JP4750782B2 - 導管を閉塞させるための方法及び装置 - Google Patents
導管を閉塞させるための方法及び装置 Download PDFInfo
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- JP4750782B2 JP4750782B2 JP2007500782A JP2007500782A JP4750782B2 JP 4750782 B2 JP4750782 B2 JP 4750782B2 JP 2007500782 A JP2007500782 A JP 2007500782A JP 2007500782 A JP2007500782 A JP 2007500782A JP 4750782 B2 JP4750782 B2 JP 4750782B2
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- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
- A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
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Description
医療及び研究の分野において、身体の管又は導管内の物質の通過、流れ、又は移動を、閉塞又は封鎖を生じさせることにより停止させることが望まれ、又は必要とされる多くの臨床的状況がある。後に閉塞が再び開放されることが望ましい場合がしばしばある。不都合なことに、多くの閉塞技術が、しばしば有害であり、又は、有害である可能性があり、患者のニーズ又は要望の変化に適応するように可逆的ではない。
本発明は、導管を閉塞させるための組成物を配送するための方法、システム及び装置を含む。特に、本発明は、ヒト又は他の動物の導管を閉塞させるための方法、システム及び装置を含む。本発明の装置は、導管を閉塞させる材料を含む組成物を配送するために用いられる。導管は、天然に生じている導管、例えば、身体内の管又は血管であり得る。或いは、導管は、身体内に導入された導管、例えば、医療装置であり、又は外科的手段により導入された導管であり得る。閉塞材料は永久的な埋め込み材料であることができ、又は、身体により分解され、若しくは再吸収されて、閉塞を維持するための組織内部成長を可能にする材料であり得る。
本発明は、導管を閉塞させるためのデリバリーシステム、方法及び装置を含み、また、導管内の閉塞を解除するための方法、システム及び装置を含む。本発明は、身体内の導管を、デリバリー装置を用いて閉塞材料を配置することにより閉塞させるためのデリバリーシステム及び方法を含む。本発明の一態様は、導管を永久的に閉塞させることを含む。別の態様において、本発明は、導管を可逆的に閉塞させることを含む。本発明のさらに別の態様は、雌の哺乳類の卵管を閉塞させるための方法、デリバリーシステム及び組成物と、このような閉塞を再開放するための方法及びシステムとを含む。本発明のさらなる態様は、雄の哺乳類の輸精管を閉塞させるための方法、デリバリーシステム及び組成物と、このような閉塞を再開放するための方法及びシステムとを含む。本発明の方法、システム及び組成物は、非外科手術的な、診療所で行われる可逆的な避妊を可能にする実施形態にて用いられ得る。
“a”,“an”)及び「その」(“the”)は、文脈上明らかに他のものを示す場合を除き、複数の指示対象を含むことを留意されたい。
埋め込み可能な材料Aの調製
n−メチル−ピロリドン(NMP)中に、ポリ(ラクチド−コ−ε−カプロラクトン)(PLCL)(ラクチド/ε−カプロラクトン単位比が25/75)を50重量%溶解させた溶液を調製し、滅菌した。2−メトキシプロピルシアノアクリレート(MPCA)と、生体適合性の酸(この場合は氷酢酸(AA))との混合物(MPCA:AAを約1:1の割合で含む)を調製し、滅菌した。埋め込み可能な材料Aを、0.8ccのPLCL溶液と、0.2ccのMPCA混合物とを混合する(混合物の均質性が達成するまで)ことにより、使用直前に調整した。得られた混合物は、水性環境がない状態での室温にて、最初に温かくなり、硬化を示すが、少なくとも15分間、組織への付着を維持し、且つ、20G IVカテーテルを通して流動可能である。この埋め込み可能な材料は、水又は動物組織と接触すると、硬化を急速に達成し、比較的容易に圧縮可能で且つ鱗状に剥離する半固体材料を形成する。
埋め込み可能な材料Bの調製
エチルアルコール(EtOH)中に、ポリ(ラクチド−コ−グリコリド)(PLGA)(ラクチド/グリコリド単位比が50/50)を25重量%溶解させた溶液を調製し、滅菌した。シアノアクリル酸ブチル(BCA)とAAとの混合物(BCA:AAを約2:1の割合で含む)を調製し、滅菌した。埋め込み可能な材料Bを、0.4ccのPLGA溶液と、0.4ccのBCA混合物とを混合する(混合物の均質性が達成するまで)ことにより、使用直前に調整した。得られた混合物は、水性環境がない状態での室温にて、最初に温かくなり、硬化を示すが、少なくとも15分間、組織への付着を強度に維持し、且つ、20G IVカテーテルを通して流動可能である。この埋め込み可能な材料は、水又は動物組織と接触すると、硬化を急速に達成し、折り曲げようとすると破損する、比較的圧縮不可能な半固体材料を形成する。
埋め込み可能な材料Cの調製
塩化メチレン中にPLGAを溶解させて25重量/容量%の溶液を生成することにより、50/50PLGAの粒子を調製し、これを0.3%のポリビニールアルコール(PVA)溶液中で乳化し、さらに、PVA溶液に、2%のイソプロピルアルコールを加え、溶剤を除去した。粒子を収集し、凍結乾燥し、滅菌した。粒子(0.25g)を、BCAとAAとを2:1で含む0.75gの滅菌された混合物に加えた。得られた懸濁液は室温で流動可能であったが、水又は動物組織と接触すると硬化し、堅固な接着材料を形成した。
埋め込み可能な材料Cの調製
50/50PLGAの粒子を、例3に記載した方法で調製し、ヒドロキノン(0.5%)をPVA乳化液に加え、粒子の表面上にヒドロキノンを閉じ込めた。粒子を収集し、凍結乾燥し、滅菌した。粒子(0.25g)を、0.75gの滅菌されたBCAに加えた。粒子懸濁液は室温で流動可能であり、シアノアクリレートポリマー化を示さなかった。この組成物は、水又は組織に露出されると硬化し、堅固な接着材料を形成した。
埋め込み可能な3つの材料の、ウサギの卵管での実験
上記の例と同様に調製された3つの候補材料を、ウサギの卵管に配置したときに機械的閉塞を形成する能力、及び、組織内部成長反応を発生する能力に関して実験した。第4の材料(メチルシアノアクリレート(MCA))を、実験対照材料として用いた。メチルシアノアクリレートは、以前に、動物及びヒトの女性の避妊を実行するために用いられているが、生体適合性の面で許容されないことが示されている。実験材料および実験対照材料の各々を、3匹のニュージーランドホワイトラビットの卵管に、公開手順(20G IVカテーテルをデリバリーシステムとして用いる)により滴下した。これらの材料を、カテーテルを通して左右の子宮体の角状部に注入した。材料が子宮の他の部分に逆流することを防止するために指圧を用いた。材料が盲管内にあることを確認したならば(すなわち、腹膜からの漏出が生じたならば)、又は、十分な量の材料が配送されたならば、材料の順流を停止した。非常に急速に硬化し、カテーテルに付着し、硬化の高熱を生じる実験対照材料と比較して、実験材料は、より長い硬化時間(閉鎖前の時間内であり、且つ、粘着を生じずにカテーテルを除去するために十分に長い)を有し、また、それほど多くの熱も発生しないことが注目された。左右両方の卵管を処置したならば、生殖器官を骨盤内に再び配置し、切開を閉じた。14日後に動物を解剖した。染料注入テストが、全ての動物の卵管が閉塞されることを示した。1つの実験材料は、過剰な量の炎症および粘着を生じたので、除外した。残りの実験材料及び実験対照材料は、適切な組織反応を生じ、炎症細胞及び挫滅組織片により、卵管の内腔を完全に閉塞させた。
外植されたヒトの子宮におけるデリバリーシステムの使用
図1にされたシステムと同等の試作のデリバリーシステムを用いて、外植された3つのヒトの子宮(協会の施設内倫理委員会の規則に従って得られた)の卵管に、染料及び閉塞材料を配送した。各々の場合において、外植された子宮を検査台上に解剖的位置にて配置し、イントロデューサのシャフトを、シャフト先端が子宮底に達するまで(触感により決定)、経頸管的に配置した。次いで、2つのバルーンカテーテルの各々を、イントロデューサ内のチャネルを通して、カテーテルが子宮の角状部内で留まったことを感じるまで前進させた。抵抗が感じられるまでバルーンを膨張させた。次いで、装置の視覚化を可能にするために子宮を切開(bivalve)し、装置が各々、適切に配置されたことを確認した。上記の3体のうち、1つのケースは正常な多産子宮を示し、2つのケースが重大な平滑筋腫を示した。これは、子宮筋腫が中線の外側にあること、又は、子宮角がデリバリーシステムの使用の成功を妨げていないこと示す。配置が成功したことを確認した後、カテーテルを通して一連の液体注入を行った。第1の注入は、開存性を確認するために食塩水を用い、第2の注入は、子宮腔への逆流が起こらなかったことを証明するためにヘマトキシリン染料を用い、最後の注入は、先に示した例における動物実験から得た閉塞材料を、このシステムがヒトにおいて十分に機能することを示すために用いた。実験された各ケースにおいて、染料が、子宮腔への漏出がない順流を示し、材料が成功裡に配送された。
1.「受胎、家族計画及び女性の健康:家族成長の全国調査(1995年)のからの新データ」:JC・アブマ(Abma)、A・チャンドラ(Chandra)、WD・モーシァー(Mosher)ら(医学雑誌バイタル・アンド・ヘルス・スタティスティクス(Vital and health statistics)1997年第23(19)刊)
2.「産婦人科医のための臨床管理ガイドライン」:米国産婦人科学会公報46(医学雑誌オブステトリクス・アンド・ジネコロジー(Obstetrics and Gynecology)2003年第102刊 647〜658)
3.「精管切除術の安全性に関する事実」(泌尿器疾患財団)
4.「子宮内器具の適切な使用」:T・カナバン(canavan)(米国家庭医学会 1998年12月)
5.「精管切除術技術」:T・クレニー(Clenney)ら(米国家庭医学会 1999年7月)
6.「受胎、避妊及び人口政策」(国連人口委員会、経済社会局 2003年4月25日 ESA/P/WP.182)
7.「避妊手術及びその結果」:N・ヘンドリクス(Hendrix)ら(医学雑誌オブステトカル・アンド・ジネコロジカル・サーベイ(Obstetrical and Gynecological Survey)1999年12月第54刊(12)766頁)
8.「経口避妊薬、卵管避妊手術、及び卵巣嚢胞の機能的リスク」:VL・ホールト(Holt)ら(医学雑誌オブステトリクス・アンド・ジネコロジー(Obstetrics and Gynecology)2003年第102刊:252〜258)
9.「精管切除術と比較した女性の卵管避妊法の後悔」:DJ・ジェイミソン(Jamieson)ら(医学雑誌オブステトリクス・アンド・ジネコロジー(obstetrics and Gynecology)2002年第99刊 1073〜1079)
10.「ピル:30年の安全性」:S・スナイダー(Snider)(食品医薬品局 2001年4月)
11.「卵管結紮避妊術の副作用」(ビディヤ・メディカルニュースサービス(Viddya Medical News Service) 第1刊、論題249)
Claims (28)
- ヒト又は動物の身体内の少なくとも1つの導管を閉塞させるための方法に用いる装置であって、
a)閉塞材料を含む有効量の組成物を配送することができるデリバリーシステムを含み、
当該デリバリーシステムは、
少なくとも1つのカテーテルをもたらすための少なくとも1つのイントロデューサシャフトを含むデリバリー装置と、
デリバリー端に端部構造物を、及び近位端に取付け手段を含む少なくとも1つのカテーテルと、
閉塞材料を含む組成物と、
前記閉塞材料を含む前記組成物を前記少なくとも1つのカテーテル内に及び前記少なくとも1つのカテーテルを通してもたらすための手段と
を含み、
前記方法は、
b)前記閉塞材料を含む有効量の前記組成物を、前記イントロデューサシャフトのカテーテルチャネルを通して前記少なくとも1つのカテーテルの前記デリバリー端をターゲット部位又はその付近にもたらすことにより、前記閉塞材料が前記導管の内腔を閉塞させるように配送すること、および、
c)前記導管を閉塞させること、
を含む方法である装置。 - 前記イントロデューサシャフトの取り出し及び再挿入、又は実質的な再配置を行わずに2つの導管が閉塞される請求項1に記載の装置。
- 前記2つの導管が哺乳類の卵管である請求項2に記載の装置。
- d)前記少なくとも1つの導管を前記導管の内腔の前記閉塞を除去することによって再開放すること、をさらに含む請求項1に記載の装置。
- 前記閉塞材料を含む前記組成物が、前記内腔に配送される前に混合される請求項1に記載の装置。
- 前記閉塞材料を含む前記組成物が、液体の組織接着剤及び溶媒和ポリマーを含み、前記組成物が現場(in situ)で硬化する請求項1に記載の装置。
- 前記閉塞材料を含む前記組成物が超音波可視性である請求項1に記載の装置。
- 前記超音波可視材料が、空気若しくはガスの微小泡、又は、空気若しくはガスを閉じ込めた材料の微小粒子を含む請求項7に記載の装置。
- 前記液体の組織接着剤が、シアノアクリレート、ポリアクリル酸、ポリエチレングリコール、変性ポリエチレングリコール、トロンビン、コラーゲン、コラーゲンを基材とする接着剤、フィブリン、フィブリン接着剤組成物、ゼラチン−レゾルシノール−ホルムアルデヒド−グルタルアルデヒド(GRFG)接着剤、コラーゲン又はトロンビンと組み合わせた自家血液、架橋アルブミン接着剤、変性グリコサミノグリカン、ポリ(N−イソプロピルアクリルアミド)を基材とする接着剤、カルボジイミド又はゲネピン(genepin)で架橋されたアルギナート、キトサン又はゼラチンであり;溶媒和ポリマーが、再吸収可能なポリエステルであり、ポリラクチド、ポリグリコリド、若しくはポリカプロラクトン、又はこれらの材料のコポリマーを含み、当該コポリマーが、ポリ(ラクチド/グリコリド)酸(PLGA)、又は、ポリ(ラクチド−コ−ε−カプロラクトン)(PLCL)を含む請求項6に記載の装置。
- 前記硬化された組成物の膨潤率が20%未満である請求項6に記載の装置。
- 前記硬化された組成物が、30日〜365日の期間に、実質的に20%〜100%再吸収される請求項6に記載の装置。
- 前記閉塞が組織の内部成長により維持される請求項11に記載の装置。
- 前記閉塞材料を含む前記組成物が、液体の組織接着剤、及び粒子を含む請求項1に記載の装置。
- 前記粒子が、再吸収可能なポリマーの球体を含むナノ粒子又は微小粒子である請求項13に記載の装置。
- 前記粒子の直径が0.1マイクロメータ〜1000マイクロメータである請求項13に記載の装置。
- 前記閉塞材料が超音波により観測可能である請求項1に記載の装置。
- 前記組成物が、さらに、組織瘢痕化剤、線維化剤、受精抑制剤、避妊薬、組織成長促進物質、ホルモン、重合防止剤、重合安定剤、乳化剤、エコー源性剤、造影剤、粘性変更材料、可塑剤、着色剤、又は、これらの薬剤及び材料の組合せを含む請求項6に記載の装置。
- 前記組成物が、さらに、前記閉塞材料のための硬化可能な担体、コントロールリリース剤、組織瘢痕化剤、線維化剤、受精抑制剤、避妊薬、組織成長促進物質、ホルモン、重合防止剤、重合安定剤、乳化剤、エコー源性剤、造影剤、粘性変更材料、可塑剤、着色剤、又は、これらの薬剤及び材料の組合せを含む請求項13に記載の装置。
- 避妊のための方法に用いる装置であって、
a)閉塞材料を含む有効量の組成物を配送することができるデリバリーシステムを含み、
当該デリバリーシステムは、
少なくとも1つのカテーテルをもたらすための少なくとも1つのイントロデューサシャフトを含むデリバリー装置と、
少なくとも1つのデュアルルーメンバルーンカテーテルと、
閉塞材料を含む組成物と、
前記閉塞材料を含む前記組成物を前記少なくとも1つのカテーテル内に及び前記少なくとも1つのカテーテルを通してもたらすための手段と
を含み、
前記方法は、
b)前記閉塞材料を含む有効量の前記組成物を、前記イントロデューサシャフトのカテーテルチャネルを通して前記少なくとも1つのカテーテルの遠位端をターゲット位置又はその付近にもたらすことにより、前記閉塞材料が少なくとも1つの卵管の内腔を閉塞させるように配送すること、および、
c)卵管を閉塞させることを含む方法である装置。 - 避妊装置であって、
少なくとも1つのカテーテルをもたらすためのイントロデューサシャフトと、
デリバリー端に端部構造物を含む少なくとも1つのカテーテルと、
閉塞材料を含む組成物と、
前記閉塞材料を含む前記組成物を前記カテーテル内に及び前記カテーテルを通してもたらすための手段と
を含み、
前記イントロデューサシャフトは、前記少なくとも1つのカテーテルの前記デリバリー端が通って前記イントロデューサシャフトを出るカテーテルチャネルを含む避妊装置。 - 前記端部構造物が、カップ、ノズル又はバルーンである請求項20に記載の装置。
- 前記避妊装置を、当該装置が一度配置されたならば所定位置に保持するためのデリバリー装置安定器をさらに含む請求項20に記載の装置。
- 前記デリバリー装置安定器が、前記装置を適切な位置に保持するために、頸部に嵌め付けられ、若しくは取り付けられ、若しくは頸部内に嵌め込まれ、又は頸部内で膨張する請求項21に記載の装置。
- 少なくとも1つの閉塞された導管を開放するための方法に用いる装置であって、
a)少なくとも1つのカテーテルをもたらすための少なくとも1つのイントロデューサシャフトと、デリバリー端に端部構造物を各々が含む少なくとも1つのカテーテルと、前記導管を再開放するための手段とを含むデリバリー装置を含み、
前記イントロデューサシャフトは、前記少なくとも1つのカテーテルの前記デリバリー端が通って前記イントロデューサシャフトを出るカテーテルチャネルを含み、
前記方法は、
b)前記導管を前記導管の内腔の前記閉塞を除去することによって再開放すること
を含む方法である装置。 - 請求項1に記載の装置を用いて閉塞された少なくとも1つの閉塞導管を開放するための方法に用いる装置であって、
a)前記導管を開放する手段を配送することができるデリバリー装置を含むデリバリーシステムを含み、
前記方法は、
b)前記導管を前記導管の内腔の前記閉塞を除去することによって開放すること
を含む方法である装置。 - 前記導管を開放する手段を配送することができる前記デリバリーシステムはデリバリー装置を含み、
前記デリバリー装置は、
少なくとも2つのカテーテルをもたらすための少なくとも1つのイントロデューサシャフトと、
静的装置を一端に含む少なくとも1つのカテーテルと、
配置時に前記デリバリーシステムを適切な位置に保持するための手段と、
前記導管を開放するための手段と
を含む請求項25に記載の装置。 - 前記導管を開放するための手段が、閉塞材料を粉砕するための衝撃波、溶剤を含む化学的手段、酵素を含む生物学的手段、又は、内腔を再疎通させるための堅固な、若しくは切断用のカテーテル端を含む機械的手段をもたらすための装置又は部材を含む請求項24に記載の装置。
- c)ステントを前記導管の内腔内に設けることにより導管の開放を維持すること、をさらに含む請求項24に記載の装置。
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US11/065,886 US8048086B2 (en) | 2004-02-25 | 2005-02-24 | Methods and devices for conduit occlusion |
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US8695606B2 (en) | 2004-02-25 | 2014-04-15 | Femasys Inc. | Methods and devices for conduit occlusion |
US8726906B2 (en) | 2004-02-25 | 2014-05-20 | Femasys Inc. | Methods and devices for conduit occlusion |
US9034053B2 (en) | 2004-02-25 | 2015-05-19 | Femasys Inc. | Methods and devices for conduit occlusion |
US9238127B2 (en) | 2004-02-25 | 2016-01-19 | Femasys Inc. | Methods and devices for delivering to conduit |
US9308023B2 (en) | 2004-02-25 | 2016-04-12 | Femasys Inc. | Methods and devices for conduit occlusion |
US9402762B2 (en) | 2004-02-25 | 2016-08-02 | Femasys Inc. | Methods and devices for conduit occlusion |
US9839444B2 (en) | 2004-02-25 | 2017-12-12 | Femasys Inc. | Methods and devices for conduit occlusion |
US10111687B2 (en) | 2004-02-25 | 2018-10-30 | Femasys, Inc. | Methods and devices for conduit occlusion |
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