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JP5613566B2 - 創傷被覆材 - Google Patents

創傷被覆材 Download PDF

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Publication number
JP5613566B2
JP5613566B2 JP2010534549A JP2010534549A JP5613566B2 JP 5613566 B2 JP5613566 B2 JP 5613566B2 JP 2010534549 A JP2010534549 A JP 2010534549A JP 2010534549 A JP2010534549 A JP 2010534549A JP 5613566 B2 JP5613566 B2 JP 5613566B2
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layer
wound
wound dressing
absorbent
seal
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JP2011504391A (ja
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エドワード・イェーバリー・ハートウェル
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Smith and Nephew PLC
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Smith and Nephew PLC
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Priority claimed from GB0817040A external-priority patent/GB0817040D0/en
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    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/00051Accessories for dressings
    • A61F13/00063Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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    • A61F13/0206Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
    • A61F13/0209Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings comprising superabsorbent material
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/78Means for preventing overflow or contamination of the pumping systems
    • A61M1/784Means for preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91Suction aspects of the dressing
    • A61M1/915Constructional details of the pressure distribution manifold
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96Suction control thereof
    • A61M1/962Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96Suction control thereof
    • A61M1/964Suction control thereof having venting means on or near the dressing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98Containers specifically adapted for negative pressure wound therapy
    • A61M1/984Containers specifically adapted for negative pressure wound therapy portable on the body
    • A61M1/985Containers specifically adapted for negative pressure wound therapy portable on the body the dressing itself forming the collection container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01021Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A61F13/01029Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/01Non-adhesive bandages or dressings
    • A61F13/01034Non-adhesive bandages or dressings characterised by a property
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    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
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    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/88Draining devices having means for processing the drained fluid, e.g. an absorber
    • A61M1/882Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
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    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7527General characteristics of the apparatus with filters liquophilic, hydrophilic
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    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7536General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Otolaryngology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
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  • External Artificial Organs (AREA)

Description

本願発明は、創傷を被覆するための方法及び装置、並びに創傷被覆材を製造するための方法に関する。特に、制限されるわけではないが、本願発明は、局所的な陰圧(TNP)療法中に使用可能である創傷被覆材に関し、該局所的な陰圧(TNP)療法において、創傷被覆材自体が創傷部位から取り除かれた創傷滲出液を収集し、且つ貯蔵するように廃物容器として作用する。
局所的な陰圧療法の効果を高めるために意図された他の治療プロセスとともに、創傷への、局所的な陰圧(TNP)療法の適用のための装置及びその使用方法の提供に関連している利用可能な多くの先行技術が存在する。そのような先行技術の例は、記載されたそれらの装置及び方法を含み、該装置及び方法手短に言えば以下に記載される
局所的な陰圧療法は、組織浮腫を低減することによって、血流及び肉芽組織を促進することによって、過剰な滲出液を取り除くことによって、創傷の閉鎖及び治癒を手助けし、細菌の供給を低減し、それ故に、創傷に対する感染を低減する。さらに、局所的な陰圧療法は、創傷のより少ない外部障害を可能にし、且つより迅速な治癒を促進させる。
特許文献1には、創傷を吸引し、潅注し、且つ洗浄するための装置、創傷被覆材、及び方法が記載されている。ごく一般的に言い方をすると、この出願は、創傷を潅注する、且つ/又は洗浄するための追加の流体のさらなる提供とともに創傷を吸引するための、局所的な陰圧療法の適用による創傷の治療であって、該流体は、創傷滲出液及び洗浄流体の両方を備えており、次いで有害な材料から該有害な材料内の有益な材料を分離するための吸引手段及び循環手段によって取り除かれる、創傷の治療を記載している。創傷治癒に対して有益である材料は、創傷被覆材を通じて再循環され、創傷治癒に対して有害であるそれらの材料は、廃棄物回収バッグ又は容器に廃棄される。
特許文献2には、吸引及び潅注を使用し、且つ創傷を洗浄するための装置、創傷被覆材、及び方法が記載されている。さらに、一般的な言い方をすると、特許文献2に記載された発明は、創傷の吸引、潅注、及び洗浄に関して、特許文献1の装置に類似の装置を使用するが、しかしながら、該特許文献2の装置は、創傷部位/創傷被覆材に戻されるその有益な材料の温度を制御するために、加熱手段を提供する重要な追加のステップをさらに含み、それによって例えば、創傷の最も効果的な治療効果を有するために、該有益な材料は、適切な温度である。
特許文献3において、創傷の吸引、潅注、及び/又は洗浄のための装置及び方法が記載されている。また、ごく一般的な言い方をすると、特許文献3には、本願明細書のより前に記載された特許文献1及び特許文献2に記載の装置と類似の装置が記載されているが、創傷の治癒を促進するために、創傷部位/創傷被覆材に生理活性剤(physiologically active agents)の供給及び適用のための手段を提供する追加のステップを有する。
上記の参照した内容は、参照によって本願に組み込まれる。
しかしながら、上記の装置及び方法は、一般的に、使用される装置が複雑であり、該装置の操作方法および保守方法における専門的な知識を有する人間を必要とし、該装置が非常に重く、かさばり、例えば、患者によって病院環境の外側での容易の移動性のために適合されないので、入院している時にのみに患者に適用可能とされる。
連続的な入院期間を必要としないが、例えば、それにもかかわらず、局所的な陰圧療法の持続性の適用から利益を得る、あまり重症ではない創傷を有している何人かの患者は、容易に携帯可能であり、且つ容易に保守可能である局所的陰圧療法装置の可用性を条件として、家庭で又は仕事場で治療させることができる。この目的のために、特許文献4には、患者によって運搬されることができ、且つベルト又はハーネスに挟んで取り付けられることができる、局所的な陰圧療法の携帯用治療ユニットが記載されている。陰圧は、それ故に、創傷部位に適用されることができる。
局所的な陰圧療法中に、携帯用治療ユニット又は非携帯用治療ユニットは、創傷部位で陰圧を発生させる。空気及び創傷滲出液を含んでいる流体が創傷部位から取り除かれると、この流体は、創傷部位から離隔して、いくつかの方法で収集されなければならない。先行技術の治療ユニットとともに、創傷滲出液材料の収集及び蓄積は、該治療ユニットのポンプユニットに接続された廃棄物キャニスタによって従来実行される。しかしながら、キャニスタの使用は、治療ユニット装置自体が非常にかさばり、その製造コストが高いことを結果的にもたらす場合がある。同様に、創傷滲出液が収集されるキャニスタ又はキャニスタにおけるバッグを交換することは、時間の浪費とされる場合があり、非常に非衛生的なプロセスとされる場合がある。
先行技術の療法ユニットはまた、陰圧を発生させるために使用されるポンプを含む傾向がある。そのようなポンプは、製造するのが高価であり、且つ非常に重い。
参照によって本願に組み込まれる特許文献5には、マイクロポンプを有する内蔵型の創傷被覆材が開示される。真空空間に創傷流体を引き入れるためのポンプは、創傷被覆材自体に含まれる。それにもかかわらず、被覆材からの創傷滲出液は、複雑な一連のステップを介してのみ除去されることができる。創傷滲出液除去プロセスはまた、吸収層が創傷滲出液で完全に浸されると、吸収層及びマイクロポンプが取り除かれることができるように、アクセスドアが創傷被覆材において開口されなければならないので、汚染される傾向がある。そのような滲出液除去及びポンプ除去が、時間の浪費とされる場合があり、且つ使用者間で相互汚染に導く場合があることは、認識されるであろう。さらなる問題は、創傷被覆材が過膨脹及び破裂の傾向があることである。
国際公開第2004/037334号パンフレット 国際公開第2005/04670号パンフレット 国際公開第2005/105180号パンフレット 英国特許第2 307 180号明細書 国際公開第2007/030601号パンフレット
上記の問題を少なくとも部分的に緩和することは、本願発明の目的である。
創傷閉鎖を促進させるように創傷部位で陰圧を提供し、治癒するための方法であって、該療法中に創傷部位から抜き取られた創傷滲出液が収集され、且つ創傷被覆材内に蓄積される方法を提供することは、本願発明のある実施形態の目的である。
創傷部位上に配置されることができ、且つその創傷部位で陰圧を発生させるための一体型のポンプを含む創傷被覆材を提供することは、本願発明のある実施形態の目的である。同様に、創傷被覆材は、任意の創傷滲出液を収集することができる。
本願発明の第1の態様によれば、創傷を被覆するための装置であって、少なくとも1つのオリフィスを備えているシール層と、創傷滲出液を吸収するための、前記シール層上の吸収層と、前記吸収層上の液体不透過性及び気体透過性のフィルタ層と、を備えている装置が提供される。
本願発明の第2の態様によれば、創傷部位で局所的な陰圧を適用する方法であって、ポンプ要素を介して、創傷被覆材のシール層で密封している創傷部位及び該創傷部位の周りの周囲領域から創傷滲出液及び空気を吸い出しているステップと、前記創傷被覆材の吸収層において、前記シール層における少なくとも1つのオリフィスを通じて、前記創傷被覆から吸い出された前記創傷滲出液を収集するステップと、前記吸収層と前記創傷被覆材上に延在しているカバー層との間のフィルタ層を通じて、前記創傷被覆材から気体を排出しているステップと、を備えていることを特徴とする、方法が提供される。
本願発明のある実施形態は、使い捨て創傷被覆材が創傷部位上に固定されることができ、創傷部位で陰圧を提供し、且つ創傷滲出液を収集し且つ蓄積するように同時に使用されることができるという利点を提供する。一体型のポンプ又は遠隔のポンプが創傷部位で陰圧を発生させるので、創傷被覆材のフィルタ層は、空気が創傷被覆材から断続的に排出されることを可能にする。これは、過膨脹のリスクを防止する。
本願発明のある実施形態は、別個の療法ユニットが、創傷部位で陰圧を発生させるために必要とされず、任意の創傷滲出液を収集し、且つ蓄積するために必要とされないとの利点を提供する。それどころか、創傷被覆材が吸い出しプロセス及び創傷滲出液収集プロセスの両方を実行することができる。創傷被覆材は、その結果、使用後に廃棄されることができる使い捨てのアイテムとされることができる。これは、汚染のリスクを低減する。
本願発明のある実施形態は、創傷被覆材が陰圧療法プロセス中に発生した創傷滲出液を収集するために使用されることができるとの利点を提供する。創傷被覆材から遠隔のポンプは、創傷被覆材に接続され、且つ再利用されることができる一方、創傷被覆材自体は、創傷滲出液を収集するために使用され、且つ次いで使用後に廃棄される場合がある。
本願発明の実施形態は、添付した図面を参照して、例としてのみ、ここ以降の本願明細書に記載されるであろう。
創傷被覆材を図示している図である。 創傷被覆材の正面図を図示している図である。 創傷被覆材の一部を図示している図である。 外部ポンプを有する創傷被覆材を図示している図である。
図面において、同様の参照符号は、同様の部品に言及される。
図1は、本願発明の実施形態による創傷被覆材100の断面図を図示する。創傷被覆材100の上方からの平面図は、図1に示された断面の位置を示しているラインA−Aとともに図2に図示される。図1が、装置100の一般化された概略図を図示することは、理解されるであろう。本願発明の実施形態が、局所的な陰圧(TNP)システムにおいて使用するために適用可能とされることは、理解されるであろう。手短に言えば、陰圧創傷閉鎖法は、組織浮腫を低減することによって、血流及び粒状の組織形成を促進することによって、過剰な滲出液を除去することによって、細菌の供給を低減することによって、(及び、それ故に感染のリスクを低減することによって)「治癒しづらい」創傷の多くの形態の閉鎖及び治癒を手助けする。さらに、該療法は、創傷のより少ない障害を可能し、より迅速な治癒に導くことを可能にする。
創傷被覆材100は、治療されるべき創傷部位上に配置されることができる。創傷被覆材100は、創傷部位上に密封された空洞を形成する。任意に、創傷包装材料は、創傷被覆材の下に、創傷空洞内で使用されることができる。適切には、創傷包装材料は、ガーゼ又は網状のポリウレタンフォーム材料とされることができる。
本願発明を体現する装置のための陰圧の範囲は、約−50mmHgと約−200mmHgとの間とされる場合がある(それらの陰圧が通常の周囲大気圧に対するものであり、それ故に、−200mmHgが、実際的な言い方をするなら、約560mmHgとされるであろうことに留意するべきである)ことは、描かれる。適切には、陰圧の範囲は、約−75mmHgと約−150mmHgとの間とされる場合がある。代替的には、−75mmHgまでの陰圧の範囲、−80mmHgまでの陰圧の範囲、又は−80mmHg以上の陰圧の範囲は、使用されることができる。同様に、適切には、−75mmHg以下の陰圧の範囲は、使用されることができる。代替的には、−100mmHg以上の陰圧の範囲は使用されることができ、又は、−150mmHg以上の陰圧の範囲は使用されることができる。
図1に図示されるように、創傷被覆材100の下部表面101は、任意の創傷接触層102によって提供される。創傷接触層102は、例えば、ホットピンプロセス(hot pin process)を介して、又はいくつかの他の方法で、穿孔される、又は、他の方法で液体又は気体に対する透過可能に形成される、ポリウレタン層、ポリエチレン層、又は他の可撓性を有する層とされることができる。創傷接触層102は、下部表面101及び上部表面103を有する。複数の穿孔104は、創傷接触層における貫通孔とされ、流体が創傷接触層を通じて流れることができる。創傷接触層は、創傷被覆材の他の材料内への組織内成長を防止するのに役に立つ。複数の穿孔は、この要件を満たすために十分小さいが、それでも流体が通過することを可能にする。創傷接触層はまた、一緒に創傷被覆材の全体を保持するのに役立ち、任意の下部接触層及び上部接触層(図示せず)のためのキャリアーとして作用する。例えば、下部感圧性接着剤は、創傷被覆材の下部表面101に提供されることができる一方、上部感圧性接着剤は、創傷接触層の上部表面103に提供されることができる。シリコンベースの接着剤又はアクリルベースの接着剤、又は他のそのような接着剤とされる場合がある感圧性接着剤は、創傷接触層の両側部、又は任意には、選択された一の側部、又はいずれの側部でもない部分に形成されることができる。下部感圧性接着剤が利用される場合に、これは、創傷部位の周りの肌に創傷被覆材を付着するのに役に立つ。
フォーム層又は同様のものなどの多孔性材料層105は、創傷接触層の上方に配置される。この多孔性材料層は、創傷部位から離れて創傷被覆材の上部層への、液体及び気体を含んでいる流体の透過を可能にする。多孔性材料層105はまた、以下に詳細に述べられるポンプによって発生した圧力を分配するのに役立ち、それによって創傷部位全体には、均等な陰圧が見られる。天然又は合成とされる網状のフォーム又は不織布材料は、多孔性材料層105の多孔性材料として使用されることができる。
気体不透過性シール層106は、損傷被覆材の幅と交差して延在する。例えば、両側に感圧性接着剤を有するポロウレタンフィルムとされる場合がある気体不透過性シール層は、気体を透過不可能にさせ、この層は、損傷被覆材が配置される場所に亘って、損傷空洞を密封するために作用させる。この方法において、効果的なチャンバーは、気体不透過性シール層の下に、且つ該気体不透過性シール層と損傷部位との間に形成され、該効果的なチャンバーにおいて、陰圧が確立されることができる。適切には、気体不透過性シール層は、気体不透過性とされる一方、該気体不透過性シール層の材料は、高い透湿性を有することができる。例えば、BASF社によって製造されたエラストラン(商標名)SP9109とされる。ドットパターン状に塗布されたアクリル接着剤は、透湿性を改善するのに役立つために選択的に使用されることができる。気体不透過性シール層106としての高い透湿性材料を使用する利点は、創傷被覆材の流体処理能力が、フィルムを通じて発散し、且つ大気へ拡散する水蒸気の作用によって、著しく増加されることができる点である。有利には、発散速度は、被覆材内で達成される高い湿度、及び大気圧下で、250mmHgまでの陰圧で、該装置の使用中に達成される材料の密接な接触の結果として、3000グラム/平方センチメートル/24時間のオーダーによって容易に達成されることができる。
図1に図示されるように、単一の中央オリフィスが、気体不透過性シール層に設けられる。別の方法として、単一のオリフィス107が、複数の貫通孔として設けられることができることは、理解されるであろう。オリフィス107は、創傷被覆材と一体とされる、示されていないが、関連したバルブを有するマイクロポンプ110が、気体不透過性シール層106の下方の領域から気体不透過性シール層106の上方の領域へ流体を吸引することを可能にする。ポンプのインレットは、オリフィス107に対して対向関係で配置される一方、ポンプ110のアウトレット121は、吸収材料の層130内へポンプを通じて供給された流体を排出するように配置される。フォーム材料又は不織布天然材料、又は不織布合成材料とされる場合があり、且つ選択的に、超吸収材料を含む、又は超吸収材料とされる場合がある吸収材料は、創傷部位から取り除かれた流体、特に液体のためのリザーバーを形成する。吸収層の材料はまた、創傷被覆材において収集された液体を、スロッシング様式(sloshing manner)で流れることを防止する。吸収層130はまた、流体がポンプの排出アウトレット121に対して近位の領域から、より遠隔の領域へ抜き取られるように、吸上げ作用を介して該吸収層の至る所で流体を分配することを手助けし、それによってポンプ出口に隣接するアグロメレーション(agglomeration)が避けられる。
フィルタ層140は、吸収層130の上方に設けられる。フィルタ層140のフィルタ材料のための適切な材料は、MMT範囲(MMT range)から延伸されたポリテトラフルオロエチレン(PTFE)からなる0.2ミクロンのゴア(登録商標)である。より大きい孔の寸法は使用されることもできるが、それらは、十分なバイオバーデン含有(full bioburden containment)を確実にするために第ニのフィルタ層を必要とする場合がある。創傷流体が脂質を含有するので、必須ではないが、例えば、0.2ミクロンのMMT−323の前に、1.0ミクロンのMMT−332の油分をはじくフィルタ膜を使用することが望ましい。これは、脂質が疎水性フィルタを阻止することを妨げる。
他の種類の材料が、フィルタ層のために使用され得ることは、理解されるであろう。より具体的は、微孔性の膜には、薄く、平らな高分子材料のシートが使用されることができ、これは、数十億の微細孔を含む。選択された膜に応じて、それらの孔は、0.01マイクロメータから10マイクロメータ以上までのサイズに及ぶことができる。微孔性の膜は、親水性の形態(水濾過)及び疎水性の形態(撥水性)の両方で利用可能とされる。適切には、本願発明の特定の実施形態による創傷被覆材100は、微孔性疎水性膜(MHMs)を使用する。多数のポリマーは、微孔性疎水性膜を形成するために使用される場合がある。例えば、ポリテトラフルオロエチレン(PTFE)、ポリプロピレン、ポリフッ化ビニル(PVDF)、及びアクリルポリマーである。それらの任意のポリマーの全ては、疎水性及び油をはじく性質(oleophobic)の両方とされる特定の表面特性を得るために、処理されることができる。そのようなポリマーは、低い表面張力とともにマルチビタミン注入剤、脂質、界面活性剤、オイル、及び有機溶媒などの、液体をはじくであろう。
微孔性疎水性膜は、液体を遮断する一方、空気は該膜を通じて流れる。それらはまた、潜在的に感染性のエアロゾル及び粒子を除去する高い効率的な空気フィルタである。微孔性疎水性膜の単一の部品は、機械的なバルブ又はベントを交換するためのオプションとして周知される。微孔性疎水性膜の組込みは、それ故に、患者への利益、及び費用/利益の割合を改善する製品組立の費用を低減することができる。
フィルタ層140は、それ故に、気体が創傷被覆材を通じて上方向に排出されることを可能にする。しかしながら、液体、粒子、及び病原微生物は、創傷被覆材に含まれている。
カバー層150は、創傷被覆材100の吸収層を覆う。例えば、ポリウレタンフィルムとされる場合があるカバー層は、バクテリアバリアとして作用し、汚れることをやめるために液体中で保持されるのに役立つ。カバー層は、フィルタ層に密封される。例えば、接着技術又は溶着技術を介して密封される。それ故に、創傷被覆材から出ている気体は、フィルタ層を通過し、次いでカバー層における複数の孔151を通過する。カバー層はまた、損傷被覆材のための結合性(integrity)を提供し、例えば、穿孔のアレイによって、カバー層において設けられた複数の貫通孔151のおかげで、水蒸気及び気体を透過可能とされる。それらの複数の孔は、創傷被覆材を通じて水蒸気及び気体に対する透過性を改善することを手助けする。代替的な実施形態において、フィルタ層140は、その代わりに、シール層106とともに密封している創傷全体を覆う場合がある。保護層又は補強層は、含まれる場合がある(これは、不織布又は穿孔されたフィルムとされる場合がある)。適切には、カバー層150は、高い透湿性を有している材料から形成される。例えば、BASF社によって製造されたエラストラン(商標名) SP9109である。ドットパターン状に塗布されたアクリル接着剤は、透湿性を改善するのに役立つために選択的に使用されることができる。カバー層160として高い透湿性を有する材料を使用することの利点は、創傷被覆材の流体処理能力が、フィルムを通じて発散し、大気へ拡散する水蒸気の作用によって、著しく増加されることができることができる点である。有利には、発散速度は、被覆材内で達成される高い湿度、及び大気圧下で、250mmHgまでの陰圧で、該装置の使用中に達成される材料の密接な接触の結果として、3000グラム/平方センチメートル/24時間のオーダーによって容易に達成されることができる。
本願発明の実施形態による創傷被覆材100を図示する図2を参照して、創傷被覆材の中央から離隔して吸収層130の上に載置している中央隆起領域201を囲んでいる縁部領域200へ放射状に外側方向に延在しているカバー層150の上部表面を見ることができる。図2はまた、カバー層に形成された穿孔のアレイ151を図示するのに役立つ。
図3は、図1及び図2に図示された創傷被覆材100の縁部領域200の拡大図を図示する。図3に見られるように、カバー層150は、吸収層130上で縁部領域へ延在する。ここで、カバー層は、シール層106及び創傷接触層102に固定される。図3はまた、創傷接触層102における複数の穿孔104がどのようにフォーム層105の周りに延在しているのかを図示するのに役立つ。
本願発明の実施形態によれば、創傷接触層がオプションとされることは理解されるであろう。使用される場合に、この層は、水に対して浸透性であり、下に載置している創傷部位と対向する。網状のポリウレタンフォーム層などの下部多孔性層105は、気体及び流体除去を分散するために使用され、それによって、創傷の全ての領域が等しい圧力にさらされる。シール層は、創傷に亘って略気密密封を形成する。それ故に、ポンプ110が吸い上げるにつれて、陰圧は、シール層の下で発生する。この陰圧は、それ故に目標となる創傷部位で経験される。空気及び創傷滲出液を含んでいる流体は、創傷接触層及び網状のフォーム層を通じて抜き取られ、ポンプ110でオリフィス107を通じて流体インレット120内に引き入れる。ポンプは流体出口を通じて流体を排出し、該流体出口において、液体コンポーネントは、吸収層130の至る所で集められ、且つ蓄積されるように、逃がれる。いくつかの水蒸気とともに排出された流体の気体状のコンポーネントは、フィルタ層を通じて、且つカバー層の複数の穿孔を通じて排出される。フィルタ層は、病原微生物及び不快臭が吸収層によって形成されたレシーバ領域から生じないことを確実にする。
フィルタ層の上に載置しているカバー層を有するというよりむしろ、カバー層がそれ自体、フィルタ層によって上に載置されることは、当業者によって理解されるであろう。カバー層はそれ故に、創傷被覆材の最も外側層とされる場合がある、又はフィルタ層は、創傷被覆材の最も外側層とされる場合がある。さらに、複数の外側層(図示せず)は、複数の外側層が気体及び水蒸気の透過可能とされる限り、任意に使用される場合がある。
さらなるオプションとして、創傷被覆材は、抗菌性、例えば、創傷接触層上の微小結晶性銀物質(nanocrystalline silver agents)及び/又は吸収層における硫化銀ジアジン(silver sulphur diazine)を含むことができる。
これらは、別々に、又は一緒に使用される場合がある。これらは、創傷における微生物及び吸収マトリックスにおける微生物をそれぞれ殺す。さらなる任意の他の有効成分として、例えば、イブプロフェンなどの痛み抑制剤が含まれる場合がある。同様に、例えば、成長因子などの細胞活動を高める物質、又はマトリックスメタロプロテアーゼ阻害剤(matrix metalloproteinase inhibitors)、組織性メタロプロテアーゼ阻害因子(tissue inhibitors of metalloproteinase (TIMPS))、又は亜鉛キレート剤(zinc chelators)などの阻害物質(inhibit enzyme)が使用されることができる。さらなるオプションとして、活性炭(activated carbon)、ジクロデキストリン(cyclodextrine)、ゼオライト(zealite)、又は同様のものなどの臭気分離要素(odour trapping elements)は、吸収層内に含まれでもよく、又はフィルタ層上のさらなる層として含まれてもよい。
図4は、ポンプが創傷被覆材400内で一体型に設けられていない本願発明の代替的な実施形態を図示する。それどころか、接続チューブ401がシール層におけるオリフィス107に接続される。アウトレットチューブ401は、その外側周囲の周りでカバー層150及びフィルタ層140に対して密封される。アウトレット導管401は、創傷被覆材400からある程度離隔して存在していることができる、又は創傷被覆材の縁部に取り付けられることができる遠隔のポンプに接続される。遠隔のポンプのアウトレットは、インレットチューブ402に固定され、該インレットチューブ402は、その周囲に関して開口部403に導いているカバー層150に密封される。この方法において、ポンプがシール層106の下の領域に陰圧を適用するために作動されるにつれて、滲出液は、創傷接触層102及び下部流体分散層105を通じて抜き取られ、オリフィス107を通じて出口チューブ401に沿って抜き取られる。空気及び創傷滲出液を含んでいる流体は、ポンプを通過し、アウトレットチューブ402における開口部403に近接した領域で排出される。流体の液体部分は、吸収層130の本体において収集されるように逃れる(wicked away)。空気及び水蒸気は、フィルタ層を通過し、カバー層における開口を通過し、周囲空気へ消え去る。
本願発明の実施形態によれば、流体が創傷部位から抜き取られるので、吸収層が伸張される場合があることは、理解されるであろう。これは、フィルタ層及びカバー層の上部表面に現れる僅かな膨らみを生じる場合がある。多くの態様において、僅かな膨らみは、いつ創傷被覆材が交換されるべきであるかを示すために、視覚的な合図として使用されることができる。
図4に示された実施形態に対して上述されるように、遠隔のポンプは、創傷被覆材の縁部に取り付けられることができ、その場合において、チューブ401、402は、該ポンプに直接的に接続されることができる。単一の使用に続いて、創傷被覆材及びポンプは、廃棄されることができる。オプションとして、チューブには、クリックフィットコネクタ(click fit connector)、又は遠隔のポンプに対応するチューブを介して接合された、対応する相手コネクタに接続されることができる他の容易なフィットコネクタが設けられる場合がある。この方法において、遠隔のポンプは、再使用されることができる一方、接続チューブ及びコネクタを含んでいる創傷被覆材自体は、単一の使用後に使い捨てされる。
カバー層又は創傷被覆材の周囲の縁部領域上に取り付けられたポンプを含む本願発明の実施形態のために、一体型の電源及び制御回路が含まれることができることは、理解されるであろう。代替的には、電源がポンプの外部とされ、且つ遠くに取り付けられることができる。遠隔の電源及び/又は制御回路は、創傷被覆材の廃棄可能性を改善し、予備のバッテリーが使用される場合にバッテリーの再チャージを可能にする。
使用中に、創傷被覆材が所定の角度で、又は垂直に逆さまにして使用されることができることは、同様に理解されるであろう。上部及び下部に対する参照は、それ故に、説明の目的のためだけに使用される。
代替的には、チューブ401、402が単一の二重ルーメンチューブとされることができることは、理解されるであろう。さらなる代替として、チューブ401、402は、単一の連続的なループ状のチューブとされることができ、該チューブは蠕動ポンプのためのピンチローラを通過することができる。
この明細書の説明及び特許請求の範囲の至る所で、「備える」及び「含む」との用語、それらの変形、例えば「備えている」及び「備える」との用語は、「制限されないが、含んでいる」ことを意味し、他の一部、追加部、コンポーネント、一体部、及びステップを排除するために意図されない(排除されない)。
この明細書の説明及び特許請求の範囲の至る所で、単数は、文脈が別な方法で必要とする限り、複数を含んでいる。特に、不定冠詞が使用される明細書は、文脈が別な方法で必要とする限り、単数と同様に複数を考慮するので、理解されるべきである。
本願発明の特定の態様、実施形態、又は例と併せて記載された特徴、完全体、特性、混合物、化学成分、又はグループは、それらとともに不適合ではない限り、本願明細書に記載された任意の他の態様、実施形態、又は例に適用可能とされるように、理解されるべきである。
100 創傷被覆材
101 下部表面
102 創傷接触層
103 上部表面
104 複数の穿孔
105 多孔性材料層、下部流体分散層
106 気体不透過性シール層
107 オリフィス
110 マイクロポンプ
120 流体インレット
121 アウトレット、排出アウトレット
130 吸収材料の層
140 フィル多層
150 カバー層
151 複数の孔、穿孔のアレイ
200 縁部領域
201 中央隆起領域
400 創傷被覆材
401 接続チューブ、アウトレットチューブ、アウトレット導管
402 インレットチューブ
403 開口部

Claims (14)

  1. 局所的な陰圧療法のための、創傷を被覆するための装置であって、
    創傷接触層と、
    前記創傷接触層上に配置された多孔性層と、
    前記多孔性層上に配置された気体不透過性シール層であって、少なくとも1つのオリフィスを備えている気体不透過性シール層と、
    創傷滲出液を吸収するための、前記シール層上の吸収層と、
    前記吸収層上の液体不透過性及び気体透過性のフィルタ層であって、前記吸収層とその上に載置しているカバー層との間に配置される、液体不透過性及び気体透過性のフィルタ層と
    ポンプ要素と、を備えており、
    前記ポンプ要素は、前記カバー層と前記シール層との間に配置され、前記シール層の前記オリフィスと流体連通しているインレットと、前記吸収層と流体連通しているアウトレットと、を備えていることを特徴とする装置。
  2. 前記シール層が、各オリフィスから離隔した領域において、前記シール層を通じて流体流れに対して実質的に不透過性とされることをさらに備えていることを特徴とする請求項1に記載の装置。
  3. 前記シール層は、創傷部位に局所的陰圧(TNP)の適用より前に、前記創傷部位を密封するように配置されることを特徴とする請求項1又は2に記載の装置。
  4. 前記吸収層は、前記オリフィスを通過している創傷滲出液を吸収するように配置されることを特徴とする請求項1〜3のいずれか一項に記載の装置。
  5. 前記吸収層に流体連通し、前記フィルタ層及び/又は前記カバー層を通じて密封された方法で延在しているインレットチューブ状導管をさらに備えていることを特徴とする、請求項1〜4のいずれか一項に記載の装置。
  6. 抽出チューブ状導管及び/又はインレットチューブ状導管は、遠隔のポンプ要素に接続可能とされることを特徴とする、請求項に記載の装置。
  7. 前記創傷接触層の上側及び/又は下側に接着層をさらに備えていることを特徴とする、請求項1〜6のいずれか一項に記載の装置。
  8. 前記創傷接触層が、穿孔されたポリウレタン層又は穿孔されたポリエチレン層とされることを特徴とする請求項1〜7のいずれか一項に記載の装置。
  9. 前記創傷接触層の下側表面に除去可能な保護層をさらに備えていることを特徴とする請求項1〜8のいずれか一項に記載の装置。
  10. 前記シール層及び前記カバー層が、前記吸収層の縁部領域から外側に向けて放射状に延在しており、それによって周囲縁部領域を形成し、
    前記シール層及び前記カバー層は、前記周囲縁部領域において一緒に密封されることを特徴とする請求項1〜9のいずれか一項に記載の装置。
  11. 前記創傷接触層が、前記周囲縁部領域において前記シール層及び前記カバー層とともに密封されることを特徴とする請求項10に記載の装置。
  12. 創傷接触層及び/又は前記吸収層に抗菌物質をさらに備えていることを特徴とする請求項1〜11のいずれか一項に記載の装置。
  13. 鎮痛物質及び/又は細胞活動強化物質をさらに備えていることを特徴とする請求項1〜12のいずれか一項に記載の装置。
  14. 臭気分離要素をさらに備えていることを特徴とする請求項1〜13のいずれか一項に記載の装置。
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