman)眼圧計では、圧平化領域の直径はおおよそ3.1mmであり、典型的な扁平化領域の広さは7.55mm2となる。典型的な最大圧力50mmHgは、圧力0.00666N/mm2で足りる。このFrequiredは、次の式を使って決められる。
数学的にFrequired=0.050Nを代入した場合、解析された磁気作動力Fと、要求される力Frequiredは、実際の磁気駆動力Fに比べて小さい。従って、眼圧により決定される角膜4を圧平化するに必要な最大圧力は、本発明による駆動手段と可動中央部片16とによって容易に得られる。
大きなパルス状の磁界を得る、及びパルス状のレーザーパワーシステムを操作するような適用のために、電流の大きいパルスを発生させるように従来的に用いられている物と同様の、R-L-C系回路を、この配列は与える。電気部品の値及びコンデンサーの初期電圧を適切に選ぶことによって、駆動手段を操作するためにコイル30に供給・生成する上述の電流パルスを生成することができる。
ます。
1)駆動手段がオフであると、接触装置2に磁界は発生しない。
2)駆動手段がオンにされた場合の磁界の初期値はゼロである。
3)患者がひとたび位置につくと、患者はその眼を駆動手段と位置合わせする。眼が正しい位置関係になるまで、磁界はゼロのままである。
4)眼が完全に位置合わせされると(自動的に光学的位置合わせセンサが検出する)、磁界(電流が増加するように駆動される)はゼロから増加を始める。
5)電流が増加する間(およそ0.01秒)可動中央部片の力も増える。
6)増加する可動中央部片の力に反応して、角膜の表面領域の平坦化が進行する。
7)角膜の平らにされた表面領域からの光は、予め定義された圧平度に達したことを検出する検出手段に向けて反射される。角膜から直接反射される光の量は平坦化された領域の大きさに比例し、予め設定された量だけ角膜が圧平化されたこと(例えば直径3.1mmの円形状など)は正確に検出可能である。また、0.1mmから10mmまでのどのような直径の範囲でも使用できる。
8)特別の表面積の圧平(つまり予め定義した圧平量)を達成するのに必要な時間は、圧平検出手段の一部であるタイミング回路によって検出される。先に校正及び求めた換算表に基づき、この時間は眼圧の表示に変換される。特定のエリアを圧平化するために必要な時間が長い場合は眼圧が高く、逆に時間が短い場合は眼圧は低い。
9)前もって定義した圧平量が達成された後、磁界が止められる。
10)その後、眼圧は読み出し計器によって表示される。そして、患者の目が位置合わせし続けた場合に、自動的に測定サイクルが直接繰り返されないように、回路はすべて、15秒間完全に止められることが好ましい。しかしながら、回路はオンのままかもしれないし、眼圧の継続的な測定が自動的な測定サイクルの作成により達成することもできる。そのときこの自動的な測定サイクルによって提供されるデータは血流を計算するために使用されてもよい。
11)主電源がOFFにされていなかった場合、15秒後にすべての回路はONに戻され、次の測定の準備が完了する。
a)最初に、角膜と同等の曲率半径をもつ凸ガラス面(レンズの片面)が角膜及びその表面の反射の模擬実験に用いられる。このガラス面は、コイルの長さ方向の軸に沿ってマイクロメートルで調節できる構成に配列されることが好ましい。マイクロメートルで調節できる構成は、2つの軸回転(チップ(tip)とチルト(tilt))と三次元での平行移動(x−y−z)とができるように配列される。
b)電圧又は電流計に接続された検出器D1を用いて、レンズL4から25mmの設計距離に配列された凸ガラス表面は、読み出しメータで出力信号を最大限にすることにより完全に位置合わせする(チップ/チルト/x/y/z)。
c)完全な位置合わせが達せられた後、位置合わせ検出装置は、位置の自由度(チップ/チルト/x/y/z)の各々のために再調整されており、そのためにシステムの位置合わせへの感度を定義するために、各自由度で湾曲がプロットされる。
d) 位置合わせへの感度は、測定の再現性中の希望の許容範囲と比較され、位置の関数として可動中央部片上の磁力の変動に基づく。
e) その後、位置合わせシステムの感度は、位置合わせセンサD1であるシリコンフォトダイオードの開口の変更及び/又はレンズL4における開口を変更する手順により、必要に応じて変更することができる。
a) 4-5mmの直径を備えた平らなガラス表面(例えば短い磨かれた棒の1つの端面)は圧平された角膜及びその表面の反射をまねるために用いられる。
b)黒い不透明な開口度定義機構(外径は前記棒と同じであって、0.5から4mm直径の透明な内部開口が形成されている。)が、棒の表面の部分を覆うように配列され、種々の圧平状態のシミュレーションができる。
c) 平らな表面の棒は、約2つの軸(チップとチルト)で回転させることができ、三次元のx-y-z空間で移動可能なマイクロメートルで調節できる構成にコイルの長さ方向の軸に沿って配列される。
d) その後、圧平センサD2からの出力信号を最大限にすることにより、レンズL4から25mmの設計距離に棒を完全に位置合わせ(チップ/チルト/x/y/z)する間、圧平センサD2は電圧計か電流計に接続される。この場合、位置合わせは、X軸の位置合わせに敏感でない。
e)完全な位置合わせが達せられた後、位置合わせ検出装置は、位置の自由度(チップ/チルト/x/y/z)の各々のために再調整されており、そのためにシステムの位置合わせへの感度を定義するために、各自由度で湾曲がプロットされる。このデータは棒の面における、種々の大きさに合わせられた開口(つまり圧平の異なる程度)について得られる。
f)その後、位置合わせへの感度は、位置合わせ手段による前述の検査及び校正方法の中で得られた結果に左右される圧平測定における再現に必要な許容量と比較される。
g) その後、圧平検出手段の感度は、圧平センサD2の前の開口のサイズを変更したり、及び/又はビームスプリッタBS2における開口(小さな孔)を変更することによって、必要に応じて変更される。
1.I(t)は、駆動手段を動作させるために変化なく供給される電流パルスとして与えられる独立した信号である。この信号I(t)は、一つの測定から他の測定に移るときにも、部分的な短い変化を除いて一定値である。I(t)は、以下に議論する他の波形であるAPPLN(t)とALIGN(t)とに対して比較の基準となる。
2.APPLN(t)は、出力信号に依存する。APPLN(t)は、I(t)がゼロであるとき、ゼロである値(つまり駆動手段のコイルのパルス電流のごくはじめの時点)をもつ。この理由は、電流がゼロであるとき磁界はなく、可動中央部片上には圧平力をもたないからである。I(t)が増加すると圧平の程度も増加し、従ってAPPLN(t)も増える。APPLN(t)が、眼球内圧力に依存するI(t)の増加に従って増加することに着目することは重要である。低い眼圧をもつ眼球が圧平化するのは、高い眼圧をもつ眼球を圧平化圧で応答させるよりも簡単であるので、APPLN(t)は、高い眼圧をもつ眼球よりも低い眼圧をもつ眼球の方がより急速に増加する。従って、APPLN(t)は、完全な圧平が達成される場合、極大値に達するまで、眼圧に反比例する変化率でゼロから増加する。
3.ALIGN(t)もまた、出力信号に依存する。眼球がセットアップの中で位置合わせしたと仮定すると、I(t)がゼロである(つまり駆動手段のコイルのパルス電流のごくはじめの時点)ときに、ALIGN(t)信号はある極大値から開始される。この理由は、I=0のとき磁界はなく、その結果、角膜の曲率を変化させるための可動中央部片に力は作用しないからである。角膜の反射が位置合わせ信号を生じさせるものであるので、I(t)の増加は圧平を引き起こし(及び対応する角膜の屈曲の程度の減少)、ALIGN(t)信号は完全な圧平状態であるゼロに達するまで減少する。ALIGN(t)が、眼圧に依存するI(t)の増加によって、減少する値であることは重要である。眼球外の圧力は、高い眼圧を備えた眼球より容易に圧平化できるので、ALIGN(t)は、高い眼圧がある眼球よりも低い眼圧がある眼球の方が、より急速に減少する。従って、完全な圧平が達せられる場合に、ALIGN(t)は、眼圧に反比例する変化率にて0に達するまである極大値から減少する。
次に、単一のプロットは、勾配の眼圧に対するデータを示すのみならず、データを通じての最良適合曲線もそれぞれの眼球について準備される。理想的には、10の豚の眼球のすべての曲線は、同様に得られた10の人間の眼球に完全に一致する。理想が実現される場合、本発明のための校正用として、任意の曲線が利用できる(それらはすべて同じなので)。実際上、しかしながら、理想は恐らく実現されない。
・圧入法による眼圧測定法の他の実施例
図20A及び20Bを参照して、圧入により眼圧を測定する代わりの実施例を説明する。
・新たな利用可能性
本発明の装置及び方法によれば、上述したように眼圧の測定のみならず、目の剛性、目の流体の流出率や流入割合のような目の流体力学、強膜静脈内の圧力のような目の血行力学、血液の流れの脈動、眼圧を人工的に増加させること、及び眼圧の連続的な記録が可能になる。
-衝撃加速度-
可動中央部片は、よく定義された速度で角膜に向けられる。それは角膜に衝突し、一定時間の接触後、跳ね返る。衝突時及び衝突後の時間と速度との関係を検討する。圧平する中央部片は、接触装置の固い環状部材に弾性をもって連結されることができる。角膜の表面が固い場合は衝撃時間は短い。同様に、角膜表面が柔らかい場合は衝撃時間は長い。光学的センサは、衝撃の持続及び可動中央部片が当初の位置に復帰するまでに、どの程度の時間がかかるかを検出する。
-衝撃の持続時間-
眼圧は、眼球に対して、弾性で駆動される可動中央部片の接触の継続時間を測定することによっても評価できる。前述された光学的手段は、角膜が平らになり続ける時間の量を評価することができる。
-跳ね返り速度-
さらに、弾んだ後に単位時間当たり移動する距離は、はね返りエネルギーを示し、このエネルギーは眼圧に比例する。
-振動原理-
眼圧は、接触装置に接する振動要素の周波数の測定によっても評価でき、振動数の変化は眼圧と関係がある。
-時間-
本発明の装置はまた、上述したように、角膜を圧平化するのに必要な時間の測定にも利用できる。角膜が固くなればなるほど眼圧は高くなり、角膜の変形に長い時間を要する。一方、角膜が柔軟になるほど眼圧は低くなり、角膜の変形に要する時間は短くなる。従って、角膜の変形に要する時間は眼圧に比例する。
1.従来の圧入
従来の圧入技術が利用される場合、本発明の可動中央部片は角膜を圧入するために用いられ、その結果、人為的に眼圧が増加する。この人為的な眼圧の増加により、眼球から流体を平常より急速に流出させる。流体が眼球を出るとともに、圧力は徐々に本来の水準に戻る。眼圧が落ちる速度は、眼球の排水システムがどれくらいよく機能しているかに依存する。時間の関数としての圧力降下によって、C値又は房水流出率の係数が計算できる。C値は、眼圧の変化が流体流出の速度の変化をもたらす程度を示す。これは目の排水システムの流出抵抗を示す。房水流出率を決定するための様々な手続きは、トノグラフィとして広く知られており、C値は、mmHg当たり毎分当たりのマイクロリットルによって表される。C値は、接触装置の可動中央部片を用いて眼圧を上昇させ、時間に対する眼圧の減衰を観測することで決定できる。高められた眼圧により液体の流出速度は増加する。体積のこの変化は、体積変化と圧力変化との関係を示すフリーデンワルド表から計算できる。体積減少の速度は、流出の速度と等しい。トノグラフィ手続きの間の眼圧の変化は、2分間隔の連続する圧力増加の相加平均として計算できる。従って、C値は次の方程式:C=ΔV/t×(Pave−Po)から求められる。ここでtは手続の時間間隔、Paveは試験中の平均圧力上昇で、測定可能である。Poは初期の圧力でこれも測定可能である。そしてΔVは最初と最後の体積の差で、既定の表から求めることが出来る。液体の流れ(“F”)は、式:F=C×(Po−Pv)から求めることが出来る。ここでPvは強膜上静脈の圧力で、測定可能であり、一般的には一定値10である。
2.一定深さの圧入
一定深さの圧入技術を利用する場合、方法は眼球における一定の前もって定義した量の圧入を引き起こすのに必要な可変力を使うことが要件とされる。従って、本発明の機器は角膜に対して前もって定義した量を圧入するのに必要な力を測定するように構成される。圧入量は前述した光学的手段にて検出できる。可動中央部片は、例えば約0.5mmだけ圧入するように角膜に押しつけられる。圧入量は前述した光学的手段とフィルタとで検出される。中央部片に10gと同等な力をかけて角膜を圧入した場合に、通常の圧力(例えば15mmHgの眼圧)と平均的な角膜の曲率とを仮定すると、0.5mmのへこみが得られる。その圧入量及び標準的な中央部片の大きさとすることで、流体の2.5mm3が排除されるだろう。本発明によって記録された力は緩やかに下降し、2〜4分後には多かれ少なかれ定常状態になる。圧力の減衰は、中央部片の最初の圧入の値と、一定時間の後に達せられた最終的な水準との間の差に基づいて測定される。圧力降下は、可動中央部片の圧入によって人為的に高められた後、その通常の圧力値に復帰する。減衰の既知の正常値は基準として用いられ、得られた値と比較される。前述したように、圧力を連続記録できるので、この方法は、showing(例えば深呼息中の圧力の増加)による生理学の研究用の重要なツールになりうる。パルス波形とパルス振幅とを評価でき、脈動血液流が計算できる。
3. 定圧圧入
定圧圧入技術を利用する場合、流体が眼球から漏れるので、眼圧は、磁界を増加させていくことで、角膜に対する力を増加させることにより一定に保たれる。任意の圧力における力と流出速度とはフリーデンワルド眼圧測定法表に従う直線的な関係がある。眼圧は従来の圧入眼圧測定のために記述されるのと同じ方法を用いて計算される。体積置換は眼圧測定法表を使って計算できる。房水流出率(C)は2つの異なる技術を用いて計算できる。第1の技術によれば、Cは以下の方程式に従う異なる2つの定圧トノグラムから計算できる。
4.定圧圧平化
定圧扁平化技術を利用する場合、流体が眼球から漏れるので、眼圧は、磁界を増加させていくことで、角膜に対する力を増加させることにより一定に保たれる。角膜が球の一部だと考えられるならば、数式は、その球状の断片の底部の半径と、球の曲率半径とに、球状の断片の体積を関係づける。置換された体積は、V=A2/(4×π×R)の数式に基づいて算出できる。ここで、Vは体積、Aは断片の底部の面積、そしてRは球の曲率半径(これは角膜の曲率半径である)である。A=重量/圧力であるから、V=W2/(4×R×P2)である。重さは電磁界の力によって構成され、Rは角膜の曲率でケラトメーターで測ることが出来る。Pは眼圧で、従来の圧平眼圧測定法として記述されたのと同じ方法を用いて測定できる。従って、置換体積及びC値又は房水流出率を計算することは可能である例えば、置換体積は15秒間隔で計算でき、時間の関数としてプロットできる。
5.定面積圧平化
定面積圧平化を用いるとき、この方法は第一に平坦部の面積が一定である間に圧力低下曲線の評価することからなる。先に述べた光学的圧平化検出配列は可動中央部片により平担化された面積を一定に保つために使うことが出来る。平担化された面積を一定に保持するのに必要な力の量は減少し、この減少量は記録表示される。圧平化の種々の面積による置換体積の量がわかる。例えば、5mmの中心部片による圧平化は7.8mmの平均角膜半径に対する体積4.07mm3に置換される。式ΔV/Δt=1/(R×ΔP)を使って、Cの逆数であるRを計算できる。長時間にわたり圧力を連続に記録することが出来るので、血流の研究と評価に重要な手段となり得る。
6.定力圧平化
定力圧平化を用いるとき、同じ力を一定にかけ、先に述べた光学的圧平化検出配列を用いて圧平化面積が測定される。一度、既定の力によって平担化された面積が測定されると、圧平化された面積で力を割ることにより圧力が計算できる。流体が目から流れ出るにつれて圧平化面積は時間と共に増加する。この方法は第1に一定の力が負荷される間に生じる増加曲線の面積を評価することから成る。圧平化された種々の面積による置換体積量がわかる。式ΔV/Δt=1/(R×ΔP)を使って、Cの逆数であるRを計算できる。
・まぶたを閉じることにより作動する代替実施例
図25及び31を参照して、システムの代替実施例をここで記述する。代替の機器と方法は、接触装置402が角膜上にあるとき、作動機器として働き、かつ接触装置に装着された少なくとも一つの変換器(トランスデューサ)400を活性化するために、眼が瞬きするか閉じる間にまぶたにより生み出される力と動きを利用するものである。この方法と装置は、眼瞼組織を通して、好ましくは電磁波によって、情報を送信することにより、圧力と他の生理学上の現象を遠隔で監視することを容易にする。送信された情報は、接触装置402から遠隔に置かれた受信器404で再生される。その受信機404は眼鏡のフレーム408に取り付けられることが好ましい。この代替実施例は、強く目を閉じること利用して流出能力を測定することを容易にさせる。変換器は、好ましくは超小型感圧変換器400であり、それは変換器400上で用いられる物理的な圧力を示すようにラジオ波信号に変える。
1.近赤外線光の多数の波長を生成する光源。
1.光路長を測定することができない。標準の分光器の校正及び生体外の測定では、光路長は、例えばセルの中に含まれていたように、評価されている試料中の光によって横断された長さを含む。身体のどんな部分でも、熱放射は、身体の中深く熱の出所から表面に達するまでの未知の経路を進む。
A= log(I0/I)=E・c・d (1)
そして、未知の濃度(c)を測定するために書き直された。
投射の放射線の本来の強度としてI0を測定することができる場合、Iは、選択された波長によって重要な物質に対応する試料を通して伝送された強度であり、光検出器で検出することができる。
・いくつかの模範になる重要な物質のための実例となる共鳴吸収ピーク
(nm波長)
アルブミン:2170
ビリルビン:460
二酸化炭素:4200
コレステロール:2300
クレアチニン:2260
チトクロム:700
エタノール:3300
グルコース:2120
ヘモグロビン:600
ケトン:2280
テクサフィリンルテチウム:732
L−アスパルチルクロライン(L-aspartylchlorine):6664
酸素:770
フォトポルフィリン(Photoporphyrin):690
ポルフィリン:350
プルリチン(Purlytin):664
トリグリセリド:1715
尿素:2190
ベルテポルフィン(Verteporfin):689
水:11000
身体は目の一定の血流量を維持する。しかし、皮膚、筋肉及び内蔵の血流は、変化する心臓血液拍出量及び周囲条件に応じて変わる。目の中の酸素は連続的に潅流を監視し、血行力学の変化を早期に検出することができる。さらに、まぶたのポケットで見つけられた酸素レベルは中央の酸化を反映する。目の中の酸素監視は身体の一般的な血行力学上の状態の表すことができる。敗血症(流布した感染)か心臓の疾患のような多くの危篤状態は、ほとんどの身体中の潅流を変えることができる。従って、器官潅流の妥当性を評価するのは難しい。
多くの患者が、疾病のための診断及び治療が実施された後でさえ、盲目となる。1つの典型例は緑内障である。緑内障の治療は、彼らの視力を保護するために一日単位で点眼薬を注入することを患者に要求する。視力を保存する点眼薬を処方された後でさえ、患者はまだ盲目となる。時々、患者は、様々な疾病のために点滴薬を1日当たり数回滴下する必要がある。研究は、患者の60%近くが点眼薬の自己管理に苦労したことを示した。問題の目の薬剤を投与する目下の手段は熟練を要求する。患者は正確な量で点滴薬を管理しなければならないだけでなく、やや困難な技術をマスターしなくてはならない。
2…接触装置
6…駆動手段
8…検出配列
10…計算ユニット
12…環状部材
14…可撓性膜
16…可動中央部片
26…磁気応答性要素
28…磁場を作る機構
30…コイル
86…測距ビーム検出器
90…マルチフィルタ光学要素
94…ビーム強度検出センサ
96…収束レンズ
Claims (6)
- 結膜に存する少なくとも1つの物質の濃度の非侵襲性測定用の機器であり、前記機器は以下を含む:
結膜に向けて配設され、結膜より生成され放射される赤外線エネルギーを受け取るとともに、結膜より生成され放射される赤外線エネルギーに基づく前述の結膜に存在する前記物質の赤外線吸収を測定するための検出装置、及び、
その赤外線吸収に基づいた前記物質の濃度を測定するための処理装置。 - 前記物質がグルコース、エタノール及びコレステロールの少なくとも1つを含む請求項1に記載の機器。
- 前記検出装置は、赤外線センサの冷接点及び熱接点と、それらの間の温度こう配を拡大するための冷却機とを備える請求項1に記載の機器。
- 前記検出装置のハウジングは、測定の間中、結膜の表面に接触する請求項1に記載の機器。
- 前記検出装置は、眼から放射される赤外領域のうちの2つの波長(一方の波長は測定される前記物質による光の吸収が前記物質量と高い相関をもち、他方の波長は測定される前記物質による光の吸収が前記物質量と低い相関をもつ)の放射強度を検出する請求項1に記載の機器。
- 結膜の温度を測定するためのセンサを有し、
前記検出装置は、結膜から赤外線エネルギーを受け取るための受信装置であり、
前記処理装置は、結膜より生成された前記赤外線エネルギーから結膜に存在する前記物質の赤外吸収を測定された温度及び赤外吸収に基づいて、前記物質の濃度を確定する請求項1に記載の機器。
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