JP6130865B2 - 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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- 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
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
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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
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- 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
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7235—Details of waveform analysis
- A61B5/7253—Details of waveform analysis characterised by using transforms
- A61B5/726—Details of waveform analysis characterised by using transforms using Wavelet transforms
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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
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7235—Details of waveform analysis
- A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
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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
- A61B5/72—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
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 (23)
- 胸部組織中の液レベル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つの胸部組織からの0.3GHzから20GHzの範囲の無線周波数(RF)信号を受信するために電磁変換器を使用するように構成されたプローブと、
前記RF信号を処理することによって、前記RF信号を変調する周期的な生理学的過程を識別し、前記RF信号及び前記周期的な生理学的過程の解析に従って、及び人体組織の誘電性モデルに基づいて、前記少なくとも1つの胸部組織の中の液レベルを決定するために前記受信されたRF信号を解析するように構成された処理ユニットとを備え、
前記処理ユニットは、前記液レベルに従って換気機を制御するための命令を発生するように構成されており、
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時間の期間中に複数の放射セッションで前記受信および前記解析を実行するように構成されており、
前記人体組織の誘電性モデルは、少なくとも胸壁の複数の組織層のそれぞれについて、それぞれの組織層内を伝搬するRF信号に課せられる影響を捕捉するそれぞれの組織層の等価周波数応答を規定する、監視装置。 - 前記処理ユニットは、前記受信されたRF信号を解析して、前記少なくとも1つの胸部組織における液レベルの増加または減少を決定するように構成されており、前記処理ユニットは、前記液レベルの増加または減少に従って前記換気機を制御するための命令を発生するように構成されている、請求項1に記載の監視装置。
- 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1に記載の監視装置。
- 前記監視装置は静止しており、前記複数の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1に記載の監視装置。
- 前記液レベルに従って治療指示を与えるように構成された投薬インターフェースをさらに備える、請求項1に記載の監視装置。
- 前記患者の呼吸量を検査するように構成された医療用装置と通信するように構成されたインターフェースをさらに含み、前記処理ユニットは前記呼吸量に従って前記液レベルを決定するように構成される、請求項1に記載の監視装置。
- 前記処理ユニットは、前記液レベルに従って病理学的指標を検出するように構成され、前記監視装置は、前記病理学的指標に応答して通知を発生するように構成された出力ユニットをさらに含む、請求項1に記載の監視装置。
- 前記処理ユニットは、前記受信されたRF信号の第1セグメントとその第2セグメント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セグメントはそれぞれ前記少なくとも1つの胸部組織の第1および第2領域から受信され、前記処理ユニットが前記液レベルを決定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1に記載の監視装置。
- 前記処理ユニットは、前記受信されたRF信号の第1セグメントとその第2セグメントの間の差異に従って、姿勢の変化、配置の変化、前記受信されたRF信号のパワーの変化、および前記受信されたRF信号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1に記載の監視装置。
- 前記処理ユニットは、前記患者の現在の姿勢を識別して、前記液レベル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ように構成されている、請求項1に記載の監視装置。
- 前記少なくとも1つの胸部組織は患者の肺組織と胸壁との間である、請求項1に記載の監視装置。
- 前記処理ユニットは、前記患者のバイタルサイン、バイタルサインの傾向及び生理学的過程のうちの少なくとも1つを検出するように構成され、前記処理ユニットは、前記液レベルに対して、及び前記バイタルサイン、バイタルサインの傾向及び生理学的過程のうちの少なくとも1つに対して前記患者の臨床状態を計算するように構成され、前記プローブは、少なくとも1つの胸部組織が運動している間に前記RF信号を受信する、請求項1に記載の監視装置。
- 前記処理ユニットは、信号の異なるセグメントの少なくとも1つの中の信号と異なる時間に測定された信号における差異を解析することによって前記液レベルを決定するように構成される、請求項1に記載の監視装置。
- 前記期間中、前記処理ユニットは、少なくとも1つの運動効果を低減すること、及び監視装置を再配置すること及び監視された患者をある姿勢に誘導することのうちの少なくとも1つのための誘導命令を発生することのうちの少なくとも1つを実行する、請求項1に記載の監視装置。
- 前記液レベルは、液レベルの変化を含み、前記期間中、前記処理ユニットは、監視装置の誤配置及び脱離のうちの少なくとも1つを検出すること、データ捕捉セッションを実行するために適した期間を識別すること、及び関心のある場所に対する前記プローブのアンテナの相対運動を補償するための追跡アルゴリズムを使用することのうちの少なくとも1つを実行する、請求項1に記載の監視装置。
- 前記処理ユニットは、前記液レベルに対する運動の影響を低減し、前記運動は、胸部運動、内部生理学的活動、外部生理学的活動不規則性、器官運動、アンテナ運動、姿勢運動の変化、身体の運動、及び活動関連運動からなる群の項目を含む、請求項1に記載の監視装置。
- 前記監視装置は、ユーザインターフェース(UI)をさらに含み、前記ユーザインターフェースは、呼吸深度及び呼吸数、並びに心拍数と共に鬱血レベルを表わし、前記鬱血レベル、前記呼吸深度及び呼吸数、並びに心拍数は、前記受信されたRF信号の解析から計算される、請求項15に記載の監視装置。
- 患者の少なくとも1つの胸部組織の液レベルを検出するためのアンテナを有するウェアラブル監視装置の作動方法であって、前記ウェアラブル監視装置が、少なくとも24時間の期間に複数のセッション時に少なくとも1つのアンテナの出力を受信し、前記出力が少なくとも1つの胸部組織から受信された0.3GHzから20GHzの範囲のRF信号に基づくこと、前記ウェアラブル監視装置が、前記RF信号を処理することによって、前記RF信号を変調する周期的な生理学的過程を識別すること、前記ウェアラブル監視装置が、前記RF信号及び前記周期的な生理学的過程の解析に基づいて、及び人体組織の誘電性モデルに基づいて、少なくとも1つの胸部組織中の液レベルを決定すること、及び前記ウェアラブル監視装置が、前記液レベルに従って換気機を制御するための命令を発生することを含み、
前記人体組織の誘電性モデルは、少なくとも胸壁の複数の組織層のそれぞれについて、それぞれの組織層内を伝搬するRF信号に課せられる影響を捕捉するそれぞれの組織層の等価周波数応答を規定する、方法。 - 前記液レベルは、液レベルの変化を含み、前記出力が、前記少なくとも1つの胸部組織から受信されたRF信号に基づくとき、前記液レベルの変化は前記液レベルの変化に対する患者の姿勢の影響に関して計算される、請求項18に記載の方法。
- 前記液レベルが、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少なくとも1つの病理学的パターンの指標である、請求項18に記載の方法。
- 前記ウェアラブル監視装置が、医療情報、予め定められた周期、及び撮像データのうちの少なくとも1つに従って前記人体組織の誘電性モデルを調整することをさらに含む、請求項18に記載の方法。
- 前記液レベルは、液レベルの変化を含み、前記出力が前記少なくとも1つの胸部組織から受信されたRF信号に基づくとき、前記液レベルの変化は少なくとも1つの組織移行部を示す、請求項18に記載の方法。
- 前記周期的な生理学的過程は、前記患者の呼吸周期であり、前記液レベルは、液レベルの変化を含み、前記出力が前記少なくとも1つの胸部組織から受信されたRF信号に基づくとき、前記解析は、前記ウェアラブル監視装置が、前記患者の前記呼吸周期を識別し、それに応じて前記液レベルの変化を検出することを含む、請求項18に記載の方法。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2022157685A1 (en) * | 2021-01-22 | 2022-07-28 | Cilag Gmbh International | Thoracic post-surgical monitoring and complication prediction |
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US20230172474A1 (en) | 2023-06-08 |
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JP2010537766A (ja) | 2010-12-09 |
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US10561336B2 (en) | 2020-02-18 |
EP2190344B1 (en) | 2017-12-27 |
US20110160549A1 (en) | 2011-06-30 |
WO2009031150A3 (en) | 2010-03-04 |
ES2664239T3 (es) | 2018-04-18 |
EP2194871A2 (en) | 2010-06-16 |
WO2009031150A2 (en) | 2009-03-12 |
JP5677841B2 (ja) | 2015-02-25 |
US20100256462A1 (en) | 2010-10-07 |
EP2190344A2 (en) | 2010-06-02 |
US11564586B2 (en) | 2023-01-31 |
US11944419B2 (en) | 2024-04-02 |
US20200397333A1 (en) | 2020-12-24 |
EP3415090A1 (en) | 2018-12-19 |
JP2010537767A (ja) | 2010-12-09 |
WO2009031149A2 (en) | 2009-03-12 |
EP2194871A4 (en) | 2013-03-20 |
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