JP5939523B2 - 動作/姿勢を検出する着用型治療装置 - Google Patents
動作/姿勢を検出する着用型治療装置 Download PDFInfo
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Description
また、電池充電器と呼ばれる第3の装置があり、この装置は二つの機能を有し得る。すなわち、第1の機能はモニタ電池41の充電であり、第2の機能は中央サーバーへデータをダウンロードするために、モニタのゲートウエー(入口)として働くことである。モニタは、無線Bluetooth(登録商標)リンクを介して充電器に接続でき、充電器はインターネットを介して中央サーバーに接続できる。
この情報は、信頼性のある不整脈検出アルゴリズムで使用され、過去および現在の身体運動歴および/または姿勢歴に基づく治療実施を急ぐか、または延期するタイミングを加速することができる。
加速度計の代わりに使用可能と思われる他の器械には、ジャイロスコープ、磁力計、ホール効果装置、その他の力運動センサまたは位置センサが含まれるが、これらに限定されるわけではない。
以下の米国特許の記載内容を、引用によって本明細書の記載として援用する。
ベルトに配置される加速度計は、患者の胴上部に位置するので、患者の姿勢の検出に使用できる。結果として、ベルトの加速度計は、高感度データが、可能な体位(例えば患者の姿勢)から測定または検出できるように選択されよう。モニタに配置される加速度計は、高感度データ(例えば、呼吸、その他の小運動)、低感度データ(例えば、機械的な衝撃)のいずれか、または、両者を測定できるように選択できる。低感度データおよび高感度データを測定できるように、さらに付加的に複数の加速度計を用いてもよく、あるいはまた、低感度および高感度の両データを測定可能な加速度計を用いてもよい。
前記治療装置は、患者に隣接して患者の皮膚近くに配置され、
前記患者動作検出器は、前記治療装置に連結され、かつ、患者の動作を表示する信号を発し、
前記制御装置は、前記患者動作検出器から出る信号を評価して、治療にふさわしい患者の動作を表示しているか否かを確定する。
実施形態は、少なくとも一つの多軸加速度計を含む少なくとも一つの加速度計の使用を含み、かつ、二つの3軸加速度計を含むことができ、該3軸加速度計の一方が患者のチョッキ部分に取付けられ、他方がモニタまたはその他の部分に取付けられる。幾つかの実施形態は、前記モニタ部分に設けた視認可能なディスプレーを含み、このディスプレーの向きは、前記加速度計の出力によって制御される。
患者の身体の向きは、立位、および、うつ伏せ姿勢を含む、少なくとも一つの加速度計の出力によって確定される。
本発明は、前記加速度計の前記記憶出力に基づいて、或る時間にわたる患者の動作レベルに基づく患者の状態を検出することができ、かつ、例えば、うっ血性心不全または睡眠障害等の状態を検出するために使用できる。
患者の心臓治療の一方法は、
心臓状態の検出、
患者が着用した加速度計等のセンサによる患者の動きの検出、および、
検出された患者の動作を評価して、前記心臓状態に対して処置が適切かどうかを決定することを含む。
実施形態として、立位、および、うつぶせ姿勢を検出して、患者の動作と、患者の体位を確定できる。
患者の身体状態:患者は立位、患者は水平位(左下、右下)。
患者は各パターンで運動している:振動(環境)、痙攣。
患者は加速している:患者は転倒している。
装置(ベルトおよびモニタ)の状態:x/y/z位置。
装置の加速。
装置の機械的衝撃(大きい力による衝撃、加速)。
ベルト・ノードにおける触覚的モータ動作の確認。
運動センサは、どのようなものを使用してもよい。本好適例では、加速度計が使用される。これらのセンサは加速運動を表示する。概ね短距離かつ短時間であるのが人の動きの性質であるため、加速度計によって与えられる患者の動きの表示は、極めて満足のゆくものである。多軸加速度計のみならず、単軸加速度計も使用できる。
加速度計の使用により、不整脈検出中の患者の状態を検出できる。また、加速度計は、物理的に雑音の多い環境が不整脈誤検出の原因となるかどうかを検出するのに使用してもよい。
加速度計により検出された患者の身体状態を含む多くの入力の影響を受ける信頼アルゴリズムは、患者の不整脈が除細動を要するか否を検出するのに使用される。
一般に、心臓の治療は、患者に意識がある場合には要求されない。加速度計の使用によって患者の身体状態をモニタすることができる。単数または複数の加速度計により検出される或る時間にわたり患者の身体状態に変化がない場合、患者に意識が無いとするアルゴリズムの信頼性が増すだろう。加速度計によって患者の身体状態に変化が検出された場合には、患者に意識が無いとするアルゴリズムの信頼性は低くなるだろう。着用可能な細動除去器は、患者に意識が無いとする高レベルの信頼性が得られた場合には、治療実施の決定を急ぐことができる。患者の運動が検出される一方、他のセンサおよびアルゴリズムが、治療可能な律動の存在を指示する場合には、システムのメッセージに応答する付加的な時間を患者に与えるために、治療の開始を遅らすことができる。
時として、物理的な運動、すなわち身体や衣服に対する電極やケーブルの動きのために、システムが、患者のECGに偽偏位を生じさせる擬似不整脈を検出することがある。不整脈が検出され、振動(振戦)または患者/装置の加速が検出された場合、患者には、この状態に対する警告を発すことができる。触覚的な刺激器が励起されるか、または可聴音量が高められて、患者に基準1が報知される。この情報は、また治療信頼アルゴリズムにも与えられ、それにより、物理的動きが偽陽性を検出させる可能性があるとすれば、信頼性が引き下げられる。加速度計の使用は、偽不整脈の望ましくない治療を減少させることができる。
電極ベルトの運動は、ECG信号の受信を妨害し、偽検出を生じさせる可能性がある。加速度計から得られる信号は、ECG信号汚染の有無を検出するために、ECG信号と相関させることができる。この相関関係の質は、不整脈検出アルゴリズムの付加的な信頼因子として利用できる。不整脈が検出され、ECG信号と加速度計信号との間に高レベルの相関関係が存在する場合、不整脈検出の信頼性は、往々にして低くなる。信号の相関関係の欠如は、不整脈の検出が正確である信頼性が高いことを示している。
加速度計は、また治療直後に、突然の運動が検出されるか、または患者に筋攣縮が検出されることで、治療が行われたことを検証するためにも使用できる。筋攣縮は、加速度計に全身痙攣に似た検出可能な運動を生じさせるだろう。
数回の除細動の試みが不成功に終わった後に患者のショック後運動が見られる場合は、複数の人が居合わせることを示す。居合わせた人々は、おそらくEMT(救急救命士)等の救急人員だろう。その場合、特別の警報、または声によるメッセージが発せられることで、装置のそばおよび治療のさいに居合わせた人々に情報が与えられる。追加ショックは、居合わせた人々または救命士にショックが加えられることを防止するために遅延または中止可能である。
ショックが与えられると、患者は突発的に動いた後、動かない状態に戻る。更なる動きが検出されない場合、往々にして、なお不整脈が存在する信頼性が高い。この情報は、検出アルゴリズムおよび状態継続の付加的ショック後信頼因子として利用できる。ショック後運動が継続している場合、または患者の身体姿勢が水平位から垂直位に変化した場合は、除細動が成功した信頼性が高いので、追加ショックは遅延することができる。
ベルト品質のフィードバック
ベルトの全体的品質は、電極や治療パッドの脱落が検出される等の一定の故障状態中に加速度計を使用してデータを収集することで検証する。
電極10または治療パッド18の1つが患者から脱落した場合、システムは、脱落事象中の患者の身体状態を記録する。患者の姿勢は、上体を起こした状態、横たわり状態(左下状態、右下状態)を含む。振動または患者の転倒が検出された場合、それが脱落事象の原因かもしれないので、そのことも同じように記録される。
或る時間にわたってデータは分析され、脱落を生じさせがちな姿勢の検出に使用される。この情報は、次いで、ベルト設計の改善に使用でき、それらの一定の動きまたは姿勢での脱落を低減し、かつ出来る限り無くすことができる。
一例を挙げると、数ヶ月間にわたりデータを分析した後、ECG素子の脱落の75%が患者の左下横臥時に発生することが分かれば、左側のベルト構成を調べて、患者の前記姿勢時に脱落しやすい原因のありかを明らかにできるだろう。
或る時間にわたり収集した加速度計データを利用して、より快さを求める傾向のある新しい患者に患者の身体についての情報を与えることもできよう。長時間にわたり装置を着用した患者は、異なる幾つかの姿勢(就寝姿勢、座位等)で極めておあつらえ向きの実験をしたことになり、かつ最も快適な姿勢をとる傾向があるにちがいない。そのデータを記録し、かつ利用して、他の姿勢の場合についてベルトを改良し、かつ新しい患者に勧めることもできる。
ベルトの快適性の改善
患者の使用中に収集した加速度計データを利用して、患者の就寝中の癖または他の選択した動きの際の癖を調べることにより、ベルトの快適性を改善できる。
患者の80%は右下で寝る傾向があると仮定すれば、そう仮定することで、左下で横になる患者にはベルトの快適性が劣るという事態に対して何らかの処置が可能になる。その情報の研究により、ベルトが不快になる姿勢がどのようなものかを決定でき、ベルトの快適性を技術的に改善できる。
また、ベルト・ノード触覚式刺激器(Belt Node Tactile Stimulator)(振動/加速)による自己試験等の自己診断を行うことができる。
触覚式刺激器12(患者への報知装置)は、軸に不均衡錘(おもり)を有するモータである。このモータが励起されると、ベルトが振動モードで携帯電話器によく似た振動を発生させる。
触覚が付勢されると、ノードの加速度計17を使用して、触覚が働いていることを意味するノードの振動を検証できる。
物理的事象の患者への報知
加速度計を利用して、一定の機械的事象について患者へのフィードバックを行うことができる。また、加速度計を利用して、患者の現状に基づき装置の音量を調節することもできる。
物理的な衝撃または振動等の、装置を損傷することのある一定の物理的状態が加速度計によって検出された場合、システムは、その状態を患者に通知し、その状態についてモニタ15のコンピュータ・スクリーンで助言できる。
モニタまたはベルトが、脱落するか、または予め決められた許容可能な力以上の大きい力を生じる他の何らかの物体にぶつかった場合、モニタは、事象が発生したことを患者に対し聴覚または視覚(ディスプレー)を通じて報知し、再度そのような事象が起こり得ることを警告する。
予め決められた許容閾値を超える連続的振動が或る時間にわたって検出された場合は、モニタ15が患者に警告を与えることもできる。このような振動により、電極やケーブルに十分な大きさの物理的な運動が加わると、電極または治療パッドの脱落、もしくは不整脈の誤検出さえ生じさせることがある。
加速度計が、長時間にわたり患者の身体状態の不変化を記録し、かつ患者が横たわった状態または座位にある場合、モニタは、患者が睡眠中と仮定し、患者を覚醒させる必要があれば、何らかの聴覚メッセージの音量出力を増大させる。モニタは、また重大な聴覚メッセージを発する場合には、触覚式刺激器により患者を覚醒させることができる。
モニタ加速度計を使用して、モニタ15のシステム・ディスプレーまたはLCD出力の適切なローテーションを決定することができる。モニタ15はディスプレーを内蔵しており、このディスプレーを使用して、患者への視覚メッセージを発したり、介護者が患者に対し最初の設定(setup)を行うことができる。モニタは患者のほぼ中央部に位置するので、患者に視覚メッセージを送る場合は、ディスプレーをモニタに対して逆さにする(180度転回)。しかし、患者への設定中、モニタは、熟練者の前で右側を上に保持できよう。結果としてディスプレーは右側が上となる。モニタ加速度計のデータは、このためディスプレーをどう読もうとするかに応じて調節するのに使用できる。
装置の誤用の検出
使用中および輸送中の装置誤用が検出される。装置の誤用は、落下の回数や強度等のパラメータによって確定できる。装置の誤用が検出されると、内部診断、自動ダウンロード、装置の保守点検勧告等のアクションを起動できる。
加速度計が、予め定めた許容閾値を超える物理的衝撃を検出した場合、モニタは落下事象を記録する。日付/時間の刻印、その時点の作動モード等の他のパラメータも、同じように記録される。
日付/時間の刻印は、モニタ位置と損傷事象とを相関させることができ、それにより、輸送中に該損傷が生じた場合、更に情報を運送車追跡番号を利用して得ることができる。
運送中ではなく、患者が使用中、落下後、何らかの形式の装置故障が生じた場合には、そのことを装置故障の根本原因に関連付けることができる。その情報は、装置を損傷する可能性のある物理的衝撃の種類について患者に助言する際に使用できる。また、その情報を利用して、装置の堅牢さを改善し、将来は同じような力に耐えられるようにすることもできる。
モニタ加速度計16、ベルト加速度計17が、予め定めた許容閾値を超える物理的衝撃を記録した場合、または予め定めた許容数の物理的衝撃が生じた場合、モニタは、符号15の素子を介して聴覚または視覚(ディスプレー)メッセージにより患者に装置を保守点検するよう勧告する。モニタ15は、また次のダウンロード時、製造者に保守点検すべきことを報知する。
内部診断
加速度計がベルトまたはモニタに対する過剰な物理的衝撃を検出すると、内部で自己診断が始められる。モニタ15およびノード11の双方が、図3および図4に示した組込み回路を有し、これによって構成素子の大部分の自己診断が可能である。
ベルトまたはモニタに対する著しい物理的衝撃が加わると、モニタは、直ちに自動式にダウンロードして製造者に保守点検を要求できる。
或る時間にわたる患者動作(活動)のモニタ
加速度計データを或る時間にわたって測定し、記憶させることで、患者の動作を調べることができる。患者の動作データは、患者の具体的な状態を医師にフィードバックするために使用できる。
患者の動作(活動)データおよび治療
治療事象以前に得られた患者の動作データは、治療事象のデータも含めて、治療事象後にダウンロードできる。このデータを複数患者から収集し、利用することで、加速度計16,17から得られる患者の動作と治療事象が起こりうる確率との相関関係を明らかにすることができる。これらの相関関係を利用して、過去に治療事象が生じた患者と似た活動を有する患者に対しては、予防処置を講じることができる。
患者の動作データは、或る時間にわたって医師またはデータ評価システムによって使用され、それによって患者の動作レベルが適正か否かが検出できる。検出すべき対象の例としては、極端に乏しい患者の動作、勧められた運動を患者が行っているかどうか、リアルタイムでの患者の動作レベルとそれに対応する心拍数データ等が挙げられだろう。うっ血性心不全を経験している患者の場合には、身体動作や静止時の身体姿勢をモニタできる。患者の動作が漸減し動きの乏しさが指示された場合、往々にして、うっ血性心不全状態の悪化を示している。うっ血性心不全患者は水平位で休息(静止)することが難しいので、身体姿勢が休息時に主として垂直位であれば、静止時の身体姿勢も、往々にして患者の状態の悪化を指示するものである。
加工加速度計52を使用できる。ベルト・ノード・コンピュータ54は、g選択ラインを制御し、これらのラインが、また感度を1.5gから6gへ変更できる。RCフィルタ並びに振幅スケーリング53が、加速度計出力の各々に対して使用できる。ベルト・ノード・コンピュータ54内部のMUXおよびADCにより加速度計のアナログ出力が、コンピュータに直接にデジタル接続できる。
雑音を有するECGチャネルが存在する場合のアルゴリズムは、無雑音のECGチャネルの心拍数検出器に対して、より大きく加重するように働くことが可能だろう。加速度計のアルゴリズムの信頼性が高い場合、加重には、図5の流れ図に示すように、患者の動きが検出される間、治療付与が遅延されるように指定できるだろう。
通常、患者が着用可能な装置でデータを追跡かつ記憶するのが望ましいが、この場合も、追加される運動データの記憶、追跡、評価も可能である。そのような1つの使用法は、運動/動作レベル歴を評価して、うっ血性心不全等の状態を検出することだろう。それらの疾患は、心臓治療装置を着用している患者で発見されることが多い。
10a,10b,10c,10d 電極
11 ノード
12 触覚式刺激器
13 中継ケーブル
15 モニタ
16,17 加速度計
18 治療装置
20 ベルトまたはチョッキのノード
21 加速度計
22 マイクロ制御器
31 加速度計
32 システム・コンピュータ
41 モニタの電源、バッテリ
42 調整器
43 加速度計
44 RCフィルタ
45 マルチプレクサ(MUX)
46 アナログ/デジタル・コンバータ(ADC)
47 主モニタ・コンピュータ
51 モニタの電源、電力調整器
52 加速度計
53 振幅スケーリング装置
54 ベルト・ノード・コンピュータ
Claims (11)
- 外部から着用可能な患者の治療装置において、
患者の心臓の情報を検出するために患者に隣接して外部に配置されるように構成される心臓検出電極と、
患者に隣接して外部に配置されるように構成される治療要素と、
前記治療装置の動作を表示する信号を発生するように構成される少なくとも一つの動作検出器と、
前記治療装置に配置され、前記少なくとも一つの動作検出器、前記心臓検出電極、及び前記治療要素に連結され、前記治療装置の動作を表示する信号を受信するように構成され、前記治療装置が、前記治療装置に対する損傷、前記治療装置の故障、および前記治療装置の誤動作の少なくとも1つが起こる可能性がある予め決められた許容可能な力よりも大きい力に曝されているかどうかを前記信号に基づき決定する、少なくとも一つの制御装置と、を備える治療装置。 - 前記少なくとも一つの動作検出器が少なくとも二つの3軸加速度計を含み、前記少なくとも二つの3軸加速度計の一方が前記治療装置の患者のチョッキ部分に取付けられ、前記少なくとも二つの3軸加速度計の他方が前記治療装置のディスプレー部分に取付けられている請求項1に記載の治療装置。
- 前記ディスプレー部分における視覚ディスプレーを更に含み、
前記視覚ディスプレーの向きが前記ディスプレー部分に取り付けられた前記少なくとも二つの3軸加速度計の他方の出力による請求項2に記載の治療装置。 - 前記視覚ディスプレーの向きが前記信号に基づく、請求項3に記載の治療装置。
- 前記少なくとも一つの制御装置に連結され、前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して、警報を発するように構成される、可聴警報を更に備える、請求項1に記載の治療装置。
- 前記少なくとも一つの制御装置は、
前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して装置の保守点検勧告を提供する、
前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して患者に不正事象を報知する、
前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して検出された不正事象のデータ、及び時間を検出するように、
前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して内部の自己診断を開始する、及び
前記治療装置が予め決められた許容可能な力よりも大きい力に曝されているとの決定に応答して、前記治療装置の製造者に保守点検の要求を提供する、
の少なくとも一つを行うように構成される、請求項1に記載の治療装置。 - 前記少なくとも一つの制御装置は、前記信号に基づく物理的に雑音の多い環境を検出するように、更に構成される、請求項1に記載の治療装置。
- 前記少なくとも一つの制御装置が患者の検出された心臓の情報に基づき、患者の心臓の不整脈を検出し、物理的に雑音の多い環境の検出に応答して、検出された心臓の不整脈の信頼性を減少するように、更に構成される、請求項1に記載の治療装置。
- 前記少なくとも一つの制御装置は、検出された患者の心臓の情報に基づく患者の心臓の不整脈を検出し、前記信号と患者の前記検出された心臓の情報との間に高度の相関が存在しているかどうかを決定する、及び、前記信号と患者の前記検出された心臓の情報との間に高度の相関が検出されたことに応答して検出された患者の心臓の不整脈の信頼性を減少するように、更に構成される請求項7に記載の治療装置。
- 前記少なくとも一つの制御装置は、前記信号を使用して、患者の身体状態が変わりないとの決定に基づき、患者への聴覚メッセージの音量出力を増大するように、更に構成される請求項1に記載の治療装置。
- 前記少なくとも一つの制御装置は、前記治療装置が、前記信号に基づき、予め決められた許容可能な力よりも小さい力に曝される回数を決定し、前記治療装置が、少なくとも予め決められた回数、予め決められた許容可能な力よりも少ない力に曝されたとの決定に応答して、装置の保守点検の勧告を提供するように構成される、請求項1に記載の治療装置。
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DE (1) | DE102008020562B4 (ja) |
FR (1) | FR2917298B1 (ja) |
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JP2008307382A (ja) | 2008-12-25 |
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JP2016105831A (ja) | 2016-06-16 |
US8676313B2 (en) | 2014-03-18 |
DE102008020562B4 (de) | 2018-10-11 |
US11877854B2 (en) | 2024-01-23 |
US20220296152A1 (en) | 2022-09-22 |
US11395619B2 (en) | 2022-07-26 |
US20140163334A1 (en) | 2014-06-12 |
US20200253486A1 (en) | 2020-08-13 |
US9398859B2 (en) | 2016-07-26 |
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