Devices for therapeutic vascular procedures
Abstract
Methods and devices for removing thrombi are described. The device includes an expandable cylindrical structure made of wire and a self-expandable transparent shell located at the distal end of the cylindrical structure. Methods and devices for treating cerebral aneurysms are described. The device may include a distal self-expanding elastic permeation shell, a proximal self-expanding elastic permeation shell, and an extension support member located between the distal and proximal permeation shells. The extension support member may be rigid or may be a coil such as an expansion spring. Distal and proximal permeation shells may be made from multiple braided filaments, the shells having different pore sizes. The device may also be a braided implant with a force urging component such as a coil or substantially circular extension attached to its distal end.

Term
8.6 yearsto projected expiry
Projected expiry 13 April 2035, counted from filing; an application has no term until it is granted.
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131 claims: 11 independent, 120 dependent
- 1近位端および遠位端を有し、複数のワイヤから形成される、拡張可能円筒構造であって、隣接ワイヤは、複数の捻転によって相互に係合させられ、前記複数のワイヤは、前記円筒構造の前記遠位端および前記近位端においてともに固着され、前記円筒構造は、半径方向に拘束された状態と、拡張した弛緩状態とを有する、拡張可能円筒構造と、 近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記自己拡張型弾性透過シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、近位および遠位端において固着され、前記自己拡張型透過シェルは、半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張した弛緩状態とを有し、前記自己拡張型透過シェルは、前記編組構造内に複数の開口部を有する、自己拡張型弾性透過シェルと、を備え、前記自己拡張型透過シェルは、前記拡張可能円筒構造内に封入され、前記拡張可能円筒構造の前記遠位端に位置付けられる、血管からの血栓の除去のためのデバイス。
- 2前記拡張可能円筒構造は、約10~約18本のワイヤから形成される、請求項1に記載のデバイス。
- 3前記拡張可能円筒構造は、約12本のワイヤから形成される、請求項1に記載のデバイス。
- 4前記複数のワイヤは、ニチノールワイヤから形成される、請求項1に記載のデバイス。
- 5前記複数のワイヤは、ニチノール、コバルトクロム合金、ステンレス鋼、およびそれらの混合物から成る群から選択される材料から形成される、請求項1に記載のデバイス。
- 6前記複数のワイヤの中のワイヤの直径は、約0008インチ~0.0035インチである、請求項1に記載のデバイス。
- 7前記複数のワイヤは、ハブによって前記遠位端においてともに固着される、請求項1に記載のデバイス。
- 8前記複数のワイヤは、バンドによって前記近位端においてともに固着される、請求項1に記載のデバイス。
- 9前記複数の捻転のうちの各捻転は、長さを有する、請求項1に記載のデバイス。
- 10各捻転の前記長さは、約0.25mm~約3mmである、請求項9に記載のデバイス。
- 11前記複数の捻転のうちの各捻転は、1つの完全な巻目を有する、請求項1に記載のデバイス。
- 12前記複数の捻転のうちの前記捻転の少なくともいくつかは、1つの完全な巻目を有する、請求項1に記載のデバイス
- 13前記複数の捻転のうちの各捻転は、2つの完全な巻目を有する、請求項1に記載のデバイス。
- 14前記複数の捻転のうちの前記捻転の少なくともいくつかは、2つの完全な巻目を有する、請求項1に記載のデバイス。
- 15前記複数の捻転のうちの前記捻転の少なくともいくつかは、1つと半分の巻目を有する、請求項1に記載のデバイス。
- 16自己拡張型弾性透過シェルは、前記拡張可能円筒構造内で血栓を維持するために十分な編組密度を有する、請求項1に記載のデバイス。
- 17血管から近位および遠位端を有する血栓を除去するための方法であって、血栓除去デバイスであって、近位端、中央部分、および遠位端を有し、複数のワイヤから形成される、拡張可能円筒構造であって、隣接ワイヤは、複数の捻転によって相互に係合させられ、前記複数のワイヤは、遠位端においてともに固着され、かつ近位端においてともに固着され、前記円筒構造は、半径方向に拘束された状態と、拡張した弛緩状態とを有する、拡張可能円筒構造と、近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記自己拡張型弾性透過シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、近位端および遠位端において固着され、前記自己拡張型透過シェルは、半径方向に拘束された伸長状態と、前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張した弛緩状態とを有し、前記自己拡張型透過シェルは、前記編組構造内に複数の開口部を有する、自己拡張型弾性透過シェルと、を備え、前記自己拡張型透過シェルは、前記拡張可能円筒構造内に封入され、前記拡張可能円筒構造の前記遠位端に位置付けられる、血栓除去デバイスを取得するステップと、マイクロカテーテル内に摺動可能に位置付けられた前記血栓除去デバイスを患者に挿入するステップであって、前記マイクロカテーテルは、遠位端を有し、前記拡張可能円筒構造および自己拡張型弾性透過シェルは両方とも、前記マイクロカテーテル内で前記半径方向に拘束された状態にある、ステップと、前記血栓の遠位端に隣接して前記マイクロカテーテルの前記遠位端を位置付けるステップと、前記拡張可能円筒構造内に位置する前記自己拡張型弾性透過シェルの前記近位端が、前記血栓の遠位に位置し、前記拡張可能円筒構造の前記中央部分が前記血栓の前記近位端および前記遠位端に重複するように、前記血栓除去デバイスおよび前記マイクロカテーテルの相対変位によって前記マイクロカテーテルから前記血栓除去デバイスを展開するステップであって、一旦、前記血栓除去デバイスが前記マイクロカテーテルから外へ前進させられると、前記自己拡張型弾性透過シェルおよび前記拡張可能円筒構造は、それらの拡張状態に向かって移行する、ステップと、前記円筒構造の前記遠位端に前記自己拡張型弾性透過シェルを伴って前記拡張した円筒構造を近位方向に移動させ、それによって、血管の管腔内表面から前記血栓を着脱し、前記拡張可能円筒構造内で前記血栓を捕捉するステップと、前記血管から前記血栓除去デバイスおよび前記捕捉された血栓を除去するステップと、を含む、方法。
- 18前記血栓除去デバイスおよび前記マイクロカテーテルは、ともに前記血管から除去される、請求項17に記載の方法。
- 19前記血栓除去デバイスは、前記マイクロカテーテルが前記血管内で定位置に残された状態で前記マイクロカテーテルから除去される、請求項17に記載の方法。
- 20前記血栓除去デバイスおよび前記マイクロカテーテルは、ともに前記患者から除去される、請求項17に記載の方法。
- 21前記血栓除去デバイスは、前記マイクロカテーテルが前記患者内で定位置に残された状態で前記マイクロカテーテルから除去される、請求項17に記載の方法。
- 22前記自己拡張型透過シェルは、前記円筒構造内で前記血栓を維持し、また、血液が前記自己拡張型透過シェルを通って流れることを可能にするために十分に高い編組密度を有する、請求項17に記載の方法。
- 23近位端、遠位端、および長手軸を有する、遠位自己拡張型弾性透過シェルであって、前記遠位透過シェルは、編組フィラメントの間に形成された複数の開口部を伴う編組構造を有する、複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくともその近位端において集合させられ、前記遠位透過シェルは、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伸長状態と、前記半径方向に拘束された状態に対して軸方向に短縮された構成を伴う拡張状態とを有し、前記遠位透過シェルの前記拡張状態は、前記遠位透過シェルの前記遠位端に凸形状を有する、遠位自己拡張型弾性透過シェルと、近位端、遠位端、および長手軸を有する、近位自己拡張型弾性透過シェルであって、前記近位透過シェルは、編組フィラメントの間に形成された複数の開口部を伴う編組構造を有する、複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくともその近位端において集合させられ、前記近位透過シェルは、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伸長状態と、前記半径方向に拘束された状態に対して軸方向に短縮された構成を伴う拡張状態とを有し、前記近位透過シェルの前記拡張状態は、前記近位透過シェルの前記近位端に略凸形状を有する、近位自己拡張型弾性透過シェルと、近位端および遠位端を有する、伸長支持部材であって、前記遠位および近位透過シェルの間に位置付けられる、伸長支持部材と、を備え、前記遠位および近位透過シェルの前記拡張状態は、それを通って前記伸長支持部材が延在する、トロイダル空洞を画定する、患者の血管系内の動脈瘤の処置のためのデバイス。
- 24前記遠位透過シェル内の前記複数の開口部の平均サイズは、前記近位透過シェル内の前記複数の開口部の平均サイズより大きい、請求項23に記載のデバイス。
- 25前記遠位透過シェル内の前記複数の開口部の前記平均サイズは、約300μm~約900μmである、請求項24に記載のデバイス。
- 26前記遠位透過シェル内の前記複数の開口部の前記平均サイズは、約300μm~約900μm、約300μm~約700μm、および300μm~約500μmから成る群から選択される、請求項24に記載のデバイス。
- 27前記近位透過シェル内の前記複数の開口部の前記平均サイズは、約50μm~約200μmである、請求項24に記載のデバイス。
- 28前記近位透過シェル内の前記複数の開口部の前記平均サイズは、約50μm~約200μm、約100μm~約200μm、および50μm~約150μmから成る群から選択される、請求項24に記載のデバイス。
- 29前記遠位透過シェルの前記編組構造は、第1の編組密度を有し、前記近位透過シェルの前記編組構造は、第2の編組密度を有し、前記第1の編組密度は、前記第2の編組密度より大きい、請求項23に記載のデバイス。
- 30前記第1の編組密度は、約0.10~0.20である、請求項29に記載のデバイス。
- 31前記第1の編組密度は、約0.10~0.15である、請求項29に記載のデバイス。
- 32前記第2の編組密度は、約0.15~0.40である、請求項29に記載のデバイス。
- 33前記第2の編組密度は、約0.17~0.30である、請求項29に記載のデバイス。
- 34前記伸長支持部材は、剛性である、請求項23に記載のデバイス。
- 35前記伸長支持部材は、ハイポチューブである、請求項23に記載のデバイス。
- 36前記伸長支持部材は、コイルである、請求項23に記載のデバイス。
- 37前記コイルは、拡張ばねである、請求項36に記載のデバイス。
- 38前記コイルが静止しているとき、前記コイルは、より小さい長さまで圧縮可能ではない、請求項36に記載のデバイス。
- 39前記遠位透過シェルの前記複数のフィラメントは、前記遠位透過シェルの前記遠位端において集合させられる、請求項23に記載のデバイス。
- 40前記遠位透過シェルの前記複数のフィラメントのそれぞれは、第1の端部および第2の端部を有し、前記遠位透過シェルの前記複数のフィラメントの前記第1のおよび第2の端部は、前記遠位透過シェルの前記近位端において集合させられる、請求項23に記載のデバイス。
- 41前記遠位透過シェルの前記伸長弾性フィラメントは、延伸充填管を含む、請求項23に記載のデバイス。
- 42前記近位透過シェルの前記伸長弾性フィラメントは、延伸充填管を含む、請求項23に記載のデバイス。
- 43前記遠位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤと、延伸充填管とを含む、請求項23に記載のデバイス。
- 44前記近位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤと、延伸充填管とを含む、請求項23に記載のデバイス。
- 45前記遠位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤを含む、請求項23に記載のデバイス。
- 46前記近位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤを含む、請求項23に記載のデバイス。
- 47前記遠位透過シェルの前記拡張形状は、前記近位透過シェルの前記拡張形状に接触する、請求項23に記載のデバイス。
- 48前記遠位透過シェルの前記拡張形状および前記近位透過シェルの前記拡張形状は、実質的に球状の形状を形成する、請求項23に記載のデバイス。
- 49前記複数のフィラメントは、ハブによって前記近位透過シェルの前記近位端において集合させられる、請求項23に記載のデバイス。
- 50前記ハブは、前記近位透過シェルの前記近位端の拡張した周囲の下方で陥凹状である、請求項49に記載のデバイス。
- 51前記伸長支持部材は、約2mm~約10mmの長さを有する、請求項23に記載のデバイス。
- 52前記伸長支持部材は、約3mm~約8mmの長さを有するコイルである、請求項51に記載のデバイス。
- 53前記伸長支持部材は、約3.5mm~約5.5mmの長さを有するハイポチューブである、請求項51に記載のデバイス。
- 54インプラントであって、近位端、遠位端、および長手軸を有する、遠位自己拡張型弾性透過シェルであって、前記遠位透過シェルは、編組フィラメントの間に形成された複数の開口部を伴う編組構造を有する、複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくともその近位端において集合させられ、前記遠位透過シェルは、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伸長状態と、前記半径方向に拘束された状態に対して軸方向に短縮された構成を伴う拡張状態とを有し、前記遠位透過シェルの前記拡張状態は、前記遠位透過シェルの前記遠位端に凸形状を有する、遠位自己拡張型弾性透過シェルと、近位端、遠位端、および長手軸を有する、近位自己拡張型弾性透過シェルであって、前記近位透過シェルは、編組フィラメントの間に形成された複数の開口部を伴う編組構造を有する、複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくともその近位端において集合させられ、前記近位透過シェルは、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伸長状態と、前記半径方向に拘束された状態に対して軸方向に短縮された構成を伴う拡張状態とを有し、前記近位透過シェルの前記拡張状態は、前記近位透過シェルの前記近位端に略凸形状を有する、近位自己拡張型弾性透過シェルと、近位端および遠位端を有する、伸長支持部材であって、前記遠位および近位透過シェルの間に位置付けられる、伸長支持部材と、を有し、前記遠位および近位透過シェルの前記拡張状態は、それを通って前記伸長支持部材が延在する、トロイダル空洞を画定する、インプラントを提供するステップと、マイクロカテーテル内で前記薄型の半径方向に拘束された状態における前記インプラントを脳動脈内の着目領域まで前進させるステップと、前記脳の動脈瘤内で前記インプラントを展開するステップであって、前記遠位および近位透過シェルは、それらの拡張形状まで拡張する、ステップと、前記インプラントを展開した後に、前記着目領域から前記マイクロカテーテルを引き抜くステップと、を含む、脳動脈瘤を処置するための方法。
- 55前記遠位透過シェルの前記拡張形状および前記近位透過シェルの前記拡張形状は、実質的に球状の形状を形成する、請求項54に記載の方法。
- 56前記遠位透過シェルの前記拡張形状および前記近位透過シェルの前記拡張形状は、前記脳の動脈瘤を実質的に充填する、実質的に球状の形状を形成する、請求項54に記載の方法。
- 57前記遠位透過シェル内の前記複数の開口部の平均サイズは、前記近位透過シェル内の前記複数の開口部の平均サイズより大きい、請求項54に記載の方法。
- 58前記遠位透過シェル内の前記複数の開口部の前記平均サイズは、約300μm~約900μmである、請求項57に記載の方法。
- 59前記遠位透過シェル内の前記複数の開口部の前記平均サイズは、約300μm~約900μm、約300μm~約700μm、および300μm~約500μmから成る群から選択される、請求項57に記載の方法。
- 60前記近位透過シェル内の前記複数の開口部の前記平均サイズは、約50μm~約200μmである、請求項57に記載の方法。
- 61前記近位透過シェル内の前記複数の開口部の前記平均サイズは、約50μm~約200μm、約100μm~約200μm、および50μm~約150μmから成る群から選択される、請求項57に記載の方法。
- 62前記遠位透過シェルの前記編組構造は、第1の編組密度を有し、前記近位透過シェルの前記編組構造は、第2の編組密度を有し、前記第1の編組密度は、前記第2の編組密度より大きい、請求項54に記載の方法。
- 63前記第1の編組密度は、約0.10~0.20である、請求項62に記載の方法。
- 64前記第1の編組密度は、約0.10~0.15である、請求項62に記載の方法。
- 65前記第2の編組密度は、約0.15~0.40である、請求項62に記載の方法。
- 66前記第2の編組密度は、約0.17~0.30である、請求項62に記載の方法。
- 67前記伸長支持部材は、ハイポチューブである、請求項54に記載の方法。
- 68前記第1の遠位透過シェルの前記複数のフィラメントは、前記遠位透過シェルの前記遠位端において集合させられる、請求項54に記載の方法。
- 69前記遠位透過シェルの前記複数のフィラメントのそれぞれは、第1の端部および第2の端部を有し、前記遠位透過シェルの前記複数のフィラメントの前記第1のおよび第2の端部は、前記遠位透過シェルの前記近位端において集合させられる、請求項54に記載の方法。
- 70前記遠位透過シェルの前記伸長弾性フィラメントは、延伸充填管を含む、請求項54に記載の方法。
- 71前記近位透過シェルの前記伸長弾性フィラメントは、延伸充填管を含む、請求項54に記載の方法。
- 72前記遠位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤと、延伸充填管とを含む、請求項54に記載の方法。
- 73前記近位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤと、延伸充填管とを含む、請求項54に記載の方法。
- 74前記遠位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤを含む、請求項54に記載の方法。
- 75前記近位透過シェルの前記伸長弾性フィラメントは、ニチノールワイヤを含む、請求項54に記載の方法。
- 76前記遠位透過シェルの前記拡張形状は、前記近位透過シェルの前記拡張形状に接触する、請求項54に記載の方法。
- 77前記伸長支持部材は、剛性である、請求項54に記載の方法。
- 78前記伸長支持部材は、ハイポチューブである、請求項54に記載の方法。
- 79前記伸長支持部材は、コイルである、請求項54に記載の方法。
- 80前記コイルは、拡張ばねである、請求項79に記載の方法。
- 81前記コイルが静止しているとき、前記コイルは、より小さい長さまで圧縮可能ではない、請求項79に記載の方法。
- 82近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくとも、その前記近位端または前記遠位端のうちの1つにおいて固着される、自己拡張型弾性透過シェルと、第1の直径を有するワイヤから形成される、金属コイルであって、前記金属コイルは、前記自己拡張型弾性透過シェルの前記遠位端において固着される、金属コイルと、を備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有し、前記金属コイルは、マイクロカテーテル内での送達のために構成される、直線状の真っすぐな形状と、二次直径を有する少なくとも1つのループを有する、拡張状態とを有する、患者の血管系内の動脈瘤の処置のためのデバイス。
- 83前記金属コイルは、前記透過シェルが動脈瘤内で前記拡張状態であるときに、前記透過シェルに付勢力を加えるように構成される、請求項82に記載のデバイス。
- 84前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも0.27グラムの軸方向付勢力を印加する、請求項82に記載のデバイス。
- 85前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも2.67グラムの軸方向付勢力を印加する、請求項82に記載のデバイス。
- 86前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも16.6グラムの軸方向付勢力を印加する、請求項82に記載のデバイス。
- 87前記金属コイルは、3次元フレーミング形状に順応するように構成される、請求項82に記載のデバイス。
- 88前記金属コイルは、白金を含むワイヤから形成される、請求項82に記載のデバイス。
- 89脳動脈瘤を処置するための方法であって、インプラント構造であって、近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくとも、その前記近位端または前記遠位端のうちの少なくとも1つにおいて固着される、自己拡張型弾性透過シェルと、第1の直径を有するワイヤから形成される、金属コイルであって、前記金属コイルは、前記自己拡張型弾性透過シェルの前記遠位端において固着される、金属コイルと、を備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有し、前記金属コイルは、マイクロカテーテル内での送達のために構成される、直線状の真っすぐな形状と、二次直径を有する少なくとも1つのループを有する、拡張状態とを有する、インプラント構造を提供するステップと、マイクロカテーテル内の前記インプラントを前記脳動脈瘤近傍の領域まで前進させるステップと、前記脳動脈瘤内で前記インプラントを展開するステップであって、前記金属コイルは、前記脳動脈瘤のドーム近傍に位置付けられ、前記拡張状態を成し、前記透過シェルは、前記脳動脈瘤内で前記拡張した展開状態を成す、ステップと、前記インプラントを展開した後に、前記脳動脈瘤近傍の前記領域から前記マイクロカテーテルを引き抜くステップと、を含む、方法。
- 90前記金属コイルは、前記脳動脈瘤の開口部に前記透過シェルを押し付ける、請求項89に記載の方法。
- 91前記金属コイルは、前記脳動脈瘤の直径の周囲を追跡する、請求項89に記載の方法。
- 92前記金属コイルの前記二次直径は、前記透過シェルの直径にほぼ等しい、請求項89に記載の方法。
- 93前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも0.27グラムの軸方向付勢力を印加する、請求項89に記載の方法。
- 94前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも2.67グラムの軸方向付勢力を印加する、請求項89に記載の方法。
- 95前記金属コイルは、軸方向に少なくとも部分的に圧縮されたときに、少なくとも16.6グラムの軸方向付勢力を印加する、請求項89に記載の方法。
- 96近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくとも、その前記近位端または前記遠位端のうち1つにおいて固着される、自己拡張型弾性透過シェルと、前記自己拡張型弾性透過シェルの前記遠位端において固着される、力付勢部材と、を備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有し、前記力付勢部材は、マイクロカテーテル内での送達のために構成される、直線状の真っすぐな形状と、前記マイクロカテーテルからの送達後の拡張状態とを有する、患者の血管系内の動脈瘤の処置のためのデバイス。
- 97前記力付勢部材は、前記透過シェルが動脈瘤内で前記拡張状態であるときに、前記透過シェルに付勢力を加えるように構成される、請求項96に記載のデバイス。
- 98前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも0.27グラムの軸方向付勢力を印加する、請求項96に記載のデバイス。
- 99前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも2.67グラムの軸方向付勢力を印加する、請求項96に記載のデバイス。
- 100前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも16.6グラムの軸方向付勢力を印加する、請求項96に記載のデバイス。
- 101前記力付勢部材は、3次元フレーミング形状に順応するように構成される、請求項96に記載のデバイス。
- 102前記力付勢部材は、白金を含むワイヤから形成される、請求項96に記載のデバイス。
- 103前記複数のフィラメントは、前記透過シェルの前記遠位端において固着され、前記複数のフィラメントのうちの少なくともいくつかの遠位領域は、前記透過シェルの前記遠位端を超えて延在し、略円形を有する拡張部を形成し、前記力付勢部材は、拡張されたときに前記略円形を有する、前記拡張部を備える、請求項96に記載のデバイス。
- 104前記複数のフィラメントは、近位および遠位端を有する、円筒ハブによって固着され、前記拡張部は、前記円筒ハブの前記遠位端から延在する、請求項103に記載のデバイス。
- 105前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、編組される、請求項103に記載のデバイス。
- 106前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、部分的に編組される、請求項103に記載のデバイス。
- 107前記編組遠位領域は、少なくとも部分的に解かれる、請求項105に記載のデバイス。
- 108脳動脈瘤を処置するための方法であって、インプラント構造であって、近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、少なくとも、その前記近位端または前記遠位端のうち1つにおいて固着される、自己拡張型弾性透過シェルと、前記自己拡張型弾性透過シェルの前記遠位端において固着される、力付勢部材と、を備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有し、前記力付勢部材は、マイクロカテーテル内での送達のために構成される、直線状の真っすぐな形状と、前記マイクロカテーテルからの送達後の拡張状態とを有する、インプラント構造を提供するステップと、マイクロカテーテル内の前記インプラントを前記脳動脈瘤近傍の領域まで前進させるステップと、前記脳動脈瘤内で前記インプラントを展開するステップであって、前記力付勢部材は、前記脳動脈瘤のドーム近傍に位置付けられ、前記拡張状態を成し、前記透過シェルは、前記脳動脈瘤内で前記拡張した展開状態を成す、ステップと、前記インプラントを展開した後に、前記脳動脈瘤近傍の前記領域から前記マイクロカテーテルを引き抜くステップと、を含む、方法。
- 109前記力付勢部材は、前記脳動脈瘤の開口部に前記透過シェルを押し付ける、請求項108に記載の方法。
- 110前記力付勢部材は、前記透過シェルが動脈瘤内で前記拡張状態であるときに、前記透過シェルに付勢力を加えるように構成される、請求項108に記載の方法。
- 111前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも0.27グラムの軸方向付勢力を印加する、請求項108に記載の方法。
- 112前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも2.67グラムの軸方向付勢力を印加する、請求項108に記載の方法。
- 113前記力付勢部材は、軸方向に少なくとも部分的に圧縮されたときに、少なくとも16.6グラムの軸方向付勢力を印加する、請求項108に記載の方法。
- 114前記力付勢部材は、3次元フレーミング形状に順応するように構成される、請求項108に記載の方法。
- 115前記力付勢部材は、白金を含むワイヤから形成される、請求項108に記載の方法。
- 116前記複数のフィラメントは、前記透過シェルの前記遠位端において固着され、前記複数のフィラメントのうちの少なくともいくつかの遠位領域は、前記透過性シェルの前記遠位端を超えて延在し、略円形を有する拡張部を形成し、前記力付勢部材は、拡張されたときに前記略円形を有する、前記拡張部を備える、請求項108に記載の方法。
- 117前記複数のフィラメントは、近位および遠位端を有する、円筒ハブによって固着され、前記拡張部は、前記円筒ハブの前記遠位端から延在する、請求項116に記載の方法。
- 118前記複数のフィラメントは、近位および遠位端を有する、円筒ハブによって固着され、前記拡張部は、前記円筒ハブの前記遠位端から延在する、請求項116に記載の方法。
- 119前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、編組される、請求項116に記載の方法。
- 120前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、部分的に編組される、請求項116に記載の方法。
- 121前記編組遠位領域は、少なくとも部分的に解かれる、請求項119に記載の方法。
- 122近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、その前記遠位端において固着され、前記複数のフィラメントのうちの少なくともいくつかの遠位領域は、前記透過シェルの前記遠位端を超えて延在し、拡張されたときに略円形を有する拡張部を形成する、自己拡張型弾性透過シェルを備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有する、患者の血管系内の動脈瘤の処置のためのデバイス。
- 123前記複数のフィラメントは、近位および遠位端を有する、円筒ハブによって固着され、前記拡張部は、前記円筒ハブの前記遠位端から延在する、請求項122に記載のデバイス。
- 124前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、編組される、請求項122に記載のデバイス。
- 125前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、部分的に編組される、請求項122に記載のデバイス。
- 126前記編組遠位領域は、少なくとも部分的に解かれる、請求項124に記載のデバイス。
- 127脳動脈瘤を処置するための方法であって、インプラント構造であって、近位端、遠位端、および長手軸を有する、自己拡張型弾性透過シェルであって、前記シェルは、編組構造を有する複数の伸長弾性フィラメントを備え、前記複数のフィラメントは、その前記遠位端において固着され、前記複数のフィラメントのうちの少なくともいくつかの遠位領域は、前記透過シェルの前記遠位端を超えて延在し、拡張されたときに略円形を有する拡張部を形成する、自己拡張型弾性透過シェルを備え、前記透過シェルは、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伸長状態を有し、かつ前記半径方向に拘束された状態に対して球状の軸方向に短縮された構成を伴う拡張状態を有し、前記透過シェルは、編組フィラメントの間に形成された複数の開口部を有する、インプラント構造を提供するステップと、マイクロカテーテル内の前記インプラントを前記脳動脈瘤近傍の領域まで前進させるステップと、前記脳動脈瘤内で前記インプラントを展開するステップであって、前記拡張部は、前記脳動脈瘤のドーム近傍に位置付けられ、前記略円形を成し、前記透過シェルは、前記脳動脈瘤内で前記拡張した展開状態を成す、ステップと、前記インプラントを展開した後に、前記脳動脈瘤近傍の前記領域から前記マイクロカテーテルを引き抜くステップと、を含む、方法。
- 128前記複数のフィラメントは、近位および遠位端を有する、円筒ハブによって固着され、前記拡張部は、前記円筒ハブの前記遠位端から延在する、請求項127に記載の方法。
- 129前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、編組される、請求項127に記載の方法。
- 130前記拡張部を形成する、前記複数のフィラメントのうちの少なくともいくつかの前記遠位領域は、部分的に編組される、請求項127に記載の方法。
- 131前記編組遠位領域は、少なくとも部分的に解かれる、請求項129に記載の方法。
Independent claims131
138 paragraphs, as filed
0001(Related application) This application is an international application with US Application No. 14 / 684,212 filed on April 10, 2015, and this US application is filed with US Provisional Application No. 61 / on April 14, 2014. Claims priority under US Provisional Application No. 62 / 093,313 filed on 979,416 and December 17, 2014, and all of these disclosures are for reference in their entirety for all purposes. As incorporated herein by reference.
0002(Field of invention) Embodiments of the devices and methods herein are intended to block the flow of fluid through tubular blood vessels or into small internal chambers of saccular cavities or vascular defects within a mammalian body. More specifically, embodiments herein specifically cover the treatment of a patient's cerebral aneurysm, including some embodiments, devices and methods for the treatment of a patient's vascular defect. Is targeted.
0003(background) The mammalian circulatory system consists of a heart that acts as a pump and a vascular system that transports blood to various points in the body. Due to the force exerted by the blood flowing against the blood vessels, the blood vessels can develop various vascular defects. One common vascular defect known as an aneurysm results from abnormal enlargement of blood vessels. Vascular aneurysms are typically formed as a result of weakening of the walls of blood vessels, followed by expansion and dilation of the walls of blood vessels. For example, death can occur if an aneurysm is present in an artery in the brain and the aneurysm results in cerebral hemorrhage and rupture.
0004Surgical techniques for the treatment of cerebral aneurysms typically involve craniotomy, which requires the creation of a craniotomy in the patient's skull through which the surgeon can insert surgical instruments directly into the patient's brain. .. For some surgical approaches, the brain must be opened and surgical instruments must be used to expose the parent vessel where the aneurysm occurs. Once access to the aneurysm is gained, the surgeon places a clip across the neck of the aneurysm, thereby preventing arterial blood from entering the aneurysm. With the correct placement of the clip, the aneurysm will disappear in just a few minutes. Surgical techniques can be an effective procedure for many aneurysms. Unfortunately, surgical techniques for treating these types of symptoms include invasive major surgical procedures that often require long periods of time under anesthesia with high risk to the patient. Therefore, such procedures require that the patient is generally in good health in order to be a candidate for such procedures.
0005Various alternative and minimally invasive procedures have been used to treat cerebral aneurysms without major surgery. Some such procedures involve the delivery of embolization or filling material into the aneurysm. Delivery of such vascular occlusion devices or materials may be used to facilitate hemostasis or to completely fill the cavity of the aneurysm. Vascular occlusion devices are typically via a catheter to block blood flow through a blood vessel with an aneurysm through the formation of an embolus, or to form such an embolus within an aneurysm originating from a blood vessel. It may be placed in the vascular system of the human body. Various implantable coiled vascular occlusion devices are known. The coil of such a device may itself be formed into either a secondary coil shape or a variety of more complex secondary shapes. Vascular occlusion coils are commonly used to treat cerebral aneurysms, but lack of packing density, compression due to dynamic pressure from the bloodstream, and lack of stability in aneurysms with a wide neck. And because most aneurysm treatments with this approach require the deployment of multiple coils, they suffer from some limitations, including the complexity and difficulty of their deployment.
0006Another approach to treating an aneurysm without the need for invasive surgery involves the placement of a sleeve or stent into the blood vessel and across the area where the aneurysm occurs. Such a device maintains blood flow through the blood vessels while reducing the blood pressure applied to the inside of the aneurysm. Some types of stents are expanded to the appropriate size by inflating a balloon catheter called a balloon inflatable stent, while other stents are designed to elastically expand in a self-expanding manner. .. Some stents are typically coated with a sleeve of polymeric material called a graft that forms a stent graft. Stents and stent grafts are generally delivered through delivery catheters to preselected locations adjacent to vascular defects. In the treatment of cerebral aneurysms, coated stents or stent grafts are used very limitedly due to the potential for inadvertent obstruction of small perforator vessels that may be in the vicinity of the vascular defect being treated. It seems.
0007In addition, current uncoated stents are generally not sufficient as a single treatment. In order for the stents to fit through the microcatheter used in small cerebrovascular disease, their density is usually reduced so that there is only a small amount of stent structure that bridges the aneurysm neck when expanded. Will be done. Therefore, they do not block sufficient flow to cause blood coagulation in the aneurysm and are therefore generally used in combination with vascular occlusion devices such as the coils described above to achieve aneurysm occlusion. To.
0008Several devices have been attempted to cross-link the aneurysm neck with a defect area or region, but any of these devices has led to significant clinical success or use. Not in. A major limitation in their adoption and clinical utility is the inability to position the defect area to ensure coverage of the neck. Existing stent delivery systems that are neurovascularly compatible (ie, deliverable through a microcatheter and are highly flexible) do not have the required rotational positioning capability. Another limitation of many aneurysm cross-linking devices described in the prior art is lack of flexibility. Cerebral vessels are meandering and require a high degree of flexibility for effective delivery to the location of most aneurysms in the brain.
0009What is needed is a device and method for delivery and use within small and winding blood vessels that can substantially block the flow of blood into an aneurysm such as a cerebral aneurysm. Is. In addition, what is needed is a method and device suitable for blocking blood flow in a cerebral aneurysm for an extended period of time without significant risk of deformation, compression, or dislocation.
<p num="0010"> (Summary) In one embodiment of the invention, a device for removing thrombi from blood vessels is described. The device includes an expandable cylindrical structure that has proximal and distal ends and is formed from multiple wires, the adjacent wires being engaged with each other by multiple twists. The wires are secured together at the distal and proximal ends of the cylindrical structure. The cylindrical structure has a state of being constrained in the radial direction and a state of being relaxed in an expanded state. The device also includes a self-expanding elastic transmission shell with proximal, distal, and longitudinal axes. The self-expanding elastic transmission shell comprises a plurality of eccentric elastic filaments having a braided structure with a plurality of openings, the plurality of filaments being fixed at the proximal and distal ends. The self-expanding transmissive shell has an extended state constrained in the radial direction and an extended relaxed state with a configuration shortened in the axial direction in a spherical direction with respect to the state constrained in the radial direction. The self-expandable transmission shell is enclosed within an expandable cylindrical structure and is located at the distal end of the expandable cylindrical structure.</p><p num="0011"> In another embodiment of the invention, a method for removing a thrombus having proximal and distal ends from a blood vessel is described. A thrombectomy device is acquired. The thrombectomy device comprises an expandable cylindrical structure having a proximal end, a central portion, and a distal end. The expandable cylindrical structure is made up of multiple wires, the adjacent wires are engaged with each other by multiple twists, and the multiple wires are anchored together at the distal end and together at the proximal end. .. The cylindrical structure has a state of being constrained in the radial direction and a state of being relaxed in an expanded state. Thrombectomy devices also include a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The self-expanding elastic transmission shell comprises a plurality of eccentric elastic filaments having a braided structure with multiple openings, the plurality of filaments being secured at the proximal and distal ends. The self-expanding transmissive shell has an extended state constrained in the radial direction and an extended relaxed state with a configuration shortened in the axial direction in a spherical direction with respect to the state constrained in the radial direction. The self-expandable transmission shell is enclosed within an expandable cylindrical structure and is located at the distal end of the expandable cylindrical structure. The thrombectomy device was slidably positioned within the microcatheter, the microcatheter was inserted into the patient, and both the expandable cylindrical structure and the self-expandable elastic permeation shell were radially constrained within the microcatheter. It is in a state. The distal end of the microcatheter is located adjacent to the distal end of the thrombus. The thrombectomy device is deployed from the microcatheter by the relative displacement of the thrombectomy device and the microcatheter. Upon deployment, the proximal end of the self-expanding elastic permeation shell located within the expandable cylindrical structure is located distal to the thrombus, and the central portion of the expandable cylindrical structure overlaps the proximal and distal ends of the thrombus. And once the thrombectomy device is advanced out of the microcatheter, the self-expandable elastic permeation shell and expandable cylindrical structure transition towards their expanded state. Then, with a self-expanding elastic permeable shell at the distal end of the cylindrical structure The expandable expanded cylindrical structure is moved proximally, thereby removing or removing one or more thrombi from the luminal surface of the blood vessel and trapping the thrombus within the expandable cylindrical structure. The thrombectomy device and one or more captured thrombi are then removed from the blood vessel.</p><p num="0012"> Both the thrombectomy device and the microcatheter may be removed from the blood vessel. Alternatively, the thrombectomy device may be removed from the microcatheter and the microcatheter may be left in place within the blood vessel. Both the thrombectomy device and the microcatheter may be removed from the patient. Alternatively, the thrombectomy device may be removed from the microcatheter and the microcatheter may be left in place within the patient. The self-expanding permeable shell may have a braid density high enough to maintain the thrombus within the cylindrical structure and allow blood to flow through the self-expanding permeable shell.</p><p num="0013"> In another embodiment of the invention, a device for the treatment of an aneurysm is described. The device includes a distal self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The distal transmission shell comprises a plurality of eccentric elastic filaments having a braided structure with multiple openings formed between the braided filaments. Multiple filaments are assembled at least at their proximal ends. The distal permeation shell is configured for delivery within the microcatheter, with a radially constrained extended state and an expanded state with an axially shortened configuration relative to the radially constrained state. The expanded state of the distal permeation shell has a convex shape at the distal end of the distal permeation shell. The device also includes a proximal self-expanding elastic transmission shell with proximal, distal, and longitudinal axes. Proximal transmission shells include a plurality of eccentric elastic filaments having a braided structure with multiple openings formed between the braided filaments. Multiple filaments are assembled at least at their proximal ends. Proximal permeation shells are configured for delivery within a microcatheter, with a radially constrained extended state and an expanded state with an axially shortened configuration relative to the radially constrained state. The expanded state of the proximal transmission shell has a substantially convex shape at the proximal end of the proximal transmission shell. The device also includes an extension support member with proximal and distal ends. The extension support member is located between the distal and proximal permeation shells. The expanded state of the distal and proximal permeation shells defines a toroidal cavity through which an extension support member extends.</p><p num="0014"> The average size of the multiple openings in the distal permeation shell can be larger than the average size of the multiple openings in the proximal permeation shell. The average size of the plurality of openings in the distal permeation shell may be from about 300 μm to about 900 μm, as an alternative from about 300 μm to about 700 μm, and as an alternative from 300 μm to about 500 μm. The average size of the plurality of openings in the proximal transmission shell may be from about 50 μm to about 200 μm, as an alternative from about 100 μm to about 200 μm, or as an alternative from 50 μm to about 150 μm. The braided structure of the distal permeation shell may have a first braid density and the braided structure of the proximal permeation shell may have a second braid density. The first braid density can be higher than the second braid density. The first braid density may be from about 0.10 to 0.20, or, as an alternative, from about 0.10 to 0.15. The second braid density may be about 0.15 to 0.40 and, as an alternative, about 0.17 to 0.30.</p><p num="0015"> The extension support member may be rigid or may be a coil. If the extension support member is rigid, it may be formed from hypotubes. If the extension support member is a coil, it may be an expansion spring. At rest, the expansion spring is not compressible to a smaller length. The extension support member may have a length of about 2 mm to about 10 mm, an alternative of about 3 mm to about 8 mm, or an alternative of about 3.5 mm to about 5.5 mm. The expansion spring may have a length of about 2 mm to about 10 mm, an alternative length of about 3 mm to about 8 mm, and an alternative length of about 3.5 mm to about 5.5 mm. The rigid support member may have a length of about 2 mm to about 10 mm, an alternative of about 3 mm to about 8 mm, or an alternative of about 3.5 mm to about 5.5 mm.</p><p num="0016"> The filaments that make up the distal and proximal permeation shells may include nitinol wire, stretched fill tubes, and mixtures thereof. Multiple filaments of the distal permeation shell may be assembled at the distal end of the distal permeation shell. Also, each of the plurality of filaments in the distal transmission shell has a first end and a second end. The first and second ends of the filaments of the distal permeation shell may be assembled at the proximal end of the distal permeation shell.</p><p num="0017"> The extension of the distal transmission shell may contact the extension of the proximal transmission shell. The extension of the distal transmission shell and the extension of the proximal transmission shell may also form a substantially spherical shape.</p><p num="0018"> In another embodiment of the invention, a method for treating a cerebral aneurysm is described. The method comprises providing an implant having a distal self-expanding elastic permeation shell, a proximal self-expanding elastic permeation shell, and an extension support member located between the distal and proximal permeation shells. .. The distal self-expandable elastic permeation shell has multiple eccentric elastic filaments with a proximal, distal, and longitudinal axis and a braided structure with multiple openings formed between the braided filaments. Including. Multiple filaments were assembled at least at their proximal ends, and the distal permeation shell was radially constrained with a radially constrained extension configured for delivery within the microcatheter. It has an expanded state with an axially shortened configuration relative to the state, and the expanded state of the distal permeation shell has a convex shape at the distal end of the distal permeation shell.</p><p num="0019"> In one embodiment of the invention, a device for the treatment of an aneurysm in a patient's vascular system is described. The device includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell is made of a plurality of eccentric elastic filaments having a braided structure, the plurality of filaments being fixed at least at one of its proximal or distal ends. The permeation shell has multiple openings formed between the braided filaments. The device also includes a metal coil formed from a wire having a first diameter. The metal coil is secured at the distal end of the self-expanding elastic transmission shell. The permeation shell has a radially constrained extended state configured for delivery within the microcatheter and has a spherical axially shortened configuration relative to the radially constrained state. Has an accompanying dilated state. The metal coil has a straight straight shape configured for delivery within a microcatheter and an expanded state with at least one loop having a secondary diameter.</p><p num="0020"> The metal coil may be configured to exert an urging force on the permeation shell when it is in an expanded state within the aneurysm. When compressed at least partially in the axial direction, the metal coil weighs at least 0.27 grams, at least 2.67 grams as an alternative, at least 16.6 grams as an alternative, about 0.27 grams to about 40 grams as an alternative, about about 40 grams as an alternative. Axial urging forces of 2.67 grams to about 30 grams and, as an alternative, about 16.6 grams to about 20 grams can be applied.</p><p num="0021"> In another embodiment of the invention, a method for treating a cerebral aneurysm is described. Implant structures are provided. The implant structure includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell comprises a plurality of eccentric elastic filaments having a braided structure, the plurality of filaments being fixed at least at at least one of its proximal or distal ends. The implant structure also includes a metal coil formed from a wire having a first diameter, which is anchored at the distal end of a self-expanding elastic permeation shell. The permeation shell has multiple openings formed between the braided filaments. The device also includes a metal coil formed from a wire having a first diameter. The metal coil is secured at the distal end of the self-expanding elastic transmission shell. The permeation shell has a radially constrained extended state configured for delivery within the microcatheter and has a spherical axially shortened configuration relative to the radially constrained state. Has an accompanying dilated state. The metal coil has a straight straight shape configured for delivery within a microcatheter and an expanded state with at least one loop having a secondary diameter. The implant is advanced within the microcatheter to the area near the cerebral aneurysm. The implant is deployed within the cerebral aneurysm such that the metal coil is located near the dome of the aneurysm and forms an expanded state, and the permeation shell forms an expanded and deployed state within the cerebral aneurysm. The microcatheter is then withdrawn from the area near the cerebral aneurysm after the implant has been deployed.</p><p num="0022"> Once deployed into the cerebral aneurysm, the metal coil may press the permeation shell against the opening of the cerebral aneurysm. The metal coil may track around the diameter of the cerebral aneurysm. The secondary diameter of the metal coil can be approximately equal to the diameter of the transmission shell. When at least partially compressed, the metal coil weighs at least 0.27 grams, as an alternative at least 2.67 grams, as an alternative at least 16.6 grams, as an alternative about 0.27 grams to about 40 grams, as an alternative about 2.67 grams ~ About 30 grams, as an alternative, about 16.6 grams to about 20 grams of axial urging force can be applied.</p><p num="0023"> In another embodiment of the invention, a device for the treatment of an aneurysm in a patient's vascular system is described. The device includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell is made of a plurality of eccentric elastic filaments having a braided structure, the plurality of filaments being fixed at least at one of its proximal or distal ends. The permeation shell has multiple openings formed between the braided filaments. The device also includes a force urging member that is anchored at the distal end of a self-expanding elastic transmission shell. The permeation shell has a radially constrained extended state configured for delivery within the microcatheter and has a spherical axially shortened configuration relative to the radially constrained state. Has an accompanying dilated state. The force urging member has a straight, straight shape configured for delivery within the microcatheter and an expanded state after delivery from the microcatheter.</p><p num="0024"> The force urging member may be configured to exert urging force on the permeation shell when it is in an expanded state within the aneurysm. When compressed at least partially in the axial direction, the metal coil weighs at least 0.27 grams, at least 2.67 grams as an alternative, at least 16.6 grams as an alternative, about 0.27 grams to about 40 grams as an alternative, about about 40 grams as an alternative. Axial urging forces of 2.67 grams to about 30 grams and, as an alternative, about 16.6 grams to about 20 grams can be applied. The force urging member may be configured to adapt to the three-dimensional framing shape. The force urging member may be made of wire containing platinum.</p><p num="0025"> The force urging member may also have a substantially circular shape. The filaments forming the permeation shell may be anchored at the distal end. At least some distal regions of the filaments extend beyond the distal end of the permeation shell to form an extension with a substantially circular shape that can be a force urging member. The filaments may be secured by a cylindrical hub having proximal and distal ends, and the extension may extend from the distal end of the cylindrical hub. The distal region of the filament forming the extension may be straight, braided, or partially braided, or the braid may be partially disassembled or unraveled.</p><p num="0026"> In another embodiment of the invention, a method for treating a cerebral aneurysm is described. Implant structures are provided. The implant structure includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell comprises a plurality of eccentric elastic filaments having a braided structure, the plurality of filaments being fixed at least at at least one of its proximal or distal ends. The device also includes a force urging member that is anchored at the distal end of a self-expanding elastic transmission shell. The permeation shell has multiple openings formed between the braided filaments. The permeation shell has a radially constrained extended state configured for delivery within the microcatheter and has a spherical axially shortened configuration relative to the radially constrained state. Has an accompanying dilated state. The force urging member has a straight, straight shape configured for delivery within the microcatheter and an expanded state after delivery from the microcatheter. The implant is advanced within the microcatheter to the area near the cerebral aneurysm. The implant is deployed within the cerebral aneurysm such that the force urging member is located near the dome of the aneurysm and is in a dilated state, and the permeation shell is in a dilated and deployed state within the cerebral aneurysm. .. The microcatheter is then withdrawn from the area near the cerebral aneurysm after the implant has been deployed.</p><p num="0027"> Once deployed into the cerebral aneurysm, the force urging member may press the permeation shell against the opening of the cerebral aneurysm. When compressed at least partially in the axial direction, the metal coil weighs at least 0.27 grams, at least 2.67 grams as an alternative, at least 16.6 grams as an alternative, about 0.27 grams to about 40 grams as an alternative, about about 40 grams as an alternative. Axial urging forces of 2.67 grams to about 30 grams and, as an alternative, about 16.6 grams to about 20 grams can be applied. The force urging member may be configured to adapt to the three-dimensional framing shape. The force urging member may be made of wire containing platinum.</p><p num="0028"> In another embodiment, a device for the treatment of an aneurysm in a patient's vascular system is described. The device includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell contains a plurality of eccentric elastic filaments having a braided structure. Multiple filaments are anchored at the distal end of the transmission shell. At least some of the distal regions of the filaments extend beyond the distal end of the permeation shell and form an extension with a substantially circular shape when expanded. The filaments may be secured by a cylindrical hub having proximal and distal ends, and the extension may extend from the distal end of the cylindrical hub. The distal region of the filament forming the extension may be straight, braided, or partially braided, or the braid may be partially disassembled or unraveled.</p><p num="0029"> In another embodiment of the invention, a method for treating a cerebral aneurysm is described. Implant structures are provided. The implant structure includes a self-expanding elastic permeation shell with proximal, distal, and longitudinal axes. The shell contains a plurality of eccentric elastic filaments having a braided structure. Multiple filaments are anchored at the distal end of the transmission shell. At least some of the distal regions of the filaments extend beyond the distal end of the permeation shell and form an extension with a substantially circular shape when expanded. The implant is advanced within the microcatheter to the area near the cerebral aneurysm. The implant is deployed within the cerebral aneurysm such that the dilatation is located near the dome of the aneurysm and forms a substantially circular dilated state, and the permeation shell forms a dilated and deployed state within the cerebral aneurysm. To. The microcatheter is then withdrawn from the area near the cerebral aneurysm after the implant has been deployed. The filaments may be secured by a cylindrical hub having proximal and distal ends, and the extension may extend from the distal end of the cylindrical hub. The distal region of the filament forming the extension may be straight, braided, or partially braided, or the braid may be partially disassembled or unraveled.</p>
0030<figref num="1">FIG. 1 is an elevational view of an embodiment of a device for treating a patient's vasculature, with multiple arrows indicating medial radial forces.</figref><figref num="2">FIG. 2 is an elevational view of the beam supported by two simple supports, with multiple arrows indicating the force on the beam.</figref><figref num="3">FIG. 3 is a bottom perspective view of an embodiment of a device for treating a patient's vascular system.</figref><figref num="4">FIG. 4 is an elevational view of the device for treatment of the patient's vascular system of FIG.</figref><figref num="5">FIG. 5 is a cross-sectional view of the device of FIG. 4 taken along line 5-5 of FIG.</figref><figref num="6">FIG. 6 shows the device of FIG. 4 in a longitudinal section taken along line 6-6 of FIG.</figref><figref num="7">FIG. 7 is an enlarged view of the woven filament structure taken from the enclosed portion 7 shown in FIG.</figref><figref num="8">FIG. 8 is an enlarged view of the woven filament structure taken from the enclosed portion 8 shown in FIG.</figref><figref num="9">FIG. 9 is a proximal end view of the device of FIG.</figref><figref num="10">FIG. 10 is a cross-sectional view of the proximal hub portion of the device of FIG. 6, shown by line 10-10 of FIG.</figref><figref num="11">FIG. 11 is an elevational view of a partial cross section of the distal end of a delivery catheter with a device for the treatment of the patient's vascular system of FIG. 3 placed therein in a folded restraint.</figref><figref num="12">FIG. 12 is an elevational view of the distal portion of a delivery device or actuator showing some internal structure of the device.</figref><figref num="13">FIG. 13 is an elevational view of the delivery device of FIG. 12 with some tubular elements added on top of the internal structure.</figref><figref num="14">FIG. 14 is an elevational view of the distal portion of the delivery device of FIG. 13 with the outer coil and marker in place.</figref><figref num="15">FIG. 15 is an elevational view of the proximal portion of the delivery device.</figref><figref num="16">FIG. 16 illustrates an embodiment of a filament configuration for a device for treatment of a patient's vascular system.</figref><figref num="17">FIG. 17 is a schematic representation of a patient being releasably secured to the distal end of a delivery device or actuator and accessed by an introductory sheath, a microcatheter, and a device for treatment of the patient's vascular system.</figref><figref num="18">FIG. 18 is a cross-sectional view of the terminal aneurysm.</figref><figref num="19">FIG. 19 is a cross-sectional view of the aneurysm.</figref><figref num="20">FIG. 20 is a partial schematic of an aneurysm showing vertical arrows indicating the internal nominal longitudinal and lateral dimensions of the aneurysm.</figref><figref num="21">FIG. 21 is a partial aneurysm of FIG. 20 with a dashed contour of a device for the treatment of the vasculature of a relaxed, unrestrained patient that extends laterally outside the wall of the aneurysm. It is a schematic diagram.</figref><figref num="22">FIG. 22 is a partial schematic of the contour of the device, represented by the dashed line in FIG. 21, unfolded and partially constrained within the aneurysm.</figref><figref num="23">Figures 23-26 show the deployment sequence of devices for the treatment of the patient's vascular system.</figref><figref num="24">Figures 23-26 show the deployment sequence of devices for the treatment of the patient's vascular system.</figref><figref num="25">Figures 23-26 show the deployment sequence of devices for the treatment of the patient's vascular system.</figref><figref num="26">Figures 23-26 show the deployment sequence of devices for the treatment of the patient's vascular system.</figref><figref num="27">FIG. 27 is an elevational view of a mandrel used in the manufacture of a braided tubular member for the construction of an embodiment of a device for the treatment of a patient's vascular system with the initiation of the braided process shown.</figref><figref num="28">FIG. 28 is an elevational view of the braiding process for braided tubular members used in the manufacture of devices.</figref><figref num="29">FIG. 29 is an elevational view of a partial cross section of an embodiment of a fixture for thermosetting a braided tubular member for the manufacture of a device for the treatment of a patient's vascular system.</figref><figref num="30">FIG. 30 is an elevational view of a partial cross section of an embodiment of a fixture for thermosetting a braided tubular member for the manufacture of a device for the treatment of a patient's vascular system.</figref><figref num="31">FIG. 31 is an elevational view in cross section illustrating blood flow within an aneurysm of the patient's vascular system.</figref><figref num="32">FIG. 32 is a perspective view of a cross section of the composite filament embodiment.</figref><figref num="33">FIG. 33 is an elevational view of an embodiment of a device for treating a patient's vascular system.</figref><figref num="34">FIGS. 34A-34B illustrate a method for implanting a second configuration of the embodiment of FIG. 33 within a vascular defect.</figref><figref num="35A">35A-35B illustrate a method for implanting a third configuration of the embodiment of FIG. 33 within a vascular defect.</figref><figref num="35B">35A-35B illustrate a method for implanting a third configuration of the embodiment of FIG. 33 within a vascular defect.</figref><figref num="35C">FIG. 35C illustrates an elevation view of an embodiment of a device for treating a patient's vascular system.</figref><figref num="35D">FIG. 35D illustrates an upper perspective view of the device of FIG. 35C.</figref><figref num="35E">Figures 35E-35F illustrate the device of Figure 35C being delivered from a microcatheter.</figref><figref num="35F">Figures 35E-35F illustrate the device of Figure 35C being delivered from a microcatheter.</figref><figref num="36">FIG. 36 is a partial cross-sectional view of an embodiment of the mesh device.</figref><figref num="37">FIG. 37 is a partial cross-sectional view of an embodiment of the multi-leaf mesh device.</figref><figref num="38">FIG. 38 is an elevational view of a partial cross section of the distal end of a delivery catheter in which a device for the treatment of the patient's vascular system of FIG. 37 is placed in a folded restraint state.</figref><figref num="39">FIG. 39 is a partial cross-sectional view of an embodiment of a multi-leaf mesh device.</figref><figref num="40">FIG. 40 is a partial cross-sectional view of the multilobe mesh device of FIG. 37 in place with respect to a vascular defect.</figref><figref num="41">FIG. 41 is a grooved mandrel assembly used in the braiding process of an embodiment of a device for the treatment of a patient's vascular system.</figref><figref num="42">FIG. 42 is a cross-sectional view of the grooved mandrel assembly of FIG.</figref><figref num="43A">Figures 43A-43C illustrate how to load the grooved mandrel assembly of Figure 41 for the braiding process of the device for the treatment of the patient's vascular system.</figref><figref num="43B">Figures 43A-43C illustrate how to load the grooved mandrel assembly of Figure 41 for the braiding process of the device for the treatment of the patient's vascular system.</figref><figref num="43C">Figures 43A-43C illustrate how to load the grooved mandrel assembly of Figure 41 for the braiding process of the device for the treatment of the patient's vascular system.</figref><figref num="43D">FIG. 43D illustrates an alternative embodiment for loading the grooved mandrel assembly of FIG. 41.</figref><figref num="44">Figures 44A-44B illustrate how to load the grooved mandrel assembly of Figure 41 for the braiding process of the device for the treatment of the patient's vascular system.</figref><figref num="45">FIG. 45 is an elevational view of an embodiment of a device for treating a patient's vascular system.</figref><figref num="46">FIG. 46 is an elevational view of a partial cross section of the distal end of a delivery catheter in which a device for the treatment of the patient's vascular system of FIG. 45 is placed in a folded restraint state.</figref><figref num="47">FIG. 47 is an embodiment of a device for the treatment of the patient's vascular system of FIG. 45 deployed within an aneurysm.</figref><figref num="48">FIG. 48 is an embodiment of a device for the treatment of a patient's vascular system deployed within an aneurysm.</figref><figref num="49">FIG. 49 is an elevational view of an embodiment of a mesh device prior to being compressed in the longitudinal direction.</figref><figref num="50">FIG. 50 is an elevational view of the mesh device of FIG. 49 after a certain amount of longitudinal compression.</figref><figref num="51">FIG. 51 is an elevational view of the mesh device of FIG. 49 after an additional amount of longitudinal compression.</figref><figref num="52">FIG. 52 illustrates an embodiment of a system that includes a multi-leaf mesh device.</figref><figref num="53">FIG. 53-56 illustrates the system of FIG. 52 delivered from a microcatheter.</figref><figref num="54">FIG. 53-56 illustrates the system of FIG. 52 delivered from a microcatheter.</figref><figref num="55">FIG. 53-56 illustrates the system of FIG. 52 delivered from a microcatheter.</figref><figref num="56">FIG. 53-56 illustrates the system of FIG. 52 delivered from a microcatheter.</figref><figref num="57A">FIG. 57A is an embodiment of a multilobal mesh device for the treatment of a patient's vascular system deployed within an aneurysm.</figref><figref num="57B">FIG. 57B is a partial cut view of the multi-leaf mesh device of FIG. 57A.</figref><figref num="57C">FIG. 57C is a partial cut view of the multi-leaf mesh device of FIG. 57A.</figref><figref num="58">FIG. 58 is a partially cut perspective view of the multi-leaf mesh device of FIG. 57A.</figref><figref num="59">FIG. 59 is an elevational view of a partial cross section of the distal end of the delivery catheter in which the device for the treatment of the patient's vascular system of FIGS. 57A-58 was placed in a folded restraint.</figref><figref num="60">FIG. 60 is a partially cut perspective view of an embodiment of a multi-leaf mesh device.</figref><figref num="61">Figure 61 is a single diamond-shaped module within a multi-leaf mesh device.</figref><figref num="62">FIG. 62 is a perspective view of an embodiment of a self-expanding device for removing thrombi from a patient's vascular system.</figref><figref num="63">FIG. 63 is a detailed view of the self-expanding device of FIG. 62 taken within circle 63.</figref><figref num="64">Figure 64-67 illustrates a thrombectomy device in use to remove a thrombus from a blood vessel.</figref><figref num="65">Figure 64-67 illustrates a thrombectomy device in use to remove a thrombus from a blood vessel.</figref><figref num="66">Figure 64-67 illustrates a thrombectomy device in use to remove a thrombus from a blood vessel.</figref><figref num="67">Figure 64-67 illustrates a thrombectomy device in use to remove a thrombus from a blood vessel.</figref>
0031(Detailed explanation) As used herein, devices and methods for the treatment of vascular defects are described that are suitable for minimally invasive deployment within the patient's vascular system, particularly within the patient's cerebrovascular system. With respect to such embodiments for safe, efficient and effective deployment to the desired treatment site, some device embodiments are delivered through the inner lumen of the microcatheter, and distant thereof. It may be configured for folding into a low profile restraint state with lateral dimensions suitable for deployment from the position edge. Embodiments of these devices, once deployed to withstand dynamic forces over time in the patient's vascular system, can result in compression of the otherwise deployed device, sufficient. It is possible to maintain a clinically effective configuration with a good mechanical integrity. In order to provide the treating physician with more immediate feedback on the success of the procedure, it may be desirable that some device embodiments acutely occlude the patient's vascular defect during the course of the procedure. is there. Unless otherwise specified, one or more of the features, dimensions, or materials of the various embodiments may be used in other similar embodiments discussed herein.
0032Some embodiments are particularly useful in the treatment of cerebral aneurysms by reconstructing the vascular wall so as to completely or partially isolate the vascular defect from the patient's blood flow. Some embodiments may be configured to deploy within the vascular defect and promote remodeling, cross-linking, or both of the vascular wall to treat the vascular defect. For some of these embodiments, the permeation shell of the device may be configured to moor or anchor the permeation shell in a clinically beneficial position. For some embodiments, the device may be placed completely or partially within a vascular defect to moor or anchor the device to a vascular structure or vessel. The permeation shell isolates the vascular defect or a portion thereof from the patient's nominal vascular system to allow the defect to heal or otherwise minimize the risk of the defect to the patient's health. Therefore, it may be configured to extend to the opening, neck, or other part of the vascular defect.
0033Permeation shells or layers of one or more devices, or multiple permeation shells or layers, for some or all of the device embodiments for the treatment of the patient's vascular system discussed herein. May be configured to allow some initial perfusion of blood through a permeation shell or layer. The porosity of the permeable shell provides sufficient isolation of vascular defects to facilitate defect healing and isolation, but is exercised onto the membrane by the dynamic flow of blood or other fluid within the vascular system to the device. It may be configured to allow a sufficient initial flow through the transparent shell to reduce or otherwise minimize the mechanical force generated. For some embodiments of the device for the treatment of the patient's vascular system, only a portion of the permeation shell that extends to the opening or neck of the vascular defect, sometimes referred to as the defect area, is a thrombus in the patient's bloodstream. It needs to be transparent and / or contribute to the formation. For such embodiments, the opening of the vascular defect or that portion of the device that does not extend to the neck is substantially accompanied by pores or opening configurations that are too large to effectively promote thrombus formation. It may be opaque or completely permeable. In addition, a portion of the permeable shell that is initially permeable or translucent to the bloodstream may become substantially opaque or completely opaque due to thrombus formation on the filament of the device. .. In some cases, thrombus formation on the filaments of the permeation shell or any other part of the device may serve to reduce the pore size between the filaments or to completely close the pores of the permeation shell.
0034In general, in some cases it may be desirable to use a hollow, thin-walled device with a permeation shell of elastic material, which may be constrained to a low profile for delivery into the patient. Such devices are also radially outward when the restraint is removed so that the device shell fills in a larger volume or otherwise occludes the vascular defect in which the shell is deployed. It may be configured to extend in the orientation. The outward radial extension of the shell may serve to engage part or all of the inner surface of the vascular defect, thereby between the outer surface of the transparent shell of the device and the inner surface of the vascular defect. The mechanical friction between them efficiently anchors the device within the vascular defect. Some embodiments of such devices may also be partially or completely mechanically captured, in particular within the cavity of a vascular defect, where the defect has a narrow cervical region with a larger internal volume. .. In order to achieve low profile and low volume for delivery and to allow high expansion rate by volume, some device embodiments are still substantially regularly spaced, while allowing adaptation and capacity constraints. Includes a matrix of woven or braided filaments that are woven together by a woven structure to form a self-expanding transmission shell with stable filament connections or intercropping pore or opening patterns. ..
0035As used herein, the terms woven and braid are used interchangeably to mean any form of weaving of filaments that form a mesh structure. In the textile industry or other industries, these terms may have different or more specific meanings depending on the product or application, such as whether the article is made in sheet or cylindrical form. For the purposes of this disclosure, these terms are used interchangeably.
0036For some embodiments, three factors are very important for a textile or braided wire occlusion device for the treatment of a patient's vascular system, which can achieve the desired clinical outcome in the intravascular treatment of a cerebral aneurysm. Can be important. We have found that for effective use in some applications, the implant device has sufficient radial stiffness for stability and limited pore size for near-complete acute (in-procedural) occlusion. And found that it may be desirable to have a folding profile that is small enough to allow insertion through the medial lumen of the microcatheter. Devices with radial stiffness below a threshold can be unstable and, in some cases, at greater risk of embolization. Larger pores between filament crossings in braided or woven structures may not occlude vascular defects without forming thrombi in an acute setting, so flow disruption is complete and persistent of the vascular defect being treated. It may not give the treating physician or healthcare professional such clinical feedback that it leads to an acute obstruction. Delivery of a device for the treatment of a patient's vascular system through a standard microcatheter may be highly desirable so that access through the winding cerebrovascular system is possible in a manner that the treating physician is accustomed to.
0037For some embodiments, the use of filaments having two or more different diameters or lateral dimensions forming a transparent shell to produce the desired configuration, as discussed in more detail below. However, it can be desirable. The radial stiffness of a textile device with two filaments (two different diameters) may be expressed as a function of the number of filaments and their diameters, as follows. S<sub>radial</sub>=(1.2×10<sup>6</sup>lbf / D<sup>4</sup>) (N<sub>l</sub>dl<sup>4</sup>+ N<sub>s</sub>d<sub>s</sub><sup>4</sup>) During the ceremony, S<sub>radial</sub>Is radial stiffness in pounds force (lbf) D is the diameter (horizontal dimension) of the device N<sub>l</sub>Is the number of large filaments N<sub>s</sub>Is the number of small filaments d<sub>l</sub>Is the diameter of a large filament in inches, d<sub>s</sub>Is the diameter of a small filament in inches.
0038Using this formula, for some embodiments of specific clinical values, the radial stiffness S<sub>radial</sub>May have a force of about 0.014 to about 0.284 lbf. In some embodiments, the radial stiffness S<sub>radial</sub>May be from about 0.015 to about 0.065 lbf. Radial stiffness in some embodiments<sub>Sradial</sub>May be measured at about 50% deformation.
0039Desirable for some useful embodiments of the woven wire device for the treatment of the patient's vasculature, the maximum pore size in a part of the device extending to the neck or opening of a vascular defect is the total number of filaments, of the filaments. It may be expressed as a function of diameter and device diameter. Differences between filament sizes where two or more filament diameters or lateral dimensions are used are ignored for devices where the filament size is very small compared to the device dimensions in some cases May be done. For two filament devices, the smallest filament diameter may be used in the calculation. Therefore, the maximum pore size for such an embodiment may be expressed as follows. P<sub>max</sub>= (1.7 / N<sub>T</sub>) (ΠD- (N<sub>T</sub>d<sub>W / 2</sub>)) In the formula, P<sub>max</sub>Is the average pore size, D is the diameter (horizontal dimension) of the device N<sub>T</sub>Is the total number of filaments d<sub>W</sub>Is the diameter of the filament (minimum) in inches.
0040Using this formula, for some embodiments, the maximum pore size P of a portion of the device that extends to the opening or neck of the vascular defect, or any other suitable portion of the device.<sub>max</sub>May be less than about 0.016 inches or about 400 microns. In some embodiments, the maximum pore size for a defect area portion or any other suitable portion of the device may be less than about 0.012 inches or about 300 microns. In some embodiments, the maximum pore size relative to the vessel range portion or any other suitable portion of the device may be less than about 0.008 inches or about 200 microns.
0041The folding profile of a woven filament device with two filaments (profiles with two different filament diameters) may be expressed as a function of: P<sub>c</sub>= 1.48 ((N<sub>l</sub>d<sub>l</sub><sup>2</sup>+ N<sub>s</sub>d<sub>s</sub><sup>2</sup>))<sup>1/2</sup>In the formula, P<sub>c</sub>Is the folding profile of the device, N<sub>l</sub>Is the number of large filaments N<sub>s</sub>Is the number of small filaments d<sub>l</sub>Is the diameter of a large filament in inches, d<sub>s</sub>Is the diameter of a small filament in inches.
0042Using this formula, for some embodiments of specific clinical values, the folding profile P<sub>c</sub>May be less than about 1.0 mm. In some embodiments of a particular clinical value, the device is a factor of all three above (S) within the scope discussed above.<sub>radial</sub>, P<sub>max</sub>, And P<sub>c</sub>), That is, S of about 0.014 lbf ~ about 0.284 lbf or about 0.015 lbf ~ about 0.065 lbf<sub>radial</sub>, P less than 300 microns<sub>max</sub>, And P less than about 1.0 mm<sub>c</sub>May be constructed to have at the same time. In some such embodiments, the device may be made to include from about 70 filaments to about 300 filaments. In some cases, these filaments may have an outer lateral dimension or diameter of about 0.0004 inches to about 0.002 inches. In some cases, these filaments may have an outer lateral dimension or diameter of about 0.0005 inches to about 0.0015 inches and, as an alternative, about 0.00075 inches to about 0.00125 inches.
0043As discussed, some embodiments of devices for the treatment of a patient's vasculature are devices that approximate (or with some oversize) the dimensions of the vascular site to fill the vascular site. Request to fit the size of. It can be estimated that scaling the device to larger dimensions and using larger filaments will be sufficient for such larger embodiments of the device. However, for the treatment of cerebral aneurysms, the diameter or profile of the radially folded device is limited by the size of the catheter that can efficiently navigate within the small, winding blood vessels of the brain. In addition, since the device is made larger with a predetermined number or fixed number of elastic filaments of a given size or thickness, the pores or openings between the joints of the filaments correspond accordingly. Become bigger. In addition, for a given filament size, the flexural modulus or stiffness of the filament, and hence the structure, decreases as the dimensions of the device increase. The flexural modulus may be defined as the ratio of stress to strain. Therefore, if the strain (deflection) is lower than a predetermined force, the device can be considered to have a high flexural modulus or stiffness. Rigid devices can also be said to have low extensibility.
0044To properly configure a larger sized device for the treatment of the patient's vasculature, the device has a diameter or lateral dimension that is smaller than the nominal diameter or lateral dimension of the device in a relaxed, unrestrained state, a blood vessel or It may be useful to model the force on the device when deployed into a vascular site or defect such as an aneurysm. As discussed, in some cases it may be wise to "oversize" the device so that there is a residual force between the outer surface of the device and the inner surface of the vessel wall. The inward radial force on the device 10 due to oversize is graphically illustrated in FIG. 1, where the arrow 12 represents the inward radial force. As shown in FIG. 2, these compressive forces on filament 14 of the device of FIG. 1 are simply supported beams 16 with distributed loads or forces, as indicated by arrows 18 in the figure. , Can be modeled. From the following equations for the deflection of the beam with two simple supports 20 and the distributed load, it can be seen that the deflection is a function of length L with respect to the fourth power. Beam deflection = 5FL<sup>4</sup>/ 384EI In the formula, F = force, L = beam length, E = Young's modulus, I = moment of inertia.
0045Therefore, as the size of the device increases and L increases, extensibility increases substantially. Thus, the outward radial force exerted by the outer surface of the filament 14 of the device 10 on the binding force when inserted into a vascular site such as a blood vessel or aneurysm is a predetermined amount of compression or compression of the device. Lower for oversizing. In some applications, this force can be important to ensure the stability of the device and thus reduce the risk of device migration and the potential for distal embolization.
0046In some embodiments, the device is made with the desired radial extensibility and is small, and has a folding profile configured to fit through the medial lumen of a commonly used microcatheter, and A combination of large filament sizes may be utilized. Note that even devices manufactured with a small number of relatively large filaments 14 provide reduced radial extensibility (or increased stiffness) compared to devices all manufactured with smaller filaments. be able to. Even a relatively small number of larger filaments may provide a substantial increase in flexural rigidity due to the change in moment of inertia due to the increase in diameter without increasing the total cross-sectional area of the filaments. The moment of inertia (I) of the circular wire or filament may be defined by the following equation. I = πd<sup>4</sup>/ 64 In the formula, d is the diameter of the wire or filament.
0047Since the moment of inertia is a function of the fourth power of the filament diameter, a small change in diameter will greatly increase the moment of inertia. Therefore, small changes in filament size can have a significant effect on deflection under a given load and thus on the extensibility of the device.
0048Therefore, the stiffness can be increased by a significant amount without a large increase in the cross-sectional area of the folding profile of device 10. This can be especially important when the embodiment of the device is made large to treat a large aneurysm. Large cerebral aneurysms can be relatively rare, but they are an important treatment challenge because some occlusion devices currently available to physicians have relatively poor results compared to smaller aneurysms. Is presented.
0049Thus, some embodiments of the device for the treatment of the patient's vascular system involve several different diameters, such as two, three, four, five, or more different diameters or lateral dimensions. It may be formed using a combination of filaments 14. In device embodiments where filaments with two different diameters are used, some larger filament embodiments may have a lateral dimension of about 0.001 "to about 0.004" and some smaller filaments. Embodiments may have lateral dimensions or diameters of about 0.0004 inches and about 0.0015 inches, more specifically about 0.0004 inches to about 0.001 inches. Some structures may use filaments with lateral dimensions up to about 0.001 inch. The ratio of the number of large filaments to the number of small filaments may be about 2-12 and may be about 4-8. In some embodiments, the difference in diameter or lateral dimension between the larger and smaller filaments is less than about 0.004 inches, more specifically less than about 0.0035 inches, and even more specifically less than about 0.002 inches. May be. As generally discussed above, it is not always necessary for all wires or filaments to meet the parameters for the various relationships discussed herein. This may be especially true when a relatively large number of filaments are used in distinctly different structures. In some cases, the filamentous structure may meet the relational constraints discussed herein, where the filament dominance of the transparent shell or internal structure meets the size constraints.
0050As discussed above, embodiments of device 10 for the treatment of a patient's vasculature include multiple wires, fibers, threads, tubes, or other filaments that form a structure that acts as a permeation shell. It may contain a shape element. For some embodiments, the sphere may be formed from such filaments by connecting or fixing the ends of the tubular braided structure. For such embodiments, the density of the braided or woven structure is inherently increased at or near the end where the wire or filament 14 is attracted together, with the proximal and distal ends of the transmission shell 40 being increased. It may be reduced at or near the intermediate portion 30 located between and between 34.
0051For some embodiments, the end of the permeation shell 40 or any other suitable portion may be positioned within the opening or neck of a vascular defect such as an aneurysm for treatment. Thus, a braided or woven filament device with a permeation shell does not require the addition of a separate defect range structure that has different properties than the nominal portion of the permeation shell to achieve hemostasis and occlusion of vascular defects. Good. Such filament devices may be manufactured by braiding, weaving, or other suitable filament manufacturing techniques. Embodiments of such devices may be shaped into various three-dimensional shapes as discussed herein.
0052Reference to FIG. 3-10 shows embodiments of device 10 for the treatment of the patient's vascular system. Device 10 has a proximal end 32, a distal end 34, a longitudinal axis 46, and at least two different lateral dimensions of the large filament 48 and the small filament, as shown in more detail in FIGS. 5, 7, and 18. Includes a self-expanding elastic permeable shell 40 further comprising a plurality of eccentric elastic filaments 14, including 50. The filament 14 has a woven structure and is fixed to each other at its proximal end 60 and distal end 62. The transparent shell 40 of the device is shown in FIG. 11 with a thin woven filament 14 extending radially from the proximal end 42 to the distal end 44, adjacent to each other radially along the length of the filament. As such, it has a radially constrained extended state configured for delivery into the microcatheter 61.
0053As shown in FIG. 3-6, the permeation shell 40 also has an extended relaxed state with a spherical and longitudinally shortened configuration relative to the radial constrained state. In the expanded state, the woven filament 14 forms a self-expanding elastic transmission shell 40 in a smooth path extending radially from the longitudinal axis 46 of the device between the proximal end 32 and the distal end 34. .. The woven structure of the filament 14 includes a plurality of openings 64 of the transmission shell 40 formed between the woven filaments. For some embodiments, the largest of the openings 64 may be configured to allow blood flow through only the opening at a rate below the thrombus critical rate. The thrombus critical rate is defined by at least a few people as the time average rate at which more than 50% of the vascular graft surface is covered by the thrombus when deployed within the patient's vasculature. Slightly different thresholds may be appropriate in the context of aneurysm occlusion. Thus, a thrombotic critical rate as used herein is that blood flow into a vascular defect treated by the device is less than about 1 hour, otherwise substantially blocked during the procedure. As such, it shall include the rate at which blood clots form in or on a device, such as device 10, which is deployed within the patient's vascular system. In some cases, blockage of blood flow into a vascular defect is visualized as a sufficient amount of contrast medium is injected into the upstream of the vasculature at the patient's implantation site and dissipates from that site. It may be indicated by a minimal contrast agent that enters the vessel. Such continuous blockage of flow within less than about an hour of the implantation procedure or during the implantation procedure can also be referred to as acute obstruction of vascular defects.
0054Thus, once device 10 is deployed, blood flowing through the permeation shell may be decelerated below the thrombus critical rate, with thrombi forming on and around the opening in the permeation shell 40. Begin to. Ultimately, this process may be configured to result in an acute occlusion of a vascular defect in which device 10 is deployed. For some embodiments, at least the distal end of the permeation shell 40 is flipped so that the fixed distal end 62 of the filament 14 is axially pulled out within the expanded nominal permeation shell structure or contour. It may have a reverse bend in the configured configuration. For some embodiments, the proximal end of the transmission shell is further flipped so that the fixed proximal end 60 of the filament 14 is axially pulled out within the nominal transmission shell structure 40 in the expanded state. Including reverse bending in the configuration. As used herein, the term flipped over is accompanied by flipping, partially flipping, and / or reverse flexion, as shown in the device embodiment of Figure 3-6. May include a recessed structure. For such embodiments, the hub structures located at the ends 60 and 62 of the filament 14 of the transparent shell, or around the ends, are pulled into or below the spherical circumference of the transparent shell of the device. You may.
0055The eccentric elastic filament 14 of the transmission shell 40 is relative to each other at its proximal end 60 and distal end 62 by one or more methods, including welding, soldering, adhesive bonding, epoxy bonding, or equivalents. May be fixed. In addition to the filament ends being fixed together, the distal hub 66 may also be fixed to the distal end 62 of the filament 14 of the transmission shell 40, the proximal hub 68 being the thin of the transmission shell 40. It may be fixed to the proximal end 60 of the filament 14. The proximal hub 68 may include a cylindrical member that extends proximally beyond the proximal end 60 of the thin filament to form a cavity 70 within the proximal portion of the proximal hub 68. Proximal cavities 70 may in turn be detachably secured to a delivery device as shown in Figure 11-15, such as epoxy, solder, or any other suitable binder to secure the stretchable detachable tether 72. It may be used to hold the adhesive.
0056For some embodiments, the elongate elastic filament 14 of the transmission shell 40 may have a substantially circular cross section or may be made from a superelastic material which may be a shape memory metal. .. The shape memory metal of the filament of the transmission shell 40 may be thermoset into a relaxed, expanded spherical configuration, as shown in FIG. 3-6. Suitable elastic shape memory metals may include alloys such as NiTi alloys and equivalents. The hyperelastic properties of such alloys are that the alloy is thermoset into the indicated spherical morphology, completely constrained for delivery into the medial lumen of the microcatheter, and then deployed within the patient's body. It may be useful to provide elastic properties to the elongated filament 14 so that it can be released to substantially return to its original thermosetting shape in a spherical configuration and self-expand.
0057The device 10 may have an inverted filamentous structure with a permeation shell 40 having a proximal end 32 and a distal end 34 in an expanded relaxed state. The transparent shell 40 has a substantially closed configuration with respect to the embodiments shown. Some or all of the permeation shells 40 of device 10 substantially block or impede the flow or pressure of liquid into vascular defects over a period of time after the device has been deployed in an expanded state. Otherwise, it may be configured to isolate the vascular defect. The transparent shell 40 and device 10 also generally have an elongated tubular or cylindrical configuration that includes a proximal end 32, a distal end 34, and a longitudinal axis 46, in the radial direction of the low profile as shown in FIG. It also has a restrained state. While in a radially constrained state, the elongate flexible filament 14 of the transmission shell 40 is placed between the proximal and distal ends substantially parallel to each other and in close proximity to the sides. Substantially tubular or compression cylindrical configurations may be formed.
0058The proximal end 60 of at least some filament 14 of the transmission shell 40 may be secured to the proximal hub 68, and the distal end 62 of at least some filament 14 of the transmission shell 40 to the distal hub 66. Fixed, the proximal hub 68 and the distal hub 66 are arranged substantially concentrically with respect to the longitudinal axis 46 as shown in FIG. The ends of the filament 14 are hubs 66 and 68, respectively, by any of the methods discussed above for fixing the filament ends to each other, including the use of adhesives, solders, welds, and equivalents. It may be fixed to. The intermediate portion 30 of the permeation shell 40 may have a first lateral dimension with a low profile profile suitable for delivery from a microcatheter, as shown in FIG. Radial constraints on the device 10 may be applied by the inner surface of the inner lumen of the microcatheter, such as the distal end portion of the microcatheter 61 shown, or the device 10 is ejected from the distal end of the catheter. It may be applied by any other suitable mechanism that can be released in a controllable manner. In FIG. 11, the proximal end of device 10 or hub 68 is anchored to the distal end of extension delivery device 110 of delivery system 112, located at proximal hub 68 of device 10.
0059Embodiments of some devices 10 having a braided or woven filamentous structure include from about 10 filaments to about 300 filaments 14, and more specifically from about 10 filaments to about 100 filaments 14. More specifically, it may be formed using about 60 filaments to about 80 filaments 14. Some embodiments of the permeation shell 40 have from about 70 filaments to about 300 filaments extending from the proximal end 32 to the distal end 34, more specifically from the proximal end 32 to the distal end. It may contain from about 100 filaments to about 200 filaments extending up to 34. For some embodiments, the filament 14 may have a lateral dimension or diameter of about 0.0008 inches to about 0.004 inches. In some cases, the eccentric elastic filament 14 has an outer lateral dimension of about 0.0005 inches to about 0.005 inches, more specifically about 0.001 inches to about 0.003 inches, and in some cases about 0.0004 inches to about 0.002 inches. It may have a diameter. For some device 10 embodiments, including filaments 14 of different sizes, the large filament 48 of the transmission shell 40 may have a width or diameter of about 0.001 inches to about 0.004 inches and is small. The filament 50 may have a lateral dimension or diameter of about 0.0004 inches to about 0.0015 inches, more specifically about 0.0004 inches to about 0.001 inches. In addition, the lateral dimension or diameter difference between the small filament 50 and the large filament 48 is less than about 0.004 inches, more specifically less than about 0.0035 inches, and even more specifically about 0. It may be less than 002 inches. For embodiments of the transmission shell 40 containing filaments 14 of different sizes, the number of small filaments 50 in the transmission shell 40 relative to the number of large filaments 48 in the transmission shell 40 is about 2: 1 to about 15: 1, more specifically. May be about 2: 1 to about 12: 1, and more specifically, about 4: 1 to about 8: 1.
0060As shown in FIG. 4, the extended relaxed state of the permeation shell 40 is axial with respect to the constrained state so that the proximal hub 68 is located closer to the distal hub 66 than it is in the constrained state. It has a shortened configuration. Both hubs 66 and 68 are located substantially coaxially with the longitudinal axis 46 of the device, with each filament element 14 between the proximal and distal hubs 66 and 68 with reverse flexion at each end. Form a smooth arc. For some embodiments, the longitudinal spacing between the proximal and distal hubs 66 and 68 of the transparent shell 40 in the deployed relaxed state is the proximal and distal hubs 66 and 68 in a constrained cylindrical state. It may be about 25% to about 75% of the longitudinal spacing between 68. The arc of filament 14 between the proximal and distal ends 32 and 34 is configured such that the middle portion of each filament 14 has a second lateral dimension that is substantially larger than the first lateral dimension. May be good.
0061For some embodiments, the transmissive shell 40 has a first lateral dimension of about 0.2 mm to about 2 mm in a folded radial constraint and a second in a relaxed extended state of about 4 mm to about 30 mm. May have a lateral dimension of. For some embodiments, the second lateral dimension of the transparent shell 40 in the expanded state is about 2 to about 150 times the first lateral dimension, more specifically about the first or constrained lateral dimension. It may be 10 times to about 25 times. The longitudinal spacing between the proximal end 32 and the distal end 34 of the transparent shell 40 in the relaxed and dilated state is the distance between the proximal end 32 and the distal end 34 in the constrained cylindrical state. It may be about 25% to about 75%. For some embodiments, the main lateral dimensions of the relaxed and expanded transmission shell 40 are from about 4 mm to about 30 mm, more specifically from about 9 mm to about 15 mm, and even more specifically from about 4 mm to. It may be about 8 mm.
0062The arcuate portion of filament 14 of the transmission shell 40 is sinusoidal with a first or outer radius 88 and a second or inner radius 90 near the end of the transmission shell 40, as shown in FIG. It may have a similar shape. This sinusoidal or multi-curved shape may provide a recess in the proximal end 32 that may reduce flow closure in the parent vessel adjacent to the vascular defect. For some embodiments, the first radius 88 and the second radius 90 of the transmission shell 40 may be from about 0.12 mm to about 3 mm. For some embodiments, the distance between the proximal end 32 and the distal end 34 may be less than about 60% of the overall length of the transparent shell 40 for some embodiments. Such a configuration may allow the distal end 34 to bend downwards towards the proximal end 32 when the device 10 is resisted at the distal end 34, thus adapting in the longitudinal direction. May be provided. In some embodiments, the filament 14 may be formed so that there are no non-curved portions over distances greater than about 2 mm. Therefore, for some embodiments, each filament 14 may have a substantially continuous curvature. This substantially continuous curvature may provide smooth deployment and may reduce the risk of vascular perforation. For some embodiments, one of the ends 32 or 34 is retracted or flipped to a greater extent than the other so that it is longitudinally or axially adapted from the other end. May be good.
0063For some embodiments, the first radius 88 and the second radius 90 of the transmission shell 40 may be from about 0.12 mm to about 3 mm. For some embodiments, the distance between the proximal end 32 and the distal end 34 may be greater than about 60% of the overall length of the extended transmission shell 40. Therefore, the maximum longitudinal distance between the inner surfaces may be about 60% to about 90% of the longitudinal length of the outer surface or the overall length of the device 10. The gap between hubs 66 and 68 at the proximal end 32 and the distal end 34 allows the distal hub 66 to bend downward toward the proximal hub 68 when device 10 receives resistance at the distal end. It may be possible and therefore provides longitudinal adaptation. The filament 14 may be molded so that there are no non-curved portions over distances greater than about 2 mm. Therefore, for some embodiments, each filament 14 may have a substantially continuous curvature. This substantially continuous curvature may provide smooth deployment and may reduce the risk of vascular perforation. The distal end 34 is retracted or flipped to a degree greater than the proximal end 32 so that the distal end portion of the permeation shell 40 may be more radially adaptable than the proximal end portion. You may. The adaptability of the distal end portion may provide a better device match for irregularly shaped aneurysms or other vascular defects. The convex surface of the device may form a concave surface and bend inward to adapt to the curvature of the vessel site.
0064FIG. 10 shows an enlarged view of the filament 14 placed within the proximal hub 68 of device 10 with two different sized filaments 14 constrained by the outer ring of the proximal hub 68 and tightly packed. The tether member 72 may optionally be located in the middle portion of the filament 14 or in the cavity 70 of the proximal hub 68 located proximal to the proximal end 60 of the filament 14 as shown in FIG. .. The distal end of the tether 72 is at a knot 92 formed at the distal end thereof, which is mechanically captured within the cavity 70 of the proximal hub 68 formed by the proximal shoulder portion 94 of the proximal hub 68. It may be fixed. The distal end 92 of the knot of the tether 72 can also optionally be mechanically compressed, adhesively bonded, welded, soldered, brazed, or equivalent by bonding or potting the distal end of the tether 72 within the cavity 70. It may be fixed between the proximal ends 60 of the filament 14 in use. The tether 72 embodiment shown in FIG. 6 has a knot distal end 92 that is glued into the cavity of the proximal hub 68. Such a tether 72 may be part of the delivery device 110 used to deploy device 10, as shown in FIGS. 11 and 23-26, which can be soluble, cleaved, or releaseable. It may be a tether. FIG. 10 is also placed and constrained within the proximal hub 68, which may be configured to anchor large and small filaments 48 and 50 in place with respect to each other within the outer ring of the proximal hub 68. Also shown are large filament 48 and small filament 50.
0065Figures 7 and 8 illustrate some configuration embodiments of the braided filament 14 of the permeation shell 40 of device 10 for the treatment of the patient's vascular system. The braided structure of each embodiment is shown with a circular shape 100 in contact with each adjacent filament segment, along with a circular shape 100 arranged within the pores 64 of the woven or braided structure. The pore opening size may be at least partially determined by the size of the braided filament elements 14, the formation of angle-overlapping filaments relative to each other, and the number of drives per inch of the braided structure. For some embodiments, the cell or opening 64 may have an elongated, substantially rhombic shape, as shown in FIG. 7, and the pores or openings 64 of the permeation shell 40 are shown in the figure. As shown in 8, it may have a substantially more square shape towards the middle portion 30 of the device 10. The diamond-shaped pores or openings 64 may have a length substantially greater than the width in particular near the hubs 66 and 68. In some embodiments, the ratio of the length of the diamond-shaped pores or openings to the width may exceed the 3: 1 ratio for some cells. The diamond opening 64 may have a length greater than the width and therefore has an aspect ratio defined as a length / width greater than 1. The openings 64 in the vicinity of the hubs 66 and 68 may have a substantially larger aspect ratio than those farther from the hub as shown in FIG. The aspect ratio of the opening 64 adjacent to the hub may be greater than about 4: 1. The aspect ratio of the opening 64 near the maximum diameter may be from about 0.75 to 1 to about 2: 1 for some embodiments. For some embodiments, the aspect ratio of the openings 64 in the transmissive shell 40 may be from about 0.5: 1 to about 2: 1.
0066The pore size defined by the maximum circular shape 100, which can be placed within the opening 64 of the braided structure of the transmission shell 40 without displacement or distortion of the filament 14 surrounding the opening 64, is in some embodiments. With respect to, it may range in size from about 0.005 inch to about 0.01 inch, more specifically from about 0.006 inch to about 0.009 inch, and even more specifically from about 0.007 inch to about 0.008 inch. In addition, at least some of the openings 64 formed between the adjacent filaments 14 of the permeation shell 40 of the device 10 allow blood flow through only the openings 64 only at rates below the thrombus critical rate. It may be configured to allow. For some embodiments, the maximum opening 64 in the permeation shell structure 40 may be configured to allow blood flow through only the opening 64 only at rates below the thrombus critical rate. As discussed above, the pore size may be less than about 0.016 inches, more specifically less than about 0.012 inches, for some embodiments. For some embodiments, the openings 64 formed between adjacent filaments 14 may be from about 0.005 inches to about 0.04 inches.
0067With reference to FIGS. 12-15, an embodiment of the delivery device 110 of the delivery system 112 of FIG. 11 is shown in more detail. Device 110 includes an extension core wire 114 extending from the proximal end 116 of device 110 to the distal portion 118 of device 110, as shown in FIG. The core wire 114 provides sufficient strut strength to push the restrained device 10 for the treatment of the patient's vasculature through the inner lumen 120 of the microcatheter 61 of the delivery system 112, as shown in FIG. It is configured to do. The core wire 114 also has sufficient tensile strength to pull out or retract the device 10 axially from a position outside the microcatheter 61 and within the medial lumen 120 of the microcatheter 61. A tether 72 extending proximally from the proximal hub 68 is placed on a portion of the tether 72 and the distal section of the core wire 114 and is a contractible tube of length that is contracted on both as shown in FIG. Although fixed to the distal end of the core wire 114 using class 122, any other suitable fixing means may be used.
0068The heating coil 124, which is electrically connected to the first conductor 126 and the second conductor 128, is located on the most distal portion of the tether 72. The heating coil 124 also acts as a heat shield, minimizing heat leakage from the heating coil 124 into the environment, such as the patient's blood flow, around the delivery device 110. It may be covered with a predetermined length of polymer tubing 130 placed on the heating coil 124 distal to the tubing 122. Once the heat shrink tubing 122 and the insulating polymer tubing 130 were secured to the distal portion 118 of the device 110, the proximal portion of the tether 72 located proximal to the heat shrink tubing 122 is shown in FIG. It may be cut out as shown in. An overcoil 132 extending from the distal end 134 of the delivery device 110 to the proximal section 136 of the device 110 then extends over the heating coil 124, core wire 114, tether 72, first conductor 126, and second conductor 128. These elements may be placed together to create a low friction outer surface and maintain the desired flexibility of the delivery device 110. The proximal compartments 136 of the device 110 are arranged circumferentially around the proximal compartment 136 of the core wire 114 and are insulated from it, the first conductor 126 and the second conductor, respectively, as shown in FIG. Includes the proximal end of the overcoil 132 located distal to the first contact 138 and the second contact 140, which is electrically connected to 128.
0069The heating coil 124 is a current supplied through the first conductor 126 and the second conductor 128 from the electrical energy source 142 connected to the first contact 138 and the second contact 140 in the proximal section 136 of the device 110. May be configured to accept. The current passed through the heating coil 124 heats the heater coil to a temperature above the melting point of the tether material 72 so that it melts the tether 72 and cuts it when the device 10 is deployed.
0070Embodiments of the delivery device 110 may generally have a length greater than the overall length of the microcatheter 61 used in the delivery system 112. This relationship allows delivery while having sufficient length to extend from the proximal end 150 of the microcatheter 61, as shown in FIG. 17, discussed below, to allow its manipulation by the physician. The device 110 can extend from the distal port of the medial lumen 120 of the microcatheter 61 along the device 10 anchored to its distal end. For some embodiments, the length of the delivery device 110 may be from about 170 cm to about 200 cm. The core wire 114 may be made from any suitable high strength material such as stainless steel, NiTi alloy, or equivalent. Embodiments of core wire 114 may have an outer diameter or lateral dimension of about 0.010 inches to about 0.015 inches. The overcoil 132 may have an outer diameter or lateral dimension of about 0.018 inches to about 0.03 inches. The embodiment of device 110 shown in FIG. 12-15 is activated by electrical energy passed through a pair of conductors, but remotely heats a distal heating member or element, such as the heating coil 124, of the tether 72. Similar configurations or any other suitable arrangement can be used to utilize the light energy passed through the optical fiber to cut the distal portion. In addition, other delivery device embodiments that may be used in any of the ten embodiments of the device for the treatment of the patient's vascular system discussed herein are discussed herein. Be incorporated.
0071Other delivery and positioning system embodiments may provide the ability to rotate the device for treatment within the body of the patient's vascular system without transmitting torque along the entire length of the delivery device. Several embodiments for delivery and positioning of device 10 are described in Co-owned International Application No. PCT / US 2008/065694, which is incorporated as a whole by reference. The delivery and positioning device may include a distal rotating member that allows rotational positioning of the device. The delivery and positioning device may include a distal rotating member that rotates the implant within the body without transmitting torque along the entire length of the device. Optionally, the delivery system may also rotate the implant without the transfer of torque within the intermediate portion between the proximal and distal rotatable ends. The delivery and positioning device may be releasably secured to any suitable portion of the device for treatment of the patient's vascular system.
0072The device embodiments discussed herein may be free from any suitable flexible extension delivery device or actuator, such as a guidewire or guidewire-like structure. Release of embodiment of the device from such a delivery device is any other known in the technique of thermal mechanism, electrolytic mechanism, hydraulic mechanism, shape memory material mechanism, or intravascular implant deployment as discussed above. It may be activated by the mechanism of.
0073Embodiments for the deployment and release of treatment devices, such as the deployment of embolic devices or stents within the patient's vasculature, are such via an openable connection to the distal portion of an indenter or other delivery device member. It may include the step of connecting such a device. The treatment device 10 may be detachably mounted on the distal portion of the device by a filament tether 72, string, thread, wire, suture, fiber, or equivalent, which may be referred to herein as a tether. .. The tether 72 may be in the form of a monofilament, rod, ribbon, hollow tube, or equivalent. Some embodiments of the tether may have a diameter or maximum thickness of about 0.05 mm to 0.2 mm. The tether 72 may be configured to withstand a maximum tensile load of about 0.5 kg to 5 kg. For some embodiments, some known detachable devices are discussed herein due to the mass of the deployed device 10, which can be substantially larger than some embolic devices. There may be insufficient tensile strength to be used in some embodiments. Therefore, it may be desirable to use small ultra-high strength fibers for some tether embodiments that have a "breaking load" greater than about 15 Newtons. For some embodiments, tethers made from a material known as Dyneema Purity commercially available from Royal DSM (Heerlen, Netherlands) may be used.
0074The tether 72 may be cut off by the input of energy, such as an electric current, to the heating element that causes the release of the treatment device. For some embodiments, the heating element may be a coil of wire with high electrical resistivity, such as a platinum-tungsten alloy. The tether member may pass through the heating element or be positioned adjacent to the heating element. The heater may be substantially constrained within the distal portion of the delivery device to provide insulation to reduce the potential for thermal damage to surrounding tissue during attachment and detachment. In another embodiment, the current may pass through a tether that also functions as a heating element.
0075Many materials may be used to make embodiments of tether 72, including polymers, metals, and composites thereof. One class of materials that may be useful for tethers are polyolefin elastomers such as polyolefins, polyethylene, block copolymers such as polyester (PET), polyamide (nylon), polyurethane, polypropylene, PEBAX or Hytrel, and ethylene vinyl alcohol ( It contains polymers such as EVA) or rubbery substances such as silicone, latex, and Kraton. In some cases, the polymer may also be crosslinked using radiation to manipulate its tensile strength and melting temperature. Another class of materials that may be used in tether embodiments may include metals such as nickel-titanium alloys (nitinol), gold, platinum, tantalum, and steel. Other materials that may be useful for tether construction may provide high performance properties and include fully aromatic polyester polymers, which are highly inert liquid crystal polymers (LCPs). The commercially available LCP polymer is Kuraray Co., Ltd. (Tokyo, It is a Vectran generated by Japan). The choice of material may depend on the melting or softening temperature, the power used for attachment and detachment, and the treatment site of the body. The tether may be joined to the implant and / or pusher by crimping, welding, thread knotting, soldering, adhesive bonding, or other means known in the art.
0076Also, many variations of filament and proximal hub construction as detailed above with respect to FIG. 10 may be used in useful embodiments of device 10 for the treatment of the patient's vascular system. Please also note. FIG. 16 shows an enlarged view of the cross section of the proximal hub configuration. In the embodiments shown, the filament 14 is constrained by the outer ring of the proximal hub 68 and is located within the proximal hub 68 or end portion of the device 10 with the tightly packed filament 14. The tether member 72 may be located in the middle portion of the filament 14 or in the cavity of the proximal hub 68 located proximal to the proximal end 60 of the filament 14. Such a tether 72 may be a meltable, cuttable, or releaseable tether that may be part of a release device as discussed above, which is used to deploy the device.
0077FIG. 16 illustrates a cross-sectional view of an embodiment of the proximal hub 68 showing a configuration of filaments that are tightly packed by the inner surface of the proximal hub 68 and can be constrained in the radial direction. In some embodiments, the braided or woven structure of the transmission shell 40 formed from such filament 14 may be constructed using a large number of small filaments. The number of filaments 14 may be greater than 125 and may be from about 80 filaments to about 180 filaments. As discussed above, the total number of filaments 14 for some embodiments is from about 70 filaments to about 300 filaments, more specifically from about 100 filaments to about 200 filaments. There may be. In some embodiments, the braided structure of the transparent shell 40 may be constructed in two or more sizes of filament 14. For example, the structure has some larger filaments that provide structural support and some smaller filaments that provide the desired pore size and density, and thus, in some cases, thrombus criticality. It may have a flow resistance to achieve speed. For some embodiments, the small filament 50 of the transmission shell 40 has a lateral dimension or diameter of about 0.0006 inches to about 0.002 inches for some embodiments and about 0.0004 inches to about 0.001 inches for other embodiments. You may. The large filament 48 may have a lateral dimension or diameter of about 0.0015 inches to about 0.004 inches in some embodiments and about 0.001 inches to about 0.004 inches in other embodiments. Filament 14 is braided in a plain weave with alternating top and bottom structures (shown in Figures 7 and 8) or ancillary weaves, one by one, with more than one warp interwoven with one or more wefts. You may. The pick count may vary between approximately 25 picks and 200 picks (PPI) per inch.
0078For some embodiments, the permeable shell 40 or portion thereof may be porous or highly permeable to liquids. Typically 2,000 ml / min / cm when measured at a pressure of 120 mmHg<sup>2</sup>In contrast to most vascular prosthetic fabrics or grafts, which have a water permeability below, the permeation shell 40 of some embodiments discussed herein is approximately 2,000 ml / min / cm.<sup>2</sup>Larger, in some cases about 2,500 ml / min / cm<sup>2</sup>May have a greater water permeability. For some embodiments, the water permeability of the permeation shell 40 or its portion is approximately 2,000 ml / min / cm when measured at a pressure of 120 mmHg.<sup>2</sup>~ 10,000ml / min / cm<sup>2</sup>, More specifically, about 2,000 ml / min / cm<sup>2</sup>~ Approximately 15,000 ml / min / cm<sup>2</sup>It may be.
0079Embodiments of the device and its components may include metals, polymers, biomaterials, and composites thereof. Suitable metals include zirconium-based alloys, cobalt-chromium alloys, nickel-titanium alloys, platinum, tantalum, stainless steel, titanium, gold, and tungsten. Potentially suitable polymers are acrylic resin, silk, silicone, polyvinyl alcohol, polypropylene, polyvinyl alcohol, polyester (eg polyethylene terephthalate or PET), polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), Polyvinyl Polyurethane (PCU), and but not limited to polyurethane (PU). Embodiments of the device may include materials that are degraded or absorbed or eroded by the body. Bioabsorbable (eg, degraded and absorbed by cells, tissues, or other mechanisms in the body) or bioabsorbable (similar to bioreabsorbable) materials may be used. Alternatively, it is bioerodible (eg, eroded or degraded over time by contact with surrounding tissue fluid by cell activity or other physiological degradation mechanisms), biodegradable (eg, enzymes or water in the body). Decomposition over time, or by other mechanisms), or soluble materials may be employed. Each of these terms is interpreted as interchangeable. Bioabsorbable polymer. Potentially suitable bioabsorbable materials are poly (α-hydroxy acid) such as polylactic acid (PLA), poly-L-lactide (PLLA), poly-D-lactide (PDLA), polyglycolic acid (PGA). , Polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymer, modified cellulose, collagen, poly (hydroxybutyric acid), polyacid anhydride, polyphosphate ester, poly (amino acid), or related copolymer material including. Absorbent composite fibers are about 18% with a matrix material consisting of a mixture of the above copolymers with about 20% polycaprolactone (PCL).
0080In any of the preferred device 10 embodiments discussed herein, the permeation shell structure 40, one or the other, facilitates immobilization of the device within a blood vessel or other vascular site. May include more immobilization elements or surfaces. Immobilization elements may include hooks, hooks, protrusions, pores, microfeatures, patterns, bioadhesives, or combinations thereof. Embodiments of the support structure may be manufactured from a metal tube from which a plurality of parts are removed. Material removal may be done by laser, electric discharge machine (EDM), photochemical etching, and conventional mechanical techniques. In any of the embodiments described, the support structure is constructed of multiple wires, cut from a sheet of material, or etched, cut from a tube, or cut from a tube, as in the technique of vascular stent manufacturing. It may be etched or a combination thereof.
0081Embodiments of the transparent shell 40 may be formed from wires, ribbons, or other filament elements 14, at least in part. These filamentous elements 14 may have a circular, oval, oval, square, rectangular, or triangular cross section. Embodiments of the transmission shell 40 may also be formed using conventional machining, laser cutting, electrical discharge machining (EDM), or photochemical machining (PCM). If made of metal, it may be formed from either a metal tube or a sheet material. The permeation shell embodiment 40 may be thermoformed to maintain their shape. In some embodiments, this may be done at a temperature of about 500 ° C.
0082Embodiment 10 of the device discussed herein is delivered and deployed from a delivery and positioning system 112 that includes a microcatheter 61, such as a microcatheter 61 of a type known in neurovascular progression determination and treatment techniques. May be done. Embodiment 10 of the device for the treatment of the patient's vasculature is elastically folded and constrained by a tube such as the medial lumen 120 of the microcatheter 61 or other radial constraint for delivery and deployment. You may. The microcatheter 61 may generally be inserted through a small incision 152 that accesses peripheral vessels such as the femoral or brachial artery. The microcatheter 61 is delivered from a location outside the patient's body 156 to the desired treatment site 154 under fluorescence fluoroscopy or by other suitable leading method, or otherwise. You may proceed. The guide wire 159 is optionally removed during such a procedure to allow insertion of the device 10, which is secured to the delivery device 110 of the delivery system 112 through the medial lumen 120 of the microcatheter 61. You may. FIG. 17 illustrates a schematic of patient 158 undergoing treatment for vascular defect 160 as shown in FIG. The access sheath 162 is shown placed either within the radial artery 164 or the femoral artery 166 of patient 158, with a delivery system 112 including a microcatheter 61 and a delivery device 110 placed within the access sheath 162. ing. The delivery system 112 is shown extending distally into the vascular system of the patient's brain, adjacent to the vascular defect 160 in the patient's brain.
0083Access to various vessels of the patient may be established to achieve percutaneous access to the vascular defect 160, including arteries such as the femoral artery 166, the radial artery 164, and the equivalent. In general, patient 158 is prepared for surgery, access arteries are exposed via a small surgical incision 152, and access to the lumen is provided by a dilator or a series of dilators on the blood vessels. Acquired using a Seldinger, where the introduction needle is used to place the wire that expands and allows the introduction sheath 162 to be inserted into the blood vessel. This allows the device to be used percutaneously. Along with the in-situ introduction sheath 162, the guide catheter 168 is then used to provide a safe passage from the entry site to the area near the target site 154 to be treated. For example, when treating a site in the human brain, from the invasion site 152 of the femoral artery, through the aortic arch, through the aorta extending around the heart, and up, and in the aorta, such as the carotid artery 170. A guide catheter 168, which can extend downstream through one of the arteries extending from above, may be selected. Typically, the guidewire 159 and the neurovascular microcatheter 61 are then placed through the induction catheter 168, with the distal end 151 of the microcatheter 61 adjacent to or in a target vascular defect 160 such as an aneurysm. It is advanced through the patient's vascular system until it is placed in. Exemplary guidewires 159 for neurovascular use include Synchro2®, manufactured by Boston Scientific, and Glidewire Gold Neuro®, manufactured by MicroVention Terumo. Typical guide wire sizes are 0.014 inches and 0. 018 inches may be included. Once the distal end 151 of the catheter 61 is positioned at the site by placing its distal end, usually through the use of radiopaque marker material and fluorescence fluoroscopy, the catheter is cleared. .. For example, if the guide wire 159 is used to position the microcatheter 61, it is withdrawn from the catheter 61 and then the implant delivery device 110 is advanced through the microcatheter 61.
0084Delivery and deployment of the embodiment of device 10 discussed herein is performed by first compressing device 10 into a radially constrained longitudinally flexible state, as shown in FIG. May be done. The device 10 is then delivered to the desired treatment site 154 while being placed within the microcatheter 61 and then ejected from the distal end 151 of the microcatheter 61 or otherwise deployed. May be good. In other embodiments of the method, the microcatheter 61 may first be advanced to the desired treatment site 154 on the guide wire 159 or by other suitable progression determination techniques. The distal end of the microcatheter 61 is positioned so that the distal port of the microcatheter 61 is directed towards or inside the vascular defect 160 to be treated and the guide wire 159 is pulled out. May be good. The device 10 anchored to a suitable delivery device 110 is then radially constrained, inserted into the proximal portion of the medial lumen 120 of the microcatheter 61, and distant through the medial lumen 120 to the vascular defect 160. You may be advanced to the position.
0085Once placed within the vascular defect 160, the device 10 is then in an extended relaxed state or with a permeation shell 40 of the device that spans or extends a portion of the vascular defect 160 or the entire vascular defect 160. Partial relaxation may be allowed. For some embodiments, the device 10 may be activated by application of an energy source to form an expanded deployment configuration once ejected from the distal section of the microcatheter 61. Once the device 10 is deployed at the desired treatment site 154, the microcatheter 61 may then be withdrawn.
0086Some embodiments of the device 10 for the treatment of a patient's vascular system discussed herein may be intended for the treatment of a vascular defect in a particular type of patient. For example, with reference to FIG. 18, an aneurysm 160, commonly referred to as a terminal aneurysm, is shown in cross section. A terminal aneurysm typically branches within the patient's vasculature, where blood flow from the supply vessel, indicated by arrow 172, splits into two or more branched vessels directed away from each other. Occurs in. The mainstream of blood from the supply vessel 174, such as the basilar artery, sometimes collides with the vessel at the point where the vessel branches, forming an aneurysm sac. The terminal aneurysm may have a well-defined cervical structure in which the profile of the aneurysm 160 narrows adjacent to the nominal vascular profile, but other terminal aneurysm embodiments are less defined. It may have an unexposed cervical structure or may have no cervical structure. FIG. 19 cross-sectionally illustrates a typical intracranial aneurysm 160 in which a portion of the wall of the nominal vascular segment weakens and expands into a saccular structure that swells away from the surface and profile of the nominal vessel. Some intracranial aneurysms may have a well-defined cervical structure, as shown in FIG. 19, while others may have a less defined cervical structure. , Or either structure may not be present. FIG. 19 also shows some optional procedures in which a stent 173 or other type of support is placed in a parent vessel 174 adjacent to an aneurysm. Also shown is the embolic material 176, which is placed into the aneurysm 160 through the microcatheter 61. One or both of the stent 173 and the occlusion material 176 may be so deployed either before or after the deployment of the device 10 for the treatment of the patient's vascular system.
0087Prior to delivery and deployment of the device 10 for the treatment of the patient's vascular system, it may be desirable for the treating physician to select the device 10 of the appropriate size to optimize the treatment outcome. Some embodiments of the procedure include a step of estimating the volume of the vessel site or defect 160 to be treated, and a volume of substantially the same or slightly larger size relative to the volume of the vessel site or defect 160. It may include the accompanying step of selecting device 10. The volume of the vascular defect 160 to be occluded may be determined using 3D angiography or other similar imaging techniques, along with software that calculates the volume of the selected area. The amount of oversize may be about 2% to 15% of the measured volume. In some embodiments, such as a highly irregularly shaped aneurysm, it may be desirable to have a substandard volume of device 10. A lobule or "daughter aneurysm" may be excluded from the volume and defines a truncated volume that can only be partially filled by the device without affecting outcome. Embodiments of such a method also include implanting or deploying the device 10 such that the vascular defect 160 is substantially filled in volume by the device and the combination of blood contained therein. It may be. Device 10 adapts to irregularly shaped vascular defects 160 such that at least about 75%, and in some cases about 80%, of the vascular defect volume is occluded by the device 10 and the combination of blood contained therein. It may be configured to be sufficiently submissive.
0088Specifically, for some treatment embodiments, the device 10 is properly oversized in lateral dimensions to achieve the desired adaptability, radial force, and fit after deployment of the device 10. Can be desirable. Figure 20-22 shows that the lateral dimension is initially oversized by at least about 10% of the maximum lateral dimension of the vascular defect 160, and sometimes by up to about 100% of the maximum lateral dimension, for proper mating after deployment. , A schematic diagram of how the device 10 may be selected is illustrated. For some embodiments, device 10 is considered to be a small amount (eg, less than about 1.5 mm) oversized in relation to the dimensions measured relative to the width, height, or neck diameter of the vascular defect 160. May be good.
0089FIG. 20 shows a vascular defect 160 in the form of a cerebral aneurysm, with horizontal and vertical arrows 182 indicating the nearly maximum internal dimensions of the defect 160. A horizontally extending arrow 180 indicates the maximum lateral dimension of the defect 160. In FIG. 21, the dashed contour 184 of the device for the treatment of vascular defect 10 is shown superimposed on vascular defect 160 in FIG. 20 and selected so that the lateral dimension is approximately 20% oversized. Illustrates what the device 10 looks like in its unrestrained relaxed state. FIG. 22 illustrates how device 10, indicated by dashed line 184 in FIG. 21, can adapt to the inner surface of vascular defect 160 after deployment, thereby nominally in a relaxed, unrestrained state. The lateral dimension is slightly constrained by the medial radial force 185 exerted on the device 10 by the vascular defect 160. Correspondingly, the filament 14 of device 10, and thus the transmission shell 40 made from it, has a constant length, so that device 10 is elongated and defective 160, as indicated by the down arrow 186 in FIG. It has a slightly elongated shape on the axis or longitudinal axis of the device 10 to better fill the internal capacitance of the device 10.
0090Once the device 10 of the appropriate size is selected, the delivery and deployment process may then proceed. Also, the characteristics of the embodiment of device 10 and the embodiment of delivery system 112 discussed herein are generally after initial deployment into defect 160, but before attachment and detachment of device 10. It should also be noted that it allows for retreat. Therefore, after fitting within the defect 160, the device 10 of a different size is evaluated as preferable, and it is possible and desirable that the device 10 initially deployed can be pulled out or recovered. An example of a terminal aneurysm 160 is shown in cross section in FIG. The tip 151 of a catheter, such as the microcatheter 61, may be advanced into or adjacent to a vascular site or defect 160 (eg, an aneurysm), as shown in FIG. For some embodiments, the aneurysm is such that the embolic coil or other vascular occlusion device or material 176 (eg, as shown in FIG. 19) optionally provides a framework for receiving the device 10. It may be placed within 160. In addition, stent 173 removes the aneurysm neck before or during delivery of a device for the treatment of the patient's vascular system discussed herein (eg, also as shown in FIG. 19). It may be placed within the parent vessel 174 of some aneurysms substantially across. An example of a suitable microcatheter 61 with an inner lumen diameter of about 0.020 "to about 0.022" is Rapid Transit® manufactured by Cordis Corporation. Some examples of suitable microcatheter 61 are approximately 0.026 inches, such as Reber® from Ev3 Company, Renegade Hi-Flow® from Boston Scientific Corporation, and Mass Transit® from Cordis Corporation. ~ About 0. It may include a microcatheter with an inner lumen diameter of 028 inches. Suitable microcatheter with an inner lumen diameter of about 0.031 inch to about 0.033 inch may include Marksmen® from Chestnut Medical Technologies, Inc., and Vasco® from Bait Extrusion. Suitable microcatheter 61 with an inner lumen diameter of about 0.039 inch to about 0.041 inch includes Vasco 35 from Balt Extrusion. These microcatheter 61s are listed only as exemplary embodiments, and other suitable microcatheter may also be used with any of the embodiments discussed herein.
0091The attachment / detachment of the device 10 from the delivery device 110 disconnects the tether 72 that secures the proximal hub 68 of the device 10 to the delivery device 110, and may also be coupled to the energy source 142, the proximal end of the delivery system 112. It may be controlled by a control switch 188 arranged in. As shown in FIG. 11, while placed within the microcatheter 61 or other suitable delivery system 112, the filament 14 of the permeation shell 40 is non-extended and substantially parallel to each other and the longitudinal axis of the catheter 61. An inverted configuration may be formed. Once the device 10 is pushed out of the distal port of the microcatheter 61 or the radial constraint is removed otherwise, the distal end 62 of the filament 14 is then vascularized, as shown in FIG. They may be in axial contact with each other to form a spherically inverted configuration within the defect 160.
0092The device 10 may be inserted through the microcatheter 61 such that the catheter lumen 120 constrains the radial expansion of the device 10 during delivery. Once the distal tip or deployment port of the delivery system 112 is positioned adjacent to or at the desired location within the vascular defect 160, the device 10 is deployed out of the distal end of the catheter 61. It may therefore allow the device to begin to expand radially as shown in FIG. When the device 10 emerges from the distal end of the delivery system 112, the device 10 expands to a dilated state within the vascular defect 160, but may be at least partially constrained by the inner surface of the vascular defect 160.
0093Upon full deployment, the radial expansion of device 10 is to at least partially isolate the vascular defect 160 from the flow, pressure, or both of the patient's vascular system adjacent to the vascular defect 160, as shown in FIG. In addition, the device 10 may serve to be immobilized within the vascular defect 160 and to deploy a permeation shell 40 across at least a portion of the opening 190 (eg, aneurysm neck). Adaptation of device 10, especially within the cervical region 190, may provide improved sealing.
0094For some embodiments, once deployed, the permeation shell 40 can substantially slow the flow of fluid and impede the flow into the vascular site, and therefore the pressure within the vascular defect 160. To reduce. For some embodiments, the device 10 may be substantially implanted within the vascular defect 160, however, in some embodiments, a portion of the device 10 may be in the defect opening or neck 190 or It may extend into bifurcated vessels.
0095Once device 10 is deployed within a vascular defect, defect isolation, flow deceleration, decompression, or any combination of these effects can occur within the internal volume of device 10, outside of device 10, or the device itself. Or on some component thereof, it can cause thrombus formation. In some cases, embodiments of the device 10 for the treatment of the patient's vasculature generally braid a substantially tubular braided structure with filamentous elements 14 to form the braided tubular structure into the desired shape. It may be produced by thermosetting the braided filament to a desired shape. Once so formed, the ends of the elongate elastic filament 14 are then relative to each other by any of the methods discussed above, as well as by the added proximal and distal hubs 66 and 68. Both may be fixed.
0096Such a braiding process may be performed by automatic machine manufacturing or may be performed manually. An embodiment of the process for braiding a tubular braid structure by a manual process is shown in FIG. The plurality of stretch elastic filaments 14 are fixed at one end of the stretch cylindrical braided mandrel 202 by a restraint band 204. The band 204 may include any suitable structure, such as a band of adhesive tape, a rubber band, an annular clamp, or an equivalent, in which the end of the filament 14 is secured to the mandrel 202. The loose end of the filament 14 on the opposite side of the fixed end is a braid or as indicated by arrow 206 to achieve a one-by-one alternating braid pattern for the formation of the braided tubular member 208. Manipulated with a woven pattern. As discussed above, simple braided patterns that alternate up and down one by one are shown and discussed, but other braided or woven patterns may also be used. One such embodiment of another braided configuration may include a pattern in which two are on top and one is on the bottom. FIG. 28 illustrates a braided tubular member 208 that forms and lengthens as the braiding process continues, as indicated by arrow 206 in FIG. Once the braided tubular member 208 has achieved sufficient length, it may be removed from the braided mandrel 202 and positioned within the molding fixture, such as in the molding fixture embodiments shown in FIGS. 29 and 30.
0097FIG. 29 shows a tubular braided member 208 disposed on an internal rod mandrel 210 extending through the central lumen of the internal ball mandrel 212 and a pair of opposed recessed end shaped mandrel 214s. The tubular braid member 208 is also placed on the outer surface of the inner ball mandrel 212 and also within the respective inner lumen of the end forming mandrel 214. In order to hold the braided tubular member 208 on the outer contour of the inner ball mandrel 212, including its recessed end 216, the inner surface of the braided tubular member 208 is held relative to the outer contour of the inner ball mandrel 212. The end forming mandrel 214 is configured to be pressed against and pushed into the recessed end 216 of the internal ball mandrel 212 so that it is fixed in place. The entire fixture 220 with the inner surface of the braided tubular structure 208 held against the outer surface of the inner ball mandrel 212 is then the elastic filament 14 of the braided tubular member 208 forming the outer contour of the central ball mandrel 212. Appropriate heat treatment may be performed so that the shape is formed into the outer contour separately. In some embodiments, the filamentous element 14 of the transmission shell 40 is held by a fixture configured to hold the transmission shell 40 in the desired shape and takes about 5-10 minutes to shape the structure. It may be heated to about 475 to 525 ° C.
0098The central ball mandrel 212 provides a shaping tubular braid member 208 that forms a transparent shell 40 having the desired shape and size, such as the spherical configuration of device 10 in FIG. 3-6 above, or any other suitable configuration. It may be configured to have any desired shape to produce. Thus, the central ball mandrel 212 may be a spherical ball with recesses on opposite sides of the hubs 66 and 68 located inside the tubular braid 208. Even if one or more molds with one or more parts assembled to form a cavity with the desired device shape are used in conjunction with or in place of the end forming mandrel 214. Good. Once the thermosetting process is complete, fibers, coatings and surface treatments may be applied to the resulting filament with the structure of the permeation shell 40, multiple parts of the filament, or all of them. In addition, for some embodiments of device processing, the permeation shell 40 secures the proximal and distal ends 60 and 62 of the elongated filamentous element 14, or the proximal and distal hubs 66 and 68, respectively. , May be formed as discussed above.
0099FIG. 30 shows another embodiment of the fixture for shaping the permeation shell 40 of the device for the treatment of the patient's vascular system. In embodiment 230 of the fixture of FIG. 29, instead of the central ball mandrel 212, the internal tube mandrel 232 is used in conjunction with the external tube restraint 234 to maintain the shape of the braided tubular member 208 during the thermosetting process. It may be used in essentially the same manner as in embodiment 220 of the fixture of FIG. More specifically, the tubular braided member 208 is disposed on an internal rod mandrel 210 extending through the central lumen of an internal tube mandrel 232 and a pair of opposing recessed recessed mandrel 214s. The tubular braid member 208 is also arranged on the outer surface of the inner tube mandrel 232 and also within the respective inner lumen of the end forming mandrel 214.
0100In order to keep the braided tubular member 208 in the desired shape, including its recessed end, the inner surface of the braided tubular member 208 is held relative to the outer contour of the inner tube mandrel 232 and is positioned at the end of the tube mandrel 232. The end forming mandrel 214 is configured to be pressed against and pushed into the recessed end 238 of the internal tube mandrel 232 so as to be secured by.
0101Between the ends of the tube mandrel 232, the braided tubular member 208 extends radially outward until it touches the inner surface of the outer tube mandrel 234 and is thereby constrained radially. Axial constraint and fixation of the braided tubular member 208 at the end of the internal tube mandrel 232, combined with an inner radial constraint on the outer surface of the braided tubular member 208 located between its proximal and distal ends. The combination may be configured to produce the desired spherical configuration suitable for the transparent shell 40 of the device 10.
0102Here again, the inner surface of the end of the braided tubular structure 208 held against the outer surface of the end of the inner tube mandrel 232, and the braided tubular member radially constrained by the inner surface 233 of the outer tube member 234. The entire fixture 230 with the outer surface of the 208 may then be subjected to appropriate heat treatment. The heat treatment may be configured such that the elastic filament 14 of the braided tubular member 208 forms or is shaped into a spherical contour of the filament 14 produced by the fixture 230. In some embodiments, the filamentous element 14 of the transmission shell 40 is held by a fixture configured to hold the braided tubular member 208 in the desired shape and takes about 5-10 minutes to shape the structure. It may be heated to about 475 to 525 ° C. The inner surface 233 of the inner tube mandrel 232 and the outer tube member 234 forms a permeation shell 40 having the desired shape and size, such as the spherical configuration of the device of Figure 3-6 above, or any other suitable configuration. It may be configured to have any desired shape so as to produce the shape setting annular braid member 208.
0103For some embodiments, the permeation shell of device 10 is such that the material substantially reduces the size of windows, cells, or pores 64 between filaments 14 and thus reduces porosity in that area. It may be attached to 40 filaments 14. For example, coating embodiments may be placed on multiple portions of filament 14 to produce a smaller window or cell and thus a higher density of transparent shell 40. An active material, such as a responsive hydrogel, is mounted or incorporated into the permeation shell 40 of some embodiments so that it swells over time upon contact with the liquid and reduces the porosity of the permeation shell 40. You may.
0104The embodiment of device 10 discussed herein may be coated with various polymers that enhance its performance, immobilization, and / or biocompatibility. In addition, embodiments of device 10 may be made of various biomaterials known in the field of implant devices, including, but not limited to, polymers, metals, biomaterials, and composites thereof. The device embodiments discussed herein may include cells and / or other biological materials that facilitate healing. The device embodiments discussed herein also provide elution or delivery of one or more beneficial agents, other bioactive substances, or both into blood or surrounding tissues. May be constructed in.
0105Embodiments of the permeation shell 40 of device 10 for the treatment of the patient's vascular system may include multiple layers. The first or outer layer may be constructed from materials with low bioactivity and blood compatibility to minimize the aggregation or attachment of platelets and thus the tendency to form blood clots and thrombi. Optionally, the outer layer may be coated or incorporate an antithrombotic agent such as heparin, or another antithrombotic agent as described herein or known in the art. .. One or more inner layers that are deployed towards the vascular defect relative to the first layer have better biological activity and / or promote blood clots and thus blood clots within the vascular defect. And may be constructed from materials that enhance the formation of the closed mass of the device. Some materials that have biological activity and / or have been shown to promote blood clots are silk, polylactic acid (PLA), polyglycolic acid (PGA), collagen, alginic acid, fibrin, fibrinogen, fibronectin. , Methyl cellulose, gelatin, small intestinal submucosal tissue (SIS), poly-N-acetylglucosamine, and copolymers or composites thereof.
0106Suitable bioactive agents for use in the embodiments discussed herein may include those having a specific action in the body as well as those having a non-specific action. Certain agents are typically thrombogenic and / or in the form of collagen, thrombin, and fibrogen, each of which may provide the optimal combination of activity and cost, as well as elastin and von. A protein that contains Willebrand factor (which may tend to be less active and / or cheaper agents), as well as the active portions and regions of each of these agents. Angioplastic proteins typically act using specific interactions with either platelets or enzymes that are involved in the cascade of events that ultimately lead to clot formation. Drugs with non-specific thrombolytic activity are generally in the form of positively charged molecules such as chitosan, polylysine, poly (ethyleneimine), or primary, secondary, or tertiary amines, or quaternary salts. It is a polymer molecule such as acrylic polymerized from acrymid or methacrylamide that incorporates a positively charged group, or a non-polymer drug such as (tridodecylmethylammonium chloride). Positively charged hemostatic agents promote clot formation by non-specific mechanisms, including physical adsorption of platelets via an ionic interaction between the negative charge on the surface of the platelets and the positive charge of the drug itself.
0107Embodiments of device 10 herein may include surface treatments or coatings on partial, side, or whole surfaces that facilitate or inhibit thrombus, blood clots, healing, or other embolic performance techniques. The surface treatment or coating may be synthetic, biological, or a combination thereof. For some embodiments, at least a portion of the inner surface of the permeation shell 40 is a surface treatment or coating made from a biodegradable or bioreabsorbable material such as polylactic acid, polyglycolic acid, or a copolymer thereof. May have. Other surface treatment or coating materials that can enhance the embolic performance of the device include polysaccharides such as alginate-based materials. Some coating embodiments may include extracellular matrix proteins such as ECM proteins. An example of such a coating is Finale, commercially available from Surmodics Inc. (Eden Prairie, MN.).<sup>TM</sup> It may be a Prohealing coating. Another exemplary coating may be Polyzene-F commercially available from CeloNovo BioSciences, Inc. (Newnan, Ga). In some embodiments, the coating may be applied to a thickness of less than about 25% of the lateral dimension of the filament 14.
0108Antiplatelet agents include aspirin, glycoprotein IIb / IIIa receptor inhibitors (including abciximab, eptifibatide, tyrofibane, lamifibatide, fradafiban, clopidogrel, toxifiban, XV454, lefradafiban, clerubal, rotrafiban, orbofifan, and dipyridamole), dipyridamole. -May contain dipyridamole, persantin, prostacycline, ticlopidine, clopidogrel, chromafiban, cilostazol, and nitrogen monoxide. To deliver nitric oxide, device embodiments may include a polymer that releases nitric oxide. Embodiments of device 10 also include heparin, low molecular weight heparin, hirudin, warfarin, vivalyldin, hirudin, argatroban, forskolin, ximeragatran, bapiprost, prostacyclin and prostacyclin analogs, dextran, synthetic anticoagulant, Vasoflux, argatroban, efegatran. , Tick anticoagulants, Ppacks, HMG-CoA reductase inhibitors, and thromboxane A2 receptor inhibitors, and other anticoagulants may be delivered or included.
0109In some embodiments, the permeation shell 40 of device 10 may be coated with a composition that may include a material of nanoscale structure or a precursor thereof (eg, a self-assembling peptide). Peptides may have alternating hydrophilic and hydrophobic monomers that allow the peptides to self-assemble under physiological conditions. The composition may include a series of amino acid residues. In some embodiments, the permeation shell may include a thin metal membrane material. The thin film metal may be produced by sputter vapor deposition or may be formed into a plurality of layers. The thin film may be a nickel-titanium alloy, also known as nitinol.
0110In some cases, the saccular aneurysm may have substantially circulating hydrodynamics of blood, as indicated by the arrow 250 shown in FIG. While the shell of a monolayer device such as device 10 slows blood flow into the aneurysm, thrombosis and embolism may be further enhanced by the internal porous structure. Specifically, the circular flow 250, in particular the structure configured to force the maximum velocity region to pass through one or more porous layers, has a synergistic therapeutic effect and is rapid. Can promote thrombosis.
0111As discussed above for embodiments of the deployment method shown in Figures 23-26, once the properly sized device 10 for the treatment of the patient's vascular system is selected, the delivery and deployment process It may be done. During deployment, the tip of the microcatheter 61 may be advanced into or adjacent to the vessel site or defect 160. The device 10 for the treatment of the patient's vasculature may be inserted through the microcatheter 61 so that the catheter lumen constrains the radial expansion of the device during delivery. Once the distal tip or deployment port of the delivery system is positioned adjacent to or at the desired location within the vascular defect 160, the device 10 may be deployed out of the distal end of the catheter. Well, therefore, it allows the device to begin to expand radially as shown in Figure 25. As the device emerges from the distal end of the delivery system, the device 10 expands radially outward to an expanded state within the internal volume of the vascular defect. Upon deployment, the device 10 may also be at least partially constrained by the inner surface of the vascular defect 160, depending on the size of the device relative to the size of the inner surface of the vascular defect 160. Upon full deployment, the radial extension of device 10 acts to exert an outward radial force on the inner surface of the vascular defect with respect to the outer surface of the device, as if the device was mechanically anchored within the vascular defect. You may. Deployment of device 10 may serve to partially isolate the vascular defect from flow, pressure, or both from the patient's vascular system adjacent to the vascular defect.
0112In any of the device embodiments discussed or incorporated herein for the treatment of a patient's vascular defect or aneurysm, the device may comprise one or more composite filaments. Composite filaments (eg, wires) may be defined as filaments containing multiple materials, either in a mixture or alloy, or in a composite structure in which two materials are physically incorporated into one. The addition of at least some composite wires into the device may provide improved visibility of the device under external imaging such as X-rays, fluorescence fluoroscopy, magnetic resonance imaging, and equivalents. In some embodiments, the composite wire may provide improved mechanical properties.
0113For some composite filament embodiments, the composite filaments may be arranged in a coaxial arrangement with one material substantially inside the other material, as shown in FIG. One known processing method for such coaxial composite wires is stretch-filled tube wires, in which the materials of the stretch-filled tubes are combined and retain their individual mechanical properties. Stretched filling tube wire is Ft. Wayne It is commercially available from Metals (Ft. Wayne, Indiana). In some cases, the process for producing stretch-filled tube filaments is extreme so that the mechanical bond between the outer surface 334 of the inner filling wire 332 and the inner surface 338 of the outer tube 336 is metallurgically robust. May include various compressive forces. In some cases, multiple outer tubes of different materials may be layered over the inner wires and each other to combine the mechanical properties of the multiple materials. For such embodiments, the stretch-filled tube filament may include two, three, four, five, or more outer tube layers. In some embodiments, the stretch-filled tube wire is formed from a combination of an external Nitinol (NiTi) tube and a highly radiation-impermeable filling wire that can be arranged concentrically within the outer tube. Various radiation opaque materials and metals known in the art that can be used as filling wires include, but are not limited to, gold, platinum, tantalum, and equivalents. One advantage of NiTi's composite materials with highly radiation-impermeable filled wires on the outside and inside is that the device can substantially maintain its highly elastic or hyperelastic behavior, resulting in a large blood contact surface. The part is to remain nitinol. This enables devices with substantially improved visibility under radiography while maintaining an appropriate range of mechanical properties.
0114In some cases, the specific structure of the stretch-filled tube wire or filament may be important to maintain the desired performance characteristics of the device for the treatment of vascular defects. More specifically, it may be important to balance the stiffness, elasticity, and radiation impermeability of the composition. Specifically, with respect to an embodiment of a stretch-filled tube filament comprising an inner wire 332 of a ductile radiation opaque material such as platinum and an outer tube 336 of an elastic or superelastic material such as NiTi, the total cross-sectional area of the filament. It may be necessary to carefully balance the ratio of the cross-sectional area ratio of the internal wire to. Such a ratio may be referred to as a filling ratio. If the embodiments include an inner tube material that is excessively less or highly opaque to the outer tube material, there may not be sufficient radiation opacity and visibility. On the other hand, when the embodiment contains an internal wire material that is excessively large with respect to the elastic outer tube, the mechanical properties of the ductile radiation opaque material can overwhelm the elastic properties of the outer tube material, causing the filament to compress, etc. It is easy to cure after and can result in permanent deformation. For some embodiments, the desired composite or stretch-filled tube wire is from about 10% to about 50%, more specifically from about 20% to about 40%, and more specifically from about 25% to about. It may be constructed with a filling ratio of the cross-sectional area of the internally filled wire to the cross-sectional area of the entire composite filament of 35%.
0115In some embodiments, the number of composite wires may be from about 40 to 190, in other embodiments from about 50 to 190, and in other embodiments from about 70 to 150. In some embodiments, the device for the treatment of the patient's vasculature may have at least about 25% of the composite wires relative to the total number of wires, and in some embodiments such devices. May have at least about 40% of the composite wires relative to the total number of wires in the device. For example, a first subset of eccentric elastic filaments may comprise filaments, each of which has a composite material of a highly radiation impervious material and a high strength material, and the second subset of eccentric elastic filaments is essential. It may be made of a high-strength material. For example, the highly radiation opaque material may include platinum, platinum alloys such as 90% platinum / 10% iridium, or gold, or tantalum. The high-strength material may include NiTi. Composite wires may provide enhanced visualization and / or mechanical properties, but in some configurations they have reduced tensile strength compared to NiTi wires of similar diameter. In some configurations, the composite wire may increase the folding profile of the device, depending on their diameter. Therefore, it can be beneficial to minimize the number. Lower proportions of composite wire may not be sufficiently visible with current imaging equipment, specifically in neurovascular applications where imaging is done through the skull. In addition, too many composite wires (or composite wires with extremely high fill ratios) can result in devices with excessive artifacts on CT or MRI imaging. The described ratios and amounts of highly radiation opaque materials are such that the periphery of the device is just visible under transcranial fluorescence fluoroscopy, but the device imaging region is substantially made of platinum or a platinum alloy. It provides a unique situation for neurovascular implants that is not completely removed (ie, by artifacts) like traditional embolic coils.
0116One way to achieve the desired degree of radiation impermeability is by selecting a particular combination of composite wire fill ratios and proportions of composite wires relative to the total number of wires. A device according to an embodiment having a single-layer braided (woven) structure was constructed. For example, an embodiment of a braided structure comprising 72 composite platinum / NiTi stretch-filled tube wires having a diameter of 0.00075 inches and a platinum filling ratio of 30% and 72 NiTi wires having a diameter of 0.00075 inches. Was built. The total proportion of platinum in the braided structure (by% total cross-section) was about 15%. Another embodiment of the braided structure comprising 108 composite platinum / NiTi stretch-filled tube wires having a diameter of 0.001 inches and a platinum filling ratio of 30% and 72 NiTi wires having a diameter of 0.00075 inches. Was built. The total proportion of platinum in the braided structure was about 22%. Still another braided structure with 72 composite platinum / NiTi stretch-filled tube wires with a diameter of 0.00125 inches and a platinum filling ratio of 30% and 108 NiTi wires with a diameter of 0.00075 inches. An embodiment has been constructed. The total proportion of platinum in the braided structure was about 19.5%. Yet another implementation of the braided structure, comprising 108 composite platinum / NiTi stretch-filled tube wires with a diameter of 0.00125 inches and a platinum filling ratio of 30% and 108 NiTi wires with a diameter of 0.00075 inches. The form was constructed. The total proportion of platinum in the braided structure was about 22%. Each device constructed according to each of these embodiments was implanted in vivo and imaged using fluorescence fluoroscopy. In each case, the perimeter of the device was visible under transcranial fluorescence fluoroscopy, but the device imaging area was not completely legible (ie, due to artifacts).
0117In some embodiments, the total cross-section of the highly radiation-impermeable material is from about 11% to about 30% of the total cross-section of the plurality of elongating elements. In some embodiments, the total cross-section of the highly radiation-impermeable material is from about 15% to about 30% of the total cross-section of the plurality of elongating elements. In some embodiments, the total cross-section of the highly radiation-impermeable material is from about 15% to about 22% of the total cross-section of the plurality of elongating elements. In some embodiments, the total cross-section of the highly radiation-impermeable material is from about 19% to about 30% of the total cross-section of the plurality of elongating elements. In some embodiments, the total cross-section of the highly radiation-impermeable material is from about 11% to about 18.5% of the total cross-section of the plurality of elongating elements.
0118The radiopaqueness of composite filaments, including highly radiopaque materials, is not very radiopaque, as it can allow sufficient device visualization (eg, with fluorescence fluoroscopy). Alternatively, it may be desired to make one or more hubs from non-radiation impermeable materials. In some embodiments, platinum, platinum alloys (eg, 90% platinum / 10% iridium), their radiation opacity overwhelms the radiation opacity of composite filaments, thus making their depiction difficult. If so, it may not be desired. Therefore, the use of less radiation-impermeable or non-radiation-impermeable materials for making these hubs may be desired in these embodiments, but may be used on hubs of other embodiments. Can also be done. One or more titanium or titanium alloy hubs or NiTi hubs may be used in place of the highly radiation impervious hubs. The use of titanium, titanium alloys, or NiTi hubs also welds to NiTi filaments when their melting temperatures are matched more closely than, for example, platinum, platinum alloys, or gold hubs were used. Can help. The result can be the junction between the filament and the hub with higher tensile breaking force. This type of joint was constructed and demonstrated an approximately 48% improvement in tensile strength.
0119FIG. 33 illustrates an embodiment of a composite mesh and coil device 1700 for the treatment of vascular defects. The composite mesh and coil device 1700 includes a mesh portion 1702 and a coil portion 1704. The mesh portion 1702 has a proximal end 1708 and a distal end 1710 and may incorporate any number of embodiments described herein, but is generally braided from filament 1712. The filament 1712 may be secured at the proximal end 1708 using a marker band 1715. Coil portion 1704 comprises a proximal end 1719 and a distal end 1721 and is ticketed to one or more secondary diameters, a primary platinum or platinum alloy coil (eg, 92% platinum, 8% tungsten). ) May be constructed from. The coil part 1704 is 0.0008 inch to 0.005 inch, or 0.001 inch to 0. It may be ticketed from a single filler or multifiller wire 1723 with a diameter of 0035 inches. The secondary diameter 1725 may approximate the diameter 1621 of the mesh portion 1702 or may be smaller than the diameter 1621 of the mesh portion 1702, depending on the application. For example, it may be configured to be about half the diameter 1621 of the mesh portion 1702. The distal end 1721 may include a first loop 1717 with one or more secondary diameters of 1727. The coil portion 1704 may or may not need to be radiation opaque due to the general radiation opacity of the platinum material of the coil portion 1704, in band 1729, mesh portion 1702. It may be fixed to. The composite mesh and coil device 1700 has a mesh portion 1702 of a spherical or other shape and a coil portion 1704 having a secondary diameter of 1725, 1727 of one or more thereof, as shown in FIG. It is configured to have a relaxed dilated state. The composite mesh and coil device 1700 also has a radially constrained stretched state in which the mesh portion 1702 is folded and stretched and the coil portion 1704 is straight and elongated for delivery through a microcatheter.
0120The potential usefulness of coil portion 1704 is diverse. First, the composite mesh delivered to the vascular defect and the first part of the coil device 1700, the coil portion 1704, non-traumatically traces around the diameter of the vascular defect and the composite mesh within the vascular defect. And can assist in the engagement of the coil device 1700. The secondary diameter 1725 of one or more loops 1714 allows the coil portion 1704 to form a three-dimensional frame around the vascular defect and the mesh portion 1702 to extend within this three-dimensional frame. It may be chosen to be close to the diameter 1621 of 1702 or, in some cases, slightly larger. The reduced secondary diameter 1727 may be selected to be 50% to 85% of the secondary diameter 1725, and when the coil portion 1704 is first inserted into the vascular defect, the coil portion 1704 is vascular defect. It serves to keep inside and, for example, outside the parent vessel. An additional use of the coil portion 1704 is to serve as an urging member for pressing the dilated mesh portion 1702 against the opening of a vascular defect (such as the neck of an aneurysm). This allows the smaller diameter mesh portion 1702 to effectively block the flow inside the larger diameter vascular defect without the need to volumetrically fill the entire vascular defect. These uses are illustrated in more detail in the figures below.
0121Figures 34A-34B illustrate a method for implanting a composite mesh and coil device 1700b into an aneurysm 160 with a neck 167 and a dome 161 through a microcatheter 1761. The composite mesh and coil device 1700b comprises a mesh portion 1702b and a coil portion 1704b. In FIG. 34A, coil portion 1704a is delivered outward from the microcatheter 1761. The coil portion 1704b has a spiral shape and has a significant axial spring constant. The length of the helix (ie, the number of coils) is when the mesh portion 1702b is delivered completely out of the microcatheter 1761 and self-expands within the portion of the aneurysm 160 adjacent to the neck 167 (FIG. 34B). , The coil portion 1704b is selected so that it can be axially compressed between the dome 161 of the aneurysm 160 and the mesh portion 1702b. After delivery of the entire composite mesh and coil device 1700b into the aneurysm 160, the composite mesh and coil device 1700b is detached from its delivery device 1732b and the microcatheter 1761 is retracted and removed from the patient. .. The delivery device 1732b may be completely removed from the microcatheter 1761 or only retracted within the microcatheter 1761 before the microcatheter 1761 is retracted and removed from the patient. The mesh portion 1702b may incorporate at least some radiation opaque filaments made from, for example, platinum or platinum alloys. The compressed coil portion 1704b applies a force F onto the dilated mesh portion 1702b that holds it against the neck 167 of the aneurysm 160. It is predicted that a force as large as 0.27 grams or greater (axial urging force) will be exerted from the flow moment over the neck of the aneurysm at the tip of the basilar artery during part of each cardiac cycle. There is. The spring constant of coil portion 1704b is 0. when at least partially compressed. A force F (axial urging force) greater than 27 grams can be configured to be applied to the mesh portion 1702b and thus to the neck 167 of the aneurysm. Basilar aneurysms typically have the highest flow of cerebral aneurysms. Calculating the effects of systolic and diastolic blood pressure on the dilation and contraction of blood vessels and aneurysms in the neck and the area surrounding the neck, we make some assumptions to further extend the force F requirement. be able to. Choosing a low diastolic blood pressure of 40 mmHg and a neck diameter of 2.5 mm predicts a force of 2.67 grams. Choosing a high diastolic blood pressure of 120 mmHg and a neck diameter of 3.6 mm predicts a force of 16.6 grams. Thus, the coil portion 1704b, when at least partially compressed, has a force F greater than 0.27 grams, or more specifically a force F greater than 2.67 grams, more specifically a force F greater than 16.6 grams. , Mesh portion 1702b, and thus may be configured to be applied to the neck 167 of the aneurysm. Since the mesh portion 1702b does not have to fill the entire volume of the aneurysm 160, the mesh portion 1702b can be significantly smaller, and by being smaller it fits into the smaller microcatheter lumen and is more winding. It can be delivered through a blood vessel and thus can be used in a more distant aneurysm. Thus, the composite mesh and coil device 1700b can be used in large or giant aneurysms, but is still deliverable within standard small diameter microcatheter lumens. A force F greater than 6 grams may be configured to be applied to the mesh portion 1702b and thus to the neck 167 of the aneurysm. Since the mesh portion 1702b does not have to fill the entire volume of the aneurysm 160, the mesh portion 1702b can be significantly smaller, and by being smaller it fits into the smaller microcatheter lumen and is more winding. It can be delivered through a blood vessel and thus can be used in a more distant aneurysm. Thus, the composite mesh and coil device 1700b can be used in large or giant aneurysms, but is still deliverable within standard small diameter microcatheter lumens.
0122Figures 35A-35B illustrate a method for implanting a composite mesh and coil device 1700c into an aneurysm 160 with a neck 167 and a dome 161 through a microcatheter 1761. The composite mesh and coil device 1700c comprises a mesh portion 1702c and a coil portion 1704c. In FIG. 35A, coil portion 1704c is delivered outward from the microcatheter 1761. The coil portion 1704c has a spiral shape and has one or more loops. The purpose of coil portion 1704c is to allow the composite mesh and coil device 1700c to be delivered from the microcatheter 1761 and positioned into aneurysm 160 before and after mesh portion 1702c self-expands within aneurysm 160 (Fig. 35B). It is to protect the aneurysm 160 while it is. After delivery of the entire composite mesh and coil device 1700c into the aneurysm 160, the composite mesh and coil device 1700c is detached from its delivery device 1732c and the microcatheter 1761 is retracted and removed from the patient. .. The mesh portion 1702c may incorporate, for example, at least some radiation opaque filaments made from platinum or platinum alloys. The composite mesh and coil devices 1700a, 1700b, 1700c may also share one or more of each other's properties (ie, shape, force application, non-traumatic coil).
0123FIG. 35C-35D illustrates an embodiment of a mesh device 2200 delivered through a microcatheter 1761. The mesh device 2200 includes a mesh portion 1702 comprising a filament 2212 anchored at the distal end 2213 in a cylindrical hub 2215. The filament 2212, each having a filament end 2221, extends substantially radially beyond the distal end 2217 of the cylindrical hub 2215 to form a circular protrusion 2219 with a diameter D. FIG. 35E-3F illustrates a mesh device 2200 delivered from a microcatheter 1761 (eg, into a vascular defect). In some embodiments, the circular protrusion 2219 is similar to the coil portion 1704b of the composite mesh and coil device 1700b of FIGS. 34A-34B and may be configured to apply urging forces. In some embodiments, the filament 2212 is braided. In some embodiments, the circular process 2219 is configured to protect the aneurysm 160, similar to the coil portion 1704c of the composite mesh and coil device 1700c of FIGS. 35A-35B. Circular projection 2219 may include filament 2212, which has a braided, partially braided, disassembled, or unraveled braid.
0124FIG. 36 illustrates an embodiment of a mesh device 2050 having a single tubular mesh structure 2052 that is anchored at its proximal end 2054 at the proximal hub 2056 and at its distal end 2058 at the distal hub 2060. Illustrated. The inner length IL of the mesh device 2050 is the overall length L due to the shape with the concave surface 2062 due to the shape that is thermoset into a single tubular mesh structure 2052.<sub>O</sub>Relatively short compared to.
0125FIG. 37 is anchored at its proximal end 2104 at the proximal hub 2106 and at its distal end 2108 at the central hub 2110 in a manner similar to the single tubular mesh structure 2052 or mesh device 2050 of FIG. An embodiment of a multi-leaf mesh device 2100 having a lobe 2102 is illustrated. However, the multilobed mesh device 2100 further comprises a distal lobe 2112 that can be nested within the concave surface 2114 within the central lobe 2102. The distal lobe 2112 is secured by the central hub 2110 and the distal hub 2116. In addition, the multi-leaf mesh device 2100 comprises a proximal lobe 2118 secured by a proximal hub 2106. In some embodiments, the entire multilobe mesh device 2100 is configured to be implanted within a vascular defect. In some embodiments, the central lobe 2102 and the distal lobe 2112 are configured to be present within the vascular defect, while the proximal lobe 2118 is located opposite the entry point to the vascular defect. It is configured as follows. For example, in FIG. 40, the proximal lobe 2118 is at least partially present in the parent artery 414 adjacent to the neck 167 of the aneurysm (vascular defect 160). In some embodiments, the central lobe 2102 and the proximal lobe 2118 serve as bookends to hold the multilobed mesh device 2100 at the neck 167.
0126With reference to FIG. 38, the multilobe mesh device 2100 is shown in a radial constrained state for delivery along the longitudinal axis 2128 through the microcatheter 61. The multi-leaf mesh device 2100 is releasably coupled to the delivery device 2122 at its proximal end 2124. The distal end 2120 of the multilobed device 2100 in its radial restraint corresponds to the distal tip of the distal lobe 2112. A series array 2126 of three leaves 2112, 2102, 2118 ensures that there is no layer overlap that would increase the profile upon delivery. Thus, the multi-leaf mesh device 2100 may be deliverable through a microcatheter 61 having a small radial constrained profile and a small inner diameter of as small as 0.021 inches and even as small as 0.017 inches.
0127FIG. 39 shows the proximal lobe 2134 and the distal lobe 2132, having the proximal lobe 2134 anchored at the proximal hub 2136 and the distal lobe 2132 anchored at the proximal hub 2136 and the central hub 2138. , a multi-lumen mesh Device illustrates the chair 2130. As in the embodiment of the multilobed mesh device 2100 of FIG. 40, the proximal lobe 2134 may be configured to be in a vascular defect or in a parent artery, and thus in the neck. Straddle.
0128With reference to FIGS. 41 and 42, a grooved (castle-like) mandrel assembly 1038 is illustrated with a grooved mandrel 1034 having a round cap 1044 within its central cavity 1046. Grooved mandrel 1034 includes a cylindrical battlement-like structure 1048 with multiple slots or gaps 1052, separated by multiple struts or convex walls 1054. The embodiments illustrated in FIGS. 41 and 42 include 18 gaps 1052 and 18 convex walls 1054, whereas alternative embodiments include 27 gaps 1052 and 27 convex walls 1054, or the like. May include the quantity of. The round cap 1044 has a convex radius of 1056, the surface of which is contained within a portion of the central cavity 1046 whose surface 1058 is preferably surrounded by the interstitial battlement-like structure 1048. Pin 1064 extends from the round cap 1044 and into hole 1066 within the grooved mandrel 1034. The round cap 1044 may be secured to the grooved mandrel 1034 by attaching pin 1064 to hole 1066 using threaded screws, adhesives, epoxies, welds, or similar methods. The round cap 1044 and the grooved mandrel 1034 may be made from a rigid durable material such as stainless steel.
0129The loading of the grooved mandrel assembly 1038 for the process of constructing an embodiment of the mesh device is illustrated in Figures 43A-43C. The convex walls 1054a-r are arranged circumferentially around the interstitial battlement-like structure 1048 with a gap 1052a-r between each convex wall 1054a-r. In FIG. 43A, the first filament 1412a is loaded downward into the gap 1052a (between the convex walls 1054r and 1054a) and the gap 1052j (between the convex walls 1054i and 1054j) and is a grooved mandrel assembly. Stick to 1038. The first filament 1412a may be secured, for example, so that the central portion 1068a of the first filament 1412a is firmly held across the surface 1058 of the convex radius 1056 of the round cap 1044. In the 18-slit embodiment of the grooved mandrel assembly 1038, the locations of the gaps 1052a and 1052j are, for example, 180 ° from each other, close to the 12 o'clock and 6 o'clock locations on the clock face. However, other non-180 ° configurations, such as the configuration of FIG. 43D, may be selected for loading filament 1412a or subsequent filament 1412. In Figure 43B, the second filament 1412b is loaded downward into the gap 1052b (between the convex walls 1054a and 1054b) and the gap 1052k (between the convex walls 1054j and 1054k) and is a grooved mandrel assembly. Stick to 1038. The central portion 1068b of the filament 1412b is crossed beyond the central portion 1068a of the first filament 1412a and is firmly held across the convex radius 1056 of the round cap 1044. This loading continues until all filaments 1412 have been loaded and secured to the grooved mandrel assembly 1038. Multiple filaments 1412 may be loaded into their respective gaps 1052, or only into certain selected gaps 1052. Load all of the filament 1412 into the gap 1052 and After fastening the filament 1412 to the grooved mandrel assembly 1038, the filament 1412 is ordered and radially extended, and the braiding process is performed as previously described for these figures. Due to the manner in which filaments 1412 are layered over each other in a round cap 1044, the resulting mesh device, such as mesh device 1800 in FIG. 47, has a substantially closed distal apex 1807. The mesh device 1800 of FIG. 47 may be made of, for example, 72 to 216 filaments 1412, but 36 to 36 because the mandrel loading produces an equivalent of two filaments 1412 from one wire. Only 108 wires are needed. A mixture of platinum or platinum alloy filaments with nickel titanium filaments may be selected to add radiation impermeable to the mesh device 1800, especially at the distal end. Alternatively, a stretch-filled tube (DFT) with a radiation-impermeable (eg, platinum or platinum alloy) core may be used. In the mesh device 1800 of FIG. 47, the filament diameter may range from about 0.0005 inches to about 0.002 inches, or about 0.00075 inches to 0.00125 inches.
0130FIG. 43C illustrates a top view of a loaded grooved mandrel assembly 1038 of mesh device 1800 made in conjunction with the method described in FIGS. 43A-43B. The substantially closed distal apex 1807 of the mesh device 1800 contains many layers of filament 1412 at this central intersection 1073 because each filament 1412 intersects the central intersection 1073. However, the molding and thermoforming of the mesh device 1400 at least partially reforms some or all of the filaments 1412 at the central intersection 1073 and expands them to reduce the volume at the central intersection.
0131An alternative filament loading method is illustrated in FIG. 43D. Filament 1115 is loaded in alternating fashion. Filament 1115a is loaded into the gaps 1052a and 1052f and thus extends inward of the convex walls 1054a, 1054b, 1054c, 1054d, and 1054e and traverses part of the convex radius 1056 of the round cap 1044. It is held firmly. The filament 1115b is loaded into the gaps 1052b and 1052g and thus extends inward of the convex walls 1054b, 1054c, 1054d, 1054e, and 1054f and intersects over the filament 1115a. This continues until all of the filament 1115 is loaded and the configuration in Figure 43D becomes visible. In this embodiment, the central opening 1091 is formed in contrast to the closed distal apex 1807 of the mesh device 1800. The size of the central opening 1091 can vary depending on both the diameter of the grooved mandrel 1034 in the interstitial battlement-like structure 1048 and the total number of interstitial 1052s that are skipped when loading each filament 1115.
0132The formation of a mesh device with an open distal end is illustrated in Figures 44A-44B. In FIG. 44A, the first filament 1512a is loaded downward into the gap 1052a (between the convex walls 1054r and 1054a) and the gap 1052b (between the convex walls 1054a and 1054b). The central portion 1168a of the first filament 1512a is firmly held around the convex wall 1054a, and the first portion 1170a and the second portion 1172a of the filament 1512a are secured to the grooved mandrel assembly 1038. In FIG. 44B, the second filament 1512b is loaded downward into the gap 1052b (between the convex walls 1054a and 1054b) and the gap 1052c (between the convex walls 1054b and 1054c). The central portion 1168b of the second filament 1512b is firmly held around the convex wall 1054b, and the first portion 1170b and the second portion 1172b are secured to the grooved mandrel assembly 1038. This loading continues until all filaments 1512 have been loaded and secured to the grooved mandrel assembly 1038. Multiple filaments 1512 may be loaded around each convex wall 1054, or only one selected convex wall 1054. After loading all of the filaments 1512 into the gap 1052 and anchoring the filaments 1512 to the grooved mandrel assembly 1038, the filaments 1512 were ordered and radially extended, and the braiding process was previously described for these figures. It is done as it was done. Multiple loops result from the central portion 1168 of filament 1512, which is initially curved around the convex wall 1054 of the grooved mandrel assembly 1038. The diameter of the grooved mandrel 1034 in the interstitial battlement-like structure 1048 may be varied to control the diameter of the open portion 1518. The number and size of convex walls 1054 may be varied to control the number and size of loops 1516. Loop 1516
0133FIG. 45 illustrates an embodiment of a multi-leaf mesh device 1800 for the treatment of a patient's vascular system. In this particular embodiment, the multi-leaf mesh device 1800 comprises a proximal lobe 1802, a central lobe 1804, and a distal lobe 1806. In some embodiments, the leaves 1802, 1804, 1806 are formed from a single layer braided tubular member. The leaves may be braided individually and connected in parallel together via the proximal hub 1808, the central hub 1810, and the distal hub 1812. In some embodiments, the proximal leaf 1802 has a relatively small first porosity P.<sub>1</sub>It may be configured to have, to be located at the entry site or neck of the vascular defect, and to facilitate the occlusion of the vascular defect. In some embodiments, the central lobe 1804 may be configured to have radial stiffness and overall mechanical properties configured to support the multilobed mesh device 1800 within vascular defects. In some embodiments, the central leaf 1804 has a first porosity P.<sub>1</sub>Larger second porosity P<sub>2</sub>May have. In some embodiments, the distal lobe 1806 has a relatively small third porosity P.<sub>3</sub>And may be configured to be located in the distal or dome portion of the vascular defect. In some embodiments, the third porosity P<sub>3</sub>The distal lobe 1806 with is configured to be located adjacent to the previous rupture site and may be configured to provide a protective micromesh that limits or eliminates re-rupture. In some embodiments, the first porosity P of the proximal leaf 1802<sub>1</sub>Is the third porosity P of the distal lobe 1806<sub>3</sub>Can be approximately equal to. In some embodiments, the distal lobe 1806 In some embodiments, the proximal leaf 1802 may be constructed from about 108 to about 180 filaments 1814. In some embodiments, the proximal leaf 1802 may be constructed from from about 54 to about 90 nitinol filaments and from about 54 to about 90 stretched filling tube (DFT) filaments. In some embodiments, the DFT filament is an outer high-strength material such as nitinol and a platinum alloy such as platinum, 90% platinum / 10% iridium, or a highly radiation-impermeable material such as gold or tantalum. May include an inner core of. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 10% to about 50% of the highly radiation opaque material. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 20% to about 40% of the highly radiation opaque material. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 25% to about 35% of the highly radiation opaque material. In some embodiments, the proximal leaf 1802 comprises a nitinol filament having a lateral dimension or diameter of about 0.0004 inch to about 0.0006 inch and a DFT filament having a lateral dimension of about 0.0006 inch to about 0.0009 inch. You may. In some embodiments, the proximal leaf 1802 may also include about 72 nitinol filaments having a lateral dimension of about 0.0005 inches and about 72 DFT filaments having a lateral dimension of about 0.00075 inches. Good.
0134In some embodiments, the central leaf 1804 may be constructed from about 36 to about 54 filaments 1816. In some embodiments, the central leaf 1804 may be constructed from DFT filaments. In some embodiments, the central leaf 1804 may be constructed from nitinol filaments. In some embodiments, the central leaf 1804 may be constructed from a mixture of nitinol and DFT filaments. In some embodiments, the central leaf 1804 may comprise a filament having a lateral dimension of about 0.0009 inches to about 0.0014 inches. In some embodiments, the central leaf 1804 may comprise a filament having a lateral dimension of about 0.001 inch to about 0.00125 inch.
0135In some embodiments, the distal lobe 1806 may be constructed from about 108 to about 180 filaments 1818. In some embodiments, the distal lobe 1806 may be constructed from from about 54 to about 90 nitinol filaments and from about 54 to about 90 DFT filaments. In some embodiments, the DFT filament is an outer high-strength material such as nitinol and a platinum alloy such as platinum, 90% platinum / 10% iridium, or a highly radiation-impermeable material such as gold or tantalum. May include an inner core of. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 10% to about 50% of the highly radiation opaque material. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 20% to about 40% of the highly radiation opaque material. In some embodiments, the DFT filament may have a cross-sectional area ratio of about 25% to about 35% of the highly radiation opaque material. In some embodiments, the distal lobe 1806 comprises a nitinol filament having a lateral dimension or diameter of about 0.0004 inch to about 0.0006 inch and a DFT filament having a lateral dimension of about 0.0006 inch to about 0.0009 inch. You may. In some embodiments, the distal lobe 1806 may also comprise about 72 nitinol filaments having a lateral dimension of about 0.0005 inches and about 72 DFT filaments having a lateral dimension of about 0.00075 inches. Good. In some embodiments, the distal lobe 1806 may have an additional distal hub (thus not necessarily made with a grooved mandrel). In these embodiments, the additional distal hub is radiopaque and can therefore be visualized by X-ray or fluorescence fluoroscopy. In these embodiments, the filament may be mostly or entirely nitinol.
0136In some embodiments, the multilobe mesh device 1800 has a proximal lobe 1802 but a first diameter D.<sub>1</sub>The central leaf 1804 has a second diameter D<sub>2</sub>The distal lobe 1806 has a third diameter D<sub>3</sub>It may be constructed to have an extended state with. In some embodiments, the three diameters D<sub>1</sub>, D<sub>2</sub>, D<sub>3</sub>Can be approximately equal to each other. In some embodiments, the first diameter D<sub>1</sub>And the second diameter D<sub>3</sub>A second diameter D to allow the multilobe mesh device 1800 to adapt to the shape of vascular defects 160 such as aneurysms.<sub>2</sub>Can be smaller. With reference to FIG. 46, the multi-leaf mesh device 1800 is shown in a radial constrained state for delivery along the longitudinal axis 1828 through the microcatheter 61. The multi-leaf mesh device 1800 is releasably coupled to the delivery device 1822 at its proximal end 1824. The distal end 1820 of the multilobed device 1800 in its radial restraint corresponds to the distal tip of the distal lobe 1806. A series array 1826 of three leaves 1802, 1804, 1806 ensures that there is no layer overlap that would increase the profile upon delivery. Thus, the multi-leaf mesh device 1800 may be deliverable through a microcatheter 61 having a small radial constrained profile, an inner diameter as small as 0.021 inches, and even as small as 0.017 inches.
0137FIG. 47 illustrates an embodiment of the multi-leaf mesh device 1800 after being delivered into the vascular defect 160. Distal lobe 1806 is delivered adjacent to rupture site 163. The proper size of the multilobe mesh device 1800 has been selected so that the central lobe 1804 is extended within the vascular defect 160 and gives it mechanical support. Proximal lobe 1802 is delivered to be dilated across the neck 167. The relatively short longitudinal distance between the proximal hub 1808 and the central hub 1810, the relatively short longitudinal distance between the central hub 1810 and the distal hub 1812, and the distal hub 1812 and the distal end 1820. All relatively short longitudinal distances between are responsible for reducing the likelihood that the multilobed mesh device 1800 will undergo longitudinal compression leading to in vivo compaction. This longitudinal compression / consolidation is sometimes referred to as clot shrinkage and is described by some as somewhat similar to the contractions that occur in wounds during healing. Longitudinal compression of the mesh device 1850 is demonstrated in Figures 49-51. After implantation, compressive forces from several different sources F<sub>LC</sub>However, by forcing the distal internal ends 1852 and / or the proximal internal ends 1854 to approach each other, the overall length of the mesh device 1850 is increased over time.<sub>O</sub>(Figs. 49 to 51, L<sub>O1</sub>, L<sub>O2</sub>, L<sub>O3</sub>) May be shortened, while some inversion of the mesh device 1850 occurs, thus shortening the inner length (IL).<sub>1</sub>, IL<sub>2</sub>, IL<sub>3</sub>As seen in Figures 49-51). In some embodiments of the mesh device 1850, this is a low longitudinal compressive force F of as low as 0.2 Newton and even 0.1 Newton.<sub>LC</sub>May happen at. Additional longitudinal compression is unlikely to occur because the normal extended configuration of the multi-leaf mesh device 1800 in Figure 45-47 has leaves 1802, 1804, 1806 that approximate partial longitudinal compression. In some embodiments, the distal lobe 1806 may have an additional distal hub (thus not necessarily made with a grooved mandrel). In these embodiments, the additional distal hub is radiopaque and can therefore be visualized by X-ray or fluorescence fluoroscopy. In these embodiments, the filament may be mostly or entirely nitinol.
0138FIG. 48 illustrates an embodiment of a multi-leaf mesh device 1900 with proximal leaf 1902 and support leaf 1904. Filament 1910 in proximal lobe 1902 and filament 1912 in support lobe 1904 are anchored to each other by a distal hub 1908. In some embodiments, the proximal hub 1906 anchors filament 1910 of proximal leaf 1902 at its proximal end 1914. In some embodiments, the proximal leaf 1902 may be constructed similar to and using similar materials as the proximal leaf 1802 of the multi-leaf mesh device 1800 of Figure 45-47. In some embodiments, the support leaf 1904 may be constructed similar to and using similar materials as the central leaf 1804 of the multi-leaf mesh device 1800 of FIGS. 45-47. In some embodiments, as shown in FIG. 48, the supporting leaf 1904 of the multi-leaf mesh device 1900, like the distal leaf 1806 of the multi-leaf mesh device 1800, does not have a hub at its distal end. It may be constructed. In both cases, this may be done to protect the dome 161 of the aneurysm (vascular defect 160). Support lobe 1904 is configured to provide both radial and longitudinal support within the vascular defect 160. In some embodiments, the support leaf 1904 may have an additional distal hub (thus not having to be made with a grooved mandrel). In these embodiments, the additional distal hub is radiopaque and can therefore be visualized by X-ray or fluorescence fluoroscopy. In these embodiments, the filament may be mostly or entirely nitinol. As described, in the multilobular mesh device 1800 of FIG. 47, the proximal lobe 1802 has a relatively lower porosity than the central lobe 1804 for the purpose of minimizing blood flow in the neck 167 of the aneurysm 160. It may be produced accordingly. The distal lobe 1806 may also have a lower porosity than the central lobe 1804 to prevent rebleeding and / or accelerate healing at rupture site 167. In some embodiments, The central lobe 1804 is constructed from filaments with a diameter larger than either the proximal lobe 1802 or the distal lobe 1806. The structure may allow the central lobe 1804 to provide increased radial stiffness in the central portion of the aneurysm 160, eg, to maintain the position of the multilobed mesh device 1800 within the aneurysm. Any of the three leaves 1802, 1804, 1806 may be constructed of filaments 1814, 1816, 1818 having more than one material and / or more diameter or lateral dimension. In the multilobe mesh device 1900 of FIG. 48, the proximal lobe 1902 may be made with a relatively smaller porosity than the support lobe 1904 for the purpose of minimizing blood flow in the cervical 167 of the aneurysm 160. Good. In some embodiments, the support leaf 1904 is constructed from filaments with a diameter larger than the proximal leaf 1902. The structure may allow the central lobe 1904 to provide increased radial stiffness in the central portion of the aneurysm 160, eg, to maintain the position of the multilobed mesh device 1900 within the aneurysm. One of the two leaves 1902, 1904 may be constructed of filaments 1910, 1912, having more than one material and / or more diameter or lateral dimension. It may be prepared with a porosity of less than 4. In some embodiments, the support leaf 1904 is constructed from filaments with a diameter larger than the proximal leaf 1902. The structure may allow the central lobe 1904 to provide increased radial stiffness in the central portion of the aneurysm 160, eg, to maintain the position of the multilobed mesh device 1900 within the aneurysm. One of the two leaves 1902, 1904 may be constructed of filaments 1910, 1912, having more than one material and / or more diameter or lateral dimension. It may be prepared with a porosity of less than 4. In some embodiments, the support leaf 1904 is constructed from filaments with a diameter larger than the proximal leaf 1902. The structure may allow the central lobe 1904 to provide increased radial stiffness in the central portion of the aneurysm 160, eg, to maintain the position of the multilobed mesh device 1900 within the aneurysm. One of the two leaves 1902, 1904 may be constructed of filaments 1910, 1912, having more than one material and / or more diameter or lateral dimension.
0139FIG. 52 illustrates an embodiment of a multi-leaf mesh device 2000 with proximal leaf 2002 and support leaf 2004 constructed according to an embodiment of the present invention. The multi-leaf mesh device 2000 has a proximal hub 2006 that anchors the proximal end 2012 of the filament 2014 of the proximal leaf 2002, and a proximal of the filament 2020 of the filament 2014 of the proximal lobe 2002 and the distal end 2016 of the supporting leaf 2004. It has a central hub 2008 to anchor the end 2018 and a distal hub 2010 to anchor the distal end 2022 of filament 2020 of support leaf 2004. The multi-leaf mesh device 2000 is releasably secured to the delivery device 2024. The multi-leaf mesh device 2000 was constructed with a relaxed extended diameter D of 7 mm. Proximal lobes 2002 were constructed using a combination of 72 nitinol filaments with a diameter of 0.0005 inches and 72 DFT filaments with a diameter of 0.00075 inches (a nitinol outer shell with a platinum core). Support leaf 2004 was constructed using 54 DFT filaments (Nitinol outer shell with platinum core) with a diameter of 0.00125 inches. After assembly, the multilobe mesh device 2000 was successfully passed through the 0.017 inch diameter medial lumen of the microcatheter 61 (VIA-17 produced by Sequent Medical, Inc. (Aliso Viejo, CA)). In comparison, the standard single-leaf mesh device, which has a length equal to the overall length L of the two leaves 2002, 2004 of the multi-leaf mesh device, is currently unable to pass through the medial lumen of 0.017 inch diameter, Requires a 0.021 inch diameter medial lumen. In fact, the folding profile of the supporting leaf 2004 is about 0.013 inches and the folding profile of the proximal leaf 2002 is about 0.011 inches. In some embodiments, the diameters of hubs 2006, 2008, 2010 are about 0. It is 016 inches. In the multi-leaf mesh device 2000 of FIG. 52, the proximal leaf 2002 may be made with a relatively lower porosity than the support leaf 2004. In some embodiments, the support leaf 2004 is constructed from filaments with a diameter larger than the proximal leaf 2002. The structure may allow the supporting lobe 1904 to provide increased radial stiffness in the central portion of the aneurysm 160, eg, to maintain the position of the multilobed mesh device 2000 within the aneurysm. One of the two leaves 2002, 2004 may be constructed with filaments 2014, 2020, having more than one material and / or more diameter or lateral dimension.
0140FIG. 53-56 illustrates in vitro delivery (simulated use) of a multileaf mesh device 2000 through a microcatheter 61 (VIA-17). The distal tip 69 is shown in each of the four figures. In FIG. 53, the support lobe 2004 begins to dilate when extruded from the distal tip 69 of the microcatheter 61. In FIG. 54, the supporting leaf 2004 reaches its relaxed dilated diameter. In vascular defect 160, the support leaf 2004 may not reach its fully relaxed dilated diameter because the vascular defect itself can apply some compression to the support leaf 2004. In FIG. 55, the proximal lobe 2002 begins to dilate when extruded from the distal tip 69 of the microcatheter 61. In FIG. 56, the proximal lobe reaches its relaxed dilated diameter. In vascular defect 160, the proximal lobe 2002 may not reach its fully relaxed dilated diameter because the vascular defect itself can apply some compression to the proximal lobe 2002.
0141FIG. 57A-58 illustrates an embodiment of a multi-leaf mesh device 2140 having proximal lobe 2142 and distal lobe 2144. The filament 2146 of the proximal lobe 2142 and the filament 2148 of the distal lobe 2144 are secured to each other by the support member 2150. In some embodiments, the proximal hub 2152 anchors filament 2146 of the proximal leaf 2142 at its proximal end 2154. In some embodiments, the proximal leaf 2142 may be constructed similar to and using similar materials as the proximal leaf 1802 of the multi-leaf mesh device 1800 of Figure 45-47. In some embodiments, the distal lobe 2144 may be constructed similar to and using similar materials as the central lobe 1804 of the multilobe mesh device 1800 in FIGS. 45-47. In some embodiments, the distal lobe 2144 of the multilobe mesh device 2140 may be constructed without a hub at its distal end 2155 (Fig. 59). This may be done to protect the dome 161 of the aneurysm (vascular defect 160). Support member 2150 is positioned between the proximal lobe 2142 and the distal lobe 2144.
0142The distal lobe 2144 may have a substantially convex shape at its distal end. Proximal leaf 2142 may have a substantially convex shape at its proximal end. Support member 2150 is located between the distal and proximal lobes 2144, 2142. The dilated states of the distal and proximal lobes 2144, 2142 define the toroidal cavity 2151 through which the support member 2150 extends.
0143In some embodiments, the support member 2150 may include a substantially rigid cylindrical member. In some embodiments, the support member 2150 may include hypotubes. The rigidity of the support member 2150 is such that when the proximal lobe 2142 and the distal lobe 2144 are in their extended configuration, the longitudinal axis 2156 of the proximal lobe 2142 and the longitudinal axis 2158 of the distal lobe 2144 are relative to each other. Can help maintain at a substantially fixed angle. The rigidity of the support member 2150 is substantially mutual with the longitudinal axis 2156 of the proximal lobe 2142 and the longitudinal axis 2158 of the distal lobe 2144 when the proximal lobe 2142 and the distal lobe 2144 are in their extended configuration, respectively. Can help keep parallel to. The rigidity of the support member 2150 is substantial with respect to the longitudinal axis 2156 of the proximal lobe 2142 and the longitudinal axis 2158 of the distal lobe 2144 when the proximal lobe 2142 and the distal lobe 2144 are in their extended configuration, respectively. Can help keep you on the same line. Maintaining alignment between the proximal lobe 2142 and the distal lobe 2144 can aid in the "fitting" of the multilobed mesh device 2140 within the aneurysm. In some embodiments, it can assist in fitting within an aneurysm having a substantially symmetrical shape.
0144In some embodiments, the distal lobe 2144 may have an additional distal hub (thus not having to be made with a grooved mandrel). In these embodiments, the additional distal hub is radiopaque and can therefore be visualized by X-ray or fluorescence fluoroscopy. In these embodiments, the filament may be mostly or entirely nitinol. The resistance to the forces provided by the support member 2150 can limit the effect of "clot compression" as described herein. In the embodiment of Figure 57A-58, the support member 2150 constructed from the hypotube is for both compressive and tension between the proximal end 2163 of the distal lobe 2144 and the distal end 2165 of the proximal lobe 2142. Provides rigid axial support.
0145With reference to FIG. 59, the multilobed mesh device 2140 is shown in a radial constrained state for delivery along the longitudinal axis 2158 through the microcatheter 61. The multi-leaf mesh device 2140 is releasably coupled to the delivery device 2153 at its proximal end 2154. The distal end 2155 of the multilobed device 2140 in its radial restraint corresponds to the distal tip of the distal lobe 2144. The series array 2157 and support member 2150 of the two leaves 2142, 2144 ensure that there is no layer overlap that would increase the profile upon delivery. Thus, the multi-leaf mesh device 21400 may be deliverable through a microcatheter 61 having a small radial constrained profile and a small inner diameter of as small as 0.021 inches and even as small as 0.017 inches.
0146FIG. 60 shows a multi-leaf mesh device 2640 with properties and components similar to those of the multi-leaf mesh device 2140 of FIGS. 57A-59, whereas the support member 2650 of the multi-leaf mesh device 2640 has a coil of 2659. Be prepared. The coil 2659 may be constructed from stainless steel, nitinol, or other suitable material, or may be constructed from a radiation opaque material such as platinum or a platinum alloy. In some embodiments, the coil 2659 provides rigid axial support for compressive forces while allowing some degree of longitudinal separation or elongation between the proximal lobe 2642 and the distal lobe 2644. In some embodiments, the coil 2659 is an expansion spring that applies urging forces between the proximal lobe 2642 and the distal lobe 2644 and pushes them together. When the expansion spring is stationary, the expansion spring is not compressible to a smaller length, that is, each ticket turn of the spring is an adjacent ticket turn at the first and second circumferential points on each ticket turn. Is in contact with. This can assist in the production of the multi-leaf mesh device 2640 and allow the expansion spring to be held in at least a partially expanded configuration, with the distal end 2665 of the proximal leaf 2642 being proximal to the expansion spring. Attached to the end 2667, with at least some space between the spring ticket turns, while the proximal end 2663 of the distal lobe 2644 is attached to the distal end 2669 of the expansion spring. After assembling the expansion springs with the proximal lobes 2642 and the distal lobes 2644, the expansion springs serve to align the proximal lobes 2642 with the distal lobes 2644 and hold them adjacent to each other in the central portion 2673. .. When the multi-leaf mesh device 2640 is placed through a meandering microcatheter, the coil 2659 adds flexibility and therefore less force to push the multi-leaf mesh device 2640 through the microcatheter. I need. Having a coil 2659 as a support member 2650, the multi-leaf mesh device 2640 is also more flexible and has improved safety when delivered into an aneurysm. Permanence may be provided. The multilobe mesh device 2640, which has a coil 2659 as a support member 2650, may also be more easily oriented and aligned within an aneurysm having an irregular shape.
0147Module braid density (BD) as illustrated in FIG.<sub>M</sub>) Is a two-dimensional representation of the area coverage of the filaments in the substantially diamond-shaped module 1008 in the braid. Braid density (BD) as described herein differs from traditional "braided wire density" expressed in number of drives (picks) / inch (PPI) or picks / centimeter. The "braided wire density" is not the ratio of areas, but rather the number of wire intersections within a particular length of the tubular section. The "braided wire density" does not take into account the diameter of one or more wires and is therefore independent of the amount of material coating within an area. Braid density (BD), on the other hand, is specific to the material coverage within an area. The virtually diamond-shaped module 1008 has a two-dimensional area A inside the dashed line in Figure 50D.<sub>M</sub>Is. The substantially diamond-shaped module 1008 is surrounded by four filaments, namely the first filament 1013, the second filament 1015, the third filament 1017, and the fourth filament 1019, in area A.<sub>O</sub>Includes a substantially diamond-shaped opening 1011 with. As further described, the four filaments 1013, 1015, 1017, 1019 may include four individual wires, or, as an alternative, two or more filaments are made from the same wire. May be done. The four filaments 1013, 1015, 1017, 1019 are the first crossing 1023 between the first filament 1013 and the second filament 1015, the second between the second filament 1015 and the third filament 1017. A rhombus at two intersections 1025, a third intersection 1027 between a third filament 1017 and a fourth filament 1019, and a fourth intersection 1029 between a fourth filament 1019 and a first filament 1013. Intersect each other around the opening 1011 of. Area A in diamond-shaped module 1008<sub>M</sub>And area A within the diamond-shaped opening 1011<sub>O</sub>Can each be estimated by the formula for the area of a parallelogram (height is perpendicular to the base, the base multiplied by the height). Each of the four dashed lines in FIG. 61 is centered between two outer ranges of filament transverse thickness (eg, filament width or circular filament diameter). Therefore, the area A of the diamond-shaped module 1008<sub>M</sub>Is the area A of the diamond-shaped opening 1011<sub>O</sub>And the area of half the thickness of each of the four filaments 1013, 1015, 1017, 1019 surrounding the diamond-shaped opening 1011. As described, two or more filaments may have different thicknesses from each other, or all may have the same thickness. Module braid density calculated in a single module (BD<sub>M</sub>) Is as follows: BD<sub>M</sub>= (A<sub>M</sub>-A<sub>O</sub>) / A<sub>M</sub>In the formula, A<sub>M</sub>Is the area of the diamond-shaped module, A<sub>O</sub>Is the area of the diamond-shaped opening.
0148In an embodiment of a braided tubular member having a fixed diameter, fixed circumference, and fixed number of filaments, how sparsely or densely the number of diamond-shaped modules 1008 that fit within the fixed circumference is formed. Regardless, it does not change. Therefore, the module width 1084 remains the same size regardless of how loosely or densely the braid is formed. However, the module length 1086 becomes shorter when the braid is formed more densely, and the module length 1086 becomes longer when the braid is formed more sparsely. During braiding, the filaments 1015 and 1017 intersect while the angle 1082 and the angle directly opposite the angle 1082 change to adapt to this change in module length 1086 without a change in module width 1084. Filament 1013 and filament 1019 slide over each other at 1025 and slide over each other at intersection 1029. Along with this, the filaments 1013 and 1015 swivel relative to each other at the intersection 1023 and the filaments 1017 and 1019 swivel relative to each other at the crossover 1027, while the angles 1078 and directly opposite the angle 1078 change. For example, as the braid is more tightly ticketed, the angle 1082 and the angle 1082 directly opposite both increase, while the angle 1078 and the angle 1078 directly opposite both decrease. Moreover, as the braid is more sparsely ticketed, the angle 1082 and the angle 1082 directly opposite both decrease, while the angle 1078 and the angle 1078 directly opposite both increase. Note that the angle 1082 in braid terminology will be twice the "braid angle".
0149An increase or decrease in module length 1086 with a change in braid "density", used with a constant module width 1084, does not change with changes in the number of modules in a circumferential "row" at angles 1078, 1082. , Means that the number of modules in a certain axial "column" changes. Cylindrical braid density (BD<sub>C</sub>), The numerator and denominator of all module braid densities in a cylindrical area with k modules must be summed together and then the following ratio must be obtained. BDC = Σ (AMk-AOk) / Σ (A)<sub>M</sub>k) k = 1,2,3, ...., n In the formula, A<sub>M</sub>Is the area of the diamond-shaped module, A<sub>O</sub>Is the area of the diamond-shaped opening.
0150Module Braid Density (BD) across a specific portion of a braided tubular member or a mesh device made from a braided tubular member<sub>M</sub>) Fluctuates to some extent, the cylindrical braid density (BD)<sub>C</sub>) May be calculated. Variable module braid density (BD)<sub>M</sub>The first example of) is the module braid density (BD)<sub>M</sub>) Is the longitudinal axis Z<sub>L</sub>The transition part 1003, which increases or decreases along. Variable module braid density (BD)<sub>M</sub>The second example of) is the module braid density (BD)<sub>M</sub>) Decreases toward the outer radius of the mesh device and the center or longitudinal axis Z of the mesh device<sub>L</sub>A mesh device having a spherical or spherical shape that increases toward. The major braid density (BD) within the braid portion located near the maximum flow into a vascular defect such as an aneurysm is assumed to be the braid density (BD) at the most dilated diameter. Braid density (BD) is essentially because the effective diameter (and thus the circumference) is reduced, thus leaving less space for the same number of filaments 1005, and thus reducing the module width 1084 for each module. It becomes larger toward the central axis of the mesh device.
0151In some embodiments of the mesh device, the mesh device is a braided tubular member having at least two distinctly different braided portions 1002, 1004 so that the mesh device itself can have at least two distinctly different braided portions. Formed from. One of the main objectives of having at least two braided portions is a winding path in which the more loosely braided portions are diametrically constrained for intraluminal delivery of the microcatheter 61. While it may be mechanically easier to provide a more flexible device for delivery through, a more tightly braided portion, for example, a tightly braided portion may be an aneurysm or other blood vessel. It can be more effective in blocking blood flow when placed in the neck or opening of a defect. As the second braided portion 1004 is braided more tightly (ie, with an increased angle 1082 and a decreased angle 1078), resistance to flow through the diamond-shaped opening 1011 increases. The flow through the diamond-shaped opening 1011 is the hydraulic diameter (D), which is a theoretical circular diameter that exhibits the same flow characteristics as the diamond-shaped opening 1011.<sub>H</sub>) Can be characterized by 1033. Hydraulic diameter (D<sub>H</sub>) Is typically used to represent flow through various non-circular lumens or openings such as the diamond opening 1011. This is because the non-circular opening can have a low flow zone such as the low flow zone 1088 within the diamond-shaped opening 1011. Hydraulic diameter (D<sub>H</sub>) Is as follows. D<sub>H</sub>=(4<sup>X</sup>A<sub>O</sub>) / P<sub>O</sub>In the formula, A<sub>O</sub>Is the area of the diamond-shaped opening, P<sub>O</sub>Is around the diamond-shaped opening. Braid density (BD) may be used to compare one portion of a braided tubular member to another portion of the braided tubular member. Braid Density (BD) is also the longitudinal axis Z of the braided tubular member<sub>L</sub>It may be used to compare the portion adjacent to the most expanded compartment within the same portion of the braided tubular member. Braid Density (BD) is a second division of one part of a mesh device constructed from a braided tubular member with another portion of the mesh device constructed from a braided tubular member, for example the most extended section of the first part. May be used to compare with the most extended section of the part. As described, the most dilated compartment of the part intended to obstruct the flow (eg, in the neck of the aneurysm) is the effectiveness of obstructing the flow in the worst case high flow locations. Related to predicting. The braid density may also be expressed as the average (ie, average, median) of several different parts of the braided tubular member of the mesh device made from the braided tubular member. The braid density may also be expressed as the average of measurements of the same portion of a mesh device constructed from several braided tubular members or braided tubular members.
0152(Thromctomy) Figures 62 and 63 illustrate a thrombectomy device 2400 with a self-expanding structure 2402 at its distal end 2404. Patients with ischemic stroke often have blood clots that block blood flow to parts of the brain. Removal of these blood clots can allow recovery of symptoms and can even save lives. The self-expandable structure 2402 has a configuration that is secured to an extension shaft 2406 and is radially constrained for delivery through a microcatheter or sheath, and an expansion configuration (as shown in FIGS. 62 and 63). .. The self-expanding structure 2402 includes a cylindrical engagement structure 2408 and a capture structure 2410. The cylindrical engagement structure 2408 is configured to engage the thrombus within its boundaries, the capture structure 2410 is located at the distal end of the cylindrical engagement structure 2410, and when the thrombus removal device 2400 is removed from the patient. , Constructed to maintain a thrombus trapped within the cylindrical engagement structure 2408.
0153Cylindrical engagement structure 2408 has a distal end 2415 and a proximal end 2416, some wires 2412, in some embodiments about 10 to about 18 wires, or about 12 wires. Formed from. In some embodiments, the cylindrical engagement structure 2408 is formed from nitinol wire. In another embodiment, the cylindrical engagement structure 2408 is made of cobalt-chromium alloy or stainless steel. In some embodiments, the lateral dimension or diameter of the wire is from about 0.0008 inches to 0.0035 inches, or from about 0.001 inches to about 0.003 inches, or about 0.002 inches. In some embodiments, the wire 2412 is incorporated herein by reference in its entirety, either manually or by reference for any purpose, by Marchand et al., U.S. Pat. No. 8,261,648, "Braiding Mechanism and Methods." of The cylindrical engagement structure 2408 may be formed by the use of automatic or partially automatic braiding devices and processes such as the braiding devices and processes described in Use. The wire 2412 is secured at the distal end 2415 of the cylindrical engagement structure 2408 by the distal hub 2414 and at the proximal end 2416 by the proximal band 2418. Referring to FIG. 63, the cylindrical engagement structure 2408 includes wires 2412a-p, which are mutually ticketed with a series of twists 2420a-N, N = total number of twists 2420. In FIG. 63, the twist 2420 is shown as one full roll or 360 °, but the cylindrical engagement structure 2408 of various embodiments (eg, two full rolls, one and half rolls). ) May be used for other parameters. By varying the number of turns, the length L of each twist 2420<sub>T</sub>May be varied. Length L<sub>T</sub>May range from about 0.25 mm to about 3 mm, or about 0.35 mm to about 1 mm, or about 0.5 mm. Following a particular wire 2412b from a location near the distal end 2404 and moving proximally, the wire 2412b is ticketed with wire 2412a to twist 2420f. The wire 2412b is then ticketed around the twist 2420b with the wire 2412c. The wire 2412b is then ticketed around the twist 2420c with the wire 2412e. With a full (360 °) turn, the wire 2412b continues to follow the general spiral pattern when it is ticketed with the other wire 2412. Other wires, such as the 2412a and 2412e, follow a common spiral pattern, but in the opposite direction of the common spiral pattern of wire 2412b. In some other embodiments, the twist may be varied with respect to the total number of turns, eg, half-roll increments, which allows the formation of various other structures. In some embodiments, the braid angle β is the longitudinal axis Z.<sub>L</sub>It may be varied along the length of. The braid angle β, extending from the twist (eg 2420b), is half the angle between the two twist wires (eg 2412b and 2412c).
0154Since the wire 2412 is held together with the twist 2420, the cylindrical engagement structure 2408 is durable, engages with the thrombus, contacts the vessel wall, and maintains its expanded shape as it is pulled through the vessel. The capture structure 2410 may comprise a braided mesh structure comprising filaments 2424 that are secured at their ends by the distal hub 2414 and the proximal hub 2426. The braided mesh structure 2422 has a radially constrained configuration for delivery through a microcatheter. In some embodiments, the capture structure 2410 may be located entirely within the cylindrical engagement structure 2408. In some embodiments, the lateral dimension or diameter of the filament 2424 is from about 0.0005 inches to 0.002 inches, or about 0.00075 inches to about 0.0015 inches, or about 0.001 inches. Both the cylindrical engagement structure 2408 and the capture structure 2410 may be thermoformed to maintain their shape. In some embodiments, this may be done at a temperature of about 500 ° C. In some embodiments, the cylindrical engagement structure 2408 and the capture structure may each be thermoformed separately from each other. In some embodiments, the cylindrical engagement structure 2408 and the capture structure 2410 may both be thermoformed.
0155The braided mesh structure 2422 of the capture structure 2410 is for maintaining the thrombus within the cylindrical engagement structure 2408 as the thrombectomy device 2400 is pulled proximally through a blood vessel or another catheter (induction catheter, delivery sheath, etc.). Has an extended configuration (as seen in FIGS. 62 and 63) with a sufficiently high braid density BD. The adaptability of the cylindrical engagement structure 2408 to the vessel wall, combined with the inability of the thrombus to pass through the capture structure 2410, coalesces to create a compartment 2417 that captures the thrombus and reciprocates it proximally. In some cases, the thrombectomy device 2400 is drawn into a microcatheter after being used to remove a thrombus from a blood vessel. In some cases, the thrombectomy device 2400 is only drawn into a larger catheter or sheath after being used to remove a thrombus from a blood vessel. In some cases, the thrombectomy device 2400 is used to remove a thrombus from a blood vessel and then is drawn into a larger catheter or sheath with a microcatheter. Another property of the capture structure 2410 is that in some embodiments, the thrombus is cloted, while allowing normal blood flow at the same time, for example, to allow perfusion of the distal vascular system and terminal tissue. This can be made with a braid density BD so that it can be captured.
0156FIG. 64-67 illustrates a thrombectomy device 2400 in use to remove thrombus 2430 from blood vessel 2428. The catheter 2432 is delivered such that its distal end 2419 is distal to thrombus 2430 or adjacent to thrombus 2430 distal end 2421, as shown in FIG. The 2410 expands and is located distal to the thrombus and is extruded from the catheter 2432 so that the cylindrical engagement structure 2408 expands around the thrombus 2430 and compresses it (Fig. 65). The thrombectomy device 2400 is pulled proximal to the catheter 2432 to capture the thrombus 2430 (Fig. 66) and the thrombectomy device 2400 is removed (Fig. 67).
0157The invention described above has been described in some detail as an illustration and an example for the purposes of clarity and understanding, but it is clear that certain modifications and amendments may be practiced that are still within the appended claims. It becomes.
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| EP3131515A4 | European Patent Office (EPO) | A4 | |
| EP3171793A4 | European Patent Office (EPO) | A4 | |
| US9955976B2 | United States of America | B2 | |
| US2018206849A1 | United States of America | A1 | |
| JP2018130605A | Japan | A | |
| US10136896B2 | United States of America | B2 | |
| US2019192166A1 | United States of America | A1 | |
| US2019223881A1 | United States of America | A1 | |
| JP6594898B2 | Japan | B2 | |
| CN106413590B | China | B | |
| CN111248966A | China | A | |
| JP2020163180A | Japan | A | |
| US10813645B2 | United States of America | B2 | |
| US10939914B2 | United States of America | B2 | |
| US2021106337A1 | United States of America | A1 | |
| US2021275184A1 | United States of America | A1 | |
| JP2022168039A | Japan | A | |
| JP7175638B2 | Japan | B2 | |
| US11678886B2 | United States of America | B2 | |
| US11723667B2 | United States of America | B2 | |
| US2023270441A1 | United States of America | A1 | |
| CN111248966B | China | B | |
| US2023338035A1 | United States of America | A1 | |
| EP3171793B1 | European Patent Office (EPO) | B1 | |
| US12096940B2 | United States of America | B2 | |
| JP7576067B2 | Japan | B2 | |
| US2024398416A1 | United States of America | A1 | |
| US12226102B2 | United States of America | B2 | |
| US2025143709A1 | United States of America | A1 | |
| US2025152177A1 | United States of America | A1 | |
| US12318091B2 | United States of America | B2 | |
| US2025186049A1 | United States of America | A1 |
18 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Written notification of registration of transferJAPANESE INTERMEDIATE CODE: R350R350 | R350 | |
| Request for change of ownership or part of ownershipJAPANESE INTERMEDIATE CODE: R313113S111 | S111 | |
| Receipt of annual feesJAPANESE INTERMEDIATE CODE: R250R250 | R250 | |
| Notification of acceptance of power of attorneyJAPANESE INTERMEDIATE CODE: R3D02RD02 | RD02 | |
| Written notification of registration of transferJAPANESE INTERMEDIATE CODE: R350R350 | R350 | |
| Written request for registration of change of domicileJAPANESE INTERMEDIATE CODE: R313531S531 | S531 | |
| Certificate of patent or registration of utility modelJAPANESE INTERMEDIATE CODE: R150R150 | R150 | |
| First payment of annual fees (during grant procedure)JAPANESE INTERMEDIATE CODE: A61A61 | A61 | |
| Written decision to grant a patent or to grant a registration (utility model)JAPANESE INTERMEDIATE CODE: A01A01 | A01 | |
| Decision of grant or rejection writtenTRDD | TRDD | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Report on retrievalJAPANESE INTERMEDIATE CODE: A971007A977 | A977 | |
| Notification of reasons for refusalJAPANESE INTERMEDIATE CODE: A131A131 | A131 | |
| Request for written amendment filedJAPANESE INTERMEDIATE CODE: A523A521 | A521 | |
| Written request for application examinationJAPANESE INTERMEDIATE CODE: A621A621 | A621 |
Numbers
- Publication
- 2017511202
- Application
- 2016562548
Titles2
- Japanese
- 処置的血管手技のためのデバイス
- English
- Device for procedural vascular procedures
Classification
- CPC, 16
- A61B17/12113
- A61B2017/00526
- A61B2017/12068
- A61B17/12031
- A61B17/1214
- A61B2017/00867
- A61B2017/00893
- A61B2017/00898
- A61B2090/3966
- A61B17/12172
- A61B17/12177
- A61F2310/00149
- A61B17/12145
- A61B2017/1205
- A61B17/1215
- A61M2025/0042
- IPC, 1
- A61B17 12
Designated states5
- Regional, 4
- Zimbabwe
- Turkmenistan
- Türkiye
- Togo
- National, 1
- United States of America