JP2022089932A - 陰圧創傷療法システムにおける自動化創傷結合検出 - Google Patents
陰圧創傷療法システムにおける自動化創傷結合検出 Download PDFInfo
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Abstract
【解決手段】システムは、陰圧源、センサおよびコントローラを含む。陰圧源は、流体流路を介して創傷被覆材に陰圧を与えることができる。センサは、流体流路内の圧力を監視することができる。コントローラは、陰圧源が圧力範囲内に流体流路内の陰圧を維持する間、定常状態よりも混沌とした状態を示す経時的な流体流路内の圧力の大きさの変化から、創傷被覆材が創傷に結合されているかどうかを決定することができる。また、コントローラは、創傷被覆材が創傷に結合されていることを示す第1の表示、および創傷被覆材が創傷に結合されていないことを示す第2の表示を出力することができる。
【選択図】図5
Description
一部の実例において、TNP装置(時々ポンプアセンブリとして本明細書で言及される)のポンプなどの陰圧源が、患者に使用されているかどうかを確証することは困難であり得る。TNP装置は、陰圧源の起動と停止との間の時間のほか、TNP装置によって管理される療法プログラムに対するアラーム、測定された圧力または変化などのログイベントの関数として、その陰圧源の使用をログに記録することができる。しかし、起動と停止との間の時間およびログイベントは、TNP装置が、陰圧源が作動しているが流体流路を介して創傷に結合されていないかどうかを確信的に決定することを可能にし得ない。TNP装置は、例えば、陰圧源が創傷を治療するために使用されているか、またはその代わりに、創傷に結合されていない、また創傷被覆材が、いくつかの表面にわたる実質的な流体密封を形成していない、もしくは患者の組織以外の表面にわたる封止を形成していない状態(例えば、被覆材がテーブル、ドアなどの上に配置され得る)で、記憶装置のそばにもしくは記憶装置に単に置かれている間に使用されているかどうかの確信を区別することができない場合がある。さらに、TNP装置は、治療に強い影響を与える方法で調整され、変更されて使用される場合があり、または患者への使用の準備に時間がかかり得る。結果として、こうした使用または状況から集められたデータと患者への治療使用から集められたデータとを区別することは困難であり得る。
図1は、創傷くぼみ110であって、創傷カバー120によって封止された創傷くぼみの内部に置かれた創傷充填材130を備える、陰性のまたは低減された圧力創傷治療(またはTNP)システム100の実施形態を示す。創傷カバー120と組み合わされた創傷充填材130は、創傷被覆材として言及され得る。単一または複数の内腔管または導管140は、創傷カバー120と、減圧圧力を供給するように構成されるポンプアセンブリ150とを接続する。創傷カバー120は、創傷くぼみ110に流体連通することができる。図1に示される実施形態のような本明細書で開示されるいくつかのシステムの実施形態において、ポンプアセンブリは、キャニスターレスポンプアセンブリ(滲出液が、創傷被覆材に集められる、または別の位置に集めるために管140を介して運ばれることを意味する)であることができる。しかし、本明細書で開示されるいくつかのポンプアセンブリの実施形態は、キャニスターを含むまたは支持するように構成され得る。追加的に、本明細書で開示されるいくつかのシステムの実施形態において、いくつかのポンプアセンブリの実施形態は、被覆材に取り付けられ、もしくは被覆材によって支持され、または被覆材に隣接することができる。
図5は、図1のポンプアセンブリ150、図2A~図2Cのポンプアセンブリ230、図3AのTNP装置310、またはあらかじめその全体が参照によって本明細書に援用された米国特許公開第2016/0136339号および第2016/0184496号に記載のものと同様のその他のポンプアセンブリなどのデバイスによる創傷結合検出プロセス500を示す。便宜上、創傷結合検出プロセス500が図3AのTNP装置310との関連において説明されるが、代わりに、本明細書に記載の他のシステムで、または示されていない他のシステムによって実行される場合もある。
一部の実施形態では、陰圧創傷療法デバイスの準拠した使用および準拠しない使用を検出するための装置が開示される。装置は、メモリデバイスおよびプロセッサを含むことができる。メモリデバイスは、陰圧源と創傷被覆材を接続する流体流路内のある期間にわたる圧力の大きさを示す、圧力データを記憶することができる。プロセッサは、メモリデバイスと通信することができる。プロセッサは、陰圧源が創傷被覆材に陰圧を与えた時に、創傷被覆材が創傷に結合されているかどうかをある期間にわたる大きさの変化から決定することができ、陰圧源が創傷被覆材に陰圧を与えた時に創傷被覆材が創傷に結合されていることの決定に応答して、第1の表示を出力することができ、陰圧源が創傷被覆材に陰圧を与えた時に創傷被覆材が創傷に結合されていないことの決定に応答して、第1の表示とは異なる第2の表示を出力することができる。
313 陰圧源
316 センサ
Claims (16)
- 創傷に陰圧を加える装置であって、
創傷被覆材に流体流路を介して結合して、前記創傷被覆材に陰圧を与えるように構成される、陰圧源と、
前記流体流路内の圧力を監視するように構成される、センサと、
コントローラであって、
前記陰圧源が目標圧力範囲内に前記流体流路内の陰圧を維持する間、前記創傷被覆材が、混沌とした状態を示す継続時間にわたる前記流体流路内の圧力の大きさの変化から、前記創傷被覆材が創傷に結合されていることを決定すること、
前記創傷被覆材が前記創傷に結合されていることを示す、第1の表示を出力すること、
前記陰圧源が前記目標圧力範囲内に前記流体流路内の陰圧を維持する間、前記創傷被覆材が、定常状態を示す前記継続時間にわたる前記流体流路内の圧力の前記大きさの前記変化から、前記創傷に結合されていないことを決定すること、および
前記創傷被覆材が前記創傷に結合されていないことを示す、前記第1の表示とは異なる第2の表示を出力すること、を行うように構成される、コントローラと、を備える、装置。 - 前記コントローラが、前記創傷被覆材が前記創傷に結合されている前記決定に応じて、前記陰圧源の準拠した使用を示すデバイス使用データをメモリデバイスに記憶するようにさらに構成される、請求項1に記載の装置。
- 前記コントローラが、前記創傷被覆材が前記創傷に結合されていない前記決定に応じて、前記陰圧源の誤った使用を示すデバイス使用データをメモリデバイスに記憶するようにさらに構成される、請求項1または2のいずれか1項以上に記載の装置。
- 前記デバイス使用データが、圧力レベル、アラーム、滲出液レベル、イベントログ、または療法継続時間のうち1つ以上を含む、請求項2または3に記載の装置。
- 前記コントローラが、前記継続時間にわたる前記大きさの前記変化の不規則性の測定を閾値と比較して、前記継続時間にわたる前記大きさの前記変化が前記定常状態を示すかどうかを決定するようにさらに構成され、かつ、随意、不規則性の前記測定が、少なくとも1秒、10秒、30秒、1分または5分の前記継続時間にわたる前記大きさの前記変化に応答する、請求項1~4のいずれか1項以上に記載の装置。
- 前記コントローラが、
前記継続時間にわたる前記大きさに基づく統計動作、トレンディング動作、フィルタリング動作、累積合計動作、またはローパスフィルタリング動作を実行して、出力値を生成することと、
前記出力値が前記定常状態を示す決定に応じて、前記継続時間にわたる前記大きさの前記変化が、前記定常状態を示すことを決定することと、を行うようにさらに構成される、請求項1~5のいずれか1項以上に記載の装置。 - 前記コントローラが、前記継続時間にわたる前記大きさの時間領域表示および前記継続時間にわたる前記大きさの周波数領域表示から、前記継続時間にわたる前記大きさの前記変化が前記定常状態を示すことを決定するように構成される、請求項1~6のいずれか1項以上に記載の装置。
- 前記コントローラが、前記継続時間にわたる前記大きさを圧力パターンと比較して、前記継続時間にわたる前記大きさの前記変化が前記定常状態を示すかどうかを決定するようにさらに構成される、請求項1~7のいずれか1項以上に記載の装置。
- 前記圧力パターンが、前記陰圧源が前記目標圧力範囲内に前記流体流路内の陰圧を維持する間の、前記創傷被覆材が前記創傷に結合された時の前記流体流路内の圧力を示すか、前記圧力パターンが、前記陰圧源が前記目標圧力範囲内に前記流体流路内の陰圧を維持する間の、前記創傷被覆材が前記創傷に結合されていない時の前記流体流路内の圧力を示す、請求項8に記載の装置。
- 前記第1の表示が、前記陰圧源の準拠した使用を示し、前記第2の表示が、前記陰圧源の準拠しない使用を示す、請求項1~9のいずれか1項以上に記載の装置。
- 前記コントローラが、
メモリデバイスに記憶するために前記第1の表示を出力するように、または
前記メモリデバイスに記憶するために前記第2の表示を出力するようにさらに構成される、請求項1~10のいずれか1項以上に記載の装置。 - 前記コントローラが、
送信機に通信ネットワークを介して前記第1の表示をコンピュータ装置に送信させることによって、前記第1の表示を出力するように、または
前記送信機に前記通信ネットワークを介して前記第2の表示を前記コンピュータ装置に送信させることによって、前記第2の表示を出力するようにさらに構成される、請求項1~11のいずれか1項以上に記載の装置。 - 前記コントローラが、
ユーザーへの呈示のために前記第1の表示を出力するように、または
前記ユーザーへの呈示のために前記第2の表示を出力するようにさらに構成される、請求項1~12のいずれか1項以上に記載の装置。 - 前記流体流路が、少なくとも1つの内腔または複数の内腔を含む、請求項1~13のいずれか1項以上に記載の装置。
- 前記コントローラが、前記第1の表示または前記第2の表示に応答して、前記陰圧源を起動および停止するように構成される、請求項1~14のいずれか1項以上に記載の装置。
- 前記陰圧源が、前記継続時間にわたる前記大きさが前記目標圧力範囲内に維持されている場合に、陰圧療法を実施するように構成される、請求項1~15のいずれか1項以上に記載の装置。
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