JP7313435B2 - エネルギ変換モニタ装置、システム及び方法 - Google Patents
エネルギ変換モニタ装置、システム及び方法 Download PDFInfo
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Description
本出願は、出願が本明細書に全て援用される、「睡眠時無呼吸モニタ、システム及び方法」と名付けられた2018年9月18日に出願された米国仮特許出願第62/732,876号の利益を主張する、2019年9月16日に出願された米国特許出願第16/572,106号の優先権を主張する。
本出願に言及された全ての刊行物、特許及び特許出願は、それぞれ個々の刊行物、特許、または特許出願が参照によって組み込まれるために具体的に及び個々に示されるのと同じ範囲で参照によって本明細書に組み込まれる。参照は、例えば以下を含む。
使用の例は、単独でまたは1またはそれ以上の二次装置でシステムの一部として本開示のECMセンサの使用に関する。二次装置は、第2のセンサ、睡眠時無呼吸(SDB)治療装置、遠隔計算装置、及び睡眠ポリグラフ(PSG)システムから選択される。
1つの例において、本開示のセンサは、睡眠時無呼吸(SDB)の診断を助けるために用いられる。SDBの大人の診断試験のための本開示のECMセンサの臨床的有用性は、サンフランシスコのシオン山病院のUCSF睡眠障害センタの概念実証(POC)PSG睡眠研究で検証された。本開示のECMセンサは、また家庭での遠隔SDB試験に適切であることがわかった。UCSF POC睡眠研究は、長期間のいびきの間、皮膚の細胞低酸素症のECM検出は、例えば高血圧、心房細動、心臓発作、脳卒中及び早期発症型認知症など、SDB併存症の統計的リスクの上昇の生理学的機構をよりよく理解し、定義するために医師によって潜在的に用いられる重要な新しい発見であったことを実証した。POC研究の間、PSGパルスオキシメータデータは、いびき発症のほとんどの間、SpO2の「記録可能な」低下(例えば、3%以上の減少)を検出せず、OSA及びCSAのさらにひどい長期の発症の間、動脈血中酸素の減少のみを示した。PSG器具類は、現在酸素吸入量を監視する手段として、パルスオキシメトリを含むのみである。
別の例において、本開示のセンサは、慢性の健康状態と共に及び病院からの退院に続く大人の継続的な監視を提供するために用いられる。高齢者の慢性心不全及び慢性肺疾患の継続的な家庭での監視は、統合アプローチを必要とする。異常呼吸及び生理学的ストレスの他の一般的な形態は、これらの重要な変数を最適に監視するために必要とされる感度と応答性の程度まで、家庭で監視することができない。患者が病院で回復し、家に退院したとき、アームバンドのECMセンサは、遅発性合併症に役立つ監視を提供できる。
別の例において、本開示のセンサは、手術の麻酔を受ける及び麻酔後の回復の間、患者の細胞酸素供給監視を提供するために用いられる。肺の異常な通風を検出するために、及び酸素の不十分または過剰な吸入の両方を検出するために、本開示のセンサ対パルスオキシメトリの実証された診断優位性は、患者に重大な利益と、手術の間及び手術後の改善された臨床ガイダンスを提供する。皮膚かん流の減少及び皮膚への細胞酸素供給の減少への本開示のセンサのさらなる感度は、パルスオキシメトリで検出可能でなく、そうでなければ生命を脅かす危機が発生するまで認識されず、潜在的に不利な結果をもたらす、手術の間の共通のリスクである、減少した血液量と、血液損失及びIV液による血液希釈による血液の減少した酸素運搬能力に関連性の高い新モニタを提供する。
別の例において、本開示のセンサは、SIDSで死ぬリスクのための新生児のスクリーニングのために用いられる。睡眠の間の体位及び姿勢は、SDBの悪化要因として指摘され、幼児のSIDSのリスクの一部として明確に定義される。仰向けに寝る幼児は、統計的にお腹で寝ているリスクの等しい幼児と比較して、SIDSのリスクが統計的に約半分である。幼児は、通常周期的呼吸とも呼ばれる、睡眠の間、呼吸しないまたは無呼吸の繰り返し期間を有することが知られている。本開示のセンサは、睡眠の間、周期的呼吸の指標として、周期的段階で呼吸のタイミングと努力がいつ変化するかを検出するように構成可能である。センサシステムは、例えば、SIDSリスクの幼児で発生するなど、「暴走」ループ利得の潜在的に致命的な状態が発生する指標として連続した周期的呼吸段階と共にある呼吸努力の漸進的な増加を検出するように構成可能である。センサは、:(1)即座の介入を介護者に警告する及び(2)同時に、周期的呼吸または潜在的に生命を脅かす長周期中枢性無呼吸を中断するように睡眠から幼児を目覚めさせるために、幼児の腕に機械振動触覚刺激を発生するために、検出された「暴走」ループ利得と長期の無呼吸イベントに警告応答できるように構成可能である。
本開示のセンサの別の役立つ適用は、例えば敗血性ショックの発生時になど、皮膚のかん流の減少の検出である。本開示のセンサは、850nm光の安定した増加した強度の検出と同時に、685nmの強度の減少の検出によって皮膚のかん流の減少を検出し、通常、初期にパルスオキシメトリによって安定したSpO2との関連で連続して減少するECi傾向を生成する。敗血性ショックの発症のための臨床評価は、現在病院ケアの間、定期的なバイタルサインチェックの時に毛細血管補充試験手順で実行される。しかしながら、そのようなチェックの間隔と試験を実行する熟練した臨床医の要求は、一般的に検出を遅らせる。敗血症のリスクのあると見なされる患者の継続的な入院患者監視に本開示のセンサを使用することにより、関連監視の継続的で高感度で応答性のある手段を提供し、医療及び手術ケアのこの共通の及び潜在的な致命的な合併症を検出する。病院から退院に続いて即座の期間に適用されたとき、本開示のセンサは、また臨床的に遠隔「早期警告」監視を提供し、早期の退院ができ、医療費を減少しながら、結果の品質を改善する可能性がある。
二重インターフェースの例において、本開示のセンサは、虚血組織の再かん流を導くために用いられる。第1のセンサインターフェースは、例えば通常のかん流皮膚など、通常の基準組織に設置される一方で、第2のインターフェースは、例えば1つの例として、虚血性心臓発作の再かん流治療の間、心臓の心筋の影響される部分など、虚血組織に設置される。監視された組織への通常の酸素飽和血液の突然の再供給のECi傾向の一時的過剰反応の検出は、実験的に誘導された血流の停止期間の後、一貫して見られる。センサ部位に影響されない、基準からのレベルより非常に大きなレベルへの典型的な685nmの検出強度の急速な増加は、組織が、現在細胞酸素供給の低い割合に適応されていることを示す。センサは、また再かん流血液の酸素含有量の増加に応答して、850nmの検出強度の減少と同時に、685nmの強度の増加の検出によって、再かん流血液が監視組織へ潜在的に損傷するレベルの酸素を供給していることを示すように構成可能であり、それにより、より安全で効果的な速度へ酸素供給の治療を控えることができる。本開示のセンサは、またフィードバック制御データを提供し、自動的に再かん流ポンプの静脈/動脈血液混合システムを動作する。
本開示のセンサの二重プローブ実施例の適用の別の例は、移植臓器の血液再かん流の際の酸素の供給の安全で効果的な増加に関する客観的なガイダンスを提供することであり、第1のセンサインターフェースは、例えば患者の皮膚など、基準「通常」組織に設置される。この適用において、第2のセンサインターフェースは、再かん流される移植臓器に光学的に接触して設置され、動脈血のみが用いられ、細胞高酸素のフォトニックな証拠がなくなるまで、様々に混合された静脈及び動脈かん流血液によって供給される酸素の細胞許容値を示す。本開示のセンサは、またフィードバック制御データを提供し、自動的に静脈/動脈血液混合システムを動作する。
二重インターフェースの実施例の適用の別の例において、本開示のセンサは、未熟児に適用されて呼吸ガスの酸素割合の増加に応答して、850nmの減少した強度の検出に沿って、それと共に、685nmの増加した強度の検出によって、例えば未熟児の管前皮膚など、監視組織が酸素を安全及び効果的なレベルより多く供給されていることを示し、より安全で効果的な速度に呼吸ガス酸素含有量の治療を控えることができる。本開示のセンサ及び関連する新しい使用方法は、例えば呼吸空気に慣れる新生児などに、高い酸素利用可能性に細胞順応するための十分な時間を提供し、それにより目、脳及び他の重要な臓器への「酸化ストレス」を最小にするまたは防ぐ。本開示のセンサは、またフィードバック制御データを提供し、自動的に呼吸ガス混合システムを動作して、生理学的に安全で効果的な方法で酸素レベルを調整する。
別の例において、本開示のセンサは、運動の間及び運動後アスリートの継続的な監視を提供するために用いられる。血液ガス及びSpO2によって測定されるように、血中酸素飽和度は、健康な大人のアスリートの身体運動によって影響されないことが運動生理学者によってよく知られ、公開された研究文献に記載される。より速い心拍数とより深くてより急速な呼吸は、働く筋肉による増加した酸素消費に応じて酸素吸入量を増加するよく知られた反射駆動手段である。しかしながら、身体運動の間、ECM記録は、おそらく運動の間、働く筋肉及び重要な臓器の酸素要求をよりよく供給するために、皮膚の酸素消費を減らす自然な微小血管の応答が皮膚にあることを示した。身体運動の間、皮膚の減少した血液かん流は、一貫してSpO2の低下さえなく、ECMセンサによって検出される皮膚の細胞低酸素症をもたらす。複数の運動のセッションの間の実験的な記録は、作業負荷を評価する際に、心拍数、心拍数変動、及びパルスオキシメトリをはるかに超えて、生理学応答の新しく観察されたパターン対人の生理学予備力及び応答特性を実証した。運動回復期間の間、ECiデータの追加は、現在欠落した生理学的洞察を提供する。睡眠の間の細胞低酸素症を作り出すいびき発症の検出を含む、睡眠品質監視は、現在の技術の適応性とSpO2監視に欠如している。本開示のセンサが、睡眠の間、アスリートに適用されたとき、生成されたデータは、睡眠の間、呼吸にアクセスでき、回復プロセスに関する監視の既存の方法からの情報と共に、潜在的に関連する新しい洞察を提供する。
別の例において、本開示のセンサは、例えば宇宙飛行士、運転士、消防士、地下鉱山労働者、及びパルスオキシメータセンサが装着できないまたは適切にまたは役立つ方法で機能しない潜在的に毒性の工業環境の作業者など、高リスク呼吸環境の作業者の継続的な監視の提供するために用いられる。
別の例において、本開示のセンサは、訓練及び戦闘で高性能飛行機を飛行する軍パイロットの継続的な監視を提供するために用いられる。これらのパイロットは、高地でのコックピットの空気圧力の損失から低酸素症のリスクがあることがよく知られている。彼らは、また飛行機の高g負荷誘導操縦を実行しながら頭への血流損失のリスクがある。これらの脅威のいずれかまたは両方は、飛行機システムの故障の指標が全くなく、パイロットから突然能力を奪う。パイロットの額への本開示のセンサの適用は、額皮膚の細胞低酸素症または皮膚の血流の損失または両方を即座の客観的な指標を提供する。パイロットのこれらの検出された生理学的応答は、飛行機のコントロールに自動的に通信されたならば、自動化されたパイロットレスキュプロセスは、飛行機を安定で安全な飛行状態に操縦し、緊急事態を指揮官に知らせることを引き起こす。危険な存在が自動的に解消してすぐに、パイロットが飛行機の操作を回復するならば、彼/彼女は、任務を続ける。
Claims (8)
- 筐体と、
電源と、
第1の波長で第1の光を放出するように構成された、前記筐体の内部内に配置された第1の光放出体と、
前記第1の波長と異なる第2の波長で第2の光を放出するように構成された、前記筐体の内部内に配置された第2の光放出体と、
前記筐体の内部内に配置され、前記第1の光放出体と前記第2の光放出体から光学的に分離された光検出器であって、前記光検出器は、第1の光放出体からの結果として生じる第1の組織相互作用光信号と、前記第2の光放出体からの第2の組織相互作用光信号と、を検出するように構成された、光検出器と、
前記第1の光放出体と前記第2の光放出体と通信する照明電力制御回路であって、前記照明電力制御回路は、コンピュータプログラムで定義された照明電力を提供し、それぞれのコンピュータプログラムで定義された照度で、前記第1の光放出体と前記第2の光放出体にエネルギを与えるように構成された、照明電力制御回路と、
前記光検出器と通信する信号増幅器と、
前記第1の組織相互作用光信号から第1の出力データ値と前記第2の組織相互作用光信号から第2の出力データを計算するように構成されたA/Dコンバータを有するマイクロコントローラとを備え、
前記マイクロコントローラは、初期化プロセスの間、前記第1の光放出体の持続可能な最大定格電力レベルまで、前記第1の光放出体に供給される電力を段階的に増加することによって皮膚の色素沈着レベルの変化を補償するように構成可能で、
前記マイクロコントローラは、前記第1の光放出体に対する前記持続可能な最大定格電力レベルに達したとき、前記A/Dコンバータのフルスケールの85%における光の検出強度が検出できない場合、オーバーサンプリング及び数学的積算法を実施するように構成されたエネルギ変換モニタセンサ。 - 前記エネルギ変換モニタセンサは、インビボ分光法によって選択された複数の波長の光を用いる、請求項1に記載のエネルギ変換モニタセンサ。
- 前記複数の波長の光は、監視組織に影響を与える既知の細胞生化学現象及び既知の生理学現象の少なくとも1つに対して検出細胞光吸光度のそれぞれの変動を最大にするように選択される、請求項2に記載のエネルギ変換モニタセンサ。
- 前記第1の光放出体は、675nmから695nmまでを含めた第1の光放出体中心波長値を有する、請求項1に記載のエネルギ変換モニタセンサ。
- 前記マイクロコントローラは、前記A/Dコンバータのフルスケールの85%以上の計算強度値が達成されるまで、名目上の数を超えてバーストサンプルの数を増やし、前記バーストサンプルの全てを合計し、前記バーストサンプルの全ての合計を前記名目上の数で割るように構成可能である、請求項1に記載のエネルギ変換モニタセンサ。
- 前記第2の光放出体は、840nmから860nmまでを含めた第2の光放出体中心波長値を有する、請求項1に記載のエネルギ変換モニタセンサ。
- 前記光検出器は、1またはそれ以上の時間間隔において、前記第1の組織相互作用光信号と前記第2の組織相互作用光信号を検出する、請求項1に記載のエネルギ変換モニタセンサ。
- 筐体と、
電源と、
第1の波長で第1の光を放出するように構成された前記筐体の内部内に配置された第1の光放出体と、
前記第1の波長と異なる第2の波長で第2の光を放出するように構成された前記筐体の内部内に配置された第2の光放出体と、
前記筐体の内部内に配置され、前記第1の光放出体と前記第2の光放出体から光学的に分離した光検出器であって、前記光検出器は、第1の光放出体からの結果として生じる第1の組織相互作用光信号と、前記第2の光放出体からの第2の組織相互作用光信号と、を検出するように構成された、光検出器と、
前記第1の光放出体と前記第2の光放出体と通信する照明電力制御回路であって、前記照明電力制御回路は、コンピュータプログラム定義光度を提供し、それぞれのコンピュータプログラム定義照度で、前記第1の光放出体と前記第2の光放出体にエネルギを与えるように構成された、照明電力制御回路と、
前記光検出器と通信する信号増幅器と、
前記第1の組織相互作用光信号から第1の出力データ値と前記第2の組織相互作用光信号から第2の出力データを計算するように構成されたA/Dコンバータを有するマイクロコントローラであって、
前記マイクロコントローラは、初期化プロセスの間、前記第1の光放出体の持続可能な最大定格電力レベルまで、前記第1の光放出体に供給される電力を段階的に増加することによって皮膚の色素沈着レベルの変化を補償するように構成可能で、
前記マイクロコントローラは、前記第1の光放出体に対する前記持続可能な最大定格電力レベルに達したとき、前記A/Dコンバータのフルスケールの85%における光の検出強度が検出できない場合、オーバーサンプリング及び数学的積算法を実施するように構成されたマイクロコントローラと、
第2のセンサ、睡眠時無呼吸(SDB)治療装置、遠隔計算装置、及び睡眠ポリグラフ検査(PSG)システムから選択された少なくとも1つの二次装置を備える、システム。
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US20200085321A1 (en) | 2020-03-19 |
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