JP6588897B2 - 腹部の電気生理学的信号を検出するためのパッチ、読出装置、システム及び方法 - Google Patents
腹部の電気生理学的信号を検出するためのパッチ、読出装置、システム及び方法 Download PDFInfo
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- JP6588897B2 JP6588897B2 JP2016524442A JP2016524442A JP6588897B2 JP 6588897 B2 JP6588897 B2 JP 6588897B2 JP 2016524442 A JP2016524442 A JP 2016524442A JP 2016524442 A JP2016524442 A JP 2016524442A JP 6588897 B2 JP6588897 B2 JP 6588897B2
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Description
基準特徴部を腹部に固定し、
続いて、パッチの各電極を順に腹部に付着する
工程を備えてもよい。
電極を皮膚に付着し、
電極と皮膚との間の電気的接続のインピーダンスを検査し、
インピーダンスが所定値より高い場合は、
パッチの基準特徴部又は任意の他の電極を皮膚から引き離すことなく、その電極を取り外し、
皮膚に下準備をして、そのインピーダンスを低減し、
電極を再び付着する
工程を備えてもよい。
Claims (20)
- 母体及び/又は胎児の電気生理学的信号を腹部で検出するための多電極のパッチであって、
前記パッチが、
複数の電極を相互接続する可撓性基板と、
母体及び/又は胎児の電気生理学的信号を前記電極から検出するための電子的な読出装置と取り外し可能に係合するためのモジュール・ユニットと、
前記パッチに関連付けられた認証コードを、前記読出装置に提供するセキュリティ装置であって、前記セキュリティ装置を含まないパッチ、又は、間違った前記認証コードを提供するパッチとともに前記読出装置を使用するのを防止するセキュリティ装置と、
を備え、
前記モジュール・ユニットが、
前記読出装置の筐体と取り外し可能に機械的に係合するための機械モジュール・ユニットと、
前記電極から前記読出装置に電気的に接続するための電気モジュール・ユニットと
を備え、
前記パッチの前記読出装置との係合が、前記機械モジュール・ユニット及び前記電気モジュール・ユニットの両方の係合を備える、
パッチ。 - 請求項1のパッチにおいて、
前記機械モジュール・ユニットが、磁石又は強磁性材料を備える、
パッチ。 - 請求項1又は2のパッチにおいて、
前記機械モジュール・ユニットが、前記筐体の少なくとも一部を受け台のなかへ摺動させることにより前記筐体と機械的に係合する受け台を備える、
パッチ。 - 請求項1乃至3いずれかのパッチにおいて、
前記可撓性基板が、弓形の、蛇行した又は波形の部分を有する可撓性下部構造を備え、
前記電極が、表面に追従可能であり、少なくともいくつかの前記電極の前記表面上における互いに対する相対位置が、前記電極の移動及び前記可撓性下部構造の変形により調整できる、
パッチ。 - 請求項4に記載のパッチにおいて、
前記電極が、共通電極と、複数の検知電極と、電圧を印加するための駆動電極とを備え、
前記検知電極が、前記共通電極から及び互いに離間している、
パッチ。 - 請求項5のパッチにおいて、
前記可撓性下部構造が、前記共通電極と前記検知電極との間に配置され、前記表面上における前記共通電極の位置を前記検知電極に対して調整でき、
前記検知電極が、円弧に沿って配置され、第1の検知電極が前記円弧の一端にあり、第3の検知電極が前記円弧の他端にあり、第2の検知電極が前記円弧上で前記第1及び第3の検知電極の間にあり、
第1の可撓性下部構造が、前記第1及び第2の検知電極の間の前記表面に沿った距離が変化し得るよう配列され、第2の可撓性下部構造が、前記第3及び第2の検知電極の間の前記表面に沿った距離が変化し得るよう配列されている、
パッチ。 - 請求項4乃至6いずれかのパッチにおいて、
前記可撓性基板が、更に、臍と位置合わせするための基準特徴部を備え、前記可撓性下部構造により、前記基準特徴部から少なくとも1つの電極までの前記表面に沿った距離を調整することができる、
パッチ。 - 請求項1乃至7いずれかのパッチにおいて、
前記可撓性基板が、複数の導電層及び絶縁層を備え、
前記複数の導電層が、
電気信号を前記電極から伝達するための信号層と、
前記信号層を電磁干渉から遮蔽するためのシールド層と
を備え、
前記シールド層が、前記絶縁層により前記信号層から分離されている、パッチ。 - 請求項8のパッチにおいて、
前記シールド層が、前記信号層の第1の側に隣接して配置され、
前記複数の導電層が、前記信号層の第2の側に隣接して配置された更なるシールド層を備え、
前記更なるシールド層が、更なる絶縁層により前記信号層から分離されており、
外部絶縁層が、前記更なるシールド層の外へ向いた側に隣接して配置されている、
パッチ。 - 請求項1乃至9いずれかのパッチとともに使用して、前記パッチの前記電極からの少なくとも一つの信号を増幅してフィルタするための電子的な読出装置であって、
前記読出装置が、
電力を貯蔵して前記装置に供給するための電源と、
前記パッチの前記機械モジュール・ユニットと機械的に係合するための機械モジュール・ユニットを有する筐体と、
前記パッチの前記電気モジュール・ユニットと電気的に係合するための電気モジュール・ユニットと、
前記読出装置が、前記パッチのセキュリティ装置から適切な認証を受信しない限り、前記読出装置がパッチとともに機能するのを防止するために配置されたセキュリティ装置を備える、
を備える、読出装置。 - 請求項10の読出装置において、
前記読出装置の前記電気モジュール・ユニットが、弾性変形可能な要素上に装着された少なくとも1つの接点を備える、
読出装置。 - 請求項10又は11の読出装置において、
前記読出装置が、前記信号から得た情報を送信するための無線送信機を備え、
前記読出装置が、前記無線送信機を介して、出力を送信するよう動作可能であり、前記出力が、胎児心拍数、胎児ECG、母体心拍数、母体ECG及び子宮活動のうち少なくとも1つを備える、読出装置。 - 請求項10乃至12いずれかの読出装置において、
前記読出装置が、受信機におけるビット誤り率及び前記受信機における信号強度のうち少なくとも1つに基づいて、前記無線送信機の出力を制御するよう構成されている、
読出装置。 - 請求項10乃至13いずれかの読出装置において、
前記読出装置が、更に、母体の移動、母体の呼吸、母体収縮及び胎動のうち少なくとも1つを検出するよう構成されている慣性センサを備える、
読出装置。 - 請求項10の読出装置において、
前記セキュリティ装置が、特定の患者に関連付けられたパッチ認証コードを記憶するよう動作可能であり、前記読出装置が、特定の患者に関連付けられた認証コードを有するパッチとともにのみ動作可能となる、
読出装置。 - 請求項10乃至15いずれかの読出装置と、該読出装置から情報を受信するための受信端末とを含むシステムにおいて、
前記受信端末が、
胎児心拍数、胎児ECG、母体心拍数、母体ECG及び子宮活動のうち少なくとも1つを表示するための表示部と、
前記読出装置の前記筐体を受け入れるためのドック領域とを備え、
前記ドック領域が、前記読出装置の前記電源を充電するための充電器を備える、
受信端末。 - 腹部の電気生理学的検出のためのシステムであって、
前記システムが、
請求項1乃至9いずれかのパッチと、
読出装置と
を備え、
防水シールが、前記モジュール・ユニットと前記読出装置との間の電気的接続のために設けられている、
システム。 - 請求項17のシステムにおいて、
圧縮シールが設けられ、前記読出装置を前記モジュール・ユニットに機械的に係合することにより、前記シールが係合方向に圧縮される、
システム。 - 腹部の電気生理学的信号を判定する方法であって、
請求項1乃至9いずれかのパッチを使用し、
前記パッチを妊娠者である対象者の腹部に付着し、
読出装置を使用して、前記パッチの前記電極を介して電気生理学的信号を検出する、
ステップを含み、
前記パッチが、前記パッチを着用者上に位置決めするための基準特徴部を備え、
接着領域が、前記基準特徴部に又は隣接して設けられており、
前記パッチを前記対象者の前記腹部に付着する際のステップとして、
前記基準特徴部を前記腹部に固定し、
続いて、前記パッチの前記電極を、それぞれ、順番に前記腹部に付着する、
ステップを含んでおり、
前記パッチの各電極を前記腹部に付着する際のステップとして、
前記電極を皮膚に付着し、
前記電極と前記皮膚との間の電気的接続のインピーダンスを検査し、
前記インピーダンスが所定値より高い場合に、
前記皮膚に付着され得る前記パッチの前記基準特徴部又は任意の他の電極を引き離すことなしに、前記電極を取り外し、
前記皮膚に下準備をして、前記インピーダンスを低減し、
前記電極を再び付着する、
ステップを含む、方法。 - 請求項19の方法において、
導電媒体を、前記対象者の皮膚と少なくとも1つの前記電極との間に設け、
前記導電媒体が、電解質を少なくとも9重量%備える、
方法。
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