JP6679483B2 - 減圧治療を実施するためのシステムおよび方法 - Google Patents
減圧治療を実施するためのシステムおよび方法 Download PDFInfo
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- JP6679483B2 JP6679483B2 JP2016534618A JP2016534618A JP6679483B2 JP 6679483 B2 JP6679483 B2 JP 6679483B2 JP 2016534618 A JP2016534618 A JP 2016534618A JP 2016534618 A JP2016534618 A JP 2016534618A JP 6679483 B2 JP6679483 B2 JP 6679483B2
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Description
本出願は、2013年8月13日に出願された米国仮出願第61/865,516号の利益を主張し、その開示はこの引用によってその全体が本明細書中に組み込まれる。
図1は、創傷キャビティ110内に配置された創傷充填材130を備えた負圧または減圧創傷治療(またはTNP)システム100の実施形態を示しており、創傷キャビティは創傷カバー120によって密閉されている。創傷カバー120と組み合わされた創傷充填材130は創傷ドレッシングと呼ぶことができる。単一または複数のルーメンチューブまたは導管140が、低減圧力を供給するよう構成されたポンプアセンブリ150および創傷カバー120に接続されている。創傷カバー120は創傷キャビティ110と流体連通状態となることができる。本明細書に開示されたシステムの実施形態のいずれかにおいて、図1に示す実施形態におけるように、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であってもよい(創傷ドレッシング内に収集された滲出液は別の場所へと収集のためのチューブ140を介して移動されることを意味する)。しかしながら、本明細書に開示されたポンプアセンブリの実施形態のいずれかは、キャニスターを含むかあるいは支持するよう構成することができる。さらに、本明細書に開示されたシステムの実施形態のいずれかにおいて、ポンプアセンブリの実施形態のいずれかは、ドレッシングに対して取り付けられあるいはそれによって支持されても、あるいはドレッシングに隣接して取り付けられあるいはそれに隣接して支持されてもよい。創傷充填材130は、親水性または疎水性の発泡体、ガーゼ、膨張可能なバッグ等といった、いかなる好適なタイプのものであってもよい。創傷充填材130は、それが実質的に大気圧でキャビティを満たし、そしてまた負圧下にあるとき実質的に減少した圧縮体積を有し得るように、創傷キャビティに可能であってもよい。傷カバー120は、創傷キャビティ110上に実質的に流体不透過性シールを提供できる。ある実施形態では、創傷カバー120は上面および下面を有し、そして下面は創傷キャビティ110と接着方式で(またはその他の適切な方法で)密着する。導管140または本明細書に開示されるその他の導管は、ポリウレタン、PVC、ナイロン、ポリエチレン、シリコーンまたはその他の適切な材料から形成できる。
図2Aは、ある実施形態に係るポンプアセンブリ230およびキャニスター220の正面図200Aを示している。図示されるように、ポンプアセンブリ230とキャニスターとは接続され、これによってデバイスが形成されている。ポンプアセンブリ230は、アラームを示すよう構成された視覚的インジケータ202およびTNPシステムの状態を示すよう構成された視覚的インジケータ204などの一つ以上のインジケータを含む。インジケータ202および204は、ユーザーに正常または適切な動作状態、ポンプの故障、ポンプに供給される電力または電力障害、創傷カバーまたは流路内の漏れの検出、吸引閉塞またはその他の類似のまたは適切な状態またはその組合せをユーザーに警告することを含む、さまざまなシステムの動作および/または障害の状態をユーザーに警告するように構成することができる。ある実施形態では、ポンプアセンブリ230は、追加のインジケータを含むことができる。ある実施形態では、単一のインジケータが使用される。他の実施形態では、複数のインジケータが使用される。ビジュアル、オーディオ、触覚インジケータといった適切なインジケータを使用することができる。インジケータ202は、キャニスター満杯(またはキャニスターレスシステムの場合にはドレッシング満杯)、電力低下、導管140切断、創傷シール120のシール破損等のアラーム条件を通知するよう構成することができる。インジケータ202は、ユーザーの注意を引くために、赤色の点滅光を表示するよう構成することができる。インジケータ204は、治療システムがOKである、漏れが検出された等の、TNPシステムの状態を通知するよう構成することができる。インジケータ204は、緑色、黄色等の一つ以上の異なる色の光を表示するよう構成することができる。例えば、TNPシステムが正常に動作しているときに緑色の光を発することができ、そして黄色の光は注意を示すために発することができる。
図3は、ある実施形態に係る流体流路300Aを示している。流路300Aは、創傷キャビティ310と、キャニスター320と、圧力センサー330と、負圧源340とを含む。流体の流れは左から右(例えば創傷310から負圧源340へ)である。図3は、ある実施形態に係る流体流路300Bを示している。流路300Bは、創傷キャビティ310と、圧力センサー330と、キャニスター320と、負圧源340とを含む。流体の流れは左から右(例えば創傷310から負圧源340へ)である。図示されるように、流路300Aと300Bとの間の差は圧力センサー330の配置である。流体流路300Aにおいては、圧力センサー330はキャニスター320の下流側に(例えば負圧源340のインレットに)配置され、一方、流体流路300Bにおいては、圧力センサー320はキャニスター320の上流側に配置される。
ある実施形態では、閉塞および一つ以上のチューブまたはルーメン内の滲出液の存在は、センサー280,282および284などの一つ以上の圧力センサーからのデータを処理することによって検出される。この検出は、ポンプによって提供される真空レベルを増大させる、真空レベルを減少させる、ポンプを停止させる、ポンプ速度を変化させる、ポンプのリズムを変化させるなど、真空ポンプの一つ以上の設定変更することによって向上させることができる。ある実施形態では、ポンプが作動するとき、それは、流体流路を介して伝搬される圧力パルスまたは信号を生成する。圧力信号は、ある実施形態に係る図4の圧力曲線402に示される。領域404に示されるように、流体流路内の圧力は、システムの通常動作中、(例えばユーザーによって選択されるような)特定の圧力設定値または設定点408の周りで変化あるいは振動する。領域406は、例えばキャニスター(またはドレッシング)が満杯になりかつ/またはキャニスターフィルターが遮られるかまたは閉塞するなど、負圧源の遠位に閉塞がある場合の流路内の圧力パルスを示している。図示されるように、遠位閉塞によって、キャニスター(またはドレッシング)の上流に低減体積が見られるようになり、そして圧力パルスの振幅が増大する。圧力信号の周波数は、ある実施形態では、低下または減少させられる。特定の実施形態では、圧力パルス信号の大きさ(または周波数)のこの変化または「バウンス」は、PWMパラメーターを調整するなど、ポンプ速度を変化させ、ポンプのリズムを変化させることによって拡大または増強することができる。ポンプ動作のそうした調整は必要とされないが短い時間にわたって実施することができ、そして変化は、システムの動作が比較的影響を受けないままであるように小さくすることができる。ある実施形態では、キャニスターフィルターは、空気の流れが許容されている間は液体の流れが実質的に遮断されるように疎水性であってもよい。流量検出のさらなる詳細は、その全体がこの引用によって組み込まれる米国特許出願公開第2012/0078539号に開示されている。
本明細書中に提供しかつ/または図面に示された大きさ、周波数、閾値、制限、持続時間の値は絶対的なものではなく、おおよそのものである。さらに、本明細書中に提供しかつ/または図面に示された大きさ、周波数、閾値、制限、持続時間は、自動的にまたはユーザーによって固定または変化させることができる。さらに、本明細書中に提供しかつ/または図面に示された大きさ、周波数、閾値、制限、持続時間の値は例示であり、実施形態に応じて変更させることができる。例えば、表(表1〜5)に提供された値は、キャニスター(またはドレッシング)体積、センサーレンジなどに依存して変動し得る。本明細書で使用するように、基準値に関して、上回る、大きい、小さいなどの相対的な用語は基準値に等しいことをも包含するものである。例えば、正である基準値を超えることは、基準値と等しいかそれよりも大きいことを包含し得る。さらに、本明細書で使用するように、基準値に関して、上回る、大きい、小さいなどの相対的な用語は、基準値に関して、下回る、小さい、大きいといった開示された関係の逆をも包含するものである。
110 創傷キャビティ
120 創傷カバー
130 創傷充填材
140 チューブ
150 ポンプアセンブリ
200 キャニスター
202,204 視覚的インジケータ
206 ディスプレイ
208 リセス
210 把持部
212,212a〜c ボタン
214 把持部
216 窓
218 チューブチャネル
220 キャニスター
221 キャニスターラッチ
222 ラッチリセス
224 空気アウトレット
226 ストラップマウント
230 ポンプアセンブリ
232 スピーカポート
234 アクセスドア
236 把持部
238 カバー
239 電源ジャック
242 把持部
244 脚
246 チューブマウントリリーフ
248 キックスタンド
249 孔
252 キャニスターコネクター
253 シールリング
256 アクセスドア
260 制御プリント回路基板(PCB)
266 真空ポンプ
268 電源
270 スピーカー
272 パイプ
276 アンテナ
278 流量制限器
280,282,284 圧力センサー
286,288 ルーメン
289 コネクター
300A,B 流体流路
310 創傷キャビティ
320 キャニスター
320,330 圧力センサー
340 負圧源
Claims (12)
- 負圧創傷治療装置であって、
創傷の上に配置されるよう構成された創傷ドレッシングと流体連通状態であるよう構成された負圧源であって、創傷へ負圧を提供するよう構成された負圧源と、
前記創傷ドレッシングおよび前記負圧源と流体連通状態であるよう構成されたキャニスターであって、創傷から吸引された液を収集するよう構成されたキャニスターと、
前記負圧源によって生成される圧力信号の一つ以上の特性をモニターするよう構成された圧力センサーであって、前記圧力信号の前記一つ以上の特性は前記圧力信号の大きさを含み、前記圧力信号の大きさは前記キャニスター内の滲出液のレベルが増大するにつれて増大する圧力センサーと、
コントローラーであって、
前記負圧源に関する圧力設定値に基づいて一つ以上の圧力閾値を決定し、かつ、
前記圧力信号の大きさが前記圧力閾値を満たすことの特定に応答して前記キャニスターが滲出液で満杯であることを示すよう構成されたコントローラーと、
を具備する負圧創傷治療装置において、
前記圧力センサーは、複数のサンプル期間から前記圧力信号の一つ以上の特性を特定するよう構成され、かつ、前記コントローラーは、前記複数のサンプル期間にわたって前記圧力信号の大きさが前記圧力閾値を満たすことの特定に応答して前記キャニスターが滲出液で満杯であることを示すよう構成され、
前記コントローラーは、(i)前記負圧源の活性レベルが流体流路内に漏れが存在することを示すこと、あるいは(ii)キャニスター圧力が前記流体流路内の低真空状態を示すことの特定に応答して、キャニスター満杯検出を中断あるいは終了するよう構成される、負圧創傷治療装置。 - 前記コントローラーは、前記負圧源の活性レベルにさらに基づいて、前記圧力閾値を決定するよう構成される、請求項1に記載の装置。
- 前記負圧源は真空ポンプを備え、かつ、前記活性レベルは前記真空ポンプの回転速度に対応する、請求項2に記載の装置。
- 前記回転速度を測定するよう構成されたタコメーターをさらに備える、請求項3に記載の装置。
- 前記コントローラーは、前記創傷ドレッシング、前記キャニスターおよび前記負圧源に流体的につながるよう構成された前記流体流路における流体の漏れレートを前記負圧源の活性レベルに基づいて特定し、前記漏れレートにさらに基づいて前記圧力閾値を決定するよう構成される、請求項1〜4のいずれか1項に記載の装置。
- 前記コントローラーは、
前記創傷ドレッシング、前記キャニスターおよび前記負圧源に流体的につながるよう構成された前記流体流路における流体の漏れレートを前記負圧源の活性レベルに基づいて特定し、
前記漏れレートおよび前記圧力信号の一つ以上の特性に基づいて前記キャニスター内の滲出液のレベルを特定するよう構成される、請求項1〜4のいずれか1項に記載の装置。 - 測定された前記一つ以上の特性は圧力パルスの大きさおよび周波数を含み、かつ、前記コントローラーは、前記圧力信号の大きさおよび周波数に、少なくとも部分的に基づいて、前記キャニスター内の滲出液のレベルを特定するよう構成され、前記圧力信号の大きさは前記キャニスター内の滲出液のレベルが増大するにつれて増大し、かつ、前記圧力信号の前記周波数は前記キャニスター内の滲出液のレベルが増大するにつれて減少する、請求項1〜6のいずれか1項に記載の装置。
- 前記圧力センサーは、前記負圧源のインレットにおいて、前記圧力信号の前記一つ以上の特性をモニターするよう構成される、請求項1〜7のいずれか1項に記載の装置。
- 負圧創傷治療装置の作動方法であって、
負圧源を創傷ドレッシングおよびキャニスターと流体的に接続するよう構成された流体流路内で前記負圧源によって生成される圧力信号を圧力センサーがモニターするステップであって、前記圧力信号の一つ以上の特性は前記圧力信号の大きさを含み、前記圧力信号の大きさは前記キャニスター内の滲出液のレベルが増大するにつれて増大するステップと、
前記負圧源に関する圧力設定値に基づいて一つ以上の圧力閾値をコントローラーが決定するステップと、
前記圧力信号の大きさが前記圧力閾値を満たすことの特定に応答して前記キャニスターが滲出液で満杯であることを前記コントローラーが示すステップと
を備える作動方法において、
前記圧力センサーは、複数のサンプル期間から前記圧力信号の一つ以上の特性を特定するよう構成され、かつ、前記コントローラーは、前記複数のサンプル期間にわたって前記圧力信号の大きさが前記圧力閾値を満たすことの特定に応答して前記キャニスターが滲出液で満杯であることを示すよう構成され、
前記コントローラーは、(i)前記負圧源の活性レベルが前記流体流路内に漏れが存在することを示すこと、あるいは(ii)キャニスター圧力が前記流体流路内の低真空状態を示すことの特定に応答して、キャニスター満杯検出を中断あるいは終了するよう構成される、作動方法。 - 前記圧力閾値を特定するステップは、前記負圧源の活性レベルにさらに基づいて、前記圧力閾値を決定することを含む、請求項9に記載の作動方法。
- タコメーターが前記負圧源の真空ポンプの回転速度を測定するステップをさらに備え、前記活性レベルは前記回転速度に対応し、前記モニターするステップは、前記負圧源のインレットにおいて、前記圧力信号の前記一つ以上の特性をモニターすることを含む、請求項10に記載の作動方法。
- 前記流体流路における流体の漏れレートを少なくとも前記負圧源の活性レベルに基づいて前記コントローラーが特定するステップと、
少なくとも前記漏れレートおよび前記圧力信号の一つ以上の特性に基づいて前記キャニスター内の滲出液のレベルを前記コントローラーが特定するステップと、をさらに備え、
前記圧力閾値を決定するステップは、前記漏れレートにさらに基づいて前記圧力閾値を決定することを含む、請求項9〜11のいずれか1項に記載の作動方法。
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CA2920850A1 (en) | 2015-02-19 |
RU2016108629A (ru) | 2017-09-19 |
CN105916530B (zh) | 2019-09-17 |
CA2920850C (en) | 2022-08-30 |
EP3033119B1 (en) | 2023-10-11 |
AU2014306876A1 (en) | 2016-03-03 |
US20210252208A1 (en) | 2021-08-19 |
US10912870B2 (en) | 2021-02-09 |
RU2016108629A3 (ja) | 2018-04-25 |
US10155070B2 (en) | 2018-12-18 |
JP7171640B2 (ja) | 2022-11-15 |
JP2020108804A (ja) | 2020-07-16 |
ZA201600832B (en) | 2017-03-29 |
WO2015023515A1 (en) | 2015-02-19 |
CN105916530A (zh) | 2016-08-31 |
BR112016002906A2 (pt) | 2017-08-01 |
EP3033119A1 (en) | 2016-06-22 |
AU2014306876B2 (en) | 2019-05-02 |
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