JP5702723B2 - 声帯および軟組織の増強および修復用ヒドロゲル - Google Patents
声帯および軟組織の増強および修復用ヒドロゲル Download PDFInfo
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- JP5702723B2 JP5702723B2 JP2011526044A JP2011526044A JP5702723B2 JP 5702723 B2 JP5702723 B2 JP 5702723B2 JP 2011526044 A JP2011526044 A JP 2011526044A JP 2011526044 A JP2011526044 A JP 2011526044A JP 5702723 B2 JP5702723 B2 JP 5702723B2
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- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 1
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- VLPFTAMPNXLGLX-UHFFFAOYSA-N trioctanoin Chemical compound CCCCCCCC(=O)OCC(OC(=O)CCCCCCC)COC(=O)CCCCCCC VLPFTAMPNXLGLX-UHFFFAOYSA-N 0.000 description 1
- PHYFQTYBJUILEZ-IUPFWZBJSA-N triolein Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC PHYFQTYBJUILEZ-IUPFWZBJSA-N 0.000 description 1
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- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
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- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
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- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
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Landscapes
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Description
本願は、米国特許法第119条(e)に基づいて、2008年9月4日に出願された米国仮特許出願第61/094,237号の優先権を主張し、この米国仮特許出願第61/094,237号は、ここに引用により援用されている。
声帯ヒダは、発声に必須の最も重要な振動組織である。ヒトには2つの声帯ヒダがあり、各々が、固有層(lamina propria: LP)および声帯筋を被包する重層扁平上皮からなる(Hirano, Phonosurgery: Basic and Clinical Investigations. Otologia (Fukuoka), 1975.21:p.239-442; Hirano, Structure of the vocal fold in normal and diseased states: anatomical and physical studies. The Conference on the Assessment of Vocal Patology; The American Speech-Language-Hearing Association, 1981.11:p.11-27の議事録;この各々がここに引用により援用されている)。固有層は、表面、中間、深部の3層に大まかに分割できる軟組織である。声帯靱帯は固有層の中間層および深層で構成され、声帯筋は声帯靱帯の深くに位置している。図1a−1b参照。声帯粘膜(すなわち表面固有層およびそれを覆う上皮)は、正常な発声に不可欠な主要な振動層であると長年にわたり認識されている(Bishop, J., Experimental Researches into the Physiology of the Human Voice. The London & Edinburgh Philosophical Magazine & Journal of Science, 1836;ここに引用により援用されている)。表面固有層(superficial lamina propria: SLP)は比較的無細胞の柔軟な軟組織であり、振動を担う発声粘膜の主要な構成要素である。これは、ほとんどの音声外科手術において同定、評価、および維持されなければならない(Zeitels, S.M., Hillman, R.E., Franco, R.A., Bunting, G., Voice and Treatment Outcome from Phonosurgical Management of Early Glottic Cancer. Annals of Otology, Rhinology and Laryngology, 2002.111(Supplement 190):p.1-20; Zeitels, S.M., Hillman, R.E., Desloge, R.B., Mauri, M., Doyle, P.B., Phonomicrosurgery in Singers & Performing Artists: Treatment Outcomes, Management Theories, & Future Directions. Annals of Otology, Rhinology, & Laryngology, 2002.111(Supplement 190):p.21-40; Zeitels, S.M., Healy, G.B., Laryngology and Phonosurgery. New England Journal of Medicine, 2003.349(9):p.882-92;この各々がここに引用により援用されている)。声帯粘膜の柔軟性が減少すると典型的に、永続的な嗄声が引起こされる(Zeitels, S.M., Hillman, R.E., Franco, R.A., Bunting, G., Voice and Treatment Outcome from Phonosurgical Management of Early Glottic Cancer. Annals of Otology, Rhinology and Laryngology, 2002.111(Supplement 190):p.1-20; Zeitels, S.M., Hillman, R.E., Desloge, R.B., Mauri, M., Doyle, P.B., Phonomicrosurgery in Singers & Performing Artists: Treatment Outcomes, Management Theories,& Future Directions. Annals of Otology, Rhinology,& Laryngology, 2002.111(Supplement 190):p.21-40; Zeitels, S.M., Healy, G.B., Laryngology and Phonosurgery. New England Journal of Medicine, 2003.349(9):p.882-92;この各々がここに引用により援用されている)。この柔軟性の減少は、良性腫瘍、悪性腫瘍、疾病、および挿管(たとえば、麻酔または長期の集中治療室での呼吸補助のため)に起因し得る。長期にわたって過度に話す(音声外傷)という形での声帯ヒダに対する自己誘発性損傷、または煙、アルコール、もしくは逆流症による胃酸などの環境性損傷でさえ、表面固有層の硬化および瘢痕化を引起し得る。最も一般的な欠陥の1つは、SLPの瘢痕化を引起す、声帯発声粘膜における上皮下I型コラーゲンの堆積である。
本発明は、ヒドロゲルを用いて対象の発声粘膜の柔軟性を修復するためのシステムを提供する。本システムは、表面固有層が欠けている(たとえば声帯癌の治療が成功した後)、または表面固有層の機能的な振動能力が減少している(たとえば声の使い過ぎおよび/もしくは喫煙による慢性嗄声)上皮下発声粘膜領域に、ヒドロゲルまたは他の材料を挿入または注入することを伴う。これは、発声粘膜の柔軟性および正常な声帯振動を回復し、それによって硬直およびそれに伴う嗄声を減少させるために行なわれる。約25Paの剪断弾性係数を有するヒドロゲルが声帯修復用の発明のシステムに特に有用であることが判明した。本発明に有用なヒドロゲルは典型的に、1つのポリマーが非架橋性ポリマーの存在下で自己架橋すると形成される、半相互浸透網状組織である。本発明は、声帯修復用の発明のシステムに有用な新規のヒドロゲル組成、ならびに表面固有層の直下または内部に形成された空間にヒドロゲルを送達するための方法および装置を提供する。注入されたヒドロゲルは発声粘膜を増強するように作用し、この組織の振動および発声を可能にする。たとえば、限定されないが、関節保護薬(たとえばHYALGAN(登録商標)(ヒアルロン酸ナトリウム)、SYNVISC(登録商標)(Hylan G-F 20)、ORTHOVISC(登録商標)(高分子量ヒアルロナン))および皮膚充填剤(たとえばRESTYLANE(登録商標)(ヒアルロン酸)、PERLANE(登録商標)(ヒアルロン酸)、HYLAFORM(登録商標)(安定化ヒアルロン酸)、RADIESSE(登録商標)(水性ゲル中のカルシウムヒドロキシルアパタイトミクロスフェア))などの他の材料も、声帯修復のために用いられ得る。当業者によって認識されるように、本明細書中に記載のヒドロゲルは、他の軟組織を修復および/または増強するのにも有用である。たとえば、ヒドロゲルは、中央化(たとえば麻痺性発声障害)用の深部声帯インプラント(副声門筋肉)、皮膚充填剤、乳房インプラント、失禁治療用膀胱頚部インプラント、椎間円板、筋量、顔の輪郭矯正、および関節液として用いられ得る。さらに、傷、または鼻や耳などの開口部を含む切開部を埋めるためにも用いられ得る。
本明細書中で用いられる「抗炎症剤」とは、炎症の1つ以上の徴候または症状を抑制する任意の物質を指す。
本発明は、声帯ヒダの発声上皮下軟組織が振動および発声可能なように柔軟性を有しなければならないという認識に由来している。正常な状態では、これは表面固有層(SLP)である。この認識に基づいて、発声上皮の内部または下にヒドロゲルを注入すると、硬化および/または瘢痕化した声帯ヒダを有する患者の発声を向上できることが判明した。この方法に有用なヒドロゲルは典型的に、約15Paから約35Paの範囲の剪断弾性係数を有する。本発明はさらに、患者の声帯修復および他の軟組織(たとえば皮膚、筋肉、乳房、膀胱、椎間円板)に有用な新規のヒドロゲルおよびその組成を提供する。
本発明は、声帯修復、または他の軟組織修復もしくは増強に用いる新規のヒドロゲルを提供する。ヒドロゲルは、超吸収性の天然または合成ポリマーである。ヒドロゲルは、最大99重量%の水を含有し得る。ある一定のヒドロゲルが声帯修復に有用であることが判明した。ヒドロゲルは、1つ以上のポリマーを含み得る。ある実施形態では、ヒドロゲルは、架橋および/または非架橋ポリマーの混合物である。特に、ヒドロゲルを形成するポリマーの半相互浸透網状組織が声帯修復に有用であることが分かった。ヒドロゲルおよび一成分ヒドロゲルを形成するポリマーの相互浸透網状組織も声帯修復に有用であることが分かった。さらに、約15Paから約35Paの範囲の剪断弾性係数を有するヒドロゲルが、声帯の発声粘膜の柔軟性の回復に特に有用であることが判明した。ある実施形態では、ヒドロゲルの剪断弾性係数は約20Paから約30Paの範囲である。ある実施形態では、ヒドロゲルの剪断弾性係数は約25Paである。
本発明はさらに、瘢痕化した声帯ヒダの柔軟性を回復するために、声帯の内部または声帯の発声上皮の直下にポリマーヒドロゲルまたはその組成を注入する方法を提供する。ある実施形態では、ヒドロゲルは、粘膜の損失上皮下表面固有層に注入される。発明のヒドロゲルは、他の軟組織を修復または増強するためにも用いられ得る。ある実施形態では、ヒドロゲルは尿失禁治療のために膀胱頚部を増強するために用いられる。他の実施形態では、ヒドロゲルは、皮膚充填剤、乳房インプラント、椎間円板、筋量、および関節液として用いられる。
本発明はさらに、本明細書中に記載の1つ以上のヒドロゲルまたはヒドロゲル成分を容器に含むパッケージまたはキットを提供する。たとえば、容器には、患者に使用できる状態にあるヒドロゲル組成が入っていてもよい。または、容器には、ヒドロゲルを形成するために混合および架橋される必要があるヒドロゲル(たとえば架橋性ポリマー、非架橋性ポリマー)の成分が入っていてもよい。パッケージはまた、典型的に、医療機器および/または医薬品の製造、使用または販売を規制する政府機関によって処方された形態の、容器に関連付けられた告知を含み得、この告知は、声帯疾患または他の軟組織修復もしくは増強用の治療のヒトまたは動物投与についての、政府機関による組成の承認を反映している。ヒドロゲル組成の使用に関する指示も含まれ得る。そのような指示は、患者へのヒドロゲルの投与に関する情報を含み得る。特に、その指示は、患者の声帯へのヒドロゲルの注入に関する情報を含み得る。
実施例1:瘢痕化した声帯ヒダに注入するためのヒドロゲルの調製
半相互浸透網状組織技術を用いて、本実施例のヒドロゲルを作製した。この処理は、非架橋性ポリマー(Y)の存在下で重合する架橋性ポリマー(X)の使用を伴う。ゲルの物理化学的性質は、i)溶液中のXの画分(f);ii)成分の濃度(CXおよびCY);ならびにiii)ヒドロゲルの成分の分子量(MXおよびMY)を独立して変更することによって制御した。本実施例のヒドロゲルを形成するために用いたポリマーは、すべて水溶性であった。Irgacure 2959(Ciba Specialty Chemicals, Tarrytown, NJ)を光開始剤として使用して、UV光(中央値が365nm)を用いた光重合を行なった。以下に与えられる説明では、ある例示的なヒドロゲルを調製するための詳細なプロトコルを概説する。ここにおいて、
X=SunBio Inc.社から入手したポリエチレングリコールジアクリレート(PEG−DA)
Y=ポリエチレングリコール(PEG)
CX=混合前の100mg/mL(10% w/v)
CY=混合前の100mg/mL(10% w/v)
MX=10,000(10kDa)
MY=10,000(10kDa)
f=0.3
である。
1.リン酸緩衝食塩水(PBS)中で、PEG−DAおよびPEGの別個の溶液(両方100mg/mL)を作る。脱イオン水中のエタノール溶液(70%v/v)中で、Irgacure 2959の溶液(50mg/mL)を作る。
a.上記のようにして得られるポリマーの溶液を、無菌PBSを用いてオートクレーブバイアル内で作製し、注射器フィルタで濾過しない。一方、光開始剤溶液は、使用前に注射器フィルター(0.2μm)で濾過する。
a. X=SunBio Inc.社のポリエチレングリコールジアクリレート
Y=Genzyme社のヒアルロン酸
MX=10kDa
MY=560kDa
CX=100mg/mL
CY=1mg/mL
f=0.27
b. X=SunBio Inc. 社のポリエチレングリコールジアクリレート
Y=デキストラン
MX=10kDa
MY=200kDa
CX=100mg/mL
CY=20mg/mL
f=0.3
とした。
ウシ(cow)喉頭モデル。エクスビボのウシ喉頭モデルを用いて、声帯ヒダ柔軟性の測定値として、粘膜の波振幅に対するゲル硬さの影響を評価した。甲状腺薄膜に1cm×3cmの窓を切った後、甲状披裂筋の塊を除去して、SLPと甲状披裂筋との間のコラーゲン性組織の層である声帯靭帯の深面を露出させることによって、成牛(cow)死骸の喉頭を準備した。超小型はさみで靭帯を開き、固有層の軟質内容物を声帯ヒダの全範囲にわたって注意深く除去し、最小限のSLPが付着した薄い透明の上皮だけを残した。試験材料を、除去した固有層の体積と等しい体積(〜0.25ml)で上皮の後ろに層状に重ねた結果、2−3mmの厚みのゲル層が得られた。硬質ラテックスシートの楕円形片を、試験材料の後ろの、以前に声帯靭帯が占めていた場所に配置した。次に、高速画像法を用いた粘膜の波振幅の測定用に、筋肉および甲状軟骨全体の残りの空洞を硬質アルギネートで充填した。アルギネート、ダム、および試験材料を、同じ生体力学的環境における異なるヒドロゲルのその後の試験用に、容易に除去した。PEG30(G’=25Pa)、PEG34(G’=121Pa),およびPEG50(G’=566Pa)を調製し、試験した。制御として、声帯ヒダをさらにアルギネートのみで充填して硬直状態を作り出し、わずかな量のSLPしか残らないようにした。すべての材料を同じ喉頭内で試験し、各材料を2回試験した。声門圧力を下回る圧力用に制御される試験からの複数の高速ビデオクリップを選択し、最大の中央膜状声帯ヒダ可動域を2名の観察者によって盲検的に測定した。VF可動域は、各ゲルの駆動圧力と高度に相関関係があり(図3)、本モデルはゲルの硬さに敏感であった。図3に示されるように、PEG30はより硬いゲルよりも広い声帯ヒダ可動域に対応し、アルギネート充填状態はほとんど移動を示していない。
イヌでの試験。16匹の正常なイヌのVFにPEG30を一側性に(unilaterally)注入し、1、2、3、および4ヶ月(n=4/時点)の注入後生存期間を用いた。平均60μmのPEG30をVFに注入した。我々は、MGH Center for Laryngeal Surgery and Voice Rehabilitationで開発された方法を用いて、VF外観およびインビボでの機能を定期的に検査した。これらの検査時に、気管針を用いて発声のために空気を注入しつつ、VF振動のストロボ高速映像(4000フレーム/秒)を記録した。これらの記録によって、生理的条件下でのVFの柔軟性を評価することができる。麻酔後に切除した喉頭に高解像度MRIおよび組織学的検査を行なって、VF内のPEG30の場所を同定し、注入材料に対する組織反応を観察した。
単一のエマルション技術を用いて、抗線維薬であるラパマイシンを組込むポリ-L-乳酸−コ−グリコール酸(PLGA)ナノ粒子(NP)を作った。この技術は、多数の他の薬投与PLGAナノ粒子を調製するために用いられてきた。ラパマイシン投与NPを、乳酸:グリコール酸比が異なる2つのPLGAポリマー:すなわち乳酸:グリコール酸比がそれぞれ75:25および50:50のPLGA75:25およびPLGA50:50を用いて調製した。図6に示されるように、水性緩衝液中のPLGA75:25NPからのラパマイシンの放出割合は、同量の全投与薬品に対するPLGA50:50NPからの割合よりも低い。緩衝液中のPLGA75:25の分解割合は、PLGA50:50の割合よりも緩やかである。したがって、PLGA75:25を用いて作ったラパマイシン投与NPは、PLGA50:50を用いて作ったものよりも緩徐に薬品を放出すると予測された。約200nmのサイズのラパマイシン投与PLGA50:50NPを、ゲル化前の前駆体溶液にNPを取込むことによって、PEG30ヒドロゲルに投与した。最大8mg/mL(前駆体溶液中で)のラパマイシン投与PLGA NPを含有するPLGA50:50−PEG30ゲルは、NPをまったく含有しないPEG30と同様の生体力学的性質を有していた。この結果は、PEG30は発声粘膜の柔軟性を修復するために用いられ得るだけではなく、ラパマイシンなどの治療薬を声帯ヒダに放出することもできることを示唆している。薬品投与PLGA NPの作製過程は、ありとあらゆる薬品の取込みおよび徐放を受け入れられる。さらに、これらのNPが我々のヒドロゲルの好ましい力学的性質を損なわずにヒドロゲルに取込むことができる容易性から、さまざまな薬品溶出の、生体力学関連ヒドロゲルを声帯ヒダで用いるために特定的に調製可能であると考えられる。
当業者は、本明細書中に記載の本発明の具体的な実施形態の多くの均等物を認識するか、通常の実験を用いるだけで把握することができるであろう。本発明の範囲は上記の説明に限定されるよう意図されておらず、むしろ添付の請求項に記載される。
Claims (12)
- 表面固有層が欠けている、または表面固有層の機能的な振動能力が減少している上皮下発声粘膜領域の柔軟性を、発声粘膜の柔軟性を向上させ、それによって嗄声を減少させるために、ヒドロゲルを前記上皮下発声粘膜領域に挿入または注入することによって修復するためのヒドロゲルであって、前記ヒドロゲルは、
ポリエチレングリコールのアクリル化誘導体またはヒアルロン酸のアクリル化誘導体を含む架橋ポリマーおよび
水溶性ポリマーを含み、
前記ヒドロゲルは前記架橋ポリマーおよび前記水溶性ポリマーの半相互浸透網状組織または相互浸透網状組織であり、前記ヒドロゲルは約15Pa〜約121Paの範囲の剪断弾性係数を有する、ヒドロゲル。 - 前記架橋ポリマーはポリエチレングリコールジアクリレート(PEG−DA)を含み、
前記水溶性ポリマーはポリエチレングリコール(PEG)を含み、
前記ヒドロゲルは前記ポリエチレングリコールジアクリレート(PEG−DA)と前記ポリエチレングリコール(PEG)の半相互浸透網状組織である、請求項1に記載のヒドロゲル。 - 前記水溶性ポリマーは、ポリエチレングリコール(PEG)、ポリ(リシン)、ポリエーテル、ポリオール、ポリビニルアルコール、タンパク質、ポリサッカリド、ヒアルロン酸(HA)、デキストラン、アルギネート、ゼラチン、エラスチン、コラーゲン、セルロース、メチルセルロースおよびこれらの誘導体からなるグループより選択され、前記ヒドロゲルは前記架橋ポリマーおよび前記水溶性ポリマーの半相互浸透網状組織である、請求項1に記載のヒドロゲル。
- 前記ポリエチレングリコールジアクリレート(PEG−DA)の分子量が10kDa〜20kDaの範囲、および前記ポリエチレングリコール(PEG)の分子量が10kDa〜20kDaの範囲の両方または一方を満たす、請求項2に記載のヒドロゲル。
- 前記ヒドロゲルは、約15Pa〜約35Paの範囲の剪断弾性係数を有する、請求項1〜4のいずれか1項に記載のヒドロゲル。
- 前記ヒドロゲルは、瘢痕化した声帯の柔軟性を回復するために、声帯の内部に、前記声帯の発声上皮の下に、または前記粘膜の損失上皮下表面固有層に注入される、請求項1〜5のいずれか1項に記載のヒドロゲル。
- 前記架橋ポリマーは、ポリエチレングリコールジアクリレート(PEG−DA)を含み、および
前記水溶性ポリマーは、ポリエチレングリコール(PEG)、ポリ(リシン)、ヒアルロン酸(HA)、デキストラン、アルギネート、ゼラチン、エラスチン、コラーゲン、セルロース、メチルセルロースおよびこれらの誘導体からなるグループより選択され、
前記ヒドロゲルは前記架橋ポリマーおよび前記水溶性ポリマーの半相互浸透網状組織であり、
前記ヒドロゲルは約15Pa〜約35Paの範囲の剪断弾性係数を有する、請求項1〜6のいずれか1項に記載のヒドロゲル。 - 前記架橋ポリマーはポリエチレングリコールのアクリル化誘導体またはヒアルロン酸のアクリル化誘導体を含み、
前記水溶性ポリマーはポリサッカリドを含み、
前記ヒドロゲルは前記架橋ポリマーおよび前記水溶性ポリマーの半相互浸透網状組織を含む、請求項1に記載のヒドロゲル。 - 生理活性剤をさらに備える、請求項1〜8のいずれか1項に記載のヒドロゲル。
- 前記生理活性剤は細胞または医薬品である、請求項9に記載のヒドロゲル。
- 前記ポリエチレングリコールジアクリレート(PEG−DA)および前記ポリエチレングリコール(PEG)は、約30:70の割合で前記ヒドロゲル中に存在する、請求項2または4に記載のヒドロゲル。
- 対象の声帯を修復するためのキットであって、針と、請求項1〜11のいずれか1項に記載のヒドロゲルが入った注射器とを含む、キット。
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2009
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- 2009-09-03 US US12/553,800 patent/US9216188B2/en not_active Expired - Fee Related
- 2009-09-03 EP EP09811836.7A patent/EP2341953B1/en not_active Not-in-force
- 2009-09-03 WO PCT/US2009/004974 patent/WO2010027471A2/en active Application Filing
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20160126208A (ko) * | 2015-04-23 | 2016-11-02 | 광주과학기술원 | 그래핀 기반의 광열화 반응을 이용한 수화겔 제조용 조성물 및 수화겔 제조방법 |
KR101693497B1 (ko) * | 2015-04-23 | 2017-01-09 | 광주과학기술원 | 그래핀 기반의 광열화 반응을 이용한 수화겔 제조용 조성물 및 수화겔 제조방법 |
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US20160175483A1 (en) | 2016-06-23 |
EP2341953B1 (en) | 2018-11-21 |
EP2341953A2 (en) | 2011-07-13 |
WO2010027471A3 (en) | 2010-07-08 |
EP2341953A4 (en) | 2013-03-27 |
WO2010027471A2 (en) | 2010-03-11 |
US20100055184A1 (en) | 2010-03-04 |
JP2012501724A (ja) | 2012-01-26 |
US9682169B2 (en) | 2017-06-20 |
US9216188B2 (en) | 2015-12-22 |
WO2010027471A9 (en) | 2010-05-20 |
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