JP5788323B2 - 界面層の創傷包帯 - Google Patents
界面層の創傷包帯 Download PDFInfo
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- JP5788323B2 JP5788323B2 JP2011529677A JP2011529677A JP5788323B2 JP 5788323 B2 JP5788323 B2 JP 5788323B2 JP 2011529677 A JP2011529677 A JP 2011529677A JP 2011529677 A JP2011529677 A JP 2011529677A JP 5788323 B2 JP5788323 B2 JP 5788323B2
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- wound
- foam
- wound dressing
- hyaluronic acid
- conduit
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Description
本明細書で使用される「創傷床」という用語は、創傷部位の最上の可視的組織層を指す。
本発明の創傷包帯は、多糖コーティングしたフォーム内導管を有するポリマーフォーム基質を含む。創傷表面のその配置前、導管壁は基質内の占有しないまたは部分的に占有しない区画またはチャネルの輪郭をはっきりと示す。使用中、この多糖は創傷浸出物を吸収して水和物となり、従ってゲルを形成し、このゲルは拡大する。この拡大した多糖は占有していなかった区画またはチャネルをほぼ十分におよび/または部分的に占めるが、フォームの2つの対面する外表、すなわち、創傷床と直接接触せず外部環境に曝露する外表と、創傷床に直接接触する対面する外表との間の気体と液体の伝送のために十分な開存を残す。上記の対面する外表は、本明細書において、創傷表面に対する位置に関連してそれぞれフォームの「外表面」および「内表面」とも称される。
本発明は、開放導管ポリマーフォームおよび少なくとも1つの多糖を含む、創傷床における界面層微小環境を作るための創傷包帯を提供する。
選択される多糖は、創傷床から滲出する液体および浸出物を吸収するように十分に親水性であるべきである。適切な多糖類としては、ヒアルロン酸、硫酸グリコサミノグリカン、キトーサン、アルギン酸塩、ヒドロキシエチルセルロース、カルボキシメチルセルロース、セルロース派生物、ペクチン、アラビアゴム、デンプン、それらの医薬上許容可能な塩およびそれらの組み合わせが挙げられるが、これらに限定されない。
本発明の創傷包帯において、この多糖はこのフォーム内導管内面、および任意にこのフォームの少なくとも1つの外表に乾燥形態で配置されている。
この創傷包帯は、コルチコステロイド、増殖因子、殺菌剤、抗生剤、および植物抽出体からなる群から選択される医薬品成分または薬をさらに含んでよい。植物抽出体の1つの非限定的な例は、海生クロウメモドキ(Hippophae rhamnoides)から引き出された植物抽出体である。特定の1つの実施形態において、この医薬品成分はフォームの創傷床と直接接触しない外面に配置されているが、この基質固有の特性のため、この医薬品成分は創傷表面の基質を濾過できる。特定の1つの実施形態において、この医薬品成分は、溶液、油、フォーム、ゲル、乳脂および軟膏からなる群から選択される形態にある。
本発明は、創面切除された創傷床の治療を、それを必要としている対象において行うためのILMに基づく方法をさらに提供し、この方法はこの創傷床上への創傷包帯の適用工程を含み、ここで創傷包帯は開放導管ポリマーフォームおよび少なくとも1つのゲル形成親水性多糖を含み、ここで親水性多糖は、この開放導管フォーム内導管内面に乾燥形態で配置されている。特に好ましくは、フォーム基質を形成する導管の直径が少なくとも300μmである。
この創傷表面で排出された血清は導管壁に沿って進み、そこでヒアルロン酸に吸収され、創傷表面における液体量(湿気)に応じて(図2に示すように)完全にまたは部分的にヒアルロン酸を水和する。湿潤ヒアルロン酸は包帯表面にガイドされた上皮化を高める治癒創傷の乾燥を予防する。排液中のヒアルロン酸とフィブリンの複合体はこの包帯を創傷に接着させ、「人為的な強化痂皮」を形成して、任意の感染病巣の繁殖を防止する。上皮化が(通常、真皮残片上で)進行するにつれ、図3に示すように、角質化上皮層は創傷から創傷包帯を分離する。この分離した創傷包帯領域は鋏で刈り取ることができる。接着した創傷包帯は外来患者状態における初期の創傷ケアを可能とする。この「人為的な痂皮」が存在する限り、この包帯は元の色と外見を維持する。治癒していない創傷がヒアルロン酸の水和力を超えて持続する場合(通常、全層欠損の場合)、排液の変化のために湿潤性暗変色領域が出現する。これは治療変化用の診断マーカーとして使用できる。顆粒化組織形成を避けるため、(図3に示すように)コルチコステロイド溶液または乳脂を創傷包帯の表面に適用して創傷表面に滲出させることができる。この包帯が乾燥していて領域が狭い場合、治癒(上皮化)が完成するまでこの創傷包帯をその場に保ち得る。この包帯の外見が変化し続ける場合、変色部分を切除して創傷の直接ケア(すなわち、グラフト)を可能とすることができる。長期の静置された包帯(>1週間)において、ヒアルロン酸を創傷包帯に、創傷包帯の外表の水溶液中に適用して添加することが可能である。
一般的な実施例1に記載したように、創傷表面で排出された血清は導管壁に沿って進み、ヒアルロン酸に吸収され、創傷表面の液体量(湿気)に応じて(図2に示すように)完全にまたは部分的にヒアルロン酸を水和する。湿潤ヒアルロン酸は包帯表面にガイドされた上皮化を高める治癒創傷の乾燥を予防する。正常な炎症反応を伴う湿潤環境は、焼痂残片の浸解(「自己融解」)および汚染された病巣の分解を促進する。排液中のフィブリンと共にヒアルロン酸に吸収された自己融解生成物は包帯を創傷に接着させ、任意の感染病巣の繁殖を防止する「人為的な強化痂皮」を形成する。一般的な実施例1のように、上皮化は図3に示すように(通常、真皮残片上で)進行し、角質化上皮層は創傷包帯を創傷から分離する。この分離した創傷包帯領域は鋏で刈り取ることができる。接着した創傷包帯は外来患者状態における初期創傷ケアを可能とする。この人為的な痂皮が存在する限り、この包帯は元の色と外見を維持する。治癒していない創傷がヒアルロン酸の水和力を超えて持続する場合(通常、全層欠損の場合)、排液のために湿潤性暗変色領域が出現する。これは治療変化用の診断マーカーとして使用できる。顆粒化組織形成を避けるため、コルチコステロイド溶液または乳脂を創傷包帯の表面に適用して創傷表面に滲出させることができる。この包帯が乾燥していて領域が狭い場合、治癒(上皮化)が完成するまでこの創傷包帯をその場に保ち得る。この包帯の外見が変化し続ける場合、変色部分を切除して創傷の直接ケア(すなわち、グラフト)を可能とすることができる。上述のように、長期の静置された包帯(>1週間)において、ヒアルロン酸を創傷包帯に、創傷包帯の外表に適用して添加することが可能である。
一般的な実施例1および2に記載したように、創傷表面で排出された血清および膿は導管壁に沿って進み、ヒアルロン酸に吸収され、創傷表面の液体量(湿気)に応じて(図2に示すように)完全にまたは部分的にヒアルロン酸を水和する。膿の性質は変化し、創傷包帯の表面を着色して、正確な微生物培養、診断および治療を可能にする。この湿潤ヒアルロン酸は包帯表面にガイドされた上皮化を高める治癒創傷の乾燥を予防する。正常または増大した炎症反応を伴う湿潤環境は、焼痂残片の浸解(「自己融解」)および通常、汚染された病巣の分解を促進する。排液中のフィブリンと共にヒアルロン酸に吸収された自己融解生成物は包帯を創傷に接着させ、通常、感染の繁殖を防止する「人為的な強化痂皮」を形成する。上の実施例のように、上皮化は角質化上皮層を(通常、真皮残片上で)進行させ、創傷から創傷包帯を分離する。この分離した創傷包帯領域は鋏で刈り取ることができる。接着した創傷包帯は外来患者状態における初期創傷ケアを可能とする。この人為的な痂皮が存在する限り、この包帯は乾燥した化膿物により着色され得るが乾燥したまま残る。治癒していない創傷または感染がヒアルロン酸の水和力を超えて持続する場合(通常、全層欠損または汚染した焼痂の場合)、排液のために湿潤性暗変色または着色(汚染菌による)領域が出現する。これは治療変化用の診断マーカーとして使用でき、感染と闘うため、消毒液または抗生剤液または乳脂を創傷包帯の表面に適用して創傷表面に滲出させることができる。感染が鎮静して包帯が乾燥している場合、治癒(上皮化)が完成するまで創傷包帯をその場に保ち得る。この包帯が化膿し湿り続けて外見が変化する場合、抗微生物溶液(例えば酢酸マフェニド5%)をこの包帯上に適用できる。場合によっては、外表に真空を適用できる。感染が持続するまれなケースでは、創傷の直接ケア(すなわち、局所投薬、排液、摘出または剥離)を可能にするために、変色部分を切除することができる。長期の静置された包帯(>1週間)において、ヒアルロン酸を創傷包帯に、創傷包帯の外表に適用して添加することが可能である。
開放導管ポリウレタンフォームをヒアルロン酸ナトリウム溶液により処置して、約0.005gの乾燥ヒアルロン酸ナトリウム/cm3フォームを有するポリウレタンフォーム包帯を得た。ポリウレタンフォーム(300個の導管/cm2表面積、導管直径約500μm;Ashkelon Polymers Industries Ltd., Israelから入手)の偏平状シート(0.4×20×20cm)の上面に40mlのヒアルロン酸ナトリウム溶液2.1%(Bio−Technology General Ltd., Israelから入手)を適用して覆った。真空ボックスの20×20cm透過性スクリーン壁上に遮蔽シートを置き、低真空バースト(−20mmHg)を5分間適用した。溶液がフォームの表面で不可視となり次第、このシートを真空乾燥ボックス中に置いて26℃で48時間一定真空(−550mmHg)下に保った。この処置したフォームシートを使用時まで乾燥環境で保存した。
外来患者皮膚科臨床現場において、右前腕(肘から掌まで)に沿って持続した深部第2度蒸気熱傷を呈する成人男性患者を、Debrase(商標)を用いた迅速酵素デブリードマン、次いで創傷包帯により治療した。酵素的に創面切除された創傷の隣接領域に、乾燥ヒアルロン酸(ILM)で露出した表面をコーティングするように実験の実施例1のように調製した開放細胞ポリウレタンフォーム(4mm厚;細胞直径約500μm;300細胞/cm2)または市販品Aquacel(商標)Ag(AqAg)のいずれかで包帯した。図4は約2週間にわたる治癒過程を実証する。図4aは、Debrase(商標)による迅速酵素デブリードマン後の熱傷を示す。図4bは、3日目、2つの異なる部位におけるILM包帯およびAqAg包帯による包帯後の熱傷を示す。ILM包帯部位は、外部ガーゼ包帯により排液が吸収され一貫性および色を保持する創傷包帯の非常にはっきりした外見を示す一方、AqAg部位は創傷浸出物により相対的に着色され吸収された。図4cは、包帯後5日目の熱傷のクローズアップを示す。写真上部は清浄なILMの端を示す一方、革様に乾燥したAqAgが右に見える。AqAgが移動し治癒床表面を裂いた出血床の中心は明らかである。図4dは、包帯後7日目の熱傷を示す。ILM包帯は無欠性を保持する一方、AqAg包帯により偶発的亀裂および組織内部増殖が起こった。図4eは、包帯後9日目の熱傷を示し、上皮化進行を示す。創傷の治癒した一部上のILM包帯は切断および除去され、コルチコステロイド溶液が顆粒化組織および上皮化の制御に適用される。対照的に、AqAg部位は、治癒床を通していずれの薬剤も移行していない着色された乾燥表面を示す。図4fは、ILM包帯部位の治癒の完成を示す包帯後13日目の熱傷を示す。ILM包帯は上皮化した創傷から容易に剥れる一方、AqAg包帯はこの床に密着する。
図5は実験仔豚系(20〜25kgの動物)において科した熱傷の治療を実証する一連の写真を示す。各熱傷の中心が全層であり、残りが深部真皮の第2度熱傷である標準的な深部熱傷(4.5cm×4.5cm)を科した。
Claims (21)
- 2つの対面する外表を有する合成ポリマーフォーム基質の乾燥した偏平状シート形態の創傷包帯であり、1つ目の外表は創傷床に向き合うよう設定されており、2つ目の外表は外部環境に曝露し、前記基質が開放導管ポリマーフォームおよび少なくとも1つのゲル形成親水性多糖を含み、前記多糖が前記フォーム内開放導管内面に乾燥形態で配置されている、創傷包帯であって、
前記開放導管ポリマーフォームはポリウレタンを含み、
前記ゲル形成親水性多糖はヒアルロン酸または医薬上許容可能な塩もしくはその派生物であり、かつ
前記ポリマーフォーム内導管直径は500〜1000μmである創傷包帯。 - 前記ポリウレタンがポリエステルポリウレタン、ポリエーテルポリウレタンおよび架橋ポリウレタンからなる群から選択される
請求項1に記載の創傷包帯。 - 前記多糖が前記フォームの少なくともの1つの対面する外表に乾燥形態でさらに配置されている、請求項1に記載の創傷包帯。
- 前記多糖が前記フォームの創傷床に向き合うよう設定されている外表に配置されている、または、
前記多糖が前記フォームの対面する両外表に乾燥形態で配置されている、
請求項3に記載の創傷包帯。 - 前記フォームの乾燥シート厚が水和前に2〜12mmである、または、
ヒアルロン酸が0.001グラム〜1.0グラム/cm 3 の量で存在する、
請求項1の創傷包帯。 - 前記開放導管ポリマーフォームが開放導管ポリウレタンを含み、前記ゲル形成親水性多糖がヒアルロン酸またはその医薬上許容可能な塩もしくは派生物であり、前記ヒアルロン酸が0.001グラム〜0.01グラム/cm 3 の量で存在する、請求項1に記載の創傷包帯。
- 前記ポリマーフォーム内導管の少なくとも75%が前記フォームの対面する外面間で実質的に連続している、または、
前記ポリマーフォームが200〜500個の導管開口部/cm2を有する、または、
前記ポリマーフォーム基質の密度が0.1〜0.4g/cm 3 である、または、
コルチコステロイド、増殖因子、殺菌剤、静菌剤、抗生剤、追加の多糖および植物抽出体からなる群から選択される医薬品成分をさらに含み、前記医薬品成分が前記フォーム基質の創傷床と直接接触することを目的としていない外表に配置されている、
請求項1に記載の創傷包帯。 - 前記ポリウレタンフォーム内導管直径が500μmである
請求項1に記載の創傷包帯。 - それを必要としている対象における創面切除された創傷の治癒を促進する、請求項1〜8のいずれかに記載の創傷包帯。
- 前記創傷包帯が酵素デブリードマン手順後に酵素的に創面切除された創傷床上で適用され、前記酵素デブリードマン手順がブロメライン派生物、デブリダーゼ、コラーゲナーゼ、パパイン派生物、ストレプトキナーゼ、スティラインズ、フィブリノリジン、デオキシリボヌクレアーゼ、オキアミ派生物、トリプシンおよびそれらの組み合わせからなる群から選択される酵素の適用を含む
請求項9に記載の創傷包帯。 - それを必要としている対象における酵素的に創面切除された創傷床を治療する、請求項1〜7のいずれかに記載の創傷包帯。
- 前記創傷床が、ブロメライン派生物、デブリダーゼ、コラーゲナーゼ、パパイン派生物、ストレプトキナーゼ、スティラインズ、フィブリノリジン、デオキシリボヌクレアーゼ、オキアミ派生物、トリプシンおよびそれらの組み合わせからなる群から選択される酵素で治療される
請求項11に記載の創傷包帯。 - (i)溶液形態のヒアルロン酸を、ポリウレタンフォームの少なくとも1つの外表に、前記外表を覆うように適用する工程;ならびに(ii)(i)で得られるフォームを減圧乾燥させる工程を含む、請求項6に記載の前記創傷包帯を産生する方法。
- 前記過程が工程(iii)前記フォーム内開放導管への親水性ポリマー溶液の注入をさらに含み、前記(iii)が(ii)の前に行われ、
(i)におけるポリウレタンフォームの外表に適用したヒアルロン酸の量が、前記ポリウレタンフォームの外表の1.0〜10.0mg/cm 2 である、
請求項13に記載の方法。 - 前記創傷床の起源が、静脈性下肢潰瘍、圧力潰瘍、糖尿病性足潰瘍、熱傷からなる群から選択され、あるいは、前記創傷床の起源が全層性熱傷、部分層性熱傷、切断創傷、分層植皮術、植皮ドナー部位、外傷、咬傷、凍傷、皮膚剥離、および外科的創傷から成る群から選択される、
請求項10に記載の創傷包帯。 - 前記創傷包帯を創傷床上で少なくとも1週間維持し、あるいは、前記創傷包帯を創傷床上で上皮化が完成するまで維持する、
請求項10に記載の創傷包帯。 - 前記フォームの創傷床と向き合わない外表が、コルチコステロイド、増殖因子、殺菌剤、静菌剤、抗生剤、追加の多糖および植物抽出体からなる群から選択され、あるいは、溶液、エマルジョン、油、フォーム、ゲル、乳脂および軟膏からなる群から選択される形態にある医薬品を含む、
請求項10に記載の創傷包帯。 - 前記創傷床の起源が、静脈性下肢潰瘍、圧力潰瘍、糖尿病性足潰瘍、熱傷からなる群から選択され、あるいは、前記創傷床の起源が全層性熱傷、部分層性熱傷、切断創傷、分層植皮術、植皮ドナー部位、外傷、咬傷、凍傷、皮膚剥離、および外科的創傷から成る群から選択される、
請求項12に記載の創傷包帯。 - 前記創傷包帯を創傷床上で少なくとも1週間維持し、あるいは、前記創傷包帯を創傷床上で上皮化が完成するまで維持する、
請求項12に記載創傷包帯。 - 前記フォームの創傷床と向き合わない外表が、コルチコステロイド、増殖因子、殺菌剤、静菌剤、抗生剤、追加の多糖および植物抽出体からなる群から選択され、あるいは、溶液、エマルジョン、油、フォーム、ゲル、乳脂および軟膏からなる群から選択される形態にある医薬品を含む、
請求項12に記載の創傷包帯。 - (iii)が遠心分離、負圧の適用、正圧の適用および真空の適用から成る群から選択される操作を含む、
請求項14に記載の方法。
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CA2673409A1 (en) * | 2006-12-19 | 2009-06-26 | Ferrosan A/S | Wound or tissue dressing comprising lactic acid bacteria |
KR100777908B1 (ko) | 2006-12-19 | 2007-11-28 | 주식회사 바이오폴 | 보수율이 향상된 폴리우레탄 폼 드레싱재 |
US8460258B2 (en) * | 2008-01-08 | 2013-06-11 | Southeastern Medical Technologies, Llc | Methods and apparatuses for the treatment of wounds with pressures altered from atmospheric |
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BRPI0920612A2 (pt) | 2018-06-19 |
BRPI0920612B1 (pt) | 2021-06-08 |
WO2010038231A1 (en) | 2010-04-08 |
EP2337536A4 (en) | 2017-07-19 |
KR20110092269A (ko) | 2011-08-17 |
AU2009299453B2 (en) | 2014-10-02 |
ZA201103127B (en) | 2012-11-28 |
MX2011003557A (es) | 2011-09-01 |
US20110275972A1 (en) | 2011-11-10 |
ES2829956T3 (es) | 2021-06-02 |
CN102223858A (zh) | 2011-10-19 |
US8624077B2 (en) | 2014-01-07 |
JP2012504451A (ja) | 2012-02-23 |
EP2337536B1 (en) | 2020-08-12 |
AU2009299453A1 (en) | 2010-04-08 |
CN102223858B (zh) | 2015-04-01 |
EP2337536A1 (en) | 2011-06-29 |
CA2739243C (en) | 2017-08-22 |
CA2739243A1 (en) | 2010-04-08 |
KR101789337B1 (ko) | 2017-10-23 |
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