JP2005194272A - 生体材料を低侵襲移植するための装置及び方法 - Google Patents
生体材料を低侵襲移植するための装置及び方法 Download PDFInfo
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- JP2005194272A JP2005194272A JP2004361673A JP2004361673A JP2005194272A JP 2005194272 A JP2005194272 A JP 2005194272A JP 2004361673 A JP2004361673 A JP 2004361673A JP 2004361673 A JP2004361673 A JP 2004361673A JP 2005194272 A JP2005194272 A JP 2005194272A
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- Materials For Medical Uses (AREA)
Abstract
【解決手段】 送達システムは、柔軟なテザー手段を備えた可撓性の生物学的構造とすることができる。送達システムは、例えば腹膜組織などの血管組織の近傍に経皮的に挿入することができる。送達システムを挿入したら、送達システムをテザーで血管組織に向かって引張って送達システムを血管組織に固定することができる。テザーを実質的に張った状態にして、送達システムの前面と血管組織の接触を維持することができる。送達システムは、活性物質の持続的な送達を達成することができる。
【選択図】 図10
Description
本発明は、薬物及び他の生物活性物質を含む化合物を、例えば1層または複数層の動物の上皮組織や内皮組織などの組織内及びその組織を通過して移送するのに有効な組成物及び方法を提供する。この方法では、目的の化合物を含む活性物質送達システム10を組織に接触させる。この方法及び組成物は、薬物及び他の生物学的に活性な分子の送達、並びに撮像用分子及び診断用分子の送達に有用である。本発明の方法及び組成物は、生物学的効果を得るために上皮及び内皮を介して移送する必要がある、それ自体が生物学的活性を殆ど或いは全く示さない化合物の送達に特に有用であろう。
代替の移殖用活性物質送達装置は、少なくとも1種類の治療薬を産生する真核細胞と担体を含む送達システム10を含む。場合によっては、送達システム10は、そこから治療薬が放出するのを刺激するために送達システム10に機能的に結合した刺激要素を含むことができる。別の実施形態では、送達システム10は更に、患者の少なくとも1つの生理的な特性を監視するための検出要素を含み、移植された送達装置が刺激要素と通信して送達システム10から治療薬が放出するのを刺激する。担体は、ステント、人工血管、ステントグラフト、合成パッチ、注入スリーブ、及びカテーテルから選択することができる。
(1)患者に活性物質を供給するための移殖用活性物質送達システムであって、
前面及び後面を有する一定量の活性物質を含む生体材料を含み、
前記生体材料の前記前面が前記患者の血管組織に実質的に近接して保持されるように適合されており、
前記生体材料が、前記患者に生物活性物質を投与できる或いは代謝機能または免疫機能を提供できることを特徴とする移殖用活性物質送達システム。
(2)前記送達システムが更に、移植部位に固定するため或いは移植後に回収するためにテザーを含むことを特徴とする実施態様(1)に記載の送達システム。
(3)前記テザーが、前記生体材料を血管組織に実質的に近接して保持できるように適合されていることを特徴とする実施態様(2)に記載の送達システム。
(4)前記テザーの材料が生体吸収性であることを特徴とする実施態様(3)に記載の送達システム。
(5)前記テザーが、前記送達システム内の活性物質を補充する手段として機能できることを特徴とする実施態様(3)に記載の送達システム。
(7)前記送達システムが、活性物質を腹膜に送達できるように適合されていることを特徴とする実施態様(3)に記載の送達システム。
(8)前記送達システムが、網に活性物質を送達できるように適合されていることを特徴とする実施態様(3)に記載の送達システム。
(9)前記送達システムが、カニューレを介して送達できるように適合されていることを特徴とする実施態様(7)または(8)に記載の送達システム。
(10)前記送達システムが実質的に平坦なシートであることを特徴とする実施態様(7)または(8)に記載の送達システム。
(12)前記活性物質が、抗体、酵素、栄養因子、成長因子、ホルモン、及び生物応答変更因子からなる群から選択されることを特徴とする実施態様(1)、(7)、または(8)に記載の送達システム。
(13)前記活性物質が鎮痛薬または苦痛緩和剤であることを特徴とする実施態様(1)、(7)、または(8)に記載の送達システム。
(14)前記活性物質がペプチドまたはタンパク質であることを特徴とする実施態様(12)に記載の送達システム。
(15)前記活性物質がサイトカインまたはリンホカインであることを特徴とする実施態様(14)に記載の送達システム。
(17)前記活性物質がワクチンとして用いるための予防薬であることを特徴とする実施態様(3)に記載の送達システム。
(18)前記活性物質が抗原及びアジュバントを含むことを特徴とする実施態様(3)に記載の送達システム。
(19)前記生体材料が更に、ポリエチレンオキシド(PEO)、ヘパリン、アルブミン、組織成長因子、血管成長因子(angiogenic growth factor)、界面活性剤、抗酸化剤、抗炎症剤、及び拒絶反応抑制剤からなる群から選択される1または複数の送達促進剤を含むことを特徴とする実施態様(3)に記載の送達システム。
(20)前記血管成長因子が、塩基性線維芽細胞成長因子、酸性線維芽細胞成長因子、血管内皮成長因子、血小板由来内皮細胞成長因子bb、血管新生因子‐1、形質転換成長因子‐β、形質転換成長因子‐α、肝細胞成長因子、腫瘍壊死因子‐α、アンジオジェニン、インターロイキン‐8、低酸素誘導因子‐I、アンギオテンシン変換酵素インヒビターキナプリラット(quinaprilat)、アンギオトロピン(angiotropin)、トロンボスポンジン、乳酸、インスリン、及び成長ホルモンからなる群から選択されることを特徴とする実施態様(3)に記載の送達システム。
(22)前記送達システムが、約0.001μg/時間〜約200μg/時間の範囲の投与速度で活性物質を送達するように適合されていることを特徴とする実施態様(3)に記載の送達システム。
(23)前記送達システムが、約0.001μl/日〜約2ml/日の範囲の投与割合で活性物質を送達するように適合されていることを特徴とする実施態様(3)に記載の送達システム。
(24)前記生体材料の前記後面が更に、前記生体材料の形状を実質的に維持できる実質的に弾性の基材を含むことを特徴とする実施態様(3)に記載の送達システム。
(25)前記生体材料が組織に接着するのに適したパッチを含むことを特徴とする実施態様(3)に記載の送達システム。
(27)更に前記送達システムが、中空スペースを有する活性物質層材料と、微小孔または半透過性の膜を有する上面とを含むことを特徴とする実施態様(25)に記載の送達システム。
(28)更に、活性物質を受容するレザバーを含み、前記レザバーが、前記組織に送達するために前記前面に前記活性物質を送達できるように適合されていることを特徴とする実施態様(25)に記載の送達システム。
(29)前記送達システムが更に浸透促進剤を含むことを特徴とする実施態様(25)に記載の送達システム。
(30)前記浸透促進剤が、細胞外被障害化合物、溶媒、及びこれらの混合物からなる群から選択されることを特徴とする実施態様(29)に記載の送達システム。
(32)前記膜の前記分子量遮断が約50kD〜2000kDの範囲であることを特徴とする実施態様(31)に記載の送達システム。
(33)前記膜の前記分子量遮断が約100kDであることを特徴とする実施態様(31)に記載の送達システム。
(34)前記コアが、ヒドロゲルから形成された生体適合性の基質を含むことを特徴とする実施態様(31)に記載の送達システム。
(35)前記ヒドロゲルが薬物中に含浸されていることを特徴とする実施態様(34)に記載の送達システム。
(37)前記外被が更に、親水性または疎水性の添加物を含むことを特徴とする実施態様(36)に記載の送達システム。
(38)前記生体材料が組織基質構造であることを特徴とする実施態様(3)に記載の送達システム。
(39)前記組織基質構造が哺乳動物細胞を含むことを特徴とする実施態様(38)に記載の送達システム。
(40)前記細胞が、移植する時に同種または同系であることを特徴とする実施態様(39)に記載の送達システム。
(42)前記細胞がインスリン産生細胞であることを特徴とする実施態様(39)に記載の送達システム。
(43)前記細胞が抗体を分泌することを特徴とする実施態様(39)に記載の送達システム。
(44)前記細胞の全てが、前記送達システムの前記前面から約800μm以内の距離に配置されていることを特徴とする実施態様(39)に記載の送達システム。
(45)前記送達システムが更に、生体適合性ヒドロゲル基質に分散された容量が1μlを超える少なくとも約104の生細胞を含むコアを含み、前記生細胞が活性物質を分泌できる或いは代謝機能または免疫機能を提供できることを特徴とする実施態様(39)に記載の送達システム。
(47)前記細胞が、単位容量当たりのパッキング効率を上げるように適合された拡散凝集形態に凝集されることを特徴とする実施態様(39)に記載の送達システム。
(48)患者に材料を移植する方法であって、
(a)テザーが付いた活性物質送達システムインプラントを患者の体内に挿入するステップと、
(b)前記送達システムを血管組織に近接させて前記体内に留置するステップと、
(c)前記送達システムが前記血管組織に実質的に近接するまで前記テザーを引張るステップと、
(d)前記血管組織に実質的に接触した状態に前記送達システムを実質的に保持するように前記テザーの基端部を一般に固定するステップとを含み、
前記送達システムが、所定量の活性物質を含む生体材料を含み、前記生体材料が、前記患者に生物活性物質を投与できる或いは代謝機能または免疫機能を提供できることを特徴とする方法。
(49)前記投与が治療効果のある量の送達であることを特徴とする実施態様(48)に記載の方法。
(50)前記治療効果のある日用量が、活性物質が体重1kg当たり約0.1mg〜約100mgの範囲であることを特徴とする実施態様(49)に記載の方法。
(52)組織に接触させる前記ステップが、細胞が増殖する条件下で細胞の増殖に十分な時間、細胞及び組成物の接触を維持するステップを含むことを特徴とする実施態様(48)に記載の方法。
(53)組織に接触させる前記ステップが、治療が必要な患者に組成物を投与して治療効果のある量の活性物質を送達することを特徴とする実施態様(48)に記載の方法。
(54)前記活性物質が組成物の移植によって投与され、基材が所望の組織形状に一致する形状であることを特徴とする実施態様(48)に記載の方法。
(55)前記生体材料が生体適合性であることを特徴とする実施態様(48)に記載の方法。
(57)前記生体材料が、20日以上の期間に亘る患者の治療に十分な量の活性物質を含むことを特徴とする実施態様(48)に記載の方法。
(58)前記生体材料が、30日以上の期間に亘る患者の治療に十分な量の活性物質を含むことを特徴とする実施態様(48)に記載の方法。
(59)前記送達システムが、1日当たり約0.01μl〜3μlの用量範囲で前記活性物質を送達できるように適合されていることを特徴とする実施態様(48)に記載の方法。
(60)前記送達システムが、1時間当たり約0.01μg〜約300μgの割合で前記活性物質を送達することを特徴とする実施態様(48)に記載の方法。
5 治療部位
10 送達システム
11 挿入器具
12 テザー
13 ハンドル
14 内側チューブ
16 外側チューブ
18 キャビティ
20 腹部
22 カニューレ
23 クリップ
24 基材
26 生体材料
28 物質
29 レザバー
30 開口
Claims (11)
- 患者に活性物質を供給するための移殖用活性物質送達システムであって、
前面及び後面を有する一定量の活性物質を含む生体材料を含み、
前記生体材料の前記前面が前記患者の血管組織に実質的に近接して保持されるように適合されており、
前記生体材料が、前記患者に生物活性物質を投与できる或いは代謝機能または免疫機能を提供できることを特徴とする移殖用活性物質送達システム。 - 前記送達システムが更に、移植部位に固定するため或いは移植後に回収するためにテザーを含むことを特徴とする請求項1に記載の送達システム。
- 前記テザーが、前記生体材料を血管組織に実質的に近接して保持できるように適合されていることを特徴とする請求項2に記載の送達システム。
- 前記テザーの材料が生体吸収性であることを特徴とする請求項3に記載の送達システム。
- 前記テザーが、前記送達システム内の活性物質を補充する手段として機能できることを特徴とする請求項3に記載の送達システム。
- 前記送達システムが更に放射線不透過性材料を含むことを特徴とする請求項3に記載の送達システム。
- 前記送達システムが、活性物質を腹膜に送達できるように適合されていることを特徴とする請求項3に記載の送達システム。
- 前記送達システムが、網に活性物質を送達できるように適合されていることを特徴とする請求項3に記載の送達システム。
- 前記送達システムが、カニューレを介して送達できるように適合されていることを特徴とする請求項7または8に記載の送達システム。
- 前記送達システムが実質的に平坦なシートであることを特徴とする請求項7または8に記載の送達システム。
- 患者に材料を移植する方法であって、
(a)テザーが付いた活性物質送達システムインプラントを患者の体内に挿入するステップと、
(b)前記送達システムを血管組織に近接させて前記体内に留置するステップと、
(c)前記送達システムが前記血管組織に実質的に近接するまで前記テザーを引張るステップと、
(d)前記血管組織に実質的に接触して前記送達システムを実質的に保持するように前記テザーの基端部を概ね固定するステップとを含み、
前記送達システムが、所定量の活性物質を含む生体材料を含み、前記生体材料が、生物活性物質を投与できる或いは前記患者に代謝機能または免疫機能を提供できることを特徴とする方法。
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US7780973B2 (en) | 2010-08-24 |
BRPI0406172B1 (pt) | 2018-10-09 |
CA2489735C (en) | 2014-02-11 |
BRPI0406172B8 (pt) | 2021-06-22 |
EP1543851B1 (en) | 2014-04-23 |
US20050131386A1 (en) | 2005-06-16 |
AU2004235619A1 (en) | 2005-06-30 |
EP1543851A1 (en) | 2005-06-22 |
BRPI0406172A (pt) | 2006-03-28 |
CN1788688A (zh) | 2006-06-21 |
JP4959130B2 (ja) | 2012-06-20 |
PL1543851T3 (pl) | 2014-09-30 |
CA2489735A1 (en) | 2005-06-15 |
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