JP2005502426T5 - - Google Patents

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Publication number
JP2005502426T5
JP2005502426T5 JP2003528257T JP2003528257T JP2005502426T5 JP 2005502426 T5 JP2005502426 T5 JP 2005502426T5 JP 2003528257 T JP2003528257 T JP 2003528257T JP 2003528257 T JP2003528257 T JP 2003528257T JP 2005502426 T5 JP2005502426 T5 JP 2005502426T5
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drug delivery
delivery device
capsule
therapeutic agent
reservoir
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JP2003528257T
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JP2005502426A5 (en )
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Claims (32)

  1. 以下を含むドラッグデリバリデバイス: Drug delivery device, including the following:
    (a)以下を含む、体内への移植のためのカプセル: (A) including the following, capsule for implantation into the body:
    (i)物質を収容するための貯蔵部; (I) a reservoir for containing the substance;
    (ii)前記物質を前記貯蔵部から拡散させる又は別の方法で前記貯蔵部から出させるための少なくとも1つの開口; (Ii) at least one opening for allowing out from the reservoir or in other ways to diffuse the substance from the reservoir;
    (b)前記少なくとも1つの出口からの前記物質の拡散速度を調節するために、前記カプセルと連結しているナノ細孔膜。 (B) the in order to adjust the diffusion rate of the substance from the at least one outlet, nano pore membranes which are connected to the capsule.
  2. さらに前記ナノ細孔膜の構造的支持体を提供するためのスクリーンを含み、前記スクリーンが前記カプセルを完全に若しくは部分的に取り囲み、又は前記膜上、前記膜の底面、若しくは前記膜上及び底面の両方に位置付けられる、請求項1記載のドラッグデリバリデバイス。 Further comprising a screen for providing structural support of the nanopore membrane, the screen completely or partially surrounds the capsule, or the film, the bottom surface of the membrane, or the film and the bottom surface positioned both, drug delivery device of claim 1, wherein.
  3. 前記デバイスが皮下の体内、体内の定義された解剖学的区画、病理部、又はその組み合わせに移植される、請求項1記載のドラッグデリバリデバイス。 Body of the device subcutaneously, body defined anatomical compartments, Pathology, or is implanted in the combination, the drug delivery device of claim 1, wherein.
  4. 前記カプセルが、前記デバイスを保護しかつ生体適合性界面を与えるための多孔質ポリマー材料によって被覆される、請求項1記載のドラッグデリバリデバイス。 The capsule, to protect the device and are covered by a porous polymeric material for providing biocompatible surfactant, drug delivery device of claim 1, wherein.
  5. 前記カプセルが、不浸透性非変形可能性生体適合性カプセルであり、さらに第1開放端、第2開放端、前記第1開放端を閉じるための第1エンドキャップ、及び前記第2開放端を閉じる第2エンドキャップを有する、請求項1記載のドラッグデリバリデバイス。 Wherein the capsule is impermeable non deformable biocompatible capsule and further first open end, a second open end, the first end cap for closing said first open end, and said second open end Close with a second end cap, drug delivery device of claim 1, wherein.
  6. 前記カプセルの各開放端に取り付けられたときに、前記カプセルの両端が弾丸型であるように前記エンドキャップが先細になっている、請求項5記載のドラッグデリバリデバイス。 When attached to each open end of the capsule, the two ends of the capsule tapers said end caps as a bullet-shaped, drug delivery device of claim 5, wherein.
  7. 前記カプセルの断面が実質的に円筒型である、請求項1記載のドラッグデリバリデバイス。 Wherein a cross-section substantially cylindrical capsule, drug delivery device of claim 1, wherein.
  8. さらに、前記ドラッグデリバリデバイスの移植後前記カプセルのサイド-トゥ-サイド回転を防止するために、前記カプセルの各端部、又は前記カプセルの長さ方向のいずれかに取り付けられた半三角回転防止装置を有する請求項7記載のドラッグデリバリデバイス。 Furthermore, the drug delivery device side after transplantation the capsule - toe - side rotation in order to prevent each end of the capsule, or the semi-triangular anti-rotation device attached to one of the longitudinal direction of the capsule drug delivery device of claim 7, further comprising a.
  9. 前記カプセルの断面が実質的に長円形である、請求項1記載のドラッグデリバリデバイス。 Wherein a cross-section substantially elliptical capsule, drug delivery device of claim 1, wherein.
  10. 前記カプセルがチタン合金、外科用グレードステンレス鋼、又はポリマー材料から作られる、請求項1記載のドラッグデリバリデバイス。 Wherein the capsule is a titanium alloy, surgical grade stainless steel, or made of polymeric materials, drug delivery device of claim 1, wherein.
  11. 前記物質が治療剤の水溶液又は懸濁液である、請求項1記載のドラッグデリバリデバイス。 Wherein the substance is an aqueous solution or suspension of the therapeutic agent, drug delivery device of claim 1, wherein.
  12. 前記治療剤が、ペプチド、蛋白薬物、又はポリ核酸である生理活性高分子である、請求項11記載のドラッグデリバリデバイス。 Wherein the therapeutic agent is a peptide, a bioactive macromolecule is a protein drug, or polynucleic acid, drug delivery device of claim 11, wherein.
  13. 前記ペプチド又は蛋白薬物が増殖因子、ホルモン、抗感染薬、サイトカイン、免疫モジュレーター、制癌薬、又はホルモン拮抗薬である、請求項12記載のドラッグデリバリデバイス。 Wherein the peptide or protein drug growth factors, hormones, anti-infectives, cytokine, an immune modulator, Seigan'yaku, or hormone antagonists, claim 12 drug delivery device according.
  14. 前記抗感染薬がインターフェロンα2bである、請求項13記載のドラッグデリバリデバイス。 The antiinfective is an interferon? 2b, drug delivery device of claim 13, wherein.
  15. 前記サイトカインがインターフェロンβである、請求項13記載のドラッグデリバリデバイス。 Wherein the cytokine is an interferon beta, drug delivery device of claim 13, wherein.
  16. 前記治療剤が低分子量分子である、請求項11記載のドラッグデリバリデバイス。 Wherein the therapeutic agent is a low molecular weight molecule, drug delivery device of claim 11, wherein.
  17. 前記低分子量分子が鎮痛剤又は抗精神病薬である、請求項16記載のドラッグデリバリデバイス。 The low molecular weight molecule is an analgesic or an anti-psychotic drug, drug delivery device of claim 16, wherein.
  18. 前記ナノ細孔膜が、さらに平行チャネル微細加工アレーを有し、前記チャネルの最も小さいアスペクトが前記物質の一定の放出速度を与えるように選ばれる、請求項1記載のドラッグデリバリデバイス。 The nanopore membrane further has parallel channels microfabricated array, the smallest aspect of the channel is chosen to provide a constant release rate of the substance, drug delivery device according to claim 1.
  19. 前記平行チャネルアレーの最も小さいアスペクトが前記物質の分子の大きさの約1〜5倍であるように得らばれる、請求項18記載のドラッグデリバリデバイス。 Smallest Aspect Bareru Tokura as about 1-5 times the size of molecules of the substance, drug delivery device of claim 18 wherein the parallel channels array.
  20. 前記ナノ細孔膜がシリコン、ポリシリコン、シリコン材料の組み合わせ、ポリマー、又はコポリマーから微細加工される、請求項1記載のドラッグデリバリデバイス。 The nanopore membrane silicon, polysilicon, a combination of a silicon material, a polymer, or microfabrication copolymers, drug delivery device of claim 1, wherein.
  21. 以下を含むドラッグデリバリデバイス: Drug delivery device, including the following:
    (a)以下を含む、体内への移植のためのカプセルと: (A) including the following, and the capsule for implantation into the body:
    (i)治療剤を収容するための貯蔵部; (I) a reservoir for containing a therapeutic agent;
    (ii)前記治療剤を前記貯蔵部から拡散させる又は別の方法で前記貯蔵部から出させるための少なくとも1つの開口; (Ii) at least one opening for allowing out the therapeutic agent from the reservoir at or otherwise diffuse from the reservoir;
    (b)前記少なくとも1つの出口からの前記物質の拡散速度を調節するために、前記カプセルと連結しているナノ細孔膜; (B) the in order to adjust the diffusion rate of the substance from the at least one outlet, nano linked with the capsule pore membrane;
    (c)以下を含む、前記デバイスを通る流体の流れに影響を与える浸透圧エンジン: (C) include, affects the flow of fluid through the device osmotic engine:
    (i)前記カプセルの壁の一部に組み込まれた半透膜; (I) a semipermeable membrane that is incorporated into a part of the capsule wall;
    (ii)前記半透膜及び前記ナノ細孔膜の両方を通過するのを防止するのに十分な分子量である、前記治療剤と混合した浸透性活性剤、 (Ii) a molecular weight sufficient to prevent the passage of both the semipermeable membrane and the nanopore membrane permeable active agent mixed with the therapeutic agent,
    (iii)前記半透膜を通って前記貯蔵部に入り、前記ナノ細孔膜を通って前記デバイスから出る水の正味のフラックス。 (Iii) the semipermeable membrane through enters the reservoir, the water net flux exiting the device through the nanopore membrane.
  22. 前記浸透性活性剤が前記半透膜又は前記ナノ細孔膜のいずれかを通って前記貯蔵部の外への前記剤の通過を防止するのに十分に大きな分子量を有する水混和性ポリマーを含む、請求項21記載のドラッグデリバリデバイス。 Comprising a water-miscible polymer having a molecular weight enough to the osmotically active agent to prevent the passage of said agent out of the reservoir through one of the semi-permeable membrane or the nano pore membrane , drug delivery device of claim 21, wherein.
  23. 前記ポリマーの分子量が約5,000〜数百万ダルトンである、請求項24記載のドラッグデリバリデバイス。 Wherein a molecular weight of about 5,000 to millions dalton polymer, drug delivery device of claim 24, wherein.
  24. 前記ポリマーがPluracol V-10、UCON潤滑剤シリーズ、Pluronic界面活性剤シリーズ、及びTetronic界面活性剤シリーズからなる群から選ばれる、請求項22記載のドラッグデリバリデバイス。 It said polymer Pluracol V-10, UCON lubricant series, Pluronic surfactant series, and is selected from the group consisting of Tetronic surfactant series, drug delivery device of claim 22, wherein.
  25. 前記ポリマーが重量で50/50混合物まで水を加える、請求項24記載のドラッグデリバリデバイス。 It said polymer water is added to a 50/50 mixture by weight, drug delivery device of claim 24, wherein.
  26. 前記治療剤が前記ポリマー内に懸濁したミクロ化した乾燥粉末を含む、請求項22記載のドラッグデリバリデバイス。 Comprises a dry powder in which the therapeutic agent that is micronized and suspended in said polymer, drug delivery device of claim 22, wherein.
  27. 以下の工程を含む、 ドラッグデリバリデバイスの作動方法: Comprising the steps of drug delivery devices method of operation:
    (a)治療剤をドラッグデリバリデバイスに導く工程であって 、前記デバイスはさらにカプセルを含み、前記カプセルはさらに前記治療剤を収容するための貯蔵部、前記治療剤を前記貯蔵部から拡散させる又は別の方法で前記貯蔵部から出させるための少なくとも1つの開口、及び前記少なくとも1つの出口からの前記物質の拡散速度を調節するために前記カプセルと連結しているナノ細孔膜を含み、前記ナノ細孔膜はさらに平行チャネル微細加工アレーを含む前記工程 Comprising the steps of: (a) directing a therapeutic agent to the drug delivery device, said device further comprises a capsule, reservoir for accommodating the capsule further the therapeutic agent to diffuse the therapeutic agent from the reservoir or at least one opening for allowing out from the storage unit in a different way, and includes a nanopore membrane that is connected to the capsule in order to adjust the diffusion rate of the substance from the at least one outlet, said It said step nano pore membrane further comprising a parallel channel microfabricated array.
  28. 皮下に、又は体内の解剖学的区画に置くことによって前記デバイスを外科的に移植する直前に、さらに前記治療剤の水溶液又は懸濁液を前記貯蔵部で前記治療剤の乾燥形態に水を与えることによって形成する工程を含む請求項27記載の方法。 Subcutaneously, or by placing the body of anatomical compartments just prior to surgically implanting the device, providing water to the dry form of the therapeutic agent further an aqueous solution or suspension of the therapeutic agent in the reservoir the method of claim 27, further comprising the step of forming by.
  29. さらに前記治療剤の水溶液又は懸濁液を前記貯蔵部で前記デバイスを取り囲む媒体から誘導される生物学的流体の、皮下に、又は体内の解剖学的区画に置くことによって外科的に移植した前記デバイスへの導入によって形成する工程を含む請求項27記載の方法。 Wherein further the therapeutic agent an aqueous solution of the biological fluid to be induced or suspension from the medium surrounding the device by the reservoir of, subcutaneously, or surgically implanted by placing the body of anatomical compartments the method of claim 27, further comprising the step of forming the introduction into the device.
  30. 前記治療剤の放出速度が実質的にゼロ次である、請求項27記載の方法。 The release rate of the therapeutic agent is substantially zero order, method of claim 27, wherein.
  31. 前記治療剤の放出速度が前記カプセルの内部の前記治療剤の濃度に実質的に無関係である、請求項27記載の方法。 The release rate of the therapeutic agent is substantially independent of the concentration of the therapeutic agent of the interior of the capsule 28. The method of claim 27, wherein.
  32. 前記治療剤の放出速度が前記デバイスの外科的な移植後数週間から数ヶ月の間実質的に一定である、請求項27記載の方法。 The release rate of the therapeutic agent is a surgical constant substantially weeks to months after implantation of the device, The method of claim 27, wherein.
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Cited By (27)

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US7931683B2 (en) 2007-07-27 2011-04-26 Boston Scientific Scimed, Inc. Articles having ceramic coated surfaces
US7938855B2 (en) 2007-11-02 2011-05-10 Boston Scientific Scimed, Inc. Deformable underlayer for stent
US7942926B2 (en) 2007-07-11 2011-05-17 Boston Scientific Scimed, Inc. Endoprosthesis coating
US7976915B2 (en) 2007-05-23 2011-07-12 Boston Scientific Scimed, Inc. Endoprosthesis with select ceramic morphology
US7981150B2 (en) 2006-11-09 2011-07-19 Boston Scientific Scimed, Inc. Endoprosthesis with coatings
US8002823B2 (en) 2007-07-11 2011-08-23 Boston Scientific Scimed, Inc. Endoprosthesis coating
US8029554B2 (en) 2007-11-02 2011-10-04 Boston Scientific Scimed, Inc. Stent with embedded material
US8067054B2 (en) 2007-04-05 2011-11-29 Boston Scientific Scimed, Inc. Stents with ceramic drug reservoir layer and methods of making and using the same
US8066763B2 (en) 1998-04-11 2011-11-29 Boston Scientific Scimed, Inc. Drug-releasing stent with ceramic-containing layer
US8071156B2 (en) 2009-03-04 2011-12-06 Boston Scientific Scimed, Inc. Endoprostheses
US8070797B2 (en) 2007-03-01 2011-12-06 Boston Scientific Scimed, Inc. Medical device with a porous surface for delivery of a therapeutic agent
US8187620B2 (en) 2006-03-27 2012-05-29 Boston Scientific Scimed, Inc. Medical devices comprising a porous metal oxide or metal material and a polymer coating for delivering therapeutic agents
US8216632B2 (en) 2007-11-02 2012-07-10 Boston Scientific Scimed, Inc. Endoprosthesis coating
US8221822B2 (en) 2007-07-31 2012-07-17 Boston Scientific Scimed, Inc. Medical device coating by laser cladding
US8231980B2 (en) 2008-12-03 2012-07-31 Boston Scientific Scimed, Inc. Medical implants including iridium oxide
US8287937B2 (en) 2009-04-24 2012-10-16 Boston Scientific Scimed, Inc. Endoprosthese
US8353949B2 (en) 2006-09-14 2013-01-15 Boston Scientific Scimed, Inc. Medical devices with drug-eluting coating
US8431149B2 (en) 2007-03-01 2013-04-30 Boston Scientific Scimed, Inc. Coated medical devices for abluminal drug delivery
US8449603B2 (en) 2008-06-18 2013-05-28 Boston Scientific Scimed, Inc. Endoprosthesis coating
US8574615B2 (en) 2006-03-24 2013-11-05 Boston Scientific Scimed, Inc. Medical devices having nanoporous coatings for controlled therapeutic agent delivery
US8771343B2 (en) 2006-06-29 2014-07-08 Boston Scientific Scimed, Inc. Medical devices with selective titanium oxide coatings
US8815273B2 (en) 2007-07-27 2014-08-26 Boston Scientific Scimed, Inc. Drug eluting medical devices having porous layers
US8815275B2 (en) 2006-06-28 2014-08-26 Boston Scientific Scimed, Inc. Coatings for medical devices comprising a therapeutic agent and a metallic material
US8900292B2 (en) 2007-08-03 2014-12-02 Boston Scientific Scimed, Inc. Coating for medical device having increased surface area
US8920491B2 (en) 2008-04-22 2014-12-30 Boston Scientific Scimed, Inc. Medical devices having a coating of inorganic material
US8932346B2 (en) 2008-04-24 2015-01-13 Boston Scientific Scimed, Inc. Medical devices having inorganic particle layers
US9284409B2 (en) 2007-07-19 2016-03-15 Boston Scientific Scimed, Inc. Endoprosthesis having a non-fouling surface

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8066763B2 (en) 1998-04-11 2011-11-29 Boston Scientific Scimed, Inc. Drug-releasing stent with ceramic-containing layer
US8574615B2 (en) 2006-03-24 2013-11-05 Boston Scientific Scimed, Inc. Medical devices having nanoporous coatings for controlled therapeutic agent delivery
US8187620B2 (en) 2006-03-27 2012-05-29 Boston Scientific Scimed, Inc. Medical devices comprising a porous metal oxide or metal material and a polymer coating for delivering therapeutic agents
US8815275B2 (en) 2006-06-28 2014-08-26 Boston Scientific Scimed, Inc. Coatings for medical devices comprising a therapeutic agent and a metallic material
US8771343B2 (en) 2006-06-29 2014-07-08 Boston Scientific Scimed, Inc. Medical devices with selective titanium oxide coatings
US8353949B2 (en) 2006-09-14 2013-01-15 Boston Scientific Scimed, Inc. Medical devices with drug-eluting coating
US7981150B2 (en) 2006-11-09 2011-07-19 Boston Scientific Scimed, Inc. Endoprosthesis with coatings
US8070797B2 (en) 2007-03-01 2011-12-06 Boston Scientific Scimed, Inc. Medical device with a porous surface for delivery of a therapeutic agent
US8431149B2 (en) 2007-03-01 2013-04-30 Boston Scientific Scimed, Inc. Coated medical devices for abluminal drug delivery
US8067054B2 (en) 2007-04-05 2011-11-29 Boston Scientific Scimed, Inc. Stents with ceramic drug reservoir layer and methods of making and using the same
US7976915B2 (en) 2007-05-23 2011-07-12 Boston Scientific Scimed, Inc. Endoprosthesis with select ceramic morphology
US8002823B2 (en) 2007-07-11 2011-08-23 Boston Scientific Scimed, Inc. Endoprosthesis coating
US7942926B2 (en) 2007-07-11 2011-05-17 Boston Scientific Scimed, Inc. Endoprosthesis coating
US9284409B2 (en) 2007-07-19 2016-03-15 Boston Scientific Scimed, Inc. Endoprosthesis having a non-fouling surface
US8815273B2 (en) 2007-07-27 2014-08-26 Boston Scientific Scimed, Inc. Drug eluting medical devices having porous layers
US7931683B2 (en) 2007-07-27 2011-04-26 Boston Scientific Scimed, Inc. Articles having ceramic coated surfaces
US8221822B2 (en) 2007-07-31 2012-07-17 Boston Scientific Scimed, Inc. Medical device coating by laser cladding
US8900292B2 (en) 2007-08-03 2014-12-02 Boston Scientific Scimed, Inc. Coating for medical device having increased surface area
US7938855B2 (en) 2007-11-02 2011-05-10 Boston Scientific Scimed, Inc. Deformable underlayer for stent
US8216632B2 (en) 2007-11-02 2012-07-10 Boston Scientific Scimed, Inc. Endoprosthesis coating
US8029554B2 (en) 2007-11-02 2011-10-04 Boston Scientific Scimed, Inc. Stent with embedded material
US8920491B2 (en) 2008-04-22 2014-12-30 Boston Scientific Scimed, Inc. Medical devices having a coating of inorganic material
US8932346B2 (en) 2008-04-24 2015-01-13 Boston Scientific Scimed, Inc. Medical devices having inorganic particle layers
US8449603B2 (en) 2008-06-18 2013-05-28 Boston Scientific Scimed, Inc. Endoprosthesis coating
US8231980B2 (en) 2008-12-03 2012-07-31 Boston Scientific Scimed, Inc. Medical implants including iridium oxide
US8071156B2 (en) 2009-03-04 2011-12-06 Boston Scientific Scimed, Inc. Endoprostheses
US8287937B2 (en) 2009-04-24 2012-10-16 Boston Scientific Scimed, Inc. Endoprosthese

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