JP2017077486A - 血管障害の治療のためのフィラメントデバイス - Google Patents
血管障害の治療のためのフィラメントデバイス Download PDFInfo
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Abstract
Description
本願は、米国仮特許出願第61/050,124号(名称「Filamentary Devices for Treatment of Vascular Defects」、2008年5月2日出願)の米国特許法第119条第(e)項の優先権の利益を主張し、この出願は、その全体が本明細書に参考として援用される。
本願のデバイスおよび方法の実施形態は、哺乳類の体内で、管状容器を通る、あるいは嚢状空洞または血管障害の小型内部チャンバの中への液体の流れの遮断を対象とする。より具体的には、本願の実施形態は、具体的には患者の脳動脈瘤の治療を対象とする、一部の実施形態を含む、患者の血管障害の治療のためのデバイスおよび方法を対象とする。
+Nsds 4)によって定義される、約0.014重量ポンド(lbf)から約0.284lbfの半径方向剛性を有するように、拡張状態にある透過シェルの直径と、大型フィラメントの数および直径と、小型フィラメントの数および直径とが構成されるように、特性を有し得、式中、Dは、インチ単位の拡張状態にある透過シェルの直径であり、Nlは、透過シェルの中の大型フィラメントの数であり、Nsは、透過シェルの中の小型フィラメントの数であり、dlは、インチ単位の大型フィラメントの直径であり、dsは、インチ単位の小型フィラメントの直径である。上記式は、2つのワイヤサイズを考慮しているが、しかしながら、式はまた、dlがdsと等しいような場合において、1つのワイヤサイズを有する実施形態にも適用可能である。
一つの実施形態において、例えば、下記の項目が、提供される。
(項目1)患者の血管系の治療のためのデバイスであって、該デバイスは、
近位端と、遠位端と、縦軸とを有する自己拡張型弾力性透過シェルであって、
複数の細長い弾力性フィラメントであって、該フィラメントの近位端および遠位端において相互に対して固定される織物構造を伴う、フィラメントと、
マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、それに伴って該薄い織物フィラメントが、該フィラメントの長さに沿って相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在している、細長い状態と、
該半径方向に拘束された状態に対する、球状の縦方向に短縮された構成を有する拡張した弛緩状態であって、それに伴って該織物フィラメントは、該織物フィラメント間に形成された該シェルの中に複数の開口部を含む、該近位端と遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを形成し、該開口部のうちの最大のものは、血栓臨界速度を下回る速度での該開口部を通る血流を可能にするように構成される、弛緩状態と
をさらに備える、自己拡張型弾力性透過シェルを備える、デバイス。
(項目2)少なくとも前記遠位端が、陥凹構成の逆屈曲を含むことにより、前記フィラメントの前記固定された遠位端は、前記拡張状態にある前記透過シェル構造の名目輪郭内において軸方向に配置される、項目1に記載のデバイス。
(項目3)前記シェルの近位端が、陥凹構成の逆屈曲をさらに備えることにより、前記フィラメントの前記固定された近位端は、前記拡張状態にある前記名目透過シェル構造内において軸方向に引き抜かれる、項目2に記載のデバイス。
(項目4)前記透過シェルの前記フィラメントは、溶接、半田付け、接着、およびエポキシ接着から成る群より選択される1つ以上の方法によって、該透過シェルの近位端および遠位端において相互に対して固定される、項目1に記載のデバイス。
(項目5)前記透過シェルの前記フィラメントの遠位端に固定される、遠位ハブをさらに備える、項目1に記載のデバイス。
(項目6)前記透過シェルの前記フィラメントの近位端に固定される、近位ハブをさらに備える、項目1に記載のデバイス。
(項目7)前記近位ハブは、前記フィラメントの近位端を越えて近位に延在する円筒形部材をさらに備え、該円筒形部材は、分離テザーを固定するための空洞を形成する、項目6に記載のデバイス。
(項目8)前記近位ハブの前記空洞内に固定される遠位端を有する分離テザーをさらに備える、項目7に記載のデバイス。
(項目9)前記透過シェルの前記フィラメントは、約0.0005インチから約0.005インチまでの横寸法を有する、項目1に記載のデバイス。
(項目10)前記透過シェルは、第1の端部から第2の端部まで延在する、約70個から約300個までのフィラメントを備える、項目1に記載のデバイス。
(項目11)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される、前記最大開口部は、約0.005インチから約0.04インチまでである、項目1に記載のデバイス。
(項目12)前記透過シェルの障害範囲部分の中の隣接するフィラメント間に形成される、前記最大開口部は、最大で約0.016インチである、項目1に記載のデバイス。
(項目13)前記透過シェルは、血栓形成剤、抗血小板剤、抗血栓形成剤、および治癒促進剤から成る群より選択される生物活性剤をさらに備える、項目1に記載のデバイス。
(項目14)前記弛緩した拡張状態にある前記透過シェルの前記近位端と遠位端との間の間隔は、前記拘束された円筒形状態にある該近位端と遠位端との間の間隔の約25%から約75%までである、項目1に記載のデバイス。
(項目15)前記透過シェルの前記フィラメントは、超弾性材料を備える、項目1に記載のデバイス。
(項目16)前記超弾性材料は、形状記憶金属を備える、項目15に記載のデバイス。
(項目17)前記透過シェルの前記フィラメントは、前記弛緩した拡張状態の構成で熱硬化される形状記憶材料を備える、項目1に記載のデバイス。
(項目18)前記形状記憶金属は、NiTi合金を備える、項目17に記載のデバイス。(項目19)患者の血管系の治療のためのデバイスであって、
近位端と、遠位端と、縦軸とを有する自己拡張型弾力性透過シェルであって、
少なくとも2つの異なる横寸法の大型フィラメントおよび小型フィラメントを含む複数の細長い弾力性フィラメントであって、織物構造が、該フィラメントの近位端および遠位端において相互に対して固定される、フィラメントと、
マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、該薄い織物フィラメントは、該フィラメントの長さに沿って、相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、
該半径方向に拘束された状態に対する、球状の縦方向に短縮された構成を有する拡張した弛緩状態であって、該織物フィラメントは、該織物フィラメント間に形成された該シェルの中に複数の開口部を含む、該近位端と遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に、該自己拡張型弾力性透過シェルを形成する、弛緩状態と
をさらに備える、透過シェルを備える、デバイス。
(項目20)少なくとも前記遠位端が、陥凹構成の逆屈曲を有することにより、前記フィラメントの前記固定された遠位端は、前記拡張状態にある前記名目透過シェル構造内において軸方向に配置される、項目19に記載のデバイス。
(項目21)前記透過シェルの前記大型フィラメントは、約0.001インチから約0.004インチまでである横寸法または横径を備える、項目19に記載のデバイス。
(項目22)前記透過シェルの前記小型フィラメントは、約0.0004インチから約0.001インチまでである、横寸法または横径を備える、項目19に記載のデバイス。
(項目23)前記透過シェルの前記大型フィラメントの数に対する該透過シェルの前記小型フィラメントの数の比は、約2対1から約15対1までであり得る、項目19に記載のデバイス。
(項目24)前記小型フィラメントと前記大型フィラメントとの間の前記横寸法または横径の差は、約0.0035インチ未満である、項目19に記載のデバイス。
(項目25)前記透過シェルは、前記第1の端部から前記第2の端部まで延在する、約70個から約300個までのフィラメントを備える、項目19に記載のデバイス。
(項目26)前記透過シェルの障害範囲部分の中の隣接するフィラメント間に形成される、前記最大開口部は、約0.005インチから約0.04インチまでである、項目19に記載のデバイス。
(項目27)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される、前記最大開口部は、最大で約0.016インチである、項目19に記載のデバイス。
(項目28)前記デバイスの前記障害範囲部分の隣接するフィラメント間に形成される、前記開口部のうちの少なくとも一部は、血栓臨界速度を下回る速度で該開口部を通る血流を可能にするように構成される、項目19に記載のデバイス。
(項目29)弛緩した拡張状態にある前記透過シェルの主要横寸法は、約4mmから約30mmまでである、項目19に記載のデバイス。
(項目30)患者の血管系の治療のためのデバイスであって、該デバイスは、
近位端と、遠位端と、縦軸とを有する自己拡張型弾力性透過シェルであって、
複数の細長い弾力性フィラメントであって、織物構造が、該フィラメントの近位端および遠位端において相互に対して固定される、フィラメントと、
マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、それに伴って該織物フィラメントは、該フィラメントの長さに沿って、相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、
主要横径を伴う該半径方向に拘束された状態に対する、球状の縦方向に短縮された構成を伴う拡張した弛緩状態であって、それに伴って該織物フィラメントは、該近位端と該遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを形成し、該織物フィラメント間に形成された該シェルの中に複数の開口部を含む、弛緩状態と
をさらに備える、透過シェルを備えており、
拡張状態にある該透過シェルの該直径と、大型フィラメントの数および直径と、小型フィラメントの数および直径とは、拡張状態にある該透過シェルが、式(1.2×106lbf/D4)(Nldl 4+Nsds 4)によって定義される、約0.014lbfから約0.284lbfまでの半径方向剛性を有するように構成され、式中、Dは、インチ単位の該拡張状態にある該透過シェルの直径であり、Nlは、該透過シェルの中の該大型フィラメントの数であり、Nsは、該透過シェルの中の該小型フィラメントの数であり、dlは、インチ単位の最大フィラメントの直径であり、dsは、インチ単位の最小フィラメントの直径である、デバイス。
(項目31)少なくとも前記遠位端が、陥凹構成の逆屈曲を有することにより、前記フィラメントの前記固定された遠位端は、前記拡張状態にある前記名目透過シェル構造内に軸方向に配置される、項目30に記載のデバイス。
(項目32)前記透過シェルは、該透過シェルの前記近位端から前記遠位端まで延在する、約70個から約300個までのフィラメントを備える、項目30に記載のデバイス。
(項目33)弛緩した拡張状態にある前記透過シェルの主要横径は、約4mmから約30mmまでである、項目30に記載のデバイス。
(項目34)前記透過シェルの前記大型フィラメントは、約0.001インチから約0.004インチまでである、横寸法または横径を備える、項目30に記載のデバイス。
(項目35)前記透過シェルの前記小型フィラメントは、約0.0004インチから約0.001インチまでである、横寸法または横径を備える、項目30に記載のデバイス。
(項目36)前記透過シェルの前記大型フィラメントの数に対する、該透過シェルの前記小型フィラメントの数の比は、約2対1から約15対1までであり得る、項目30に記載のデバイス。
(項目37)前記小型フィラメントと前記大型フィラメントとの間の横寸法または横径の差は、約0.0035インチ未満である、項目30に記載のデバイス。
(項目38)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される、前記最大開口部は、約0.005インチから約0.04インチまでである、項目30に記載のデバイス。
(項目39)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される、前記最大開口部は、最大で約0.016インチである、項目30に記載のデバイス。
(項目40)前記透過シェルの前記フィラメントは、異なる横径の大型フィラメントおよび小型フィラメントをさらに備える、項目30に記載のデバイス。
(項目41)患者の血管系の治療のためのデバイスであって、該デバイスは、
近位端と、遠位端と、縦軸とを有する自己拡張型弾力性透過シェルであって、
その近位端および遠位端において相互に対して固定される織物構造を伴う複数の細長い弾力性フィラメントと、
マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、それに伴って該薄い織物フィラメントは、該フィラメントの長さに沿って、相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、
主要横径を伴う該半径方向に拘束された状態に対する、球状の縦方向に短縮された構成を伴う拡張した弛緩状態であって、それに伴って該織物フィラメントは、該近位端と該遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを形成し、該織物フィラメント間に形成された該シェルの中に複数の開口部を含む、弛緩状態と
をさらに備える、透過シェルを備えており、
拡張状態にある該透過シェルの直径と、全てのフィラメントの数と、小型フィラメントの直径とは、拡張状態にある該透過シェルの平均開口部サイズが、式(1.7/NT)(π−NT/2×dW)によって定義される該平均開口部サイズによって約0.016インチ未満となるように構成され、式中、Dは、インチ単位の該拡張状態にある該透過シェルの直径であり、NTは、該透過シェルの中の該フィラメントの総数であり、dWは、インチ単位の最小フィラメントの直径である、デバイス。
(項目42)少なくとも前記遠位端は、陥凹構成の逆屈曲を有することにより、前記フィラメントの前記固定された遠位端が、前記拡張状態にある前記名目透過シェル構造内に軸方向に配置される、項目41に記載のデバイス。
(項目43)前記透過シェルは、該透過シェルの前記近位端から前記遠位端まで延在する、約70個から約300個までのフィラメントを備える、項目41に記載のデバイス。
(項目44)弛緩した拡張状態にある前記透過シェルの主要横径は、約4mmから約30mmまでである、項目41に記載のデバイス。
(項目45)前記透過シェルの前記大型フィラメントは、約0.001インチから約0.004インチまでである、横寸法または横径を備える、項目41に記載のデバイス。
(項目46)前記透過シェルの前記小型フィラメントは、約0.0004インチから約0.001インチまでである、横寸法または横径を備える、項目41に記載のデバイス。
(項目47)前記透過シェルの前記大型フィラメントの数に対する、該透過シェルの前記小型フィラメントの数の比は、約2対1から約15対1までであり得る、項目41に記載のデバイス。
(項目48)前記小型フィラメントと前記大型フィラメントとの間の横寸法または横径の差は、約0.0035インチ未満である、項目41に記載のデバイス。
(項目49)前記透過シェルの障害範囲部分の中の隣接するフィラメント間に形成される、前記最大開口部は、約0.005インチから約0.04インチまでである、項目41に記載のデバイス。
(項目50)前記透過シェルの障害範囲部分の中の隣接するフィラメント間に形成される、前記最大開口部は、最大で約0.016インチである、項目41に記載のデバイス。
(項目51)前記透過シェルの前記フィラメントは、異なる横径の大型フィラメントおよび小型フィラメントをさらに備える、項目41に記載のデバイス。
(項目52)患者の血管系の治療のためのデバイスであって、該デバイスは、
近位端と、遠位端と、縦軸とを有する自己拡張型弾力性透過シェルであって、
複数の細長い弾力性フィラメントであって、織物構造が、該フィラメントの近位端および遠位端において相互に対して固定される、フィラメントと、
マイクロカテーテル内における送達のために構成される半径方向に拘束された細長い状態であって、該織物フィラメントが、該フィラメントの長さに沿って、相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、
主要横径を伴う該半径方向に拘束された状態に対する、球状の縦方向に短縮された構成を伴う拡張した弛緩状態であって、それに伴って該織物フィラメントは、該近位端と該遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを形成し、該織物フィラメント間に形成された該シェルの中に複数の開口部を含む、弛緩状態と
をさらに備える、透過シェルを備えており、
拡張状態にある該透過シェルの直径と、大型フィラメントの数および直径と、小型フィラメントの数および直径とは、拘束状態にある該透過シェルが、式1.48((Nldl 2+Nsds 2))1/2によって定義される、約0.04インチ未満の外側横径を有するように構成され、Nlは、該透過シェルの中の最大フィラメントの数であり、式中、Nsは、該透過シェルの中の最小フィラメントの数であり、dlは、インチ単位の最大フィラメントの直径であり、dsは、インチ単位の該最小フィラメントの直径である、デバイス。
(項目53)少なくとも前記遠位端が、陥凹構成の逆屈曲を有することにより、前記フィラメントの前記固定された遠位端が、前記拡張状態にある前記名目透過シェル構造内において軸方向に配置される、項目52に記載のデバイス。
(項目54)前記透過シェルは、該透過シェルの前記近位端から前記遠位端まで延在する、約70個から約300個までのフィラメントを備える、項目52に記載のデバイス。
(項目55)弛緩した拡張状態にある前記透過シェルの主要横径は、約4mmから約30mmまでである、項目52に記載のデバイス。
(項目56)前記透過シェルの前記大型フィラメントは、約0.001インチから約0.004インチまでである、横寸法または横径を備える、項目52に記載のデバイス。
(項目57)前記透過シェルの前記小型フィラメントは、約0.0004インチから約0.001インチまでである、横寸法または横径を備える、項目52に記載のデバイス。
(項目58)前記透過シェルの前記大型フィラメントの数に対する、該透過シェルの前記小型フィラメントの数の比は、約2対1から約15対1までであり得る、項目52に記載のデバイス。
(項目59)前記小型フィラメントと前記大型フィラメントとの間の横寸法または横径の差は、約0.0035インチ未満である、項目52に記載のデバイス。
(項目60)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される前記開口部は、約0.005インチから約0.04インチまでである、項目52に記載のデバイス。
(項目61)前記透過シェルの障害範囲部分の隣接するフィラメント間に形成される前記開口部は、最大約0.016インチである、項目52に記載のデバイス。
(項目62)前記透過シェルの前記フィラメントは、異なる横径の大型フィラメントおよび小型フィラメントをさらに備える、項目52に記載のデバイス。
(項目63)患者の血管障害を治療する方法であって、
a)織物フィラメントの自己拡張型弾力性透過シェルを備える、患者の血管系の治療のためのデバイスを提供することであって、該透過シェルは、近位端と、遠位端と、縦軸と、マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、該織物フィラメントが相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、該半径方向に拘束された状態に対する球状の縦方向に短縮された構成を伴う拡張した弛緩状態であって、該織物フィラメントは、該近位端と該遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを、該織物フィラメント間に形成された該シェルの中に複数の開口部を形成する、弛緩状態とを有する、ことと、
b)送達システムの遠位端が、治療される血管障害に隣接して、またはその内側に配置されるように、患者の体内に該送達システムを前進させることと、
c)半径方向に拘束された状態にある間に、該送達システム内において該患者の血管系の治療のための該デバイスを軸方向に前進させることであって、細長い送達装置は、患者の血管系の治療のための該デバイスの近位端に解放可能に固定される遠位端を有する、ことと、
d)該デバイスが該送達システムの遠位端から遠位に出現するまで、該デバイスを軸方向に前進させ、該デバイスを配備することであって、それにより、該デバイスの該織物フィラメントが、半径方向に拘束された状態から半径方向に拡張し、そこを通る血液の流れを血栓臨界速度を下回る速度まで減速する該透過シェルの孔径に起因して、該血管障害の開口部または頚部の少なくとも一部分を被覆し、急性的に閉塞する該透過シェルの球状構成へと拡張する、ことと
を含む、方法。
(項目64)前記細長い送達装置の前記遠位端から、前記デバイスを解放することをさらに含む、項目63に記載の方法。
(項目65)前記患者の血管系の治療のための前記デバイスは、該デバイスの解放前に、前記細長い送達装置の近位端の操作によって、前記血管障害内に位置付けられる、項目63に記載の方法。
(項目66)前記デバイスの解放前に、前記細長い送達装置の軸方向後退によって、該デバイスを部分的または完全に前記送達システム内に戻るように引くことをさらに含む、項目65に記載の方法。
(項目67)前記デバイスの前記透過シェルの内部空間内に血塊の形成を促進しながら、該透過シェルへの血小板の付着を阻害することをさらに含む、項目63に記載の方法。
(項目68)前記デバイスの配備前または後に、親血管の中にステント支持デバイスを埋め込むことをさらに含み、それにより、該ステント支持デバイスは、前記血管障害の範囲に及ぶ、項目63に記載の方法。
(項目69)前記デバイスの配備後に、前記透過シェルの後方または内側の前記血管障害の中へ、塞栓デバイスまたは材料を送達することをさらに含む、項目63に記載の方法。(項目70)前記血管障害の狭窄による半径方向の拘束に応じて、前記透過シェルの伸長を付与することをさらに含む、項目63に記載の方法。
(項目71)前記患者の血管系の治療のためのデバイスを選択することをさらに含み、該デバイスは、患者の血管障害の横寸法に対して過大である外側横寸法を伴う拡張状態にある透過シェルを有する、項目63に記載の方法。
(項目72)前記横寸法の過大化の量は、前記血管障害の最大横寸法より少なくとも約10%大きい、項目71に記載の方法。
(項目73)患者の血管系の血管障害を閉塞する方法であって、
複数のフィラメント部材の織物シェルから形成される拡張可能な多孔性血管閉塞デバイスを提供することであって、該複数のフィラメント部材は、該血管障害のサイズおよび形状に近似する形状を伴う実質的に閉鎖された球状の構造を形成する該部材の少なくとも近位端上で相互に接続される、ことと、
該患者の該血管系の中への送達のために、該デバイスを折り畳むことと、
該患者の体内の切開を通して、該折り畳まれたデバイスを挿入することと、
該デバイスの外面輪郭が該血管障害を実質的に充填するように、該血管障害において該デバイスを解放し、拡張することと、
凝固血液で実質的に被覆される該デバイスによって、急性的に該血管障害を実質的に閉塞することと
を含む、方法。
(項目74)前記フィラメント部材は、少なくとも2つの異なる横寸法または横径を有する、項目73に記載の方法。
(項目75)前記閉塞デバイスの前記織物シェルは、フィラメント部材の少なくとも2つの異なるサイズを含み、該フィラメント部材の前記横寸法または横径の差は、約0.004インチ未満である、項目74に記載の方法。
(項目76)前記血管障害における血液の速度は、前記デバイスの配備後に血栓臨界速度を下回るまで減速され、血栓が、該デバイスの前記シェルの内部容積内に形成する、項目73に記載の方法。
(項目77)前記血管障害の容積を測定し、該血管障害の少なくとも一部分を充填するような容積を伴うデバイスを選択することをさらに含む、項目73に記載の方法。
(項目78)前記選択されたデバイスは、前記血管障害の前記測定された容積とほぼ同じ容積を有する、項目77に記載の方法。
(項目79)前記測定された容積は、切頂容積を生じるように前記血管障害の全体積より小さく、前記選択されたデバイスは、該切頂容積を実質的に充填する、項目77に記載の方法。
(項目80)前記デバイスが弛緩した拡張状態にあるときに、前記血管障害の最大横寸法を測定し、該血管障害の該最大横寸法より少なくとも約10%大きい寸法を有するデバイスを選択することをさらに含む、項目73に記載の方法。
(項目81)患者の血管系の治療用のデバイスの配備のための送達システムであって、
内側管腔を有するマイクロカテーテルであって、該内側管腔は該マイクロカテーテルの長さに延在する、マイクロカテーテルと、
該マイクロカテーテルの該内側管腔内に配置され、かつ薄いフィラメントの自己拡張型弾力性透過シェルを備える、患者の血管系の治療用のデバイスであって、該透過シェルは、近位端と、遠位端と、縦軸と、マイクロカテーテル内での送達のために構成される半径方向に拘束された細長い状態であって、それに伴って該薄い織物フィラメントは、相互に半径方向に隣接して該近位端から該遠位端まで縦方向に延在する、細長い状態と、該拘束状態に対する球状の縦方向に短縮された構成を伴う拡張した弛緩状態であって、それに伴って該織物フィラメントは、該近位端と該遠位端との間の該縦軸から半径方向に拡張される平滑経路の中に該自己拡張型弾力性透過シェルを形成し、該織物フィラメント間に形成された該シェルの中に複数の開口部を形成する、弛緩状態とを有し、該透過シェルは、該拡張した弛緩状態にあるときに、患者の血管障害の開口部に範囲が及ぶように構成される部分をさらに有する、デバイスと、
該デバイスの近位ハブに解放可能に固定される近位端および遠位端を有する細長い送達装置と
を備える、システム。
(項目82)患者の血管系の治療のためのデバイスを製造する方法であって、
編組管状部材を形成する円筒形マンドレルを覆って、複数の細長い弾力性フィラメントを編むことと、
拘束状態に対する、球状の縦方向に短縮された構成を伴う拡張した弛緩状態において、該編組管状部材の該細長いフィラメントを熱硬化させることであって、該織物フィラメントは、裏返された構成で遠位端に逆屈曲を有するシェルを伴う該デバイスの近位端と遠位端との間にある該デバイスの縦軸から半径方向に拡張される平滑経路の中に、自己拡張型弾力性透過シェルを形成し、それにより、該遠位端にあるハブが、該透過シェル構造内に軸方向に引かれ、該シェルの中の複数の開口部が、該織物フィラメント間に形成される、ことと、
該フィラメントの該近位端を一緒に固定することと、
該フィラメントの該遠位端を一緒に固定することと
を含む、方法。
(項目83)前記デバイスの前記近位端が前記フィラメントの前記近位端に固定される近位ハブをさらに備え、該近位ハブは、空洞を形成する該フィラメントの該近位端を越えて延在する円筒形部材を含む、項目82に記載の方法。
(項目84)前記近位ハブの前記円筒形部材の前記空洞内に分離テザーを固定することをさらに含む、項目83に記載の方法。
(項目85)前記フィラメントの前記近位端に近位ハブを固定することと、該フィラメントの前記遠位端に遠位ハブを固定することと、該近位および遠位ハブ内に放射線不透過性材料を挿入することとをさらに含む、項目82に記載の方法。
(項目86)円筒形マンドレルを覆って複数の細長いフィラメントを編むことは、少なくとも2つの異なる横寸法を有する大型フィラメントおよび小型フィラメントを編むことを含む、項目82に記載の方法。
(項目87)円筒形マンドレルを覆って複数の大型および小型フィラメントを編むことは、フィラメントを編むことを含み、該大型フィラメントに対する小型フィラメントの数の比は、約2対1から約15対1までである、項目86に記載の方法。
式中、Sradialは、重量ポンド(lbf)単位の半径方向剛性であり、
Dはデバイスの直径(横寸法)であり、
Nlは大型フィラメントの数であり、
Nsは小型フィラメントの数であり、
dlはインチ単位の大型フィラメントの直径であり、
dsはインチ単位の小型フィラメントの直径である。
式中、Pmaxは平均の孔径であり、
Dはデバイスの直径(横寸法)であり、
NTは全フィラメントの総数であり、
dWはインチ単位のフィラメント(最小)の直径である。
式中、Pcはデバイスの折り畳み外形であり、
Nlは大型フィラメントの数であり、
Nsは小型フィラメントの数であり、
dlはインチ単位の大型フィラメントの直径であり、
dsはインチ単位の小型フィラメントの直径である。
式中、F=力、
L=ビームの長さ、
E=ヤング率、
I=慣性モーメント。
式中、dはワイヤまたはフィラメントの直径である。
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