JP2010537767A - 胸部組織液を監視するための方法およびシステム - Google Patents
胸部組織液を監視するための方法およびシステム Download PDFInfo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7271—Specific aspects of physiological measurement analysis
- A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
Abstract
Description
本願は、「method, system and apparatus for using electromagnetic radiation for monitoring a tissue of a user」と称する、Amir SAROKA、Shlomi BERGIDA、 Nadav MIZRAHI、Dan RAPPAPORT、Benyamin ALMOG、およびAmir RONENによる特許出願の同時係属出願であり、それが完全に本明細書に記載されているかのように、その内容を参照によって本明細書に援用する。
本発明は、その一部の実施形態では、患者の病理学的状態を監視するためのシステムおよび方法に関し、さらに詳しくは、限定するわけではないが、EM放射を用いてユーザの病理学的および生理学的状態を監視するためのシステムおよび方法に関する。
1.急性呼吸困難症候群(ARDS)、外傷、感染原因、毒物吸入、外因性毒物循環、血管刺激物質、播種性血管内凝固異常(DIC)、免疫学的過程反応、尿毒症、溺水、およびその他の吸引を含む毛細血管透過性変化による続発性肺水腫。
2.心臓原因ならびに肺静脈血栓、狭窄または静脈閉塞症、および体液量過剰をはじめとする心臓以外の原因を含む肺毛細血管圧上昇による続発性肺水腫。
3.低アルブミン血症に見られる膠質浸透圧低下による続発性肺水腫。
4.リンパ管不全による続発性肺水腫。
5.終末呼気量の増加を伴う大きい負の胸腔内圧による続発性肺水腫。
6.高地肺水腫(HAPE)、神経原性肺水腫、ヘロインまたは他の過剰投与、肺塞栓症、子癇、心臓除細動後、麻酔後、抜管後、および心肺バイパス術後をはじめとする混合または未知の機序による続発性肺水腫。
ここで図4も参照すると、それは、本発明の一部の実施形態に係る、胸部の基準胸壁モデル200である。図1および図3に示した方法は、任意選択的に患者の生理機能および姿勢、ならびに動的な周期的過程に従って経時的に変化する、人体組織の誘電性モデルのような基準胸壁モデルに基づくことができる。そのような基準胸壁モデルは、胸部組織液レベルのレベルおよび/または増加ペースの逸脱を評価するために、特性および/または特性範囲をモデル化するための基準として使用することができる。任意選択的に、基準胸壁モデルは、肺組織のような胸部組織からの反射を解析するために使用される。
皮膚組織層(1〜3mm);
脂肪組織層(50〜500mm);
筋組織層(50〜200mm);
骨層(30〜60mm);および
肺組織層(100mm以下)
相対誘電係数;
例えば上述した厚さ;
推定信号形状;および
層内を伝搬するRF信号に課せられる影響を捕捉する層の等価周波数応答、例えばそれぞれの層を通過伝搬するパルスの減衰および分散の推定。
上述の通り、監視は、患者の胸部から反射したEM放射を解析することによって実行される。解析の精度は、信号の関心領域(ROI)の分離に基づく信号のレジストレーションによって影響される。特定のROIにおける信号の取得はゲーティングによって実行される。ゲーティングは記載した胸部モデルに基づくことができる。
運動、周期的な生理学的過程、および外乱
1.患者の年齢
2.病状およびその重症度
3.体重、身長、および胸部直径の概数のような1つ以上の身体計測値
4.監視位置付け‐ウェアラブル監視装置400は患者の胸部に対して幾つかの位置に配置することができる。任意選択的に、構成プロセスは手動的および/または自動的サブプロセスを含み、そこでウェアラブル監視装置400の位置が定義されるか選択される。装置を配置するための場所は、肺組織のような胸部組織が全呼吸周期中に検出可能であるように選択される。例えば、位置は、例えば図10に示す通り、右中腋窩線の第5および第6肋骨の前とすることができる。呼吸周期を幾つかに分けた部分で肺壁を監視する位置を選択することもできることに注目されたい。
本発明の一部の実施形態では、患者に関する追加情報を使用することができる。任意選択的に、図1および図3に記載する方法は、胸壁モデル、調整プロセス、呼吸周期、および/または反射EM放射の解析を調整することを含む。任意選択的に、ウェアラブル監視装置は、病理学的性質、年齢、性別、体重、身長、ならびに/または肺の容量および/もしくは機能に影響する任意の他の医療情報のような、患者に関連する医療情報をユーザに定義させる。任意選択的に、ウェアラブル監視装置は、特定の臨床レベルを反映するベースラインを設定し、かつ測定値をそれに関連付けることを可能にする。そのようなベースラインを定めることにより、胸部組織液レベルの変化に対するウェアラブル監視装置の診断感度が増大し得る。例えば鬱血性心不全(CHF)患者は、正常な肺と比較して、肺液含有量が90%以上の肺で圧倒的に認められる。医療センタで施されるドライアップ治療の監視は、病理学的ないし安定化パラメータ値の範囲を調整するために使用することができる。こうしてパラメータおよび閾値を調整することが可能になる。
Claims (33)
- 少なくとも1胸部組織の変化を検出するための方法であって、この方法は、
少なくとも24時間の期間中に少なくとも1放射セッションで患者の少なくとも1胸部組織から反射した電磁(EM)放射の少なくとも1反射をインターセプトするステップと、
前記少なくとも1反射をそれぞれ解析することによって少なくとも1胸部組織の誘電率の変化を検出するステップと、
前記変化を示す通知を出力するステップとを含み、
前記少なくとも1反射は、前記期間中の少なくとも1胸部運動の結果として変化する、方法。 - 胸部組織は肺組織である、請求項1に記載の方法。
- 前記インターセプトステップの少なくとも一部は、前記患者が歩行している間に実行される、請求項1に記載の方法。
- 前記変化は前記少なくとも1胸部組織における胸部組織液含有量変化を表す、請求項1に記載の方法。
- 前記解析ステップは、前記少なくとも1反射に基づく信号において、前記少なくとも1胸部組織を表すセグメントを識別するステップと、前記セグメントに従って前記変化を検出するステップとを含む、請求項1に記載の方法。
- 前記識別ステップは、前記セグメントを識別するために予め定められた胸壁モデルを使用することを含む、請求項5に記載の方法。
- 前記識別ステップの前に前記患者に関する医療情報に従って前記予め定められた胸壁モデルを調整するステップをさらに含む、請求項6に記載の方法。
- 前記識別ステップは、前記信号における少なくとも1組織移行部を識別するステップと、前記セグメントを識別するために前記少なくとも1組織移行部を使用するステップとを含む、請求項5に記載の方法。
- 前記検出ステップは、前記患者の呼吸周期を識別するステップを含み、前記セグメントは前記呼吸周期に従って識別される、請求項5に記載の方法。
- 前記胸部組織液含有量は血管外肺水分(EVLW)レベル、血管内肺水分、および細胞内水分の組合せを含む、請求項4に記載の方法。
- 前記解析ステップは、前記患者の現在の姿勢を識別するステップと、前記変化に対する前記現在の姿勢の影響に関する前記検出を実行するステップとを含む、請求項1に記載の方法。
- 活動レベルを識別するステップをさらに含み、前記変化に対する前記活動レベルの影響に関して前記検出が実行される、請求項1に記載の方法。
- 前記少なくとも1胸部組織は患者の肺組織と胸壁との間である、請求項1に記載の方法。
- 前記少なくとも1胸部組織は患者の心膜と心臓との間である、請求項1に記載の方法。
- 前記変化と病理学的パターンの少なくとも1つを表す少なくとも1つの値との間の一致を識別するステップをさらに含み、前記少なくとも1病理学的パターンを示すために前記通知が構成される、請求項1に記載の方法。
- 前記少なくとも1病理学的パターンが、退行変性過程、急性呼吸窮迫症候群(ARDS)、鬱血性心不全(CHF)、外傷、無気肺、術後無気肺、術後経過、吻合気管支、肺炎症の進行、肺血液貯留、感染原因、毒物吸入、外因性毒物循環、血管刺激物質、播種性血管内凝固異常(DIC)、免疫学的過程反応、尿毒症、溺水後の肺水分レベル、肺静脈血栓、狭窄、静脈閉塞症、低アルブミン血症、リンパ管不全、高地肺水腫(HAPE)、神経原性肺水腫、薬物過剰投与、肺塞栓症、子癇、心臓除細動後、麻酔後、抜管後、および心肺バイパス術後から成る群から選択される項目のパターンである、請求項15に記載の方法。
- 医用センサを用いて前記患者の生物学的パラメータを監視するステップをさらに含み、前記検出ステップは、前記少なくとも1反射および前記生物学的パラメータに基づくデータの組合せに従って実行される、請求項1に記載の方法。
- 前記医用センサは、心電図(ECG)、筋電図(EMG)、超音波トランスデューサ、パルスオキシメータ、血圧センサ、凝固計、および光学式血液飽和検出器から成る群から選択される、請求項17に記載の方法。
- 前記インターセプトステップは複数の断続的放射セッションで実行される、請求項17に記載の方法。
- 胸部組織液の変化を検出するように構成された監視装置であって、
患者の少なくとも1胸部組織からの電磁(EM)放射の少なくとも1反射をインターセプトするように構成されたプローブと、
前記少なくとも1反射を解析することによって少なくとも1胸部組織の胸部組織液含有量の変化を検出するように構成された処理ユニットと、
前記変化を示す通知を出力するように構成された出力ユニットと
を備え、
前記プローブおよび前記処理ユニットはそれぞれ、少なくとも24時間の期間中に少なくとも1放射セッションで前記インターセプトおよび前記解析を実行するように構成され、前記少なくとも1反射は前記期間中に少なくとも1胸部運動の結果として変化する、監視装置。 - 前記患者は歩行することができ、監視装置を前記患者の胸部に取り付けるように構成された取り付けユニットをさらに備える、請求項20に記載の監視装置。
- 前記監視装置は実質的に静止しており、前記少なくとも1放射セッションは前記患者が監視位置にあるときに実行される、請求項20に記載の監視装置。
- 前記監視装置は、保健医療機関センタの外で前記少なくとも1放射セッションを実行するように構成された在宅医療装置である、請求項20に記載の監視装置。
- 前記少なくとも1胸部組織は少なくとも1肺組織を含み、前記検出は、前記胸部組織液の貯留、前記胸部組織液の分散、前記胸部組織液の濃度、および胸部組織液の組成から成る群の項目に基づく、請求項20に記載の監視装置。
- 前記通知に従って前記患者に少なくとも1薬剤を投与すべく投薬ユニットに指示するように構成された投薬インタフェースをさらに備える、請求項20に記載の監視装置。
- 前記通知に従って医療用弁の作動を制御するように構成された機械的インタフェースをさらに備える、請求項20に記載の監視装置。
- 前記出力ユニットは、前記患者の呼吸量を検査するための医療用装置と通信するように構成され、前記処理ユニットは前記呼吸量に従って前記検出を実行するように構成される、請求項20に記載の監視装置。
- 前記処理ユニットは前記変化に従って病理学的指標を検出するように構成され、前記出力ユニットは前記病理学的指標に応答して前記通知を発生するように構成される、請求項20に記載の監視装置。
- 前記患者に関する調整情報を受信するための調整ユニットをさらに備え、前記処理ユニットは前記調整情報に従って前記検出を実行するように構成される、請求項20に記載の監視装置。
- 前記処理ユニットは、患者の少なくとも1胸部組織の少なくとも1誘電性関連性質を評価するように構成され、前記解析は前記少なくとも1誘電性関連特性に従って実行される、請求項20に記載の監視装置。
- 前記患者の少なくとも1姿勢を検出するように構成された姿勢検出ユニットをさらに備え、前記処理ユニットは前記少なくとも1姿勢に従って前記変化を検出するように構成される、請求項20に記載の監視装置。
- 前記処理ユニットは前記反射の第1部分と前記反射の第2部分との間の差異を識別するように構成され、前記第1および第2部分はそれぞれ前記少なくとも1胸部組織の第1および第2領域から捕捉され、前記処理ユニットが前記検出を実行するために前記差異を使用することを可能にする、請求項20に記載の監視装置。
- 前記処理ユニットは、前記差異に従って、姿勢の変化、配置の変化、前記EM放射のパワーの変化、および前記EM放射の周波数の変化から成る群の項目の影響を低減する、請求項32に記載の監視装置。
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EP2190344B1 (en) | 2017-12-27 |
US20230172474A1 (en) | 2023-06-08 |
JP6130865B2 (ja) | 2017-05-17 |
EP2190344A4 (en) | 2013-03-13 |
JP2015107338A (ja) | 2015-06-11 |
ES2603283T3 (es) | 2017-02-24 |
US20200397333A1 (en) | 2020-12-24 |
EP2194871A4 (en) | 2013-03-20 |
EP2194871B1 (en) | 2016-08-17 |
JP2010537766A (ja) | 2010-12-09 |
WO2009031149A3 (en) | 2010-03-04 |
WO2009031150A3 (en) | 2010-03-04 |
US10561336B2 (en) | 2020-02-18 |
WO2009031149A2 (en) | 2009-03-12 |
ES2664239T3 (es) | 2018-04-18 |
US20110160549A1 (en) | 2011-06-30 |
US11944419B2 (en) | 2024-04-02 |
US20100256462A1 (en) | 2010-10-07 |
JP5677841B2 (ja) | 2015-02-25 |
EP2190344A2 (en) | 2010-06-02 |
EP3415090A1 (en) | 2018-12-19 |
US10758150B2 (en) | 2020-09-01 |
US20200178837A1 (en) | 2020-06-11 |
US11564586B2 (en) | 2023-01-31 |
EP2194871A2 (en) | 2010-06-16 |
WO2009031150A2 (en) | 2009-03-12 |
US20130281800A1 (en) | 2013-10-24 |
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