JP6086627B2 - バルーンカテーテルにスキャフォールドを装着する方法 - Google Patents
バルーンカテーテルにスキャフォールドを装着する方法 Download PDFInfo
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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
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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
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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
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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A—HUMAN NECESSITIES
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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
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- 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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- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0071—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof thermoplastic
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T29/49913—Securing cup or tube between axially extending concentric annuli by constricting outer annulus
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T29/49915—Overedge assembling of seated part
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Description
[0031] 図2は、本発明の態様による、バルーンにクリンピングされたポリマースキャフォールドの一部の平面図である。この図は、図1のプロセスによってバルーンにクリンピングされた、完全に展開されたスキャフォールドの耐荷重構造のパターンを説明している。
[0032] 図3は、スキャフォールドの位置合わせ機器及びその方法の第1の実施形態を示す概略図である。
[0033] 図4は、スキャフォールドの位置合わせ機器及びその方法の第2の実施形態を示す概略図である。
[0034] 図5は、スキャフォールドの位置合わせ機器及びその方法の第3の実施形態を示す概略図である。
[0042]本発明は、バルーン上に保持される必要があるスキャフォールドが有する独自の難題に対処する。こうした難題は、いくつかの理由のために存在する。最初に、クリンピング状態においてストラット間には利用可能な空間が少なく、それによってバルーン材料がストラット間で伸張することが妨げられる。その結果、バルーン上のステントの保持力を増大するために従来利用されている、ストラットとバルーン材料の間の当接又は干渉が小さくなる。この状態の結果、適切な、展開された径方向の強度をもたらすために、金属ステントに比べてスキャフォールドのストラットをより広く且つより厚く製作する必要が生じる。第2に、ポリマーは金属とは異なり、温度変化に極めて敏感である。当技術は、従来、金属ステントをバルーン上で保持するために熱を利用してきている。しかし、従来、ステント保持に効果的であると見出されている温度は、ポリマーのTg内に含まれる。したがって、スキャフォールドをTgの範囲内又はそれ以上に加熱することにより、ポリマー材料の分子配向に大きな変化が誘発され、その結果、スキャフォールドがその展開直径に塑性的に変形されたときに強度の損失を生じさせるので、そのような温度は回避されている。
[0063]本開示の別の態様によれば、本発明は、スキャフォールドの高い不良品率の問題に対する解決策を見出しており、この解決策は、クリンピングプロセスにおける変更にあった。この発見がなされる前、スキャフォールド不良の問題は、クリンピング問題をそれぞれ診断又は解決する既存の方法によって説明する又は是正することはできなかった。プレクリンピング中、スキャフォールドの直径は、バルーン上でその開始直径の中間の直径及び最終のクリンピング直径に低減される。スキャフォールド直径がクリンパーによって直径低減された後、スキャフォールドは、送達カテーテルのバルーン上に置かれ、クリンパーに再度挿入される。クリンパーは、スキャフォールド直径をバルーン上でその最終のクリンピング直径まで低減する。最終クリンピング直径まで低減されたとき、スキャフォールドとバルーンの間には、スキャフォールドをバルーン上に保持するための保持力が存在する。(本開示は「スキャフォールド」を参照する。本明細書で説明する同じプロセス及び機器は、スキャフォールドをその耐荷重構造として使用するバルーン拡張式「ステント」にも適用されることを理解されよう)。
Claims (16)
- スキャフォールドをバルーンにクリンピングする方法であって、
Tg−lowの下限値を有するガラス転移温度によって特徴付けられたポリマーを備えるスキャフォールドを用意するステップと、内径を形成したクリンパーヘッドを有するアイリスクリンパーであるクリンピング装置を使って、前記スキャフォールドが約Tg−lowからTg−lowより15°低い温度までの間の温度を有する間に、前記スキャフォールドをバルーンにクリンピングするステップとを備え、これらのステップは、
前記クリンピング装置を用いて、前記スキャフォールドを第一の直径から第二の直径にクリンピングし、
前記第二の直径へのクリンピングの後であって、最終クリンプ直径にクリンピングする前に、前記スキャフォールドを前記クリンピング装置から取り除き、
前記スキャフォールドを前記クリンピング装置に戻し、
前記クリンピング装置を用いて、前記スキャフォールドを前記第二の直径から最終クリンプ直径にクリンピングするステップを含み、
前記スキャフォールドが前記クリンピング装置に戻されるときに前記スキャフォールドが前記バルーン上で位置合わせされ、
さらに、前記スキャフォールドの直径が最終クリンプ直径へ減縮された後の滞留ピリオドと、前記クリンピング装置から前記スキャフォールドを取り出した後に前記スキャフォールドをシース内に置くステップとを含み、
前記滞留ピリオドでは前記スキャフォールドの直径が最終クリンプ直径である状態で前記クリンパーヘッドの内径が一定に保たれる方法。 - 前記スキャフォールドが、前記第二の直径から前記最終クリンプ直径にクリンピングされる前に、前記バルーン上で最終位置合わせを受ける、請求項1に記載の方法。
- 前記クリンピング装置が、前記スキャフォールドにクリンピング力を加える顎部を含む、請求項1に記載の方法。
- 前記ポリマーが、ポリ(ラクチド−co−グリコリド)(PLGA)である、請求項1に記載の方法。
- 前記PLGAが約5%のグリコリド含有割合を有し、クリンピング温度が摂氏約46〜53度である、請求項4に記載の方法。
- 前記スキャフォールドの前記第一の直径から前記第二の直径へのクリンピングが、前記第一の直径から中間直径への前記スキャフォールドの直径の減縮とそれに続く前記クリンパーヘッドの内径が一定に保たれる第一の滞留ピリオドと、その後の前記中間直径から前記第二の直径への前記スキャフォールドの直径の減縮とそれに続く前記クリンパーヘッドの内径が一定に保たれる第二の滞留ピリオドとを含む、請求項1に記載の方法。
- 前記スキャフォールドを、ポリ(L−ラクチド)(PLLA)を備えるチューブから形成する、請求項1に記載の方法。
- 前記チューブが径方向に拡張されたチューブである、請求項7に記載の方法。
- 前記スキャフォールドの前記第一の直径から前記第二の直径へのクリンピングが、前記第一の直径から中間直径への前記スキャフォールドの直径の減縮とそれに続く前記クリンパーヘッドの内径が一定に保たれる第一の滞留ピリオドと、その後の前記中間直径から前記第二の直径への前記スキャフォールドの直径の減縮とそれに続く前記クリンパーヘッドの内径が一定に保たれる第二の滞留ピリオドとを含む、請求項8に記載の方法。
- 前記中間直径から前記第二の直径への前記スキャフォールドの直径の減縮が、前記バルーンの膨張を含む、請求項9に記載の方法。
- クリンピングに先立ち前記スキャフォールドを脱イオン化することを更に備える、請求項10に記載の方法。
- クリンピングするステップは、クリンピング中に前記バルーンを膨張させて前記スキャフォールドを支持することを更に含む、請求項1に記載の方法。
- 前記スキャフォールドが前記クリンピング装置に戻されるときに前記スキャフォールドがバルーンマーカの間に位置合わせされる、請求項1に記載の方法。
- 前記スキャフォールドが前記第一の直径から前記第二の直径へクリンピングされているとき、前記スキャフォールドが前記バルーン上にある、請求項1に記載の方法。
- 前記スキャフォールドの前記第一の直径が前記最終クリンプ直径の少なくとも約2.5倍である、請求項1に記載の方法。
- 前記スキャフォールドをバルーンにクリンピングするステップが、前記スキャフォールドが約Tg−lowからTg−lowより5°低い温度までの間の温度を有する間に行われる、請求項1に記載の方法。
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US12/776,317 US8844113B2 (en) | 2010-04-30 | 2010-05-07 | Methods for crimping a polymeric stent scaffold onto a delivery balloon |
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US8844113B2 (en) | 2014-09-30 |
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US20180116830A1 (en) | 2018-05-03 |
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