JP7431777B2 - 生理学的信号をモニターする方法 - Google Patents
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Description
この出願は、2013年1月24日に出願された、発明の名称PHYSIOLOGICAL MONITORING DEVICEの米国仮出願No.61/756,326号の利益を請求する。この出願の内容は、その全体があたかも完全にここに述べられるかのように、参考としてここに組み込まれる。先の出願への優先権の利益は、制限されることなく35 U.S.C.§119(e)を含み、適切な法的根拠の下で請求される。
この発明は、一般的には医療機器に関する。より具体的には、この発明は生理学的モニタリング装置及びその使用方法に関する。
ここに記述された実施形態は、少なくとも1週間もしくはより多く、及びより典型的には2から3週間もしくはより多くの間、人間又は動物の被験者によって連続的かつ快適に着用されてもよい生理学的モニタリング装置に関する。1つの実施形態において、この装置は、心リズム(すなわち、心電図、ECG)データを感知し記録するように特に設計されており、別の種々の実施形態では、一もしくは複数の追加の生理学的パラメーターが感知され記録されてもよい。生理学的モニタリング装置は、患者の体験を容易にし及び/又は増強するための、不整脈の診断をより正確にするための、及び、装置の製造をより簡単かつコスト効率良くするための、多くの特徴を含む。
剛性のあるハウジングから横に延在する少なくとも2つの柔軟なウィングと、ここでこのウィングは、哺乳動物の表面に従うことを可能にする第1の材料一式を備え、剛性のあるハウジングは第2の材料一式を備え、
剛性のあるハウジング内に収容されたプリント回路基板組立体と、ここで剛性のあるハウジングは哺乳動物の動きに応じたプリント回路基板の変形を防ぐように構成され、
柔軟なウィング内に埋め込まれた少なくとも2つの電極と、ここでこの電極は、哺乳動物の表面と等角接触を提供し、かつ哺乳動物の生理学的信号を検出するように構成され、
ウィング内に埋め込まれ、かつ剛性のあるハウジングから機械的に切り離された少なくとも2つの電極トレースと、ここでこの電極トレースは、哺乳動物の表面との等角接触を提供し、かつ電極からプリント回路基板組立体に電気信号を伝送するように構成され、
剛性のあるハウジングにウィングを接続する少なくとも1つの蝶番部と、ここでこの蝶番部は、剛性のあるハウジングに接合されるエリアで自由に曲がるように構成される、
を備える。
哺乳動物に電子装置を取り付けること、ここで装置は、
哺乳動物から生理学的信号を検出するように構成された少なくとも2つの電極と、
2次信号を検出するように構成された少なくとも1つの測定器と、
電極及び剛性のあるハウジングに接続される少なくとも2つの電極トレースと、
を備え、
アーチファクトを見分けるため、生理学的信号と2次信号とを比較すること、
を備えてもよい。
7日を超える期間、哺乳動物へ請求項1の装置を適用して生理学的データを集めること、
第1の一連の生理学的信号を検出するために請求項1の装置を使用すること、
哺乳動物の表面から請求項1の装置を除去すること、
請求項1の装置から第1部品を除去すること、
第2生理学的モニタリング装置へ第1部品を組み込むこと、ここで第2生理学的モニタリング装置は、第2の一連の生理学的信号を検出するように構成される、
を備えてもよい。
以下の記載は多くの様々な実施形態に関する。しかしながら、記述された実施形態は、この発明の権利範囲から外れることなく多くの異なる方法において実施され及び/又は変更されてもよい。例えば、記述された実施形態は、多くの生理学的パラメーターのいずれをもモニターする、いかなる適切な装置、器具、あるいはシステムにおいて実施されてもよい。例えば、以下の論議は、主として長期で、パッチに基づいた心リズムモニタリング装置に着目する。1つの代わりの実施形態では、生理学的モニタリング装置は、例えば、パルスオキシメトリ、及び閉塞型睡眠時無呼吸の診断に使用されてもよい。種々の代わりの実施形態では、生理学的モニターの1つのサイズは、成人患者用に使用されてもよく、別のサイズは小児科の患者用に使用されてもよい。生理学的モニタリング装置の使用方法は、また変化するかもしれない。幾つかの場合では、装置は1週以下の間、着用されるかもしれない。一方、他の場合では、装置は少なくとも7日間、及び/又は7日を超える間、例えば14日と21日との間、あるいはさらに長い間、着用されるかもしれない。他の多くの代わりの実施形態、及び記述した技術の適用が可能である。よって、以下の記述は、例示の目的だけのために提供される。明細書全体を通して、用語「等角(conformal)」に言及がなされるかもしれない。これは、本明細書で使用される「等角」は、第1面あるいは構造が第2面あるいは構造の輪郭に十分に適合するところの面間あるいは構造間の関係を言うものと当業者によって理解されるだろう。
Claims (16)
- 哺乳動物における生理学的信号をモニターする方法であって、
哺乳動物の皮膚に可撓性の着用可能な装置を提供するステップを含み、ここで、この着用可能な装置は、複数の電極を備え、各電極は、上部基板層と下部基板層との間に位置する電極トレースに接続しており、ここで、下部基板層は、哺乳動物の皮膚表面に従うように構成されており、各電極トレースは、ハウジング内でプリント回路基板組立体と電気通信しており、ハウジングは、着用可能な装置に装着されており、患者事象トリガーを含み、
着用可能な装置は、ある期間、哺乳動物からの生理学的信号を集めるように構成され、
着用可能な装置は、生理学的信号データをプリント回路基板組立体に格納するように構成され、
プリント回路基板組立体を収容するハウジングは、着用可能な装置から除去可能であるように構成される、
方法。 - 上部基板層は、下部基板層を越えて外側へ延在するリムを備える、請求項1に記載の方法。
- 上部基板層は、第1の接着剤を備え、下部基板層は、第2の接着剤を備える、請求項1又は2に記載の方法。
- リムは、皮膚表面に実質的に垂直な方向に延在する垂直面において、着用可能な装置の隣接部分よりも薄く、
上部基板層は、第1の接着剤を備え、下部基板層は、第2の接着剤を備える、
請求項2に記載の方法。 - ハウジングを第2の着用可能な装置に装着することをさらに備えた、請求項1から4のいずれかに記載の方法。
- 第2の着用可能な装置を哺乳動物に取り付けることをさらに備えた、請求項5に記載の方法。
- 第2の着用可能な装置を第2の哺乳動物に取り付けることをさらに備えた、請求項5に記載の方法。
- 生理学的信号データをプリント回路基板組立体からデータ処理施設へ転送することをさらに備えた、請求項1から7のいずれかに記載の方法。
- 各電極は柔軟である、請求項1から8のいずれかに記載の方法。
- ハウジングは、上部ハウジング部材及び下部ハウジング部材を備える、請求項1から9のいずれかに記載の方法。
- ハウジングは、上部ハウジング部材と下部ハウジング部材との間に位置するガスケットを備える、請求項10に記載の方法。
- 電極トレースは、第1の材料を備え、電極は、第1の材料とは異なる第2の材料を備える、請求項1から11のいずれかに記載の方法。
- 装置は、14日以上、哺乳動物に付着されたままであるように構成されている、請求項1から12のいずれかに記載の方法。
- データ処理施設は、報告書を作成するよう構成されており、該報告書は、生理学的信号データの分析を提供する、請求項8に記載の方法。
- 着用可能な装置は、除去可能なライナーをさらに備える、請求項1から14のいずれかに記載の方法。
- 哺乳動物における生理学的信号をモニターする方法であって、
哺乳動物の皮膚に可撓性の着用可能な装置を提供するステップを含み、ここで、この着用可能な装置は、複数の電極を備え、各電極は、上部基板層と下部基板層との間に位置する電極トレースに接続しており、ここで、下部基板層は、哺乳動物の皮膚表面に従うように構成されており、各電極トレースは、剛性および防水性を有するハウジング内でプリント回路基板組立体と電気通信しており、ハウジングは、着用可能な装置に装着されており、
着用可能な装置は、ある期間、哺乳動物からの生理学的信号を集めるように構成され、
着用可能な装置は、生理学的信号データをプリント回路基板組立体に格納するように構成され、
プリント回路基板組立体を収容するハウジングは、着用可能な装置から除去可能であるように構成される、
方法。
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