JP2018079329A - らせん状ハイブリッドステント - Google Patents
らせん状ハイブリッドステント Download PDFInfo
- Publication number
- JP2018079329A JP2018079329A JP2017234740A JP2017234740A JP2018079329A JP 2018079329 A JP2018079329 A JP 2018079329A JP 2017234740 A JP2017234740 A JP 2017234740A JP 2017234740 A JP2017234740 A JP 2017234740A JP 2018079329 A JP2018079329 A JP 2018079329A
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- JP
- Japan
- Prior art keywords
- stent
- sideband
- endband
- component
- helical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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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
- A61F2/90—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
- A61F2/91—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
- 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
- A61F2002/9155—Adjacent bands being connected to each other
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- A—HUMAN NECESSITIES
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
-
- 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
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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- A—HUMAN NECESSITIES
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
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- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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Abstract
【解決手段】ステントは主要ステント部品及び固定部で形成し得る。主要ステント部品は、幾何学的に成形されるセル430を形成するように接続することができ、らせん状に巻かれる第1、第2の波形サイドバンド401、402を有する平板ストリップから形成される。主要ステント部品のらせん状のコイルは、互いに空間的に隔たっていても近接していてもよく、平板ストリップは、単一の波形パターンを含み得、主要ステント部品の各末端には、エンドバンド407があり、これは巻かれると、円柱状の環を形成する。有窓ストラットはループ又はターンによって接続することができ、この場合の材料は、可撓性を高めるために有窓ストラットのものよりも幅が狭く、らせん状の管は固定部で維持される。
【選択図】図1
Description
82,824号明細書、Hillsteadの米国特許第4,856,516号明細書及び同第5
,116,365号明細書、Wiktorの米国特許第4,886,062号明細書及び同第4,969,458号明細書、Pinchukの米国特許第5,019,090号明細書、Palmaz
及びSchatzの米国特許第5,102,417号明細書、Wolffの米国特許第5,104,
404号明細書、Towerの米国特許第5,161,547号明細書、Cardon et al.の米国特許第5,383,892号明細書、Pinchasik et al.の米国特許第5,449,373号明細書、及びIsrael et al.の米国特許第5,733,303号明細書が挙げられる。
場合が多い。従って、当技術分野では十分な半径方向の強度と高度な長さ方向の可撓性とがバランスしたステントについて継続的なニーズが存在する。
すなわち、本発明は、
(1)管状構造を有するステントであって、
第1及び第2のサイドバンド並びに第1及び第2のエンドバンドを有するコイル状の主要ステント部品であって、前記バンドのそれぞれが波形パターンを有し、前記第1及び第2のサイドバンドが途切れ途切れに(intermittently)接続され、前記エンドバンドが前記ステントの長さ方向の末端において直円柱を形成する、主要ステント部品と、
前記ステントの前記管状構造を維持する固定部と
を含むステント、
(2)らせん構造を有するステントであって、主要ステント部品と固定部とを含み、前記主要ステント部品が、
a)波形を有する第1のサイドバンドと、
b)波形を有し、前記第1のサイドバンドに接続した第2のサイドバンドと、
c)波形を有し、前記第1のサイドバンドに接続した第1のエンドバンドと、
d)波形を有し、前記第2のサイドバンドに接続した第2のエンドバンドと
を含み、
前記第1及び第2のサイドバンドが前記ステントの縦軸に沿ってらせん状に巻かれ、前記第1のエンドバンドが前記ステントの第1の末端において縦軸に対して第1の直円柱を形成し、前記第2のエンドバンドが前記ステントの第2の末端において前記ステントの縦軸に対して第2の直円柱を形成し、
前記固定部が、前記主要ステント部品の少なくとも一部分の前記らせん構造を維持する、ステント、
(3)平板ストリップ形態の主要ステント部品であって、
波形を有する第1のサイドバンドと、
波形を有し、前記第1のサイドバンドに接続した第2のサイドバンドと、
波形、第1の端部、及び第2の端部を有する第1のエンドバンドであって、前記第1のサイドバンドに接続し、前記第1のサイドバンドに対して斜めの角度で伸びている第1のエンドバンドと
を含む主要ステント部品、
(4)波形、第1の端部、及び第2の端部を有する第2のエンドバンドであって、前記第2のサイドバンドに接続し、前記第2のサイドバンドに対して斜めの角度で伸びている第2のエンドバンドをさらに含む、上記(3)に記載の平板ストリップの主要ステント部品、
(5)平板ストリップ形態の主要ステント部品であって、
波形を有するサイドバンドと、
波形、第1の端部、及び第2の端部を有する第1のエンドバンドであって、前記サイドバンドに接続し、前記サイドバンドに対して斜めの角度で伸びている第1のエンドバンドと、
波形、第1の端部、及び第2の端部を有する第2のエンドバンドであって、前記サイドバンドに接続し、前記サイドバンドに対して斜めの角度で伸びている第2のエンドバンドとを含む主要ステント部品、
(6)1又は2以上のサイドバンドが、1又は2以上の開窓を有するストラットを含む、上記(1)、(2)、(3)、又は(5)のいずれかに記載の主要ステント部品、
(7)平板ストリップ形態の主要ステント部品であって、
波形を有する第1のエンドバンドに接続した波形を有するサイドバンドを含み、前記第1のエンドバンドが、前記サイドバンドの方向に対して斜めの角度で伸びており、
前記サイドバンド及びエンドバンドが、ループにより結合されたストラットの波形パターンを有し、1又は2以上の前記ストラットが開窓を有し、前記ループが、前記開窓を有する前記ストラットの幅よりも狭い幅を有する、主要ステント部品、
(8)サイドバンド及び第2のエンドバンドに接続された第2のサイドバンドをさらに含み、前記第2のエンドバンドが、前記第2のサイドバンドの方向に対して斜めの角度で伸びており、
前記第2のサイドバンド及び前記第2のエンドバンドが、ループにより結合されたストラットの波形パターンを有し、1又は2以上の前記ストラットが開窓を有し、前記ループが、前記開窓を有する前記ストラットの幅よりも狭い幅を有する、上記(7)に記載の平板ストリップの主要ステント部品、
(9)開窓が治療薬で満たされている、上記(6)、(7)、又は(8)のいずれかに記載の主要ステント部品、
(10)波形パターンのいくつかの隣り合うストラットが、同一の長さを有する、上記(7)又は(8)に記載の主要ステント部品、
(11)糸、ワイヤー、及びリボンからなる群から選択される構造物を含む、上記(1)又は(2)に記載の固定部、
(12)主要ステント部品のらせん経路とは異なるらせん経路でステントの周りに巻かれる、上記(11)に記載の固定部、
(13)ステントの全長にわたり、規則的に主要ステント部品と接続点において重なり合う、上記(11)に記載の固定部、
(14)繊維メッシュを含む、上記(1)又は(2)に記載の固定部、
(15)多孔性材料を含む、上記(1)又は(2)に記載の固定部、
(16)耐久性材料を含む、上記(1)又は(2)に記載の固定部、
(17)耐久性材料がポリウレタンである、上記(16)に記載の固定部、
(18)らせん状の主要ステント部品の全長にわたり埋め込まれている、上記(1)又は(2)に記載の固定部、
(19)らせん状の主要ステント部品に末端で取り付けられている、上記(1)又は(2)に記載の固定部、
(20)金属を含む、上記(1)、(2)、(3)、(5)、又は(7)のいずれかに記載の主要ステント部品、
(21)金属の平板シートから切り出される、上記(20)に記載の主要ステント部品、(22)アモルファス金属合金を含む、上記(1)、(2)、(3)、(5)、又は(7)のいずれかに記載の主要ステント部品、
(23)アモルファス金属合金が、ケイ素、ホウ素、及びリンからなる群から選択される元素を含む、上記(22)に記載の主要ステント部品、
(24)アモルファス金属合金が、Fe、Cr、B、及びPを含有する鉄基合金である、上記(22)に記載の主要ステント部品、
(25)アモルファス金属合金がケイ素を含有する、上記(22)に記載の主要ステント部品、
(26)アモルファス金属合金がFe−Cr−B−P合金を含む、上記(22)に記載の主要ステント部品、
(27)第1及び第2のサイドバンドが、少なくとも1つのクロスストラットにより接続されている、上記(1)、(2)、(3)、又は(8)のいずれかに記載の主要ステント部品、
(28)少なくとも1つのクロスストラットがループを有する、上記(27)に記載の主要ステント部品、
(29)第1のサイドバンドが、らせん状に隣り合った第2のサイドバンドに近接する、上記(1)又は(2)に記載のステント、
(30)上記(3)、(5)、又は(7)のいずれかに記載の平板ストリップからステントを作製する方法であって、
a)縦軸に沿って主要ステント部品をらせん状に巻くステップと、
b)前記ステントの前記縦軸に対して直円柱が形成されるように、第1のエンドバンドの第1の端部を前記第1のエンドバンドの第2の端部と近接近させるステップと
を含む方法、
(31)上記(4)、(5)、又は(8)のいずれかに記載の平板ストリップからステントを作製する方法であって、
a)らせんコイル状の構造を形成するために、縦軸に沿って主要ステント部品をらせん状に巻くステップと、
b)前記縦軸に対して直円柱が形成されるように、第1のエンドバンドの第1の端部を第2の端部及び前記第1のエンドバンドと近接近させるステップと、
c)前記縦軸に対して直円柱が形成されるように、第2のエンドバンドの第1の端部を前記第2のエンドバンドの第2の端部と近接近させるステップと
を含む方法、
(32)固定部を適用するステップをさらに含む、上記(30)又は(31)に記載の方法、
に関する。
り画定される1列のセル430を含む。また、エンドバンド406及び407は、サイドバンド401及び402に対して斜めの角度で伸びている。主要ステント部品は管形状に形成されるので、セル430の列は、ステントの縦軸の中央部分に沿った連続らせん巻状物となる一方、エンドバンド406及び407は、ステントの各末端で直円柱形状を形成する。このような方法で平板なパターン化されたバンドから、管状でらせん状の中央部本体部分を形成することは、設計が既存の管状材料から形成されるようなプロセスとは区別される。
401、402と比較して同一の幅をそれぞれ有し得る。或いは、第1のクロスストラット403は、特定の用途にふさわしいように第1及び第2のサイドバンド401、402とは異なる幅、又は互いに異なる幅を有し得る。クロスストラットは、第1及び第2のサイドバンド401、402の隣り合うトラフ又はオフセットトラフを接続し得る。さらに、第1のクロスストラット403は、直線状の部材を含み得、又は1つ若しくは2つ以上のループを含み得る。図1に示すように、異なるセル形状を有するステントが形成可能なように、異なる形状のクロスストラット又はクロスストラットを用いない方式も、ステントの特定の用途に応じて、単一ステント設計において代替的に採用可能である。典型的なセル形状は、米国特許第7,141,062号明細書(三角形のセル)、又は同第5,733,303号明細書(四角形のセル)に開示されており、四角形及び三角形のセル構造に関する開示を、本明細書において参考として上記特許から援用する。四角形のセルは半径方向に支持する要素の間に4箇所の接続部を有し、一方、三角形のセルは半径方向に支持する要素の間に3箇所の接続部を有する。サイド及びエンドバンドの波形は、本発明の半径方向に支持する要素を提供する。
角度的に遠ざかるように伸びているので、第2のクロスストラット426は第1のエンドバンド406を第1のサイドバンド401と接続する。同様に、第2のエンドバンド407は、例えばトラフ420のところで第2のサイドバンド402と直接接続しているが、第2のエンドバンド407は第2のサイドバンドから角度的に遠ざかるように伸びているので、第2のクロスストラット426は第2のエンドバンド407を第2のサイドバンド402に接続する。図1に示すように、第2のクロスストラット426は、隣り合うエンドバンド及び/又はサイドバンドと共に接続点の間に1又は2以上のループを含み得る。第1のエンドバンド406及び第2のエンドバンド407のピークは、図1により示されるように、ピーク(例えば、423、424)から伸びる追加の環状構造を有していてもよい。
に近接するものとして説明され得る。図3では、第1及び第2のサイドバンド401及び402は、クロスストラットが存在することのみにより空間的に隔たっている。示す通り、近接する巻状物間の距離はクロスストラット403の長さよりも短い。さらに、第1のサイドバンド及び隣り合う第2のサイドバンドの間で直接的に接続することなく、第1のサイドバンドはらせん状で隣り合う第2のサイドバンドに向かって近接している。図3のステントは、以下でさらに議論するように、隣り合う巻状物が近接すると、ステントの可撓性を全く損なうことなく、管腔壁及び/又は固定部において支持されない領域が最小限に抑えられ、拡張した時に管内に固定部が垂れ下がるのを防止するという更なる利点を有する。さらに、らせん状のコイルが分離した状態で近接すると、管形状で構造を維持するのに役立ち得る。
も細めのループ又はターン1270により接続されている。図5Aに示すように、ストラットは長さが変化しており、また各ストラット内の開窓の数も異なる。例えば、ストラット1217は、ストラット1215とは異なる長さ及び開窓の数を有する。ストラット1216はストラット1215とは異なる長さを有するが、同一数の開窓を有する。並びに、ストラット1214及び1215は同一の長さ、及び開窓の数を有する。図5Aのステントでは、第1のサイドバンド1201の各末端の近傍のストラット(例えば、1217)は、ストラット1214及び1215とは異なる長さを有することができ、またらせん巻状物に役立つように構成される。
の湾曲した部分を有する可撓性コネクタである。サイドバンドを第2のエンドバンドに接続するクロスリンクは、少なくとも1つのループを含み得る。
あるポリマー固定部601が主要ステント部品600上に塗布されている。第1のサイドバンドの2つの隣り合うストラットは、「ディンプル」を備えたターン602により互いに接続されている。ターンにディンプルを含めることは、得られるステントの望ましい特性に応じた任意選択的な特徴である。図6は、ディンプルを有さない、また本実施形態においてクロスストラットが第1のサイドバンドを第2のサイドバンドに接続するポイントで採用されるターン603を示す。
材料が、糸、ワイヤー、又はリボンの形態の固定部として、主要ステント部品を固定するのに利用可能である。金属又は非金属製の固定部としてのワイヤー、糸、又はリボンは、上記で明らかにしたような1又は2以上の様々な手段により、これらが重なり合う箇所で主要ステント部品に固定可能である。第2の部品を製造するために採用された材料が、望んだよりも長さ方向の可撓性に劣る場合には、接続点の間の糸、ワイヤー、又はリボンの長さを増加させることにより、可撓性を高めることができ、こうすることでステントが拡張又は屈曲した時に伸長可能な長さのゆとりが第2の部品に確保される。
の公知材料から構成される部品を有することができる。それなりの利点を有するこれらの合金の詳細は、米国特許第5,836,964号明細書及び同第5,997,703号明細書に開示されており、これらを本明細書において参考として明示的に援用する。
ント部品は、薬物が配置された少なくとも1つの開窓を有し得る。かかる薬物の非限定的な例として、例えば、シロリムス、ラパマイシン、エベロリムス、及びパクリタキソール、並びにこれらのアナログが挙げられる。さらに、ステントは、ステントが管腔壁に埋め込まれた後、より長期間有利となる薬剤等の能動的又は受動的表面成分を有するように処理可能である。
Claims (35)
- ループにより結合されたストラットの波形パターンを有し、第1の長さを有し、かつ複数のらせん巻状物を形成する単一のサイドバンド;
波形パターンを有し、前記サイドバンドに接続され、ある角度で前記サイドバンドへと伸長し、かつ前記第1の長さよりも短い第2の長さを有する、第1のエンドバンド;
波形パターンから形成され、前記サイドバンドに接続され、ある角度で前記サイドバンドへと伸長し、かつ前記第2の長さを有する、第2のエンドバンド;及び
波形パターンから形成され、前記第2のエンドバンドに結合され、かつ前記第2の長さよりも短い第3の長さを有する、第3のエンドバンド
を備えるらせん状の主要ステント部品を備えるステント。 - らせん状の主要ステント部品のらせん巻状物を相互接続する固定部であるポリマー材料をさらに備える、請求項1に記載のステント。
- 固定部が、らせん状の主要ステント部品の全外周に伸長する、請求項2に記載のステント。
- 固定部が、らせん状の主要ステント部品の末端を固定して、ステントの縦軸に対して直円柱を形成する、請求項2に記載のステント。
- サイドバンドの、隣り合うらせん巻状物の波形が互いに近接する、請求項1に記載のステント。
- 1又は2以上のストラットが開窓を含む、請求項1に記載のステント。
- ストラットの少なくとも1つが、別のストラットとは異なる数の開窓を含む、請求項6に記載のステント。
- ストラットの少なくとも1つが、別のストラットとは異なる長さを有する、請求項1に記載のステント。
- ループが、ストラットの幅よりも狭い幅を有する、請求項1に記載のステント。
- エンドバンドの1又は2以上が、開窓のあるストラットの幅よりも狭い幅を有するループによって結合された、前記開窓のあるストラットを含む、請求項1に記載のステント。
- ステントを広げて平置きにしたときに、角度が、ステントの中央部本体に対して45度未満である、請求項1に記載のステント。
- 第1のエンドバンドをサイドバンドに、第2のエンドバンドを前記サイドバンドに、第3のエンドバンドを前記第2のエンドバンドに接続する可撓性コネクタであるクロスリンクをさらに備える、請求項1に記載のステント。
- クロスリンクが1又は2以上の湾曲した部分を備える、請求項12に記載のステント。
- クロスリンクが1又は2以上のループを備える、請求項12に記載のステント。
- 第1のエンドバンド及び第2のエンドバンドが、サイドバンドに等しく接続しておらず、前記第1のエンドバンド及び第2のエンドバンドが、前記サイドバンドの両端で、前記サイドバンドに接続している、請求項1に記載のステント。
- ポリマー材料が多孔性材料である、請求項2に記載のステント。
- ポリマー材料が繊維メッシュである、請求項2に記載のステント。
- ポリマー材料が耐久性材料である、請求項2に記載のステント。
- 耐久性材料がポリウレタンである、請求項18に記載のステント。
- ポリマー材料がらせん状の主要ステント部品の隙間内に埋め込まれている、請求項2に記載のステント。
- ポリマー材料が、その中にらせん状の主要ステント部品を包み込む、請求項2に記載のステント。
- らせん状の主要ステント部品が金属を含む、請求項1に記載のステント。
- 薬剤コーティングをさらに含む、請求項1に記載のステント。
- ポリマー材料が薬剤を溶出するためのマトリックスである、請求項2に記載のステント。
- 開窓のあるストラットが、前記開窓に治療薬を含む、請求項6又は10に記載のステント。
- らせん状の主要ステント部品が管状構造から形成される、請求項1に記載のステント。
- らせん状の主要ステント部品が金属の平板シートから切り出される、請求項1に記載のステント。
- らせん状の主要ステント部品がアモルファス金属合金を含む、請求項1に記載のステント。
- アモルファス金属合金が、ケイ素、ホウ素、及びリンからなる群から選択される元素を含む、請求項28に記載のステント。
- アモルファス金属合金が、Fe、Cr、B、及びPを含む鉄基合金である、請求項28に記載のステント。
- アモルファス金属合金がケイ素を含む、請求項28に記載のステント。
- アモルファス金属合金がFe−Cr−B−P合金を含む、請求項28に記載のステント。
- 縦軸に沿ってらせん状の主要ステント部品をらせん状に巻いて、らせんコイル状の構造を形成するステップと、
第1のエンドバンドの第1の端部を前記第1のエンドバンドの第2の端部と近接近させて円柱を形成するステップと、
第2のエンドバンドの第1の端部を前記第2のエンドバンドの第2の端部と近接近させて円柱を形成するステップと
を含む、請求項1に記載のステントを作製する方法。 - ポリマー材料をらせん状の主要ステント部品に適用するステップをさらに含む、請求項33に記載の方法。
- ポリマー材料が、連続及び不連続な状態のいずれかでらせん状の主要ステント部品に適用される、請求項34に記載の方法。
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