JP2015155005A - 医療用移植片 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
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- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
- D10B2403/00—Details of fabric structure established in the fabric forming process
- D10B2403/01—Surface features
- D10B2403/011—Dissimilar front and back faces
- D10B2403/0112—One smooth surface, e.g. laminated or coated
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- D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
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- D10B2509/00—Medical; Hygiene
- D10B2509/06—Vascular grafts; stents
Abstract
Description
本発明は、医療用移植片、より具体的には、患者の管腔または腔内に配置することが意図された自己拡張型医療用移植片に関する。
自然の体管腔内へのチューブ状デバイスの植え込みによって、様々な医学的状態が治療可能である。例えば、動脈が再狭窄を起こすであろうリスクを最小限に抑えるために、バルーン血管形成術後に、心臓病を有する患者の冠状動脈に金属ステントを植え込むことがよくある。近年、市販ステントは、再狭窄のリスクをさらに低減するように設計された薬物溶出性ポリマーコーティングを含むようになっている。従来のチューブ状医療用移植片の他の例は、血管瘤に橋渡しするために用いられるウーヴングラフトおよびステントグラフト、輸尿管および尿道において狭搾をバイパスするために用いられるポリマーチューブおよびカテーテル、ならびに末梢血管系、前立腺、および食道に用いられるステントを含む。
本発明の好ましい実施形態では、例えば以下が提供される:
(項目1)
植え込み型医療デバイスであって、該植え込み型医療デバイスは、
自己拡張型チューブ状構造であって、
約1GPaより大きい弾性係数によって特徴付けられる第1のポリマーを備える少なくとも1つのストランド;および
該ストランドを少なくとも部分的に被覆する第2のポリマーであって、該第2のポリマーは、37℃での約150パーセントより大きい破壊伸び率によって特徴付けられる、第2のポリマー;
を備える、自己拡張型チューブ状構造
を備え、該第2のポリマーは、該自己拡張型チューブ状構造の質量を少なくとも約20パーセント増加させる、植え込み型医療デバイス。
(項目2)
前記第1のポリマーは、生分解性である、項目1に記載の植え込み型医療デバイス。
(項目3)
前記第1のポリマーは、乳酸‐グリコール酸共重合体を含む、項目2に記載の植え込み型医療デバイス。
(項目4)
前記乳酸‐グリコール酸共重合体は、少なくとも約75重量パーセントの乳酸を含む、項目3に記載の植え込み型医療デバイス。
(項目5)
前記乳酸‐グリコール酸共重合体は、約85重量パーセントの乳酸を含む、項目4に記載の植え込み型医療デバイス。
(項目6)
前記乳酸‐グリコール酸共重合体は、約20重量パーセントまでの乳酸を含む、項目3に記載の植え込み型医療デバイス。
(項目7)
前記第1のポリマーは、約6Gpaより大きい弾性係数によって特徴付けられる、項目1に記載の植え込み型医療デバイス。
(項目8)
前記第2のポリマーは、生分解性である、項目1に記載の植え込み型医療デバイス。
(項目9)
前記第2のポリマーは、架橋されたランダム共重合体である、項目8に記載の植え込み型医療デバイス。
(項目10)
前記第2のポリマーは、乳酸−カプロラクトン共重合体、グリコリド−カプロラクトン共重合体、ポリトリメチレンカーボネート、および乳酸−ジオキサノン共重合体からなる群から選択される、項目8に記載の植え込み型医療デバイス。
(項目11)
前記第2のポリマーは、約50から70重量パーセントの乳酸を含む乳酸−カプロラクトン共重合体である、項目4に記載の植え込み型医療デバイス。
(項目12)
前記乳酸−カプロラクトン共重合体は、ヘキサメチレンジイソシアネートで架橋される、項目11に記載の植え込み型医療デバイス。
(項目13)
前記第2のポリマーの数平均分子量(Mn)は、約24,000Daより大きく約100,000Da未満である、項目10に記載の植え込み型医療デバイス。
(項目14)
前記第2のポリマーは、約5℃未満のガラス転移温度を有する弾性セグメントによって特徴付けられる、項目1に記載の植え込み型医療デバイス。
(項目15)
前記自己拡張型チューブ状構造は、編組構造である、植え込み型医療デバイス。
(項目16)
前記編組構造は、16と48との間のストランドを備える、項目15に記載の植え込み型医療デバイス。
(項目17)
前記ストランドは、約90度と約135度との間の平均編組角を形成する、項目16に記載の植え込み型医療デバイス。
(項目18)
前記ストランドは、約110度と約135度との間の平均編組角を形成する、項目17に記載の植え込み型医療デバイス。
(項目19)
前記第1のポリマー材料および前記第2のポリマー材料のうちの少なくとも1つの中に治療薬をさらに備える、項目1に記載の植え込み型医療デバイス。
(項目20)
前記第2のポリマーは、前記自己拡張型チューブ状構造の前記質量を少なくとも約30パーセント増加させる、項目1に記載の植え込み型医療デバイス。
(項目21)
前記自己拡張型チューブ状構造は、第1の端部と第2の端部とを有する、項目1に記載の植え込み型医療デバイス。
(項目22)
前記第2のポリマーを少なくとも部分的に被覆する第3のポリマーをさらに備える、項目1に記載の植え込み型医療デバイス。
(項目23)
前記第3のポリマー内に治療薬をさらに備える、項目22に記載の植え込み型医療デバイス。
(項目24)
前記第2のポリマーは、約5℃未満のTgを有する第1のセグメントと該第1のセグメントより硬い第2のセグメントとを備える、項目1に記載の植え込み型医療デバイス。
(項目25)
植え込み型医療デバイスであって、該植え込み型医療デバイスは、
自己拡張型チューブ状構造であって、
少なくとも約75重量パーセントの乳酸を含む乳酸−グリコール酸共重合体を備える、少なくとも1つの生分解性ストランド;および
該ストランドを少なくとも部分的に被覆する乳酸−カプロラクトン共重合体
を備える、自己拡張型チューブ状構造
を備え、
該乳酸−カプロラクトン共重合体は、架橋されて約30,000Daより大きい数平均分子量(Mn)を有し;
該乳酸−カプロラクトン共重合体は、該自己拡張型チューブ状構造の質量を少なくとも約24パーセント増加させ;
該自己拡張型チューブ状構造は、約110度と約135度の間の平均編組角を形成する16と48との間のストランドを備える編組構造である、植え込み型医療デバイス。
(項目26)
植え込み型医療デバイスであって、該植え込み型医療デバイスは、
自己拡張型チューブ状構造であって、
第1のポリマーを備える少なくとも1つのストランド;および
該ストランドを少なくとも部分的に被覆する第2のポリマーであって、該第2のポリマーは、約5℃未満のTgを有する第1のセグメントと該第1のセグメントより硬い第2のセグメントとを備える、第2のポリマー
を備える、自己拡張型チューブ状構造
を備え、該第2のポリマーは、該自己拡張型チューブ状構造の質量を少なくとも約20パーセント増加させる、植え込み型医療デバイス。
重量比を有するPLCLを含む。また別の好ましい実施形態において、ヘキサメチレンジイソシアネートで架橋されたPLCL 50:50の支持コーティングがPLGA 75:25の編組移植片に付けられる。
PLGA 10:90共重合体を用いて、ファイバを紡いだモノフィラメントを個別のボビン上へ巻くことによって編組移植片が製造された。編組機上に各ボビンが配置され、ローラーとアイレットとを通して張られて、心棒の周りに巻き付けられた。モノフィラメントのサイズに対して機械の編組帳力が設定された(すなわち、0.005インチのファイバに対して最小70g、最大215g)。半径方向の強度を最大にして、なおかつ編組を心棒から取り外すことを可能にする理想的な角度(すなわち、6mmの心棒に対して110から135度)を得るべく、ピクセル/インチが設定された。編組パターンが選択され、編組機によってモノフィラメントがスプールから心棒上へ編まれた。熱アニールして高係数特性を得るために重要なことがあるフィラメント上の張力を維持するために、各心棒の端部にタイラップが用いられた。編組ポリマーが心棒上で熱アニールされ、その後、ブレードを用いて望ましい長さに切断されて、心棒から取り外された。代表的な移植片は、約6.0mmの外径と約20mmの長さとを有することが測定された。
移植片とコーティング溶液とが実施例1に記載されるように製造された。支持コーティングは、移植片に一様に付ける代わりに、移植片の端部(すなわち、各端部のおよそ4〜5mm)のみに付けられた。2.5mmにクリンプされて、水浴中に37℃で1時間保持された後に、非被覆移植片が元の直径の約48%しか復元できなかったのに対して、端部を被覆した移植片は、同じ条件下で、元の直径の約82%まで復元することができた。そのうえ,これらの同じ移植片に対して、RRFおよびCOFは、それぞれ83.4mmHgおよび11.6mmHgから595.0mmHgおよび55.0mmHgへ増加した。
(図1に記載される移植片のような)被覆移植片のゲル含有量が抽出によって測定された。PGCL/HDI被覆デバイスが5mLのジクロルメタン中に置かれて、室温で約1時間振盪された。溶媒が除去されて、デバイスがジクロロメタンで十分に濯がれ、その後、約10分間風乾された。一切の残留溶媒を除去するために、デバイスが100℃で対流オーブン中に置かれた。コーティング中のゲル含有量は、次式:コーティング中の%ゲル含有量=((抽出後の被覆デバイスの質量−非被覆デバイスの質量)/(抽出前の被覆デバイスの質量−非被覆デバイスの質量)×100を用いて決定された。非被覆織物PLGA 10:90構造に関する対照実験は、同様の実験で感知可能な質量損失を示さなかった。
自己拡張型医療用移植片を作るために、チューブ状基材中にパターンがレーザカットされた。いくつかの移植片が、実施例1に記載されるように、HDIで硬化したPGCLでできた支持コーティングによって被覆された。前の実施例と同様に、被覆移植片は、非被覆移植片と比較してより高いRRFおよびCOF特性を実証した。
製造時の直径が6mmの編組移植片が、PLGA 75:25共重合体を用いて、実施例1のものと同様の製造プロセスによって製造された。この移植片が、次にように調製されたPLCL 50:50でできた支持コーティングによって被覆された。250mLの丸底フラスコがオーブン中において110℃で乾燥され、窒素雰囲気中で室温に冷却された。フラスコがそれぞれSn(Oct)2(11.5mg)、ペンタエリトリトール(204mg)、ラクチド(30.0g)およびε−カプロラクトン(30.0g)で満たされた。その後、フラスコに磁気撹拌子と窒素バルーンに接続された3方バルブとが装備された。フラスコが減圧下で十分に脱気されて、窒素でフラッシュされた。次に、フラスコが170℃に予熱された油浴中に置かれた。反応物が窒素雰囲気下において170℃で48時間攪拌された。室温への冷却後に、得られた高粘性液体がおよそ200mLのジクロロメタン中に溶解されて、1200mLの無水ジエチルエーテルから析出された。溶液がデカントされ、残った粘着性のポリマーがジエチルエーテルで十分に洗浄されて、真空中で乾燥された。精製を通じて、典型的に約48gのポリマーが回収された。GPCによるキャラクタリゼーションから、数平均分子量(Mn)52,500および多分散性指数(PDI)1.2が明らかになった。
PLGA 75:25共重合体を用いて、製造時の直径が6mmの編組移植片が実施例1と同様の製造プロセスによって製造された。この移植片がポリトリメチレンカーボネート(PTMC)およびヘキサメチレンジイソシアンテでできた支持コーティングによって被覆された。PTMC3分岐ポリマーは、次のように調製された。加熱および真空下で予め乾燥された100mLの丸底フラスコがそれぞれSn(Oct)2(20mg)、トリエタノールアミン(298.4mg)およびトリメチレンカーボネート(30g)で満たされた。続いて、フラスコに磁気撹拌子と窒素バルーンに接続された3方バルブとが装備された。フラスコが減圧下で十分に脱気され、窒素でフラッシュされて、次に70℃に予熱された油浴中に置かれた。次に油浴温度が15分にわたって100℃まで増加された。反応物が窒素雰囲気下において100℃で23時間撹拌された。室温への冷却後に、得られた粘性液体がおよそ50mLのジクロロメタン中に一晩溶解され、続いて550mLのエタノールから析出された。析出されたポリマーが1時間攪拌され、その後にエタノールがデカントされた。ジクロロメタン中にポリマーを溶解してエタノール中に析出させるプロセスが繰り返された。次にポリマーがジクロロメタン中に溶解され、550mLのジエチルエーテル中に析出されて、1時間攪拌され、その後にジエチルエーテルがデカントされた。次にポリマーが真空下において70℃で72時間にわたって乾燥された。上記のプロセスを用いて、典型的に24gのポリマーが回収された。最終ポリマーのGPCによるキャラクタリゼーションから、数平均分子量(Mn)29kDaおよび多分散性指数(PDI)2.0が明らかになった。
本発明の移植片が、いくつかの市販の生体内安定性自己拡張型移植片、すなわちVIABAHN(登録商標)エンドプロテーゼ(W.L.Gore & Associates,Inc.製の自己拡張型ニチノール・ステントグラフト)、S.M.A.R.T.(登録商標)ステント(Cordis Corp.製の自己拡張型ニチノール・ステント)、WALLSTENT(登録商標)エンドプロテーゼ(Boston Scientific Corp.製の自己拡張型スチール・ステント)と比較された。具体的には、これらの市販移植片のRRFおよびCOF値が測定されて、PLGA 75:25でできた(127°の編組角を有する)6mmおよび(127°および110°の編組角を有する)7mmの直径の移植片と比較された。PLGA移植片は、実施例1と同様の製造プロセスを用いて作られ、実施例5に記載されるように、PLCL 50:50共重合体およびヘキサメチレンジイソシアネートでできた支持コーティングによって、7mmデバイスでは44%と50%との間のコーティング重量、6mmデバイスでは47%から57%の重量で被覆された。RRFおよびCOF値は、意図された目標脈管直径の範囲に対応するクリンプ後の直径において測定された。結果は、本発明の移植片がそれらの市販金属製カウンターパートに匹敵するRRFおよびCOFのような機械的特性によって特徴付けられることを示した。
製造時の直径が6mmの編組移植片が、PLGA 75:25共重合体を用いて、実施例1と同様の製造プロセスによって製造された。移植片の一方のセットは、PGCL 50:50およびヘキサメチレンジイソシアネートを含む支持コーティングによって被覆され、移植片のもう一方のセットは、PLCL 50:50およびヘキサメチレンジイソシアネートを含む支持コーティングで被覆された。これらの移植片が脈管の伸展性を有する配管内に実装されて、0、7、14、および28日間、疑似的な流れ条件下で37℃に維持された。これらの時点で移植片が配管から外植されて、一晩乾燥され、クリンプ後の直径4.5mmにおいて移植片のCOFが測定された。結果は、図9に示され、両セットの移植片でCOFが経時的に減少し、PGCL被覆移植片では28日時点でCOFがゼロになることが実証された。比較例1に記載されるようなS.M.A.R.T.ステントおよびWALLSTENTエンドプロテーゼについて測定されたCOF値も図9に示されるが、これらのデバイスは金属であり、経時的に分解も弛緩もしないために値は一定である。移植片が周辺組織に経時的に加える連続的な力は、慢性刺激と炎症とを引き起こし、再狭窄を招きかねないことから、本発明の移植片におけるCOFの経時的な著しい減少は、それらの金属ステント・カウンターパートを凌ぐ利点であると本発明者は信じる。
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- 明細書に記載された発明。
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2019088251A1 (ja) | 2017-11-06 | 2019-05-09 | 日本毛織株式会社 | ステント及びそれを含む医療機器 |
KR20200085736A (ko) | 2017-11-06 | 2020-07-15 | 이에이 파마 가부시키가이샤 | 스텐트 및 그것을 포함하는 의료기기 |
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US20100298952A1 (en) | 2010-11-25 |
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GB2470484B (en) | 2011-09-28 |
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JP2012527321A (ja) | 2012-11-08 |
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EP3384878A1 (en) | 2018-10-10 |
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AU2010249558A1 (en) | 2011-12-08 |
GB201008366D0 (en) | 2010-07-07 |
US9155638B2 (en) | 2015-10-13 |
EP2432425A1 (en) | 2012-03-28 |
GB2470484A (en) | 2010-11-24 |
CA3186201A1 (en) | 2010-11-25 |
GB2495649A (en) | 2013-04-17 |
GB2495649B (en) | 2014-02-26 |
US20130304177A1 (en) | 2013-11-14 |
CA2762811C (en) | 2023-03-21 |
JP5820370B2 (ja) | 2015-11-24 |
GB2470484B8 (en) | 2013-06-12 |
US8137396B2 (en) | 2012-03-20 |
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