JP4143265B2 - 加熱および冷却するための設備が設けられた真空補助閉鎖システム - Google Patents
加熱および冷却するための設備が設けられた真空補助閉鎖システム Download PDFInfo
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Description
(関連出願)
本願は、1999年4月2日に米国特許庁の出願された「加熱および冷却するための設備が設けられた真空補助閉鎖システム」を発明の名称とする米国仮特許出願第60/127,596号に対する優先権を主張するものである。本書では、この米国仮特許出願第60/127,596号の図面を含む全開示内容をレファレンスとして援用する。
【0002】
(技術分野)
本発明は、創傷部の治療に関し、より詳細には、本発明は創傷部の治癒を促進するために炎症系の代謝機能を加速または抑制するのに、局部的な加熱または冷却を使用する、創傷部の真空補助閉鎖体に関する。
【0003】
(背景技術)
創傷部を閉鎖するには、創傷に隣接する上皮および皮下組織の内部への移動が必要である。この移動は、血流が増加し、種々のタイプの機能細胞が活性化するように、炎症プロセスを通って通常促進される。炎症プロセスを通って、損創傷を受けたかまたは破壊された血管を通過する血流は毛細管レベルの詰まりによって停止し、その後、クリーンアップおよび再生動作を開始できる。不幸なことに、このプロセスは創傷部が大きかったり、または感染した場合には阻害される。かかる創傷部では創傷部の表面の近くにうっ血ゾーン(すなわち組織の局部的な腫れが組織への血流を制限する領域)が生じる。
【0004】
十分な血流がない場合、創傷部を囲む上皮および皮下組織は、受ける酸素および栄養分の量が少なくなるだけでなく、バクテリア感染と戦うことができる能力が低下し、よって自然に創傷部を閉じる能力も低下する。最近まで治癒が困難なかかる創傷部は縫合糸またはステープルを使用してしか治療されていなかった。かかる機械的な閉鎖技術はまだ広く実施されており、有効であることが多いが、これら閉鎖技術は創傷部に隣接する皮膚組織に引っ張りを生じさせるという主な欠点を有する。特に縫合糸またはステープルを使用して閉鎖を実行するのに必要な引っ張り力によって、縫合糸またはステープルの挿入点に極めて高い局所的な応力が生じる。これら応力は一般に挿入点で組織の破断を生じさせ、これによって最終的に創傷部の裂開を生じさせたり、更に組織の喪失を生じさせ得る。
【0005】
更に、感染によってステープリングまたは縫合による閉鎖を不能する程度に硬化したり、炎症が生じるような創傷もある。縫合またはステープリングによって修復できない創傷部は、一般に長期の入院が必要であり、付き添い人の高いコストと、大きな手術、例えば周辺組織の移植が必要となる。例えばステープルまたは縫合により容易に治療できない創傷の例として、大きい創傷、深い創傷、開いた創傷;床擦れ潰瘍、慢性骨髄炎から生じる潰瘍および後に全深度熱傷に至るような部分深度熱傷がある。
【0006】
機械的閉鎖装置のこれらおよびそれ以外の欠点の結果として、連続的な負圧を加えることにより、創傷部で排出を行うための方法および装置がこれまで開発されている。かかる負圧を創傷部の十分な面積に加えると、かかる負圧は上皮および皮下組織の創傷部に向かう移動を促進することが判っている。実際に創傷部に負圧を加える方法(一般に真空補助閉鎖(V.A.C.(登録商標))治療と称される方法)は、一般に過剰な体液を同時に除去することによる創傷部の機械的な収縮を行っている。このように、V.A.C.(登録商標)治療は公知の本来の副次的効果の多く、例えば適正な静脈還流がない場合の浮腫の発生を軽減しながら、体の自然な炎症プロセスを高める。
【0007】
このV.A.C.(登録商標)治療は創傷部の閉鎖の促進に大いに効果があるが、多くの創傷部の治療はこれまで治療できないと考えられており、ある問題も残っている。個々の患者には炎症プロセスは極めて固有なものであるので、V.A.C.(登録商標)治療を加えても、特に梗塞、初期のクリーンアップおよび再生ステージ中にある創傷部を適当に治療するための急速な十分な応答は得られない。従って、本発明の主な目的は、炎症応答を制御することにより、公知のV.A.C.(登録商標)治療を改善する方法および装置を提供することにある。
【0008】
更に再び、患者間のばらつきに少なくとも部分的に起因し、正しく開始した炎症応答が過度に大きくなり、この結果、浮腫および痛みが生じることがあり得る。従って、本発明の別の主な目的は、炎症応答を制御しながら抑制することにより、公知のV.A.C.(登録商標)治療法を改善するような方法および装置を提供することにある。
【0009】
本発明によれば、創傷部に於ける炎症応答を調節及び/又は遅延させることにより患者の創傷を治癒するための装置であって、創傷箇所に挿入する発泡パッド、該パッドに液流通できるよう接続され体液排出を促進するための真空源、及び創傷滅菌布を備えたものに於いて、
内部に加熱又は冷却媒体を循環させる手段を備えた加熱及び冷却パッドが前記発泡パッドを覆うように更に配設され、且つ、前記創傷滅菌布は創傷箇所に於いて前記発泡パッドと加熱及び冷却パッドとを気密に囲うように配設されることを特徴とする装置が提供される。
【0010】
上記装置によれば、炎症応答の一部として局部的代謝機能を制御するためにこれまで公知のVAC治療に加熱及び冷却設備が加えられる。
その他の通常のVAC治療と組み合わせた局部的加熱を行うことにより、急速な毛細管の詰まりおよびクリーンアップおよび再生ステージの早期の開始が発生するように、炎症応答全体を相乗的に加速することができる。
同様に、炎症応答が過度に活性化されたと付き添っている臨床医が判断した場合、浮腫の管理およびその他の方法で提供されるVAC治療の他の特徴を犠牲にすることなく、身体の炎症応答を抑制するように、VAC治療と組み合わせて局部的冷却を行うことができる。
【0011】
本発明の好ましい実施例では、加熱および冷却パッドは可撓性の呼吸可能な水の層を含み、この層は一般に高周波溶接可能な材料から構成された2枚のシートを含む。パッドのうちの2枚のシートは複数のチャンネルの間に複数の開口部が形成されたワッフル状パターンにRF溶接されている。これら開口部は患者の皮膚からの水分の蒸散を可能にし、一方、チャンネルはパッドを加熱または冷却するために、このパッドを通して必要とされるように、暖かい、または低温の水を給水チューブおよび排水チューブを通して循環できるようにしている。
【0012】
本発明の加熱中に加熱および冷却パッドを創傷滅菌布の内外に置くことができるが、本発明の冷却中には、創傷滅菌布の内部に加熱および冷却パッドを設置することが重要である。このように布の接着剤を緩めたり、最終的に創傷場所において真空状態を創出させ得る、布の内部およびエッジの近くにおける凝縮物の形成を最小にできる。特に創傷滅菌布の内部に加熱および冷却パッドを設置すると、V.A.C.(登録商標)治療の吸引特性によって最小にされている、創傷場所の閉じ込め部内に生じている水分レベルまで周辺水分量が制限される。
【0013】
本発明の冷却特性はこのように実施すべきであり、V.A.C.(登録商標)治療を開始した後、臨床医は任意の時間に冷却が必要であることを示すことができるので、本発明の好ましい方法は、最初に加熱が指示されているか、または冷却が指示されているかに拘わらず、発泡パッドおよび創傷パッドの近くにて、創傷滅菌布の下方に加熱および冷却パッドを設置することを含む。パッドを設置すると、創傷滅菌布は給水チューブおよび排水チューブのまわりに強固に付着し、真空の漏れを防止する。
【0014】
最後に、これまでの説明、次の図面および詳細な説明、特許請求の範囲を特に参照すれば、当業者には本発明の上記以外の特徴、目的および利点が明らかとなろう。
【0015】
本発明の範囲は特定の実施例よりも広いが、図解のための図面と共に、以下、好ましい実施例について詳細に説明する。図中、同様な参照番号は同様な部品を示す。
【0016】
(発明を実施するための最良の態様)
当業者であれば、本明細書に示した図を特に参照すれば、多数の別の実施例について容易に認識できようが、この詳細な説明は本発明の好ましい実施例、すなわち特許請求の範囲によってのみ範囲が限定される、加熱および冷却するための設備が設けられた真空補助閉鎖システムを説明するものである。
【0017】
次に、図面を参照すると、ここには実質的に創傷場所12に挿入するための発泡パッド11と、創傷場所12において発泡パッド11の密閉体をシールするための創傷用減菌布13とを含む、本発明10が示されている。本発明によれば、発泡パッドは体液の排出を促進するよう、真空源と流体連通するように設置され、身体の炎症応答の代謝機能部分をそれぞれ制御しながら加速または抑制するための加熱および冷却パッドを通過するように、暖かい流体または低温流体が循環される。
【0018】
本発明の好ましい実施例によれば、発泡パッド11、創傷用減菌布13および真空源は公知技術で知られているように実現されており、これらの各々は1995年8月22日に出願された米国特許出願第08/517,901号に詳細に説明されている。本明細書では、米国特許出願第08/517,901号の完全な開示内容は本明細書に記載されているが、特許請求の範囲および図面を含むこの特許出願の完全な開示内容をレファレンスとして援用する。更に、かかるV.A.C.(登録商標)システムは米国テキサス州サンアントニオのカイネティックコンセプツ社および/またはその子会社を通して容易に入手できるものである。
【0019】
上記米国特許出願第08/517,901号に詳細に説明されているように、発泡パッド11は吸引時に、創傷部の体液を良好に透過できる、高度に微細な連続気泡ポリウレタンまたはポリエーテル製発泡体を含むことが好ましい。また、米国特許出願第08/517,901号に詳細に記載されているように、発泡パッド11はプラスチックまたは同様な材料のホース15を介して真空源に流体連通するように設けられていることが好ましく、真空減は介在された疎水性膜フィルタを介し、真空ポンプと流体連通することにより、安全に真空状態に置かれたキャニスターを含むことが好ましい。最後に、米国特許出願第08/517,901号は、創傷用減菌布13についても詳細に述べており、この創傷用減菌布14は創傷場所12上にシール張り付けするための感圧性アクリル接着剤によって少なくとも周辺がカバーされたエラストマー材料を含むことが好ましい。
【0020】
本発明の好ましい方法によれば、米国特許出願第08/517,901号に記載されているような部品を、公知技術で知られているように一般に使用するが、炎症応答の一部としての局部的代謝機能を制御するのに、本発明の加熱および冷却設備が常設されている点が異なっている。その他の通常のV.A.C.(登録商標)治療と組み合わせた局部的加熱を行うことにより、急速な毛細管の詰まりおよびクリーンアップおよび再生ステージの早期の開始が発生するように、炎症応答全体を相乗的に加速することができる。同様に、炎症応答が過度に活性化されたと付き添っている臨床医が判断した場合、浮腫の管理およびその他の方法で提供されるV.A.C.(登録商標)治療の他の特徴を犠牲にすることなく、身体の炎症応答を抑制するように、V.A.C.(登録商標)治療と組み合わせて局部的冷却を行うことができる。
【0021】
本発明の好ましい実施例では、加熱および冷却パッド13は可撓性の呼吸可能な水の層16を含み、この層は一般に高周波溶接可能な材料から構成された2枚のシート17、18を含む。パッドのうちの2枚のシート17、18は、複数のチャンネル20の間に複数の開口部19が形成されたワッフル状パターンにRF溶接されている。これら開口部19は患者の皮膚21からの水分の蒸散を可能にし、一方、チャンネル20はパッド13を加熱または冷却するために、このパッド13を通して必要とされるように、暖かい、または低温の水を給水チューブ22および排水チューブ23を通して循環できるようにしている。
【0022】
本発明の加熱中に加熱および冷却パッド13を創傷滅菌布の内外に置くことができるが、本発明の冷却中には、創傷滅菌布14の内部に加熱および冷却パッド13を設置することが重要である。このように布の接着剤を緩めたり、最終的に創傷場所12において真空状態を創出させ得る、布14の内部およびエッジの近くにおける凝縮物の形成を最小にできる。特に創傷滅菌布14の内部に加熱および冷却パッド13を設置すると、V.A.C.(登録商標)治療の吸引特性によって最小にされている、創傷場所12の閉じ込め部内に生じている水分レベルまで周辺水分量が制限される。
【0023】
本発明の冷却特性はこのように実施すべきであり、V.A.C.(登録商標)治療を開始した後、臨床医は任意の時間に冷却が必要であることを示すことができるので、本発明の好ましい方法は、最初に加熱が指示されているか、または冷却が指示されているかに拘わらず、発泡パッド11および創傷パッド12の近くにて、創傷滅菌布14の下方に加熱および冷却パッド13を設置することを含む。パッド13を設置すると、創傷滅菌布14は給水チューブ22および排水チューブ23のまわりに強固に付着し、真空の漏れを防止する。
【0024】
これまでの説明は本発明の好ましい実施例を示すものであるが、当業者であれば、この説明、添付図面および添付されている特許請求の範囲を特に参照すれば、容易に可能である多くの変形例、変更例、改善例、置換例を思い付くことができよう。例えば当業者であれば、加熱および冷却パッド13を広範な種々の形状、寸法および内部構造で製造できることを認識できよう。かかる別の実施例では加熱および冷却パッド13を創傷滅菌布14の多層状変形布内に一体化してもよい。いずれの場合においても、本発明の範囲は特定の実施例よりも広いので、これまでの詳細な説明は、特許請求の範囲のみによって限定される発明の範囲を限定するものであると見なしてはならない。
【0025】
(産業上の利用性)
本発明は創傷の治療技術に適用できる。
【図面の簡単な説明】
【図1】 哺乳類の創傷場所に使用される、本発明の好ましい実施例の一部切り欠き斜視図である。
【図2】 図1の本発明の加熱および冷却パッドの閉横断面図である。
Claims (4)
- 創傷部に於ける炎症応答を調節及び/又は遅延させることにより患者の創傷を治癒するための装置であって、創傷箇所に挿入する発泡パッド、該パッドに液流通できるよう接続され体液排出を促進するための真空源、及び創傷滅菌布を備えたものに於いて、
内部に加熱又は冷却媒体を循環させる手段を備えた加熱及び冷却パッドが前記発泡パッドを覆うように更に配設され、且つ、前記創傷滅菌布は創傷箇所に於いて前記発泡パッドと加熱及び冷却パッドとを気密に囲うように配設されることを特徴とする装置。 - 前記加熱及び冷却パッドが互に連結する一対の可撓性材料シートで形成されたフレキシブルで呼吸可能な水の層からなる請求項1記載の装置。
- 前記一対のシートが高周波溶接により連結された請求項2記載の装置。
- 前記一対のシートが複数のチャンネルの間に複数の開口部が形成されたワッフル状パターンに連結され、患者の皮膚からの水分の蒸散を可能にする一方温又は冷媒が該パッドのチャンネル内を隈無く循環できるように構成されている請求項2又は3記載の装置。
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PCT/US2000/008759 WO2000059418A1 (en) | 1999-04-02 | 2000-03-31 | Vacuum assisted closure system with heating and cooling provision |
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