JP5081228B2 - 薬物貯留体インプラント設計及び植え込みの方法 - Google Patents
薬物貯留体インプラント設計及び植え込みの方法 Download PDFInfo
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Description
現在、治療薬は、変性、傷害、感染、悪性腫瘍、又は発育性奇形に関係する骨及び軟骨関連の欠陥を治療するために、全身的に送達されている。現在使用されているTNF阻害薬は、静脈内注射及び皮下注射により全身的に投与されるのが一般的であるが、抗TNF療法には、それら療法で通例になっている投与量の多い全身投与に伴う副作用がある。それら全身的薬物送達システムの重大な欠点は、抗炎症薬は、半減期が短い緩衝液に入れて送達されるため、患者に繰り返し投与する必要があり、結果的に送達システムでは投与量が相対的に多くなり悪影響が出る、ということである。不幸にも、それでは、組織を通して目標部位に進めることができる薬剤の量は限られてしまう。この方法は、患者の必要に応えるには不適切である。抗TNF療法は、通常、長期にわたって必要であるため、反復的な注射が必要になる可能性が高い。また、抗TNF薬剤には、時には注射部位に痛みと反応が発現することもある。最近は、患者の疾病を治療するための容認できるインプラントと方法を開発する試みが数多く行われている。
米国特許出願公開第20050177118号には、骨、軟骨、及び軟組織の空隙の治癒を促すための多価電解質複合体を備えている植え込み可能な装置が開示されている。この開示によれば、インプラントは、生体内で、種々の組織の又は均質的な病変部において組織細胞の生体内培養を行うか、又は1つ又は複数の治療薬の患者への非全身的送達を行う。このインプラントは、装置の一部として電気的構成要素を提供しているが、装置の一部として治療薬成分は含んでおらず、ましてや、治療薬を所望の組織に送達することには関与しない。
本発明の1つの方法では、狙い撃ち送達システムは、カテーテルを目標部位又はその付近に挿入することによって局所的に投与される薬物貯留体インプラントシステムを備えており、このカテーテルは、近位端と遠位端を有し、遠位端には現場で治療薬を送り込むための開口部があり、近位端は医薬送出ポンプに流体接続されている。例えば、カテーテルの近位端は、治療薬を、目標部位の10cm以内、更に望ましくは目標部位の5cm以内、なお一層望ましくは目標部位の3cm以内に送達することができる。本発明の様々な実施形態では、治療薬は、目標部位に、目標部位に隣接して、又は目標部位から約0cm乃至目標部位から約10cmのところに、送達されるが、それら範囲内の距離であれば目標部位からどれだけでもよい。
組織壊死及び/又は損傷を遅らせる方法も開示されており、この方法は、治療を必要とする被術者の目標部位に、1つ又は複数の治療薬を含んでいる有効量の医薬組成物を投与することから成り、この方法では、1つ又は複数の治療薬は、医薬組成物の局所的及び徐放的放出を提供する貯留体によって投与される。1つの実施形態では、この貯留体は、被術者の、限定するわけではないが、炎症を起こしている神経又は脊椎部位、例えば脊椎円板又は脊椎円板空間、の様な目標部位又はその付近に植え込まれる。
本発明の別の態様は、関節嚢貯留体は、キャップと組み合わされた逆棘を有しており、貯留体が、一旦、関節嚢の壁の中に挿入されたら、逆棘が展開し、貯留体はキャップと展開した逆棘によって定位置に保持されるようになっている。本発明のこの態様では、逆棘は貯留体が後退しないにようにし、キャップは貯留体が関節空間にすっぽり入り込んでしまわないようにしている。本発明の別の態様では、貯留体は、治療薬が貯留体の関節空間の滑液の中に突き出ている部分にしか埋め込まれないように設計することができる。本発明のこの態様では、関節が関節運動をした際に、それによって滑液全体に治療薬が配送され易くなる。1つの実施形態では、3乃至6ヶ月後に、貯留体は完全に分解し、もはや関節嚢を横断してはいない。
「備える」「備えている」「含む」「含んでいる」「有する」及び「有している」という用語は、包含的に広い意味で使われており、即ち、追加の要素が含まれる場合もあるという意味である。ここで使用されている「〜の様な」「例えば」「即ち」という用語は、非制限的であり、説明のためだけに使われている。「〜を含め」と「限定するわけではないが〜を含め」は、置き換え可能に使用されている。
例えば、BMPの様な治療薬は、凍結乾燥形態で提供してもよいし、コラーゲンゲル又は何か他の適したゲル担体内に再構成してもよい。治療薬を目標物に送達することができるあらゆる適したゲル担体が考えられる。或る特定の実施形態では、用量は、貯留体インプラントによって提供され、当該用量を目標部位に又はそれに密接に近接する位置に供与すべく植え込まれる。
微小球を目標である組織部位に送達するのに、ポンプ又などの様な局所式送達装置を使用できるものと理解頂きたい。同じく、微小球の有無にかかわらず、本発明のゲルを目標部位に送達するのにポンプを使用してもよい。局所式送達システムの例は、同時係属米国特許出願第11/091,348号に提示されており、同出願を参考文献としてここに援用する。抗炎症薬又は同化化合物を椎間円板又は関節動作関節に送達するのに貯留体インプラントを使用することは、以前には開示されていなかった。本発明に開示し、本発明で考えている特定の設計は、組織崩壊と正常な関節運動への干渉を最小限にしながら、貯留体インプラントを円板又は関節嚢の中に挿入する1つのやり方を提供している。本発明は、更に、貯留体が、炎症を起こしている組織から移動するのを防止し、薬物を、より均一に配布することができるようにしている。
Claims (10)
- 薬物貯留体インプラントにおいて、
表面及び両側部を有する本体と、
前記本体から延びており、少なくとも2つの可撓性を有する角度のついた逆棘を備える錨着システムであって、前記少なくとも2つの可撓性を有する角度のついた逆棘の各々が、前記本体の前方並進運動を許容するとともに目標である組織からの前記本体の後方並進運動を制限する突端を備え、少なくとも2つの可撓性を有する角度のついた逆棘が前記本体の前記表面にあり、前記少なくとも2つの可撓性を有する角度のついた逆棘が前記本体の前記両側部に配置されている、錨着システムと、
前記本体及び前記錨着システムの全体に配置されている治療薬であって、前記本体及び前記錨着システムが前記治療薬を溶出することが可能であり、前記薬物貯留体インプラントが固体であり前記薬物貯留体インプラントから1cm乃至5cm離れた位置に前記治療薬の最適濃度を提供する、治療薬とを備え、
前記薬物貯留体インプラントはカニューレの中に配置され、前記少なくとも2つの可撓性を有する角度のついた逆棘が前記カニューレから抜け出ると延びる、薬物貯留体インプラント。 - 前記本体はロッド形状をしており、前記錨着システムは、前記ロッド形状の本体から延びていて、前記本体の、前記ロッド形状の本体の長手方向軸に沿った並進運動を制限するようになっている、請求項1に記載の薬物貯留体インプラント。
- 前記錨着システムは、組織面に当接するようになっている表面を提供している、請求項2に記載の薬物貯留体インプラント。
- 前記錨着システムは、前記ロッド形状の本体の端に配置されたエンドキャップである、請求項2又は3に記載の薬物貯留体インプラント。
- 前記錨着システムは、縫合糸である、請求項1乃至4の何れか1項に記載の薬物貯留体インプラント。
- 前記薬物貯留体インプラントのX線撮影を支援するようになっているX線マーカーを更に備えている、請求項1乃至5の何れか1項に記載の薬物貯留体インプラント。
- 前記本体は、中実の生物分解性材料で形成されており、前記治療薬は、前記生物分解性材料の少なくとも一部分に分散している、請求項1乃至6の何れか1項に記載の薬物貯留体インプラント。
- 前記生物分解性材料内に配置されている複数の微小球を更に備えており、前記微小球には、前記治療薬の少なくとも一部が封入されている、請求項7に記載の薬物貯留体インプラント。
- 前記治療薬は、抗炎症薬である、請求項1乃至8の何れか1項に記載の薬物貯留体インプラント。
- 薬物貯留体インプラントにおいて、
表面及び両側部を有するロッド形状の本体と、
前記ロッド形状の本体から延びている錨着システムであって、目標である組織から前記ロッド形状の本体が移動することを制限するようになっており、前記ロッド形状の本体の前記表面に少なくとも4つの可撓性を有する逆棘を備え、前記少なくとも4つの可撓性を有する逆棘の第一の対が前記ロッド形状の本体の前記両側部に配置され、前記第一の対の各々が目標である組織からの前記ロッド形状の本体の後方移動を制限する突端を備え、前記少なくとも4つの可撓性を有する逆棘の第二の対が前記ロッド形状の本体の前記両側部に配置され、前記第二の対の各々が目標である組織からの前記ロッド形状の本体の前方移動を制限する突端を備える、錨着システムと、
前記ロッド形状の本体及び前記錨着システムの全体に配置されている治療薬であって、前記ロッド形状の本体及び前記錨着システムが前記治療薬を溶出することが可能であり、前記薬物貯留体インプラントが固体であり前記薬物貯留体インプラントから1cm乃至5cm離れた位置に前記治療薬の最適濃度を提供する、治療薬とを備え、
前記薬物貯留体インプラントはカニューレの中に配置され、前記少なくとも4つの可撓性を有する逆棘が前記カニューレから抜け出ると延びる、薬物貯留体インプラント。
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US11/403,733 | 2006-04-13 | ||
US11/403,733 US7741273B2 (en) | 2006-04-13 | 2006-04-13 | Drug depot implant designs |
PCT/US2007/066496 WO2007121288A2 (en) | 2006-04-13 | 2007-04-12 | Drug depot implant designs and methods of implantation |
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JP2009533185A JP2009533185A (ja) | 2009-09-17 |
JP2009533185A5 JP2009533185A5 (ja) | 2010-04-08 |
JP5081228B2 true JP5081228B2 (ja) | 2012-11-28 |
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EP (1) | EP2007353A2 (ja) |
JP (1) | JP5081228B2 (ja) |
CN (1) | CN101442983B (ja) |
WO (1) | WO2007121288A2 (ja) |
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CN101442983A (zh) | 2009-05-27 |
US7727954B2 (en) | 2010-06-01 |
US20100189757A1 (en) | 2010-07-29 |
CN101442983B (zh) | 2012-09-26 |
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