JP2012516224A5 - - Google Patents
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- JP2012516224A5 JP2012516224A5 JP2011548352A JP2011548352A JP2012516224A5 JP 2012516224 A5 JP2012516224 A5 JP 2012516224A5 JP 2011548352 A JP2011548352 A JP 2011548352A JP 2011548352 A JP2011548352 A JP 2011548352A JP 2012516224 A5 JP2012516224 A5 JP 2012516224A5
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- Japan
- Prior art keywords
- treatment device
- porous structure
- therapeutic agent
- reservoir
- therapeutic
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000003814 drug Substances 0.000 claims 22
- 230000001225 therapeutic Effects 0.000 claims 11
- -1 aldesleukin Proteins 0.000 claims 10
- 210000003786 Sclera Anatomy 0.000 claims 8
- 230000036499 Half live Effects 0.000 claims 7
- 230000000875 corresponding Effects 0.000 claims 5
- 108010050904 Interferons Proteins 0.000 claims 4
- 102000014150 Interferons Human genes 0.000 claims 4
- 229940079322 interferon Drugs 0.000 claims 4
- 239000000463 material Substances 0.000 claims 3
- 210000003161 Choroid Anatomy 0.000 claims 2
- 210000000795 Conjunctiva Anatomy 0.000 claims 2
- BLCLNMBMMGCOAS-URPVMXJPSA-N Goserelin Chemical compound C([C@@H](C(=O)N[C@H](COC(C)(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1[C@@H](CCC1)C(=O)NNC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 BLCLNMBMMGCOAS-URPVMXJPSA-N 0.000 claims 2
- 229960002913 Goserelin Drugs 0.000 claims 2
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- 102000007562 Serum Albumin Human genes 0.000 claims 2
- 108010071390 Serum Albumin Proteins 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
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- DEQANNDTNATYII-OULOTJBUSA-N (4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-19-[[(2R)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-N-[(2R,3R)-1,3-dihydroxybutan-2-yl]-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxa Chemical compound C([C@@H](N)C(=O)N[C@H]1CSSC[C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC=2C3=CC=CC=C3NC=2)NC(=O)[C@H](CC=2C=CC=CC=2)NC1=O)C(=O)N[C@H](CO)[C@H](O)C)C1=CC=CC=C1 DEQANNDTNATYII-OULOTJBUSA-N 0.000 claims 1
- HMLGSIZOMSVISS-ONJSNURVSA-N (7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(2,2-dimethylpropanoyloxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid Chemical compound N([C@@H]1C(N2C(=C(C=C)CSC21)C(O)=O)=O)C(=O)\C(=N/OCOC(=O)C(C)(C)C)C1=CSC(N)=N1 HMLGSIZOMSVISS-ONJSNURVSA-N 0.000 claims 1
- CZKPOZZJODAYPZ-WSGIOKLISA-N 2-[(3S,6R,12R,20S,23R)-20-carbamoyl-12-[4-(diaminomethylideneamino)butyl]-3-(1H-indol-3-ylmethyl)-2,5,8,11,14,22-hexaoxo-17,18-dithia-1,4,7,10,13,21-hexazabicyclo[21.3.0]hexacosan-6-yl]acetic acid Chemical compound N1C(=O)[C@@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](CCCCN=C(N)N)NC(=O)CCSSC[C@H](C(N)=O)NC(=O)[C@H]2CCCN2C(=O)[C@@H]1CC1=CNC2=CC=CC=C12 CZKPOZZJODAYPZ-WSGIOKLISA-N 0.000 claims 1
- OGBMKVWORPGQRR-UMXFMPSGSA-N 52232-67-4 Chemical compound C([C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CNC=N1 OGBMKVWORPGQRR-UMXFMPSGSA-N 0.000 claims 1
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- 108010090726 Alefacept Proteins 0.000 claims 1
- 108010090838 Alemtuzumab Proteins 0.000 claims 1
- 229960000983 Anistreplase Drugs 0.000 claims 1
- 108010058207 Anistreplase Proteins 0.000 claims 1
- 108010039627 Aprotinin Proteins 0.000 claims 1
- 108010024976 Asparaginase Proteins 0.000 claims 1
- 102000015790 Asparaginase Human genes 0.000 claims 1
- 108010067213 Basiliximab Proteins 0.000 claims 1
- 108010005144 Bevacizumab Proteins 0.000 claims 1
- OIRCOABEOLEUMC-GEJPAHFPSA-N Bivalirudin Chemical compound C([C@@H](C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CC(C)C)C(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 OIRCOABEOLEUMC-GEJPAHFPSA-N 0.000 claims 1
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- 108010082834 Brain Natriuretic Peptide Proteins 0.000 claims 1
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- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 claims 1
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- COCFEDIXXNGUNL-RFKWWTKHSA-N Glargine Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(=O)NCC(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 COCFEDIXXNGUNL-RFKWWTKHSA-N 0.000 claims 1
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Claims (25)
- 後部チャンバおよび強膜を持つ目を治療するための、埋め込み可能な、治療装置であって、前記治療装置は、
前記強膜を貫通させて前記患者の目の前記後部チャンバ内に埋め込むための、硬質かつ補充可能な中空本体と、
注入される治療薬を貯蔵部内に受け入れ、前記後部チャンバの外側に残るように構成されたキャップ部分と、
複数の不規則な相互接続チャネルを備える硬質の多孔質構造体であって、前記多孔質構造体は前記貯蔵部の離れた遠位端に連結され、長期間にわたって、前記貯蔵部から前記複数の相互接続チャネルを通って、治療に必要な量の治療薬を前記後部チャンバに放出する、前記多孔質構造体と、
から構成され、
前記中空体は、実質的に、生体適合材料から成る硬質の不透過性の壁により形成されるとともに、前記中空体は、前記強膜の外側に配置される近位のキャップ部分と、中間の首部と、前記後部チャンバの外に配置されるように構成された遠位の前記貯蔵部とを備えるため、前記治療装置が前記患者の目の中に設置されている間、前記強膜は前記中間の首部周辺に配置され、前記首部の外のり横断寸法は、前記キャップおよび前記貯蔵部より小さく、
前記治療装置が埋め込まれ使用されている間は、前記治療装置の容積は実質的に固定されていることを特徴とする、治療装置。 - 前記硬質多孔質構造体の前記チャネルは、相互接続し、実質的に固定されたチャネルを備えることを特徴とする請求項1に記載の治療装置。
- 前記治療薬が前記貯蔵部内へ圧力により注入されるとき、前記硬質多孔質構造体は実質的にその硬質を維持し、前記チャネルは実質的に固定されたままであることを特徴とする請求項2に記載の治療装置。
- 前記貯蔵部は、1つの軸に沿って前記強膜および脈絡膜へと拡がり、貫通可能な障壁が前記貯蔵部の近位端に配置されているので、前記強膜あるいは前記脈絡膜に注射針を貫通させなくても、結膜および前記貫通可能な障壁を介して注射針を進入させることによって前記貯蔵部への補充が可能になることを特徴とする、請求項1に記載の治療装置。
- 前記複数の相互接続チャネルのうち少なくともいくつかは、複数の位置で交わることを特徴とする、請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、焼結材料から成ることを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、金属の焼結材料から成ることを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、金属、セラミック、ガラスのうち少なくとも1つから成ることを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、長期間にわたって前記治療薬を放出するよう構成された厚み及び表面積部分を有することを特徴とする請求項1に記載の治療装置。
- 前記厚みは前記硬質多孔質構造体の第1の側と第2の側に亘っており、前記複数の相互接続チャネルは前記第1の側と前記第2の側の間に伸び、前記硬質多孔質構造体の前記複数の相互接続チャネルは、相互に接続された、前記第1の側から前記第2の側に伸びる有効の長さを持つ実質的に固定された蛇行状のチャネルであって、前記有効の長さは前記硬質多孔質構造体の前記厚みよりも大きいことを特徴とする請求項9に記載の治療装置。
- 前記硬質多孔質構造体の前記複数の相互接続チャネルは、前記治療薬が前記相互接続チャネルを通るように構成されることを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は硬質の焼結材料粒子を備え、前記相互接続チャネルは少なくとも部分的にに前記硬質の焼結材料粒子の周囲に伸びているため、前記治療薬は前記多孔質構造体を介し通過することを特徴とする請求項1に記載の治療装置。
- 前記治療装置は保持構造と浸透性障壁とを備え、前記保持構造は前記貯蔵部に連結され且つ前記貯蔵部の外側に伸びる延長部を有し、前記保持部は前記強膜と前記結膜の間に伸びているため、縫合することなく埋め込み位置に前記治療装置を保持するように構成されることを特徴とする請求項1に記載の治療装置。
- 前記治療装置が埋め込まれている間、前記治療薬は前記貯蔵部内において少なくとも約20日の半減期を有し、前記治療装置は、少なくとも約90日の間、前記目の中に埋め込まれて前記治療薬によって前記目を治療するように構成されることを特徴とする請求項1に記載の治療装置。
- 前記治療装置が埋め込まれている間、前記治療薬は前記貯蔵部内において少なくとも約30日の半減期を有し、前記治療装置は少なくとも約120日の間、前記目の中に埋め込まれ、前記治療薬によって前記目を治療するように構成されることを特徴とする請求項1に記載の治療装置。
- 前記治療装置が埋め込まれている間、前記貯蔵部の容積は一定であり、前記硬質多孔質構造体は一定の放出速度でもって前記貯蔵部内での半減期を伴う治療薬を提供し、目の硝子体液中に直接治療薬を注入する際は、前記貯蔵部内での半減期は、対応する前記治療薬の半減期より実質的に長く、少なくとも約120日分の治療薬量の放出に相当することを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、前記長時間にわたって治療薬量を放出するように構成された気孔率、厚み、チャネルパラメータおよび表面積を有することを特徴とする請求項1に記載の治療装置。
- 前記チャネルパラメータは、前記多孔質構造体の第1の側から第2の側に伸びる相互接続チャネルの有効の長さに対応するフィットパラメータを有することを特徴とする請求項17に記載の治療装置。
- 少なくとも1つの前記治療薬の前記放出速度は、前記チャネルパラメータに対する気孔率の比に対応しており、前記多孔質構造体が長期間にわたって少なくとも1つの治療薬を放出するように、前記チャネルパラメータに対する気孔率の比は約0.5未満であることを特徴とする請求項18に記載の治療装置。
- 前記多孔質構造体は、約5.0mm以下の放出速度指標を有することを特徴とする請求項1に記載の治療装置。
- 前記貯蔵部は、所定の長い時間に放出する治療薬の量を貯蔵するための容積を備え、前記硬質多孔質構造体は前記治療薬の前記放出速度に対応する厚みと表面積を備え、前記容積と前記放出速度は前記貯蔵部内の前記半減期に対応することを特徴とする請求項1に記載の治療装置。
- 前記治療薬を治療濃度で提供できるように、前記半減期は、前記所定の長い時間において最大速度に達した時に対応することを特徴とする請求項21に記載の治療装置。
- 前記目に埋め込む前に、前記治療装置は前記貯蔵部内に初期量の前記治療薬をさらに含むことを特徴とする請求項1に記載の治療装置。
- 前記硬質多孔質構造体は、第1の領域を有する第1の側と、実質的に前記第1の領域に対応する第2の領域を有する第2の側と、前記第1の側と前記第2の側の間の厚みと、気孔率と、前記貯蔵部から前記目の後部チャンバに前記治療薬を放出するためのチャネルパラメータを備えることを特徴とする請求項1に記載の治療装置。
- 前記治療薬は、次の薬物すなわちアバレリックス、アバタセプト、アブシキシマブ、アダリムマブ、アルデスロイキン、アレファセプト、アレムツズマブ、α1プロテイナーゼ阻害剤、アルテプラーゼ、アナキンラ、アニストレプラーゼ、抗血友病因子、抗胸腺細胞グロブリン、アプロチニン、アルシツモマブ、アスパラギナーゼ、バシリキシマブ、ベカプレルミン、ベバシズマブ、ビバリルジン、ボツリヌス毒素タイプA、ボツリヌス毒素タイプB、カプロマブ、セトロレリクス、セツキシマブ、コリオゴナドトロピンα、凝固因子IX、凝固因子VIIa、コラゲナーゼ、コルチコトロピン、コシントロピン、シクロスポリン、ダクリズマブ、ダルベポエチンα、デフィブロチド、デニロイキンジフチトクス、デスモプレシン、ドルナーゼα、ドロトレコギンα、エクリズマブ、エファリズマブ、エンフビルチド、エポエチンα、エプチフィバチド、エタネルセプト、エクセナチド、フェリプレシン、フィルグラスチム、フォリトロピンβ、ガルスルファーゼ、ゲムツズマブオゾガマイシン、グラチラマーアセテート、組換えグルカゴン、ゴセレリン、ヒト血清アルブミン、ヒアルロンダーゼ、イブリツモマブ、イデュルスルファーゼ、免疫グロブリン、インフリキシマブ、組換えインスリングラルギン、組換えインスリンリスプロ、組換えインシュリン、インシュリン、ブタ(porcine)、インターフェロンα‐2a、組換え、インターフェロンα‐2b、組換え、インターフェロンアルファコン‐1、インターフェロンα‐n1、インターフェロンα‐n3、インターフェロンβ‐1b、インターフェロンγ‐1b、レピルジン、ロイプロリド、ルトルピンα、メカセルミン、メノトロピン、ムロモナブ、ナタリズマブ、ネシリチド、オクトレオチド、オマリズマブ、オプレルベキン、OspAリポタンパク質、オキシトシン、パリフェルミン、パリビズマブ、パニツムマブ、ウシペガデマーゼ、ペガプタニブ、ペガスパルガーゼ、ペグフィルグラスチム、ペグインターフェロンα‐2a、ペグインターフェロンα‐2b、ペグビソマント、プラムリンチド、ラニビズマブ、ラスブリカーゼ、レテプラーゼ、リツキシマブ、サーモンカルシトニン、サルグラモスチム、セクレチン、セルモレリン、ヨウ化血清アルブミン、組換えソマトロピン、ストレプトキナーゼ、テネクテプラーゼ、テリパラチド、チロトピンα、トシツモマブ、トラスツズマブ、ウロフォリトロピン、ウロキナーゼ、又はバソプレシンの1つまたは複数を含んでもよいことを特徴とする請求項1に記載の治療装置。
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