JP2020036914A - 減圧療法を施すためのシステムおよび方法 - Google Patents
減圧療法を施すためのシステムおよび方法 Download PDFInfo
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Abstract
Description
本出願は、参照によりその全体が本明細書に組み込まれている、2014年7月31日に出願した米国仮出願第62/031,704号の利益を主張するものである。
本明細書で開示されている実施形態は、減圧で創傷を治療するシステムおよび方法に関係する。本明細書で使用されているように、-XmmHgなどの減圧または陰圧レベルは、通常の環境大気圧に関する圧力レベルを表し、760mmHg(または1atm、29.93in Hg、101.325kPa、14.696psiなど)に対応し得る。したがって、-XmmHgの陰圧値は、760mmHgよりXmmHg低い絶対圧力、言い換えると、(760-X)mmHgの絶対圧力を反映する。それに加えて、XmmHgより「少ない」または「小さい」陰圧は、大気圧に近い圧力に対応する(たとえば、-40mmHgは-60mmHgより少ない)。-XmmHgより「多い」または「大きい」陰圧は、大気圧から遠い圧力に対応する(たとえば、-80mmHgは-60mmHgより多い)。いくつかの実施形態において、局所環境大気圧は、基準点として使用され、そのような局所大気圧は、必ずしも、たとえば、760mmHgでなくてもよい。
図1は、創傷被覆120によって封止される創腔110内に留置された創傷充填材130を備える陰圧または減圧創傷治療(またはTNP)システム100の一実施形態を示している。創傷充填材130は、創傷被覆120と組み合わせて、創傷被覆材と称され得る。単一または多重内腔管または導管140は、減圧を供給するように構成されているポンプアセンブリ150により創傷被覆120に接続される。創傷被覆120は、創腔110と流体的に連通することができる。本明細書で開示されているシステム実施形態において、図1に示されている実施形態と同様に、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よい(つまり、浸出液が創傷被覆材内に回収されるか、または別の場所に回収のため管140を介して移送される)。しかし、本明細書で開示されているポンプアセンブリ実施形態はどれも、キャニスターを備えるか、または支持するように構成され得る。それに加えて、本明細書で開示されているシステム実施形態では、ポンプアセンブリ実施形態はどれも、被覆材によって、または被覆材に隣接して装着されるか、または支持され得る。創傷充填材130は、親水性または疎水性発泡体、ガーゼ、膨張袋、などの好適なタイプのものであってよい。創傷充填材130は、実質的に空洞を充填するように創腔110に形状適合可能であるものとしてよい。創傷被覆120は、創腔110の上に実質的に流体不浸透性のシールを設けることができる。創傷被覆120は、頂部側と底部側とを有するものとしてよく、底部側は創腔110と接着剤で(または他の好適な手段で)シールを形成する。導管140もしくは内腔または本明細書で開示されている他の導管もしくは内腔は、ポリウレタン、PVC、ナイロン、ポリエチレン、シリコーン、または他の好適な材料から形成され得る。
図2Aは、いくつかの実施形態によ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を示す。図示されているように、ポンプアセンブリ230とキャニスターとは接続されて、それにより、デバイスを形成する。ポンプアセンブリ230は、アラームを指示するように構成された視覚的インジケータ202およびTNPシステムのステータスを指示するように構成された視覚的インジケータ204などの、1つまたは複数のインジケータを備える。インジケータ202および204は、システムの様々な動作および/または故障状態を、患者もしくは医療従事者などの、使用者に警告するように構成されるものとしてよく、これは通常または適切な動作状態、ポンプ故障、ポンプに供給される電力、または停電を使用者に警告すること、創傷被覆または流路内の漏出、吸引閉塞、または他の類似のもしくは適当な状態もしくはこれらの組合せの検出を含む。ポンプアセンブリ230は、追加のインジケータを備えることができる。ポンプアセンブリは、単一のインジケータまたは複数のインジケータを使用することができる。視覚的、聴覚的、触覚的なインジケータなどの好適なインジケータが使用され得る。インジケータ202は、キャニスターフル、電力低下、導管140の切断、創傷シール120内でシールが破れていることなどのアラーム状態を信号で伝達するように構成され得る。インジケータ202は、赤色の点滅光を表示して使用者の注意を引くように構成され得る。インジケータ204は、療法送達がokである、漏出が検出されたなどのTNPシステムのステータスを信号で伝達するように構成され得る。インジケータ204は、緑色、黄色などの1つまたは複数の異なる色の光を表示するように構成され得る。たとえば、緑色の光は、TNPシステムが適切に動作しているときに発光し、黄色の光は、警告を指示するために発光するものとしてよい。
図3は、いくつかの実施形態による、ポンプアセンブリ230などの、ポンプアセンブリの電気部品概略図300である。電気部品は、ユーザ入力を受け入れ、出力を使用者に送り、ポンプアセンブリおよびTNPシステムを操作し、ネットワーク接続を提供するなどを行うように動作し得る。電気部品は、1つまたは複数のプリント基板(PCB)上に実装され得る。図示されているように、ポンプアセンブリは、複数のプロセッサを備え得る。複数のプロセッサを利用して様々なタスクを異なるプロセッサに割り振るか、または割り当てると都合がよい場合がある。第1のプロセッサは、ユーザ活動に関与し、第2のプロセッサは、ポンプを制御することに関与し得る。このようにして、より高いレベルの反応性(より高いリスクレベルに対応する)を必要とし得る、ポンプを制御する活動は、専用プロセッサにオフロードされ、それによって、ユーザとのインタラクティブなやり取りがあることで完了に時間がかかる可能性のある、ユーザインターフェースタスクによって中断されなくなる。
いくつかの実施形態において、ポンプアセンブリ230は、画面206上に表示されているタッチスクリーンインターフェースを使用して操作することができる。様々なグラフィカルユーザインターフェース(GUI)画面に、とりわけ、システムの設定および動作に関する情報が提示される。タッチスクリーンインターフェースは、指(またはスタイラスもしくは別の好適なデバイス)で作動もしくは操作され得る。タッチスクリーンをタップすることで選択を行うことができる。スクロールさせるには、ユーザは画面にタッチし、タッチしたままドラッグすると、選択を見ることができる。スクロールするための複数の指によるスワイプ、ズームするための複数の指によるピンチ、および同様の操作などの、タッチスクリーンインターフェースを操作する追加の、または代替的な手段も実装され得る。
いくつかの実施形態において、キャニスター220などの、キャニスターは、十分に高い真空圧力の印加の下で変形し得るプラスチックまたは別の種類の材料から作られる。そのような変形は、キャニスターの容量を減らし、破損および不具合のリスクをもたらし得るので望ましくないと思われる。プラスチック材料は、安価である、軽量である、製造しやすい、および同様のことなどの、多数の利点を備えるが、十分な真空圧力がポンプアセンブリ230によって創傷に印加されるときに材料の変形に対処することは有益である。
いくつかの実施形態において、ポンプアセンブリは、選択されたまたはプログラムされたプロトコルに従って陰圧療法を創傷に送達するように真空ポンプを制御する。ポンプ制御は、ポンプ制御プロセッサ370単独で、またはプロセッサ310と組み合わせて実行され得る。たとえば、上で説明されているように、使用者は、所望の圧力(または陰圧設定点)での連続運転を選択することができる。ポンプアセンブリは、真空ポンプを作動させて、創傷のところの(たとえば、被覆材の下の)圧力を設定点に到達するように低減するか、またはドローダウンさせることができる。以下で説明されているように、ドローダウンは、設定点に達するまで、圧縮と呼ばれる単位時間当たりの陰圧の最大変化によって制限される創傷のところの陰圧を増加させることによって実行され得る。創傷ドローダウン(wound drawdown)は、療法が開始された直後の、創傷がまだ設定点に達していない、期間として定義できる。以下で説明されているように、この期間の終わりに、設定点に達したときに、流体流路内の流量は、漏れ(または高流量)閾値よりも低く、低真空閾値よりも高い値であるべきであり、そうでなければ、適切なアラームが作動される。
ポンプアセンブリなどの、TNPまたは減圧療法システムの提供者または製造業者は、ポンプアセンブリの所有または使用について代金を請求したい場合がある。しかしながら、ポンプアセンブリの所有または使用に対する課金のプロセスは、提供者はポンプアセンブリの管理および販売をコントロールできないので、提供者にとって管理することが困難な場合がある。提供者は、ポンプアセンブリの所有または使用を正確に追跡するために、病院職員などの、他の当事者に依存し得る。他の当事者は、残念なことに、ときには、ポンプアセンブリの所有または使用を正確に追跡しない場合があり、したがって、提供者は、ポンプアセンブリの使用に対して課金し、その後請求するときに他の当事者からの誤ったまたは不完全な情報に頼る可能性がある。この状況は、ポンプアセンブリの使用に対する請求額が多すぎたり、少なすぎたりするリスクをもたらし得る。したがって、開示されているシステムおよび方法は、ポンプアセンブリの提供者が、ポンプアセンブリの所有または使用について課金するためにポンプアセンブリを正確に監視し、追跡するのを支援することができる。
本明細書で提示されている閾値、制限、持続時間などの値は、絶対的であることを意図されておらず、したがって、近似的であってよい。それに加えて、本明細書で提示されている閾値、制限、持続時間などは、自動的に、またはユーザによって、のいずれかで、固定されるか、または可変であるものとしてよい。さらに、本明細書で使用されているように、基準値に関して、超える、より大きい、より小さいなどの相対的な用語は、基準値に等しいことも包含することを意図されている。たとえば、正である基準値を超えることは、基準値以上であることを包含し得る。それに加えて、本明細書で使用されているように、基準値に関して、超える、より大きい、より小さいなどの相対的な用語は、基準値に関して、より下、より小さい、より大きいなどの、開示されている関係の逆も包含することを意図されている。
110 創腔
120 創傷被覆
130 創傷充填材
140 単一または多重内腔管または導管
150 ポンプアセンブリ
202 視覚的インジケータ
204 視覚的インジケータ
206 ディスプレイまたは画面
208 陥凹部
210 把持部分
212 キーもしくはボタン
212a、212b、212c ボタン
214 把持部分
216 窓
218 配管流路
220 キャニスター
221 キャニスターラッチ
222 ラッチ陥凹部
224 空気出口
226 ストラップ装着具
230 ポンプアセンブリ
230 装置
232 スピーカーポート
234 フィルターアクセスドア
236 把持部分
238 被覆
239 電源ジャック
242 把持部分
244 足部
246 チューブマウントリリーフ
248 キックスタンド
249 穴
252 入口
256 USBアクセスドア
310 コントローラ
310 プロセッサ
320 入出力(I/O)モジュール
330 通信プロセッサ
340 アンテナ
350 メモリモジュール
360 拡張モジュール
370 ポンプ制御プロセッサ
380 プロセッサ
390 陰圧ポンプ
410 コンピュータ
420 ポンプアセンブリ
422 ユーザインターフェースプロセッサファームウェアおよび/またはソフトウェア
424 ポンプ制御プロセッサファームウェアおよび/またはソフトウェア
426 通信プロセッサファームウェアおよび/またはソフトウェア
428 追加のプロセッサ(複数可)ファームウェアおよび/またはソフトウェア
430 クラウド
440 リモートコンピュータまたはサーバ
442 データ記憶装置モジュール
444 ウェブインターフェース
500A、500B 療法設定画面
500C、500D 療法送達画面
500E 設定画面
500F 圧縮設定画面
500G、500H 流量計画面
500I トラブルシューティング画面
502 ステータスバー
503 アイコン
510 メニュー
512、514、516、518、519 メニュー項目
522 陰圧アップコントロール
524 陰圧ダウンコントロール
526 ラベル
528 メッセージ
529 メッセージ
530 連続的/間欠的療法選択
532 コントロール
534 コントロール
535 Y字型コネクタ選択
536 コントロール
538 コントロール
540、545 間欠的療法設定
542、544、546、548 コントロール
551 ラベル
552 ラベル
553 メッセージ
554 タイマー
555、556 ラベル
560 ラベル、メニュー
561 スクロールバー
562 圧縮設定、メニュー項目
564 流量計、メニュー項目
572 低
574 中
576 高
580 ゲージ
581、582、583 マーキング
584 ダイアル
585 針
587 スクロールバー
588 メニュー
600A 閉塞アラーム画面
600B 過真空アラーム画面
600C 高真空アラーム画面
600D キャニスターフルアラーム画面
600E 低真空アラーム画面
600F 漏れアラーム画面
600G アラーム解決画面
601 インジケータ
602 ラベル
603 アイコン
604、605、606 ラベル
607、608 アイコン
700A、700B キャニスター
710 スティフナー
712 ベース要素
714 コンポーネント
716 穴
800 プロセス
902 圧力曲線
904、906 領域
908 圧力設定点
1000 システム
1010 配置監視ハブ
1020 リモートコンピュータ
Claims (37)
- 陰圧療法を創傷に施すための装置であって、
創傷被覆材と流体的に連通するように構成されている陰圧源を備えるハウジングであって、前記陰圧源は前記創傷から流体を吸引するように構成されているハウジングと、
前記創傷被覆材と前記陰圧源とを流体的に接続するように構成されている流体流路内の圧力を測定するように構成されている圧力センサーと、
前記陰圧源を操作するように構成されているコントローラであって、前記コントローラは、
前記圧力センサーから前記流体流路内の圧力の測定値を受信し、
前記流体流路内の流量を決定し、
陰圧創傷療法の開始後に、前記流体流路内の前記圧力および前記流体流路内の前記流量に少なくとも一部は基づき前記流体流路内の1つまたは複数の漏れの存在を検出し、
1つまたは複数の漏れの存在の指示を与えるようにさらに構成されているコントローラとを備える装置。 - 前記ハウジングは、電子ディスプレイをさらに備え、前記コントローラは、1つまたは複数の漏れの存在を検出したことに応答して前記流体流路内の前記流量のグラフィック表現をディスプレイに表示するようにさらに構成される請求項1に記載の装置。
- 前記流体流路内の前記流量の前記グラフィック表現は、ゲージを備える請求項2に記載の装置。
- 前記陰圧源は、モーターを有する真空ポンプを備え、前記コントローラは、前記モーターの速度を測定することによって前記流体流路内の前記流量を決定するように構成される請求項1から3のいずれか一項に記載の装置。
- 前記モーターの前記速度を測定するように構成されているタコメータをさらに備える請求項4に記載の装置。
- 前記コントローラは、第1の期間に第1の複数のモーター速度を測定し、前記第1の複数のモーター速度を平均するようにさらに構成され、前記平均は前記流量を示している請求項4から5のいずれか一項に記載の装置。
- 前記コントローラは、前記第1の期間と異なる第2の期間にわたって第2の複数のモーター速度を測定し、前記第2の複数のモーター速度を平均するようにさらに構成され、前記平均は前記流量を示している請求項6に記載の装置。
- 前記コントローラは、前記第1および第2の複数のモーター速度の前記平均を利用して、前記流体流路内の1つまたは複数の漏れの存在、前記流体流路内の1つまたは複数の閉塞の存在、前記流体流路内の低い陰圧、および前記流体流路内の高い陰圧のうちの少なくとも1つを決定するようにさらに構成される請求項7に記載の装置。
- 前記創傷から吸引された流体を回収するように構成されているキャニスターをさらに備える請求項1から8のいずれか一項に記載の装置。
- 前記コントローラは、前記流量が漏れを指示する流量閾値の条件を満たしていること、およびキャニスター圧力が低い陰圧を指示する圧力閾値の条件を満たさないことを決定したことに応答して、
前記流体流路内の圧力の特性の変化を検出するステップと、
前記検出された変化に少なくとも一部は基づき前記キャニスターがフル状態であることを検出するステップとによってキャニスターフル状態を検出するようにさらに構成される請求項9に記載の装置。 - 圧力の前記特性の前記変化は、圧力の振幅の複数の変化を含み、前記コントローラは、圧力の前記振幅の前記複数の変化のうちの少なくともいくつかを閾値と比較することによって前記キャニスターがフル状態であることを検出するように構成される請求項10に記載の装置。
- 陰圧創傷療法装置を操作する方法であって、
陰圧源と創傷被覆材とを流体的に接続するように構成されている流体流路内の圧力を測定するステップと、
前記流体流路内の流量を測定するステップと、
陰圧創傷療法の開始後に、前記流体流路内の前記圧力および前記流体流路内の前記流量に少なくとも一部は基づき前記流体流路内の1つまたは複数の漏れの存在を検出するステップと、
1つまたは複数の漏れの存在の指示を与えるステップとを含み、
前記方法は、前記陰圧創傷療法装置のコントローラによって実行される方法。 - 1つまたは複数の漏れの存在を検出したことに応答して前記流体流路内の前記流量のグラフィック表現をディスプレイに表示するステップをさらに含む請求項12に記載の方法。
- 前記流体流中の前記流量の前記グラフィック表現は、ゲージを備える請求項12に記載の方法。
- 前記流体流路内の流体の前記流量を測定するステップは、陰圧源を操作するモーターの速度を測定するステップを含む請求項12から14のいずれか一項に記載の方法。
- 第1の期間に第1の複数のモーター速度を測定するステップと、前記第1の複数のモーター速度を平均するステップとをさらに含み、前記平均は前記流量を示している請求項15に記載の方法。
- 前記第1の期間と異なる第2の期間にわたって第2の複数のモーター速度を測定するステップと、前記第2の複数のモーター速度を平均するステップとをさらに含み、前記平均は前記流量を示している請求項16に記載の方法。
- 前記第1および第2の複数のモーター速度の前記平均を利用して、前記流体流路内の1つまたは複数の漏れの存在、前記流体流路内の1つまたは複数の閉塞の存在、前記流体流路内の低い陰圧、および前記流体流路内の高い陰圧のうちの少なくとも1つを決定するステップをさらに含む請求項17に記載の方法。
- 前記流量が漏れを指示する流量閾値の条件を満たしていて、キャニスター圧力が低い陰圧を指示する圧力閾値の条件を満たさないと決定したことに応答して、キャニスターがフル状態であるかどうかを、
前記流体流路内の圧力の特性の変化を検出するステップと、
前記検出された変化に少なくとも一部は基づき前記キャニスターがフル状態であることを検出するステップとによって検出するステップをさらに含む請求項12から18のいずれか一項に記載の方法。 - 圧力の前記特性の前記変化は、圧力の振幅の複数の変化を含み、前記キャニスターがフル状態であることを検出するステップは、圧力の前記振幅の前記複数の変化のうちの少なくともいくつかを閾値と比較するステップを含む請求項19に記載の方法。
- 陰圧創傷療法で使用するためのキャニスターであって、
第1の壁および前記第1の壁に対向する第2の壁であって、創傷から吸引された創傷浸出液を回収するように構成されている内部容積を画成する第1および第2の壁と、
前記第1の壁に取り付けられ、前記第2の壁の方へ延在する補強要素であって、陰圧が前記キャニスターに印加されたときに前記第1の壁および第2の壁のうちの少なくとも一方がつぶれるのを防ぐ寸法を有する補強要素とを備えるキャニスター。 - 前記補強要素は、
前記第1の壁に取り付けられているベース要素と、
第1の要素に取り付けられている突起要素であって、前記ベース要素からほぼ垂直の角度で延在する突起要素とを備える請求項21に記載のキャニスター。 - 前記突起要素は、六角形の形状を有する請求項21から22のいずれか一項に記載のキャニスター。
- 前記突起要素は、少なくとも1つの穴を備える請求項21から23のいずれか一項に記載のキャニスター。
- 前記突起要素の少なくとも一部は、陰圧が前記キャニスターに印加されないときに前記第2の壁と接触するように構成される請求項21から24のいずれか一項に記載のキャニスター。
- 陰圧が前記キャニスターに印加されるときに、前記突起要素の少なくとも一部は、前記第2の壁と接触するように構成される請求項21から25のいずれか一項に記載のキャニスター。
- 前記第1および第2の壁は、プラスチック材料を備え、前記内部容積は、約800mLの流体を保持するように構成される請求項21から26のいずれか一項に記載のキャニスター。
- 請求項21から27のいずれか一項に記載の前記キャニスターと、前記キャニスターと流体的に連通するように構成されている陰圧源とを備える陰圧創傷療法装置。
- 陰圧療法を施すための装置であって、
複数の創傷被覆材と流体的に連通するように構成されている陰圧源であって、複数の創傷から流体を吸引するようにさらに構成されている陰圧源と、
前記複数の創傷から1つまたは複数の創傷からの流体を吸引するために前記陰圧源を操作するように構成されているコントローラとを備え、前記コントローラは、
陰圧創傷療法を単一の創傷、または前記複数の創傷からの少なくとも2つの創傷に施す要求を受信し、
前記要求に基づき、前記創傷または少なくとも2つの創傷から流体を吸引するように前記陰圧源を作動させ、
前記要求に基づき、前記陰圧源と前記創傷を、または前記陰圧源と前記少なくとも2つの創傷とを流体的に接続するように構成されている流体流路内の流量を決定し、
前記流量を、前記創傷から流体を吸引することに対応する第1の閉塞閾値または前記少なくとも2つの創傷から流体を吸引することに対応する第2の閉塞閾値と比較することによって前記流体流路内の閉塞を検出するようにさらに構成される装置。 - コントローラは、前記第1の閉塞閾値を修正することによって前記第2の閉塞閾値を決定するようにさらに構成される請求項29に記載の装置。
- 前記第1の閉塞閾値を修正することは、前記第1の閉塞閾値を増加させることを含む請求項29から30のいずれか一項に記載の装置。
- ユーザインターフェースをさらに備え、前記要求は、前記ユーザインターフェースから受信される請求項29から31のいずれか一項に記載の装置。
- 前記ユーザインターフェースは、タッチスクリーンディスプレイを含む請求項32に記載の装置。
- リモートコンピューティングデバイスとの通信を、前記装置が前記リモートコンピューティングデバイスのカバーエリア内にあるときに行い、前記リモートコンピューティングデバイスが前記装置が前記カバーエリア内にあるかどうかを決定することを可能にするように構成されている送信機をさらに備える請求項1または29に記載の装置。
- 前記送信機は、前記リモートコンピューティングデバイスと繰り返し通信して、前記装置が前記カバーエリアから外れたときの一度目と前記装置がカバーエリアに戻ったときの二度目とを前記リモートコンピューティングデバイスに決定させ、それによって、前記一度目と前記二度目との比較結果に少なくとも基づき前記装置が前記カバーエリアの外に置かれている持続時間を前記リモートコンピューティングデバイスに決定させるように構成される請求項34に記載の装置。
- 前記送信機は、実質的に一定の信号強度を使用して信号を送信し、前記リモートコンピューティングデバイスが前記送信機から受信した信号の信号強度に少なくとも基づき前記カバーエリアに関する前記装置の配置を前記リモートコンピューティングデバイスが決定することを可能にするように構成される請求項34から35のいずれか一項に記載の装置。
- 前記送信機は、前記装置が前記カバーエリアの外に位置するときに前記リモートコンピューティングデバイスが前記カバーエリア内の前記装置の存在を検出することを可能にしない信号を送信するように構成される請求項34から36のいずれか一項に記載の装置。
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CN106687154B (zh) | 2021-02-09 |
CN106687154A (zh) | 2017-05-17 |
EP3659638A1 (en) | 2020-06-03 |
US10744239B2 (en) | 2020-08-18 |
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