JP2019509853A - 変性された創傷包帯 - Google Patents
変性された創傷包帯 Download PDFInfo
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- JP2019509853A JP2019509853A JP2018551313A JP2018551313A JP2019509853A JP 2019509853 A JP2019509853 A JP 2019509853A JP 2018551313 A JP2018551313 A JP 2018551313A JP 2018551313 A JP2018551313 A JP 2018551313A JP 2019509853 A JP2019509853 A JP 2019509853A
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- Prior art keywords
- wound
- dressing material
- wound dressing
- polymer
- mmp
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Abstract
Description
本出願は、2016年3月30日に出願された、米国仮特許出願第62/315,567号の利益を主張するものであり、その開示は、その全体が参照により本明細書に組み込まれ、本明細書の一部をなす。
マトリックスメタロプロテアーゼ(MMP)、エラスターゼ、およびカテプシンG等のこれらのプロテイン分解酵素の放出は、好中球の過剰な刺激に関連することが多い。
別の実施形態では、構造M−Rを含む化合物であって、Mが、ゲル形成ポリマーであり、Rが、レポーター分子である、化合物を本明細書に提供する。
ある範囲の値が提供される場合、その範囲の上限と下限との間の各々の介在値およびその記載される範囲内の任意の他の記載値または介在値は、本開示内に包含されることが意図される。例えば、1μm〜8μmの範囲が記載されている場合、2μm、3μm、4μm、5μm、6μm、および7μm、ならびに1μm以上の範囲の値および8μm以下の範囲の値も明示的に開示されていることが意図される。
創傷および創傷管理の治療および診断のための創傷包帯に使用されるべき変性された創傷包帯材料であって、使用時の創傷包帯材料が、その場での創傷内の上昇酵素レベルの存在を示す、修飾創傷包帯材料を本明細書に提供する。
本明細書に記載される実施形態は、慢性創傷を診断および/または治療するために使用され得る変性された創傷包帯を提供する。包帯剤は、ゲル形成ポリマー、非ゲル形成繊維、またはそれらの組み合わせを含み得る。本明細書に記載される創傷包帯材料は、哺乳動物の創傷における1つ以上の酵素のレベルを検出する方法において使用される。いくつかの実施形態では、本明細書に記載される創傷包帯材料は、哺乳動物の慢性創傷を診断する方法において使用される。いくつかの実施形態では、本明細書に記載される創傷包帯材料は、哺乳動物の感染性創傷を診断する方法において使用される。他の実施形態では、本明細書に記載される創傷包帯材料は、哺乳動物の創傷を治療する方法において使用される。さらなる実施形態では、本明細書に記載される創傷包帯材料は、哺乳動物の慢性創傷を治療する方法において使用される。
式中、Mがゲル形成ポリマーである場合、Rは、レポーター分子を含む領域であり、Lは、MとRとを繋ぐリンカーである。一実施形態では、リンカー(L)が存在する。別の実施形態では、リンカー(L)は存在せず、この場合、創傷包帯材料は、式M−Rの化合物を含み、MおよびRは、各々個々に、上に記載されるとおりである。
式中、Mは、ゲル形成ポリマーであり、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、Lは、MとPEPとを繋ぐリンカーである。一実施形態では、リンカー(L)が存在する。別の実施形態では、リンカー(L)は存在せず、この場合、創傷包帯材料は、式M−Rの化合物を含み、MおよびRは、各々個々に、上に記載されるとおりである。
式Iもしくは式IIの創傷包帯材料のいくつかの実施形態では、ゲル形成ポリマーは、セルロース、化学修飾セルロース、ペクチン、アルギン酸塩、キトサン、修飾キトサン、ヒアルロン酸、多糖類、もしくはガム由来ポリマー、またはそれらの誘導体、あるいはそれらの任意の混合物もしくは組み合わせから選択される化合物である。
創傷包帯材料がリンカーを含むいくつかの実施形態では、リンカーは、ゲル形成ポリマーに共有結合的または非共有結合的に付着され得る。当該技術分野で理解されているように、共有結合は、電子の共有を伴う。対照的に、非共有結合は、例えば、イオン相互作用、静電相互作用、水素結合相互作用、物理化学的相互作用、ファンデルワールス力、ルイス酸/ルイス塩基相互作用、またはそれらの組み合わせを含み得る。特に、リンカーは、共有結合相互作用を介してゲル形成ポリマーに付着または接合する。
いくつかの実施形態では、創傷包帯材料は、レポーター分子を含む領域を含む。具体的には、レポーターは、1つ以上の創傷特異的マーカー、例えば、創傷環境に見られる酵素に対する基質である。本明細書中で使用される場合、「創傷特異的酵素」は、創傷において差異的に発現される酵素である。「差異的発現」とは、酵素のレベルもしくは活性が、他の部位、例えば、正常組織もしくは周囲組織と比較して、創傷微小環境において、より高いかもしくは低いことを意味する。具体的には、差異的発現は、正常もしくは未損傷組織と比較して、創傷微小環境における酵素の発現もしくは活性のより高いレベルを示唆する。酵素の差異的発現は、慣例的手段によって分析することができる。例えば、サンプル中の酵素のレベルは、ELISAアッセイまたは他の免疫アッセイによって分析することができる。酵素の活性は、例えば、質量分析またはHPLCを使用して、基質の損失速度および/または生成物の形成速度を測定することによって分析することができる。そのような技術は、当該技術分野で知られており、実施例の項に記載されている。
表1
式中、Rは、レポーター分子を含む領域であり、mは、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、25、30以上であり、nは、例えば、201、202、203等の間の全ての単位値を含む、200〜4000、例えば、250、300、350、400、450、500、550、600、650、700、750、800、850、900、950、1000、1100、1200、1300、1400、1500、1600、1700、1800、1900、2000、2100、2200、2300、2400、2500、2600、2700、2800、2900、3000、3100、3200、3300、3400、3500、3600、3700、3800、3900、4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。いくつかの実施形態では、Rは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域である。
式中、Rは、レポーター分子を含む領域であり、nは、例えば、201、202、203等の間の全ての単位値を含む、200〜4000、例えば、250、300、350、400、450、500、550、600、650、700、750、800、850、900、950、1000、1100、1200、1300、1400、1500、1600、1700、1800、1900、2000、2100、2200、2300、2400、2500、2600、2700、2800、2900、3000、3100、3200、3300、3400、3500、3600、3700、3800、3900、4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。いくつかの実施形態では、Rは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域である。いくつかの実施形態では、Rは、レポーター分子および1つのアミノ酸を含むペプチド領域である。
式IIa
式中、Mは、セルロース、化学修飾セルロース、ペクチン、アルギン酸塩、キトサン、ヒアルロン酸、多糖類、もしくはガム由来ポリマー、またはそれらの任意の組み合わせから選択されるゲル形成ポリマーであり、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、Lは、MとPEPとを繋ぐリンカーであり、Lは、1つ以上のポリエチレングリコール亜単位もしくはポリプロピレン亜単位を含む。
式中、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、mは、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、25、30以上であり、nは、200〜4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。
式中、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、mは、1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、25、30それ以上であり、nは、例えば、201、202、203等の間の全ての単位値を含む、200〜4000、例えば、250、300、350、400、450、500、550、600、650、700、750、800、850、900、950、1000、1100、1200、1300、1400、1500、1600、1700、1800、1900、2000、2100、2200、2300、2400、2500、2600、2700、2800、2900、3000、3100、3200、3300、3400、3500、3600、3700、3800、3900、4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。
本明細書に記載される実施形態は、さらに、式Iまたは式IIの化合物を含有する組成物に関する。このような組成物は、従来の方法を使用して調製され得る。
本明細書に記載される実施形態は、さらに、式Iもしくは式IIの前述の化合物のうちの1つ以上および担体を含む、薬学的組成物および/もしくは調製物に関する。「薬学的に許容される」という語句は、健全な医学的判断の範囲内で、妥当な利益/リスク比に見合う、過剰な毒性、刺激、アレルギー反応、または他の問題もしくは合併症を伴わない、ヒトおよび/もしくは他の哺乳動物の組織と接触して使用するのに好適な化合物、塩、組成物、剤形等を指すために本明細書で用いられる。いくつかの態様では、「薬学的に許容される」とは、連邦もしくは州政府の規制機関によって承認されているか、または哺乳動物(例えば、動物)、より具体的には、ヒトにおいて使用するための米国薬局方もしくは他の一般に認識されている薬局方に列挙されていることを意味する。
特定の実施形態では、本明細書に記載されるような創傷包帯材料、例えば、式Iまたは式IIの化合物を含む創傷包帯を本明細書に開示する。いくつかの実施形態では、創傷包帯は、本明細書に記載される創傷包帯材料、例えば、式Iまたは式IIの化合物から本質的になる。
特定の実施形態では、開示される技術は、1つもしくは別個の区画内に、任意選択的に賦形剤、担体、もしくは油と共に、式Iもしくは式IIの化合物を含むキットを提供する。キットは、1つ以上の区画内に、追加の成分、例えば、ゲル化剤、皮膚軟化剤、界面活性剤、湿潤剤、粘度増強剤、乳化剤等をさらに含み得る。キットは、任意選択的に、創傷、例えば、慢性創傷もしくは感染性創傷を診断、検出、もしくは治療するための物品を処方するための説明書を含み得る。キットはまた、創傷の治療において、個々にまたは共にのいずれかで、構成要素を使用するための説明書を含み得る。
開示される技術の実施形態は、式Iもしくは式IIの前述の化合物を含む表面をさらに提供し、レポーターもしくはペプチドは、パートナー、例えば、酵素への結合を可能にするように配向される。好ましくは、表面は、固体支持体の表面である。多数の多様な固体支持体が、当業者に知られている。有用な固体支持体には、寒天、アガロース、架橋アルギン酸、置換および架橋グアーガム、特に硝酸およびカルボン酸とのセルロースエステル、混合セルロースエステル、およびセルロースエーテル等の天然ポリマー炭水化物およびそれらの合成修飾、架橋、もしくは置換誘導体;架橋もしくは修飾ゼラチンを含むプロテインおよび誘導体等の窒素を含有する天然ポリマー;ラテックスおよびゴム等の天然炭化水素ポリマー;ポリエチレン、ポリプロピレン、ポリスチレン、ポリ塩化ビニル、ポリ酢酸ビニル、およびそれらの部分的に加水分解された誘導体、ポリアクリルアミド、ポリメタクリレートを含むビニルポリマー、ポリエステル、ポリアミド等の上の重縮合物のコポリマーおよびターポリマー、ならびにポリウレタンもしくはポリエポキシド等の他のポリマー等の好適な多孔構造により調製され得る合成ポリマー;硫酸バリウム、硫酸カルシウム、炭酸カルシウム、アルカリおよびアルカリ土類金属のケイ酸塩、アルミニウムおよびマグネシウムを含むアルカリ土類金属およびマグネシウムの硫酸塩もしくは炭酸塩等の多孔無機材料;および粘土、アルミナ、タルク、カオリン、ゼオライト、シリカゲル、もしくはガラス(これらの材料は、上のポリマー材料と共にフィルターとして使用され得る)等のアルミニウムまたはシリコン酸化物もしくは水和物;ならびに既存の天然ポリマー上の合成ポリマーのポリマー化を初期化することによって得られるグラフトコポリマー等の上のクラスの混合物もしくはコポリマーが含まれる。
開示される技術の実施形態は、前述の組成物および/またはキットを含む診断システムをさらに提供する。
式中、Rは、レポーター分子を含む領域であり、mは、1、2、3、4、5、6、7、8、9、もしくは10であり、nは、200〜4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。いくつかの実施形態では、Rは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域である。
式中、Rは、レポーター分子を含む領域であり、nは、200〜4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。いくつかの実施形態では、Rは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域である。いくつかの実施形態では、Rは、レポーター分子および1つのアミノ酸を含むペプチド領域である。
式中、Mが、ゲル形成ポリマーであり、PEPが、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、Lは、MとPEPとを繋ぐリンカーである、創傷包帯材料を含む創傷包帯を本明細書に提供する。
式中、Mは、セルロース、化学修飾セルロース、ペクチン、アルギン酸塩、キトサン、修飾キトサン、ヒアルロン酸、多糖類、もしくはガム由来ポリマー、CES、酸化セルロース(もしくはその誘導体)、またはそれらの任意の組み合わせから選択されるゲル形成ポリマーであり、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、Lは、MとPEPとを繋ぐリンカーであり、Lは、1つ以上のポリエチレングリコール亜単位もしくはポリプロピレン亜単位を含む。
式中、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、mは、1、2、3、4、5、6、7、8、9、もしくは10であり、nは、200〜4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。
式中、PEPは、レポーター分子および少なくとも1つのアミノ酸を含むペプチド領域であり、mは、1、2、3、4、5、6、7、8、9、もしくは10であり、nは、200〜4000から選択される整数である。さらなる実施形態では、nは、300〜3500から選択される整数である。またさらなる実施形態では、nは、400〜3200から選択される整数である。
本明細書で提供される実施形態は、さらに、式Iもしくは式IIの化合物であって、それらの前駆体を含む式Iもしくは式IIの化合物を作製する方法に関する。「前駆体」という用語は、中間生成物または最終生成物を生成するための反応物として用いられる任意の化合物を含む。
一実施形態では、本明細書に記載される組成物、包帯材料、物品、キット、およびシステムは、創傷、特に慢性創傷もしくは感染性創傷の診断もしくは治療に有用である。任意の種類の創傷を診断および/または治療することができるが、実施形態は、創傷液を滲出させる創傷の診断および治療に特に好適である。例えば、創傷は、慢性創傷または急性創傷であり得る。慢性創傷の代表的な例には、例えば、静脈性潰瘍、褥瘡、褥瘡潰瘍、糖尿病性潰瘍、および未知病因の慢性潰瘍が含まれる。急性創傷の代表的な例には、おそらく意図的な手術切開の結果としての、例えば、急性外傷性裂傷が含まれる。
化合物1−cを質量分析バイアルに秤量した(〜0.0013g/バイアル)。およそ1mlの必要な溶媒をバイアルに追加した。最初に、サンプルを、40℃で1分間穏やかに加熱した後、10秒間超音波処理した後、かつ室温で一晩放置した後に、以下の時点での溶解度について視覚的に評価した。データを以下に示す:xは、不溶性材料を示す。
酵素効力を、PBS(0.99mL)中の純粋なエステラーゼ(0.01mL)を混合することによって到達されるエステラーゼ(約50単位/mLで検査した。
表2
酵素効力は、エステラーゼ(純粋なエステラーゼ(0.01mL)をPBS(0.99mL)中に混合することによって達成される〜58単位/mL)で検査した。
プロテアーゼ/ペプチドの酵素切断
トリプシン、キモトリプシン、およびサーモリシン等の他のプロテアーゼを含む創傷特異的プロテアーゼの活性をアッセイした。トリプシンは、P1がLysまたはArgであり、P1’が非特異的である、P1−P1’を切断する(プロリンが続く場合を除く)。キモトリプシンは、P1が任意の芳香族アミノ残基、Trp、Tyr、またはPheであり、P1’が非特異的である、P1−P1’を切断する。サーモリシンは、P1が非特異的であり、P1’がLeu、Phe、Ile、Val、Met、Alaであり、P2’がProではない、P2−P1−P1’−P2’を切断するメタロエンドペプチダーゼである。
エステラーゼアッセイにおけるより長いPEG鎖長の効果を調査するために、蛍光測定値を、77(CMC−「より長い」PEG−NH−Cys(Fmoc)−マレイミドフルオレセインジアセテート)について記録した。この試験では、サンプル当たり4回の複製を実施し、2時間の期間にわたる1分間のサイクルを記録した。より短い基質と同様に、より長い基質(77)をエステラーゼと共にインキュベートすると、蛍光が検出される。116U/mL(強)エステラーゼサンプルは、40分後にピークに到達し、58U/mL(弱)エステラーゼサンプルは、80分後にピークに到達した。116U/mLエステラーゼ反応の速度は、58U/mLサンプルの速度の2倍であり、したがって、酵素濃度の倍増により、速度が倍増した。反応速度は、より短いPEGリンカー等価物の反応速度よりも有意に低かった。ペプチドのCMCへの装荷がより低かったので、この減少は、予想された。
エラスターゼを粉末形態でのCMC−PEG−NH−AAPVC−マレイミドフルオレセインに追加するときに生成された断片を特徴付ける試みで、実験を設定した。エラスターゼ(PBS中0.5mg/mL)を78に追加し、37℃でインキュベートし、アリコートをいくつかの時点(1分〜3時間)にわたって回収し、液体窒素中で直ちに凍結することによって保存した。各解凍されたアリコートに対してHPLCを実施して、断片を分離し、次に質量分析法を実施して、その質量を分析した。分析は、エラスターゼとのインキュベーション中に切断された予想される断片の存在を確認した。予測どおり、切断部位は、AlaおよびValのP1にあった。さらに、Pro断片のいくつかの証拠があったが、これは、ProのP1位置にさらなる切断部位があることを示唆する。この結果は、蛍光光度計アッセイ中に記録された蛍光の増加と一致し、システムが特定の酵素を検出して、検出可能な信号を与えることができるという証拠をさらに構築する。
細胞研究−医療デバイスの生体適合性
医療デバイスを設計する際に考えるべき重要な点は、その生物学的安全性、および細胞傷害性、感作性、血液適合性、発熱原性、移植性、遺伝毒性、発がん性、生殖・発生毒性、生分解性等の他の因子である。新規の材料とインビトロで成長した細胞との間の相互作用の研究は、これらの材料の毒性の良好な指標を与えることができ、したがって、これらの方法のアレイが使用される(Eisenbrandら、FoodChem.Toxicol.2002、40、193−236)。デバイスの最終用途に関連する身体の領域および機能に適した試験を行うためには、好適な細胞型を選択しなければならない。本方法は、定量的または純粋に視覚的であり得、現代の技術は、顕微鏡を介した細胞の経時的ビデオ撮像の使用等、細胞相互作用の洗練された視点を可能にする。
スクラッチアッセイは、繊維芽細胞のコンフルエントな単層を平らな表面上で成長させ、次に、この表面を「引っかく」か、または「創傷を付けて」、繊維芽細胞の2つの領域を分離するチャネルを作製する技術である。サンプル溶液を細胞の頂部に追加し、細胞がどのように反応するかを見るために、共焦点顕微鏡法を使用して、経時的にチャネルを観察する(Liangら、Nat.Protocols 2007、2、329−333)。サンプルを含有する周囲領域が細胞を受け入れやすい場合、細胞は増殖および移動して、時間の経過中にチャネルを充填し、サンプルが受け入れられない場合、細胞は、移動せずに死滅するだろう。
コラーゲンマトリックスモデルは、治癒の再構成期中の真皮を表すインビトロツールである。ここでは、一連の線維芽細胞集団コラーゲン格子(FPCL)を使用して、コラーゲンマトリックスの再構成に対するそれらの効果に関して、ペプチド修飾セルロースを対照群と比較した。正常な状態下では、線維芽細胞の再構成によりFPCLの直径が減少することが予想され、これは、細胞過程が正常に進行しており、「治癒」が起こり得ることを示す(Carlsonら、Wound Repair Regen.2004、12、134−147)。
概して、試験期間中、線維芽細胞は、生存したままであり、増殖して、スクラッチチャネルを充填した。結果(図5)は、繊維芽細胞がスクラッチチャネルを完全に閉鎖するのに要した時間を示す。図5に示すように、全てのサンプルは、70時間以内にチャネルを閉鎖した。CMC粉末サンプルは、これが創傷接触用途に使用するのに安全であると知られているので、参照として使用した。CMC−PEG−NH2繊維は、対照群よりも短い時間で引っかき傷が閉鎖した唯一のサンプルであった。CMC−PEG−NH2粉末の引っかき傷の閉鎖時間は、他の修飾CMCサンプル(約40〜60時間)と略等価であり、これは、細胞が繊維形態でのサンプルの物理的構造に対して何らかの選好性を有し得ることを示唆する。
コラーゲンマトリックスモデル研究中、線維芽細胞は、全てのサンプルにわたって生存したままであった。対照群と比較して、修飾CMCサンプルについて、83のCMC−より長いPEG−NH2粉末を除いて、わずかに少ない再構成のみが観察され、これは、他のサンプルと比較して、試験を通して限定された線維芽細胞の再構成のみを示した(図8、図9、および図10)。化合物83(CMC−より長いPEG−NH2粉末、7日目に約40mm〜60mmの格子径)と化合物12(CMC−PEG−NH2粉末、7日目に約15mm〜35mmの格子径)との間に、有意な差が観察され、その結果は、図8〜10から明らかである。図11〜13の写真から明らかな生データは、それぞれ、患者A(図11)、B(図12)、およびC(図13)から得られた細胞サンプル中の3日目および7日目での化合物12、83、81、74、78、80、CMC粉末、およびCMC繊維の各々の格子径に対する効果を実証している。
本研究は、修飾CMC材料が線維芽細胞に対して有毒ではないことを実証している。また、繊維および粉末形態、より長いもしくはより短いPEGスペーサーリンカー、またはペプチドおよび検出可能な断片の追加の間に差異はなかった。線維芽細胞は、コラーゲンマトリックスモデル中の全ての場合において生存し、他の化合物と比較して減衰した効果を示した83のCMC−より長いPEG−NH2粉末を除いて、サンプルの大部分について、再構成は、対照群よりもわずかに低いのみであった。
液晶実験設定
CMCゲルが5CB液晶上に配置された間、研究を実施し、偏光顕微鏡を使用して、アンカーリングを経時的に観察した。LC研究を設定するためには、LCを設定領域内に保持することを可能にし、偏光顕微鏡を使用して視覚化することを可能にするために、チャンバを作製する必要がある。5CBのTEMグリッド閉じ込めは、公開された研究(Nazarenkoら、Physical Review E 1999、60、R3495−R3497;Brakeら、Langmuir 2003、19、6436−6442)に従って実施された。
前の実施例は、先の実施例で使用されたものに対して、開示された技術の一般的もしくは具体的に記載される反応物および/もしくは動作状態を置換することによって、繰り返すことができる。
開示された技術の好ましい実施形態が本明細書に示され、かつ説明されているが、そのような実施形態が単なる例示として提供されていることは、当業者に明らかであろう。当業者には、数多くの変形例、変更例、および置換例が、これより生じるであろう。本明細書に記載される開示された技術の実施形態に対する様々な代替例が、開示された技術の実施において用いられ得ることが、理解されるべきである。以下の特許請求の範囲は、開示された技術の範囲を定義し、これらの特許請求の範囲の範囲内の方法および構造ならびにそれらの等価物が、それによって含まれることが意図される。
Claims (42)
- 前記Lが、存在しない、請求項1に記載の創傷包帯材料。
- 前記Mが、Rと共有結合的または非共有結合的に接合している、請求項2に記載の創傷包帯材料。
- Lが、存在する、請求項1に記載の創傷包帯材料。
- 前記リンカーLが、互いに独立して、MおよびRと共有結合的または非共有結合的に接合している、請求項4に記載の創傷包帯材料。
- 前記レポーターが、酵素基質を含む、請求項1に記載の創傷包帯材料。
- 前記酵素基質が、糖、多糖類、核酸、アミド、ペプチド、プロテイン、脂質、またはそれらの誘導体もしくはそれらの組み合わせである、請求項6に記載の創傷包帯材料。
- 前記酵素基質が、糖、多糖類、アミド、ペプチド、プロテイン、またはそれらの誘導体もしくはそれらの組み合わせである、請求項7に記載の創傷包帯材料。
- 前記ゲル形成ポリマーが、セルロース、カルボキシメチルセルロース、ペクチン、アルギン酸塩、キトサン、ヒアルロン酸、多糖類、もしくはガム由来ポリマー、またはそれらの誘導体、あるいはそれらの任意の混合物もしくは組み合わせから選択される、請求項1に記載の創傷包帯材料。
- 前記ゲル形成ポリマーが、カルボキシメチルセルロースまたはその塩である、請求項9に記載の創傷包帯材料。
- 前記ゲル形成ポリマーが、約200〜約4000個のモノマー単位を含む、請求項9に記載の創傷包帯材料。
- 前記ゲル形成ポリマーが、約500〜約2000個のモノマー単位を含む、請求項11に記載の創傷包帯材料。
- Lが、エトキシル化多価アルコール、ポリビニルピロリドンポリマー、ポリプロピレン、ポリアルキレングリコール、ポリアミン、またはそれらのエーテル、アミド、もしくはエステルである中性ポリマーを含む、請求項1に記載の創傷包帯材料。
- Lが、エトキシル化多価アルコール、ポリビニルピロリドンポリマー、ポリプロピレン、ポリアルキレングリコール、ポリアミン、またはそれらのエーテル、アミド、もしくはエステルの2〜10個のモノマー単位を含む中性ポリマーである、請求項13に記載の創傷包帯材料。
- Lが、少なくとも1つのポリプロピレングリコール亜単位を含む、請求項13に記載の創傷包帯材料。
- 前記レポーター分子が、検出可能な標識を含む、請求項1に記載の創傷包帯材料。
- 前記検出可能な標識が、発光分子、化学発光分子、蛍光色素、蛍光消光剤、脂質、着色分子、放射性同位体、シンチラント、ビオチン、アビジン、ストレプトアビジン、プロテインA、プロテインG、抗体またはその断片、ポリヒスチジン、Ni2+、Flagタグ、mycタグ、重金属、および酵素からなる群から選択される、請求項16に記載の創傷包帯材料。
- 前記レポーター分子が、フルオレセイン、ローダミン、テトラメチルローダミン、R−フィコエリトリン、Cy−3、Cy−5、Cy−7、テキサスレッド、ファーレッド、アロフィコシアニン(APC)、フルオレセインアミン、エオシン、ダンシル、ウンベリフェロン、5−カルボキシフルオレセイン(FAM)、2’7’−ジメトキシ−4’5’−ジクロロ−6−カルボキシフルオレセイン(JOE)、6カルボキシローダミン(R6G)、N、N、N’、N’−テトラメチル−6−カルボキシローダミン(TAMRA)、6−カルボキシ−X−ローダミン(ROX)、4−(4’−ジメチルアミノフェニルアゾ)安息香酸(DABCYL)、5−(2’−アミノエチル)アミノナフタレン−1−スルホン酸(EDANS)、4−アセトアミド−4’−イソチオシアナトスチルベン−2,2’−ジスルホン酸、アクリジン、アクリジンイソチオシアネート、r−アミノ−N−(3−ビニルスルホニル)フェニルナフタルイミド−3,5、ジスルホネート(ルシファーイエローVS)、N−(4−アニリノ−1−ナフチル)マレイミド、アントラニルアミド、ブリリアントイエロー、クマリン、7−アミノ−4−メチルクマリン、7−アミノ−4−トリフルオロメチルクルアリン(クマリン151)、シアノシン、4’,6−ジアミジノ−2−フェニルインドール(DAPI)、5’,5’’−ジアミジノ−2−フェニルインドール(DAPI)、5’,5’’−ジブロモピロガロール−スルホンフタレイン(ブロモピロガロールレッド)、7−ジエチルアミノ−3−(4’−イソチオシアナトフェニル)−4−メチルクマリンジエチレントリアミンペンタアセタート、4,4’−ジイソチオシアナトジヒドロ−スチルベン−2,2’−ジスルホン酸、4,4’−ジイソチオシアナトスチルベン−2,2’−ジスルホン酸、4−ジメチルアミノフェニルアゾフェニル−4’−イソチオシアネート(DABITC)、エオシンイソチオシアネート、エリスロシンB、エリスロシンイソチオシアネート、エチジウム、5−(4,6−ジクロロトリアジン−2−イル)アミノフルオレセイン(DTAF)、QFITC(XRITC)、フルオレサミン、IR144、IR1446、マラカイトグリーンイソチオシアネート、4−メチルウンベリフェロン、オルトクレゾールフタレイン、ニトロチロシン、パラローザニリン、フェノールレッド、B−フィコエリスリン、o−フタルジアルデヒド、ピレン、酪酸ピレン、スクシンイミジル1−酪酸ピレン、リアクティブレッド4、リサミンローダミンBスルホニルクロライド、ローダミンB、ローダミン123、ローダミンX、スルホローダミンB、スルホローダミン101、スルホローダミン101の塩化スルホニル誘導体、テトラメチルローダミン、リボフラビン、ロゾール酸、およびテルビウムキレート誘導体からなる群から選択される蛍光分子を含む、請求項15に記載の創傷包帯材料。
- 前記レポーターが、検出可能な標識および消光剤分子を含む、請求項16に記載の創傷包帯材料。
- 前記消光剤分子を含む前記レポーターが、酵素またはその生成物によって活性化される、請求項19に記載の創傷包帯材料。
- 前記レポーター分子またはその一部分が、酵素との相互作用の際に放出される、請求項16に記載の創傷包帯材料。
- 前記レポーターが、創傷特異的酵素に特異的な基質を含む、請求項16に記載の創傷包帯材料。
- 前記創傷特異的酵素が、プロテアーゼである、請求項22に記載の創傷包帯材料。
- 前記レポーターが、MMP−1(コラゲナーゼ)、MMP−2(ゼラチナーゼA)、MMP−3(ストメリシン1)、MMP−8(好中球コラゲナーゼ)、MMP−9(ゼラチナーゼB)、ヒト好中球エラスターゼ(HNE)、カテプシンG、ウロキナーゼ型プラスミノーゲン活性化因子(uPA)、およびリゾチームからなる群から選択される創傷特異的酵素に特異的な基質を含む、請求項22に記載の創傷包帯材料。
- 前記レポーターが、MMP−2およびMMP−9またはそれらの組み合わせに特異的な基質を含む、請求項24に記載の創傷包帯材料。
- 請求項1に記載の包帯材料を含み、かつ担体をさらに含む、組成物。
- 請求項26に記載の組成物を含む薬学的組成物であって、前記担体が、薬学的に許容される担体である、薬学的組成物。
- 抗生物質化合物または創傷治癒ペプチドをさらに含む、請求項27に記載の薬学的組成物。
- 前記抗生物質が、β−ラクタム、フルオロキノロン、アミノグリコシド、テトラサイクリン、グリシルサイクリン、およびポリミキシンからなる群から選択される、請求項28に記載の薬学的組成物。
- 前記創傷治癒ペプチドが、線維芽細胞成長因子(FGF)または血小板由来成長因子(PDGF)である、請求項29に記載の薬学的組成物。
- 創傷の状態を診断する方法であって、
前記創傷を請求項1に記載の創傷包帯材料と接触させて、前記レポーター分子の検出可能な信号への変換を可能にするステップと、
信号を検出するステップと、を含む、方法。 - 前記レポーター分子の検出可能な信号への変換が、創傷特異的プロテアーゼによって実行される、請求項31に記載の方法。
- 前記創傷特異的プロテアーゼが、MMP−1(コラゲナーゼ)、MMP−2(ゼラチナーゼA)、MMP−3(ストメリシン1)、MMP−8(好中球コラゲナーゼ)、MMP−9(ゼラチナーゼB)、ヒト好中球エラスターゼ(HNE)、カテプシンG、ウロキナーゼ型プラスミノーゲン活性化因子(uPA)、およびリゾチームからなる群から選択される、請求項32に記載の方法。
- 慢性創傷または感染性創傷の存在または非存在を判定するステップをさらに含む、請求項31に記載の方法。
- 慢性創傷または感染性創傷の存在または非存在を判定する前記ステップが、前記創傷におけるパラメータを測定するステップと、前記測定されたパラメータを閾値レベルと比較するステップと、前記創傷における前記パラメータのレベルが前記閾値レベルよりも高い場合、前記創傷が、慢性もしくは感染性であると判定するステップと、を含む、請求項34に記載の方法。
- 前記パラメータが、MMP−1(コラゲナーゼ)、MMP−2(ゼラチナーゼA)、MMP−3(ストメリシン1)、MMP−8(好中球コラゲナーゼ)、MMP−9(ゼラチナーゼB)、ヒト好中球エラスターゼ(HNE)、カテプシンG、ウロキナーゼ型プラスミノーゲン活性化因子(uPA)、およびリゾチームからなる群から選択される創傷特異的プロテアーゼの量または活性である、請求項35に記載の方法。
- 慢性創傷もしくは感染性創傷を治療する方法であって、請求項1に記載の包帯材料を前記対象に投与することを含み、前記包帯材料が、前記創傷に局所的もしくは経皮的に適用される、方法。
- Lが、存在せず、前記ゲル形成ポリマーMをレポーター領域Rに接合させて、それにより式M−Rの化合物を生成することを含み、MおよびRが、各々個々に、請求項1に記載されるとおりである、請求項1に記載の式Iの化合物を作製する方法。
- Lが、存在し、前記ゲル形成ポリマーMをリンカーLに接合させて、それにより前駆体化合物M−Lを生成することと、前記前駆体化合物M−Lをレポーター領域Rに接合させて、それにより式M−L−Rの化合物を生成することと、を含み、M、L、およびRが、各々個々に、請求項1に記載されるとおりである、請求項1に記載の式Iの前記化合物を作製する方法。
- Lが、存在し、前記リンカーLをレポーター領域Rに接合させて、それにより前駆体化合物L−Rを生成することと、前記前駆体化合物L−Rをゲル形成ポリマーMに接合させて、それにより式M−L−Rの化合物を生成することと、を含み、M、L、およびRが、各々個々に、請求項1に記載されるとおりである、請求項1に記載の式Iの前記化合物を作製する方法。
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AU2017244116A1 (en) | 2018-11-15 |
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EP3436012B1 (en) | 2023-09-20 |
SG11201808528VA (en) | 2018-10-30 |
CA3019548A1 (en) | 2017-10-05 |
EP3436012C0 (en) | 2023-09-20 |
TW201806625A (zh) | 2018-03-01 |
IL262011A (en) | 2018-10-31 |
WO2017173026A1 (en) | 2017-10-05 |
JP7395630B2 (ja) | 2023-12-11 |
CN109219436A (zh) | 2019-01-15 |
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BR112018070191A2 (pt) | 2019-01-29 |
AR108054A1 (es) | 2018-07-11 |
US11865192B2 (en) | 2024-01-09 |
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