JP6188225B2 - 疾患状態を決定するために予測値と測定値とが比較されるように予測値および測定値を表示する方法 - Google Patents
疾患状態を決定するために予測値と測定値とが比較されるように予測値および測定値を表示する方法 Download PDFInfo
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Description
本出願は、それぞれ2010年11月5日に提出され、かつそれぞれ参照によりその全部が本明細書に組み入れられる、米国特許仮出願第61/410,825号、同第61/410,827号、同第61/410,830号、同第61/410,831号、同第61/410,833号、同第61/410,834号、同第61/410,835号、および同第61/410,839号に関連し、かつそれらの恩典を主張する。
糖尿病などの疾患を検出するための非侵襲的なデバイスおよび方法が開示される。具体的には、本発明の例示的な態様は、哺乳動物において真性糖尿病の存在、確度、および/または進行を決定するのに好適な方法および装置に関する。
次に、図を参照しながら、または参照せずに、本発明のさまざまな例示的態様を説明する。図において、同様の符番は同一または機能的に同様の要素を示す。本明細書に概説されかつ図に示されている例示の態様は、広範な異なる構成にアレンジおよび設計することができる。ゆえに、説明されかつ/または図に提示されている、以下の例示的態様のより詳細な説明は、特許請求される本件の範囲を制限することを意図したものではなく、例示的態様/例示の態様を提示するものにすぎない。
[本発明1001]
患者が経験する医学的状態の存在を決定する方法であって、以下の段階を含む、方法:
該患者の標的組織を励起用放射線で照射する段階;
該励起用放射線に反応して該標的組織により生成された蛍光放射を検出する段階;
該検出された蛍光放射の特性を蛍光放射の予測特性と比較する段階;および
該比較する段階の結果に基づいて、該患者が経験する医学的状態の存在を決定する段階。
[本発明1002]
前記比較する段階が、検出された蛍光放射の特性を、年齢および体重が患者とほぼ同じである個人についての蛍光放射の予測特性と比較する段階を含む、本発明1001の方法。
[本発明1003]
前記比較する段階が、検出された蛍光放射の特性を、医学的状態を有しない個人についての蛍光放射の予測特性と比較する段階を含む、本発明1002の方法。
[本発明1004]
前記検出する段階が、標的組織により生成された蛍光放射の強度を検出する段階を含む、本発明1001の方法。
[本発明1005]
以下の段階をさらに含む、本発明1004の方法:
標的組織から後方散乱した放射の強度を検出する段階;および
検出された蛍光放射の強度を、後方散乱放射の強度で正規化する段階。
[本発明1006]
前記比較する段階が、正規化された蛍光放射の検出強度を、医学的状態を有しない個人についての蛍光放射の予測正規化強度と比較する段階を含む、本発明1005の方法。
[本発明1007]
前記検出する段階が、標的組織により生成された蛍光放射の特性を、強度に基づく技法、位相シフトの技法、および偏光異方性の技法のうち少なくとも1つを用いて検出する段階を含む、本発明1001の方法。
[本発明1008]
比較される特性が、年齢、性別、身長、体重、体重指数(BMI)、腹囲、HbA1c、バイオマーカー、人種、喫煙、高血圧、高コレステロール、ドライアイ、糖尿病か白内障かまたは他の疾患の家族歴からなる群より選択されるものである、本発明1001の方法。
[本発明1009]
医学的状態が、糖尿病、糖尿病によって引き起こされる眼の状態、網膜症、網膜血管閉塞症、硝子体網膜症、加齢黄斑変性症、遺伝性網膜変性症、偽脳腫瘍、緑内障、白内障からなる群より選択されるものである、本発明1001の方法。
Claims (5)
- (1)対象の瞳孔をビデオカメラで位置特定し、該瞳孔を表す円形を作成し、該円形の直径をヒト瞳孔の正常範囲と比較し、対象の瞳孔の中心の位置を計算し、かつ、生体顕微鏡において光源を該中心に自動的にアライメントする段階;
(2)水晶体の前縁から50%〜80%下方のポイントに励起用放射線を照射された対象の眼の水晶体による反射光をスキャンする段階;
(3)スキャン中に、該瞳孔の中心の位置を追跡する段階;
(4)1つまたは複数の励起波長の励起用放射線に応答して水晶体により後方散乱された蛍光放射の放出強度、または水晶体により生成された蛍光放射の蛍光寿命を検出する段階;
(5)前記(4)の水晶体により後方散乱された蛍光放射の放出強度、または蛍光放射の蛍光寿命を、平滑化または棄却する段階;
(6)検出された蛍光放射の蛍光成分のピーク強度を決定するために、前記(5)の蛍光放射のデータを正規化する段階;
(7)(a)医学的状態を有しない個人の水晶体により後方散乱される蛍光放射の放出強度、または水晶体からの蛍光放射の蛍光寿命の予測値、ならびに、(b)医学的状態を有しない、対象と対応する年齢、性別、身長、体重、および人種の個人における、体重指数(BMI)、腹囲、HbA1cレベル、喫煙の適切なバイオマーカーレベルもしくは履歴、高血圧、高コレステロール、ドライアイ、および医学的状態の家族歴からなる群より選択される、1つまたは複数の予測される健康特性についての既定のルックアップ表を含むアルゴリズムによりエンコードされたコンピュータサブシステムに、正規化されたデータを提供する段階;
(8)疾患状態を決定するために予測値と測定値とが比較されるように、(a)水晶体により後方散乱された蛍光放出強度または検出された蛍光放射の蛍光寿命の測定値と、前記(7)の蛍光放射の放出強度または蛍光寿命の予測値とを、ならびに、(b)対象の、体重指数(BMI)、腹囲、HbA1cレベル、喫煙の適切なバイオマーカーレベルもしくは履歴、高血圧、高コレステロール、ドライアイ、および医学的状態の家族歴のうちの1つまたは複数と、前記(7)の1つまたは複数の予測される健康特性とを、表示する段階;
を含む、対象における疾患状態を決定するために予測値と測定値とが比較されるように、予測値および測定値を表示する方法であって、
該疾患状態が、糖尿病である、前記方法。 - 前記検出する段階が、水晶体により生成された蛍光放射の蛍光寿命を、位相シフトの技法、または偏光異方性の技法を用いて検出する段階を含む、請求項1記載の方法。
- 水晶体により後方散乱された蛍光放射の放出強度が検出され、かつ、後方散乱された励起光の成分が、該成分のF(蛍光信号)データポイントを S(散乱光信号)データポイントで除することにより、前記データを正規化する段階のために用いられ、該成分は、該後方散乱された励起光のRayleigh成分もしくはMie成分、またはRayleigh成分およびMie成分の組合せである、請求項1または2記載の方法。
- 前記(6)の正規化の段階が、蛍光信号と散乱光信号との和からなる全戻り信号で蛍光信号を除することにより蛍光を正規化することを含む、請求項1〜3いずれか一項記載の方法。
- 前記疾患状態の決定の正確性の信頼水準を表示する段階をさらに含む、請求項1〜4いずれか一項記載の方法。
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JP2013537920A Active JP6012614B2 (ja) | 2010-11-05 | 2011-11-07 | 生体組織の構造的性質に影響する疾患を非侵襲的に検出するための装置および方法 |
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